Category: Outpatient Practice

Next year will be the 80th anniversary of the first description of idiopathic pulmonary fibrosis (IPF). It will also mark 40 years since I graduated from medical school. I spent most of those 40 years specializing in the management of patients with IPF and there have been enormous strides forward in those 40 years. This post will look back on where we have been, where we are now, and where we are going with respect to treating IPF.

First, some definitions.

Interstitial lung diseases are characterized by the accumulation of inflammation or scar or both in the lungs. There are at least 140 different interstitial lung diseases. Pulmonary fibrosis means accumulation of scar in the lungs and many of the interstitial lung diseases can result in pulmonary fibrosis. For most of these, the cause is known, such as rheumatoid arthritis-associated pulmonary fibrosis, radiation-induced pulmonary fibrosis, and asbestosis. Idiopathic pulmonary fibrosis (IPF) is when pulmonary fibrosis occurs without any known underlying cause (“idiopathic” means no obvious cause).

Usual interstitial pneumonitis (UIP) is a pattern of findings on either a chest CT scan or a lung biopsy that is typically seen in idiopathic pulmonary fibrosis. However, the UIP pattern can also be seen in other interstitial lung diseases. For this reason, the radiologist and the pathologist generally do not diagnose idiopathic pulmonary fibrosis – it is up to the pulmonologist who is seeing the patient to diagnose idiopathic pulmonary fibrosis by taking the radiologist’s or pathologist’s finding of UIP in the context of the patient’s history, physical exam, and laboratory test results.

The historical timeline of IPF

There is no one person who discovered idiopathic pulmonary fibrosis. Instead, there has been an evolution of thought about IPF over the past century. Some of the more important points in the timeline of IPF are:

• 1944. The first clinical description of idiopathic pulmonary fibrosis is credited to Drs. Hamman and Rich from Johns Hopkins in 1944 in their description of 4 patients with interstitial lung disease of uncertain cause. Although the term “Hamman-Rich syndrome” became used as a catch-all term for many interstitial lung diseases (including idiopathic pulmonary fibrosis), their 4 patients likely had acute interstitial pneumonitis, which is a different disease.
• 1962. Dr. Gross suggested that there were two forms of Hamman-Rich syndrome: an acute form and a chronic form. This article laid the foundation for IPF as a distinct disease (the chronic form).
• 1964. Dr. Scadding from the United Kingdom proposed using the term cryptogenic fibrosing alveolitis for the chronic form of Hamman-Rich syndrome. For many years, cryptogenic fibrosing alveolitis was synonymous with idiopathic pulmonary fibrosis.
• 1969. Drs. Leibow and Carrington described 5 histologic subgroups of “chronic idiopathic interstitial pneumonia”, one of which was usual interstitial pneumonitis (UIP).
• 1976. Researchers at the National Institutes of Health, led by Dr. Crystal, proposed that idiopathic pulmonary fibrosis initiates as inflammation in the alveoli of the lungs that later progresses to fibrosis. The basis of this proposed mechanism was the findings of increased inflammatory cells in bronchoalveolar lavage fluid obtained from bronchoscopies performed on patients with IPF.
• 1998. Drs. Katzenstein and Myers proposed that usual interstitial pneumonitis is the lung biopsy finding that occurs in idiopathic pulmonary fibrosis. They determined that the disease is due to excessive fibrosis (scar) and that there is little inflammation.
• 2001. Dr. Hunninghake and colleagues determined that IPF can be often be diagnosed by the finding of usual interstitial pneumonitis on the chest CT scan, allowing some patients to avoid undergoing a lung biopsy.

What causes idiopathic pulmonary fibrosis?

In 2023, idiopathic pulmonary fibrosis is less idiopathic than it was in the past. IPF can be currently thought of as an auto-fibrotic lung disease due to a combination of inherited genes and environmental factors. An “auto-immune” disease occurs when the body’s immune system turns against itself, such as in systemic lupus erythematosis. An “auto-inflammatory” disease occurs when the body’s inflammatory system turns against itself, such as in the VEXAS syndrome. An “auto-fibrotic” disease is when the body’s scarring system turns against itself. Scar results when wounds heal and as such, auto-fibrotic diseases can be thought of as disorders of uncontrolled wound healing.

There is not one single gene that is responsible for idiopathic pulmonary fibrosis but rather there are many genes that can predispose a person to develop IPF. These genes vary in terms of how strongly they predispose IPF. For example, people with abnormal telomerase genes have a very high risk for developing IPF whereas those with an abnormal MUC5B gene have an increased risk of developing IPF that is not as great as with abnormal telomerase genes. For all of these genes, environmental injury to the lungs significantly increases the chance that a person will ultimately develop IPF. The most common cause of environmental injury is tobacco smoking but respiratory viruses, work-related dust inhalation, air pollution, and chronic gastroesophageal reflux can also increase the chance that a person with an abnormal gene will develop IPF.

How do we know if a drug for IPF works?

The only way to know if a drug against any disease works is by scientific research. But some types of scientific research are more convincing than others. Here are the common categories of research that physicians look at when determining a drug’s effectiveness.

• Case reports. These are usually publications of one or two patients who appeared to respond to some type of treatment. Case reports are the weakest evidence of a drug’s effectiveness but they can be the justification for doing additional future research about a drug.
• Case series. These are publications of numerous patients treated with a drug. Although they can provide stronger evidence than a case reports, they are still overall fairly weak. These are often called “retrospective reviews” meaning that a physician is looking back (retrospective) over a group of patients that the physician has managed in the past.
• Open-label clinical trial. This is when a researcher deliberately gives a group of patients a drug and tracks how they respond to it. There will generally be a specific test that the researcher performs to see if the drug has an impact, for example, by performing pulmonary function tests. When a clinical trial is “open-label”, it means that the researcher and the patients know whether or not they are getting the drug. However, this knowledge can lead to bias by either the patients or the researcher who may want to think that the drug is working, even if it is not.
• Randomized, double-blind, placebo-controlled clinical trial. These provide the strongest evidence that a drug is effective. Patients are randomly assigned to either receive the drug or a placebo and neither the patients nor the researchers know if a particular patient got the drug or got the placebo. In order for these studies to be statistically significant, the studies have to have a large number of patients, typically in the hundreds or thousands.

There are three “phases” of clinical trials of new drugs. The FDA will grant approval if the final phase of a clinical trial shows a statistically significant benefit of the drug without severe side effects.

• Phase 1 trials. These involve a small number of patients and are usually open-label and of short duration. The researchers are primarily interested in drug safety and side effects. Several doses of the drug will be tested in order to find the safest doses and how frequently the drug should be given.
• Phase 2 trials. These involve a larger number of patients who are randomized to receive either the drug or a placebo. During phase 2, the researchers will determine if the drug holds the possibility of being effective and will determine the best dose of the drug to use in the next phase.
• Phase 3 trials. These involve very large numbers of patients – IPF trials typically require more than a thousand subjects. There are usually many hospitals (study sites) involved from multiple states and often from multiple countries. Patients are randomized to receive placebo or the drug and are tested regularly to determine if the drug is effective compared to placebo. Most IPF phase 3 trials require each subject to participate for 1 – 2 years.

IPF treatment over the years

Prior to 2014, there were no drugs that were approved by the FDA to treat idiopathic pulmonary fibrosis. Therefore, physicians used drugs that were approved for other diseases that were already available on the market. This is called “off-label” use of these drugs. Over time, researchers performed clinical trials to determine if these off-label drugs were actually effective and pharmaceutical companies developed new drugs to test in clinical trials. Clinical trials are expensive to perform and most of the clinical trials involving off-label drugs were funded by federal grants from the National Institutes of Health. Clinical trials of newly created drugs are generally funded by pharmaceutical companies. There has been a steady evolution in the treatment of IPF:

• 1970’s – The prevailing belief about the cause of IPF was abnormal inflammation resulting in alveolitis. Thus, the drugs most commonly used to treat IPF were anti-inflammatory drugs, such as the corticosteroid, prednisone. There were no clinical trials to determine the best dose or whether corticosteroids even worked at all.
• 1980’s – After years of watching patients fail to improve with corticosteroids, physicians turned to a more powerful anti-inflammatory drug, cyclophosphamide (Cytoxan) based on case reports and retrospective case series. Cytoxan was largely used as a chemotherapy drug to treat cancer but was also being used to treat auto-immune diseases such as systemic lupus erythematosus (aka, SLE)  and granulomatosis with angiitis (aka, Wegener’s granulomatosis). A problem with Cytoxan is that it was very toxic and patients frequently developed low white blood cell counts, bladder hemorrhaging, and bladder cancer.
• 1990’s – After years of dealing with Cytoxan’s side effects, physicians looked to a different drug that was slightly less powerful as an anti-inflammatory drug but had much fewer complications. That drug was azathioprine, or Imuran. This was often given along with the corticosteroid, prednisone. A third drug as also frequently added: N-acetylcysteine (NAC). Because NAC has very few side effects and is available over-the-counter, it was seen as being fairly innocuous and possibly beneficial due to it’s anti-oxidant properties.
• 2000’s – A phase 3 study of azathioprine, prednisone, and NAC found that these drugs were not helpful in IPF and if anything, patients who took them did worse than patients who got the placebo. A small study suggested that gamma interferon might be beneficial and so physicians turned to the off-label use of gamma interferon that was already approved by the FDA for use in a rare condition called chronic granulomatous disease.
• 2010’s – A phase 3 study of gamma interferon showed that it was ineffective in IPF and thus physicians stopped using it. In 2014, large phase 3 trials found that the anti-fibrotic drugs pirfenidone and nintedanib were both effective in IPF, resulting in the FDA approving their use. Presently, these are the only drugs approved for IPF in the U.S. and are considered the current standard of care.

The past 3 decades are littered with drugs that initially held promise but were shown in clinical trials to be ineffective in IPF. A list of the most prominent of these drugs is below:

Current IPF treatment

Pirfenidone and nintedanib have both been shown to slow the progression of IPF compared to placebo, however they do not stop or cure the disease. Think of them as slowing the progression of IPF from 60 miles per hour down to 30 miles per hour. The patients will still ultimately get worse but just more slowly. There has not been a head-to-head comparison of the two drugs but the available evidence suggests that both are equally effective. The choice of which drug to prescribe is generally based on the personal preference of the physician and the patient. These preferences are most commonly based on the differing side effect profiles of the two drugs: pirfenidone cause cause skin rash and sun-sensitivity, nintedanib can cause diarrhea. The drugs also differ in drug-drug interactions – for example, nintedanib interacts with anticoagulants whereas pirfenidone interacts with ciprofloxacin.

