Harnessing Openness to Transform American Health Care

Committee for Economic Development

2000 L Street N.W. Suite 700 Washington, D.C. 20036 202-296-5860 Main Number 202-223-0776 Fax 1-800-676-7353

www.ced.org

A Report by the Digital Connections Council of the Committee for Economic Development Harnessing Openness to Transform American Health Care

Includes bibliographic references

ISBN #087186-188-7

First printing in bound-book form: 2008

Printed in the United States of America

COMMITTEE FOR ECONOMIC DEVELOPMENT

2000 L Street, N.W., Suite 700

Washington, D.C., 20036

202-296-5860

www.ced.org Contents

PREFACE BY THE CED RESEARCH AND POLICY COMMITTEE ...... ix EXECUTIVE SUMMARY ...... 1 INTRODUCTION ...... 5 I. THE STATE OF U.S. HEALTH CARE ...... 7 II. THE GENOME ERA—OPENNESS IN BIOMEDICAL RESEARCH...... 9 Th e Human Genome Project’s Open Model...... 9 Some Limits on Openness ...... 11 Recommendations Regarding Openness in Biomedical Research ...... 11 III. OPENNESS REGARDING CLINICAL TRIALS AND POST-APPROVAL SURVEILLANCE ...... 13 Th e Societal Bargain Underlying Clinical Trials ...... 13 Registration of Clinical Trials ...... 13 Data Integrity in Clinical Trials ...... 15 Confl icts of Interest in Clinical Trials ...... 15 Access to Data Produced in Clinical Trials ...... 15 Th e Need for Usable Data ...... 16 Informed Consent for Participation in Clinical Trials...... 16 Informed Consent for the Use of Tissue Samples in Clinical Trials ...... 16 Privacy and Clinical Trials ...... 16 Post-Approval Surveillance ...... 17 Comparative Testing ...... 18 Recommendations Regarding Clinical Trials and Post Approval Surveillance ...... 18 IV. ENCOURAGING OPENNESS IN PUBLISHING/DISCLOSURE OF RESEARCH RESULTS...... 21 Scientifi c and Technical Publishing ...... 21 Limits on Openness in the Present Model...... 21 New Open Alternatives Emerge ...... 22 Th e Advantages of Openness...... 22 Openness and Government-Funded Research ...... 23 Diff ering Models for Openness...... 24 Openness and Academic Advancement ...... 25 Traditional Publishers Respond to New Open Models...... 25 Th e Future of Open Publishing and Disclosure ...... 26 Recommendations Regarding Openness and Publishing and Disclosure of Research Results ...... 26

iii V. OPENNESS REGARDING ELECTRONIC HEALTH RECORDS AND EVIDENCE-BASED MEDICINE ...... 29 Th e Vision of Electronic Health Records ...... 29 Th e Reality of Electronic Health Records ...... 30 Standards ...... 31 Privacy and Security ...... 31 Today’s National Healthcare Privacy Law—HIPAA ...... 32 Recent Privacy Initiatives ...... 32 Electronic Health Records and the Development of Evidence-Based Medicine ...... 34 Recommendations Regarding Electronic Health Records and the Development of Evidence-Based Medicine...... 36 VI. EXPANDING OPENNESS FOR PATIENTS AND CAREGIVERS ...... 37 Changing Ideas About the Role of the Patient ...... 37 Patient Access to Healthcare Information...... 37 Personal Health Records ...... 38 Other Sources of Information ...... 38 Patients as Research Assistants ...... 39 Other Patient Contributions ...... 39 More Informed Health Consumers ...... 40 Greater Openness and Incentives for Improving Healthcare ...... 41 Openness and Caregivers ...... 42 Caregivers and New Sources of Information...... 42 Th e Attentive Caregiver ...... 42 Openness and Information Provided by Caregivers...... 43 Caregiver Conﬂ icts ...... 43 Recommendations Regarding Expanding Openness for Patients and Caregivers ...... 44 VII. OPENNESS AND PUBLIC HEALTH...... 45 Lessons of the SARS Outbreak...... 45 Openness and Contributions from Less Obvious Sources ...... 45 Recommendations Regarding Openness and Public Health ...... 46 VIII. OPENNESS AND MEDICAL DEVICES ...... 47 Changes in Medical Devices...... 47 Th e FDA’s Responsibility ...... 47 Recommendations Regarding the Openness of Medical Devices ...... 48 IX. OPEN BUSINESS MODELS...... 49 Not Invented Here ...... 49 Not Sold Here ...... 50 X. CONCLUSION ...... 51 ENDNOTES ...... 52

iv CED Research and Policy Committee

Chairmen KATHLEEN COOPER CONO R. FUSCO Senior Fellow Managing Partner - Strategic Relationships PATRICK W. GROSS Southern Methodist University Grant Th ornton Chairman Th e Lovell Group W. BOWMAN CUTTER GERALD GREENWALD Managing Director Chairman WILLIAM W. LEWIS Warburg Pincus LLC Greenbriar Equity Group Director Emeritus McKinsey Global Institute KENNETH W. DAM BARBARA B. GROGAN McKinsey & Company, Inc. Max Pam Professor Emeritus of American Founder and Foreign Law and Senior Lecturer, Western Industrial Contractors University of Chicago Law School RICHARD W. HANSELMAN Members Th e University of Chicago Former Chairman IAN ARNOF RONALD R. DAVENPORT Health Net Inc. Chairman Chairman of the Board Arnof Family Foundation Sheridan Broadcasting Corporation RODERICK M. HILLS Chairman ALAN BELZER RICHARD H. DAVIS Hills Stern & Morley LLP President & Chief Operating Offi cer Partner (Retired) Davis Manafort, Inc. EDWARD A. KANGAS Allied Signal Global Chairman & CEO (Retired) RICHARD J. DAVIS Deloitte Touche Tohmatsu LEE C. BOLLINGER Senior Partner President Weil, Gotshal & Manges LLP JOSEPH E. KASPUTYS Columbia University Chairman, President & Chief Executive WILLIAM DONALDSON Offi cer ROY J. BOSTOCK Chairman Global Insight, Inc. Chairman Donaldson Enterprises Sealedge Investments, LLC CHARLES E.M. KOLB FRANK P. DOYLE President JOHN BRADEMAS Executive Vice President (Retired) Committee for Economic Development President Emeritus General Electric Company New York University BRUCE K. MACLAURY W. D. EBERLE President Emeritus BETH BROOKE Chairman Th e Brookings Institution Global Vice Chair, Strategy, Manchester Associates, Ltd. Communications and Regulatory Aff airs WILLIAM J. MCDONOUGH Ernst & Young LLP ALLEN FAGIN Vice Chairman and Special Advisor to the Chairman Chairman DONALD R. CALDWELL Proskauer Rose LLP Merrill Lynch & Co., Inc. Chairman & Chief Executive Offi cer Cross Atlantic Capital Partners MATTHEW FINK LENNY MENDONCA President (Retired) Chairman DAVID A. CAPUTO Investment Company Institute McKinsey Global Institute President Emeritus McKinsey & Company, Inc. Pace University EDMUND B. FITZGERALD Managing Director ALFRED T. MOCKETT GERHARD CASPER Woodmont Associates Chairman & CEO President Emeritus Motive, Inc. Stanford University HARRY FREEMAN Chairman NICHOLAS G. MOORE MICHAEL CHESSER Th e Mark Twain Institute Senior Counsel and Director Chairman, President & CEO Bechtel Group, Inc. Great Plains Energy Services PATRICK FORD President & CEO, U.S. DONNA S. MOREA CAROLYN CHIN Burson-Marsteller President, U.S. Operations and India Chairman & Chief Executive Offi cer CGI Cebiz

v CED Research and Policy Committee

M. MICHEL ORBAN JAMES Q. RIORDAN SARAH G. SMITH Partner Chairman Chief Accounting Oﬃ cer RRE Ventures Quentin Partners Co. Goldman Sachs Group Inc.

STEFFEN E. PALKO DANIEL ROSE MATTHEW J. STOVER Vice Chairman & President (Retired) Chairman Chairman XTO Energy Inc. Rose Associates, Inc. LKM Ventures, LLC

CAROL J. PARRY LANDON H. ROWLAND VAUGHN O. VENNERBERG President Chairman Senior Vice President and Chief of Staﬀ Corporate Social Responsibility EverGlades Financial XTO Energy Inc. Associates GEORGE E. RUPP JOSH S. WESTON PETER G. PETERSON President Honorary Chairman Senior Chairman International Rescue Committee Automatic Data Processing, Inc. Th e Blackstone Group JOHN C. SICILIANO JOHN P. WHITE NED REGAN Partner Lecturer in Public Policy University Professor Grail Partners LLC Harvard University Th e City University of New York

vi Digital Connections Council

Council Chair: JONATHAN FOX Senior Manager, Privacy Governance Committee for Economic Development: PAUL M. HORN Sun Microsystems Senior Vice President, Research (Retired) CHARLES E.M. KOLB IBM Corporation DANIEL J. GREENWOOD President Distinguished Scientist in Residence Founder Stern School of Business, Courant CIVICS.com – Th e Information Age JOSEPH MINARIK Institute of Mathematical Sciences Consultancy Senior Vice President and and the Graduate School of Arts & Director of Research Sciences PATRICK W. GROSS ELLIOT SCHWARTZ New York University Chairman Th e Lovell Group Vice President and Director, Economic Studies RICHARD HOWARD Project Director: Program Manager (Retired) CHARLES JOHNSON Lucent Technologies Inc. Research Associate ELLIOT E. MAXWELL Chief Strategist LARRY JACKEL eMaxwell & Associates North-C Technologies, Inc. Fellow, Communications Program JOHN KOLB Johns Hopkins University Vice President and Chief Information Oﬃ cer Rensselaer Polytechnic Institute

Members: BOB OBEE Chief Information Offi cer CAROLYN CHIN YRC Regional Transportation Chairman & Chief Executive Offi cer Cebiz LARS RABBE Senior Vice President and Chief MICHELLE DENNEDY Information Offi cer Chief Privacy Offi cer Intuit Sun Microsystems MATTHEW J. STOVER IRWIN DORROS Chairman President LKM Ventures, LLC Dorros Associates CHRIS WU REGINALD FOSTER Open Educational Resource Fellow Managing Director Institute for the Study of Knowledge Beacon Equity Partners Management in Education

vii viii Committee for Economic Development Digital Connections Council Harnessing Openness to Transform American Health Care

Preface by the CED Research and Policy Committee CED’s Digital Connections Council (DCC), a group of information technology experts from CED trustee- affi liated companies, was established to advise CED on the policy issues associated with cutting-edge technologies. Th is report, concerning “openness” in healthcare, is the third of its products. CED appreciates greatly the eff orts of the members of the Council, and in particular, the work of DCC Chair Paul Horn, Senior Vice President, Research (retired), IBM Corporation, and Distinguished Scientist in Residence, Stern School of Business, Cou- rant Institute of Mathematical Sciences and the Graduate School of Arts and Science, New York University, for his leadership in bringing this report to completion. Special thanks are also due to Elliot Maxwell, CED’s project director and consultant, to Charles Johnson and Daphne McCurdy, CED Research Associates, for assistance with research, editing, and publication, and to Elliot Schwartz, CED’s Vice President and Director of Economic Studies. Th is report is the work of the Digital Connections Council. We welcome this report and recommend it to readers as an excellent analysis of how the system of healthcare in the United States, and importantly health outcomes, can benefi t from the application of greater openness through digital technologies. Th e recommendations of this report, along with those of CED’s policy statement, Quality, Aff ordable Health Care for All: Moving Beyond the Employer-Based Health-Insurance System, can transform healthcare in the United States by making it signifi cantly more effi cient, accessible, and responsive. Patrick W. Gross, Co-Chair Research and Policy Committee Chairman, Th e Lovell Group

William W. Lewis, Co-Chair Research and Policy Committee Director Emeritus, McKinsey Global Institute McKinsey & Company, Inc.

ix x Executive Summary

Th e Digital Connections Council (DCC) of the healthcare that have been or can be changed by the Committee for Economic Development (CED) has Internet, the continued growth in computing power been developing the concept of openness in a series of and data storage capacity, and the increasing digitiza- reports.1 We have analyzed information and processes tion of information. Th ese technological changes, and attempted to determine their openness based on and the greater openness that they enable, are visible their qualities of “accessibility” and “responsiveness.” in areas that range from biomedical research and the If, for example, information is not available or available disclosure of research fi ndings, through the process only under restrictive conditions it is less accessible and of evaluating drugs and devices, to the emergence of therefore less “open.” If information can be modi- electronic health records, and the development and fi ed, repurposed, and redistributed freely it is more implementation of treatment regimes by caregivers and responsive, and therefore more “open.” Based on their patients. Bringing greater openness to diff erent parts accessibility and responsiveness, information can be of the healthcare production chain can lead to substan- placed on a continuum of openness, stretching from tial benefi ts by stimulating innovation, lowering costs, fully open to fully closed.* reducing errors, and closing the gap between discovery and treatment delivery. Th e Council has found that an increased degree of openness often leads to greater innovation because it We have not exhaustively cataloged the healthcare allows contributions to a work from more individuals arenas that could benefi t from greater openness. We whose diff ering insights and experiences can add have simply tried to show potential benefi ts which can considerable value. But greater openness is not always be achieved with or without a fundamental restructur- appropriate or desirable. In some cases, such as an ing of healthcare in the United States or the achieve- individual’s personally identifi able information, the ment of universality of healthcare insurance. We hope last thing one would want would be to enable someone others can build upon this work. to modify the information without the appropriate authorization. Biomedical Research In other cases greater openness creates new problems. Th e report focuses fi rst on the area of biomedical re- We can, for example, be overwhelmed by the amount search. Th is realm is being transformed by the success of information available on the Internet if we lack the of the Human Genome Project (HGP). By mapping proper tools to evaluate it. It is therefore important the human genome, the HGP demonstrated the to determine, in a particular case, the degree of open- possibilities of mass collaboration and the benefi cial ness likely to bring the greatest benefi t, and the most results of allowing data to be accessed immediately and appropriate way to deal with the problems that greater manipulated by researchers around the world.2 Th e openness may bring. progeny of the HGP have adopted this open model Our goal in this report is to bring the DCC’s expertise and are fl ourishing by sharing data, applications, and in information and communications technology even network resources. Th e Council recommends and electronic commerce to bear on those aspects of that the federal research agencies push further by enunciating clear policies favoring openness,

* Th e accessibility aspect of openness is closely related to “transparency” but openness as we are using it has the additional aspect of responsiveness— permitting people other than the creator to contribute, modify, reuse, repurpose, and redistribute the work.

1 funding further work on standards for protocols, Disclosure of Results and Underlying Data formats, terminology and nomenclature that allow the sharing and manipulation of data, and support- Common to both basic research and clinical trials ing experiments with diff ering levels of openness are issues surrounding what results and what data to determine the optimal level for research under are made public and when? A new concern is how various scenarios. data will be published or disclosed, given the rise of new disclosure models, ranging from the fi ling of human genome sequences in the open GenBank to Clinical Trials new open-access scientifi c and technical journals and Questions about the openness of clinical trials have open-access archives. Th ese outlets pose a serious chal- been raised vigorously over the last decade. Although lenge to the traditional model of publishing research in the Food and Drug Administration (FDA) had long subscription-funded, paper-based scientifi c and techni- required the registration of clinical trials involving cal journals owned by commercial or not-for-profi t life-threatening interventions, there have been disputes publishers. as to the completeness of these registrations—and Th e Council recommends federal support for earlier about the lack of registration of other clinical trials. and expanded accessibility to results and data, and, Advocates of greater openness here and around the more specifi cally, the passage of legislation that world have been concerned not only about registra- would mandate public access to results of most tions, but also about access to trial results and, perhaps unclassifi ed government-funded research no later more important, to the data that underlie the results— than six months after publication. Major govern- and whether the data will be available in a computable ment funders of research should also be receptive to form. requests for funding for the publication of research Because clinical-trial populations do not refl ect the results in open-access journals. broader populations that will later use the intervention—or the length of time that they will use it—many Electronic Health Records adverse eff ects are unlikely to be discovered through clinical trials, raising questions about drug safety and Th e emergence of electronic health records (EHRs) the processes for monitoring drug impacts after ap- raises new openness issues. Utilizing such records, proval. Amendments to the FDA’s enabling legislation caregivers at any location would have access to a pain 2007 addressed these issues in part, but there are tient’s medical history. Results of tests and treatments additional ways in which greater openness can improve could be added easily as they become available, thereby clinical trials and post-approval surveillance. Most im- improving treatment, preventing duplicative testing, portant for improved healthcare research is to make and reducing medical errors. Eventually, EHRs could the trial results and the data underlying trials more be constructed including family medical histories, accessible more quickly in a form that is search- genomic and pharmacogenomic data, environmental able and computable using common standards. In exposures, lifestyle and other information, easing the addition, applicants for FDA approval should be way toward the “personalization” of treatment. Th e required to submit all studies they have conducted aggregation of such records, and others, could then on the intervention with any safety-related results facilitate the achievement of a genuine “evidence-based” being made publicly available. medical system. Such records provide far richer data than clinical trials, and could serve as the basis for pre- Th e system would also be improved by further dictive models similar to those used in other scientifi c strengthening the protections for trial participants, domains. Th e Council recommends that federal ending split federal oversight of trials, and clarifying eff orts to develop standards for an interoperable, the laws regarding tissue donations. Th e Council national EHR system should be given high priority. joins a long list of groups recommending far more comparative testing of drugs to supplement clinical trials that simply compare an intervention’s eff ects with those of a placebo.

2 Privacy and Security consumers; good caregivers should benefi t as poorer performers are weeded out. But information can be But the openness of the EHR that allows more ef- used in harmful ways such as the adverse selection of fi cient collection of more data and permits improved sicker patients or of talented, but less cost-conscious, caregiver access raises fundamental issues of privacy caregivers. Both patients and caregivers can benefi t and security that will tend to limit openness. Who from having vastly expanded access to data, but may will have access to these records and under what also be overwhelmed without appropriate support circumstances? How will the information be used? tools. Who will make these decisions? Whether patients agree to participate in an EHR system may well Th e Council recommends that the federal govern- depend on whether these questions are answered to ment move aggressively to disclose data on the cost their satisfaction. and quality of healthcare providers and procedures, and to monitor and provide fi nancial incentives for Th e Council returned to the theme of the importance compliance with evidence-based, clinical-practice of greater federal support for the infrastructural guidelines. Given the explosion of caregiver- aspects of openness—in this case the development affi liated enterprises that provide patient testing or and implementation of standards that would facilitate treatment, confl icts of interest by caregivers need the creation and exchange of data—as well as incen- to be disclosed. In order to avoid disincentives for tives for the adoption of EHRs. To protect privacy, the use of remote monitoring and telemedicine, the new rules will need to be extended to any entity that federal government should review its reimburse- handles patient-identifi able healthcare information, ment policies and work with the states to address and new resources will be needed to support vigorous confl icting state licensing and malpractice rules. enforcement of privacy and security rules. In order to foster comparative testing of drugs and treatments, Public Health strengthen drug and device safety monitoring, and spur development of evidence-based medicine and Th e global public health system depends on data shar- the generation of clinical-practice guidelines that ing and worldwide collaboration; without it, as seen would bridge the gap between discovery and treat- in the Severe Acute Respiratory Syndrome (SARS) ment, the Council calls for a public-private partner- experience, the lives of millions are threatened. ship to create large databases made up of EHRs, With lower-income countries showing reluctance health-insurance-claims data, and clinical-trial data, to share data and physical evidence, the Council etc., appropriately de-identifi ed to protect patient recommends greater attention to ensuring that all privacy. countries benefi t from discoveries that result from the global sharing of data related to the emergence New Sources of Information for Patients and of new diseases. Better electronic linkages among Caregivers public health agencies, both globally and locally, and a willingness to develop new detection methods, are also Th e Council also looked at aspects of openness related necessary when diseases can spread at the speed of a jet to new sources of information for patients and caregiv- plane. ers. Patients are now able to search through a vast store of health-related information on the Internet Medical Devices (some good, some bad, much irrelevant) and even provide their caregivers with current research. Th ey Greater openness in software-controlled medical can customize their own treatment through shared de- devices creates new opportunities and challenges. Th e cision making with their caregivers, and continuously history of practitioner innovation in scientifi c instru- contribute data through the use of remote-monitoring ments and the infi nite malleability of software suggest equipment. With greater access to information about the potential for a dramatic increase in practitioner- the quality and costs of procedures and practitioners, driven customization of such devices. At the same patients can become more responsible healthcare time, the FDA continues to have responsibility for assuring the safety and effi cacy of these devices and has

3 justifi able concerns about post-approval changes made improve the evaluation of interventions in clinical trials to them. Th e Council recommends that the FDA through patient-outcomes reporting. When game begin an examination of how to benefi t from the hunters in Cameroon provide samples to public health user-driven innovation while maintaining appropri- researchers on the lookout for disease outbreaks we are ate oversight for safety and effi cacy. witnessing greater openness. Openness is ultimately about an attitude that sees the opportunity for many Conclusion to benefi t from greater access to information, as well as to contribute much to the benefi t of us all. One point should be made explicit. Some readers might approach this report thinking it is about health- Greater openness is likely to become increasingly care and information technology—and there have been important in more and more areas driven by the a number of excellent reports on that subject.3 But relentless progress of information and communications openness, while facilitated by information technology, technology. We off er these recommendations with should not be equated with it. Th e benefi ts of greater the hope that modest changes based on greater access openness can be found when a caregiver is more to information by more people, and more possibilities attentive to a patient’s story and does not stop listen- for them to contribute based on their own expertise ing prematurely in order to narrow down potential and energy, can help improve healthcare in the United diagnoses. Greater openness is what allows us to States and around the world.

4 Introduction

Th e progress of scientifi c and technological knowledge is creators—they too, as Sir Isaac Newton wrote, “stand a cumulative process, one that depends in the long-run on the shoulders of giants.”* on the rapid and widespread disclosure of new fi ndings, Th e cycle of innovation is thus continuously sustained. so that they may be rapidly discarded if unreliable, or An equitable and eff ective intellectual property system confi rmed and brought into fruitful conjunction with other must take into account both fi rst creators and those bodies of reliable knowledge.” who come later to build upon their work. - Paul David4 Th e U.S. intellectual property system allocates rights between a fi rst creator and those who would utilize that creation for another work. Economists have For the last several years the Digital Connections pointed out that if the rights of the fi rst creator are Council (DCC) of the Committee for Economic De- extended too far there may be too little room left velopment (CED) has been documenting the growing for follow-on innovation which falls outside the fi rst impact of the Internet on innovation. Its fi rst report, creator’s control. Th is would result in the “underpro- Th e Digital Economy: Promoting Competition, Innova- duction” of follow-on innovation. If the rights of fi rst tion, and Opportunity (2001), provided an early gauge creators are reduced too much, there may be too little of how strongly the Internet was aff ecting the economy fi nancial incentive to spur additional creative activity, a few years after the development of the World Wide resulting in the underproduction of fi rst creations. Web and the release of the fi rst commercial browser. Th e Council noted that for over 200 years the United Th e Council’s second report, Promoting Innovation States has been able to maintain a reasonable balance and Economic Growth: Th e Special Problem of Digital between the rights accorded fi rst creators and follow- Intellectual Property (2004), addressed an important on innovators. Th e fi rst creator has more rights in the consequence of the increasing digitization of informa- early years after he or she creates the work. Eventually tion and the global spread of Internet connectivity: the the scales are tipped toward follow-on innovators when tension between the virtually free copying and distri- the work enters the public domain, freely available to bution of information products enabled by digitization all. Th e Council found that the Internet, even with the and the Internet and the growing concern among capabilities it provides for misappropriation of works, intellectual property rights holders over the misappro- has not so changed the environment as to justify a priation of their works. Because of this tension—and dramatic expansion of the rights of fi rst creators (with proposed legislation and regulatory responses to it— a concomitant lessening of the rights of follow-on the Council began to look more deeply at the process innovators). After reviewing the technology and the of innovation in the increasingly digital environment of law, the Council concluded that the existing balanced the early 21st century. allocation of rights had proven itself suffi ciently fl exible Innovation, the Council noted, involves both fi rst to accommodate the emergence of new technologies creators and follow-on innovators, with the latter vastly such as the player piano, phonograph, radio and outnumbering the former. But fi rst creators are almost television broadcasting, and tape and CD recording, always follow-on innovators to some previous fi rst

* Hundreds of years before Newton, Bernard of Chartres made the same point when he remarked, “We are like dwarfs standing upon the shoulders of giants, and so able to see more and see farther than the ancients.”

5 and that it should also be able to accommodate the rise Th is theory of value based on sharing focuses on of the Internet. Th e Council therefore rejected a call follow-on innovators. It is closely connected to the for vastly greater protections for rights holders and rise of the Internet, which allows more effi cient access opposed technological mandates that would seek to to the fi rst creation and more effi cient contribution of enforce those rights in every manner of digital device. suggested modifi cations. Th is ability to have access and to make changes (responsiveness) is how we defi ne In its next report, Open Standards, Open Source, and what we call “openness.” Open Innovation: Harnessing the Power of Open- ness (2006), the Council documented the growing Th e Council concluded that both theories of value— importance of open standards in the information and one based on exercising control and restricting communications technology arenas and their value in access, the other based on encouraging access and increasing competition and stimulating innovation. modifi cation—have places in the system of innovation. Th rough an analysis of the operations of the open- It noted that follow-on innovators had historically source software development community, the Council played an important role in innovation—such as in showed the many diff erent motivations that lead developing many of the popular modifi cations of the individuals to voluntarily contribute their time and fi rst automobiles—and that the open-source software eff ort and to share their creative acts. movement, with its emphasis on follow-on innovation, was consistent with a long history of innovation in Th e Council also recognized the emergence of a theory America and around the world. What the Internet has about how sharing one’s creation freely with others changed is the ability to provide access and responsive- provides a means of adding value to it. Traditional ness, and therefore to stimulate global collaboration on theories of intellectual property identify the principal a mass scale. Th is capacity to allow millions of people incentive for creative activity as coming from the eco- to work together and to contribute their own expertise nomic returns that might be obtained by the creator. has been observed by others who have labeled it an To obtain these returns, the rights holder must be able “architecture for participation,” the “read-write Web,” to control the creation so as to be able to charge for or “Web 2.0.” access and obtain compensation for the creative eff ort. Th e system of intellectual property rights and licenses For this report, the DCC decided to look at how provides the means for such controls. “openness” was being or might usefully be employed in the healthcare arena. Th is area, which now constitutes Th e open-software movement also utilizes intellectual approximately 16-17 percent of GDP, has long frus- property rights and licenses. Th e underlying premise trated policymakers, practitioners, and patients. It was of open software, however, is the mirror image of the the Council’s desire to bring its expertise in informa- traditional view that value is based on allowing control tion and communications technology to bear on issues by the rights holder and facilitating the exclusion of in healthcare using the “lens” of openness to comple- others. Open-source licensing is designed instead ment other work on healthcare being done under the to facilitate creative acts by others based on the as- auspices of the CED.* Th us, the aim of this report is sumption that the value of the original work can be to identify areas where greater openness is likely to increased most by encouraging the greatest number of increase innovation, minimize costs, improve treat- follow-on innovators to contribute to it. Open-source ments, reduce errors, and shorten the interval between intellectual property licenses prohibit anyone from research and discovery and the development of clinical restricting access to, or preventing the modifi cation of, practices based on research results. Th e following the original work. report is the result of the Council’s deliberations.

* Committee for Economic Development, Th e Employer-Based Health-Insurance System is Failing: What We Must Do About It (Washington D.C.: CED, 2007).

6 Chapter 1: The State of U. S. Health Care

Th e patient is in crisis. Th ere have been many reports on what is wrong with healthcare in the United States. What follows are not Th e symptoms are clear. suggestions for radical change. Th ey are examples of But there is no widespread agreement on how to specifi c and limited reforms that, in their cumulative proceed. impact, could be transformative. Th ey are changes that are occurring, or could occur reasonably easily, Th at is healthcare in the United States in 2007 when: utilizing the power of the Internet and an approach • We spend far more than any other industrialized that looks at all procedures and processes for improve- nation—according to the OECD more than twice ments based on two considerations: 1) will this be as much as the median of its members—while improved by providing greater access to information; having the lowest longevity rate; 5 and 2) will this be improved by allowing a broader group to be able to add their contributions through • Little more than one-half of patients receive care the modifi cation, repurposing, and redistribution of based on best medical practices;6 information? In other words, are there ways in which • Less than one-half of physicians practice using we can make parts of healthcare more “open” and allow recommended processes for care;7 the power of openness to aff ect it as it is aff ecting— and benefi ting—almost every other aspect of our • Only one-quarter of medical practices are based on world? adequate evidence of their effi cacy;8 Th ere are several reasons why we have not seen more • $3.5 billion a year is wasted on medication errors, openness in healthcare. As many have remarked, while 1.5 million patients are hurt by them;9 we have no healthcare “system.” Th e marketplace is extraordinarily fragmented among individual and in- • Most drugs prescribed in the United States stitutional players. Th e player that pays almost half of today are eff ective in only 60 percent of treated the costs, the federal government, does not fully exploit patients;10 the data it possesses and rarely exercises its power as a • 30 percent to 40 percent of every healthcare payer to improve the quality of healthcare. Increased dollar—some two trillion of them or roughly access to information is viewed as threatening by those 16-17 percent of GDP—is spent on costs associ- who now control the information, criticized by others ated with “overuse, underuse, misuse, duplication, for allowing adverse selection to maximize profi ts, system failure, unnecessary repetition, poor and condemned as potentially compromising patient communications and ineffi ciency;”11 privacy and security. Some licensed professionals may resist greater participation by others they consider less • We spend six times as much for administration as 12 qualifi ed. Th e tensions between the need for intel- any other nation. lectual property protection and controlled access to Healthcare in the United States in the 21st century is stimulate innovation and the potential gains from the pre-industrial in organization. It is a combination of widespread availability of information are becoming leading-edge science, practitioners organized in guilds increasingly clear when the consequences may be life or similar to those of the Middle Ages, operating within death. jurisdictional boundaries determined in the 18th and th th We may have assumed in the past that information 19 centuries with a 20 century payment system. should be held tightly unless there was a good reason

7 to provide access to it. As a thought experiment we might instead assume that information can be shared and improved unless there is a good reason for restricting access or controlling modiﬁ cations. What follows is an exploration of how such greater openness might beneﬁ t healthcare in the United States and the world in 2007 and beyond.

