January 15, 2017

Now Hear This

Kaiser Health News—which by the way has some of the most interesting and important articles relevant to the older population in its “aging” section, and additional interesting and important articles in its “Medicare” section—ran an encouraging piece this week about hearing aids. I blogged about hearing aids almost exactly a year ago, when the President’s Council of Advisors on Science and Technology (PCAST) issued a report recommending, among other approaches, deregulating over the counter hearing aids. It looks as though this may actually become a reality.

The concern, as with OTC medications, is that the products available without a prescription will be ineffective, if effective that they will be misused, and if misused that they will lead to the substitution of bad technology for good technology. But the smart phone, smart machine era has ushered in the possibility that people could select a high quality device for themselves without a physician or audiologist as an intermediary. It may soon be possible to connect a device inconspicuously inserted into the ear to a tablet, smart phone, or television. The device may communicate directly with a digital assistant such as Siri or Alexa. And consumers may be able to test their own hearing and determine just what kind of device would serve them best using a cell phone app or online program.

There’s much yet to figure out as the boundary between personal sound amplification devices (unregulated) and hearing aids (regulated) becomes increasingly fuzzy. Standards governing their design are in the works. But Senators Charles Grassley (R) and Elizabeth Warren (D) are planning to introduce a bill soon that would allow the sale of OTC devices. How very fitting: a bipartisan effort to allow us to hear each other better.

January 09, 2017

Growth and Transcendence?

In 2003, I decided to branch out from geriatrics and try something new. Well, a little new. I recreated myself as a palliative care physician. I’d previously been a bit dubious about palliative care, which in its early days focused principally on people with cancer and almost exclusively on people who were imminently dying. My interest was in people who were in the last phase of life, whether that phase would last days, months, or even years. My patients at Hebrew Rehab Center, where I had worked for the previous eleven years, had an average age of 88. They all had major limitations in their ability to function independently, otherwise they wouldn’t have been living at Hebrew Rehab: either significant physical problems or, a large proportion of cases, cognitive dysfunction, or both. I had come to realize that many if not all of them stood to benefit from a palliative approach to medical care. So why not embrace palliative care as a specialty, focusing principally on very old people, but also expanding my horizons to include younger individuals?

Palliative care was a good fit for me. I came to see the field as built on three legs: advance care planning (some people include communication here), psychosocial support, and symptom management. It is an interdisciplinary field and its focus is on supporting patients and their families through a difficult period of their lives. Much of the work involves making sure people understand their condition and what they are facing so they can make realistic and wise decisions about the treatments they receive as well as about where and how they live. Many of my colleagues shied away from such discussions; I thrived on them, feeling I could help assure that patients got the kind of care that made sense for them as they approached the end of their lives. Often, I rescued them from needlessly burdensome and ultimately futile medical interventions. There was, however, one strand of palliative care that disturbed me.

What bothered me was the tendency to exalt dying, to see dying as an opportunity for growth and transcendence. Now, not all palliative care physicians, hospice nurses, and other professionals are afflicted by this tendency, but for some it was kind of a religion. The business of palliative care, in this view, is to promote spiritual growth. And by implication, patients who don’t find dying uplifting, who aren’t able to reach new heights or discover new aspects of themselves, are failures.

I confess that I’ve never been enthusiastic about the American psychologist, Abraham Maslow, with his five (later nine) stages, culminating in “self-actualization,” or the experience of  “self-fulfillment” manifested by “peak growth experiences.” I’m even less enthusiastic about applying this model to people approaching the end of life.  Dying, and even living the last six or twelve or twenty-four months of life, is often a messy business. It seems to me to be good enough to be physically and emotionally reasonably comfortable. That’s hard enough to achieve. Ideally, it involves attaining a certain level of inner peace, of acceptance of the life one has led. But growth experiences? Euphoria? Joy? Wonder? That seems a bit much. So I was pleased to read the article in the Sunday NY Times about B.J. Miller, a palliative care physician who is a triple amputee and who until recently served as executive director of the “quirky” Zen Hospice Project in San Francisco.

