To: Jean Chretien; Pierre Pettigrew
Cc: Member Pariiament
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
Promoting openness and full disclosure
http://www.ahrp.org
FYI
An investigation by CanWest News Service (Canada) reveals 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. "
Canadians are finding out that behind those advertisements seeking human
subjects to test drugs is a booming $1-billion industry that has effectively
undermined the physician-patient relationship. Once upon a time, people had
reason to trust their physicians, expecting that patient confidentiality
was sacrosanct and that doctors would recommend only those treatments they
thought would be beneficial to their patient. Not anymore. CanWest reports:
"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."
Physicians have become medical entrepreneurs who exploit their access to
patients for financial gain. Doctors are getting "finders fees" of $1,000
to $5,000 for every subject they sign up for a clinical trial. "In some
trials, doctors are little more than middlemen who sign up patients and
provide the drug being tested."
It would appear that Canadian medicine is descending to the US level.
In the process the healing profession is being transformed into licensed
profiteers.
In the process, the integrity of medicine, trust in the physician-patient
contract, and the dignity of individual patients are all being undermined
for cash.
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: veracare@ahrp.org
http://www.canada.com/vancouver/vancouversun/news/story.html?id=5703c310-428
c-4b04-b731-36ecb835bb07
Vancouver Sun, February 23,2004
Doctors pressure human guinea pigs
MDs are paid up to $5,000 per patient to sign up volunteers for drug trials
Margaret Munro
CanWest News Services
Monday, February 23, 2004
CREDIT: The Calgary Herald
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.
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