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Medtronic’s bone-graft studies receive harsh criticism from spine journal

The bad news for Medtronic and its Infuse bone-graft product keeps coming.

In May, for example, a study reported that Infuse, a genetically engineered bone-growing protein that’s used in spinal-fusion surgeries, raises the risk of infertility in men. And just last week, a Senate committee announced it was investigating whether physicians with financial ties to the company had failed to reveal bad outcomes from the product in studies they had published.

Medtronic

That last issue hit Medtronic again on Tuesday when, in a truly remarkable event, the editors of a major medical journal, The Spine Journal, devoted their publication’s entire issue to a scathing series of reports about Infuse. The articles describe how 13 Medtronic-funded studies involving 780 patients misled the medical community — and the public — about Infuse’s serious side effects.  

Those studies did not report a single adverse event involving Infuse, despite the fact that Medtronic at the time was quietly reporting such problems to the Food and Drug Administration (FDA).

The Spine Journal researchers estimate that the actual rate of complications and adverse events associated with Infuse — things like infection, sterility, pain and an increased risk of cancer — is 10 to 50 times greater than was reported in those 13 studies.

The researchers also describe how some of the doctors who co-authored those studies earned millions of dollars from Medtronic, which itself earned $868 million in 2010 from Infuse sales, according to the New York Times. Yet those conflicts of interest were either not reported in the published studies, or reported in a way that was unclear.

Ironically, many one of those studies originally appeared in The Spine Journal.

A call for change
Which brings me to the amazingly blunt and self-critical editorial that also appeared in Tuesday’s special issue of The Spine Journal. It was written by the journal’s editor, Dr. Eugene Carragee (who co-authored one of the review articles as well as the sterility study published last month), and several physicians who sit on the board of the North American Spine Society, which publishes the journal.

Dr. Eugene Carragee
ortho.stanford.edu
Dr. Eugene Carragee

The editorial acknowledges the “rising, if not malignant, doubt [among the public and press] about the spine field’s ability to honestly assess and report on clinical practice and new technologies” and the troubling fact that “disclosures in our journals are more often than not self-contradictory blurbs of improbable nonsequitors bracketed by misdirection.”

The editorial also describes how the spine community, when faced with discomfiting reports of financial conflicts of interest, has resorted all too often to the “choirboy defense” — the claim that “we are an honest profession; our integrity is unimpeachable … and potential conflicts of interests are only ‘potential.’ ”

“Outside the echo chamber, however, much of this rhetoric fails to pass the test of minimum credibility,” write Carragee and his colleagues.

Excuses must stop, they say, and change must begin, starting with The Spine Journal’s own editorial processes and procedures. Those involved in publishing medical journals — and particularly spine journals — find themselves “at the precarious intersection of professionalism, morality, and public safety,” they add.

To change the current climate of suspicion and cynicism, we must look beyond minimal standards of professional conduct or legal compulsion: Beyond the media blitz of the criminal investigations, accusations, and talking-point denials; beyond another set of improbably safety assessment coupled with astounding compensation disclosures; beyond the fortunes found and reputations ruined; beyond any individual or institutional inadequacy that may have permitted these distortions of clinical research. The core of our professional faith … is to first do no harm. It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.
Yet harm has been done. And that fact creates a basic moral obligation. As John F. Kennedy stated, “This moral issue is as old as the scriptures and is as clear as the American Constitution.” It is the human right in our society to basic protections.

For a fuller accounting of this sordid story, I recommend the Milwaukee Journal Sentinel/MedPage piece. They’ve been leading the investigative reporting on the topic.

Related: Medtronic CEO moves to defuse Infuse controversy

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Comments (3)

  1. Submitted by Paul Scott on 06/29/2011 - 10:40 am.

    This was a powerful editorial. I can’t say I have ever seen, say, a psychiatry journal, look as honestly at its role in the use of medical journals to oversell innovation and undersell harm.

    I hope that we can one day see the likes of Amy Klobuchar, Al Franken and Erik Paulsen, all uncritical cheerleaders of the wonderful innovation coming out of places like Medtronic, to call for investigations into the practice of med tech drug companies to employ ghostwriting and sponsored research and junk science to distort research in the name of profits.

    Its easy to take on toys made in China, but it would take courage for any of those representatives to look at these popular industries, especially given their role in driving up the cost of health care, which is bankrupting this country. It’s why I can’t take Sen Klobuchar in particular seriously.

    She styles herself as a consumer champion, yet she fought the industry being asked to contribute to health care reform and took former Medtronic CEO Bill Hawkins to the state of the union earlier this year. She has praised them and pocketed their donations — will she say something about the pollution of medical science at their hands? Medtronic made $900 million from Infuse last year.

  2. Submitted by Bill Gleason on 06/29/2011 - 10:44 am.

    Sadly, this story is nothing really new to those of us who have been following the military-medical-industrial complex for years.

    At the U of M, one of the docs got in trouble for testifying in favor of Infuse® research before Congress without letting his audience know that he was a consultant for Medtronic, which brought down the wrath of Senator Grassley.

    See: http://grassley.senate.gov/upload/JULY-29-WSJ-article.pdf

    I’d also point out that a U of M prof, Dr. Carl Elliott, has been valiantly crusading against using clinical trials for marketing exercises and other unethical practices in clinical trials.

    Various administrative attempts to discredit him have been unsuccessful, but he is being criticized even to this day by a flack for the Academic Health Center at the University of Minnesota.

    See: http://ptable.blogspot.com/2011/06/university-of-minnesota-academic-health.html

  3. Submitted by Steve Titterud on 06/29/2011 - 08:49 pm.

    If the federal law governing IRBs proscribes participation in reviews by members with a conflict of interest, does it make any sense that researchers with a conflict are allowed to conduct and report the research

    Where were the IRBs in this case?

    This is not about the “spine field” alone.

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