TorteDeForm

Kia Franklin

22,000 what?

FDAapproved.jpg

Not dollars, or even thousands of dollars, but human lives that were lost in pursuit of the dollar. Here's the link to the article where Dr. Dennis Mangano, a researcher who published a study showing drug dangers in a Bayer AG drug used to stem bleeding during open heart surgery, said that 22,000 lives could have been saved if Trasylol had been recalled when he first published his study in January 2006.

Here's a link to the 60 Minutes program that explored this issue and revealed some troubling information about the way the FDA and drugmakers work to put drugs out. From the program:

"Why did it take Bayer and the FDA nearly two years to take the drug off the market after major studies revealed the danger? Two years in which it's estimated that Trasylol was contributing to the loss of 1.000 lives a month."

Watch the program. It indicates that there had even been concern about the drug as far back as the early 1980s. It also clarifies a few common misconceptions about what FDA approval for marketing really guarantees to patients--which is, as we continue to learn from scenarios such as this, not much. This is especially important to consider in light of yesterday's Medtronic decision granting legal immunity from state claims to medical device makers whose products have FDA approval. But how surprising is it? I mean, last month we were told the FDA approved using cloned cows for beef.

The program also explores the prevailing role of the profit motive in creating situations in which human lives are put at risk in pursuit of the bottom line. For example, two drugs that were as effective as Trasylol, with none of its adverse side effects, and which cost $50 versus Trasylol's $1000 pricetag, could have been used instead of Trasylol. But the FDA did very very little to educate doctors about these alternatives or about Trasylol's risks or to impose more strict requirements upon Bayer in regard to its drug.

Neither Bayer nor the FDA would speak to 60 Minutes, and the FDA hasn't taken any action against Bayer. Hmm...

And finally, for a dash of irony, funny thing: to get to the link to the 60 minutes report, I first had to watch an ad for a prescription drug. Or, wait, is that funny?

Kia Franklin: Author Bio | Other Posts
Posted at 7:53 AM, Feb 21, 2008 in Federal Preemption | Pharmaceuticals | reports and research
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Comments

This medication concern brings about important issues about sensationalism in media and in the recruitment of prospective clients for trial attorneys. First, the number of potential lives lost was the number of patients who died who had cardia surgery, not because of the medication. Secondly, the study in question was a retrospective review and did not take in to account that surgeons were more likely to use the drug in those patients that had acute problmes or bleeding tendancies such as being on ASA. These patients were already at higher risk. Was it the drug or the fact that these are higher risk patients that were the problem? It is not known. What is known is that there is a rush to get things in the court system before science proves one way or another. Remember breast implants?

Posted by: throckmorton | February 21, 2008 8:56 AM