Miller is by all accounts a remarkable doctor and human being. He is charismatic. He is intense. He has the capacity to truly “be” with people and help them come to terms with their condition and their lives. His story, well told by journalist Jon Mooallem, is inspiring. But he isn’t big on transcendence. In his own words, palliative care in general and Zen Hospice in particular aren’t about our need for death to be a hypertranscendent experience: “Most people aren’t having these transformative deathbed moments. And if you hold that out as a goal, they’re just going to feel like they’re failing.” Instead, the name of the game is to allow those who are dying and the people who love them to “live a succession of relatively ordinary, relatively satisfying present moments together.” Now that’s a philosophy that makes sense.

January 01, 2017

What the New Year Will Bring

I’ve been searching for something upbeat to say about health care for older people in 2017. It’s been difficult to find anything newsworthy. The best I could come up with was that the direst predictions might not come to pass. Speaker of the House Paul Ryan says he wants to privatize Medicare by instituting “premium support,” which means giving people fixed amounts of money to buy health insurance on the private market instead of using government-run Medicare. But he might not get his way; after all, there are 46 million older people on Medicare and they like their program. Assurances that any changes won’t go into effect for several years may not be good enough. The nomination of Georgia Representative Tom Price to serve as head of the Centers for Medicare and Medicaid Services strongly suggests there will be a push toward substituting block grants for the federal Medicaid program, which would mean large cuts to Medicaid in many states. It might not happen; there are roughly 6 million older people who are dually eligible—they qualify for both Medicare and Medicaid, and they survive thanks to the current arrangement.  And then there’s the vaunted repeal of the Affordable Care Act, which might mean axing the Center for Medicare and Medicaid Innovation, an institute that has been testing strategies to improve quality and save money, as well as PCORI, the Patient Centered Outcomes Research Institute, a major source of grants for studies of innovative health care programs. Congress might leave those parts of the ACA intact, but CMMI was budgeted $10 billion for the period 2010-2019, of which about $3.5 billion remains. This money looks to me to be ripe for cutting by an administration that touts ideology as the basis for decision-making, not science. But surely there must be something uplifting to say about the new year. Judith Graham of Kaiser Health News suggests there is.

Beginning in January, 2017, Medicare will introduce new rules that offer incentives for physicians to change the way they care for the sickest, most vulnerable older patients, those with multiple serious chronic conditions, those with dementia, and those suffering from mental illness, especially depression. Medicare is changing its reimbursement system for “complex chronic care management.” Basically, it will pay more for coordination of care and require jumping through fewer hoops to get the extra payments. Medicare is also going to be more generous in paying for comprehensive dementia assessment—if physicians follow a number of rules. They have to assess their patient’s ability to perform activities of daily living, they have to evaluate behavioral symptoms, they need to review medications, and they need to use standardized tests for assessing cognition. Finally, they will have to elicit the patient’s goals and values and determine the caregiver’s knowledge and resources to develop a care plan for the patient—including plans for what to do when the patient becomes acutely ill. Medicare will offer an incentive for primary care doctors and behavioral health specialists to work together to deliver effective care for older patients with mental illness. Finally, Medicare will recognize that taking care of elderly patients involves more than classic “visits” consisting of a doctor sitting opposite a patient, taking a history, doing a physical exam, and prescribing tests or treatment: it entails such activities as talking to family members and reaching out to community service providers. Recognizing the value of physician work that doesn’t involve face time with patients means reimbursing physicians for their time and that’s exactly what Medicare will initiate.
These are all good developments. Physicians do need to coordinate complex chronic disease management and they ought to properly assess patients with cognitive impairment and develop an advance care plan for them. Similarly, they have to be able to spend time working with families, caregivers, and other professionals to do a good job for their oldest patients. But whether tweaking the fee-for-service system to achieve these ends will work is another question. What we know works are special programs for eligible patients, programs such as GRACE (Geriatric Resources for the Assessment and Care of Elders) or PACE (Program of All Inclusive Care for the Elderly) or Guided Care. These are comprehensive programs with a dedicated staff of physicians, social workers, nurse practitioners, and others who already provide complex care management,  who already know how to evaluate memory, and who often work with behavioral health as well as caregivers. Whether encouraging primary care doctors to adopt these approaches simply by offering to pay extra for incorporating these strategies into routine practice will be equally effective is far from clear. But it might be a step in the right direction. And if there’s money available to measure whether it works or not, we might actually find out.

December 09, 2016

Three Strikes and You're Out

Three times, Eli Lilly has tried to demonstrate the efficacy of the drug solanezumab in the treatment of Alzheimer’s disease. And three times, the drug failed. What does this mean?

