Remedial training for neurosurgeons: “Don’t bill for procedures you didn’t do!”

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

See also:

Surgeons Make Millions on Medtronic Payroll

Is Your Surgeon Able to Understand Simple Questions?

Doctors On The Take: How To Read the Fine Print in Medical Research

“Integrity in Science”: Who’s Paying the Piper?

Harvard’s Ethical Ultimatum to Doc: “Give Up Big Pharma Moonlighting Jobs, or Lose Harvard Teaching Post

Does The Medical Profession Need To Wean Itself From its “Pervasive Dependence” on Big Pharma Money?

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Is ugliness a disease?

Something strange is happening in medicine, according to physician,  bioethicist and author Dr. Carl Elliott in his landmark article in The Guardian called Is Ugliness a Disease?  No longer, he claims, is medicine being used merely to cure illness. Medicine is now being used in the pursuit of happiness. We take Viagra at bedtime and Ritalin before work. We inject Botox into our wrinkled brows and rub Rogaine on our balding heads. We swallow Paxil for shyness, Prozac for grief, and Buspar for anxiety.

“For stage fright we use beta blockers; for excessive blushing and sweating, we get endoscopic surgery. We ask surgeons to trim down our noses and suck fat from our thighs in the pursuit of what we believe to be our true selves.  Continue reading

Paying illegal kickbacks to doctors: just the cost of doing business for Big Pharma?

The drug company Novartis has agreed to pay $422.5 million in criminal and civil penalties for promoting illegal use of its epilepsy drug Trileptaland five other Novartis drugs, the U.S. Department of Justice announced recently. The cases charged the company with promoting off-label use of Trileptal for medical conditions it had not been tested or approved to treat, and also for its illegal targeted marketing efforts.

The marketing efforts that prosecutors took exception to included paying kickbacks to physicians to encourage them to prescribe more of these drugs.

Now, that word kickbacks is a loaded word, and one that I’d imagine the docs who have been accepting this drug money would not likely ever use themselves.   Continue reading

Why you should take Zoloft – for everything!

The smarty-pants over at The Onion have come up with a few new uses for Pfizer’s blockbuster anti-depressant drug Zoloft while taking aim at those Direct-To-Consumer (“ask your doctor”) ads convincing consumers they need it. Even though this concept is a gag, it’s frighteningly close to the reality that Big Pharma is creeping towards.  Continue reading

Fewer physicians are now agreeing to see drug reps

What seems like very good news for those of us concerned about the too-cozy relationship between Big Pharma and our physicians is being viewed with alarm by the drug industry-funded website Policy & Medicine, whose motto is “Supporting Innovation Through Collaboration”.

This is a CorporateSpeak tagline that’s roughly translated as:

“We Put Doctors On Our Payroll So They’ll Flog Our Drugs For Us”

According to Policy & Medicine, a recent U.S. study is “troubling” for both patients and physicians.  Oddly enough, as a heart attack survivor and consumer of a fistful of cardiac meds every morning, I am not remotely “troubled” by this study’s results.  In fact, I’m considerably cheered up.  Here’s why:   Continue reading

Harvard cozies up with Big Pharma

It was like something out of the movie Michael Clayton – only with Big Pharma as the villain: a Pfizer drug rep sporting a severe black suit and taking cell phone pictures of students protesting Harvard Medical School’s ties to the drug industry. Staged last October, the Boston gathering was sparsely attended, with a few students holding signs and a petition delivered to an empty office (the dean was out of town).

But the photographer’s appearance was notable enough to merit a story in the New York Times, which eventually led to a U.S. Senate committee investigation.

And so it goes for Harvard Medical School, according to a report in Boston Magazine that reveals Harvard has actually been under increasingly intense scrutiny since 2008, when a series of incidents put a spotlight on the venerable university’s symbiotic –  if awkward –  relationship with drug companies.

The trouble started that summer, after Dr. Joseph Biederman, a child psychiatrist and Harvard Medical School professor, was found to have taken more than $1.6 million in payments (which he apparently failed to fully disclose to the school as required) from the maker of a major anti-psychotic drug he’d been prescribing.  Continue reading