When medical researchers have financial ties – running into millions of dollars – with pharmaceutical or medical equipment companies, and then publish scientific, peer-reviewed papers which are to the financial benefit of these companies, questions of scientific misconduct escalate to become questions of scientific fraud.
Medtronic is the world’s largest medical device company and Minnesota’s seventh-largest public company based on revenue, which totaled $15.93 billion for the fiscal year that ended April 29. Medtronic’s Infuse product is a bioengineered bone-growth protein that has been used in spinal fusion procedures for the past nine years and is used in about half of the 80,000 anterior lumbar fusion procedures performed every year in the United States.
According to Twin Cities Business, The Spine Journal recently published two articles about the product, one that claims the product may increase the risk of sterility in men, and another that claims that the product’s adverse effects were not reported in clinical research. Those effects reportedly include inflammation, back pain, infections, and potentially life-threatening complications. The Journal pointed out that researchers for 12 of the product’s 13 industry-sponsored studies had multimillion-dollar “financial associations” with Medtronic.
The Spine Journal seems to be on a crusade:
From the Nature News Blog:
The Spine Journal devoted its entire June issue – two clinical studies, two reviews, two commentaries and a scathing editorial – to picking apart Medtronic’s controversial bone growth treatment, Infuse. The drug, which is a recombinant form of the protein BMP-2, is used in some kinds of spinal fusion surgeries and racked up $900 million in sales last fiscal year, according to the New York Times.
Company-sponsored clinical trials for Infuse found no side effects directly linked to the drug. But a review and reanalysis of these studies published in Spine Journal found that the incidence of adverse events ranged from 10 to 50 percent, depending on the use. What’s more, the same review study, led by Eugene Carragee, of Stanford University School of Medicine in California, reports that the authors of the supporting studies had financial ties to Medtronic ranging from $560,000 to $23,500,000, with a median of $12 million to $16 million. In some cases, the authors of these studies did not disclose the full extent of their financial relationships with Medtronic.
“A consistent number of people involved with these studies got extraordinary sums,” Carragee told the Times.
Side effects of the drug include cancer, fertility problems, infections, dissolving bone, and leg and back pain. According to the Times, Medtronic reported the side effects to the US Food and Drug Administration, as required.
In response to the Spine Journal articles, Medtronic CEO Omar Ishrak issued a statement that said: “While the Spine Journal articles raise questions about researchers’ conclusions in their published peer-reviewed literature, the articles do not raise questions about the data Medtronic submitted to the FDA in the approval process or the information available to physicians today through the instructions for use brochure attached to each product sold.”
The US Justice Department is conducting a criminal investigation into whether Medtronic illegally promoted Infuse for “off-label” applications not approved by the FDA, the Times reports.
The American Society of Business Publication Editors have acknowledged the efforts of the Spine Journal and awarded them the 2011 “Journalism That Matters” award. From the New York Times Media Decoder blog:
In June, the publication, The Spine Journal, devoted an entire issue to editorials and reports that challenged previous medical studies supporting the safety and effectiveness of Infuse, a bone-growth product sold by Medtronic. The product, a bioengineered material, is used mainly in spinal fusions.
The Spine Journal charged that academic experts paid by Medtronic to conduct earlier research about Infuse had issued biased and misleading results that overstated the product’s benefits and claimed that it did not pose risks.
On Friday, the American Society of Business Publication Editors celebrated the journal’s effort by presenting it with its 2011 “Journalism That Matters” award, an honor given in recognition of coverage that causes change by government or industry.
It is highly unusual for one group of researchers to publicly repudiate the work of professional colleagues. And by throwing down its challenge, the special issue of The Spine Journal, which is the official journal of the North American Spine Society, was something of a turning point in the debate over conflicts of interest in research paid for by makers of medical products.
Medtronic is on the defensive and is conducting a damage limitation exercise:
But there is little doubt that The Spine Journal’s coverage has had an effect. Last week, Medtronic took the unusual step of announcing that it was giving a $2.5 million grant to Yale so that independent researchers could conduct a broad review of all Infuse studies in order to determine the facts.
Related:
Tags: American Society of Business Publication Editors, biased research, Infuse, Infuse dangers, Medtronic, Scientific misconduct, Spine Journal
The k2p blog 
August 13, 2011 at 1:16 pm
[…] The Spine Journal takes on Medtronic and publication of questionable research (ktwop.wordpress.com) […]
August 21, 2011 at 6:31 am
[…] The Spine Journal takes on Medtronic and publication of questionable research (ktwop.wordpress.com) […]
August 21, 2011 at 7:31 am
[…] The Medtronic story is not just about ghost- writing and paying for favourable peer-reviewed scientific papers and supporting researchers to the tune of millions but it is also about all the surgeons in their pocket and how they exploit and “rape” Medicare. Earl Stevens writes: […]