Solanezumab is a monoclonal antibody that selectively attaches to a form of amyloid-beta, widely thought to be the key agent that causes Alzheimer’s disease. The first two studies were phase three, double-blind studies of patients with mild to moderate Alzheimer’s disease. That means earlier studies had found the drug reasonably safe and had identified a dose that had the desired effect on brain amyloid. The results of EXPEDITION1  and EXPEDITION 2 were both published in the New England Journal of Medicine in January, 2014. The authors found that after 18 months of treatment with intravenous solanezumab, there was no improvement in either tests of cognitive function (the Alzheimer’s Disease Assessment Scale) or daily activities (the Alzheimer’s Disease Cooperative Study Activities of Daily Living scale). There was a hint in subgroup analysis that maybe the patients with milder disease might benefit; hence the new study, EXPEDITION3, which evaluated the drug in patients with clinical evidence of mild dementia and abnormalities on PET scan suggestive of amyloid deposition. But alas, the results of this trial are no more encouraging than those of its predecessors.

Solanezumab is not the only anti-amyloid monoclonal antibody that has been tested and found wanting. Two other double blind randomized, placebo-controlled phase 3 trials were conducted with Bapineuzumab in patients with mild to moderate Alzheimer’s, One trial involved carriers of the APOE-4 allele, a gene for a cholesterol carrying protein that has been associated with an increased risk of dementia; the other involved non-carriers. Once again, there was no difference between patients receiving active drug and those getting placebo, whether on tests of cognition or on measures of overall daily functioning.

So now solanezumab has failed three times. Not because it caused terrible side effects, as was the case with earlier attempts to “vaccinate” against Alzheimer’s disease, that were in some instances effective but that caused a debilitating and/or lethal inflammatory response in the central nervous system. Solanezumab failed because it didn’t work. What does this tell us about the use of monoclonal antibodies in Alzheimer’s disease?

An article in Scientific American two years ago on “Why Alzheimer’s Drugs Keep Failing” makes clear that it’s not just a handful of drugs that have fallen short of their promise. According to the article, “dementia has become a graveyard for a large number of promising drugs.” In fact, the failure rate for Alzheimer’s disease “drug candidates” is 99.6 percent (compared to 81 percent for cancer drugs). The problem, in large measure, is that symptoms begin a decade or more after the disease actually starts, by which time intervention may be too late. It’s as though we didn’t treat coronary artery disease until after a patient developed cardiomyopathy, until after so much heart muscle had died that the heart scarcely pumped at all. One strategy for drug development is therefore to identify markers for disease long before there are clinical manifestations, in principle allowing for treatment at a much earlier stage than occurred with any of the solanezumab trials. Another is to target other suspects besides amyloid—abnormal proteins such as tau that also contribute to the development of dementia. Still another strategy is to focus on “disease-modifying treatment,” an approach that slows the progression of the disease rather than one that focuses on cure.

Perhaps another reason that Alzheimer’s disease is such a hard nut to crack is that the brain is an extraordinarily complicated organ, arguably far more complex than the heart. The heart, after all, is basically a pump. An ingenious pump fed by a system of blood vessels and operated by an electrical mechanism, and one that has proved far more complicated than was initially assumed, but nonetheless simple by comparison with the brain. Because the brain is such a remarkable organ and because Alzheimer’s disease strikes its most elusive function, cognition, it is not entirely surprising that treating this disorder has proved so challenging.

The message is not that we should give up. But it is that there’s no cure around the corner. The most effective strategy to date is to decrease the likelihood of developing Alzheimer’s through a combination of smoking cessation, treatment of high blood pressure, and treatment (or prevention) of diabetes—a strategy developed for the prevention of cardiac disease and incidentally found to help stave off dementia. And in the mean time, as scientists continue to struggle to understand the pathogenesis of Alzheimer’s and devise new strategies for intervening in the relentless progression of this dread disease, we must continue to find better ways to support people who are afflicted, allowing them to find as much meaning and satisfaction as possible in their lives.

This is the last post on “Life in the End Zone” in 2016. See you next year!

December 05, 2016

Antipsychotics: Use as Directed

Antipsychotic medication is effective for people who are psychotic—period. It’s been used for other conditions, such as the behavioral symptoms of dementia, and it turned out not to work. It’s been used for delirium, a type of confusion that often arises in older people or people nearing the end of life, especially in the hospital, and many doctors swear it’s the only medication that helps this distressing and dangerous disorder. But a new study from Australia suggests that antipsychotic medication doesn’t work for delirium either. 

