Nursing homes, assisted living, and home care: Can we have reliable quality?

Getting older is unavoidable (until the end); I myself have been doing it all my life. When I was a child and getting older (being a teenager! Or an adult!), it was an entirely positive aspiration. Now, not so much. We know that we will die, and as we grow old, if we are lucky enough to not die young, we know that are going to meet that end sooner rather than later.

As I have grown past “Medicare age”, I have personally experienced many of the issues that I have worked through with patients over the decades, and am also experiencing (vicariously, but closer) the travails of my much-older parent. While not everything that happens with aging is negative (retirement, not going to work every day, is a major positive, provided you can afford it!), the body and the mind can’t do what they once did and often really start to fall apart. Those of us who are lucky enough to avoid dementia, from Alzheimer’s disease or another cause, still find ourselves with memory lapses. And hopefully, we can continue to find ourselves, and our keys, and remember the word or name that we know so well but just is evading us, or the reason we came into this room. A colleague of mine calls this “benign senile forgetfulness”, and I guess it is benign, as long as it doesn’t progress too fast.

Aging is a process of the body falling apart. Different pieces fall apart in different people at different rates, and some folks overall do better for longer than others, but there is an inexorable downward progression. There are things that we can do to help, to slow it, to lessen the risks we face (see, for example, Jane Brody’s article on How to Prevent Falls); among the most important is continued physical activity, as vigorous as we are able to do. I tell people, with a straight face because I am serious, that when I was young I worked out to get fitter and stronger, but now I work out to just fall apart a little more slowly.

As we age we are more likely to acquire disease. These include both the diseases associated with aging (although they can occur younger ages) like Alzheimer’s and arthritis, as well as almost all other diseases that become more common and often more serious: heart disease, most cancers, diabetes, stroke, high blood pressure, influenza, etc. The real question becomes when and even whether to treat them. In youth and well into (and past) middle age we are conditioned to think of illness as curable, or at least significantly treatable. This attitude is enabled by the medical profession, that can do so much more than it used to be able to, and the health care industry, which makes money on it. And we tend to take these views into older age, even when the treatment is worse than the disease, as it often is, or there is no demonstrated benefit, and sometimes definite evidence of harm, both in treatment and even in “preventive” screening (see the CDC and USPSTF recommendations for age-appropriate screening).

Aging and its accompanying diseases and infirmities may require a change in our living situation. Options can include living with family members, or having a health aide (living in or commuting, see below), or a variety of institutional settings ranging from “independent living” (your own place, but some easily accessible help, such as available meals and nurse visits), to “assisted living” (regular meals, more nursing and cleaning help, more protected environment) to full-on nursing home (skilled) care. Given the variety of options, both in terms of “level” of care and in terms of quality and cost of provider, we should be able to depend on licensing, legal standards, and ratings. Unfortunately, we are not always able to do so.

“Care Suffers as More Nursing Homes Feed Money Into Corporate Webs”, in the NY Times on January 2, 2018, documents just what the title says. Most nursing homes are owned by for-profit companies, often very large regional or national corporations, and thus there can be cuts in the quality of care (the service ostensibly being rendered) in order to increase profits. Or, looking at it the other way, every dollar spent on actually delivering care is a dollar lost to profit. The insurance industry has a cute term for this, “medical loss ratio”, which is the money lost to the bottom line by paying health insurance claims. In addition, nursing homes contract “out” for many services (food, cleaning, etc.), and management of the homes, and rent for the buildings. The companies that they contract with are often owned by the same people, but through this trick these costs now become fixed expenses, not covered by regulations governing the nursing home itself. Voilà! Instant profit!

Similar problems abound in other levels of care. “U.S. Pays Billions for ‘Assisted Living,’ but What Does It Get?”, NY Times February 3, 2018, documents the low quality of care often provided to people in assisted living for whom Medicaid is paying as much as $30,000 a year (for assisted living, mind you, not even for skilled nursing services). Part of the problem in this case is that, because Medicaid is a joint state-federal program, they operate “…under a patchwork of vague standards and limited supervision by federal and state authorities.” And, again the people being cared for are the ones who suffer.

So there is good reason to be concerned about these institutions. What about home care? At least that is in your own house, right? On January 31, 2018, the Times had two articles about it. One was from Britain, although it is actually describing institutions, “home care” settings that are like small private assisted living facilities. “Britain Was a Pioneer in Outsourcing Services. Now, the Model Is ‘Broken,” discusses serious adverse health outcomes for people in “home care” there. This could be seen as a ‘gotcha’ for those of us who advocate a national health system, which Britain has, but there are some important caveats. One, of course, is that these are not “home care” in the US sense, and a second is that the fault is clearly not with having a national health system, but rather the efforts to privatize aspects of it (“outsourcing”) which has failed because – surprise – these private sector companies make more profit if they provide cheaper, read “worse”, care! The less national, government involvement, the worse the care.

The other important point is to remember the difference between how much money is spent and how it is distributed. The US spends a lot of money, but it is incredibly unequally distributed among the population. Britain distributes it much more equitably, but has (particularly under Tory governments) underfunded it, including the efforts to privatize aspects of it described in this article. Now, if the US distributed its health care funds in a manner similar to the British NHS, it could spend a lot less and the people would get a lot more!

The other article, from the US, is about what we truly understand to be home care, but its focus is not on the quality of care for patients but the difficulties confronted by the home care workers. Titled “For Health Care Workers, the Worst Commutes in New York City,” it specifically addresses the commutes (from poorer neighborhoods where the mostly-minority mostly-female home care workers live to where they work). But these workers are also poorly paid and lack benefits, often including paid time off, and ironic but true, health coverage! They are, of course, employed by for-profit companies. We depend on these people to care for our parents, or us, but like many involved in the doing-actually-important-things-that-make-a-real-difference-in-people’s-lives industries (e.g., teaching, social work, etc.) they are underpaid and undervalued in comparison to those in the let’s-make-a-lot-of-money-for-ourselves-and-the-heck-with-them industries.

Those who advocate a for-profit capitalist market as the solution to all problems, and particularly the privatization of currently government-run activities, claim that the private sector can operate more efficiently and more cost-effectively, and provide better service than a government bureaucracy. This claim usually turns out to be untrue. Such companies, particularly when gifted with government contracts, are better at making profit, especially by keeping down workers’ wages and cutting back services. When we talk about the care of our seniors, our parents, ourselves, the tradeoff between adequate care and profit is not one any of us would want to make; we want the best quality of care, period. So whether this is compromised by inadequate funding, as in the case of British home care, or (almost worse) adequate funding but excessive profit-taking by the private sector, it is unacceptable.

There is an answer. Have the structure of our society reflect the things that most people actually value. Have a well-funded national health system or a well-regulated private one, that ensures quality of care for its clients and living wages for its workers. The elimination of excessive profits (or all profit in a government-run system) would make it not only better, but still cheaper than the way we do it now, where the “care” is the “medical loss” to profit.

