AUSTIN, Texas — The relationship between med-tech companies and surgeons has been compromised. Just consider the news stories over the last few months highlighting numerous allegations, and judgments, involving company kickbacks to doctors.

And orthopedics companies have been leading the pack in spawning widespread negative press coverage, most recently fines of $311 million paid by major companies in this sector as a result of charges of kickbacks by the Department of Justice (Medical Device Daily, Sept. 28, 2007).

“This is sort of like the David Letterman Top 10,” said Richard Guyer, MD, president of the North American Spine Society (NASS, Burr Ridge, Illinois), referring to the growing list of reported violations. “The headlines keep on coming in, unfortunately.”

The opening symposium on Thursday at the 22nd annual meeting of NASS, entitled “Industry Relationships: How to Keep the Department of Justice from Knocking on Your Door,” was quite different from earlier offerings at the conference. Rather than providing offering cheerleading for the orthopedics sector, Guyer challenged surgeons and companies to re-evaluate their relationships and ask what constitutes practices that are, or may simply be perceived, as unethical.

To illustrate this, a five-member panel — made up of Guyer, Stanley Herring MD, Sohail Mirza, MD, Peter Winn, of Depuy Spine (Warsaw, Indiana), and prosecutor Bill Christianson — presented attendees with several scenarios and asked attendees to vote on them as legal and ethical, or not.

The scenarios revolved around a doctor receiving money from a company for every device he would use in treating patients, each additional scenario then having a bit of “window dressing.”

In one instance a start-up company is asking the doctor to invest $50,000 in it, the physician then receiving more than $100,000 on that investment with the proviso that he keeps using this company’s implants.

In another, the doctor signs a written agreement which pays him $100,000 for speaking engagements to promote the company’s device, along with allowing visiting physicians to observe him implanting the product, plus other consultation work.

“Why is [the company] paying him all that money for something that isn’t worth all that much?” Christianson asked. “In reality, it’s a wink-wink, nod-nod to promote the companies device. I think ...the red herring is, how many devices is he implanting in the patient?

“If he was using a particular device before and switched after he signed a contract with the company [for that company’s device], those are the kinds of relationships that will generate grand jury subpoenas.”

Representing DePuy’s position, Winn countered by saying that companies often do enter into agreements with surgeons in ways that are quite ethical.

“We need surgeons to advise us as to what the [device] needs,” he said. “And if we were to pay for any speaking engagements, it wouldn’t be one lump sum. We think that we have drawn up well-structured contracts and agreements with surgeons. Plus, we don’t tell surgeons that they can only use our [products].”

Christianson then turned to the broader issue of how such arrangements and company payments may be perceived, primarily by eroding trust between physician and patient, and the resultant effect in a courtroom.

“It used to be so hard to convict a doctor of any crime because the juries had so much trust in them,” Christianson said. “Juries just didn’t want to convict them.”

But he said that has changed dramatically, with more juries being less sympathetic to physicians. And juries, he said, represent public opinion.

“You are losing the jury. You are losing the trust of the American people.”

Mirza also related the issue of physician-patient trust to those providing the underlying funds for products to treat patients.

Currently 73% of research in spinal innovation is industry-funded, thus bringing surgeons in direct contact with med-tech companies, according to data compiled by Mirza.

“What we’re really talking about with these conflicts of interest is losing trust with patients,” Mirza said. “These financial conflicts of interest breach patient loyalty. We have to create distance between the research and the rewards. There needs to be some intermediary agent involved.”

“How could orthopedic surgeons go so far in unethical waters for so long?” he asked. “The recent cases involving orthopedic surgeons and their patients should really get our attention.”

Mirza also argued that even full disclosure is not sufficient protection for patients, since the tendency still tends to be following a doctor’s advice.

“Your life is in danger unless you take [this] drug,” a doctor may tell a patient, he said — and, “Oh, by the way, the company that makes this drug pays for my research.”

“Patients continue to expect loyalty even when they are told a surgeon has a conflict of interest,” Mirza said. “Patients will believe that other doctors are likely to [violate] trust but not ‘their’ doctor.”

And he said that such ethical questions and conflicts are present with a physician every day, not just aired in a court room.

As an example, he cited the common use of even smaller types of incentives from med-tech companies.

Mirza cited a survey he had taken in which about 85% of medical students said that it wasn’t appropriate for an elected official to receive a $50 certificate from a contractor. But 97% of them said it was all right for surgeons to receive a dinner from a company.

Attendees raised other questions that they saw falling into areas of grey.

One asked why it might be unethical to receive additional fees for a history of producing successful outcomes for the patient, and another noted that NBA basketball superstar Kobe Bryant is paid extra for reaching certain scoring and performance goals.

Christianson countered: “What if Kobe is being paid by someone else other than his boss, and that payment could influence him to try and alter the outcome of a game – is that wrong?”

Ultimately companies and surgeons will have to ask pointed questions of themselves in the near future as a result of the industry’s recent ethical dilemma.

Christianson recommended that to answer such questions, all parties must focus on one simple guide:

“Making money can’t be the focus,” he said. “It has to be the patient.”