Calm Urged for Avandia Patients
No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed
Calls for Independent Look at Avandia Risk continued...
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
"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
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]
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 [the 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'
Alternatives to Avandia
Another drug in the 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."