On January 29, 2007, BBC-One broadcasted, "Secrets of the Drug Trials," a Panorama program based on an investigation by reporter, Shelley Jofre, which revealed how GlaxoSmithKline misled doctors into prescribing Paxil off-label to children, even after its own clinical trials found that kids could become suicidal when taking the drug.
The program was one in a series involving the relatively new class of antidepressants known as the selective serotonin reuptake inhibitors (SSRIs), which have only been sold in the US for about 20 years.
Paxil is marketed under the name Seroxat in the UK. It has never been approved for use with children for any indication in either the US or the UK.
The first program, "Secrets of Seroxat," was aired in October 2002, and the feedback that followed was unprecedented, with 67,000 people contacting a BBC helpline and 1,500 people emailing Panorama with stories similar to those revealed in the broadcast. The second, "Emails from the Edge," was aired in April 2003, in large part due to the viewer's response from the first program.
Many of the documents in the latest program were obtained in a consumer fraud class action lawsuit filed in the US by the Baum Hedlund law firm alleging that the UK based GlaxoSmithKline suppressed information about Paxil's failed efficacy and increased risk of suicidality in children. The case is filed on the behalf of the general public defined as:
All persons or entities who purchased and/or paid for paroxetine under the trade name Paxil, Paxil CR and/or Paxil Oral Suspension in the states of California, Florida, Massachusetts, Nevada, New Jersey, Pennsylvania, Texas, and Washington for consumption by a minor.
Baum Hedlund, a US law firm handling antidepressant cases for more than 15 years, has reviewed thousands of documents and taken numerous depositions of Glaxo employees and medical professionals known as academic thought leaders, hired to promote Paxil over the years.
As usual, in lawsuits against drug companies, virtually every document produced in the litigation was stamped "confidential" by Glaxo and sealed under a court order. However, through a series of legal challenges, Baum Hedlund was able to get some of the documents released in part, by getting Glaxo to admit that many did not contain trade secrets and therefore should not have been sealed to begin with.
Baum Hedlund partner, and lead attorney on the case, Karen Barth-Menzies, appeared in "Secrets of the Drug Trials," and provided many of the documents referred to by Ms Jofre in the program.
Paxil was hailed as a wonder drug in the 1990's, sold as an alternative to Prozac for treating depression in adults. But Glaxo was not satisfied with the profits from treating adults and wanted to gain a stronghold on the lucrative pediatric market.
According to Ms Menzies, under FDA rules at the time, if the company conducted tests on Paxil with children, Glaxo could get a 6-month extension on its patent, which meant enormous profits. To that end, hundreds of children were recruited from around the world for several pediatric studies with the largest conducted in the US, known as Study 329.
During the program, Ms Jofre interviewed Stephanie Gatchell who described how she had taken her daughter, Sharise, to a doctor because Sharise had not started her periods yet and was worried, at which time she was prescribed Paxil.
Although Paxil was also only approved for adults in Britain, the same as in the US, doctors are allowed to prescribe a drug off-label for an unapproved use if they believe it will help a patient. According to Panorama, at the time that Sharise was prescribed Paxil, around 7,000 children a year were on the drug in Britain.
Shortly after Sharise began taking Paxil, her mother noticed a dramatic change. "She became more confident," Stephanie said, "but with it came aggression and worse."
One day she noticed cut marks on Sharise's arm and realized that she was self-harming, "something she'd never ever done before," her mother said.
Stephanie convinced Sharise to stop taking Paxil but unbeknownst to her parents, she began taking the drug again without telling them. Not knowing she was on Paxil, her parents went away for a weekend and when they returned home, they found Sharise hanging from a loft with a suicide note laying next to a packet of Paxil.
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