Yesterday, researchers published a study showing that the drug doubled the risk of death, heart attack and stroke, and more than doubled the risk of congestive heart failure and mini strokes. There was also a higher cancer rate among those taking the drug. [JAMA 10/20/2005] (Story links open in new windows)
The FDA letter was based on the approval of the drug by an FDA committee by an 8-1 vote.
But the committee was clearly not doing its job – protecting you and me from "them." It’s hard to tell how much of that was drug-industry fellow-travelers on the committee doing their thing and how much was incompetence.
Further, an editorial in the same issue of JAMA claims that Bristol-Myers Squibb deliberately skewed the data to minimize the safety risks by including patients taking dosages well below the levels they planned to market and by excluding many patients with existing heart problems.
A spokesman for Bristol-Myers Squibb said: "These trials that were conducted on Pargluva were designed like other clinical trials for a diabetes drug."
Do you find that comforting?
I find it disturbing, particularly in light of all the recent stories about other FDA-approved drugs killing users.
And it may be just me, but I think there’s a case to made that this kind of thing became more prevalent since George W. Bush became president.
(No, wait – don’t flame out just yet – get a few facts first, then jump all over me if you still think it’s justified.)
One of the first things the President did was to appoint more than 100 industry lobbyists to oversee the industries they used to work for. This included FERC (think Enron), the EPA (to overturn strip mining and coal burning regulations), the FDA, and just about any place where government might stand in the way of unfettered business profits.
I wrote a bit about it in Government Of Business, By Business, For Business – Part I 11/11/2004.
The major appointee here was Daniel Troy, as Chief Counsel of the Food and Drug Administration.
In that post, he immediately started interceding in civil suits on the side of drug and medical device manufacturers "arguing the side of the defendant corporation against the families of people who died after using that corporation’s product."
U.S. Representative Maurice Hinchey "provided evidence that Troy worked in cooperation with the manufacturers in taking these actions [and] found evidence of inappropriate collusion or conflict of interest between Troy and the companies the counsel’s office stood up for."
Since then, Troy has resigned but the FDA doesn’t seem to be working any better, does it?
This is the same FDA that last year proved itself to be in the pocket of the drug manufacturers. When a number of states tried to lower costs by ordering drugs from Canada, the FDA joined with Big Pharma lobbyists to pressure Congress prevent this.
The FDA even used scare tactics, claiming that it was a safety issue. But when pressed in Congressional hearings, the FDA was forced to admit that they had NO evidence of ANY safety problems with imported drugs, and conveniently overlooked the fact that up 100,000 deaths occur in the US every year from FDA-approved drugs! (See my The Myth of High Drug Research Costs 02/02/2004 about two-thirds of the way down for more details, as well as Time Magazine’s Why We Pay So Much For Drugs).