Medicine should not be primarily a business: choosing appropriate care for all, not excess testing for some

The American Academy of Family Physicians (AAFP) has added five new recommendations to its Choosing Wisely campaign. I have discussed “Choosing Wisely” before (‘“Eggs Benedict” and “Choosing Wisely”: Often the best thing to do is nothing’, April 14, 2012), but will briefly review it. First introduced by the American Board of Internal Medicine Foundation (ABIM-F), the program calls for each specialty society to list at least five things that are done by members of that specialty but either should not be done at all or should only be done in far more restricted circumstances that they currently are.

The five new recommendations by the AAFP bring their total to 20; this is good, because many other specialty societies have never expanded upon their original five. And for some of those groups, even those original five were kind of tentative, almost like “well, this test or procedure is not good, so you probably shouldn’t use it too much”.  One reason Family Medicine has more is because the field is so broad and its practitioners care for problems in all areas, but I fear that another reason is the reticence of some specialty societies to make negative recommendations about things that their members make a lot of money from doing, even if they are not medically indicated. As I noted in ‘Medical interventions we shouldn’t be getting: issues of cost, health, and equity’ (December 12, 2015) regarding imaging for uncomplicated back pain:

…some of the tests chosen (MRI or CT for new-onset uncomplicated low back pain) were imaging studies not recommended by the American Academy of Family Physicians and American College of Physicians (Internal Medicine) as part of the “Choosing Wisely” campaign, but are not recommended against by the American Academy of Orthopaedic Surgeons in their “Choosing Wisely recommendations. Of course, orthopedists stand to benefit from doing surgery on these patients.

The radiologists, who perform the MRIs and CTs, also did not recommend against this procedure.

The radiologist societies also recommend screening for lung cancer with low-dose CT scans in smokers and former smokers, and in fact, to date, none of the specialty societies are recommending against it. There is some evidence that this (not inexpensive) test may be able to detect lung cancer early in many people, sometimes while it still can be effectively treated, but even this is not certain. Rita L. Redberg, MD, in an editorial in JAMA Network “Failing Grade for Shared Decision Making for Lung Cancer Screening”, notes that while (payment by Medicare for) the test was approved on the basis of one positive study, three subsequent studies have not shown the benefit. In addition, it is not without risk of harm. The harms come not only from radiation exposure, but from complications of the biopsies needed to follow up on positive tests. And, also noted by Redberg, 98% of positive tests are “false positives”, where the patient does not have cancer. Some of this high percentage of false positives comes from testing the wrong people (“screening creep”, where a test that has been shown to be of benefit in a limited population is incorrectly assumed to also be of benefit to a wider group). the US Preventive Services Task Force (USPSTF) recommends that the screening only be done on the patients for whom it is indicated (!!), and only after the doctors engage in “shared decision making” (SDM) with their patients by helping them understand both the potential risks as well as benefits to the test, and what their individual probability of each is.

Apparently, doctors do not do this, as demonstrated by the research article that Redberg’s editorial accompanies, “Evaluating Shared Decision Making for Lung Cancer Screening” by Brenner, Malo, Margolis, et al. Taping and analyzing recordings of doctors recommending this test to their patients, they found no evidence of the physicians presenting the important information and engaging in SDM. It was a small sample (this is difficult and time-consuming work), but as Redberg points out there is no reason to imagine that overall practice is significantly different. While this study specifically looks at low-dose CT screening for lung cancer, and finds that SDM doesn’t happen often, this is a concern for many other tests and interventions that are often done when they are not indicated, and rarely have the risk/benefit presented to people so that they can participate in SDM.

One example of such a test is the use of screening pelvic examinations (the part where the provider puts her hands in and feels around, not the Pap smear part) in non-pregnant women. One of the AAFP’s new “Choosing Wisely” recommendations (#16) appropriately comes out against it: “Don’t perform pelvic exams on asymptomatic nonpregnant women, unless necessary for guideline-appropriate screening for cervical cancer”.  This is because the most basic characteristic of a screening test (essentially, any test – whether a physical exam or lab or x-ray – done in asymptomatic people) is that there has to be a disease that the test can, with some reasonable rate of accuracy, screen for. There is no condition that can be screened for by a pelvic examination (including ovarian cancer, which has been cited, and is always too advanced to successfully treat by the time it can be felt). I have been teaching students and residents to not do “screening” pelvic examinations in asymptomatic non-pregnant women for decades.

