Lies & Broken Promises_Drug firm Websites Fail to Disclose Test Data
Sun, 9 Jan 2005
One year after PhRMA’s publicized proclamation of its “commitment to transparency” The Boston Globe reviewed pharmaceutical company websites searching for disclosure of clinical trial data. The Globe found that this voluntary approach failed miserably:
“Last year’s commitment by members of the Pharmaceutical Research and Manufacturers of America, the industry’s Washington lobbying organization, has resulted in a total of 26 drugs listed on the clinical trials results website (www.clinicalstudyresults.org). That is out of a total of more than 10,800 prescription medications and dosages sold in the United States.” Furthermore, the Globe review found: “Of the 26 drugs listed, just five contain data that have been previously unpublished.”
The pharmaceutical industry must be held accountable for their actions, not given the benefit of doubt for their empty words. The drug industry’s pledges bear no relationship to their actions: thus, the latest public relations initiative – this time, announcing an international database and a “pledge” to list the launch of more clinical trials on a National Institutes of Health website – should be regarded as another publicity ploy to avert attention from the mounting body of evidence linking industry’s ethical and legal violations to thousands of deaths.
Drug companies disclosed new information about just 5 out of 10,800 prescription drugs! Dr. Drummond Rennie, associate editor of the Journal of the American Medical Association said: ”It’s pathetic. ‘They get all the publicity from saying they will do it, and then they don’t.”
Failure to make good on its “commitment to transparency” is but a vivid demonstration of this industry’s bad faith and pattern of deceit. Drug manufacturers continue to conceal clinical trial documents – no doubt because the data shows that widely prescribed, high priced drugs have hazardous side effects and minimal benefits.
The American taxpayer is being deceived with slick advertisements that make false claims about the safety and benefit of drugs. And we are being fleeced by an industry that doubles the price tag on prescription drugs sold in the US. The public has lost trust in this industry’ claims and bogus “initiatives” of truth telling. Polls show the public’s low esteem for the drug industry–now regarded on par with the tobacco industry. The public’s perception of the FDA has also plummeted – the agency has lost credibility when the public discovered that drugs approved by the FDA have not necessarily been proven safe or effective – in fact, data not disclosed to the public show that FDA-approved drugs may have lethal side effects.
By contrast, Fordham University’s Center for Ethics is convening a conference: “Bio-Pharmaceuticals for the 21st Century: Responsibility, Sustainability and Public Trust” (January 10, 11). It would appear that the purpose of the conference is to demonstrate unwaivering support for the industry, by providing an academic cloak of respectability for the pharmaceutical industry. The conference showcases company representatives and other stakeholders who benefit financially from the drug business–those whose research and marketing conduct have contributed to the current credibility crisis in medical research. Of note: the exclusion criteria seems to be everyone who is not directly or indirectly funded by industry – thus, no critics of the industry were invited. See agenda for Jan 11 below: Clinical Trials Registries: Responsible Policies & Public Access, a pharmaceutical industry fest–BY INVITATION ONLY. One can only speculate what Fordham expects in return for this show of support for an industry that sacrifices human lives to increase profit-margins.
Contact: Vera Hassner Sharav
The Boston Globe
January 9, 2005
Drug firms lagging on openness; Despite vow, few studies publicized
By Christopher Rowland
Six months after the drug industry vowed to make its clinical trials more transparent, and three months after launching a common website to give the public ”unprecedented access” to studies both good and bad, drug companies have posted unpublished trial results on the site for just five drugs.
Pfizer Inc., the world’s largest drug manufacturer with $40 billion in revenues in 2003, voluntarily disclosed unpublished study results on only one of the 29 prescription brand-name drugs it actively markets in the United States, the antidepressant Zoloft.
Merk & Co. posted a listing for its withdrawn painkiller Vioxx, but clicking on the link reveals nothing but another link to the product’s label and a list of two previously published studies, but not the studies themselves. There is no information posted, for example, about an unpublished, large-scale clinical trial of Vioxx performed in 2000 that showed a six-fold increase in cardiovascular risk. That study has been cited, among others, by critics who say Merck and the Food and Drug Administration ignored risks of Vioxx years ago.
