Monday, September 15, 2014

Preventing overdiagnosis: conference (#PODC2014) and Public Citizen

A year ago, I was fortunate enough to attend the first Preventing Overdiagnosis conference in Dartmouth, New Hampshire. This annual worldwide gathering of researchers, clinicians, and laypersons aims to explore the increasing problem of overdiagnosis in modern medicine and propose strategies to restrict the identification and treatment of disease to those persons who stand to benefit, rather than others in whom unnecessary diagnosis will only lead to harm. Prostate cancer is the "poster child" for overdiagnosis, a condition that I've compared in the past to an epidemic of snipers on rooftops where aggressive efforts to "disarm the sniper" often result in devastating consequences for men who would have otherwise died with, rather than of, the condition.

The second Preventing Overdiagnosis conference in Oxford, UK began today and continues through Wednesday, September 17th. Although I didn't make it this year, I plan to follow the scientific sessions on Twitter (hashtag #PODC2014) and encourage readers to do so as well.

Speaking of overdiagnosis, my colleagues at Public Citizen have recently taken aim at direct-to-consumer cardiovascular screenings offered at 20 hospitals and medical institutions in conjunction with HealthFair, a for-profit company that provides echocardiography, electrocardiography, abdominal ultrasonography, carotid ultrasonography to all comers. As Public Citizen's experts pointed out in letters to the Federal Trade Commission, the Joint Commission, and involved hospitals and institutions, no credible medical organization supports indiscriminately providing these tests to asymptomatic patients, since they are likely to cause more harm than good by producing false positive results or leading to interventions for conditions that would not otherwise produce clinical symptoms (in other words, overdiagnosis). In fact, the U.S. Preventive Services Task Force and several primary care and cardiology groups involved in the American Board of Internal Medicine Foundation's Choosing Wisely campaign recommend against performing many of these tests.

Kudos to the organizers and participants in this year's Preventing Overdiagnosis conference, and to Drs. Michael Carome and Sidney Wolfe at Public Citizen, for their commendable efforts to protect patients from the harms of overtesting, overdiagnosis, and overtreatment.

Monday, September 8, 2014

Why are doctors still prescribing bed rest in pregnancy?

Maternity care providers have traditionally prescribed "bed rest," or activity restriction, for a host of pregnancy complications (including preterm contractions, short cervix, multiple gestation, and preeclampsia) despite evidence that it does not improve maternal or neonatal outcomes. On the other hand, prolonged activity restriction in pregnancy increases risk for muscle atrophy, bone loss, thromboembolic events, and gestational diabetes. Although it did not include this practice in its Choosing Wisely "Five Things Physicians and Patients Should Question" list, the Society of Maternal and Fetal Medicine (SMFM) recently published a strongly worded position paper recommending against activity restriction in pregnancy for any reason.

This isn't the first time reviewers have examined the evidence for activity restriction and found it lacking; a 2013 summary of several Cochrane reviews of therapeutic bed rest in pregnancy also found such poor data to support the practice that the authors concluded its use should be considered unethical outside of the context of a randomized controlled trial.

The message isn't getting through to physicians or patients, though. A 2009 survey of SMFM members found that 71 percent would recommend bed rest to patients with arrested preterm labor, and 87 percent would advise bed rest for patients with preterm premature rupture of membranes at 26 weeks gestation, even though most of them did not believe it would make make any difference in the outcome (the most common answers were "minimal benefit" and "minimal risk"). Unfortunately, the risk may be more than minimal. Not only does activity restriction expose pregnant women to harm, a secondary analysis of a randomized trial of preterm birth prevention found that nulliparous women with short cervices whose activity was restricted were actually more likely to deliver before 37 weeks' gestation than those who were not.

Similarly, a search of the terms "bed rest" on popular pregnancy websites Babyzone and yielded the following statements that fly in the face of evidence: "Changing the force of gravity usually helps minimize preterm labor." "It [bed rest] helps keep blood pressure stable and low." "In most cases, bed rest is used to help the body have the best chance to normalize." A handout on WebMD provided a more balanced assessment:

Bed rest has been a way of treating pregnancy complications for more than a hundred years. But there's a problem. While bed rest is a common treatment, there's no proof that it helps. It doesn't seem to protect your health or your baby's. In fact, bed rest has risks itself. Doctors still prescribe it, but more because of tradition than good evidence that it works.

