And while we're on the subject of the FDA . . .

Steven Nissen in BMJ has a rant that could strip paint, or strip the bark off of both the FDA and GlaxoSmithKline. After all these years, I'm still getting used to the apparently universal psychopathy of pharmaceutical executives. This one makes Charles Manson look like a sweetie pie.

Specifically, in case you didn't know, in 1999 Glaxo got approval for rosiglitazone, a drug to treat diabetes. The approval was based on a so-called secondary endpoint, specifically that it lowers blood sugar. However, even before approval publicly known studies showed that people who took it appeared to have an increased risk of adverse cardiovascular events such as heart attacks. The FDA went ahead and approved it anyway, but the Europeans required a post-marketing study called RECORD.

Under the brand name Avandia, rosiglitazone made huge bucks for GSK, but meanwhile, secretly, the company did a meta-analysis that found that yes, it raised the risk of cardiovascular events substantially. They told the FDA, but both parties kept this information secret from the public.

Nissen got access to the data from rosiglitazone trials through a lawsuit, and he found that the drug increased the risk of death by about 64%. At this point, Nissen writes, "FDA officials were infuriated with me for challenging the drug's safety." When the RECORD trial was published in 2009, it didn't show the increased risk, and the FDA convened an advisory panel which Nissen says was intended to "exonerate" the drug. But the study was garbage. The new Deputy Commissioner appointed by Obama held honest hearings, and the panel voted to remove the drug from the market or tightly restrict its use.  The New York Times later found that GSK had known since 1999 that an alteranative drug was safer, and concealed the information. But the FDA kept trying to reanalyze the data to prove that rosiglitazone was safe after all.

Now let's be clear here. We're talking about killing people for profit, with the collaboration of a federal agency. The common term for killing people for profit is felony murder. That is not very nice. But drug companies have been caught doing it again and again. Sometimes they pay fines, sometimes they just pocket the money and laugh in our faces. These are the "makers," the "job creators," the "builders." That's where we live.