November 22, 2015

Where is the lamp beside the golden door?

According to the New York Times, fewer than 2000 Syrian refugees have been accepted for resettlement to the United States. Of these, half are children and one-quarter are over age 60. So the refugee crisis, of which Syrians are a significant part, affects older people as well as the young and the middle-aged. As we hear more and more strident calls to keep out these refugees, ostensibly because they might be terrorists, when in fact they are seeking to escape from those same terrorists who roam their native lands, we would do well to remember an earlier refugee crisis. It’s a crisis I’m all too familiar with, as my parents—then ages 13 and 14—were among those who left Germany in the winter of 1939, at first merely to escape persecution, later to escape death. It would be 8 years before they finally found refuge in the United States, where they have lived productive lives for the past 68 years.
By the summer of 1942, tens of thousands of European Jews had already been rounded up by the seemingly unstoppable Germans and incarcerated in ghettoes, enslaved as forced laborers, or sent to extermination camps. Those who remained in Holland, Belgium, and France were on the run. One of the only countries to run to was Switzerland, an oasis of neutrality in war-torn Europe. But in August, the Swiss government sealed its borders to refugees, invoking the time-honored allegation that further Jewish immigration was a threat to the peace and stability of their society. In December of 1942, the government clamped down further, ordering that every refugee over the age of 16 be turned away at the border. In the coming months, the Swiss police would send about 25,000 people to almost certain death.
It was not the first time that the world had turned its back on Jewish refugees. In the summer of 1938, just days after the American Independence Day holiday, representatives from 32 countries gathered at the majestic Hotel Royale in the French lake-side resort of Evian-les-Bains to discuss the plight of the millions of European Jews who wished to immigrate to avoid discrimination, persecution, and worse. For over a week, the delegates convened to express their concern--but did nothing.

A few months later, on what would become known as Kristallnacht, synagogues were torched throughout Germany, Jewish businesses destroyed, and 30,000 people arrested for the crime of being Jews. In response, a democratic US Senator and a Republican representative introduced a bill that would have admitted 20,000 Jewish refugee children to the United States. But public opinion was resoundingly against immigration on the grounds that it could be harmful to American citizens, and the bill died an early death. 

When the United States entered the war, virtually all immigration to this country ceased. But already that fateful fall, the State Department had deliberately put barriers in the way of Jewish refugees. Even accessing the limited quotas in place as of the xenophobic Immigration Act of 1924 became increasingly difficult. Consulates abroad were instructed to “delay” and “effectively stop” the trickle of immigrants arriving in the United States by resorting to administrative devices to “postpone and postpone and postpone the granting of the visas.”

After World War II was over, the member states of the newly established United Nations recognized the callous cruelty of their behavior towards refugees. Committed to mending their ways, they drew up the Declaration of Human Rights (1948), which asserted that everyone has the right to “seek and to enjoy in other countries asylum from persecution.” This was followed in 1951 with the “Convention Relating to the Status of Refugees” which defined refugees and delineated their rights. In 2001, dozens of countries reaffirmed their commitment to the rights of refugees, acknowledging that “many persons still leave their country of origin for reasons of persecution and are entitled to special protection on account of their position.”

In light of this history, the current attempts by state governors, including Charlie Baker of Massachusetts, to close their hearts and barricade the gates to refugees is both tragic and intolerable. We must not confuse the persecuted with their persecutors. We need to remember the words engraved on the Statue of Liberty, a gift to us from France, from the poem, “The New Colossus” by Emma Lazarus:

Give me your tired, your poor,
Your huddled masses yearning to breathe free,
The wretched refuse of your teeming shore.
Send these, the homeless, tempest-tossed, to me:
I lift my lamp beside the golden door.

