Personal Injury Law

Diabetes Drug Manufacturer Failed to Disclose Data On Risks

By Mark Siesel, Esq.

In follow up to our post on February 22, 2010 entitled Diabetes Drug Blamed For Heart Problems, there is new information which reveals that SmithKline Beecham actively attempted to cover up studies which showed that the diabetes drug Avandia was dangerous to the heart. In a July 12, 2010 article by Gardiner Harris in the New York Times, it was revealed that since Avandia's success was so vital to SmithKline, company executives decided not to publicize results of studies on its website or, more importantly, to submit these negative results to drug regulators at the Food & Drug Administration.

One particular company executive, when he found out that data revealed that Avandia was riskier to the heart than a competing drug Actos, wrote in an e-mail: "Per Sr. Mgmt request, these data should not see the light of day to anyone outside of the [company]." Apparently, according to the article, SmithKline knew as early as 1999 of extensive heart problems from the use of Avandia, but had determined that they would lose between "$600 million from 2002 to 2004 alone" if the risks became public. Even worse, an F.D.A. reviewer who reviewed an Avandia clinical trial named "Record" found that 12 patients who suffered severe heart problems from Avandia were not included in the trial's listing of "adverse events."

Surprisingly, the issue of whether to withdraw Avandia as a dangerous drug from the market has split the F.D.A., with some regulators arguing in favor of keeping the drug on the market despite the risks. Other diabetes drugs available include Actos and an older diabetes drug named glyburide, which is also less expensive.

In 2004, when GlaxoSmithKline was found to have hidden data regarding the suicidal thoughts teenagers and children were having from its antidepressant Paxil, the company settled a lawsuit by publicizing all data from its clinical trials. The posting of clinical trial data became federally mandated in 2007. It would appear that the Paxil experience has not changed Smith Kline's procedures when it comes to disclosing the risks of its products.

Full post as published by New York Legal Blog on July 13, 2010 (boomark / email).