September 13, 2008
'Had I taken on a consultant fee with one of the companies, it was going to cloud my judgment,' said Dr. Dennis Mollman, a former Twin Cities spine surgeon who moved last month to Illinois. 'I don't care how upright you are, if you're taking significant cash ... it's going to cloud what you perceive to be the best way to treat a patient.'
Questions about payments that have emerged over the past three years have focused largely on the relationships between pharmaceutical companies and doctors. Now attention is turning toward device makers, in particular Medtronic, which dominates the fast-growing spine surgery market.
The concern is that doctors paid by Medtronic will be more likely to pursue surgery than continued medical therapy for back pain and will be inclined to use Medtronic products even if cheaper or better alternatives exist. The lawsuit — filed last year in U.S. District Court in Massachusetts — also accuses the paid doctors of overusing Infuse, a bone protein made by Medtronic
a bone protein made by Medtronic that can improve the durability of spine surgeries but also is expensive and can result in complications. John Lundquist, a Minneapolis attorney representing the eight Minnesota physicians cited in the lawsuit, said his clients opt for surgeries and select products such as Infuse when they work best for patients — not because of financial relationships.
Some legal experts say the lawsuit is unlikely to go far. The U.S. Department of Justice has declined to join as a plaintiff, even though the whistleblowers — two former Medtronic employees — filed the case on the government's behalf.
The lawsuit has nonetheless made an impact by providing one of the first public glimpses at how much Medtronic pays out. It asserts that Medtronic paid more than $800,000 in 2006 to the eight Minnesota surgeons, including $344,375 to Dr. David Polly, the chief of spine surgery at the University of Minnesota.
Overall, the lawsuit names more than 110 U.S. doctors and alleges they received more than $8 million during 2006 in "sham" consulting fees — under the pretense of conducting research or education but in reality taking money in exchange for using and promoting Medtronic products.
Physicians in the case deny the charges, which are similar to those brought against Medtronic by whistleblowers in earlier lawsuits. One such case was settled in 2006, with Medtronic agreeing to pay $40 million but admitting no wrongdoing.
Medtronic views its paid partnerships with doctors as "critical to the delivery of state-of-the-art health care in this country," said company spokeswoman Marybeth Thorsgaard. "Medtronic has rigorous processes designed to ensure that all physician compensation is fair, relative to current market values, and is fully compliant with the law."
Some of Medtronic's largest payments are royalties doctors earned as the inventors of successful devices, she said. The company also pays spinal surgeons to train colleagues in how to safely use its products.
While Thorsgaard would not discuss specific financial terms between Medtronic and its consultants, other orthopedic device manufacturers operating under a settlement with the U.S. Department of Justice are allowed to pay up to $500 per hour — and even more, in some cases — to physician consultants.
It's not uncommon, industry sources say, for a top surgeon to earn $4,000 to $8,000 for teaching one weekend-long course.
Even so, the dollar figures were startling to Dr. John Stark, a spine surgeon in private practice who served on the U of M faculty until this month. Whether or not the money truly influences doctors, Stark said, "It raises questions in an area where people need to have confidence."
Polly's base university salary is $58,000, according to state records, but that doesn't include his regular payments for treating patients — which are likely much higher.
It's unclear whether the amount in the lawsuit included royalties. Polly declined to be interviewed for this story, and his attorney wouldn't elaborate. But if the Medtronic money was entirely for consulting — at a theoretical $500 per hour — Polly would have had to work for the company nearly two hours every day of the year to earn it.
Stark said he respects Polly, but wonders whether colleagues can freely discuss their own ideas for innovations or inventions with him when "he's admittedly a representative of Medtronic and pretty much nobody else."
U.S. Sen. Charles Grassley, R-Iowa, launched a public inquiry in September 2007, asking Medtronic's Tennessee-based spine division to provide information about payments to 15 doctors, including Polly. In a letter to Medtronic chief executive Bill Hawkins, the senator questioned whether "inordinately high consulting fees, free travel and other perks distort decision-making among physicians and obscure the best interest of patients."
A final report or hearing is expected once Grassley's investigators complete their review. However, Medtronic has yet to disclose all requested information.
Grassley's solution to the conflict-of-interest issue is legislation that would require device makers and drug companies to disclose the exact amounts they pay to doctors. Minnesota is unique in already requiring drug companies to report such payments, but response has been inconsistent and the law doesn't apply to the device industry.
The dollar amounts gain headlines, but some doctors don't believe they indicate conflict.
Dr. John Sherman, of Twin Cities Orthopedics in Edina, said he has consulted for device companies when they asked him to provide a legitimate service. But some companies have waved money at him for little more than using their products, and he has declined.
Sherman said those "rotten apple" arrangements shouldn't be confused with the necessary give and take between engineers who make devices and doctors who use them. "The engineers aren't surgeons any more than I'm an engineer," he said.
