What Is Junk Science?

The Litigator’s Guide to Combating Junk Science

Table of Contents

Introduction ...... 3

What Is Junk Science? ...... 5

Anti-Junk Science Websites ...... 7

Anti-Junk Science Books ...... 11

Resources for Regulatory Guidance ...... 13

Resources for Scientific Standards ...... 16

Placebo and Nocebo Effects ...... 20

About Innovative Science Solutions ...... 21

The Litigator’s Guide to Combating Junk Science

Introduction

Science plays a critical role in the courtroom. Access to scientific research and an understanding of scientific principles enable the litigator to build a powerful case. The team’s expert witnesses can effectively communicate to the judge and jury technical concepts that support the central arguments of the case.

Five types of legal cases often rely on scientific information:

• Personal Injury: Scientific evidence is typically presented in mass torts involving allegations of personal injury from a product, an environmental exposure, or a chemical exposure. In these cases, plaintiffs rely on scientific studies to demonstrate a link between the exposure and the injury. The defense presents scientific research to cast doubt on the purported causal relationship between the exposure and the injury.

• Consumer Fraud: To counter the plaintiff’s claim that a product failed to achieve the results promised, the defense argues that its marketing claims are supported by reliable scientific evidence. Plaintiffs will present evidence that questions or counters the defense’s data.

• Medical Malpractice: To counter the plaintiff’s claim that a healthcare provider’s error resulted in harm, the defense will present scientific studies to demonstrate the provider adhered to the generally accepted standard-of-care.

• Securities and Shareholders Lawsuits: In securities and shareholder lawsuits involving medical devices or pharmaceutical products, the defense presents scientific evidence to demonstrate that the information relayed to shareholders was reasonable and reliable.

The Litigator’s Guide to Combating Junk Science

• Patent Challenges: Opposing parties in patent infringement cases will most likely agree on the fundamental science. But the plaintiff will present specific scientific evidence to support the claim that the patent does not meet the necessary requirements.

The parties involved in any legal dispute will typically engage in a legitimate debate about the validity of the scientific evidence presented. Even the experts often disagree when interpreting scientific data.

However, dubious or bias scientific information is occasionally presented in court cases, influencing the outcome. Judges and juries who lack the background and knowledge to properly evaluate the validity of scientific data tend to accept the information placed before them.

When a case relies on misinformation, unsubstantiated claims, and misleading data, opposing counsel can successfully counterattack with access to the right resources.

In the following pages, we provide you with the tools and resources you need to combat junk science in the courtroom.

• What Is Junk Science identifies examples of junk science. • Anti-Junk Science Websites provides access to resources dedicated to exposing junk science. • Anti-Junk Science Books lists publications focused on illuminating the issue of junk science. • Resources for Regulatory Guidance provides access to government resources that will allow you to counter misinformation with scientifically sound principles. • Resources for Scientific Standards provides access to reputable online resources that present generally accepted scientific methods. • Placebo and Nocebo Effects provides the latest research on this medical phenomenon, which is central to many pharmaceutical cases.

The Litigator’s Guide to Combating Junk Science

What Is Junk Science?

Legitimate controversies erupt daily in political arenas, the news media, the courtroom, and the court of public opinion. In these debates, valid evidence usually emerges to support both sides. However, we have observed a number of controversies in which one side relies on faulty data – or junk science – rather than rigorous scientific methodologies.

Junk science refers to scientific research that fails to meet the criteria characteristic of a rigorous scientific investigation, such as falsifiable hypotheses, replication, peer- review and publication, general acceptance, neutrality, objectivity, and adherence to the scientific method. Purveyors of junk science typically have an agenda, and research and results are driven by non-scientific motives that are often political, financial or ideological.

To illuminate the issue, we provide below examples of controversial claims based on junk science, and links to resources refuting these questionable claims.

Controversial Claim #1: Electromagnetic radiation causes adverse health effects.

