June 20, 2018

Much Ado About CPR

Two short essays in this week’s New England Journal of Medicine present differing perspectives on how to treat a desperately ill woman w in the ICU of an American hospital, a woman who is unable to make her own decisions and has no advance directive. One author responded that the right course of action was to “institute a DNR order” and the other that it was to “continue full resuscitative measures,” setting up a quasi-debate. I say a quasi-debate because the two authors, as per the editor’s instructions, simply laid out their own arguments without responding to the other’s point of view. I know, because I am one of the two.

I asserted that the physician should declare the patient DNR—a woman with no written advance directive and no designated health care surrogate who was dying of multiple organ failure triggered by sepsis and unresponsive to maximal medical therapy. Attempted CPR in this setting, I argued, was as close to futile as medical treatment ever is; moreover, the patient had clearly stated to a friend and neighbor that she would not want aggressive measures when facing overwhelming odds. I stand by my arguments, which I won’t repeat here, but I regret that the discussion focused on the wrong question.

The wrong question is whether the patient should have a DNR status; the right question asks about the general treatment strategy rather than a specific medical intervention and about the process for deciding, not just the outcome of the process. It moves the discussion beyond considerations of futility—a debated that raged in the 1980s and ultimately led to the recognition that futility is meaningless without reference to what treatment is intended to accomplish. Maintaining a patient who is in a persistent vegetative state on artificial nutrition is futile if the goal is to restore her to full functioning as a thinking human being. But it’s entirely appropriate if the goal is to sustain life in the sense of a heart that beats and lungs that respire. Discussing how to make medical decisions for patients who have lost capacity and how to think about treatment for those who are dying allows us to discuss much more important decisions than whether or not to attempt CPR.

Ever since 1984, when a New York hospital was found guilty of putting purple dots on patients’ charts signaling that they were not to be resuscitated—without their knowledge or input or that of their next of kin—we’ve been obsessed with DNR orders. I suspect that more ink has been spilled on whether, when and why to write a DNR order than on any other medical decision. The reason, presumably, is that it seems irreversible: if a patient sustains a cardiac arrest and CPR isn’t performed, the patient will surely die. Other seemingly momentous decisions often prove not quite so momentous—even Karen Ann Quinlan, the first patient to bring the possibility of not intervening medically to public attention, lingered for nine years after her “life-sustaining” ventilator had been disconnected. A choice not to resuscitate is far more unambiguous—although CPR, it should be pointed out, is hardly a guarantee of life.

Cardiac arrest may have special cachet because it seems to divide the living from the dead. But in fact, for older patients who are critically ill, it is often merely the last step in what is often a relentless progression of markers on the way to death. From the perspective of human suffering and of doing good (and avoiding harm), other steps along the way are often far more significant. After all, a person whose heart has stopped and who is not breathing is no longer able to experience anything, neither the existential angst from awareness of imminent death nor the physical discomfort of aggressive treatment. The nurses and doctors who attempt CPR in a dying patient may feel guilty of assault; they often regard intubation, chest compressions, and electrical shocks as an undignified way to end life, but they are the ones experiencing malaise, not the patient.

Subjecting a patient who is in the final phase of life to dialysis for four hours a day, three times a week, or to major surgery to repair a damaged heart valve, or to ventilator care for advanced lung disease, by contrast, may cause pain and suffering to the person receiving treatment. Both the potential benefit of treatment (longer life) and its potential burdens (ranging from delirium and functional decline to a shorter life) are difficult to assess quantitatively. These decisions, which are difficult to make with a competent patient and correspondingly more fraught with an incapacitated patient, are the ones we should be discussing, not CPR.

Ironically, despite the now 42-year history of DNR orders, there is still confusion about whether DNR indicates that CPR will not be performed in the event of a cardiopulmonary arrest (as it is defined by the American College of Cardiology and other authorities) or something more. Indeed, the opposing piece in the New England Journal of Medicine talks about a time-limited trial of “continued resuscitative measures,” which presumably refers to ongoing ventilator treatment for respiratory failure, dialysis for kidney failure, and fluids and antibiotics for sepsis, rather than for a few minutes of attempted CPR. This uncertainty about what DNR means reflects another problem with the obsession with “getting the DNR order,” and that is the widespread belief that treatment decisions must be all-or-nothing: if you don’t want CPR, then surely you don’t want any potentially life-prolonging medical interventions. The reality is that many people don’t want burdensome treatments that are extremely unlikely to be beneficial, but that doesn’t mean they want to focus exclusively on comfort. 

