Vol. 70 July 1, 2012 There’s a New “F” Word in Town

July 1, 2012

Care is never futile, but medical interventions sometimes are. (1)

Ten years ago our community hospital’s Ethics Committee spent a lot of time trying to reach a consensus on the meaning and implications of the “F” word. Our context almost always was the ethical dilemmas of end-of-life decisions, renal dialysis, continued ICU care, and mechanical ventilation support. Was it ethical to continue renal dialysis on the Jamaican woman when we considered dialysis to be a medically futile treatment or should we send her back to her country as she requested where it ws not avialable?  Should the young man comatose after being struck by lightening be continued on ventilation support when any further treatment appeared to be futile?

At that time our futility discussions focused primarily on patient or family “demands” to continue expensive therapy with little hope of real benefit to the patient. Our discussions closely mirrored articles in the medical and popular literature at the time, and, likewise, did not result in a consensus of the definition of futility. At a 2003 meeting our Ethics Committee reviewed four different kinds of failed attempts to define futility, 1) by reaching a medical consensus, 2) by using empirical data, 3) accepting patient-defined futility, and 4) accepting physician-defined futility. We could only conclude that sometimes all we could say was, “We feel that further care is futile.” There are three “F” words in that simple sentence. Our attremptd emphasis on feelings never really helped in making the message any easier to deliver, understand, or accept. Trying to substitute one “F” word for another never really stuck to the wall.

With the passage of the Affordable Care Act the context of “futility” discussions has broadened considerably as legislators, insurance companies, and providers struggle with the central problem of how to pay for universal access to all kinds of medical care without using the “R” word.  The most recent example of that changing context is an essay by a MD lawyer advocating the new “F” word of “Frugality” (2).

The author argues that even if and when we reduce medical care costs by eliminating the estimated 30% spent on “wasted or ineffective measures” (3) we will still be facing the apparently inexorable annual rise of medical care costs “unless we start saying no to some beneficial care”. He does not think that the Independent Payment Advisory Board (IPAB) with the authority to change Medicare payment policies, or the Medicare “luxury tax” on Cadillac employment-based health insurance, or the current incentives for new Accountable Care Organizations and insurance companies will be enough to slow the rise of medical care costs. The new “Frugality” will only be achieved by more selective adoption of new technology. This means that after we say “no” to non-beneficial technology “we will need to say ‘no’ to some potentially beneficial new technologies because of imperfect data about clinical effectiveness”.

Daniel Callahan, President Emeritus of the Hasting Centers and one of our most respected Medical Ethics gurus, made the same argument in his 2009 book, Taming the Beloved Beast: How Medical Technology Costs are Destroying Our Health Care System (4) His opinion is that multiple studies in the 1980s-1900s comparing the cost reduction effects of regulation vs. competition are inconclusive, and that there is little evidence that the “business model” of competition works in health care. His solution to reducing medical care costs is to restrict the unbridled introduction of new technology. In his view new technology often raises the cost of medical care without improving health. The answer is rigorous assessment of new technology (both drugs and devices). “Technology assessment must COMMAND, not just COMMEND.”

“Futility” is such a negative, dead-end word. It is the end. “There is nothing more we can do.” It is colored by end-of-life issues, discussion of which are necessary and important, but which have become politicized.

“Frugality” implies a positive value, a process. “Thrifty” made it to the Boy Scout pledge, but it could have been “frugality” just as easily.
Lets hope that “frugality” sticks to the wall.
We shall see.

1.Poncy M. Ethics and futile care. Program and abstracts of the National Conference of Gerontological Nurse Practitioners 25th Annual Meeting; September 27-October 1, 2006; Ponte Vedra Beach, Florida.
2. Beyond the “R Word”? Medicine’s New Frugality, NEJM 366;21, G. Bloche, pg. 1951
3. Implications of Regional Variations in Medicare Spending, Ann Int Med 2003;138, Winneberg, et al., pg. 288-298
4. Princeton University Press, 267 pages

Vol. 69 June 15, 2012 How to Avoid the “R” Word.

