Healthy Skepticism Library item: 15451

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Blackwell T.
Study on cholesterol drugs raises ethical questions
Ottawa Citizen 2009 Apr 2
http://web.archive.org/web/20090417075829/http://www.ottawacitizen.com/Health/Study+cholesterol+drugs+raises+ethical+questions/1457939/story.html

Abstract:

Que. MDs offered $100 per prescription

Full text:

Quebec doctors are being offered $100 for every new patient they put on cholesterol-lowering statin drugs as part of a major, federally subsidized study that’s raising questions about the influence of the pharmaceutical industry on health research.

Critics say the OBSTAT trial seems more about drug marketing than science, getting thousands more people to take an already popular medicine.

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.

Whether they work well as primary prevention – for people who have high levels of cholesterol but don’t have heart disease yet – is more debatable, though millions of such patients are taking them.

Considered relatively safe, the drugs can nevertheless cause muscle pain – sometimes severe – and other side effects.

The researchers acknowledge that this particular 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.

OBSTAT’s stated goal 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.

It has received $1.5 million from the Canadian Institutes for Health Research (CIHR), a government agency, and $400,000 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.”

Drug studies driven by marketing are sometimes called “seeding trials,” a phenomenon believed common in the industry, but for which there has been relatively little direct evidence.

The lead researcher on OBSTAT, however, strongly denied there was any marketing motive behind the research.

Dr. Jacques LeLorier said the research is driven by the fact that many patients – about 50 per cent in Quebec – stop 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.

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.

“I knew that any study of a drug already on the market would look suspicious,” said LeLorier. “(But) I really think that I took every possible precaution.”

OBSTAT does seem to have some scientific merit, given that poor compliance with drug therapy is a well-documented problem, said Dr. Gordon Guyatt, an epidemiology professor at McMaster University in Hamilton, Ont. LeLorier himself is well-regarded and unlikely to be “hoodwinked” by drug firms, he added.

On the other hand, the study clearly has some commercial benefits for the sponsoring companies, raising questions about whether the government, with its limited health research funds, should be supporting it, he said, noting t“all sorts of investigations with no commercial aspect are underfunded.”

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 LeLorier said recruiting patients who were already taking the medicine could have skewed the results, and said researchers will prevent abuses by monitoring closely any physician who refers more than five patients to the study.