The New Presidential Ethics Commission Report

You may never have heard of a national bioethics commission. At best, such commissions can perform a valuable synthetic function, summarizing the best current thinking on a controversial ethical topic. The 2 reports of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, one on defining death and one on decisions to forgo life-sustaining treatment, did exactly that. As Alexander Morgan Capron comments in his article, “Governmental Bioethics Commissions: the Nature of the Beast,” (Lahey Clinic, Fall, 2002) these reports were successful because they “built a bridge connecting the legislative and executive branches, experts and academics in science, philosophy and law, and the general public,” resulting in the adoption of better policies. Regrettably, the current “President’s Council on Bioethics,” appointed by President George W. Bush and chaired by Dr. Leon Kass, has not served as a forum for public discussion of controversial issues, but rather as support for the president’s political agenda (for a discussion of how this problem could be remedied, see Arthur Caplan’s article, “Free the National Bioethics Commission”.)

The newest report, “Taking Care: Ethical Caregiving in Our Aging Society,” (September, 2005) has unfortunately adopted the ideological coloring of the executive branch. Taking Care is important in recognizing that one of the major challenges our society faces is how best to deal with the growing elderly population, many of whom will develop dementia. It makes the critical point that dementia in particular and frailty in general are unlikely to disappear any time soon. But the ideological driving force behind the report is the belief that euthanasia and assisted suicide are “antithetical to ethical caregiving” and “should always be opposed.” The report devotes one of its four chapters to a tirade against advance directives. The authors seem to think that the purpose of advance directives is to enable patients to decide, at the first sign of incipient frailty, to end their lives by forgoing life sustaining treatment. They envisage long lines of patients clamoring for physician assisted suicide. In fact, in Oregon, the one state where PAS is legal, a total of 33 people availed themselves of it in 2004, accounting for less than one-eighth of one percent of the deaths in that state. And advance directives, for all their flaws and limitations, have as their goal to enable prospective patients to avoid unwanted, burdensome, and often near-futile treatment near the end of life.

The report is also disturbing in its excessive focus on family caregivers. Having attacked individual autonomy as inadequate, Taking Care endorses family responsibility for the frail elderly. The relentless emphasis on individual responsibility that characterizes much of modern biomedical ethics may indeed be inadequate to address the situation of impaired elders. But surely a more communitarian vision warrants consideration—a society in which we build nursing homes and assisted living facilities that are truly resident-centered, rather than “total institutions,” a society in which we develop a system of health insurance that includes long term care and that provides excellent treatment for chronic as well as acute conditions, and in which we find ways to enable people to remain engaged and contributing citizens, even if they have problems with their hearing, their vision, their memory, or their walking. Taking Care seems to echo the party line that “family values” are paramount. Let us hope that this report receives the disregard it deserves.

The Medicare Cuts

Last week, President Bush released his proposed budget for 2007, which included $36 billion cuts in Medicare spending over 5 years. The response has been anxiety on the part of older people who worry their benefits will be slashed, as well as by hospitals and physicians who depend heavily on the Medicare population for their business. But are the cuts—if they go through, and in an election year, many will not—such a bad idea?

Medicare spending is growing at a phenomenal rate. If we don’t put the brakes on it, according to some projections, Medicare will consume 24% of all federal income tax revenue by 2019 and 51% by 2042 (quoted in “Medicare: A Ticking Time Bomb for Tax Increases” by Daniel Mitchell of the Heritage Foundation). We won’t have much left for education, housing, and other social programs (leaving aside the issue of national security). The Medicare prescription drug benefit alone, crucial as it is for the millions of elderly people who rely on medicines to treat chronic illnesses and who previously had no drug coverage, is expected to cost at least $700 billion over the next 10 years. It won’t do to protest every attempt to control Medicare spending. The question is not whether Medicare should be trimmed back, but how.

The suggested approaches in the President’s budget largely reflect the recommendations of the Medicare Payment Advisory Commissions (MedPac), an independent, bipartisan panel that has a reputation for thoughtful, careful proposals. And it’s important to realize that the budget proposal isn’t calling for lower reimbursement rates than currently prevail; it’s calling for a smaller increase than previously planned (eg payments to hospitals would increase by 2.9% rather than 3.3%). Moreover, to complement moderately increased reimbursement rates, Medicare would introduce a quality incentive payment policy for hospitals. While this has to be done carefully to make sure hospitals are not penalized for taking care of the sickest patients (if quality is defined in part by mortality rates, for example, adjustments must be made to take into consideration just how complex and elderly a hospital’s patients are), it is potentially a means of stimulating improved quality of care.

One piece of the budget that is worrisome is the freeze on prospective payment rates to home care agencies and skilled nursing facilities. Home health care has been one of the fastest growing components of the Medicare budget and is thus a logical target for cost-cutting. But a large fraction of the cost of home health care and of nursing home care is labor. And most of this labor is provided by aides, who are among the lowest paid, least appreciated workers in the US economy. The average hourly wage for a nursing home aide, as reported in 2002, was $8.29, less than what she would earn working in a fast food chain. Only 68% of home health aides receive health insurance from their employers. To make matters worse, home health aides and certified nursing assistants experience higher injury rates than workers in any other industry, including the construction industry. Lifting and turning sometimes resistant older people is literally backbreaking work. (Statistics are from Nora Super, “Who Will Be There to Care? The Growing Gap between Caregiver Supply and Demand,” a National Health Policy Forum Background Paper, issued January, 2002). To freeze payments to home health agencies and nursing homes will prevent wages from rising for their workers. As it is, we are facing an imminent shortage of long term care workers. The number of people who will need personal care (whether in a nursing home, assistant living facility, or at home) is going to soar from 8 million today to 19 million in 2050, at the same time that the working population is growing slowly. If we want to have aides to care for older people, we need to make the work more attractive—and freezing salaries at their current low rate is exactly the wrong way to proceed.

What’s striking about the proposed Medicare spending cuts is what measures aren’t included that should be. Right now, Medicare will reimburse for any medical treatment that it accepts as “reasonable and necessary.” Costs don’t figure into reimbursement decisions at all: the Centers for Medicaid and Medicare Services (CMS), which runs the Medicare program, pays for technology and now medications even if their added benefit is miniscule and their cost is enormous. As an example, Medicare will pay for the left ventricular assist device, a kind of partial artificial heart. This device is implanted in people with extremely severe heart failure who are too sick or too old to qualify for a heart transplant, at a cost of roughly $250,000. Even with the device, about half such patients are dead within a year and only a quarter are alive at the end of 2 years. People who have the device are at high risk of developing severe infections, bleeding, or device failure (which necessitates a second open heart operation). One way to rein in Medicare spending is for CMS to consider costs in its decisions about which treatments to reimburse. A well-established way of doing this is with cost-effectiveness analysis, a means of comparing the costs of alternative strategies for treating the same condition relative to their efficacy. For the left ventricular assist device, a cost-effectiveness analysis by Blue Cross/Blue Shield shows that the cost/quality-adjusted-life-year, the standard unit of measurement, is about $500,000, compared to the benchmark of $100,000/quality-adjusted-life-year for widely accepted procedures such as kidney dialysis (see the report by the Technology Evaluation Center of BC/BS, “Special Report. Cost-Effectiveness of Left-Ventricular Assist Devices as Destination Therapy for End-Stage Heart Failure,” released in April, 2004).

The Bush budget proposal starts the critically important process of controlling Medicare spending. It includes a number of reasonable strategies, and several short-sighted ones. But it misses a major opportunity, the chance to systematically build considerations of cost into the process of deciding what Medicare will cover and what it won’t.

Americans, Alzheimer’s, and Aricept

According to the drug company giant Pfizer, 2.4 million Americans have taken donepezil (Aricept) since it was approved by the Food and Drug Administration in 1996 for use in mild to moderate Alzheimer’s disease. The British think tank, NICE (National Institute for Health and Clinical Excellence), which evaluates the effectiveness of drugs and devices, reported last month that the drug’s usefulness is very limited. If it’s helpful to anyone, it’s mainly those with somewhat more advanced Alzheimer’s who stand to benefit. By contrast, the American Academy of Neurology says that “considering” Aricept is the “standard” approach for mild to moderate disease (RS Doody et al, “Practice Parameter: Management of dementia: An Evidence Based Review. Report of the Quality Standards Subcommittee of the American Academy of Neurology,” Neurology 2001; 56: 1154-66.) And the Alzheimer’s Association, the leading non-profit advocacy group in the field, while falling short of endorsing the use of Aricept and related drugs, recommends their use “if clinically indicated, to treat cognitive decline.” (California Workgroup in Guidelines for Alzheimer’s Disease Management: Alzheimer’s Association of Los Angeles, Riverside and San Bernardino Counties, 2002).