"Blockbuster" drug or slanted reporting: never forget "cui bono"

‘Drug Aimed at Inflammation May Lower Risk of Heart Disease and Cancer’, by Denise Grady in the New York Times, August 27, 2017, reports on a study in the New England Journal of Medicine, ‘Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease’ by Paul M. Ricker, et al. The study, funded by the drug’s manufacturer, Novartis, examined the impact of the use of canakinumab (brand name: Ilaris) on heart attack survivors. The drug is in a class called “monoclonal antibody inhibitors” (as is almost anything ending in “…mab”); in its case, it inhibits antibodies known as “interleukin 1β”. The main effect is anti-inflammatory, which is why it was originally developed for treatment of juvenile rheumatoid arthritis, an inflammatory disease. However, research showing that inflammation plays a major role in coronary artery disease (the cause of heart attacks) stimulated this large multi-center, drug-company sponsored, trial.

So what did the study show? Of the over 10,000 people in the study, those who were treated with canakinumab had lower rates of what the study designers defined as the “primary end point”, the main thing that they were looking for, “nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death.” That is, did patients have another heart attack or stroke, whether they lived or died. The lower rates in the canakinumab groups were statistically significant, with the group that did the best, the middle-dose (they tested 3 different dosages), having 3.86 “events” per 100 person-years, compared to 4.50 for the placebo group. In absolute terms, there were, thus, 0.64 fewer “events” for each 100 person-years (which is a valid concept, one person taking a drug for 100 years, or 100 people for one year, or any combination in between).

There was, however, no significant difference in “all cause” mortality between the treated and untreated groups, mainly because of the increase in deaths from infections in those treated.  This is not surprising because the anti-inflammatory effect of canakinumab also decreases the body’s immune response. It is also not surprising that the people most likely to die of infection were those who were oldest and sickest in the first place. Six people developed tuberculosis.

Given that the cost of the drug is about $200,000 a year (think about that!), 100 person-years of treatment would cost $20,000,000. And for this price, 0.64 fewer people have a cardiac “event”, and no fewer people die. And some untold number suffering serious side effects from canakinumab, including the infections that occurred that didn’t kill them (not reported). These could be really serious – long hospitalizations for sepsis or pneumonia or cellulitis, non-fatal but significant events like amputations, etc. No wonder the Times article quotes Dr. David J. Maron, the director of preventive cardiology at Stanford University School of Medicine, as saying “This is fantastic”! Dr. Maron, I imagine, has terrific insurance.

Of course, it didn’t cost Novartis $200,000 a year for the drug for the study; that is the retail price that it plans to charge hospitals, insurers, and patients. We have no idea what the drug actually costs Novartis to manufacture; the price they will charge is based on the highly scientific formula called “what the market will bear”. For their own bizarre reasons (see Elizabeth Rosenthal’s “An American Sickness” and this commentary by Jacob Hacker) insurers may gladly pay for this drug (they get to keep a percent, and a higher price means a higher percent, and they just raise rates). Or they may get a discounted charge. Certainly, many poor and uninsured people are not likely to get it. Maybe – probably – Novartis will have a program for giving the drug for little or no money to poor people. But, given how common coronary heart disease (CHD) is, they are incredibly unlikely to give it for free to every uninsured person who has CHD. Maybe they’ll give them a discount, say 90%. Then the poor person would only have to pay $20,000 a year out of pocket. To reduce their risk of another coronary event by 0.0064 per year. And have no lower likelihood of dying. And a greater likelihood of severe infection. Maybe this is, after all, a boon to the poor and uninsured, as they are unlikely to get this terrific opportunity.

The other amazing thing is the actual story in the Times, and what that says about health journalism. As noted by the insightful Howard A. Rodman, the

·        Headline says: "Drug... May Lower Risk of Heart Disease and Cancer"

·        The 2^nd paragraph tells us it is a "major milestone"

·        The 3^rd paragraph quotes Dr. Maron saying "This is fantastic."

But then you have to scroll down to find

·        In the 5^th paragraph, that the drug costs $200,000 per year. It's available only from Novartis, and that Novartis paid for the study.

·        And in the 7^th paragraph, that the drug suppresses immune response. In the study, the number of deaths from drug-caused infections equaled the number of lives saved.

Lead with the positives, and then let us down later, maybe after those of us scanning the article have stopped reading.

Is the Times trying to mislead us? I don’t think so. I think that they want, however, to get our attention, get us reading, show us blockbusters. Blockbusters are good for getting attention. It is a big article for the New England Journal of Medicine also. This is why there is a built-in prejudice in medical journals for publishing articles with positive results, and why the authors do their best to “spin” results to positive. As if the incredible amount of work they have put in to the study, not to mention the interest of the sponsor, in this case, a pharmaceutical company that makes the drug in question, was not sufficient impetus. After all, getting our attention is what it is all about; it is why reality TV is so big, and why a reality TV star is now POTUS; see Matt Taibbi’s piece “The Media Is the Villain – for Creating a World Dumb Enough for Trump”. He notes that “If a meteor crashes into jello night at the Playboy mansion, it doesn't matter if you send Edward R. Murrow to do the standup. Some things sell themselves.” Maybe a drug that treats a disease that treats heart disease isn’t that big, but it is big; after all, as Grady notes, “Cardiovascular disease is the leading cause of death worldwide and in the United States, where it killed nearly 634,000 people in 2015. Globally, it killed 15 million,” (paragraph 4, if you’re tracking it).

Neither does this mean that published scientific research is unreliable. Some of it is very good science (even this study is generally good science, despite the published report in NEJM and the coverage in the Times being unconscionably skewed to the positive). Some of it actually reports on drugs or other interventions that make a difference. Sadly, however, in addition to the “blockbuster” effect that the media (including medical journals) want to cover, those interventions that will make a lot of money for a company get more publicity. Especially when the company funds the research. Aspirin, by the way, is still cheap, and it is more effective than this drug, recommended by the US Preventive Services Task Force (USPSTF) for prevention of CHD in adults with greater than a 10% 10-year risk.

I tell medical and other health professions students (at all levels) that, although the Introduction and Discussion sections of the article may seem most interesting, the important parts to read are the Methods and Results, which have the meat (or soy, if you’re vegan) and from which you should draw your own conclusions, without the authors’ spin. If you’re not a health professional, and depend on the mass media for coverage, then you better read the whole article and not stop after the fanfare. It is the reporter’s job to provide the necessary information, but your job to read it wisely.

Certainly, health professional or reporter or consumer, look at who is funding the study. It is important information. And think about conflict of interest. And think, of course, about cui bono. It is likely to be the manufacturers, and maybe the researchers, and sometimes those who are wealthy or well-insured enough to get the drug or intervention (when it is of benefit).

And, surprise, it is never likely to be the poor, uninsured, or those most in need.

