The New England Journal of Medicine yesterday released a study showing that Avandia, a popular drug for treatment of Diabetes, increases the risk of heart attack by 43%.
This story was widely reported in the mainstream media (see, e.g., the Associated Press story) and pharmaceutical/health care blogs. We can expect much more on this story in the weeks to come.
Annual U.S. sales of Avandia were $2.2 billion in 2006, putting the drug well into the blockbuster category. This does not include sales of Avandamet, which combines Avandia with metformin, another diabetes drug. Either way, this is a very profitable drug for Glaxo Smith Kline, and their stock took a significant and predictable hit yesterday on the news.
This is only the latest in a string of revelations about GSK drugs. PAL members were among those that sued GSK for a variety of alleged illegal activity (see PAL's pages on the Relafen, Augmentin, and Average Wholesale Price settlements, totalling $174 million).
Several years ago, former NY Attorney General (and now NY Governor) Elliot Spitzer sued GSK for concealing the fact that Paxil increases suicidal thoughts and behavior in depressed children and teens. As part of that settlement, GSK agreed to publish their clinical trials in a publicly available clinical trials registry. (GSK also agreed to pay $63.8 million to parents who purchased Paxil for their children, as part of a consumer class action. In fact, parents who did so can submit claims for reimbursement from that settlement from now until August 31, 2007 - details at www.paxilpediatricsettlement.com.)
In fact, much of the data in the NEJM study came from that registry. This underscores the importance of such registries, and of the necessity of mandating that drug companies register all their clinical trials in such registries. Various federal and state bills have been filed to enact such a mandate. (See the National Conference of State Legislatures for updated info on these bills.)
Given the importance of this information, why don't more government prosecutions of drug company fraud include provisions requiring the defendant to submit all its trials to these registries? We previously discussed in this blog the question of whether recent US Attorney settlements with drug companies have real and lasting imapct. (See "Do government fraud settlements deter illegal pharma behavior?")
Finally, this news further demonstrates the inadequacy of the FDA's oversight of drug safety after a drug has been approved. In 2006, the Office of the Inspector General of HHS issued a report showing that numerous studies of prescription drugs that the FDA required drug makers to conduct after the drug had been approved had apparently not been conducted or even begun, and the FDA took little action to address the shortfall.
The studies that are used to approve a new drug usually involve, at most, a few thousand patients using the drug for short periods. But many side effects and safety issues only emerge after millions of people have taken the drug, and often only after a number of years. "Post-market" studies are essential to identify these problems. The FDA's failure to ensure that these studies are done (or lack of authority to do anything meaningful when the studies are not done, depending on who you ask) is a huge and gaping hole in the U.S. drug safety system. Patients and doctors rightly want effective treatments to be available as quickly as possible. But that must be balanced with ongoing monitoring of the safety of drugs, to ensure that side effects and problems that only emerge later are detected and acted upon.
Lastly, it is a sobering thought that, had the NY Attorney General not learned of GSK's deception regarding Paxil, and sued, and required GSK to submit all its trials to a public registry, the information about Avandia might not have been discovered. How many more Avandia users would have had a heart attack as a result? And how many more Avandia and Vioxx disasters are lurking, unknown, in the hidden and unavailable data of drugmakers that are not subject to the kinds of settlement that GSK is?