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 
                  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                  unpublished data that suggested the antidepressant Paxil was 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.