"There's a sucker born every minute": False and inflated health claims

“There is,” in a phrase rightly or wrongly attributed to P.T. Barnum, “a sucker born every minute.” To Barnum, and to countless others before and since, this was a business opportunity. They can get rich off us because we want stuff to be true even when every input from our senses should show us that it isn’t; we want magical, easy cures and money-making schemes, even when we know that they only work for the scheme’s designers, not the suckers who take the bait. Betsy DeVos, the recently approved Secretary of Education, who knows nothing about education and devalues public education (I could go on, but that’s another story…) is the beneficiary of such desires. She is in the position that she is in because of her great wealth which has bought her great influence, and that great wealth, at least the portion from her husband’s side, derives from the Ponzi scheme known as Amway. It is clear that Amway was in fact the path to wealth that it was claimed to be, for the DeVoses anyway.

The persistent and widespread greed of people despite evidence that the odds are stacked way against them is testimony to either optimism or stupidity, or some of both. It is one of the oldest memes in literature, from the alchemists who would turn lead into gold (or Rumpelstiltskin who would weave it) to Faust who would sell his soul to the devil (and maybe so did guitarist Robert Johnson) to Ralph Kramden (and his cartoon successor Fred Flintstone) and George “Kingfish” Stevens, doubly oppressed and vulnerable, being poor and black. And the outcome is always the same, the little guy gets screwed.

We could go on and on with this theme. The temptation to tie it to the election and reign of Donald Trump is enormous; people want something to be true (that they’ll get good jobs back, that their streets will be safe, that they can have all the health care they want and need without paying for it when they don’t need it, whatever) and Trump promised it all, and of course he is not and will not deliver, but many still love him. If you want a good article about this, try Matt Taibbi in Rolling Stone, “The end of facts in the Trump era”. But, after all, this blog is about public health and medicine, and there is no shortage of examples in those fields. After all, con men and grifters, whether low level hucksters, Amway merchants, or Wall Street bankers are all regularly called “snake oil salesmen”, and what was snake oil but a promise of better health? And the liniment sold by these folks might have worked a bit since it had red pepper, a bit like current capsaicin. When they were convicted it was because their oil did not come from snakes, not because it was a fraudulent cure.

You’d think that people would wonder why, if there is a miracle easy (and sometimes even relatively cheap) cure for all their ills that everyone else hasn’t benefited from it. Ah, but that is part of the attraction – being in the know about something everyone else isn’t. Is that not the way that inside traders work? Isn’t that how they fix sporting events, how your brother-in-law knows that this 100-1 shot will come in at Santa Anita? Is that not how Arnold Rothstein got rich? So, sure, it’s done in health. Watch daytime television sometime. It is mostly about medicine, from Dr. Oz (a font of misinformation), to an electric scooter you can get FREE (or at no cost to you, other than as a taxpayer paying into Medicare), or a miracle drug that will allow you to have even better relief from your arthritis or asthma or will keep your blood from clotting even better than warfarin, at only 1000 times the price, and at great potential risk to your immune system.

The hucksters present not only misinformation about individual medical care, but also public health. The most obvious, and likely most serious, current issue is that of vaccines. Despite there being no evidence linking vaccines to autism, and strong evidence showing there is no link, the myth persists. The price will likely be serious outbreaks of vaccine-preventable diseases, especially measles, as discussed by Peter J. Hoetz in his NY Times Op-Ed “How the anti-vaxxers are winning”, February 7, 2017. Water fluoridation suffers from similar myths. Public health may be even more susceptible to such hype than medical care, since so many of its benefits are things (like measles, or tooth decay) that don’t happen, rather than those that do. We rarely wake up saying “Gee, I’m glad I don’t have cholera today because we have clean water”; indeed, we mostly worry about water quality when something specifically bad is happening, like lead poisoning in Flint. People are susceptible to liars and charlatans who tell them things that they want to believe, as well as things that seem to make sense, but as I tell students, something that seems to make sense is called a research question; only when the study is done will we know if it is true.

But it is not only the more obvious (to the discerning, anyway) scams. Mainstream medicine does it often. Every new discovery, every potential ameliorant (if not cure) is trumpeted by both the companies that manufacture it and, at an earlier stage, the university for which they work. Of course, most of these discoveries are scarcely the magic breakthroughs that they are initially claimed to be. That is the nature of science; things are learned and knowledge grows incrementally. But a new discovery by a scientist at your university is worth a lot of publicity! Maybe it is a cure for Alzheimers! Or at least a step in that direction! Certainly worth millions of dollars more in NIH funding! There is nothing wrong in incremental discoveries; the problem is when they are hyped as the Holy Grail. Indeed, on July 16, 2010, I wrote about Rosiglitazone and the "Holy Grail", and how disappointed diabetes advocates were that Avandia® was being taken off the market just because it caused heart disease, because it did lower blood sugar! (A diabetes advocate noted that lowering blood sugar was the “Holy Grail”.) This story is a terrific example of the peskiness caused by the human body being an integral organism; something that is very good for one condition may still cause big problems. And so, maybe we should wait before we hype it too much. On the other hand, what an opportunity we have to get big publicity before that happens…

A recent example involves using low-dose CT screening for lung cancer. The US Preventive Services Task Force recommends it (as a “B” recommendation) for men 55-80 years old with a history of smoking. This “B” recommendation is worth a lot to the CT manufacturers and radiologists who read them, since the ACA requires insurers to cover USPSTF “A” and “B” recommendations. But a big Veterans Administration study just published in JAMA shows that it is not quite as good as previously thought. “Of the 2106 patients screened, 1257 (59.7%) had nodules; 1184 of these patients (56.2%) required tracking, 42 (2.0%) required further evaluation but the findings were not cancer, and 31 (1.5%) had lung cancer.” Does this mean that it is a bad idea to get screened? Not necessarily; if I had a patient with a significant smoking history, I would discuss the risks inherent in getting this procedure but prepare them for the probability that even a positive test would likely not mean they had cancer, and that they might have to undergo more procedures with some risk to find out. The point is not that this is a bad idea, but it is not some amazing breakthrough, as touted.

Just because you want to get rich quick, or avoid needle sticks, or find the magic cure for your arthritis or cancer that has been denied you, and someone is selling something that claims to do it, doesn’t make it true. If you think so, I’ve got a couple of bridges to sell you.

"Inconvenient truth", science, politics and USPSTF

There are a lot of things that we can expect to be different in a Trump administration, not only than in the Obama administration but even compared to that of G.W. Bush (my previous gold standard for irrational and right-wing policies). Many of these are important, and dangerous, but are arguably political, such as the change in our relationships with other countries (Russia, China, Europe, Israel). However disastrous these policies will be for people in the world (say, Syria) and even possibly destroy the world (nuclear weapons), they proceed from a different political perspective. Also arguably political will be the domestic changes, in the rights of LGBT citizens (such as marriage, use of restrooms), and access to reproductive health services for women, not only abortion but even contraception. The impact on people will be horrific, but it derives from a different perspective (admittedly one that completely devalues huge numbers of people; majorities in the case of women and non-wealthy people).

