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.