April 26, 2017

Quack, Quack--if it Sounds Like a Duck....

When Lydia Pinkham (1819-1883) began selling her patent medicine in the mid-nineteenth century, she advertised it as a panacea for all sorts of “female complaints.” Whether you suffered from “neurasthenia,” from menstrual cramps, from infertility, or from postmenopausal depression, Lydia Pinkham’s Vegetable Compound was the drug for you. It made Mrs. Pinkham and her descendants a bundle: as described by James Harvey Young in his book, Toadstool Millionaires, the remedy grossed $300,000 in the year of her death and in 1925, it earned a profit of $3.8 million. I’m not sure what that is in 2017 dollars, but it’s a lot.

Other patent medicines made similarly broad claims of effectiveness and were likewise lucrative for their developers. Warner’s "Safe Cure" stated on the label that it treated “Bright’s disease (nephritis), urinary disorders, female complaints, general debility, malaria,” and “all disorders caused by disordered kidneys and liver.”

These potions remained unregulated until the passage of the Pure Food and Drug Act in 1906, at which point the labels were required to be “truthful” about their ingredients. In particular, 11 dangerous substances including morphine, cocaine, and alcohol, which were frequently found in patent medicines (even in cough syrup for children) needed to be explicitly listed. There would be no evidence of efficacy required for another 32 years.

In the intervening years, both physicians and the public gradually began to appreciate that any drug that was touted as the treatment or even the cure for as many as ten distinct diseases was almost invariably a fraud and the disseminator of claims of its miraculous properties a quack. No one drug can plausibly have so many unrelated beneficial properties. Today, we are afflicted with the inverse of the one-drug-many-cures scam. We are bombarded with claims that a single disease can have many unconnected causes. And the disease for which such assertions are most commonly made is Alzheimer’s disease.

A few years ago, the media was all riled up by an article purporting to show that the anti-anxiety drugs, benzodiazepines,  were associated with an increased risk of Alzheimer’s disease. A year later, we learned that anti-allergy medicines and some antidepressants had also been associated with developing Alzheimer’s. Last year, the culprit was the class of anti-ulcer medications, proton pump inhibitors (drugs such as omeprazole). And now, instead of a medication, we have soda and other sugar-laden beverages allegedly leading to stroke and dementia.

Really? Do all these substances launch innocent people on the path towards dementia?

To be fair, there are disorders with multiple well-established risk factors. Coronary artery disease, for example, is associated with elevated cholesterol, diabetes, high blood pressure, and smoking. But in this case, we understand something of how the disease develops and how each of these risk factors affects that pathway. High blood pressure damages the lining of the coronary arteries, and the resulting areas of inflammation tend to trap cholesterol, producing plaques, etc. 

There are also single substances that produce diffuse toxicity: cigarette smoking has been associated with lung cancer, bladder cancer, and cancers of the head and neck (three very different types of cancer), as well as with heart disease and stroke. But again, we understand the mechanism of action that is responsible for the disparate effects. 

In the case of dementia, the connection between benzodiazepines and dementia, allergy medicine and dementia, proton pump inhibitors and dementia, and now soda and dementia, is purely statistical. Nobody has made a plausible argument for how each of these agents might work to trigger Alzheimer’s—even though we now know quite a bit about how the disease develops. No one has made a good argument because they haven't found one.

Nor is there a persuasive statistical argument. The studies based on which all these factors have been implicated in causing dementia are retrospective, non-randomized studies. The authors try to control for various “confounding factors” that might be the real explanation for the association, but they might not know what the relevant factor is or they might not be able to figure out if it was present or not. For example, maybe people who were ultimately diagnosed with Alzheimer’s disease were more likely than others to have taken benzodiazepines a few years before their diagnosis because they were already exhibiting very early symptoms, and those symptoms created anxiety.

Much exciting research is underway on Alzheimer’s disease, research that may someday result in treatment, prevention, or even cure. But fishing expeditions to come up with a commonly used drug or other substance as an explanation of this complex disease are a distraction. We don’t need people abandoning their ulcer medication or their allergy treatment out of an ill-founded fear that they are bringing dementia upon themselves. Stirring up hysteria—and potentially depriving individuals of good drugs—is a really bad idea.



April 23, 2017

Advantage, (Medicare) Advantage

I said last week that I was a statistics junkie. A related penchant is for reports, especially government reports.  And few reports pull together more interesting facts about health care in the older population today than MedPAC, the Medicare Payment Advisory Commission. The Commission just sent its mandatory report on payment to Congress last month—it sends such a document every March, this most recent one totaling 483 pages. The report begins by telling us that total spending on health care in the US in 2015 was a stunning $3.2 trillion, or 17.8 percent of GDP. Of that, Medicare accounted for $642.2 billion, representing a rate of growth that has actually fallen in recent years. But the chapter I want to focus on today is the one on Medicare Advantage plans, those capitated, private plans that constitute an alternative to traditional Medicare.

My question is simply: how well do Medicare Advantage plans work? Do they save money? And most importantly, are they good for patients? How do clinical outcomes compare between Medicare Advantage (MA) plans and standard, fee-for-service (FFS) Medicare? What other benefits, if any, accrue to patients from enrollment in such plans?

It turns out I’ve been interested in this question for a long time because such plans have the opportunity to coordinate care, to mandate some services that are essential for the geriatric population (eg geriatric assessment for high risk patients), and to cover other important benefits (eg hearing aids and glasses). In fact, exactly 30 years ago I published an article in the Annals of Internal Medicine called, The Impact of Health Maintenance Organizations on  Geriatric Care. At that time, there were only 87 plans nation-wide (compared to 3500 today). Some were doing all right—as long as the patients they enrolled were all healthy older people. Others weren’t doing so well and several folded altogether. The challenge and, I suggested, the opportunity, was to decrease the rate of hospitalization among enrollees (the main way to cut costs), which in turn would require geriatric assessment in the ambulatory setting and geriatric consultation in the inpatient setting. It would work, I cautioned, only if HMOs provided case management, podiatry, and home physical therapy. They didn’t do those things and they never took off.

After two overhauls—the early capitated plans authorized by the Tax Equity and Fiscal Responsibility ACT (TEFRA) in 1982 were reborn as “Medicare Plus Choice” thanks to the Balanced Budget Act (BBA) in 1997, and then christened “Medicare Advantage”  by the Medicare  Modernization Act of 2003—capitated plans are finally on the upswing. In 2016, 17.5 million Medicare beneficiaries (31 percent) enrolled in such a program. The appeal is to some degree simplicity: instead of having to purchase separate coverage for physician care (Part B Medicare) and for prescription drugs (Part D Medicare) on top of free hospital care (Part A Medicare) along with Medigap insurance to pay for most of what Parts A, B, and D do not cover, you could sign up for a Medicare Advantage Plan that does it all. In exchange for restricting which hospital(s) patients can be admitted to and which physicians they go to, MA plans also offer some of those extras I advocated years ago, such as case management, and basic vision and dental care. So how good are they?

MedPAC mainly pays attention to costs. But it does devote a few pages to quality. It relies on HEDIS measures (Healthcare Effectiveness Data and Information Set) that plans are required to report as well as the quality measures that go into the star rating system of health plans used by CMS. And what it finds, over and over, is that FFS Medicare plans and MA plans are indistinguishable, whether in terms of objective measures (percent of enrollees who get flu shots) or subjective measures (percent of enrollees who say they can get an appointment quickly or who rate the quality as high).

I’d like to see the breakdown for individuals who are frail or who have advanced illness. I’d like to learn what services such as case management or palliative care consultation MA plans use (always, often, or sometimes) for this population. And I’d like to know whether seriously ill patients are apt to dis-enroll from MA plans once they become ill, as used to be the case, presumably because they were concerned about the limitations on choice of physicians they encountered. But in the meantime, at least for the average older patient, it seems that MA plans are an attractive alternative to conventional Medicare.

April 16, 2017

Counting what Counts

A confession: I’m a data junkie. I don’t generally collect data (though I have carried out a few empirical studies) and I don’t analyze data statistically. But I am fascinated by descriptive data, which often provide  remarkable insights into how things were or how things are. 

When I was working on my latest book (Old and Sick in America will come out in October), and I wanted to know what nursing homes were like on the eve of the introduction of Medicare, I consulted the report, “Characteristics of Residents in Institutions for Aged or Chronically Ill: 1963,” put out by the US DHEW (as the Department of Health and Human Services was called then). I learned there were just over half a million people living in 16,370 nursing homes (just about the same number of nursing homes we have today) and that they stayed there, on average for 3 years. 

When I wanted to know what hospitals were like in the 1960s, I read “Trends in Hospital Utilization: US 1965-1986” and found that circulatory disease, which has been the number one reason for hospitalization from the 1980s to the present, was only number 6 in 1965. Over the period from 1970 to 1986, the number of catheterizations done each year in people aged 65 and older would soar from 8,000 (or 3.8/10,000 people) to 275,000 (or 85.8/10,000) and that CABG (coronary artery bypass surgery) would likewise jump from 0 to 125,000 (or 42.9/10,000). So periodically, I check whether the National Center for Health Statistics has released any “Data Briefs” about older people. This past February, the agency published “Emergency Department Visits for Injury and Illness Among Adults Aged 65 and Over, US 2012-2013.” It is a compelling reminder that the emergency department is a key source of health care for older people.

Focusing exclusively on illness (as opposed to accidents), the report finds that the elderly go to the emergency room often and the older they get, the more often they go. Each year, 29 percent of people aged 65-74 have at least one emergency visit, as do 42 percent of those aged 75-84, and 57 percent of those aged 85 and up. About a third of these older patients arrive in the emergency room by ambulance—highlighting the role of ambulances as another locus of health care for this population.

These numbers don’t tell us what actually happens to older people when they reach the ER, but other data give a few clues. In the ER, the elderly are very likely to have some kind of imaging procedure (63 percent do), with about half of those getting a plain X-ray and a quarter getting a CT scan. And fully 32 percent of those presenting to the emergency department with an illness are admitted to the hospital; 5 percent to a critical care unit. There’s much that is left out if we focus only on descriptive statistics: we don’t know whether these patients typically have a friend or family member with them; we don’t know if anyone asks about their home situation; we are in the dark about whether anyone addresses their goals of care or checks if they can walk or determines their mental status. But the numbers are a place to start.

What is abundantly clear is that with 15.5 million visits to the emergency department by older people every year, it’s high time we pay more attention to what actually goes on there. We have the opportunity to figure our whether the hospital is the right place to take care of whatever the problem is and, if not, how to shore up the home environment to make it a viable alternative. To answer these questions, we need to make certain that older patients routinely undergo a brief assessment of both their cognitive and physical functioning. We need to involve a family member if support will be needed at home. I would bet that if we did all this, we’d make far more headway in avoiding hospitalization and decreasing the rate of readmission than many of the elaborate transitional care programs operating today.