Dr. Kenneth Burkus is quite confident his eight-year relationship as a paid consultant for Fridley-based medical device maker Medtronic Inc. hasn't compromised his patients' care.
In fact, amid the growing chorus of questions about the practice from government investigators and some of his own colleagues in spine surgery, Burkus poses this question: "If you needed a [neck] disc replacement, would you want to go to one of the guys down the street or to the person who helped develop it?"
The Columbus, Ga., surgeon said he receives royalties for helping to develop the company's artificial neck disc and other products. A whistle-blower lawsuit filed in Massachusetts federal court alleges that he was paid $416,775 for consulting work in 2006.
Such lawsuits, and probes by Congress and the Justice Department, have fueled confusion among doctors about just how far they can ethically and legally go in working with the device industry.
Some doctors and lawmakers say the cure for that confusion and the key to curbing any questionable payments is public disclosure of the compensation -- on a government website for all to see.
A bill introduced last year in Congress, called the Physician Payments Sunshine Act, would require drug and device makers to reveal the amount of money they give doctors in payments such as gifts, honoraria and travel on such a website.
The manner in which surgeons are paid is "very carefully constructed,'' said John Lundquist, a Minneapolis lawyer who represents 82 surgeons in the Massachusetts lawsuit. Consultants are paid an hourly fee that represents their fair-market value, he said.
"We do not apologize for the fact that we pay physicians to provide training on our products," said Marybeth Thorsgaard, Medtronic spokesperson. "That training is essential to the well-being of patients. Physicians are busy people whose schedules are packed with appointments. Often, the only opportunity they have for training is on a weekend or at night, and we think that it is appropriate to pay presenters for their time during those non-working hours."
But congressional investigators say competitive pressures in the $7.5 billion spine device business make it a natural habitat for questionable consulting arrangements because so much money is being made. Although hospitals pay for the devices, surgeons' personal preferences guide the brand used.
"If these physicians are essentially putting their medical judgment up for sale, where does the patient's well-being fit into the equation?'' asks Sen. Chuck Grassley, R-Iowa, sponsor of the bill and ranking member of the Senate Finance Committee.
With Congress freshly back in session, the bill is awaiting action in his committee.
Do patients really care?
While many lawmakers are convinced that patients are curious about the payments, there are doctors who maintain the opposite. Patients, they say, don't care.
Count Ron Troyer among them. Three years ago, he had just about lost his will to live.
The retired funeral director from Hudson, Wis., had battled chronic back pain most of his adult life. By the summer of 2005, his mind "muddled with narcotics," Troyer, 62, heard about a new pain treatment using an implanted pacemaker-like device that zaps the spinal cord with tiny electrical impulses.
"I was ready to try anything, I was so desperate," he said.
Like many patients with searing chronic pain, Troyer placed his complete faith in his doctor. Whether his doctor was paid consulting fees by the maker of the medical device implanted in his body was "of no consequence,'' he said.
"If he got a million dollars, I could have cared less,'' said Troyer. "What he did for my quality of life was just tremendous.''
As it turned out, the neurostimulator made by a division of Little Canada-based St. Jude Medical Inc. relieved nearly all of Troyer's pain.
"I've never had a patient who has had an issue with it,'' said Dr. Lawrence Lenke, a professor of orthopedics and neurosurgery at Washington University in St. Louis. Lenke, a Medtronic consultant for eight years, is among those referred to in Grassley's investigation of the spine industry. The Massachusetts whistle-blower lawsuit alleges that Lenke was paid $175,000 by Medtronic in 2006 in grants and fellowships.
Lenke and Burkus said they disclose their relationship with Medtronic to their patients. None of the patients ever seemed surprised or offended, the doctors said.
Can doctors self-police?
In Chicago's cavernous McCormick Place convention center, more than 200 companies filled 800 booths, touting their products to the crowd.
Dr. Charles Burton, a St. Paul neurosurgeon and spine specialist, remembers surveying the glittering scene at the annual meeting of the American Association of Neurological Surgeons with dismay. It had the aura, he recalled, of a consumer electronics show.
