On 25 October, at the time when NASS was taking place, Senate Finance Committee Chairman Max Baucus and senior member Chuck Grassley released the results of their 16-month investigation into Medtronic, which revealed questionable ties between the company and the physician consultants tasked with testing and reviewing the bone-growth product InFuse.
A press release from The United States Senate Committee on Finance stated: “Without public disclosure of their roles, Medtronic employees collaborated with physician authors to edit and in some cases, write segments of published studies on its bone-growth product InFuse. The studies as published may have inaccurately represented InFuse’s risks and may have placed added weight on side effects of alternative treatments. Medtronic, which describes itself as ‘the world’s largest independent medical technology company,’ also maintained significant, previously-undisclosed financial ties with physicians who authored studies about InFuse, making US$210 million in payments to physicians over a 15-year period.”
“Medtronic’s actions violate the trust patients have in their medical care. Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients are at serious risk when companies distort the facts the way Medtronic has,” Baucus said. “Patients everywhere will be better served by a more open, honest system without this kind of collusion.”
“These findings emphasise the value of the Grassley-Kohl Physician Payments Sunshine Act, which will result in public disclosure of industry payments to physicians starting next year. The findings also should prompt medical journals to take a very proactive approach to accounting for the content of the articles along with the authorship of the articles and studies they feature,” Grassley said. “These publications are prestigious and influential, and their standing rests on rigorous science and objectivity. It is in the interest of these journals to take action, and the public will benefit from more transparency and accountability on their part.”
In 2002, The Food and Drug Administration (FDA) approved InFuse for use stimulating spinal bone growth in patients with a degenerative disease affecting the lower spine. According to Medtronic, InFuse has been used to treat more than 500,000 patients.
The report released by Senators Baucus and Grassley on behalf of the Finance Committee which has sole jurisdiction over Medicare and Medicaid is the product of an investigation they began in June 2011. Medtronic cooperated with the committee’s inquiry and produced more than 5,000 documents pertaining to 13 different studies of InFuse for the investigation.
Major findings of the investigation include:
- Medtronic was involved in drafting, editing, and shaping the content of medical journal articles authored by its physician consultants who received significant amounts of money through royalties and consulting fees from Medtronic. The company’s significant role in authoring or substantively editing these articles was not disclosed in the published articles. Medical journals should ensure any industry role in drafting articles or contributions to authors be fully disclosed.
- Medtronic paid a total of approximately US$210 million to physician authors of Medtronic-sponsored studies from November 1996 through December 2010 for consulting, royalty and other arrangements.
- An e-mail exchange shows that a Medtronic employee recommended against publishing a complete list of adverse events, or side effects, possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
- Medtronic officials inserted language into studies that promoted InFuse as a better technique than an alternative by emphasising the pain associated with the alternative.
- Documents indicate that Medtronic prepared one expert’s remarks to the FDA advisory panel meeting prior to InFuse being approved. At the time, the expert was a private physician but was later hired to be a vice president at Medtronic in 2007.
Response from Medtronic
A press release from Medtronic has stated:
“Medtronic cooperated with the inquiry, providing documents as requested and addressing questions raised by the Committee Staff. As Medtronic has repeatedly stated, patient safety and integrity are its highest priorities.
Medtronic does not agree with many of the findings in the staff report. In particular, Medtronic vigorously disagrees with any suggestion that the company improperly influenced or authored any of the peer-reviewed published manuscripts discussed in the report, or that Medtronic intended to under-report adverse events. In fact, Medtronic reported to the FDA the potential adverse events addressed in the staff report, and these risks were reflected on the product’s FDA-approved label. In addition, the staff report’s characterisation of payments received by physicians is also misleading and unfair. The vast majority of such payments were royalty payments made to compensate physicians for their intellectual property rights and contributions, not consulting payments. In general, royalty and consulting payments are a commonplace and appropriate practice in the medical device industry.
Medtronic agrees with many of the recommendations in the staff report to ensure increased transparency for industry interactions with physicians, and indeed has played a leadership role in this area. Scientific and engineering collaboration between physicians and industry is vital to innovation and advancing patient care. In the context of publications and consistent with best practices, physician authors interact with Medtronic employees who have scientific or clinical backgrounds and deep expertise in data related to our products because this collaboration is important to patient care. Medtronic has worked diligently over many years to lead the industry in reforms designed to eliminate or mitigate potential conflicts of interest, including disclosure of payments to physicians. Medtronic was one of the first companies to voluntarily disclose payments to physicians on a public website, more than a year ahead of new federal disclosure requirements under the Affordable Care Act. And Medtronic recently commissioned the first-ever industry proposed programme with Yale University to make data regarding a marketed product transparent to researchers and the public. The staff report recognised some of the significant steps that we have taken specifically related to transparency and disclosure.”