The specific situation the Australian doctors looked at was delirium in the setting of patients with advanced illness, either patients on an inpatient palliative care service or patients enrolled in a hospice facility. Out of well over 1000 patients with delirium, they were able to identify 247 who were both eligible and willing to enter the study. This group, with a mean age of 75, were randomized to risperidone (a commonly used antipsychotic), haloperidol (another commonly used antipsychotic), or placebo. Patients were also given unspecified non-medicinal treatment, presumably things like a sitter (someone to stay with them) or relaxation techniques such as massage. They were also given subcutaneous midazolam, a very short acting anti-anxiety medication under the skin, for extreme agitation. The results? Patients receiving either risperidone or haloperidol had more severe symptoms of delirium than those treated with placebo. They also, not surprisingly, had more Parkinsonian symptoms, the main side effect of these antipsychotic medications, and were more likely to die.

This is a disturbing result. Not only did antipsychotics fail to help, but they also seemed to make matters worse. Now maybe there’s something different about Australians, or maybe the specific environment they were in—a palliative care service or hospice, though neither is clearly described—makes generalization to the American general hospital impossible. Or maybe people with delirium and advanced illness are somehow different from people with delirium who don’t have an advanced illness. And conceivably, other antipsychotics such as quetiapine or olanzapine are different. More likely, antipsychotics are simply a bad choice in the treatment of delirium.

Antipsychotic medications are remarkable medications—for the treatment of psychosis in psychiatric conditions such as schizophrenia and bipolar disorder. But maybe we should stop using them for anything other than these indications.

November 28, 2016

Something to be Thankful For

Back in February, I wrote that “some news is good news.The news in question came from the Framingham study and it showed that the incidence of dementia had been falling in the US by 20 percent each decade since the 1980s. However, I was concerned about the generalizability of the finding since the total number of people identified as having dementia was 371—and they were all from Framingham, MA. Now another, larger study points to a similar decrease. That’s something to be grateful for this Thanksgiving season. 

Before we get too excited—or complacent—let’s consider a few caveats. The new study was based on data from the Health and Retirement Study, a large, nationally representative cohort study that’s been going on since 1992. It looked at the prevalence of dementia in all those in their survey who were over age 65 and lived either in the community or a nursing home in one or both of two sample years, 2000 and 2012. That turned out to be 21,057 people, of whom a total of about 2000 developed dementia. So far, so good: a bigger sample, drawn from the entire country, with a respectable sized group of individuals with dementia. 

But now for the problems. Dementia was diagnosed using a modified version of the Telephone Interview on Cognitive Status, a measure involving a 27-point scale. Sounds good, except that the full Telephone Interview on Cognitive Status is not an established way to diagnose dementia, and the abridged version used by the investigators is even less well established. And indeed, when compared to a different test which the authors regard as the gold standard, the telephone interview correctly classified dementia in 78 percent of respondents. The other 22 percent of people were either falsely diagnosed as having dementia or incorrectly assessed as normal. That’s worrisome. The point of the study was to compare the prevalence of dementia in 2000 and 2012, which is awfully difficult to do if you can’t accurately determine prevalence.

Still, the findings of a decline in prevalence from 11.6 percent in 2000 to 8.6 percent in 2012 (corrected for the change in age and sex distribution of the population) are consistent with those of the Framingham Heart Study and of a British study. They show a 24 percent decline in prevalence of the disease, despite an increase in obesity and diabetes during the same period. And, as with the earlier studies, increases in education and improvement in control of cardiovascular risk factors (high blood pressure, smoking, and diabetes) are associated with the fall in dementia.

So maybe it’s really true. Maybe the risk for each us individually is not quite as bleak as I have been suggesting in this blog. On the other hand, the projection is that by 2050, there will be 83.7 million people age 65 or older. If even 8.6 percent of them have dementia, as suggested in the current study, that’s over 7 million people. Unless we find a cure soon, which doesn’t seem terribly likely, we’re still going to be faced with an enormous public health problem.  

