Healthy Skepticism Library item: 13227

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

Schering's Zetia Promotion to Physicians Draws Inquiry From Senator Kohl
FDA Legislative Watch 2008 Mar 19
http://www.fdalegislativewatch.com/2008/03/scherings-zetia.html

Full text:

Senate Aging Committee Chairman Herb Kohl, D-Wisc. requests that Schering-Plough provide information on a recent physician-aimed marketing campaign for Zetia (ezetimibe), in a March 13 letter to the firm.

With the inquiry, Kohl turns up the heat on congressional interest in marketing practices for Zetia and Vytorin (ezetimibe/simvastatin) in light of the negative ENHANCE results). The House Energy and Commerce Committee also has sent letters to Schering and Merck on the issue.

Kohl’s letter expresses concern with “any attempts to persuade physicians to prescribe the drug for any reason other than the patient’s condition and the drug’s effectiveness in treating it.”

The committee chairman cites news reports indicating that a promotion known as “49 plan” instructs Schering-Plough sales representatives to “do whatever is necessary, within 49 days, to convince physicians to prescribe Zetia in the face of falling prescription rates for this particular drug.”

The letter seeks a written description of the plan, the number of sales representatives involved and their compensation.

Kohl also requests an explanation of how the promotion complies with industry guidelines and information on internal oversight of the plan. Kohl has not sent similar letters to other companies, a spokesperson said.

Schering-Plough said in a press statement it has a “number of ongoing sales force programs in place to help representatives correct misimpressions and mischaracterizations of Zetia and Vytorin recently presented in the media.”

The firm added that “all” of its marketing programs “are in strict compliance with [Pharmaceutical Research and Manufacturers of America] guidelines and promotional laws.”

PhRMA Task Force Targets Detailing

PhRMA has created a task force on physician detailing and other types of “interactions” with healthcare professionals to “see if we can build a much more professional relationship and one that is perceived as more professional,” PhRMA President Billy Tauzin told “The Pink Sheet.”

“In some cases the criticisms we’ve received we think are valid and we want to answer them, and in some cases it is a matter of perception – in either case that is not good,” he commented.

At the same time, “we want to make sure what we do is acceptable … that it does not destroy the very important relationships between what we do and academia, and … what physicians do and how we educate them and their patients about new medicines,” Tauzin pointed out. The task force’s agenda could include looking at the association’s current guidelines.

Kohl/Durbin “Academic Detailing” Bill

Kohl is drafting legislation with Assistant Majority Leader Dick Durbin, R-Ill., to establish a federal “academic detailing” program that would counter current marketing and detailing practices in the pharmaceutical market.

Under the bill, HHS would fund grant programs to develop and distribute educational materials to physicians on the comparative effectiveness of prescription drugs.

The two senators expect the “academic detailing” program to lower government health care costs by reducing prescriptions for newer, more costly drugs when a generic or lower-priced alternative would be equally effective. The legislation is expected to be introduced this spring.

A draft version of the bill outlines two grant programs. One, to be administered by HHS’ Agency for Healthcare Research and Quality, would underwrite the production of “independent” educational materials for doctors.

Organizations eligible for the grants include medical schools, academic medical centers, schools of pharmacy and medical societies.

The other grant program would be sponsored by CMS and involve sending trained medical professionals (pharmacists and nurses) to physicians’ offices to distribute the information.

The activities could be handled by private organizations, public entities such as states or counties, or public/private partnerships.

The detail force would target physicians or other prescribers with a large number of total patients or a large number of Medicare patients, according to the draft proposal. However, the bill would not permit use of individual prescribing patterns to identify prescribers for office visits.

The legislation would authorize funding the grants through appropriations, but the amount is not yet specified. However, Kohl emphasized that because it would reduce government spending on drugs, the program would “pay for itself.”

The committee has requested a Congressional Budget Office “score” for the program and expects to include funding levels in the final bill.

“We are not proposing that expenses be the main factor in deciding a course of treatment for a patient,” Kohl said during a March 12 Aging Committee hearing on detailing.

“But research has shown that when doctors have full access to comprehensive and unbiased data on all the drugs available, they prescribe the best drug – not just the newest one – and health care spending is lowered.”

During the hearing, Jerry Avorn, Harvard Medical School, reviewed his efforts at promoting academic detailing.

“Now that Medicare has become the nation’s single biggest payer of drug bills, it would be fiscally irresponsible not to equip doctors with the information we need to make the best choices for our patients,” Avorn asserted.

Avorn has co-authored a number of articles on academic detailing, including research showing that such a program could save $2 for every $1 it costs to operate, he noted. The cost-benefit estimate is based on a four-state randomized trial involving 400 doctors.

Pennsylvania Department of Aging Secretary Nora Dowd Eisenhower reported at the hearing on an academic detailing pilot effort being sponsored by the state’s prescription assistance program for seniors, the Pennsylvania Assistance Contract for the Elderly.

The detailing service is currently being offered in 28 of the 67 counties in the state. PACE is planning to expand the effort statewide.