Undermining the USPSTF: The most important stakeholders are the patients

A strange “health care” drama plays out daily in our clinics and hospitals. A healthy person has a medical test done (even though he or she is healthy): a blood test, a chest x-ray or mammogram, maybe an ultrasound of some body part. The test comes back abnormal. The patient (for she has now gone from being a healthy person to being a patient) is struck with worry, and undergoes a further round of testing to determine whether the initial, “screening” test was accurate. This more invasive, risky definitive testing causes the patient pain, complications, infections, further procedures to fix the complications. But the testing shows that the original screening test was wrong, and the patient is relieved of their worry and overcome with a sense of gratitude: “Yes, the follow-up surgery was painful, but at least it’s not cancer.” However, notice what caused the worry in the first place: not some symptom that they were experiencing, but a test that was performed on a healthy person. What a marvelous bit of sorcery: we take a happy patient, create unnecessary worry, then win their undying gratitude by performing risk-laden procedures on them to remove their worry!

There is something very intuitive about the concept that detecting a disease (especially cancer) early leads to better outcomes, that screening tests are inherently good. Yet when one studies the actual outcomes of implementing mass screening programs in a population of people who have no signs or symptoms of a particular disease, one finds to one’s surprise that, not infrequently, more people are harmed by our screening test than are helped (See: PSA testing, carotid ultrasounds, annual stress tests, etc). This harm may take many forms: worry, invasive procedures with all the risk they bring, radiation exposure, disfiguring treatments, stroke, even death. Yet there is no shortage of promoters of various tests that capitalize on our intuition that “More testing is better.”

In steps the United States Preventive Services Task Force (or USPSTF), a group of experts in preventive medicine and primary care (since it is mostly primary care providers who order screening tests). Their task is to examine the scientific evidence of the potential risks and harms of preventive strategies like screening tests, and to make recommendations based solely on that evidence. They strive to use the best scientific data available to benefit the most people possible. Even when their recommendations are unpopular (because they go against our intuition that more screening is better), they have a large effect on what tests are performed — and what tests insurance will pay for.

This week the USPSTF recommended against screening for thyroid cancer in people without symptoms. The data show that screening has found lots of thyroid cancer that never would have been found otherwise. The data also show that screening has not produced a reduction in death from thyroid cancer or an increase in quality of life. What it has produced is an increase in harms, such as injuries to vital nerves from the increase in thyroid surgery. Who knew?

Now there is legislation pending in Congress proposing that “stakeholders” — that is, specialists and industry representatives — be included in the membership of the USPSTF. This is a very bad idea. Consider: What do specialists like thyroid surgeons (who are not experts in screening for thyroid cancer; rather, their livelihood is tied to operating for it) or drug and device manufacturers (who sell the tests and ultrasound machines used to screen for thyroid cancer) add to the USPSTF’s process?  The main thing “stakeholders” (that is, people with a financial interest in seeing the test done) add is a conflict of interest. Whatever difference such “stakeholders” make would be tilted to the advantage of the few who stand to profit from the screening, and to the detriment of the many in the population who would be harmed from the screening. The USPSTF’s work must not be transformed from a transparent procedure that seeks to minimize harm into a get-rich-quick scheme.

All We Need is (Unconditional) Love

On March 24, 2017, Joe Gibes posted an entry on this blog, entitled “A ‘disabled’ person speaks out against a particular form of discrimination.”[1] That post featured links to several stories about Kathleen Humberstone, a young woman with Down Syndrome who spoke at a recent UN event commemorating World Down Syndrome Day, which was observed on March 21.

After reading through Joe’s post and the stories to which his post links, I’d like to add the following two very basic observations (which I will only state here – further elaboration shall have to await another time):

  • OBSERVATION #1: Thankfulness and disability are entirely compatible – indeed, one can be genuinely thankful for one’s disability. “Thank you Down’s syndrome!” Kathleen says enthusiastically, in her prepared remarks for the UN event.[2] It’s hard to imagine she doesn’t mean this sincerely.
  • OBSERVATION #2: As Hans S. Reinders has said repeatedly,[3] often the thing that people with profound intellectual disabilities need most is simply to be chosen as friends. This point is easily generalizable to persons with any kind of disability—very often, what we “need” most is simply friendship, not “healing” or “relief” or “freedom” from the (supposed) “burden” of disability itself.

