Negative drug effects hidden from public

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http://www.canada.com/edmonton/edmontonjournal/story.asp?id=2E00FC1D-

A3C8-467A-A66D-05EB5264E368

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 Jane Garland was shown unpublished data that suggested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

GlaxoKline 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

GlaxoKline 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. 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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