Junkscience.com - EMFs and Cell Phones

National Institute of Environmental Health Sciences - Electric and Magnetic Fields

Controversial Claim #2: Endocrine disruptors disturb human hormone balances.

SafeChemicalPolicy.org - Endocrine Disruptors

Sciencebasedmedicine.org - Endocrine disruptors—the one true cause?

The Litigator’s Guide to Combating Junk Science

Controversial Claim # 3: Hydraulic fracturing leads to adverse health effects for nearby residents.

Junkscience.com - Penn pilot study: Group of Bradford Co, Pa. residents concerned about health effects of hydrofracking

K&L Gates Law Firm - Junk Science Meets Hydraulic Fracturing: Unfounded Environmental Scare Threatens Energy Development

Controversial Claim #4: Multiple chemical sensitivity causes a host of adverse health effects.

Junkscience.com - Multiple Chemical Sensitivity Testimony Inadmissible Under Daubert, Court Says

Skepdic.com - multiple chemical sensitivity (MCS) from Skeptic’s dictionary

Controversial Claim #5: Vaccines lead to autism.

Junkscience.com - The risk of autism is not increased by ‘too many vaccines too soon’

Nature - A case of junk science, conflict and hype

The Litigator’s Guide to Combating Junk Science

Anti-Junk Science Websites

The following online resources are dedicated to exposing junk science. They offer a wealth of information that counters assertions based on unreliable data.

Bad Science

Dr. Ben Goldacre, author of the bestseller Bad Science, continues his campaign against junk science in his witty and insightful blog of the same name. In his book and blog, he exposes the tenuous scientific claims of newspapers, doctors, government reports and drug companies.

Bjorn Lomborg

Bjorn Lomborg, an adjunct professor at Copenhagen Business School, a bestselling author, and a frequent media commentator, challenges mainstream concerns about the environment. In news articles and social media posts, he strives to focus attention on effective solutions to environmental issues.

Debunked & Exposed

Maintained by JunkScience.com, Debunked & Exposed offers Debunkosaurus™, a Wiki-based tool for researching health scares and scams.

Gary Taubes

Gary Taubes is a science writer and the author of Nobel Dreams (1987), Bad Science: The Short Life and Weird Times of Cold Fusion (1993), and Good Calories, Bad

The Litigator’s Guide to Combating Junk Science

Calories (2007). He has won the Science in Society Award of the National Association of Science Writers three times and was awarded an MIT Knight Science Journalism Fellowship for 1996-97. Taubes’ books deal with controversies in the field of science. Nobel Dreams takes a critical look at the politics and experimental techniques behind the Nobel Prize-winning work of physicist Carlo Rubbia. Bad Science chronicles the short-lived media frenzy surrounding the Pons-Fleischmann cold fusion experiments of 1989.

JunkScience

“All the Junk That’s Fit to Debunk.” As its motto indicates, JunkScience.com’s mission is to reveal the facts behind junk science in the media and the courtroom. JunkScience takes on Global Warming theorists, the EPA, the American Heart Association and others.

Not Even Wrong

William H. Kinney, associate professor in the University at Buffalo Physics Department, named his website after the Wolfgang Pauli quote “It is not even wrong.” The website is described as “A page dedicated to the ample evidence that we need better science education.” Topics include vaccines and autism, EMFs, plastic softeners, silicone breast implants, and more.

QuackWatch

QuackWatch is an international network of advocates who are concerned about health-related frauds, myths and misconduct. Activities include investigating questionable claims, debunking pseudoscientific claims, and distributing reliable

The Litigator’s Guide to Combating Junk Science

publications, among others. Visitors can search the website’s vast database of questionable products, services and theories by topic.

Science-Based Medicine

Science-based medicine evaluates medical treatments and products in a scientific context. “Good science is the best and only way to determine which treatments and products are truly safe and effective,” according to the website. Recent articles have analyzed placebo prescribing, cancer screening tests, and SPECT scans.

Science-ish

Science-ish, a blog on the Maclean’s magazine website, checks health-related news against the evidence to hold politicians, opinion leaders, and journalists accountable for the information they disseminate.

Skeptoid

Skeptoid is a weekly podcast dedicated to debunking the widespread “pseudosciences.” According to the website, “Skeptoid attempts to expose the folly of belief in non-evidence based phenomena, and more importantly, explains the factual scientific reality.” Topics include hydraulic fracturing, high-fructose corn syrup, DDT, vaccine ingredients, cell phone radiation, and more.

STATS

Are you interested in the latest research questioning the purported connection between cell phone use and brain cancer? Do you want to know why a leading

The Litigator’s Guide to Combating Junk Science expert condemned the crusade against BPA? Do you question the supposed link between sugary beverages and obesity? You can find information on these topics and more on the STATS website, an affiliate of George Mason University that aims to correct scientific misinformation in the media and public policy. STATS offers analyses of the latest research on key issues and links to revealing articles.

The Litigator’s Guide to Combating Junk Science

Anti-Junk Science Books

The following books offer insight into the insidious nature of junk science and how we can guard against it.

Junk Science Judo: Self-Defense against Health Scares and Scams Steven J. Milloy Cato Institute, 2001 218 pages

Book Description: This book is a simple, easy-to-read guide to debunking health scares and scams before you get hurt.

Galileo's Revenge: Junk Science In The Courtroom Peter Huber Basic Books, 1993 288 pages

Book Description: A scathing indictment of the growing role of junk science in our courtrooms. Peter W. Huber shows how time and again lawyers have used—and the courts have accepted – spurious claims by so-called expert witnesses to win astronomical judgments that have bankrupted companies, driven doctors out of practice, and deprived us all of superior technologies and effective, life-saving therapies.

The Litigator’s Guide to Combating Junk Science

Voodoo Science: The Road from Foolishness to Fraud Robert Park Oxford University Press, 2001 240 pages

Book Description: In a time of dazzling scientific progress, how can we separate genuine breakthroughs from the noisy gaggle of false claims? From Deepak Chopra's "quantum alternative to growing old" to unwarranted hype surrounding the International Space Station, Robert Park leads us down the back alleys of fringe science, through the gleaming corridors of Washington power and even into our evolutionary past to search out the origins of voodoo science. Along the way, he offers simple and engaging science lessons, proving that you don't have to be a scientist to spot the fraudulent science that swirls around us. While remaining highly humorous, this hard-hitting account also tallies the cost: the billions spent on worthless therapies, the tax dollars squandered on government projects that are doomed to fail, the investors bilked by schemes that violate the most fundamental laws of nature. But the greatest cost is human: fear of imaginary dangers, reliance on magical cures, and above all, a mistaken view of how the world works. To expose the forces that sustain voodoo science, Park examines the role of the media, the courts, bureaucrats and politicians, as well as the scientific community. Scientists argue that the cure is to raise general scientific literacy. But what exactly should a scientifically literate society know? Park argues that the public does not need a specific knowledge of science so much as a scientific world view – an understanding that we live in an orderly universe governed by natural laws that cannot be circumvented.

The Litigator’s Guide to Combating Junk Science

Resources for Regulatory Guidance

The following government websites contain a plethora of valuable resources that can be tapped when confronting junk science. Available information includes research studies, databases, publications, news, regulatory guidelines, and a host of other materials.

Food and Drug Administration (FDA)

The FDA is responsible for protecting public health by ensuring that foods are safe, wholesome, sanitary and properly labeled (except for meat from livestock, poultry and some egg products, which are regulated by the U.S. Department of Agriculture). The FDA is also charged with ensuring that human and veterinary drugs, vaccines and other biological products and medical devices intended for human use are safe and effective. In addition, the FDA is responsible for protecting the public from electronic product radiation, ensuring that cosmetics and dietary supplements are safe and properly labeled, regulating tobacco products, and advancing public health by promoting product innovations.

The following links to FDA guidances provide authoritative information related to dietary supplements, food health claims, and radiation-emitting products:

Dietary Supplements - Draft Guidance for Industry

Food Health Claims - Guidance for Industry

Radiation-Emitting Products

The Litigator’s Guide to Combating Junk Science

National Institute for Occupational Safety and Health (NIOSH)

The NIOSH is responsible for conducting research and making recommendations to prevent work-related injury and illness. The mission of NIOSH is to generate new knowledge in the field of occupational safety and health and to put that knowledge into practice to benefit workers. To accomplish this mission, NIOSH conducts scientific research, develops guidance and authoritative recommendations, disseminates information, and responds to requests for workplace health hazard evaluations. NIOSH is part of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services.

United States Environmental Protection Agency (EPA)

The EPA’s mission is to reduce environmental risks based on the best available scientific information. The agency is charged with protecting human health and the environment by developing and enforcing regulations based on laws passed by Congress.

United States Geological Survey (USGS)

The USGS provides impartial information on the health of the Earth’s ecosystems and environment, the natural hazards that threaten humans, the natural resources we rely on, the impacts of climate and land-use change, and the core science systems that help us provide timely, relevant, and useable information. The USGS provides reliable scientific information to describe and understand the Earth; minimize loss of life and property from natural disasters; manage water, biological, energy, and mineral resources; and enhance and protect our quality of life.

The Litigator’s Guide to Combating Junk Science

United States Department of Agriculture (USDA)

The USDA is responsible for developing and executing U.S. federal government policy on farming, agriculture, forestry and food. The agency provides leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on sound public policy, the best available science, and efficient management.

The Litigator’s Guide to Combating Junk Science

Resources for Scientific Standards

The following independent organizations provide information on generally accepted scientific standards and practices. Specific knowledge of scientific principles will enable you to formulate an argument discrediting junk science.

The Cochrane Collaboration

From the Cochrane website:

“Cochrane Reviews are systematic reviews of primary research in human health care and health policy. Cochrane Reviews are internationally recognized as the highest standard in evidence-based health care. They investigate the effects of interventions for prevention, treatment and rehabilitation. They also assess the accuracy of a diagnostic test for a given condition in a specific patient group and setting. They are published online in The Cochrane Library.

Each systematic review addresses a clearly formulated question; for example: Can antibiotics help in alleviating the symptoms of a sore throat? All the existing primary research on a topic that meets certain criteria is searched for and collated, and then assessed using stringent guidelines, to establish whether or not there is conclusive evidence about a specific treatment. The reviews are updated regularly, ensuring that treatment decisions can be based on the most up-to-date and reliable evidence.

Cochrane Reviews are designed to facilitate the choices that practitioners, consumers, policy-makers and others face in health care.”

The Litigator’s Guide to Combating Junk Science

Consolidated Standards of Reporting Trials (CONSORT)

From the CONSORT website:

“The main product of CONSORT is the CONSORT Statement, which is an evidence- based, minimum set of recommendations for reporting RCTs. It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation.

The CONSORT Statement comprises a 25-item checklist and a flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial.”

Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

From the PRISMA website:

PRISMA “is an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses.

The aim of the PRISMA Statement is to help authors improve the reporting of systematic reviews and meta-analyses. We have focused on randomized trials, but PRISMA can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions. PRISMA may also be useful for critical appraisal of published systematic reviews, although it is not a quality assessment instrument to gauge the quality of a systematic review.

The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. It is an evolving document that is subject to change periodically as new evidence emerges. In fact, the PRISMA Statement is an update and expansion of the now-out dated QUOROM Statement. This website contains the current definitive version of the PRISMA Statement.”

The Litigator’s Guide to Combating Junk Science

Grading of Recommendations Assessment, Development and Evaluation (GRADE)

From the GRADE website:

“The Grading of Recommendations Assessment, Development and Evaluation (short GRADE) Working Group began in the year 2000 as an informal collaboration of people with an interest in addressing the shortcomings of present grading systems in health care. The working group has developed a common, sensible and transparent approach to grading quality of evidence and strength of recommendations. Many international organizations have provided input into the development of the approach and have started using it.”