There will be other changes, however, that proceed from a rejection of science, or of what Al Gore calls “inconvenient truth”. Clearly the biggest one is the one that Mr. Gore was speaking of, global warming, because this will eventually destroy the planet. Maybe later, as we have already been so slow in implementing limits on warming. Maybe sooner, if his climate change deniers have their way. The title of Mr. Gore’s film has several meanings; it is “inconvenient” for all of us to try to find ways to use fossil fuels less rapaciously, but it is a financial issue for others. I am not talking about the coal miners who will lose their jobs; that is going to happen anyway. I am talking about the Captains of Industry, who, unlike the miners, will never be anywhere close to poor but have the possibility of making fewer billions if we seriously address global warming. Oh, the horror!

While of course the destruction of the environment is a health issue, there are also more prosaic health results from those who will try to make policies, or pass legislation, that benefits themselves or their friends and contributors at the expense of truth. Certainly we have seen this regarding reproductive health for years, especially at the state level, where laws restricting women’s access to abortion (targeted regulation of abortion providers, or TRAP, laws) have been based on what might be generously called phony science, or, more correctly, lies. These have included fetal pain syndrome, need for facilities appropriate for major surgery, need for admitting privileges for doctors doing abortions, excessive waiting periods,  and other made-up justifications for doing what legislators really wanted to do – restrict access to abortion. In Florida, a law was passed forbidding doctors from asking their patients if they had a gun in the home, meaning they couldn’t even have a discussion about how to keep them safe from their children accessing them.

So now we have the probability that Congress will be restructuring the membership of the US Preventive Services Task Force (USPSTF) to include more specialists on a body largely made up of primary care doctors and epidemiologists. The goal of the USPSTF is to dispassionately and objectively evaluate the evidence for the effectiveness of tests and procedures aimed at preventing disease. It gives ratings in easy to understand letters (A,B,C,D,I ) that are not based upon the opinions of the task force members but on the actual data. Unfortunately, this doesn’t always make providers happy; if you provide a service (say, mammography for breast cancer screening) on which you make money, then a recommendation that says it doesn’t need to be done quite so often hits you where it hurts – in the pocketbook. So you might come out against it. And while advocacy groups may not have the same direct financial interest (although if you are such an advocacy group, contributions are usually closely related to how serious how many people think a problem is), it may challenge your long-held beliefs. And then, if you find some doctors who agree with you (for example, those whose income may be decreased) you are more confident you were right.

But the goals of USPSTF recommendations is to synthesize the existing data and base their recommendations on that, not to reach “compromise” between those who want something done more (because they are “true believers” and/or have a financial stake in it) and those who believe it is unnecessary cost with little or no benefit and potential risk. This is why it is not necessary to include specialists on these panels because of their “expertise”. Other scientists can interpret the data accurately; a panel reviewing the data on, say, the frequency with which mammography should be performed in a particular population does not need mammography radiologists and breast surgeons to understand the research. This is not to say that such specialists are inherently biased and shouldn’t be on USPSTF; they could be as objectively good scientists as others. But it is to say that the reason being put forward for them being added to the panel – that they are ‘experts’ in the topic – is wrong. They should not bring their experiences and expertise to ‘balance’ the data. They should be guided by it.

It is not necessarily true that expert specialists are purposely obtuse, that they will advocate for recommendations that will make them more money. It is also true that their perspective is skewed by the populations that they see. Specialists see people with a disease, which is a selected population. Screening is, by definition, testing people who are asymptomatic and are statistically unlikely to have the disease. Therefore different standards are applied for screening asymptomatic people (say, all adult women between 50-75 by mammography) and for following up people previously diagnosed with breasts cancer, or those who are at higher risk (defined as a first-degree relative, mother or sister, with breast cancer, not a great-aunt). And, of course, doctors are not necessarily above advocating for laws to keep their incomes up. When, about 20 years ago, the federal Agency for Health Research and Quality (AHRQ) recommended against a specific type of spine surgery because it didn’t help, was risky, and cost a lot, groups of spine surgeons tried to get that agency defunded! Oh, yes, and AHRQ continues to be threatened with funding cuts because special interest groups don’t like their findings!  With the ACA requiring insurers pay for any USPSTF recommendation with an “A” or “B” rating, the political pressure is on to get such recommendations, whether the data supports them or not. On the positive side, the American Academy of Family Physicians (AAFP) has come out against such stacking of the USPSTF.

Once, when I lived in a good-sized condominium, I was one of the few families with children, and it seemed like they and their friends were often harassed for violation of (sometimes) condo rules and (more often) an individual’s belief of what should be a rule. Even the rules, however, were often, in my opinion, unreasonable; I thought the condo association rules should protect our investment and our safety, but should not be just anything 51% of the owners wanted. On the positive side, while they may have inconvenienced me and my family, they did not try to overrule natural law or science. The same cannot be said for current federal, state, and local efforts to make a law about anything they want to be true. They cannot make global warming disappear by a law, but they can make it illegal! And they can violate the rights and human dignity of our people. And stack federal agencies with anti-science people or at least turn what should be scientifically-driven decisions into a political negotiation.

This is going to be a long battle. Those with money and power are entitled and feel that it is their right to stack the deck. Happy New Year!

The cost of health care: insurance companies, high-profit and low value care

We know that health care in the US is incredibly expensive. Those who read about health policy from a variety of sources (perhaps including this blog) know this in terms of data – our per capita cost is 50% more than the second highest-cost nation (Norway), twice what most comparable (rich) countries spend, and almost 3 times that of the United Kingdom. But you don’t have to be a policy wonk to know that health care is expensive; you just have to be a consumer who is trying to buy health insurance and is seeing their premiums go up – and their out-of-pocket costs (deductibles, co-pays, co-insurance) go up as well. All those other countries cover everyone, equitably, despite spending so much less money (and those that spend more, like Norway, have especially good coverage). Not so here.

“My premiums are more than $600 a month, which is more than our mortgage payment,” a cancer survivor quoted by the New York Times in its August 14, 2016 article by Robert Pear “Health insurers use process intended to curb rate increases to justify them”, said. “I am grateful that the Affordable Care Act is here for my family, but I am disappointed by its limitations. All I want is a plan that makes our health care affordable, but it doesn’t exist.” She is likely to be disappointed, because this was not how the Affordable Care Act (ACA) was set up, and unless control of Congress changes dramatically, we probably will not see a fix. ACA passed because it guaranteed continued profit for insurance companies, and this has led to both the rate increases and out-of-pocket cost increases we have seen. Insurance companies can do this because the law allows them to ask for premium hikes when they are not making “enough” money. Essentially, ACA requires the American people (subsidized by the federal government if they are poor) to ensure private insurance companies are profitable. Because they believe that they have not been permitted to jack up rates “enough”, some companies (Humana, United, Ætna) are leaving the exchanges in many places.