Lung transplant is the only curative treatment for IPF. In the U.S., IPF is now the most common indication for lung transplant, accounting for 37%. Not all patients with IPF are eligible for transplant, however. The decision of eligibility is made by each hospital’s transplant team and limiting factors can include active tobacco use, obesity, older age, deconditioning, and presence of other concurrent diseases. Moreover, transplant comes with it’s own risks – 15% of patients with IPF die in the first 12 months after transplant and of those who survive the first 12 months, only 67% are still alive 5 years after transplant. However, post-transplant care is improving and survival rates are expected to improve in the future.

In addition to anti-fibrotic medications and lung transplant, there are other interventions that have been shown to be useful in patients with idiopathic pulmonary fibrosis. Oxygen is effective in improving the quality of life of patients with IPF. It can reduce shortness of breath, improve ability to exercise, and facilitate travel. Pulmonary rehabilitation is also effective in improving quality of life and should be considered for all IPF patients with shortness of breath or exercise limitation. Patients with IPF are at increased risk of obstructive sleep apnea and physicians should have a low threshold for performing sleep studies and prescribing CPAP when indicated. Although treating asymptomatic patients with proton pump inhibitors is ineffective in IPF, whose with symptoms of gastroesphageal reflux should be treated in order to reduce on-going lung injury. Patients with large hiatal hernias may benefit by surgical repair if they are able to tolerate surgery. Smoking cessation is essential to stop on-going lung injury, improve quality of life, and make patients eligible for lung transplant. All patients with IPF should be vaccinated to prevent pneumococcal pneumonia, influenza, respiratory syncytial virus (RSV) and COVID. Patients with IPF are at higher risk of death from respiratory infections and even if they survive the infection, it can result in additional lung injury that can accelerate the progression of IPF. During the first 12 months of the pandemic, 5% of my outpatients with interstitial lung disease died from a COVID infection due to their greater susceptibility.

Although cure of IPF is not yet possible (other than with transplant), it appears that our current treatment approach is making a difference. A recent study from Italy compared patients with IPF over a 15-year period from 2002 to 2016. Over this time, there was an increase in life expectancy, decrease in the rate of hospitalization, and decrease in the rate of acute exacerbations. Correlated with these improved outcomes was an increase in the use of anti-fibrotic drugs (pirfenidone and nintedanib), decrease in the use of anti-inflammatory drugs (corticosteroids, cyclophosphamide, and azathioprine), and increase in the use of bronchoscopic cryobiopsies as opposed to the more invasive surgical lung biopsies.

The future of IPF treatment

Prior to the FDA approval of pirfenidone and nintedanib, most IPF clinical trials compared a promising drug to placebo. Now that pirfenidone and nintedanib are the accepted standard of care, future trials have to either compare new drugs to pirfenidone and nintedanib or have to compare new drugs to placebo in patients who are already taking pirfenidone or nintedanib. Performing clinical trials in IPF is complicated for a number of reasons:

• The heterogeneity of IPF makes trial design difficult. Given that there are multiple predisposing genes involved in IPF and given that there are multiple environmental risks for IPF, no two patients with IPF are exactly alike and treatments that work for one patient may not work for another.
• Mortality cannot be used as an endpoint. The current average survival of a patient with IPF is 5.5 years based on the Italian study. If researchers were to use death as the endpoint in a clinical trial, that trial would have to last for a decade or more in order to recruit a sufficient number of patients and follow them until death. This is too long of a length of time to realistically perform a clinical trial.
• Pulmonary function tests are currently the best outcome measure for IPF clinical trials. We use change in the forced vital capacity and diffusing capacity as markers of the progression of IPF. Although this is appealing from a logical standpoint, PFT changes may not necessarily correlate with life expectancy. But for now, PFTs are the best that we have.
• To be statistically significant, trials must include hundreds of patients. The CAPACITY and ASCEND studies that led to approval of pirfenidone enrolled 1,247 subjects. The IMPULSIS studies that led to the approval of nintedanib enrolled 1,066 subjects. To recruit this many subjects, many study sites are required – the IMPULSIS studies required 205 hospital locations in 24 countries, the CAPACITY studies required 110 hospital locations in 13 countries, and the ASCEND study required 127 hospital locations in 9 countries.  Because future trials will need to incorporate multiple treatment arms including those taking pirfenidone, those taking nintedanib, and those taking neither, the number of subjects in future trials will need to be even larger than in previous IPF trials.
• Clinical trials are costly. The average cost to bring a new drug to market, from initial drug discovery to FDA approval is $2.3 billion. Consequently, for pharmaceutical companies to recoup their drug development costs, any new drug is expensive and IPF drugs are no exception. The retail price of pirfenidone is $16,000 per month ($2,200 per month if using coupons such as GoodRx) and the retail price of nintedanib is similar.

There are a number of new drugs currently in phase 1 and phase 2 trials and several of these hold early promise to add to our treatment options for IPF patients. Some of the questions likely to be answered in future IPF treatment research include:

• Is combination therapy more effective than mono therapy? Currently, patients receive either pirfenidone or nintedanib but not both. We do not know if the combination of the two be better than either one alone. The same holds for any new drug that is developed – whether it should be given alone or in combination with one of the two currently approved drugs.
• Is inhaled therapy better than oral therapy? Giving drugs to treat lung disease by inhalation is attractive – it offers the possibility of giving relatively high concentrations of the drug directly to the airways with lower concentrations in the blood. This has the potential to reduce systemic side effects while boosting the effect in the lungs.
• What are the chemical pathways involved in fibrosis? At present, it appears that transforming growth factor-β (TGF-β) is a key player in fibrosis development. Drugs that specifically target TGF-β may be effective in slowing fibrosis. Because TGF-β is secreted as inactive form that is converted to an active form by αvβ6 integrin, this molecule is another attractive target for future treatments. We need to identify the other proteins in the body that are involved in fibrosis.
• Are there biomarkers of IPF that would be better to use in clinical trials than changes in pulmonary function tests? In atherosclerosis, we have a great biomarker in the cholesterol level that allows us to determine if a drug is working without having to wait to see whether or not a patient develops a heart attack or stroke. Measurement of biomarkers that are involved in the chemical pathways of fibrosis would allow us to more quickly tell if a drug is working for a particular patient without having to wait months or years to see if there are changes in pulmonary function tests.
• Can genetics direct treatment? The different genes involved in idiopathic pulmonary fibrosis affect different proteins in the body and each of these proteins has a different role in the development of fibrosis. In lung cancer, we use the genetics of a person’s cancer to choose which chemotherapy will be most effective. As we learn more about the genetics of IPF, it is likely that a person’s specific genetic make-up will help us pick the best treatment for that particular individual.
• What is the role of gene therapy? Gene editing is in its infancy in medicine but is already showing great promise in muscular dystrophy and sickle cell anemia. As we learn more about the genes involved in IPF, we may be able to edit those genes, not only in patients with IPF but also potentially in their relatives with the hope of preventing the onset of IPF in the first place. Because IPF only affects the lungs, it is possible that only the genes of lung tissues would need to be edited, for example, by inhalational techniques.

When I first started specializing in treating IPF 35 years ago, it was my hope to see effective treatments arise during my career. Not only do we now have effective treatments but we also know which medications can actually make patients worse. For these reasons, our management of IPF is much better today than ever before. The treatment will be even better yet in the future with translational research that results in taking the word “idiopathic” out of idiopathic pulmonary fibrosis and clinical research to bring us more effective therapies for patients with IPF.

November 14, 2023

One out of every two women will develop a pelvic floor disorder at some point in their life. These disorders usually require physical therapy and often require surgery. So, why don’t we hear more about pelvic floor dysfunction?

The pelvic floor is a hammock-like group of muscles and ligaments that drape across the pelvis and support all of the pelvic organs. If these muscles and ligaments become damaged, then they cannot hold organs in the pelvis (resulting in prolapse) and cannot maintain sphincter control (resulting in incontinence). The most common cause of dysfunction of these muscles and ligaments is pregnancy and childbirth. During pregnancy, the weight of the gravid uterus plus changes in intra-abdominal pressure can stretch the components of the pelvic floor. During delivery, the levator ani muscle, pubococcygeus muscle, and pudendal nerve are all susceptible to stretch injury. In addition, more than half of vaginal deliveries result in vaginal lacerations which can involve the pelvic floor muscles and sphincters.

The frequency of these disorders is shockingly common. At one year after vaginal delivery, 41% of women experience stress urinary incontinence, 32% experience nocturia, 23% experience flatus incontinence, and 9% have some degree of prolapse. Age also affects the pelvic floor with loss of muscle and ligament integrity, particularly after menopause. The Women’s Health Initiative study found that 41% of older women with a uterus have some degree of prolapse.

So, why don’t we hear about it?

Pelvic floor dysfunction is a silent epidemic because all too often, women do not bring it up when seeing their doctor and their doctor does not ask the right questions.

Assumption of normal. Many women just assume that symptomatic pelvic floor dysfunction is just a normal and expected consequence of “everything getting stretched out” during labor and delivery. Because of this assumption of normal, women frequently do not discuss postpartum urinary incontinence, anal incontinence, or vaginal bulges with their doctor.

Patient embarrassment. Many women have a hard time bringing up issues regarding their urination or bowel movements, even with their physician. Some women don’t know enough about normal female pelvic anatomy to tell when their pelvic structures are not quite right.

Doctors do not ask the right questions. Obstetricians are generally good at asking about pelvic floor dysfunction symptoms but primary care physicians and other non-obstetricians frequently are not. Sometimes it is because the primary care physician just assumes that the obstetrician will take care of any problems resulting from pregnancy and sometimes it is because of lack of familiarity with the clinical manifestations of pelvic floor dysfunction. When asking women about pelvic floor dysfunction, we should remember the 3 “B’s”: Bladder, Bowel, and Bulge.