There’s much more to discuss—I haven’t even touched on the process for making medical decisions. That includes not only who the surrogate should be in the event of decisional incapacity and what standard that surrogate should use for making decisions (substituted judgment is the usual standard, with best interests the back-up if no information about the patient’s preferences is available), but also how the discussion should unfold. Typically, physicians are so eager to reach a decision about what to do that they jump to this step in the process without first clarifying the patient’s underlying health state (in the NEJM vignette, the crucial bit of information is that the patient was dying), as though preferences are independent of any broader context. But for now, let me leave you with the thought that both medical decision-making and advance care planning involve much more than checking off items on a menu, and that if we do engage in intervention-specific planning, CPR should be low on the list of what we discuss.

June 07, 2018

The Sting of the Jellyfish

Several years ago, the public health community launched an initiative to persuade pharmacies to stop selling cigarettes. Responding to steady pressure, CVS announced in 2014 that it was pulling all tobacco products from the shelves of its approximately 7700 stores. The result? Overall sales of cigarettes dropped, with fewer teens starting to smoke and more people quitting. The other chains, such as Walgreen’s and Rite Aid, have not yet followed suit, but the precedent has been set: retailers dedicated to the promotion of health should not be in the business of peddling death—and cigarettes are the leading cause of preventable death in the U.S., accounting for over half a million deaths per year.

In the same vein, we might ask why news organizations that are dedicated to ferreting out the truth continue to allow ads that peddle falsehoods. And that’s exactly what CNN, Fox News and MSNBC are doing when they advertise Prevagen, a protein that its manufacturer, Quincy Bioscience (a company that seems to be devoted almost exclusively to making and selling Prevagen) touts as “clinically shown to improve memory,” exhorting aging individuals to “try Prevagen for yourself today” in order to “support healthier brain function, a sharper mind and clearer thinking.”

These claims are untrue. The FDA issued a warning letter to the company in 2012, arguing that the company’s unverified health claims indicate that it is selling a drug and not a “supplement” (as the company calls Prevagen) and thus must go through the rigorous approval process for new drugs. Today, the manufacturer continues to call Prevagen a “supplement” because it is a synthetic version of a protein found in jellyfish and continues to make the same claims about its effectiveness, though with the disclaimer in small print that “these statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat cure or prevent any disease.” 

In 2016, the Federal Trade Commission’s Bureau of Consumer Protection and the NY State Attorney General filed a lawsuit arguing that, contrary to its manufacturer's claims, Prevagen has not been shown to improve memory in 90 days; it has not been shown to reduce memory problems associated with aging; and it has not been shown to produce other cognitive benefits.That lawsuit, incidentally, was dismissed because the judge failed to understand that the methodology used in the clinical trial on which the company’s assertions are based is irredeemably flawed. With the added support of AARP, the case has been appealed to the Second Circuit Court of Appeals. 

Why anyone should be motivated to take Prevagen based on its activity in jellyfish, which are not known for their cognitive abilities, is a mystery to me. 

Why anyone should think that the active ingredient, Apoaequorin, could possibly do anything when it is destroyed in the stomach by the enzyme pepsin and therefore doesn’t even make it into the circulation is another puzzle. And why anyone should believe that Apoaequorin could affect brain function (if it somehow managed to elude stomach enzymes and find its way into the blood stream) when it is 40 times too large to cross the blood-brain barrier is also unknown. But what is clear is that Quincy Bioscience has been successful in earning $165 million between 2007 and 2015. It is willing to spend big bucks on advertising on national television to promote its product because it knows the strategy works.

Followers of CNN, MSNBC, or Fox trust the news they hear from commentators on those stations. Because they trust the station, they tend to trust its advertisers. News programs have an ethical responsibility to vet the ads they run; they don’t have to like the products, they don’t have to want the products themselves, but they should be committed to fact-checking their veracity.