8 Chapter 2: The Genome Era—Openness in Biomedical Research

Just weeks before the 50th anniversary of Watson haplotypes (HapMap), which describe variations in the and Crick’s article describing DNA’s double-helix human genome that tend to occur together in “neigh- structure, scientists produced a fi nished sequence of borhoods” or haplotypes.18 Data about the genotype of the human genome, launching “the genome era.”13 the individual haplotypes is being released publicly as Th e mapping of over 3-billion base-pairs was an soon as it is identifi ed. Th e openness of the HapMap extraordinary accomplishment that at the same time eff ort is reinforced by its use of a licensing system that demonstrated the power of an open and collaborative is “self-consciously modeled on the ‘copy-left’ system model of discovery that has become a paradigm for of open-source software licensing” and which prevents modern database-oriented biomedical research. those who utilize the date from attempting to close it to others via patents.19 The Human Genome Project’s Open Model Utilizing the results of the HapMap process, a public- Like the race to discover DNA’s structure, the search private partnership, the SNP Consortium, is identify- for the human genome sequence was very competi- ing panels of a few hundred thousand single-nucleotide tive. Celera, a private-sector fi rm led by Craig Ventor, polymorphisms (SNPs) that can be used to identify sought to be fi rst to establish the sequence while, common variants in an individual’s entire 3-billion as was the norm, keeping much of its data private, base-pair genome that might be associated with a to be made available on commercial terms to other disease.20 As with the HapMap project, participants researchers. In contrast, the publicly funded Human in the consortium have agreed to put the data they Genome Project (HGP) followed an open model produce in to the public domain.21 making its data publicly available and welcoming input In the reasonably near future, according to Dr. Francis from around the world. HGP pushed participating Collins, leader of the National Human Genome researchers to disclose their fi ndings as quickly as pos- Research Institute (NHGRI) in the National In- sible.14 While Celera made important contributions to stitutes of Health (NIH), the HapMap should help the sequencing, it was the HGP’s model of discovery make practical case-controlled studies using SNP’s that has transformed the research process by reducing to identify gene variants that “contribute to diabetes, “transaction costs and secrecy that may impede follow- heart disease, Alzheimer disease, common cancers, on research.”15 mental illness, hypertension, asthma, and a host of Th e HGP researchers not only put raw sequencing other common disorders.”22 Th at future seems nearer data into the public domain, but as the “data were than ever today with scientists fi nding correlations being produced, an open-source software program between diseases such as multiple sclerosis and breast known as the distributed annotation system (DAS) cancer and specifi c genetic variations.23 was set up to facilitate collaborative improvement In the area of “chemical” genomics the National and annotation of the genome.”16 Th is allowed any Institutes of Health (NIH), as part of its “Roadmap” researcher to choose the annotation they wanted to process, has established a network of chemical genom- view and enabled the ranking of annotations by the ics centers available to all researchers, as well as a new number of researchers that used them, something akin database, PubChem, that makes much of the data to Google’s methods for ranking search results.17 generated by the centers freely accessible. Today’s Th is open model is now being used in a feder- drugs target only about 500 of the more than 20,000 ally funded international eff ort to create a map of genes in the human genome considered “druggable”

9 even though pharmaceutical researchers have created is publishing its data on the Web; all the participants libraries of hundreds of thousands of potentially have agreed to disavow intellectual property rights in useful compounds.24 Th e open tools established by their research.32 NIH should help researchers identify new targets for Similarly the National Cancer Institute (NCI) of the research. NIH has established caBIG, the Cancer Biomedical Among the legacies of the HGP are the development Informatics Grid—a network for cancer research made of pharmacogenomics, the study of the relationship up of over 50 cancer-research centers and 30 other between pharmacological substances and genomic data organizations that voluntarily share data, tools, ap- and epigenomics, the study of proteins that control plications, and infrastructure.33 It has also established, gene activation.25 Eventually research in these areas among other initiatives, the Cancer Gene Data Cura- will help determine which patients will benefi t from tion Project which has created a database of associa- which drugs as well as those likely to have adverse reactions between genes and diseases and genes and drug tions, enabling practitioners to give the right medicine compounds, the National Cancer Imaging Archive at the right time in the right amount to the right which provides an image archive to assist in the devel- patient. We are already benefi ting from improved opment of tools to detect and classify lesions, and is predictions of the need for chemotherapy in certain planning a Clinical Research Information Exchange breast cancers and the potential for adverse reactions as a common electronic infrastructure linking those in particular patients to warfarin, a commonly used developing biomedical therapies and those overseeing medicine to prevent blood clotting.26 Such research the drug development and approval process.34 NCI has also identifi ed a drug that had been written off for is also addressing the underappreciated need for the most lung-cancer patients but which now appears to creation of standards necessary for data exchange by be potentially lifesaving for a small number of patients supporting the development of a standardized clinical with a particular genotype.27 vocabulary for cancer. Th e velocity of discovery is likely to revolutionize the Among international organizations, the World Health development and use of pharmaceutical agents. Most Organization has created www.TDRtargets.org, a drugs prescribed today have positive impacts on fewer publicly accessible Internet-based clearinghouse of than 60 percent of those receiving them.28 If we knew genetic information on such diseases as malaria and more about who would benefi t and who would be African sleeping sickness. Th e clearinghouse is provid- harmed, we could provide more eff ective therapies ing this genetic data on often-neglected diseases to with less risk, reduce the length, size and expense assist researchers in identifying genetic targets for new of clinical trials (all of which are tied to the risk of interventions.35 adverse events), and get more valuable treatments to Th ese more open approaches stand out in contrast to a market sooner.29 Th e value of pharmacogenomics will tendency in biomedical research to become “increasing- only increase as the cost of sequencing an individual’s ly proprietary and secretive” because of the importance genotype continues to decline, the number of cost- of such data for potential commercial applications or eff ective diagnostic tests increase, and genomic data because of competition among academics for prestige become part of medical records as is now happening and career progress based on journal publication.36 In in some leading-edge healthcare providers such as the response to this “privatization of data,” and to harness Mayo Clinic and the Kaiser-Permanente system.30 the power of openness to speed the development of Refl ecting the openness of the HGP, the National medicines and vaccines for less lucrative commercial Institute of General Medical Sciences has funded markets, the Bill & Melinda Gates Foundation is now grants intended to make “resources available for inde- conditioning its grants to require researchers to share pendently funded scientists to form research teams to their results promptly so that rival teams can build on solve a complex biological problem that is of central successes, avoid pitfalls, and eliminate redundancy.37 importance to biomedical science…and that would Th ere is growing agreement on the value of increased be beyond the means of any one research group.”31 openness in pre-competitive research; the broad Th e Alliance for Cell Signaling, one of the grantees,

10 participation of for-profi t and not-for-profi t entities crafted under which the data holder agrees to respond in the SNP consortium is an example of open pre- to queries from qualifi ed researchers utilizing the data competitive research at work.38 But there remains a they control but will not share. considerable tension between those who seek intellec- It is clear, however, that the open model of progress tual property protection for research results and those through sharing has found great resonance in the bio- who advocate greater disclosure. Th e disputes are not medical research world. Even Craig Ventor of Celera, theoretical. Many genes have already been patented. a vigorous proponent of the privatization of genomic A number of biomarkers are tied up by restrictive data, has recognized this. He literally has been sailing patent-licensing agreements.39 And patents cover tools the seven seas gathering and classifying organisms. critical for future research.40 Rather than charging for access to the data, he is mak- Th e HGP dealt with the patent issue from the top ing it available to all through the open-access Public down and participants agreed to forego patent protec- Library of Science (PLoS).43 tion. Other collaborative eff orts have chosen diff erent paths including defensive patenting (with non-exclusive Recommendations Regarding Openness in licensing to prevent other parties from appropriating Biomedical Research research results and using them in patent applications) Th e leading federal research agencies should continue and defensive publishing to thwart patent claims.41 their support for open models of research, whether entirely publicly funded or in public/private partner- Some Limits on Openness ships, such as the Human Genome Project, the Complete openness of data is neither easy to accom- HapMap Project, or the SNP Consortium, and should plish nor necessarily the best answer in all cases. Much enunciate policies with a strong preference for utilizing work still needs to be done to establish standards for the most open models, particularly in pre-competitive protocols, formats, terminology and nomenclature that research. will allow data to be combined easily. Th e integrity of Experiments with diff ering levels of openness should existing data must be protected. Th ere may be privacy continue as appropriate, but greater openness should issues that limit accessibility as well as disputes over be preferred absent strong countervailing interests. ownership and control of data. Th ere are public policy questions about the wisdom of allowing free-and-open Because the absence of agreed upon standards for access to, for example, databases of pathogens.42 And protocols, formats, terminology, and nomenclature there are contentious issues to be addressed about the undercuts the ability of researchers to share data in its eff ects of openness and sharing in diff erent parts of most usable form, the leading federal research agencies the production chain on incentives to develop com- should increase their support for the development of mercially viable products. Given all these issues it is these infrastructural underpinnings of openness. not surprising that models with varying degrees of openness are being tested. Th e leading federal research agencies should continue to require data-sharing agreements from recipients Not all of the NCI’s program participants, for of federal support and should, to the greatest extent example, provide all their data to any and all comers. possible, encourage recipients to share results and Certain materials produced with NCI support are underlying data generated by the research. shared only with participating cancer researchers. In other cases, where participants in NCI programs are reluctant to give up control over data they have collected or generated, an innovative solution has been

11 12 Chapter 3: Openness Regarding Clinical Trials and Post-Approval Surveillance

In 2003 Andrew von Eschenbach articulated the Our society recognizes a moral obligation not to do challenge of closing the gap between basic research and harm to others. Any intervention on a participant in a the development of clinical and public health interven- clinical trial presents some level of risk, so some off set- tions. We have seen the impact of greater openness in ting benefi t is expected. Society will thus authorize an basic research. How could the processes of approving entity to conduct a clinical trial, with its inherent risks drugs and devices and the monitoring of the eff ects of borne by the individual participants, in exchange for these interventions after approval benefi t from being the potential benefi ts from the drug or device as well as made more open? the knowledge that is gained from the trial. Th e value to society as a whole is directly related to the knowl- The Societal Bargain Underlying Clinical Trials edge generated and its availability. To obtain U.S. Food and Drug Administration (FDA) Th is societal bargain does not always work as intended. approval for a drug or device, the intervention must be Over the last decade, many questions have been raised tested on humans as part of a multistage-clinical trial about the registration of trials, the transparency of in which the intervention is compared for safety and their conduct, as well as the accuracy and accessibility effi cacy with a placebo. A clinical trial such as this of their results and the data they produce. Recent is considered “the gold standard” for human testing headlines, for example, reveal examples of fraudulent and generates the evidentiary basis for applications results and raise questions as to whether results for FDA approval. Some 10,000 clinical trials are have been selectively reported with negative, even conducted every year. life-threatening, evidence suppressed.45 Research has shown a strong publication bias favoring the disclosure Approval by the FDA does not require that the of favorable results and disfavoring the disclosure intervention be without risk. Both risks and benefi ts of negative trials or negative outcomes.46 Studies must be considered, as the FDA’s decision can have reveal that research results and disclosures appear to profound consequences. When approval is denied or be aff ected by the fi nancial interests of researchers delayed those who might have benefi ted are harmed; and sponsors; research supported by entities with a when approval is granted, or granted before the risks fi nancial interest in the outcome reported signifi cantly are understood, those who can benefi t from the inter- higher positive outcomes than research supported by vention are rewarded but some suff er adverse eff ects. neutral parties.47 Th e FDA attempts to fi nd the right balance, but given the state of our knowledge, the attempt is as likely to Registration of Clinical Trials resemble art as much as science. Registration of clinical trials in the United States Until 2007, FDA rules required the registration of has been very uneven, despite the FDA’s regulatory clinical trials only for interventions dealing with requirements; there is little evidence that the FDA has serious or life-threatening illnesses.44 (Many trials that made any signifi cant eff ort to determine if its require- did not meet these criteria have been registered at the ments were met.48 In some cases, requirements for same location: www.clinicaltrials.gov.) Th e registration registered trials were met only 3 percent of the time.49 requirement was not only pragmatic—other researchers should know whether a drug or other intervention In an attempt to address the incompleteness of clinical- has been studied—but principled. trial registrations, the editors of some of the world’s most prestigious biomedical journals jointly published

13 a statement in September 2004 that their journals Proponents of earlier disclosure noted that many trials would not publish fi ndings based on clinical trials that never progress to these later stages; there were good were not registered. Analysis following the editors’ reasons to disclose the results of early stage trials, even announcement demonstrated a spike in compliance those deemed to have “failed.”55 Th ere is no convinc- with registration requirements, at least arguably due to ing justifi cation, they argued, to waste scarce research the importance, both scientifi cally and commercially, resources on work already done, and there may well be of publication in these journals.50 (We discuss issues important data gathered on the safety (and effi cacy) regarding publication/disclosure in Chapter 4.) of interventions in the earliest stages.56 Proponents of early and full disclosure point to the peer-reviewed An extensive examination of the issues surrounding Journal of Negative Results in Biomedicine and PLoS clinical-trial registrations, including what data should Clinical Trials, which publishes trial results irrespec- be disclosed and when, has taken place over the last tive of the outcomes, as proof of the scientifi c value of several years in Geneva under the auspices of the learning from what does not work.57 (One can imagine World Health Organization (WHO) International that at least some participants in clinical trials would Clinical Trial Registry Platform.51 Th e WHO began have second thoughts about their participation if they an eff ort to establish a universal set of minimum data knew that the results might be kept secret.) requirements for clinical trials based on the need of researchers to have access to the broadest possible After completion of its consultation, the WHO’s In- array of compatible data and to increase the effi ciency ternational Clinical Trials Registry Platform rejected of clinical research by preventing unnecessary duplica- the arguments for delayed disclosure, noting the wide tion.52 Th e WHO also sought to provide guidance to variation in disclosure practices about trials among lower-income countries facing an increasing number trial sponsors and the availability of information about of clinical trials within their jurisdictions and lacking the trials from other sources.58 It called for the “regis- well-developed regulatory structures. At the same tration of all interventional trials, including early-phase time, major private-sector sponsors of clinical trials uncontrolled trials in patients or healthy volunteers” were attempting to harmonize clinical-trial reporting and for “full public disclosure of all registration data requirements around the world in order to reduce the items at the time of registration and before recruitment costs of complying with diff ering regimes. of the fi rst participant.”59 Although the aims of the WHO were broadly shared It is beyond the scope of this paper to answer defi ni- among the various stakeholders, and the fi nal list of tively the core questions as to the impact of the data- twenty data elements to be required for registration disclosure requirements proposed by WHO’s Inter- were largely agreed to, the various stakeholders were national Clinical Trials Registry on innovation and ultimately unable to reach agreement as to when trials how the impact might vary based on the timing of the would have to be registered and when certain data disclosures. A number of countries adopted the WHO elements would have to be disclosed. Th e principal requirements, although the United States initially took argument against early disclosure was that “prema- a diff erent path, with the FDA arguing that it did not ture” disclosure would stifl e innovation. Premature have the authority to impose such requirements.60 disclosure, it was argued, would alert competitors who Congress recently passed and the President has signed might use the data for their own patent applications. It the Food and Drug Administration Amendments Act would hinder companies in their eff orts to obtain intel- of 2007 (hereinafter referred to as the 2007 Amend- lectual property protection and to commercialize the ments) which requires the registration of all clinical tri- products being tested, thus reducing their incentives als and the fi ling of all results in a results database; the for research.53 Private-sector trial sponsors suggested FDA is to study what disclosures should be required.61 postponing registration until the initiation of larger, Given the complexity of the issue, it would be helpful if later-stage trials (stages III and IV), and placing the a neutral and expert party such as the National Acad- data that is generated in escrow with an independent emy could conduct a public study, specifi cally with third party to be disclosed at the time of the approval input from the FDA and NIH, on the optimal timing of the drug or device.54

14 of disclosures of registrations and results, considering Data Integrity in Clinical Trials the potential impacts on innovation, the progress and Th ere have recently been allegations of fraudulent data effi ciency of biomedical research, and patient safety. being incorporated into reports on clinical trials and Th e 2007 FDA amendments did not resolve all of the of abuse of clinical data by sponsors.63 Such actions important issues about openness in clinical trials. We fundamentally undercut the value of clinical trials believe that the following steps would further improve and strike at the heart of the drug and device approval the utility, safety and effi cacy of clinical trials: processes. Although present regulations appear to permit the reporting of fraudulent data to be delayed • Th e existing registry, www.clinicaltrials.gov, until approval is sought for the drug or device being should be continued and strengthened, as it is the trialed, legislation should make clear that evidence that largest and most advanced clinical-trial registry in would lead a reasonable researcher to conclude that it the world. Any results database should build upon is likely that clinical trial data has been fraudulently this infrastructure and existing trial records. altered should be reported immediately.64 • Each trial should be issued a unique identifi er To further safeguard the integrity of clinical trials, so that the trial can be tracked through various any agreements that limit the ability of researchers to reviews and over time. As more and more trials freely discuss their fi ndings, particularly with respect are taking place internationally a solution that to potential problems, should be disclosed. Th e has each registry issuing its own unique identifi er legitimate goal of protecting proprietary information is unlikely to be the best long-term solution. A can not justify a “gag order.” more appropriate solution might be found in the WHO’s plan to issue a Universal Trial Reference Confl icts of Interest in Clinical Trials Number for all trials worldwide; another possible solution would be to use some variant of the Recent research strongly suggests that the conduct and Internet’s domain name registry system. reporting of clinical trials can be aff ected by fi nancial interests.65 With private sector funding playing a • Companies seeking FDA approval for an interven- larger role in support of research, and with growing tion are not required to fi le all the studies that ties between academic researchers and commercial they have conducted regarding that intervention, enterprises, it is important to disclose potential just those conducted for purposes of obtaining confl icts so that those who rely upon these studies can approval. Th e vast majority of other, non-fi led, make more informed judgments about them. Here, as studies are never published. All company studies in other areas, “sunlight is the best disinfectant.”66 of the agent should be made available to the FDA, decreasing any incentive to submit only the most favorable; any study relevant to the agent’s safety Access to Data Produced in Clinical Trials should be publicly available. Similarly the FDA Even more contentious than the issues surrounding should consider providing access to any FDA registration of clinical trials and reports of results is studies it conducted during the approval process. the issue of access to the underlying data generated by • Th ere is still much to be learned about how to the clinical trials. Such data are not generally available measure trial outcomes. NIH is now building even after the trials are completed and the drugs or a pilot results database with information from devices approved; in fact, the data can be protected by NIH-funded trials. Th e National Library of law for an additional period of time after the FDA has 67 Medicine is funding TrialBank, which will provide acted. open access to computable trial results.62 Based on Th ese data may well still be of value to the trial’s spon- the experience with these databases, it should be sor. But their value to the research community at large possible to make more informed judgments about is likely to be even greater. Moreover, even if the data what data should be made available and when, and are disclosed the sponsor does not lose all of its benefi ts what conditions would maximize the utility of the having had a multiyear head start in analyzing the data data. and preparing itself to act upon that analysis.68

15 The Need for Usable Data clinical trials in which they might participate, as well as providing information that can help them make de- Researchers now read journal articles about the results cisions about whether to enroll. Th is resource should of trials in hard copy or in Microsoft Word or PDF continue to be enhanced as the 2007 Amendments are fi les and generally lack access to the underlying data. implemented. But, as one student of clinical trials has noted, computers don’t read journals, they process data. Imagine the Informed Consent for the Use of Tissue added value to a researcher of access to the underlying Samples in Clinical Trials data from a journal article. Th en imagine the added value to society of a searchable database containing the Almost three-quarters of trials submitted to the aggregated data underlying multiple clinical trials. FDA are based on the use of patient-tissue samples.74 Th e willingness of patients to provide such samples Th e present situation is in stark contrast. Most of the in the future is crucial for the success of biomedical data from applications to the FDA lies in a “bottomless research, and there are signs of a growing reluctance pit,” and “is not cataloged, tagged, or in any usable on the part of individuals to provide samples without form that would allow it to be found.”69 compensation when the samples might be used by In the past, the FDA has not required that applica- others for commercial purposes without any benefi t for tions be submitted in electronic form or specifi ed the donor.75 Here too there are no general rules, and data formats.70 Ultimately, policymakers will have the law is unclear. Th e expert federal agencies should to determine what types of data from clinical trials make recommendations as to the appropriate balance ought to be disclosed and when, but it is increasingly between the rights of donors and the needs of research- important that if data are made available they should ers, including what kinds of disclosures of risks and be in a searchable computable form—interoperable benefi ts are required, and what would constitute at both a semantic and syntactical level—allowing for informed consent. interpretation both statistically and medically.71 Th is Ideally the patient should be informed of all the uses is no easy task. It will require signifi cant eff orts to that will be made of the donation. But it is obviously reach agreement on the appropriate standards, but the diffi cult to predict all the uses—remember that scien- potential gains are enormous. tists recently used tissue samples obtained during the great fl u epidemic of 1918 to better understand the Informed Consent for Participation in Clinical potential for future pandemics. Even so it is important Trials to be open about existing plans and to consider care- No matter how important the trial, the protection of fully whether additional consent should be required in the patient must be a central concern. To ensure that the future, and under what circumstances. the rights of patient participants in clinical trials are Given the extraordinary pace of developments in protected, it is important that they have access to and genomics, pharmacogenomics and related fi elds, the understand the conditions of participation, the risks FDA should consider whether DNA samples should involved, as well as the potential benefi ts, and any be requested as a matter of course from all clinical-trial potential confl icts of interest. Th ere are no general participants, especially as the cost of sequencing an rules that apply to clinical trials and, surprisingly, there individual’s genome falls. Eventually, it seems likely is no single federal agency with authority over them.72 that genomic data will be an important component of Given recent examples that suggest that participant the data produced by any well-conducted clinical trial. consent has been less than informed, it would be helpful for expert federal agencies to help craft gener- Privacy and Clinical Trials ally applicable rules regarding consent.73 In addition, those who recruit participants should make clear any Participants in clinical trials have important privacy fi nancial stake they have in such recruiting. interests and should be confi dent that information about them is not disclosed to unauthorized parties or Th e website www.clinicaltrials.gov now provides useful used for purposes to which they have not consented. information for those seeking to identify relevant

16 Expanded collection of genomic data would only Th ese processes have not always worked as intended. increase the privacy stakes. Recent litigation raises the As many as thirty-fi ve percent of the post-approval issue of whether privacy protections can be maintained studies mandated by the FDA may never have been when the results of clinical trials are subpoenaed.76 fi led or completed as required.80 Th e Inspector Gen- Policymakers should carefully examine how to protect eral of the Department of Health and Human Services the privacy of clinical-trial participants while ensur- (HHS) reported that the FDA did not know the fate ing that appropriate information is made available in of these studies and made little eff ort to follow up.81 related litigation. If personally identifi able information Th e Institute of Medicine has called for a better system is disclosed, either to unauthorized parties or pursuant of adverse-event reporting.82 And more major drugs to legal order, trial participants should be notifi ed. have been withdrawn from use in recent years than at any time since 1990.83 Post-Approval Surveillance Th e 2007 Amendments greatly increase the availabil- While properly conducted and reported clinical trials ity of information regarding post-approval surveillance are the “gold standard” for determining the eff ect of monitoring. Th ey grant new powers to the FDA an intervention on the trial population during the trial regarding post-approval studies—such a study, for period, clinical trials have important limitations. Th ey example, served as the basis for the 2007 re-evaluation are very expensive. Th ey take a substantial amount of Avandia—as well as post-authorization reporting.84 of time to complete. More important, it is not clear Some 449,000 adverse events were reported in 2006. whether they are truly generalizable or eff ective in Many experts believe this represents only a small predicting safety and effi cacy over longer periods of percentage of actual problems.85 Th e 2007 Amend- time by larger groups of users. ments direct the FDA to contract with private-sector Clinical-trial populations have been justifi ably criti- entities, such as healthcare providers or insurers, to cized for not adequately refl ecting the much larger use massive databases (100 million records or more) of populations, particularly minority and older popula- patient records to identify possible safety issues related tions and those with multiple medical conditions, who to drugs and devices.86 Advocates for such a use of will ultimately use the intervention if it is approved.77 massive databases believe that it will facilitate the Th e relatively limited durations of trials do not allow earlier discovery of adverse eff ects from drugs such as them to predict long-term adverse results or demon- Vioxx.87 (We will discuss the use of such databases in strate long-term eff ects.78 It is not surprising then evidence-based medicine in Chapter 5.) that the exposure of a drug or device to a much larger Additional steps may be desirable. Th e FDA should population with much greater individual variation consider creating incentives for the reporting of adverse for a much longer period of time will sometimes lead events, broadening the means by which interested to unpredicted consequences; these include not only parties can report them, and increasing access to the adverse events not foreseen at the time of approval but reports that are received.88 also the development of evidence of effi cacy in treating conditions that had not been the subject of the trial. Greater disclosure raises issues such as the potential for misinterpretation of reports and the gaming of Recognizing these limitations of clinical trials, the FDA processes by competitors. But these possibilities FDA has often required, as a condition of approval, are outweighed by the gains from having the active post-authorization follow-up studies. Th e agency participation of patients and practitioners who experi- has also established a system, MedWatch, to receive ence adverse reactions on medicine’s front lines.89 reports on post-approval adverse events.79 In response Practitioners are already seeing the benefi t of using the to reports of adverse events, the FDA has convened Internet to share such reports with each other, without expert advisory councils to make recommendations waiting for FDA action, in order to improve their own about changing drug labels, imposing new conditions practice of medicine.90 on use, or even ordering drugs off the market.

17 Comparative Testing NIH should continue its work to increase the availability of the results of clinical trials, starting with As one expert put it, for a new drug to be approved the results of trials funded by the federal government. by the FDA it “must merely be slightly better than Th is work should inform any FDA decision on the (the) placebo in achieving a surrogate outcome over appropriate conditions for disclosure of data generated a few months, in modest numbers of highly selected by clinical trials as well as on standards to improve the patients.”91 Is this really all we need to know? utility of such data for biomedical research. Billions of dollars are spent each year on groups of To assist the FDA in setting requirements for clinical drugs that act in similar ways. For caregivers and trials and approving drugs and devices, the National patients to make more informed decisions, they need Academy should be commissioned to conduct a study to know whether one intervention is superior to and prepare recommendations as to the nature and another for a particular patient or group of patients. timing of clinical-trial registrations and disclosures of Such information does not normally emerge from the data generated by clinical trials and other submissions FDA’s drug approval process. Individual companies to the FDA, based on the impact on innovation, the are unlikely to undergo the expense of conducting progress and effi ciency of biomedical research, and rigorous comparative trials. If healthcare resources are patient safety. not infi nite and if better, more cost-eff ective care is the goal, we should identify the best possible sources for Th e National Academy should be commissioned to comparative testing and fund them accordingly. conduct a study on the state of the existing law regarding the rights of patients and the use of their tissues HHS’s Agency for Healthcare Quality and Testing or fl uids in biomedical research, including issues of and the NIH Center for Transitional Medicine may be consent, privacy, and payment, and make recommen- equipped to conduct such studies but they are inad- dations as to whether changes are required. equately funded to undertake such eff orts. In a recent report the CED suggested the creation of a new entity, Th e FDA should review existing requirements as to the Institute for Medical Outcomes and Technology patient consent to participate in clinical trials and Assessment, which would “assess the eff ectiveness, make changes as appropriate. Th e bifurcated authority cost, and overall value of health interventions and prac- in this area should be ended. tices.”92 Whatever the vehicle, rigorous comparative Th ose recruiting participants for clinical trials should assessments are both critical and largely unavailable to be required to disclose any fi nancial interest in the caregivers and patients alike. recruitment. Recommendations Regarding Clinical Trials Th e FDA should consider whether to require DNA and Post-Approval Surveillance samples to be taken of participants in clinical trials when the price of individual sequencing declines Support for the government’s leading clinical trials to a level where mass sequencing can be done cost database (www.clinicaltrials.gov) should be enhanced eff ectively. so that it will include all clinical trials in the United States, whether publicly or privately funded, as well Th e FDA should require electronic fi ling for all drug as information useful for individuals searching for and device approvals. Th e Agency should set stan- relevant clinical trials and guidance for those seeking dards for and require the fi ling of data in a form that to participate in them. allows subsequent machine aggregation, search, and manipulation. Th e United States should work to promulgate a universal clinical-trial reference-number system so that Th e FDA should require the fi ling of all studies that an clinical trials may be more readily tracked globally. applicant has commissioned on a drug or device that is being submitted for approval, whether or not the study

18 was commissioned as part of the application. Any studies refl ecting safety issues should be made public. Th e FDA should consider making public any studies that it conducts in the course of a drug or device approval. Th ose conducting clinical trials should be required to report to the FDA, upon detection, any instances that would reasonably suggest the use of fraudulent data. Th e FDA should require disclosure of any limitations on researchers’ ability to comment on clinical trials with which they are involved. Th e FDA should require reporting on the progress of all required post-approval studies. FDA should broaden the means by which post-approval adverse events can be reported and should make the reports more widely available. Th e FDA should encourage the disclosure of post- approval data indicating the effi cacy of interventions for non-approved purposes. Th e federal government should dramatically increase its eff orts to directly compare the safety and effi cacy of similar drugs and devices.

