DOCSLIB.ORG

The Financing of Drug Trials by Pharmaceutical Companies and Its

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
The Financing of Drug Trials by Pharmaceutical Companies and Its MEDICINE ORIGINAL ARTICLE The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences Part 1: A Qualitative, Systematic Review of the Literature on Possible Influences on the Findings, Protocols, and Quality of Drug Trials Gisela Schott, Henry Pachl, Ulrich Limbach, Ursula Gundert-Remy, Wolf-Dieter Ludwig*, Klaus Lieb* Arzneimittelkommis - SUMMARY linical drug trials funded by pharmaceutical sion der deutschen companies yield favorable results for the spon- Ärzteschaft, Berlin: Background: In recent years, a number of studies have C Dr. med. Schott, sor’s products more often than independent trials do. Dipl.-Biol. Pachl, shown that clinical drug trials financed by pharmaceutical This has been demonstrated by a number of studies in Prof. Dr. med. companies yield favorable results for company products recent years (1–4). Various ways have been described Gundert-Remy, more often than independent trials do. Moreover, Prof. Dr. med. Ludwig in which pharmaceutical concerns exert influence on pharmaceutical companies have been found to Klinik für Hämatologie, the protocol and conduct of drug trials, as well as on influence drug trials in various ways. This paper Onkologie und the interpretation and publication of their results (1, 3, Tumorimmunologie, provides an overview of the findings of current, 5, 6). HELIOS Klinikum systematic studies on this topic. Berlin-Buch: Two important reviews on this topic were published Prof. Dr. med. Ludwig Methods: Publications retrieved from a systematic in 2003 (7, 8): Klinik für Psychiatrie Medline search on this topic from 1 November 2002 to und Psychotherapie, Bekelman et al. carried out a quantitative analysis Universitätsmedizin 16 December 2009 were independently evaluated and of 37 studies to investigate the extent and the Mainz: selected by two of the authors. These publications were relevance of financial links between biomedical Cand. med. Limbach, supplemented by further ones found in their references Prof. Dr. med. Lieb companies on one hand and academic institutions and sections. * The authors Ludwig scientists on the other (7). This systematic review and Lieb have Results: 57 publications were included for evaluation in showed widespread conflicts of interest in the shape equally contributed of financial connections between scientists, academic to the manuscript. Parts 1 and 2 of this article. Published drug trials that were financed by pharmaceutical companies, or whose institutions, and the pharmaceutical industry. Around authors declared a financial conflict of interest, were one quarter of academic staff and two thirds of aca- found to yield favorable results for the drug manufacturer demic institutions had financial relationships with more frequently than independently financed trials industry. Analysis of 8 review articles embracing a whose authors had no such conflicts. The results were total of 1140 original articles (including randomized also interpreted favorably more often than in independently controlled trials [RCT], economic analyses, and retro- financed trials. Furthermore, there was evidence that spective cohort studies) revealed a statistically signifi- pharmaceutical companies influenced study protocols cant association between funding by biomedical in a way that was favorable to themselves. companies and conclusions favorable to the pharma- The methodological quality of trials financed by ceutical industry (summarized odds ratio [OR] 3.6, pharmaceutical companies was not found to be any 95% confidence interval [CI] 2.6–4.9). Industry worse than that of trials financed in other ways. financing was also connected with limitations of pub- Conclusion: Published drug trials that are financed by lication rights and constraints on access to trial data. pharmaceutical companies may present a distorted In the second review, a systematic analysis of 30 picture. This cannot be explained by any difference in publications, Lexchin et al. showed that drug trials methodological quality between such trials and trials financed by pharmaceutical companies are less likely to financed in other ways. be published, but that those published more frequently yield positive results for the sponsors’ products than do independently funded studies (8). The quality of the methods employed (analyzed in 13 publications) in Cite this as: Dtsch Arztebl Int 2010; 107(16): 279–85 trials financed by pharmaceutical companies was not DOI: 10.3238/arztebl.2010.0279 inferior to that in studies with other sources of funding. Deutsches Ärzteblatt International | Dtsch Arztebl Int 2010; 107(16): 279–85 279 MEDICINE Influence on many different aspects of a clinical Evaluation of the literature drug trial can affect the results, from the purpose via the The basic characteristics, purpose, and principal find- planning and conduct of the study all the way to its ings of each of the studies reviewed were recorded evaluation and publication (5). (eTable). The quality of the studies’ methods was not The authors of the present systematic review set out systematically evaluated, because there is no validated, to assess whether recently published studies reveal a reliable instrument for quality assessment that can be connection between financing of drug trials by pharma- applied to all of the various study designs (including ceutical companies and results favorable to these systematic reviews, meta-analyses, case studies, and companies’ products. Part 1 investigates whether and, if cross-sectional studies). so, how the type of funding affects study protocol and In the effort to ensure comprehensive portrayal