Tuesday, December 11, 2007

The Pots and Kettles Argue About Conflicts of Interest at the Cleveland Clinic

There is yet another twist to the tangled story of conflicts of interest at the renowned Cleveland Clinic.

Two years ago investigative reporting published in the New York Times revealed the complicated relationships among the Clinic, its current CEO Dr Toby Cosgrove, the Clinic's venture capital fund, Foundation Medical Partners, and a small medical device company called Atricure. This coincided with the Clinic's firing of Dr Eric Topol from his leadership positions there. (See posts here and here.) The Cleveland Plain Dealer uncovered more conflicts, involving Dr Cosgrove, the Clinic's board of trustees, Dr Bernadine Healy, and Invacare (see post here.)

In response, last year the Clinic promised to revise its conflicts of interest policy, and held a big conference on the topic of conflicts of interest, although some were skeptical of these efforts (see post here.)

Now for the latest twist. David Armstrong writing in the Wall Street Journal revealed that last year, the clinic fired Dr Jay Yadav allegedly for violating its conflict of interest disclosure rules. But Yadav sued the Clinic in return, claiming he was a scapegoat whose firing distracted attention from even more conflicts at the clinic:

A former department head at the Cleveland Clinic sued the hospital over alleged defamation and discrimination, saying that the institution is plagued by financial conflicts of interest similar to the kind that were cited as grounds for his dismissal.

Jay Yadav, who headed the clinic's vascular intervention unit until he was fired last year, said a number of the hospital's top doctors promote devices and treatments that they have a financial interest in, sometimes without informing patients.

The clinic, in a statement, denied the allegations in the lawsuit and said it planned to file a response as well as a 'counter claim for substantial expenses incurred to review his research.'

Getting rid of doctors over issues related to conflicts of interest is rare. Dr. Yadav says others at the clinic weren't sanctioned -- and his legal action could become an embarrassing public battle for the clinic.

Dr. Yadav had financial stakes in two companies whose experimental products were tested on clinic patients. He says the clinic was well aware of his conflicts and that he properly reported them -- but that he was fired so that the clinic could look tough ahead of a Cleveland Plain Dealer article about his outside activities.

His suit alleges the clinic has been 'indifferent' to financial conflicts of interest and that such situations are "widespread and pervasive." Those conflicts start at the top with clinic chief executive Delos 'Toby' Cosgrove, according to the complaint.

The lawsuit says the clinic heavily promotes and uses an invention of Dr. Cosgrove's in patients undergoing heart-valve surgery. Dr. Cosgrove and the clinic both receive royalties from sales of the product, known as the Cosgrove-Edwards ring and marketed by Edwards Lifesciences Corp. The lawsuit says patients aren't given the choice of using competing rings or told that the hospital and its chief executive profit from sales of the Cosgrove-Edwards ring.

The clinic confirmed Dr. Cosgrove and the hospital share royalties, but declined to answer questions about what patients are told and how much the institution and Dr. Cosgrove earn from sales of the ring. The clinic said the royalty payments were proper.

In another case, the lawsuit says orthopedic surgeon Isador Lieberman, a member of the hospital's conflict-of-interest committee, 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. The clinic said Dr. Lieberman fully cooperated with a review of his conflict disclosures and that 'all appropriate actions were taken.'

In all of the cases cited in the lawsuit, Dr. Yadav alleges there was no disciplinary action taken against those doctors. The lawsuit alleges that Dr. Yadav, who was born in India, was a victim of discrimination. The clinic, however, said it 'consistently and fairly applied its policies to all of its physicians.'

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. While he doesn't receive royalty payments, Dr. Yadav says he was compensated with shares by the company that acquired his technology. That company, called Angioguard Inc., was bought by a unit of Johnson & Johnson in 1999 [apparently Cordis].

A copy of that purchase agreement indicates that all shareholders of Angioguard were entitled to deferred payments if certain milestones were met, such as sales targets. Among the other shareholders entitled to the same deferred payments were top officials at the clinic, such as surgeon Kenneth Ouriel, according to the lawsuit.

Dr. Ouriel didn't disclose these payments, according to the lawsuit. The clinic yesterday said: 'Dr. Ouriel received a few hundreds of dollars versus tens of thousands of dollars that Dr. Yadav received. Dr. Ouriel's situation was thoroughly reviewed and he fully cooperated by taking appropriate actions to rectify the situation immediately. After the review, the Clinic officials determined that Dr. Ouriel had not knowingly violated Cleveland Clinic policies.'

A conflict here, and conflict there, soon it starts adding up.

What can one conclude from all this? First, it seems that there are lots of conflicts of interest at the Cleveland Clinic. Of course, perusal of Health Care Renewal suggests that the Clinic is therefore like many other generally revered US medical centers.

Second, it reminds us how confusing and, well conflicted conflicts of interest can become. I will not offer an opinion about the merits of Dr Yadav's lawsuit.

It does suggest that when highly conflicted high powered academics get in disputes over their respective conflicts, the result is lots of smoke and not much light. Will Angioguard, now Cordis guy win, or will the Atricure, Edwards Lifescience, and Kyphon guys win? Will the results benefit anyone other than the parties involved and the companies they represent? But core values like putting individual patients first, teaching the next generation of physicians, and practicing medicine informed by science are likely to be lost in smoke from the battle among vested economic interests.

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