November 15, 2015

The Sound of Music

From a mathematical perspective, adding and subtracting are equivalent:  with addition, you perform an operation on two positive numbers; with substraction, you perform the same operation on one positive and one negative number. In medicine, by contrast, addition and subtraction couldn’t be more different. Introducing another drug or another procedure is considerably easier than discontinuing a long-standing practice, even when there is mounting evidence that the practice is not beneficial, perhaps even harmful. One way to wean patients and doctors from an established treatment is to substitute a different, more effective or safer treatment. It’s a lot easier to change behavior if you can offer a new, improved treatment rather than just asking people to forgo something that they believe must be helping them. So clinicians ought to be very enthusiastic about the strong evidence supporting the use of music to aid in postoperative recovery, as shown in a systematic review and meta-analysis recent published in the British journal, the Lancet.

Taking all available studies of the utility of music into consideration, the authors conclude that playing music before and/or after an operation decreases the amount of pain medication patients take, it decreases their degree of pain, and it lessens their anxiety. That means opioid medications, currently in the news because of the epidemic of overdose deaths from these drugs, can be given in lower doses, for shorter periods of time, or potentially not at all. Ditto for anti-anxiety medications, which have been associated with increased confusion, increased falls, and other problems in older people.

This is a rare instance where we should go ahead and change the way we practice medicine without demanding additional studies, better studies, or more definitive studies. Here's an intervention that has no disadvantages that I can think of, it's cheap, and there's even moderately persuasive evidence that it is effective. Not only that, but playing music for patients doesn't mean we have to stop doing what we're currently doing, only that we should do a little less of it. 

If we don't introduce music into surgical units and recovery rooms (parenthetically, I'd like to see a study of the effect of classical music on surgical performance in the operating room--my guess is that it would calm the doctors as well as the patients), that will say a great deal about what we value in medicine today. It will suggest that what drives the diffusion of medical care is not so much evidence as advertising. There are, after all, no medical device manufacturers or pharmaceutical companies that will promote and market classical CDs and portable CD players to hospitals. I can't say I'm very optimistic, but I hope we will do the right thing.

November 10, 2015

November 08, 2015

Just the Facts

This week’s JAMA included an article that describes prescription drug use in the US and compares current usage to the pattern twelve years earlier. The data for older patients is striking: in 1999-2000, 84% of people took at least one prescription drug; in 2011-2012, fully 90% of people took a prescription drug. More impressive, in the earlier period, 24% of older individuals took at least 5 prescription drugs (the cutoff for “polypharmacy”), while today it’s up to 39%. Is this good news or bad news?

One of my colleagues, who is an expert on drug policy, thinks that on the whole, more is better. Treatment of high blood pressure prevents strokes; treatment of high cholesterol prevents heart disease; antidepressants prevent suicide. My colleague worries about barriers to access for these life-saving and/or quality-of -ife-enhancing medications. The finding that more people are taking such drugs is encouraging: perhaps high cost or lack of primary care are not preventing patients from getting the medications they need. Other colleagues, who are geriatricians, think that on average, less is better. Polypharmacy is dangerous in frail, older individuals. The side-effects of medications, such as dizziness causing falls or low blood sugar causing fainting, may outweigh their benefits, especially when drugs are taken in combination.

The truth is that medication use in general and polypharmacy in particular are neither inherently good nor bad. Whether a given medication should or should not be prescribed depends very much on the circumstances. What the new report does is to describe patterns, allowing and encouraging us to zero in on classes of drugs whose use has changed markedly over time.

Particularly intriguing were the few drugs whose usage fell over the 12 year period studied. Almost all drugs were used more commonly. Among patients over age 65, only two categories of drugs fell to a statistically significant extent: sex hormones (almost exclusively estrogen replacement therapy) and anti-arrhythmics (drugs that were once widely used to try to control irregular heart rhythms). Now this is interesting because it’s very hard to get doctors to stop prescribing medication and to persuade patients that the medicine they've been taking for years, a drug they are convinced is beneficial, actually is useless or even harmful. But in the case of estrogen, new studies convincingly demonstrated that what was previously received wisdom—estrogen replacement in women prevented heart disease—was wrong. And in the case of anti-arrhythmics, drugs like quinidine and procainamide, which were once used to suppress abnormal ventricular rhythms, it turned out these medications were associated with an increased risk of sudden death. These drugs have virtually disappeared, replaced by other classes of drugs entirely. What these examples demonstrate is that when new data become available that are truly compelling, physician and patient behavior can change. It’s particularly helpful to be able to offer an alternative—a beta blocker instead of quinidine—rather than to subtract one drug without adding anything in its place.

