Whether it’s the New Yorker’s summer fiction issue or Nature’s African science special (to be published later today), everyone loves a themed issue of their favourite periodical. Unless, that is, you work or consult for the Minneapolis, Minnesota-based medical device company Medtronic and your favourite read is the Spine Journal.
The publication 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. While last week, members of the US Senate Finance Committee asked the company for information about payments and communications with researchers who conducted the Infuse studies.
The other articles in Spine Journal’s Infuse special issue include: a clinical study on an alternative to BMP-2 treatment; a study of one of the drug’s potential side effects, osteolysis, or dissolving bones; and a review of the drug’s link to another potential side effect, nerve damage.
But if you have to read just one article, go for journal’s editorial, which provides a nice summary of the whole affair.
Carragee, the journal’s editor, and his colleagues write: “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.”