With continued developments in prenatal genetic testing techniques, including the relatively recent advent of non-invasive prenatal testing (NIPT), it has become even easier to detect, at earlier and earlier points in pregnancy, the presence of disabilities such as Down syndrome. And this, of course, opens the door to so-called “selective termination” of unborn children who test “positive” for such conditions.

For Denise Humberstone, Kathleen’s mom, this makes no sense whatsoever. Why shouldn’t we accept all persons, Denise wonders, including those with Down syndrome and other disabling conditions, with the same kind of unconditional love that we would offer to any other, nondisabled person?

“Whatever happened to unconditional love?” she asks. “When did society decide we should want and love a child only if it is as perfect as medical research allows?”

In a Facebook post[4] written just prior to Kathleen’s speech at the UN event, Denise addresses the “unrealistic demands for perfection” that appear to drive so many of these decisions to abort unborn children diagnosed with Down syndrome and other disabilities:

I’m also wondering if in parallel to scientific research, these unrealistic demands for perfection stem from the fact that we are also now living in a world where we can not only get anything we want off the internet but that item always comes with a return form should it not be up to your expectations. Not perfect? Bam! Return it, free-post, no questions asked, item will be replaced in no time….

What are we teaching our children? People are worthy of life and love only if they are perfect? We can’t cope with children unless they’re perfect? Your marriage/partnership won’t last unless your children are perfect? Siblings will be ok as long as they are all perfect? I can assure you that my friends are not happier because they don’t have a child with special needs…. There is always something to be unhappy about, it’s human nature.

So why can’t we just go back to the basics and try and love unconditionally? Why can’t we just deal with the hand we’ve been dealt… and rise up to the challenges that life throws at us?

Around the same time as Joe posted his blog entry about Kathleen Humberstone, quadriplegic and disability advocate Joni Eareckson Tada posted a blog entry[5] about World Down Syndrome Day. Here’s what she wrote:

I love smiling children… the image imparts such hope and joy, reminding us we are all made in the image of God. I especially delight in the smile of a child with Down syndrome. Anyone who has rubbed shoulders with someone who has Down syndrome will rave about the love, openness, and zest for life they bring to every family. Their laughter and joy is infectious. Today, as we celebrate World Down Syndrome Day, I’m reminded of a touching video I saw two years ago – titled “Dear Future Mom,” it shows children and teens with Down syndrome. Each has something brief and sweet to say about their disability. Then, they look into the camera and address the worries of any pregnant woman who is fearful about carrying a child with Down syndrome.

This video blessed me so much, I just had to share it with you. Perhaps you know of an expectant mother who has learned her baby has a genetic disorder. Please share this with her – the smiles on the faces of these young people will ease fears and give hope, helping her welcome her precious baby into the world.[6]

In the end, Kathleen Humberstone and the children and teens featured in “Dear Future Mom” remind us of what we all need the most: unconditional love.

 

[1] See http://blogs.tiu.edu/bioethics/2017/03/24/a-disabled-person-speaks-out-against-a-particular-form-of-discrimination/.

[2] http://www.bbc.co.uk/newsbeat/article/39339338/downs-syndrome-teenager-addresses-the-un-in-geneva

[3] See, for example, his Receiving the Gift of Friendship: Profound Disability, Theological Anthropology, and Ethics (Grand Rapids, MI: Eerdmans, 2008).

[4] https://www.facebook.com/denise.humberstone/posts/10155948159319126?comment_id=10155950465429126&reply_comment_id=10155950568324126&notif_t=feed_comment_reply&notif_id=1488705525554890

[5] http://www.joniandfriends.org/blog/world-down-syndrome-day-2017/

[6] “Dear Future Mom” can be viewed here: https://youtu.be/Ju-q4OnBtNU.

