Avandia under scrutiny – FDA found GSK study flawed

Avandia, one of the blockbuster drugs for Diabetes from GlaxoSmithKline is under scrutiny by Food and Drug Administration (FDA) after it has been attributed to increase in risk for cardiovascular or heart disease.  FDA is expected to give its verdict sometime this week. 

In my last post “Avandia helps diabetes but makes heart cry”, we covered the news that came out regarding two recent studies that show Avandia increases risk of heart disease.  GlaxoSmithKline has carried out its own studies that show Avandia is safe for the heart and the one of the biggest studies among them is called “Record”, which was reported in Lancet last year. 

The reviewer, Dr. Thomas Marciniak of the FDA took a deep dive in studies conducted by GlaxoSmithKline.  Dr Marciniak found that the record study misrepresents the data that Avandia is safe for your heart and here are the main points from his analysis: 

  • RECORD study repeatedly submitted sloppy data and failed to follow up on reports of problems in patients — including reports of patient deaths.
  • The design of the study “inappropriate and biased,” in large part because it was not “blinded”. Which means GlaxoSmithKline was aware at all times of which patients were getting Avandia and which were on other medications.
  • In many cases there was missing data, or that investigators failed to follow up on likely cases of heart problems.
  • In most cases the omissions made the safety data for Avandia look better than it really was.
  • After re-analysis of the data, the studies conducted by GlaxoSmithKline actually show an increased risk of heart attack, much like the studies it was meant to refute.


If you are interested in reading reports by the review committee or presentation made by Dr. Marciniak, feel free to browse through the links.  It is more evident from Dr. Marciniak’s analysis, that Avandia seems real threat for increased heart...

attack, as stated by Dr. Marcinia “RECORD confirms and extends the recognized concerns regarding increased heart failure and heart failure deaths with rosiglitazone [Avandia].”

Reaction from GlaxoSmithKline
Glaxo’s vice president for Clinical Development, Dr. Murray Stewart, said that

  • Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.
  • There’s just no evidence of an increase in heart attacks
  • What’s more, all the clinical trials show no evidence in mortality versus standard of care. They all show decreased mortality.

It is true that GlaxoSmithKline conducted the studies, but recent reports reveal that the studies were biased and did not address the issue properly.

Reaction from doctor representing Diabetic community
Dr. David Nathan, the director of the Diabetes Center at Massachusetts General Hospital, said that in the view of recent results and discussion there are various concerns:

  • how do they count the adverse events, how do they investigate them — if there are problems with that, it’s really worrisome,
  • It is recommended that doctors use medications other than Avandia
  • There’s just no rationale for using a drug that might be dangerous, especially when other options are available.

It looks like jury is leaning against use of Avandia, prescribed medicine for Diabetes.  I am keeping an eye on the final decision from FDA and bring back the news to my readers.  I would suggest that if you are currently on Avandia, consult your doctor and ask him for alternative option, until FDA makes its decision.

Source: cnn.com

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