Doctors Group Sues FDA Over Diabetes Drug Labeling

A group of doctors today filed suit against the Food & Drug Administration for failing to alert diabetes patients to safer alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart attack and death.

The suit, filed in U.S. District Court for the District of Columbia by the non-profit Physicians Committee for Responsible Medicine, faults FDA Commissioner Margaret Hamburg for declining to act on the group's 2007 petition.

The petition urged the FDA to require diabetes drugs to carry a warning label telling patients that a low-fat, plant-based diet can be as effective or better than drugs in reducing blood glucose and cholesterol.

“People are getting sick and sometimes dying because they are taking a medicine they may not even need,” said Daniel Kinburn, who is general counsel of the Physicians Committee for Responsible Medicine. “A low-fat, vegan diet is clearly safer and at least as effective.”

The group in its petition asked the FDA to require labeling disclosures about the effect of diet on diabetes and to advise consumers and doctors that “oral medications are not always necessary to manage diabetes.”

But Kilburn said the FDA failed to provide a substantive response to the petition in a reasonable time, in violation of the Administrative Procedure Act. Instead, all the FDA did was issue an “interim response” in which it stated it had been “unable to reach a decision” about the petition, according to the complaint, which was filed by Kilburn.

The suit asks the court to order the FDA to respond to the petition, and to award the Physicians Committee attorney fees and costs.

The risks from Avandia first became public in May 2007. The New York Times reported today that drugmaker SmithKline Beecham (now GlaxoSmithKline) had data hinting at Avandia’s extensive heart problems almost as soon as the drug was introduced in 1999.

The FDA is currently reviewing the drug, and is holding a special joint meeting of two advisory panels today and tomorrow to determine whether to pull Avandia from the market.

GlaxoSmithKline faces more than 13,000 suits for hiding the drug’s heart attack risks. Bloomberg reported today that the company will settle 10,000 cases for $460 million.

Comments

[online discount pharmacy]

At least this type of mistake is not expected from FDA. It is always good to mention a alternative to any critical drug
on its packet and also need of explanation its side effects. Thanks for this very precious information. From next time I will take care and be aware while purchasing such risky drugs.

I am very much thankful to this non-profit Physicians Committee which has taken this decision to filed the complaint against FDA
at U.S. District Court for the District of Columbia.

They have done very appreciating job. I would once again thanks to this team

best regards
Smith Alan
http://www.raymeds.com/purchase/avandia.aspx

[Natasha]

These doctors actually know about health and nutrition (unlike most)so I'm thrilled they are suing Avandia which could care less about health.

[Charlie]

This so-called "doctors group" is actually an arm of PETA. No joke. Its president ran the PETA Foundation for many years.

What a farce. You got snookered.

See http://www.physicianscam.com

[Matt, M.D.]

Type two diabetes is largely caused by getting fat and not eating right. Expecting these people to change their diet and exercise is a pipe dream. This is a little like saying safe driving is more effective than seatbelts at preventing car accident deaths. True but irrelevant.
According to the thought process here, just about all medications should carry the warning, "you probobly caused your own disease, if you eat right, exercise and don't smoke you might not need this medicine."
Sad.

[shannon]

it is so terrible that people are still taking avandia and getting sick from it--and that they have no idea that there are alternative ways to control diabetes. this needs to change immediately.

[Marsha R.]

I'm glad doctors are holding the FDA accountable for this. Avandia and other dangerous diabetes drugs should have been pulled from the market long ago--and consumers should be made aware of the healthy lifestyle changes that can help manage and even REVERSE diabetes. It's amazing what a diet of fruits, vegetables, and whole grains can do for the body.

[marvin yap]

Avandia provides durable glycemic control to my patients. I strongly agree that avandia be retained in the market.

[Dennis Knicely]

Drugs like Avendia used of diabetes are basically not necessary regardless for many type 2 cases. Simply eating correctly while avoiding those food groups exacerbating the symptoms often naturally reverses the illness. It does take discipline, though...
http://www.healingnews.com/Healing_Diabetic_article101.html