Testing, testing: Prenatal genetic screening

The June 2016 issue of Obstetrics and Gynecology includes a study of the conversations between patients and “Health Care Providers” about prenatal genetic screening (PGS). The objective of the study was to “assess how obstetric health care providers counsel patients regarding prenatal genetic screening and how these conversations influence patients’ screening decisions.” PGS refers to blood and ultrasound tests performed early in pregnancy to determine whether a fetus is at high risk for various chromosomal anomalies, especially the anomaly that leads to Down syndrome. Several findings of the study are troubling.

First troubling finding: providers’ counseling of patients about PGS lasts an average of 1.5 minutes.

Second troubling finding: False-positive rates of PGS are discussed so rarely that they could not be reliably analyzed in the study. The false-positive rate refers to how often the screening test is wrong when it suggests that an abnormality is present; when a test says the baby has Down syndrome, but the baby in fact does not have Down syndrome, it is a false-positive. The guidelines of the American College of Obstetricians and Gynecologists suggest that false-positive rates ought to be discussed in counseling about PGS.

But counseling about false-positive rates is itself troubling. The false-positive rate of PGS is somewhere around 5%. Most of us hear this and think, “OK, 95% of the time the test is right when it says that the baby has Down Syndrome.” However, to answer the question, “What percentage of the time is a positive test correct?” you can’t look at the false-positive rate; instead, you have to know something called the Positive Predictive Value. And for PGS, the positive predictive value is only 10%. That means that 90% of the time when PGS says “Down syndrome,” the baby does not have Down syndrome. (Numbers are higher for cell-free fetal DNA testing; however, this test is fraught with its own problems, and the study under consideration here did not include this test.)

Third troubling finding: In 51% of the discussions analyzed, health care providers did not clarify the fact that PGS is not diagnostic. PGS is a screening test, not a diagnostic test. The difference is crucial. Since 90% of abnormal PGS tests are wrong, an abnormal test requires a follow-up procedure to actually make a diagnosis. That follow-up test is usually an invasive test involving a needle into the uterus and a small chance of causing a miscarriage. I have known of several women who didn’t understand the screening nature of the test when they had it performed; when the test came back showing high-risk for a genetic abnormality, they then refused the more definitive diagnostic test. The result was either they spent their entire pregnancy in needless anxiety until the child was born without the anomaly, or they aborted the child on the basis of a false test result.

Why is all of this so troubling? Because medical tests are a big deal. Our understanding — or misunderstanding — of the results of medical tests shape how we see and understand ourselves. And PGS medical tests are a bigger deal than most; because if the results of this study are true, parents are frequently getting cursory explanations (1.5 minutes) from “providers” who give inadequate information about PGS tests. They are then using that (mis)information to make life-or-death decisions for the children they carry. If we’re going to practice eugenics, we should at least make sure that we’re doing so in a fully-informed fashion.

Truth-telling and preventive interventions

 

Recent articles in two different medical journals address an important concept in medical ethics as it pertains to screening tests: truth-telling.

The articles appeared in the New England Journal of Medicine (NEJM) and the Annals of Family Medicine (AFM). The NEJM article relates how, in the zeal to encourage people to have screening tests such as mammography for breast cancer and colonoscopy for colon cancer, “uninformative persuasion” is often employed, in which the benefits of having the test are extolled and the harms conveniently ignored. The truth behind the claims of benefit, however, is sometimes quite surprising. How effective would you estimate that mammography is at saving lives? It’s not as good as I guessed: mammography reduces a 50-year-old woman’s chance of dying from breast cancer by at best 25%. Another way to look at it: the chance of dying from breast cancer is reduced from 23 in 1000 to 19 in 1000. A reduction, yes, but not nearly as impressive as the hype would have it. Of course, it’s of paramount importance to the 4 in 1000 whose lives were saved. But wait, there’s more: for every breast cancer death prevented, three women are diagnosed with a cancer that they never would have known about because it would not have become apparent during their lifetime. Yet those women, as a result of their screening, go on to have unnecessary lumpectomies and mastectomies and radiation therapy (which can cause other cancers!) and all the emotional trauma that comes along with breast cancer treatment.