The other takeaway message for me from this study is the tremendous importance of the National Center for Health Statistics. The data presented in the JAMA article come from NHANES, the National Health and Nutrition Examination Survey. This is a representative survey of a large number of Americans (37,959 in 2011-2012), conducted every few years, that gathers information about health and diet. It is, as the JAMA authors say, “a stratified, complex, probability-based survey” that over-samples older adults, low income individuals and certain racial and ethnic groups. Just what is the National Center for Health Statistics, the source of this treasure trove of data?

The National Center for Health Statistics was established in 1960. Since 1987, it has been part of the Centers for Disease Control (CDC). Its mission is to: “to provide statistical information that will guide actions and policies to improve the health of the American people.” In addition to conducting the NHANES surveys, it has three other data collection programs. There is the National Vital Statistics System, which gathers information about births and deaths and generates information about life expectancy. Then there is the National Health Interview Survey, which interviews Americans about their heath insurance coverage, health care resource utilization, and immunization status, along with other aspects of health. And there is the National Health Care Survey that studies the organizations that provide health care, such as hospitals, hospices, and nursing homes.

The studies carried out by the National Center for Health Statistics are invaluable. No private organization can be relied upon to carry them out systematically, regularly, and reliably. In a time when the federal government is under relentless attack, it’s worth drawing attention to some of its most remarkable—and unsung—achievements.

November 01, 2015

Advantage: Medicare Advantage

I’ve always liked the idea of a geriatric managed care organization. I liked it back when they were called Medicare HMOs (after they were first introduced in 1972 via an amendment to Social Security); I liked the idea when Medicare HMOs got a new lease on life from the Tax, Equity, and Fiscal Responsibility Act of 1982 (TEFRA, which launched a number of demonstration projects); I liked it when Medicare HMOs were reincarnated as Medicare+Choice programs after passage of the Balanced Budget Act of 1997; and I liked the idea when the program was renamed Medicare Advantage in 2003. It made sense because it encouraged coordination of care by making a single organization responsible for outpatient, hospital, and post-acute care; it made sense because it could offer benefits important to older people such as glasses and, in the pre-Medicare Modernization Act era, prescription drugs. But it’s never had a wide following. Recently, that trend may be changing.

A new report from the Henry J. Kaiser Family Foundation, “Medicare Advantage and Traditional Medicare: Is the Balance Tipping?” isn’t quite ready to conclude the balance has shifted, but it presents some compelling statistics. Enrollment in Medicare Advantage plans has been growing steadily for the past ten years. It went from 16% in 2006 to 24% in 2010 to 31% in 2015. By way of comparison, the highest rates previously achieved were in the late 1990s, before HMOs generally got a bad rap and went into decline, when 15% of the Medicare population were enrolled.

What is particularly interesting about the new report is that it shows the tremendous geographic variability in HMO penetration. There are areas of the country where over 50% of Medicare enrollees have signed up for a Medicare Advantage plan (9% of people on Medicare live in such areas) and other areas where 40-50% of enrollees have signed up (another 21% of those on Medicare live in these parts of the country). In fact, nearly 2/3 of those who live in counties with high rates of Medicare Advantage use live in just 5 states: California, Florida, New York, Ohio, and Pennsylvania.

