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Conflict-of-Interest: Prescription Drugs, Medical Equipment and the Medical Profession

Editors Note: Please also see our article: Medical Ethics and Research with the Elderly

(1/30/08)- A recent incentive program by Blue Care Network, a health-maintenance organization owned by Blue Cross Blue Shield of Michigan has brought the issue of conflict-of-interest to the forefront. The company initiated a three-month program, called Blue Reward$ wherein primary care physicians were asked to consider switching their patients from a brand-name statin drug to a generic statin version of the drug.

This situation became more evident when Merck's cholesterol lowering statin drug Zocor went off patent, and became available as a generic drug. Pfizer's statin drug Lipitor is the best selling drug in the world with an estimated over $14 billion in drug sales in 2007

The physician received a payment of $100 for each of their patients who made the switch. The program ended in March 2007, but the issue raised by this program continues to reverberate through the medical ethical system.

The American Medical Association posted advice to doctors on its Web site under the heading "Kickback Questions and Answers." Its view: "Accepting payment for moving a patient from a brand name to a generic could be viewed as an anti-kickback statute violation."

Other insurers are pushing doctors to prescribe more generics by making it a factor in annual "pay-for-performance" bonuses that have become increasingly common in the medical insurance industry.

Blue Cross Blue Shield of Massachusetts gives doctors a bonus of up to $4 per patient a month, paid annually, for meeting a list of goals that includes higher generic prescription rates.

(12/17/07)- Jay Yadav, the former head of the Cleveland Clinics vascular intervention unit has sued the hospital over alleged defamation of character and discrimination. He further alleges that the institution is ripe with conflicts-of-interests similar to the kind that were cited as grounds for his dismissal.

Dr. Yadav was fired by the hospital in 2006 for not complying with the institution's conflict-of-interest policies. He filed his lawsuit in state court in Ohio, the state in which the clinic is located.

The clinic denied his allegations and said it planned to file a response as well as a "counter claim for substantial expenses incurred to review his research." The clinic instituted tougher conflict-of-interest policies in 2006, after an article in the Wall Street Journal pointed out the fact that many of the doctors in the clinic had undisclosed interests in companies that made some of the medical equipment used on them. The patients were never informed about this possible conflict.

It was also pointed out that many of the medical professionals received payments from the drug companies as well as the medical equipment companies for doing consulting work while never revealing this fact to the institute or their patients.

Dr. Yadov had financial stakes in two companies whose experimental products were tested on clinic patients. He was fired shortly before the Cleveland Plain Dealer had an article about his outside activities.

According to the complaint in this pending case the clinic has "widespread and pervasive" conflicts-of-interest, as is exemplified by the chief executive of the clinic Delos "Toby" Cosgrove. The clinic heavily promotes and uses an invention by Dr. Cosgrove's in patients undergoing heart valve surgery. The device is known as the Cosgrove-Edwards ring for which both the clinic and Dr. Delos receive substantial royalties. Edwards Lifesciences Corp markets the product.

Dr. Yadav lawsuit also cited the surgeon Isador Lieberman, a member of the hospital's conflict-of-interest committee, who failed to disclose his significant financial interests in Kyphon Inc. That company manufactures equipment for an orthopedic procedure that Dr. Lieberman advocated and tested at the clinic. Dr. Yadav, was born in India and also alleges discrimination in his lawsuit.

Dr. Yadav says the clinic accused him of not properly disclosing royalty payments for a device he invented to prevent blockages in patients who receive a neck stent. Among the other shareholders in Angioguard Inc., the company that acquired the technology from Dr.Yadav, which in turn was acquired by Johnson & Johnson are several other top officials at the hospital.

Dr. Kenneth Ouriel, a surgeon at the hospital received some small payments for the neck device but he did not reveal them to the clinic, and yet he was not terminated for that failure to report those payments.

Dr.Yadav said that he properly disclosed the deferred payments as early as 2002 in a document filed with a clinic review board. In 2003 he made a similar disclosure to the FDA. 

FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"

By Allan Rubin
updated January 30, 2008

http://www.therubins.com

To e-mail: hrubin12@nyc.rr.com or rubin@brainlink.com

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