Cleveland Clinic To Disclose Drug & Device Ties
1 CommentBy Ed Silverman // December 3rd, 2008 // 7:43 am
The prominent research center is about to publicly report business relationships between any of its 1,800 staff doctors and scientists have with drug and device makers, The New York Times reports.
The move appears to be the first such step by a major medical center to disclose such relationships and, as the Times writes quite pointedly, comes as doctors and hospitals are under mounting pressure to address potential financial conflicts of interest that can occur when they work closely with companies to develop and research new drugs and devices.
The disclosures, which will be made on the organization’s web site, are part of an effort to address conflict-of-interest issues after some of its leading docs came under fire several years ago following reports of financial links, the paper continues. The clinic’s work for drugmakers, for instance, has been used to criticize, Steve Nissen, who chairs the clinic’s cardiovascular medicine department but says any payments are given away as donations.
“They are breaking a new path here,” David Rothman, the president of the Institute on Medicine as a Profession, a nonprofit group based at Columbia University that studies potential conflicts of interest, tells the Times.
Critics argue that such relationships can taint the integrity of medical research and patient care, the Times writes, and points to the controversy involving Emory University’s Charles Nemeroff, who is being investigated by the US Senate Finance Committee for allgedly failing to disclose at least $1 million in consulting fees from drugmakers (back story).
Chuck Grassley, the ranking Republican on the committee, has introducd a bill to require drug and device makers to divulge payments made to doctors. In a statement given the Times, he praised the clinic’s move: “Patients deserve easy access to information about their doctors’ relationships with drug companies and the Cleveland Clinic is making that possible.”
Some drugmakers say they plan to starting publicly disclosing such payments next year (back story here and here). Regulators have also forced some of the major makers of orthopedic devices to publish similar info on their web sites as part of a government settlement (see here). And a few states are following the example Minnesota set in 1993, requiring companies to disclose gifts to doctors valued at more than $100 in any given year (look here and here).
The clinic tells the Times that fewer than a quarter of its doctors have anything to disclose, although the Times has a tally of relationships - of the clinic’s docs, 24 have dealings with Pfizer; 21 with Sanofi-Aventis; 20 with Merck; 19 with Novartis; 16 with Medtronic; 12 with Glaxo and 10 each with Stryker and Wyeth. All totalled, 400 docs have ties to at least one company and 250 receive at least $5,000 a year from one company.
According to Guy Chisolm III, the cell biologist who is chairman of the conflict-of-interest committee, patients should know about such links so they can talk to their doctors or others at the clinic about any financial tie that raises questions. “Patients are vulnerable,” he tells the paper.
Delos Cosgrove, a cardiothoracic surgeon who is the clinic’s ceo, takes pride in the institution’s entrepreneurial zeal and active involvement in the R&D of drugs and devices, but acknowledges the environment has changed significantly as relationships have come under scrutiny, some of which he considers excessive. “You can’t get a coffee mug from a drug company,” he complains.
His own business dealings, which were extensive when he became chief executive in 2004, have also been the subject of unflattering publicity, the Times writes. He has since severed his industry ties, including his previous oversight of the clinic’s own venture capital efforts, although he still receives royalties from five companies for his development of various heart devices, the paper adds.
As Cosgrove sees it, potential conflicts of interest need to be managed, not automatically eliminated, because working with industry encourages innovation by the clinic and its doctors. He has even made “innovation management” part of the committee’s official title: the Cleveland Clinic Innovation Management and Conflict of Interest Committee, the Times writes.
“We’re trying to be about transparency in everything we do,” he says, citing the clinic’s other efforts in publishing data on the outcomes of its care or giving patients easier access to their medical records.
Every scientist and doctor employed by the clinic must report any industry relationship to the clinic at least once a year, according to the Times. Members of the committee, which meets monthly, typically interview the doctors involved, often requiring documentation like letters to academic journals alerting editors to relationships.
The paper adds that consulting payments of more than $5,000 a year, and all royalty and equity interests, will be disclosed. Current disclosure only lists companies for whom the consulting takes place. He said the group was planning to improve the clinic’s ability to audit the information it received from doctors, because the clinic must now rely on doctors’ self-reporting to find potential conflicts.
At a recent committee meeting, 16 people - clinic board members, lawyers, doctors and scientists - discussed a handful of cases. Proceedings of the committee are confidential, but a Times reporter was allowed to attend.
One case involved a retired doctor now working full time for a drugmaker. The doctor wanted to work with his former colleagues on some research projects at the clinic and to continue serving as a mentor there. During the discussion, one board member emphasized the importance of industry collaborations, but another argued that allowing such a relationship might suggest favoritism. “There has to be equal footing with other competitors,” Joseph Scaminace, a Cleveland business executive who is on the clinic’s board, according to the paper. The committee granted the doctor no special privileges.
In another case, a doctor developing educational materials with a company was required to submit for review any materials using the clinic’s name. In yet another matter before it, the committee gave approval to a doctor who wanted to collaborate with an investment firm, on the condition that the clinic’s lawyers review the contract.
Among the most difficult potential conflicts to manage are those that involve the clinic’s own entrepreneurial activities, the Times writes. In one case, the clinic is undertaking research about a medical treatment after surgery developed by one of its own start-up companies. The committee, working with the clinic’s board, developed a management plan that barred any of the research being conducted by someone directly involved in the company. And it called for the possible review of the research findings by an independent party.
Some critics argue that the clinic applies its rules only when convenient. Last December, the clinic was sued over charges of defamation and related claims by a doctor whose contract had not been renewed because the clinic said he had not disclosed all of his industry ties. In the lawsuit, which is still pending, Dr. Sanjay Yadav, a cardiologist, cites what he describes as “widespread and pervasive conflicts of interest” at the Cleveland Clinic. The clinic declined to comment on the suit.
Ken Schields
Can we please tell it like it is?
Stop the kick-backs. Disclosure is yet another joke, insult and farce in the name of health care reform and another insult to American health care consumers. Just take a look at the web sites of the hip and knee replacement companies involved in the $300+ million dollar False Claims settlement of 2007. They now have to disclose their payments to the greedy orthopedic physicians. Disclose, not stop.
What happens now? Look at the big payments (as now disclosed on their relative web sites) in 2007 and then look at the minimal payments to date in 2008. Can’t you just visualize the rep talking to the docs at dinner while dissolving their $150 bottles of wine? ‘Hey doc, we paid you big bucks last year. We are in the cross-hairs right now because of last year’s legal issues, therefore we can’t pay you too much this year. As the exposure subsides we will slowly increase your payments over future years back to the big bucks - as long as you continue to use and promote our hardware.”
The issue for the industry, including the Pharmafia, is lay low for a while and when the spotlight dims get the payoffs back into gear!
And, please absorb the word settlement. If you don’t get the ramifications, run for Congress. By the way, the DOJ will avoid additional prosecution if the company agrees to establish “compliance programs and monitoring.” Maybe we should do the same for drug traffickers and street gangs? Oops, they already do that. Just Google the Purdue Pharma settlement.
Cynical, you say? Yes, and it’s about time we took off the gloves, got real and begin to combat the charlatans who exhibit so much control over our health care and OUR ever-increasing costs. Are you listening Mr. Daschle? Enough for now.