yeah, right
believe it when I see it
Sheri

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Hoey says Health Canada should pressure all drug companies to follow 
the lead of Merck-Frosst, which plans to publish the results of all 
clinical trials, regardless of the outcome.

Drug risks hidden from public
Drug companies keep test failures quiet, medical journal says

Sharon Kirkey

Tuesday, February 17, 2004

OTTAWA - Pharmaceutical companies are deceiving patients and doctors 
by keeping negative results from drug trials "locked in the filing 
cabinet," Can-ada's leading medical journal warns.
The Canadian Medical Association Journal says Health Canada is 
complicit in this "file drawer phenomenon" by too often keeping quiet 
about buried evidence that questions drug safety and effectiveness.

In an editorial published today, the CMAJ accuses drug companies of 
silencing medical researchers by having them sign agreements that 
suppress the release of negative findings in drug trials -- sometimes 
for as long as a decade after the test results are in -- while 
positive findings are promoted.
Most "negative studies" go unreported because they showed no 
beneficial effects of the drug being tested. But some hold 
information that would hurt the drug companies.

It takes $1 billion on average to bring a new drug to market, a huge 
investment that "puts pressure on companies to suppress results that 
might slow or extinguish sales," the CMAJ says.
But by burying data, drug companies "deceive physicians, their 
patients and, perhaps, shareholders. Worse, such concealment is a 
flagrant abuse of the trust" patients put in doctors when they agree 
to be test subjects in medical experiments.

A leading B.C. child psychiatrist has vowed never to do another drug-
company sponsored trial unless "drastic" changes are made. Three 
years ago, Dr. Jane Garland was shown unpublished data that suggested 
the antidepressant Paxil was ineffective in children -- but only 
after she had signed an agreement prohibiting her from sharing the 
information with other doctors and investigators for 10 years.

Garland, head of the Mood and Anxiety Disorders Clinic at British 
Columbia's Children's and Women's Hospital, was about to do a study 
testing Paxil on children with mood disorders when she was sent a 
confidential "investigator's brochure" that summarized what 
GlaxoSmithKline knew about its drug.
Buried in the material were results from two studies that showed 
Paxil was no more effective than a placebo, or sugar pill, in 
treating depression in children.

At that time, the only study of Paxil in depressed children that had 
been published suggested a benefit. None of the Paxil-like drugs have 
been approved in Canada for use in anyone under 18, but they're 
increasingly being prescribed to children as young as three for 
depression, obsessive-compulsive disorder, social phobia and anxiety.

"My jaw dropped because I already signed a form saying I can't reveal 
anything I'm about to see," says Garland, whose commentary is one of 
several articles on the burying of clinical evidence in today's CMAJ.

"I do the continuing medical education (for doctors). I run the 
specialty clinic for the province. I teach students and residents and 
I have to tell them that the medication works based on the one study 
published, and I'm not allowed to mention that I've seen the other 
data. It felt terrible." The evidence came to light last summer, when 
GlaxoSmithKline warned doctors Paxil should not be given to children 
because several large trials also found that two to three per cent of 
children taking the drug developed suicidal thoughts while on the 
medication, twice as many as children on a placebo.

Last month, Health Canada issued a public advisory about the 
increased risk of suicide in children for all SSRIs (Selective 
Serotonin Reuptake Inhibitors).

Garland says the safety data involving Paxil had been available at 
least since the 1990s. She estimates 10,000 to 15,000 B.C. children 
are taking the drugs.

In a written response to a request for an interview, the company said 
it "began communicating results" from its pediatric studies in 1998 
through posters, abstracts and other publications.
"GSK takes very seriously our responsibility to provide health-care 
professionals the information they need to prescribe medicines. We 
are devoting significant time and energy to finalize the process of 
communicating study results so that we have a sound and sustainable 
policy."

But the problem of hidden drug information is much more widespread, 
says CMAJ editor Dr. John Hoey.

"It means that physicians who are prescribing these drugs may not 
have complete information about how good the drug is, does it work 
or, equally important, how safe is it," Hoey said in an interview.
Drug companies have to make the results of all clinical trials 
available to Health Canada to get initial approval for a drug, Hoey 
says. But there is no requirement for the results to be published, or 
even made available to other researchers.

A Health Canada spokeswoman said that information is owned by the 
drug company.

Companies are required by law to report serious side effects to the 
government. But the secrecy in the drug-approvals process and weak 
systems for monitoring adverse drug reactions are also keeping unsafe 
medicines on the market, U.K. and Canadian researchers report in the 
CMAJ.

Patient reports of drug reactions are often dismissed as "anecdotal 
or unscientific," the researchers say. In addition, Health Canada 
keeps confidential any rejected applications to expand the use of a 
drug to another patient group, such as giving drugs designed for 
adults to children.

Hoey says Health Canada should pressure all drug companies to follow 
the lead of Merck-Frosst, which plans to publish the results of all 
clinical trials, regardless of the outcome.
 
 
 
 

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