While other counties make sure everyone is covered by some national health insurance (a national health service in the UK, a single-payer national health insurance system in Canada, and highly-regulated multi-payer systems in many other European countries such as France, Germany, and Switzerland), we have tried a patchwork that leaves many people out (e.g., the undocumented, poor people in the 19 states that haven’t expanded Medicaid), and encourages others to buy policies on the health insurance exchanges based solely on their cost. This is examined in a story by Reed Abelson in the Times from August 12, 2016, “Cost, not choice, is top concern of health insurance customers”. It notes that people who are healthy and young but don’t have employer-based health insurance are either buying the cheapest policies available on the exchanges or “particularly those not eligible for generous subsidies, are shunning plans altogether, finding all of the prices too high.” When they don't buy insurance, it messes with the insurance company model of offsetting costs for sick people with the premiums paid by healthy people, the reason for increasing premiums. And many other people, neither young nor healthy, are also buying the cheapest policy they can find because they can’t afford the cost (and maybe can’t understand the details); for these folks, it is not the insurance companies that pay the financial price, but themselves, when they get hospitalized or otherwise need costly care and discover that their “insurance” is inadequate (the technical term here is “crap”).

And this is just the health insurance contribution to high health care cost. Also very important is the cost of the care itself, particularly high-tech, high-cost care, provided to many Americans (at least those with good insurance coverage). This is driven, at least currently, by the fact that in most places, where insurance companies pay providers by piecework (“fee-for-service”), high-cost is also high-profit for providers, both individual physicians and the large institutional providers (hospitals and health systems) that often employ them. This blog, and a variety of exposés in many news articles including in the Times (particularly the work of Elisabeth Rosenthal) have given example after example of such incentives driving both the kind of care delivered and the cost of that care. In the worst instances, this is the result of rapacious greed that provides unnecessary care at very high cost. In many other settings, the opportunity for profit subtly (I hope) tips the scales toward providing high-cost, high-profit services rather than just as good, or almost as good, alternatives. But there are even more insidious drivers of cost; these are in the “everyday tests”, such as those done for screening, that in themselves, one by one, don’t seem to be excessive but multiplied by the number of people receiving them cost a lot (and make a lot of money for providers). The practice of ordering such tests is often driven by advocacy groups, providers in certain specialties and relatively small numbers of people with a specific condition who think everyone needs to be tested for it.

A good example is screening for lipid disorders (basically, high cholesterol) in children. Yes, some children have a genetic disorder which means that they should be tested and treated, but the vast majority do not and screening them (barring a history of familial hyperlipidemia or very early heart attacks) should not be done. It is not recommended by either the US Preventive Services Task Force or the American Academy of Family Physicians (AAFP), nor by the UK National Screening Committee. This example is discussed in an outstanding editorial in JAMA Internal Medicine by Thomas B. Newman, Alan R. Schroeder, and Mark J. Pletcher published on August 9, 2016, titled “Lipid screening in children: Low-value care”, preceded by the tagline “Less is more.” The authors contrast the USPSTF and AAFP recommendations to those of the National Heart, Lung and Blood Institute of the NIH, endorsed by the American Academy of Pediatrics, which recommends it. The authors of the editorial demonstrate the amazing lack of cost-effectiveness for this screening test, and note that is only because USPSTF does not consider cost-effectiveness that it gave the test an “I” (insufficient evidence to recommend for or against”) and not a “D” (recommend against testing).

But the most important point made in the editorial is that our recommendations for testing – and how to spend our healthcare dollars – are individually focused, and virtually ignore (and thus dramatically underfund) those interventions in public health and the social determinants of health that would truly make a major difference in the health of millions of Americans. The authors say it extremely well:

Tackling major public health concerns such as climate change, poverty, obesity, and gun violence is likely to yield high-value solutions, and many advocate policy and community-level interventions that might achieve such solutions. Meanwhile, other segments of our health care establishment continue to try to solve health problems by doubling down on individual-level health care solutions that tend to be low in value...The need for clinicians and leaders to focus on sustainability and health care value has never been greater, and it is likely that policy and community-based interventions will get us there much more quickly than adding more clinic-based interventions that have low value and are wasteful of resources and clinicians’ time.

We need to take this advice to heart. It goes way beyond lipid screening in children. It means supporting interventions that actually  improve the health of the public on a large scale. And, as always, “support” is spelled M-O-N-E-Y.

“Good enough for Government Work”: Quality, cost, and gaming the system, Part 2 (of 4 parts)

This is part two of the Charles Odegaard Lecture, delivered at the 27th National Conference on Primary Health Care Access, April 6, 2016

We have all heard the business mantra “do more with less”, which, on the face of it, is either absurd or, perhaps, a very cynical indictment of how much is currently being “wasted”, waste being differently defined depending upon the point the user wishes to make. I, for example, would consider “waste” to be money designated as “health care dollars” going to excessive profits for private corporations rather than actually being spent delivering health care; others, perhaps in the insurance industry, might consider “waste” to be an excessive “medical loss ratio”, their quaint term for the money that they actually have to spend delivering health care and don’t get to pocket. Politicians, of course, are more malleable; “waste” is whatever is being spent on what they don’t like, provided of course, it doesn’t get them into trouble with their constituents (like the VA scandal), in which case switching definitions is always an option.

What might be waste in the provision of health care? One is providing, and charging for, services that are unnecessary or possibly even harmful. A current example is the performance of pelvic examinations (as distinct from collecting Pap smears) in asymptomatic women (without pain, discharge, or bleeding) just to see what we can find. The American College of Physicians (ACP), the internists’ group, recommends against them. ACOG, the American College of Obstetricians and Gynecologists, recommends doing them, or at least leaving it up to the physician. Guess which group stands to lose more financially? ACOG’s position includes the statement that “…the College continues to firmly believe in the clinical value of pelvic examinations, through which gynecologists can recognize issues such as incontinence and sexual dysfunction. While not evidence-based, the use of pelvic exams is supported by the clinical experiences of gynecologists treating their patients.”![1] Hm. Maybe the best way to discover issues like incontinence or sexual dysfunction is not to put one’s hands inside a woman, but, perhaps, to ask her!

The US Preventive Services Task Force (USPSTF), of course, makes no recommendations on whether to do a particular exam or procedure, as its recommendations are for or against screening for particular diseases (with, in that context, exams or procedures discussed). It recommends against (“D” recommendation) screening for ovarian cancer, a major “benefit” cited by some ob-gyns, because it is inadequately sensitive and specific and doesn’t save lives. In a recent survey of ACOG members, the “potential benefits” of pelvic examination in asymptomatic women were cited, but not the costs – in dollars or to patients in terms of discomfort and morbidity. 

This is relevant here because when costs, both potential for harm as well as dollars, are not considered, everything could be potentially of benefit. Another recent study showing mild benefit from the use of the diabetes drug pioglitazone to prevent strokes or TIAs in people who have previously had them shows some benefit, but at the cost of an increase in the number of fractures requiring surgery or hospitalization; the editorialist in Journal Watch General Medicine emphasizes the benefit rather than the risk of harm, but is a neurologist, not an orthopedist. Should we do an MRI on everyone every week, just to see what we can find? Certainly there could be some things found! What about CT scans for screening for lung cancer (USPSTF “B” rating)? The best study, from the US, shows absolute risk reduction for death in 6.5 years of 0.33%; some smaller recent studies from Italy and Denmark show no benefit for mortality, and even in the US the frequency being recommended is moving to less than annually.  Should we be on track to weekly MRIs?

