Healthy Skepticism Library item: 1349

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

Zuckerman G.
Biovail Is Paying Physicians Prescribing New Heart Drug
The Wall Street Journal 2003 Jul 21

Full text:

Biovail Corp., a large Canadian drug company, has been paying as much as $1,000 each to thousands of doctors in the U.S. prescribing the company’s new heart medication, according to company documents, Biovail representatives and doctors in the program.

The strategy, part of Biovail’s effort to launch a medicine called Cardizem LA, underscores how some companies aggressively market their drugs to doctors. In an unusual move, office managers who assist doctors in the program will receive as much as $150. But neither doctors nor office managers can receive the full payment unless they put 11 to 15 new patients on Cardizem LA.

And some heart specialists say the Biovail drug is no more effective than much-cheaper generic versions of a similar drug.

Providing incentives for doctors to prescribe drugs is nothing new, of course. Some drug makers have supplied services, meals and other perks to doctors, though there are indications these practices are on the wane amid criticisms from regulators and patient groups.

And $1,000 may not be much to some doctors, many of whom earn more than $200,000 annually. But Biovail’s program to compensate both doctors and office contacts is among the most generous, some doctors say.

“A thousand dollars is still a lot of money,” argues Eric Topol, chairman of cardiovascular medicine at Cleveland Clinic, one of the nation’s top heart centers. “This reeks of badness and overt marketing.”

A Biovail spokesman defends the program, saying the effort is intended to “generate physician survey data, with respect to Cardizem LA, that will be published.”

He adds that “ultimately [the program] is to market Cardizem LA, but only after we have obtained the extensive data from this study.” The program “was created after extensive discussions between Biovail,

Quintiles and Biovail’s legal and regulatory consultants. It was determined the program is within existing legal and regulatory framework,” he said.

Quintiles Transnational Corp., a Durham, N.C., company that helps run the program, said it “does not comment on the legal or regulatory compliance of pharmaceutical company-sponsored studies,” according to a spokeswoman. “That is the domain of the drug sponsor. In rendering clinical and commercial services, Quintiles complies with all applicable government regulations,” she says.

But some participating doctors dismiss the idea that Biovail could use the data for scientific papers or trials. “They can call it a study, but there’s no science with it whatsoever,” asserts George Massing, a cardiologist in Mobile, Ala., who has received $250 so far and expects to receive an additional $750 from Biovail. “It’s worthless data. It takes less than five minutes for each patient, and an extra few minutes to explain to the patient that I want you try this medicine and why.”

Biovail says the $1,000 payment isn’t excessive, because the program takes time for doctors, who usually are highly compensated, to complete.

But another doctor who expects to receive the $1,000 payment says he didn’t need to do any of the paperwork himself. “My staff did all the work, I let them keep the money,” says Joseph Guzzo in Raleigh, N.C. He didn’t address the value of the data being collected.

Some doctors receiving payments say the purpose of Biovail’s program is to market Cardizem LA. “They’re saying, ‘We’d like to get you more comfortable with our medicine and we’ll reimburse you and give your patients free samples,’ “ according to Dr. Massing, who says he has also taken time to do some reading for the program. Dr. Massing has given talks to doctors in two cities for Biovail, to explain the “ins and outs” of the Biovail program, which he says pays doctors more than any previous program he is aware of.

“We provide data on the different patient types to help physicians determine where it is appropriate to use Cardizem LA,” says the Biovail spokesman. “The data we collect will help us guide” future clinical trials. People who dismiss the data being collected “don’t know what they’re talking about,” the spokesman said.

Cardizem LA is formulated to be taken at night and reach its greatest strength in the early morning, when more heart attacks occur. As such, some doctors say it is an improvement over the company’s older drug, Cardizem CD, which has been facing a great deal of competition.

Biovail adds that Cardizem LA is longer lasting and releases its drug smoothly over the course of 24 hours, and can be used in higher doses, in comparison with generics, helping control hypertension.

