In a bond market where corporate yields are a shadow of their former selves and Treasury yields begin with naught, investors are beating the bushes for vehicles with better income.

Tax-free municipal bonds have long been a desirable refuge for well-heeled investors, but the munibond market is now darkened by a cloud of potential risk from the coronavirus pandemic.

Many of these investors would do well to consider preferred shares, an asset class that’s overlooked even though it’s currently paying the highest after-tax yield of any fixed-income investment except corporate junk bonds.  

Though traded as shares of stock, preferred shares in many ways act like a bond. But unlike bonds, their yield is mainly in the form of qualified dividends--a key reason for their superior after-tax yields.

Issued mainly by banks, insurance companies and large financial firms, preferred shares fulfill different corporate financing goals. For investors, they can be an effective portfolio diversifier that delivers reliable income. If the worst happens and the issuing company tanks, preferred shareholders line up behind bondholders, but ahead of equity shareholders, for payment.

For shares of preferred stock in issues of intermediate duration, annual total yields in June averaged 5.1%. Most of this is qualified dividend income, on which individuals in the top bracket pay a tax rate of 20%, as opposed to the hurtful ordinary income tax rate of 37% that they pay on bond and short-term stock gains.

Preferred shares’ after-tax yield of 3.6% is substantially above the yield of tax-free municipal bonds--2.7%--and corporate bonds’ after-tax yield of 1.4%. And it’s not far below the 4.1% after-tax yield of junk bonds, considering that preferred shares have a critical advantage over them: better credit quality.

What counts most regarding preferred share credit is the issuing company, rather than any particular issue. It’s the nature of the beast for a company’s preferred share issues to have credit quality a few notches below that of the overall credit of the company itself. Preferred investors need to worry about the credit quality of the issuing company versus that of individual issues. If they buy the preferred shares of high-quality companies, they don’t need to worry about where they would stand in a bankruptcy line because staying away from companies with poor credit makes this consideration moot.

Questions about near-term credit quality currently surround munibonds because the local and state governments that issue them are experiencing negative impacts from the coronavirus—the double-whammy of less revenue and higher costs to deal with public health and safety measures. Top-rated muni issues, AA and above, are better able to weather storms, and concerns about risk center more on munis of lower credit quality. As of mid-July, rating agencies hadn’t downgraded munibond credit ratings over pandemic-related fiscal damage, presumably out of expectations that Congress will provide more fiscal support. Nonetheless, markets are watching the ratings closely.

To assess risk on an issue-by-issue basis, individual investors buying munis need to know the source of funds for paying interest. For example, a munibond that depends on revenue from a parking garage tied to a sports arena might have trouble meeting its obligations if games and concerts are cancelled due to the pandemic. But if interest payments come entirely from local government coffers, then concerns would center on the fiscal health of that government.

By contrast, preferred share investors currently don’t have such credit quandaries because institutions issuing are in good shape with good outlooks. Consider these scenarios:

Banks have long met the Fed’s stress-test requirements spawned by the financial crisis of 2008. And on June 25, 2020 

 stress test results showing that banks are “a source of strength” amid the pandemic. Even if banks begin to show weaknesses, the Fed’s actions in 2008-09 indicate a likely willingness to shore them up again to protect the economy. Moreover, most big banks currently have good balance sheets and profitability, enabling them to continue paying dividends to preferred shareholders.

There’s a low probability that insurance company issuers will have to pay claims related to the pandemic because efforts to retroactively define policy terms to trigger such liability seem likely to fail.

The financial services sector continues to be fortified by high international demand for U.S. securities, meaning good revenue ahead for large financial services firms issuing preferred shares.

However attractive preferred shares are right now, there’s a limit to how heavily the average investor should probably invest in them for a number of reasons. Among these is that credit quality can be confusing. An issuer may have a rating of A2 by Moody’s, but their preferred might be rated Baa2 due to its place in line to get paid back in the event of bankruptcy.