November 20, 2016

It's the Social Stuff, Stupid

Health care policy mavens are finally recognizing that we need to do a better job taking care of the sickest and costliest patients in American society. These are people on whom we spend a large percentage of our health care dollars without much to show for it, either in terms of standard health care outcomes or quality of life. Many of them have advanced illness. Many have multiple chronic diseases plus functional impairment plus extensive social needs. They’ve gotten the attention of people like David Blumenthal, who published an article called “Caring for High-Need, High-Cost Patients—An Urgent Priority” in the New England Journal in September and another article in JAMA sounding a similar call to action a few weeks later. They are the focus of the Coalition to Transform Advanced Illness, which produced a white paper mapping out a strategy for care and which just held a National Summit on Advanced Illness Care. Everyone defines the relevant population slightly differently and everyone makes somewhat different proposals for moving forward. One of the most creative is an idea that has been tried in England with good results.

This model gives high need patients a personal health care budget. The budget is determined by negotiation between the patient and the health care team. It “relies on a goal-setting and care-planning process in which patients and health care teams consider medical and social needs.” The budget allows payment for home supports and for technology that facilitates their remaining at home. It includes coverage for unusual and somewhat controversial non-medical needs such as a garden shed for someone with dementia so he could stay home because he had something to keep him occupied—the alternative was for him to become agitated and restless and quite likely require sedation and/or institutionalization. Interestingly, the budgets exclude access to primary care and hospital care, which are uncapped. Studies to date have found the system cost effective and associated with enhanced quality of life for the participants.

The result is not entirely surprising in light of the pioneering work done by Elizabeth Bradley and Lauren Taylor, popularized in a NY Times article in 2011 (and recently the subject of a book, The American Health Care Paradox.) What these researchers found was that though the US spends as much as 50% more than other developed countries on acute hospital care, imaging studies, lab tests, and other standard medical care, it spends much less than most other OECD countries on social services including old age pensions, disability, family support, and housing. If you combine the expenditures on both health and social services to give the true per capita spending in each country (with the amounts adjusted for GDP), it becomes clear why American health outcomes are so often inferior to those achieved in other countries: our total per capita spending is actually less than that of similar countries. The US over-invests in medical care and under-invests in social services.

A personal health budget that allows individuals to buy social services and other not strictly medical items that have the potential to enhance the coordination of care—a smart phone or a laptop, for example—is a way to compensate for America’s weakness. It fits into the prevailing ethos of individual control and of having “skin in the game.” 

If dressed up in sufficiently capitalistic sounding language, the proposal might even pass muster in a Republican-controlled federal government. It could finally transform care for the sickest, most vulnerable patients in the US health care system--and save money, too.


November 08, 2016

Medicare and the Election

Today is Election Day. The choice is stark. And it’s not just a matter of choosing a knowledgeable, capable, and rational, although flawed Democratic candidate over an ignorant, incompetent, bombastic narcissistic Republican candidate. The election matters for health issues and older people as well. Here’s how.

The Trump and Ryan plans call for a repeal of the ACA. That means more uninsured people who will be sicker and costlier to care for once they become Medicare eligible.  That’s bad for those individuals and it is bad for Medicare. Trump and Ryan want to permit interstate sales of health insurance, which they think will create more competition and bring down costs. They don’t seem to understand that regional insurers don’t want to expand nationally: they have to negotiate contracts and rates with the hospitals in every state whose market they enter. Health insurance is not the same kind of commodity as furniture. That goes for Medicare Advantage plans along with private plans for those under age 65. Trump and Ryan want to expand the use of health savings accounts—potentially to Medicare patients. These high deductible plans encourage people to make foolish decisions about their health. Moreover, they affect the first few thousand dollars of health care expenses—enough to make a difference to people with limited incomes, but of no consequence for the most expensive parts of the health care system, namely hospital care.

Clinton and the Democrats would make insurance coverage more affordable by increasing tax credits for low income households. That means fewer uninsured people who will be sicker and costlier to care for once they become Medicare eligible. Families USA wants to add dental coverage to all public and private health plans—the one big gap in coverage for older individuals, even though poor dentition has been associated with pneumonia, nutritional problems, and other disorders. Clinton et al favor Medicare negotiating drug prices with manufacturers, potentially controlling one of the major contributors to out of pocket spending among older people.

For a more detailed analysis of “the choices on health reform in the US presidential and congressional elections” that doesn’t focus on older people, see the viewpoint piece in today’s JAMA Internal Medicine

Go out and vote! It matters, for Medicare along with so much else.