19 20 Chapter 4: Encouraging Openness in Publication/ Disclosure of Research Results

Scientifi c and Technical Publishing the research itself would allow outright fraud to be caught.) Scientifi c and technical journals are the traditional vehicles for disclosure of results of basic research and A recent explosion of corrections and retractions in clinical trials. Scientifi c-and-technical publishing is leading journals confi rms these limitations. A New a major commercial activity with industry revenues York Times headline captures the problem: “For upward of $7 billion annually.93 It is estimated that Science Gatekeepers, A Credibility Gap.” Th e article some 2.5 million research articles are published each which bears this headline roots some of the problems year in over 24,000 peer-reviewed journals.94 Most of in both organizational and very human terms: “eco- these journals are owned by commercial publishers, nomic pressures for journals to avoid investigating although some of the most highly regarded and widely suspected errors, the desire to avoid displeasing the distributed are published by not-for-profi t “learned authors and the experts who review manuscripts, and societies” such as the American Chemical Society. the fear that angry scientists will withhold the manuscripts that are the lifeline of the journal putting them Th ere is a hierarchy of scientifi c-and-technical pub- out of business.”97 lications. For researchers in both the for-profi t and not-for-profi t sectors, publishing in a leading journal is Limits on Openness in the Present Model important for advancement as well as to gain attention for one’s work. Th ere are, from the standpoint of openness, three serious problems with the traditional journal-publishing Most journals only publish articles that have survived system. Th e fi rst is that the costs of subscriptions or a “peer-review” process with the most prestigious licenses have been rising, putting them out of the reach being the most selective. Th e peer-review process has of many subscribers.98 Prices for subscriptions have anonymous experts in the appropriate fi eld review a climbed four times faster than the rate of infl ation in submitted manuscript and make recommendations the recent past, increasing some 300 percent over the as to whether it merits publication and, if so, what last twenty years, leading some institutions to cut back changes would improve it. on their subscriptions, thus reducing access to cutting- Th is process has a long history and many admirable edge research results.99 Researchers in poorer coun- attributes. At its best it provides free and valuable tries are most at risk, having to rely on the generosity assistance to journal editors, allowing them to receive of others, including the WHO’s HINARI program, an unvarnished critique from an expert in a fi eld about which provides free or almost-free access to journals for which they may know little. It may detect analytic or many poorer countries.100 If researchers do not have methodological errors, raise design issues, challenge access to the results of others’ work, it is far more likely assumptions, point to overlooked research, prevent that they will duplicate it, and it is a certainty that they duplication, and discourage cronyism by the editors. cannot build upon it. On the other hand, the process, as applied, has signifi - Th e second problem is that the intellectual property cant limitations that are sometimes overlooked.95 It rights that protect the content and underlying data does not serve as an independent check on the integrity of many of the journals prevent those researchers of the underlying data or the processes by which data who do have access from doing what researchers are collected. It may not reveal even extensive fraud.96 are most skilled at—adding to, revising, modifying, (Only access to the data and a chance to replicate repurposing, and reusing the content to generate new

21 knowledge. Some of these actions might be possible as quickly as possible (for many reasons, both public under today’s intellectual property rules, but research- spirited and private-interest enhancing). Harnad ers without access to underlying data may be prevented showed how electronic archiving could achieve these from making use of new and powerful computational aims. Researchers would no longer have to rely exclu- techniques such as machine aggregation and manipula- sively on intermediaries such as journal publishers but tion of data. could—and should, according to Harnad—create publicly accessible digital archives of their own works.103 Finally, as has been true in other areas where information is being digitized, journals are increasingly provid- Th e potential for open-access publishing—moving ing electronic versions under license. Th ese licenses beyond depositing preprints into archives to Web- may cut off a subscriber’s access immediately and even based publications unconstrained by subscription limit access to older collections, include some, but not requirements or paper-based publishing formats—was all, of the journals that had previously been available, bolstered by pioneering journals from the Optical So- and prevent researchers from transferring journals to ciety of America in 1997 and the Institute of Physics in new institutions if they change employers. Th e practice 1998 and later by the larger-scale and more ambitious that some large multi-journal publishers employ of Public Library of Science. Open-access publishing has providing discounts to subscribers who take a “bundle” increasingly been endorsed by academics and policy of publications to ensure access to one or two “must- makers. As the Budapest Initiative put it in 2002, “An have” journals tends to increase the larger-publishers’ old tradition and a new technology have converged to share of an institution’s subscription budget, threaten- make possible an unprecedented public good.”104 ing smaller-journal publishers and learned societies. The Advantages of Openness New Open Alternatives Emerge Th ere is no generally agreed-upon defi nition of open- But digitization and the Internet have done more than access publishing but some elements are constant—the create the opportunity for publishers to put journal removal of cost barriers imposed by subscription and content in a digital lockbox. Th ey have created new licensing fees, and any other conditions on access.105 means for providing “open access” whether via open Proponents of open-access publishing claim that more digital archives or alternatives to the traditional- than 2,500 open-access journals now exist, providing journal regime in the form of “open-access” publishing. clear benefi ts over traditional subscription-based paper publications.106 In launching the Public Library of In 1991, Paul Ginsparg created “arXiv” as an open Science’s open-access journal PLoS Biology, Patrick digital archive for preprints (now often called e-prints) Brown, Michael Eisen, and Harold Varmus explained in physics.101 Submissions poured in. ArXiv has why they believed they were making the information expanded to include mathematics, computer science, they would publish more valuable: and, most recently, quantitative biology and now holds over 400,000 e-prints.102 Some academics, particularly Freeing the information in the scientifi c those outside of physics and mathematics, have resisted literature from the fi xed sequence of pages and posting their materials to arXiv and other open the arbitrary boundaries drawn by journals or archives because of a concern that journals might not publishers—the electronic vestiges of paper accept their manuscripts if the materials had already publication—opens up myriad new pos- been deposited in an open archive; ironically, by not sibilities for navigating, integrating, ‘mining’, posting they substantially delayed wider access to their annotating and mapping connections in the fi n d i n g s . high-dimensional space of scientifi c knowledge. Consider how the open availability and free- In 1994, Stevan Harnad broadened the debate about dom to use the complete archive of published open-access science. His “subversive proposal” rested DNA sequences in the GenBank, EMBL, on an obvious fact—researchers, particularly academic and DDBJ databases inspired and enabled researchers, have a tradition of sharing, and want to get scientist to transform a collection of individual their results to as many of their colleagues as possible sequences into something incomparably richer.

22 With great foresight, it was decided in the important issues. But this is not one of them. Open- early 1980’s that published DNA sequences access journals, like traditional journals, are typically should be deposited in a central repository, in peer reviewed. And to the extent that open-access a common format, where they could be freely journals provide access to data underlying their articles accessed and used by anyone. Simply giving they provide a means superior to traditional peer scientists free and unrestricted access to the review for replicating research and detecting fraud. raw sequences led them to develop the powerful methods, tools, and resources that have made Open access in fact can provide new methods for the whole much greater than the sum of the evaluating materials. Having material available to individual sequences. Just one of the resulting anyone creates a vastly greater number of potential software tools—BLAST—performs 500 tril- “reviewers” in the form of readers of the article. All of lion sequence comparisons annually! Imagine these potential “post-publication peer reviewers” can how impoverished biology and medicine track comments and changes, and comment accord- would be today if published DNA sequences ingly, thereby creating an annotated version that would were treated like every other kind of research not otherwise exist.112 publication—with no comprehensive database searches and no ability to freely download, Openness and Government-Funded Research reorganize, and reanalyze sequences. Now imagine the possibilities if the same creative A special case of open access concerns disclosure of the explosion that was fueled by open access to results of government-funded, non-classifi ed research. DNA sequences were to occur for the much Th e OECD Ministerial of 2004 focused on this issue; larger body of published scientifi c results.107 this led to a 2007 OECD Recommendation Concern- ing Public Access To Research Data from Public Th e Public Library of Science, an admittedly inter- Funding, which notes the benefi ts of improved access ested party, has published several papers attempting to to, and sharing of, data in terms that could be applied compare the performance of open-access models with well beyond publicly funded research: 113 those of traditional publishing. Th ese studies found that there were higher rates of citation for online open- • Reinforces open scientifi c inquiry, access materials during the early months of availability • Encourages diversity of analysis and opinion, when only subscribers to traditional journals would have had access to non-open access articles. More • Promotes new research, encouraging to open-access advocates were the fi ndings • Makes possible the testing of new or alternative that the positive gap in citation rates continued after hypotheses and methods of analysis, six months when formerly restricted articles were made more broadly available.108 Th e research also suggests • Supports studies on data-collection methods and that a broader, more cross-disciplinary audience used measurement, the open-access materials.109 Th is is particularly encouraging because research has found that scientists • Facilitates the education of new researchers, working together with those in diff erent fi elds are more • Enables the exploration of topics not envisioned by likely to solve scientifi c problems.110 the initial investigators, and Certain advantages are inherent in open-access • Permits the creation of new data sets when data publishing. Open-access publishing can reach more from multiples sources are combined.114 people because more people have access. More people can reach-open access materials more quickly than can Th e OECD Recommendation, citing a U.S. National reach articles available only in traditional journals. Research Council Report, states: “Th e value of data lies in their use. Full and open access to scientifi c One traditional-journal editor criticized open-access data should be adopted as the international norm for publishing because “substandard science could be the exchange of scientifi c data derived from publicly widely circulated without being subjected to more funded research.”115 Open access should be “easy, rigorous peer review.”111 Greater openness does raise

23 timely, user-friendly, and preferably Internet based.”116 publishing model. In addition to the pure open-access Such a regime, according to the Recommendation, not journals, the principles of open access are being only “helps to maximize the research potential of new implemented in journals that provide open access digital technologies and networks, but provides greater to some articles and not others (hybrid open-access returns from the public investment in research.”117 journals), or that provide open access after some delay following publication (delayed open-access journals). Following the OECD’s lead, the European Com- Open-access principles are also being furthered in mission has agreed to provide millions of dollars in diff erent forms in blogs, wikis, e-books, listserves, and funding to support the creation and maintenance of fi le-sharing systems. An Autism Wiki, for example, an open-access digital repository.118 CERN, Europe’s managed by adults with autism and Asperger’s syn- leading high-energy physics organization, announced drome, publishes information on autism and related that it will only publish the results of its supercollider conditions.125 trials in open-access publications.119 Th ere are also many economic models being proposed In the United States, the National Institutes of Health to support open-access publishing.126 Th e most com- have taken the lead in pushing for broader disclosure mon funding model is that of the author paying the of the fruits of government-funded research. NIH journal the cost of publication. Fee waivers would has “recommended” that funding recipients “submit be possible for those unable to pay. Wellcome Trust an electronic version of the author’s fi nal manuscript advocates a variant of the “author-pays” model, under upon acceptance for publication,” although NIH which the funding organization would pay for publica- policy does allow the author to designate a timeframe tion with disclosure/publication being considered as for public release anytime within 12 months of fi nal simply another phase of the research project.127 publication.120 Th is recommendation, explicitly not a requirement, has largely been ignored, with fewer than It is not yet clear whether incorporating the cost of 5 percent of grantees complying.121 Like NIH, the disclosure/publication into research grants would, as NSF requires that grantees provide a data-sharing plan critics charge, reduce the total amount of research that but has not required “open access” to the results of its is supported in the long run; running PubMedCentral funded research.122 costs NIH approximately 0.02 percent of its budget. But it is possible that if NIH grant budgets were Th e proposed Federal Research Public Access Act, declining, adding even small amounts of publication introduced in 2006 with both liberal and conserva- costs into grant budgets might cumulatively reduce the tive support, would require that unclassifi ed research number of NIH grants. funded by any U.S. government agency that makes research grants totaling more than $100 million annu- Other models include foundation support, advertiser ally would have to be made public within six months support, and subscription support by research-oriented of publication.123 Conservative supporters of the institutions, which would allow researchers from the legislation who might have been expected to champion subscribing institution to publish in the journal—a private-sector publishers argued that the research was form of “co-op” journal.128 Another model would have paid for by taxpayers who should not have to pay twice commercial entities charged for access while maintain- by having public institutions pay for journal subscrip- ing open access for not-for-profi t entities and inde- tions. Th e House and Senate appropriations bills pendent researchers. Like the open-source software (funding NIH) include a similar provision for access community, the open-access publishing community is within 12 months, but passage of the Public Access exploring a wide range of activities to support its mis- Act would highlight the policy of greater openness sion, ranging from print sales and value-added research with respect to government-funded research.124 services to the conduct of related conferences and the establishment of electronic marketplaces. Differing Models for Openness Among the many unknowns about the relatively Just as there is no agreement as to the precise new area of open-access publishing is whether any of defi nition of open access, there is no one open-access these models are economically sustainable. Th ere are

24 confl icting analytic studies. Th e Wellcome Trust, a on their career prospects. Will some peer-reviewed, long-time open-access champion, commissioned several open-access journals (such as those of PLoS) achieve studies that showed that open-access publishing was the prestige of Nature or Science?133 Will they be 30 percent cheaper than traditional publishing.129 shown to have a high impact in their fi eld? How will Indeed, most open-access publishers have reduced tenure committees, made up of senior academics (who costs by embracing “lean-publishing” methods and free may play major roles in learned societies), react to a open-source publishing tools.130 Traditional publishers colleague’s choice to publish in an open-access journal? have countered with other studies showing that open- Will new models of recognition for scholarship— access publishing is at least as costly, if not more so, based on the number of citations, number of times than traditional publishing. Elsevier has argued that downloaded, BioMed Central’s “most viewed” designa- higher education in the United Kingdom would have tion, or the amount of data generated or annotated— to pay 30 percent to 50 percent more to cover the costs begin to substitute for more traditional methods of imposed by author-pays publishing models, given the judging an article’s worth? Will scholarly journals growth of research.131 Th ese disputes about sustain- and tenure committees give recognition to work in ability are likely to be resolved only by the passage of database science which utilizes immediate web posting time. of data? (Currently researchers who immediately post their results must forego traditional publishing because Another argument raised against open-access publish- traditional journals generally do not accept already- ing is that it will eventually reduce the volume of disclosed work.) research as publishers, particularly learned societies, will reduce or eliminate their publishing activities. Arti Rai, who has written widely on the issues sur- Many learned societies depend on journals to support rounding open science, has suggested that a major their other activities and might be forced to fi nd other step forward would be for a prestigious peer-reviewed revenue streams or cut back their activities. Whether journal in the biomedical arena to confront the issue competition from open-access journals will force the of academic competition by committing not to dis- closing of these journals is yet to be seen. But research criminate against articles analyzing data already made good enough to be published in learned-society publicly available.134 journals seems likely to fi nd a place in new journals or expanded old journals, open access or not. Traditional Publishers Respond to New Open Models Openness and Academic Advancement Traditional journals have responded in diff ering ways A more important issue today may be that of prestige. to the new open-access models. Some are becoming For academic researchers, many rewards—appoint- open-access hybrids, providing authors, whom they ments, promotions, tenure, access to research support, would otherwise have published under traditional reputation within their scholarly community—depend rules, with the option to pay the cost of publication on publication. Th e greatest rewards usually go to and eliminate any period of exclusivity.135 Some, those who publish in the most prestigious journals. such as Nature, and publishers Blackwells, Oxford While academic researchers may support the goal of University, and Springer, have shortened the period of advancing science and may obtain personal satisfaction exclusivity that they impose, sometimes to as little as from working collaboratively with their peers, they six months. understand the realities of academic advancement. Even six months may be conservative. In 2001, the Th ey realize they are competing with others for future American Society for Cell Biology began providing publication glory and, like all of us, want recognition of free access to all articles published in their journal, their work.132 Molecular Biology of the Cell, two months after initial Some academics, particularly more junior ones, may release based on an analysis that showed that the fi rst well be concerned with the eff ect of publication in an two months were the critical period for citations of the open-access journal (as opposed to a traditional one) article, and thus should be the period of exclusivity.136

25 Other traditional publishers are actively hostile to the meta-data—subject, author etc.—are made accessible open-access publishing model and appear committed through bibliographic databases so that others can to fi ghting it—even for publicly funded research. As learn of the works. one publishing executive noted “We’re like a fi rm under Both open access and traditional journals can be more siege.”137 An article in Nature.com, quoting from the open by being more rigorous in ensuring that authors minutes of a meeting of a committee of the American disclose potential confl icts of interest. Similarly, both Association of Publishers (AAP), noted that AAP open access and traditional journals should expand the members need to pay special attention to PubMed availability of standardized data that can be aggre- Central, whose work “threatens our livelihoods.”138 It gated, searched, and manipulated. was suggested that members should raise the issue of censorship against PubMed Central. “When any Finally, whether research results are disclosed through government funding agency houses and disseminates traditional or open-access publication, or via archiving, for public consumption only the work it itself funds, the time interval between disclosure and incorpora- that constitutes a form of selection and self promotion tion into clinical-treatment regimens is tragically of that entity’s interests.”139 long. According to research cited by the Agency for Healthcare and Quality Research and the National Such a response implies that we must choose between Cancer Institute, it takes from 13-17 years to get open-access and closed-proprietary models. Th is is not 14 percent of research into healthcare practice.144 the case. Th ere are many diff erent models that occupy Th ose who study, fund, and utilize healthcare-related disparate places along the broad continuum of “open- research need to identify and address the problems ness.” As Paul David has written: “Considered at the inhibiting the dissemination of research results and macro-level, open science and commercially oriented their implementation in treatments.145 To continually R&D based upon proprietary information constitute improve healthcare we will need to ensure that the complementary sub-systems. Th e public-policy extraordinary discoveries of creative researchers do not problem, consequently, is to keep the two sub-systems remain “academic” but rather reach those in need more in proper balance by public funding of ‘open-science’ quickly. research, and by checking the excessive intrusions of claims to private property rights over material that would otherwise remain in the public domain of Recommendations Regarding Openness and Publishing and Disclosure of Research Results scientifi c data and information.”140 Th e explicit policy of the federal government should The Future of Open Publishing and Disclosure be to promote the broadest possible access to research results in the healthcare arena, particularly govern- In the coming years open access may well continue ment-supported research. to pressure more-traditional models. More institutions are following MIT’s lead and creating digital Th e principles of the proposed Federal Research Public archives.141 Proponents of open access are attempting Access Act should be enacted into law. to educate their academic colleagues about their intellectual property rights and the opportunities to Th e federal government should not discriminate provide access to their works; Science Commons is among models for publication/disclosure. attempting to create a system by which authors can Th ose federal agencies supporting research should easily modify traditional copyright transfer agree- positively respond to requests for funding to pay for ments to ensure that they retain suffi cient IP rights to publication/disclosure of sponsored research. archive their works.142 Whether academic institutions ever adopt Stevan Harnad’s suggestion to mandate In evaluating applicants for research funding, federal self-archiving—“Publish or perish, self-archive to agencies supporting research should recognize the fl ourish”—it is likely that we will see new models scientifi c value of database science and scholarly work emerging to provide greater openness.143 Harnad him- that may be validated by means other than traditional self supports self archiving of even “closed materials” if scholarly publication.

26 Federal agencies supporting research should require that sponsored researchers disclose potential conﬂ icts of interest in any publications/disclosure of the sponsored research. Federal agencies supporting research should target eﬀ orts to reduce the interval between publication/disclosure of research and its implementation in accepted treatment regimes.

27 28 Chapter 5: Openness Regarding Electronic Health Records and Evidence-Based Medicine

The Vision of Electronic Health Records Having access to more complete and accurate information would allow caregivers to off er better and more Over the last decade the United States has been lurch- personalized treatment; HHS data show, for example, ing toward implementing a system of electronic health that one-seventh of primary-care visits are aff ected records (EHRs). What is being sought in the EHR by missing data.149 Th e improvement in data access would not merely replicate, in electronic form, today’s would be particularly marked if the patient moved, or patient record, but could include, in addition to the if the patient’s records were physically destroyed, or if individual’s medical history, other information such as the patient came to an emergency facility that had not his or her family medical history, as well as genomic, previously provided treatment, or if the patient were pharmacogenomic, and nutrigenomic data, environ- comatose —in the aftermath of Hurricane Katrina all mental exposures, dietary and exercise practices etc. It of these conditions might have been simultaneously would be the key to “empower individual patients to met for a single patient. An EHR would be extremely assume a much more active, controlling role in their useful when a patient is being treated by multiple own health care; improve access to timely, eff ective, healthcare providers for multiple ailments and when and convenient care; improve patient compliance with healthcare information is scattered across multiple clinician guidance; enable continuous monitoring of facilities—which is often the case for chronically ill patient conditions by care professionals/care teams; patients who generate a disproportionately large pro- and enable care providers to integrate critical informa- portion of healthcare costs. It would, if comprehensive tion streams to improve patient-centered care, as well and accurate, help avoid duplicative testing, confl icting as to analyze, control, and optimize the performance of prescriptions, and redundant treatments. It could, as care teams.”146 one observer put it, improve a caregiver’s ability to deal From the standpoint of openness the EHR would with misinformation, missing information, mishandled be a major step forward in both accessibility and information, mislabeled information, and misfi led responsiveness. Th e Health Insurance Portability information.150 and Accountability Act (HIPAA) today guarantees a An EHR could serve as a platform for writing pre- patient the right to access his or her records, although scriptions and having them fi lled, ordering tests, sched- anecdotal evidence suggests that it is a right that is uling appointments, providing reminders, and issuing rarely invoked.147 Ideally, the EHR would be easily alerts.151 By recording prescriptions and reactions available and more valuable, with electronic access for it could provide useful inputs for an expanded FDA patients and other authorized users anytime and any- post-authorization surveillance system. And having where. It would be far more responsive than today’s data in standardized electronic form could potentially medical record, capable of electronically receiving data reduce health spending. RAND researchers estimate regarding treatments, lab results, hospital-discharge that EHR implementation costs could total $8 billion information, prescription records etc. from any per year over 15 years.152 But the same RAND study authorized user who deals with the patient anywhere predicts that annual savings from health IT would and anytime. And it could arguably be made more average $81 billion over 15 years.153 HHS estimates secure with greater protections for patient privacy that the widespread adoption of EHRs could reduce than today’s paper records, which do not seem to be health spending by 7.5 percent to 30 percent, and easily protected from the gaze of those interested, for further cut administrative costs, which constitute one- example, in a celebrity’s medical status.148 third of all healthcare expenses.154 (Because an EHR would be created, maintained, and utilized by real and

29 fallible people, the chance that it would completely systems utilize diff erent standards and procedures and fulfi ll all these goals approaches zero—but it off ers the are not designed to be interoperable. opportunity for enormous advances.) Moreover, any major information technology project can be daunting and contains some risk of failure. A The Reality of Electronic Health Records series in the Los Angeles Times demonstrated how EHRs might be characterized today as an extremely even leading healthcare organizations such as Kaiser slowly developing success story. In 2004 President Permanente, which have embraced information and Bush set a goal of having an electronic medical record communications technology, are struggling to over- for every American in 10 years—by 2014.155 At come technical problems in accomplishing their EHR present only a quarter of U.S. doctors utilize electronic goals.161 records although that is a 30 percent increase from Th e lowest take-up rate for EHRs is in physician’s 2001 (By contrast 98 percent of physicians in the offi ces consisting of one or two physicians—and 50 Netherlands utilize electronic records, 92 percent in percent of U.S. physicians practice in such settings.162 New Zealand, and 89 percent in the United Kingdom. Th e use of information technology in these practices, Th ese electronic records, however, do not necessarily beyond billing and lab-based tests, is not a matter of have all the characteristics of the EHRs described course.163 above.) 156 Th ere are few clear incentives for a small medical prac- In early 2007 four HHS-funded prototype electronic- tice to convert its records. It would bear the relatively records systems linking healthcare systems from high costs—researchers estimate a cost of $33,000 around the country were showcased in Washington.157 per physician to adopt EHRs—but the real benefi ts At almost the same time a consortium of employers would go to the healthcare system as a whole.164 Th ere led by Wal-Mart and Intel announced that it would is a need to demonstrate real gains in results and establish an EHR system managed by a not-for-profi t effi ciency to caregivers, particularly if the most im- third party and covering their 2.5 million employees mediate impacts may be from fewer patient visits and who would be given control over access to information fewer authorized tests. Even major institutions that about themselves.158 Th e Veterans’ Administration, are already benefi ting from the improvements made acknowledged as the government leader in EHRs, is possible by the use of EHRs may be reluctant to share rolling out MyHealtheVet, a system for its 7.6 million data if sharing increases the likelihood that they will enrollees, which will gradually be extended to include lose patients. treatment records, appointments, chemical and blood tests, allergies and immunizations, and hospital While the cost of establishing an EHR system is discharge records; the Department of Defense and the high, there is no ready source of funding for the eff ort. Veterans’ Administration have agreed to a process for One regulatory step, permitting hospitals to donate a seamless real-time exchange of data between them- medical-record systems to physician practices, has been selves, although completion of this process is many taken.165 Various bills have been introduced in the years away.159 IBM and the Mayo Clinic are collabo- Congress to address the cost issue by means such as rating on a system for the Clinic’s 4.4 million records grants and loans to smaller medical practices, increas- which will include personal histories, imaging, tissue ing depreciation rates for health IT investments, and analyses, as well as biochemical and genetic data.160 bonuses for those connecting and providing Medicaid reporting electronically.166 Th ere are a number of major obstacles to the at- tainment of the EHR vision. Th e balkanization of Several innovative responses are already addressing the healthcare has resulted in very diverse participants cost issue. On the local level, New York City is plan- using many diff erent legacy systems with few areas ning to provide free software to 1500 large and small of consistency across the country. Attempts to share practices that have a substantial percentage of Medic- information between diff erent systems now produce aid eligible patients.167 On a larger scale, the National a mosaic with too many missing pieces, as diff erent E-Prescribing Patient Safety Initiative is off ering “free

30 electronic prescribing software to every physician in government will have to play a major role; as the party the United States.”168 World VISTA, an open-source that pays roughly half of the healthcare costs in the software system for EHRs, modeled on the Veterans United States, it can exercise enormous leverage should Administration’s VISTA patient-record system, has it choose to do so or if it is perceived as willing to do so. been created and is available to all.169 It appears likely, Technology will also surely play an important role in however, that further fi nancial incentives to encourage facilitating interoperability. For example, just as the and support adoption of EHRs will be necessary to Extensible Business Reporting Language (XBRL) meet the 2014 goal; even with such incentives there www.xbrl.org, was developed for fi nancial reporting is virtually no chance that all existing records will be purposes, new languages may provide semantic harmo- converted due to the cost and the quality of the records nization of the many legacy systems that today exist in themselves.170 the healthcare sector.174 Two additional obstacles to the establishment of an interoperable national EHR system are the lack of Privacy and Security standards necessary for interoperability, and the lack of agreement on how to achieve acceptable levels of Probably the most contentious issue is the impact of privacy and security. EHRs on patient privacy—an area where total openness is certainly not the goal. We need thoughtful eff orts to reconcile the benefi ts of openness made Standards possible by an eff ective EHR system with the require- A broadly based, joint public-private eff ort, led ment that we close the system by restricting access by HHS, is attempting to develop the necessary suffi ciently to protect privacy. Th e EHRs of the future standards to allow data in one part of the healthcare that we have been describing would raise the stakes system, when authorized, to be available for access for for privacy and security solutions dramatically, as they clinical, administrative, payment and research pur- would vastly increase the amount and kinds of sensitive poses. Standards would cover how the messages that data available. update the EHR would be sent and accepted as well as Studies by the Markle, Pew, and California Health the content of the messages.171 Th e present schedule Foundations have shown that while most Americans for standards development calls for this work to be are enthusiastic about improving how their healthcare completed by 2008.172 information is shared among their caregivers, they Th ere is some dispute over the progress of the stan- are concerned about the potential for abuse of privacy dards development process which, even under the very regarding that information.175 Underlying that con- best of circumstances, would be diffi cult, given the cern is the belief that the leak of a patient’s medical number of standards involved and the fragmentation condition or genomic attributes or other sensitive of the healthcare industry. Compounding the problem information could result in great harm to the patient are the myriad disputes over intellectual property that including loss of employment, loss of access to insur- competing vendors would like to have included as part ance, or other possibly irrevocable consequences.176 of the standards. (For similar reasons, few Americans, for example, have expressed a willingness to undergo genetic testing. One small but illustrative example: Th ere are three Th is may change given the broad bipartisan support in proprietary systems for describing allergenic reactions Congress and the White House for legislation forbid- to penicillin. It would obviously be preferable to ding discrimination based on genetic information. choose one system so that data on allergenic reactions Some prominent individuals are, however, already to penicillin can be fed into the EHR in a standardized making their genetic profi les public.)177 format, but in a consensus-based process this is not always easy—and the 2008 deadline for this standard Unauthorized disclosure may also increase the growing is looming. Even if one proprietary system is chosen, problem of “medical identity theft” (called the most issues might arise over royalties.173 To keep the underreported and poorly documented of identity standards-development process on track, the federal crimes) spurred by the high cost of medical care