Further, it’s generally not advisable for the average individual investor to have more than 15% of a portfolio in preferred shares, though investors with higher risk tolerances, substantial assets and high income are in a position to go heavier—and may want to during this period of bottom-scraping bond yields. 

In allocating resources to preferred shares, investors should be aware of the degree to which their value moves with other asset classes. A correlation of 1.0 means that the value of investments in one asset class tends to vary directly with another. The 10-year monthly correlation of S&P Preferred Total Return Index to the S&P 500 stock index is .65. The preferred index has a .299 correlation to the US Aggregate Bond Index, making preferred shares an even better diversifier against bonds than they are against stocks.

While all investors like superior yield, preferred shares aren’t for everyone because their hybrid nature tends to make them quite complicated. Issues aren’t uniform in nature, issuer versus issue credit ratings can be confusing and information on their various differences and downsides can be difficult to find.

Accordingly, it’s best for individual investors to avoid indexes and stick to actively managed mutual funds. Passively managed preferred funds (the category of most preferred ETFs) tend to underperform actively managed funds because, in tracking indexes, they can’t avoid undesirable issues. For investors, this can result in loss of principal, offsetting gains from dividends—a dynamic that has been demonstrated in Morningstar studies. But active managers can avoid these pitfalls by picking and choosing between issues. For investors, avoiding the indexes is usually well worth the expense of active management.  

While fund shareholders can benefit from active management, choosing funds involves its own complexities. Some function as closed-end funds, meaning that shares can only be sold on an exchange, perhaps at a discount to net-asset-value. And many closed-end funds employ leverage, further exacerbating price movement, so research before buying is critical.

Also, many funds that bear the “preferred” moniker invest in more than just preferred shares. Many also trade various complex forms of debt that are esoteric to the average investor and fall into the broader category of “preferred securities.” This can present individual investors with a steep learning curve.

Yet, for individual investors willing to do the homework to expand their knowledge of the vast fixed-income world—or for those who have qualified advisors to guide them through it&mdash;preferred shares and actively managed funds can be used effectively to garner superior after-tax yields with relatively low risk.  

Dave Sheaff Gilreath is a founding principal and J.R. Humphreys is a senior portfolio manager with Sheaff Brock Investment Advisors LLC, an investment management firm based in Indianapolis. The firm, which Gilreath started with partner Ron Brock in 2001, started out managing $60 million in assets, which have since grown to about $1 billion

Gilreath is a Certified Financial Planner®. 

Humphreys is a Chartered Financial Analyst® 

and a Chartered Alternative Investment Analyst.

This Overlooked Fixed-Income Vehicle Pays High Yields 

 JR Humphreys

This article, "Satralizumab Approved for Treatment of Neuromyelitis Optica Spectrum Disorder," was originally published in NeurologyLive.

The US Food and Drug Administration (FDA) has approved satralizumab for the treatment of adult patients with anti-aquaporin-4 (AQP4-IgG) antibody positive 

neuromyelitis optica spectrum disorder (NMOSD)

The approval, awarded to Genentech, is only the second targeted treatment for this patient population and the first eligible for at-home administration.

Marketed under the name Enspryng, the humanized monoclonal antibody targets and inhibits interleukin-6 receptor activity, which is thought to play a key role in the inflammation observed in 

Novel recycling technology allows for a longer duration of antibody circulation, translating into a subcutaneous dosing regimen of every 4 weeks after an initial loading dose.

The approval pins satralizumab against the only other targeted treatment in this space, Alexion’s eculizumab (Soliris), which was approved with the same indication on June 27, 2019.

“For people with NMOSD, relapses can cause devastating, irreversible and disabling neurological effects,” Jeffrey Bennett, MD, PhD, professor of neurology and ophthalmology at the University of Colorado, and an investigator for the satralizumab pivotal clinical trials, said in a statement. “Having an approved therapy that can be administered subcutaneously in the home and has demonstrated an impact on the frequency of relapses is an important advancement for patients.”