June 15, 2012

“We make those decisions all the time. The decision is not whether or not we will ration care — the decision is whether we will ration with our eyes open.” –Donald Berwick, MD

When infinite demand exists for finite resources certain decisions have to be made by those responsible for distribution of the resources. It is called “rationing“.  And that is what is causing all the palaver about reducing medical care costs. Who decides, how do they decide, and how do the decisions get implemented? “Rationing” has become the political lighting rod of that discussion and any politician or candidate (or even Director-designee of CMS) that does not successfully avoid its use is at great political peril.

A recent thoughtful essay in the NEJM advances the case for substituting “avoidance of waste” for the “R” word. (1) Since 30% of our medical care costs go to tests, treatments, drugs, and medical devices that in truth result in no patient benefit (2), the author argues that, at least, we should first eliminate the non-beneficial expenses. Consumer Reports in cooperation with American Board of Internal Medicine and 16 other medical specialty societies has recently published its list of non-beneficial medical activities for us to avoid. They call the campaign “Choosing Wisely”.

Since many very expensive items can be categorized as new technology, the author also argues for a more rigorous standard for the approval of new technology. New technology currently needs ONLY to prove that is safe and that is better than a placebo. There is NO requirement that it show that it has better outcomes than existing technology. This is true for drugs, PET scanners, linear accelerators, organ and bone marrow transplants, cardiac surgery, and all the different kinds of heart vessel stents. Highly technical, complex, and expensive gene treatment (“personalized medical therapy”) is just now peeking at us around the corner.

If a standard of improved outcome for new technology were in place, how would it be implemented? The ACA established the Center for Comparative Effectiveness Research within CMS to gather comparative outcome data and make recommendations, but the ACA also explicitly denies the CMS the authority to use such recommendations in setting Medicare reimbursement rates!

For example, in the very same issue of the NEJM there is an elegant multi-center study that leads to the implementation questions for a less dramatic, not-quite-so-emotionally-laden, but much more common condition than heart transplants and exotic “savior” cancer drugs; urinary incontinence in women. This study showed beyond a doubt that urodynamic testing results on women who go to a urologist because of urinary stress incontinence had no effect on the outcome of the surgery. The surgery is successful 69-72% of the time whether the urodynamic testing is done or NOT. In other words, the clinical judgement of the urologist in the office is enough to indicate who is likely to benefit from the surgery.

The urodynamic testing, with it’s charge in the U.S. of $640-$1503 depending on the insurance company and region, adds no benefit. The article’s authors (all 34 of them) flatly state that urodynamic testing for women presenting with stress incontinence should not be done. (the same conclusion made by NICE, National Institute for Health and Clinical Excellence, in the U.K. in 2006). The article does list four specific instances where urodynamic testing might prove helpful; 1) patients with previous surgery for incontinence, 2) presence of neurological disease, 3) patients planning more extensive pelvic-organ relapse corrective surgery, and 4) urge-predominant incontinence rather than stress-incontinence. All of these definable situations can be documented in the medical record for the few patients who have them.

How could such a reasonable, well-founded recommendation to reduce costs without compromising quality be implemented?

1) Medicare could refuse to reimburse for urodynamic tests in uncomplicated stress incontinence patients. This is without doubt the most direct way to save these costs. Private insurance would soon follow suit after the political and medical backlash quieted down (urodynamic studies are almost always done in the urologist’s office and can represent a significant revenue stream to the office). Current ACA language explicitly prohibits this action.

2) ACO’s could implement a practice guideline recommending avoidance of urodynamic testing before usual stress continence surgery. Any resulting cost savings could be shared by all the physicians in that ACO. Urologists would receive a portion of the savings to offset their revenue loss, and they in turn could ask the other specialties in the ACO, “What have you done for us lately, so that we can share in some of your cost savings”.

3) Physician leaders in the urological specialty and academic centers could support educational efforts to inform their members of the non-benefits of urodynamic testing for most patients and wait for its use to fade away under the weight of replicating, confirming studies, and editorial comments.

This third option is often how our practice patterns currently change, but it is a slow process as shown by our continued discussions of the comparative benefits of open heart surgery or various vascular stents. That this “revelation” about the non-benefits of urodynamic testing has been around since 2006, but still warrants an article published in a 2012 NEJM is another clue about the pace of change. Given the inevitability of rationing and the moral repugnance of doing so with broad-brush budget caps monitored by bureaucrats, arbitrary decisions by non-accountable insurance companies, price-based decisions by for-profit drug companies, age-based discrimination, or by economic or social class classifications, we can only hope that we can find a better way.