Despite the high-profile lawsuits and ongoing government investigations, there was little discussion about the growing controversy over the consulting fees medical device companies pay surgeons, Burton said. As the vice president of the Association for Ethics in Spine Surgery, he thinks the time has come for his profession to elevate the debate over the practice.
There is no shortage of professional codes of ethics theoretically governing financial relationships between doctors and medical device companies. The medical technology trade group AdvaMed has one and Thorsgaard said Medtronic was instrumental in developing it. Medical schools, including the University of Minnesota, have agreements about outside conflicts of interest. The big medical societies also have codes of ethics. Many device companies have their own codes of ethics on marketing practices.
"Medtronic has a robust compliance program designed to assure that our arrangements with physicians fully comply with those principles and the law," Thorsgaard added. An employee can be terminated for violating the standards, according to the code.
The codes largely rely on voluntary enforcement -- and some think that's enough to do the job. The North American Spine Society, for example, counts on spine surgeons to report peers for unethical behavior. Ultimately, the offender may be kicked out of the society, reported to a national database that tracks disciplinary actions against doctors, and have his or her name publicly outed in the society's newsletter.
"It has some teeth," said Dr. Stanley Herring, a spine surgeon at the University of Washington and past president of the spine society. "Doctors don't like to be shamed." He thinks a key component of any code of conduct is disclosure.
But the founder of the two-year-old Association for Ethics in Spine Surgery said those codes don't go far enough to eliminate the insidious pull money has on spine surgeons.
Dr. Charles Rosen, a spine surgeon at the University of California-Irvine and the grassroots society's founder, said the group now has about 250 members. All, he added, have signed an affidavit declaring that they will not accept consulting fees, royalties, or other compensation from any company whose products they use.
Rosen said he has paid a price for his advocacy. After he criticized the safety record of the first artificial lumbar disc approved by the Food and Drug Administration, Rosen said, his critics personally attacked him and attempted to have him fired.
Undeterred, he recently formed a second group called the Association for Medical Ethics, in which doctors from all specialties agree to forgo payments from the medical device and drug industries.
Burton was an early member of the spine ethics group. He hopes all the attention on the spine industry will bring about a "return to an understanding of what doing the right thing for the patient is really all about."
The case for disclosure
The federal legislation to force disclosure by medical device companies and others is modeled in part on a 1993 Minnesota law requiring pharmaceutical companies to reveal what they pay doctors. But the Minnesota law does not cover the state's signature medical device industry.
Other states, including Vermont, West Virginia and Maine, and the District of Columbia have similar laws also focusing solely on the drug industry.
Minnesota Sen. Amy Klobuchar, a Democratic co-sponsor of the Sunshine bill, said disclosure on both drugs and devices will help ensure the integrity of the health care system.
Klobuchar said consulting relationships can work. "In many cases it's a good thing, they should be doing it, it's part of the work of developing drugs and devices. But the more transparency you have, the more bad actors will be sloughed off.''
At least one state has not waited for Congress to act. In August, Massachusetts adopted a law requiring all medical device and drug companies doing business there to abide by a strict marketing code of conduct, the first state disclosure law to include devices.
Some gifts, such as sports tickets and free travel, are banned under the Massachusetts law. It also requires that drug and medical device firms publicly disclose gifts worth more than $50. If violated, the law carries a $5,000 penalty.
Christopher White, general counsel for AdvaMed, called the piecemeal nature of state disclosure laws "troubling." "There's clearly confusion created when you have multiple reporting systems,'' White said. His group prefers the uniformity of a federal standard. Medtronic supports Grassley's Sunshine Act, Thorsgaard said.
Dr. Jerome Kassirer, a professor at the Tufts University School of Medicine, has written a book titled "On the Take," about how money paid to doctors influences patient care. He said the legislation requiring disclosure might force doctors to do a little soul-searching and re-assess their relationships with device companies, especially if there's a looming prospect that patients might ask about it.
"The first thing to do is expose people getting outlandish fees. At the very least, that disclosure is embarrassing to some people. That's good. Identifying people who were way off the scale of getting money requires them to say what they did for that money," Kassirer said.
Janet Moore • 612-673-7752