Many US Medical Schools Allow Drug Company Sponsors To Control Research, Survey

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Many US Medical Schools Allow Drug Company Sponsors To Control

Research, Survey Says

27 May 2005 Medical News Today

US medical schools " vary widely " in how involved they allow drug

companies sponsors to be in clinical research, with most schools

saying they would not permit drug companies to " quash publication " of

research but many saying they would allow other activities, according

to a study published Thursday in the... New England Journal of

Medicine, the New York Times reports (Dean, New York Times, 5/26).

The study -- led by Mello, an assistant professor at the

Harvard School of Public Health -- includes responses from 107

unnamed academic medical institutions about their standards for

accepting research contracts with pharmaceutical companies that

prohibit independent disclosure of trial results (Rowland, Boston

Globe, 5/26).

NEJM study researchers were not able to examine actual contracts

between the medical schools and drug companies (New York Times,

5/26). The following findings appear in the study:

Half of U.S. medical schools said they would allow pharmaceutical

companies to write articles detailing clinical trials for publication

in medical journals.

Twenty-four percent said they would allow drug companies to include

their own statistical analysis in the report, according to the study.

Forty-one percent of medical schools said they would allow contracts

that prohibit physicians and scientists from independently disclosing

trial results (Boston Globe, 5/26).

Sixty-nine percent of medical school administrators said competition

for research money " created pressure on administrators to compromise "

with drug companies looking to finance trials.

Eighty-two percent of medical schools reported at least one dispute

with a pharmaceutical industry sponsor after a research agreement was

signed. Such disputes usually involved money, but sometimes

showed " embedded ethical issues, " researchers said (New York Times,

5/26). Seventeen percent of the institutions had disputes with drug

companies related to access to data, the study finds (Chang, AP/Los

Angeles Times, 5/26).

Ninety-three percent of institutions said they would not enter into

agreements with drug companies that would keep researchers from

publishing negative trial results (AP/Richmond Times-Dispatch, 5/26).

Pharmaceutical Industry Connection

According to researchers, the pharmaceutical industry contributes

about 70% of the funding for clinical trials in the United States

through contracts with academic medical centers and commercial

research enterprises. Mello said those contracts " tend to look pretty

different " from government research contracts because, for

example, " there is no issue with proprietary information " and " a

government sponsor would not be involved in shaping manuscripts " (New

York Times, 5/26).

Perspective Piece

Steinbrook, who wrote a perspective piece accompanying the

study, said that the study " raises issues about the integrity of

studies that are published in medical journals. " Steinbrook is a

national correspondent for NEJM and an adjunct professor of medicine

at Dartmouth Medical School (Boston Globe, 5/26). In the perspective

piece, he examines efforts by several organizations to limit the

control drug companies have over clinical trial results. For

instance, the American Medical Association is working with the

pharmaceutical industry to eliminate gag clauses in research

contracts, and Congress is considering a bill that would require

public and private sponsors of clinical trials to register studies in

a government database (Chang, AP/USA Today side bar, 5/26).

Last year, 11 members of the International Committee of Medical

Journal Editors said they would not publish results of studies not

registered in the database, according to the perspective piece. In

addition, the Association of American Medical Colleges is creating a

set of principles for researchers and sponsors of clinical trials,

the piece states (AP/Los Angeles Times, 5/26). Steinbrook called for

the elimination of gag rules that prevent disclosure of negative

study results, according to the Globe.

Reaction

Mello said, " These things can be extremely powerful in influencing

the quantity and quality of information that reaches the public "

(Boston Globe, 5/26). Jerome Kassirer, former editor in chief at

NEJM, said, " These results are really bothersome. Some investigators

may be willing to accept constraints just to maintain good relations

with the company " (AP/USA Today, 5/26). Lassman, a spokesperson

for the Pharmaceutical Research and Manufacturers of America,

questioned the relevancy of the study to actual research,

saying, " It's a hypothetical study. " It is unlikely that drug

companies base research funding on whether an institution will grant

them more control over study results, he said. " The main thing [drug

companies] focus on is whether the researchers are high quality, "

Lassman added (New York Times, 5/26).

WSJ Examines 'Newfound Activism' of NEJM Editor

The Wall Street Journal on Thursday examined the " newfound activism "

of NEJM Editor Drazen against the pharmaceutical industry,

which many had previously criticized him for " embracing too closely. "

After Drazen became NEJM editor in 2000, he received criticism for

his financial ties to the pharmaceutical industry. In addition,

Drazen received criticism in 2002 when he adopted a policy that under

which physicians who write reviews or editorials for NEJM could

accept as much as $10,000 annually from pharmaceutical companies in

consulting and speaking fees. However, Drazen since that time

has " severed all ties " to the pharmaceutical industry, the Journal

reports. Drazen earlier this week said that Merck, Pfizer and

GlaxoKline have made a " mockery " of ClinicalTrials.gov, a public

online database of clinical trial data sponsored by NIH, because they

have failed to provide the names of many of the medications involved.

Drazen also has recently written articles that allege pharmaceutical

companies conceal negative trial data from the public. Officials for

Merck, Pfizer and GSK have said that the trial data the companies

provided to the NIH database have complied with federal law and that

they hope to expand the amount of available information

(Zimmerman/Tomsho, Wall Street Journal, 5/26).

" Reprinted with permission from kaisernetwork.org kaisernetwork.org.