Health Canada has quietly introduced new rules for clinical drug trials after a man with tuberculosis was included in a trial at a Montreal lab last year, exposing dozens of staff and other participants to the contagious disease.
Under the new rules, potential participants must be screened for symptoms such as coughing up blood and asked whether or not they are intravenous drug users or suffer from HIV, according to internal documents obtained by Canadian Press using federal access-to-information laws.
"They did, as a result of this, create guidelines for first-phase clinical trials," confirmed Alistair Sinclair, spokesman for Health Canada. "And they are binding. Companies are required to abide by them."
The new screening process, put in place after the incident during a clinical trial by SFBC Anapharm, requires companies to ask participants whether they have ever had an active case of tuberculosis and whether they suffer unexplained symptoms such as chest pains, weight loss, fever, loss of appetite or night sweats.
If the answer is Yes to either question and they haven't been tested for TB, they are excluded from the trial until a medical exam rules out the disease.
If potential trial subjects, who are paid for their participation, say they have been tested, then companies must ask for proof.
Twenty people tested positive for latent tuberculosis earlier this year after a man with an active case of the disease was included in a human drug trial by SFBC Anapharm in the fall.
According to reports, the man was kept in the on-site study and housed with other participants despite visible signs of illness.
A total of 19 participants in the drug trial and 50 employees had to be tested. Latent tuberculosis means they were infected but did not have active cases and were not contagious.
SFBC Anapharm is the Canadian subsidiary of New Jersey-based SFBC International, which was at the centre of a U.S. Senate committee investigation earlier this year over some of its practices south of the border.
Under the federal rules governing clinical trials, Health Canada cannot disclose whether any action was taken against the company.
Critics say the lax oversight by Canadian federal officials leaves the $14-billion-a-year biotech industry vulnerable to abuse.
But from now on, companies conducting the trials have to ask participants if they have HIV-AIDS, an organ transplant, kidney disease requiring dialysis, diabetes, lymphoma, silicosis or leukemia and whether they are injection drug users, take steroids or immunosuppressive drugs.
If they answer affirmatively to any of those questions, they will be excluded from the trial.
The companies must also ask trial candidates to list countries where they have lived or visited in the previous eight weeks. People who have been to a country with a high incidence of TB are excluded because it may be too soon to test for infection.