Bayer drug pulled off the market

THE FDA HAS DONE IT AGAIN!

In November, the FDA pressured the Bayer Pharmaceutical Company to halt the sale of the anti-bleeding drug Traysol after a Canadian clinical study determined that it could be linked to a higher risk of death than other drugs. But don't for a minute believe that the FDA is as pure as the proverbial driven snow in this situation. They're not.

The FDA's announcement that it "cannot identify a specific patient population where we believe the benefits of using Traysol outweighs the risk" came ONE MONTH after FDA advisors recommended that Traysol REMAIN on the market - in spite of its known links to an increased risk of death and other serious side effects.

Whoops.

This is a disturbing item that should, once again, shake your confidence in the FDA - assuming you have any left to shake. Once again, our "saviors" at the FDA gave a drug promoted by Big Pharma the benefit of the doubt - in spite of the fact that studies had suggested the drug was dangerous.

Why did this happen? Well, call me crazy, but I believe that it might have had a little something to do with money. Worldwide sales of Traysol were roughly $135 million for just the nine months between January and September of 2007. U.S. sales accounted for $91 million of that total - nearly 68%. Are you hearing the same alarm bells in your head that I am?

With so much money at stake, it's hardly surprising that the FDA was slow-footed when the initial results from the Canadian study suggested the potential dangers of Traysol. The FDA's advisory committee did not find the concerns "compelling enough to recommend a withdrawal from the market." Before such a drastic (and, may I say, costly) measure, the committee was interested in "obtaining additional data."

Worse still, the FDA had begun re-evaluations on Traysol's safety in January 2006, after a different study suggested serious side effects like kidney problems, heart attack, and strokes. During this time, Traysol remained on the market.

Want more? How about this sickening little gem: Other recent studies also suggested the potential deadly effects of Traysol BEFORE the Canadian study - and one of those studies was WITHHELD from the FDA by Bayer! Why? It was written off as "regrettable human error." Yeah, right. Want to buy a bridge in Brooklyn?

In spite of this error - THE DRUG REMAINED ON THE MARKET. Ask yourself this: Why are you hearing about this for the first time from ME? How is it that this story wasn't plastered all over the newspaper, the evening news, and the Internet!? We've all heard of the scandalous wrongdoings of Enron - but at least they never put anyone's life at risk!

Are you shocked? Are you outraged? Are you spitting mad? Well, you oughta be. How long will it be before the money-minded decision making of our FDA guardians allow a 21st century Thalidomide tragedy to occur here in the U.S.?

In case you're not old enough to remember this nightmare, Thalidomide was a sedative that was widely prescribed in the late 1950s and early 1960s to pregnant women to help combat morning sickness. The drug was inadequately tested, and the results were catastrophic. Approximately 10,000 children (mostly in Europe) were born with severe and gruesome birth defects, such as flippers for hands and feet, and extra appendages. In 1962, the FDA stepped in to tighten testing restrictions on this and other drugs.

But if this Traysol story proves anything, it shows how far the FDA has fallen from its one-time status as White Knight to seedy, anything-for-a-buck business partner. It's a sobering reminder that, in spite of the hundreds of government checks and balances put into effect to ostensibly keep us safe, we're still very much on our own. And our well- being is often in the hands of the highest bidder.