Pelvic floor dysfunction symptoms

The most common serious consequences of pelvic floor dysfunction are incontinence and prolapse. Types of urinary incontinence include stress urinary incontinence, urgency urinary incontinence, and mixed urinary incontinence. Bowel control issues include fecal incontinence, flatus incontinence, and fecal urgency.

Prolapse occurs when a pelvic organ herniates. A cystocele is when the bladder herniates into the anterior vaginal wall. A rectocele is when the rectum herniates into the posterior vaginal wall. And a uterovaginal prolapse is when the cervix and uterus descends into the lower vagina. Prolapse can result in urinary incontinence, constipation, pelvic discomfort, and pain during sexual intercourse.

What can be done about it?

Pelvic floor physical therapy. Fortunately, there are effective treatments that can significantly improve the quality of a woman’s life. This generally starts with pelvic floor physical therapy. This is performed by a specially-trained physical therapist who can teach women exercises to strengthen the pelvic muscles and help restore normal pelvic function. Most notably are Kegel exercises when the pelvic muscles are contracted and then relaxed.

A bit of history about Kegel exercises. If I was to then ask you who invented Kegel exercises, you might say American gynecologist Arnold Henry Kegel who published an article about exercises to strengthen the pelvic floor in the Annals of Western Medicine and Surgery in 1948. But that wouldn’t be exactly right. Instead, we have to go back 12 years earlier when a book was published by a professional dancer named Margaret Morris. She was born in 1891 and began her career as a child actress and ballet dancer. By age 19, she was an internationally known choreographer and theater producer. In her 30’s she opened a dance school and became interested in how movement and posture affected health. So, in 1925, she went to London’s St. Thomas Hospital to study physiotherapy. She further developed her ideas about exercises and health that culminated in her 1936 book titled “Maternity and Post-Operative Exercises”. In her book, she outlined 21 exercises for women to perform that could improve urinary incontinence and other consequences of childbirth. Her book was reviewed in JAMA in 1937 where the reviewer stated that he was: “..satisfied with the soundness of Miss Morris’s scheme and believe that their application will yield most beneficial results.” Dr. Kegel then wrote about her exercises more than a decade later and he now gets all of the credit for Margaret Morris’s pelvic floor exercises.

Other non-surgical treatments. When symptoms persist despite pelvic floor physical therapy, there are other treatment options. Diet and lifestyle measures to reduce urinary incontinence include weight loss, avoidance of excessively large fluid ingestions, and avoiding drinking fluids shortly before bedtime. Pessaries and over-the-counter vaginal inserts can also be useful. Measures to reduce fecal incontinence include dietary soluble fiber (but avoid insoluble fiber), ritualization of bowel movements, and over-the-counter loperamide. Avoidance of caffeine and avoidance of vigorous exercising after meals can also reduce fecal incontinence.

Surgical options. When these measures are ineffective, there are a variety of surgical options. There have been many recent developments in surgical procedures for pelvic floor dysfunction. For example, in the past, uterine prolapse was primarily treated with hysterectomy; however, now there are many uterine-sparing procedures that can be performed. Other new techniques include sacroneuromodulation for fecal incontinence and onobotulinum toxin for urinary urgency incontinence. This is where a urogynecologist can be an invaluable resource. Many larger medical centers have comprehensive subspecialty peripartum pelvic floor disorder clinics overseen by a urogynecologist. Physicians at smaller hospitals that cannot support a full subspecialty clinic should be familiar with regional pelvic floor disorder clinics for referral.

The bottom line: talk with your patients

Given the frequency of pelvic floor dysfunction, it is incumbent on every primary care physician to be familiar with the symptoms and to be willing to speak openly about them with patients. If your hospital has a labor and delivery unit, then it needs a pelvic floor physical therapist. As an emeritus faculty, I’ve been doing some pro bono teaching at the Ohio State University and recently guest-moderated an OSU MedNet webcast on pelvic floor disorders by Dr. Lisa Hickman. This webcast is a great resource for physicians, nurse practitioners, nurse midwives, and physician assistants who need to brush up on the diagnosis and management of pelvic floor dysfunction. You can view the webcast by clicking on this link.

September 20, 2023

Artificial intelligence (AI) is causing a paradigm shift in the education, business, and legal professions. But AI is also poised to irreversibly change the way medicine is practiced. Jobs that traditionally relied on extensive training by memorization may be able to be performed as well (or better) by AI than by humans. Jobs that have relied on image analysis or sound pattern analysis are also at risk of being displaced by AI.

Let me give you an example from my hobby of birdwatching. In the past, bird species identification relied on comparing a bird that you saw in a tree to a drawing or photograph in a bird identification book. To become an expert birder, you needed thousands of hours of birding to identify birds by their calls and by their seasonal plumage. But now, we have the Merlin app. When birding, I can turn on my phone’s microphone and Merlin will identify bird species by bird calls. I can take a photograph of a bird, upload it to the app, and Merlin will tell me what bird I saw. With Merlin, even a novice birder like me can identify birds like a seasoned expert.

So, what if we have the Merlin app equivalent to identify heart sounds by auscultation? Or diagnose a rash by a photograph? Or interpret CT scan images? Or read cytology specimens on microscopic slides? Like it or not, artificial intelligence is coming to medicine and it will make many skills traditionally requiring hundreds of hours of training, obsolete.

Artificial intelligence and advance practice providers

To become a primary care physician (general internist, general pediatrician, or family physician) requires 11 years of education and training after high school. To become a nurse practitioner (NP) or physician assistant (PA) only requires 6 years of training after high school. As a result, it is far less expensive to become an NP or PA than to become a primary care physician but the trade-off is that NPs and PAs generally have a  lower annual income than physicians. However, if the salary of an NP and a primary care physician was the same, most hospitals would prefer to hire the physician under the presumption that additional 5 years of training to be a primary care physician would translate to greater skill and knowledge than the NP or PA. On the other hand, if the skillset and knowledge of an NP or PA was the same as that of a primary care physician, most hospitals would prefer to hire the NP or PA because they are cheaper.

Artificial intelligence now offers the possibility of eliminating the need to acquire many of the skills and much of the knowledge currently required to become a physician. This offers a future where an NP armed with a few AI apps may be able to perform many of the tasks currently relegated to physicians.

Need to diagnose a child with a fever and a rash? There’s going to be an app for that. Need to decide the best blood pressure medication to prescribe for a patient with newly diagnosed hypertension? There’s going to be an app for that. Need to recommend follow-up of a pulmonary nodule given a patient’s age and smoking history? There’s going to be an app for that.

The FDA and medical devices

At first glance, it would seem logical to embed artificial intelligence into electronic medical record (EMR) software programs. After all, the EMR is the database of all information about a patient – their blood pressure, their family history, their medication list, etc. However, a barrier to incorporating AI into the electronic medical record is that the U.S. Food and Drug Administration considers AI to be a medical device whereas the electronic medical record is just considered a documentation tool. Medical devices are regulated differently than documentation tools. Medical devices require extensive clinical trials and then FDA approval; documentation tools do not. Clinical trials and FDA regulation are very expensive and can pose a barrier to regular EMR software upgrades. For these reasons, the major electronic medical record companies have been reluctant to incorporate artificial intelligence algorithms into their EMR programs.

For the most part, this makes sense. You don’t want to have an artificial intelligence program to recommend a chemotherapy regimen for advanced lung cancer unless it has been shown in clinical trials to be accurate and has been approved by the FDA. The fear of the electronic medical record companies is that if their EMRs become classified as medical devices, then they will have to get FDA approval every time they want to change the font size in their blood chemistry test results in the EMR. So, at least for now, the electronic medical record and artificial intelligence programs will need to be separated, and that means that there will have to be a human to do a history and physical examination and then to interface between the EMR and the AI. But in many situations, that human can be an NP or a PA, rather than a physician.

Artificial intelligence and primary care

Much of primary care is based on clinical practice guidelines. The U.S. Preventative Services Taskforce has guidelines for everything from colon cancer screening to pre-exposure prophylaxis to prevent HIV. The American College of Cardiology has a hypertension diagnosis and management guideline. The Advisory Committee on Immunization Practices has guidelines for childhood and adult vaccination schedules. And the American Diabetes Association has a guideline for the prevention, diagnosis, and treatment of diabetes. If you roll all of these clinical practice guidelines into one artificial intelligence program, then you have the majority of primary care medicine routine visits covered.

As a medical student, I spent hours memorizing vaccination schedules, hypertension treatment algorithms, diabetes medication drug interactions, and the staging systems for various cancers. And guess what? An artificial intelligence program can do all of these things better than my memory allows me to do. In other words, AI eliminates the need for much of the education and training that we currently require in medical school and residency. Artificial intelligence will allow a practitioner with lesser training (such as an NP or PA) to be just as good as a physician when it comes to preventative care medicine and algorithm-based management of most common medical conditions.

However, artificial intelligence is not infallible

Artificial intelligence is actually not new in medicine. I’ve been using simple forms of AI for decades. Every EKG and pulmonary function test that I have ordered in the past 30 years that comes with a computer interpretation has incorporated rudimentary AI into those interpretations. These interpretations programs are fairly good at identifying normal but invariably come up with an incorrect diagnosis in a substantial percentage of those tests that are abnormal. So, before I am willing to allow an AI program to diagnosis breast cancer from a histopathology slide and before I am willing to allow an AI program to diagnose idiopathic pulmonary fibrosis from a chest CT scan, these programs are going to have to get very, very good. Until then, the use of artificial intelligence for more complex pathologic and radiologic diagnoses will supplement rather than replace a physician.

And then there is legal liability…

If a radiologist misses a lung cancer on a chest X-ray, the radiologist is named in a medical malpractice lawsuit. If a patient dies of sepsis when a hospitalist made an incorrect antibiotic choice for the patient’s pneumonia, the hospitalist is named in the malpractice suit. But if an artificial intelligence program misses the lung cancer or selects the wrong antibiotic, who gets named in the malpractice case? The company that created the AI program? The hospital that purchased the AI program? The FDA that approved the program? The physician who entered the patient’s clinical data into the program? All four of them?