The lack of information comes amid heightened public concern about drugs similar to Vioxx, such as Pfizer Inc.’s Celebrex and Bextra. Pfizer has not posted any information on Celebrex or Bextra. A spokeswoman declined to say when the company would post past studies or if unpublished data on the heavily prescribed drugs even exist.
”It’s pathetic,” said Dr. Drummond Rennie, associate editor of the Journal of the American Medical Association and an advocate for mandatory disclosure of all clinical trial results. ”They get all the publicity from saying they will do it, and then they don’t.”
A Globe review of websites indicates that the voluntary approach has produced limited disclosures thus far. Last year’s commitment by members of the Pharmaceutical Research and Manufacturers of America, the industry’s Washington lobbying organization, has resulted in a total of 26 drugs listed on the clinical trials results website (www.clinicalstudyresults.org). That is out of a total of more than 10,800 prescription medications and dosages sold in the United States.
Of the 26 drugs listed, just five contain data that have been previously unpublished, according to the Globe review. The majority of the remaining 21 drugs on the website contain listings of scientific papers that were already published in medical journals and have been available to physicians.
Some legislators, physicians, editors of academic medical journals, and consumer groups said the snail’s pace of voluntary disclosure is all the more reason Congress this session should craft laws to require that companies disclose all information to the public about potentially life-threatening side effects hidden in America’s drug supply.
”The drug companies just hide the negative results and hope the public can’t seek them out,” said US Representative Edward J. Markey, a Massachusetts Democrat and sponsor of one of several initiatives in Congress that would make disclosures of clinical trial data mandatory. ”It’s set up a like a poker game. The less information you give, the more likely you are to make money,” he said.
Last week, the industry launched an initiative for an international disclosure database and pledged to list the launch of more clinical trials on a National Institutes of Health website. The announcements were the latest of at least four announcements since last June about increasing the volume of voluntary disclosures. ”These sporadic, inconsistent, partial responses by a few companies have to be viewed as thinly disguised public relations efforts,” said Dr. Sidney Wolfe, director of the health research group Public Citizen, a Washington consumer group that has joined the call for mandatory disclosure of trial results.
But drug company representatives said the work is proceeding as intended. At the height of the industry’s political crisis last September, its lobbying group said it would take a full year for all results to be posted. PhRMA also said it would post data from trials completed after October 2002, although in practice much of the data posted thus far precede that date.
”The progress has been fine. We gave people a full year to post things, and the companies are taking that very seriously,” said Dr. Alan Goldhammer, associate vice president for regulatory affairs for PhRMA. He said he expected the pace of postings to increase this year as drug companies compile data.
Companies generally keep the existence of unpublished studies secret. Companies notify the FDA if a trial is performed in the United States, but the data generally only have to be made public if they are part of the FDA application for an approved drug. Such rules make estimating the amount of unpublished data from clinical trials difficult if not impossible, said editors of medical journals and consulting firms expert in the field.
Rennie estimated in a July 2003 study that 1 million late-stage, controlled clinical trials had been conducted since 1948, and that only half the results were ultimately published, although many may have been presented as a poster or paper at scientific conferences. Getting a grip on the universe of unpublished data is one of the goals of Rennie and other advocates of mandatory disclosure.
Most of the world’s 10 largest drug companies, with collective annual revenues over $200 billion, either said last week said they did not know how many drugs they would ultimately post on the common US website, or they did not respond to the question. PhRMA officials said they were unable to quantify how much data can be expected to be revealed.
GlaxoSmithKline, Novartis AG, Eli Lilly and Co., and Bristol-Myers Squibb said they would place published and unpublished study information about more than 90 drugs on the website during 2005.
Drug companies said they were taking so long to publicly post information because they are taking raw data from unpublished studies and placing them into an internationally recognized, uniform format. A Pfizer spokeswoman, Alison Lehanski, said disclosing trial results is a ”massive undertaking” that takes considerable time. Pfizer has established a team of workers to cull through studies, pull together information, make sure it fits in the PhRMA website guidelines, and make sure its postings are of ”very high quality,” she said.