Comparative Effectiveness Research under the ACA could develop evidence-based standards to be implemented by ACOs of high quality, cost-conscious physicians who would then share in the savings resulting from their hard work of changing practice patterns appropriately. Otherwise, we may have to settle with our current system of “muddling through” and try to be patient with the plodding pace of change as we watch the treasury run dry.

It might help if we did replace “rationing” with “avoidance of waste”, but I don’t hold out too much hope for that. It will take more than one article and a less insipid term to capture our imagination.

In my next blog on July 1, I will describe how to avoid the “F” word.

1. “From an Ethics of Rationing to an Ethics of Waste Avoidance”, Howard Brody, M.D.,Ph.D; NEJM 366;21 May 24, 2012: p. 1949
2. “The Implications fo Regional Variations in Medicare Spending”, Wenneberg et al., Ann Intern Med 2003;138: p. 288
3. “A Randomized Trial of Urodynamic Testing before Stress-Incontinence Surgery”, Nager et al., NEJM 366;21 May 24, 2012: p.1987

Vol. 53 October 15, 2011 The Heart of the Matter

October 14, 2011

Imagine that you are over 65 years old and you have a failing heart. Your doctor tells you that you are at “maximum medical treatment” and are not eligible for a heart transplant because of your age and other medical conditions.  Then the doctor mentions that a pump could be implanted in your body to help your heart pump more blood; a left ventricular assist device or LVAD.

Imagine a small device put into your chest during open heart surgery that could help you pump enough blood around so that some of your old energy would return and you could resume some, but not all, of your usual activities.

Imagine that Medicare would pay for the operation, device, and medical follow-up. Then try to imagine what the $228,039,342 Medicare paid for about 1500 of these operations would look like if spread out on a table in hundred-dollar bills.

Imagine what it would be like to be one of the 55% (815) of patients who survived the operation and left the hospital alive after receiving this pump. Imagine how even happier you would be if you were one of the 43%  (350) discharged alive who was still alive 2 years later. Imagine your relief when Medicare pays the average $1,000 a day hospital rate for the 56% of pump recipients who have to be rehospitalized at least once in the 6 months after implantation.

Imagine your perplexing thoughts when a statistician tells you that your life extension cost about $60,057 “per quality-adjusted life-year”.

Imagine that your psyche and your family can handle the burdens of multiple medical visits, utter dependence on the infallibility of a medical device, 24/7 family care and vigilance, strict adherence to medication regimens, worries about medical and financial complications, and alteration of body image perceptions that can lead to depression and anxiety.

Imagine how your life might actually end. If you turn off the pump it is suicide. If your doctor or family member turns off the pump it is either euthanasia, assisted suicide, or ethical withdrawal of therapy depending on the status of your permission (and maybe the State you are in).  Perhaps you will develop a new fatal condition from which you will die with the pump running. Imagine if you lived long enough to require a pump replacement.

Imagine that part of the pre-operative process before the pump is implanted is a detailed discussion with your physician (and your family hopefully) about how and when YOU would want the pump turned off.


Then imagine how a “rationing” process to cut medical care costs under Medicare might work in this situation.

Imagine how it might work if you were the patient rather than Mr. Cheney.

Blogs have already appeared making the argument that Steve Jobs would not have lived his “extra” two years with a liver transplant under U.K. or Canadian health systems.

Medical ethics are about “where you draw the line”. Remember that in the beginning of this scenario your doctor said you were “ineligible” for a heart transplant. That was a drawn line, a rationing decision. Our current dilemma and sometimes heated discussion is really about WHO draws the line. (Medicare, Medicaid, private insurance or pharmaceutical company, Congress, professional specialty societies, health care lobbyists, medical ethics committees, Comparative Effectiveness Research in the U.S., NICE in the U.K., individual physicians and patients, or God)

*shamelessly copied from Matthew McConaughey’s dramatic closing speech to the jury
saving Samuel L. Jackson’s life in A Time To Kill  by John Grisham.

