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Why Is the FDA Having Another Hearing on Avandia?

| May 23, 2013 | Avandia Diabetes Drug, Drug and Medical Device Litigation

On June 5-6, 2013, the FDA will convene an advisory committee meeting on Avandia, a drug which was removed in most countries in 2010 and placed under severe restrictions in the US.

Avandia, a project of GSK (GlaxoSmithkline), was the subject of extreme medical controversy and massive litigation in both the MDL and in State courts, all of which is winding down in settlements as none of the cases were tried.  In addition, GSK paid a near record $3 billion dollar fine pertaining to charges of misconduct.

The checkered history of Avandia and medical studies reveals a well-documented course of misrepresentation of findings and suppression of evidence from medical professionals and consumers.

According to Dr. Steven Nissen of the Cleveland Clinic, in 2005 and 2006 GSK “secretly conducted an analysis of the cardiovascular safety of Avandia and concluded that the drug increased the risk of heart attacks and related events by about 30%. This observation had grave implications: two-thirds of diabetics, the intended recipients of the drug, eventually die of cardiovascular complications. Initially, GSK withheld the internal analysis from the FDA, but in 2006, the company informed CDER of the findings. FDA statisticians confirmed the risks, but, incredibly, CDER and GSK agreed privately to conceal this hazard from patients and practitioners.

In May 2007, Dr Steven Nissen and Kathy Wolski published an independent analysis of Avandia in the New England Journal of Medicine (NEJM), showing a statistically significant 43% increase in heart attack.  In Congressional hearings later the officials of the division of the FDA responsible for drug regulation, the Center for Drug Evaluation and Research (CDER) officials acknowledged that FDA statisticians had confirmed Nissen’s findings, reporting a 40% increase in the risk of heart attack.

So with the door closed on this drug, why is the FDA convening a public meeting?

In a May 23, 2013 article in Forbes, Dr Nissen examines the medical studies history, points out the failures of the FDA’s CDER, the extraordinary bias in the conduct of the RECORD trial, GSK’s major effort to justify the benefits of Avandia, and calls to task the CDER:

” However, this time the meeting seems systematically designed to absolve the drug of harm and the CDER leadership of any responsibility for ignoring the public health hazard of Avandia.  The current effort is intended to “whitewash” the Avandia scandal and re-write history.”

Click here to read the full Forbes article: Steven Nissen: The Hidden Agenda Behind The FDA’s New Avandia Hearings

Nissen says the FDA has been rocked by scandal and has lost sight of its mission;

We have endured a series of drug and device safety disasters (Vioxx, Avandia, Ketek, defective defibrillator leads, and recently, compounding pharmacy oversight, and the list goes on) that have harmed many of our fellow citizens.  In each case, the permanent FDA bureaucracy has sought to deny responsibility and often failed to learn the appropriate lessons necessary to prevent future catastrophes.  In the middle of the sequester, CDER is willing to spend a large sum of taxpayer dollars to conduct a 2-day advisory meeting on a drug nobody uses, for the sole purpose of absolving its own bureaucracy of responsibility for a terrible drug safety tragedy.  The current Director of CDER, Janet Woodcock, has directed this division for nearly 20 years, increasingly insulated from the Agency’s true constituency, the American public.  If CDER is allowed to re-write the history of Avandia, this vital FDA Center will continue to function as an unsupervised, self-regulating bureaucracy, accountable to no one.  That’s just unacceptable when the public health is at stake.”

We welcome Dr. Nissen’s thoughts to the public dialogue.  The Brandi Law Firm represented a number of people seriously injured or killed from Avandia and continues to represent people injured by ACTOS, FOSAMAX, Transvaginal Mesh and the DePuy hip implants.  If you would like more information, go to our website, or contact us at 1-800-481-1615 or email us.