US-based medical device maker Medtronic has, over the past decade, enlisted a small group of prominent surgeons from around the country to do clinical research or write articles about its new spine surgery product, bone morphogenetic protein-2 (BMP-2). According to a Journal Sentinel analysis of newly released company payments in 2010 alone, many of those doctors received payments of hundreds of thousands to millions of dollars each in royalties for a variety of other Medtronic spinal devices. Medtronic began disclosing the payments this year, in advance of a federal requirement set to take effect in 2013.
Since it won approval for narrow uses in 2002, BMP-2 has been an increasingly dominant force in spinal fusion surgery, with sales of about $800 million a year, often for use in other procedures, it has been observed. Independent doctors say the product's success is due largely to positive findings made by the surgeons affiliated with the company.
Doctors involved with two of the many research articles on BMP-2 published since it was approved - one in 2002, the other in 2004 - received a combined $6 million in royalties this year for other Medtronic spinal products, the newspaper found. The payments went directly to the doctors or business entities they are associated with.
There is no evidence any of the surgeons who have published articles on BMP-2 received royalties they did not deserve. However, the spinal surgery field has been plagued by troubling questions about transparency.
For years, published articles revealed scant information about the financial conflicts of authors, including not spelling out how much royalty money an author received. Doctors say those articles have incalculable value to device-makers trying to increase sales of their products. But that impact is greatly diminished when doctors read that an author got a large amount of money.
At the time BMP-2 was approved in 2002, little was known about the financial connections between Medtronic and doctors associated with the clinical trial. Likewise, little was known that year when the Journal of Spinal Disorders & Techniques published the article on the trial. The paper made no mention of doctors getting royalties or having any financial connection to the company.
However, earlier this year Medtronic began listing payments to doctors on its website, a practice that will become law when the Physician Payment Sunshine Act goes into effect in 2013. Journal Sentinel used that database to check payments made this year to a core of prominent doctors who have published research about BMP-2 since its approval.
Three of the four authors of a 2004 article on the study of the product are listed as receiving nearly $4 million that year in royalties from Medtronic for a variety of spinal products, not BMP-2. That paper was important because it involved a clinical trial that had to be stopped because the product was causing troubling bone formation in the spinal canal of patients. In the paper, that finding was downplayed, with the authors describing the results as "encouraging."
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