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Sunday, July 11, 2010

Avandia: Is it time to pull it off the market?

UPDATE: 15 July - FDA reviewer David Graham told the panel Avandia's risks were real enough "to put you in a hospital or a cemetery."

Graham, who wants the pill banned, recently published an analysis estimating that as many as 100,000 heart-related problems may have been caused by Avandia among seniors on Medicare.


I remember back in 2004 coming across a report on the cardiovascular risk from Avandia. It caught my eye because I knew someone taking the drug and I took the opportunity to advise him of the issue.

Over the almost seven years since I first had reports of problems, it seems as if the controversy hasn't stopped.

Since the problems in the US were reported recently, Avandia now seems to be having problems in Europe.

Diabetes Drug Maker Hid Test Data on Risks, Files Indicate - Dates to 1999

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: July 11, 2010

WASHINGTON -- FDA staff reviewers blasted rosiglitazone (Avandia) in briefing documents released Friday, recommending that the diabetes drug be yanked from the market because of the "serious" cardiovascular risks it poses.
Rosiglitazone is no more effective at improving glycemic control in type 2 diabetes than pioglitazone (Actos) and provides no known unique health benefits, FDA reviewers wrote. While both drugs increase the risk of congestive heart failure, the effects of rosiglitazone are "substantially greater," the briefing documents concluded.
It remains to be seen whether a joint panel of outside medical experts will agree with this assessment. The panel meets July 13 and 14 to make recommendations about rosiglitazone -- including whether to pull the drug from the market.
Next week's meeting will be the second time an advisory panel has been asked to guide the FDA on what to do about rosiglitazone.
In 2007, a panel voted 20 to 3 that rosiglitazone increased cardiovascular risks, but then decided 22 to 1 that the benefits outweighed the risks.
In their current review, the FDA faulted the logic of the 2007 advisory decision, saying the panel failed to document the specific benefits of rosiglitazone. Since then, the benefits of the drug remain unclear, the agency said.
Next week's panel will review a number of different studies, including a post-marketing study the FDA reviewers branded as unethical.
A spokeswoman for GlaxoSmithKline said the company stands behind the safety and efficacy of rosiglitazone.

To me this falls into that category of covering up the facts as we have seen with so many other drugs throughout the last decade. And its an adjunct to this smirky comment about looking at the health protection agencies of the planet; they put forth propaganda with the purpose of causing fear....and to sell drugs.

The focus too long has been the profit motive and not public health!
GlaxoSmithKline's Diabetes Drug Avandia Draws More Scrutiny in Europe
By MELLY ALAZRAKI, Daily Finance, 07/09/10

Problems for GlaxoSmithKline's (GSK) diabetes drug Avandia seem to be getting worse. The European Medicines Agency said Friday it's launching a new review of Avandia's benefit-risk profile following new data on the possibility of cardiovascular problems.

Avandia has been in the crosshairs of scientists, regulatory agencies and even U.S. senators in the past year. The EMA decision only adds to the already existing pressure. GSK shares tumbled 2.5% in premarket trading.

Last month, two new studies linked rosiglitazone, or Avandia, to heart attacks and other cardiovascular complications. The authors of the studies said the results should prompt regulators to pull the drug from the market. A U.S. Food and Drug Administration panel is indeed going to study the data next week.

A New Reevaluation

Now, the EMA will also be considering Avandia following the recent studies. Already, the product has been reviewed several times by the agency's Committee for Medicinal Products for Human Use, which has updated the product information to include warnings on the use of these medicines in patients with heart problems. In 2008, the committee concluded that "rosiglitazone retained a small, if diminishing, place in diabetes type 2 therapy." Then again, it looked at the drug earlier this year.

The committee is now assessing the new data and will be discussing the issue at its next plenary meeting, July 19-22.

"Once all relevant data on the benefits and the risks of rosiglitazone have been looked at, the CHMP will issue an opinion on whether or not the marketing authorisations for these medicines should be revoked, suspended or changed," the EMA said in a statement.

The EU has authorized rosiglitazone on its own is as Avandia, in combination with metformin as Avandamet, and with glimepiride as Avaglim.

"Insufficient Data"?

GSK has defended Avandia, saying two heart associations have found that "Insufficient data exist to support the choice of" one treatment over the other. Still, sales of Avandia, which topped $2.6 billion in 2006, fell to $1.2 billion in 2009 after the FDA added a label warning regarding the elevated cardiac risk.

Judging from investors' reaction, the pressure on this drug is likely to keep mounting.
from Natural Health News - 4 of 14 articles referring to Avandia
FDA and Avandia: Ethics Lacking
Jun 05, 2010
FDA-Sanctioned International Diabetes Drug Trial Is Unethical and Dangerous “Surely no patient would willingly participate in a trial in which they have a substantial likelihood of taking a drug that, in the opinion of a large group of ...

Risks Potentially Outweigh Benefits with Avandia®
Jan 14, 2009
Avandia®, manufactured by GlaxoSmithKline (GSK), was first approved by the FDA in 1999 for marketing on the basis of its ability to lower blood glucose and reduce insulin resistance. By 2006 the drug had become the top selling oral ...

Avandia Increases Bone Risk for Women
Dec 10, 2008
GlaxoSmithKline, which markets rosiglitazone as Avandia, said the safety and effectiveness of the drug was backed by one of the largest clinical trial programmes ever undertaken for any medicine, with 52000 patients studied. ...

Here is another well thought out idea
Sep 15, 2006
Now for women you'll get more drug because Avandia is not as effective for you. However if you already have liver or kidney dis-ease you should not take this drug! And it will increase your LDL level so - hey - more drugs. ...

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