of quality. Part 2 identifies and depicts the aspects of clini- the various ways in which influence could be exerted, a cal drug trials that can be influenced by financial descriptive approach was chosen; no hypotheses were support from the pharmaceutical industry. advanced or statistical analyses performed. The studies were arranged by topic according to their results. Methods Systematic literature review Results The criteria for the selection of systematic investi- The search of the PubMed database yielded 1705 publi- gations into the effects of financing on study results cations. After inspection of reference lists, 57 publi- were oriented on the above-mentioned reviews (7, 8). cations that satisfied the inclusion and exclusion The literature search was carried out in the PubMed criteria were evaluated (Figure). The results of this database. The most important MeSH terms and search evaluation are described in Parts 1 and 2 of the present terms, combined by means of Boolean operators, were study. “conflict of interest”, research support as topic”, clini- The publications included were primarily studies cal trials as topic”, “commerce”, “drug industry”, performed with the expressed goal of comparing clini- “authorship”, “publication bias”, and “financial cal trials funded by pharmaceutical companies with support”. clinical trials that had not received financial support The following limits, among others, were imposed: from such companies, e.g., with regard to the results or “publication date”, “clinical trial”, “meta-analysis”, conclusions. These studies were accompanied by a and “randomized controlled trial”. number of publications that investigated the conse- Searches were carried out on 26 May 2008 (for the quences of financing of a study by pharmaceutical period 1 November 2002 to 26 May 2008), 4 December companies. These included, for example, articles in 2008 (for 26 May 2008 to 3 December 2008), and 16 which information from the files of the US licensing December 2009 (for 1 October 2008 to 16 December authority (Food and Drug Administration, FDA) was 2009). compared with data from publications in medical jour - Publications in all languages were included. Two of nals, and case studies on individual substances. the authors (G. Schott, U. Limbach) independently se- Two systematic reviews carried out for much the lected suitable studies on the basis of the inclusion and same reason as the present review were excluded on the exclusion criteria (see below). In the case of disagree- grounds that their principal primary studies had already ment, consensus was achieved by discussion with a been included (10, 11). The results of the publications third author (K. Lieb). The reference lists of all selected covered in the present review are based largely on clini- articles were inspected for further relevant publications cal drug trials conducted principally in the Anglo- (9). American countries. A few publications also analyzed studies performed in Germany. The most recent studies Inclusion and exclusion criteria whose data were taken into account in the papers cov - The criteria for inclusion were: ered were published in November 2008. The publi- ● Publication between 1 November 2002 and 16 cations evaluated concern various areas of medicine, December 2009 (i.e., directly following on from but it cannot be completely ruled out that original data the period analyzed by Bekelman et al. [7]) from a small number of drug trials were included more ● Description of the methods employed than once. A few studies dealt with several aspects. ● Provision of empirical data as to whether and how financing by pharmaceutical companies affects Connection between type of funding and results of drug trials various aspects of clinical trials (e.g., protocol, Twenty-six of the 57 publications analyzed sought to conduct, results, conclusions, or publication). ascertain whether the results and/or conclusions of
Load more

Recommended publications
  • Sensitivity and Specificity. Wikipedia. Last Modified on 16 November 2013
    Sensitivity and specificity - Wikipedia, the free encyclopedia Create account Log in Article Talk Read Edit View Sensitivity and specificity From Wikipedia, the free encyclopedia Main page Contents Sensitivity and specificity are statistical measures of the performance of a binary classification test, also known in statistics as Featured content classification function. Sensitivity (also called the true positive rate, or the recall rate in some fields) measures the proportion of Current events actual positives which are correctly identified as such (e.g. the percentage of sick people who are correctly identified as having Random article the condition). Specificity measures the proportion of negatives which are correctly identified as such (e.g. the percentage of Donate to Wikipedia healthy people who are correctly identified as not having the condition, sometimes called the true negative rate). These two measures are closely related to the concepts of type I and type II errors. A perfect predictor would be described as 100% Interaction sensitive (i.e. predicting all people from the sick group as sick) and 100% specific (i.e. not predicting anyone from the healthy Help group as sick); however, theoretically any predictor will possess a minimum error bound known as the Bayes error rate. About Wikipedia For any test, there is usually a trade-off between the measures. For example: in an airport security setting in which one is testing Community portal for potential threats to safety, scanners may be set to trigger on low-risk items like belt buckles and keys (low specificity), in Recent changes order to reduce the risk of missing objects that do pose a threat to the aircraft and those aboard (high sensitivity).
