Background
Medical research is essential for helping to discover and test new medical treatments. Researchers write about the results of their work and submit it to medical journals for publication. This way, not only do the researchers get recognition for their studies, but the results are made known to physicians, nurses, and other researchers around the world. The medical journals perform a rigorous review of the articles before they are published to make sure the science and statistics are sound.

What seems like a straightforward process, however, is not. Performing research such as studying how a drug works costs money. With managed care and cuts in Medicare reimbursement, hospitals, laboratories, and universities don't have enough funds to support research. However, pharmaceutical companies (drug manufacturers) have money, and these companies started financing drug research many years ago. According to U.S. News & World Report, pharmaceutical companies financed 70 percent of the drug trials performed in the United States last year. Typically, when a manufacturer develops a new drug and wants it tested in a clinical trial, it gives a team of researchers a grant to perform the necessary research. Often the drug company gives a grant which goes above and beyond the cost of the clinical trial; researchers use this money to support other research they're doing.

No free lunch
This sweet deal for researchers sometimes comes with a price. The drug company giving the research grant may control some or all of the research being done on its drug, such as telling the researchers how to conduct the study. Researchers often accept whatever conditions the company imposes so that they won't lose the grant money.

In some cases the drug company takes too much control of the clinical trial, going as far as designing the study, explaining to the researchers how to do it, taking the data from the researchers, and then deciding which parts should be published. Results that make the company's drug look bad can be left out.

Example: Deferiprone
Dr. Nancy Olivieri experienced the problems with drug company-funded research in 1996. Apotex Inc. gave her money to study their drug deferiprone as a treatment for iron overload problems in thalassemia major, a rare inherited blood disorder. Her study showed that the drug was not effective. Apotex cut off her funding. Dr. Olivieri wanted to warn patients about the serious side effects (such as increased liver scarring). Apotex threatened her with legal action to enforce a confidentiality agreement she had signed. Finally in 1998 Dr. Olivieri published her findings in the New England Journal of Medicine despite Apotex's objections.

New publication policy
The world's medical journals have been slow to recognize the undue influence drug companies have had over the research they sponsor. There are many more cases like Dr. Olivieri's, and worse, including companies who withhold data from researchers or try to keep results secret. On September 10, 2001, the editors from 12 major medical journals, including Journal of the American Medical Association, Lancet, and New England Journal of Medicine, issued a new policy which requires researchers to pledge in writing that they had access to all study data, the freedom to analyze the data the way they wanted, and the ability to publish their findings no matter how they turned out.

The journals want to make sure all the articles they publish contain accurate information, since wrong or incomplete information about a drug is dangerous for patients. Since researchers will have to verify before publication that they haven't traded their scientific integrity for funding, they will now have more clout when negotiating research contracts with drug companies. This should help prevent the publication of journal articles that are nothing more than a sales pitch for a drug. Of course, that begs the question: how many of those have been published already?

Information for this article was taken from:
Aoki, Naomi. "Journals pool clout to ensure integrity." The Boston Globe, 9/10/01.
Olivieri, N. F., Brittenham, G. M., McLaren, C. E., Tampleton, D. M., Cameron, R. G., McClellan, R. A., Burt, A. D., & Fleming, K. A. (1998). Long-term safety and effectiveness of iron-chelation therapy with deferiprone for thalassemia major. New England Journal of Medicine, Vol. 339 No. 7, 417-423.
Schultz, Stacey. "True, false, whatever." U.S. News & World Report, 9/17/01.

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