Calm Urged for Avandia Patients
No Urgent Need to Stop Avandia, Some Experts Say; More Study Needed
Calls for Independent Look at Avandia Risk
Drexler says these safety boards should go one step farther and do a separate and specific analysis to ensure that no signal of heart risk has been missed for any group of patients.
"We are interested not just in whether the drug helps some patients, but in whether the drug is riskier for some patients," he says. "If the Nissen paper is valid, you should be able to see these differences by now."
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."