Calm Urged For Avandia Patients

Some Experts Say There's No Urgent Need to Stop Taking Diabetes Medicine; More Study Needed

(WebMD)  Drexler believes that patient faith in Avandia can only be restored if GSK hands over all the data it has to an outside panel of experts for independent review.

"GSK should ask some organization, preferably the Endocrine Society, to put together a group of scientists chosen by the organization, and open up their files without restriction and let that group study it," he says. "Unless they do that, I think they are going to have a very hard time
selling this drug."

GSK's Krall says this is unnecessary as the FDA is already assembling an expert panel. He promises that GSK will make all of its data available to the FDA panel.

"We will try to share everything we have with the community of physicians," he says.

Nissen is skeptical.

"I have been discussing this with GSK, and they do not want to have a complete analysis done of all their data," he says. "If they are going to clear the air, now is the time. The reason they don't want to do it, I think, is they have already done it themselves and don't like the results."

Drexler says GSK's reassurances have so far been more of a public relations effort than a scientific effort. Krall bristles at that suggestion.

"There are a number of scientific manuscripts in preparation, that have been in preparation, that will help communicate to the scientific community the data that the FDA and European regulatory authorities already have seen," Krall says. "All of this is not under GSK control. Some of these studies have been done by external academic experts. It is they who are writing the actual manuscripts. There is an interest in this scientific data, and we are trying to respond as quickly as we can with scientific communications."

Avandia gained FDA approval in 1999. That approval was based on the drug's ability to lower diabetes patients' blood-sugar levels.

"Why do we control blood sugar in diabetes? The reason is to control complications of diabetes," Nissen says. "Avandia has never been shown to control any diabetes complication. They have had eight years to show a health-outcome benefit. Yet they've shown no reduction in microvascular [eye, kidney, and extremity] complications and no reduction in cardiovascular [heart] outcomes."

Krall says such studies began very soon after Avandia approval.

"It takes studies of 10 years' duration or more to show clinical endpoints," he says. "It took 10 years to see clinical results in studies of [older diabetes drugs] metformin and sulfonylura. It is not fair to expect those results yet for Avandia. What is clear is that if you do manage [blood sugar levels], you do see those endpoints in 10-plus years' time."

Alternatives To Avandia

Another drug in he same class as Avandia, Actos, has already been shown to lower — not raise — the risk of heart disease in diabetes patients.

"It may be hard to justify continuing to prescribe Avandia if there is an alternative, Actos, that does not have same risk profile," Meneghini says. "So in terms of new Avandia prescriptions, I don't think so. It is not so much a clinical decision as a liability decision. Because if a patient says, 'I want to come off the drug,' and his doctors says, 'No, continue taking it,' and the patient has a heart attack — for whatever reason — well, you can imagine what comes after that."

But Meneghini still says Avandia is helping some patients.

"In terms of patients currently on the drug, if they have had a good response in terms of blood sugar control, and no prior cardiovascular event, I don't see why they should not continue," he says. "In those with a history of heart trouble, maybe they should consider a change. Insulin therapy is one of the cleanest options we have at this point in time."

And, of course, there are non-drug treatments, too.

"Avandia and Actos reduce insulin resistance. You can achieve that with physical activity and losing weight, especially around the waist," Meneghini says. "These are healthy ways to achieve better blood sugar control without side effects. This should be adopted by anybody. After all, the mainstay of diabetes treatment is healthy weight, healthy diet, and lose some weight if you are overweight."

[heresmy2cent]

Don't forget the mantra that you hear endlessly on television commercials today.

"Ask your doctor if Avandia is right for you."

or in this case,

"Ask your doctor if a heart attack is right for you."

[asor1-2009]

"Avandia increases a diabetes patient's already-high risk of heart attack by 43%."
Oh, right, remain calm! Who wrote this tripe?
Diabetes alone presents a greater danger, this medication multiplied that danger greatly.
What an outrage to suggest we remain calm. As we said as kids, "drop dead twice", we shouldn't stop taking Avandia?

[dhirya]

i would say if at all anybody wants to sue they should consider FDA.For any drug to come into the market it has to be approved by the FDA.The responsibility goes to the FDA.Terrapin78 beleive me your doctor had the best intentions in his mind when he prescribed you AVANDIA.This group of drug had the potential to halt the progression of the disease.my question is if Avandia is causing problems then why ACTOS is not included in the warning?It also works the same way as Avandia and it has proved to lower the risk of heart disease in diabetics.We need to be calm and wait till FDA constitutes an independent commitee to evaluate the data GSk has.If Avandia and Actos (Both are Thiazolidinedione Group of medicines)are implicated in causing cardiovascular complications then it is a real bad news for diabetics.I also confirm i am not a fan of big pharma companies.

[alert15]

It is your life, do not trust this article, the publisher of this article is paid by the GlaxoSmithKlien and BU$H FDA. There are so many medication in the market you can take the one is which is safe. (Terrapin78, I like the way you call BU$H). Once again, it is your life, take care. Sue the Doctor, FDA and GSK.

[oleander8]

"When people read these stories about heart attack risk, they often stop taking their diabetes drugs. ... Everyone says, 'Consult your doctor before stopping any prescribed medication,' but we really must stress this point more strongly."

If the media wouldn't sensationalize these studies there wouldn't be the ensuing panic from the public.

[ionion-2009]

It makes no sense to sue your doctor. Did he cram it down your throat? You are responsible as well. If you have a problem GSK is who to sue. Your doctor only has the latest information.
But seriously take some responsibility for yourself.

[terrapin78]

I resisted taking Avandia when my doctor suggested it. My reasoniong was that I don't TRUST EITHER THE BIG PHARMA OR THE BU$H FDA to provide the true results of studies.

I told him that I don't want to end up like Fen-Fen, Vioxx, Celebrex etc patients and be HARMED permanently.

My doctor continued to push me on it and I relented. NOW I AM PISSED!

I may have to look at suing my doctor.