The report is purely descriptive. It says nothing about why more people are joining Medicare Advantage plans. It does not even speculate. My guess is that they are attractive primarily because they are simpler. Fee-for-service Medicare Parts A (hospital coverage) and B (physician and lab test coverage) have deductibles and co-pays. If your physician is a “Medicare participating physician,” he must “accept assignment,” which means agreeing to the payment Medicare provides without billing you for the difference between the doctor’s charge and Medicare’s reimbursement—but if the physician is a “non-participating provider” she can both get the standard reimbursement from Medicare and bill the patient an additional amount. The drug benefit, Medicare Part D, makes people select from a dizzying array of plans with varying coverage and cost.

Medicare patients, like every one else these days, are supposed to have “skin in the game.”  Economists and politicians hope that they will choose the best “value for the money,” keeping costs down. But for many people, the choices they have to make, both in selecting a plan in the first place and then in deciding what tests to have and what drugs to take, are hopelessly complicated. Medicare Advantage plans restrict choice—which can be a very good thing if you have a wise and trusted physician narrowing the choices.

Whatever the reasons for Medicare Advantage plans’ appeal to older patients, they offer the possibility of providing higher quality care than the usual fragmented fee-for-service approach to care. They offer a model for truly integrated, streamlined care, in which physicians in the office, the hospital, and the skilled nursing facility share information, maybe even work together. And the model is more likely to work than are “Accountable Care Organizations,” the new form of health care delivery that expects that health care systems will provide coordinated care even though patients have the freedom to go to doctors and hospitals in different systems: the organization is responsible for the cost of their patients' care but have no control over something as basic as which doctors they see or what hospitals they go to.

But if Medicare Advantage plans are going to achieve their promise, and do more than offer patients simplicity, they are going to have to make other changes as well. As I argued back in 1987, in an essay in the Annals of Internal Medicine on “The Impact of Health Maintenance Organizations on Geriatric Care,” these organizations can only survive if they cut costs and the most efficient way to cut costs is by decreasing the rate of hospitalization and, for those who are hospitalized, shortening their length of stay. That’s not so easy to do for older patients, especially if a significant fraction of them are frail and sick. But outpatient medicine that incorporates the principles of geriatric assessment can help, as can case management to coordinate services. In the hospital, the use of geriatric consultation or, better yet, special inpatient units structured to care for frail older people (sometimes called ACOVE or Acute Care of the Vulnerable Elderly units) can minimize the risk of functional decline and iatrogenesis.

Medicare Advantage plans need to recognize that they have an opportunity to do the right thing for older patients—but if they fail to incorporate geriatric know-how into their programs, they are doomed to go the way of their ancestors.

October 25, 2015

You Only Die Once

The palliative care community has been rallying to defend itself this past week in the aftermath of a scathing attack in the New England Journal of Medicine.  A short article written by Scott Halpern, a specialist in intensive care medicine, asserts that none of the approaches used by palliative care clinicians, and he singles out advance care planning tools such as physician orders for life-sustaining treatment (POLST) and videos depicting CPR, have been proven to work. He implies that the only way to know whether they are effective is to use the same criteria as those employed by the FDA in approving a new drug: typically, large, multi-center, randomized clinical trials. Superficially, this seems advisable—or even, to use the language that Medicare invokes in determining what it will cover—reasonable and necessary. It is, after all, a plea for evidence-based medicine, and surely all right-thinking physicians are in favor of using scientifically supported treatment. But to propose that we can learn all we need to know about how to provide excellent palliative care from randomized, double blind, placebo-controlled trials, studies in which two groups are compared that are identical in all respects except for the intervention being tested, is sadly na├»ve and hopelessly reductionist.

Advance directives are promoted to enable patients to shape their own destiny by choosing, with input from their doctors, how they will be treated when they are seriously ill. Advance care planning seeks to protect patients by safeguarding their autonomy in the event of incapacity; it also aspires to help all patients prepare for the future, even those who retain their cognitive capacity. It’s difficult for anyone to think clearly in the throes of serious illness; prior consideration of the goals of care can provide a useful framework for decision-making under stress. But if the point of advance care planning is to encourage patients to think about their goals and preferences and to allow them to have a say in their care, then readily measurable outcomes—things like how much pain patients experience at the end of life or how many procedures they have or how long they live or what their care costs—are the wrong endpoints.