So, I just wanted to be clear that it is not true that I am for anything that could improve quality whatever the cost. That is ridiculous. But there is a baseline of quality which not only can, but regularly is, compromised when there is a potential for financial benefit from doing so. 

More recently, and wildly popular in health care, is the Triple Aim. The idea is to improve quality, improve patient satisfaction, and cut costs, all at once. It is difficult to find anyone, regardless of political affiliation or medical specialty, politician, provider, or consumer advocate, who doesn’t think that this is a good idea. To some degree, even I think this is a good idea, but I also believe that, like a lot of good ideas, the devil is in the details, the proof is in the pudding, where the rubber meets the road, or whichever is your favorite saying. While I am certain that many well-meaning pundits and providers, such as the leaders of family medicine, the experts at the Institute for Healthcare Improvement (IHI) and others are serious about improving quality, the reality, as M. Gregg Bloche notes in his NEJM piece (see Part 1, ref #3), is that almost all of the rewards are for cost-cutting. Yes, ACA has given us some modest revenue enhancements for meeting quality goals, although in general they are either very broad or very precise, and in either case poor measures of actual quality, and thus of limited impact. But almost all of the rewards, on either side of the Atlantic, in the NHS, or the VA, or for the ACOs created by the ACA, are for reducing costs. And it is almost always in the public sector that the impact is the greatest.

For example, outside the VA, we have our RACs, the bounty hunters licensed by Medicare to come into hospitals to find “fraud and abuse”. This usually manifests as discovering that some Medicare patients have been “admitted” to the hospital, rather than placed on “observation” status, which costs Medicare less. We have been well-socialized by our institutions, prompted by Medicare, into ensuring that we have reason to believe a patient will be in for “two midnights” (a bizarre conception with regard to health, much easier to achieve when a patient is admitted at 11pm than at 1am!), but how many of us realize that it is our patients who pay, literally with dollars? The excess cost is because “observation” is officially outpatient and paid by Medicare Part B, which requires much higher co-pays than the Medicare Part A that covers admissions. I have to admit that it was only relatively recently, when I heard a cousin being admonished by a friend to “make sure that your mom is admitted, not put on observation, or she’ll go bankrupt”, that I realized this.

[part 3 next week: The VA, the private and public sector, and the profit motive]

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[1] http://www.acog.org/About-ACOG/News-Room/Practice-Advisories/ACOG-Practice-Advisory-on-Annual-Pelvic-Examination-Recommendations

Prostate Screening and the Public’s Health

For the first time in several years, I am writing about prostate cancer screening. I had hoped that this was sufficiently covered in 2009, with PSA Screening: What is the value? (March 21) and the excellent guest piece by Robert Ferrer, PSA Screening: “One of Medicine's Great Success Stories"? (October 27), and finally a bit of celebration in 2011 with PSA redux: The USPSTF finally recommends NOT getting it! (October 14). However, like the proverbial bad penny (or to use a more au courant analogy, zombie), this issue continues to return from the dead. The most recent effort is “Bring Back Prostate Screening”, a NY Times op-ed piece by Deepak A. Kapoor on July 6, 2015.

What Dr. Kapoor is suggesting is obvious from the title, but the question is “is there some new information, some new research, that now makes such screening more reasonable or appropriate?" The answer, unfortunately (because it makes more work for the zombie hunters) is “no”. Dr. Kapoor suggests that there is. He notes research is this field is “... now paying off.” He says that the decision to recommend against prostate screening by the US Preventive Services Task Force “…didn’t take into account adaptations that urologists have made to help better identify patients likely to develop deadly prostate cancers.” He cites the increased sensitivity of PSA screening, the individualization of it to the risks of different men, and the use of PSA trajectory (its rate of increase, or not), as well as new methods of assessing cancer like MRI. However, his assertion is incorrect; all of this information was available to the USPSTF when it made its recommendations, and was taken into account. It is not new.

“At the time,” Dr. Kapoor notes, “I and many other urologists warned of public health repercussions. Our fears have materialized. Since 2010, fewer biopsies have been performed and fewer prostate cancers found. But studies show an increase in the risk that a cancer, when found, will be more aggressive.” This sounds scary, but it is to be expected; when you stop screening everyone you won’t find the cancers early. A big part of recommending against PSA screening was that so many of the cancers it identified were indolent and not going anywhere; the aggressive cancers will be the ones that eventually show up. Indeed, he actually acknowledges that “No increase in cancer mortality has been observed,” but continues to raise the alarm with “…that may be a matter of time; aggressive cancers are less treatable.” So maybe we should be scared.

Well, in fact all prostate cancer is treatable. All cancer is; in fact all conditions are. The question is how effective is the treatment? Does it cure? Does it prolong life? Does it improve the quality of remaining life? This is the area that Dr. Kapoor and his colleagues do not address, because, for prostate cancer, the answer is basically no. If you have the more common kind of prostate cancer, it is slow-growing (indolent) and may even disappear itself; you will die with it, rather than from it. If you have the less-common aggressive form, you may well die from it, and unpleasantly; prostate cancer metastases go to bone and cause a lot of pain. Sadly, however, treatment does not seem to impact this. The “cures” from treatment of prostate cancer are of the ones that would have “cured” themselves, or at least not have manifested with symptoms. The mortality from aggressive deadly cancers is not changed by treatment. This is the critical point that discussions of the sensitivity and specificity of PSA or any other kind of screening often ignores. Not only can they not reliably distinguish between the indolent and aggressive types of cancer well, even if they could and we had a test to reliably tell which one you had, it is only of importance if treatment can make a difference. And in terms of mortality, it doesn’t. What about the other results from treatment? Improved quality of life? Well, here even Dr. Kapoor notes that “cancer treatment can reduce quality of life.” If you consider impotence, urinary incontinence, and the many unpleasant and painful effects of radiation on the rectum to lower quality of life, you betcha.

We can dismiss Dr. Kapoor’s comments by saying he is a urologist, and they make their money treating prostate cancer; can you imagine the impact on their income if we didn’t treat it? But this misses the far bigger issue, which is that we are enamored with – and, more important, spend huge amounts of money on-- high-technology interventions rather than the prosaic, low-tech interventions that have actually been demonstrated to improve the public’s health. Screening for prostate cancer, and overuse and reliance on mammographic screening for breast cancer, are huge industries which (even in breast cancer) have had relatively little impact on mortality. Providing good prenatal care and preventing unwanted pregnancy, ensuring treatment of common diseases like hypertension and diabetes, ensuring that children are not only immunized against infectious disease but are well-fed, well-housed, and well-educated, and free from poisoning by environmental toxins (including bullets) – the basic components of public health and primary care -- may seem less sexy and stimulate our collective psyches less, but they are the things that actually increase population health.

