The BBC has once again launched a scathing attack on GlaxoSmithKline and accused the drugs giant of covering up evidence that its antidepressant Seroxat had performed badly in clinical trials on teenagers suffering from the condition.
The BBC’s Panorama said that it had seen internal company emails which the programme claimed reveal that GSK distorted trial results of Seroxat (paroxetine), sold in the USA as Paxil, and in doing so covering up a link with suicide in teenagers. The allegations are similar to those made by the same programme in 2002 and 2004 and GSK gave a firm 'no comment' to PharmaTimes World News when asked whether it will take legal action over the broadcast.
The claims in the Panorama programme shown on Monday night centre around GSK's biggest clinical trial of Seroxat on children in the 1990s and called Study 329 and focused on the role of child psychiatrist Neal Ryan of the University of Pittsburgh who was paid by GSK as a co-author of said study.
The programme noted that in 2002 Dr Ryan also gave a talk on childhood depression at a medical conference sponsored by GSK and told a Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates. Ms Joffre also noted that she had found an email from a public relations executive working for the firm which said: "Originally we had planned to do extensive media relations surrounding this study until we actually viewed the results. Essentially the study did not really show it was effective in treating adolescent depression, which is not something we want to publicise."
GSK responded to the claims before the programme had gone out, saying that it “strongly denies suggestions that it has acted in any way improperly,” and noting that “we are extremely concerned that Panorama will again, through misleading and deliberately provocative commentary, alarm patients about using their antidepressant medication, with potentially serious consequences.”
The company pointed out that it conducted nine studies, over eight years, to examine the use of Seroxat in treating patients under the age of 18 with depression and other psychiatric disorders, the results of which “were documented and submitted to regulators in accordance with regulatory requirements.” No suicides were reported in any of the nine paediatric trials and when reviewed individually (GSK’s italics), none of them were considered by the firm or independent investigators to show a clinically meaningful increase in the rate of suicidal thinking or attempted suicide.
It was only when all the data became available, at the end of the research programme, and were analysed together was an increased rate of suicidal tendencies revealed. GSK says it brought this analysis to the attention of the regulatory authorities and “utterly rejects any suggestion that it has improperly withheld drug trial information.” The UK's Medicines and Healthcare products Regulatory Agency declared that Seroxat should not be used amongst the under-18s in June 2003 and began a criminal investigation in October that year to ascertain whether GSK withheld important information on the drug's effect on children. The agency has not yet finished its inquiry.
And yet Panorama must have made uncomfortable viewing for GSK, especially given that the firm was accused of promoting Seroxat to doctors for teenagers, an allegation it vehemently denies. The programme featured Karen Barth Menzies, a lawyer involved in the class action lawsuit being brought against GSK in the USA over paroxetine, who said: "Even when they have negative studies that show that this drug Seroxat is going to harm some kids they still spin that study as remarkably effective and safe for children."
New pre-pandemic flu vaccine gets EU review
Far better news for GSK came with the announcement that the its new generation H5N1 split antigen pre-pandemic influenza vaccine has been accepted for review by the Committee for Medicinal Products for Human Use (CHMP) in Europe. The company noted that in a recent Phase III clinical trial, two very low doses of the vaccine given 21 days apart combined with the company's adjuvant system gave 80% of the individuals a high seroprotective response. That means a larger number of vaccine doses could be produced for mass vaccination. The vaccine also had an acceptable safety and reactogenicity profile, GSK concluded.