A separate question is why FDA regulation of “supplements” is confined to assuring that they are accurately labeled—that is, that the ingredients are correctly listed on the bottle. Manufacturers of dietary supplements do not have to prove them safe nor do they have to make claims about efficacy that are accurate or truthful. A related question is why products such as Prevagen can bypass the FDA's regulatory process for new drugs by calling themselves “supplements,” a term primarily applied to vitamins and minerals but increasingly used for all sorts of “herbs and botanicals” as well as other substances found in nature, or their synthetic analogs. 

In today’s anti-regulatory climate, we cannot realistically expect increased government protection for vulnerable consumers. We can expect—and demand—ethical behavior from any organization dedicated to promulgating the truth.

May 17, 2018

Can We Talk?

This week, the Massachusetts Coalition for Serious Illness Care released the results of a survey of state residents about advance care planning. The coalition wanted to know whether people were talking about their preferences for care near the end of life and if so, with whom—family? Physicians? The concern was also with whether people who had suffered a serious illness over the preceding year were more likely to have had such conversations and whether factors such as age, ethnicity, or gender influenced behavior. And regardless of whether people had discussed their views, had they designated a health care proxy, a substitute decision-maker in the event of incapacity?

On the assumption that more talk is better, it’s difficult to spin the results as encouraging. Massachusetts residents do not talk much to their doctors about such issues, even if they have had a serious illness and even if they are over age 65—although these two groups do have appreciably higher talk rates than their healthier or younger counterparts. On average, they are not very different from people in the rest of the country and the rates of conversation have not appreciably changed since the last such survey was administered in 2016.

In the population as a whole (the survey sampled adults over the age of 18), only 13 percent had had a conversation with a health care provider about their end of life preferences. Among those with a serious illness or over age 65, this rose to 27 percent.

Those surveyed were more likely to have chosen who would make decisions for them than to talk about what their surrogate should decide, with 63 percent of those over 65 having completed a health care proxy form. 

Perhaps what’s most interesting is that among those who reported they had had a discussion of their wishes, 59 percent said they had initiated the conversation, not the physician or other member of the health care team. Moreover, 34 percent of those surveyed said they did not want to have such a discussion with their doctor—they felt confident that their family members understood their wishes.

Before we get too carried away by the numbers, we should note that only about 210 of the participants were over age 65 (according to the 2010 Massachusetts census, 14 percent of the population was over 65; there were 1500 people sampled in the survey). That’s not many people on whom to base sweeping conclusions and this is the group for whom advance care planning is most essential.

Which leads me to my conclusion: advance care planning doesn’t make much sense in young people or healthy people. The likelihood that such a plan will have to be implemented is just too remote (Karen Ann Quinlan, Nancy Beth Cruzan, and Terri Schiavo notwithstanding—they are the exceptions, not the rule) and the chance that their perspective on what they would want if they were in an unimaginable future state reflects what they would actually want if such a situation came to pass seems slim. Efforts to think about future wishes make most sense for people who already have the condition that is apt to kill them in the future. Once they have started on a particular path, they are better positioned to think about the next steps on that journey.

Geriatricians learned a long time ago that “targeting” interventions to the appropriate population is crucial if they are to be beneficial (and cost-effective). Proponents of advance care should likewise concentrate their efforts on the people who stand to gain the most from discussions of the goals of care—and who are in a position to imagine their future. Even in this arena, we have a great deal of work to do. But spreading our efforts too thinly won't help.

May 07, 2018

To Fix or Not To Fix

Over the past ten years, people with advanced dementia have gradually come to be recognized as dying. Death may not come in a day or a month, but it will usually arrive within six months and almost always within a year. In recognition of this reality, growing numbers of physicians recommend a palliative approach to medical care for persons with advanced dementia, and increasing numbers of family members accept comfort care for their relatives. But what, exactly, is the best way to make someone with advanced dementia comfortable?