The handout went on to advise patients to question their physicians closely or get a second opinion if bed rest is recommended. That's sensible advice. Doctors who are reluctant to abandon this useless and potentially harmful maternity practice should consult the SMFM paper or the American Family Physician By Topic collections on Prenatal Care and Labor, Delivery, and Postpartum Issues, where no articles recommend activity restriction for pregnancy complications.


This post first appeared on the AFP Community Blog.

Thursday, September 4, 2014

PSA screening for prostate cancer: a bad idea then and now

Few scientists have been fortunate enough to make a single discovery that ultimately revolutionized the practice of medicine. So one might expect Dr. Richard Ablin, who identified prostate-specific antigen (PSA) more than forty years ago, to take satisfaction in the way his accomplishment has transformed the field of urology and the way clinicians detect and treat prostate cancer in the twenty-first century. A study published last week in JAMA Internal Medicine found that even though three major guidelines – from the U.S. Preventive Services Task Force (USPSTF), the American College of Physicians, and the American Urological Association  raise serious concerns about the PSA test's effectiveness and adverse effects, nearly one-half of all men between the ages of 65 and 74 reported being screened with the PSA test within the previous 12 months.

But after reading Dr. Ablin's 2010 New York Times editorial, "The Great Prostate Mistake," and his revelatory followup book, The Great Prostate Hoax, I think he probably feels that the world would have been better off if PSA had remained undiscovered  or, at least, if his discovery had not been so shamelessly exploited by the medical-industrial complex to cause erectile dysfunction and urinary incontinence in a generation of terrified men who had surgery for screen-detected prostate cancers that otherwise would not have bothered them at all.

As longtime readers know, I played a minor role in this saga. Dr. Ablin mentions me on page 174 of his book, during his recap of the excruciating delay between the USPSTF's initial (and unanimous) vote to recommend against PSA screening and the final publication of that report:

According to Michael L. LeFevre, MD, the vice chairman of the task force that issued the [2012 USPSTF] report, in 2009 he and his fellow panel members had voted to recommended against PSA testing, but knowing they would have to defend themselves against the inevitable firestorm of criticism – from the AUA and advocacy groups – they slowed the process down, issuing their recommendation three years later in 2012. … 

Kenneth Lin, a central researcher on the PSA review panel, resigned in protest. How many men might have been spared an unnecessary life-changing radical prostatectomy during that delay? ... LeFevre’s admission speaks to the culture of fear promulgated by the prostate cancer industry. And in this case the industry won. Between 2009 and 2012, it obtained a three-year window of opportunity during which more than 3 million more men had painful needle biopsies and about 300,000 of those men needlessly had their prostate glands cut out of their bodies.

It wasn't just the "prostate cancer industry" that was supplying fear and pressure. After being thrown under the bus by the Obama administration when the furor over downgrading its recommendation on breast cancer screening for women in their 40s threatened to derail the Affordable Care Act, USPSTF members weren't convinced that they could count on the Department of Health and Human Services to protect them from prostate cancer fallout less than a year later. They were right to worry. In October 2010, my boss at the Agency for Healthcare Research and Quality received explicit instructions from the White House to call off the Task Force's November meeting (where prostate cancer screening would be reconsidered). With no good options, Dr. Ned Calonge, the outgoing Chair, decided to cancel the meeting himself, allowing the USPSTF to save face and not be pigeonholed as a partisan panel that only produced scientific statements supportive of the administration's goals (which, to my jaded eye, boiled down to extolling the benefits of "free" screenings and downplaying or shelving inconvenient evidence of harm).

Today, Dr. Ablin is hardly alone in calling for an end to PSA screening for prostate cancer. Dr. Vinay Prasad, who has written widely about medical reversals, recently chimed in with "It Is Time To Stop Screening for Prostate Cancer," where he observed that "the history of the PSA test will one day serve as a reminder that, although all of us in health care want to do everything possible to reduce the mortality of cancer, the early adoption of screening techniques on the basis of insufficient evidence can lead to more harm than good." I could not agree more. PSA screening is a tragedy born from physicians' good intentions. It was a bad idea when it began in the evidence-free world of the early 1990s, and it continues to do far more harm than good to older men today.

Thursday, August 28, 2014

In U.S. and U.K., statin debate goes on

As previewed in a previous blog post, the August 15th issue of American Family Physician features a concise summary of the American College of Cardiology / American Heart Association updated cholesterol treatment guideline. Key points include an expansion of the role of statins in the primary prevention of atherosclerotic cardiovascular disease (ASCVD); elimination of specific low-density lipoprotein cholesterol (LDL-C) target levels; and a new tool for assessing of 10-year and lifetime risk for ASCVD. An accompanying POEM notes that full implementation of the new guideline would increase the number of U.S. adults eligible to take statins by nearly 13 million, with the percentage of adults 60 to 75 years of age for whom statins are recommended rising from 47.8% to 77.3%.

