Massive overdoses in drug trial killed boy, 4
Parents hoped to beat son's cancer, but study was bungled and turned out to be unauthorized
Margaret Munro
CanWest News Service
Thursday, February 26, 2004
Four-year-old Ryan Lucio survived the first four drug overdoses. The last two killed him.
Ryan's liver, heart and lungs began to fail. He developed hallucinations and severe bleeding and died at an Ottawa hospital from an experimental drug administered at 25 times the correct dose.
The youngster from Sault Ste. Marie, Ont., had been diagnosed in early 2002 with neuroblastoma, a rare and deadly form of cancer. The cancer appeared to be in remission when his parents, Peter and Maria, learned their only child had been selected to participate in an international clinical trial under way across Canada. They agreed to enrol Ryan in the Ottawa arm of the trial.
His death in September 2002 stands as a tragic reminder of how dangerous clinical research can be. And as a CanWest News Service investigation has found, it illustrates how American health authorities are more likely to blow the whistle on scientific and ethical misconduct involving Canadian researchers than federal agencies in this country.
U.S. health authorities were so concerned they sent an investigator to Ottawa to find out how things could have gone so terribly wrong with a trial funded by the prestigious U.S. National Cancer Institute.
Patricia Murphy, a U.S. Food and Drug Administration inspector, spent a week at the Children's Hospital of Eastern Ontario in January 2003 combing through notes kept on Ryan and other youngsters who received the experimental interleukin-2 treatment.
"You failed to protect the rights, safety and welfare of subjects when you administered overdoses of the study drug interleukin-2 that were 22 to 25 times higher than the dose specified in the protocol," the FDA said in a subsequent letter sent to Dr. Jacqueline Halton, lead investigator of the Ottawa arm of the trial.
The letter, dated April 14, 2003, goes on to say that "as a result of the overdoses" Ryan died and another child "suffered adverse events."
The child who survived received 22 times the correct dose during his first round of four treatments. He developed fever, lethargy and a skin rash so severe doctors discontinued his treatment, says the FDA warning letter.
Health Canada confirms that Ryan's trial and seven related cancer trials across Canada were, through much of 2002, violating regulations that require federal approval.
Department officials learned in March 2002 -- seven months before Ryan's death -- that the trials "had not been authorized by Health Canada," said spokeswoman Krista Apse. The trials were allowed to continue since they had been reviewed and approved by U.S. authorities. But Health Canada urged the Canadian researchers to quickly complete the Canadian approval process.
After Ryan's death the doctors involved in the trials requested "provisional clinical trial approval." Health Canada refused.
Apse says that after Ryan's death, departmental officials suspended enrolment of patients in the trials, which were finally authorized Oct. 25, 2002, seven months after they started and a month after Ryan died.
Dr. Mark Bernstein -- a Montreal cancer specialist who was representing the Canadian researchers running the trials -- declined to be interviewed, as did Dr. Max Coppes of Alberta's Children's Hospital in Calgary, a co-ordinator for the trials.
But in e-mails, Bernstein and Coppes suggested that trials undergo a rigorous approval process in the U.S. and should not need more approvals by Health Canada. Bernstein argued that jurisdictions such as New Zealand and Australia recognized multinational studies already reviewed by competent U.S. authorities.
Prof. Jocelyn Downie, director of the Health Law Institute at Dalhousie University in Halifax, disagrees.
"We have different standards than the Americans," she says.
And by letting the cancer researchers break the rules for so long, Downie says Health Canada sent a message to the research community that "not much happens if you don't comply."
� The Vancouver Province 2004
This totally avoidable death of an innocent child - more than ever - should be a wake up call to Parliament.
Health Canada is dysfunctional. They wrongly continue to try and regulate nutritional supplements as drugs while ignoring the problem with the pharmaceuticals in the interest of protecting the profits of the pharma cartels.
Canada's Parliamentarians need to be reminded that access to information has revealed two audits over a ten year period in the 1980's clearly demonstrated how Health Canada wasted its money and resources harassing the natural health products industry whose products kill no one, while at the same time Health Canada virtually ignored and continues to ingnore the pharma cartels whose products kill hundreds if not thousands of Canadians every year and permanently damage many more.
Nothing has changed. Since 1997 twelve pharmaceuticals and one vaccine were allowed on the market and then had to be withdrawn because, even though they had been correctly prescribed, they killed or otherwise harmed people and in the case of the Rota Virus vaccines innocent babies.
650 pages of Access To Information reveals the close connection between Health Canada middle management, the pharma cartels and their anti nutrient, anti herb quack buster friends.
Health Canada needs to be thoroughly overhauled. - CW
Back to top of document