A scam is shaping up in Canada over a new statin trial. Doctors in the Quebec province are being offered $100 for every new patient enrolled in a federally subsidized study. Ethicists dub it marketing and not science.
Statins are among the most successful medications in history, with Lipitor — Canada's top-selling prescription drug — racking up almost $1.4 billion in national sales in 2008. There is ample evidence that, by cutting levels of blood cholesterol, they lower the risk of heart attacks and strokes in people already diagnosed with cardiovascular disease.
The stated goal of the new study is to examine why certain patients stop taking their statin, potentially putting their health in danger and squandering any support they received from public drug plans.
The researchers acknowledge that the study, which aims to recruit 4,500 patients who have never been on the pills before, might look suspicious. But they say they need to track first-time statin consumers to maintain scientific purity, and stress that the doctor payments have been approved by ethics committees and regulators.
The Canadian Institutes for Health Research (CIHR), a government agency, has contributed $1.5 million to the study, while $400,000 comes from Pfizer and Astra Zeneca, pharmaceutical giants that make the two best-selling statins — Lipitor and Crestor, respectively.
"What shocks me most about it is that CIHR contributed to it," said Jim Wright, a pharmacology professor and head of the University of British Columbia's Therapeutics Initiative, which advises the province on drug safety and efficacy.
"I'm sure it has some value to the company, but I don't see that it has any value to the public. It's a real problem, because it's an incentive for doctors to put people on statins where it may be questionable."
For their $100, doctors must write the prescription, ensure their patients have never taken the drug before, and have them fill out a consent form, which the physicians fax back. The research team contacts the patients and has them respond to questionnaires over the three years of the study.
Researchers usually ask physicians for permission to enrol existing patients in their trials, not start them anew on a drug, said Dr. Colin Rose, a Montreal cardiologist and longtime statin skeptic.
Drug-company payments to physicians should reflect the amount of work they actually perform, said Dr. Joel Lexchin, a health policy professor at Toronto's York University, who studies the industry's relationship with the medical profession.
"One hundred dollars to ask three questions seems excessive to me," he said. "Are these patients appropriate candidates for statins?"
But lead researcher Dr. Jacques LeLorier denied there was any transgression of ethical standards in the study or that it was market driven.
He said it was essential to find out why about 50 per cent in Quebec stopped their statin treatment within a year, though the drugs don't take effect until after about 18 months. That can have "disastrous" implications for the patients' health, and also wastes the money spent by government drug plans, a study summary on the CIHR website says.
As for the payments, they started at $50 per patient, but were doubled because of lack of interest from busy physicians, said LeLorier. The fees are covered by the Pfizer and Astra money, as CIHR will not pay for physician compensation, he said.
He argued that recruiting patients who were already taking the medicine could have skewed the results, and said they will prevent abuses by monitoring closely any physician who refers more than five patients to the study.
The University of Montreal professor said he received approval from medical and pharmacy regulators and professional associations, as well as ethics committees at the hospitals involved, Tom Blackwell reported for National Post.