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.

Contraception, women's health and dignity, teens, and stupid legislators

A bill before the Maine legislature would allow women to obtain a year’s worth of oral contraceptives at a time, rather than the previous 3-month limit. This is a good thing, as argued by its sponsors and supporters. Women typically take oral contraceptives for long periods of time, and the requirement that they return to refill their prescriptions every 3 months is at best an inconvenience and at worst a burden. It is a burden women should not have. Indeed, there is no good reason to require a prescription for oral contraceptives at all.

This does not mean that there are no reasons put forward by opponents; if there were none, there would be no opponents. Overall, the opposing arguments fall into 3 categories: money, control, and wacko paranoia. If women only have to fill prescriptions once a year there will be fewer prescriptions being filled, which could be a small hit to pharmacies. The bigger objection is from insurers, as addressed in an article in the Portland Press-Herald of April 19, who worry that it could become a “mandate” for coverage with no cost share for other contraceptives, particularly those that are more expensive for insurers.

Control is a big and insidious issue. The idea that women are incapable of making their own decisions, particularly with regard to their reproductive systems, is as outrageous as it is persistent. For generations women have fought and often won struggles to be considered legally as “people” (implicit definition: men); to have the vote, to own property, to divorce. But no area has been as fraught with (yes, “fraught” requires a preposition!) opposition as the entire area of women’s reproduction. From before the time of Margaret Sanger, every source of pressure – religious, economic, and legal – has been brought to bear against the idea that women should have control of their own bodies and particularly their reproduction. The struggle continues; abortion rights are the most vulnerable today, but as the opposition to the Maine bill illustrates, contraceptive rights are scarcely secure.

Even among the biggest supporters of contraception, there can be poor decisions. Nearly 20 years ago I sat on a Planned Parenthood advisory board, and many of its members were surprised that I strongly opposed a requirement that women have a Pap smear before receiving a contraceptive prescription. The logic of those who supported it was that the inducement of receiving contraceptives would encourage women to get their Pap, which was then recommended. My position was that the negative incentive of the Pap (and associated pelvic examination, see below) would keep women, especially young women and teens, from getting their contraceptives, and thus likely increase unwanted pregnancies. I am sure that that Planned Parenthood, and other contraceptive providers, no longer have such a requirement. Indeed, we no longer recommend Pap smears for women under the age of 21, and for others, they are recommended only every 3 years. Regarding the screening pelvic examination, it simply violates the first criterion for a screening test – there must be condition that can be screened for in an asymptomatic person. This has led the American College of Physicians, having reviewed the evidence, to recommend against it, while the US Preventive Services Task Force (USPSTF) somewhat incomprehensibly, gives it an “I” (evidence is insufficient to recommend for or against) recommendation. This is summarized in a recent review from the Agency for Health Research and Quality (AHRQ). The American College of Obstetricians and Gynecologists still basically advocates it, although it suggests the decision be made individually between the woman and her doctor, no real change from when I discussed it on July 3, 2014 (”The screening pelvic examination: not annual, not ever”).

Being a major provider of contraception does not save PP from the wrath of Congressional Republicans; indeed, while abortion is the flaming tip of the spear of conservative opposition, the right’s opposition to PP is also against those that do not do abortions, but mainly provide contraception and other women’s health services. The good news is that the GOP may be unable to attach defunding PP to the “health” bill (Obamacare repeal) because it is being done at a budget resolution. You might think that providing contraception would be seen as a good thing, since fewer unwanted pregnancies would lead to fewer abortions, but this is not their logic. [I think that they are, basically, anti-sex, at least that practiced by others, as demonstrated by all the patently false claims we hear constantly in school-based clinics that prescribing contraception will “encourage” sex.]

Of course, it does not. Hormones encourage sex, yes. Social pressure encourages sex, for sure. But not contraceptives; what they do is prevent pregnancy. Amazing. And if the whole campaign against PP, as well as opposition to allowing a year’s worth of OCPs, is grounded in a mindset that wants to control women, the issue for young women (and their partners) is far worse. They are seen as not only women, but immature and incapable of making wise decisions. There is some basis for the idea that they are immature, as parents know; the brain is not fully developed until at least the mid-20s and the last part to develop is the ability to make “executive decisions” – taking the information that you have, looking at it completely and objectively, and making a smart choice.  This is why teens and young adults make poor decisions in driving and, conversely, make the best soldiers.

But this is not a justification for restricting access to contraceptives, condoms, or other health services that might prevent bad outcomes. Because teens make not make the most mature decisions, and often regret them later, it doesn’t mean that they won’t make them. So we need to make it as easy as possible for them to not have long-lasting negative consequences, like STIs and unintended pregnancy. There need to be as few barriers as possible for young people to not get (or make another) pregnant, to not get preventable sexually-transmitted infections (STIs). These would include making oral contraceptives over the counter, making condoms in front of the counter, and preferably free. Should a young woman (or man) come to a clinic for care, invite them in, see them quickly, meet their needs. For goodness sake, don’t make it hard, don’t send them somewhere else to register as they’ll walk out the door!

The editorial in the New York Times, May 13, 2017, “The health care bill’s insults to women”, documents the degree to which women in rural and underserved areas, where more than half of PP’s clinics are, will lose if Medicaid doesn’t cover services at PP. It notes that in 105 counties, PP is the only provider of reproductive health services. The editorial starts with insensitive “sophomoric” quotes from several congressmen and senators, including one from Kansas Sen. Pat Roberts that “I wouldn’t want to lose my mammograms!”. Sen. Roberts would be well advised to identify which of the areas in Kansas, particularly in the very rural “Big First” district he once represented as a congressman, would be among those losing services. A lot, actually, especially since one OB/Gyn from Great Bend is now busy representing the district in Congress. Of course, Dr. Roger “the poor just don’t want health care” Marshall probably didn’t take care of many underserved folks.

This is not the way to go. Our goal must be to increase health as much as possible, not to create obstacles to it.

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