"Scathing" was the way that Kerry Sheridan of AFP:
--described the editorial that's just now appearing in The Spine Journal, authored by a number orthopedists plus Dr. David J. Rothman of Columbia. (Note: The article is apparently to appear in the June issue of the journal which seems not yet to be up on the journal's website. One needs a subscription to access the site.)
Necessary background--this brings us back to our old friends the device company Medtronic (see most recently http://brodyhooked.blogspot.com/2010/12/in-defense-of-paranoia-suspecting.html). In previous posts I discussed in very general terms the fact that this firm sells "hardware" for spinal fusion surgery and has been implicated in a number of shady practices that have been exposed by John Fauber at the Milwaukee Journal-Sentinel, among others, and also earned them the close interest of Sen. Charles Grassley's subcommittee. I have not as yet focused on a specific product called Infuse (or generically, rhBMP-2). This chemical is a bone growth factor that is applied to bone to make new bone grow. It is supposed to be enclosed in a little cage so that it causes the bone to grow only where the surgeon wants it to. The big advantage is to cause new bone to grow, for example to fuse two vertebrae togerther, instead of having to make a separate incision and take a bone graft from another site (like the hip) for the same purpose.
The authors of this editorial begin by noting a series of 7 published reports (one of which was published in their own journal) about Infuse, all by authors with significant financial ties to the manufacturer--they state that one trial in particular apparently paid its investigators a cool $26M. These reports are quite remarkable in one way--not a single adverse reaction is attributed to the product. Think of that. Ever heard of anything in medicine that never, ever, produces even one adverse reaction?
Not surprisingly, as soon as articles began to be published by those not in the pay of Medtronic, toxic effects began to be reported--the short list includes inflammatory reactions, persistent pain, inability to urinate, inappropriate abnormal bone growth, and displacement of the implanted apparatus. The major systematic review published in the same issue of the journal estimated that actual complications and adverse events "are perhaps 10 to 50 times the original estimates calculated from industry-sponsored studies" by the FDA.
The editors now face squarely the implications for their own practices. They allude to what they call the "choirboy defense" that all physicians are of stellar integrity, potential conflicts of interest are only potential, etc. This defense, they conclude, won't pass muster, either inside or outside of medicine. Add to this is the problem that "disclosures in our journals are more often than not self-contradictory blurbs of improbable nonsequiturs bracketed by misdirection." They use as an example a published disclosure statement which is actually a denial rather than a disclosure, stating both that the manuscript is not about medical devices or drugs, and that "no benefits in any form have been or will be received from a commercial party." The editors then state, "Even a most cursory review shows that this was all about devices and drugs used in an off-label manner and reported by authors who, by conservative estimates, have tens of millions of dollars of financial association with the sponsor."
The editors conclude, "The core of our professional faith...is to first do not harm. It harms patients to have biased and corrupted research published." Saying "We all must do a better job going forward," they promise a series of later changes to be announced to improve their editorial policies.
Comment: First, kudos to the editors of The Spine Journal for so frankly throwing down the gauntlet for themselves. Second, I am not a business ethicist, but I have to borrow a note from my old friend Leonard Weber in his nice book about the pharmaceutical industry, Profits Before People? I believe that Professor Weber would ask--how can it possibly benefit Medtronic to run its business in this fashion? How could any business plan, other than the most cynical short-term stockholder gain (maybe with the CEO exiting via the famous golden parachute), include exposing one's firm to this barrage of apparently-fully-justified criticism and condemnation? Or has the idea of "in the long run" so totally ceased to function in American culture?
Carragee EJ, Ghanayem AJ, Weiner BK, et al. A challenge to integrity in prine publications: years of living dangerously with the promotion fo bone growth factors [editorial]. Spine Journal 11:463-68, 2011.