Sunday, November 11, 2007

Over A Year After I Gave You The Scoop, Trasylol Finally Bites The Dust,

...and joins the distinguished company of Rezulin, Baycol, Bextra, Duract, Posicor, Propulsid, Tequin, Redux, Seldane, and Vioxx. From the November 6th New York Times:

Pressured by regulators, the German pharmaceutical giant Bayer AG announced Monday that it had agreed to withdraw the controversial heart surgery drug Trasylol after a Canadian study suggested that it increased death rates.

Dr. John K. Jenkins, a leading official of the Food and Drug Administration, said, “F.D.A. could not identify a specific patient population where the benefits of using Trasylol could outweigh the risks.”


Here's an idea. How about maybe identifying a specific patient population where the benefits of a drug outweigh the risks BEFORE YOU LET IT ON THE MARKET. It wouldn't have to be a big population. Just some friggin' evidence that somebody, somewhere, might get some net good out of the thing before you give it to them.

You may say I'm a dreamer.........

Here's another idea. How about maybe doing something to hold people accountable when they hide evidence that a drug is killing people? Last September I told you about this:

The F.D.A. convened a panel of experts in September of last year to review the safety of the drug, and the panel concluded that Trasylol should remain on the market. But within days of the panel’s meeting, the agency discovered that Bayer had sponsored yet another study of Trasylol suggesting that the drug increased the risks of death and stroke.

The company had failed to disclose the results of its study to the agency or the advisory panel. Indeed, Bayer scientists had defended Trasylol at the panel’s hearing but had not mentioned their own study or its worrisome findings. A company investigation later concluded that the findings had been withheld as a result of “regrettable human error.”


Are you getting this? Bayer:

1) Sponsored a study that concluded Trasylol kills people.

2) Then sent its scientists to an FDA panel meeting to tell them how safe Trasylol is, without mentioning that it knows it kills people.

In fairness though, Bayer was only building on the strategy of GlaxoSmithKline, which hid information on the suicide risk of Paxil in teenagers. Gotta stay competitive in this dog-eat-dog, profit before life corporate world we live in you know.

And I really do believe Bayer regrets this whole episode. They regret very sincerely that news of this got out and was published in the newspaper.

So the feds are getting ready to kick some ass, Enron-style, right? I mean, at least Ken Lay never hid evidence of dead people. We can all rest assured that someone at Bayer has been held to account.......

Um, no, we can't. Over a year and all that has happened is a new law saying they can't do it again. You see, hiding evidence that your drug killed people wasn't illegal at the time. The fact they misled the FDA panel seems to have been forgotten.

GSK was sued by the Attorney General of New York over the Paxil episode. It settled for $2.4 million dollars. The equivalent of a $50 fine for me based on my rate of pay and GSK's 2004 profit. Meaning that California took my last speeding ticket more seriously than anyone took the fact that GSK was hiding negative information about Paxil, which was taken more seriously than Bayer hiding negative information about Trasylol and then misleading the FDA.

Wonder if I could get away with killing someone for 50 bucks? You may say I'm a dreamer......

2 comments:

Romius T. said...

I keep trying to convince all the pharmacy techs and folks to read your diatribes, but most make squishy faces when tell them it is a blog. Fuck them.

Of course I hope they find my blog "accidentally" after checking yours out.

Anonymous said...

Oh, Bayer, can't you bring back something safe, like heroin?