CANADA: Drug Companies Pay Doctors Big Bucks For Volunteers

[Murray Charters <mcharters@xxxxxxxxxxxxxx>]

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


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