U.S. Preventive Services Task Force (USPSTF)

From the USPSTF website:

“Created in 1984, the U.S. Preventive Services Task Force (USPSTF or Task Force) is an independent group of national experts in prevention and evidence-based medicine that works to improve the health of all Americans by making evidence- based recommendations about clinical preventive services such as screenings, counseling services, or preventive medications. The USPSTF is made up of 16 volunteer members who come from the fields of preventive medicine and primary care, including internal medicine, family medicine, pediatrics, behavioral health, obstetrics/gynecology, and nursing. All members volunteer their time to serve on the USPSTF, and most are practicing clinicians.”

The Litigator’s Guide to Combating Junk Science

The National Research Council (NRC) and National Academy of Sciences (NAS)

From the NRC website:

“The National Research Council, created under the NAS charter in 1916 by executive order of President Woodrow Wilson, extended the scope of the NAS in its advisory role. The National Academy of Engineering (NAE) and the Institute of Medicine (IOM) were founded under the NAS charter in 1964 and 1970, respectively. Together, the NAS, NRC, NAE and IOM enlist the aid of the nation’s most knowledgeable scientists, engineers, health professionals, and other experts who volunteer their time to produce reports that have led to some of the most significant and lasting improvements in the health, education, and welfare of all the world’s citizens. The Academy's service to government has become so essential that Congress and the White House have issued legislation and executive orders over the years that reaffirm its unique role.”

The Litigator’s Guide to Combating Junk Science

Placebo and Nocebo Effects

The placebo effect refers to a positive health outcome that results from a patient’s belief that a treatment will be effective. The nocebo effect is the antithesis – it refers to the symptoms patients experience due to their anticipation of those symptoms. Both are real, physiological phenomena that can be measured using standard scientific techniques. The placebo effect plays a significant role in lawsuits against drug companies. Clinical drug trials typically include a placebo control group, allowing researchers and the Food and Drug Administration to effectively evaluate the efficacy of any new medication. The nocebo effect is also a factor, as participants taking the placebo occasionally experience negative side effects.

The following resources provide essential background information on the placebo and nocebo effects:

Pain Physician Journal - Placebo and Nocebo in Interventional Pain Management: A Friend or a Foe - Or Simply Foes?

Journal of Biobehavioral Medicine - Drug-Related Information Generates Placebo and Nocebo Responses That Modify the Drug Response

Badscience.net - Ben Goldacre on the Placebo and Nocebo Effect

Philosophical Transactions B (Biological Sciences) - Harnessing the placebo effect: the need for translational research

The Psychiatrist - The placebo effect

The New Yorker - The Nocebo Effect: How We Worry Ourselves Sick

Discover - Are Warnings About Drug Side Effects Actually Making Us Sick?

Nocebo Effect - Think Sick and You’ll Be Sick

The Litigator’s Guide to Combating Junk Science

About Innovative Science Solutions

Innovative Science Solutions (ISS) is a leading scientific consulting firm for the worldwide pharmaceutical, biotechnology, and medical device industries. Our expert team of scientists, regulatory strategists, and consultants provide a wide range of fully integrated services to industry and counsel.

From strategic insight for FDA Advisory Committee meetings to scientific expertise for complex litigation, ISS delivers specialized and effective solutions for your legal and regulatory challenges. Let our proven combination of experience and innovation work for you.