Satralizumab’s approval was based on robust data from the phase 3 SAkuraStar and SAkuraSky clinical trials, which combined included more than 170 patients who were randomly assigned to receive satralizumab 120 mg or placebo.

In SAkuraSky, patients added treatment to baseline immunosuppressive therapy.

All patients received a loading dose of the study drug at baseline, week 2, and week 4, followed by 4-week treatment intervals.

The primary end point in both studies was time to protocol-defined relapse. Notably, both studies included a population of patients who were AQP4-IgG antibody positive and negative to accurately reflect clinical practice.

In SAkuraStar, 30% of patients treated with 

 experienced relapse compared with 50% of those who received placebo (HR 0.45; 95% CI, 0.23–0.89; 

Among those who were AQP4-IgG antibody positive, a 74% reduction in relapse risk was observed.

In the overall satralizumab-treated population, 76.1% and 72.1% were relapse-free at 48 and 96 weeks, respectively, compared with 61.9% and 51.2% with placebo.

Data from the AQP4-IgG seropositive subgroup showed that 82.9% and 76.5% were relapse-free at 48 and 96 weeks compared with 55.4% and 41.1% with placebo, respectively.

In total, 92% (n = 58) of those in the satralizumab group experienced an adverse event compared with 75% (n = 24) of the placebo group. Serious AEs were similar between groups; only 1 event led to study drug discontinuation in the treatment group.

In SAkuraSky, the overall population saw a 62% reduction in the risk of relapse (HR 0.38, 95% CI, 0.16-0.88; 

 =.0184), while the group of AQP4-IgG seropositive patients experienced a 79% reduction in relapse risk (HR 0.21, 95% CI, 0.06-0.75; 

Results showed 88.9% and 77.6% of patients in the total population were relapse-free at 48 and 96 weeks, respectively, compared with 66% and 58.7% of patients in the placebo group.

Among AQP4-IgG seropositive patients, 91.5% treated with satralizumab were relapse-free at 48 and 96 weeks compared with 59.9% and 53.3% of patients in the placebo group.

The most common AEs observed were upper respiratory tract infection, nasopharyngitis, and headache.

Genentech reports that the drug will be available in the US within 2 weeks. It is already approved and available in Japan, Canada, and Switzerland, with applications under review in the European Union and China.

Satralizumab represents only the second targeted treatment for NMOSD and the first cleared for at-home administration.

FDA Approves New Neuromyelitis Optica Spectrum Disorder Treatment

Alicia Bigica

I spoke to a patient, a 63-year-old woman who immigrated to the United States from Central America in 1978, about her experience living with liver disease. She is now an 

 NAFLD patient advocate who was diagnosed with autoimmune hepatitis and NAFLD in 2005. After experiencing the devastation of her diagnosis, she has managed to learn to live with the disease and wants to help others achieve better quality of life.

Our patient had been diagnosed with autoimmune hepatitis for several years and doing well. She developed pain in her upper right abdomen and saw three specialists. They assumed she was an alcoholic even though she told them she didn’t drink. She talked to her primary care physician who sent her to a liver specialist. 

The doctor spent 90 minutes talking to her and, based on blood work every three months and ultrasounds every six months, determined that her autoimmune hepatitis medication- prednisone, was causing fatty liver. It took three liver biopsies to confirm the diagnosis of NAFLD on top of autoimmune hepatitis.

Helpful Tips About Healthy Diet and Finding Support

This woman has made huge changes to her lifestyle. Sheexercises regularly, meditates, drinks plenty of water and has changedher eating habits by following a healthy diet and avoiding sugary drinks, such as soda and concentrated juice drinks. She prepares her own food and only takes medicine prescribed by a physician, who do so with caution because she has been at the last stage of liver cirrhosis for the last three years.

