Dr. Vishal James Makker is an Oregon neurosurgeon with movie star good looks, a bedside manner that’s been described as “charming”, and a distressingly questionable track record for performing multiple spinal operations on his patients. In fact, the Pulitzer Prize-winning investigative journalists at ProPublica have revealed that an analysis of Medicare data shows that Makker had the highest rate of repeat surgeries in the U.S. - a rate that’s nearly 10 times the national average.
Makker operated on patients up to seven times; many patients complained of additional health problems as a result of those extra surgeries. And as fellow spine surgeon Dr. Charles Rosen, who is president of the Association for Medical Ethics, says:
“When you get to numbers like six and seven surgeries on someone’s spine in a short period of time, that starts to be suspicious.”
Makker told The Wall Street Journal that he never convinced patients to have surgery, and that all the procedures he performed were medically necessary.
But he’d allegedly also told his colleagues that he was a partner in a physician-owned distributorship, or POD, called Omega. Documents show Omega paid surgeons up to $500,000 a year to use specific spinal implants.
Makker is not alone. 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.
And a U.S. Senate committee has 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.
UPDATE, June 30, 2011*: 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 has 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 powerful members of the Senate Finance Committee contacted Medtronic on June 21, 2011 demanding an extensive list of documents, including 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”.
Meanwhile, back in Oregon, the Oregon Medical Board issued a “complaint and notice of proposed disciplinary action” in April 2006, alleging that Dr. Vishal James Makker:
- performed “medically unnecessary” spinal fusions on several patients without obtaining their prior consent
- did not provide the patients with adequate follow-up care
- billed for procedures he didn’t do
Without admitting or denying wrongdoing, Makker agreed to complete a remedial training program and a billing course.
I love that kind of brutal disciplinary action. What do they teach docs in remedial training programs like this anyway?
“Never perform medically unnecessary spinal fusion operations without getting the patient’s permission first!”
Q: Don’t they already teach you that in med school?
In less than nine years of practice, Makker has been sued by eight patients alleging medical malpractice, court records show, compared with the national average for American neurosurgeons of about one lawsuit every two years, according to the medical malpractice insurer, The Doctors Company.
Dr. Charles Rosen also told ProPublica:
“The action against Dr. Makker by the Oregon Medical Board means it had to intervene to protect the public health. That’s serious.”
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, as Makker did. 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.”
Read the rest of the ProPublica report.
* 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
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