One common problem in this population, an event that is decidedly uncomfortable, is falling, especially when it results in a hip fracture. In nursing homes, which many family members assume is a perfectly safe environment, falls and fractures among individuals with advanced dementia in fact occur with some regularity. Individuals with advanced dementia by definition have poor judgment, limited awareness of the risks to their own safety, and may suffer from visual problems or gait abnormalities on top of their cognitive impairment. Nursing home staff members cannot provide constant one on one supervision. At the same time, walking around may be one of the few remaining sources of enjoyment for the person with dementia. If he or she does fall and does break a hip, and if the person’s family has indicated that comfort is the most important goal, how should that goal be translated into practice?

While we know that over one-third of nursing home residents with advanced dementia and a hip fracture die within six months of their fracture, what we don’t know is how operative treatment (hip fracture repair) compares to non-operative treatment (bed rest and pain medication) in terms of either comfort or mortality. Berry and colleagues attempt to provide some insight into this question in an article appearing in JAMA Internal Medicine

Because it’s not currently feasible to randomize patients to the two strategies, the authors emphasize, they resorted to administrative databases. They use information from the Minimum Data Set, an extensive database mandated for use in long term care facilities, together with Medicare claims data to define a population of nursing home residents with advanced dementia and a hip fracture and to look at what happened to them. So, what did they find?

Over a two-year period, they were able to identify 3083 nursing home residents with both advanced dementia and a hip fracture. Fully 85 percent of them underwent surgical repair; the remaining 15 percent were treated non-operatively. Those who underwent surgery were considerably less likely than those treated conservatively to die; early on, there was a 12 percent mortality rate in the surgical group compared to a 31 percent rate in the comparison group. The median survival among those with surgery was 1.4 years; the median survival in the other group was 5 months. 

Perhaps more interesting than survival, since family members tend to regard comfort rather than life-prolongation as the primary goal of care, is differences in pain control. This is especially important since one of the main reasons given for advocating surgery is to control pain. What Berry et al found was that at six months, 29 percent of the post-surgical group were in pain vs 31 percent of the non-operative group. While this difference was statistically significant, it’s actual clinical importance is less clear. Moreover, we really want to know how much pain was experienced in the immediate post-fracture period, probably the first 30 days, which the methodology used cannot tell us. The investigators also found that only 11 percent of those individuals who had been able to walk before the fracture and who underwent surgery were still able to walk six months after the surgery. Retaining the ability to walk is the other major reason for contemplating surgical repair of a hip fracture.

One problem with the study is that we don’t have any information about why surgery was not done in 15 percent of people. Maybe their physicians or their family members perceived them as closer to the end of life than their counterparts who underwent surgery, even if the two groups are indistinguishable in terms of measurable risk factors, and maybe they were correct in their assessment. Or, what is at least as likely, the families who advocated a non-surgical approach were also likely to favor withholding antibiotics or other treatments (with the exception of pain medication) in the ensuing months. It may well be that it was the decision to minimize all kinds of interventions, not just surgery, that led to a shorter life. 

A second problem is that we don’t know anything about the quality of life in the immediate post-fracture period. We know about pain, restraint use and pressure ulcers at six months—but not at one month, which is the time frame over which the treatment decision is most apt to matter. For all we know, people who don’t have surgery have better, more aggressive pain management in the weeks after the fall because physicians understand they are in pain, whereas they are notoriously poor at pain management after an operation, especially with patients who cannot articulate that they are in pain.

Berry et al deserve kudos for asking the right question—what constitutes good palliative care in advanced dementia? They've made a good start, but much more research is necessary to answer the question.

April 19, 2018

Medicare Part E?

Congress first created the Medicare hospice benefit in 1982. During the first full year after the law went into effect, only 200 Medicare patients enrolled in hospice, accounting for less than one-half percent of the deaths that year. By 1986, seven percent of Medicare patients who died were enrolled in hospice at the time of death; in 1998, it was 19 percent and in 2013 it reached 47 percent. A new report from the National Hospice and Palliative Care Organization shows this percentage has remained fairly stable: in 2017, it was 48 percent.

