The statement submitted to Panorama by Glaxo also states:
In the case of study 329 although a numerical difference in adverse events was observed by the company and the study's investigators, for patients taking Seroxat compared to placebo, these findings were not, by themselves, considered clinically meaningful due to the limited number of patients involved and the fact that suicidal thinking and behaviour is a recognised symptom of the underlying disease.
Critical experts say it is amazing to hear an SSRI maker still trying to blame suicidal thinking or behavior on the "recognised symptoms of the underlying disease," when it has long been stressed that if that were the case, the kids on a placebo would become suicidal instead of those on the medication.
According to Ms Jofre, this Paxil scandal shows how tightly the drug companies control medical research and Dr Healy agrees. "We're in a situation now," he says, "where people who are ill generally have been deeply betrayed by the whole process, deeply betrayed by the pharmaceutical companies and by all the experts that have been willing to actually lend their names to the process."
These so-called opinion leaders are basically unregulated loose canons. According to Dr Healy, "the role of a drug regulator is to regulate any claims a manufacturer might make as regards a new product in its advertising or detailing to doctors."
But they have no control over what academics say in lectures, medical journals or elsewhere and "no control over what assessments these academics might make in their roles as experts called on to contribute to an expert consensus on new versus older drugs," he says.
The European Medicines Agency (EMEA) alerted the FDA to the suicide risk in mid-2003. Glaxo did not. According to an internal June 2, 2003, FDA email provided to this author by Baum Hedlund, written by Dr Russell Katz to Dr Andrew Mosholder, the FDA had just learned about the increased suicide rate hidden under the term emotional lability and realized that Glaxo had pulled a fast one. Dr Katz stated in the email:
We have recently become aware of a presumed association between Paxil and suicidality in pediatric patients. We received a call from the EMEA a little over a week ago. A Dr. Raines told us that the company (GSK) had submitted data that demonstrated that use of Paxil in kids was associated with increased suicidality compared to placebo, and that the company proposed labeling changes.
I believe she also said that it was in the news, and it was a big issue. Tom and I told her that the company had not informed us of any of this, and we agreed to look into it.
"It turns out that the sponsor was in the process of submitting to us a partial response to a question we asked in the Approval letter for the pediatric use (you, you may recall, were the reviewer). Specifically, we had asked them to further elaborate the events subsumed under the preferred term 'Emotional Lability'. Mr Katz further stated:
We received this partial response, and almost all of these events related to suicidality. The bottom line is that when data from the controlled trials in depression, OCD, and Social Anxiety are pooled, for "possible suicide related" events occurring during treatment or within 4 days after discontinuation, the rate is 0.14/patient-year on drug, and 0.05/patient-year on placebo, p=0.02.
"We have some problems with the methodology they used to capture cases," he said, "but this is the major finding, and it has us worried."
"The sponsor has not proposed labeling changes," Dr Katz noted, "and makes a feeble attempt to dismiss the finding."
"We want to move quickly to evaluate this signal," he told Dr Mosholder.
"We are planning to look at the NDAs for other SSRIs," he wrote, "to see whether or not similar events are being hidden by various inappropriate coding maneuvers, but we'd also like to compare the drugs in other meaningful ways if we can."
"We also want to call the sponsor very soon," he noted, "and ask some questions about their methodology."
Must Read (
Well Said (
News (
Touching (
Funny (
Supported (
Interesting (
Inspiring (
Valuable (
