As Simple as ABCD: A Better Care Directive

Kudos to Barak Gaster, a general internist at the University of Washington, who has developed a dementia-specific advance directive. In this document, he starts out by explaining what dementia is and why patients and families might not want every possible medical treatment throughout the course of this long illness. Then he simply and clearly characterizes each of the three main stages of dementia: mild, moderate, and severe (or early, mid-stage, and late) and asks what the goal of care would be in each instance. 

I like the framework because it's basically what I have used for the past twenty years in articles and books. Gaster uses the same formulation that I propose—prolonging life, maximizing comfort, and something in between that is related to maintaining function and dignity—but adds one more option, life prolonging therapy minus attempted CPR. That’s it. No long list of potential treatments, ranging from ventilators to iv’s as with typical instructional directives (or, indeed, with the POLST, which is an instructional directive turned into a medical order). No complicated list of symptoms for each of the three stages of dementia, a list that leaves people reeling and uncertain about just what stage a given person is actually in.

            

Here are the parts of the document:

    1. What is dementia? Three short paragraphs indicating that Alzheimer’s disease and other dementias are progressive, ultimately fatal diseases. Indicates average time from onset to death (says 8 years, though some of the data I’ve seen indicate 5-7 is more accurate). Highlights features of last stage.

     2. Why is it important to express your wishes? Emphasizes that patients lose capacity and families benefit from receiving guidance.

     3. What kind of guidance can you give? Explains that tests and procedures are more difficult to tolerate as dementia progresses. Also emphasizes that many people would not want life-prolongation as their thinking and ability to derive meaning from life deteriorate.

     4. Stages of dementia:

     

     Stage I (mild): lose ability to remember recent events; 

     routine tasks become difficult (ie cooking); other tasks can

     be more dangerous (ie driving).

     

     Stage II (moderate): lose ability to have conversations and

     to understand what is going on around them. Require full 

     time assistance with dressing (I would quibble over this one;

     people do need some help with their “activities of daily

     living,” one of which is dressing, but I don’t think singling out

    dressing and saying “full time assistance” is needed is quite

    accurate.

    

    Stage III (severe): no longer able to recognize family, may become angry and agitated (one caveat here: agitation often starts in moderate dementia); need round the clock help with all daily activities.

    Even the description of the goals of care are well done: there is some explanation of why a person might choose a particular goal. For example, if the goal of care is “to only receive care in the place where I am living,” the text clarifies that the reason for not wanting to go to an emergency room or be hospitalized is to avoid the “possible risks and trauma that can come from being in the hospital.”

    For people who find images helpful to elucidate the words, I suggest viewing the videos from acpdecisions.org addressing dementia. Angelo Volandes, president of ACPdecisions, has filmed a series of dementia-related videos based on the script I offered: one addresses the stages of dementia, and another details the goals of care across the spectrum of the disease (suggesting that many people favor different goals as the illness becomes more advanced).

    

    The proposed new "advance directive for dementia" is a

    valuable contribution to the tools available to help individuals plan for the future. I hope it will be used widely--and that individuals who are physically frail will also engage in a similar type of advance care planning. It's high time we recognized that thinking about the future is not just for those who have no future.

Who's Alex?

Alex Azar is almost certain to be confirmed as the next head of the Department of Health and Human Services, taking the place of Tom Price, the previous chief, who resigned after a few months following the revelation that he frequently used taxpayer money to pay for chartered flights for himself. Azar will likely be confirmed despite a major conflict of interest: for ten years (2007-2017) he worked for Eli Lilly, the 14^th largest pharmaceutical company in the US, starting out as a top lobbyist and ending up as President. He left Lilly to start a consulting company, Seraphim Strategies, which doesn’t seem to have a website but reportedly consults to the pharmaceutical and health insurance industries. My guess is that the consultations involve helping Pharma and the insurance companies get what they want from Congress.

The reason I suspect this conflict between Azar’s work for Pharma and his role as head of HHS won’t matter to Congress is that Tom Price’s purchase of stock in a biomedical firm when he was a member of the House of Representatives didn’t bother Congress, even though Price bought the stock just before Congress was to pass legislation that would benefit the company in which he was investing. And Azar, unlike most of Trump’s cabinet appointees, is both smart and knowledgeable about the agency he is to head—he served as deputy secretary of HHS under Bush 2.

There are some positives with respect to the Azar nomination. I was pleased to learn that during his confirmation hearings this past week, he supported mandatory participation in “bundling;” an approach to payment introduced under Obama in which physicians, hospitals, and rehab facilities receive a single payment for a given “illness episode” such as hip replacement, giving them an incentive to work together to optimize care. The reason that Azar didn’t favor voluntary participation in such a program is that he understands that if we are to collect meaningful data on its efficacy, we mustn’t confine participation to those institutions that wanted to participate. He’s right, and seems to endorse the value of assessment of new programs and to understand what constitutes scientifically valid evaluation. There’s another aspect of his background that is in Azar’s favor: his grandfather immigrated to the U.S. from Lebanon, which he would do well to remember when he participates in Cabinet meetings at which immigration is discussed.

