Friday, September 24, 2010

About Time

In July, I had a series of posts on Avandia, the blood glucose lowering drug offered by pharmaceutical giant GlaxoSmithKline which in too many cases led to increased risk of heart attacks, heart failure, and even death. The thrust of the posts was that the company knew about the increased risks of the drug which in fact lowered blood glucose among Type II diabetes, but hid the details of even its own studies from the FDA and from doctors and their patients.

After nearly two years of investigations, independent studies and reviews, the FDA has finally made its decision and announced it in concert with its counterparts in Europe.

From the New York Times:

In a highly unusual coordinated announcement, drug regulators in Europe and the United States said Thursday that Avandia, the controversial diabetes medicine, would no longer be widely available.

The drug’s sales will be suspended entirely in Europe, while patients in the United States will be allowed access to the medicine only if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of the drug’s substantial risks to the heart. Patients now taking Avandia may continue to do so.

The Food and Drug Administration’s decision shows that the Obama administration is taking a harder line on drug safety issues, even in the face of scientific uncertainty. Along with its announcement, the agency for the first time immediately posted on its Web site internal memorandums from top staff members that in some cases offered entirely contradictory advice. Dr. Margaret Hamburg, the agency’s commissioner, said that passions within the agency had run high on the Avandia decision.

A couple of things came to mind as I read the article. The first is that the whole process could have and should have been less devastating to the 47,000 people who got hit with the side effects, some of whom died. If the drug company had been forced to come forward with the information on the possible side effects before FDA approval, some of the suffering might never have occurred. This rushing to market of drugs with great promise has too often resulted in disaster, and it appears that the FDA just might have learned its lesson this time, at least under this administration.

Another thing which came to mind is that pharmaceutical companies might have finally learned their lesson, at least for the nonce. As I noted in this post in July, the members of the industry trade group have put together some guidelines for more transparency in their clinical trials, mandating revealing both the good news and the bad news.

Perhaps the most important thing which struck me, however, is that ultimately the whole post-release review process came about because some fine investigative journalism by the NY Times and other media outlets was done once the hints of the problem were sniffed out. This is one of the vital functions of our free press, and one that has been lamentably absent over the past decades as money and political power trumped any attempt at rational public discourse.

This time the system worked, even if it did take too damned long.

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Anonymous Anonymous said...

Often side effects take months or years to develop. After 5 years of lipitor I began to develop hand cramps, on both hands at the same time. what was a rare event grew into a weekly occurance. Then the leg cramps started. They grew from annoying to devastating. The doctor told me to quit lipitor for 2 weeks. Yeah, that was it. The point is, I did fine for 5 years and it took two years to determine what it was. Don't assume because you did well with a medication that it continues well for you.

1:45 PM  

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