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Prescription for change: refuse InFuse.

We all know that some pharmaceutical companies put their own corporate profits ahead of patient safety But, those companies don't have a lock on this behavior--here's an example of a medical device company that has also compromised patient safety.

InFuse is a genetically engineered protein (rh-BMP-2 or bone morpnogeneuc protein 2) manufactured by Medtronic that stimulates bone growth. It's used in spinal fusion surgery along with a specific fusion device to treat degenerative disc disease in the lower spine. Approved in 2002, InFuse has been used in more than 500,000 patients to date.

Although InFuse was approved only for a specific kind of surgery in which the spine is accessed from the front of the patient's body (to reduce the risk of neurological injury), about 85 percent of InFuse's use is off-label, for spine surgeries that are more dangerous. Life-threatening swelling of the neck has been reported with InFuse, and more than 75 percent of the cases complicated by neck swelling were associated with its off-label use. In addition, concerns have been raised that InFuse also increases cancer risk; for this reason, the Food and Drug Administration (FDA) refused to approve use of a higher dose in 2011.

Now it seems that InFuse may have other major problems that Medtronic has tried to conceal from the FDA and from the public. In October 2012, a 16-month investigative report was released by Senate Finance Committee Chairman Max Baucus (D-MT) and senior member Chuck Grassley (R-IA). The report detailed numerous abuses by Medtronic, including the use of ghost-written or ghost-managed medical journal articles that misrepresented InFuse's benefits and concealed adverse event data. (1) One of Medtronic's marketing messages was that InFuse was a less painful alternative to spinal surgery using bone grafts; to advance this view, Medtronic staff edited drafts of articles slated for publication in medical journals to include this and other messages.

In addition to Medtronic employees editing articles on InFuse without revealing their involvement, in at least one case, they also recommended against fully reporting adverse event data. In that instance, Rick Treharne, a Medtronic Senior Vice President of Clinical and Regulatory Affairs, attempted to tone down language about troubling complication rates occurring after use of high-dose InFuse. Treharne contacted one of the study authors before his article's publication and unsuccessfully attempted to modify the critical language. Treharne wrote, "Again it is probably too late, but page 14 line 13 says 'The high complication rate is alarming and warrants intense scrutiny.' I think what you are trying to say is that the occurrence [of] adverse events (not effects as in the title) in these patients was higher than expected and warrants further investigation." (1)

The abuses related to disinformation about InFuse were so serious that, in June 2011, The Spine Journal published an entire issue documenting the actions of select academic surgeons who were paid by Medtronic and who misled other surgeons about the dangerous side effects associated with InFuse. (2) From November 1996 to December 2010, Medtronic paid an astounding $210 million to physicians for consulting, royalties, and other fees associated with Medtronic-sponsored studies of InFuse. Individual physicians were paid as much as $34 million. You read that right: over $34 million to one surgeon alone. Who needs the lottery when someone holds the Medtronic lucky ticket? The Spine Journal's analysis found that 13 studies sponsored by Medtronic reported adverse event rates for InFuse that were 10-50 times lower than those found by the FDA and other researchers. (2)

InFuse is an appalling example of how an irresponsible corporation can willfully distort research in pursuit of profits and at the expense of patient health. Unfortunately this is not an example of an isolated problem with one medical device company For more on device marketing (particularly metal-on-metal hip replacements), see Nicole Dubowitz's article in this issue, (3) and our column in the January/February 2012 issue of the Women's Health Activist. (4)

The medical device industry would have us believe that all new devices are amazing and beneficial innovations. This perspective was illustrated in a recent Wall Street Journal opinion piece by Evan Bayh. Bayh, a Republican, is a former Indiana governor and US Senator who now works at McGuire-Woods LLP, a law firm that represents several medical device companies. Decrying a 2.3 percent tax on the sale of each medical device that will start in January 2013 as part of the Affordable Care Act, Bayh warned that jobs will be lost and medical innovation stifled as a result of the tax. He argued that industry's role is to "save and sustain lives," while providing health care cost savings "each time an angioplastic balloon made open heart surgery unnecessary."

However, not every medical device invented is life-saving--or even life-sustaining; in fact, the failure of inadequately tested medical devices has cost lives, limbs, and billions of dollars. Since many medical devices are implanted without good evidence that they will work well (or work at all), the bill for problems caused by faulty devices is often footed by tax-payers via higher health insurance premiums or increased Medicare costs. Our bottom line: Insufficiently tested and unethically marketed medical devices can increase health care costs and hurt patients.

References are available online or by emailing

by Charlea T. Massion, MD & Adriane Fugh-Berman, MD

Charlea T. Massion, MD, is a family physician and cofounder of the American College of Women's Health Physicians; she teaches at Stanford University School of Medicine's Center for Education in Family Medicine. Adriane Fugh-Berman, MD, is an associate professor in the Georgetown University Medical Center, a former chair of the NWHN, and director of PharmedOut, which educates prescribers about pharmaceutical marketing techniques.
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Author:Massion, Charlea T.; Fugh-Berman, Adriane
Publication:Women's Health Activist
Date:Jan 1, 2013
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