http://media.jsonline.com/documents/Medtronic_Infuse_6_21_2011.pdf
June 21, 2011Via Electronic TransmissionOmar Ishrak, Ph.D.Chairman and Chief Executive OfficerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432Dear Dr. Ishrak:The United States Senate Committee on Finance (Committee) has jurisdiction over the Medicare and Medicaid programs. As Chairman and a senior member of the Committee, we have a special responsibility to the more than 100 million Americans who receive health care under those programs to ensure that beneficiaries receive treatments that are safe and effective.We are extremely troubled by press reports suggesting that doctors conducting clinical trials examining the safety and effectiveness of Infuse on behalf of Medtronic were aware that Infuse, a treatment commonly used in spinal surgery, may cause medical complications, but failed to report this in the medical literature. This issue is compounded by the fact that some clinical investigators have substantial financial ties to Medtronic. Last year, the Milwaukee Journal Sentinel reported that a Medtronic-funded study published in 2004 found that 75% of bone morphogenetic protein 2 (BMP-2) patients experienced ectopic bone growth, where potentially harmful bone growth occurs outside of the fusion area. The authors, who had financial ties to Medtronic, “concluded that „although not desirable,‟” the ectopic bone growth “did not appear to have an ill effect on the patients.” However, in a separate 2008 study conducted by physicians without financial ties to Medtronic, “neurological impairment occurred” in five patients who had the same ectopic bone formation.1 According to the New York Times, a recent study “found that men treated with Infuse developed a condition that causes temporary or permanent sterility at a far higher rate than men who received a bone graft.” This link to sterility was not reported in the original Medtronic-funded study.2 In addition, the Milwaukee Sentinel Journal reports that one author of the original study, Thomas A.1 “Complications rise along with off-label use of BMP-2,” Journal Sentinel, August 28, 2010.2 “New Study Links Spine Product From Medtronic to Risk of Sterility in Men,” New York Times, May 25, 2011.Zdeblick, an orthopedic surgeon at the University of Wisconsin School ofMedicine and Public Health, received “more than $23 million in various royaltypayments from Medtronic since 2002.” In addition, “Zdeblick also is the editor ofthe journal where two of the Infuse papers that failed to mention the link [tosterility] were published.”3We are also concerned that other severe side-effects of Infuse and similar bone-growthproducts developed by Medtronic may have been unreported or under-reported in clinicalliterature. Reports have linked Infuse to potentially fatal swelling in the neck and throat, andradiating leg pain. Concerns have also been expressed about a potential link to cancer.4Given these concerns, please provide the Committee with the following documents:1. All documents and communications pertaining to adverse postoperative events and/ormedical complications relating to the use of recombinant human bone morphogeneticprotein 2 (rhBMP-2) treatments, including but not limited to:a. All communications with and regarding medical journals or theirrepresentatives pertaining to adverse postoperative events and/or medicalcomplications relating to the use of recombinant human bone morphogeneticprotein 2 (rhBMP-2) treatments.b. All communications with and regarding clinical investigators who participatedin Medtronic sponsored clinical trials pertaining to adverse postoperativeevents and/or medical complications relating to the use of rhBMP-2treatments.c. All communications with and regarding the Food and Drug Administration(FDA) pertaining to adverse postoperative events and/or medicalcomplications relating to the use of rhBMP-2 treatments.d. All communications and records between and among Medtronic and membersof FDA Advisory Boards pertaining to adverse postoperative events and/ormedical complications relating to the use of rhBMP-2 treatments.e. All communications and records between and among Medtronic and physicianconsultants pertaining to adverse postoperative events and/or medicalcomplications relating to the use of rhBMP-2 treatments.2. A detailed account of payments that Medtronic made to all Infuse clinicalinvestigators. Please include payments to corporate entities in which MedtronicsponsoredInfuse clinical investigators are principals.3. For each individual and organization identified in question number 2 above, pleaseprovide the following information for each payment in table format:3 “Researchers get royalties, papers omit sterility link,” Journal Sentinel, May 25, 2011.4 “Complications rise along with off-label use of BMP-2,” supra note 1.a. Date of paymentb. Payment description (CME, royalty, honorarium, research support, etc.)c. Amount of paymentd. Year end or year-to-date payment totalIn cooperating with the Committee‟s review, no documents, records, data, or otherinformation related to these matters, either directly or indirectly, shall be destroyed, modified,removed, or otherwise made inaccessible to the Committee.We look forward to hearing from you by no later than July 11, 2011. All documentsresponsive to this request should be sent electronically, on a disc, in searchable PDF format toChristopher_Law@finance.senate.gov and Brian_Downey@judiciary-rep.senate.gov.If you have any questions, please do not hesitate to contact Christopher Law with SenatorBaucus at (202) 224-4515 or Brian Downey with Senator Grassley at (202) 224-5225.Sincerely,Charles E. Grassley Max BaucusSenator Chairman