31 and the large number of uninsured or underinsured be subject to enforceable privacy and security criteria people.178 Victims of medical identify theft may not at least equivalent to the relevant HIPAA require- only be charged for someone else’s treatment, exposed ments.184 Th e National Committee on Vital and to inappropriate treatment based on medical records Health Statistics has made a similar recommendation that refl ect another person’s medical condition, but regarding any entity that creates, stores, transmits or also may face the loss of their own health insurance.179 uses personally identifi able health information.185 Th ey may wind up with mixed records including Th ere is, moreover, considerable skepticism about information about themselves as well as somebody else. the enforcement of even current rules. Over thirty All stakeholders in the eff orts to create an interoper- thousand complaints have been fi led pursuant to the able national EHR system stress their commitment regulations, but there have been few enforcement to protecting the privacy and security of the system. actions and fewer sanctions imposed.186 Th ousands of Th e Acting Coordinator of Health Information Policy complaints remain unresolved.187 has emphasized the Administration’s commitment in According to a recent CIO Magazine survey, only 39 calling for a system that would give “people the capabil- percent of companies surveyed believed that they were ity to decide how they view, store and control access to fully HIPAA compliant; the survey showed that, on their own information. A person could say how that the whole, HIPAA compliance today is lower than in information fl ows to specifi c entities or completely earlier years.188 Another poll showed that three out of block the fl ow of information.”180 fi ve people interviewed do not trust HIPAA to protect But a gap exists between the professions of commit- their privacy.189 ment and the eff orts required for the diffi cult task of creating and implementing generally acceptable Recent Privacy Initiatives privacy and security protections. Th e Government Accountability Offi ce has been highly critical of the An enormous amount of work has been done over Administration’s privacy eff orts.181 Th e chair of a the last fi ve years to try to resolve issues of healthcare panel providing advice to HHS on health-information privacy and security. Th e Markle Foundation has policy accused the Administration of lacking “a sense led a group of over 100 organizations in an eff ort of urgency” about privacy and resigned.182 over the past several years to develop a “Com- mon Framework”—a set of technical and policy standards—for health information exchange.190 Today’s National Healthcare Privacy Law—HIPAA Health information, under this “federated” model, would remain under control of the parties that collect HIPAA is the controlling federal law governing the it, leaving judgments about who should and should not privacy and security of patient medical records. Th ere see patient data in the hands of the patient, the physi- are many additional laws at the state level which refl ect cians, and the institutions that are directly involved varying levels of privacy protection. (Th e patchwork in providing treatment. Th is federated model aims nature of these laws serves as an additional barrier to to avoid a large, centralized database which might be the implementation of an interoperable national EHR more vulnerable to privacy and security breaches. Th e system.) system would be based on common, open technical and policy standards that could work with existing hard- Th e application of current HIPAA regulations, which ware and software, and would rely on model business took several years to draft and were quite contentious, contracts to govern the exchange among organizations is not acceptable to many stakeholders. For example, holding the data.191 It would support variation and HIPAA does not cover many parties likely to have innovation to respond to local needs and would contain access to EHRs.183 Th e American Health Information feedback mechanisms to fi x faulty data. Community’s “Confi dentiality, Privacy and Security Workgroup” has recommended that every party that Central to the Common Framework is a set of prin- participates in an electronic health-information ex- ciples to protect privacy and security that would be change of individually identifi able health information embodied in the technology. Th ese principles are:

32 • Openness and Transparency: Individuals should be would leave data collections decentralized. Th ey able to know what information exists about them, provide for data minimization and cleansing, auditing where it is, and who can access it; of data use, as well as remedies for breaches of privacy and security. • Purpose Specifi cation and Minimization: Th e purposes for which information is collected should But agreement on principles still leaves many diffi cult be specifi ed when it is collected. Subsequent use issues to be resolved. Rules must be developed about should be limited to those purposes, or if used for who is allowed to have access to what information and other purposes, those purposes must be specifi ed; under what conditions. Th en the system must be able to verify that the party requesting access is authorized • Collection Limitation: Personal health information to have access, and can be identifi ed and authenticated should only be collected for the specifi ed purposes, as the appropriately authorized party.193 Th ese au- by lawful and fair means, and where possible, with thorization, identifi cation, and authentication issues the knowledge or consent of the data subject; are being addressed in other domains that deal with • Use Limitation: Personal data should not be sensitive information, such as banking and fi nance and disclosed or otherwise made available for purposes homeland security; healthcare will surely benefi t from other than those specifi ed; eff orts to fi nd answers in other sensitive areas. • Individual Participation and Control: Individuals Th ere are obviously a myriad of other questions should control access to their personal informa- that will have to be decided. Will there be national tion. Th ey should be able to obtain a response standards for privacy and security preempting state from any entity that controls personal health rules or will national standards create baselines for information about whether that entity has per- privacy and security protections? How will the system sonal health information about them. Th ey should deal with circumstances that do not readily allow a be able to obtain that information in a reasonable patient to authorize access to information? (Studies time in an understandable form for a reasonable on how to improve emergency care show how conten- price. Th ey should be able to have that information tious issues of consent can be.) What, if any, are the amended. Th ey should be able to appeal denial of appropriate limits on patient control of access? How access; will exceptions be dealt with? How will disputes be resolved? How will the system be structured so that • Data Integrity and Quality: Personal data that is the patient-centered processes for controlling access to collected should be relevant to the purposes speci- information do not impede the delivery of services—so fi ed, current, complete, and accurate; that practitioners, wary of anything that gets in the • Security Safeguards and Controls: Personal data way of their providing quality patient care, will not should be protected by reasonable security safe- reject or undercut the system? How will public health guards against such risks as loss or unauthorized needs, such as in the case of a pandemic, be balanced access, destruction, use, modifi cation or disclosure; against patient privacy rights? What will be done in the case of unauthorized access to patient informa- • Accountability and Oversight: Entities in control of tion? Will patients be able to opt out of the system, personal health data must be held accountable for or will the system, as one leading expert suggests, gain implementing these principles; support by requiring that patient’s opt-in?194 And • Remedies: Legal and fi nancial remedies must exist given researchers’ concerns (it has been argued that for security breaches or privacy violations.192 the famous Framingham Heart Study could not be conducted now under today’s less rigorous HIPAA Th ese principles would provide a sound basis for an regime), will a system designed to protect patient EHR system. Th ey put the focus clearly on the patient privacy be fl exible enough to allow the use of EHRs for and his or her role in controlling access. Although research purposes? Th e questions go on and on. they do not defi nitively establish who “owns” personal health information, they would establish obligations And even if we feel confi dent that the major ques- for any entity that collects such information, and tions have been answered, there are very substantial

33 challenges to implementation. For example, the with the need for better information to guide clinical business contracts between organizations that the decision making.”196 Clinical trials, as we have seen, Common Framework foresees as necessary for the provide such data but they are expensive, time consum- exchange of information are not in place and will not ing, limited in scope and “fraught with questions of come into being without great eff ort. Much of the data generalizability.”197 that exists in today’s records are inaccurate and should We can do better. Imagine if we were able to construct be corrected but it is easier and cheaper to avoid cleans- collections of appropriately de-identifi ed EHRs that ing records; much information is missing and will be have been bulked up with genomic, pharmacogenomic, expensive and time consuming to fi x. Th ere is little proteonomic, epigenomic, and nutrigenomic data, evidence that suffi cient resources and commitment will supplemented with environmental-exposure infor- be available to enforce new privacy and security rules. mation, diet and exercise data, and family medical However great the diffi culties, if EHRs are likely to histories. What if we added insurance claims data and provide the benefi ts described earlier, we should be the data underlying clinical trials and research funded able to fi nd solutions. We must recognize that no by governmental agencies? system is born perfect or ever achieves perfection, but Building such databases, providing appropriate ac- any EHR system must have the capacity to evolve. cess, (perhaps in some cases limited to professional No massive system for exchanging information exists researchers as opposed to anyone and everyone), and that will guarantee absolute confi dentiality. Th ere ensuring privacy and security are, of course, not easy will be violations and breakdowns, so there must be tasks. Some goals may not be achievable, such as strong provisions to protect privacy and effi cient and a perfectly de-identifi ed system. (Th e inadvertent eff ective mechanisms to deal with violations. Patients disclosure of supposedly de-identifi ed AOL search and practitioners alike must feel confi dent that their data and the relatively quick identifi cation of AOL interests are adequately refl ected in the rules; both users illustrate the diffi culties.) Some goals remain in must feel that the benefi ts outweigh the costs. tension; researchers generally prefer more information Andy Grove, formerly of Intel, has predicted that the to be available for correlation in developing clinical United States will transform its healthcare system guidelines while privacy advocates generally prefer less. through the use of information and communications But around the world we are seeing important steps technology as has occurred in other sectors of the forward. In Europe, Asia, and the United States, economy, “only after the next pandemic.” To prove researchers are recruiting hundreds of thousands of him wrong and bring an interoperable, nationwide, people to participate in biobank initiatives that compile effi cient, patient-centered, and privacy-respecting EHR an individual’s genetic, health and lifestyle informa- system to fruition will require a strong commitment tion, and track it over time through electronic health by the federal government with its role in healthcare- records.198 Biobanks seek to better understand the funding and national perspective. linkages between these and other factors to improve the prevention and treatment of myriad disabling and Electronic Health Records and the life-threatening diseases—including cancer, heart Development of Evidence-Based Medicine diseases, diabetes, arthritis and types of dementia. EHRs are important in their own right, being the key Biobanks are not a new phenomenon, although these to personalized patient treatment. EHRs are also biobanks aren’t your grandfather’s or even your father’s likely to play an important role in monitoring drug biobanks. (Fifty years ago, Sir Richard Doll followed safety. But perhaps their greatest potential lies in fur- the health of 50,000 doctors and ultimately unveiled thering the development of evidence-based medicine. the link between smoking and lung cancer.)199 Little hard evidence exists to demonstrate that many But for all of the possibilities to prevent and cure of today’s medical treatments are based on reliable disease, biobanks remain controversial. Some medical data.195 As the Institute of Medicine described it, we experts worry that “volunteers will be asked to donate face a “structural inability of evidence to keep pace their DNA without really knowing how it’s to be

34 used or who’s going to use it.”200 Others worry about be representative of the U.S. population. Some cohort whether private companies will be permitted access studies of women and children, traditionally funded by to the sensitive data.201 And these worries say noth- the federal government, were cut back in recent years ing of the technical hurdles that computer scientists because of budget pressures. Th e announcement in the must overcome to ensure that the data generated by fall of 2007 of a National Children’s Study targeting biobanks can be structured to respond to queries 100,000 children from birth to age 21 by the National that may change in unexpected ways over time. How Institute of Child Health and Human Development of these issues are resolved will undoubtedly shape the the NIH is therefore very good news. direction of biomedicine and the healthcare industry Th ink of what we could learn if researchers could have generally, for years to come. access to all this information. Not only would we be Beyond these new biobanks, sponsored by govern- able to personalize treatments and monitor drug safety, ments and not-for-profi ts such as the American Cancer but we could be increasingly confi dent that recom- Society, there are existing data collections which are mended treatments actually are based on evidence, being used in new ways. While they contain only a not anecdote or habit. As more data are added, and as small portion of the possible data sources, even at this data mining improves, researchers will be able to create early stage they provide a far richer data environment predictive models and test these against the aggregated than even the best clinical trials. Both the VA and data and through better-targeted clinical trials. We Kaiser-Permanente, with roughly 8 million patient will also be better able to compare the effi cacy of vari- records apiece, have patient-record collections includ- ous interventions which we do all too little today. ing more cancer patients than have participated in all Perhaps in no other sector of the economy do we spend the cancer clinical trials ever conducted.202 so little eff ort to measure and improve performance. As part of its Research Program on Genes, Environ- HHS’s Agency for Healthcare Research and Quality ment and Health, Kaiser’s Northern California has a relatively small budget of $500 million to con- Division is sending a detailed survey to each of its two duct studies of comparative eff ectiveness of procedures. million adult subscribers asking for information on But comparing this $500 million with the $2 trillion their habits and family medical histories.203 (Th e risk dollars in healthcare expenditures (0.025 percent) that a woman will develop breast cancer, for example, validates what one noted physician author has writ- is inextricably linked to family medical histories.) 204 A ten: “Th e scientifi c eff ort to improve performance in year from now Kaiser plans to solicit genetic samples medicine—an eff ort that gets only a pitifully miniscule from its patients to test and add to their records.205 portion of scientifi c budgets—can arguably save more Kaiser’s long-term vision, similar to that of the VA, lives in the next decade” than all the basic break- the Mayo Clinic, and others, is to use its vast record throughs that we hear about in the news.208 holdings to determine the optimal treatment regime Eventually we will be able to identify and extract the for each patient. A consortium of health insurance right data. Eventually we will be able to perform the providers and several medical-practice associations are right comparisons. Eventually we will fi nd the right exploring collaborations to the same end.206 balance between effi cient, standardized care which While such eff orts are dominated by large groups, serves most patients well, and individualized treat- even sophisticated smaller institutions are moving in ments based on less common attributes in a patient the same direction. Geisinger Health, for example, which is likely to be much more expensive.209 In the is attempting to utilize its relatively stable patient future we might, for example, see fewer blockbuster population in central Pennsylvania to build a database drugs—like any other manufacturer, a pharmaceutical rich in extended-family histories, and is supplementing company searches for a product useful for the largest these with U.S. Geological Survey data on local water possible group in order to maximize revenues and supplies to determine environmental exposures.207 amortize costs over the largest number of users—and more targeted therapeutic regimens. (But the individu- Large-cohort studies can usefully supplement other da- alized pill is likely to remain an expensive and distant tabases, such as those from clinical trials that may not dream.210)

35 Th e mining of these databases should continually gen- New rules designed to ensure the privacy and security erate new clinical best practices. Th ere are hundreds of healthcare records must be adopted to provide of guidelines already in the Agency for Healthcare assurance to patients and practitioners. Th ese must Research and Quality’s Guidelines Clearinghouse but cover all entities involved in the handling of indi- with over 10,000 various medical conditions we still vidually identifi able health-related information. Th e have a long way to go.211 And we still need to ensure federal government must demonstrate a commitment that those clinical best practices inform the work of to enforcement of these rules and provide suffi cient clinicians. Without eff ective monitoring and rewards funding to do so. for their use, however, they will be an empty tribute to Th e federal research agencies should increase their our ability to gather and manipulate data. We would support for the development of the very large databases have demonstrated that access to information is not necessary for progress toward evidence-based medicine suffi cient, but that improved healthcare will result only including the necessary data standards. Support if we incorporate our more sophisticated understand- should also be provided for research on how such data ings into real world actions. should be structured to facilitate the varying queries Th e issue of potential confl icts of interest is particu- necessary to develop evidence-based clinical treatment larly acute when recommended-treatment regimes are practices, to compare the safety and effi cacy of various being created. Th ese regimes should be based solely on treatments, and to allow the development of predictive the best possible scientifi c information. Any potential models of diseases and treatments. for the skewing of these recommendations based on Th e National Academy of Sciences should undertake fi nancial interest must be avoided. Strenuous eff orts a study of de-identifi cation techniques that might be should be made to ensure that participants in the applied in the creation of large databases to protect process are not subject to potential confl icts and strict the privacy of patients in order to provide guidance to disclosure requirements should be in eff ect. federal policymakers. Recommendations Regarding Electronic Strict requirements on the disclosure of confl icts of Health Records and the Development of interest should be applied to those participating in Evidence-Based Medicine the development of recommended clinical practice Th e federal eff ort to develop standards for an interop- regimens. erable, national EHR System should be given high Congress should provide additional support for long- priority and suffi cient support, including a strong com- term cohort research for groups underrepresented in mitment by the federal government to use its leverage existing biomedical research results. to obtain timely agreement on standards. Legislation should promote the establishment of national health HIPAA should be amended to require that those par- data standards and an interoperable national EHR ties who hold a patient’s medical records must provide system. the patient with the opportunity to receive copies of those records pursuant to HIPAA in digital form.212 Individuals and groups providing and funding healthcare should institute appropriate incentives for the adoption of information and communications technologies (including EHRs) to reduce healthcare’s burdensome administrative costs.

36 Chapter 6: Expanding Openness for Patients and Caregivers

Biomedical research and evidence-based medicine We have learned that the most important drivers of are cases where the increased access to information healthcare costs are chronic conditions and serious and the ability to manipulate data reveal the value illnesses that may be prevented or mitigated by patient of greater openness. Th is Chapter will focus on the actions.214 Th erapeutic encounters between a sick impact of providing more and better information to patient and his or her trusted doctor do not dominate patients and caregivers, and being more responsive to healthcare costs; as many of us have experienced, these the unique contributions they can make. encounters seem to get shorter and shorter and may involve doctors whom we have never seen before—or Th e kinds of openness described in this section—such even no physician at all.215 as allowing patients to evaluate the interventions being tested on them in clinical trials or increased attentive- Under these conditions, how can openness improve a ness by caregivers to patients’ stories—are not treated potential patient’s ability to prevent problems and to be by economists as precisely the same as the openness a better partner in dealing with those that arise? that enhances the research process. But they can be understood using the same characteristics of acces- Patient Access to Healthcare Information sibility and responsiveness described earlier, and can provide signifi cant benefi ts, particularly with regard to Perhaps the greatest opportunities arise from the disease prevention and treatment. increased availability of healthcare-related information via the Internet, including information on prevention, exercise, and nutrition. In 2006, ninety-fi ve million Changing Ideas About the Role of the Patient Americans searched the web for information on In the past, patients were often viewed as passive specifi c diseases, how to treat chronic illnesses, how to recipients of health-related information and treatment assess a specifi c health risk, who or where to go to for decisions from their caregiver. Healthcare revolved help, or where to buy health-related products.216 around meetings between sick patients and their Some of the information consumers get from the doctors; the patient’s role in the “production” of good Web is right, some of it is wrong, and much of it is health was basically to do what an oracular caregiver not suffi ciently particularized to be of great value instructed. Treatments were based on limited data for an individual.217 (Here again the double-edged and anecdotal evidence. Patients were given few sword of openness is visible. Much more information incentives and little training to take more responsibil- is available but we lack good tools for evaluation and ity for their own well being. One did not look to the there is too little transparency about the sources of mainstream medical community for information on the information.) Th ere is a tremendous need for “lifestyle” choices. evidence-based, comprehensible, consumer-friendly, Today we live in a world of patient-centered healthcare. and relevant healthcare information and for quality We are awash in information. Increasingly, eff orts are measures to allow readers to make better judgments being made to encourage individuals to take greater about information from the many players who would responsibility for their own health and to make choices like to be their source for healthcare information. that reduce the likelihood of illness. 213 An advertise- Th e government is playing a vital role, one that the ment for Pfi zer sums it up: “Get well soon’? We prefer, National Library of Medicine (NLM), in particular, ‘Stay healthier longer.” has embraced.218 Its MedLinePlus website provides

37 well-vetted information based on the most current example, all patients carry their medical records on a scientifi c data on everything from conditions such as single computer chip.225 arthritis and back pain to frequently asked healthcare PHRs off er a potentially valuable resource for those questions. NLM has consistently worked to make its individuals who choose to adopt them. Th ey include healthcare information more accessible to individuals. a wide variety of information such as medical history, Other governmental agencies also provide excellent present medications, the results of tests and remote sources of healthcare information.219 monitoring, a patient’s reporting on his or her health, Many valuable sources of information are sponsored and current treatment regimens.226 Th ey hold out the by private-sector organizations. Th e American Cancer promise that patients will change their behaviors if Society and the American Heart Association for they have more convenient access to their records— example, provide high-quality information related to something that, unfortunately, does not always follow. the diseases that they fi ght. For-profi t entities operate But there are signifi cant obstacles to PHR develop- healthcare portals such as WebMD, Revolutionhealth- ment. Healthcare-related entities are not required by care.com, Everydayhealth.com, and the HealthCentral HIPAA to supply information to patients in a digital Network.220 Microsoft recently purchased Medstory, format. Standards for electronic data exchange are not Inc., a healthcare search engine for consumers, and yet resolved. Concerns about privacy and security are in October of 2007 released HealthVault, a free and also aff ecting PHR take-up.227 ad-supported portal that will allow individuals to download data from their caregivers or from digital devices such as glucometers, upload data on their diet Other Sources of Information and exercise routines, and share the encrypted data Th e Internet allows access to another source of with others.221 Th e healthcare portals are all trying information—peer groups made up of individuals (or to diff erentiate themselves with additional services— people related to them) who share an interest in the displaying health tips, linking patients with insurers, same medical condition. Even more important for rating medicines, doctors and hospitals and providing group participants than the information provided may decision-support capabilities. One can even get “sec- be the sense of connection to others facing similar ond opinions” via the Internet.222 problems—others just like oneself. Th e information As is true in other areas, confl icts of interest due to the and support are particularly helpful for patients with role of advertisers or donors may aff ect the healthcare less-common conditions where an individual’s care- information provided; patients can, however, fi nd giver may have encountered the condition rarely, if at disinterested sources of information at government all. In one well-designed web-based group for suff erers websites and those of groups such as Consumers from rare carcinoid cancer, for example, a healthcare Union or the Center for the Study of Services.223 expert off ers scientifi cally validated information that 228 Patients themselves are likely to publish ratings of helps patients separate fact from fi ction. information sources on healthcare, just as they rate One of the most contentious sources of healthcare other goods and services off erings in today’s Web 2.0 information for patients is prescription drug advertis- world.224 ing directed to consumers—one of the fastest growing advertising categories. Th ere is no doubt that such Personal Health Records advertising plays an important role in informing consumers about various medical conditions and the Some healthcare portals (and many employers and availability of pharmaceutical treatments, and has insurers) are building infrastructures that allow an triggered countless valuable conversations between individual to create a web-based “personal health patients and their caregivers. At the same time, critics record” (PHR), an individual’s version of the EHR. contend, such advertising has been accompanied by PHRs are designed to be portable and under the growth in inappropriate prescriptions at considerable control of the individual. As with EHRs, certain other cost to individual patients and to the healthcare sector countries have made greater progress. In Germany, for in general.229 Proposals for greater FDA powers over

38 such advertising were off ered but were not included in cases, individuals actively recruited researchers who the 2007 Amendments.230 otherwise would have been working on diff erent problems.236 Patients as Research Assistants Another way patients, or those who care about them, Th e abundance of information has begun to change the are stimulating practical research and increased relationship between patients and caregivers. Accord- collaboration is via innovation prizes. Th e use of ing to one survey, 52 percent of primary care physicians contests, open to all with large prizes to stimulate report that their patients are now arriving with print- creative activity, has a long and honorable history.237 A outs from web searches.231 Patients are gathering the $10 million prize is now being off ered, for example, to latest research about a disease or a treatment, fi nding whomever develops a cheaper, faster, gene-sequencing notices of, and solicitations for, clinical trials, and giv- device, a breakthrough necessary to fully realize the ing them to their caregivers—along with folk remedies benefi ts made possible by increased genomic and and charlatan’s cures. pharmacogenomic information.238 Th is may be annoying to some caregivers used to Increased patient activism is not an unalloyed good. greater patient acquiescence, but thoughtful caregiv- Patient pressure for new treatments may help speed ers recognize that making the patient-caregiver their development and approval, but there is a risk of relationship more of a partnership is fundamental to rushing out remedies before they have been properly increased patient responsibility and, ultimately, better evaluated.239 Patient persistence may lead to over- outcomes.232 Patient-provided research may also aid prescription or prescriptions for highly advertised in fi lling the gap between the publication/disclosure drugs that are not as cost-eff ective as other treatments; of research and its implementation in treatment one partial explanation for the rise in drug-resistant in- regimes; patients and their families with their intense fections is that many caregivers have acquiesced in the motivations to fi nd solutions may prove to be helpful over prescription of antibiotics in response to patient “research assistants” for their caregivers. pressure to “do something.” Patient reports about their symptoms are generally valuable, but like all Other Patient Contributions stories may be inaccurate, biased, or at least in confl ict with what is considered the best applicable science.240 Viewed through the lens of openness, patients are not Patient lobbying can aff ect healthcare funding in ways only the benefi ciaries of increased access to informa- that may not refl ect the best cost-benefi t analysis for tion but they are among the most important sources the society as a whole. (Although there are legitimate of information for the healthcare system. Patients reasons to be concerned about this “politicization” of provide the most direct evidence of what they are healthcare research priorities, one can still applaud 233 experiencing when they tell their stories. Th ey are the eff orts by patients and their supporters to increase also the most immediate source of their own and their high-quality research and to speed the application of family’s medical histories. research to treatments and cures.) Patients and their supporters also collectively con- Th e potential importance of patient input in another tribute as they lobby for funding for disease-specifi c setting is just now being recognized. Patient-recorded 234 research. Th e Genetic Alliance, for example, rep- outcomes (PROs), the patient’s view of the impact of resents over 600 groups of patients with diff erent an intervention, are increasingly seen as valuable to genetic conditions; the Alliance presses for funding certain clinical trials. Studies have shown that PROs for these conditions and also helps organize donations are, in some cases, better predictors of the eff ectiveness of tissue samples and solicits volunteers for clinical of an intervention than clinical indicators. In cancer- 235 trials. In some cases patients and their support- related clinical trials, for example, PROs provided ers are directly funding research and clinical trials. additional information on outcomes, particularly on Private foundations, often disease specifi c, provided how the intervention aff ected the patient’s ability to $5 billion in funding for research last year; in some lead a “normal” life —which is of great interest to patients. 241

39 Increased patient involvement has also been shown to centers to specialists who can obtain diagnostically have a positive eff ect in a diff erent way. Greater patient relevant data or conduct consults at a distance. Th e participation in choosing among treatments—so-called 1996 Telecommunications Act recognized this oppor- “preference-sensitive care”—has reduced the use of the tunity and the FCC recently revised its rules to further most aggressive, invasive, and expensive treatments encourage telemedicine.248 But issues regarding by 23 percent over what the healthcare provider state-based licensing and medical-malpractice regimes would otherwise have chosen.242 Even the attitudes still inhibit the growth of telemedicine, and questions that patients bring to fi ghting their illnesses can have about privacy and security, reimbursement for remote considerable impact on the success of treatments.243 monitoring, data standards, and the interoperability of devices have not been fully resolved.249 Patients are providing vital information in yet another way. More and more data can be, and is beginning More Informed Healthcare Consumers to be, collected from patients via remote monitoring. Remote monitoring is being integrated into more treat- Greater access to information can help harness market ment regimes in order to increase outpatient treatment forces to improve quality and reduce costs in health- while continuing observation and data collection, and care. Economists know that it is not possible for a to involve the patient more directly in his or her own market to function without information about quality care. and costs, but such information has been in short supply regarding hospitals, procedures, practitioners, Increased monitoring is facilitated by expanded Inter- and treatments. net access, as well as by the falling prices and greater functionality of communications-capable devices. Patients often look to their caregivers for informa- Cell phones are being sold with glucose monitors and tion on cost and quality but most caregivers do not breathalyzers; digital cameras are being used to send have this information. Some limited information is pictures of meals for nutritional analysis; implants are available from the federal government, for example, communicating their host’s condition to the Web to on the costs of common medical procedures.250 Much be remotely scrutinized by his or her caregiver; remote more information could and should be made available devices that measure blood oxygen are reducing doctor given the vast amounts of payment data the federal visits and providing doctors with signs of developing government has accumulated; the total costs associated problems.244 Devices worn by homebound patients with a procedure, for example, are rarely disclosed.251 now allow relatives to check if the patient has been (Costs for the same procedures surprisingly vary by immobile too long.245 New radiofrequency identifi ca- up to 400 percent from region to region and the use of tion devices may ultimately allow remote monitors to procedures can vary remarkably within regions, cast- determine if a refrigerator, or a vial of pills, has been ing doubt on whether clinical-treatment regimes are opened, allowing inferences to be drawn about whether being consistently followed. 252) Th ere are encouraging patients are eating or taking medications. signs that, as one leading consultancy wrote, “the federal government and leading private-sector payers Information can be passed both from and to the are driving providers to make cost and quality data patient. Remote devices can broadcast reminders more transparent so that consumers can make better for smokers to stop smoking. Th ey can nag patients choices.” 253 to take their medications—an important task when 50 percent of prescriptions are never completed as Th e Department of Health and Human Service’s prescribed.246 Such reminders can in fact change website (www.hospitalcompare.hhs.gov) provides behaviors.247 comparative information on 19 diff erent quality measures that the federal government gathers on Th e same progress in information and communica- every hospital. It bases its ratings on what is done for tions technology that is allowing greater access to the patient. Th e data are available, however, on only information and facilitating remote monitoring is help- a limited number of conditions and “ignores entire ing to improve rural America’s access to healthcare. departments and specialties.”254 In February of 2007, Telemedicine is connecting patients far from medical HHS announced a plan to create local health-quality

