May 25, 2007
Calm Urged For Avandia Patients
Some Experts Say There's No Urgent Need to Stop Taking Diabetes Medicine; More Study Needed
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(CBS/AP)
"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."
By Daniel DeNoon
Reviewed by Louise Chang
© 2007 WebMD, Inc. All rights reserved.
Best-selling author Mitch Albom on his first nonfiction work since "Tuesdays with Morrie."
"Ask your doctor if Avandia is right for you."
or in this case,
"Ask your doctor if a heart attack is right for you."
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?
If the media wouldn't sensationalize these studies there wouldn't be the ensuing panic from the public.
But seriously take some responsibility for yourself.
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.