The length of time that Medicare patients are actually enrolled in hospice remains woefully short, particularly for some diagnoses: while the average length of stay is 71 days, reflected a few very long stay patients, the median length of stay is only 24 days. In fact, fully 28 percent of individuals got between one and seven days of care, far less than most clinicians regard as optimal. Patients enrolled in hospice because of a cancer diagnosis tended to have the shortest lengths of stay in the program. Nonetheless, the historical shift towards hospice as a reputable and popular approach to end of life care demonstrates that we can introduce a new Medicare benefit package and expect it to catch on. The same happened with Medicare Part D, the drug benefit (though this was an add-on rather than a substitution), with enrollment going from 52 percent in 2006 to 71 percent in 2016. Medicare Part C, the partially privatized HMO-style benefit now known as Medicare Advantage, has also taken off: in 2003, only 13 percent of Medicare beneficiaries opted for such a plan but by 2017, 33 percent did. 

The time is ripe for adding a new alternative benefit package to Medicare’s offering: whether we call it Medicaring, the name preferred by Joanne Lynn, Director of the Elder Care and Advanced Illness division of the Altarum Institute,
or Intermediate Care, my term, or something else, it would provide enhanced home care services for frail elders and others with advanced illness in exchange for limitations on access to intensive, expensive, burdensome, and seldom beneficial treatments such as bone marrow transplantation or open-heart surgery. 

Americans tend to dislike or at least be very skeptical about any kind of limits to care. But often the problem is that we focus on what people cannot have rather than emphasizing what they can have—and what they often need and want. In fact, I think one reason that patients only enroll in hospice very late in the course of their illness is that hospice is presented as the withdrawal of care, the discontinuation of care, rather than as the substitution of one approach to care for another. Many patients may be unwilling to forgo treatment altogether, which is how hospice is frequently presented, but are eager to choose a less invasive, less burdensome form of care: infusions of very toxic chemotherapy drugs in the physician’s office every week or two may be rejected if there is an oral medication they can take at home that has far fewer side effects. But if the only alternative is certain death, chemotherapy looks far more attractive.

Important and interesting work has been done on developing and implementing programs to care for people with advanced illness or frailty, such as the Coalition to Transform Advanced Illness Care's 2017 reportThe way forward is now to create a Medicare benefit to accommodate this approach.

April 02, 2018

Vavavoom--the Vital VA

The Veterans Health Administration, as its website reminds us, is the largest integrated health care system in the US, where “integrated” is a contemporary buzzword in health care. It denotes coordination across many sites and implies a focus on populations, not just individuals, both of which are generally viewed as essential features of a good health care system—and which are widely lacking in the US. The VA, as it is known, provides care to 9 million people at 170 medical centers and over 1,000 outpatient sites. It is also the only form of socialized medicine in the United States: the federal government does not just provide health insurance (as is the case with Medicare); it employs the physicians, nurses, administrators, and others who actually provide medical care. Not surprisingly, the VA is under threat from the current administration, despite its popularity with veterans and the organizations that represent them.

The goal of the current administration is to privatize the VA, and arguably the real reason the Secretary of Veterans Affairs was summarily fired is that he wasn’t moving rapidly enough in that direction. At issue may not be money—Trump’s proposed 2019 budget for the VA would be nearly $200 billion, or a 12 percent increase over the current year. Rather, the main concern is ideological—getting government out of health care. My question is: what would that mean for older people, many of whom receive VA benefits?

In many respects, the VA provides excellent care for older veterans. It has a long history of innovation in the geriatric realm: it has for years had a network of Geriatric Research and Clinical Education Centers (GRECC) that carry out research and provide clinical care to older people. Its Geriatric Evaluation and Management Units (GEMU) that offer inpatient geriatric assessment have been shown to slow the rate of functional decline compared to standard care. The VA has a model Extended Care program that provides room, board, and medical care to veterans needing long term care. And in recent years, it has developed an innovative home visit program for its neediest members. Are all these programs a fluke?

To understand, we need a little perspective. The VA health system was created by Congress in the immediate aftermath of World War II. It had several missions including: improving the health and function of US veterans, providing education and training to medical students and residents, and conducting research. But for many years, it was the poor stepchild of the federal government. The Secretary of Veterans Affairs did not become a cabinet level position until 1989. The system became known for inefficiency and mediocrity. But then in 1994, then Under Secretary for Health in the VA John Kizer initiated a radical transformation of the VA system. He created a new system of regional integrated service networks. He developed and implemented a system of quality indicators to drive improved performance.

