Baucus, Grassley Question Medtronic about Unreported Side Effects, Financial Ties to Clinical Investigators

Finance Leaders Begin Investigation Into Medtronic Infuse Trials

Washington, DC – Senate Finance Committee Chairman Max Baucus (D-Mont.) and senior Committee member Chuck Grassley (R-Iowa) asked medical device manufacturer Medtronic on Tuesday to produce documents related to its controversial bone growth product Infuse.  In a letter sent to Medtronic, the Committee raised concerns over recent media reports that indicate medical researchers in charge of Infuse clinical trials may have been aware of and failed to report evidence that the product may cause sterility in men and potentially-harmful bone growth.  The letter also notes many of these investigators had substantial financial ties to the device manufacturer.

 “These reports that doctors conducting medical trials while on Medtronic’s payroll may have hidden serious side effects for patients are deeply troubling,” said Senate Finance Committee Chairman Baucus.  “Information is one of the most important tools patients and doctors have when making medical decisions.  Patients have a right to know the risks associated with their treatments, and medical device companies have a duty to disclose this information.  We need to do everything we can to ensure companies aren’t concealing serious medical complications from patients just to increase profits.”

 “A patient having surgery has to rely on his doctor’s knowing the risks and benefits of a medical device.  The doctor in turn has to rely on the medical literature.  If the medical literature has been written by those with financial ties to the device maker, the doctor and his patient should know that.  A lack of transparency leaves doctors and patients in the dark on something any of us would want to know before surgery.  It’s alarming to learn after the fact that articles draw conflicting conclusions about a device’s safety and complications.  The lack of disclosure of payments raises questions about the integrity of the conclusions reached, whether integrity was compromised or not,” senior committee member Grassley said.

The full text of Baucus’s and Grassley’s letter to Medtronic appears below:

June 21, 2011

Via Electronic Transmission

Omar Ishrak, Ph.D.
Chairman and Chief Executive Officer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432

Dear 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. Zdeblick, an orthopedic surgeon at the University of Wisconsin School of Medicine and Public Health, received “more than $23 million in various royalty payments from Medtronic since 2002.”  In addition, “Zdeblick also is the editor of the journal where two of the Infuse papers that failed to mention the link [to sterility] were published.”[3]

We are also concerned that other severe side-effects of Infuse and similar bone-growth products developed by Medtronic may have been unreported or under-reported in clinical literature.  Reports have linked Infuse to potentially fatal swelling in the neck and throat, and radiating leg pain.  Concerns have also been expressed about a potential link to cancer.[4] 

Given these concerns, please provide the Committee with the following documents:

1.  All documents and communications pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments, including but not limited to:

a.  All communications with and regarding medical journals or their representatives pertaining to adverse postoperative events and/or medical complications relating to the use of recombinant human bone morphogenetic protein 2 (rhBMP-2) treatments. 

b.  All communications with and regarding clinical investigators who participated in Medtronic sponsored clinical trials pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments. 

c.  All communications with and regarding the Food and Drug Administration (FDA) pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.  

d.  All communications and records between and among Medtronic and members of FDA Advisory Boards pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments.  

e.  All communications and records between and among Medtronic and physician consultants pertaining to adverse postoperative events and/or medical complications relating to the use of rhBMP-2 treatments. 

2.  A detailed account of payments that Medtronic made to all Infuse clinical investigators.  Please include payments to corporate entities in which Medtronic-sponsored Infuse clinical investigators are principals.

3.  For each individual and organization identified in question number 2 above, please provide the following information for each payment in table format:

a. Date of payment

b. Payment description (CME, royalty, honorarium, research support, etc.)

c. Amount of payment

d. Year end or year-to-date payment total

In cooperating with the Committee’s review, no documents, records, data, or other information 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 documents responsive to this request should be sent electronically, on a disc, in searchable PDF format to [staff] and [staff].

If you have any questions, please do not hesitate to contact [staff] with Senator Baucus at (202) 224-4515 or [staff] with Senator Grassley at (202) 224-6522.

Sincerely,

Charles E. Grassley                                                             Max Baucus

Senator                                                                              Chairman

[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.

[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.

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