    [Show full text]
  • Supreme Court of the United States ______
    No. 15-1525 IN THE Supreme Court of the United States ____________________ SERGEANTS BENEVOLENT ASSOCIATION HEALTH AND WELFARE FUND, NEW ENGLAND CARPENTERS HEALTH BENEFITS FUND, ALLIED SERVICES DIVISION WELFARE FUND, Petitioners, v. SANOFI-AVENTIS U.S. LLP., SANOFI-AVENTIS U.S., INC. Respondents. ____________________ On Petition for a Writ of Certiorari to the United States Court of Appeals for the Second Circuit ____________________ BRIEF OF AARP, AARP FOUNDATION, COMMUNITY CATALYST, AND PUBLIC CITIZEN, INC. AS AMICI CURIAE IN SUPPORT OF PETITIONERS ____________________ Julie Nepveu Jason L. Lichtman AARP FOUNDATION Counsel of Record LITIGATION LIEFF CABRASER HEIMANN 601 E Street NW & BERNSTEIN, LLP Washington, DC 20049 250 Hudson Street, 8th Floor New York, NY 10013 Andrew R. Kaufman (212) 355-9500 LIEFF CABRASER HEIMANN [email protected] & BERNSTEIN, LLP 150 Fourth Ave N., Suite 1650 Nashville, TN 37219 i TABLE OF CONTENTS Page STATEMENT OF INTEREST................................... 1 SUMMARY OF THE ARGUMENT........................... 2 ARGUMENT .............................................................. 3 I. PHARMACEUTICAL MANUFACTURERS AGGRESSIVELY MARKET TO DOCTORS TO BOLSTER SALES................................................... 3 II. PHARMACEUTICAL MARKETING IS FREQUENTLY MISLEADING. ..................................... 6 A. Unlawful promotion of drugs is commonplace................ 7 B. The use of biased clinical studies as marketing tools is highly misleading and corrupts the information process doctors rely upon to
    [Show full text]
  • Is This a Seeding Trial? by Mark Hochhauser
    Vol. 5, No. 6, June 2009 “Can You Handle the Truth?” Is this a Seeding Trial? By Mark Hochhauser Seeding trials are clinical studies primarily intended to promote use of the study drug by physicians and/or to convert physicians, especially opinion leaders — and study subjects — into advocates for the study drug. Seeding trials seed the market with product samples. The sponsor hopes that physicians and patients will continue using the drug after the trial. Seeding trials are unethical because they exploit study subjects for commercial purposes, create little or no medically useful knowledge, and deceive researchers, subjects and IRBs. In the interest of protecting human welfare, institutional review boards (IRBs) should not approve seeding trials. A seeding trial can occur only because the sponsor “does not disclose its true purpose to anyone who could say ‘no.’” 1 (p. 279) The question for the IRB thus becomes: Is the study under review a seeding trial? Inexperienced investigators and IRB members may not be familiar with the characteristics of seeding trials. Table 1 summarizes the six seeding trial criteria of Kessler, et al2 and six additional criteria of Sox and Rennie1. These researchers suggested that clinical trials sharing one or more of these flaws might be seeding trials, although some information may be difficult or impossible for the IRB to obtain. With the criteria in Table 1, IRBs can identify most seeding studies. Case Study Our IRB reviewed a Phase IIIb rollover trial (“Study A”) using subjects from a Phase III study. Phase III trials are large, multicenter, randomized controlled trials designed to evaluate a drug’s effectiveness in comparison to the standard treatment.