40 information exchanges that would “collect information Greater Openness and Incentives for on the quality of local healthcare providers based on Improving Healthcare nationally established standards. Th at data would More important than the voluntary actions of indi- then be pooled to create a public, nationwide quality vidual consumers will be the actions of employers in reporting system.”255 forcing the disclosure of cost and quality information Private-sector actors, including web-health portals, and in responding to it. Facing the economic pres- see a potentially profi table role in providing quality sures that they do, fi rms are already working to create ratings to the public. Using the same records relied incentives for improved medical outcomes and reduced upon by the federal government, Healthgrades (www. costs, capping their costs, or even dropping health healthgrades.com) off ers ratings focused on medical insurance altogether.260 Even more important, given outcomes, adjusting them for the severity of the disease the percentage of the nation’s healthcare costs that it and the health of the patient; in addition it computes pays, will be how the federal government deals with “patient-safety” ratings.256 Healthgrades charges information regarding cost and quality. hospitals for its complete reports and for allowing Over the long run, eff orts by the federal government them to publicize their Healthgrade ratings.257 and employers to harness market forces must go Experiments suggest that even minimal disclosures beyond the disclosure of information to more value- can have benefi cial results. Th e release of risk-adjusted conscious healthcare consumers. Th ey will have to mortality data from cardiac-bypass surgery by doctors create strong incentives for improved care at lower in New York, for example, had the salutary eff ect of costs. shining a spotlight on the worst performers, many of New clinical practice guidelines are likely to emerge as whom simply ceased to practice in New York.258 we strive to move toward evidence-based medicine. But Th ere are reasonable concerns raised about the New caregivers and institutions will need to be monitored York study and its use of mortality data as the basis to determine whether they are following new, as well as for the quality metric. Th ere are intense debates about existing, guidelines. As it is easier for individuals and quality measures—as well as a number of initiatives to organization to continue to do what they have been improve them.259 Care obviously needs to be taken in doing—a system at rest remains at rest—incentives are defi ning the metrics, avoiding punishing hospitals and likely to be necessary to increase compliance.261 other providers that take on more diffi cult cases, and Medicare has recently taken an important step in this preventing hospitals and caregivers from “gaming the direction. Traditionally Medicare has covered the system” by turning away sicker patients etc. But the costs of all hospital procedures, even those required to eff orts to devise better quality measures and to gather deal with complications resulting from medical errors. and release quality and cost data are easily justifi ed by Medicare announced in August 2007 that it will no the potential benefi ts from unleashing market forces to longer reimburse hospitals for additional procedures improve healthcare. incurred as a result of “preventable errors.” Medicare One would expect that many individuals, reliant until will no longer pay, for example, for treatments for now largely on word-of-mouth recommendations, hospital-based infections. Th ese are now considered would respond to better information. Th at assump- preventable because of the development of guidelines tion underlies the establishment of consumer-directed and best practices which have been proven to eliminate health plans (CDHP’s) which are designed to provide their occurrence with little or no increase in costs.262 incentives for healthcare consumers to make more State medical-error-reporting systems, which have informed purchasing decisions. But given present helped identify the causes of preventable errors such practices in health insurance—limited deductibles, as those that lead to hospital-based infections, provide little choice among caregivers in many plans—it would useful inputs for any system designed to improve be unduly optimistic to assume that the majority of quality. But many states do not require the report- insured individuals want to, or will soon become, ing of medical errors. Congress has established a skilled healthcare shoppers. voluntary national patient-safety network for reporting

41 and analyzing errors but regulations have not yet been Proponents of greater openness and more information issued for its implementation.263 A mandatory system recognize the dilemma of having too much informa- may well be preferable given the grave consequences tion and too little time to process it during a meeting of many medical errors and the need to identify errors with a patient. Kaiser’s “Project Isobel” and similar so that performance-enhancing feedback systems can work at the Veterans Administration and elsewhere operate.264 are aimed at developing decision-support tools to help providers sort out possible diagnoses.266 Beyond Other information, not directly concerned with providing possible diagnoses, these tools might suggest specifi c procedures, drugs, or devices would also be additional diagnostic questions, cue relevant tests, and valuable. From the standpoint of improving healthcare list alternative treatment regimes. and providing greater protection for patients, there seems to be little reason, for example, for any state to Decision-support systems cannot replace the insights withhold information about disciplinary actions taken that mark gifted diagnosticians.267 Th ey are not meant by its licensing boards against licensed healthcare to reduce the practice of medicine to a mechanistic providers. process overseen by automatons. But with over 10,000 known conditions and more than 1,900 existing Openness and Caregivers clinical-practice guidelines, decision-support tools are increasingly needed for better and timelier decisions If patients in the past were sometimes seen as passive aimed at personalizing treatments in a data-rich actors, caregivers were usually accorded great deference environment.268 In theory these tools should be all as highly educated sources of information and provid- inclusive, down to patient preferences for generic ers of treatments. If patients are now empowered by drugs, but the systems now being constructed have new sources of information, some caregivers may now much more limited capabilities.269 feel swamped by new kinds of information, less likely to be knowledgeable about all the interventions that Even these limited systems are not easy to build. A patients have received as more disparate caregivers much simpler tool, such as a computerized physician- are involved, more time constrained in their interac- order entry (CPOE) system for drugs, required consid- tions with patients, more burdened by administrative erable development and testing eff orts and substantial requirements and battles with third-party payers, while amounts of time before it began to help hospitals receiving less respect and being accorded less status reduce medication errors and improve operating than in the times of Drs. Casey, Kildare and Welby. effi ciency.270 In this new environment, caregivers, like patients, are Caregivers and New Sources of Information also turning to their peers, utilizing support groups Caregivers, like patients, can benefi t from dramatic in- to exchange information as they do with adverse creases in genomic, pharmacogenomic, epigenomic and drug events. Sermo (www.sermo.com), for example, nutrigenomic information and the further evolution of provides an opportunity for registered physicians to evidence-based medicine. If able to use this informa- exchange ideas and solicit help on diffi cult medical tion, they will be increasingly capable of personalizing diagnostic questions.271 treatments for their patients. But while caregivers are expected to bring order to this information explosion, The Attentive Caregiver many may feel information “overload.”265 Th ey are Patients contribute by telling caregivers how they feel. expected to integrate new kinds of information which But caregivers may not be as “open” or receptive to might not have been part of their medical education what their patients are saying as they should be, or for with evidence gleaned from massive databases and as long as they should be.272 Observers have noted that then determine the right treatment given the patient’s many caregivers cease listening to their patients much individual and family medical history, his or her too quickly, interrupting the patient or prematurely symptoms, and the various diseases that this informa- beginning the process of narrowing down potential tion might suggest.

42 diagnoses even before the patient is fi nished providing to be too expensive or inappropriate for the patient his or her story.273 for some reason. If shared decision-making between patient and caregiver is desirable, then it follows that “Premature closure” is likely to aff ect diagnostic patient participants should be aware of any limits set quality. Estimates of faulty diagnoses range as high as by their caregivers that prevent the patients from fully 30 percent; misdiagnoses are the source of almost 60 evaluating the treatment choices available.280 percent of malpractice claims.274 Increased time pressure on patient-caregiver interactions only heightens Caregiver Confl icts this problem Caregivers have traditionally played the principal role Th e use of decision-support systems may allow caregiv- in determining what treatment a patient will receive. ers to spend more time actually listening to patients.275 Recently there has been a dramatic increase in the Similarly, the use of e-mail and other electronic com- fi nancial stakes that caregivers have in treatment alter- munications tools should, among other eff ects, enable natives.281 Th ese fi nancial interests—whether they are patients to fi ll out forms and provide information in in outpatient treatment facilities, hospitals, procedures, advance rather than during the visit, allowing richer etc.—have been demonstrated to aff ect a caregiver’s and fuller conversations.276 objectivity, yet there is little information available to patients regarding such interests.282 Increased Openness and Information Provided by openness would require, at the least, that the fi nancial Caregivers interests of the caregiver in any aspect of treatment be Caregivers have unique tacit information about their disclosed. Medicare has recognized these confl icts and practices—what and how processes work or don’t is cutting back on “self-referrals.”283 work, what patients are likely to do in a given situation, Narrowing the interval between discovery and clinical and what can or can’t be accomplished under specifi c practice is, as we noted earlier, a major challenge. One conditions. Th is information is often diffi cult to way to shorten this interval is to help caregivers stay codify and transfer, but it is critical for developing ef- informed of developments in their fi eld. fective treatment regimes. Greater involvement in the development of treatment regimes or clinical trials by Pharmaceutical companies play a crucial role in turn- experienced caregivers would allow tacit, experience- ing research into treatments. Th ey off er their expertise based knowledge to better inform the necessary in new treatments to caregivers and justify visits by decisions. their sales representatives to caregivers, in part, on the basis that the representatives help in keeping caregivers Th e root of the word doctor is from the Latin docere— current.284 Th ere is no doubt that they do provide to teach.277 Doctors have always taught patients about useful information.285 But they also often come their illnesses. Th ey are increasingly educating them bearing gifts, including entertainment tickets and free about how to maintain and improve their health. samples; they sometimes stay for (and provide) lunch, Now they can help patients deal with the information and suggest non-FDA approved uses and higher doses tsunami by teaching them how to evaluate medical for the drugs they represent.286 Research suggests that information. In doing so, doctors can improve their these visits can aff ect what caregivers prescribe.287 patients’ performance both as research assistants and healthcare consumers. In 2002, the American Medical Association established a voluntary code governing the receipt of gifts Surveys have shown that 8 percent of caregivers do including meals. The Pharmaceutical Research and not provide their patients with a complete range of Manufacturers of America has also established guide- treatment alternatives based on their own moral views lines including, for example, prohibiting gifts of free about one or more of the alternatives.278 Eighteen tickets. Recent surveys show, however, that four out percent of caregivers do not provide their patients with of five doctors would allow pharmaceutical company information about doctors whose work they believe is representatives to buy them meals and 7 percent of unsatisfactory.279 Other caregivers may not provide caregivers are willing to accept free tickets.288 information on treatment alternatives that they judge

43 Policymakers should support other, more disinter- The National Library of Medicine and other fed- ested, sources for the continuing education of caregiv- eral healthcare-research agencies should work with ers.289 More information should be available about private-sector providers of healthcare information and the relationship between caregivers and those, other web-search firms to determine if standards or other than patients, who profit from their decisions, so that measures could be implemented to assist users search- patients can better evaluate treatment alternatives.290 ing for accurate healthcare information. Lawmakers at the federal and state levels have taken The federal government should more aggressively steps toward requiring such disclosures. Legislation move to disclose information on the cost and quality has been introduced in Congress that would force of healthcare procedures with careful attention paid to pharmaceutical companies to report all payouts in the development of appropriate metrics and the quality excess of $25 including gifts to physicians to be pub- of the available data. lished in a national on-line registry.291 The federal government should lead efforts to monitor Some states such as Vermont already require drug compliance with clinical practice guidelines and use companies to reveal payouts to physicians but the long- financial incentives to encourage compliance. The term effects of these laws are not yet known. In the federal research agencies should support research on short run they do not appear to have reduced pharma- the development and evaluation of decision-support ceutical payments to caregivers; in Vermont payments systems for caregivers. have increased since 2002 when the disclosure law was The federal research agencies should support research passed. 292 on the appropriate use of patient-reported outcomes Pharmaceutical companies target visits by their sales and preference-sensitive care. representatives using state records of prescriptions by State governments should provide access to informa- caregivers; they focus on caregivers who prescribe the tion on disciplinary actions taken by licensing boards most.293 Some pharmaceutical companies even provide regarding licensed healthcare providers. direct financial incentives via rebates or other means to those who prescribe their drugs most often.294 The federal government should work with state governments and practice groups to reduce barriers to A number of states have attempted to limit access the practice of telemedicine resulting from state-based by pharmaceutical companies to the records of what licensing and malpractice rules. caregivers prescribe but these restrictions have been challenged.295 Openness generally favors the availabil- The federal government should re-examine its health- ity of more rather than less information but there is an care reimbursement policies to determine if changes argument that caregivers should be able to opt out of are necessary to foster the development of appropriate these states systems to the extent necessary to prevent telemedicine practices, to encourage the use of remote- the use of their prescribing records for marketing monitoring devices and the evaluation of the data they purposes; alternatively a national or state level do-not- provide, to reflect efforts by caregivers to help patients call/visit list might be created. monitor chronic conditions, and to compensate caregivers for communicating with patients outside of Recommendations Regarding Expanding officers hours in order to improve patient care.296 Openness for Patients and Caregivers The appropriate federal agencies should work with the The federal government should increase the provision appropriate private-sector groups to develop model of consumer-oriented healthcare information based on disclosure requirements dealing with the financial the best scientific information available. interests of caregivers in treatments they recommend.

44 Chapter 7: Openness and Public Health

Th e Human Genome Project demonstrated the power the DNA fi ngerprints of the contaminant.299 Th e of openness when researchers were collaborating at Center for Infectious Disease Research and Policy and the microscopic level. Th e Severe Acute Respiratory the Pew Center on the States have created a web site Syndrome (SARS) outbreak of 2002-2003 demon- (www.pandemicpractices.org) to allow public health strated the need for openness in public health when professionals to exchange information and improve even telescopes could not help the global public-health pandemic planning.300 On the local level in the United community see an oncoming epidemic. States, though, only 13 states are capable of being interconnected with the Public Health Information Th e SARS outbreak began quietly in China. Th e Network to be able to share public-health information. Global Public Health Intelligence Network, which Th e number is expected to grow to 40 by 2012, but gathers information from various sources around the there is still much to be done.301 world, helped identify the start of the SARS outbreak from articles published in China about a mysterious Th e second lesson is that almost any facility designed illness aff ecting otherwise healthy people, even before for collaboration can help in providing an eff ective any offi cial reports were received by the WHO.297 As public-health response. For example, collaborative the outbreak gathered momentum it was clear that search tools developed by Google are being provided greater resources were needed—and scientists and to disaster-response organizations to facilitate early public-health workers around the world began an eff ort detection of potential healthcare disasters.302 to identify the disease and to formulate responses. Th e WHO helped to coordinate the work of multiple Openness and Contributions from Less laboratories to ensure the availability of appropriate Obvious Sources research materials and to reduce duplication of eff ort. Other lessons may be less obvious. A corollary to the Eventually the outbreak was contained.298 fi rst lesson is that countries that share information and provide materials essential to identifying a disease and Lessons of the SARS Outbreak fi nding a cure—often lower-income countries where Th ere are some obvious lessons to be gained about new diseases are more likely to emerge—are provid- the value of openness in the public-health arena when, ing the global health establishment with materials given our interconnected world, diseases can be spread of extraordinary value. Th ey understandably want at close to supersonic speed. Th e fi rst is the impor- their contributions recognized. Th ey are increasingly tance of obtaining and sharing information locally resistant to arrangements that they view as providing and globally. Even given heroic actions by individual the bulk of the benefi ts, including supplies of vaccines doctors and ordinary citizens to address the SARS and licensing fees or royalties, to other, more economi- outbreak, it was not until authorities in China were cally advanced countries. prepared to acknowledge that a problem existed and to Recent examples of foreign governments withholding provide relevant data that the capabilities of the global sample materials suggest that this issue is likely to scientifi c community could be mobilized. become more pressing in the future.303 In response Th e Centers for Disease Control and Prevention are to these concerns, the WHO is now considering now linking public-health laboratories around the stockpiling vaccines to ensure that poorer countries world to allow, for example, the rapid identifi cation that provide data and tissue samples but that might not of food contamination through the comparison of be able to aff ord costly medicines will be guaranteed

45 help in dealing with healthcare threats to their own Public health eff orts depend on gathering informa- citizens.304 tion from a wide variety of sources, including some of society’s most vulnerable populations. It is therefore Sometimes the mutuality of benefi t can only be important to consider who will have access to the data. recognized over time. It is clear that researchers in Should, for example, the information that is gathered sub-Saharan Africa receive substantial benefi ts today for public health purposes be readily available to law from the WHO’s Hinari Project providing them ac- enforcement offi cials? If so, what impact would such cess to scientifi c literature. What is not yet visible are access have on the willingness of individuals to provide the contributions that these researchers are more likely critical information? Our society has struggled with to make in the future because of their access today to this question in the context of the HIV Aids epidemic research journals and better research tools.305 and it is likely that we will continue to wrestle with the What is also not yet fully appreciated are the potential issue again.308 benefi ts available to researchers from data collection by, and the tacit knowledge of, individuals in these Recommendations Regarding Openness and lower-income countries. Important contributions can Public Health come from quite unexpected sources. More-open, Th e federal agencies should lead eff orts to support more-responsive systems for gathering data should multilateral surveillance networks and cooperative be designed to refl ect this. Th e International Health activities. Regulations, for example, are being changed to allow the WHO to accept disease reports from sources Th e United States should recognize, in material other than governmental offi cials and, as one observer ways, the contributions made by other, particularly noted, to empower “ordinary people to notify the right lower-income, countries that provide valuable data and authorities, without getting snarled in politics, com- samples. mercial interests, or bureaucracy.”306 In one extraordi- Priority should be given to the electronic interconnec- nary example of an unexpected source, Nathan Wolfe, tion of federal and local public-health authorities. an epidemiologist at UCLA, has established in Cam- eroon a “network of hunters to supply blood samples from themselves and the animals they eat to check for new viruses—[and] to report quickly any novel animal diseases.”307 Greater openness in public health, can, and should, be stretched to the ends of the earth.

46 Chapter 8: Openness and Medical Devices

When proponents of greater openness give examples do it safely.314 If the device is approved by the FDA, it of its value they rarely point to medical devices. Th ey is exempt from state liability rules in the normal course are more likely to cite innovations in general-purpose of its operation, reducing the manufacturer’s potential personal computers that are the result of individuals state product-liability exposure.315 “tinkering” with them—making improvements in Th e FDA approves a device “as is”—with the existing hardware and software without seeking approval from hardware and software. As with warranties from the government or the manufacturer.309 computer, electronics, and automobile manufacturers, the FDA’s approval is voided if “the hood is opened” Changes in Medical Devices and changes are made.316 Medical devices are increasingly coming to resemble Can the potential for greater user-driven innovation in these computing devices. More medical devices have medical devices be reconciled with the FDA’s mission computational capabilities; more devices are controlled to ensure the safety and effi cacy of medical devices? by software that can be modifi ed to cause the device to It may not be possible for all of the technically adept 310 do new things or to do existing things diff erently. At caregivers to successfully resist the challenge to hack/ the same time, the open-source movement has demon- improve FDA-approved medical devices. Given this, strated that software is almost infi nitely malleable and could and should the FDA provide some form of a that millions of people are willing to suggest ways to “safe harbor” for physicians and physician-directed 311 improve it. programmers where they might “tinker” without Eric Von Hippel of MIT points out in his book, penalty, similar to the safe harbor the FDA provides Democratizing Innovation, that “lead users”—those for physicians who prescribe drugs for non-FDA ap- with deep knowledge of their own needs and the proved purposes and for pharmacists who customize a resources to satisfy them—have played an important drug compound at the direction of a physician? Could role in innovation.312 Von Hippel’s work demonstrates, and should the FDA authorize small-scale experi- in particular, that much of the innovation in the area of ments with modifi ed hardware or software overseen by scientifi c instruments came from users of these instru- institutional review boards and based on the informed ments rather than from their manufacturers. Given consent of patients? Could and should the FDA this history, it would be surprising if “lead users” e.g. create a less intensive (and less-costly) review process caregivers, aren’t tempted to modify their tools, which for minor software changes in programmable medical are medical devices. Moreover, there are situations devices analogous to the less-intensive FDA review where the need to customize devices for an individual, processes for minor changes in already-approved drugs, such as in the fi eld of prosthetics, seems to invite user- while requiring rigorous reporting of adverse events? driven innovation.313 Could and should the FDA delegate, to a specialized expert body outside of the FDA, the power to review The FDA’s Responsibility and recommend proposed changes for approval? Or will the acknowledged complexity of software interac- At the same time that many medical devices are be- tions and the critical mandate to ensure patient safety coming more susceptible to modifi cation by users, they prevent the kind of innovation we would expect when continue—and justifi ably so—to be subject to review information and communications technologies infi l- by the FDA. FDA jurisdiction over medical devices is trate a new area of practice? designed to ensure that they perform as promised and

47 One other point might be made about the openness Recommendations Regarding the Openness of of medical devices. If one examines a device-rich Medical Devices environment such as a hospital intensive-care unit, one Th e FDA should begin an inquiry into the appropri- is struck by the very large number of devices making ate long-term regulatory treatment, consistent with critical measurements, with each device providing patient-safety needs, of software-controlled medical valuable data. But in many instances the output of an devices given the innovation potential demonstrated by individual device is not in a form that can be captured, the open-source software movement and the history of recorded, and manipulated together with the outputs user-led innovation in scientiﬁ c instruments. of the other devices. Just as the data underlying clinical trials need to be in machine-discoverable, Th e FDA should engage the private-sector medical- searchable, and manipulatable formats to be of greatest device community and the federal research agencies use, the value of the outputs of medical devices would to stimulate greater interoperability among medical be enhanced if they were standardized in a similar devices and greater standardization of data outputs to fashion. facilitate the creation and use of integrated data sets.

48 Chapter 9: Open Business Models

Th e returns to increased openness in research dem- describes several business models that companies can onstrate the potential for societal gains from greater embrace to increase their openness and improve their openness. But is greater openness compatible with performance.320 He analyzes two “syndromes”—“Not private returns in markets downstream from research? Invented Here” and “Not Sold Here”—that have inhibited organizations from becoming more open by As the open source software movement has grown, drawing upon innovations from outside the organiza- some critics have asserted that the model, which makes tion and from profi ting by sharing their own innova- computer source code available to all, is incompatible tions with others.321 with the profi t motive, a threat to investment in “real,” (proprietary) software, and dependent on the altru- Not Invented Here ism of programmers.317 Altruism is among the many reasons that programmers participate in the open-soft- We all have experienced the rejection of ideas or ware movement and that other individuals contribute suggestions because they were “not invented here.”322 It their time and eff ort to other “open” products. But it is is not hard to understand why this syndrome has such not the only reason. power. By defi nition, an innovation from outside an organization cannot refl ect an intimate understanding Openness, in the open-source software movement, and of the organization. Such an understanding is only in other manifestations we have described, results from possible inside an organization. An innovation from many diff erent motivations and is compatible with the outside arguably cannot be as good because it has creation of private value. It refl ects a newly emerging not passed the internal approval screens to which an theory of how value can be created.318 inside innovation is subject. If an outside innovation Th e creation of private economic value via innovation is signifi cant, the fact that it came from outside may has long been linked with the ability of a creator to be taken by others as a sign that the organization’s control his or her creation. Th e creator can then own vehicle for innovation is underperforming or even monetize the value of the creation by charging others unnecessary. for the right to access, replicate or modify it. Open- Over the years, some of the most prominent and ness, on the other hand, assumes that the public and innovative organizations encouraged a “not-invented- private value of a creation can be increased by sharing here” attitude. Proctor and Gamble (P&G), for the creation as broadly as possible, so that others example, built a widely admired product development with diff erent experiences, knowledge, insight, and process closed to outsiders. But more recently P&G incentives can contribute to and improve it. Th is idea has recognized the vast amount of creative work done of how to create value is the mirror image of creating outside of its R&D units and the potential gains value through control. available from tapping into knowledge and creativity We do not always have to choose one model or the dispersed globally—both in terms of the costs of other. But given the long history of more-closed busi- development and the time required to bring a product ness models, it is noteworthy that the idea that greater to market.323 Instead of “not invented here” P&G is openness, appropriately applied, can help build better urging its researchers to fi nd innovations that can be businesses is gaining wider acceptance.319 labeled “proudly developed elsewhere” and “reapplied with pride.”324 Henry Chesbrough, of the University of California at Berkeley, in his book, Open Business Models,

49 Even large pharmaceutical companies that tradition- the stimulation of other work in the area.331 Merck, ally have sought to develop their own drugs and for example, has invested millions in a public genome protect them with a barricade of patents rather than database to stimulate research it hopes will help to relying on the creative work of others are exhibiting develop its core “end products.”332 greater openness. As the CEO of Novartis stated, Other pharmaceutical companies are collaborating “we can’t possibly do it all ourselves.”325 Th e CEO of with companies (often smaller and more focused) by Glaxo SmithKline announced that managers will be making available, from their large libraries of small rewarded for nurturing products whether developed molecules, certain molecules that they are not pursu- in-house or acquired from the outside.326 More open ing, with the prospect of sharing in any profi ts that the attitudes have led to links between large pharmaceuti- other company might obtain.333 (One can even imagine cal companies and smaller outside fi rms, particularly an Internet-enabled auction where companies with biotech and diagnostic companies, as well as a greater such molecular libraries might progressively “open” willingness on the part of large pharmaceutical compa- them, providing more and more information about nies to collaborate with each other, and with academic specifi c molecules they are not pursuing in return for and government researchers such as in the SNP increased payments or larger shares of any downstream Consortium.327 It is telling that InnoCentive, one of profi ts.) the premier examples of bringing outsiders into the R&D process, began as a subsidiary of Eli Lilly.328 We have not addressed in any detail possible public- policy initiatives to encourage more open business Not Sold Here models—companies will make their choices about the appropriate degree of openness based on their Th e other syndrome, “Not Sold Here,” also is becom- own situations. But others have made proposals, ing less useful in defi ning and predicting organiza- for example, to provide tax incentives for greater tional behavior. “Not sold here” is when an organiza- collaboration.334 In some cases, public policies have tion doesn’t attempt to pursue a direction or capture been adopted that may discourage greater openness. the value of an idea that it has generated because it is P&G, for example, had a policy in the past of making outside the core activities of the organization—what research results available after three years if the com- the organization “sells.” One example would be a pany decided not to pursue them. P&G provided these company’s refusal to sell or lease research results results to colleges and universities to be developed and that have not led to the company’s development of a commercialized but ceased doing so when the tax code product.329 Again, it is not hard to understand the was changed. Perhaps the tax code should not favor reasoning. A company’s employees might fear that its openness, but it should not discourage it either. rivals will benefi t from their ideas—even if their own company will not. Maybe the other company will take Companies seeking a profi t understand the importance the idea and make it into a brilliant success. Who of innovation and are increasingly building global strat- would want to acknowledge responsibility for letting egies to locate and benefi t from innovations around the that now successful idea get away?330 Th ere is also world. Th e beliefs underlying the move toward greater value for competitors in learning about what doesn’t openness—that more people can benefi t from more work so they can avoid research “rabbit holes”—why information and that more people can make unique make life easier for rivals? contributions based on their interests, experiences, and insights—may be captured in the maxim: All Yet here, too, changes are in the wind. Novartis is other things being equal, the team with the most smart making the raw data from its genomic research on people wins.* Th ere are obviously many diff erent kinds Type 2 diabetes broadly available. Perhaps this is due, of “smartness.” Diff erent kinds are needed in diff erent in part, to altruism, but observers point to the benefi ts circumstances—just as the optimal degree of openness for Novartis, including the building of stronger will depend on the specifi cs of a situation. But greater relationships with leading academic researchers and openness off ers an opportunity to benefi t from the contributions of more people, whether to create public * Coined by DCC project director Elliot Maxwell. or private value.

50 Conclusion

Openness is not binary; information or processes are This report is a first attempt to identify some of the not open or closed. They sit on a broad continuum areas that are being changed by greater openness. It stretching from closed to open, based on their accessi- is not exhaustive and, as information and communica- bility and responsiveness. And the most open result is tions technologies suffuse the healthcare arena, the not always the best result, depending on the particular list is likely to grow over time. We hope that others goals to be accomplished and the specific circum- will be encouraged to develop this theme and spotlight stances. But greater openness can be of great benefit, other areas where openness can help us transform from the academic world to the business world, from today’s pre-industrial and wasteful healthcare system the research endeavor to the delivery of treatment, toward one that is more responsive, more efficient, from the development of medical devices to the foster- more personalized, more evidence-based, and more ing of a more-responsive global public-health system. oriented toward fostering life-long good health. Greater openness enhances, and is in turn fostered by, increased collaboration.

