During the Panorama program, Ms Jofre interviewed SSRI expert, Professor Dr David Healy, of the North Wales Department of Psychological Medicine at the University of Wales, an academic who has long challenged SSRI makers. Dr. Healy is concerned that doctors were deceived into prescribing Paxil to children.
"We were all hoodwinked, misled, duped," he stated in the interview.
"If you'd heard the experts talk," Dr Healy said, "they all say the drug was extremely safe and very effective."
"They produce these clinical trials," he noted, "which appear to be evidence and they aren't, they're adverts."
In five studies, 329, 377, 701, 329-extension and 716, Glaxo coded suicidal thinking and acts, under "emotional lability." In a recent paper titled, "Manufacturing Consensus," in Culture, Medicine and Psychiatry (2006), Dr Healy describes how regulators came to recognize the significance of the term "emotional lability," stating:
As a result of a GlaxoSmithKline application to the regulators for a license for Paxil to treat childhood nervous disorders, the raw data from clinical trials were lodged with a number of national regulators.
Within a fortnight of seeing the raw data in response to queries as to the events behind the term emotional lability, in May 2003 the regulators in the United Kingdom issued a warning against the use of Paxil (Seroxat) for minors.
"A few weeks later," Dr Healy reports, "GlaxoSmithKline wrote to all doctors noting that Paxil use was linked to suicidality and that withdrawal from Paxil was also linked to an apparent doubling of the rate of suicidality."
In the Panorama program, Ms Jofre points out that Sharise Gatchell's doctor, "like thousands of others, prescribed Seroxat in good faith."
Stephanie discussed how she and Sharise watched the April 28, 2003, Panorama program together and how she had told her daughter, aren't "we lucky that you're off it," not realizing that Sharise was taking Paxil secretly.
Less than a month later, public health officials in the UK warned that Paxil should not be prescribed to anyone under 18, after reviewing the secret clinical trials that Glaxo finally turned over 2 years after the last study was completed.
The warning came 2 weeks too late for Sharise.
According to Ms Jofre, Glaxo refused to be interviewed for the program but issued a written statement saying the company rejects any suggestion that it improperly withheld trial data and that Paxil was never approved for children under 18.
Its statement seems to place the blame for off-label prescribing squarely on the doctors. "Any decision to prescribe a medicine outside its authorised indications, in the EU or the US," Glaxo wrote, "is made by a doctor on the basis of his/her clinical judgement and the interests of their patient."
However, this comment infers ignorance on Glaxo's part of the fact that Paxil was being prescribed off-label to children in massive numbers. In the US, the company knows exactly when Paxil is prescribed and by which doctor, because Glaxo pays a small fortune to purchase the detailed prescribing records for every physician in the US for use by sales representatives in targeting their customer-doctors.
One former sales representative recently said that she could see whether a perk such as a lunch she purchased for a doctor one week increased the sale of the drug that she was promoting simply by checking the prescribing records the next week.