Currently, a physician in primary care practice will pay about $12,000 per year in malpractice insurance premiums whereas a primary care nurse practitioner pays about $1,200. The reason for the 10-fold difference is that in most situations, a nurse practitioner is understood to be working under the supervision of a physician and that physician is ultimately responsible or at least shares responsibility for the management of patients seen by the nurse practitioner.  Artificial intelligence is likely to be similar – if it is considered to be a medical device then that device will need to be used by a licensed medical practitioner who will have the greater burden of malpractice liability. Clearly, laws will need to be written to clarify liability before artificial intelligence can be autonomously implemented in clinical practice.

Who will AI benefit the most – nurse practitioners or physicians?

A recent study from MIT researchers found that artificial intelligence has the greatest impact on the least skilled workers. Workers who were new or had low skills were helped more by AI than highly skilled workers. In other words, AI allows those with less training to be “upskilled” much more than those with advanced training.

Extrapolating from this study, it is likely that nurse practitioners and physician assistants will derive greater benefit from artificial intelligence than physicians. Artificial intelligence can make up for the fewer years of training that it takes to become an NP or PA.

Which physicians are most vulnerable to being displaced by artificial intelligence?

Although artificial intelligence has received a lot of press about its potential in radiology, I would argue that primary care physicians are most vulnerable to being displaced by artificial intelligence. Notice that I used the word “displaced” rather than “replaced”. That is because artificial intelligence is likely to be used to supplement a practitioner rather than become a practitioner, at least in the foreseeable future. In this regard, an NP or PA using an artificial intelligence program can replicate much of the skillset of a primary care practitioner. Thus the combination of an NP or PA plus an artificial intelligence program will together displace the primary care physician.

Physicians who are the least vulnerable are those who perform procedures such as surgeons and interventional cardiologists. Although this could change in the future, for now, no AI program or nurse practitioner is capable of independently performing a hip replacement surgery or a coronary artery stent placement. In primary care practice, the office procedures are far less complex – cerumen removal, IUD placement, and laceration suturing can be performed by an NP or PA and do not require a physician.

Also less vulnerable are physicians who are highly specialized. For example, an artificial intelligence program for brain MRI imaging will need to be used under the supervision of a practitioner who can confirm or contradict the AI’s findings. This will require a practitioner who is already an expert in brain MRI image interpretation, in other words, a physician specializing in neuroradiology. Artificial intelligence can still benefit the neuroradiologist, however, by serving in a capacity similar to that of a radiology resident who performs a preliminary read of the MRI that is then over-read and confirmed by the attending neuroradiogist.

“I’m a medical student, should artificial intelligence affect my career choice?”

The answer is… maybe. Fully implemented artificial intelligence in medicine is still a long way off. There will have to be significant improvements in software, significant legal liability questions resolved, and supervision requirements defined. However, if AI can replace certain medical specialists at a lower cost, then economic theory indicates that it eventually will. General internists, general pediatricians, and family physicians may be more vulnerable to displacement than other specialties, especially if the field of medical artificial intelligence matures coincident with an increase in the number of nurse practitioners and physician assistants. However, when it comes to cajoling a cardiologist to add in a patient with chest pain to their already full Friday afternoon schedule, an AI program simply cannot replace a persuasive family physician. The primary care physician may become more of a manager: coordinating care and overseeing a group of nurse practitioners who each have access to the artificial intelligence program.

Things are about to get interesting…

Change in medicine is inevitable but initial resistance to change is also inevitable. When electronic medical records were initially implemented, physicians universally hated them and many refused to use them. Now, no physician in his or her right mind would want to return to an era of paper records kept in manila folders. Ten years ago, the idea of driverless vehicles was met with skepticism but today, you can order a driverless Waymo taxi in San Francisco and you can buy a driverless John Deere tractor to plow your farm.

Artificial intelligence is coming in medicine and its widespread implementation is unavoidable. The question is whether it will augment physicians or displace physicians. I believe that it will do both, depending on the specialty.  From my vantage point, primary care physicians may be the most vulnerable to displacement. And employment opportunities for NPs and PAs are looking bright.

August 30, 2023

In March 2023, the U.S. Drug Enforcement Agency (DEA) announced new education requirements for all physicians applying for new or renewal DEA licenses. This was the result of provisions in the Consolidated Appropriations Act of 2023 that enacted a one-time requirement of 8 hours of continuing medical education (CME) on the treatment and management of patients with opioid or other substance use disorders. The requirement went into effect on June 27, 2023. Because DEA licenses are renewed on a rolling 3-year basis, all physicians with DEA licenses must meet this requirement sometime in the next 3 years.

Another provision of the Consolidated Appropriations Act of 2023 was to eliminate the DATA-Waiver (X-Waiver) Program that was previously required for physicians to prescribe buprenorphine. In the past, hospitalists, emergency medicine physicians, and other practitioners needed to obtain an X-Waiver to initiate buprenorphine when patients with opioid use disorder were admitted to the hospital or seen in the emergency department. Because only a small number of physicians took the time and effort to obtain an X-Waiver, the requirement was seen as a barrier to getting patients started on treatment. Now, any practitioner with a current Drug Enforcement Administration (DEA) registration may prescribe buprenorphine for opioid use disorder (if permitted by state law). The trade-off for elimination of the X-Waiver was the requirement that all practitioners with a DEA license be trained in the treatment of opioid use disorder, including the use of buprenorphine.

Who does this affect?

Any practitioner with a DEA registration must meet this requirement. This includes physicians, dentists, nurse practitioners, and physician assistants. However, only practitioners who prescribe controlled substances need to register with the DEA and obtain a DEA number. Although the majority of U.S. physicians have DEA numbers, some physicians do not, either by nature of their practice (for example, pathologists and researchers) or by choice (for example, general practitioners who do not want the hassle of prescribing opioids and other controlled substances).

To obtain a DEA number, a physician must apply to the DEA and pay an $888 fee. DEA numbers are valid for 3 years at which time the physician must re-apply. The DEA waives the fee for certain physicians including those who work in the military, for U.S. government hospitals or institutions, and for state government hospitals or institutions. As an employee of the Ohio State University (a state government institution), my DEA fees were waived. However, even if the fee is waived, the practitioner must still apply for and obtain a DEA number and the practitioner must still meet the new education requirements.

Certain practitioners are exempt from the new educational requirement including veterinarians, physicians board-certified in addiction medicine, and practitioners who have graduated from their professional school within the past 5 years. The latter means that most residents in training are exempt.

What are the specifics of the requirement?

When applying for a new or renewal DEA number, physicians (and other practitioners) must check a box attesting to having completed 8 hours of training on treatment and management of patients with opioid or other substance use disorders. This is a fairly broad topic area and it is up to physicians to maintain their own documentation of completion of education in the event of an audit. In addition, if the physician faces legal action (such as a medical malpractice lawsuit), documentation of completion may be necessary to establish physician competency. The details of the requirement are as follows:

• The 8 hours of education do not need to occur in one session and (for example) can be 8 individual 1-hour CME events.
• This is a one-time requirement and will not need to be repeated every three years when re-applying for a DEA number.
• Education can take the form of grand rounds, classroom sessions, on-line materials, or professional society meetings.
• Education hours obtained prior to the new requirement also count. For example, attending a grand rounds on buprenorphine in past years can count; just be sure that you have documentation of participation or attendance. Physicians with an X-Waiver can count the training hours from their original X-Waiver application.
• The education can come from any organization accredited to provide CME credits by the Accreditation Council for Continuing Medical Education.

What do hospitals need to do?

Although the DEA requirement is left to the responsibility of the individual practitioner applying for a DEA number, hospitals do have an obligation to facilitate education. First, if practitioners fail to get the required 8 hours of training and are unable to obtain a DEA number, the hospital’s ability to dispense controlled substances or manage patients requiring controlled substances will be compromised. Second, in the event of a medical malpractice lawsuit involving a practitioner on the medical staff who lacks documentation of completion of the educational requirements, the hospital could be accused of being complicit by not confirming that their practitioners were appropriately trained. Specific steps that hospitals should take now include:

• Make sure that all members of the medical staff are aware of the new DEA requirements.
• Inventory practitioners’ DEA license expiration dates and remind practitioners at least 6 months in advance of that date that they must fulfill the educational requirements prior to the renewing their DEA number.
• Require practitioners with DEA numbers to submit documentation of completion of the educational requirements and then maintain that documentation in each practitioner’s employment record.
• Require any new practitioners to include documentation of completion of substance abuse treatment CME as part of their application to the medical staff. Those lacking documentation should be required to complete training during their provisional/probational appointment period.
• Schedule grand rounds or other CME events covering treating and managing patients with opioid or other substance use disorders.
• Provide practitioners with links to on-line CME resources. For nearly a quarter of a century, I moderated the CME webcast, OSU MedNet-21. We produced many CME webcasts on substance abuse disorders and these webcasts are available to anyone. A recent example is:
  • Addiction, Stigmata, & First-Person Language
• Many professional societies have included sessions on substance abuse disorders as part of their annual meetings or have prepared on-line CME sessions to help fulfill the requirements. Examples of on-line education programs include:
  • The American College of Physicians
  • The American Society of Addiction Medicine
  • The American Medical Association
  • The American Society of Anesthesiologists
  • The American Academy of Pediatrics
• The Centers for Disease Control offers a free on-line 1-hour CME activity about substance abuse disorders
• Journal subscription materials can count. Practitioners with subscriptions to resources such as UpToDate, JAMA, and the New England Journal of Medicine can obtain CME credit by reading relevant articles and then applying for CME hours.

Why has Congress required this?

The primary impetus for the new requirement is a directive of the U.S. Congress to address the opioid epidemic. Eliminating the X-Waiver program was seen as a way of improving access to treatment for patients with opioid use disorder. But to justify elimination of the X-Waivers, Congress needed a mechanism to ensure that all practitioners were knowledgable in initiating treatment for opioid use disorder.

In 2021, a total of 106,699 Americans died of a drug overdose. Although street-purchased fentanyl was the most common drug implicated, prescription opioids accounted for 16,706 of the overdose deaths in 2021. In fact, the number of deaths from prescription opioids exceeded the number of deaths from heroin (9,173).

Drug overdose deaths are particularly high in Appalachian states. West Virginia has the highest overdose death rate at 90.9 per 100,000 population, followed by Kentucky and Tennessee (each 56.6 per 100,000 population) and Louisiana (55.9 per 100,000 population). My state of Ohio ranks 7th highest at 48.1 per 100,000 population. Nebraska comes in lowest at 11.4 per 100,000 population.