Two editorials in the same issue further explore the implications of the new guideline. Writing for the members of the guideline panel, Dr. Patrick McBride and colleagues emphasize that the recommendations are largely based on high-quality evidence from randomized controlled trials that measured patient-oriented outcomes. They argue that "these changes should simplify the approach to clinical practice by reducing titration of medication, the addition of other medications, and the frequency of follow-up laboratory testing." In a second editorial, Dr. Rodney Hayward concurs with the panel's decision to abandon LDL-C targets, but disagrees with setting a universal 10-year ASCVD risk threshold of 7.5% for treatment with a statin:

My biggest criticism of the new guideline is that it does not acknowledge a specific gray zone—a range in which the potential benefits and harms of a statin make the “right decision” predominantly a matter of individual patient circumstances and preferences. It may be reasonable to set 7.5% as a starting point for discussion (e.g., for every 33 patients treated for 10 years, roughly one heart attack will be prevented [i.e., number needed to treat = 33]). But these risks and benefits are estimates with a nontrivial margin of error. The guideline does note that shared decision making should be used, but it provides no clear direction on when statins should be recommended rather than just discussed.

A similar debate is taking place in the United Kingdom, where its National Institute for Health and Care Excellence (NICE) recently recommended offering a statin to all persons with a 10-year cardiovascular event risk of 10% or more. An editorial in BMJ observed that doctors need better shared decision making tools to help patients understand the tradeoffs involved in taking medications that have potentially large population health benefits but are unlikely to prevent a bad outcome in an individual patient:

Doctors are unlikely to start giving patients clear numerical information simply because they are told to do so. They might do so if NICE can recommend information tools with the same force as when it recommends drugs, and if it becomes as easy to give contextual numerical advice as it is to print a prescription. ... We will need better data, from bigger trials, and better risk communication than for conventional medical treatment. ... Without such innovation in the use of medical data, we can say only that statins are—broadly speaking—likely to do more good than harm. That is not good enough.

If you are a clinician reading this, have you already integrated the ACC/AHA or NICE cholesterol guideline into your practice? If so, how do you decide whether to "recommend" versus "discuss" statins with patients? If not, what reservations or workflow issues have stopped you from transitioning to the new guidelines?


This post first appeared on the AFP Community Blog.

Monday, August 25, 2014

Don't do stupid sh*t in cancer screening

The electronic medical record that my office uses features a clinical protocol button that we are encouraged to click during patient visits to remind us about potentially indicated preventive services, such as obesity and tobacco counseling and cancer screenings. I once tried it out while seeing a 90 year-old with four chronic health problems. The computer suggested breast cancer, colorectal cancer, and cervical cancer screenings - three totally inappropriate tests for the patient.

At the residency program where I precept one afternoon a week, we recently held a "chart rounds" on an elderly patient with advanced dementia: when should you stop cancer screening? The answer boils down to the patient's predicted life expectancy compared to the number of years needed for a patient to benefit from a test. Although forecasting how long someone has left to live is not a precise science, knowing averages is essential to deciding if the inconvenience, expense, and potential adverse effects of screening (and treatment, if an abnormality is discovered) can be justified by the potential benefit. Since advanced dementia is a terminal disease, with more than half of nursing home residents in a National Institutes of Health-sponsored study dying within 18 months, there is virtually zero chance that a patient with this condition would benefit from cancer screening of any type. The same statement applies to a healthy 90 year-old in the U.S., who is expected to live around 4-5 more years.

But as one might expect in our crazy health non-system, cancer screening in patients with limited life expectancies happens all the time. A study published last week in JAMA Internal Medicine found that one-third to one-half of surveyed Americans with a 9-year mortality risk of more than 75 percent reported receiving recent cancer screenings. 55% of men in this group had knowingly been screened for prostate cancer within the previous 2 years - a test that, if it works at all, requires a decade to show a mortality benefit. (Nonetheless, my late father-in-law, who passed away at age 75 from chronic obstructive pulmonary disease, faithfully went in for annual PSA tests up until the year of his death.)

