Impugning the integrity of Medical Science Vioxx

April 18, 2008
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Impugning the Integrity of Medical Science
The Adverse Effects of Industry Influence


Editorial
Journal of the American Medical Association
April 16, 2008; Vol. 299 No. 15, pp. 1833-1835


Catherine D. DeAngelis, MD, MPH; Phil B. Fontanarosa, MD, MBA
Dr. DeAngelis is Editor in Chief and Dr. Fontanarosa is Executive Deputy Editor,
Journal of the American Medical Association.
THESE AUTHORS NOTE:
“The profession of medicine, in every aspect—clinical, education, and
research—has been inundated with profound influence from the pharmaceutical and
medical device industries. This has occurred because physicians have allowed it to
happen, and it is time to stop.”

Two articles in this issue of JAMA provide a glimpse of drug company Merck’s
“misrepresentation of research data and its manipulation of clinical research articles
and clinical reviews; such information and articles influence the education and
clinical practice of physicians and other health professionals.”
“The direct influence of for-profit companies on education and clinical practice
has been well documented, so this Editorial deals primarily with clinical research.”
Merck apparently manipulated dozens of publications to promote its Cox-2
inhibitor pain drug Vioxx. The manipulation included study results, authors, editors,
and reviewers, and it only became public because of litigation involving Vioxx.
Clinical trial articles and review articles related to Vioxx were frequently
“written by unacknowledged authors who were employees of for-profit information
industries, and often attributed first (or primary) authorship to academically
affiliated investigators who either had little to do with the study or review or who
did not disclose financial support from the company.”
It is clear that some of the authors played little direct roles in the study or
review, yet still allowed themselves to be named as authors. “Individuals,
particularly physicians, who allow themselves to be used in this way, especially for
financial gain, manifest a behavior that is unprofessional and demeaning to the
medical profession and to scientific research.”
2
Merck may have misrepresented the risk-benefit profile of Vioxx in clinical
trials involving patients with Alzheimer disease or dementia by purposely
minimizing evidence of significantly increased mortality risk among patients
assigned to receive Vioxx. Eight of the 11 authors named in the published article
were Merck employees.
“Journal editors also bear some of the responsibility for enabling companies to
manipulate publications. Some editors may allow articles and supplements to be
published without requiring complete disclosure of individual financial support, and
without requiring clear and complete disclosure of industry support of and direct
involvement with research articles or reviews.”
In another Merck study, there was “no disclosure that the manuscript had
been written by Scientific Therapeutics Information Inc, a company specializing in
the development of scientific literature, ie, writing papers for a price.”
It appears that professional “ghost writers” are the actual writer of medical
journal articles rather than the listed principal investigator, who may have become
involved in the project after it was already completed.
Additionally, disclosing relationships with for-profit companies and identifying
who actually writes articles for publication does little to stop unethical relationships
or relationships in which the [drug company] sponsor has inappropriate influence
over the data or control over the manuscript.
Problems with drug company sponsored studies include data analysis
misrepresentation and selective reporting.
“Another source that may contribute to the manipulation of research studies
involves peer reviewers who have relationships with industry. Such reviewers may
provide biased reviews that favor products of companies with which they have
strong financial relationships, may fail to disclose their conflicts of interest to
journal editors, or may even provide for-profit companies with confidential
information obtained during the peer review process.”
“Manipulation of studies and misrepresentation of study results could not
occur without the cooperation (active and tacit) of clinical researchers, other
authors, journal editors, peer reviewers, and the FDA.”
“In addition to clinical research, clinical practice and medical education also
are greatly influenced by for-profit companies. Drastic action is essential, and
cooperation of everyone involved in medical research, medical editing, medical
education, and clinical practice is required for meaningful change to occur.”
3
These authors demand that:
1) “Journal editors must seriously consider funding sources and authors’
disclosed financial conflicts of interest and financial relationships when deciding
whether to publish a study or review.”
2) “For-profit [drug] companies that sponsor biomedical research studies should
not be solely or primarily involved in collecting and monitoring of data, in
conducting the data analysis, and in preparing the manuscript reporting study
results.”
3) “All journals must require a statistical analysis of clinical trial data conducted
by a statistician who is not an employee of a for-profit [drug] company.”
4) “Professional organizations and providers of continuing medical education
courses should not condone or tolerate for-profit companies having any input into
the content of educational materials or providing funding or sponsorship for medical
education programs.”
5) “Individual physicians must be free of financial influences of pharmaceutical
and medical device companies including serving on speaker’s bureaus or accepting
gifts.”

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