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CANADA: Drug Companies Pay Doctors Big Bucks For Volunteers Margaret Munro CanWest News Service Tuesday, February 24, 2004 VANCOUVER - The Research Promoters Come Courting Dr. Kam Shojania Every Few Weeks. The busy rheumatologist was recently asked to enrol patients in a gene-therapy experiment sponsored by a U.S. biotech firm that involves injecting live, genetically engineered viruses in patients' arthritic joints. Other companies came looking for volunteers to test new drugs that promise to arrest the crippling effects of rheumatoid arthritis. Money is not a problem. The companies will pay $3,000, $4,000, $5,000 for every patient Shojania enrols -- sometimes much more. One current trial is paying $18,000 per patient. "It's very labour intensive," says Shojania, who heads clinical trials at an arthritis research centre in Vancouver. The young doctor says he turns down about half the studies he is offered. But the research promoters keep pitching more trials because Shojania has ready access to something they cannot buy: human volunteers. Pharmaceutical companies are not allowed to pay patients with disease to test or try their experimental medicines. But the companies are permitted to pay doctors to test new drugs and treatments on patients as part of clinical trials, which are a sideline for a growing number of Canadian doctors. Physicians say there are perks -- a steady flow of research money, expense-paid trips to investigator meetings, being on the leading edge -- but they insist they are not getting involved in clinical trials to get rich. The money is compensation for work done and the patients benefit most by getting early access to new medicines, says Shojania. But some people, privy to the deals doctors are signing with research companies, say the fees paid to doctors for enrolling patients in trials are often generous, and sometimes excessive. "The max I've ever seen is $2,000 for a single visit," says Dr. Muhammad Mamdani, who sits on an Toronto ethics board that reviews clinical trials and has seen a few eye-popping numbers cross his desk. So has Dr. Douglas Kinsella, retired assistant dean of medical bioethics at the University of Calgary, who now works as a consultant in Kingston, Ont. He knows of one psychiatry trial that paid doctors close to $20,000 for every patient enrolled. "The fee was excessive, as they often are," says Kinsella, who is particularly concerned with the growing number of doctors in community clinics running drug trials "like a business." "The docs basically sign the forms and collect the cheques. The research nurses do most of the work," says Kinsella. Dr. Paul Flynne, assistant registrar of the College of Physicians and Surgeons of Alberta, sees details of clinical trial contracts signed by community-based doctors in Alberta. "Money is an issue I can assure you," he says. Physicians cannot charge provincial health plans for work done for trials and are paid instead by the sponsoring companies. The fees, when broken down in the budgets Flynne sees, are often double the rate paid by provincial plans for the same procedures. A patient consultation and checkup that would earn a doctor about $150 from the provincial health plan typically pays closer to $300 when done as part of a trial, he says. Simple trials, known as Phase 4s, involve new drugs approved by Health Canada and are widely seen as marketing tools. They usually entail the doctor giving a patient a new medication and asking him or her to fill out a questionnaire or two for the sponsoring company. Doctors are paid a fee for each patient they enrol -- $10 to $300 for what often takes no more than 15 minutes, says Mamdani. But fees can be even higher, he says, citing the $2,000 payment for a single visit which his ethics board ruled excessive and didn't allow. Phase 3 trials involve drugs not yet approved for use by Health Canada and typically involve several return visits to the doctor's office. They pay $2,000 to $5,000 per patient. But the fee can climb to $10,000 or more per patient for more complex, time-consuming trials like the current arthritis project in Vancouver. "It's paying $18,000 per patient, but everything is spoken for in the budget," says Shojania. The patients have to undergo a drug infusion every six months -- a procedure that involves three nurses and a supervising doctor, he says. Then there are monthly checkups and tests over the course of the five-year study. Shojania says the profit margin on trials is typically 10 to 20 per cent -- money that he and his colleagues put towards other research projects at the arthritis centre. Many observers say it is hard to know if the interests of the patients are paramount. They say doctors and universities should be open and tell patients how much they are paid to enrol them in a study, be it $100 or $10,000. "I don't see why it should be hidden," says Flynne. Ethicist Michael McDonald at the University of British Columbia is even more emphatic. "Doctors should be absolutely clear how much they are being paid," he says. - Drug trials poorly run see page A2. Second of a Series SOURCE: The Edmonton Journal http://tinyurl.com/29l9j * * * ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn