For the past five years, Coon Rapids cardiologist Dr. Jeffrey Chambers has led a nationwide study that found doctors could safely use a Minnesota-made medical device to drill out hardened calcium in clogged arteries around the heart.

A report of the study’s results published last year disclosed that Chambers was a paid consultant.

Federal data published last week reveal the extent of those payments — $296,000 in 2014 from New Brighton-based Cardiovascular Systems, Inc. It was among the highest such totals in the state.

Cardiovascular Systems says Chambers’ expertise is a vital asset for a study investigating the safety of its product, and that the amount of its payments are typical for the industry.

Critics ranging from bioethicists to consumer groups say such payments create a risk of bias in clinical studies. It’s a long-running debate in Minnesota’s health care community, and one of the key questions emerging from the federal data published last week disclosing $6.5 billion in drug and device-company payments to 600,000 doctors in 2014.

Manufacturers have a huge financial stake in the outcomes of clinical studies because positive results are crucial to getting regulatory approval to sell their products. Organizations like the Mayo Clinic and the University of Minnesota no longer allow their doctors to serve as investigators on studies if they have consulting deals with makers of the devices or drugs being tested.

“When a Mayo employee is doing consulting for a company, it is Mayo Clinic policy that is inappropriate for them to do research on the company’s products,” said Mayo radiologist and industry-relations expert Dr. Richard Ehman, describing the health system’s policy on financial relationships with industry.

Proponents argue doctors shouldn’t have to work for free to advance state-of-the-art science. And close collaboration with industry is essential to inventing new technology like the Diamondback 360 Coronary Orbital Atherectomy System that has been on the market since October 2013 and that Chambers and his trial team have studied since March 2010.

“We believe the involvement of physicians in clinical trials for new medical devices and applications is critical,” Cardiovascular Systems spokesman Jack Nielsen said in an e-mail to the Star Tribune. “As a leading interventional cardiologist, Dr. Chambers’ expertise is vital when investigating the safety and efficacy of new medical technology products.”

Nielsen noted the company has rigid rules for conducting the study involving 443 patients at 49 health care centers. The company paid Chambers for serving as principal investigator of the study, and for presenting data at scientific and federal policy meetings, as well as training other doctors to use the Diamondback 360 device.

Chambers, who works at Metropolitan Heart and Vascular Institute, didn’t return calls for comment about the payments.

Enlightening data

Federal officials sought increased public scrutiny of industry payments when they decided to publicize the data. The Affordable Care Act included a section known as the Physician Payments Sunshine Act, which mandated that the Centers for Medicare and Medicaid Services set up a payment-disclosure website that came to be known as the Open Payments program. The public can search the full database at openpaymentsdata.cms.gov/search.

The latest data, published June 30, show that companies paid doctors across the country about $369 million in consulting payments in 2014, including $10 million that went to physicians in Minnesota. The highest-earning doctors in the state often had consulting deals with multiple manufacturers, and they often had travel expenses that drove up their total payments.

The Minnesota doctor with the highest consulting payments was Dr. Jack Bert, a semiretired orthopedic surgeon in Woodbury who said he sees patients about one day a week. Bert earned $476,000 from manufacturers in 2014, including $366,000 in consulting payments and $38,000 in travel expenses and meals.

The U.S.-based division of French drugmaker Sanofi paid Bert $117,000 to travel to Australia, India and Malaysia last year to give talks to physicians that included information about the company’s knee-pain drug Synvisc. Bert also took home $31,250 a month plus expenses from orthopedic devicemaker Smith & Nephew for what he called “a proprietary business-development subject.”

Bert said he always discloses his industry ties before his lectures to doctors, and backs up his comments with evidence from published clinical studies.

“I try to stay as unbiased as I can, because I think it inappropriate if you are biased and aren’t giving factual information. I just think that’s wrong,” Bert said. “I use evidence-based material every time I talk. I have references every time I talk. I’m just not a paid speaker that is trying to push a drug.”

Bert also noted that his consulting pays far less than what most orthopedic surgeons make from their practice. Median pay for orthopedic surgeons was about $538,000 in 2014, according to industry survey data from the American Medical Group Association.

In theory, payments for consulting are governed by the fair market value of the doctor’s expertise. Nielsen said Cardiovascular Systems paid market rates to each of its physician consultants — nearly $600,000 to 24 doctors in 2014.

‘No oversight’

While public scrutiny of payments of doctors has increased, bioethicists note that industry payments are largely unregulated. Until a year ago they were essentially invisible to the public, unless the companies publicized them on a voluntary basis or as part of a negotiated legal settlement.

“There is generally no oversight over what those payments are for and what people do for them,” said Eric Campbell, a researcher at the Harvard Center for Ethics who has published critical studies about the effects of industry payments in health care.

In Minnesota, where more than 400 medical device companies employ tens of thousands of people, industry payments to doctors is a particularly high-stakes topic. The vast majority of those companies need clinical trials with positive results before the Food and Drug Administration will allow them to sell their devices. Even after approval, further studies are often launched to explore expanded uses of devices and drugs.

All told, Minnesota companies paid out more than $211 million to doctors and hospitals in payments not related to research last year, according to the federal Open Payments database.

Minnesota medical device companies Medtronic and St. Jude Medical alone accounted for $81 million in such payments.

Medtronic, which moved its headquarters to Ireland this year but continues to run the business from Fridley, landed in hot water several years ago amid an uproar over its payments to doctors who wrote studies about a Medtronic spinal-fusion product called InFuse. A Senate Finance Committee report concluded in 2012 that Medtronic officials were heavily involved in editing journal articles authored by consultants downplaying adverse events. The company has since said it is a leader in physician-payment transparency.

Bert, the Minnesota orthopedic surgeon, said the key point for doctors is to be upfront about their industry payments.

“You have to hope that those people doing consulting are as ethical as they can be and are not just promoting for the sake of promoting,” he said. “Because I think that is wrong.”

 

Computer assisted reporting editor MaryJo Webster contributed to this story.

Twitter: @_JoeCarlson