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| Drug Firms Accused of Distorting Research Sarah Boseley, health editor Thirteen of the world's leading medical journals today mount an outspoken attack on the rich and powerful drug companies, accusing them of distorting the results of scientific research for the sake of profits. The Lancet, the New England Journal of Medicine, the Journal of the American Medical Association and other major journals accuse the drug giants of using their money - or the threat of its removal - to tie up academic researchers with legal contracts so that they are unable to report freely and fairly on the results of drug trials. The scientists, often from cash-starved university departments, may be prevented from having access to the raw data gathered in the trial which would tell them how well or not the drug worked and whether there were side-effects. They may be given no say in the way the trial is designed and they may have only limited participation in interpreting the results. "These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavourable to the sponsor's product," says the commentary which will run this week in 12 of the journals. The British Medical Journal is running a separate editorial with the same message. The editors say that the study produced for publication may be skewed in the interests of the pharmaceutical company, which hopes to make big profits from a new drug. It is also a betrayal of the patient who has agreed to take part in what he or she believes is research to help find new and better treatments for disease. Richard Horton, editor of the Lancet, said the editors hoped to start a debate over what patients are told when they sign a consent form to take part in a trial. "The patient should know who is in control of the study. Are you - my doctor or the scientist doing the study - in control or is the pharmaceutical company in control? They are never told anything of the sort. At the moment, informed patient consent is a fabrication." Academic scientists had little choice but to accept the restrictions imposed on them, he said, because they knew that otherwise the funding they needed for research would go to the increasing number of private contract research organisations. Those organisations last year in the USA received 60% of the research grants handed out by pharmaceutical companies. Where the company controls the trial, the data and the writing of the study, he said, "the research will be presented to favour the product that company makes. I think it happens all the time - certainly in most papers that involve a new drug. It's obvious that that will happen. For the company it is their profit we are talking about. There is a clash of interests". The editors intend to take action, by requiring all authors to disclose details of their own and the sponsoring pharmaceutical company's roles in the study. Some editors will be asking for a signed declaration from the author that they accept responsibility for the trial. If the company has sole control of the data, the journals will not publish the study.
JAMA
Vol. 286 No. 10,
September 12, 2001 Sponsorship, Authorship, and Accountability Frank Davidoff, MD; Catherine D. DeAngelis, MD, MPH; Jeffrey M. Drazen, MD; John Hoey, MD; Liselotte Højgaard, MD, DMSc; Richard Horton, FRCP; Sheldon Kotzin, MLS; M. Gary Nicholls, MD; Magne Nylenna, MD; A. John P. M. Overbeke, MD, PhD; Harold C. Sox, MD; Martin B. Van Der Weyden, MD, FRACP, FRCPA; Michael S. Wilkes, MD, PhD  As editors of general medical journals, we recognize that the publication of clinical research findings in respected peer-reviewed journals is the ultimate basis for most treatment decisions. Public discourse about this published evidence of efficacy and safety rests on the assumption that clinical trials data have been gathered and are presented in an objective and dispassionate manner. This discourse is vital to the scientific practice of medicine because it shapes treatment decisions made by physicians and drives public and private health care policy. We are concerned that the current intellectual environment in which some clinical research is conceived, study subjects are recruited, and the data analyzed and reported (or not reported) may threaten this precious objectivity. Clinical trials are powerful tools; like all powerful tools, they must be
used with care. They allow investigators to test biological hypotheses in
living patients, and they have the potential to change the standards of care.