Though difficult, she has learned to avoid greasy foods found in fast food restaurants, eats abundant greens, incorporates fruit into her breakfast and vegetables for lunch. She’s learned to prepare food in different ways by sautéing, baking or grilling her food using olive oil. She does not fry her food, which she may have done previously. She avoids additives and salt, relying instead on herbs and spices.

Before trying new foods, she and her caregivers research its possible impact on the liver. When she buys groceries, she avoids red meat, high fructose corn syrup and anything with more than five ingredients. She also practices portion control and learned that the palm of your hand is the amount of meat you should eat, which for her is mostly fish, chicken and occasionally lobster.

She advises people tofollow their doctors’ orders and, once diagnosed, find a support group to learn and share information with others living with the same disease. People can find information online from organizations, such as the 

, and Facebook groups, such as Living with Cirrhosis, Living with Fatty Liver/NASH.

She is a true reflection of what it is to live with chronic liver diseases and how changing in your lifestyle can improve liver health and overall health.

This article is the final installment of four articles exploring the epidemic of liver disease called nonalcoholic fatty liver disease and its more severe form, nonalcoholic steatohepatitis.

The Multiple, Complex Challenges of Living with and Managing Liver Disease

Amreen Dinani, MD

Nonalcoholic fatty liver disease (NAFLD) is gaining more attention as a chronic medical condition, affecting approximately 25% of the worldwide population and 100 million individuals in the United States.

 NAFLD, is an umbrella term for a range of liver conditions that occurs as a result of fat in the liver. 

This is in the absence of excessive alcohol use or other causes of fatty liver disease. Its more serious form is called non-alcoholic steatohepatitis (NASH),

 which affects 6-8% of the global population and is expected to increase 63% by 2030.

NAFLD can lead to inflammation of the liver, liver tissue damage and liver scarring (fibrosis), which can progress to cirrhosis and liver cancer (hepatocellular carcinoma). NAFLD is on track to become the leading cause of liver transplantation in the United States.

Patients with NASH typically have no or few symptoms, especially in the early stages of the disease. When a patient feels well, it can be challenging for physicians and caregivers to convince the patient that they may have a dangerous condition.

Obesity and type 2 diabetes mellitus are the leading risk factors for NAFLD. The rising population of NAFLD, closely mirrors the growing epidemic of obesity and type 2 diabetes mellitus.

Presence of metabolic syndrome is also a risk factor for the development of NAFLD. 

Several genetic predisposing factors are related to NAFLD and NASH; these genetic factors are most prevalent in Hispanics

 and associated with more aggressive disease. In individuals who do not develop cirrhosis, the leading causes of death are related to cardiovascular disease and non-liver related cancers.

The most accurate way to diagnose NAFLD and NASH and liver scarring is with a liver biopsy. This is invasive, can be expensive and has potential side effects. The need for non-invasive tests and point-of-care testing to diagnose and monitor assessment of liver fat and liver scarring are critical to helping identify individuals with NASH at risk of progression to cirrhosis.

Primary care physicians can play a central role in identifying at risk individuals because many patients with comorbidities, such as type 2 diabetes, are cared for by primary care physicians. In addition, they can assist in managing comorbidities such as obesity, type 2 diabetes and cardiovascular disease. Other subspecialties that see these patients are endocrinology, cardiology and bariatric medicine. There is a need to raise awareness on liver health.

The key message for caregivers is that NAFLD is manageable, and potentially reversible if caught in its early stages. Diet and exercise are the most effective treatments, but poor adherence often makes this a challenge for many people.

Part 2 of this series looks at current diagnostic tools and new non-invasive tests for liver disease. It will run on September 13.

 is an Assistant Professor in the Department of Medicine, Division of Liver Diseases. Dr. Dinani’s clinical and research interests are in nonalcoholic fatty liver disease (NAFLD). She is an investigator for many ongoing clinical trials in NALFD.

 is the Hepatology Section Head at the Ochsner MultiOrgan Transplant Institute. He has published literature related to his research around advanced liver disease and its complications, such as portal hypertension and cirrhotic cardiomyopathy. His current research has focused on adult deceased and living donor liver transplantation and quality of life issues in liver patients.