David H. Schwartz, Ph.D. Head of Scientific Support to Counsel

A “scientific detective,” Dr. Schwartz excels at analyzing how science and law interact. As head of ISS’s Support to Counsel practice, he helps clients defend and support pharmaceuticals, industrial chemicals, medical devices, foods, and dietary supplements in the courts, the regulatory arena, and the market place. With a talent for communicating complex scientific information, Dr. Schwartz has become a go-to for lawyers, business professionals, and financial and investment firms. Dr. Schwartz specializes in providing strategic and tactical support to counsel in legal cases

The Litigator’s Guide to Combating Junk Science

involving complex scientific issues. He has played a lead role in winning multi-billion dollar legal cases for clients. With the sheer weight of the scientific data he’s able to collect, evaluate, and present as evidence, he’s helped counsel win cases before going to trial, saving ISS clients time and money.

Dr. Schwartz counts Daubert hearings among his biggest successes. His expertise guides the ISS team across all disciplines related to the health sciences: toxicology, epidemiology, environmental health and safety, biostatistics, pharmacology, and regulatory affairs.

He has pioneered programs to critically review the scientific foundation of an adversary's case and provided persuasive, evidence-based responses. For 20 years, he has worked with the legal community evaluating product safety and defending a host of products and exposures, including the following: welding rods, cellular phones, ionizing and non-ionizing radiation, hydraulic fracturing and other drilling technologies, breast implants, wound care products, dietary supplements, general healthcare products, and a host of over-the-counter and prescription pharmaceutical agents (including: antidepressants, dermatologics, anti-malarials, anxiolytics, antipsychotics, and diet drugs).

Prior to founding ISS, Dr. Schwartz served as the Director of Scientific Litigation Support for the law firm McCarter and English, where he played a principal role in the safety evaluation of Prozac. Since then, he has guided clients using scientific principles to defend products before, during and after launch.

Dr. Schwartz received a Ph.D. in Neuroscience from Princeton University and postdoctoral training in Neuropharmacology and Neurophysiology from the Center for Molecular and Behavioral Neuroscience at Rutgers University.

The Litigator’s Guide to Combating Junk Science

Steven M. Weisman, Ph.D. Head of Clinical and Regulatory Support

Dr. Weisman knows how to bridge the gap between science and marketing. As head of ISS's Clinical and Regulatory Support practice, he focuses on the development of scientific and regulatory approaches that increase a product's market potential. He's an invaluable resource for scientific litigation support for products in crisis and, under his guidance, ISS has encouraged firms to proactively monitor the safety and effectiveness of their products and develop systems that reduce liability claims.

Dr. Weisman has over 20 years of experience in pharmacology, toxicology, pharmaceutical product development, clinical and regulatory affairs, and marketing evaluation and communication.

He played a leading role in the pharmaceutical industry's response to the removal of PPA (phenylpropanolamine) from over-the-counter products. He's worked extensively on management initiatives for opiate safety, antibiotic drug resistance, and emergency contraceptives. He's even credited with establishing the safety and continued marketing of artificial fingernail products.

Dr. Weisman is a leading authority on the switch of prescription-only products to over-the-counter status and is widely published in these areas. His development and support work includes shepherding the analgesic, Aleve, from a prescription-only product to its popular over-the-counter form, and promoting the cardiovascular uses

The Litigator’s Guide to Combating Junk Science

of aspirin for heart attack and stroke prevention. He is also recognized for effective regulatory strategies that maximize the global market potential of regulated products. His expertise in claim substantiation has helped clients successfully defend against challenges to their marketing initiatives and saved them millions of dollars.

Prior to founding ISS he ran the Pharmaceutical and Food practices at a major scientific consulting firm in Washington, DC. Before that, he served as Global Director of Medical and Clinical Affairs at Bayer, Director of Strategic Research at Sterling Winthrop, and held similar positions at Hoffman La Roche and Procter & Gamble. He has organized and presented at numerous symposia, FDA advisory committee meetings, and other regulatory venues, worldwide. He manages the FDA advisory committee process for many of the largest pharmaceutical concerns and represents companies before regulatory authorities in major markets around the world.

Dr. Weisman received his Ph.D. in Pharmacology from Cornell University Medical College and completed his postdoctoral training in Immunopharmacology at the Roche Institute of Molecular Biology.

For more information, please contact us at 973.889.1600 or [email protected].