The transformation worked. A 2007 study published in the Milbank Quarterly looked at performance over the 1998-2005 period and found that the VA outperformed traditional Medicare, Medicaid, and the private sector on a variety of indices.  

A RAND study published in 2016 examined the period from 2005 to 2015 and again found that the VA performance was comparable to or superior to standard American health care in most domains.

But there were cracks in the system. By 2014, those cracks split wide open, and a scandal over long wait times—and a cover-up to conceal the problem—erupted. As Kizer himself, the mover and shaker of the earlier reforms, argued in a New England Journal of Medicine essay in 2014 written with health policy expert Ashish Jha, the reforms have become unfocused and the bureaucracy bloated. The original idea of using quality indicators had mushroomed until there were so many indicators that both administrators and physicians were paralyzed; the earlier regionalization and centralization of the VA system, while effective managerially, had led to excess insularity of the entire system from new developments in the private sector (many of which may have taken their inspiration from the VA in the first place!) 

The solution they proposed was to fix those problems, not to outsource VA care to the private sector. Firing Secretary Shulkin, who by all accounts was a very competent and visionary leader, and replacing him with the president’s personal physician, Ronny Jackson who has no experience managing a large organization (let alone one as complex and needy of reform as the VA), is a classic case of throwing out the baby with the bathwater.

March 25, 2018

False Hope

This past week, the House passed its “Right to Try” bill, which would give dying patients easier access to experimental drugs. The Senate has already passed a version of this ill-conceived legislation and Trump is an enthusiastic supporter, viewing it as a means of defanging the FDA and of demonstrating his great compassion for the American people. The bill itself, if it is signed into law, will not affect very many people and most of them are not likely to be elderly. But it is the first step in a campaign to destroy drug regulation. That is an issue for all of us, and for older people, as the greatest per capita consumers of prescription medications, in particular.

A STAT article on the subject quotes Andrew McFadyen, executive director of a non-profit patient advocacy group: “I think this is the first step, for sure. Tear down as many regulations as possible, take away all oversight, and let it be the Wild West of medicine.” He continues that its Republican proponents “opened the door to Koch brothers and Goldwater to rip apart the FDA, and then other government bodies after that.”

It’s important to recognize three things: 1) the FDA plays an enormous role in patient safety. Tearing up the regulatory framework, as Trump and his ilk favor, would have devastating consequences for health and well-being; 2) the history of granting desperate patients access to experimental drugs is one of offering false hope and enormous suffering; 3) the track record of the experimental drugs that the current legislation would support is mediocre.

The FDA approval process keeps us safe. When the FDA was first created in 1906, all it required was that drug labels accurately report the contents of medication. No longer was it permissible to sell “tonics” such as “Pinkham’s Vegetable Compound” or “Mrs. Winslow’s Soothing Syrup” without divulging on the label that the former contained alcohol and the latter morphine. 

The idea that FDA approval required that a drug be demonstrably safe and effective came much later. This amendments to the law were finally passed in 1938--after 5 years of debate--after the sulfa disaster of 1937: a liquid form of the new antibiotic, sulfa, had become widely available and was marketed for use in children. Because there were no safety tests performed, nobody seemed to have noticed that it was made with ethylene glycol (the active ingredient of antifreeze), a toxic chemical that causes liver failure and death—and that killed over 100 children. 

The requirement that drug companies actually perform randomized controlled trials to determine the safety and efficacy of proposed new drugs had to await the thalidomide disaster of the early 1960. Only after pregnant women treated with sleeping pills gave birth to babies with severe congenital malformations was were the Kefauver-Harris amendments to the FDA passed in 1962.

The track record of experimental drugs is poor. While the proponents of the new legislation, conservative groups such as the Goldwater Institute (named after Barry Goldwater) focus on “free choice” as the rationale for making untested substances available to the public, the widespread assumption is that substances entering a “phase III” clinical trial are all but proven drugs—just a few more bureaucratic hurdles, and they will be FDA approved. In fact, a phase III trial is designed to determine whether a drug that has shown some evidence of efficacy in a smaller, earlier trial (one that was focused primarily on looking for side effects) is actually effective. Many drugs that reach the Phase III stage do not move on in the approval process because they are not found to work. For cancer drugs, only 40% move ahead.