Merck has not posted the unpublished Vioxx trial from 2000 because the PhRMA site’s voluntary guidelines only call for posting data completed after October 2002, said Merck spokesman Chris Loder. ”Given the voluminous nature, we did not go back and post trials completed prior to ’02,” he said.
Academics and physicians for several years had been pushing for more clinical trial disclosures before the issue gained momentum in 2004 when New York Attorney General Eliot Spitzer sued GlaxoSmithKline. Spitzer alleged that the British drug giant suppressed safety concerns about the effects of its antidepressant Paxil in children and adolescents. GlaxoSmithKline settled for $2.5 million in August 2004 without admitting wrongdoing.
The FDA — after reviewing data from trials of Paxil and other antidepressants — subsequently required in October that all antidepressants contain a ”black box warning” on their label disclosing slightly increased risk of suicidal thinking among young people taking the widely prescribed drugs. In cases where drugs present specific dangers, the FDA requires black box warnings to alert physicians to particularly high risk of drug side effects in some patient populations.
The New England Journal of Medicine and other prominent medical journals, meanwhile, said they will require that drug companies disclose the launch of all drug studies as a condition of publication of the eventual results. The requirement, to take effect in July, will allow physicians and the public to at least be aware of every study being conducted. The medical journals stopped short of requiring disclosure of the information gleaned from those trials.
Members of Congress, including Markey in the House and Democratic Senators Edward M. Kennedy of Massachusetts and Chris Dodd of Connecticut, introduced legislation to make trial disclosures mandatory. Republican Charles Grassley of Iowa, chairman of the Senate Finance Committee, is considering similar legislation. Some of the initiatives in Congress could lead to the expansion of an existing National Institutes of Health website that lists current clinical trials for life-threatening diseases, ClinicalTrials.gov, to include details of the trial outcomes.
In response to all the pressure, a PhRMA representative told a congressional panel in September that the industry had a ”commitment to transparency.” The industry said it would disclose results of late-stage ”hypothesis testing” trials completed since October 2002, including trials for drugs that have already been approved but which drug companies have continued to test for potentially new uses. The industry has said it envisions the site as containing mostly information about late-stage and post-market clinical trials in which both effectiveness and safety are tested in large populations.
Individual players in the industry have taken a variety of approaches to the website. The third-largest drug company in the world, for example, the newly merged Sanofi-Aventis, hasn’t decided what to do. ”We don’t have a defined policy on that yet,” said spokesman Marc Greene. Lilly meanwhile, is focusing most of its efforts on creating a website of its own. GlaxoSmithKline has yet to post information about Paxil, the drug that was the focus of controversy, on the PhRMA website, although it does have extensive disclosures for Paxil on its own company website. To further complicate matters, GlaxoSmithKline has posted information on two other drugs on PhRMA’s common website.
The presentation of individual drugs on the common website falls short of industry promises for a central, easy-to-use location to find critical health information, said Dr. Jeffrey Drazen, the editor in chief of the New England Journal of Medicine. ”It’s not like they fit into a template,” he said. ”Everyone’s kind of putting stuff in their own way. You don’t know where to look, and you might miss something.” The industry’s performance thus far, he added, ”is not at all surprising. Their past behavior suggests that would be a legitimate reason for what’s going on right now.”
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Clinical Trials Registries:
Responsible Policies & Public Access
11 January 2005 8:00 AM – 5:00 PM
7:00 – 8:30 AM Continental Breakfast & Registration
8:30 – 8:45 AM Greetings and Overview to the Day’s Events:
Celia Fisher, Ph.D., Director, Center for Ethics Education, Marie Ward Doty Chair Fordham University
8:45 – 9:00 AM Introduction to Panel I: Moderator Falguni Sen, Ph.D., Professor of Management, Graduate School of Business, Fordham University
9:00 – 9:30 AM Panel 1: Clinical Trial Registries: Current Models & Public Perceptions
Theresa Toigo, RPh, MBA, Director, Office of Special Health Issues, Office of External Relations, Food and Drug Administration
Alan Breier, Vice President of Lilly Medical, Chief Medical Officer, Eli Lilly & Co.
