Avandia

More objections to Avandia suppressed by Glaxo

Anne Zieger — Wed, 19 Nov 2008 10:10:03 -0500

We haven't heard anything for a while about Avandia, GlaxoSmithKline's diabetes drug that has been linked to a higher risk of heart attacks, but that doesn't mean no one has been paying attention. Actually, there's been an ongoing investigation in the Senate and House over whether GlaxoSmithKline actively suppressed information about the drug's link to heart attacks, and also whether the FDA ignored what evidence it did have.

Now we find out that in the course of the investigation, it has come up that another doctor noticed the link soon after Avandia was released. Dr. Mary Money, an internist in Hagerstown, MD, raised concerns back in 2000, but the company dismissed her concerns and the concerns of her colleague; the FDA was unresponsive.

Further, GlaxoSmithKline (then SmithKline Beecham) then wrote a letter to Dr. Money's hospital asking it to prevent the doctor from discussing the problems with any of her colleagues. This leaves us to wonder how many other doctors may have had their observations suppressed in order to protect GlaxoSmithKline's bottom line.

To learn more about the investigation:
- read this Wall Street Journal piece (reg. req.)

Did Glaxo conceal Paxil users' risk of suicide?

Fri, 13 Jun 2008 06:59:55 -0400

Did drugmaker GlaxoSmithKline conceal suicide risks for users of its antidepressant Paxil within the mountains of data it submitted to the FDA? That's a question Sen. Chuck Grassley (R-Iowa) would like to see answered, and in some detail. Grassley would like to find out who within Glaxo knew what, and when, about the medicine's possible link to increased suicidal behavior. In his correspondence with the FDA and HHS Secretary Michael Leavitt, Grassley notes that the U.K. recently concluded that the firm withheld safety information when submitting data for approval in Europe. Now, he wants to know whether Glaxo did the same in the U.S. In testimony on the Senate floor, Grassley noted that a report by one Harvard researcher contends that Glaxo probably knew about Paxil safety concerns all the way back in 1989, when it first asked the FDA for approval--and that it probably manipulated studies to diminish the perceived risk.

To learn more about Grassley's concerns:
- read this Wall Street Journal blog entry

Related Articles:
Study highlights link between Paxil and suicide
Glaxo wins Paxil suicide case
FDA says Glaxo didn't report Avandia data

Studies show problems with four big-name drugs

Tue, 29 Apr 2008 06:59:56 -0400

It looks like yet another set of popular drugs are facing allegations that they pose safety risks. Drugs named this week in unfavorable studies include Fosamax, which may create heart problems for women who take it for osteoporosis and epilepsy med Dilantin, which may put young women at higher risk of developing osteoporosis. Another study concludes that diabetes drugs Avandia and Actos double or triple the odds of non-spinal fractures, particularly among patients who took the drugs for a year or more. Particularly given other drug safety controversies still very much in the public eye, this can't be giving pharma marketers a warm and fuzzy feeling.

To find out more about the studies:
- read this FiercePharma item

Related Articles:
Merck expects $1.8B hit on Fosamax
Avandia problems erode GSK profits
Takeda touts Actos as heart attack-free
Despite safety issues, Vioxx still in demand