Gaping hole in med school conflict of interest policies

| 4 Comments

$20,000 or $20,000,000. Come on, it's just a difference of a few zeroes!

The Wall Street Journal story, "Medtronic Paid This Researcher More than $20,000 - Much More," should not be missed.

Plot:

Spine surgeon using Medtronic devices takes money from Medtronic.

How much money?

His university medical center only required him to say whether it was $20K or more a year.

So for five years he declared that "YES" he got more than $20K a year.

Disclosure policy satisfied, right?

It's just that the "more than" was astronomically MORE THAN - like up to $4.6 million in royalty and consulting payments a year, according to the WSJ.

The paper quotes the surgeon's med school dean agreeing that its disclosure requirements are insufficient and “indefensible.�

The WSJ reports that the surgeon says he doesn’t accept royalties on products used on his patients, and that since 1991 he has told patients about his royalty and consulting relationships.

Perhaps it should be made public exactly how that disclosure to patients is handled. I can't imagine.

"I have received $19 million in payments from a company to help develop and promote their products but that hasn't influenced my judgment in the least and I think this is the best product for you. Now, see my nurse to schedule the surgery."

We are all babes in the woods in our grasp of how complex the entanglement of conflicts of interest are in American health care.

4 Comments

What was not addressed in the article is that Dr. Zdeblick has 22 patents that generated the royalties. When someone comes up with a better idea, follows the appropriate process, isn't it the American way to financially reward them? One of his inventions, the LT cage, has proven to be as good as total hip and total knee replacement for improving patient health. It has shortened the surgery time, the hospital stay, shortened the return to work time, improved the overall success rate and probably saved the health care system substantial money (multiple millions?). Don’t we as a nation want to foster this kind of innovation?

Also the presumption that surgeons primarily decide treatments based upon reimbursements is a fallacious argument. The truth is that surgeons really prefer to do procedures that have a high probability of success for the patients. Procedures that have lower probabilities of success take up much more time and effort in the follow-up effort and are emotionally and physically draining for the patients and the surgeons.
In terms of whether surgeons chose a higher priced or lower priced procedures when there is a choice about which way to go has also recently been reviewed.

The following can be accessed through Pub Med by anyone with internet access.

J Spinal Disord Tech. 2008 Aug;21(6):381-6.

Financial incentives for lumbar surgery: a critical analysis of physician
reimbursement for decompression and fusion procedures.

Whang PG, Lim MR, Sasso RC, Skelton A, Brown ZB, Greg Anderson D, Albert TJ,
Hilibrand AS, Vaccaro AR.

Department of Orthopaedics and Rehabilitation, Yale University School of
Medicine, New Haven, CT 06520-8071, USA. peter.whang@yale.edu

STUDY DESIGN: Retrospective case-control study/economic analysis. OBJECTIVE: To
determine the treatment times required for isolated lumbar decompressions and for
combined decompression and instrumented fusion procedures to compare the relative
reimbursements for each type of operation as a function of time expenditure by
the surgeon. SUMMARY OF BACKGROUND DATA: Under current Medicare fee schedules,
the payment for a fusion procedure is higher than of an isolated decompression.
It has been recently suggested in the lay press that the greater reimbursement
for a lumbar arthrodesis may inappropriately influence the manner in which
surgeons elect to treat lumbar degenerative conditions, resulting in what they
believe to be a substantial number of unnecessary spinal fusions. METHODS: A
consecutive series of 50 single-level decompression cases performed by single
surgeon were retrospectively analyzed and compared with an equivalent cohort of
subjects who underwent single-level decompression and instrumented posterolateral
fusion with autogenous iliac crest bone grafting. The operative reports, office
charts, and billing records were reviewed to determine the total clinical time
invested by the surgeon and the Medicare reimbursement for each surgery. RESULTS:
Relative to the corresponding values of the decompression group, combined
decompression and fusion procedures were associated with a longer mean surgical
time (134.6 min vs. 47.3 min, P<0.0001), a greater number of postoperative visits
(1.0 vs. 3.2, P<0.0001), a higher mean total clinical time expenditure (186.6 min
vs. 62.2 min, P<0.0001), and a lower mean dollars received per minute of surgeon
time ($12.51 vs. $15.51, P<0.001). CONCLUSIONS: These findings challenge the
assertion that spine surgeons have an undue financial incentive to recommend a
combined decompression and instrumented fusion procedure over an isolated
decompression to patients with symptomatic lumbar degeneration, especially when
considering the greater time, effort, and risk characteristic of this more
complex operation.

