Researchers' advice stirs issue of conflict

Dr. David Van Wyck , a respected researcher and kidney disease specialist, seemed a natural choice to lead a National Kidney Foundation panel charged with updating physician guidelines for treating anemia in kidney patients.

But at the same time the University of Arizona College of Medicine professor was co chairing the panel while it considered the guidelines during 2004 and 2005, he also worked as a paid consultant to Gambro Healthcare , which profited from the use of anti anemia drugs. After more liberal prescribing guidelines for the drugs were finalized this year, Van Wyck became a paid consultant to DaVita Inc., which bought Gambro in 2005 and is the nation's second-largest dialysis chain, profiting from the use of the drugs in more than 1,200 clinics.

During that time Van Wyck also was a consultant and speaker for Amgen Inc., manufacturer of the anti anemia drug Epogen. Amgen supported the panel's review with hundreds of thousands of dollars in payments to the National Kidney Foundation.

Van Wyck's conflicts of interest -- and those of some of the other 17 medical specialists who served on the panel -- illustrate a broader debate in the medical community. Critics say that through payments to doctors and researchers like Van Wyck, businesses indirectly influence panels devising clinical guidelines for treatment, ethics review boards that monitor clinical trials, and medical-journal articles detailing trial results. Others say barring clinicians with industry ties from participating in medical reviews would mean excluding the nation's top researchers.

Dialysis patients are usually anemic, meaning their bodies do not produce enough red blood cells, and are routinely prescribed anti anemia drugs to boost red blood cell counts. Generally, achieving higher blood cell counts requires larger doses. The FDA recommends that blood cell counts should be boosted no higher than 12 grams per deciliter. But for the first time, the kidney foundation has removed the 12-gram limit from its own guidelines, which now say only that there is insufficient evidence to support exceeding 13 grams.

A New England Journal of Medicine article last month questioned the foundation's revamped guidelines. It said the FDA recommendation for red blood cell count limits should be heeded to avoid an increased risk of fatal heart attacks and strokes.

And on Wednesday, a Medicare reimbursement policy put in place in April to permit more aggressive anemia treatment in dialysis patients was criticized during a US House Ways and Means Committee hearing. Committee members said the policy wasted money and could jeopardize patient health.

Critics say the National Kidney Foundation's work was tainted by its connection to Amgen and other corporations that have ties to doctors on the panel. An analysis published last month in the British medical journal The Lancet said that of the 18 members on the panel Van Wyck co chaired, two-thirds disclosed financial ties to Amgen, Johnson & Johnson, or other manufacturers or marketers of anti anemia drugs.

"Their conflicts of interest open them to questioning their motives," said Daniel W. Coyne , a professor at Washington University in St. Louis and author of another academic article critical of the National Kidney Foundation's guideline process , who added that he doesn't believe the panel deliberately favored companies.

Amgen and DaVita said they did not interfere with the panel. The kidney foundation requires doctors serving on its panels to publicly disclose industry ties, and Van Wyck said his consulting arrangements with Gambro, DaVita, and Amgen didn't play a part in his role as co chairman. "The cost of doing the wrong thing for patients is so much greater than the cost of making a decision that might adversely affect financial outcomes for a corporation, that it is just not an issue," he said.

Van Wyck said he was paid about $8,000 to $10,000 annually by Gambro and is now a part-time hourly employee of DaVita, where he leads a medical advisory board and has helped develop Epogen dosing protocols for the company's clinics. He said he received "either nothing or just about nothing" from Amgen in 2004 and 2005. And though he sometimes gave talks before medical continuing education classes as a member of Amgen's speakers bureau, the payments -- typically about $2,000 for an engagement -- were made by the sponsoring medical center or university, he said.

The National Kidney Foundation said it received $600,000 from Amgen over two years to underwrite research and development of the anemia treatment guidelines. The Thousand Oaks , Calif., company has been the sole or primary sponsor of anti anemia guidelines since the standards were established in 1997.

Financial support "is handled completely separately from, and has no bearing or influence on, the deliberations of the work group," said foundation spokeswoman Ellie Schlam, in an e-mail.

The guidelines were based on extensive reviews of clinical trials and analyses published in medical literature. For the 2004-2005 panel's update, a detailed study was conducted by researchers at Tufts-New England Medical Center , and then interpreted by the panel.

Van Wyck said the panel did not consider the results of the clinical trial published last month in the New England Journal of Medicine because it had access only to the trial's preliminary results. The study found that exceeding FDA limits on boosting red blood cell counts increases the risk of fatal heart attacks and strokes.

Now that the full results have been published, the National Kidney Foundation says it will reconvene the anemia-management panel early next year to review it and other newly published anemia studies. Van Wyck said he plans to serve again as co chair.

He said prominent specialists in kidney disease and anemia treatment often have connections to the drug and dialysis industries because their work requires that they collaborate with manufacturers and clinics. If they were not allowed to serve on medical advisory panels, he said, "then you would end up with people on the work group who had never designed a trial, who had never participated in a trial, who had never been on a safety monitoring committee. You would lack expertise in anemia management."

But some say disclosure of panel members' ties to the dialysis and anemia-drug industries is not enough to ensure their work will be immune to bias.

"I think it's highly suspect when you have guidelines that are produced by people that have severe conflicts of interest," said Jerome Kassirer , a former editor of the New England Journal of Medicine who has written on conflicts of interest in medicine.

"These are people who really want to do a good job for patients, but the financial inducement is strong," he said.

Christopher Rowland can be reached at crowland@globe.com.