As I already indicated, I’m not sanguine about stopping the nomination of someone just because of his past dedication to the pharmaceutical industry. Yes, prices of drugs such as insulin tripled during his tenure as President of Eli Lilly. Yes, Lilly paid a $1.415 billion settlement to the Department of Justice in 2008 for illegally promoting the off-label uses of the antipsychotic drug (in particular, Lilly peddled the drug to nursing homes, alleging it was effective in treating dementia, which has not been established). And yes, the settlement included a $515 criminal fine, the largest ever health care payment of this kind—but the bad behavior occurred before Azar’s time at Lilly and the settlement with the DOJ occurred before he became President.

But I do think that Azar is the most conspicuous case yet of the “revolving door” in which former government employees draw on their experience and contacts in Congress to serve as highly paid lobbyists. Azar left his modestly paying job as deputy secretary of Health and Human Services for a far better paying job at Eli Lilly. The current value of his portfolio, according to disclosures he made to the Office of Government Ethics, is somewhere between $9.5 and $20.6 million.

Why is this phenomenon so pernicious? We’ve heard a growing chorus of complaints about the corruption that results because members of Congress spend so much of their time fundraising. Not only do legislators spend more time on the phone to potential donors than on the floor of the House or Senate; they are then beholden to their donors to pass legislation that is in their interest, not necessarily that of the public. But as Zephyr Teachout, a lawyer and would-be politician, argues in Corruption in America, the problem is both broader and deeper, and it’s something the founding fathers sought to guard against through constitutional prohibitions against public officials’ receiving gifts. “Corruption, in the American tradition,” she argues, “does not just include blatant bribes and theft from the public till, but encompasses many situations where politicians…serve private interests at the public’s expense.” And unlike England or France, the US “felt the need to constitute a political society with civic virtues and a deep commitment to representative responsiveness at the core.” Temptation and influence, in short, undermine the ability of our elected representatives to work in our interest.

How can we close the “revolving door” which Alex Azar waltzed through before and will no doubt use again? We already have a “cooling off -period,” following public office, during which lobbying is not permissible. But former government employees get around this by managing a group of lobbyists rather than serving on the front lines and registering as a lobbyist. Banning lobbying altogether seems too draconian and Congress is unlikely to shoot itself in the foot this way. 

What we need is a fundamental revision of the entire lobbying system that profoundly undercuts the ways in which corporations exert influence over government. In medicine, a multi-pronged effort was undertaken by state legislatures, hospitals, and professional physician associations to limit the baleful influence of pharmaceutical companies on the practice of medicine. “Pharmaceutical representatives,” otherwise known as “drug reps,” are now persona non grata in most hospitals and physicians’ offices. True, the industry responded by using more direct-to-consumer advertising than ever before, and by introducing “point of marketing” ads, in which they bombard patients with infomercials as they sit in physician waiting rooms. Constant vigilance is necessary to keep Pharma at bay. But surely putting a long-time advocate for the industry in the position of head of the Department of Health and Human Services is the wrong way to start. We need to double down on this major problem.

Hip Hip Hooray

             You might think it wouldn’t be difficult to figure out whether vitamin D and calcium supplements help prevent hip fracture in older people. You would be wrong. For the last twenty or thirty years, researchers have asked this question and have reached differing conclusions. The last time I blogged about the question, a study had come out showing that vitamin D matters, at least when taken in sufficient quantities (800 units a day). Since then, I’ve been dutifully taking the suggested amount of vitamin D. I still take TUMS, too, to get some extra calcium, but I haven’t been as conscientious about this because the data is weaker. Now, JAMA  has published an article that looked specifically at community-dwelling older people (that is, it excludes nursing home residents)—and concluded that neither calcium not vitamin D nor the combination of them has any discernible effect in preventing hip fractures.

            Granted, this study is a “meta-analysis,” a study of studies, rather than the gold standard, a randomized controlled trial. Granted, this study looks primarily at hip fractures, arguing that they have the greatest effect on quality of life (and health care costs), though plenty of older people manage to break a wrist or suffer from back pain due to compression fractures without breaking a hip. Maybe the real reason that the individual studies that form the basis of the current analysis have not consistently any benefit from vitamin D or calcium is that few people actually take the drugs that they say they’re taking. Whatever the explanation for the findings, the hard, cold reality is that the current research is another blow, a particularly powerful blow, against the view that diet can prevent fractures in older people.

            Here it is, New Year’s Day. Should I resolve to stop taking vitamin D and calcium? It would be an exceptionally easy resolution to stick to. It’s tempting. I might make the irrational decision to keep taking vitamin D until the bottle that I currently have is empty. Or I might wait until I see my primary care physician for my next routine appointment and do whatever she advises. But here’s what I think I will do: I will continue taking vitamin D, knowing that it probably isn’t effective, but recognizing that it might be in light of the studies to date that have arrived at differing conclusions. I will continue taking TUMS for calcium in the same somewhat haphazard way I've been doing. As long as there is almost no down side of taking these, I’ll take them. Right now, it’s fairly inexpensive, I have no trouble swallowing the pills, I’m not taking other medications, and I have had no side effects of the vitamin or calcium. This is the key point: there are almost no adverse effects of vitamin D; ditto for calcium when taken in moderation. How often can we say that about a medical intervention?