A randomized trial doesn’t make any sense in this setting: we cannot compare patients who participate in advance care planning (cases) with those who do not (controls) and measure whether the planners are more likely than the non-planners to get the kinds of treatment they want. Such a comparison presupposes that everyone actually knows whether he or she wants attempted CPR or a ventilator or third line chemotherapy in much the same way that people know whether they prefer vanilla or chocolate ice cream.  But choosing between vanilla and chocolate requires that people have already tasted both and arrived at a conclusion about which they like more. With end of life medical treatment, patients seldom have any prior experience on which to base a decision. They need help in imagining what they will go through with the various alternatives. And they can’t sample the different possibilities and then decide (though a limited trial is sometimes possible): they will only die once. Nor is it accurate to believe that all patients have well-formed preferences, based on their religious beliefs or values, and that advance care planning simply informs the medical profession of those preferences. In many cases, patients don’t have clear preferences. The essence of good advance care planning is that it elicits preferences—it helps patients figure out what makes sense for them, given the realities of their medical condition.

I’m not suggesting that all formal study of advance care planning is meaningless. Demonstrating that patients who go through a planning process are satisfied with their experience is important. So is comparing different approaches to figure out which one is best received (or perhaps which patients like which strategy). Assessing whether patients who engage in advance care planning are more knowledgeable about their options than those who do not is also useful. So are studies of the implementation of the advance care planning process: finding out whether advance directives (written documentation of the planning process) are available to physicians at the time when decisions need to be made and measuring the concordance between those requests made in advance and what actually happens. All these sorts of studies have been done and collectively make the case that advance care planning is effective.

Although Dr. Halpern longs for a large, randomized controlled study to definitively determine whether advance care planning “works,” he seems to be aware of the inaptness of his FDA analogy. He therefore proposes analyzing electronic medical records using natural language processing as a way to draw conclusions about the efficacy of various palliative care interventions, including advance care planning. Nice idea, but I’m skeptical. It’s not that I’m hostile to natural language processing or totally ignorant of its power: my son has a doctorate in computer science with a specialty in natural language processing and does remarkable work studying how machines can determine the meaning of text. My husband is the co-founder of a tech start up that makes extensive use of natural language processing. It’s a promising technique with many as yet undetermined applications. Maybe it will even prove useful in evaluating advance care planning. But surely we don’t know that. In fact, there are strong a priori reasons for thinking that mining chart notes for words that describe a patient’s experience won’t do anything other than measure how likely a physician is to ask patients about their feelings and to record their answers.   

You might think, reading the New England Journal article, that all of medicine, apart from palliative care, has been subjected to the standards demanded by the FDA. You would be mistaken. A great many of the tests and treatments used regularly by physicians have not been tested with any kind of rigor. But even more to the point, physicians still use their judgment in deciding whether to use a given drug in a given patient, even when that drug has been shown in a carefully conducted randomized clinical trials to be superior to the alternatives. Randomized clinical trials are typically carried out in patients who have nothing wrong with them except the condition being studied. Those patients are rarely over age 65. That vaunted FDA-approved pharmaceutical is then used in 85-year-old patients with multiple chronic illnesses. Maybe it will work just as well. But maybe it won’t work at all or will even cause serious side-effects. It might hasten death. Does Dr. Halpern only use treatments in his ICU that have been demonstrated in a randomized trial to be effective—and to be effective in a patient with exactly the combination of heart failure and diabetes and dementia that the patient before him has?

Of course we need to evaluate the tests and treatments that we use in patients. But we should use whatever method is most appropriate for the situation we are studying. Sometimes it will be a randomized clinical trial. Often it will be a combination of other kinds of studies, some of which may be qualitative. Whether we conclude that the test or treatment should be used will depend on the preponderance of the evidence. Only rarely will we know, beyond a reasonable doubt, that we are doing the right thing.