Big Pharma ghost-writes the scholarly articles published by MD "researchers"

   One of the medical profession's most respected journals, the Journal of the American Medical Association, published an article this week examining the extent of "ghost-writing" that occurred in published Vioxx research.  The authors unearthed evidence that documented the extent to which drug maker Merck wrote its own laudatory studies before lining up prestigious physicians to sign on to the final product as lead authors.  The study authors and the editors of JAMA  concluded that such ghost-writing is extremely common in the pharmaceutical field, in particular, and that medical journals should more carefully examine pharmaceutical research to detect undisclosed bias.

     One of the saddest factors in this entire investigation is the fact that this information was obtained not by the FDA--the regulatory agency having authority over drug research and safety--but rather from the private civil lawsuits against Vioxx.  You may recall that after evidence linked Vioxx to heart attacks and strokes, hundreds of lawsuits were filed against Merck and it ultimately settled the suits for 4.85 billion dollars in fall of 2007. (We discussed this settlement in a weblog entry last fall: if you are interested in how small it is, relative to Merck profits and people injured, review the related fall, 2007 blog entries.)

      The authors of the JAMA study gained access to "millions" of pages of Merck documents, including draft research results, e-mails searching for "external authors" for draft articles, and other internal information.  The authors identified, for example, a Merck created paper suggesting Vioxx as a possible deterrent to Alzheimer's progression.  The August, 2003 draft of the paper identified the lead writer as "External Author?"  When the paper was ultimately published in the journal Neuropsychopharmacology, three well-known academics had allowed their names to be listed as lead authors.  One now claims that he played a substantial role in editing the paper, however, the current editor of the journal noted that it now has in place prohibitions that would prevent such ghost-writing and planned an investigation.

     In the context of this kind of disclosure, it is almost criminal, given the high profit margins of the pharmacology industry (and the commensurate cost and unavailability of health care and insurance), for legislators at all levels of government to grant drug makers immunity for drugs approved by the FDA.  The FDA clearly doesn't have the resources or the regulatory tools--or the regulatory will--to adequately police the drug approval process.  Nevertheless, so long as the drug industry is allowed to pour heaps of money into the election process, we can expect it to continue to receive special favors from sympathetic legislators, judges, executives and administrators.