To put these numbers in perspective, last year, the U.S. COVID death rate was 61.3 per 100,000 population. Opioids are abused by more than 10 million Americans each year (3.8% of Americans) and 2.7 million Americans have an opioid use disorder. About half of those who become addicted to opioids first use opioids in the form of prescription pain medications. An estimated 3% – 19% of people who take prescription opioid pain medications will become addicted to opioids. Addiction can occur with only 3-5 days of prescription opioid use.

The good news is that there are effective treatments for opioid use disorder including buprenorphine (often combined with naloxone), methadone, and naltrexone. In addition, the FDA has now approved naloxone to be sold over-the-counter to treat opioid overdose. The goal of the DEA education requirements is that any practitioner in the U.S. who is licensed to prescribe opioids is also trained in identifying and treating opioid abuse.

A quarter of a century of change

In the 25 years since the American Pain Society advocated that physicians adopt “pain as the 5th vital sign” and since Purdue Pharmaceuticals falsely promoted OxyContin as a non-addictive opioid, physicians have become much more aware of the role that we have played in catalyzing the current opioid epidemic. The new DEA education requirements were created as one step in remedying the epidemic. By helping our physicians meet these new requirements, hospitals can help reduce the number of Americans who become addicted and help increase the number of Americans who get their addiction treated.

August 28, 2023

Last week, the U.S. FDA approved Opill, the first over-the-counter birth control pill. It contains 0.075 mg progesterone and must be taken every day, at the same time of day. Opill now gives hospitals a new opportunity to reduce unwanted pregnancies by counseling women in the emergency departments, inpatient settings, and outpatient clinics.

How effective is Opill?

Most currently available prescription oral contraceptives are combination estrogen/progestin pills. The estrogen component poses risks of deep venous thrombosis, pulmonary embolism, hypertension, myocardial infarction, and stroke. For this reason, it is likely that combination estrogen/progestin oral contraceptives will remain only available by prescription in the future. Since progestin-only pills lack estrogen, they are generally safer than combination birth control pills. Opill contains norgestrel, a form of progestin. The amount of progestin in Opill (0.075 mg) is much lower than the amount of progestin in most combination pills (typically about 1.0 mg) and less than currently available progestin-only prescription birth control pills (0.35 mg). Because it only contains progestin and only in a very low dose, it is sometimes called a birth control “mini-pill”. 

Opill (norgestrel) works by thickening cervical mucus, creating a barrier to prevent sperm from entering the cervix and uterus. In addition, norgestrel slows the passage of ova through the fallopian tubes and alters the endometrium to impede ova attachment. In about half of women, norgestrel also prevents ovulation. Norgestrel blood levels peak approximately 2 hours after ingestion and the drug is completely eliminated from the body by 24 hours. These pharmacokinetics are why rigid adherence to the dosing schedule at the same time every day is required.

The effectiveness of any form of contraception is often measured by the “Pearl index”, named after biologist, Raymond Pearl. This index is the number of pregnancies per 100 women using that form of contraception for one year. In a 2022 review of the literature in the journal Contraception, the average Pearl index for progestin-only oral contraceptives is about 2. This means that if 100 women use progestin-only pills for a year, 2 of them will become pregnant. However, in real life, the Pearl index is almost never as high as it is in clinical trials where researchers make every effort to ensure that women do not miss doses. It is just too easy to take a dose more than 3 hours late in the day or to forget to take a daily dose altogether. For this reason, it is likely that in regular clinical use, the Pearl index for Opill will likely be closer to the Pearl index of combination estrogen-progestin birth control pills, or around 7 pregnancies per 100 women per year. This puts Opill in an intermediately effective form of contraception: better than condoms but not as effective as IUDs or implants.

However, even with a Pearl index of 4 – 7 pregnancies per 100 women per year, Opill will now be the most effective over-the-counter contraception method available and far more effective than condoms.

Advantages and disadvantages of Opill

Advantages:

• No physician visit required for a prescription. The wait for a routine return appointment at my own PCP is 4 months. This is too long for most people to wait to get access to contraception.
• Good option for women/girls who do not want their healthcare provider to know about their sexual activity. This is particularly useful for minors who do not want their parents to know that they are sexually active.
• Useful for women who frequently travel or occasionally lose medications. It can be difficult to get an emergency refill of a prescription oral contraceptive, particularly when out of state or on weekends. Women can get a refill of their Opill anytime at any pharmacy in the country.
• Fewer side effects than prescription combination estrogen/progestin birth control pills.
• Unlike condoms and diaphragms, it is not necessary to interrupt sex to use Opill.

Disadvantages:

• No physician visit required for a prescription. This can be a missed opportunity to counsel women/girls about all of the various contraception options.
• Does not prevent sexually transmitted diseases.
• Should not be used in women with a history of breast cancer, women with undiagnosed vaginal bleeding, and women with liver disease.
• Can result in irregular vaginal bleeding.
• Other common side effects may include nausea, breast tenderness, and headaches.
• Must be taken every day and within 3 hours of the regular hour of the day that it is normally taken. If a dose is missed, delayed, or there is vomiting after taking a dose, alternative contraception must be used for at least 48 hours.
• Even with perfect use, 1 out of every 50 women will get pregnant every year.
• Possibly less effective in obese women/girls.
• Drug interactions with phenytoin, carbamazepine, barbiturates, rifampin, efavirenz, bosentan and St. John’s Wort. These drugs can render Opill ineffective.
• Not tested in girls younger than 15 years old.

An opportunity to counsel ER patients

One of the more common diagnoses we make in women in U.S. emergency departments is pregnancy. A 1994 study found that 6.3% of women of childbearing potential presenting to the ER had unsuspected pregnancies. The incidence of pregnancy in women presenting with abdominal pain is even higher at 13%. When women suspect that they may be pregnant, many will present to the emergency department for pregnancy testing rather than their primary care provider. This has become particularly true in states that have time restrictions on abortions. Because women often do not realize that they are pregnant until they miss a menstrual period, they are often 4 – 5 weeks pregnant when they begin to suspect pregnancy. In states where abortion is illegal after 6 weeks gestation, a delay in pregnancy testing of even a few days while waiting to see a primary care provider can result in exceeding the legal gestational time for an abortion. A trip to the ER is often the fastest way for a women to find out whether or not she is pregnant.

As a rule, emergency medicine physicians do not prescribe maintenance medications, including birth control pills. Consequently, until now, all that an ER provider could recommend to women who had came to the emergency department for pregnancy testing and had a negative test was to see their primary care provider for contraception counseling and prescriptions. Unfortunately, many women do not have a  regular primary care provider. Furthermore, many adolescents do not want to speak to their pediatricians about contraception for fear that their parents will find out. Many unmarried adult women do not want to admit to their primary care provider that they are sexually active or do not want that information to be recorded in an electronic medical record that any healthcare worker might get access to.

But now, our ER providers have the ability to recommend reasonably effective non-prescription contraception to any woman. But how should the information be provided and which women should get that information? It is ineffective to simply ask women if they are sexually active in the ER because they are frequently not forthcoming about their sexual history. Indeed, a 1989 study found that 7% of women ER patients who stated that there was no chance that they were pregnant were, in fact, pregnant. Sometimes it is because there is a relative or friend in the ER room with them and they don’t want that individual to know about their sexual history. Sometimes, they don’t want to risk their sexual history being recorded in the electronic medical record. Sometimes they don’t even want the ER provider to know that they are sexually active because it would acknowledge violation of cultural or religious doctrines. The most effective strategy is to provide information about contraception to all women of childbearing potential. But what is the best way to provide that information?

Unfortunately, there are insurmountable barriers to printing up information about Opill on the ER after visit summary for every female patient between the ages of 11 and 50. Twelve-year-olds can and do get pregnant but handing out information about contraception to every 12-year-old who comes to the ER with a sprained ankle will infuriate many parents who in turn will write scathing reviews of the hospital on Yelp that will then infuriate hospital administrators and board members. Although the FDA does not expressly state the youngest age that Opill is indicated for, in clinical trials, it was not used in girls younger than age 15 so hospitals could potentially face legal liability if it is perceived that they were recommending Opill for girls younger than 15. In addition, some women and girls may be offended if this information is printed on their after visit summary. This could include women with previous tubal ligation or hysterectomy, widows, lesbians, Catholics, and the celibate. One compromise would be to just include information about Opill on the after visit summary for female patients between ages 18 and 50 or between ages 15 and 50. This option is less likely to offend parents but can still offend other girls and women. Another compromise would be to only include after visit summary information for patients who had a pregnancy test or a test for sexually transmitted disease in the ER. This would target those women and girls who are presumably at a higher risk of becoming pregnant but because most ER visits do not result in pregnancy or STD testing, most women and girls will not receive any information. Alternatively, information about Opill could be posted in public areas such as posters in examination rooms, posters in waiting rooms, or screen displays on public video/TV monitors. This is the least intrusive and least likely to offend anyone. However, it may be less impactful since there is no printed information for girls and women to take with them. Information does not need to be excessively detailed. For example, a wall poster or after visit summary could simply say something like “Over the counter birth control pills are now available; to learn more, go to this website…”.

Opill and Catholic hospitals

These informational tactics will only be applicable for the nation’s non-Catholic hospitals. Currently, 16% of all U.S. hospitals are affiliated with the Catholic Church. In many communities, a Catholic hospital is the only available healthcare facility. Because of the church’s doctrine prohibiting contraception, these hospitals would face opposition to providing information about Opill from the church. This is particularly unfortunate since a primary mission of many Catholic hospitals is to provide care to the underserved, a population of women who are less likely to have regular primary care providers and thus have less access to prescription contraception. Although 99.0% of Catholic women have used some form of contraception at some time of their lives (despite church doctrine), this is less than women with no religious affiliation (99.6%), mainline Protestants (99.4%), and evangelical Protestants (99.3%). This barrier to contraception access for Catholic women is reflected in the religious demographics of American women undergoing abortion – Catholic women are more likely to have an abortion than women belonging to other religions in the United States. Data from the Guttmacher Institute indicates that 24% of American women undergoing abortion identify as Catholic but only 22% of the American population as a whole is Catholic.