    [Show full text]
  • Conflicts of Interest in Clinical Trial Recruitment & Enrollment
    Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight A White Paper by The Center for AW Health & Pharmaceutical Law L & Policy Seton Hall University School of Law One Newark Center Newark, NJ 07102 law.shu.edu November 2009 SETON HALL HALL SETON AUTHORSHIP This White Paper was produced by the staff and affiliated faculty identified below of the Center for Health & Pharmaceutical Law & Policy at Seton Hall Law School. Kathleen M. Boozang Professor of Law Associate Dean for Academic Advancement Seton Hall Law School Carl Coleman Professor of Law Faculty Director Center for Health & Pharmaceutical Law & Policy Seton Hall Law School Tracy E. Miller* Executive Director Center for Health & Pharmaceutical Law & Policy Seton Hall Law School Kate Greenwood Faculty Researcher Center for Health & Pharmaceutical Law & Policy Seton Hall Law School Valerie Gutmann Faculty Researcher Center for Health & Pharmaceutical Law & Policy Seton Hall Law School Simone Handler-Hutchinson Executive Director, Global Healthcare Compliance & Ethics Education Seton Hall Law School Catherine Finizio Administrator Center for Health & Pharmaceutical Law & Policy Seton Hall Law School * Ms. Miller served as Executive Director through September 4, 2009. ACKNOWLEDGEMENTS On March 23, 2009, the Center for Health & Pharmaceutical Law & Policy at Seton Hall Law School hosted an invitation-only Forum to address the ethical, legal, and policy issues posed by conflicts of interest that could influence investigator judgment in the recruitment and enrollment of research participants. Entitled Protecting Participants, Advancing Science: An Agenda for Reform of Clinical Research Recruitment and Enrollment, the Forum brought together leaders from academic medicine and industry, consumer representatives, legal and ethics experts, and government officials.
    [Show full text]
  • [T]His Advertising Promotes Only the Most Expensive
    presents "[T]his advertising promotes only the most expensive products, it drives prescription costs up and also encourages the 'medicalization' of American life — the sense that pills are needed for most everyday problems that people notice, and many that they don’t." — Jerry Avorn, New York Times Convincing people they are sick and need a drug is a multi-billion dollar industry. In 2015, Big Pharma dropped a record- breaking $5.4 billion on direct-to-consumer (DTC) ads, according to Kantar Media. And it paid off for Big Pharma. The same year, Americans spent a record $457 billion on prescription drugs. The U.S. and New Zealand are the only countries where DTC is legal. Americans also pay more for drugs and devices than any other country. The bulk of these ads appear on TV at a rate of 80 ads per hour of programming, according to Nielsen. Behind the drug and device ads saturating TV, radio and digital media are hidden costs and devastating side effects that companies don't advertise, and critics say the ads drive up drug prices and erode the patient-doctor relationship. With the price of drugs skyrocketing, politicians and health-care providers question Pharma's DTC spending, which exceeds money spent on research and development. Even presidential hopeful Hillary Clinton called for an end to tax breaks for drug ads and for tougher regulations. But the money spent on DTC is just one small cog in Big Pharma's well-oiled marketing machine. Companies spend billions more on getting doctors to write prescriptions for their expensive brand-name drugs or devices for uses not approved by the Food and Drug Administration — a controversial practice called off-label marketing.
    [Show full text]
  • Science and Commerce in Medical Epistemology DISSERTATION
    UNIVERSITY OF CALIFORNIA, IRVINE The Fundamental Antagonism: Science and Commerce in Medical Epistemology DISSERTATION submitted in partial satisfaction of the requirements for the degree of DOCTOR OF PHILOSOPHY in Philosophy by Bennett Harvey Holman Dissertation Committee: Professor P. Kyle Stanford, Chair Professor Jeffrey Barrett Associate Professor Kent Johnson Distinguished Professor Brian Skyrms 2015 Portion of Chapter 5 © 2015 University of Chicago Press. Chapter 6 © 2015 University of Chicago Press All other materials © 2015 Bennett Harvey Holman DEDICATION To: My father who inspired me to make the world a better place. And My mother who demanded that I love my work. I learned this, at least, by my experiment: that if one advances confidently in the direction of his dreams, and endeavors to live the life which he has imagined, he will meet with a success unexpected in common hours. He will put some things behind, will pass an invisible boundary; new, universal, and more liberal laws will begin to establish themselves around and within him; or the old laws be expanded, and interpreted in his favor in a more liberal sense, and he will live with the license of a higher order of beings. In proportion as he simplifies his life, the laws of the universe will appear less complex, and solitude will not be solitude, nor poverty poverty, nor weakness weakness. If you have built castles in the air, your work need not be lost; that is where they should be. Now put the foundations under them. Henry David Thoreau Walden No one who has not given the subject especial attention can imagine what impudent mendacity, what incredibly absurd claims, what impossible statements, are indulged in by those nostrum manufacturers who have made the physician their special prey… It is a false and pernicious theory that error should be left alone; that it will die out by itself.