Clinicians, researchers, and experts interested replying to this submission, or submitting their own work to HCPLive, can contact the editorial team 

Perumpail BJ, Khan MA, Yoo ER, Cholankeril G, Kim D, Ahmed A. Clinical epidemiology and disease burden of nonalcoholic fatty liver disease. 

. 2017;23(47):8263-8276. doi:10.3748/wjg.v23.i47.8263. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5743497/

https://liverfoundation.org/for-patients/about-the-liver/diseases-of-the-liver/non-alcoholic-fatty-liver-disease/#facts-at-a-glance

https://www.the-nash-education-program.com/what-is-nash/how-prevalent-is-nash/

 Centers for Disease Control and Prevention (2018). 

Behavioral Risk Factor Surveillance System

Pan JJ, Fallon MB. Gender and racial differences in nonalcoholic fatty liver disease. 

. 2014;6(5):274-283. doi:10.4254/wjh.v6.i5.274; accessed July 28, 2020.

This article is the first in a series of 4 articles exploring the epidemic of liver disease called nonalcoholic fatty liver disease and its more severe form, nonalcoholic steatohepatitis.

The Battle Against Growing Burden of “Silent” Liver Disease Begins with Early Detection

Amreen Dinani, MD; George Therapondos, MD

Healthcare is in a state of flux. As extraordinary measures are taken to stem the spread of the coronavirus, regular medical care—from routine checkups and screenings to in-office treatments and procedures—has been subject to significant disruptions and challenges. Social distancing requirements of the 

 pandemic have created new limitations on in-person physician visits. 

Office closures and safety concerns have resulted in the delay or cancelation of medical appointments for some patients. Compounding matters is the dynamic and uncertain nature of the pandemic. The issues that patients and physicians are confronting today have evolved since the COVID-19 shutdowns began in March—and further change is undoubtedly on the horizon.

 patients and their eye care professionals, the pandemic has led to an array of stressors, given the progressive but indolent nature of a disease that can lead to blindness and requires close ongoing monitoring and treatment. The current health environment is particularly worrisome for elderly patients because they are most at risk for vision loss from glaucoma and are also among the highest risk groups for COVID-19 mortality.

To better understand the concerns and experiences of glaucoma patients during the pandemic, the Glaucoma Research Foundation (GRF) commissioned an online survey in May 2020. The aim was to gain valuable, real-time patient input that can help eye care professionals better address patients’ emotional needs as they adapt to the new, and continually changing, care requirements of COVID-19. 

The GRF survey, which was supported by Aerie Pharmaceuticals, assessed patients’ confidence in their disease management during the pandemic; specific disease management concerns; patients’ experience with telemedicine; and patients’ comfort in returning to eye professionals’ offices. The survey drew a national response, with 1051 adult glaucoma patients from 49 states participating in the questionnaire.

The survey findings bring to light several key considerations for ophthalmology practices evolving glaucoma care in the COVID-19 environment.

Notably, the survey found that more than half of respondents (53%) had to delay and/or cancel an eye care appointment during the first months of the pandemic. These disruptions seem to have significantly impacted patients’ confidence in their disease management, with approximately one-third (36%) of glaucoma patients surveyed saying they were not confident that their disease was well-managed. Those who had the lowest confidence levels in their glaucoma management were 30% more likely to have had an eye care appointment delayed or canceled.

This feedback highlights the central role of communication in enhancing glaucoma care and the importance of nurturing the physician-patient relationship during the pandemic. With physician offices open again, personal and direct doctor-patient communication is paramount to helping patients understand their unique level of risk and rebuild confidence in their disease management. 

