Send a Tweet
Most Popular Choices
Share on Facebook Share on Twitter Share on LinkedIn Share on Reddit Tell A Friend Printer Friendly Page Save As Favorite View Favorites
General News

Avandia Hearing Exposes FDA as Negligent Watchdog

By       Message Evelyn Pringle       (Page 1 of 3 pages)     Permalink    (# of views)   No comments

Related Topic(s): ; ; ; ; ; ; ; ; ; , Add Tags
Add to My Group(s)

View Ratings | Rate It

opednews.com

Author 58
- Advertisement -
The FDA has ignored repeated warnings about the potential cardiac risks associated with the diabetes drug Avandia, and medical experts predict Americans will likely pay a heavy price for trusting its negligent watchdog because US doctors wrote 13 million Avandia prescriptions in 2006 alone, according to IMS Health a medical information tracking firm.

On May 21, 2007, the New England Journal of Medicine published a meta-analysis of the heart attack and death rates from 42 Avandia trials completed before or after drug approval, that showed a 43% excess incidence of heart attack in Avandia patients. Dr Steven Nissen, Chairman of the Department of Cardiovascular Medicine at Cleveland Clinic and Immediate Past-President of the American College of Cardiology, and statistician, Kathy Wolski, MPH conducted the study.

The very same day, the Chairman of the US House Energy and Commerce Committee's Oversight Subcommittee, Representative Bart Stupak (D-Mich), stated, in essence, that the Avandia debacle was the last straw.

"The FDA is on notice," he said in a statement, "that we have reached the end of our rope on their stonewalling of investigations into their failures to keep Americans safe from dangerous drugs and poisonous foods."

- Advertisement -
Avandia was approved on May 25, 1999, and the primary FDA reviewer of the clinical trials submitted recommended approval because the data showed the drug to be effective in reducing blood sugar, however, he also noted that the clinical trials raised questions about Avandia's effect on the heart.

Specifically he noted the "increase in body weight" and "undesirable effects on serum lipids [cholesterol] is cause for concern."

"Heart disease due to atherosclerosis," he wrote, "is a major cause of morbidity and mortality in patients with type 2 diabetes, and it cannot be assumed that treatment with [Avandia] will decrease the risk."

- Advertisement -
Because of these concerns, the reviewer recommended "a postmarketing study to address these concerns needs to be a condition of approval," which never took place.

On June 6, 2007, the US House Committee on Oversight and Government Reform held a hearing to review the FDA's role in evaluating the safety of Avandia, during which Committee Chairman Henry Waxman (D-Cal) stated, "The medical reviewer did everything right," but unfortunately at that point the FDA dropped the ball.

He noted that the FDA and Glaxo did agree on a post-market study called ADOPT, but it
was designed to show whether Avandia provided long-term control of blood sugar levels, not to assess whether the drug increases the risk of heart attacks.

Subsequently, the FDA received many more warnings about a link between Avandia and heart attacks. In March 2000, Dr John Buse wrote a letter to the FDA to request "cardiovascular safety trials in high-risk populations."

Dr Buse, head of endocrinology at the University of North Carolina, testified at the hearing and told lawmakers that in 1999, after he drew attention to the Avandia heart risks, the company warned him that it might try to hold him accountable for the drop in stock value.

During phone calls, he testified, "it was mentioned on two occasions that there were some in the company who felt that my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalization."

- Advertisement -
In a letter he wrote to the firm at the time, which was distributed at the hearing, Dr Buse said: "Please call off the dogs. I cannot remain civilized much longer under this kind of heat."

"In the end," he told the Committee, "I offered to help the company with further studies and signed a clarifying statement drafted by SKB [SmithKline Beecham], which was to be used with the investment community."

In February 2003, the World Health Organization issued a warning about the potential cardiac risks associated with all glitazones (TZDs), drugs in the same class as Avandia.

Next Page  1  |  2  |  3

 

- Advertisement -

View Ratings | Rate It

opednews.com

Evelyn Pringle is a columnist for OpEd News and investigative journalist focused on exposing corruption in government and corporate America.

Evelyn Pringle Social Media Pages: Facebook page url on login Profile not filled in       Twitter page url on login Profile not filled in       Linkedin page url on login Profile not filled in       Instagram page url on login Profile not filled in

Go To Commenting
The views expressed herein are the sole responsibility of the author and do not necessarily reflect those of this website or its editors.
Writers Guidelines
Contact AuthorContact Author Contact EditorContact Editor Author PageView Authors' Articles
Support OpEdNews

OpEdNews depends upon can't survive without your help.

If you value this article and the work of OpEdNews, please either Donate or Purchase a premium membership.

STAY IN THE KNOW
If you've enjoyed this, sign up for our daily or weekly newsletter to get lots of great progressive content.
Daily Weekly     OpEdNews Newsletter
Name
Email
   (Opens new browser window)
 

Most Popular Articles by this Author:     (View All Most Popular Articles by this Author)

Glaxo Promotes Mental Disorders - Then Paxil

Government Investigation Finds Autism Vaccine Related

Paxil Five-Year Litigation History

Suicide Risk of Neurontin Kept Hidden for Years

Gambro Healthcare - Dialysis Fraud Pays Big Bucks

Johnson & Johnson Chirate Spinal Disc Under Fire