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Friday, October 8, 2010

Can You Believe the Medical Studies?

An article in the September 2010 issue of PLoS Medicine gives us a fascinating look at how pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. In July 2009, a US federal court decision resulted in the release of approximately 1500 documents. They have now been analyzed by Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC:

·         Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HRT), and to cast competing therapies in a negative light.
·         Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HRT, to defend the unsupported cardiovascular “benefits” of HRT, and to promote off-label, unproven uses of HRT such as the prevention of dementia, Parkinson's disease, vision problems, and wrinkles.

A medical education and communication company called DesignWrite produced ghostwritten articles. DesignWrite, “where we put clinical data to work,” is located in Princeton, NJ. Fugh-Berman found the company was paid $25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on the HOPE trials of low-dose Prempro. DesignWrite was also assigned to write 20 review articles about the drug, for which it was paid $20,000 each.

Mary Budinger's comment:

And it's not just Wyeth, and it's not just what PR companies are paid to do. For example, earlier this year, researchers published a re-examination of the extremely influential JUPITER trial that sold a lot of statins. The original 2008 study was found to be both flawed and biased, in no small part because nine of 14 authors of the JUPITER trial had financial relationships with AstraZeneca, which sponsored the trial. The JUPITER trial basically said that if you give people who have not yet had heart trouble 20 mg of a statin drug, you will see a 44% reduction in nonfatal heart attacks and strokes, and confirmed death from cardiovascular causes. But when researchers re-examined the JUPITER data, they found no evidence of the "striking decrease in coronary heart disease complications" reported in the trial. "The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors," the authors wrote in The Archives of Internal Medicine.

A friend of mine argued profusely with me that his doctor told him the JUPITER trial was the reason to be on statins, and that I just didn’t get it. I told him here’s what I do get: (1) cholesterol is not a cause of heart disease, and lowering it can cause other problems, (2) the patient population in that study was not typical – they searched 26 countries to find people who had both normal LDL-cholesterol levels [defined as 130 mg/dl or below) and elevated C-reactive protein levels, (3) JUPITER stands for “Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin.” Translation – by George, we will justify Crestor’s use. We won’t put a hypothesis on the table and see what happens, we will justify the results we want.

No surprise somebody would finally break through all the hype and say that study was a fairy tale – the emperor has no clothes.  

So consumer beware – find out who paid for these studies you read about in the news. Try to find studies done by objective researchers, not ones paid to “justify” a result or sell a drug. There have been many calls to reform these kinds of bad practices in the journals, but so far, its mostly just talk.

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