On the other hand, Opill provides a new opportunity for physicians employed by Catholic hospitals – including primary care providers at hospital-owned outpatient clinics. Many such hospitals and clinics prohibit their physicians from prescribing contraception, inserting IUDs, or even performing tubal ligation or vasectomy for the purpose of contraception. Many physicians at these hospitals are not even willing to include documentation of discussions about contraception in the electronic medical record for fear of being identified by hospital officials as providing forbidden services during medical record audits. Now, however, physicians and other providers at Catholic hospitals, emergency departments, and clinics can verbally recommend over-the-counter Opill to their patients interested in contraception without creating an incriminating documentation trail in the electronic medical record that could result in job termination.

Reducing unwanted pregnancies

Abortion legislation is currently one of the most controversial socio-political issues in the U.S. The most effective way to reduce abortion is not by making abortion illegal but instead by preventing unwanted pregnancies in the first place. As Americans, we waste way too much emotional energy arguing about abortion laws while often ignoring tactics to reduce unwanted pregnancies. The availability of Opill now gives us a new opportunity to reduce these unwanted pregnancies by increasing the availability of reasonably effective contraception to women who otherwise have barriers to obtaining prescription contraception. 

We do not yet know how Opill will be priced. Most prescription oral contraceptives currently cost $10 – $50 per month without insurance and presumably, Opill will be in this general price range. Health insurance policies typically only cover prescription medications and generally do not cover over the counter medications. It is unclear if health insurance companies and Medicaid will cover Opill. The cost of Opill for a year is far, far less than the cost of a pregnancy. The Kaiser Family Foundation estimates that the total cost of pregnancy, child birth, and postpartum care is $18,865. In addition, the average healthcare costs per child is $2,966 per year which adds up to $53,388 from birth to age 18. This means that the total healthcare cost of an unintended pregnancy is $72,253. In addition, the average cost of $4 per child per day for SNAP (Supplemental Nutrition Assistance Program, aka food stamps) adds another $26,280 charged to taxpayers over 18 years for every unwanted pregnancy to a low-income woman. Even at a cost of $50 per month, insurance companies and Medicaid programs would be financially foolish to not cover Opill. Indeed, by preventing unwanted pregnancies, Opill could reduce health insurance premiums and reduce taxpayer costs of Medicaid and SNAP.

Not perfect, but…

Opill is not the most effective form of contraception, nor is it for all women and girls. But it is a well-needed addition to the current contraception options and holds the promise of reducing unwanted pregnancies and abortions. Hospitals, and especially emergency departments, can play an important role in educating women and girls about Opill. Each hospital should decide for itself what the best method of patient education is in its own facilities.

July 17, 2023

The prostate cancer screening pendulum just swung… again. One of the most vexing problems in outpatient medicine has been prostate cancer screening: who should be screened and when should they be screened? New developments are finally giving us some clarity. We have a highly effective screening test in the prostate specific antigen test (PSA). This simple blood test is inexpensive and widely available. Finding an elevated PSA can result in detecting prostate cancer at an early, curable stage. But sometimes, the PSA can be too good.

Every year, our hospital holds an annual Community Day where physicians and hospital staff volunteer their time to provide free health information and screening tests to the public. Many of the community members attending are uninsured and low income so Community Day is their only source of screening for chronic diseases and cancers. A few years ago, the hospital agreed to perform free PSA tests and I asked two doctors to staff a prostate cancer screening station. One doctor said “If attendees don’t get PSA tests, I’m not going to participate” and the other doctor said “If attendees do get PSA tests, I’m not going to participate“. So which doctor was right? This is a question that as a 64-year-old man I’ve thought about a lot and it turns out that that both of them were right and both of them were wrong.

The history of PSA screening

Prostate cancer is the most second most common cancer in men (after skin cancer) and the second most common cause of cancer death in men (after lung cancer). It is estimated that 288,300 American men will be diagnosed with prostate cancer and 34,700 American men will die from prostate cancer in 2023. Prostate cancer is most commonly first identified by an elevated PSA level.

The PSA test was first approved in 1986 and became widely used to screen for prostate cancer in the 1990’s. With widespread screening came a dramatic increase in the number of new prostate cancer diagnoses that peaked in 1992 at 225 per 100,000 population, as shown by the light green squares in the graph below.

But despite all of these new cancers being found, there initially was no significant reduction in the prostate cancer death rate, as shown by the dark green triangles in the graph above. The implication was that the PSA test was finding lots of very low-grade, slow-growing cancers that were never going to spread during a man’s life. This raised a concern that we were doing a lot of unnecessary prostatectomies on men who did not need them… and prostatectomies have a significant risk of causing urinary incontinence and impotence. In addition, at the time, an elevated PSA was followed by a transrectal prostate biopsy that carried with it a 2-4% incidence of sepsis and further concern was raised that we were subjecting a lot of men to unnecessary biopsies. The enthusiasm for universal PSA testing began to wane and then in 2009, the PLCO study was published in the New England Journal of Medicine that caused many physicians to stop screening for prostate cancer altogether.

The PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) examined 76,693 men American men who were randomized to either get annual PSA tests for 6 years or get “usual care”. After 7 to 10 years, there was no difference in prostate cancer mortality between the two groups and it was concluded that annual PSA testing does not lower the death rate from prostate cancer. As a result, in 2012, the United States Preventive Services Task Force (USPSTF) gave the PSA a grade “D” recommendation, meaning that the harm of testing outweighed the benefits of testing. Overnight, prostate cancer screening braked to a halt. A second study in 2009 from Europe looked at 182,000 men randomized to either be screened every 4 years with a PSA or to not be screened. This study did find a 20% reduction in prostate cancer deaths in the group undergoing screening but the USPSTF chose to base its decision on the U.S. study rather than the European study.

But then in 2016, it came to light that in the PLCO, 90% of the men randomly assigned to the “usual care” group actually had a PSA test before or during the PLCO study by their regular physicians. In other words, both groups of men were getting screened using the PSA. It is not surprising, therefore, that there was no difference in the prostate cancer survival between the two groups in the PLCO study. This new revelation was published as a letter to the editor in the New England Journal of Medicine in 2016 and thus did not get as widespread attention as the original PLCO study 7 years earlier. Another important feature of the PLCO study was that only 4% of subjects were African American (who have a higher risk of prostate cancer) whereas in the U.S. as a whole, 12% of men are African American. In 2018, the USPSTF published new prostate cancer screening guidelines upgrading the PSA test to a grade “C” recommendation that stated “The decision to be screened for prostate cancer should be an individual one.” In other words, the USPSTF left it up to each doctor to decide whether or not to screen any given man for prostate cancer using a “shared decision making” approach.

In the past five years, there have been 4 new studies of PSA screening that have all shown that screening reduces prostate cancer death, ranging from 1 death prevented for every 101 men screened to 1 death prevented for every 570 men screened. Taken together, the data to support PSA screening is looking better and better every year.

New developments

Since the peak use of the PSA to screen for prostate cancer in 1992, there have been a number of developments that have changed our approach to the diagnosis and treatment of prostate cancer:

• The open radical prostatectomy has been largely replaced by the minimally invasive robotic prostatectomy which has lowered the complication rate of surgery.
• Advances in radiation therapy have led to radiation therapy now being a non-surgical treatment option for many men with prostate cancer.
• There is greater recognition that certain men are at significantly higher risk of getting prostate cancer and of dying from prostate cancer. These include African Americans, those with a family history of prostate cancer, those with the BRCA gene and those with another genetic condition called Lynch syndrome. In addition, men who develop prostate cancer at a young age are more likely to have aggressive, fatal prostate cancer than those who develop it during older ages.
• The prostate MRI has emerged as the preferred initial test for men with an elevated PSA and this has reduced the need for subsequent biopsy by 28%.
• The transrectal prostate biopsy that carried with it a 2 – 4% risk of sepsis has been largely replaced by the less risky transperineal prostate biopsy which has a < 1% risk of sepsis.
• There are new androgen-deprivation treatments and chemotherapies for patients with metastatic prostate cancer that can significantly prolong survival.

The net result of all of these developments in addition to the use of PSA testing has been a reduction in the mortality rate of prostate cancer from 39.2 per 100,000 men in 1992 to 18.6 per 100,000 men in 2020. That is a 50% reduction in mortality!

So who should we screen in 2023?

It remains true that many men with prostate cancer have slow-growing cancers that will never require any treatment. In these men, if you find a prostate cancer, you probably are not going to treat it and knowledge of the cancer only causes the man anxiety. Screening these men violates the cardinal rule of “Don’t ask a question that you don’t want to know the answer to“. Our challenge is to preferentially screen only those men who are at higher risk of developing a prostate cancer that will actually kill them. The current USPSTF recommendations of “shared decision making” between the primary care provider and the patient is vague and nebulous. It can leave the physician with the sense that the USPSFT is just saying “We really don’t know what to recommend, so you decide“. In order to provide a bit more direction, here are my personal recommendations:

• PSA testing starting at age 40: African American men, men with a family history of prostate cancer, men with BRCA1 or BRCA2 gene and men with Lynch syndrome.
• PSA testing starting at age 50: all other men.
• Don’t do a rectal exam as part of screening (reserve it only for those men with an elevated PSA).
• Repeat the screening PSA every 1-2 years.
• Stop PSA testing in most men at age 70 or in men with less than 10 years to live. For exceptionally healthy men, continued screening into their 70’s is prudent.

There are a few other caveats to PSA screening. Do not do a PSA test in a man with a urinary tract infection (false positives). If the PSA is elevated, the next step is usually to just repeat the PSA in 4 – 6 weeks (there are other reasons for false positives). What constitutes an elevated PSA depends on the man’s age: PSA > 2 in their 40’s, PSA > 3 in their 50’s & 60’s, PSA > 4 in their 70’s. Not every elevated PSA is from prostate cancer – chronic prostate inflammation, prostatic hypertrophy, and prostate trauma can also cause a high PSA level.

For a more in-depth update on PSA testing, you can watch a recent OSU MedNet webcast on prostate cancer screening by the Ohio State University’s Dr. Shawn Dason by clicking here.

