Tuesday, November 20, 2007
FDA Finally Moves On Avandia
We wrote about
diabetes drug Avandia's dangers in June. We noted the FDA had not moved with much speed yet, which seems somewhat ironic given the rhetoric and cries surrounding the Consumer Product Safety Commission.
But while doctors continued prescribing Avandia (and its partner Avandamet and other combinations) with a warning, the Food and Drug Administration waited because of conflicting studies. Last week, the agency finally
added its most strident warning, (pdf link) the black box, to Avandia and also includes a statement warning of an increased risk of heart trouble among diabetes patients who already have increased risk.
Dr. Janet Woodcock of the FDA said that pharma giant GlaxoSmithKline (
NYSE:GSK) was cooperating with the agency. Woodcock also said that tests showing increased heart attack risk were tempered by longer-term studies that conflicted with the data.
The frustrating part of this issue is that months elapsed before the FDA got to this point and now years may be go by before a decision is made. Dr. John Jenkins, also speaking on behalf of the FDA, added that "So this will likely be, you know, a long term study. It could take as many as four or five years. So over that time it’ll be multiple comparisons."
Despite strong questions from
The Los Angeles Times' Ricardo Alonso-Zaldivar, FDA representatives refused to address the issue of the agency's own safety officers calling for the drug's removal from the market. Alonso-Zaldivar pushed well, but was eventually silenced. Follow-ups from
The Wall Street Journal and other media outlets were similarly stonewalled. FDA officials also refused to disclose the panel's vote and other information that will undoubtedly be challenged with a Freedom of Information Act request.
For now, diabetics taking Avandia or one of the two commercially available compounds containing Avandia are
strongly urged to talk with their physician about whether this drug is appropriate for them.
Labels: Avandia, FDA, Glaxo, GSK
Wednesday, June 13, 2007
Diabetes Drugs Continue To Come Under Fire
We
wrote last week about Avandia, the diabetes drug from Glaxo, under fire since a prominent cardiologist named Steven Nissen said that use of the drug could cause a higher risk of heart attacks. Diabetics are already in a high risk group for heart attacks, but Nissen concluded that Avandia use increased that risk.
Where the FDA has yet to act, the plaintiff's bar moved fast. On Monday, a New York law firm filed suit against Glaxo, its CEO and its CFO. This suit doesn't have the drama of a health-related suit. Instead, the case, for which firm Kaplan Fox & Kilsheimer are reportedly seeking class-action status, accuses the company of misleading shareholders about Avandia's safety.
Whether the truth comes out as a result of regulatory or legal action is moot. With a growing diabetes epidemic, knowing the truth fast is critical.
In related news, pharma giant Eli Lilly settled nearly 1,000 lawsuits stemming from its drug, Zyprexa. News reports peg the number of cases resolved at approaching 30,000. Zyprexa allegedly causes diabetes.
Labels: Avandia, Eli Lilly, Glaxo, Zyprexa
Thursday, June 07, 2007
Vioxx Award Overturned As Avandia Cases Heat Up
Remember our quote telling consumer that the "
blood is in the water" regarding lawsuits over Merck drug
Vioxx?
That's what we said two years ago on the heels of a $50 million plus verdict against the drug's maker. Juries were apparently buying the argument that using the drug contributed to cardiac difficulties. Merck, makers of
Vioxx, has consistently stood by its product and taken the cases one by one, winning more than losing. And even when losing, Merck has used judicial remedies to manage their liability.
That strategy has paid off now that U.S. District Judge Eldon Fallon has proposed a $1.6 million settlement in lieu of a $50 million cash award. If the plaintiff, a retired FBI agent, does not accept the proposed settlement, the circus starts over again later this year. If the offer is accepted, Merck still lost, but priced down its liability from $50 million to less than $2 million.
Next up? Diabetes drug
Avandia.
Traditional media outlets jumped all over
GSK today when a highly respected physician said he was pressured into remaining quiet about his suspicions that the drug was also involved in cardiac issues. This case is even stickier according to various legal pundits because of the increased cardiac risks diabetics already have. Despite that, the
drugmaker is spending big bucks on full page ads in major newspapers to stand by its product as the attorneys and plaintiffs begin lining up for a whack at another drug's alleged side effects
Labels: Avandia, diabetes, Vioxx
