icon caret-left icon caret-right instagram pinterest linkedin facebook twitter goodreads question-circle facebook circle twitter circle linkedin circle instagram circle goodreads circle pinterest circle

Recent Newspaper & Online Columns by Kate Scannell MD

When patients are treated like ATMs, conflicts sure to arise -- Medical Devices

By Dr. Kate Scannell
First Published in Print: 07/10/2011

A FEW weeks ago, I visited a hospitalized friend who was recuperating from hip-replacement surgery. While unpacking the deli items I promised to bring, he said, "Too bad! You just missed my orthopedic surgeon. He invented my hip replacement!"

"Really?" I said, almost spilling a carton of matzo ball soup.

"Yeah, he designed and patented it!" my friend bragged. "And he uses it in all of his hip surgeries!"

But I didn't feel as hip-hip-hooray about the news. An orthopedic surgeon inserting his patented, royalty-generating medical device into my friend's body as though it were an ATM card?

As a rheumatologist who'd cared for many arthritic patients needing joint replacements, I knew that the medical-device market was already steeped with tried-and-true hip replacement models. How could my friend have possibly evaluated the safety and efficacy of his surgeon's new -- and, undoubtedly, more expensive -- device? Was he aware that it had no known or knowable track record? What authentic choice did he truly have when consulting with his one-hip-wonder surgeon?

My friend's next comment answered the latter question. With unbridled pride, he exclaimed that his surgeon was "also a researcher!" and "an inventor!" and "a really nice guy!" who "owns lots of medical patents!"

In other words, the surgeon sold himself -- and his patented hip device -- to my trusting friend who conflated the surgeon's research and industry claims with clinical expertise.

I was not going to express my cynicism and risk deflating my friend's trust in his surgeon. Besides, it was possible -- right? -- that his surgeon was supremely skilled in research and marketing and surgery and clinical care, and his patented hip device was the best in the world, and the profit made from its sale to my friend had no influence whatsoever on his recommendation to use it in surgery.

These disquieting financial conflicts of interest are rampant within the medical profession. Anyone doubting their menacing significance is either not paying attention or protecting himself. But that's understandable. Because acknowledging the problem's all-encompassing reach also risks losing one's faith in doctors and trust in medicine. That can leave you feeling thoroughly vulnerable.

Still, it's better to know the lay of the land, if you have to negotiate health care's terrain. Making safe and sure-footed medical decisions demands alertness about hidden land mines.
In this regard, last week delivered a sad but wholly instructive education involving "Infuse" -- a bioengineered protein tagged to a metallic device that is used primarily to promote spinal fusion for people with back pain. Within the most recent fiscal year it generated $900 million for its manufacturer, Medtronic — our country's largest device manufacturer. The lesson also involved spineless researchers on the company payroll who declared Infuse to be free of side effects, and suspicious colleagues who showed some backbone in exposing the fallacy of that claim.

It also was unprecedented -- a group of spine specialists, disgusted with the commercial encroachment on their professional integrity, publicly chastising other physicians for conducting misleading research.

After reviewing 13 Medtronic-funded studies involving 780 patients, the specialists reported in The Spine Journal that the authors of those studies had deceived doctors and patients about Infuse's safety. In fact, they did not report a single side effect attributed to its use. Not one.
Meanwhile, The Spine Journal estimated the Infuse side effects occurred in 10 percent to 50 percent of cases, depending on how it was used.

Adverse effects included infections, bone loss, male sterility, a potential cancer risk, various neurologic injuries, and undesirable bone growth. Furthermore, Medtronic had paid various researchers between $12 million and $16 million for conducting their "work."

We'll be hearing more about this issue while the Justice Department pursues its criminal investigation to determine whether Medtronic illegally promoted Infuse for off-label uses. That follows Medtronic's $40 million in 2006 to settle charges of paying kickbacks to doctors through "sham" consulting and royalty agreements. And the 2009 withdrawal from a British medical journal of a study supporting Infuse after its author -- who'd received over $800,000 from Medtronic -- was charged with manipulating data as well as forging the signatures of colleagues on the publication.

Meanwhile, if you look at the "benefits and risk" page on Medtronic's own website for patients (oops, "consumers"), you still don't worry too much about Infuse. You read that some patients may develop an allergic reaction, and, if Infuse is implanted in the spine through a particular route, "some males may experience retrograde ejaculation (a form of sexual dysfunction)." The only other warning is presented as an obscure dismissal -- Medtronic noting that, while "not seen" in its studies, "there is a possibility that too much bone may form at the implantation site (exuberant bone formation), bone may form at a location away from the implantation site (ectopic bone formation), or the bone that is formed may be abnormal." That's it.

Medtronic also directs consumers wanting to review the research behind Infuse to a "Clinical Research" page. There you read that Infuse "was found to be safe and effective," and no side effects are mentioned. You are offered "relevant journal article citations if you would like to do some further research." Those citations are two in number, each at least 9 years old, and both referring to Medtronic-funded studies that claim no side effects from Infuse.

While we worry about skyrocketing health care costs in this country, it would be wise to consider the enormous amount of money wasted on corrupt research and researchers. The millions of dollars paid to cover our use of drugs and devices with tainted legacies of safety and merit. The billions spent correcting harm to patients from improperly marketed new medical technologies. And the incalculable toll on patients, whose lives suffer the greatest injustice of it all.
------------------------------------------------
Kate Scannell is a Bay Area physician and syndicated columnist. Her new novel is "Flood Stage."
iopyright 2011, Kate Scannell