Drug-testing rules broken by Canadian researchers
From TheStar.com
Top Canadian doctors running clinical drug trials failed to report serious side-effectssuffered by their human test subjects.
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.
Using records obtained through U.S. freedom of information legislation, a Star investigation has found the following problems in the system designed to ensure newdrugs are safe and effective:
- In 2012, a top Toronto cancer researcher failed to report a respiratory tract infection, severe vomiting and other adverse events.
- A clinical trial run by an Alberta doctor reported that patients responded more favourably to the treatment than they actually did.
- 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.
- And numerous doctors across the country failed to tell participants that one of the goals of the clinical trial was to test the safety of the drug they were taking.
Health Canada inspects a small number of the 4,000 drug trials running at any one time across the country. The inspection results are kept secret.