    [Show full text]
  • Sponsorship Bias in Clinical Trials
    Sponsorship bias in clinical trials Nr 11 | 2015 (49) | Page 123-130 | Main article | 21-11-2015 Joel Lexchin, the author of the translated article, indicates that the pharmaceutical industry is in a situation of conflict. The economic fate of pharmaceutical companies depends on the favourable outcomes of the trials they sponsor, which may make it tempting for them to try and influence studies they are involved in. This situation exists not only in the pharmaceutical industry, but also in the tobacco industry, the banking community, the food and drinks industry and even, as has recently emerged, in the automotive industry. Lexchin mentions several interventions that the pharmaceutical industry can use to influence the results of the scientific research they sponsor. When these positively biased? results are published in journals as research papers, readers who are unaware of this bias can be misled. Below we discuss a number of points that could help readers evaluate papers that present overly optimistic messages. In fact, most of these aspects have already been discussed in previous issues of Geneesmiddelenbulletin. In Gebu 2012; 46: 138-145, Lexchin discussed several aspects of the way the pharmaceutical industry is influencing the results of clinical drug trials. The present article can be regarded as a further clarification of these matters. Information about new drugs should not be provided by persons who might stand to gain financially from the information provided, even more so when gifts or presents are involved. When doctors of pharmacists read or discuss articles, it might be useful if they do so together with an expert on evidence-based medicine (EBM).
    [Show full text]
  • Plant Pathology at Washington State University, 1891-1989, and Cereal Research at Pullman
    Plant Pathology at Washington State University, 1891-1989, and Cereal Research at Pullman George W. Bruehl Table of Contents FOREWARD .................................................................................................................................................1 INTRODUCTION...........................................................................................................................................2 CHRONOLOGY ............................................................................................................................................4 THE START .................................................................................................................................................4 THE TIMES OF CHARLES V. PIPER, 1893-1903.............................................................................................7 THE R. KENT BEATTIE PERIOD, 1904-1909 ...............................................................................................10 THE HARRY B. HUMPHREY PERIOD, 1910-1913.........................................................................................12 THE IRA D. CARDIFF PERIOD, 1913-1916 ..................................................................................................14 THE FREDERICK D. HEALD ERA, 1917-1941 ..............................................................................................20 J. G. HARRAR AND EARL J. ANDERSON, 1941-1945...................................................................................26 THE GEORGE
    [Show full text]
  • Clinical Drug Trials in General Practice: a 10-Year Overview of Protocols Anja Maria Brænd*, Kaspar Buus Jensen, Atle Klovning and Jørund Straand
    Brænd et al. Trials 2013, 14:162 http://www.trialsjournal.com/content/14/1/162 TRIALS RESEARCH Open Access Clinical drug trials in general practice: a 10-year overview of protocols Anja Maria Brænd*, Kaspar Buus Jensen, Atle Klovning and Jørund Straand Abstract Background: Drugs predominantly prescribed in general practice should ideally be tested in that setting; however, little is known about drug trials in general practice. Our aim was to describe drug trials in Norwegian general practice over the period of a decade. Methods: The present work concerns a 10-year retrospective study of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). We analyzed the number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion. We also analyzed one trial in greater detail. Results: Out of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved.