One of the most dramatic examples of the unfortunate consequences of premature access to an experimental therapy is the case of bone marrow transplant for advanced breast cancer. In the 1990s, more than 30,000 American women received bone marrow transplants at the cost of millions of dollars, extremely unpleasant side effects (including death—treatment-related mortality was reportedly as high as 15%). Insurance companies found themselves pressured to pay for the therapy—until several randomized controlled trials definitively demonstrated that it was no better than conventional chemotherapy.

The sad reality is that dying patients are vulnerable to claims that a cure is lurking around the corner. More often than not, what they are being offered is an opportunity to spend their dwindling resources on a bottle of false hope, often suffering enormously in the process. This is what the “right to try” legislation offers. The House and Senate versions must be reconciled for “right to try” to become law. Tell your senator to halt the assault on the FDA and keep drugs safe and effective.

March 04, 2018

When Skim Milk Masquerades as Cream

         Researchers at the University of Michigan surveyed just over 2000 people between the ages of 50 and 80 to find out whether they thought physicians prescribe too much, too little, or just the right amount. What they found is surprising.
         Contemporary wisdom holds that physicians are aware that they order unnecessary tests, recommend too many procedures, and prescribe too many medications. They  behave this way, practicing “low value medicine,” in large measure because this is what patients demand. Respecting autonomy, physicians argue, compels them to accede to patients’ wishes—together with the fear of malpractice suits. The new study suggests both that many patients are aware that their physicians over-treat them and that they don’t want those unnecessary treatments. Fully one quarter of those surveyed said their own physicians over-treat, and double that number said that physicians in general over-treat. One in six said within the last year, their doctor had advised them to have a test or take a drug that was unnecessary. But half of those admitted to doing what they were told to do. By contrast, just under ten percent of those surveyed said their physician had declined to order a test or medicine that the patients felt was indicated.
         We already had fairly good evidence that the fear of lawsuits was greatly over-stated: if physicians explain why they don’t believe a test or drug to be warranted and document the conversation, the chance of being sued for failing to order whatever it was that they didn’t recommend is very slim. Now we have fairly good evidence that it isn’t patient pressure that is influencing physician behavior. The “Choosing Wisely” campaign, which encourages physicians to talk to patients about why the patients shouldn’t be requesting various tests, has it backwards.
           Physicians need to look in the mirror and recognize that we are the problem. We need to stop arguing to ourselves that it’s better to be safe than sorry or that more is better than less. Even relatively non-invasive tests have risks and even moderately inexpensive medications have costs. The older the patient and the greater the number of co-morbid conditions, the more likely a test is to have side effects. And even the small ticket items add up when they are performed very often. “Low value” care isn’t really low value; it’s just bad medicine.

February 28, 2018

Sacred Aging

This week, I was interviewed  by Rabbi Richard Address on his program addressing the consequences of the longevity revolution for baby boomers and their family. The interview can be accessed on the site, Jewish Sacred Aging.

February 19, 2018

Good for Nothing?