Getting back to the hospital’s Community Day

Should you offer PSA testing as part of a cancer screening program at a hospital community day or health fair? I think that the answer is “Yes!”. However it should be targeted to men between the ages of 50 – 70 years old. For those men with risk factors (African American, family history, genetic predisposition), an age range of 40 – 70 is preferred. Screening should be accompanied by a discussion with the patient that not every man with an elevated PSA will have prostate cancer and not every prostate cancer has to be treated. That discussion should also include that prostate MRI and transperineal biopsy can now be done instead of the older transrectal biopsy, resulting in fewer complications.

The PSA pendulum has swung from screen all men to screen no men and most recently to screen some men. I believe that the pendulum is now swinging towards screening all men at an appropriate age. Primary care providers should get ahead of the pendulum and implement these screening practices now.

June 23, 2023

Long-COVID is also known as PASC (post-acute sequela of COVID). A study in this week’s JAMA found that 10% of people infected with COVID had symptoms lasting for more than 6 months. These symptoms negatively affect quality of life and can result in significant impairment. There is a need for hospitals to create specialty clinics for PASC patients.

Long-COVID symptoms

Development of long-COVID symptoms depends on several variables. For example, women are twice as likely to develop long-COVID symptoms after an infection than men. People with repeated COVID infections are more likely to develop long-COVID symptoms than those with a single infection. People infected with the Delta variant are more likely to develop long-COVID symptoms than those infected with the Omicron variant. The severity of the initial infection also affects the likelihood of developing long-COVID: infected persons requiring hospitalization or ICU care are twice as likely to develop long-COVID symptoms compared to those with milder infections treated as outpatients. Other risk factors for developing long-COVID symptoms are being unvaccinated, older age, smoking, pre-existing chronic medical conditions, and obesity.

Long-COVID is a heterogeneous condition and patients can have a wide variety of symptoms. Most of these symptoms are non-specific. Among those who develop long-COVID symptoms, the most common include:

• Post-exertional malaise (87%)
• Fatigue (85%)
• Brain fog (64%)
• Dizziness (62%)
• GI symptoms (59%)
• Palpitations (57%)
• Hearing difficulties (54%)
• Joint pain (42%)
• Weakness (42%)
• Sexual impairment (42%)
• Smell/taste impairment (41%)
• Headache/muscle pain (39%)
• Shortness of breath (36%)
• Cough (33%)

Long-COVID clinic structure

Because of the wide variety of symptoms that people with long-COVID can develop, the evaluation of patients should be tailored to the specific presenting symptoms. The key purposes of a long-COVID clinic should be (1) to measure quantifiable impairment, (2) exclude other conditions that mimic long-COVID, (3) prescribe treatments to relieve symptoms, and (4) direct rehabilitation efforts. The long-COVID clinic should in a location that has on-site EKG testing, phlebotomy for lab testing, and radiology for chest x-rays. It should also be in close proximity for schedulable tests such as pulmonary function tests and echocardiograms.

A full set of vital signs (including resting pulse oximetry) should be performed for each visit. The clinic should be able to refer patients for speciality consultation including cardiology, pulmonary, rheumatology, physical medicine, sleep medicine, physical therapy, occupational therapy, and dietary. Ideally, there should also be access to a pulmonary rehabilitation and cardiac rehabilitation program in the area. Because of their protocol-driven nature, long-COVID clinics are an opportunity for advance practice providers (nurse practitioners and physician assistants).

For most patients, symptoms of acute COVID infection can take many days or even several weeks to fully resolve. The majority of these patients do not require evaluation in a specialized long-COVID clinic. It is reasonable to set a threshold of symptoms persisting for more than 6 – 12 weeks as criteria for referral to a long-COVID clinic. The initial evaluation should include a complete history and physical examination with attention to symptoms during the acute phase of the COVID infection, severity of the infection, vaccination status, age, BMI, smoking status, and co-morbid medical conditions.

Special effort should be given to medication reconciliation at the initial visit. Patients who were hospitalized for acute COVID infection are particularly likely to have had previous medications discontinued during hospitalization and/or new medications started. Sometimes these changes were because a chronic medication was not needed during hospitalization. Sometimes a chronic medication was stopped or changed during hospitalization due to a prohibitory drug-drug interaction with a medication necessary to treat the COVID infection. Or sometimes a drug was changed during hospitalization because that drug was not on the inpatient hospital formulary. During medication reconciliation, attention should be directed toward eliminating duplicate medications, discontinuing unnecessary medications, and resuming maintenance medications held during the acute infection.

Symptom-directed diagnostic testing

The history and physical exam may dictate initial testing. For example, the finding of dry crackles on pulmonary auscultation may dictate pulmonary function tests and a high resolution chest CT. On the other hand, pedal edema, an S3, and moist crackles may dictate a BNP test and an echocardiogram. Sudden onset of dyspnea and pleuritic chest pain shortly after resolution of an acute COVID infection may dictate a d-Dimer test and/or a CT pulmonary angiogram. Diagnostic testing in other patients should be ordered based on the specific long-COVID symptoms each patient has:

Fatigue: Laboratory testing should include: CBC, TSH, chemistry panel, and LFTs. An EKG should be performed. Oxygen saturation at rest and during exercise should be measured (for example, using the 6-minute walk test). Because many of the risk factors of long-COVID are also risk factors for obstructive sleep apnea, patients with fatigue should be screened for sleep apnea (for example, using the STOP-BANG questionnaire). Patients who received corticosteroids as part of their acute COVID treatment should be tested for adrenal insufficiency.

• • • Mimics include: anemia, chronic kidney disease. chronic liver disease, sleep apnea, adrenal insufficiency, and hypothyroidism

Shortness of breath: Initial testing should include: BNP, CBC, TSH, chemistry panel, LFTs, chest x-ray, 6-minute walk test and EKG. If these tests are unremarkable, then additional testing could include a full set of pulmonary function tests (spirometry, flow-volume loop, lung volumes, diffusing capacity) and an echocardiogram. If these tests are also unremarkable, then a cardiopulmonary exercise test (CPET) should be considered. If post-inflammatory pulmonary fibrosis is suspected based on chest x-ray abnormalities (or crackles on pulmonary auscultation), a high resolution chest CT should be obtained. Patients with resting or exertion hypoxemia in the absence of radiographic abnormalities should be screened for thromboembolic disease with a d-Dimer test or CT pulmonary angiogram.

• • • Mimics include anemia, heart failure, hypothyroidism, chronic kidney disease, chronic lung disease (asthma, COPD, interstitial lung disease), pulmonary embolism, and vocal cord dysfunction

Cough: Initial testing should include a chest x-ray and spirometry with flow-volume loop.

• • • Mimics include asthma, gastroesophageal reflux, post-nasal drip, use of ACE inhibitor medications, and vocal cord dysfunction

Brain fog: Initial testing should include CBC, chemistry panel, LFTs, TSH, and 6-minute walk test. A screening test for cognitive impairment should be performed; in the past, this was typically the Mini-Mental State Examination (MMSE) but because that test now requires a fee to perform, the free SAGE test may be preferred. Another screening test for cognitive dysfunction is the Montreal Cognitive Assessment (MoCA); however completion of a mandatory 1-hour training program is required to perform this test.

• • • Mimics include anemia, hypothyroidism, chronic liver disease, hypoxemia, sleep apnea, and early dementia

Dizziness or palpitations: Initial testing should include CBC, BNP, EKG, orthostatic blood pressure measurement, and 6-minute walk test. If these tests are unremarkable, additional testing could include Holter monitor, echocardiogram, and tilt-test.

• • • Mimic include anemia, heart failure, orthostatic hypotension, and cardiac arrhythmias

GI symptoms: Initial testing should include CBC and LFTs. Patients with diarrhea should be tested for C. difficile if they received antibiotics or were hospitalized. Older age is a risk factor for both long-COVID and lactose intolerance.

• • • Mimics include C. diff gastroenteritis, lactose intolerance, and irritable bowel syndrome

Weakness or muscle pain: Initial testing should include chemistry panel, CK, TSH, and LFTs.

• • • Mimics include electrolyte disorders, drug side effects (statins), and hypothyroidism

Taste and olfactory dysfunction: These are common after COVID infection, particularly with the earlier Delta variants. There is no particular testing required but nutritional assessment may be useful in those losing weight due to altered diet resulting from abnormal taste and smell. Patients with smell dysfunction should be advised to have working smoke detectors in their homes.

• • • Mimics include chronic sinusitis

Chest x-ray abnormalities: Patients with pulmonary infiltrates at the time of the initial COVID infection should have a follow-up x-ray. If infiltrates persist beyond 12 weeks, a chest CT should be performed. It should be noted that 50% of patients hospitalized with COVID who have x-ray abnormalities at the time of initial infection will still have x-ray abnormalities 6 months after the infection. However, because older age and cigarette smoking are risk factors for both long-COVID and lung cancer, resolution of chest x-ray abnormalities must be confirmed.

• • • Mimics include lung cancer

Rehabilitation

Patients with severe impairment, particularly those with neuromuscular impairment, may require referral to a physical medicine specialist to direct rehabilitation. Patients with fatigue, mild-moderate exercise limitation, cardiac symptoms, and pulmonary symptoms can usually have rehabilitation efforts overseen from a long-COVID clinic. Prior to recommending a rehabilitation regimen, patients should complete diagnostic testing to exclude other medical conditions mimicking long-COVID and to identify any objective evidence of cardiorespiratory impairment.

Deconditioning is common following COVID infection. Patients are often sedentary for many days and often sustain weight loss and nutritional deficits during the acute COVID infection. In these patients, dietary guidance to restore body mass coupled with a regular exercise program can be very effective. There is not a single “best” exercise for patients with long-COVID symptoms, rather the best exercise is whatever exercise the patient will actually do consistently. In general, patients should be given a target of 150 minutes of weekly aerobic exercise (walking, stationary bike, treadmill, swimming, etc.). Patients with moderate or severe deconditioning may require several weeks to work up to 150 minutes per week. One of the barriers to aerobic exercise is the fear that exercise-induced dyspnea is a warning sign that the body is being harmed from exercise. A pulse oximeter can be very helpful to reassure patients that their oxygen level remains normal despite dyspnea and to help guide the heart rate during exercise. Patients should target keeping their heart rate during exercise at < 60% of their maximum predicted heart rate (maximum predicted heart rate = 220 – age).

