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.
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.
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.