A Medical Device Daily

It's not enough to admit you have financial ties to a company, you have to disclose the dollar amounts as well. That's what the North American Spine Society (NASS; Burr Ridge, Illinois), a medical society representing U.S. spine surgeons, is telling its members and others through its recently revised disclosure policy.

The organization says the new policy – which goes "several steps further" than the original policy adopted in 2006 – applies to both members and nonmembers participating in NASS activities.

The new policy was adopted by the NASS board of directors at its Toronto annual meeting in October, but the organization just announced the changes last week.

The policy requires participants to disclose actual dollar amounts of all relationships held in the 12 months preceding disclosure. According to the NASS ethics committee, which authored the new policy, "the goal is to create an environment of scientific validity, in which learners can trust the information they receive is objective and unbiased, and to be sure that our members are current and forthright in their dealings with one another and with their colleagues and patients."

The organization, which has more than 5,000 members, warns that failure to abide by the new policy may result in one- or two-year suspension of membership, membership expulsion, public letters of censure, and/or barring the member from presenting at a specified number of future meetings.

According to Marjorie Eskay-Auerbach, MD, the current chair of the NASS ethics committee, NASS strives to "raise the bar for ethics and professionalism, not only within NASS but in the entire field of spine care . . . to that end, our policies are constantly being reviewed and strengthened."

NASS says the new policy comes on the heels of a recently completed retooling of the society's board, committee and staff structure. Part of this restructuring included a rewrite of the NASS mission, which now includes ethics as a pillar of the society's mission: "NASS is a multidisciplinary medical organization dedicated to fostering the highest quality, evidence-based, and ethical spine care by promoting education, research, and advocacy."

The revised policy also includes non-financial conflicts of interest such as unpaid faculty positions at educational events directly supported by industry, unpaid service on a company's scientific advisory board, and private investments in venture capital firms and start-ups that have no current value but hold the potential for future return on investment.

Kate Scannell, MD, a physician and a syndicated columnist, wrote in a recent column that the organization's new policy is important because "a medical society has officially acknowledged the significance of money in the conduct of medical research."

According to Scannell, the new NASS disclosure policy will give patients "a more transparent view of what drives their health care costs and determines the price tags on their medical devices." As an example, she cites a recent Wall Street Journal report that Medtronic (Minneapolis) paid more than $19 million over a five-year period to a spine surgeon in Wisconsin to develop and promote its products.

In 2007 U.S. Sen. Charles Grassley (R-Iowa) sent a letter to Medtronic concerning its payments to orthopedic physicians using spinal repair products made by the company's Sofamor Danek (Memphis, Tennessee) unit. At that time, the payments apparently had reached $6 million (Medical Device Daily, Sept. 28, 2006), even after Medtronic agreed to pay the government $40 million in 2006 to settle charges in federal court that it paid kickbacks to doctors. The company paid that fine but denied any wrongdoing (MDD, Aug. 2, 2006).

Also in 2007, a group of orthopedic device makers were investigated by federal authorities in connection with allegations of improper payments to doctors (MDD, Sept. 28, 2007). Stryker (Kalamazoo, Michigan), Smith & Nephew (London), and Zimmer Holdings (Warsaw, Indiana), DePuy Orthopaedics (Raynham, Massachusetts), and Biomet (also Warsaw) were all involved, but Stryker avoided fines while the other four companies agreed to pay about $311 million total and consented to federal monitoring and other reforms.

The NASS board also said it has appointed a non-member, academic ethicist David Rothman, PhD, to the board. Rothman will serve on the board for a three-year term, which started in January.

"The issues of best practices in the governance of professional medical societies is now of central concern to medical leaders, the media, and public officials," Rothman said. "NASS is in a position to set national standards in this domain and I am eager to do all that I can to move this process forward."

Rothman is president of the Institute on Medicine as a Profession (New York) and Bernard Schoenberg Professor of Social Medicine at Columbia University's (also New York) College of Physicians & Surgeons.

Additionally, the NASS board approved a new policy on conflict of interest in leadership positions, which governs the relationship that any committee or board member serving in each specific volunteer role may have with industry.

The policy establishes three levels of divestment from industry relationships, with the most stringent divestment occurring within the presidential line, and including the chairs of certain highly influential committees, the NASS said. According to the organization, relationships at this level are "severely restricted" and are examined in detail by the vetting committee, with consideration of the exact nature of remuneration (including dollar amounts for financial arrangements) and services provided.

If a potential candidate for a leadership position has an industry relationship deemed unacceptable for the desired leadership level, the individual will be given the opportunity to divest from that relationship before assuming a new position, NASS said.

The organization has even established a conflict of interest review board to serve as a consulting entity for NASS members seeking advice on how to disclose, and even help determine appropriate relationships between NASS leaders and outside organizations. That board was approved in May, the organization noted.

NASS says it began taking an aggressive role in ensuring its members are informed of their ethical obligations, the definition and pitfalls of conflicts of interest, and the need for full disclosure in November 2001 with Stanley Herring's NASS presidency.

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