Friday, August 17, 2007

welcome to America, home of the (not so) free

This story pretty much sums up how our gub'ment works now days. If someone is saying something you don't like about a big money making endeavor, don't look into it and see if they're correct, just get rid of 'em.

The Food and Drug Administration (FDA) has reportedly removed a senior FDA scientist from work on diabetes drug Avandia because the unnamed scientist voiced concerns about the drug’s safety.

"This new allegation is especially significant and raises our level of concern about FDA interference in safety decisions regarding Avandia," Congressional investigators said in a letter sent to the FDA.

Since 2005, the scientist, a medical officer who was once Avandia’s primary reviewer, believed that Avandia’s risks warranted a strong “black box” warning for its risk of congestive heart failure.

In May 2007, a study in the New England Journal of Medicine found that those taking Avandia had a 43 percent higher chance of having a heart attack.

The scientist was "sidelined after voicing safety concerns," the Congressional letter said, and “was told to stop participation in the review of potential cardiovascular safety problems associated with Avandia.”

The FDA said it did ask for a black box warning for Avandia’s heart risks in June, and an outside advisory panel is meeting to discuss the risks further. The Agency has received the letter, according to FDA spokeswoman Julie Zawisza, and is planning to respond.

Avandia, made by GlaxoSmithKline Plc, brought in more than $3 billion in sales in 2006.

3 comments:

Mushy said...

My doc said that over 90% of the cases where there had been problems, the patients already had heart problems. She says the advantages of the drug far out-weigh the risk as long as your heart is in good shape.

Since I didn't die on the AT...the redneck stress test...I'm good to go!

~Fathairybastard~ said...

Take Metformin myself, 1000 mgs a day (two pills), and the only trouble was a brief case of the shits until I got used to the dose.

*Goddess* said...

My husband takes the same, FHB, and in all the studies and test results we've read, that one consistently comes back as the safest diabetes pill on the market. I think one of the oldest, too.