For similar reasons, previous AAFP “Choosing Wisely” recommendations, had already recommended (#5) against doing Pap smears in women in whom it is not indicated (those who are under 21 or have had removal of their cervix for non-cancer disease), and in women over 65 who have had negative prior Paps and are not at high risk for cervical cancer (#9), and not requiring either Paps or pelvic exams for prescribing oral contraception (#15). In addition to not doing a screening test when there is no disease to screen for (pelvic exams), they should also not be done when the risk is very low and lead to excessive false positive tests. This seems like a lot of “don’t dos” in the same general area of women’s screening, but it is warranted not only because family physicians do a lot of such screening, but, more embarrassingly, because many OB/Gyn specialists both continue to do them and to teach students and residents to do so. Indeed, not doing screening pelvic examinations is distinctly not one of the 10 “Choosing Wisely” recommendations by the American College of Obstetricians and Gynecologists (ACOG).

Yes, OB/Gyns do make some of their living doing such procedures (as do family doctors), but frankly it is a small percent compared to doing surgical procedures. Sometimes tests and procedures continue to be done even when they are not indicated (or potentially harmful) because of tradition. Or because of publicity campaigns run by disease-specific advocacy groups, especially for various types of cancer, that sow fear rather than truth.

But when such tests and procedures continue to be done, even in part, because those who perform them, the doctors and hospitals and laboratories and device makers, make money doing them rather than for medical benefit, it is reprehensible. And, even more, it saps funds from other important health-related care, particularly for those people who have the least money and are least likely to be insured. We do not have a unitary national health system in which money not needed in one area can be easily transferred to spending on necessary care for other people or conditions, but we need to get there.

It is unacceptable for people to get tests and procedures that are dangerous and of no benefit regardless of funding. It is similarly wrong for even relatively benign tests and procedures that are not medically indicated to be done because those performing them make money. But it is worst that many people do not get even basic, indicated, beneficial care while money is being wasted, or worse, on these other procedures.

The terribly flawed attitude of treating healthcare as a business was illustrated by a comment from Charles Bouchard, senior director of theology and ethics at The Catholic Health Association, in a NY Times article that found fewer than 3% (all in Washington State, which legally requires it) of Catholic hospital websites “contained an easily found list of services not offered for religious reasons.” He said '“I think that any business is not going to lead off with what they don’t do. They are always going to talk about what they do do. And that goes for contractors and car salesmen. They are not going to start off by saying, ‘We don’t sell this model,’ or ‘We don’t do this kind of work.’”

That’s the problem. Selling things people do not need to them if they have money (and not offering things there is no profit in so doing) is a common way to run a business. It is no way to run healthcare.

"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.

Lung Cancer Screening: Benefits, Costs, and Opportunity Costs for the Public Health

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In a rather unusual action, the National Cancer Institute (NCI), a division of the National Institutes of Health (NIH), issued a press release on November 4, 2010 announcing preliminary findings from a research study that, at that time had yet to be published (it since has been). This bulletin, Lung cancer trial results show mortality benefit with low-dose CT, announces that a large, multi-center, randomized controlled trial (RCT), called, the National Lung Screening Trial (NLST), has found that regular screening of current and former heavy smokers with low-dose chest computed tomography (CT) scanning aged 55-74, compared to screening by regular chest x-ray, led to 20% fewer deaths from lung cancer. It is unusual in that it is there is no associated published study in a journal describing these results (the statement says that it is being “prepared for publication in a peer-reviewed journal within the next few months”); the only concurrently published article is a description of the methods of the NLST study, with discussion of previous screening studies for lung cancer, is the “National lung screening trial: overview and study design” published in the November issue of Radiology and made available November 2, 2010.

The study comparing these two screening tests – x-ray and CT – appears very strong. Because it is randomized, there is no significant difference between the pre-existing characteristics of those assigned to CT versus chest x-ray screening, and because the end point is death, it largely eliminates one of the most important confounding issues in prior studies called “lead time bias”. This means that if a more sensitive test identifies cancer earlier in its course, the time between diagnosis and death will be longer even if the death itself is not forestalled. (E.g., you have cancer and one test finds it at 55 and you die at 60; another test could find it at 50 and you die at 60; finding the cancer earlier didn’t make you live longer.) It is also a very large study (53,000 people) and well designed in many other ways, so that a 20% reduction in death is important. There is an excellent FAQ for this study, including graphics of lead-time and length-time bias, at the NCI website