51 End Notes:

1 Committee for Economic Development, Open Delivery System: A New Engineering/Health Care Part- Standards, Open Source, and Open Innovation nership (Washington, D.C.: The National Academies (Washington, D.C.: CED, April 2006); Committee Press, 2005), p. 1. for Economic Development, Promoting Innovation and Economic Growth: The Special Problem of Digital 7 Reid, Compton, Grossman, and Fanjiang, eds., Build- Intellectual Property (Washington, D.C.: CED, March ing a Better Delivery System, p. 1. 2004). 8 John Carey, “Medical Guesswork,” BusinessWeek, May 2 Tim Hubbard and James Love, “Paying for Public 29, 2006, p. 73. Goods,” in Rishab Aiyer Ghosh, ed., Code: Collabora- 9 Nancy Ferris, “Medical mishaps,” Government tive Ownership and the Digital Economy (Cambridge: HealthIT, February 19, 2007, available at ; 3 Daniel Castro, “Improving Healthcare: Why a Dose Committee for Economic Development, The Em- of IT May Be Just What the Doctor Ordered,” The ployer-Based Health-Insurance System is Failing: What Information Technology & Innovation Foundation, We Must Do About It (Washington, D.C.: CED, October 2007, available at ; “Health Information Technol- Care in America, “Crossing the Quality Chasm: A ogy Leadership Panel: Final Report,” The Lewin New Health System for the 21st Century,” Institute Group, March 2005, available at ; President’s America’s Hospitals,” Newsweek, October 16, 2006, p. Information Technology Advisory Committee, 46. Claudia Kalb adds that a report from the Institute “Transforming Health Care Through Information of Medicine conducted in 1999 declared that 100,000 Technology,” February 2001, available at ; Karen patient healthcare information constitutes the source Davenport, “Navigating American Health Care: How for one-fifth of these errors. But see also Clement J. Information Technology Can Foster Health Care McDonald, Michael Weiner, and Siu L. Hui, “Deaths Improvement,” Center for American Progress, May Due to Medical Errors are Exaggerated in Institute of 2007, available at ; Benton Founda- sociation 284 (2004), pp. 93-95; Robert G. Berger and tion, “Networking for Better Care: Health Care in J.P. Kichak, “Computerized Physician Order Entry: the Information Age,” 1999, available at ; Informatics Association 11, (2004), pp. 100-103. eHealth Initiative, “Blueprint: Building Consensus 10 Mara G. Aspinall and Richard G. Hamermesh, “Real- for Common Action,” October 10, 2007, available izing the Promise of Personalized Medicine,” Harvard at . 11 Reid, Compton, Grossman, and Fanjiang, eds., Build- ing a Better Delivery System, p. 1. 4 Paul A. David, “The Economic Logic of ‘Open Science’ and the Balance Between Private Property 12 Nancy Ferris, “Health IT Incentives,” Government Rights and the Public Domain in Scientific Data and Health IT, April 29, 2007, available at . Policy Research, March 17, 2003, available at . the Promise of Genomics in Biomedical Research,” 5 IBM, Patient-Centric Healthcare: It’s Here, But Just Not Journal of American Medical Association, vol. 294, no. Widely Distributed (New York: IBM, 2006), pp. 3-4. 11, p. 1399. 6 Proctor P. Reid, W. Dale Compton, Jerome H. 14 Arti K. Rai, “Open and Collaborative Research: A Grossman, and Gary Fanjiang, eds., Building A Better New Model for Biomedicine” Duke University School of Law, October 2004, p. 17.

52 End Notes:

15 Rai, “Open and Collaborative Research,” p. 3. Cancer,” The Wall Street Journal, October 18, 2007, p. A17; Ben Hirschler, “Personalized Medicine Slowly 16 Rai, “Open and Collaborative Research,” pp. 17-18. Taking Shape,” Reuters, November 15, 2007, available 17 Google Technology, “The technology behind Google’s at . Waxman and Gambino technology/pigeonrank.html>. report that epigenetic therapy “involves correcting and reversing abnormal cancer-causing gene expressions 18 Collins and Guttmacher, “Realizing the Promise of through the use of drugs designed to target specific Genomics in Biomedical Research,” p. 1399. proteins involved in gene control.” 19 Rai, “Open and Collaborative Research,” pp. 2-19. 26 Jennifer Corbett Dooren, “Breast-Cancer Options Although it might have been possible for private- Are Studied,” The Wall Street Journal, May 24, sector researchers to access the HapMap database, 2006, p. D5; Anna Wilde Mathews, “In Milestone, combine it with their own genotype data, and file an FDA Pushes Genetic Tests Tied to Drug,” The Wall application for a patent on a haplotype, the HapMap Street Journal, August 16, 2007, p. A1. Shortly after project’s licensing scheme “requires those who access research revealed the potential for certain patients the HapMap database to agree that they will not file to react adversely to warfarin, the FDA added to product-patent applications in cases where they have warfarin’s label a warning that a lower initial dose relied in part on HapMap data.” “should be considered for patients with certain genetic variations.” 20 The SNP Consortium LTD, “Single Nucleotide Polymorphisms for Biomedical Research,” available at 27 Emily Singer, “Still Waiting for Personalized . Medicine,” Technology Review, November/December 2006, p. 76. It is important to note that a group of 21 Rai, “Open and Collaborative Research,” p. 19. pharmaceutical companies and academic institutions 22 Collins and Guttmacher, “Realizing the Promise of recently formed the International Serious Adverse Genomics in Biomedical Research,” pp. 1399-1402. Events Consortium to study the relationship between genomic information and adverse events. 23 “Researchers find heart disease, type 2 diabetes gene link,” iVillage Total Health, October 21, 2004, avail- 28 Mara G. Aspinall and Richard G. Hamermesh, “Real- able at ; Nicholas Wade, Business Review, October 2007, p. 111. “Research Teams Identify Gene Seen as Tied to 29 Aspinall and Hamermesh, “Realizing the Promise of Multiple Sclerosis,” The New York Times, July 30, Personalized Medicine,” pp. 110-111. 2007, p. A9; Nicholas Wade, “Genome Researchers Find New Indicators of Breast Cancer Risk,” The 30 Keith Winstein, “DNA Decoding Maps Mainstream New York Times, May 29, 2007, p. A13. Nicholas Future,” The Wall Street Journal, October 4, 2007, p. Wade reports that one study found that the presence B3; Aspinall and Hamermesh, “Realizing the Promise of two relatively rare genetic variations indicated a 44 of Personalized Medicine,” p. 111; “Mayo Clinic, IBM to 64 percent greater risk of breast cancer. See also Aim to Drive Medical Breakthroughs,” Mayo Clinic, U.S. Department of Health and Human Services, August 4, 2004, available at ; Steven Reinberg, . “Kaiser Permanente Study Hopes to Find Factors Behind a Range of Diseases,” MedicineNet.com, Feb- 24 Collins and Guttmacher, “Realizing the Promise of ruary 4, 2007, available at ; But see 25 National Institute of General Medical Sciences, Gautam Naik, “As Gene Tests Spread, Questions “Pharmacogenetics Fact Sheet,” May 2006, available Follow” The Wall Street Journal, December 12, 2007, at ; Samuel Waxman and Richard Gambino, “The New Ways We Fight

53 End Notes:

31 Rai, “Open and Collaborative Research,” p. 20. Innovations,” Berkeley Technology Law Journal, vol. 2, no. 2 (Spring 2005), p. 42. Cambia, an Australian 32 Rai, “Open and Collaborative Research,” pp. 21-22. open biotech research organization aims to create 33 National Cancer Institute Center for Bioinformatics, “portfolios of essential biotech research tools and “Projects,” available at . already created two technologies that engineer around proprietary tools critical for biotechnology-based 34 National Cancer Institute Center for Bioinformatics, research.” For further information on Cambia, see “Cancer Gene Data Curation Project,” available at Nathanael Johnson, “Steal This Genome!” East Bay ; National Express, March 30, 2005, available at . baseDef.tiles>; National Cancer Institute, “Clini- cal Research Information Exchange,” available at 41 The Welcome Trust, “The Approach of the Welcome . Trust in Managing Intellectual Property to Maximise Public Health Benefit,” November 2006, available 35 Tom Paulson, “UW researcher building disease at . available at . 42 Eric S. Raymond, “The Cathedral and the Bazaar,” First Monday, 1998, available at . PLOS strong supporters of openness recognize the need has suggested that anyone should be able to search to provide recognition for contributions. One of through public databases on pathogens, searching for the creative commons license, for example, provides familiar proteins and identifying drug candidates that among the choices for creators, “distribution with might bind to them. The proposal would give new attribution.” meaning to Eric Raymond’s open software development aphorism, “Given enough eyeballs, all bugs are 37 Marilyn Chase, “Gates Won’t Fund AIDS Research- shallow.” ers Unless They Pool Data,” The Wall Street Journal, July 20, 2006, p. B1. 43 Gautam Naik, “Seafaring Scientist Sees Rich Promise in Tiny Organisms,” The Wall Street Journal, March 38 “Human Genome Project and SNP Consortium 13, 2007, p. B1. Announce Collaboration To Identify new Genetic Markers for Disease and Enhance Utility of Hu- 44 Peter Gotzsche, Charlotte Haug and Torben man Genome ‘Working Draft,’” Whitehead Institute Schroeder, “Registries and Registration of Clinical for Biomedical Research, July 11, 2000, available Trials,” The New England Journal of Medicine (Decem- at ; “Novartis maps genome of type-2 diabetes patients,” Reuters, February 12, 2007, avail- 45 Statement of Jim Guest, President and CEO, able at . Health, Education, Labor, and Pensions on S. 3807, the Enhancing Drug Safety and Innovation Act of 39 MedicineNet, “Definition of Biomarker,” available 2006, November 16, 2006. Jim Guest notes that in at . According to MedicineNet. of fraud in the company’s clinical trial of about 24,000 com, a biomarker is a “biochemical feature or facet patients, some cases of which the maker Sanofi that can be used to measure the progress of disease or already knew about yet failed to notify the agency.” the effects of treatment.” 46 Statement of Jim Guest, November 16, 2006. 40 Amy Kapczynski, Samantha Chaifetz, Zachary Katz & Yochai Benkler, “Addressing Global Health Inequi- ties: An Open Licensing Approach for University

54 End Notes:

47 Statement of Jim Guest, November 16, 2006; Nanci 2007, available at . too Closely,” USA Today, January 9, 2007, p. D7. 58 Chan and others, “Clinical Trial Registrations,” p. 48 Statement of Jim Guest, November 16, 2006; 1631. “Report identifies FDA IT system weaknesses,” Modern Healthcare, September 28, 2007, available at 59 Chan and others, “Clinical Trial Registrations,” p. . 60 Ida Sim, “Registration of Clinical Trials: Background 49 Jeffrey Drazen and Alastair Wood, “Trial Registra- and Implementation,” World Health Organization, tion Report Card,” The New England Journal of August 22, 2006, available at . 50 Drazen and Wood, “Trial Registration Report Card,” 61 Food and Drug Administration Amendments Act of p. 2810. 2007, H.R. 3580, 110th Cong., 1st sess. (2007); Anna Wilde Matthews, “Drug Industry Faces Bitter Pill,” 51 World Health Organization, “Formal Consultation The Wall Street Journal, February 2, 2007, p. A6. on Disclosure Timing Policy,” April 26, 2006, available at . Evidence-Based Medicine,” University of California San Francisco, February 2007, available at . Registration of Clinical Trials,” p. 2812. 63 Statement of Jim Guest, November 16, 2006; Anna 53 World Health Organization, “Formal Consultation Wilde Mathews and Jeanne Whalen, “Diabetes on Disclosure Timing Policy.” Expert Raised Issue of Avandia Heart Risk in 2000,” The Wall Street Journal, May 24, 2007, p. A4. 54 AdvaMed, “AdvaMed Response to the World Health Organization International Clinical Trials Registry 64 Anna Wilde Mathews, “FDA Considers Tougher Platform Request for Comments on Delayed Disclo- Rules on Drug Trials,” The Wall Street Journal, June sure,” March 31, 2006, available at ; Michael Goodyear, Lisa Golec, and Sabina Calais, “Commen- 65 Rich Daly, “Positive Clinical-Trial Results Linked to tary on WHO International Clinical Trials Registry Competing Interests,” Psychiatric News, vol. 40, no. 20, Platform,” November 11, 2005, available at . author with a reported financial conflict of interest. 55 An-Wen Chan and others, “Clinical Trial Registra- 66 Louis Grumet, “Sunlight Is the Best Disinfectant,” tions: Transparency is the Watchword,” The Lancet, The CPA Journal, December 2003, available at vol. 367, (2006), p. 1631. . 56 Chan and others, “Clinical Trial Registrations,” p. 1631. 67 Aaron S. Kesselheim and Michelle Mello, “Confi- dentiality Laws and Secrecy in Medical Research: 57 Journal of Negative Results in Biomedicine, “Journal Improving Public Access to Data on Drug Safety,” of Negative Results in Biomedicine,” available at Health Affairs, vol. 26, no. 2, (2007), pp. 483-491. ; PLOS Clinical Trials, “PLoS Clinical Trials,” available at ; See also Thomas Standards, Open Source, and Open Innovation (Wash- Goetz, “Freeing the Dark Data of Failed Scientific ington, D.C.: CED, April 2006), p. 14. According to a Experiments,” Wired Magazine, September 25, recent CED report, “Companies that provide proprietary technology for the implementation of standards

55 End Notes:

under RF (royalty free) licenses still retain important 72 Gardiner Harris, “Report Assails F.D.A. Oversight advantages with respect to their technology. They are of Clinical Trials,” The New York Times, Septem- not barred from exercising their intellectual property ber 28, 2007, available at . implementing the standard. Moreover, their familiarity with the technology can be employed in developing 73 Harris, “Report Assails F.D.A. Oversight of Clinical other applications.” Trials.” 69 “Getting the Formula Right in Post-Marketing Com- 74 Arthur L. Caplan and Bernice S. Elger, “Consent and mitment Studies,” Pharmaceutical Commerce, (Janu- Anonymization in Research Involving Biobanks,” ary/February 2007), p. 14; Lynn M. Etheredge, “A EMBO Reports, vol. 7, no. 7 (2006), pp. 1-6. Rapid Learning Health System,” Health Affairs, vol. 75 Recebba Skloot, “Taking the Least of You,” The 26, no. 2 (2007), p. 117. Lynn M. Etheredge notes the New York Times Magazine, April 16, 2006, avail- seemingly endless possibilities of national computer- able at ; Larry Rohter, “In the Ama- the NIH and required by the FDA. He argues that zon, Giving Blood but Getting Nothing,” The New “the NIH could require that all NIH-funded clinical York Times, June 20, 2007, available at . type formats to national research databases. Re- searchers who try to reach conclusions from multiple 76 Catherine Arnst, “Keeping Lawyers Out of the Lab,” studies now must engage in ‘meta-analyses’ of reported BusinessWeek, February 5, 2007, pp. 54-55. statistics rather than being able to analyze combined 77 Lori Rodriguez, “Feds aim to get more minorities in data sets. Biomedical research could advance more clinical trials,” The Houston Chronicle, May 7, 2007; rapidly, and these databases could also prove useful Lorraine Woellert, “Drug Trials Sometimes Exclude to evaluate new evidence-based protocols and new the Elderly, U.S. Auditors Say,” Bloomberg News, Oc- technologies, since the NIH funds leading-edge work tober 29, 2007, available at . Test populations are overwhelmingly Near You,” Bio-IT World.com, October 25, 2007, white and male. They tend to exclude older patients available at ; “I.T. Thin in HHS Regulatory Plans,” opposed to patients with high co-morbidity or at high Health Data Management, December 10, 2007, risk. available at . The FDA November 29, 2004, available at . The Vioxx case serves as an in the new electronic common technical document important reminder that due to the limited duration (eCTD) format as of January 1, 2008. of clinical trials, adverse events are not easily predict- 71 Clinical Data Interchange Standards Consortium, able. No adverse events showed up during the initial “Mission and Strategy,”available at . The CDISC has already a placebo in a long-term study of patients at risk for taken steps to make data computable by establishing colon cancer, a rise in heart attacks was clear. “worldwide industry standards to support the elec- 79 U.S. Food and Drug Administration, “MedWatch,” tronic acquisition, exchange, submission and archiving available at ; “FDA of clinical trials data and metadata for medical and Addresses Conflicts of Interest Among Advisers,” biopharmaceutical product development.” The Associated Press, November 15, 2007.

56 End Notes:

80 “HHS Implores FDA to Improve Oversight of 88 Larry Brilliant, “The Spreading Epidemic,” Forbes, Drug-Maker Data,” Th e Wall Street Journal, July 10, May 7, 2007, p. 174. 2006, p. A9; Statement of Jim Guest, November 16, 2006. Out of 860 studies that one study revealed as 89 Stephanie Saul, “Drug Safety Critic Hurls Darts incomplete, some 260 were mandated to follow up From the Inside,” The New York Times, July 22, 2007, drugs that had been approved for five or more years. available at . In one 81 “HHS Implores FDA to Improve Oversight of Drug- rather unusual case, Dr. Steven Nissen, chairmen Maker Data,” p. A9; Harris, “Report Assails F.D.A. of cardiovascular medicine at the Cleveland Clinic, Oversight of Clinical Trials.” In a recently released cast severe doubts on the safety of Avandia diabetes report, the inspector general of the Department of medication. But his initial criticisms were questioned Health and Human Services, Daniel R. Levinson, because he worked as a consultant to a competing found that “federal health officials did not know how drug maker at the time. Later, Nissen reviewed 42 many clinical trials were being conducted, audited clinical studies of Avandia involving 28,000 patients, fewer than 1 percent of the testing sites and, on the and linked Avandia to the risk of heart attacks. This rare occasions when inspectors did appear, generally time Nissen’s findings did not fall on deaf ears. This showed up long after the tests had been completed.” case demonstrates that one cannot always conclude The New York Times also reported that “the agency that a doctor or researcher who has a potential (FDA) almost never followed up with inspections to conflict of interest is necessarily wrong and that the determine whether the corrective actions that the data must be examined independently. agency demanded had occurred.” 90 Kathleen Kerr, “New Online Tool for Physicians,” 82 Shankar Vedantam, “FDA Told U.S. Drug System is Newsday, January 16, 2007, available at . Washington Post, September 23, 2006, p. A1. 91 Lynn M. Etheredge, “A Rapid Learning Health 83 Julie Fleming Brown, “Book Review of Powerful System,” p. 109. Medicines: The Benefits, Risks, and Costs of Pre- scription Drugs,” Jurimetrics, vol. 46 (Winter 2006), p. 92 Committee for Economic Development, Quality, 217. Affordable Health Care for All: Moving Beyond the Employer-Based Health-Insurance System (Washington, 84 Anna Wilde Mathews and Jeanne Whalen, “Diabetes D.C.: CED, 2007), p. 57. Expert Raised Issue of Avandia Heart Risk in 2000,” The Wall Street Journal, May 24, 2007, p. A4; Anna 93 Helen Fallon, “Electronic Journals: Current trends/ Wilde Mathews, “Senators to Propose New Safety future directions” (address given at the “LIR An- Tactics for FDA,” Th e Wall Street Journal, June 21, nual Seminar,” NUI Maynooth, 2004), available at 2006, p. D9. . 85 “Former FDA Commissioner McClellan Says Agency Should Review Health Care Databases to Improve 94 Stevan Harnad, “Maximizing Research Impact Prescription Drug Safety Efforts,” Medical News Through Institutional and National Open-Access Today, March 15, 2007, available at . Science E-Prints Repository, May 2006, available at . FDA Oversight,” U.S. Medicine Information Central, June 2007, available at . to Be Tainted By Sloppy Analysis,” The Wall Street Journal, September 14, 2007, p. B1. 87 Lynn M. Etheredge, “A Rapid Learning Health System,” Health Affairs, vol. 26, no. 2 (2007). 96 Lawrence K. Altman and William J. Broad, “Global Trend: More Science, More Fraud,” The New York Times, December 20, 2005, p. D1.

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97 Lawrence K. Altman, “For Science’s Gatekeepers, a 106 Michael Geist, “Push for Open Access to Research,” Credibility Gap,” The New York Times, May 2, 2006, BBC News, February 28, 2007, available at . 98 Mary Waltham, “JISC: Learned Society Open Access Business Models,” June 2005, available at . Goods,” in Rishab Aiyer Ghosh, ed., Code: Collabora- tive Ownership and the Digital Economy (Cambridge: 99 Wayne Johnston, “The Library as an Agent for MIT Press, 2005), pp. 207-229. Transforming Scholarly Communications,” University of Guelph, available at . 2006), p. 696. 100 World Health Organization, “Health InterNetwork 109 Gunther Eysenbach, “The Open Access Advantage,” Access to Research Initiative,” available at . (April-June 2006), available at . 101 arXive on-line database (Cornell University Library, Ithaca, NY., 1991 onward), available through Cornell 110 Karim R. Lakhani and others, “The Value of Open- University Library at . ness in Scientific Problem Solving,” Working Paper 07-050, October 2006, available at . 103 Open Citation Project, “The Effect of Open Ac- 111 Katharine Sanderson, “Open access for chemistry,” cess and Downloads (‘Hits’) on Citation Impact: A Royal Society of Chemistry, August 22, 2006, available Bibliography of Studies,” available at . August/22080601.asp>. 104 Leslie Chan and others, “Budapest Open Access 112 A discussion of the relative merits of anonymous Initiative,” February 14, 2002, available at . In 2003, of this paper. the Berlin Declaration, the Bethesda Statement, the Wellcome Trust, and the ACRL Principles and Strat- 113 Organization for Economic Cooperation and egies for the Reform of Scholarly Communications Development, “OECD Principles and Guidelines echoed these messages. See for example, Hans-Jorg for Access to Research Data from Public Fund- Bullinger and others, “Berlin Declaration on Open ing,” 2007, available at . Heinz Nixdorf Zentrum fur Informationsmanagement in der Max-Planck-Gesellschaft, October 22, 2003, 114 OECD, “OECD Principles and Guidelines.” available at ; Patrick O. Brown and others, “Bethesda Statement on Open Access 116 OECD, “OECD Principles and Guidelines.” Publishing,” Earlham College, June 20, 2003, available 117 OECD, “OECD Principles and Guidelines.” at . 118 Geist, “Push For Open Access to Research.” 105 Gary Byrd, Shelley Bader, and Anthony Mazzaschi, 119 David Weinberger, “BioMed Central and Open Sci- “The status of open access publishing by academic ence Endeavors,” The Berkman Center for Internet & societies,” Journal of the Medical Library Association, Society at Harvard Law School, January 2007, available vol. 93, no. 4 (October 2005), p. 423. at . This follows the tradition of support for open access by the high energy physics community (e.g. arXiv.org).

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120 “Accessing NIH Research,” The Los Angeles Times, 131 Select Committee on Science and Technology July 27, 2007, available at . at . Taxpayer-Funded Research Access,” (press release, Washington, D.C., July 20, 2007). 132 Amy Dockser Marcus, “Will Sharing Ideas Advance Cancer Research?” The Wall Street Journal, September 122 National Science Foundation Office of Inspector 18, 2007, p. D1. Many academic researchers refuse General, “Audit of Interest in NSF Providing More to share information with others with whom they Research Results,” September 25, 2006, available at may be competing. This stems from the desire to be . published, the potential for tenure and professional 123 Federal Research Public Access Act, S. 2695, 109th awards, competition in getting grants and the secrecy Cong., 2nd sess. (2006). inherent to processes of commercialization and patents. To encourage the sharing of ideas in science, 124 H.R. 1867 was sponsored by the House Subcom- Avichai Kremer co-founded Prize4Life, a $1 million mittee on Research and Science Education. It was prize for ALS biomarker discovery. passed on May 2, 2007 by a vote of 399 yes to 17 no. President Bush vetoed the bill on November 13, 2007 133 Rick Anderson, “Author disincentives and open ac- for budgetary reasons. cess,” Serials Review, vol. 30, no. 4 (2004), pp. 288-291; Nicholas Zamiska, “Outbreak of Pig Disease in China 125 Cass Sunstein, “A Brave New Wikiworld,” The Prompts Monitoring in Vietnam,” The Wall Street Washington Post, February 24, 2007, p. A19. Journal, August 20, 2007, p. A4. Open-access journals such as the Journal of High Energy Physics have 126 Wikipedia, “Leo Szilard,” October 14, 2007, available demonstrated such an impact. at . Some 60 years ago, the noted physicist Leo Szilard, 134 Arti K. Rai, “Open and Collaborative Research: A even suggested that each scientist be issued 100 New Model for Biomedicine” Duke University School vouchers to pay for publishing papers. of Law, October 2004, p. 27. 127 The Wellcome Trust, “Costs and Business Models in 135 Eysenbach, “Citation Advantage of Open Access Scientific Research Publishing,” April 2004, available Articles,” p. 697. at . 136 Gary Ward, “Thoughts on digital scholarship in mi- crobiology,” Create Change, 2006, available at . (West Sussex: Association of Learned and Profes- sional Society Publishers, October 2005), p. 1; Rick 137 Jim Giles, “PR’s ‘Pit Bull’ Takes on Open Access,” Weiss, “Health Findings From Institute to be Free Nature.com, January 24, 2007, available at . But see also ; Brian Crawford, “Chairman’s Corner,” Profes- of Hughes supported research 6 months after the sional Scholarly Publishing Bulletin, vol. 7, no. 1, (Spring reports are published. 2007), available at . 129 Mark Walport, “Everyone’s a Winner,” The Times Higher Education Supplement, May 7, 2004. 138 Giles, “PR’s ‘Pit Bull’ Takes on Open Access.” 130 Gunther Eysenbach, “The Open Access Advantage,” 139 Giles, “PR’s ‘Pit Bull’ Takes on Open Access.” Journal of Medical Internet Research, vol. 8, no. 2 140 Paul A. David, “The Economic Logic of ‘Open (April-June 2006), available at . Rights and the Public Domain in Scientific Data and

59 End Notes:

Information: A Primer,” Stanford Institute for Economic Healthcare Through Information Technology,” Policy Research, March 17, 2003, available at . 150 Barbara McConnell, “Hospital Leaders Target Elec- 141 Australian National University, “Demetrius: The tronic Medical Record Implementation,” Louisiana Institutional Repository of the ANU,” available at Medical News, November 3, 2006, available at ; University of Toronto, acadiana.medicalnewsinc.com>. “University of Toronto Repository,” available at ; Univer- 151 Kate Ackerman, “States Take Action on E-Rx, But sity of British Columbia, “Public Knowledge Project,” Federal Role Remains Unclear,” iHealthBeat, Septem- available at . ber 4, 2007, available at . Already, available at . e-prescriptions have advanced considerably at the state level. While Alaska recently became the last state to 143 Stevan Harnad, “Publish or Perish – Self-Archive allow e-prescribing, some states, including Minnesota, to Flourish: The Green Route to Open Access,” mandate that doctors use e-prescriptions. Others, like European Research Consortium for Informatics and Massachusetts, have undertaken initiatives to provide Mathematics, no. 64 (January 2006), p. 19. physicians with the necessary software to speed the 144 Louise Liang, “The Gap Between Evidence And transition toward e-prescribing. Practice: We still have much to learn about practice 152 Frederico Girosi, Robin Melli and Richard Scoville, and patient factors that affect clinical outcomes,” Extrapolating Evidence of Health Information Technol- Health Affairs, vol. 26, no. 2 (2007), p. 120; E.A. ogy Savings and Costs (Santa Monica, CA: RAND Balas and S.A. Boren, “Managing Clinical Knowledge Corporation, 2005), available at . Informatics, 2002; Jon F. Kerner, Ph.D., “Translating Research into Improved Outcomes” (presentation 153 Girosi, Melli, and Scoville, “Extrapolating Evidence.” by the National Cancer Institute at the American Jan Walker et al., “The Value of Health Care Infor- Association for Cancer Education, October 12, 2006). mation Exchange and Interoperability,” Health Affairs, vol. 19 (2005), available at . Other research- Outcomes.” See also “U.K. Names Expert to Lead ers estimate national savings of $78 billion per year. Translational Research Model,” Medical Laboratory World, December 7, 2007. 154 “Overview: Health IT improves care and saves lives,” Health IT Now, 2007, available at ; Bernie Monegain, Grossman, and Gary Fanjiang, eds., Building A Better “Drowning in claims,” Healthcare IT News, April 1, Delivery System: A New Engineering/Health Care Part- 2007, available at . Press, 2005), p. 1. 155 Long and others, “Ending the Document Game,” p. 147 United States Department of Health & Human 115. Services, “Your Health Information Privacy Rights,” available at . Computers Spilling Your History,” The New York Times, December 3, 2006, p. 1; Christopher Lee, 148 William Hersh, “Health Care Information Technol- “U.S. Lags in Several Areas of Health Care, Study ogy: Progress and Barriers,” Journal of the American Finds,” The Washington Post, November 3, 2006, p. Medical Association 292, (2004), pp. 2273-2274. A14; Catherine Rampell, “Your Health Data, Plugged 149 Michael Long and others, “Ending the Docu- In to the Web,” The Washington Post, October 5, ment Game: Connecting and Transforming Your 2007, p. D1. According to the Department of Health and Human Services, about 90 percent of physicians