Journal of Medical Ethics, Spring 2011, Vol.18, issue 2, published by Lahey Clinic; LVADs as destination therapy: difficult ethical decisions.

Taming the Beloved Beast: How Medical Technology Costs are Destroying Our Health Care System, Daniel Callahan, 2009, Princeton  University Press

Vol. 49 August 1, 2011 How Did “Fat” Become “Obese”?

August 1, 2011

I was really tired of words like ‘plus size,’ ’round’ and ‘large.’ I thought, ‘Come on, we’re fat.’

Kirstie Alley

For the first time ever, overweight people outnumber average people in America. Doesn’t that make overweight the average then? Last month you were fat, now you’re average – hey, let’s get a pizza!
Jay Leno

We used to call overweight people “fat”.  Now they are “obese”.

This now politically-correct nomenclature has emerged from the medicalization of heaviness.

You use to be able to tell when someone was overweight by just looking at them. Now you must calculate their BMI, a measurement derived from height and weight, that superseded the more primitive measurement of skin fold thickness that nobody liked doing anyway. Scientific-looking graphs allow you to plot BMIs on a percentile scale. If your BMI is over the 90%tile you are REALLY FAT, excuse me, obese.

You can graduate from being merely obese to the Metabolic Syndrome with just a few blood tests; triglycerides, cholesterol, and insulin levels. People with Metabolic Syndrome have large belt circumferences; ie. they are fat. If your belt length is over 47 inches your mortality rate is doubled. (1) If you are a man with a belt circumference over 35 inches you are at increased risk for heart disease, stroke, hypertension, and , of course, diabetes. Overweight people tend to develop diabetes, so now all fat people are “pre-diabetic”. In fact half of the U.S. population could be called “pre-diabetic”. This recognized medical diagnosis has changing criteria. Just ask your own doctor what level of blood sugar he or she now considers “pre-diabetic”.

A pediatrician and a lawyer from Children’s Medical Center in Boston recently suggested that really fat children should be removed from their families by the state because extreme obesity in a child should be considered a form of child abuse; a striking example of the medicalization of  heaviness (2). One of the problems with this idea is that “you can’t pick your parents” and obesity does have a large genetic component. If parents are fat, their children will tend to be so also (even if they reside in a foster home).Once you start expanding the definition of child abuse where do you stop? What about parents with more than the  “normal number” of guns in the house. What  is that number? What about parents who watch more than 6 hours of TV a day? More than likely their kids do too, and we know that  prolonged TV watching leads to obesity.

No less a moral authority than renowned biomedical ethicist Daniel Callahan, retired Director of The Hastings Center  (dare I call him a “heavyweight”), has joined the discussion. In “Harnessing Stigma or Stigmatizing Stigma? The Case for Obesity” he proposes that the obese be subject to the same social stigmatization as smokers. The similarities are numerous. Both cause expensive medical illness. Both seem to be the result of individual’s choices. Calorie counts on foods are now required like Surgeon General’s warnings on cigarette packs. Callahan never published the article after public health researchers battling against the stigmatization of fat people changed his mind; i.e he returned to  “political correctness”. (Ah hah! When battling for a cause it is OK to call them “fat”, not “obese”.) Ironically if everyone stopped smoking the improvement in life expectancy would be completely cancelled out by the decreased life expectancy of obesity. If everyone in the U.S. stopped smoking AND returned to normal weight, our average life span would increase by almost 4 years. (3)

The many modes of obesity treatment are only 4% effective. Gastric bypass surgery has great potential for weight loss, though its reasons for effectiveness are still a subject for speculation and research. (4) So unlike smoking which is an addiction and perhaps more amenable to behavioral therapy and temporary medication aids, being fat is “more about the person and less about the behavior” according to Rebecca Puhl, Director of Research at Yale’s Rudd Center for Food Policy and Obesity.

That title definitely plays better than “Yale’s Research Center on Fat People.”      Q.E.D.

1. Arch Int Med 2010 Aug9/23 170:1293
2.State Intervention in Life-Threatening Childhood Obesity    JAMA. 2011;306(2):206-207.
3. NEJM 361;23 22252
4. Lee Kaplan, MD, 2007, MGH Weight Center, MGH)

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