But some heart specialists say the drug is no more effective than much-cheaper generic versions of Cardizem CD. (A one-month supply of 120 milligram Cardizem LA sells for $51.99 at a CVS store in West Orange, N.J., compared with $50.59 for an equivalent supply of Cardizem CD, and $34.99 for the generic version, called Cartia XT, made by Andrx Corp. in Davie, Fla.)

“There’s not any evidence there’s a difference in the prevention of heart attacks or stroke,” says Daniel Jones, dean of the School of Medicine at the University of Mississippi and a member of the board of the American Heart Association. “I tend to use the generic version.

There’s not a substantial difference, and pricing is an issue.”

According to terms of Biovail’s program, doctors are offered an “honorarium” of $250 for their time filling out a “Consultant Contract and Baseline Questionnaire” and returning it in a postage-paid envelope.

“An honorarium of $50 will also be provided to the office contact for his/her time and assistance,” according to Biovail documents being circulated to doctors around the country.

After completing the initial paperwork, doctors receive a coupon for a free 30-day prescription trial of Cardizem LA, good for 15 patients.

Doctors are told that if at least 11 of their patients redeem the trial drug prescription, the program’s “Support Team will provide a full honorarium of $750 for your time and participation. A partial honorarium will be provided for an enrollment of less than 11 patients. An honorarium of $100 will also be provided to the office contact” for assistance.

To receive more than the initial $750 payment, doctors complete a “Final Evaluation Questionnaire” and a “Patient Tracking Log” providing indications of the patient’s blood-pressure readings and some other information at three different intervals. The program isn’t open to doctors in Canada, where the drug is under regulatory review.

There is no requirement for doctors in the program to inform patients of the compensation they receive from Biovail. “I was not informed about that and I wouldn’t have inquired,” says Stephen North, a 48-year-old patient of Dr. Massing. Mr. North, an educator, says he wasn’t aware there is a cheaper, generic version of Cardizem CD, but trusts his doctor to prescribe the best medicine available.

For Biovail, the rollout of Cardizem LA has been a shot in the arm.

Cardizem CD, one of Biovail’s best-selling drugs, has been facing tough generic competition. Biovail in March introduced Cardizem LA, a move that has helped Biovail’s shares soar almost 60% this year.

The drug is expected to reach sales of about $70 million this year, 7% of Biovail’s overall sales, according to analysts. They expect the figure to hit nearly $150 million next year for the company, based in Mississauga, Ontario. Biovail has a market value of more than $6 billion.

“Cardizem LA is psychologically crucial [to Biovail]; it’s the first drug developed in-house that they’re marketing,” says Christine Charette, an analyst at BMO Nesbitt Burns Inc. “If it’s successful, it shows they can market their own drug successfully.”

Biovail has projected that 6,500 doctors will be part of the program, which a spokesman said is “winding down” after “higher-than-expected” participation.

Although patients receive an initial 30-day free trial of Cardizem LA as part of the program, some doctors say patients likely will stay with the drug, because most patients don’t like switching medications unless they aren’t working. “Usually when medicine is prescribed, patients just stay on it, and they could be on this kind of drug for decades,” says Dr. Topol.

Dr. Massing said the money didn’t encourage him to prescribe more Cardizem LA. “I didn’t force them to pay me,” Dr. Massing says. “I would have used the drug [without the payments] but if they want to pay me $1,000, that’s their choice. It won’t make me use the drug more or less.”

But others offered the chance to participate in the program have turned it down, saying they were uncomfortable with the compensation Biovail is paying.

“They said, ‘If you give it to 15 patients, you’ll get $1,000, would you do that?’ “ says Emanuel Goldberg, a New York cardiologist who recently received a phone call from a Cardizem LA salesperson. “I said no, because it’s a conflict of interest — if you’re getting money to give a drug, it’s not clear why you’re really giving the drug.”