In addition all of the recent randomized trials in spine surgery (SPORT trials) comparing surgical to non-surgical treatment for lumbar disc herniation, spinal stenosis and degenerative spondylolisthesis have all shown that surgery is superior to non-operative care, yet that has not been the media message. Is there biased reporting because this is not sensational news? I think that balanced presentation of the data showing the benefits (and risks) from the advances in spinal surgery need to be in the public domain. Certainly it is not a panacea but it helps several hundred thousand people every year, now with less morbidity than ever before due to innovations from people like Dr. Zdeblick.

I am sure there are some outlier surgeons who do procedures that are marginally indicated, however the majority offer patients procedures with high probabilities of success. And yes, there are surgeons who have good ideas that do consult with industry and are paid for their time. If they have really good ideas that lead to patents and products, they receive royalties on those products. They do NOT receive royalties for those products that they personally use or are used in any hospitals where they practice.

My perspective comes as someone who was a salaried surgeon in a government setting for 20 years, now working in a public setting. I do consultant work and receive an hourly rate in conformance with the Department of Justice approved range. My decision making to recommend or not recommend surgery is the same as it was before. Approximately 1 out of 10 new patients in my practice receive a surgery recommendation. The recommendation is based entirely upon the clinical scenario.

Please Mr. Schwitzer, pursue the whole story and not just the attention grabbing, tabloid headlines. People deserve to know the whole truth, ever if it sells less well than tabloid journalism.

Thanks for your note.

You wrote: "People deserve to know the whole truth."

I couldn't agree more. That's why I take the time to maintain this blog.

The WSJ story - and my post - were about med school conflict of interest policies. The dean of the med school in question agrees that the school's disclosure requirements are insufficient and “indefensible.�

His words, not mine.

That doesn't sound, to me, like people getting the whole truth from current disclosure policies.

That's what I wrote about.

And, as evidenced by the handling of your own medical school's recent conflict of interest task force, I stand by my closing line that we are all babes in the woods in our grasp of how complex the entanglement of conflicts of interest are in American health care.

Dr. Polly,

You might take your own advice and also pursue the whole story.

"In one of the lawsuits settled by the government’s agreement, a former Medtronic employee said Dr. Zdeblick received a “sham� 10-year consulting contract with Medtronic. A copy of the contract shows that he agreed to do two days of work per quarter over 10 years for $400,000 a year…"

Source: Wall Street Jouranal - January 16, 2009.

As Mark Twain said: "Denial ain't just a river in Egypt."

With direct payments to physicians coming under scrutiny, at my institution we've seen a new twist: big pharma donating to tiny "not-for-profits" that exist to increase "education" on a given topic. The funds are used to pay the physician who manages the not-for-profit (that may be run out of a physician's basement office), and to pay other physicians as consultants to the not-for-profit. The consultants meet to write grants for NIH funding of studies using products made by the donors to the not-for-profit.
When a physician/faculty member receives a five-figure honorarium/salary from a not-for-profit funded entirely by big pharma is there a conflict of interest? The recipient, of course, does not believe there is.

About this Entry

This page contains a single entry by Gary Schwitzer published on January 17, 2009 8:55 AM.

Is "substantially equivalent" good enough for approval of new medical devices? was the previous entry in this blog.

Surprise! PhRMA chief doesn't want Medicare negotiating drug prices is the next entry in this blog.

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