One of the newer fascinations is genomics, the identification of each person’s sequence of DNA. The promise of “precision medicine” is that we will find out who has the risk gene for which disease, and treat it directly and appropriately; treatment for cancer will be based on the genes you have just as treatment for bacterial infections is based on the organism identified by culturing it in a microbiology laboratory. It is so exciting! It is so “sci-fi today”! The American Board of Family Medicine, for example, is planning to create a new self-assessment module (“SAM”, tests that family doctors have to complete one of each year to maintain their Board certification) on genomics. On the other hand, it doesn’t think we need one on contraception, which is too small an area (isn’t it just part of “women’s health”? Oh, do men have a role in contraception also?), unlike genomics, which could affect EVERYTHING!

Except, so far, it hasn’t and there is little evidence to suggest that it will anytime soon. I wrote a blog on the topic on February 1, 2015 (“Precision medicine, trade policy and the cost of drugs: benefiting people or profit for business?) after the appearance of a Times op-ed by Mayo Clinic cancer expert Michael Joyner (“’Moonshot’ medicine will let us down”, January 15, 2015); Dr. Joyner has more recently contributed more comprehensive articles on the topic to JAMA (“Seven questions for personalized medicine[1]) and The Lancet (“Is precision medicine the route to a healthy world?”[2]) in which he makes the important point that most disease is not the result of a single gene, but rather the result of a complex interplay of different genes and the environment. Indeed, the only cancer-specific genes that have been identified so far are the breast cancer genes BRCA1 and BRCA2, and no treatment has emerged; we simply say “get mammograms more often and consider prophylactic mastectomy”.

Spending all this money on precision medicine, on high-tech interventions, expensive drugs and devices is like blowing your house budget on art for the walls before you have built it. Some art is great, some is mediocre, and some is poor, but none will hang well on a jerry-rigged house made poorly of shoddy materials because there was no money left. Some high-tech, expensive interventions are worthwhile but what we really need to increase the population’s health is public health nurses making home visits to pregnant and recently delivered women, and their children; public health nurses or community health workers or even doctors making visits to people’s homes to assess the real risk factors to their health and reasons that they might not be able to comply with treatment plans. We need more primary care, not more interventionalists. But most important, we need to apply what we know works, what we know how to do, to everyone.

That is how we move the needle on population health.

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[1] Joyner MJ, Paneth N, Seven Questions for Personalized Medicine, JAMA. 2015 Jun 22. doi: 10.1001/jama.2015.7725. [Epub ahead of print]

[2] Coote, John H, Joyner, Michael J. Is precision medicine the route to a healthy world?. The Lancet385.9978 (Apr 25, 2015): 1617.

Medical testing: is it about quality?

In her New York Times “Well” blog of April 13, 2015, physician Abigail Zuger comments upon “Quantifying Tests, Instead of Good Care”. She discusses a variety of factors that lead to physicians ordering more and more tests. In part, this is the simply the result of the advance of technology and thus the profusion of tests that can be done --  laboratory tests, imaging (like x-rays and their ever more complex cousins), and even parts of the physical examination (“Yes, little blood pressure cuff over there in the corner, that means you”) --  which sometimes can be seen as meaning they should be done. Other factors are about money. The tests cost money, a negative for patients and insurers, but they make money for the laboratories and imaging facilities and the hospitals which often own them, and frequently employ the physicians doing the ordering. Dr. Zuger notes that “Ordering tests, chasing down and interpreting results, and dealing with the endless cycle of repeat testing to confirm and clarify problems absorb pretty much all our time.”

Another impetus is our desire – patients and physicians alike – to find out what is wrong when there is something wrong. Or, when there is nothing really wrong, to perhaps prevent later disease by finding something hidden lurking inside. There are all these tests we can get! The patient may have had many of them before, ordered by another provider, or know people who have had them. They hope that something will give them an answer. The doctor may feel that there may be an answer out there that s/he might miss if a test is not ordered, or if s/he is a primary care physician that a specialist might order these tests so maybe we should do it first; after all, it sometimes seems as if one thing specialists do when we refer patients to them is order a bunch of tests that we could have. Or, and this is a big focus of Dr. Zuger, that their “quality ratings” may suffer if s/he doesn’t order these tests.

Quality ratings are measures of things that doctors should do (or, sometimes but more rarely, should not do) for patients with certain conditions or complaints; increasingly, insurers, employers, and third-party groups are assessing the quality of care that a physician delivers in this way. Are these recommendations not based on evidence? In many cases, they are. For prevention, the US Preventive Services Task Force assesses the degree to which tests may be indicated or not for different people, often based upon their age and sex. It gives them ratings: ‘A’ is strongly recommended based on good evidence, ‘B’ means there is some, but weaker, evidence to support doing it, ’C’ means there is conflicting evidence and patient preference should be taken into account, ‘D’ means not recommended (might even be harmful), and ‘I’ means insufficient evidence to assess. A smart phone app, ePSS, can be downloaded by anyone; put in age and sex and it tells you which preventive tests are recommended.

Of course, not all doctors do all the recommended screening tests, and frequently they do tests that are not recommended (e.g., PSA to screen for prostate cancer) or more frequently than recommended (Pap smears to screen for cervical cancer), or in people for whom the test is not recommended (mammograms in younger women). When it comes to diagnostic testing rather than screening, looking for the cause of something when the patient is actually ill, there is even less consensus, and often a prevailing attitude of “more (testing) is better”. One effort to combat this is the Choosing Wisely campaign begun by the American Board of Internal Medicine Foundation. This campaign asked specialty societies to identify 5 or more commonly-done tests or interventions in their specialty that should not be done. However, the same recommendations are not always endorsed by every relevant organization. For example, the American Academy of Family Physicians recommends “Don’t do imaging for low back pain within the first six weeks, unless red flags are present.” Great, but neither the American College of Radiology nor the American Academy of Orthopaedic Surgeons, arguably the groups that could make money from this, has such a recommendation.

And then there is the risk. Some of the tests receiving USPSTF ‘D’ recommendations are more than not helpful; they can lead to harm, and this is even more true of the many potential tests that can be done looking for disease. Discussing the work of a collaboration at the Dartmouth Medical School that looks at the utility of tests, Dr. Zuger notes that such iconic treatments as controlling blood pressure can lead to bad outcomes in many older people where the benefits (avoiding stroke and other complications) begin to be outweighed by the risks:  “One study found that nursing home residents taking two or more effective blood pressure drugs did remarkably badly, with death rates more than twice that of their peers. In another, dementia patients taking blood pressure medication with optimal results nonetheless deteriorated mentally considerably faster. Yet no quality control system that I know of gives a doctor an approving pat on the head for taking a fragile older patient off meds.”