The U of M declined to provide documents Polly was required to submit regarding his consulting relationships — stating they are private personnel files.
The 67-page federal lawsuit mentions other defendants briefly, but commits three pages to Polly. It claims he produced suspiciously favorable research on Infuse and aggressively marketed the product while he was a U.S. Army surgeon. Payments from Medtronic allegedly started shortly after his active service ended in November 2003.
It also makes anonymous reference to the December 2003 surgery of Beverly Hemmingson, a Grand Rapids, Minn., woman who became paralyzed after her procedure and sued Polly. She settled the case, but originally complained that Polly's high-risk surgery damaged her spinal cord and that his consulting arrangement with Medtronic affected his judgment.
Lundquist, the physicians' attorney, said Polly's "judgment has not been compromised.
"What's going to motivate Dr. Polly and I think any of my surgical clients is good outcomes," he added, "because that's what their reputation stands or falls on."
Mollman, the former U of M surgeon critical of consulting, said Polly has wrongfully emerged as the poster child of this controversy. While his former boss heavily favors Medtronic products, Mollman said, he also doesn't stand for inferior products and works with the company when it produces something subpar.
"Dave is one of the guys who has actually participated as a true consultant," Mollman said. "He really takes the consultant fee and says 'OK, it's for a job and I've got to perform a task for this.' Other surgeons that are on that list get paid consultant fees and just say 'Well, I use Medtronic stuff and that accounts for my end of it.' "
The other seven local spine surgeons in the lawsuit work for Twin Cities Spine, a nationally renowned group based at Abbott Northwestern Hospital in Minneapolis that pioneered treatments for scoliosis and other structural deformities of the spine.
The real growth industry isn't in those surgeries, but in serving the millions of Americans who develop back pain over time and are potential candidates for fusion. In Minnesota alone, 6,370 inpatient spinal fusion surgeries were performed in 2006, up 30 percent from 2001, according to the federal Healthcare Cost and Utilization Project.
Medtronic is the main beneficiary as the world's largest maker of spinal devices — from the cylindrical cages that stabilize the spine, to the bone screws and rods that straighten it out. The company gained nearly $3 billion in revenue from spine products in its most recently completed fiscal year.
In 2007, the company had a 37.2 percent share of the U.S. market for spinal fusion devices, according to Toronto-based Millennium Research Group. That's double the market share for the closest competitor, a division of New Jersey-based Johnson & Johnson.
Infuse is a big reason for Medtronic's dominance. One medical device insider said the cost of a basic Medtronic kit for spinal fusion surgeries doubles from $5,000 to $10,000 when it includes Infuse.
The federal lawsuit alleges that Polly and other Medtronic-funded doctors were lobbying their colleagues to use Infuse in ways that weren't approved by the U.S. Food and Drug Administration. The doctors allegedly promoted Infuse through off-label studies, promotional efforts at professional meetings and instruction provided at a clinic in Memphis.
At least one "off-label" use resulted in a public health warning in July. The FDA reported 38 complications during the past four years resulting from the unapproved use of Infuse in cervical spine fusions near the neck. (The FDA only approved Infuse for certain fusions of the lower spine.)
Some of those patients needed emergency care after receiving Infuse and suffering swelling in their necks and throats that made it difficult to breathe, according to the FDA.
Lundquist, the defense attorney, noted the FDA warning was preceded by warnings in medical journals about problems with this off-label use of Infuse in the cervical spine. Paid Medtronic consultants were among the doctors who wrote those early warnings.
More broadly, off-label use of medical devices and drugs is legal and common, Lundquist said. "The FDA recognizes that doctors are in the best position to determine the best medical care for their patients. Patients would rather have their medical care determined by their doctors — not by FDA regulators or commentators."
Of course, critics worry device companies are influencing patient decisions through their payments to doctors.
The financial arrangements are commanding attention at Twin Cities hospitals, which rely on doctors to recommend the best devices. Hospitals often use those recommendations to negotiate discounts with device companies in exchange for giving their products preferred status.
At the University of Minnesota Medical Center, Fairview, physicians involved in research or purchasing decisions must disclose financial relationships, said hospital spokesman Ryan Davenport. They must recuse themselves from purchasing discussions about devices in which they have an ownership or monetary interest.
Davenport said the hospital may consider requiring disclosures from all doctors on the medical staff, along with the exact dollar amounts they receive.
The lawsuit and congressional investigation were hot topics Thursday at a meeting of The Collaborative, a networking group for entrepreneurs that convened in Golden Valley to learn about emerging opportunities in the spinal implant market.
A U of M orthopedic surgeon, Dr. Marc Swiontkowski, told the group he favored public disclosure of the amounts. People are shocked by the dollars but, he said, Polly and other colleagues are good surgeons with legitimate consulting work.
"The dollar amounts should be there," he said. "Let's get it out there."
Jeremy Olson can be reached at 651-228-5583. Chris Snowbeck can be reached at 651-228-5479.
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