Inside the human guinea pig capital of North America

Quebec accounts for over 40 per cent of the country’s pharmaceutical output. The 10 largest pharmaceutical companies in the world all have operations in Quebec, and with them have come dozens of generic drug companies, who, like the name brands, require fast, reliable, government-sanctioned testing of their wares. The federal government further obliged these companies in 2001, when the clinical trial review period was slashed; suddenly it took half the time for pharmaceutical companies to have their drug tests approved by Health Canada. The change, according to Health Canada officials, reflected the body’s two overarching objectives: “To strengthen protections for clinical trial subjects; and to attract and sustain investment in research and development in Canada.”

Health Canada’s oversight was put to the test in the fall of 2005, when a volunteer with tuberculosis infected 20 people during an Anapharm-sponsored study. As internal documents show, Health Canada officials didn’t seem to know of the outbreak until they were contacted three months after the fact by David Evans, a reporter for the Bloomberg news agency. Emails exchanged between Health Canada officials, obtained by Maclean’s, show how the agency scrambled to get information from Anapharm and from the reporter himself, who seemed to know more about the outbreak than it did.

In the of fall 2005, Anapharm had recruited 20 subjects in a clinical test of ISA 247, an experimental immunosuppressant drug produced by Alberta-based Isotechnika. The test subjects were promised $6,800 should they finish the five “confinement” stints totalling 31 days over 10 weeks, with the bulk of the payment coming at the end of the trial. Fifteen of the 20 subjects were born outside of Canada, including a man from Haiti who, according to his roommate’s account published in a report from the Bloomberg news agency, began coughing up blood on the first day of the trial. Though staff were apparently told the volunteer was coughing blood, they kept the subjects in the trial for four more days. The study was then halted and the patient eventually tested positive for tuberculosis, but some 20 people, including 11 Anapharm staff, later tested positive for latent tuberculosis.

Anapharm informed Health Canada of the single TB case within the mandated 15-day limit following the termination of the study. However, Anapharm didn’t report the subsequent spread of the disease; nothing in Health Canada’s regulations obliged the company to do so.

Then on Dec. 12, 2005, a media inquiry came in to Health Canada about the spread of tuberculosis at the trial. The request set off a flurry of notes. “Not aware of TB case,” wrote Yadvinder Bhuller, manager of Health Canada’s Office of Clinical Trials. “Do we have a record of this trial? Did we issue no objection letter? We need something definitive from HC [Health Canada] that we are aware of this trial,” wrote media relations senior advisor Jirina Vlk on the same day. “Who’s [sic] role is it to monitor this and ensure compliance? I guess this is what we need to know,” Vlk wrote. “What type of actions would we take?” Apparently starved for information, Health Canada officials asked reporter David Evans “to obtain more info” about the tuberculosis outbreak.

According to spokesperson Gary Holub, Health Canada launched an investigation into the outbreak before the media requests. However, a timeline in Health Canada’s internal documents show Health Canada scheduled its compliance verification of the Anapharm site on Dec. 21, a week after the Bloomberg article appeared. The ensuing investigation uncovered several violations at Anapharm’s testing site, including the lack of a “cleaning procedure for clinical areas where subjects are confined and for the equipment used by them,” of training “for personnel responsible for the cleaning,” as well as a lack of a proper signed record “of all personnel who were implicated in the study.” Anapharm says it has since rectified the problems, and has changed its policy on TB testing. “We do all the required testing, including for tuberculosis, when an immunosuppressant is involved,” Anapharm president and CEO Johane Boucher-Champagne told Maclean’s. “This happened in 2005. It’s an old story.”

Perhaps so. Yet apart from a Health Canada list of non-binding guidelines suggesting companies should test patients for tuberculosis, little has changed since. “Health Canada didn’t change anything. They recommend that companies should test for tuberculosis when conducting a clinical trial for a drug that suppresses the immune system,” says Martin Letendre, director of ethics and legal affairs at Ethica, a CRO. Its non-profit division, Veritas, was the independent review board that until August 2005 oversaw Anapharm’s testing protocols. (According to Health Canada regulations, contract research organizations must have an independent review board oversee their clinical trials.) “It’s a guideline, so if you aren’t doing the TB test you aren’t actually breaking the law.”

Part of the problem, Letendre says, is simple disclosure. In the U.S., the Food and Drug Administration posts the findings of its inspections on its website. Anyone, prospective volunteers included, can view the history of CROs. Health Canada doesn’t disclose its inspection findings. Anyone curious about Anapharm’s tuberculosis outbreak, for example, is out of luck. “You should call the company to get more info,” is how one Health Canada official responded when asked about the number of people infected.

“There’s not enough questions about how the sausage is made, as long as you have hot dogs at the other end,” says Martin Letendre. He frequently uses words like “broken” and “conflicted” when describing the profession in which he himself works. “There is room for someone to abuse the system and no one would know about it.”