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A Stand for Scientific Independence

Medical Journals Aim to Curtail Drug Companies' Influence

By Okie

Washington Post Staff Writer

Sunday, August 5, 2001; Page A01

Editors at the world's most prominent medical journals, alarmed that drug

companies are exercising too much control over research results, have agreed

to adopt a uniform policy that reserves the right to refuse to publish drug

company-sponsored studies unless the researchers involved are guaranteed

scientific independence.

The New England Journal of Medicine, the Lancet, the ls of Internal

Medicine and the Journal of the American Medical Association (JAMA) are

among the journals that have agreed to publish a joint editorial in

mid-September outlining the new policy, which was drafted by a committee of

editors over the last several months.

The unprecedented move could have a significant impact on how medical

research is conducted and reported by giving researchers more leverage in

their dealings with the pharmaceutical industry. Companies are eager to

publish studies in these prestigious journals because doctors view them as

credible sources of information to help them decide which drugs to prescribe

to patients.

Editors said the new policy is a response to companies' increasingly tight

hold over how research is done -- and, in many cases, over whether and how

the results are made public. In recent years, drug companies have become the

dominant funder of biomedical research, especially of large studies of

medicines' safety and effectiveness.

The authors who receive top billing on drug studies published in respected,

peer-reviewed journals are usually medical school professors who are experts

in their fields, but much of the research is paid for, and in large measure

carried out, by companies with an enormous financial stake in the outcome.

Company employees usually collect and analyze the data, and they often

decide how it should be presented and write the reports.

The journal editors decided to act after several recent cases involving

charges that drug companies tried to withhold research results or present

them in the most favorable way, several said during interviews last week.

" It's become a huge problem, " said off, who as editor of the

ls of Internal Medicine was among those who decided to take a stand on

the issue at an international meeting of medical journal editors in May in

Philadelphia.

D. DeAngelis, the editor of JAMA, said her journal already has a

policy of demanding that study authors vouch for the integrity of their

data. " The goal would be that all of the major journals would adopt similar

.. . . principles, " she said.

M. Drazen, editor in chief of the New England Journal of Medicine,

confirmed that the editorial is to be published in mid-September but

declined to discuss its content other than to say " it's an important issue. "

The decision was praised by several observers of biomedical studies who have

become alarmed about the influence of the drug industry on the integrity of

medical research.

In large, company-sponsored drug trials involving multiple hospitals, all of

the information collected is typically held by the company, said Marcia

Angell, former editor in chief of the New England Journal of Medicine. " Not

even the principal author sees all the data, " she said.

As editor of the journal, Angell recalled, she sometimes received

manuscripts from company-sponsored studies that had the " methods " section --

the explanation of how the study was carried out -- left blank. " They'd say,

'This is proprietary,' " she said.

Surveys of the medical literature have shown that studies paid for by drug

companies are more likely than those with other sponsors to show results

favorable to the product tested, said Bero, a professor of clinical

pharmacy and health policy at the University of California at San Francisco.

Many medical schools include clauses in grant agreements with companies

stating that researchers will be free to publish even if the results are

negative. " But even if you have one of those, you can still get hassled,

still get pressure put on you for fear that you won't get any future

funding, " Bero said.

Bert A. Spilker, senior vice president for scientific and regulatory affairs

at the Pharmaceutical Research and Manufacturers of America (PHRMA), called

the journal editors' concerns " patently absurd. "

" The journals are becoming more and more antithetical to even considering an

industry perspective, " Spilker said. Academic researchers participating in

studies " are given every opportunity to review, make suggestions and sign

off " on manuscripts, he said. " Except for some very, very rare exceptions .

.. . [the process] is working very well. "

Spilker said companies often control access to data and decide who writes

the article. " It is often easier for the sponsor or a contracted group to

write the paper, " he said. " The most common situation is that the academics

are too busy to take all the time needed to create the publication. "

J. Temple, director of medical policy at the Food and Drug

Administration's Center for Drug Evaluation and Research, said, " One of the

things I learned a long time ago is that the person who writes the rough

draft has a lot of control.

" What the journals have to figure out is, if that's the way it's done,

should it be explained that way? Should the senior author say, 'This was

drafted for me, but I believe it?' " he said.

The journal editors decided to issue the joint editorial in response to

" three or four well-known egregious examples, and many less well-known "

cases in which companies tried to block publication of unfavorable studies

or tried to put a positive spin on the findings, said off, who stepped

down as editor of the ls in July.

In a case last year, researchers at the University of California at San

Francisco defied a corporate sponsor by publishing a study concluding that

Remune, a vaccine-like product developed as an HIV therapy, did not benefit

patients who were already receiving standard treatments. The company, Immune

Response Corp. of Carlsbad, Calif., is seeking $7 million to $10 million in

compensatory damages from the university for harming its business.

University of Toronto physician Olivieri lost her research contract

with Apotex Inc., a Canadian drug company, after she spoke out and published

an article in 1998 about a serious side effect of deferiprone, a drug for a

blood disorder. Olivieri's contract with Apotex contained a non-disclosure

clause. Elie Betito, director of public and government affairs for Apotex,

said Olivieri's contract was terminated because she failed to follow the

protocol specifying how the study should be carried out, not because she

published her findings.

In the early 1990s, UCSF pharmacologist Betty J. Dong found that cheaper

generic versions of thyroid hormone worked as well as Synthroid, the

brand-name drug whose maker had funded the research. The company, Knoll

Pharmaceuticals, successfully blocked publication of Dong's findings for

seven years. In 1999, Knoll agreed to pay 37 states almost $42 million to

settle a suit alleging that it had made false claims that Synthroid was

superior to competing brands and had interfered with the publication of the

study.

, a professor of clinical pharmacology at the University of

British Columbia, predicted that if medical journals take a stand in favor

of scientific independence, it will have an impact on drug companies'

behavior. " The company wants [its drug] to be in one of these prestigious

journals, " he said. " All they need to do is say, 'We won't publish it unless

it has all the information.' "

© 2001 The Washington Post Company