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.
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