Drug companies keep test failures
quiet, medical journal says
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
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
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
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
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
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unpublished data that suggested the antidepressant Paxil was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
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
"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
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