In an effort to curb the influence and power that drug companies exercise in research results, editors from 12 of the most prominent medical journals, have published a joint editorial. The editorial outlines how the journals will reserve the right to refuse to publish drug company-sponsored studies unless the researchers involved are guaranteed scientific independence.
The journals plan to reject studies that do not offer "assurance" that the sponsor "gave researchers complete access to the data and freedom to report the findings." The journals "will routinely require authors to disclose details of their own and the sponsor's role in the study" and "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." Sponsors of studies will be asked to review manuscripts only 30 to 60 days before publication and "should not be able to suppress aspects of a study that are detrimental to their products".
The New England Journal of Medicine, the Lancet, the Annals of Internal Medicine and the Journal of the American Medical Association are just a few of the journals that have decided to publish the editorial. This editorial could have a significant impact on how medical research is conducted. The editorial is a response to the drug companies' increasingly tight hold over how research is done--and, in many cases, over whether and how the results are made public. In the past few years, drug companies have become the major funder of biomedical research, especially of large studies of medicines' safety and effectiveness. In some cases this has led to biased information. Lisa Bero, professor of clinical pharmacy and health policy at the University of California at San Francisco, notes that "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."
There have many three or four well-publicized examples where drug companies have tried to block publication of unfavorable studies or tried to positively embellish research findings.
In 2000, researchers at the University of California at San Francisco went against 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. As a result, Immune Response Corp. filed suit against the University seeking $7-$10 million in compensatory damages.
In another case, Nancy Olivieri, a University of Toronto physician, lost her research contract with Apotex Inc., after she spoke out and published an article about the serious side effects of deferiprone, a drug for a blood disorder, produced by Apotex Inc.
The drug companies have a different view of the issue. Bert Spilker, senior vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America (PHRMA) called the concerns "patently absurd...[academic researchers] are given every opportunity to review, make suggestions and sign off" on manuscripts. He believes that the process works "very well."
Related Links:
