Medical Trial Data Activists Score Win Over Glaxo

All data on completed medical experiments are to be made available to the general public by GlaxoSmithKline, the biggest UK pharmaceutical company. The announcement is a major win for the AllTrials campaign mounted by healthcare activists as well as researchers that has gathered widespread support.

"There is a fundamental lack of scientific progress because clinical trial evidence is being withheld," Carl Heneghan, the director of the Centre for Evidence-Based Medicine at the University of Oxford said when the campaign was launched last month. "The missing results from the last 20 years also represent lost opportunities to replicate results and learn from all that research, and to develop some of it in light of new discoveries."

Support has flooded in from groups like the U.S. National Physicians Alliance, the German Institute for Quality and Efficiency in Health Care and the UK Medical Research Council, as well as from the British Library and the British Medical Journal.

The campaign provided an opportunity for GlaxoSmithKline which is seeking to get beyond the negative publicity generated by a massive $3 billion fine last year for pushing bupropion for sexual dysfunction and weight loss and targeting children with paroxetine, an antidepressant, despite a lack of approval for either.

Paroxetine - better known as Paxil in the U.S. - is an antidepressant that was licensed only for adults. Doctors are allowed to prescribe it to children and teenagers if they think it will help their patient, a practice called "off-label" prescribing, an effort GlaxoSmithKline has supported covertly for many years.

Lawsuits against the company allowed Dr. David Healy, a British psychiatrist and an expert witness, to dig deep into GSK's secret archives, where they found a series of damning internal documents.

Healy discovered that hundreds of children had been 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.

But the outcome of these the trials was not what GlaxoSmithKline had been hoping for. Paroxetine proved no better than placebo. In the biggest trial, Study 329, which was conducted across several sites in the U.S., 11 of the 93 children who took paroxetine developed serious side-effects; seven had to be hospitalized. Significantly more had self-harmed or attempted suicide on the drug than on placebo.

The data was finally published starting in 2002 by Shelley Jofre, an investigative reporter with the BBC. (Read her story on CorpWatch here)

GlaxoSmithKline went beyond just suppressing the evidence, it "participated in preparing, publishing and distributing a misleading medical journal article," according to the U.S Department of Justice, while it "sponsored dinner programs, lunch programs, spa programs and similar activities to promote the use of Paxil in children and adolescents. GSK paid a speaker to talk to an audience of doctors and paid for the meal or spa treatment for the doctors who attended."

Likewise bupropion - known as Wellbutrin in the U.S. - was pushed by GlaxoSmithKline's experts as the "happy, horny, skinny pill."

The Department of Justice noted that the company gave out "cash payments disguised as consulting fees, expensive meals, weekend boondoggles and lavish entertainment." For example, doctors who promoted Wellbutrin were taken on "training sessions" to Jamaica. "Dr. Drew," a TV doctor, was paid $275,000 in two months in 1999 alone to "deliver messages about [Wellbutrin SR] in settings where it did not appear that Dr. Pinsky was speaking for GSK."

In July 2012 GlaxoSmithKline agreed to pay out $3 billion to settle the charges on bupropion and paroxetine (as well as their failure to report safety data about the drug Avandia to the U.S. Food and Drug Administration) - the largest such fine ever paid by a pharmaceutical company.

Seven months later it is trying to make further amends, although some remain skeptical. "We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment," said Patrick Vallance, GSK's president of pharmaceuticals research and development." The company said it would also develop a system where researchers will be able request access to detailed (but anonymized) patient level data that sit behind the results of clinical trials.

"Is this just a cure for Glaxo's own ills?" wrote the Independent newspaper. "The drugs giant is to lay bare its research findings in a groundbreaking move. But it may be clever PR rather than altruism."

• 185 Corruption