This is just the tip of the iceberg. Tests cost money, and often show results that lead to more tests, and then maybe to procedures (biopsies, for example) that maybe show abnormalities that lead to bigger interventions. And, sometimes these interventions are life-saving, but not always. Or maybe, even, not often.  And they do often have side effects, some of which are not insignificant. The person in whom a series of tests identifies cancer and is then treated and then survives is almost always grateful for the testing and the treatment, although in many cases they would have survived just the same with no treatment, and without the costs both in dollars and in side effects. The classic example is prostate cancer, where the evidence of any treatment making a difference in survival is weak at best; it is either a devastating disease from which one dies, painfully, or more commonly a benign condition that one dies with but not from but which treatment seems to have little influence on. Except for the cost, and the non-trivial side effects of impotence, incontinence, and the effects of radiation on the rectum.

Increasingly, data is showing that much breast cancer is similar. As discussed in my December 2012 blog post “More on mammography: just because you don't like the results doesn't make research junk science”, a large study by Bleyer and Welch showed that, with new and more sensitive mammographic screening, many more women are being diagnosed with early-stage breast cancer. However, despite treatment, we are not seeing anything like that reduction in late-stage breast cancer, which means most of those early stage cancers would not have progressed at all. And yet every woman diagnosed and treated sees herself as a survivor who has been cured, even in those cases where progression would not have occurred. In his wonderful recent New Yorker article “Overkill” (May 11, 2015), Atul Gawande notes that we treat all “cancer” as if it were rabbits in a pen who have to be chased down before they escape, when in fact many cancers are “birds” that have flown away and are gone before we can do anything and many others are “turtles” who are not going anywhere whatever we do.

The goal of medical care is now to achieve the “Triple Aim” of high quality, patient satisfaction, and lower cost. As with many things that come in threes, it is not that hard to achieve two but very challenging to achieve all three. Patients satisfaction is important, but not at any cost. Cost control is good, but not if it seriously limits quality. One place to start, then, is with quality, and specifically not doing what is useless or even harmful as assertively as we do what is likely to be of value.

And, of course, to make sure that it is the disease or risk of disease that determines what tests are done, not people’s insurance or socioeconomic status, ethnicity, gender or personality.

The screening pelvic examination: not annual, not ever

The Dispute Over Annual Pelvic Exams, an editorial in the New York Times July 3, 2014, highlights an issue about which I have written before, including Primary Care Contributes More than Money...., June 2, 2013 and President Bush's stent: inappropriate screening and care for the rich, nothing for the poor, September 7, 2013. The Times has also had articles on the same subject, notably Questioning the pelvic exam, by Jane Brody, April 29, 2013. The impetus was a recent guideline recommendation from the American College of Physicians (ACP), the specialty society for internal medicine physicians, that recommended against doing this test on an annual basis.[1]

This examination is not to be confused  with the Pap smear screening test for cervical cancer (although it regularly is). The Pap smear involves obtaining cells for cytological examination from the cervix by means of a spatula and/or small brush. The Pap smear is not perfect, but it is probably the best of the cancer screening tests available to us; the US Preventive Services Task Force (USPSTF) recommends them in women 21-65 years of age every 3 years. The pelvic exam, the part where the doctor puts her/his hands inside a woman and feels around, is often done in conjunction with the collection of the Pap, thus the basis for the confusion among many women. It is not recommended by USPSTF at all, at any frequency[2], but the American College of Obstetricians and Gynecologists (ACOG) recommends it on an annual basis.

I have long been a teacher of family medicine, and for many years have told my students and residents that there was no indication for this examination, at any frequency, for screening. I do this despite the fact that I know they are taught to do so on their OB-Gyn clerkships and rotations, and not because I believe I am more experienced in providing women’s reproductive health care than are the OB-Gyns. I can, however, read the evidence. By definition screening occurs in asymptomatic people; should a woman present with symptoms referable to the pelvic region (for example, pain, bleeding or discharge) the examination may be indicated. However, in the absence of symptoms it is a screening test, and should not be done because there is nothing that it can screen for. Years ago, an argument for doing it was screening for ovarian cancer, but many studies have demonstrated that it is not effective for this purpose, because by the time an ovarian cancer can be felt by the examiner, it is very far gone. These are essentially the same reasons that USPSTF and ACP recommend against it.

And, yet, ACOG, as noted, continues to recommend it (”Annual pelvic examination of patients 21 years of age or older is recommended by the College.”). The Times editorial notes that

…the gynecologists group argues that the “clinical experiences” of gynecologists, while not “evidence-based,” demonstrate that annual pelvic exams are useful in detecting problems like incontinence and sexual dysfunction and in establishing a dialogue with patients about a wide range of health issues.

This defense ranges from the indefensible (that it is not evidence based) to the absurd (that it is the way to find problems like incontinence and sexual dysfunction). If a woman has incontinence or sexual dysfunction, she knows it and the way to discover it is not by a pelvic exam, but by asking her. Clearly, the same is true of “establishing a dialogue with patients about a wide range of health issues.” I strongly doubt that most women would feel that having the doctor put his/her hands inside her vagina is the best way to open such a dialogue!

Why, then, would ACOG continue to recommend it? Long ago, when I was in medical school and residency, almost all OB-Gyns were men, and lack of empathy could be a possibility, but this is far from the case now or in recent decades. There is also the fact that such an examination, as a procedure, is reimbursed at a much higher rate than simply talking to a patient. This is true also for family physicians and other primary care providers (such as general internists, which explains the ACP’s interest in the issue), but for OB-Gyns it is a much greater percentage of their practice and thus their income. It is hard to break with tradition, to change the way that you have always been taught, and it is probably harder when there is a concrete disincentive (loss of income) for changing.

But women, and all people, need to be able to trust that their doctors are recommending and doing procedures, particularly invasive and uncomfortable procedures like the pelvic examination, only when they are indicated by the evidence. They need to have confidence that those physicians are not motivated, consciously or not, by a conflict of interest (e.g., financial gain). One step is for physicians to honestly look at the evidence, and avoid prioritizing their anecdotal experience over that evidence.

More profoundly, however, our society, our health care system, needs to eliminate perverse incentives for doing “more” even when it is not indicated, still less when it is also unpleasant for the patient (like a pelvic exam), and least of all when it is also dangerous (as other procedures are). Physicians should be paid for maintaining and increasing the health of their patients, not for “doing things”. If talking to the patient about “a wide range of health issues”, including but not limited to incontinence and sexual dysfunction, is the right way to find out about these problems, and if it takes a long time, then this is what needs to be reimbursed, not a procedure.

We are currently a long way from this sort of reimbursement, for spending the time needed to provide the best health care for a person. It is good that ACP has added its voice to recommending against screening pelvic examinations, but it is unsurprising that doctors do what they are paid to do. We need system change.

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[1] Qaseem A, et al, “Screening Pelvic Examination in Adult Women: A Clinical Practice Guideline From the American College of Physicians”, Annals of Internal Medicine 2014;161(1):67-72. doi:10.7326/M14-0701.

[2] http://www.uspreventiveservicestaskforce.org/uspstf12/ovarian/ovarcancerrs.htm