Thursday, October 25, 2012

The Risk of Deviating from Guidelines - Oklahoma

Medicine is frequently cited as a major cost driver in workers' compensation systems (heck, medicine is seen as a major inflationary contributor to the overall economy).

It's been a sadly accepted fact that medical costs outpace overall inflation by several basis points for a couple of decades - and usually the blame is put on societal expectations, malpractice protection costs, and various other fundamentals that factor into the complex equation of cost generation.

We forget though that medical inflation very often isn't tied to the community physician over-billing or performing unnecessary procedures. I think that much of medical inflation can be traced back to Big Medicine.

Oklahoma is in the process of adopting treatment guidelines. The legislature saw fit to designate Work Loss Data Institute's Official Disability Guidelines (ODG) as the standard for measuring and controlling medical care. But Senate Bill 878, passed in 2011, authorized the Workers’ Compensation Court to adopt state guidelines as exceptions to the ODG.

I've opined before that the human body is no different in one state than another (or even country), and that there is no justification for deviation from well researched, scientifically established, peer reviewed, evidence-based guidelines.

The argument presented to me in rebuttal by the medical community is that such guidelines are behind the times because of the latency between introduction of a new procedure and the publication of research. I've also taken heat from the medical community because, they argue, there ARE local differences that can not be accounted for on a national (what about international?) basis, and that physicians who are on the front lines with the patients know best how to treat because of their experience and expertise.

ODG is a national standard, and though its primary competition, the American College of Orthopedic and Environmental Medicine (ACOEM) guidelines have some differences, those deviations are minor. Both are based on evidence-based medicine that has been independently peer-reviewed. Where evidence does not adequately support a procedure then either a procedure is not recommended or is advisory only subject to future research and review.

Thus, these guidelines, sometimes derided for being "cookbook medicine," provide a solid foundation for medical treatment that is supported by years of scientific research.

But sometimes legislators and regulators become subject to persuasion from outside interests that have agendas beyond "cure and relieve." And without proper independent scrutiny those at the helm can be convinced that any given procedure has validity.

So in Oklahoma the Physician Advisory Committee of the Oklahoma Workers’ Compensation Court has approved proposed spine treatment guidelines that would allow physicians to deviate from the ODG.

The committee guidelines differ from the ODG on use of cervical and lumbar discography, spinal fusion, and most notably the use of bone-morphogenetic proteins (BMPs).

BMPs stimulate bone growth in the human body. The proteins can be produced, concentrated and placed in the area of the spine where a spinal fusion is to take place.

The primary goals of using BMP in spinal fusions are to create a spinal fusion as good as or better than using the patient’s own bone and to eliminate the need for harvesting the patient's bone from the hip to avoid the potential side effects and complications of the bone-harvesting procedure.

Big biotech company Medtronic makes the Infuse Bone Graft that contains BMP. Medtronic reported revenue of $16.184 billion in fiscal 2012.

The Oklahoma committee was doubtlessly persuaded as to the efficacy of BMP and the other procedures by alleged medical research (and perhaps lobbying by Medtronic agents).

But in June 2011, The Spine Journal published two articles about Medtronic's product Infuse, one that alleged the product may increase the risk of sterility in men, and another that asserted the product’s adverse effects were not properly reported in clinical research. The publication pointed out that researchers for 12 of the product’s 13 industry-sponsored studies had multimillion-dollar “financial associations” with Medtronic.

A federal probe of Medtronic closed in May of this year without disclosure of its findings though other investigations and civil lawsuits continue. Medtronic has already settled a shareholder class-action lawsuit that was filed in 2008. The lawsuit claimed that Medtronic misled shareholders by not disclosing how much of the company’s Infuse-related revenue was derived through uses that were not approved by the FDA. The lawsuit also accused Medtronic of illegally marketing the product for unapproved uses.

I'm not saying that Medtronic is behind Oklahoma's deviation from ODG, but simply pointing out that there can be considerable conflicts of interest when an agency is permitted to deviate from an independent, published, national standard (although in other states Medtronic has been quite publicly behind liberalization of treatment guidelines - Arizona in particular of late).

Doctors don't like to be told how to practice medicine. I get that. But in reality the training of a physician IS to follow the science first. And to do no harm.

There's a reason why there are practice guidelines in the first place - to replace as much as possible "expert opinion" with factually established patterns of efficacy, and minimal harm.

This blog is opinion. Some people think I'm an expert.

Would you seriously rely on this blog to support a decision that has otherwise been the subject of scientific research?

Then why would one rely on "expert opinion" in the face of altering another's life?

Medical inflation has many causation ties to Big Medicine. Big Medicine can and does influence medical decision making and the conflicts of interest are great.

There's not a lot going on in occupational medicine that is cutting edge or experimental. Ergo, deviation from established guidelines (ODG and ACOEM) is unnecessary and has no place in workers' compensation medical treatment.

EDITED 10:14 PDT: Coincidentally  a Senate finance committee report released concurrently with this blog post takes Medtronic to task for paying about $210 million from 1996 to 2010 in consulting fees, royalties and other payments to doctors involved in outside research on Infuse.

1 comment:

  1. David,
    Your thoughts regarding the use and misuse of medical treatment guidelines are very much appreciated.
    As I read your essay today, three points came to mind. First, corporate interaction with health care decision making is endemic, whether that corporation is a device or drug manufacturer, a commercial health plan, the corporate parent of a medical group/foundation, a comp insurer or the publisher of treatment guidelines (to name a few). I believe one is hard pressed to tell any meaningful difference between the intentions of one or the other when it comes to decisions about a patient's medical health and the corporate bottom line. There is no altruism. Second, I believe you agree that Guidelines are just that, guidelines. Too often, especially in comp, treatment guidelines become hard and fast rules used primarily to control costs rather than decide what is, and is not, effective medicine. Third, I believe that EBM guidelines remain, in the large majority, the result of community consensus building rather than a straight-line relationship between "grade-A scientific studies" and a predictable medical outcome. One organization may use a fancier name for “consensus” than another, but when it comes down to it, putting a group’s collective heads together and agreeing, is still the bedrock of how guidelines are built. Therefore, I believe it should also be the process that physicians must use to make decisions about their patient’s care and treatment – regardless of the health care system in which they practice.
    It’s no wonder that legislators can easily be confused. I am not sure that anyone can or should tell us where the brightest line exists except as an advisory – a guideline. To attempt to do so in law should never be anything more than the proverbial line in the sand that must be redrawn as time goes by. All eyes must be wide open.
    I also believe you might agree that an attempt to codify behavior of any sort is only effective when the participants cooperate in the process. When either or both attempt to get the upper hand for their own sake, to gain undue control, it results in unnecessary victims. In comp, too often the victims are the person who is already injured and by extension, their employer who pays to clean up the mess.
    Steve Cattolica