FiDA highlight added
New federal law will expose ties to
medical device, drug companies.
WASHINGTON – The nation’s medical
device makers and drug companies will begin collecting this week what is expected
to become a massive
stockpile of data on their financial relationships with doctors,
researchers and teaching hospitals.
A new federal disclosure law mandates
that an array of pharmaceutical and medical manufacturers report payments to
physicians, hospitals and other health care businesses that are more than $100 a year.
Payments can include travel expenses, entertainment, consulting fees and
research support.
The new rules emerged after six years
of legislative and regulatory battles to address growing concerns that health companies were gaining
inappropriate influence over research, education and clinical decisions.
The provisions were eventually folded into the Affordable Care Act in 2010.
“Patients
should have the right to know if their physician is getting paid by a certain
drug company or has a financial interest in something that they are
prescribing,” said Sen. Amy Klobuchar, D-Minn., who co-sponsored the 2007 bill to require disclosures.
Executives within Minnesota’s
multibillion-dollar medical technology sector, as well as other health-related
companies, say they hope the data will dispel worries that their financial ties with doctors and
researchers lead to unethical behavior or unsafe patient outcomes.
“We need to restore public confidence
in why a company like [ours] would be interacting with doctors,” said Tom
Schumacher, vice president of ethics and compliance at Medtronic Inc.
Those ties lead to innovation and
better care, said Chris White, the general counsel for the Advanced Medical Technology
Association (AdvaMed). “The public needs to understand the value of
these relationships,” he said.
A recent case that highlighted worries
over doctor payments involved Fridley-based Medtronic, one of the world’s
largest device makers.
The
U.S. Senate Finance Committee alleged in October that Medtronic heavily
influenced the content of medical-journal reports about its spinal fusion
product, Infuse. The committee questioned whether
doctors who supervised the studies understated Infuse’s risk and overstated its
benefits while receiving
$210 million in royalties and consulting fees from Medtronic over a
15-year period.
Medtronic has denied that it
improperly influenced peer-reviewed reports or sought to minimize potential
harm.
Sen.
Chuck Grassley, an Iowa Republican who was the
principal sponsor of the original bill, said Americans need a way to assess
whether there’s an unethical relationship between a doctor advocating a product
and the company that makes it.
“[Infuse] is an example of what this
is aimed at, but it isn’t just aimed at Medtronic,” said Grassley, adding that his staff has found many other
instances.
Dr.
Eugene Carragee, a Stanford University surgeon and editor of the Spine Journal,
was among those who revealed the links between Medtronic and the Infuse
scholarship. “If your main mission is taking care of patients, you
have an obligation not to be so financially vested in the outcome of the
equipment you’re using,” Carragee said.
The
new law doesn’t outlaw payments or business deals between companies and doctors
or teaching hospitals, but it makes those transactions easily accessible to all
Americans.
Starting Thursday, drug and medical
companies must track transactions with doctors, teaching hospitals and some
other health-related businesses. The first round of data must be submitted to
federal regulators by the end of the year and will be made public by next September.
The new law comes with fines of up to $1.15 million for
companies that fail to disclose. It also requires senior managers to sign off
on the data, making them personally accountable to the Centers for Medicare
& Medicaid Services, the agency compiling the information.
The federal disclosure law is much
broader than a Minnesota one that since 1993 has banned certain gifts and
required drug companies to reveal certain payments to doctors. The federal
rules require disclosure of various forms of compensation to doctors or their
immediate family members, including consulting fees, speaking fees, gifts,
charitable contributions, royalty or license fees, stock options or other
investment incentives. This
includes payments of more than $10 or payments under $10 that together
top $100 in a year.
“Virtually every interaction with a
covered recipient has to be kept and analyzed,” said AdvaMed’s White.
Medtronic has spent more than a year
and an estimated $10 million preparing to track interactions with an estimated
60,000 physicians.
Medtronic had to integrate and make
adjustments to computer systems to make sure they capture information
consistently. In particular, it meant identifying doctors who might have done
business with different departments or company locations.
Schumacher said some doctors have told the firm
they are uncomfortable with the change, saying “it’s not worth the stigma of
having their income posted on a website.”
A greater concern may be that doctors
don’t realize those dealings with will now be tracked.
The
American Medical Association has a website devoted to the change and the AMA
president posted tips in a blog.
Schumacher believes that may not have
been enough. “I’m not sure the physician community knows this is coming,” he
said.
At Advanced Circulatory, a 25-person
company in Roseville, CEO Mike Black had to create a
system for gathering payments and other valuable transfers to doctors or their
immediate families. That includes more than software: It means making sure
salespeople get information they never had to gather before.
Black estimates that the adjustments
will cost his firm $20,000 a year to implement.
He already has heard from doctors who
don’t want to participate in his company’s symposiums because they are afraid
the free lunch might land them in a government database. Black worries that the
new law will cause doctors “to shy away from perfectly legitimate educational
opportunities” about his products, which are used to increase blood
circulation.
Black has his doubts that many
Americans will make use of this new trove of information. “I don’t believe the
average consumer is going to take the time to go look at a database for a
particular device or a
particular company,” he said.
Grassley counters that even if
individuals don’t, the media will. Concern about negative publicity will discourage doctors from giving
biased information, the senator said.
Doctors
may not like it, Carragee acknowledged, but the law should help ensure that
“research done with industry financing will have to be vetted.”
That’s
“how science is supposed to work,” Carragee added.
Jim Spencer • 202-383-6123
gemie1
Jul. 28, 13
12:27 PM
Excellent! The patient has a right to know the
relationship between a doctor and the manufactures of drugs and medical
devices. A patient or a consumer has the right to know that their doctor does
not have a conflict of interest when prescribing medical care.
3
0
explanthis
Aug. 1, 13
1:05 PM
The legislation is commendable if data is accurately compiled
and shared with patients. The resistance to transparency is understandable,
given the easy access that pharma and medical device industry operatives had to
doctors for so many years. The conflicted doctors that miss this cozy
relationship are not the doctors I wish to support with my trust and tax
dollars. Thank you, Jim Spencer and StarTribune for reporting on this important
story.
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