Edward Campion, M.D., Senior Deputy Editor, New England Journal of Medicine
Laurence Hirsch, M.D., Executive Director, Medical Communications, Merck Research Laboratories
John Schneider, MD, Ph.D., Chair-Elect, Council on Scientific Affairs, American Medical Association
Richard Barker, M.D., Director General, Association of the British Pharmaceutical Industry
Objective. Panel members will describe current registry models and identify similarities and differences in goals, content, process, and accessibility. The panel and the discussion that follows will probe how the current discourse has affected public trust and the value and feasibility of a common or multiple goals.
9:30 – 10:15 AM Discussion
10:15 – 10:30 AM Break
10:30 – 11:00 AM Panel 2: Current Models: Promise, Problems & Meaningful Public Access Moderator Justin McCarthy, Esq., General Counsel, Pfizer Global Research & Development
Bernard Schwetz, DVM, Ph.D., Director, Office for Human Research Protections
Pearl O’Rourke, M.D., Director, Human Research Affairs, Partners HealthCare Systems, Inc.
Herbert Pardes, M.D., President and CEO, New York Presbyterian Healthcare System
Emma Sergeant, President, Clinical Trials Worldwide of Fast4wd Ogilvy
Objective. Panel members will identify pros and cons of the different registry models in targeting specific goals. The panel and the discussion that follows will identify stakeholder perspectives on intended and unintended consequences of registries on research and development, public welfare, and public trust.
11:00 – 11:45 AM Discussion
11:45 – Noon Summary and Reflections on Morning Panels: Moderator Felix Gyi, PharmD, MBA, CIP, CEO, Chesapeake Research Review, Inc.
Noon – 1:00 PM LUNCH hosted by Fordham
1:00 – 1:45 PM Panel 3: Ideal Registry(ies): Panacea or Placebo? Moderator Tom Adams, CAE, CEO, Association of Clinical Research Professionals
Michael Werner, Esq., Vice President & Chief of Policy, BIO: Biotechnology Industry Organization
Ken Getz, Board Chairman, Center for Information and Study on Clinical Research Participation
Malcolm Wheeler, Wheeler, Trigg & Kennedy, LLP Gary Cohen, M.D., Vice President, Ethics & Corporate Responsibility, Millennium Pharmaceuticals, Inc.
Robert Rubin, M.D., Ph.D., Associate Director, Division of Infectious Disease, MIT Harvard Center for Experimental Pharmacology and Therapeutics
Marc Wilenzick, Esq. Senior Corporate Counsel, Pfizer, Inc.
Objective. Panel members will identify registry elements that would be essential to meeting specified goals. The panel and discussion that follows will focus on alternative pathways to achieving different stakeholder goals and specify what registries cannot and should not try to do.
1:45 – 2:30 PM Discussion
2:30 – 2:45 PM Break
2:45 – 3:15 PM Panel 4: Key Points & Recommendations: Moderator Doug Peddicord, Ph.D., Legislative Director, Association of Clinical Research Organizations (ACRO)
Debra Aronson, Esq., Director of Bioethics, BIO: Biotechnology Industry Organization
Marc Boutin, Esq. Vice President, Policy Development & Advocacy, National Health Council
Kevin Dahill, MBA, President & CEO, Nassau Suffolk Hospital Council
Lee Farrow, Esq., Vice President, ACE Medical Risk
Matthew Whalen, Ph.D., Co-Founder & Chief Development Officer, Chesapeake Research Review, Inc.
Objective. Panel members and full group discussion on key points and recommendations to inform the public and policy makers about the promise and challenges of different models for clinical trials registries.
3:15 – 3:45 Discussion
3:45 – 3:45 – 4:15 PM Evaluating Recommendations: Anticipating Public Reaction:
Moderator Marc Boutin, Esq., Vice President, Policy Development & Advocacy, National Health Council
Objective. Full group discussion to realistically assess potential stakeholder reactions to the Summit’s recommendations and identify best ways of addressing anticipated concerns and reaching decision-makers.
4:15 – 4:45 PM Discussion & Consensus on Summit Recommendations: Moderator Celia Fisher
4:45 – 5:00 PM Next Steps
Dissemination on Websites & Publications