The AFM article describes the results of a study in which patients were asked to estimate the number of deaths and other events prevented by various interventions, including screening for breast and bowel cancer and using medications to prevent hip fractures and cardiovascular disease. Unsurprisingly, anywhere from 69 to 94% of participants overestimated the benefit of each intervention.

An accompanying editorial in the AFM discusses some of the reasons behind the widespread acceptance of these false beliefs. One reason is that they buttress the illusion that we are in control: “. . .false beliefs meet the psychological needs of patients for hope and safety, as well as for action, agency, and a sense of control.”  (The same holds true for physicians as well as patients.)

The fixed nature of these false beliefs means that anyone who tries to correct them is looked upon with suspicion. After all, it seems so right, so rational, so simple and safe to use preventive tests and medications to save lives. But the truth is not so simple, and the tests are not so safe. Modernity is all about control, and the hype behind these interventions panders directly to the control-mindset of modernity. But hype is lies, and lies cause harm. The duty to tell the truth is especially important in these instances when patients and their physicians must make potentially life-impacting decisions that have the potential for great harm as well as great good.

Eugenics and the genetic testing of embryos and fetuses

In a recent article in the Australian media Julian Savulescu, a noted Oxford ethicist who is a visiting professor at Monash University in Melbourne, makes the contention that selecting which babies are born by doing genetic testing on embryos or fetuses and only allowing those that are desired to live to birth in the way that it is allowed in Australia shares the moral problems of past eugenics programs that we have rejected. His point is that the current practice in Australia allows selection of embryos by preimplantation genetic diagnosis and fetal testing with selective abortion only for diseases and not for sex selection or other non-disease characteristics. By allowing selection based only on diseases the society is saying that “lives with disability are less deserving of respect, or have lower moral status.” That is why we rejected the eugenics programs of the past.

Savulescu points out that “If either the embryo or the fetus has a moral status – then it would be wrong to kill either, whether or not a disability is present. If the embryo or fetus does not have a moral status, it should be permissible to destroy an embryo or abort a fetus for any reason. In this way, paradoxically, allowing testing for diseases, but not for other genes, is eugenic in objectionable ways.”

It would be easy to go from there to saying that genetic testing of embryos and fetuses for the purpose of selecting who will be allowed to be born should not be done based on the principle of the value of all human lives underlies our rejection of eugenics, but he does not go that direction. Instead he moves toward the permissibility of all embryonic and fetal testing by saying that lifting the restrictions on personal liberty imposed by limiting genetic testing of embryos and fetuses to testing for disease would resolve the moral objection that the current policy involves morally impermissible eugenics. He gets there by saying that since most people already accept the testing of embryos and fetuses for diseases, we should not say that all such selective testing is wrong based on the moral status of embryos and fetuses and the way to validate people’s acceptance of testing for diseases is to allow testing for non-disease characteristics.

Savulescu’s means of getting to his conclusion is an interesting and commonly used one to justify things that have previously been understood to be wrong. Rather than giving arguments for why we should believe that a human embryo or fetus does or does not have full moral status, he says we have already accepted a limited practice that would otherwise have been considered immoral, so we should accept a broader version of the same sort of practice. This is the process by which immoral behavior takes over a society, and also the process by which an individual falls into immorality. First justify a very limited violation of morality, and then once that is accepted use that to justify further immorality.
That is why we need to stand firm on basic moral values such as the dignity and value of every human life. Defending the moral status of the weakest and most defenseless human beings is essential to avoid the acceptance of things like aborting fetuses because they are female that currently seem obviously wrong, but may become accepted by a gradual breakdown of moral values.

Do doctors make you sick?

It seems the doctor’s role has changed in the past 50 years. At one time, doctors saw sick people and helped to make them well. They still do that, of course, but now their role has expanded: they see well people and help to make them sick.

That, at least, is the contention of Dartmouth professor of medicine H. Gilbert Welch, who wrote in a short, incisive op-ed piece in the New York Times this week about our obsession with early diagnosis as preventive medicine. He writes, “The basic strategy behind early diagnosis is to encourage the well to get examined — to determine if they are not, in fact, sick. But is looking hard for things to be wrong a good way to promote health? The truth is, the fastest way to get heart disease, autism, glaucoma, diabetes, vascular problems, osteoporosis or cancer … is to be screened for it.”

