There is nothing like a stack of internal documents to tell a story. And so, the US Senate Finance Committee has released a wad showing Medtronic employees were secretly involved in drafting and editing favorable journal articles about its spinal fusion product while the device maker paid millions to influential doctors whose names were on the studies.Over a 15-year period, Medtronic paid $210 million to 13 doctors and two corporations linked to doctors, including more than $34 million to University of Wisconsin orthopedic surgeon Thomas Zdeblick, who co-authored a series of papers about the product, according to the documents, which were first reported by The Milwaukee Journal-Sentinel and Medpage Today.
Meanwhile, Medtronic (MDT) execs inserted language into studies that promoted InFuse as a better technique than an alternative by emphasizing the pain associated with the alternative, according to the Senate investigation. And there is an e-mail exchange showing a Medtronic employee recommended against publishing a complete list of adverse events that were possibly associated with InFuse in a 2005 Journal of Bone and Joint Surgery article.
“These publications are prestigious and influential, and their standing rests on rigorous science and objectivity,” says US Senator Chuck Grassley in a statement. “It’s in the interest of these journals to take action, and the public will benefit from more transparency and accountability on their part.” Grassley spearheaded investigations into conflicts of interest among physicians and academics with ties to drug and device makers.
The investigation extends long-running scrutiny of the controversial device maker and Infuse, which was approved by the FDA in 2002 and contains a genetically engineered version of a naturally occurring protein. Since then, Infuse has been implanted in more than 500,000 patients by more than 2,300 surgeons and racked up hundreds of millions of dollars in annual sales…
I am usually not so interested in the misadventures of pharmaceutical and device makers outside of psychiatry,
Mickey, when I first started following your blog, I was not particularly interested in the misadventures of psychiatry. As a non-medical layperson, much of my ‘investigation’ had been ferreting out the mischief use to bring to market the “first of its kind, genetically-engineered insulin–the latest and assuredly the greatest.” It’s been interesting and informative to watch the the blinders coming off an ‘insider’s’ eyes. Your revelations about the shenanigans occurring within your field adds support to my belief that the misdeeds are occurring across the entire spectrum of medicine. I think most any doctor willing and able to do the investigation and analysis within his/her own field, would have similar revelations to share.
(BTW, I thank you for your contribution . . . it’s sorely needed. You keep writing, and I’ll keep reading. Preaching to the choir may not be particularly rewarding; but it gives purpose to the choirmaster, lets the members of the choir understand they are not solo performers . . . and hopefully invites new members to join. And who knows when the choir will get so voluminous that its collective voice cannot be ignored!
Misdeeds are indeed happening across medicine but you’d be hard put to find a kernel of truth about the efficacy of any psychiatric medications developed in the last 30 years.
Surprisingly, some leading spine surgeons at least have responded to this scandal with the outrage it deserves. Check out this editorial from The Spine Journal: pretty hot stuff.
http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf
“Clearly, the entire concept of peer-reviewed literature, systematic topic reviews and evidence-based clinical decision-making rests on the assumption that the published literature being reviewed has sufficient integrity to make the exercise worthwhile. It is this concept of “sufficient integrity” that has been questioned.”
Sorry to hear that your personal spine has been stuffed with Infuse … Hope you will be a success story! But if you have difficulties, especially pain down one leg, or Guy Problems, please get a 2d opinion from someone other than the doc who placed the Infuse. Working in the workers comp field, I have watched a whole lot of apparently needless misery unfold in back surgery patients, without having any idea what I was looking at till now.
1BOM.
Look at this list of 13 physician researchers:
http://www.grassley.senate.gov/about/Disclosure-of-Drug-Company-Payments-to-Doctors.cfm
5 Spine Orthopedists.
All the rest, 8, psychiatrists (half of them AACAP members).
Read the editorial above written in 2011.
Where is a sister editorial in JAACAP?
Dr. Haid and Dr. Burkus, are two of those who received money from Medtronic. I wonder how many people at orthopedics conferences realized when they saw Dr. Haid’s or Dr. Burkus’ disclosure slides with “Medtronic” listed, perhaps with an additional note stating “has received more than $10,000”, that that represented respectively $7,783,000 and $712,000 on top of $10,000. Those are not misprints. That is over seven million and over seven hundred thousand respectively. Perhaps that method of listing potential conflicts of interest leaves something to be desired? (I got those numbers here: http://hcrenewal.blogspot.com/2012/10/marketers-systemic-influence-over.html )
This is the heart of why physicians and allied prescribers who work with kids, be they pediatricians or family practitioners or nurse practitioners or adult/adolescent psychiatrists or child/adolescent psychiatrists are impacted by all this:
“Clearly, the entire concept of peer-reviewed literature, systematic topic reviews, and evidence-based clinical decision-making rests on the assumption that the published literature being reviewed has sufficient integrity to make the exercise worthwhile.”
“The core of our professional faith, as Spengler points out, is to first do not 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.”
“Biased and Corrupted.” not the Straw Men of “fraud” or “misconduct.”
The core of professional faith. The message of that last paragraph is the heart and soul of why this fight, and it is a fight, for the soul of these professions matters so. That paragraph should be brought to every pediatrician, family practitioner, nurse practitioner, or psychiatrist who works with children.
It should hang as a plaque in their offices and be present as witness every time a
drug rep hands them a reprint.
There are those who believe that that soul is already rotted. You have worked with enough of these professionals to know that this fight is not over.
But where the hell is a sister editorial to this one in JAACAP? Much less retraction of that damnable 2001 paper.
“The core of our professional faith … is to first do not 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.”