By Margaret Munro – CanWest News Service
VANCOUVER – Canadian human research subjects are an increasingly sought-after commodity in a $1-billion drug-testing industry that recruits patients by the head.
Seniors with dementia are testing pills designed to slow mental decline. Heart attack victims are signing on to test new clot-busting drugs. And a growing number of Canadians are responding to newspaper and Internet ads recruiting volunteers to try new treatments for everything from arthritis to flagging sex drive.
Testing medicines on human volunteers is an essential stage in developing new, potentially lifesaving drugs. Animal testing can only go so far and drugs must be tested on humans – and lots of them – before they can be allowed on the market.
But a four-month CanWest News Service investigation has found that research companies are pressuring Canadian doctors to enroll patients quickly into ‘trials’, engaging in questionable recruiting practices and are at times conducting ‘trials’ that are not ethically or scientifically sound.
Some companies are going through medical records provided by doctors to identify people suitable for specific ‘trials’, a practice that is considered unethical and might violate federal privacy laws.
Research ethics boards, which are supposed to protect trial volunteers, have been caught cutting corners and reprimanded for not properly warning patients of the risks involved in ‘trials’. One major Canadian university for years broke federal ethics rules and failed to warn patients of all the dangers and side- effects associated with its medical experiments and drug ‘trials’.
In some ‘trials’, doctors are little more than middlemen who sign up patients and provide the drug being tested. They then leave it to private companies to field patient queries, collect and analyze the data, and write the trial reports.
Physicians are typically paid $1,000 to $5,000 per patient enrolled in a trial, compensation seldom declared to the patients swallowing the pills. Some physicians and academics who have built careers doing research for drug companies can pull in as much as $500,000 a year.
Professor Trudo Lemmens, a lawyer at the University of Toronto, says “finders fees” for recruiting patients are now commonplace, even though they are seldom described as such. The fees are typically integrated into per-patient payments to doctors involved in ‘trials’, he says. Or they come in the form of honorariums, invitations to meetings in interesting parts of the world, and offers of more research contracts to doctors who are good recruiters.
The scientific value of some ‘trials’ is another concern. Patients and doctors are often told their participation in ‘trials’ will help lead to new knowledge. “You can make a difference by assisting medical research,” says a recent recruiting ad in Montreal. But there is no guarantee the data collected in ‘trials’ will ever be released or the studies completed.
There have been several ‘trials’ where data that might have harmed the sales of certain drugs has been suppressed. Other studies have been abruptly cancelled. A huge international trial comparing blood pressure treatments, which included more than 3,000 Canadians, was aborted last spring when the sponsoring company suddenly stopped the project. “We were very frustrated,” says Dr. Yves Lacourciere, the Quebec City-based principal investigator for the Canadian arm of the trial.
Detailed information on clinical ‘trials’ underway in Canada and the “per patient” fees paid for specific ‘trials’ is hard to come by. The deals signed between research companies, doctors, and universities are secret. But a report prepared for the federal government last year estimated between $800 million and $1 billion is spent on clinical ‘trials’ in Canada each year – making it the largest pot of medical research funding in the country.
There is a detailed list of the number of rats, mice, dogs and cats used in research in Canada each year. But no one knows for certain how many Canadians are recruited into clinical ‘trials’. One rough estimate, reached by extrapolating from U.S. numbers, suggests as many as 1,865,000 Canadians participate in clinical ‘trials’ each year.
Health Canada, federal research councils, the pharmaceutical industry, universities, medical associations, and the National Council on Ethics in Human Research all have rules about clinical ‘trials’. Those rules state that ‘trials’ must be scientifically and ethically sound; patients cannot be coerced or misled into joining ‘trials’; they must be clearly told the risks; doctors should be properly trained to run ‘trials’ and not paid excessive fees for recruiting patients.
But not nearly enough is being done to ensure the rules are followed, says Professor Michael McDonald, an ethicist at the University of B.C. He headed a Law Commission of Canada study that in 2000 pointed to major problems with the system meant to ensure protection of Canadians volunteering for ‘trials’. McDonald and many of his colleagues say the secretive industry cries out for better oversight. Canadians, they say, deserve a more proactive and transparent system of protection. “It’s a really sad situation,” says McDonald.