Earlier this year, the Chicago Tribune reported on a surgeon who implanted devices in patients without telling them he had invented them himself, that he made a profit every time one was used, and that the devices had not yet received FDA approval.
A U.S. Senate committee launched an investigation into reports that doctors with financial ties to the medical device company Medtronic were aware of potentially serious complications with a spine surgery product made by the company, yet failed to reveal those problems in published journal articles.
And in an extraordinary move, a group of U.S. spine specialists are publicly repudiating the research of other experts that has backed the widespread use of a Medtronic bone growth product called Infuse. In a joint editorial along with a series of reports published in the The Spine Journal on June 28, 2011, the five specialists called this research “misleading and biased”, adding:
“It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”
As the New York Times described the journal’s action:
“It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”
At the heart of the issue are potential side effects related to Infuse’s use that emerged during patient studies conducted about a decade ago by outside researchers with significant financial ties to Medtronic. The studies favoured Infuse’s performance over a bone graft, the material traditionally used in spinal fusion procedure. The Times added that it’s too early to predict how the Spine Journal articles will affect the financial fortunes of Medtronic, which earned an estimated $900 million from Infuse in its most recent fiscal year.
Several researchers who were involved in the Medtronic-sponsored studies defended their reports, telling The New York Times that their studies were “scientifically sound and free of company influence, either directly or indirectly”.
One of them, Dr. Thomas A. Zdeblick of the University of Wisconsin, told The Times that he did not have a “direct financial interest in the success of Infuse or Medtronic.” Over the years, however, Dr. Zdeblick received over $20 million in royalty payments from Medtronic in connection with patents on their devices, including one that is used with Infuse.
Five other neurosurgeons at Norton Hospital in Louisville, Kentucky, are also among the largest recipients nationwide of payments from Medtronic. Drs. Steven Glassman, Mitchell Campbell, John Johnson, John Dimar and Rolando Puno allegedly received more than $7 million from Medtronic in just one nine-month period.
Do the math here: five docs, nine months, $7 million in kickbacks.
Two members of the Senate Finance Committee contacted Medtronic on June 21, 2011 demanding financial records and communications between the company and doctors who have received millions in royalties and other payments from Medtronic over the last decade.
Tellingly, Medtronic was also warned by Senate Finance Committee investigators “not to destroy or make inaccessible any of the documents, data or other related information”.
Controversial doctors are as old as medicine itself, according to ProPublica investigators. These doctors’ identities are often known to their peers and even to the government, which compiles a confidential database of physician sanctions.
But patients rarely know.
Restrictions imposed by the U.S. Department of Health and Human Services prohibit naming these sanctioned doctors unless they agree to discuss their Medicare work. The Wall Street Journal explained:
“The data also reveal that a foreign-born surgeon currently operating in Texas has an unusual number of patient deaths associated with an elective procedure. The surgeon was excluded from both the Medicare and Medicaid programs for nine years in the 1990s after the Office of Inspector General of the Department of Health concluded that he had performed unnecessary and inappropriate procedures on seven patients while practicing in New Jersey.
“In two of these cases, the surgeon inappropriately operated on patients who were nearly dead, and he contributed to a third patient’s death by misdiagnosing his condition, according to a letter the Inspector General sent him when he was ousted from Medicare. He was temporarily barred from practicing in New Jersey.
“The surgeon relocated to southern Texas in 2005. He currently operates at five hospitals there.”
* North American Spine Society, June 28, 2011: The Spine Journal Calls for an End to “Years of Living Dangerously” in Promotion of Bone Growth Factors