So is there any problem? Will lung cancer, the biggest killer among cancers, become like breast cancer, where a screening test can find the cancer earlier, lead to earlier and effective treatment, and decrease mortality? Not exactly. In addition to a 20% reduction in mortality being far less than the reduction in breast cancer mortality from mammography, lung cancer is not breast cancer; we know the cause of the vast majority of cases: smoking. The authors, and the NCI, emphasize that such screening, even if widely adopted, is no substitute for stopping smoking or increasing efforts to get people to stop smoking. The real question is what is the benefit of spending huge amounts of money (while there is no statement of cost of screening in either the NCI brief or the Radiology article, estimates are as much as $12 billion a year -- 30 million screened at $400 per CT screening with interpretation, including follow-up exams -- to screen people who smoke, or smoked, heavily for cancer in pursuit of a significant, but relatively small, reduction in mortality? Moreover, there is no estimate of the potential risk of repeated CT scans (even low-dose, such as studied) and the degree to which the existence of a screening test might decrease the interest of smokers in stopping. (If this seems perverse, it is almost certain to happen; it happens every time news of a possible preventive intervention is announced: some people decide there is no need to stop their risky behavior.) Thus, to save 1 in 300 lives (about 100,000 of the 30 million screened, or 0.039% of the US population), not even considering quality of life (generally low for long-term smokers with cancer who have other conditions such as chronic lung disease), will cost about $40 per every person in the US per year.

How do we evaluate cost-benefit? In the current political environment, the popular theme is “don’t spend public money”, but there is always the implicit caveat “except if it benefits me” – and in this country we have over 300 million “me’s”. Dr. Robert Bowman, who has previously contributed to this blog, describes for us the potential alternative uses of not only the ongoing cost of screening, but even the cost of the study itself:

· The $250 million for this one study involving CT screening for lung cancer is about what the United States spent for all Agency for Healthcare Research and Quality (AHRQ) health care cost, quality, and outcomes research in 2008. (AHRQ is the main government agency looking at these issues, including “outcomes”, particularly important as I have previously discussed; it is obviously funded at a lot less than the $30 billion for NIH.)

· $250 million is the entire sum that the Health Resources and Services Administration (HRSA, the government agency that funds workforce research, training programs in primary care, dentistry, physicians assistants, pipeline programs, etc.) could scrape together to address emergent needs for primary care workforce this year.

· $250 million, if used to train family doctors at about $30,000 cost per Standard Primary Care provider, would produce 8333 Standard primary care years of workforce in family medicine graduates, or about 333 FM physicians serving their entire careers and improving cost, quality, and access where it is most needed.[1]

And the $12 billion?

· The $12 billion a year spent on CT screening for 30 million current or former smokers could graduate 16,000 family physicians a year.

· $12 billion a year, expended each year for the 30 years required to actually build any workforce (i.e., a generation), if applied to family medicine would supply the entire nation enough primary care for all locations and populations in need of primary care. Sufficient primary care for over 90% of Americans in all needed locations would begin 30 years after reaching 16,000 annual graduates and would be maintained with continued funding of 16,000 annual graduates. (Indeed, compared to less-efficient spending on training programs, such as internal medicine, that yield far fewer primary care years per dollar spent, this $12 billion is actually is a savings of a few billion dollars!)

Or, if we are concerned about lung cancer, using this for tobacco control campaigns, both the "stop smoking" kind and the legislating non-smoking venues, cities and states.

Dr. Bowman continues:
"The US continues to fail, time after time, in the most basic choices regarding care for Americans most in need of care. The US can focus on the health care needed for nearly all people nearly all of the years of their lives in nearly all locations or the US can continue to spend its $7000 per person ($2.5 trillion) on the health care needs for only some of its people for a only a few years of their lives, with health care delivery services concentrated in only a limited number of locations (4% of the land area).

There is little point to research about rural workforce, health access, or primary care until the nation makes a decision to quit sending health care spending to locations with top concentrations for the care of Americans already with the most care."

Any economist – or wise investor or businessperson – can tell you about “opportunity cost”. This means “if you spend money on one thing, you can’t spend it on something else.” Therefore, the benefit of what you spend money on needs to be looked at not only for its intrinsic value (“will spending $12 billion a year on lung cancer screening with CT save lives?”) or against a very limited range of options (“Is it more cost effective than screening with chest x-rays?”) but weighed against reasonable alternative strategies to improving the health of people – all people.

Dr. Bowman gives strong arguments for the benefit of investing in primary care workforce development, and particularly in family medicine. Maybe there are other strategies for most improving the health of most of our people. But looking at new scientific advances in isolation is clearly a flawed approach.

[1] For a detailed description both of this measure – standard primary care (SPC) years – and the reasons that Family Medicine, as opposed to other physician and non-physician primary care training (internal medicine, pediatrics, physician’s assistants, nurse practitioners) is the most efficient producer of SPC years, see Ten Biggest Myths Regarding Primary Care in the Future, January 15, 2009.
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