60 End Notes:

and more than 80 percent of hospitals still rely on 164 David Gans et al., “Medical Groups’ Adoption of paper records. Electronic Health Records and Information Systems,” Health Affairs, vol. 24 (2005), pp. 1323-1333. 157 Grant Gross, “Vendors demonstrate e-health record network,” IDG News Service, January 23, 2007, avail- 165 David Twiddy, “Electronic Medical Records Use May able at . at . 158 “Bit by Bit,” The Economist, December 9, 2006, p. 69; Gary McWilliams, “Medical-Record Enterprise 166 Diana Manos, “House Bill Targets Cost of Healthcare Is Mired in Dispute,” The Wall Street Journal, July IT,” Healthcare IT News, April 20, 2007, available at 27, 2007, p. B5. The software developer behind the ; Richard Dunham, project recently stopped work as a result of a non- “Health-Care Reform is in the Air, But. . .” Business- disclosed dispute. Intel and Wal-Mart hope to court Week, February 5, 2007, p. 34. new vendors to continue with the project. 167 Richard Perez-Pena, “Big Medical Step, Starting with 159 Nancy Ferris, “Vets Can See EMR Data,” Govern- the City’s Poor,” The New York Times, April 16, 2007, ment Health IT, June 24, 2007, available at ; Diane Manos, “VA and DoD to Launch Integrated 168 Beckie Kelly Schuerenberg, “Industry Initiative Healthcare IT System,” Healthcare IT News, January Plans to Give E-Rx to All Physicians,” Health Data 23, 2007, available at ; Associated Press, “Of- healthdatamanagement.com/html/current/Current- ficials Say Joint Health Records to Alleviate Delays IssueStory.cfm?articleId=14733>. Could be Years Away,” The Boston Herald, May 8, 169 Thomas Goetz, “Physician, Upgrade Thyself,” The 2007, available at . New York Times, May 30, 2007, p. A25. 160 “Mayo Clinic, IBM Aim to Drive Medical Break- 170 LaShell Stratton, “A Call for Electronic Medical throughs,” Mayo Clinic¸ August 4, 2004, available at Records,” Print Solutions, May 2006, available at . healthcare_emr.html>. 161 Daniel Costello, “Kaiser replaces chief of digital 171 Proctor P. Reid, W. Dale Compton, Jerome H. records project” The Los Angeles Times, February 27, Grossman, and Gary Fanjiang, eds., Building A Better 2007, available at . nership (Washington, D.C.: The National Academies 162 Christopher Lee, “Doctors Slow to Adopt E-Records Press, 2005). for Patients,” The Washington Post, October 12, 172 United States Department of Health and Human 2006, p. A10; “U.S. Lags in Health IT Adoption, Services, “American Health Information Com- National Coordination Says,” iHealthBeat, September munity,” Health Information Technology, September 25, 2007, available at . National-Coordinator-Says.aspx?topicID=57>. 173 United States Department of Health and Human 163 Nancy Ferris, “CMS offers free online training in Services, “Office of the National Coordinator for health IT implementation,” Government Health IT, Health Information Technology,” available at . The government article98212-04-12-07-Web>. The Centers for Medi- might take action to avoid requiring all players to care and Medicaid Services are responding to this pay royalties as it did when faced with claims by the issue by offering free online training in implementing American Medical Association that everyone would health IT to medical offices have to pay to use the AMA’s copyrighted naming system for diseases when seeking reimbursement for

61 End Notes:

services rendered. At that time the federal govern- 183 Laura Dunlop, “Electronic Health Records: In- ment purchased a non-exclusive license for a compet- teroperability Challenges Patients’ Right to Privacy,” ing disease taxonomy named SNOMED, allowing Shidler Journal of Law, Commerce + Technology, vol. caregivers and insurers to use it for free. 3, no. 4 (Spring 2007), available at . Microsoft’s PHR HealthVault, for Interoperability Paper,” September 2007. “A software example, is arguably not covered by HIPAA. application with XBRL-like mapping and processing capabilities might be able to accept healthcare 184 Kirk J Nahra, “The Healthcare Privacy Debate Heats data from any computer’s software, format it into Up,” The Privacy Advisor, vol. 7, no. 9 (September XBRL-like data, transmit it, and reformat it into any 2007), pp. 3-5. receiving computer’s software data protocol, where it can then be used without additional operations.” 185 Nahra, “The Healthcare Privacy Debate Heats Up,” pp. 3-5. 175 Milt Freudenheim and Robert Pear, “Health Hazard: Computers Spilling Your History,” The New York 186 Dennis Melamed, “Health Information Privacy/ Times, December 3, 2006, p. 1. Security Alert,” November 2007, available at ; Deborah Gage and Kim Nash, “Identity Spilling Your History,” p. 1; Amy Joyce, “Should You Theft: Providence Health’s Serious Plan,” Compli- Tell? ” The Washington Post, February 18, 2007, p. F1. ance Solutions Advisor Magazine, December 6, 2006, available at . Genetic Discrimination,” Reuters, April 25, 2007, available at ; See for example, Alert.” Esther Dyson, “Full Disclosure,” The Wall Street Journal, July 25, 2007, p. A15. 188 Susannah Patton, “The Complying Game,” CIO Mag- azine, October 15, 2006, available at ; Los Angeles Times, July 21, 2007, available at ; Kurt researchers detest it,” Government HealthIT, October Long, “Breaking Down Medical Identity Theft,” The 2, 2007, available at . Patient advocates are no. 4 (April 2007), p. 14. wary that even the patient-consent requirements under HIPAA are being whittled away, while researchers 179 Geri L. Dreiling, “Medical ID Theft,” ABA Journal, argue that HIPAA places unnecessary restrictions on January 2007, p. 36. research using human subjects. 180 Nancy Ferris, “Patient control of EHR data on 189 Ferris, “Surveys show public distrusts HIPAA; network gets mixed reaction,” Government Health IT, researchers detest it.” March 6, 2007, available at . 190 Lygeia Ricciardi and David Lansky, “The Common Framework: Overview and Principles,” The Markle 181 Nancy Ferris, “Opinions divided on health info pri- Foundation, 2006, available at . pdf>. 182 Robert Pear, “Warnings Over Privacy of U.S. Health 191 Ricciardi and Lansky, “The Common Framework: Network,” The New York Times, February 18, 2007, Overview and Principles,” p. 2. p. 16. The chair of the panel noted that “If privacy protections are not built into the network, people will 192 Ricciardi and Lansky, “The Common Framework: not trust it. They won’t participate or will opt out if Overview and Principles,” p. 4. they are allowed to.”

62 End Notes:

193 Nancy Ferris, “EHRs: On the Trail of Trust,” Govern- 205 Reinberg, “Kaiser Permanente Study Hopes to Find ment HealthIT, July 16, 2007, available at . 206 BlueCross BlueShield Association, “Blue Cross and Blue Shield Association Holds Forum to Explore 194 John Halamka, CIO, Harvard Medical School. Patient Safety and Healthcare Quality Initiatives,” September 14, 2007, available at . 196 Leigh Anne Olsen, Dara Aisner, and J. Michael 207 Etheredge, “A Rapid-Learning Health System,” p. McGinnis, “The Learning Healthcare System,” 108. Institute of Medicine, 2007, p. 2. 208 Atul Gawande, Better (Metropolitan Books: April 197 Olsen, Aisner, and McGinnis, “The Learning Health- 2007). care System,” p. 1. For further information on the limitations of clinical trials, see Chapter 3. 209 Perfectly individualized care like any custom product is likely to be more expensive; care that is effective and 198 Riken SNP Research Center, “BioBank Japan efficient for a group of patients considerably less so. Project,” available at ; “U.S. Cancer Group Launches treatments remedied by so called ‘blockbuster drugs’ Mass Cancer Study,” Reuters, April 25, 2007, available that reach the greatest number of people. If we know at ; UK Biobank, “UK of people, targeting would ease the process of FDA Biobank—what is it?” September 2007, available at approval but costs would be spread over a smaller ; S.K. Sgaier and number of people. If, however, we individualize treat- others, “Biobanks in Developing Countries: Needs ment, the same problem arises albeit to a much greater and Feasibility,” Science, vol. 318, no. 5853 (2007), pp. degree. Finding the balance between care that is cost 1074-1075. effective and efficient is as important as it is feasible. 199 UK Biobank, “UK Biobank—what is it?” September 210 Angelo DePalma, “Making Medicine Personal,” 2007, available at . Business & Finance, June 2007, p. 13. His study further provided a platform for researchers to understand the relationship between smoking, 211 United States Department of Health and Human heart disease and stroke. Services, “National Guideline Clearinghouse,” available at . 200 Pallab Ghosh, “Will Biobank pay off?” BBC News, September 24, 2003, available at . of IT May Be Just What the Doctor Ordered,” The Information Technology & Innovation Foundation, 201 Ghosh, “Will Biobank pay off?” October 2007, available at . System: What would a rapid-learning health system 213 Tim Race, “Health Costs Push Companies to Set look like, and how might we get there?” Health Affairs, Targets for Workers,” The New York Times, June 11, vol. 26, no. 2 (2007), pp. 107-108. 2007, p. H2; M.P. McQueen, “Wellness Plans Reach 203 Steven Reinberg, “Kaiser Permanente Study Hopes Out to the Healthy,” The Wall Street Journal, March to Find Factors Behind a Range of Diseases,” 28, 2007, p. D1. MedicineNet.com, February 4, 2007, available at 214 Louise Liang, “The Gap Between Evidence And Prac- . patient factors that affect clinical outcomes,” Health 204 Amy Dockser Marcus, “When Cancer Runs in Your Family,” The Wall Street Journal, May 23, 2006, p. D1.

63 End Notes:

Affairs, vol. 26, no. 2 (2007), p. 121. For further 222 e-Cleveland Clinic, “Cleveland Clinic,” available at information, see Committee for Economic Develop- . ment, The Employer-Based Health-Insurance System is Failing: What We Must Do About It (Washington 223 Consumer Union, “Best Buy Drugs,” available at D.C.: CED, 2007), p. 4. ; Center for the Study of Services, “Center for the Study of Services,” 215 Jim Rendon, “10 Things Your Primary-Care Physi- available at . cian Won’t Tell You,” Smart Money, December 2007, p. 104. A recent Massachusetts study found that 40 224 The internet already allows people to rate services, percent of patients had an appointment during which from the quality of a particular dry cleaner to the they never saw a doctor. cleanliness of a prospective apartment complex. It even serves as a platform for people to rate other people; 216 Annys Shin, “The Web Returns to Health,” The students rate professors, and tenants rate landlords. Washington Post, August 8, 2006, available at ; 226 Joel Kupersmith and others, “Advancing Evidence- “Number of ‘Cyberchondriacs’—Adults Who Have Based Care for Diabetes: Lessons From the Veterans Ever Gone Online for Health Information—Increases Health Administration,” Health Affairs, vol. 26, no. 2 to an Estimated 136 Million Nationwide,” Harris (2007), p. 164. Interactive, August 1, 2006, available at . A Harris poll conducted in 2006 the Power and Potential of Personal Health Records,” found that 80 percent of online adults search for Robert Wood Foundation, available at . adults have discussed this information with their 228 Metro NY Carcinoid Support Group, “Welcome,” doctor. available at . 217 Michelle Slatalla, “Visits to Doctors Who Are Not 229 Stuart Elliot, “With or Without Vioxx, Drug Ads In, Ever,” The New York Times, May 24, 2007, p. E2. Proliferate,” The New York Times, December 6, 2004, 218 David Hubler, “National Library of Medicine available at . Health IT, January 18, 2007, available at . Pharma,” The Wall Street Journal Health Blog, Sep- 219 United States Department of Health & Human tember 21, 2007, available at . FDA authority regarding such advertising, nih.gov/>; United States Department of Health & to date, is quite limited. Legislation aimed at bolster- Human Services “Centers for Disease Control and ing FDA authority was introduced in this session Prevention,” available at . of Congress but was ultimately left out of the final version of the bill, passed in September. 220 Heather Won Tesoriero, “The Doctor’s Office Gets Crowded on the Web,” The Wall Street Journal, Janu- 231 “Number of ‘Cyberchondriacs’—Adults Who Have ary 22, 2007, p. B1. Ever Gone Online for Health Information—Increases to an Estimated 136 Million Nationwide,” Harris 221 Catherine Rampell, “Your Health Data, Plugged In Interactive, August 1, 2006, available at ; David Noonan, “More Information, dyn/content/article/2007/10/04/AR2007100400984. Please,” Newsweek, October 29, 2007, available at html>. . On a typi- cal day, it is estimated that 8 million American adults look for health information online.

64 End Notes:

232 Tara Parker-Pope, “Lessons Learned from Doctors, 241 Amy Dockser Marcus, “Cancer Patients Gain Say in Patients, and My Mother,” The Wall Street Journal, Drug Approvals,” The Wall Street Journal, February August 28, 2007, p. D1; Jean R. Slutsky, “Moving 13, 2007, p. D1. Closer To A Rapid-Learning Health Care System: 242 John Carey, “Medical Guesswork,” BusinessWeek, May Establishing a culture of learning while providing care 29, 2006, p.78; Shannon Brownlee, “Giving Patients will take collaboration among the many participants a Larger Voice,” The Washington Post, October 23, in the US health system,” Health Affairs, vol. 26, no. 2 2007, p. HE1. (2007), pp. 122-123. 243 John Collins and others, “Report of the Fourteenth 233 Richard Horton, “What’s Wrong with Doctors” The International Symposium of the Foundation for Pro- New York Review of Books, May 31, 2007, pp. 16-20. motion of Cancer Research: Pain Control, Palliative 234 Mike Stobbe, “Politics Plays Role in Disease Re- Medicine, and Psycho-oncology,” Japanese Journal of search,” The Washington Post, February 17, 2007, Clinical Oncology, vol. 31, no. 9 (2001) p. 465; Jerome available at . 2005). 235 The Genetic Alliance, “The Genetic Alliance,” avail- 244 Richard Adler, “The Emergence of Anytime, Any- able at . November 7, 2006); Barb Dybwad, “MyFoodPhone ‘keeps dieters honest’ with camphone food shots,” 236 Sally Beatty, “Institutional Gift, With a Catch,” The endaget, May 15, 2005, available at ; Valuable Role in Innovation,” The Wall Street Journal, Barnaby J. Feder, “A Remote Heart Monitor Fails January 25, 2007, p. A6; “Google Sponsors Lunar X To Impress an FDA Panel,” The New York Times, Prize to Create a Space Race for a New Generation,” March 2, 2007, C9; Joyzelle Davis, “Lung care going X Prize Foundation, September 13, 2007, available high-tech: CU Hospital to track emphysema patients at . Use of such prizes led to the com/drmn/health_care/article/0,2808,DRMN_2 development of tools for ocean navigation, “Lucky 5396_5415725,00.html>; Microsoft HealthVault, Lindy’s” transatlantic flight, and a new space vehicle. “Blood glucose monitors,” available at . Valuable Role in Innovation,” The Wall Street Journal, January 25, 2007, p. A6; Keith J. Winstein, “DNA 245 Sarah Lueck, “The Future of Health Care?” The Wall Decoding Maps Mainstream Future,” The Wall Street Street Journal, June 26, 2006, p. R7. Journal, October 4, 2007, p. B3. 246 Julie Fleming Brown, “Book Review of Powerful 239 Marilyn Chase, “FDA Delays Approving Cancer Vac- Medicines: The Benefits, Risks, and Costs of Pre- cine,” The Wall Street Journal, May 10, 2007, p. D1. scription Drugs,” Jurimetrics, vol. 46 (Winter 2006), p. 220. 240 Jason Feifer, “Combat Zone: There’s No Neutral Ground in War of Information about Lyme Disease,” 247 Tara Parker-Pope, “Take Your Medicine: Strategies The Washington Post, May 15, 2007, p. F1. The for Sticking to a Drug Regimen,” The Wall Street conflicts over the diagnosis and treatment of Lyme Journal, May 22, 2007, p. D1. disease, for example, show how difficult such issues 248 Federal Communications Commission, “FCC Tele- can be. communications and Health Care Advisory Com- mittee: Findings and Recommendations,” available

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at ; such as MedLinePlus ‘Go Local,’ provides “informa- “FCC: $400 Million for Health Networks,” Health tion on health services in local geographic areas, Data Management, November 15, 2007, available at including hospitals, physicians, nursing homes, health . 256 Pearlstein, “Hospitals Check Their Charts,” p. D1. 249 Peter D. Jacobson and Elizabeth Selvin, “Licensing Telemedicine: The Need for a National System,” Tele- 257 Pearlstein, “Hospitals Check Their Charts,” p. D1. medicine Journal and e-Health, vol. 6, no. 4, (2000), pp. Other private sector actors develop and market 429-439; National Academy of Sciences, “Networking their reports only to the rated institutions, but Health: Prescriptions for the Internet,” Institute of do publicize a list of their top hospitals such as Medicine, 2000. www.100tophospitals.com. Such reports on health care quality have spurred hospitals to improve their 250 Joanne Silberner, “Government Posts Medical performance. However, there remain questions about Procedure Price List,” National Public Radio, June 2, the objectivity of ratings by parties that depend on the 2006, available at . 258 Committee for Economic Development, Quality, 251 Vanessa Fuhrmans, “WellPoint Aims to Get Con- Affordable Health Care for All: Moving Beyond the sumers to Compare Medical-Care Costs,” The Wall Employer-Based Health-Insurance System (Washington Street Journal, September 25, 2006, p. A12; Jane D.C.: CED, 2007), p. 31; David Wessel, “Grading Zhang and Theo Francis, “Court Gives Group Access Surgeons May Be Healthy Practice,” The Wall Street To Medicare Claims Data,” The Wall Street Journal, Journal, July 6, 2006, p. A2. According to an article August 25, 2007, p. A3. by David Wessel, out of the 31 surgeons who stopped practicing in New York, nine retired and seven worked 252 IBM, Patient-Centric Healthcare: It’s Here, But Just in administrative or other non-clinical jobs instead of Not Widely Distributed (New York: 2006, IBM), p. 4; surgery. John E. Wennberg, “Dealing with Medical Practice Variations: A Proposal for Action,” Health Affairs, vol. 259 A. Shih and S. Schoenbaum, “Measuring Hos- 3, no. 2 (1984), pp. 6-32. pitals Performance: The Importance of Process Measures,” The Commonwealth Fund, July 2007, 253 David G. Knott, Gary Ahlquist, and Rick Edmunds, available at ; “The Leapfrog business.com/press/article/07107?gko=d8bb0>. Group,” 2007, available at ; United States Department of Health The Washington Post, April 20, 2007, p. D1. & Human Services, “NIH Launches Major Program to Transform Clinical and Translational Science,” 255 “HHS to create local health shopper groups,” United October 12, 2005, available at . ; MedlinePlus, “Go Local,” National tion,” The Wall Street Journal, October 5, 2007, p. Library of Medicine, October 10, 2007, available at A17; Race, “Health Costs Push Companies to Set ; Vanessa Fuhrmans, “Changing Doctor-Rating to Help Pay for Plans to Curb Childhood Obesity,” Systems,” The Wall Street Journal, October 30, 2007, The Wall Street Journal¸ October 24, 2007, p. D4. p. D3. Although information on the quality of care Employees of BB&T, for example, save 20 percent provided by local doctors is not yet widespread, New on their premiums if they fill out an annual health York’s attorney general recently announced a deal questionnaire, give blood, and take a fitness test. with Cigna Corp that moves toward establishing an Efforts by companies such as this are useful and are industry standard for rating doctors. Other resources, likely to help control rising health care costs. But it

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is important to note that they raise important privacy 267 Malcolm Gladwell, Blink: The Power of Thinking and security issues and it is imperative that oversight Without Thinking, (Little, Brown and Company, measures be instituted to ensure that companies do 2005); Groopman, “How Doctors Think,” Houghton not abuse or misuse information, such as targeting Mifflin Company, March 19, 2007. an employee for negative treatment based on a health condition. IBM recently launched a program that 268 Walter F. Stewart, Nirav R. Shah, Mark J. Selna, would pay $150 to employees who register their child Ronald A Paulus, and James M. Walker, “Bridging to complete a three month, online diet and exercise The Inferential Gap: The Electronic Health Record training. And IBM states that it “never looks at any of and Clinical Evidence,” Health Affairs, vol. 26, no. 2 the health information entered by employees.” (2007), p. 189; Robert Kolodner, and Jonathan B. Perlin, “Advancing Evidence-Based Care for Diabetes: 261 Some medical organizations have resisted increasing Lessons From the Veterans Health Administration,” the number of guidelines, both because of the increas- Health Affairs, vol. 26, no. 2 (2007), p. 165. ing complexity that they cause, but also because their existence may increase malpractice claims that might 269 Stewart and others, “Bridging The Inferential Gap,” not be filed in the absence of clearly defined best p. 189. It is beyond the scope of this paper to discuss practices. the relationship between decision support systems and possible malpractice concerns about their use. 262 “Sick of It,” The Washington Post, August 24, 2007, p. A14; Institute for Healthcare Improvement, “Doing 270 Bill Briggs, “Medication Error Reduction Hopes Better, Spending Less,” November 30, 2005, available Pinned on CPOE,” Health Data Management, at . ingLess.htm>. Various hospital initiatives illustrate 271 Jessica E. Vascellaro, “Social Networking Goes the enormous cost-savings generated by eliminating or Professional,” The Wall Street Journal, July 12, 2006, reducing hospital acquired infections. For example, p. D1. As noted in Chapter 3, practitioners are the Allegheny General Hospital in Pennsylvania already using the internet to share data on the safety invested $35,000 to limit catheter-related bloodstream of various drugs. infections and ventilator-associated pneumonias. The hospital’s rate of these infections dropped by 272 Mohammadreza Hojat and others, “An empirical 87 and 83 percent respectively, saving the hospital study of decline in empathy in medical school,” an estimated $2.2 million. This is not an isolated Medical Education, vol. 38, no. 9, (September 2004), case. Hospitals across the country, including Swedish pp. 934-941. Paradoxically, research shows a decline Hospital Medical Center and Overlake Hospital in empathy as students move through medical school. Medical Center in Washington State, have realized This might be due to the perceived need to protect similarly high returns on their investments by lower- oneself from the inevitable pain of not being able to ing the incidence of hospital acquired infections. provide all the assistance to the sick that one might hope to be able to. 263 “Sick of It,” p. A14. 273 Jerry Adler, “Beware the Blinkers,” Newsweek, April 264 “Crossing the Quality Chasm: A New Health System 23, 2007, p. 50; Laura Landro, “Preventing the for the 21st Century,” Institute of Medicine, March 1, Tragedy of Misdiagnosis,” The Wall Street Journal, 2001. November 29, 2006, p. D1; Jerome Groopman, 265 Brown, “Book Review of Powerful Medicines,” p. 221. How Doctors Think (Houghton Mifflin Company, 2007); Gina Kolata, “Study Says Chatty Doctors 266 Laura Landro, “Preventing the Tragedy of Misdiagno- Forget Patients,” The New York Times, June 26, 2007, sis,” The Wall Street Journal, November 29, 2006, p. available at . One study, over the last year, tracked two undercover patients as they secretly recorded their visits to primary-care doctors. The study found that doctors talked about themselves in a third of the audio recordings and there was no

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evidence to suggest that the doctor’s disclosures provided false information in the past. The executives helped patients or improved the doctor-patient of Purdue Pharma were in fact fined for training relationship. its representatives to “make false representations to health care providers about the difficulty of exacting 274 Landro, “Preventing the Tragedy of Misdiagnosis,” p. oxycodone, the active ingredient, from the OxyContin D1. tablet.” 275 Landro, “Preventing the Tragedy of Misdiagnosis,” p. 286 “Is Your Doctor Tied to Drug Makers,” The New D1. York Times, July 2, 2007, p. A.20; Anne Underwood, 276 John Norris, “Asynchronous Communication Be- “Thanks, But No Thanks,” Newsweek, October tween Patients and Physicians—Current Themes,” 29, 2007, available at ; Jim Rendon, “10 Things Your November 2007). Primary-Care Physician Won’t Tell You,” Smart Money, December 2007, p. 105. The Pharmaceutical 277 Benton Foundation, “Networking for Better Care: Research and Manufacturers of America reported Health Care in the Information Age” 1999, available marketing expenditures to physicians of $23 billion in at . Off label uses by doctors may provide new information about the drug including positive indicators as 278 Rob Stein, “Values Play into Treatment Recom- well as adverse affects. mendations, Study Finds,” The Washington Post, February 8, 2007, p. A9. See also Christopher Lee, 287 “Is Your Doctor Tied to Drug Makers,” p. A20. For “Study Finds Gaps Between Doctors’ Standards and further information, see Tim Hubbard and James Actions,” The Washington Post, December 4, 2007, p. Love, “Paying for Public Goods,” in Rishab Aiyer A8. Ghosh, ed., Code: Collaborative Ownership and the Digital Economy (Cambridge: MIT Press, 2005), pp. 279 Stein, “Values Play into Treatment Recommenda- 207-229. tions, Study Finds,” p. A9. 288 Alicia Chang, “Most docs let drug makers 280 Committee for Economic Development, Quality, buy them food,” ABC News, April 25, 2007, Affordable Health Care for All: Moving Beyond the available at . D.C.: CED, 2007), p. 26. 289 Underwood, “Thanks, But No Thanks.” Some 281 Gardiner Harris and Janet Roberts, “A State’s Files independent sources of information already exist. Put Doctors’ Ties to Drug Makers on Close View,” The Medical Letter on Drugs and Therapeutics, for The New York Times, March 21, 2007, p. A1. example, is similar to a Consumer Reports for drugs. 282 Alex Berenson, “Cancer Drug Representatives Spelled It does not allow advertising and only costs $100 a Out the Way to Profit,” Th e New York Times, June 12, year. 2007, p. C6. 290 “Will Pharma Finally Have To Fess Up?” Business 283 David Armstrong, “Medicare Moves to Cut ‘Self Week, October 8, 2007, available at . 284 Brown, “Book Review of Powerful Medicines,” p. 221. 291 “Will Pharma Finally Have To Fess Up?” 285 “Purdue Pharma, Executives Plead Guilty To 292 “Will Pharma Finally Have To Fess Up?” Minnesota, Misbranding OxyContin, Fined $634.5M,” Medical Maine, West Virginia, California and the District of News Today, May 15, 2007, available at . Un- to physicians. At the same time, some companies fortunately, pharmaceutical sales representatives, to argue that these are marketing expenses and should be the detriment of their reputation and credibility, have protected by trade secret laws.

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293 Harris and Roberts, “A State’s Files Put Doctors’ Ties 302 Stefanie Olsen, “Computing Grid Hunts for Bird to Drug Makers on Close View,” p. A1. Flu Cure,” www.news.com, May 4, 2006, available at ; U.K. Doctors,” The Wall Street Journal, May 30, 2007, Brilliant, “The Spreading Epidemic,” p. 174. p. B1; Alex Berenson and Andrew Pollack, “Doctors Receive Millions in Payments in Return for Prescrib- 303 Nicholas Zamiska, “Bird-Flu Vaccine Tests Econo- ing Anemia Drugs,” The New York Times, May 9, mies,” The Wall Street Journal, March 26, 2007, p. A8. 2007, p. C4; “The Danger in Drug Kickbacks,” The New York Times, May 14, 2007, p. A22; Gardiner 304 “How Dr. Chan Intends to Defend the Planet from Harris and Janet Roberts, “A State’s Files Put Doc- Pandemics,” The Economist, June 16, 2007, p. 68. tors’ Ties to Drug Makers on Close View,” The New 305 World Health Organization, “Health InterNetwork York Times, March 21, 2007, p. A1; Avery Johnson Access to Research Initiative,” available at . Pushed Sales of Procrit,” The Wall Street Journal, May 10, 2007, p. B1. 306 Brilliant, “The Spreading Epidemic,” p. 174. 295 Christopher Lee, “Doctors, Legislators Resist Drug- 307 Brilliant, “The Spreading Epidemic,” p. 174. makers’ Prying Eyes,” Washington Post, May 22, 2007, 308 Janlori Goldman, “Roundtable: Medical Privacy,” p. A1. The restrictions have been challenged on 1st Issues in Science and Technology, available at . 296 Milt Freudenheim, “A Model for Health Care The 309 Ed Felton, “Freedom to Tinker,” September 2007 Pays for Quality,” The New York Times, Novem- available at . ber 7, 2007, available at . 310 Committee for Economic Development, Open Standards, Open Source, and Open Innovation (Wash- 297 Larry Brilliant, “The Spreading Epidemic,” Forbes, ington D.C.: CED, April 2006). May 7, 2007, p. 174. 311 Kathleen Franz, Tinkering: Consumers Reinvent the 298 World Health Organization, “SARS outbreak con- Early Automobile (University of Pennsylvania Press: tained worldwide,” July 5, 2003, available at . Press: May 1, 2007). 299 Jane Zhang, “System Set Up After ’93 Outbreak 312 Eric von Hippel and Michael Schrage, “Users are Pointed to Spinach in E.coli Cases,” The Wall Street transforming innovation,” The Financial Times, July Journal, September 25, 2006, p. A4. 11, 2007, available at . able at . 313 Greater openness should not necessarily be equated 301 Paul McCloskey, “Firm predicts tripling of public with the use of open source software health network by 2012,” Government Health IT, 314 United States Food and Drug Administration, April 24, 2007, available at . In addition, a number Medical Devices: Background Information for of organizations –NCI, AHRQ, ACS, ACoS, CDC, International Officials,” April 14, 1999, available at and SAMHSA, are cooperating in a portal specifically . designed to make it easier for public health authorities to find and use evidence from science and integrate 315 David M. Gossett, “Recent Developments in Medi- such evidence into their programs and priority setting cal Device Preemption Law,” Products Liability, vol. processes. 12, no. 2, (Spring 2005), p. 2; Mark H. Anderson, “Court Weighs Medical-Device Liability,” The Wall Street Journal, December 5, 2007, p. D8.

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316 “Labeling: Regulatory Requirements for Medical Collaboration Experience with Biotechnology” Devices,” U.S. Department of Health and Human (presentation given at the Council for Chemical Services, 1997, available at . 16-17, 207). Electronic copy available at . 318 Committee for Economic Development, Open 328 David Wessel, “Prizes for Solutions to Problems Standards, Open Source, and Open Innovation. Play Valuable Role in Innovation,” The Wall Street 319 “The love-in,” The Economist, October 11, 2007, Journal, January 25, 2007, p. A6. It might be argued available at . example of the outsourcing of research but it would not occur in a ‘Not Invented Here’ world. 320 Henry W. Chesbrough, Open Business Models: How to Thrive in the New Innovation Landscape (Harvard 329 Chesbrough, Open Business Models. Business School Press, 2006). 330 Chesbrough, Open Business Models. 321 Chesbrough, Open Business Models. 331 Committee for Economic Development, Open Stan- 322 The analogy with how the human immune system dards, Open Source, and Open Innovation. Novartis rejects foreign objects leaps to mind in a report on did not release its observations on its data, providing healthcare. See also “Innovation Networks: Looking it with a considerable head-start over any rivals. This for Ideas Outside the Company,” Knowledge@Whar- head-start via “familiarity” resembles the advantage ton, November 14, 2007, available at . royalty free to an open standard. 323 Geoﬀ Colvin, “Lafley & Immelt: Q & A,” Fortune, 332 Robert P. Merges, “A New Dynamism in the Public December 11, 2006, pp. 79-80. P&G now counts 20 Domain,” The University of Chicago Law Review, percent of its new products as the result of innova- 2004, available at . years to come. 333 “Bayer and CuraGen Enter into Two Landmark 324 Colvin, “Lafley & Immelt: Q & A,” pp. 79-80. Agreements,” CuraGen, January 16, 2007, available at . 2007, pp. 69-71. 334 Robert D. Atkinson, “Boosting Technological 326 “The nimble sumo,” The Economist, August 4, 2007, Innovation Through the Research and Experiment p. 57. Tax Credit,” The Progressive Policy Institute, May 1, 1999, available at .

