Healthy Skepticism Library item: 17962

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

Pitts G
Prescription payment for 'research' study: Biovail drug campaign causes dilemma in U.S.
The Globe and Mail 2003 July 22

Full text:

Biovail Corp. has created an ethical dilemma for physicians in the United States by paying up to $1,000 (U.S.) to doctors who prescribed its new heart medication for their patients.

The Mississauga-based pharmaceutical company would not comment yesterday on whether it will adopt a similar marketing strategy in Canada for its Cardizem LA drug, which has yet to obtain regulatory approval in this country.

But some ethicists and experts in health law say Biovail’s approach — in which it has paid doctors to enroll patients in what it says is a research study — could theoretically be used in Canada as part of a new drug launch strategy.

On both sides of the border, there is the view that this kind of approach, which is hardly new to pharmaceutical marketing practice, severely tests the ethical fibre of medical practitioners.

“There is clearly the potential for [physicians’] conflict of interest,” said Dr. Peter Singer, a leading medical ethicist and program director of the Joint Centre for Bioethics at the University of Toronto.

Ken Howling, Biovail’s vice-president of finance, said the company has complied with all U.S. regulatory requirements in designing its program.

The controversy over Biovail’s program, spurred by reports yesterday in the U.S. financial press, has raised concerns among analysts about the company’s share price — just in advance of second-quarter results to be released on July 29.

The shares fell by $2.57 yesterday to close at $55.10 on the Toronto Stock Exchange.

As part of its Cardizem LA launch in the United States, Biovail offered to pay up to $1,000 for physicians to provide patient data, as well as as much as $150 to office managers who assist the doctors. The program, which was offered to 17,000 doctors, began in April and recently concluded.

For doctors, the payment of the full $1,000 was contingent upon putting 11 to 15 of their patients on Cardizem LA.

If they didn’t get the minimum 11 patients to renew a free 30-day trial subsciption, they would get just the basic $250.

Mr. Howling said yesterday that payment was predicated on the doctors supplying research data.

“It will help us in designing future clinical trial programs,” he said, adding that the results would eventually be published.

In the medical area, it is not unusual for drug producers to pay doctors a fee for undertaking post-marketing research — basically compensating them for time being drawn away from their often well-paying medical practices.

The issue is: What is reasonable compensation for this distraction? A number of U.S. doctors quoted in newspaper articles said $1,000 is one of the highest payouts they’ve seen for such activity. Also, the incentives to front-line office contacts have raised eyebrows.

Dr. Singer, who would not comment specifically on the Biovail program, said the primary interest of any doctor should be the patient’s health. The ethical danger comes when monetary interest overshadows this primary interest.

He said it is reasonable to reimburse doctors, according to their standard compensation, for time spent on valid research activities. “What is unreasonable is for pharmaceutical companies to turn physicians into travelling salesmen on commissions.”

He said the issue boils down to the validity of the research activity and the extent to which compensation of physicians may exceed normal standards of payment.

He pointed out that such conflicts of interest are part of life, and can’t be avoided. In that case, the minimum standard is to disclose any potential conflict. “Are physicians disclosing the nature of the monetary arrangements to patients?” Dr. Singer asked.

That’s where the Biovail program could fail the test. There is no requirement for doctors in its program to inform patients of payouts they are receiving to prescribe Cardizem LA.

The Canadian Medical Association, in its policy on physicians and the pharmaceutical industry, says it is acceptable for doctors to be paid for enrolling patients in research programs. However, “research subjects must be informed if their physician will receive a fee for enrolling them in a study.”

CMA president Dana Hanson said that is one key detail that would have to be examined if the Biovail program were to pass muster in Canada. At the same time, he acknowledged that a program could be structured in a way that the CMA could contemplate its operation.

But he asserted the CMA would insist that the focus of any post-market research be on the patient’s well-being, rather than that of the drug company or physician.

Trudo Lemmens, a professor of health law policy at University of Toronto, said he is concerned that there is an increase in drug marketing campaigns masquerading as research programs.

In general, he said, there is a woeful lack of Canadian enforcement of the rules — including those in the Medical Act — regarding “the human subjects trade” for medical research projects.

The problems will become magnified, he said, because of the alarming shortage of research subjects and the rising use of “finder’s fees” paid by drug companies in the United States.

In Biovail’s case, there are concerns that Cardizem LA is intended for continued use over time, which means that once a patient starts using it, there is a natural reluctance to quit.

Corey Davis, a financial analyst with J.P. Morgan Chase & Co. of New York, said yesterday that Biovail’s program certainly “pushes the envelope” in terms of U.S. rules regarding such payments to physicians. But, he said, it is the nature of the drug industry to push the envelope.

“This is not unique to Biovail, yet for this company, it gets blown out of proportion,” he said.

He said these controversies will continue to dog the company until it convinces the market and its critics that it has made the leap from a generic distributor to “a real drug company” that markets the results of its own research.