The latest dispute over anti-Alzheimer’s drugs began last March when, after performing an exhaustive review of every study published on the effect of the drugs on cognition, on daily functioning, or on behavioral symptoms, NICE issued a report concluding that neither Aricept nor its newer cousins, Rivastigmine and Galantamine, were worth the money the National Health Service (NHS) spent on them. They clearly did something—they produced a statistically significant improvement in various test scores, but the real life benefit was miniscule. When NICE released its report, family members of Alzheimer’s patients, physicians, and of course the drug manufacturers, were outraged. They were convinced, based in many cases on anecdotal experience, that the drugs worked. NICE responded by asking the drug companies to produce evidence that there were in fact subgroups of people who benefited substantially from this entire class of drugs, known as cholinesterase inhibitors.

Last month (January, 2006) NICE released a new report in which it once again asserted the drugs are of no meaningful use in people with mild Alzheimer’s. They concede there may be enough benefit in people with moderate Alzheimer’s to warrant trying them. In other words, even after bending over backwards to find some justification for recommending the use of Aricept and similar drugs in people with early Alzheimer’s, NICE just couldn’t find any.

The view that Aricept, with US sales in 2004 of just under a billion dollars, probably shouldn’t be used in most of the patients for whom it’s prescribed, has so far been largely ignored in the U.S. It hasn’t been picked by the New York Times or the Washington Post or by the news section of leading American medical journals such as the Journal of the American Medical Association. And this isn’t the first time we in America have chosen to pay little attention to fairly compelling evidence that Aricept doesn’t work well. In 2004, another British study, this one a randomized controlled clinical trial, tested whether Aricept could delay nursing home placement, a claim made in many advertisements for the drug. The study, which compared 283 patients who got Donepezil with an equal number who did not, found the two groups had exactly the same chance of admission to a nursing home (AD2000 Collaborative Group, “Long-Term Donepezil Treatment in 565 Patients with Alzheimer’s Disease: Randomised Double-Blind Trial,” Lancet 2004; 363:2105-10.) It was published in a leading journal, the Lancet, and did generate a response by the Alzheimer’s Association, journals such as the Journal of the American Geriatrics Society, and also by the New York Times, but many practicing physicians remained unaware of its existence. The study has been criticized on a variety of technical grounds. But why accept the results of earlier, small, non-randomized studies and reject the results of a much better, although less than perfect, randomized study? Only a fervent desire to believe the conclusions of the study that professed to show Aricept keeps people out of nursing homes can explain this phenomenon.

The irony is that when the cholinesterase inhibitor Tacrine was first alleged to help in Alzheimer’s disease, back in 1986, the American neurologic community was extremely skeptical. How could a drug that worked by preventing the destruction of a neurotransmitter in the brain (acetylcholine) be useful in a disease in which the nerve cells that used that neurotransmitter had already been destroyed? And the skeptics seemed justified when the experiments behind the first enthusiastic reports were found to be if not fraudulent, at least questionable. After years of further study, rigorous tests established that the drug did have a statistically significant effect. Whether it had a clinically meaningful effect was another matter.

Even when Tacrine was approved by the FDA in 1994, and then, in record time, its successor, Aricept, was also approved, many Alzheimer’s researchers were dubious that the drugs was actually helpful. John Growdon, a prominent researcher at the Massachusetts General Hospital in Boston, wrote diplomatically in an editorial in the New England Journal of Medicine that “the expectation of benefit…exceeds reality.” Yet use of cholinesterase inhibitors in the US has become more and more widespread. In 2004, Aricept was ranked #52 in the top 200 drugs by sales in the US ($.92 billion, up from a rank of 62 and sales of $0.7 billion in 2003). Why?

Alzheimer’s is perhaps the most feared disease of old age. Called “the gray plague,” it makes once vibrant people debilitated and dependent (see my book, Tangled Minds: Understanding Alzheimer’s Disease and Other Dementias; NY: Dutton, 1998). It’s not surprising that family members of those afflicted are desperate for a treatment. It’s not surprising that physicians are eager to have something to offer—and one after another, the various proposed remedies have proved worthless or even harmful, including estrogen and Rofecoxib (Vioxx). But should we be spending nearly a billion dollars a year to indulge our wishful thinking? Or would we all be better off spending the billion dollars on research for other drugs which might actually be effective? Or perhaps we could invest the billion dollars in improving the quality of nursing homes and assisted living facilities that claim to specialize in the care of people with Alzheimer’s so as to find ways to promote dignity and well-being in some of our most vulnerable and most demeaned citizens. The British seem to recognize that an unchecked appetite for drugs that might be beneficial has consequences when our resources are unlimited. Americans are loath to accept this view. Maybe we have something to learn from our English cousins.