If two recent cases highlighting plaintiff’s lawyer’s abuse of medical experts was not enough, last week the Sanders Firm announced a study on GlaxoSmithKline’s diabetes drug Avandia regarding its safety. Although the article has not been published, the national personal injury law firm—who has a list of drugs and devices on their site—managed to get its hand on the study. Is it possible that like the Lancet article and Accutane case, plaintiff’s lawyers paid for this study?
On the firm’s website, a press release noted that “the American Diabetes Association had accepted for publication in its prestigious medical journal, Diabetes Care, a study by Harvard researchers that shows users of the diabetes drug Avandia have more than double the risk of a heart attack compared to other diabetes drugs.”
Apparently, the “Harvard group” analyzed clinical care data taken from the electronic medical records of patients at several Boston area hospitals and clinics associated with Harvard Medical School. The press release claims that “the researchers then reviewed the records for all patients between 2000 and 2006 who suffered “Myocardial Infarction” or heart attack, and found that the incidence of heart attack was more than double for Avandia compared to its competitor Actos. Who are the members of this “Harvard group” and what are their affiliations and interests in such research?
The release also mentioned a “jointly sponsored study by both GlaxoSmithKline and i3 Drug Safety, an independent drug-safety firm.” This study will appear in the journal Clinical Therapeutics, and claims to show that Avandia users have a 35-41% increased risk of a heart attack over users of Actos©, Avandia’s main competitor. The GlaxoSmithKline-i3 study analyzed health-insurance data from July of 2000 through March of 2007 for 2 groups of 47,501 subjects each; one group using Avandia and the other Actos.
The firm traced problems with Avandia back to “2007, when the Food and Drug Administration required a “Black Box” warning be added to Avandia’s label about the heart risks associated with drug.” Despite the added warning, the firm alleges that although the product on the market, “numerous endocrinologists and other diabetes experts called for its removal from the market.” Who are these endocrinologists? What are their associations with the Sanders firm, and the alleged studies? Do they have disclosures or potential conflicts of interest?
In releasing this information before the study has been published, the Sanders Firm noted that “almost 13,000 former Avandia users who have suffered heart attacks and other significant injuries have filed claims against GlaxoSmithKline in both Federal and State courts.” The firm also claimed that “the recent (unpublished) studies raise serious questions about the health risks associated with Avandia.”
More information is needed about these studies. How did the Sanders Firm get access to the results of unpublished studies? Are the numbers they quote in their release accurate?
Once that question is answered, it may be easier to understand how an attorney gets a crystal ball on yet to be published clinical trial results, yet somehow knows the future outcome.
Oh by the way did we mention the firm is looking for clients?