He continues, “Screening the apparently healthy potentially saves a few lives (although the National Cancer Institute couldn’t find any evidence for this in its recent large studies of prostate and ovarian cancer screening). But it definitely drags many others into the system needlessly — into needless appointments, needless tests, needless drugs and needless operations (not to mention all the accompanying needless insurance forms).

“This process doesn’t promote health; it promotes disease. People suffer from more anxiety about their health, from drug side effects, from complications of surgery. A few die. And remember: these people felt fine when they entered the health care system.”

Welch doesn’t think that early diagnosis is always a bad thing, just that it leads in too many cases to overdiagnosis and overtreatment. I think he’s right, and there are several characteristics of our current medical milieu that will tend to make the problem worse. Consider the following:

1. The World Health Organization’s definition of health is “ a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.” Under that breathtaking definition, everybody is sick, and every aspect of life comes under the purview of the health care provider. To the degree that we buy into this definition, we feed into the tendency towards “diseasification” of which Welch writes.

2. You ain’t seen nothin’ yet. As genomic sequencing proliferates, we are finding that you don’t have to tunnel very far into one’s DNA to discover that everybody has significant genetic dispositions towards one or more dread diseases. We already see patients worried sick believing that, because they have high cholesterol, they have a disease, when what they really have is a risk factor for a disease. Combine the tendency to equate risk factor with disease, people’s belief that genetic information is somehow more determinative than other types of information, and the messiness of our genes, and even the healthiest among us will have excuse to view themselves as cripples.

There are different kinds of “Preventive medicine.” One is worry-based: I worry about whether I have or might get a disease, I get screened for everything, and I can’t be thankful for the health that I do enjoy because anxiety is my constant companion. The other type involves getting some exercise, eating a reasonable diet, and making time for decent rest. It’s characterized more by thankfulness than worry, and has a better chance of improving our lives: for, as a wise Physician once said, “Can any of you by worrying add a single hour to your life?”

 

The ethics of PSA testing

 

The humble little PSA test has become a hot-button ethical issue.

The PSA (prostate-specific antigen) test is a blood test that can detect prostate cancer at an earlier stage than can physical exam. It is not a perfect test; it misses about 25% of cancers. But it is the best thing we have for detecting prostate cancer early.

The United States Preventive Services Task Force (USPSTF) reviews all of the available evidence regarding screening tests for various conditions, and makes recommendations based on the scientific evidence. Earlier this month, the USPSTF posted a draft of its update to its 2008 prostate cancer screening guidelines. The earlier guidelines had recommended that men over 75 not be screened with a PSA test, and said that there wasn’t enough evidence to make a recommendation one way or the other for younger men. The proposed new guidelines, based on more recent studies, go further, giving screening a “D” recommendation, which means that there is moderate or high certainty that the service has no net benefit, or that the harms outweigh the benefits, and the task force discourages use of the service.

But how can a PSA cause harm? It’s just a poke in the arm, right?

It is not the test itself that causes harm, but what we do with it. 90% of men with PSA-detected prostate cancer undergo radiation and/or surgical treatments that have considerable risks and side effects. The chair of the USPSTF said that for every 1,000 men treated for prostate cancer, five die of perioperative complications; 10-70 suffer significant complications but survive; and 200-300 suffer long-term problems, including urinary incontinence, impotence or both.

These numbers might be acceptable if there were evidence that treating early prostate cancer did some good. But, counterintuitive as it may seem, studies have shown little if any positive benefit from treating prostate cancer early. When men diagnosed and treated by PSA screening are compared with those who are not treated, there is virtually no reduction in prostate cancer mortality at 10 years.

J. A. Muir Gray wrote, “All screening programmes do harm; some do good as well.”

For a profession that takes seriously Primum non nocere, “FIrst, do no harm,” it seems, with what we know at the present time, that this particular screening test may contravene our first ethical principle.