    [Show full text]
  • Critical Appraisal of Rcts
    Critical appraisal of RCTs Bad trials What are the top three causes of death in the Western world? Top three causes of death: 1 Heart disease 2 Cancer 3 Therapeutic drugs The drug development cycle “KMR is a global leader in the area of benchmarking, analytics and performance management. Focused exclusively on biopharmaceutical R&D, we offer peerless data on topics ranging from R&D Productivity to enrollment” An expensive business Pharmaceutical industry claims that the mean cost of bring a new drug to market is US $ 800m. Gotzsche1 suggests a more reasonable figure is US $ 100m. 1 Deadly medicines and organised crime: how big pharma has corrupted healthcare. 2013. Radcliffe. Fraud and research misconduct • Fabrication (Yoshitaka Fujii, 172 studies of granisetron for prevention of postoperative nausea) • Plagiarism • Tidying up results • Manipulation of results (aversion therapy) Fraud and research misconduct • Scale of the problem 1: 2% of scientists admitted fabrication, falsification or modification, but 14% knew of colleagues who’d done this • 33% admitted other questionable practices, and 70% said they knew colleagues who’d performed these 1 Fanelli D. How many scientists fabricate and falsify research? A systematic review and meta-analysis of survey data. PLoS One. 2009; 4(5): e5738 Authorship issues • Honorary authorship • Fictitious authorship (Matzinger, P. and Mirkwood, G.) • Ghost authorship. Currently estimated in 505 of clinical trials. Healy et al. The interface between authorship, industry and science in the domain of therapeutics.
    [Show full text]
  • Nutcracker Notes, Issue No
    Issue No. 22: Spring / Summer 2012 'Look, Mom, No Hands!' see Leslie article WPEF P.O. Box 17943 Missoula, MT 59808 Join us in Kimberley WPEF Director: Diana F. Tomback University of Colorado Denver Whitebark Pine Ecosystem Foundation Dept. of Integrative Biology, CB 171 P0 Box 173364 Nutcracker Notes, Issue No. 22; Spring/Summer 2012 Denver, CO 80217 [email protected] CONTENTS PAGE Assoc. Director: Cyndi M. Smith, Box 200 Update Waterton Lakes National Park, Alberta TOK 2M0, Canada Director’s Message ............................................................................... 1 [email protected] Director’s Message—WPEF Canada..................................................... 2 Secretary: Helen Y. Smith Join Us in Kimberley.............................................................................. 2 RMRS Missoula* Guidelines for Authors........................................................................... 3 [email protected] Interview with Edie Dooley .................................................................... 4 Treasurer: Ward McCaughey RMRS retired News Items & Updates: 366 Stagecoach Trail Florence, MT 59833 Election News (Cyndi) ........................................................................... 5 [email protected] Treasurers’ Report: View it on-line ........................................................ 5 Calendar Photos Chosen ...................................................................... 5 Membership & Outreach Coordinator: Bryan L. Donner Student Research Grants .....................................................................
    [Show full text]
  • Letters to the Editor
    The Journal welcomes letters to the editor. If found suitable, they will be published as space allows. Letters she l.i Letters to the Editor behe typedtuned double-spaced,double-snared should not exceed 400 words, and arcare subiectsubject to abridementabridgment and other editorial chane”.1. ; 1 in accordance with Journal style. All letters that reference a recently published Journal article are sent to £ original authors for their reply. If no reply is published, the authors have not responded by date of publicatio' Send letters to Paul M. Fischer, Editor, The Journal o f Family Practice, 519 Pleasant Home Rd Suite A J Augusta, C,A 30907-3500, or Fax (706) 855-1107. ’ n TERAZOSIN FOR BPH prostatic hyperplasia: a primary care trial. J in treatment of symptomatic BPH. Iam Fam Pract 1994; 39:129-33. confident that the improvement seen To the Editor: 2. Kessler DA, Rose JL, Temple RJ, et al. which was more than twice the level of I read with dismay a recent article in Therapeutic-class wars— drug promotion placebo effect seen in Dr Lepor’s study is The Journal concerning treatment of hy­ in a competitive marketplace. N Engl J Med significant. 1 do think that the study is a 1994; 331:1350-3. pertension and symptomatic benign pros­ valuable addition to the double-blind tatic hyperplasia (BPH) with terazosin.1 3. Lepor H, Auerbach S, Purasbaez A, et al. A randomized, placebo-controlled multi­ data that have been accumulated by other In this study, over 700 primary care center study of the efficacy and safety of investigators in the use of terazosin and physicians throughout America were “ re­ terazosin in the treatment of benign pros­ other alpha[ blockers.
    [Show full text]