Doctors pressure human guinea pigs

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Doctors pressure human guinea pigs

MDs are paid up to $5,000 per patient to sign up volunteers for drug trials

Margaret MunroCanWest News Services

Monday, February 23, 2004

 

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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 enrol 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 analyse 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 may not 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.

 

TUESDAY: Paying for patients: When the research promoters pitch trials, doctors

stand to make big money.

 

© The Vancouver Sun 2004

 

 

 

 

 

 

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