GlaxoSmithKline's Deadly Cover-Up

A striking young woman with a talent for painting, Sharise Gatchell was -- like many teenagers -- painfully self-conscious. At 14, she moved with her family from South Africa to England where at first she found it hard to make friends. By the age of 16 she was acutely embarrassed that her periods hadn't started and felt she was sweating excessively. Just the sort of thing to make adolescence even more painful than usual. Her mother, Stephanie, took her to see a consultant physician at the local hospital. Stephanie Gatchell recalls:

"During that consultation she became a bit emotional because she was explaining to him about the problems she had and how it affected her social life. Then she started crying and I was amazed. He asked her, 'Sharise, do you sometimes feel like ending it all?', and I couldn't believe it when she said 'Yes I do.' And then he started talking about paroxetine and suggesting that she try it."

"Off-label" Prescriptions

Paroxetine -- better known as Paxil in the U.S. -- is an antidepressant. It is licensed only for adults, but doctors are allowed to prescribe any medicine if they think it will help their patient, a practice called "off-label" prescribing. Sharise was not the only teenager getting paroxetine off-label. Around 7,000 children a year were on the drug in the UK; and many more in the U.S.

Within days of starting on paroxetine, Stephanie noticed a dramatic change in her daughter: she became more confident. But with the confidence came aggression and worse:

"One day in the kitchen her sleeve pulled up slightly and I noticed that there were cut marks on her left arm. I couldn't believe my eyes. She was obviously self-harming while she was on the drug, something she's never ever done before."

Stephanie persuaded her daughter to stop taking paroxetine. But in 2003 Sharise went back on it without telling her mother. When her parents returned from a weekend break, Stephanie immediately realized something was terribly wrong:

"I went upstairs before my husband came in, and the moment I got to the landing at the top and I turned round and looked, she was hanging from the loft hatch. I tried to revive her, but before I even started I realized I was too late."

Next to her daughter's suicide note lay a packet of paroxetine. Stephanie instinctively blamed the drug and now blames herself for letting her daughter take it. But she couldn't have known what the drug's manufacturer had known for years.

GlaxoSmithKline Experiments on Children

UK-based GlaxoSmithKline (GSK), the second largest drug company in the world, which recorded 2006 sales of over $45 billion, had begun a series of clinical trials in the mid-1990s to test whether paroxetine would work in depressed children. Paroxetine had already been hailed as a wonder drug in adults as a treatment for everything from depression and stress to anxiety and even shyness. By the new millennium 100 million paroxetine prescriptions had been written worldwide, bringing in $2 billion a year for GSK and placing the antidepressant a close second to Prozac in popularity.

With the adult market sewn up, the company sought new ways to make money from the drug, or "life cycle management," as the approach is known in the pharmaceutical industry. The U.S. Food and Drug Administration wanted to boost the number of medicines tested for children and had introduced an incentive that would give companies a six-month extension on their patent just for carrying out pediatric trials. For paroxetine alone that would be worth $1 billion. And if GSK could be the first company to prove its antidepressant was safe and effective for children, the rewards would be even higher, as paroxetine could become the market leader.

Hundreds of children were recruited from around the world to take part in three clinical trials. One group was given the drug, the other a placebo. They were randomized controlled trials (RCT) where neither the children nor their doctors knew whether they were taking the active drug or the placebo until the end of the study. This is widely accepted as the best way of working out whether a drug causes a particular effect: the gold standard in terms of evidence.