Aside from making me want to pull my hair out (or turning even more of it prematurely gray), reading this study's findings brought to mind President Obama's much-mocked second-term foreign policy doctrine: "Don't do stupid sh*t." I agree with former Secretary of State Hillary Clinton that this pithy four-word directive ending with a four-letter word shouldn't be an organizing principle for foreign policy, health policy, or any national policy. But as an antidote to the ubiquitous practice of too much medicine, it could be be a useful starting point: Don't do stupid sh*t in cancer screening. Think twice before reflexively doing things to elderly patients that can't possibly help and, therefore, can only hurt. And keep in mind that electronic clinical decision support should never, ever substitute for a physician's brain.

Wednesday, August 13, 2014

The problem of pain

My patients lie to me every day. Some tell me that they have been taking their medications regularly when they haven't. Some say that they have been eating a healthy diet and exercising for at least 30 minutes every day and don't know where the extra pounds are coming from. Some lie that they are using condoms every time they have sex, that they have quit smoking, and if they drink alcohol at all, it's only a single glass of wine with dinner. They bend the truth for many reasons: because they want to please their doctor, because they don't like to admit lapses of willpower, or because they are embarrassed to tell me that they can't afford to pay for their medications. I forgive them; it's part of my job to understand that patients (and health professionals) are only human. The only lies that I find hard to forgive are the lies about pain.

Like many doctors, I have complicated feelings about prescribing for chronic pain. On one hand, I recognize that relieving headaches, backaches, arthritis and nerve pain has been a core responsibility of the medical profession for ages. On the other hand, deaths and emergency room visits from overdoses of prescription painkillers have skyrocketed over the past 25 years, and I have inherited many patients with narcotic addictions that resulted from a prior physician's well-intentioned generosity with his prescription pad.

Even worse, I've had patients I trusted turn out to be junkies in need of a fix. An earnest, well-dressed young man once came to my office complaining of a common chronic condition that, he said, had not been relieved by high doses of over-the-counter painkillers. He convinced me to to prescribe him narcotic pills, and didn't bat an eye when I asked him to sign a pain contract that required him to return every month for refills and only receive prescriptions from me in person. For the better part of a year, he never missed an appointment, and seemed genuinely receptive to unrelated preventive care that I recommended based on his age and risk factors. His deceit was exposed only after he stumbled, intoxicated, into an acute care facility staffed by a doctor who knew me and requested an early refill of a prescription for a different brand of painkillers prescribed by a third doctor for another imaginary condition. My colleague told him the gig was up, and I've never seen him again.

I believe that drug addiction is a disease. So why do I find this patient's lies (and those from others like him) so hard to forgive? Because they have consequences for people who are truly in pain. For patients' convenience, I transmit virtually all prescriptions electronically to the pharmacy, but I'm not allowed to do this with "controlled substances" such as painkillers. Wary of encouraging drug abuse, some insurers impose arbitrary limits on the number of pills a patient may be prescribed in one month, which I can only override by spending hours on the phone or not at all. One chain pharmacy recently started demanding signed copies of chart notes that included the pain-causing diagnosis before they would dispense painkillers (a practice that I believe to be an illegal invasion of privacy, but they didn't budge an inch when I told them so). And worst of all, doctors like me who have been burned before are that much more likely to view our patients with suspicion.

In the July issue of Health Affairs, Janice Schuster described a health odyssey that began with a seemingly minor surgical procedure and ended with her becoming "one of the estimated 100 million American adults who live with chronic pain" - in this case neuropathic pain, or pain from nerve damage that in my experience can be the most difficult type to treat. She wrote about how health system restrictions designed to discourage abuse created obstacles to her obtaining adequate pain relief, and about a lack of compassion from her primary care physician (who "dismissed my symptoms") and her surgeon (who "said again and again that he had not heard of a patient experiencing such pain"). As the author of a popular self-help book for persons facing serious illness, Schuster understood better than most the public health crisis posed by prescription painkillers, but that understanding offered little consolation as she navigated "the maze of pain management" that has evolved to deal with it:

Pain patients like me often feel trapped between the clinical need to treat and manage pain and the social imperative to restrict access to such drugs and promote public safety. ... When I am not overwhelmed by pain, or depressed by it, I am furious at the attitudes I encounter, especially among physicians and pharmacists. It has been stigmatizing and humiliating. ... Surely, we can find better ways to ease the suffering and devise treatments and strategies that do more good than harm and that do not shame and stigmatize those who suffer.

A few of my colleagues have become so disillusioned with the dilemmas of pain management that they have sworn off prescribing narcotic painkillers entirely. As often as I've been tempted to take that path, I won't abandon patients in pain, for whom the services of caring and competent family physicians are needed now more than ever.