It’s been five years since former U.S. Attorney Christopher Christie filed criminal charges against orthopedics’ largest device manufacturers for allegedly paying kick-backs to surgeons to use their products.
New Jersey Governor Chris Christie; Wikimedia Commons and Luigi Novi27“This industry routinely violated the anti-kickback statute by paying physicians for the purpose of exclusively using their products, ” Christie said. “Prior to our investigation, many orthopedic surgeons in this country made decisions predicated on how much money they could make—choosing which device to implant by going to the highest bidder.”
Saving the Industry
Christie later told Congress that the evidence was so egregious that had he proceeded with prosecutions, the largest device makers would have lost their Medicare credentials and the entire industry would have collapsed. By forcing companies, through deferred prosecution agreements, to pay modest fines, accept federal monitors and revamp consulting contracts with surgeons, the industry was saved.
No one challenged the then U.S. Attorney. No one was prosecuted and the supposed egregious evidence never saw the light of day. The biggest complaint we heard from surgeons was that the tens of millions of dollars paid to the Christie-approved lawyers was far more than surgeons received for doing actual consulting work which improved medical technology. But that’s another story.
Consulting Decline
As a result of the government’s intervention, consulting payments to surgeons by all of the companies went from $272 million in 2007 to $105 million in 2008. The total number of physicians receiving payments from the companies went from 1, 693 in 2007 to 628 in 2008. Current figures are hard to come by as some companies stopped reporting payments until a new federal “Sunshine” law takes effect in 2013.
“We are confident that the industry, which had been engaged in illegal kickback practices to secure market share, has made significant changes, ” said Christie’s successor after the deferred prosecutions agreements expired two years later.
Task Force Report
Where are we now? Have orthopedic surgeons and their professional societies stepped up and figured out how to police their own? What is the state of the relationship today from the orthopedic surgeon’s perspective?
We found out in a recent report released by the American Orthopaedic Association (AOA) Task Force on Orthopaedic Surgeon-Industry Relationships. The report was produced under the aegis of the Orthopaedic Institute of Medicine (OIOM).The purpose of the Task Force was to explore the critical topic of industry relations with orthopedic surgeons.
The report is the result of 22 months of study and includes 16 recommendations. The full report appeared in the July 16 edition of The Journal of Bone and Joint Surgery–American. You can read the full report here.
Surgeon Ethical Manifesto
The report explores dozens of levels of interaction between surgeons and industry from education to company reps in the OR to surgeon ownership and participation in the business of health care. The report offers unmistakable rules for proper conduct of a surgeon.
The authors of this landmark report were:
G. Paul De Rosa, M.D. (Chair)
Robert Barrack, M.D.
Jonathan Braman, M.D.
Nancy Cummings, M.D.
Edward Hanley Jr., M.D.
E. Anthony Rankin, M.D.
Surgeon-ethicist Peter Angelos, M.D., Ph.D.
Cardiologist Robert Califf, M.D.
Attorney David Hyman, JD
Pathologist David Korn, M.D.
Industry representative Stephen Peoples, VMD
Susan Roberts, Ph.D.
The report acknowledges the value of industry/surgeon relationships, but does not shy away from the potentials of abuse.
Differing Missions, Necessary Collaboration
At the core of the relationship, say the authors, surgeons and industry have very different missions. Industry’s primary mission is to expand market share and return profits to investors. The surgeons’ primary mission is to do what’s in the best interest of the patient.
E. Anthony Rankin, M.D.
Courtesy of AAOSSurgeons need industry to manufacture their innovations and industry needs surgeon input to increase market share.
According to study co-author Dr. Rankin, preserving the status quo is unacceptable and changes are needed. He said the report’s recommendations build on previous work by the American Academy of Orthopaedic Surgeons (AAOS) and emphasize that surgeons should get paid for work, not volume. He believes surgeon behavior has changed, in part, because doctors are more aware that their industry relationship is more transparent.
“We all know that self-regulation is not only desired and preferred, it is also the right thing to do, ” said Dr. Rankin in an article in AAOS Now. “I am confident that the efforts made by the AAOS, and now the AOA, in providing clarity and direction to our profession regarding appropriate physician–industry relationships will enable orthopaedists to better address this issue going forward.”
Recommendations
What does the report recommend?
Among the 16 recommendations, the report calls for the orthopedic specialty “to aspire to reduce, and eventually eliminate, industry’s financing of orthopaedic educational activities, gifts, meals, and the use of prescription drug samples.”
The following are among the recommendations from the OIOM:
Payment from industry for advice, expertise, or other services in the context of product development should be fee-for-service or hourly consulting fees based on fair market value and well-defined contractual obligations with pre-specified timelines and deliverables.
Regarding clinical studies: surgeons should only participate in research that meaningfully contributes to the professional literature, is adequately powered to clinically important endpoints, and be designed, structured, and managed to minimize bias and ensure patient safety. Analysis and reporting of research data must be independent of industry influence.
Residency, fellowship, and other training programs should receive funds from unbiased, independent, third party organizations or through central administration of the institution. Residency and fellowship training programs should stop accepting individual-focused grants from companies and require companies to submit funding through either of the aforementioned approaches.
Industry funds should not be used to develop clinical practice guidelines. When forming guideline committees, individual and composite numbers of financial ties to industry should be evaluated and minimized to avoid actual or perceived industry influence on the resultant guidelines.
History of Collaboration
The report also provides a detailed history of the relationship between surgeons and industry.
Companies rely heavily on surgeons to assist them as they develop new devices and implants. In fact, surgeons have proven to be critical in literally every stage of product design and development and that active involvement is, said the report, unique to the surgical fields of medicine.
Professor Sir John Charnley
Courtesy of johncharleytrust.orgThis model, notes the report, has created a steady stream of new innovation none more dramatic than the development of the total hip replacement by Professor Sir John Charnley in 1962, which revolutionized the field of orthopedic surgery. The biomedical device industry, with annual revenues of nearly $30 billion, has flourished from this collaboration.
The collaborative relationship between industry and surgeons is a necessary and mutually beneficial relationship. However, states the report, there is also the opportunity for conflict of interest to “erode beneficence and the integrity of the patient-physician relationship.”
Rise of Implantation
In recent decades, the practice of orthopedic surgery has evolved into one that relies heavily on device implantation to improve quality of life for patients with severe musculoskeletal disease. Prior to 1970, says the report, most orthopedic interventions consisted of non-operative treatment and surgical procedures that did not involve total joint replacement devices. “In the ensuing decades, numerous technologic breakthroughs resulted in the development of hip and knee implants that have dramatically improved the quality of life for millions of patients. Total hip replacement has been termed the “Operation of the Century.”
Essentially the vast majority of musculoskeletal technology breakthroughs were developed by surgeons. The report notes, for example, that modern fracture fixation devices were largely developed by a group of Swiss surgeons with contributions from German and Russian surgeons.
“Industry was enlisted in these efforts primarily to manufacture and distribute the devices, but the vision that led to these breakthroughs that have advanced the discipline to its current state, came largely from innovative surgeons who sought to improve the quality of care for patients.”
Marketing to Colleagues Versus Patient Quality of Care
As the practice of orthopedics has evolved from a largely non-interventional practice to a surgical one, the siren song of sales and marketing has begun to compete with patient quality of care considerations among some surgeons and in some practices.
According to the report, “More recently, the surgeon-industry relationship has evolved from the past model. In many cases, this relationship appears to prioritize influence over surgeon decision-making rather than improving the quality of devices in the marketplace.”
Dr. Rankin, who previously chaired the AAOS Conflict of Interest Project Team, which developed recommendations that led to the establishment of the AAOS Disclosure Database, concluded: “This document from the OIOM puts forth recommendations and considerations designed to protect the core values of orthopedic surgery as a discipline and to reaffirm and strengthen professionalism and integrity among orthopedic surgeons.”
The OIOM Task Force said further that conflict of interest does exist in the discipline of orthopedic surgery and while the impact of those conflicts of interest on patient care is uncertain, it is clear that “industry has grown to expect some orthopedic surgeons to facilitate their marketing objectives in exchange for monetary payments, income-earning opportunities, gifts, privileges, and prestige.”
“Relationships with industry are necessary, valuable and productive when ethical, transparent, and managed appropriately with recognition of and respect for the very different values and missions of the profession and the industry.”
Will surgeons live by these recommendations? Who knows, but as the report warns, “Failure to regulate ourselves will inevitably lead to increasingly more intrusive external regulation.”
Orthopaedic Institute of Medicine Surgeon-Industry Relationships in Orthopaedic Surgery
Recommendations (Condensed)
Understand the distinction between industry relationships that are gratuitous, self-indulging, and potentially corrupting, and those that improve the care of patients.
Refrain from establishing the former classes of vendor relationships.
Payment for consulting with industry should be fee-for-service or hourly consulting fees.
Recuse from decision-making when involved in institutional purchasing decisions.
Don’t profit from patients if involved in product development activities, in which genuine IP [intellectual property] is transferred and royalties are paid.
Avoid investigator-initiated grants for “weak” research projects.
Only participate in research that meaningfully contributes to the professional literature, are adequately powered, have a study design, operational structure, and oversight mechanism to minimize bias.
Avoid participation in speaker’s bureaus.
The use of ghostwriters is always unacceptable.
Developing a standardized core curriculum for inculcating professionalism and ethics in GME [Graduate Medical Education] programs.
Industry relationships with universities must be premised on the charitable and educational uses to which a university may put a tax-subsidized industry gift, not to a product endorsement.
Industry funds for residency, fellowship, and other training programs should be distributed through unbiased, independent, third party organizations.
Reliance on prescription drug samples should be eliminated.
Encourage industry to support research in multi-center networks to improve transparency and objectivity.
Industry funds should not be used to develop clinical practice guidelines.
Societies should measure and report the percentage of industry support received for their operating budgets.
