if you have not been following the Avandia story, an article published in the New England Journal of Medicine revealed that Avandia, a popular drug used in diabetes control significantly increased the threat of heart attacks and heart failure. A couple of things to note here, firstly, this fact was known to the FDA in 2002 per this memo obtained by Public Citizen. So, why the FDA (and GSK) thought that no one would notice, is beyond me. Secondly, when the drug was introduced in Europe, it was contra-indicated for people with heart disease. This fact must have been known to the FDA and GSK as well. It is one thing for GSk to not want to run long term epidemiological and safety studies on their drugs, but other people did the work, and the FDA just stood by and watched until the work was published in the US. The European Drug agency had acted on this information quite a while back.
So, when I come across this article in the NY Times about a “downside” to full disclosure, I don’t really know what to say. I don’t care whether there is a downside to GSK or not. If I work as a waiter in a restaurant, there is a “downside” to reporting my tip income to the IRS (yes, higher taxes!). This does not mean I should not pay my taxes! This is a matter of life and death for people. Diabetes and heart disease go together in thousands of people, they needed to know if the drug they were taking to control one disease would kill them off with the other disease.
This week, GlaxoSmithKline learned what that greater disclosure could mean.
A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.
“It was a treasure trove,” Dr. Nissen said about the Web site.
GlaxoSmithKline has disputed the journal’s interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia.
Also, note this “concern” from the FDA, no less:
“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A.
Yes, respond to results in a very prestigious peer reviewed journal by pretending that some dude with a computer in his basement (yes, all computers reside in basements) randomly picked up a couple of clinical trials and created “mass confusion”. The FDA should at least pretend to care…
The risks and benefits involved with taking a drug to control a chronic condition are completely different from those you would take for an acute, immediately life threatening condition. If you are treating cancer, you expect side effects, and deal with them because the alternative is certain death. When you’re dealing with diabetes, you have alternatives that will not kill you. In addition, millions of people have diabetes and use Avandia. So, a small percentage increase in a side-effect can affect thousands. And, they need to know because there are alternatives that would work for them.
GSK is not going to tell them because there is an obvious conflict of interest. They need to sell their new and expensive drug even if other alternatives work. This is why we have the FDA, and full disclosure of all clinical trials, not just the ones that worked for you.