Healthy Skepticism Library item: 198

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Publication type: news

Branswell H .
Suppressed data from negative drug trials distorts science: Journal
Canadian Press 2004 Feb 17

Full text:

Pharmaceutical companies “deceive” doctors and their patients – and perhaps their shareholders – when they withhold unfavourable data on prescription medicines, the Canadian Medical Association Journal argues in an editorial Tuesday.

The editorial was part of a package of articles looking at the suppression of trial data, with a particular focus on testing of antidepressant drugs in children and teenagers.

Concern has been rising for some time about how safe antidepressants called selective serotonin re-uptake inhibitors are when used by children. There is evidence that SSRIs, as the drugs are called, can induce suicidal thoughts or actions in a small proportion of people who take them.

Several countries, including Canada, have recently urged renewed caution over the use of SSRIs in children. Health Canada is striking an expert panel to study worldwide safety data on the question.

In addition to safety concerns, there are questions about whether the drugs actually work in children. Last week the journal revealed that GlaxoSmithKline deliberately withheld trial results that showed paroxetine (sold as Paxil) was no more effective than sugar pills in children.

The journal called it the “file drawer phenomenon” – when clinical trials which don’t reflect favourably on a drug get buried by the company that paid for them. The editorial called these types of trials a “commercial liability.”

“In the regulation of clinical testing of drugs and devices, safety and efficacy must trump proprietary rights every time,” the editorial board of the journal says in urging Health Canada to become more demanding of drug companies.

In their defence the drug companies insist they have a responsibility to their shareholders not to reveal information that might give a competitor a leg up.

“Premature disclosure of proprietary information by Merck (or other companies) can result in significant competitive disadvantage and loss of incentive or reward for new product development,” Dr. Laurence Hirsch, vice-president of medical communications at Merck Research Laboratories in Rahway, N.J., argued in one of the commentaries.

Hirsch, who was not available for an interview Monday, revealed Merck has adopted guidelines committing the company to publishing the results of “hypothesis-testing clinical trials, regardless of outcome,” saying Merck recognizes the ethical obligation to publish negative data from statistically sound trials.

The journal’s view was supported in a commentary by Dr. Jane Garland, a child psychiatrist who has first-hand experience in the problem. Garland, head of the mood and anxiety disorders clinic at the British Columbia Children’s Hospital, revealed that in her role as a researcher she saw negative results from trials on paroxetine but was barred from discussing them for 10 years by non-disclosure contracts.

She told the journal she would never again do a industry-funded trial under those circumstances.

Garland said much of the data that is just coming to light showing that SSRIs are ineffective – and potentially harmful – in a large portion of children have been suppressed for years.

“Some of it is more than five years old. So it’s been sitting there not informing the scientists who are making the recommendations to the general physicians out there,” she said from Vancouver.

“It’s a real concern. Because when you’ve got selective release of information, it distorts the science, really, doesn’t it?”

Only one of these drugs – fluoxetine or Prozac – has been licensed for use in children. But doctors frequently prescribe drugs for uses beyond that for which a drug is licensed. Use of SSRIs among teenagers is increasingly common. Even preschoolers are occasionally put on the drugs.

In fact, there’s been a 400 per cent increase in the use of anti-depressants in children, noted Dr. Michael Rieder, a clinical pharmacologist at the University of Western Ontario.

Rieder believes SSRIs can be safely and effectively used in some children, under close supervision. But he acknowledged that in some cases, children on the drugs may not be monitored as closely as they ought to be.

“We need to be careful about what we take,” he said. “And parents need to understand the drugs their kids take, what they’re for, how long you’re going to take them and what you expect out of them.”