November 9, 2012

Fudging the Studies — Senate Report Links Medtronic to Latest Case of Ghostwriting Medical Journal Articles

By Gordon Schnell 

In a scathing report it recently released, the Senate Finance Committee charged medical device manufacturer Medtronic, Inc. with engaging in some fairly dastardly deeds to promote its once top-selling bone growth product called InFuse.  The alleged misconduct centers around the company paying off doctors to author medical journal pieces that downplayed or downright ignored serious risks and side effects associated with the product.  The report, encompassing a whopping two-thousand plus pages, lays out in sordid detail a stream of payments over a fifteen year period amounting to more than $200 million.  In exchange for this largesse, Medtronic was allegedly given free reign to draft, edit and generally shape the contents of the medical journal articles at issue.  Click here to read the Finance Committee press release and report.

The report capped a 16-month investigation by the Finance Committee which was prompted by chatter about physician authors with financial ties to Medtronic omitting from their articles dangerous side effects associated with InFuse.  This was subsequently confirmed in the June 28, 2011 edition of The Spine Journal in which Dr. Eugene Carragee of Stanford University identified 13 studies “sponsored” by Medtronic where there was absolutely no reporting of adverse events associated with InFuse.  At the same time, The Spine Journal found the rate of adverse events associated with using InFuse to be in the range of 10 to 50 percent. 

With some sense of vindication following the Senate report, The Spine Journal stated that the Finance Committee’s findings present “a disturbing picture of what can go wrong when ethics and patient safety are compromised for profit.”  Click here to read The Spine Journal’s press release.  Echoing this sentiment, Senate Finance Committee Chairman Max Baucus (D-Mont.), who, along with the ever-present fraud-buster Chuck Grassley (R-Iowa), led the investigation, said: “patients are at serious risk when companies distort the facts the way Medtronic has.”  For its part, Medtronic denies any wrongdoing.  So do the doctors to which the company paid millions.  They claim the money was comprised of royalty payments for intellectual property rights and contributions, not consulting payments.   Click here to read Medtronic’s statement.

Whatever really happened here, it is unclear whether the government will take any further action.  The Department of Justice already investigated Medtronic’s alleged ghostwriting activity and for whatever reason closed its investigation last May.  There has been no indication that the government plans to re-open that investigation.  And the Senate report does not ask the government to do so.  It merely calls for more stringent disclosure policies for medical journals and stricter rules to prevent a company from improperly influencing the contents of journal articles.

The Senate’s findings against Medtronic follow on the heels of a recently released report in PLOS Medecine that found this kind of influence peddling may be more widespread than anyone appreciates.  See The Fraud Behind the Fraud of Off-Label Drug Marketing.  The journal reviewed more than 400 articles written by doctors on a drug company’s payroll and found that these financial ties were disclosed in only 15 percent of the articles.  Click here to read the report.  With the hopefully soon-to-be fully implemented Physician Payments Sunshine Act — also spearheaded by Senator Grassley — these illicit conflicts of interest will hopefully be a thing of the past. 

But as Senator Grassley stressed in his comments following the Senate report on Medtronic, medical journals need to do their part in taking “a very proactive approach to accounting for the content of the articles along with the authorship.”  The influence these journals have on our health and well being is profound as is the need that these publications be tethered to rigorous science and objectivity.

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