Formal cardiac rehabilitation and pulmonary rehabilitation programs can be beneficial but Medicare will only cover these programs if there is objective evidence of cardiac or pulmonary impairment (some commercial insurance companies have less strict criteria for admission into these programs). For patients not eligible for cardiac or pulmonary rehabilitation, referral to a physical therapist can be useful, not only to define physical capabilities but for exercise guidance.

The special case of athletes

Vaccine skeptics often point to vaccine-induced myocarditis as a reason to avoid vaccination. However, a 2022 study found that people are 11-times more likely to get myocarditis from a COVID infection than they are from a COVID vaccination. Moreover, previous vaccination cut the chances of getting myocarditis after a COVID infection by half. Fortunately, most people who develop myocarditis (from either infection or vaccination) go on to have complete recovery. Nevertheless, those who have myocarditis at the time of their initial COVID infection should undergo cardiology consultation prior to resuming athletic activities.

Long-COVID can be devastating for a young athlete. Missing one season of their sport can mean an end to their high school or college athletic career. It is especially important to evaluate young athletes with long-COVID symptoms for exercise-induced bronchospasm and vocal cord dysfunction since these conditions can be readily treated. This should start with spirometry before and (if obstructed) after a bronchodilator to screen for asthma. A flow-volume loop should also be performed and if inspiratory notching is observed, vocal cord dysfunction should be suspected. In athletes with exertional cough and normal spirometry, a bronchoprovocation study should be performed. If available, a eucapneic voluntary hyperventilation study is the preferred test to identify athletes with exercise-induced bronchospasm. If unavailable, then a methacholine challenge test is an alternative.

If there is no evidence of asthma or vocal cord dysfunction in athletes with persistent dyspnea on exertion following COVID infection, a cardiopulmonary exercise test should be considered. This is an under-utilized test that can be extremely helpful in the evaluation of unexplained dyspnea.

Long-COVID disability determination

For some patients, impairment from long-COVID symptoms can be disabling. Most organizations require objective evidence of impairment before granting permanent disability. In general, subjective symptoms such as fatigue and pain must have objective correlates on diagnostic testing to qualify for disability. Patients with cardiac symptoms, such as chest pain, palpitations, dizziness, or dyspnea should undergo appropriate cardiovascular tests to determine if there is objective evidence of impairment. These tests could include echocardiograms, tilt tests, or cardiac stress tests.

Patients with pulmonary symptoms such as cough or dyspnea on exertion should undergo appropriate pulmonary diagnostic tests to determine if there is objective evidence of pulmonary impairment. These tests should include pulmonary function tests (spirometry, lung volumes, diffusing capacity). If these are normal and disability is still being considered, a cardiopulmonary exercise testing (CPET) should be performed.

Patients seeking disability for brain fog should be evaluated for objective evidence of cognitive impairment with neuropsychological testing.

Long-COVID prevention

The best way to prevent long-COVID symptoms is to prevent COVID infection. All persons should be recommended to get a bivalent COVID vaccine. Not only does vaccination reduce the chance of becoming infected in the first place but those who get infected despite being vaccinated are less likely to develop long-COVID symptoms than those who were never vaccinated. Those with risk factors for long-COVID such as being older, obese, or smokers should continue to take precautions against acute COVID infection including wearing masks in crowded indoor settings and avoiding contact with other people with acute infections. It is important to emphasis that recovery from a previous COVID infection is not protective because repeated COVID infection is an independent risk for developing long-COVID symptoms.

Long-COVID is very real and very common. But by listening to our patients and by using a symptom-driven approach to evaluation and rehabilitation, we can improve their lives.

May 26, 2023

A recent study in JAMA Internal Medicine showed that the number of hours physicians work per week has fallen significantly over the past 20 years. The data was derived from the U.S. Census Bureau’s Current Population Survey that included 87,297 monthly surveys of physicians between 2001 and 2021. During this 20-year period, the average number of hours worked per week has steadily fallen.

In the study, respondents were asked how many total hours they worked at all jobs during the previous week. The average weekly work hours from 2001 – 2003 were compared to average weekly work hours from 2019 – 2021. Overall, the average physician worked 52.6 hours per week in 2001 – 2003 and this number dropped to 48.6 hours per week in 2019 – 2021. When only physicians working full-time were included, the work hours decreased from 55.6 hours per week in 2001 – 2003 to 51.1 hours per week in 2019 – 2021.

There has been a change in work hours by physician age. In the time period 2001 – 2003, the youngest physicians (age 35 – 44) worked the most hours per week, followed by middle aged physicians (age 45 – 54), and then older physicians (age 55 – 64). In the more recent time period of 2019 – 2021, the opposite was true – older physicians (age 55 – 64) worked the more hours per week than younger physicians.

On average, male physicians currently work more hours per week (49.7 hours) than female physicians (46.8 hours). However, this gap has been narrowing with a gender difference of 5.3 hours per week in 2001 – 2003 versus a gender difference of 2.9 hours per week in 2019 – 2021. Differences in the percentage of women in different specialties may be responsible for some of the gender difference in hours worked per week. Other physician demographic variables did not differ significantly in the current number of hours worked per week including race, country of origin, urban vs. rural, and dual household earners versus single household earners.

The 2023 Medscape Physician Compensation Report surveyed 10,011 physicians between October 7, 2022 and January 17, 2023. The report found that there is substantial variation in physician work hours among different specialties. Hospital-based specialties that tend to involve patient care at night and on weekends work the most hours per week including critical care, general surgery, cardiology, and nephrology. On the other hand, outpatient specialties that generally do not require seeing patients at night or on weekends had the lowest work hours per week including allergy, dermatology, and ophthalmology. Emergency medicine also had a low number of hours worked per week, owing to the shift work nature of the specialty.

A problem with the Medscape survey is that all of the information is self-reported and thus susceptible to either over-estimation or under-estimation. Furthermore, the survey is voluntary and the physicians who choose to report data may not be truly representative of the population of physicians as a whole. Nevertheless, the recent Medscape data for work hours by specialty are remarkably similar to a 2011 study published in the Archives of Internal Medicine.

At the onset of the COVID-19 pandemic (during the 2nd quarter of 2020), the average number of hours physicians worked per week fell as elective procedures were canceled. However, weekly work hours quickly rebounded by the 3rd quarter of 2020 as shown in the graph below derived from data from the recent study in JAMA Internal Medicine. Notably, over the the 24 quarters from 2016 through 2021, the overall trend has been for physician work weeks to become shorter.

Do work week hours correlate with income?

Intuitively, one might assume that specialties with longer work weeks also have higher incomes. However, the 2023 Medscape Physician Compensation Survey indicates that there is little relationship between the number of hours worked per week and the annual compensation by specialty. The graph below shows average number of hours worked per week in red and annual compensation in blue for 29 specialties.

By combining the data from the two graphs above, we can calculate the average income per work-week hour. Note that this is not same as hourly compensation – that would require dividing the income per work-week hour by the number of weeks worked per year. The Medscape Physician Compensation Survey did not report the number of work vs. vacation weeks per year by specialty so true hourly compensation cannot be determined. The graph below shows that plastic surgeons, orthopedic surgeons, dermatologists, and radiologists have the highest income per work-week hour. Infectious disease specialists, family practitioners, pediatricians, and general internists have the lowest compensation per work-week hour. Notably, family medicine, pediatrics, and general internal medicine have shorter residencies (3 years) than the other specialties.

As stated in a previous post, the data for infectious disease is particularly alarming. Physicians specializing in infectious disease have the lowest income per work week hour of all 29 specialties in the Medscape Physician Compensation Survey. In order to become board-certified in infectious disease, a physician must first complete a 3-year internal medicine residency and then complete a 2-year infectious disease fellowship. However, infectious disease specialists have both a lower total annual income and a lower income per work week hour than general internists. The implication is that an infectious disease specialist is financially penalized for doing a 2-year fellowship after internal medicine residency. As a result, many infectious disease specialists are either supplementing their income by working part-time as hospitalists or are leaving the specialty of infectious disease altogether to work as general internists or hospitalists. Because of the nature of physician billing and RVU determination, it is not possible for infectious disease specialists to increase their income by professional billing alone. There is an urgent need for U.S. hospitals to financially supplement their infectious disease specialists in order to preserve the infectious disease physician workforce.

Physicians are working fewer hours but are they happier?

The Medscape Physician Compensation Report found that 73% of physicians would choose medicine again if they were just now starting their career. However, the Medscape survey five years ago found that 77% of physicians would choose medicine again, indicating that physicians are less satisfied with their careers now than five years ago.

Undoubtably, the COVID pandemic has had an impact on physician job satisfaction. During the pandemic, many physicians retired early or left the workforce for other jobs. In 2019, there were 989,684 clinically active physicians practicing in the United States. In 2021 that number fell to 923,419, a 6.7% decrease. Hopefully, as the pandemic winds down and the practice of medicine gets back to normal, the exodus of physicians from the profession will slow.

The continued creep in paperwork and administrative tasks is a dissatisfying factor for many doctors – physicians reported spending an average of 15.5 hours per week on these chores, of which 9 hours are for electronic medical record documentation. Advances in artificial intelligence technology offers hope that the use of electronic medical records will be streamlined in the near future, giving physicians more time to engage in direct patient care. Over the past decade, there have been increasing concerns raised about the extent of physician burnout. Long work hours have been suggested to be a cause of physician burnout but the data suggests that physicians are less satisfied despite working fewer hours than in the past.

What about nurse practitioners and physician assistants?

The large number of retiring physicians coupled with reduced physician work week hours indicates that the overall supply of physician services is declining. Over the past decade, this has been offset by an increase in nurse practitioners. It is far less expensive to train a physician assistant or nurse practitioner (6 years education post-high school) compared to a physician (11 to 16 years education post-high school, depending on specialty). Many services traditionally performed by physicians can be equally or near-equally performed by PAs and NPs. However, specialized medical care and complex procedures still require the additional training and experience of physician specialists and so there is a limit to the degree that PAs and NPs can substitute for physicians.

Are the numbers good or bad?

The reduction in physician work hours is both good and bad. It indicates an improvement in a profession that has historically been seen as arduously time-consuming. But it also implies reduced availability of physician services to the general population. In the future, reduction in administrative and paperwork time coupled with strategic utilization of NPs and PAs could allow physicians to enjoy a good lifestyle while still ensuring that Americans have access to the best possible healthcare.

May 2, 2023