Rosiglitazone is a drug used in the treatment of type 2 diabetes. Back in 2007 it emerged that this drug posed significant risks to the heart health of those who took it. These facts only emerged, however, as the result of independent analysis of data that rosiglitazone’s manufacturer, GlaxoSmithKline (GSK) had been forced to publish on their website.
The fact that GSK was made to published this damning data (and did not give it up voluntarily) is bad enough. But now it looks as though the risks of rosiglitazone have been known to GSK and its previous incarnation (SmithKline Beecham) for more than a decade. This accusation comes as a result of documents seen by the New York Times. See here for the full story
According to the New York Times, SmithKline Beecham began a study back in 1999 which pitted rosiglitazone against a rival drug pioglitazone (Actos). The results were not what SmithKline Beecham executives were hoping for: not only was rosiglitazone no better in treating diabetes than pioglitazone, its posed significantly greater risks in terms of heart-related complications.
Findings such as these are obviously disappointing for drug company executives and the shareholders they seek to serve, but they have obvious relevance to those taking the drug, as well as the doctors who advise on its use and prescribe it. Here, from the New York Times article, is an excerpt from an internal email written by former SmithKline Beecham executive Dr Martin Freed in 2001: “Per Sr. Mgmt [senior management] request, these data should not see the light of day to anyone outside of GSK.”
Another shocking revelation comes in the form of what appears to be a cost relationship between GSK and certain elements within the Food and Drugs Administration (FDA) in the US. The FDA recently considered whether or not rosiglitazone should be pulled from the market, but in the end decided it should not. One of those arguing for the retention of this drug was Dr John Jenkins, director of the FDA’s office overseeing new drugs. According to the New York Times, Dr Jenkins briefed GSK extensively on the debate going on within the FDA.
If any of this is sounding remotely familiar, that might be because another apparent example of a drug company hiding data that caused significant suffering and cost many their lives came to light last year. It concerned the drug company Merck’s burying of data regarding the safety of its painkilling drug rofecoxib (Vioxx). See here for more about this.
I find it depressing and saddening that what we have here are apparent examples of drug companies allowing individuals to expose themselves to secretly known risks that could cost them their lives. But it’s not all doom and gloom. There was a time, I suppose, where drug companies had little fear of being called to account. Now, even with friends in high places, pharmaceutical companies are finding it harder to put profit before people.