A year later a review in the New England Journal of Medicine stated that "data about the effects of TZDs on cardiovascular disease are urgently needed."
Yet despite all these warnings, Rep Waxman pointed out, the FDA never required Glaxo to conduct an adequate post-market study to assess Avandia's heart risks.
Dr Nissen testified at the hearing and told the panel, "The same 42 trials that we included in our analysis are available to the company and to the FDA."
"Because both of these organizations have access to raw patient data," he said, "they can perform more statistically powerful analyses, which can help clarify the extent of the risk."
Dr Nissen said Glaxo has reported the basic results of their own meta-analysis on their clinical trials website, "which confirms a statistically significant increase in heart-related complications in patients who received Avandia."
He also noted that the FDA recently announced that their own internal analysis of patient-level data confirms an "approximately 40%" excess of heart related complications.
"However," he added, "neither the GSK, nor FDA analyses have been published, and it is therefore not possible to directly compare the results for all three analyses."
Also at the hearing was Dr Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. Dr. Psaty wrote an editorial that accompanied Dr Nissen's analysis in the NEJM.
In August 2006, he testified, Glaxo provided the FDA and the European equivalent of the FDA with the results of several studies, including a meta-analysis similar to Dr Nissen's. "By October 2006," he pointed out, "the product labels in Europe were revised to include this information."
"The US product label," Dr Psaty noted, "still does not identify heart attack as a potential adverse reaction in the general population of diabetics."
"The primary measure of regulatory success is the timeliness of information, warnings, or withdrawals," he said. "With Avandia, FDA failed to warn or inform in a timely fashion."
"Late and incomplete evaluations of the health risks and benefits of drugs such as Avandia," he said, "create confusion and uncertainty among patients, physicians, and policy makers."
"If sponsors do not voluntarily initiate large long-term trials of public health importance," he said, "then the FDA needs the authority to insist that they do so in a timely fashion."
Attorney Karen Barth Menzies, who has been litigating pharmaceutical cases against Glaxo for years, attended the hearing and also said the FDA needs the authority to force companies to conduct specific post-marketing studies and stop drug makers from designing studies that produce confusing results like with Avandia.
"This is one of the ways drug companies ignore potential risks," she said, "and the FDA cannot force a drug company to conduct a specific study that actually studies the safety risks for which there has been a signal."
"Instead," she said, "as Glaxo did here, the drug companies do the post-marketing studies as a way to increase market share by designing studies that focus on efficacy as compared to the competitor's drugs."
Yet despite all these warnings, Rep Waxman pointed out, the FDA never required Glaxo to conduct an adequate post-market study to assess Avandia's heart risks.
Dr Nissen testified at the hearing and told the panel, "The same 42 trials that we included in our analysis are available to the company and to the FDA."
"Because both of these organizations have access to raw patient data," he said, "they can perform more statistically powerful analyses, which can help clarify the extent of the risk."
He also noted that the FDA recently announced that their own internal analysis of patient-level data confirms an "approximately 40%" excess of heart related complications.
"However," he added, "neither the GSK, nor FDA analyses have been published, and it is therefore not possible to directly compare the results for all three analyses."
Also at the hearing was Dr Bruce Psaty, a professor of medicine and epidemiology at the University of Washington. Dr. Psaty wrote an editorial that accompanied Dr Nissen's analysis in the NEJM.
In August 2006, he testified, Glaxo provided the FDA and the European equivalent of the FDA with the results of several studies, including a meta-analysis similar to Dr Nissen's. "By October 2006," he pointed out, "the product labels in Europe were revised to include this information."
"The US product label," Dr Psaty noted, "still does not identify heart attack as a potential adverse reaction in the general population of diabetics."
"The primary measure of regulatory success is the timeliness of information, warnings, or withdrawals," he said. "With Avandia, FDA failed to warn or inform in a timely fashion."
"Late and incomplete evaluations of the health risks and benefits of drugs such as Avandia," he said, "create confusion and uncertainty among patients, physicians, and policy makers."
"If sponsors do not voluntarily initiate large long-term trials of public health importance," he said, "then the FDA needs the authority to insist that they do so in a timely fashion."
Attorney Karen Barth Menzies, who has been litigating pharmaceutical cases against Glaxo for years, attended the hearing and also said the FDA needs the authority to force companies to conduct specific post-marketing studies and stop drug makers from designing studies that produce confusing results like with Avandia.
"This is one of the ways drug companies ignore potential risks," she said, "and the FDA cannot force a drug company to conduct a specific study that actually studies the safety risks for which there has been a signal."
"Instead," she said, "as Glaxo did here, the drug companies do the post-marketing studies as a way to increase market share by designing studies that focus on efficacy as compared to the competitor's drugs."
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