70 CED Trustees

Co-Chairs BRUCE K. MACLAURY EDWARD N. BASHA, JR. Chief Executive Offi cer W. BOWMAN CUTTER President Emeritus Basha Grocery Stores Managing Director Th e Brookings Institution Warburg Pincus LLC STEFFEN E. PALKO NADINE BASHA Chair RODERICK M. HILLS Vice Chairman & President (Retired) Arizona Early Childhood Development Chairman XTO Energy and Health Board Hills Stern & Morley LLP DONALD K. PETERSON ALAN BELZER Chairman & CEO (Retired) President & Chief Operating Offi cer Avaya Inc. Executive Committee (Retired) Allied Signal IAN ARNOF DONNA SHALALA Chairman President DEREK C. BOK Arnof Family Foundation University of Miami Interim President Harvard University PETER BENOLIEL FREDERICK W. TELLING Chairman Emeritus Vice President, Corporate Strategic Planning LEE C. BOLLINGER Quaker Chemical Corporation Pfi zer Inc. President Columbia University ROY J. BOSTOCK JOSH S. WESTON Chairman Honorary Chairman STEPHEN W. BOSWORTH Sealedge Investments, LLC Automatic Data Processing, Inc. Dean Fletcher School of Law and Diplomacy FRANK P. DOYLE RONALD L. ZARRELLA Tufts University Executive Vice President (Retired) Chairman & CEO General Electric Company JACK O. BOVENDER Bausch & Lomb Chairman & CEO EDMUND B. FITZGERALD HCA-Health Care Corporation of Managing Director America Woodmont Associates Board of Trustees JOHN BRADEMAS JOSEPH GANTZ KENT M. ADAMS President Emeritus Partner President New York University GG Capital, LLC Caterpillar Inc. RANDY J. BRAUD PATRICK W. GROSS U.S. Country Controller Chairman PAUL A. ALLAIRE Shell Oil Company Th e Lovell Group. Chairman (Retired) Xerox Corporation WILLIAM E. BROCK STEVEN GUNBY Founder and Senior Partner Chairman, Th e Americas & Senior Vice STEPHEN E. ALLIS Th e Brock Group President Partner in Charge of Government Aff airs Th e Boston Consulting Group, Inc. KPMG LLP BETH BROOKE Global Vice Chair, Strategy, THOMAS J. KLUTZNICK HERBERT M. ALLISON Communications, President Chairman, President, & CEO and Regulatory Aff airs Th omas J. Klutznick Co. TIAA-CREF Ernst & Young, LLP CHARLES E.M. KOLB COUNTESS MARIA BEATRICE ARCO ROBERT H. BRUININKS President Chair President Committee for Economic Development American Asset Corporation University of Minnesota WILLIAM W. LEWIS DEBORAH HICKS BAILEY DONALD R. CALDWELL Director Emeritus Chairman & Chief Executive Offi cer McKinsey Global Institute Chairman & CEO Cross Atlantic Capital Partners McKinsey & Company, Inc. Solon Group, Inc.

71 CED Trustees

DAVID A. CAPUTO DAVID CRANE W.D. EBERLE President Emeritus President & CEO Chairman Pace University NRG Energy, Inc. Manchester Associates, Ltd.

GERHARD CASPER KENNETH W. DAM ROBERT A. ESSNER President Emeritus Max Pam Professor Emeritus of American Chairman, President & CEO Stanford University and Foreign Law and Senior Lecturer Wyeth University of Chicago Law School RAYMOND G. CHAMBERS ALLEN I. FAGIN PAUL DANOS Chairman of the Board (Retired) Chairman Dean, Th e Amos Tuck School of Business Amelior Foundation Proskauer Rose LLP Dartmouth College KATHLEEN FELDSTEIN ROBERT B. CHESS RONALD R. DAVENPORT President Chairman Chairman of the Board Economics Studies, Inc. Nektar Th erapeutics Sheridan Broadcasting Corporation TREVOR FETTER MICHAEL CHESSER RICHARD H. DAVIS President & CEO Chairman, President & CEO Partner Tenet Healthcare Corporation Great Plains Energy Services Davis Manafort, Inc. MATTHEW FINK CAROLYN CHIN RICHARD J. DAVIS President (Retired) Chairman & Chief Executive Offi cer Senior Partner Investment Company Institute Cebiz Weil, Gotshal & Manges LLP MARGARET FORAN JOHN L. CLENDENIN JOHN J. DEGIOIA Senior Vice President, Corporate Chairman (Retired) President Governance, Associate General Council, BellSouth Corporation Georgetown University & Corporate Secretary Pfi zer Inc MARTIN COHEN RENATO DIPENTIMA Managing Director and Assistant Secretary President and CEO, Retired PATRICK FORD Legal and Compliance Division SRA International, Inc. President & CEO, USA Burson-Marsteller Morgan Stanley SAMUEL A. DIPIAZZA Global Chief Executive Offi cer ELIZABETH COLEMAN HARRY FREEMAN PricewaterhouseCoopers LLP President Chairman Bennington College LINDA M. DISTLERATH, PH.D Th e Mark Twain Institute Vice President, Global Health Policy FERDINAND COLLOREDO MITCHELL S. FROMSTEIN Merck & Co., Inc. Chairman Emeritus MANSFELD Manpower Inc. Partner WILLIAM H. DONALDSON Cabot Properties, LLC Chairman CONO R. FUSCO Donaldson Enterprises Managing Partner - Strategic Relationships ROBERT COLSON IRWIN DORROS (Retired) Parnter Grant Th ornton, LLP Grant Th ornton, LLP President Dorros Associates PAMELA B. GANN GEORGE H. CONRADES ROBERT H. DUGGER President Chairman & Chief Executive Offi cer Managing Director Claremont McKenna College Akamai Technologies Inc. Tudor Investment Corporation E. GORDON GEE KATHLEEN B. COOPER T. J. DERMOT DUNPHY President Senior Fellow Chairman Ohio State University Southern Methodist University Kildare Enterprises, LLC THOMAS P. GERRITY DAVID M. COTE CHRISTOPHER D. EARL, PH.D Dean Emeritus Chairman & CEO President & CEO Th e Wharton School of the University of Honeywell International Inc. BIO Ventures for Global Health Pennsylvania

72 CED Trustees

ALAN B. GILMAN JOHN HILLEN ROBERT KAHN Chairman President Director, Country Risk Management Th e Steak n Shake Company Global Strategies Group (USA) LlC Citigroup Inc.

CAROL R. GOLDBERG JOHN HOFFMEISTER EDWARD A. KANGAS President President Global Chairman & CEO (Retired) Th e AvCar Group, Ltd. Shell Oil Company Deloitte Touche Tohmatsu

ALFRED G. GOLDSTEIN G. PENN HOLSENBECK JOSEPH E. KASPUTYS President & Chief Executive Offi cer VP, Associate General Counsel & Corporate Chairman, President & CEO AG Associates Secretary Global Insight, Inc. Altria Group, Inc. JOSEPH T. GORMAN WILLIAM E. KIRWAN Chairman & CEO (Retired) PAUL M. HORN Chancellor TRW Inc. Senior Vice President, Research (Retired) University System of Maryland IBM Corporation EARL G. GRAVES Distinguished Scientist in Residence KAKUTARO KITASHIRO Chairman & Publisher Stern School of Business, Courant Chairman Earl G. Graves Publishing Co., Inc. Institute of Mathematical Sciences IBM Japan and the Graduate School of Arts & GERALD GREENWALD Sciences YOTARO KOBAYASHI Chairman New York University Senior Corporate Advisor and Former Greenbriar Equity Group Chairman PHILIP K. HOWARD Fuji Xerox BARBARA B. GROGAN Partner, Senior Corporate Advisor, Founder and Strategist THOMAS F. LAMB, JR. Western Industrial Contractors Covington & Burling Senior Vice President, Government Aff airs PNC Financial Services Group, Inc. JEROME H. GROSSMAN SHIRLEY ANN JACKSON Senior Fellow President KURT M. LANDGRAF Kennedy School Health Care Delivery Rensselaer Polytechnic Institute President & CEO Project Educational Testing Service CHARLENE DREW JARVIS Harvard University President DAVID LANGSTAFF RONALD GRZYWINSKI Southeastern University Co-Chairman & CEO Chairman WILLIAM C. JENNINGS Olive Group ShoreBank Corporation Chairman W. MARK LANIER, ESQ. US Interactive, Inc. ADAM J. GUTSTEIN Partner Chief Executive Offi cer JEFFREY A. JOERRES Th e Lanier Law Firm P.C. Diamond Management & Technology Chairman & CEO RICK A. LAZIO Consultants, Inc. Manpower Inc. Executive Vice President, Global JUDITH H. HAMILTON L. OAKLEY JOHNSON Government Relations & Public Policy Chairman & CEO (Retired) Senior Vice President, Corporate Aff airs J.P. Morgan Chase & Co. Classroom Connect American International Group, Inc. ROBERT G. LIBERATORE WILLIAM HASELTINE VAN E. JOLISSAINT Group Senior Vice President President Corporate Economist Global External Aff airs and Public Policy Haseltine Associates DaimlerChrysler Corporation DaimlerChrysler Corporation

RICHARD H. HERSH ROBERT L. JOSS JOHN LIFTIN Former President Dean, Graduate School of Business General Counsel Trinity College Stanford University D.E. Shaw & Co., L.P.

HEATHER R. HIGGINS PRES KABACOFF IRA A. LIPMAN President Chief Executive Oﬃ cer Founder & Chairman Randolph Foundation HRI Properties Guardsmark, LLC

73 CED Trustees

JOHN C. LOOMIS ALAN G. MERTEN JERRY PARROTT Vice President, Human Resources President V.P., Corporate Communications General Electric Company George Mason University and Public Policy Human Genome Sciences, Inc. LI LU HARVEY R. MILLER President Senior Partner CAROL J. PARRY Himalaya Management Weil, Gotschal & Manges LLP President Corporate Social Responsibility EUGENE LUDWIG ALFRED T. MOCKETT Associates Chief Executive Offi cer Chairman & CEO Promontory Financial Group Motive, Inc. GREGG PETERSMEYER Chairman and CEO COLETTE MAHONEY Personal Pathways, LLC President Emeritus AVID MODJTABAI Executive Vice President and Marymount Manhattan College VICTOR A. PELSON Chief Information Offi cer Senior Advisor ELLEN R. MARRAM Wells Fargo & Co. UBS Securities LLC President G. MUSTAFA MOHATAREM Barnegat Group LLC PETER G. PETERSON Chief Economist Senior Chairman CECILIA MARTINEZ General Motors Corporation Executive Director Th e Blackstone Group Th e Reform Institute JAMES MOODY TODD E. PETZEL Senior Financial Advisor DAVID MAXWELL Managing Director and Chief Investment Merrill Lynch & Co., Inc. President Offi cer Azimuth Trust Management, LLC Drake University NICHOLAS G. MOORE T. ALLAN MCARTOR Senior Counsel and Director DOUG PRICE Chairman Bechtel Group, Inc. Founder Airbus of North America, Inc. Educare Colorado DONNA S. MOREA ALONZO L. MCDONALD President, US Operations & India GEORGE A. RANNEY, JR. Chairman & Chief Executive Offi cer CGI President & CEO Avenir Group, Inc. Chicago Metropolis 2020 JAMES C. MULLEN WILLIAM J. MCDONOUGH President & CEO NED REGAN Vice Chairman and Special Advisor Biogen Idec Inc. University Professor to the Chairman Th e City University of New York Merrill Lynch & Co., Inc. DIANA S. NATALICIO President JAMES D. ROBINSON III DAVID E. MCKINNEY Th e University of Texas at El Paso Partner Vice Chair RRE Ventures Th omas J. Watson Foundation MATTHEW NIMETZ JAMES E. ROHR Managing Partner SUSAN R. MEISINGER Chairman & CEO General Atlantic LLC President & Chief Executive Offi cer PNC Financial Services Group, Inc. Society for Human Resource DEAN R. O’HARE ROY ROMER Management Chairman & CEO, (Retired) Superintendent of Schools (Retired) CAROL MELTON Th e Chubb Corporation LA Unifi ed School District Executive Vice President, Global Public RONALD L. OLSON Policy DANIEL ROSE Partner Time Warner Inc. Chairman Munger, Tolles & Olson LLP Rose Associates, Inc. LENNY MENDONCA Chairman M. MICHEL ORBAN LANDON H. ROWLAND McKinsey Global Institute Partner Chairman McKinsey & Company, Inc. RRE Ventures EverGlades Financial

74 CED Trustees

NEIL L. RUDENSTINE PAULA STERN JERRY D. WEAST Chair, ArtStor Advisory Board Chairwoman Superintendent of Schools Andrew W. Mellon Foundation Th e Stern Group, Inc. Montgomery County Public Schools

GEORGE E. RUPP DONALD M. STEWART JOHN P. WHITE President Professor Lecturer in Public Policy International Rescue Committee Th e University of Chicago Harvard University

EDWARD B. RUST ROGER W. STONE HAROLD M. WILLIAMS Chairman & CEO Chairman and CEO President Emeritus State Farm Insurance Companies KapStone Paper & Packaging Corp. Getty Trust

ARTHUR F. RYAN MATTHEW J. STOVER LINDA SMITH WILSON President, Chairman & CEO Chairman President Emerita Prudential Financial Radcliff e College LKM Ventures, LLC BERTRAM L. SCOTT MARGARET S. WILSON LAWRENCE H. SUMMERS President Chairman & CEO Managing Director TIAA-CREF Life Insurance Company Scarbroughs Shaw & Co., L.P. JOHN E. SEXTON Charles W. Elliot University Professor H. LAKE WISE President Harvard University Executive Vice President and Chief Legal New York University Offi cer HENRY TANG Daiwa Securities America Inc. WALTER H. SHORENSTEIN Governor Chairman of the Board Committee of 100 JACOB J. WORENKLEIN Shorenstein Company LLC Chief Executive Offi cer JAMES A. THOMSON US Power Generating Company, LLC GEORGE P. SHULTZ President & Chief Executive Offi cer Distinguished Fellow RAND KURT E. YEAGER Th e Hoover Institution President Emeritus STEPHEN JOEL TRACHTENBERG Electric Power Research Institute JOHN C. SICILIANO President Emeritus Partner George Washington University RONALD L. ZARRELLA Grail Partners LLC Chairman & CEO TALLMAN TRASK, III Bausch & Lomb Inc. FREDERICK W. SMITH Executive Vice President Chairman, President & CEO STEVEN ZATKIN Duke University FedEx Corporation Senior Vice President, Government Relations VAUGHN O. VENNERBERG Kaiser Foundation Health Plan, Inc. SARAH G. SMITH Senior Vice President and Chief of Staff Chief Accounting Offi cer Goldman Sachs Group Inc. XTO Energy Inc.

IAN D. SPATZ ROBERT J. VILHAUER Vice President, Public Policy Vice President, Public Policy and Analysis Merck & Co., Inc. Th e Boeing Company

STEVEN SPECKER JAMES L. VINCENT Chairman & Chief Executive Oﬃ cer Chairman (Retired) Electric Power Research Institute Biogen Inc.

ALAN G. SPOON FRANK VOGL Managing General Partner President Polaris Venture Partners Vogl Communications

JAMES D. STALEY DONALD C. WAITE President & CEO Director YRC Regional Transportation McKinsey & Company, Inc.

75 CED Honorary Trustees

RAY C. ADAM JOHN H. DANIELS ROBERT S. HATFIELD Retired Chairman Retired Chairman & CEO Retired Chairman NL Industries Archer Daniels Midland Company Th e Continental Group

ROBERT O. ANDERSON RALPH P. DAVIDSON PHILIP M. HAWLEY Retired Chairman Retired Chairman Retired Chairman of the Board Hondo Oil & Gas Company Time Inc. Carter Hawley Hale Stores, Inc.

ROY L. ASH ALFRED C. DECRANE, JR. ROBERT C. HOLLAND Retired Chairman Retired Chairman Senior Fellow Litton Industries Texaco Corporation Th e Wharton School of the University of Pennsylvania ROBERT H. BALDWIN ROBERT R. DOCKSON Retired Chairman Chairman Emeritus LEON C. HOLT, JR. Morgan Stanley CalFed, Inc. Retired Vice Chairman and Chief Administrative Oﬃ cer GEORGE F. BENNETT LYLE J. EVERINGHAM Air Products and Chemicals, Inc. Chairman Emeritus Retired Chairman State Street Investment Trust Th e Kroger Co. SOL HURWITZ Retired President JACK F. BENNETT THOMAS J. EYERMAN Committee for Economic Development Retired Senior Vice President Retired Partner ExxonMobil Corporation Skidmore, Owings & Merrill GEORGE F. JAMES

HOWARD BLAUVELT DON C. FRISBEE DAVID T. KEARNS Chairman Emeritus Chairman Emeritus ALAN S. BOYD Pacifi Corp New American Schools Development Retired Vice Chairman Corporation Airbus Industrie North America RICHARD L. GELB Chairman Emeritus GEORGE M. KELLER ANDREW F. BRIMMER Bristol-Myers Squibb Company Retired Chairman of the Board President Chevron Corporation Brimmer & Company, Inc. W. H. K. GEORGE Retired Chairman FRANKLIN A. LINDSAY FLETCHER L. BYROM ALCOA Retired Chairman President & CEO Itek Corporation MICASU Corporation WALTER B. GERKEN ROBERT W. LUNDEEN PHILIP CALDWELL Retired Chairman & Chief Executive Offi cer Pacifi c Investment Management Co. Retired Chariman Retired Chairman Th e Dow Chemical Company Ford Motor Company LINCOLN GORDON RICHARD B. MADDEN HUGH M. CHAPMAN Former President Johns Hopkins University Retired Chairman & Chief Executive Offi cer Retired Chairman Potlatch Corporation Nations Bank of Georgia JOHN D. GRAY AUGUSTINE R. MARUSI E. H. CLARK, JR. Chairman Emeritus Hartmarx Corporation Retired Chairman Chairman & Chief Executive Offi cer Borden Inc. Th e Friendship Group JOHN R. HALL WILLIAM F. MAY A. W. CLAUSEN Retired Chairman Ashland Inc. Former Chairman & CEO Retired Chairman & Chief Executive Offi cer Statue of Liberty-Ellis Island Foundation Bank of America RICHARD W. HANSELMAN OSCAR G. MAYER Former Chairman DOUGLAS D. DANFORTH Retired Chariman Health Net Inc. Executive Associates Oscar Mayer & Co.

76 CED Honorary Trustees

JOHN F. MCGILLICUDDY DEAN P. PHYPERS EDGER B. STERN, JR. Retired Chairman & Chief Executive Oﬃ cer Retired Chief Financial Oﬃ cer Chairman of the Board J.P. Morgan Chase & Co. IBM Corporation Royal Street Corporation

JAMES W. MCKEE, JR. ROBERT M. PRICE ALAXANDER L. STOTT Retired Chairman Retired Chairman & Chief Executive Oﬃ cer Retired President & COO CPC International, Inc. Control Data Corporation GTE CorpoRation

CHAMPNEY A. MCNAIR JAMES J. RENIER WAYNE E. THOMPSON Retired Vice Chairman Retired Chairman & CEO Retired Chairman Trust Company of Georgia Honeywell Inc. Merritt Peralta Medical Center

J. W. MCSWINEY JAMES Q. RIORDAN THOMAS A. VANDERSLICE Retired Chairman of the Board Chairman MeadWestvaco Corporation Quentin Partners Co. SIDNEY J. WEINBERG, JR. Senior Director ROBERT E. MERCER IAN M. ROLLAND Goldman Sachs Group Inc. Retired Chairman Retired Chairman & Chief Executive Offi cer Th e Goodyear Tire & Rubber Company Lincoln National Corporation CLIFTON R. WHARTON, JR. Former Chairman & CEO RUBEN F. METTLER AXEL G. ROSIN TIAA-CREF Retired Chairman & Chief Executive Offi cer Retired Chairman TRW, Inc. Book-of-the-Month Club, Inc. DOLORES D. WHARTON Former Chairman & CEO LEE L. MORGAN WILLIAM M. ROTH Th e Fund for Corporate Initiatives Retired Chairman of the Board Caterpillar Inc. THE HONORABLE WILLIAM ROBERT C. WINTERS RUDER Chairman Emeritus ROBERT R. NATHAN Former US Assistant Secretary of Commerce Prudential Financial Chairman Nathan Associates RALPH S. SAUL RICHARD D. WOOD Retired Chairman of the Board Retired Chief Executive Offi cer JAMES J. O’CONNOR CIGNA Corporation Eli Lilly and Company Retired Chairman & Chief Executive Offi cer Exelon Corporation GEORGE A. SCHAEFER CHARLES J. ZWICK Retired Chairman of the Board Retired Chairman LEIF H. OLSEN Caterpillar Inc. Southeast Banking Corporation Chairman LHO Group ROBERT G. SCHWARTZ

NORMA PACE MARK SHEPHERD, JR. President Retired Chairman Paper Analytics Associates Texas Instruments Incorporated

CHARLES W. PARRY ROCCO C. SICILIANO Retired Chairman Chairman ALCOA Dwight D. Eisenhower Memorial Commission WILLIAM R. PEARCE Director ELMER B. STAATS American Express Mutual Funds Former Comptroller General of the United States JOHN H. PERKINS Retired President FRANK STANTON Continental Illinois National Bank and Retired President Trust Company CBS Corporation

77 CED Research Advisory Board

Chair: DOUGLAS HOLTZEAKIN Economic Policy Chair JOHN L. PALMER John McCain 2008 University Professor and Dean Emeritus Th e Maxwell School HELEN LADD Syracuse University Professor of Economics Duke University

ROBERT E. LITAN Members: Vice President, Research & Policy Ewing Marion Kauﬀ man Foundation ANTHONY CORRADO Charles A. Dana Professor of Government ZANNY MINTONBEDDOES Colby College Washington Economics Correspondent Th e Economist ALAIN C. ENTHOVEN Marriner S. Eccles Professor of Public & Private Management, WILLIAM D. NORDHAUS Emeritus Sterling Professor of Economics Stanford University Cowles Foundation Yale University BENJAMIN M. FRIEDMAN William Joseph Maier Professor of Political Economy RUDOLPH PENNER Harvard University Arjay and Frances Miller Chair in Public Policy Th e Urban Institute ROBERT HAHN Executive Director HAL VARIAN AEI-Brookings Joint Center Professor at Haas School of Business University of California Berkeley

78 CED Staff

CHARLES E.M. KOLB President

Research Development

JOSEPH J. MINARIK MARTHA E. HOULE Senior Vice President and Director of Research Vice President for Development and Secretary of the Board of Trustees

JANET HANSEN Vice President and Director of Education Studies RICHARD M. RODERO Director of Development

ELLIOT SCHWARTZ Vice President and Director of Economic Studies JENNA IBERG Development Associate

VAN DOORN OOMS Senior Fellow Finance and Administration LAURA LEE MATTHEW SCHURIN Chief Financial Oﬃ cer and Vice President of Finance and Research Associate Administration

CHARLES JOHNSON ANDRINE COLEMAN Research Associate Accounting Manager

JULIE KALISHMAN JERI MCLAUGHLIN Research Associate Executive Assistant to the President

Communications/Government Relations AMANDA TURNER Director of Administration MICHAEL J. PETRO Vice President and Director of Business and Government Relations and Chief of Staﬀ

MORGAN BROMAN Director of Communications

AMY MORSE Communications and Outreach Associate

JEANNETTE FOURNIER Director of Foundation Relations

LAURA OLDANIE Program Manager

EEVA MOORE Outreach Associate

79 Statements On National Policy Issued By The Committee For Economic Development

Selected Recent Publications:

Quality, Aff ordable Health Care for All: Moving Beyond the Reducing Global Poverty: Th e Role of Women in Develop- Employer-Based Health-Insurance System (2007) ment (2003) Reducing Risks from Golbal Imbalances (2007) How Economies Grow: Th e CED Perspective on Raising the Long-Term Standard of Living (2003) Built to Last: Focusing Corporations on Long-Term Perfor- Learning for the Future: Changing the Culture of Math and mance (2007) Science Education to Ensure a Competitive Workforce Th e Employer-based Health-Insurance System (EBI) Is At (2003) Risk: What We Must Do About It (2007) Exploding Defi cits, Declining Growth: Th e Federal Budget Th e Economic Promise of Investing in High-Quality Pre- and the Aging of America (2003) school: Using Early Education to Improve Economic Justice for Hire: Improving Judicial Selection (2002) Growth and the Fiscal Sustainability of States and the Nation (2006) A Shared Future: Reducing Global Poverty (2002) Open Standards, Open Source, and Open Innovation: A New Vision for Health Care: A Leadership Role for Busi- Harnessing the Benefi ts of Openness (2006) ness (2002) Private Enterprise, Public Trust: Th e State of Corporate Preschool For All: Investing In a Productive and Just Society America After Sarbanes-Oxley (2006) (2002) Th e Economic Benefi ts of High-Quality Early Childhood From Protest to Progress: Addressing Labor and Environ- Programs: What Makes the Diff erence? (2006) mental Conditions Th rough Freer Trade (2001) Education for Global Leadership: Th e Importance of Interna- Th e Digital Economy: Promoting Competition, Innovation, tional Studies and Foreign Language Education for U.S. and Opportunity (2001) Economic and National Security (2006) Reforming Immigration: Helping Meet America’s Need for a A New Tax Framework: A Blueprint for Averting a Fiscal Skilled Workforce (2001) Crisis (2005) Measuring What Matters: Using Assessment and Account- Cracks in the Education Pipeline: A Business Leader’s Guide ability to Improve Student Learning (2001) to Higher Education Reform (2005) Improving Global Financial Stability (2000) Th e Emerging Budget Crisis: Urgent Fiscal Choices (2005) Th e Case for Permanent Normal Trade Relations with China Making Trade Work: Straight Talk on Jobs, Trade, and (2000) Adjustments (2005) Welfare Reform and Beyond: Making Work Work (2000) Building on Reform: A Business Proposal to Strengthen Breaking the Litigation Habit: Economic Incentives for Legal Election Finance (2005) Reform (2000) Developmental Education: Th e Value of High Quality New Opportunities for Older Workers (1999) Preschool Investments as Economic Tools (2004) Investing in the People’s Business: A Business Proposal for A New Framework for Assessing the Benefi ts of Early Educa- Campaign Finance Reform (1999) tion (2004) Th e Employer’s Role in Linking School and Work (1998) Promoting Innovation and Economic Growth: Th e Special Employer Roles in Linking School and Work: Lessons from Problem of Digital Intellectual Property (2004) Four Urban Communities (1998) Investing in Learning: School Funding Policies to Foster High America’s Basic Research: Prosperity Th rough Discovery Performance (2004) (1998) Promoting U.S. Economic Growth and Security Th rough Modernizing Government Regulation: Th e Need For Action Expanding World Trade: A Call for Bold American (1998) Leadership (2003) U.S. Economic Policy Toward Th e Asia-Pacifi c Region (1997) Reducing Global Poverty: Engaging the Global Enterprise Connecting Inner-City Youth To Th e World of Work (1997) (2003)

CED Counterpart Organizations Close relations exist between the Committee for Economic Development and independent, nonpolitical research organizations in other countries. Such counterpart groups are composed of business executives and scholars and have objectives similar to those of CED, which they pursue by similarly objective methods. CED cooperates with these organizations on research and study projects of common interest to the various countries concerned. Th is program has resulted in a number of joint policy statements involving such international matters as energy, assistance to developing countries, and the reduction of nontariﬀ barriers to trade.

CE Circulo de Empresarios Madrid, Spain

CEAL Consejo Empresario de America Latina Buenos Aires, Argentina

CEDA Committee for Economic Development of Australia Sydney, Australia

CIRD China Institute for Reform and Development Hainan, People’s Republic of China

EVA Centre for Finnish Business and Policy Studies Helsinki, Finland

FAE Forum de Administradores de Empresas Lisbon, Portugal

IDEP Institut de l’Entreprise Paris, France

IW Institut der deutschen Wirtschaft Koeln Cologne, Germany

Keizai Doyukai Tokyo, Japan

SMO Stichting Maatschappij en Onderneming Th e Netherlands

82 Harnessing Openness to Transform American Health Care

Committee for Economic Development

2000 L Street N.W. Suite 700 Washington, D.C. 20036 202-296-5860 Main Number 202-223-0776 Fax 1-800-676-7353

www.ced.org

A Report by the Digital Connections Council of the Committee for Economic Development