(July 17, 2007)
Another anti-Avandia article
In another anti-Avandia
article released today (there are so many of them, that I just made up the acronym "AAAA" to describe them!),
it is breathlessly trumpeted "New review adds more reasons to avoid diabetes drug Avandia." This time, it's German researchers, rather
than physicians in Ohio, that are reporting
the results of their research.
Again, it's a meta-analysis of data from multiple clinical trials (18 trials involving 8,000 patients).
This is not big news. Contrariwise, it looks
very suspiciously like someone's doing a hatchet job on Avandia (and the FDA) to irritate people
before the FDA's advisory committee takes a dispassionate look at the data later this month.
There are folks
who despise the pharmaceutical industry, and they are having a field day (see my previous discussions at Avandia Questions and
Stimulated Reporting, and David Mendosa's take on the media reaction at Avandia Anxiety).
But remember, the FDA is not in cahoots with the pharmaceutical
industry. They are guardians (admittedly imperfect) of the public health -- that's you, that's me, that's
our pets -- everyone who takes food or drugs in the USA. And the FDA will be holding an
Advisory Committee meeting on Avandia soon:
(Information about this meeting is posted at the FDA website.)
JOINT MEETING OF THE ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY
COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE
DATE AND TIME: July 30,
LOCATION: Holiday Inn Gaithersburg, Two Montgomery Village Ave., Gaithersburg, MD 20879
CONTACT: Cathy A. Miller, Center for Drug Evaluation and Research, 301-827-7001. The Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees will meet in joint session to discuss the cardiovascular ischemic/thrombotic risks of the thiazolidinediones, with focus on rosiglitazone, as presented by FDA and GlaxoSmithKline.
The FDA intends to make background material available to the public no
later than 2 business days before the meeting. And it will be detailed!
So, hold your horses, and let's wait and see what transpires. And don't worry about more breathless headlines, until the Advisory Committee's recommendations are released.