Source | BBC

Secret emails reveal that the UK’s biggest drug company distorted trial results of an anti-depressant, covering up a link with suicide in teenagers.
Panorama reveals that GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials.

And that GSK-employed ghostwriters influenced ‘independent’ academics.

GSK told Panorama: “GSK utterly rejects any suggestion that it has improperly withheld drug trial information.”

GSK faces action in the US where bereaved families have joined together to sue the company.

As a result, GSK has been forced to open its confidential internal archive.

Karen Barth Menzies is a partner in one of the firms representing many of the families.

She has examined thousands of the documents which are stored, box upon box, in an apartment in Malibu, California.

She 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.”

GSK’s biggest clinical trial of Seroxat on children was held in the US in the 1990s and called Study 329.

Child psychiatrist Dr Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329.

In 2002 he also gave a talk on childhood depression at a medical conference sponsored by GSK.

He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.

In amongst the archive of emails in Malibu, Shelley was surprised to find that her own emails to Dr Ryan from 2002 asking questions about the safety of Seroxat had been forwarded to GSK asking for advice on how to respond to her.

She also found an email from a public relations executive working for GSK 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.”

But the article was published in the Journal of the American Academy of Child and Adolescent Psychiatry which says it ranks as number one in child mental health in the world.

The editor in chief of the British Medical Journal, Fiona Godlee, said that what she calls the “blind-eye culture of medicine” should be exposed by professionals.

She has written in response to the Panorama film: “We shouldn’t have to rely on investigative journalists to ask the difficult questions.

“Reputations for sale are reputations at risk. We need to make that risk so high it’s not worth taking.”

The Medicine and Healthcare Products Regulatory Authority (MHRA) began a criminal investigation into GSK three years ago but no action has been taken yet.

A spokesperson told Panorama that the investigation has been given substantial additional resources and remains a high priority.

Seroxat was banned for under 18s in 2003 after the MHRA, revealed that GSK’s own studies showed the drug actually trebles the risk of suicidal thoughts and behaviour in depressed children.

By Miranda Hitti

FDA and Drug’s Maker Warn Doctors of Possible Risk in Adults Aged 18-30

The antidepressant Paxil and its controlled-release version, Paxil CR, are getting a new warning about suicide risk in young adults.

The FDA and Paxil’s maker, drug company GlaxoSmithKline, are notifying doctors about the warning, which is being added to the drug’s package inserts.

Antidepressants already carry a warning about a possible increase in suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders who take antidepressants.

The new Paxil warning focuses on young adults aged 18-30. Paxil (paroxetine) is not approved for patients younger than 18.

“It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,” state an FDA news release and GlaxoSmithKline’s letter to doctors.

GlaxoSmithKline’s letter states that the company “continues to believe that the overall risk: benefit of paroxetine in the treatment of adult patients with MDD [major depressive disorder] and other non-depressive psychiatric disorders remains positive.”

About the Warning

GlaxoSmithKline’s letter to doctors is posted on the FDA’s web site.

The letter states that GlaxoSmithKline recently conducted a new analysis (in addition to numerous previous analyses) of suicidal behavior and suicidal thinking in adults participating in clinical trials of Paxil.

Participants in those clinical trials had psychiatric disorders including MDD, other depression, and nondepression disorders. Nearly 9,000 were taking Paxil and almost 6,000 others were taking a placebo.

The analysis showed a higher frequency of suicidal behavior in young adults (aged 18-24) with Paxil compared with placebo, but not in older adults. The age gap was not statistically significant, meaning it may have been due to chance.

Another analysis focused on adults of all ages with major depressive disorder. The frequency of suicidal behavior was higher among those taking Paxil than placebo, with 11 cases of suicidal behavior among 3,455 patients taking Paxil and one out of 1,978 taking placebo.

Overall, 0.32% of the Paxil patients of all ages with major depressive disorder showed suicidal behavior, compared with 0.05% of those taking placebo.

“All of the reported events of suicidal behavior in the adult patients with MDD were nonfatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30,” states GlaxoSmithKline’s letter.

Caution on the Data

The age differences in the frequency of suicidal behavior in adults of all ages with MDD were “statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution,” states GlaxoSmithKline.

Most patients who attempted suicide during the study “had an identified social stressor at the time of the event,” the letter notes.

The letter also says that “it is difficult to conclude a causal relationship between paroxetine and suicidality due to the small incidence and absolute number of events, the retrospective nature of this meta-analysis, and potential for confounding by the fact that the events of interest are a symptom of the psychiatric illnesses themselves.”

GlaxoSmithKline spokespeople were not immediately available for comment.