The secondary economic impact of such changes can be substantial. Well-done
trials published in high-profile journals may be used to market drugs and
medical devices, potentially resulting in substantial financial gain for the
sponsor. But powerful tools must be used carefully. Patients participate in
clinical trials largely for altruistic reasons Until recently, academic, independent clinical investigators were key players in design, patient recruitment, and data interpretation in clinical trials. The intellectual and working home of these investigators, the academic medical center, has been at the hub of this enterprise, and many institutions have developed complex infrastructures devoted to the design and conduct of clinical trials. 1, 2 The academic enterprise has been a critical part of the process that led to the introduction of many new treatments into medical practice and contributed to the quality, intellectual rigor, and impact of such clinical trials. But, as economic pressures mount, this may be a thing of the past.Many clinical trials are performed to facilitate regulatory approval of a
device or drug rather than to test a specific novel scientific hypothesis. As
trials have become more sophisticated and the margin of untreated disease
harder to reach, there has been a great increase in the size of the trials and
consequently in the costs of developing new drugs. It is estimated that the
average cost of bringing a new drug to market in the United States is about
$500 million.3
The pharmaceutical industry has recognized the need to control costs and has
discovered that private nonacademic research groups As CROs and academic medical centers compete head to head for the opportunity to enroll patients in clinical trials, corporate sponsors have been able to dictate the terms of participation in the trial, terms that are not always in the best interests of academic investigators, the study participants, or the advancement of science generally.4 Investigators may have little or no input into trial design, no access to the raw data, and limited participation in data interpretation. These terms are draconian for self-respecting scientists, but many have accepted them because they know that if they do not, the sponsor will find someone else who will. And, unfortunately, even when an investigator has had substantial input into trial design and data interpretation, the results of the finished trial may be buried rather than published if they are unfavorable to the sponsor's product. Such issues are not theoretical. There have been a number of recent public examples of such problems,5, 6 and we suspect that many more go unreported. As editors, we strongly oppose contractual agreements that deny investigators the right to examine the data independently or to submit a manuscript for publication without first obtaining the consent of the sponsor. Such arrangements not only erode the fabric of intellectual inquiry that has fostered so much high-quality clinical research, but also make medical journals party to potential misrepresentation, since the published manuscript may not reveal the extent to which the authors were powerless to control the conduct of a study that bears their names. Because of our concern, we have recently revised and strengthened the section on publication ethics in the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication," a document developed by the International Committee of Medical Journal Editors (ICMJE) and widely used by individual journals as the basis for editorial policy. The revised section follows this editorial. (The entire "Uniform Requirements" document is currently undergoing revision; the revised version should be available at the beginning of 2002.) As part of the reporting requirements, we will routinely require authors to disclose details of their own and the sponsor's role in the study. Many of us will ask the responsible author to sign a statement indicating that he or she accepts full responsibility for the conduct of the trial, had access to the data, and controlled the decision to publish. We believe that a sponsor should have the right to review a manuscript for a defined period (eg, 30-60 days) before publication to allow for the filing of additional patent protection, if required. When the sponsor employs some of the authors, these authors' contributions and perspective should be reflected in the final paper as are those of the other authors, but the sponsor must impose no impediment, direct or indirect, on the publication of the study's full results, including data perceived to be detrimental to the product. Although we most commonly associate this behavior with pharmaceutical sponsors, research sponsored by governmental or other agencies may also fall victim to this form of censorship, especially if the results of such studies appear to contradict current policy. Authorship means both accountability and independence. A submitted
manuscript is the intellectual property of its authors, not the study sponsor.
We will not review or publish articles based on studies that are conducted
under conditions that allow the sponsor to have sole control of the data or to
withhold publication. We encourage investigators to use the revised ICMJE
requirements on publication ethics to guide the negotiation of research
contracts. Those contracts should give the researchers a substantial say in
trial design, access to the raw data, responsibility for data analysis and
interpretation, and the right to publish Author/Article Information Author Affiliations: Dr Davidoff is editor emeritus, Annals of Internal Medicine; Dr DeAngelis is editor, JAMA; Dr Drazen is editor-in-chief, New England Journal of Medicine; Dr Hoey is editor, Canadian Medical Association Journal; Dr Højgaard is editor-in-chief, Tidsskrift for Den norske laegeforening (Journal of the Norwegian Medical Association); Dr Horton is editor, The Lancet; Mr Kotzin is executive editor, MEDLINE/Index Medicus; Dr Nicholls is editor, New Zealand Medical Journal; Dr Nylenna is editor-in-chief, Norwegian Medical Association; Dr Overbeke is executive editor, Nederlands Tijdschrift voor Geneeskunde (Dutch Journal of Medicine); Dr Sox is editor, Annals of Internal Medicine; Dr Van Der Weyden is editor, The Medical Journal of Australia; and Dr Wilkes is editor, WJM Western Journal of Medicine. Editorials represent the opinions of the authors and THE JOURNAL and not those of the American Medical Association. The Authors Are Members of the International Committee of Medical Journal Editors. The section on publication ethics from the "Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication" follows below. The full revised "Uniform Requirements" will be published later. Conflict of Interest
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Opinions expressed in this web site do not necessarily reflect the views of NAMI Santa Cruz County, NAMI California or any affiliated organizations. We attempt to present a balanced perspective on issues by presenting multiple viewpoints. Copyright 2005 National Alliance for the Mentally Ill Santa Cruz County, All Rights Reserved. FAIR USE NOTICE: This may contain copyrighted (©) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available to advance understanding of ecological, political, human rights, economic, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml If you wish to use copyrighted material for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner. |
that
is, to advance the standard of care. In the light of that truth, the use of
clinical trials primarily for marketing, in our view, makes a mockery of
clinical investigation and is a misuse of a powerful tool.
106/L CD4 cell counts: a randomized controlled trial.