               For over thirty years, we’ve been arguing about when medical care is “futile.” The debate began in the 1980s, when the most common question faced by hospital ethics committee stopped being, “do doctors have to do this procedure, even if patients or their families don’t want it?” to “do doctors have to do this procedure if patients or their families demand it, even if the doctors don’t want to?” One case that attracted a great deal of attention was that of Helga Wanglie, a woman in her late eighties who was in a vegetative state after hip surgery and whose physicians wanted a “DNR” order. Helga’s husband, speaking on her behalf, disagreed. Ultimately, the case ended up in the Minnesota courts and was settled based on a technicality—the hospital sued on the grounds that the husband wasn’t an acceptable surrogate, but the court found that he was. The issue of what qualified as “futile” treatment was largely skirted.
         The bioethics community then struggled to define futility, with Schneiderman, Jecker, and Johnson proposing what appeared to be a quantitative definition: if the treatment in question has failed in the last 100 cases, then it’s futile. There were several problems with this approach. First, it sounds nice and scientific, but nobody was collecting data on what worked in whom. Even if we had information about 100 people, they were rarely identical in what might be crucial ways—is an 85-year-old with advanced dementia, diabetes, and heart disease who has a cardiac arrest equivalent to a 75-year-old with cancer? Secondly, what exactly was meant by a treatment “failing?” Helga Wanglie’s doctors said a ventilator was “failed” treatment because it could not restore the patient to her condition before she was hospitalized—it wasn’t going to allow her to walk out of the hospital and go home. Her husband said a ventilator was “successful” treatment because it sustained Helga’s life. The answer to whether a treatment would be futile turned out to be, “it depends.” It depends on what the treatment was supposed to accomplish. The net effect was that in most of the country, the word “futility” was abandoned in discussing treatment options.
         The exception was Texas, which passed an “Advance Directives Act” in 1999, widely known as the Texas “Futile Care Law.” It spells out a process by which physicians can assert that a treatment is futile and need not be given, as well as a process for adjudicating any disputes between physicians, patients, and families. Ultimately, the physicians have the final say.
         Despite the consensus in the bioethics community and the near consensus among state legislatures that discussing futility was unhelpful, physicians have continued to believe that various treatments should not be provided in certain circumstances because it is morally wrong. To address the persistent discomfort physicians and nurses have felt administering what they regard as “futile” care, the American Thoracic Society recently came out with a position paper called “Responding to Requests for Potentially Inappropriate Treatment inIntensive Care Units.” This policy statement was endorsed by four other professional organizations. Another guideline, this one published by the Society for Critical Care Medicine, addressed what it called “non-beneficial” treatment. The originators of the quantitative futility concept, Schneiderman, Jecker, and Jonsen, continue to believe that “futility” is the best way to describe the class of treatments under consideration.
         So, which is it: Futile treatment? Potentially inappropriate treatment? Non-beneficial treatment? None of the above?
         The issue, it seems to me, is whether the problem is fundamentally a technical one or an ethical one. “Futility” advocates want to define the problem (perhaps surprisingly, since its principal supporters are ethicists) as a technical one. The proponents of “potentially inappropriate care” seem to acknowledge that the issue is ethical (again surprisingly, since its main advocates are physicians). It would be lovely to make the dilemma vanish with a technical solution! If only we could state precisely when CPR or a ventilator or dialysis or chemotherapy cannot work to achieve whatever specific goal it is supposed to accomplish. Then we wouldn’t have to ask whether it’s the right approach. Surely, we can all agree that if something cannot work, like antibiotics for a viral infection or apricot pits for cancer, providing such a “remedy” is inconsistent with professional standards. 
           Unfortunately, such cases of what has been called “physiologic futility” are relatively rare. More common is the situation where an intervention is deemed by medical professionals to be inappropriate because, in their estimation, the burdens outweigh the benefits. This conclusion rests on an understanding of the clinical situation, but also on a moral judgment.
         The desire to convert what is quintessentially an ethical dilemma to a technical one is understandable. It relies in large measure on the recognition that many medical decisions do have a technical and an ethical component, and that often, it is up to the patient (or the patient’s surrogate) to address the ethical piece. But that awareness does not preclude professional ethical standards playing a role as well. The debate about physician assisted suicide, while complicated because of varying legal standards, is to a large extent about whether physicians regard ending the life of a suffering, terminally ill patient as consistent with their ethical norms. The widespread recognition of the responsibility of physicians to care for patients who are criminals or other individuals they may find personally objectionable is based on the ethical code of conduct of the medical profession.
         Recognizing the patient’s values and shaping medical care to be consistent with those values is desirable—when the patient’s ethics and those of the medical profession do not irreconcilably conflict. It’s important to point out that I’m not just talking about the idiosyncratic views of a given physician—the personal ethical values that have been put forward as a justification for failing to provide contraception. I’m talking about an ethical standard of care set by the profession as a whole. The American Thoracic Society statement on “potentially inappropriate care,” while not perfect, is an effort to define what the profession regards as appropriate—acknowledging, through its caveat about “potentially inappropriate” care, that there could occasionally be circumstances where the profession’s norm is not applicable.