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Journals pool clout to ensure integrity

Pledge to be asked of medical authors

By Naomi Aoki
Globe Staff / September 10, 2001

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Alarmed by what they perceive as growing corporate interference in pharmaceutical research, editors of a dozen prestigious medical journals are joining forces to block the publication of articles that do not come with a guarantee of scientific independence.

The new policy, expected to be issued today, requires researchers to pledge in writing that they had access to all study data, the freedom to analyze the data as they saw fit, and the authority to publish their findings regardless of the implications for companies funding the research.

Among the publications adopting the policy are the world's most highly respected and influential medical journals, including the New England Journal of Medicine, the Journal of the American Medical Association, and Britain's Lancet. By pooling their clout, the editors said, they hope to stop drug companies from forcing academic researchers to trade their independence for funding.

"Any breach of scientific integrity can endanger the life of a patient," said Dr. Catherine D. DeAngelis, editor of JAMA. "We did this because it was clearly becoming a problem. I'm not anti-pharmaceutical companies. Without them, we'd be in bad shape. What I am against is a pharmaceutical company using my journal or any journal to advertise a product rather than to provide honest, scientific results."

Dr. Nancy Olivieri of the University of Toronto has been battling the drug company that funded her research since 1996. Olivieri was testing the drug deferiprone, made by Apotex Inc., as a treatment for a rare inherited blood disorder. When she questioned the drug's effectiveness five years ago, the company cut off her funding. When she decided to warn patients about potential problems with the drug, the company threatened her with legal action to enforce a confidentiality agreement she had signed.

In 1998, Olivieri published her findings in the New England Journal of Medicine, raising concerns about serious side effects caused by the drug. But the controversy continues to be fought out in the courts and before academic tribunals.

"We've all heard about the felonies, the really big issues," said Dr. Jeffrey M. Drazen, editor of the New England Journal. "But there are many more misdemeanors. We're constantly playing cat and mouse."

Academic researchers have long played a critical role in helping to discover and test new medical treatments. But as the cost of clinical trials has risen, industry has increasingly taken over those tasks. Companies run clinical trials to meet regulatory requirements for approval of their drugs. If academic researchers want to participate or conduct additional studies, they often depend on company funding.

The journal editors contend the shift has given corporate sponsors the ability to "dictate terms . . . that are not always in the best interests of academic investigators, the study participants, or the advancement of science." In some cases, they said, researchers have limited access to the data and little input in interpreting results. In others, they are barred from publishing without permission from the corporate sponsor. They said scientists accept the "Draconian" terms because if they don't, they won't be able to pursue their research.

The concern about industry influence in research has grown in recent years as even the most credible of medical and scientific journals have grappled with controversy. A Boston gastroenterologist published a positive review of Pharmacia's arthritis drug Celebrex last year in JAMA based on six months of study data, only to learn later that the company had withheld an additional six months of data, which indicated that the drug caused stomach problems.

A University of California-San Francisco researcher defied a corporate sponsor, publishing a study in JAMA last year showing that HIV patients on standard treatments did not benefit from the company's drug, Remune. The company, Immune Response Corp., is seeking $7 million to $10 million in damages.

Another UCSF researcher battled for seven years to publish her findings in JAMA in 1997 that a cheaper version of thyroid hormone worked as well as Knoll Pharmaceuticals' drug Synthroid.

A Lancet author was pressured by a company to remove a sentence raising questions about the safety of its drug. The company backed down only after the journal threatened to publish an editorial naming the company and describing its tactics.

Drazen, of the New England Journal, said he has decided not to publish papers after repeated calls to the author made it clear the researcher didn't really know the data. He has asked researchers to crunch the numbers another way to learn the findings don't hold up. He has called academic investigators only to get return phone calls from the sponsoring companies.

The Pharmaceutical Research and Manufacturers of America, a trade organization representing pharmaceutical and biotechnology companies, last month expressed concerns that the journals were "overreacting" to a problem not as common as they appear to believe. After reviewing the changes, however, the group said it supports the policy, affirming the importance of researchers' independence for maintaining scientific integrity and patient safety.

"Companies want good science, they want high medical standards, and most of all, they want honest data," said the group's spokeswoman, Meredith Art.

Drazen and DeAngelis believe most industry-funded studies are based on sound science. But businesses that must answer to investors and their bottom lines are sometimes tempted to cast their drugs in the best light rather than in the harsh glare of scientific scrutiny, they said.

The new policy is firm. If companies want to be published in these journals, and DeAngelis is confident that they do, they must give researchers their independence. Academics are promoted based on publication in these journals. Companies market their products based on research in the journals. And soon, the editors hope, drug companies won't have many choices. DeAngelis said she already knows of 20 other journals planning to adopt similar policies.

"We all stuck together and put out a powerful message: `Don't use the journals to sell your product,' " DeAngelis said.

Naomi Aoki can be reached by e-mail at naoki@globe.com.

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