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CANADA: Wanted: Human Guinea Pigs Testing new medicines on human volunteers is an essential step in safely bringing drugs to market. But clinical research can also threaten to undermine the sacred doctor-patient relationship MARGARET MUNRO CanWest News Service Monday, February 23, 2004 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 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," said 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 Lacourcière, the Quebec City-based principal investigator for the Canadian arm of the trial. Detailed information on clinical trials under way 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," McDonald said. First of a Series SOURCE: The Montreal Gazette http://tinyurl.com/38l8k * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn