Do Sunshine Act Disclosures Hurt Ortho Innovation? // “Holy Grail” of Registries Ramping Up // and More!

CMS’s Sunshine Act Disclosures Put Innovation at Risk

With the brouhaha in full swing over the Sunshine Act, several orthopedic surgeons are hoping to set the record straight. Brian Cole, M.D. is Professor in the Departments of Orthopaedic Surgery and Anatomy & Cell Biology at Rush University Medical Center. He told OTW, “The benefits of the Sunshine Act are that we have greater transparency related to relationships that physicians have with industry. Notably, disclosure is not synonymous with conflict. For example, licensing and royalty agreements have specific language eliminating the potential for a surgeon to have direct financial gain from implants used by the developing surgeon or when used at institutions where he operates and where colleagues may use those same implants or devices. Thus, surgeons choose implants and devices that maximally benefit their patients independent of any financial relationship.”

“Surgeons are in the best position to identify knowledge and procedural gaps, to innovate and to perform basic and clinical research related to the development of new implants and devices. Finally, consulting rates are generally far below market value or physician opportunity cost essentially leading to a physician-consultant underwriting the process on behalf of industry.” When asked why would a physician take time away from his family and practice to consult for below-market-rates, Dr. Cole indicated, “Those of us interested in furthering our field and improving patient outcomes do so in part because of the intangibles associated with the process. These activities provide a balance to our day-to-day clinical practice.”

Neal S. ElAttrache, M.D. is a sports medicine specialist with the Kerlan-Jobe Orthopaedic Clinic in Los Angeles, California. Dr. ElAttrache, the team physician for the LA Dodgers, tells OTW, “I don’t know if it’s by design, or misunderstanding, but the manner in which the government is presenting this data is difficult for the public to understand and has the possible result of damaging the public trust in the medical community. There seems to be an implication and a general air of impropriety on the part of physicians and the medical industry surrounding the government’s presentation of this data. In many cases, the media has sensationalized this data.”

“The data, especially that posted under the category of ‘General Non-research Related Payments, ’ is especially misleading if presented without context as it currently is. For example, I am not paid to USE any products on patients. I hold U.S. patents on some very popular implant technologies and products which have been assigned to Arthrex Corporation, a quality company with which I am proud to work. I am also proud of the success of these implants in helping surgeons treat thousands of patients every year. I am compensated on that assignment of rights to my patents, however, I have no financial incentive to use my products. The royalty calculation absolutely excludes the use of these implants on my patients or patients operated upon at a facility where I am on staff.”

“Innovation is as important to the advancement of medicine as it is in any other endeavor. The participation of physician-scientists and innovators in this process is beneficial, if not crucial, to the development and advancement of medical technologies that help millions of people around the world. Companies such as Arthrex make it possible for surgeons to work with their engineers to develop and perfect their ideas resulting in more rapid advancement of new surgical techniques. It is normally far too costly and time consuming for a physician to develop, produce and distribute innovative medical and surgical products independently. Therefore, the relationship between the medical community and the device manufacturers is critical to innovation.”

“I truly believe that there is great societal benefit to transparency with regard to potential conflicts of interest with regard to physician relationships to industry, just as there would be regarding such conflicts in relationships between politicians and businesses that sell to the public or tax payers. I would only hope that the data provided to the public for this transparency, is given with informative context. This would then strengthen the public trust in the medical community and raise appreciation appropriately for medical innovators.”

Stephen S. Burkhart, M.D. is an orthopedic surgeon with the San Antonio Orthopaedic Group. His recent cameo in the press was less than pleasant. Dr. Burkhart told OTW, “A recent Wall Street Journal article listed a number of surgeons who have received top payments for consulting fees and royalties, and my name was at the top of the list. The gist of the articles was, ‘Why are they paid so much?’ and ‘Are these doctors getting paid to implant their inventions in their patients or in their partners’ patients?’ So the people reading this did so without truly understanding how the process works.”

“I have consulting and royalty contracts with Arthrex, and the royalty agreement language indicates that I will not be paid any royalties for products that I have invented when they are used in my patients, or in my partners’ patients, or even in a facility where I have privileges. I have assigned the intellectual property rights from my patents to the company; probably 95% of the items that I get royalties on are patented products. I have 28 U.S. patents on which approximately 350 Arthrex products are based. We have agreed on royalty percentages for each product, and the total royalty payment is based upon worldwide sales.”

“The innuendo in the press is that there is a dark side to the doctor that makes him or her do things to line their pockets. But the fact is that there is a subset of orthopedic surgeons who are inventors and they are in the best position to identify and fill a need in the market, specifically medical devices that improve patient care. And when you think about it, these inventions reduce costs to the system and reduce morbidity. For example, when rotator cuff surgeries were done through open incisions there was an infection rate of approximately 2%; now that they are done arthroscopically the infection rate is .01%. That means that the technology and medical devices that enable surgeons to do arthroscopic rotator cuff repair have reduced the infection rate to 1/200th of what it was with open repairs; so this technological advancement has resulted in dramatic reductions in costs, and even more dramatic reductions in human misery.”

“Holy Grail” of Registries Ramping Up

It’s an unprecedented “first” in the field of device research. “Blessed” by the FDA and guided by some of the finest minds in the field, the world’s most comprehensive gathering of orthopedic registries has taken shape. Art Sedrakyan, M.D., Ph.D., Sc.D. is the principal investigator of the FDA’s International Consortium of Orthopedic Registries (ICOR). He told OTW, “This consortium came together in response to a growing need for accurate data…particularly after all of the metal-metal problems and the numerous reports on device failures. We began working with clinicians and registry leaders worldwide; we then received a grant from the FDA to create an international registry network. It started in May 2011 when we brought all stakeholders together at the FDA.”

“The FDA recognized the importance of this effort, not only from a post market surveillance perspective, but because of the implementation of unique product identifiers. They could see that the ability to uniquely identify products within registries or electronic data sources would enable the creation of learning networks. After we launched the consortium we started an aggregate level assessment and published our first ICOR book on methodology, issues related to safety, patient reported outcomes, etc. At this point we have completed eight multinational investigations that will be published as another Journal of Bone and Joint Surgery book next month.”

“We have demonstrated the value of different data sources for device surveillance and research…not just focusing on registries but showing the value of other data sources like published literature. This is an initial demonstration of what 21st century surveillance will look like, namely, literature reviews, primary data collection, and working with clinician leaders worldwide.”

“ICOR investigations provide the highest quality of evidence that has ever been generated in orthopedics because they are based on international data, they include major data owners, and the methodology is robust. Traditionally, in order to get evidence on safety and effectiveness you would do a systematic review of randomized clinical trials (RCTs). You summarize the information from all of the RCTs that address a particular research question and you synthesize that information to get an overall estimate. But there may only be, say, several RCTs. Even worse, in orthopedics we don’t have many clinical trials and the ones that exist are often small and have many biases (including inventor bias).”

“The only other robust data is that coming from registries. In the past you would review all the data in the annual reports of different countries and try to synthesize it without contacting the owner of the data. This method has even more limitations than the RCT route because you don’t know the follow-up issues, average age, cement used, etc. ICOR has created an algorithm by which all the factors that doctors think are important (for outcomes like revision surgery) would be part of the data collected. That is summary level information obtained from each party in a harmonized fashion…data such as age, distribution of cement use, head sizes, etc. You can combine this information in a similar way from each participating registry.”

“About 80% of evidence in orthopedics comes from registries; only 20% emanates from published research. In ten years 98% of all data will come from published literature, meaning that registry data will be the Holy Grail of research.”

New Osteoporosis Drug Showing Promise

A fracture trial involving over 16, 000 post-menopausal women with osteoporosis has shown that odanacatib, an investigational drug by Merck, significantly reduced the risk of fractures in hip, spine, and non-vertebral sites. Keith D. Kaufman, M.D. is vice president of Clinical Research at Merck. He tells OTW, “This work is part of the Long Term Odanacatib Fracture Trial (LOFT) that included over 16, 000 post-menopausal women at 387 centers in 40 countries who were diagnosed with osteoporosis. Odanacatib works by inhibiting cathepsin K, an enzyme involved in bone resorption and remodeling.”

“We found a 47% relative risk reduction of hip fracture with odanacatib compared to placebo. When we looked at the radiographic determination of vertebral fracture there was a 54% relative risk reduction compared to placebo. We also found a 23% relative risk reduction for nonvertebral fractures. For clinical vertebral fractures we observed a 72% relative risk reduction.”

“The trial was designed as ‘event driven’ such that once a certain number of events accrued you could look at the data. The data monitoring committee for the trial sees unblinded data and can decide whether the trial met the primary objectives; Merck doesn’t see the data at that point. In osteoporosis most trials are time delimited, meaning that the trial could be stopped earlier if the number of events accrues earlier than in a time-delimited trial. Our research was powered statistically such that we could stop the study once we had 237 women with incident hip fracture. The protocol was written such that the data monitoring committee could look at the data once we had 70% of the 237 patients with hip fracture and then again when we had 85% of 237. If the primary measures were met at one of those points then the trial could be stopped before we reached 237 patients with hip fracture. That did happen and we ended up with about 190 patients with hip fracture by the time the study was finished.”

“Adverse events overall were balanced between the two groups. The overall mortality was 3.4% with odanacatib and 3.0% with the placebo. Adjudicated strokes were more frequent with odanacatib than with placebo but investigator-reported stroke events didn’t track consistently with the adjudicated stroke events; we are planning an independent re-adjudication of major adverse cardiovascular events from the trial. Looking forward, we enrolled roughly 8, 200 people in the blinded extension study; some of those individuals will be continuing in the study in a second extension in which all patients receive odanacatib for the next five years.”