Canadian physicians and psychiatrists regularly do not report serious negative side effects during their clinical trials of drugs, according to an investigation by the Toronto Star. “The doctors, some of them esteemed researchers from Canada’s most prestigious hospitals and academic institutions, have also routinely broken rules designed to protect participants, and botched research of new treatments.”
“Health Canada inspects a small number of the 4,000 drug trials running at any one time across the country,” reports the Star. “The inspection results are kept secret.”
Oversight of Canadian drug trials is so lax, says the Star, the problems have only come to light thanks to the fact that the US FDA inspects and reports on some Canadian trials of drugs targeted for the US market. Through freedom of information requests to the FDA, the Star then discovered for example that, “A Toronto hospital’s chief of medical staff ran a clinical trial of autistic children on a powerful antipsychotic, and he did not report side-effects suffered by four of the children.”
“The FDA found objectionable conditions in more than 60 per cent of the 192 study sites they have visited [in Canada] since 1981,” reports the Star.
Drug-testing rules broken by Canadian researchers (Toronto Star, September 16, 2014)