Without scaring patients, it’s important that they understand the consequences of delaying an office visit and the real risk it may have for further, even permanent, vision loss.

At my practice in San Francisco, we went through every patient record that had an appointment during the early phase of the pandemic and conducted a risk assessment. We then communicated with each patient to make them aware of their particular situation and the risk of not coming in to be evaluated when our office reopened.

The first step was to speak with our staff about our responsibility to be safe, not just in the office, but also outside of work, with specifics about how to minimize risk. I sought their input and we developed together an action plan with new office protocols.

We also invested in an expansion of our office team. With this increased staff, we are able to directly answer more patient calls and engage in longer, in-depth conversations. In addition, we have placed a greeter at our main entrance who screens patients, which includes basic health questions, a temperature check, and a check for an appropriate mask. 

After completing these safety protocols, the greeter asks patients to use hand sanitizer prior to entering the clinic. These new measures have played a valuable role in boosting our patients’ confidence in their disease management during the pandemic.

The “COVID-19 Office” and Telemedicine

The survey also reveals that glaucoma patients place high value on being able to see their physician in person. Six in 10 (63%) respondents said they are comfortable returning to their eye doctors’ offices as long as social distancing measures, such as face masks and less crowded waiting rooms, are implemented. This preference for in-person physician visits, coupled with technology challenges, make patients largely uninterested in telemedicine. A vast majority (87%) of glaucoma patients surveyed said they would rather wait six weeks for an in-person office visit than have a telemedicine visit in two weeks.

While telemedicine has been a valuable tool in other medical specialties during the pandemic, it has significant limitations for standard diagnostic procedures in glaucoma care. Since intraocular pressure (IOP) checks, visual field evaluation, and other tests cannot be easily conducted virtually, practitioners may lose considerable clinical information by trying to manage glaucoma via telemedicine.

During these unprecedented times, the safety and well-being of patients is the principal concern of all eye care professionals. It is also important to consider the needs of your staff as well. At my center, we have modified several standard procedures that not only have enhanced patient safety during COVID-19 but have also made us operate more efficiently and safely as an eye care practice. 

I have found that when members of my office team feel safe at work, their calmness and confidence extend to the patient-provider relationship, helping patients feel more comfortable about the visit. By fostering a caring and professional approach to glaucoma care in the midst of uncertainty, we can all navigate the COVID-19 pandemic while continuing to protect the vision of our patients.

Andrew Iwach, MD, is Executive Director of the Glaucoma Center of San Francisco, Associate Clinical Professor of Ophthalmology at the University of California, San Francisco, and a faculty instructor at the California Pacific Medical Center Department of Ophthalmology. 

The article reflects the views of the author, not necessarily those of the publication.

A new survey assessed patients’ confidence in their disease management during the pandemic, specific disease management concerns, and experiences with telemedicine.

Managing Glaucoma During COVID-19: Patients Point the Way to Improved Care

Andrew Iwach, MD

We have heard the statistics many times. There are more than 7000 

 and for more than 90%, there are no treatments available. Our organization supports a community affected by one of the 90%—Niemann-Pick Disease including ASMD and NPC, both rare genetic, progressive, and often-fatal lysosomal storage disorders.

There are fewer than 2000 known cases worldwide, many affecting children. Symptoms include cognitive impairment, clumsiness and difficulty walking, enlarged spleen and liver, difficulty swallowing and eating, fatigue, increased fracture risk, and early satiety. There are currently no approved treatment options in the US.

The great news for the Niemann-Pick community is that promising treatments are in the later stages of clinical development with the potential for regulatory approval in the coming year. Achieving this milestone would be a significant victory for patients and their families who face significant challenges living with Niemann-Pick. But this potential good news also highlights an important consideration in planning for the introduction of new treatments for patients who are in desperate need. How do you prepare patients and families to transition from an era of no hope to one where treatment is available?

Much of our work at the National Niemann-Pick Disease Foundation (NNPDF) in recent years has focused on meeting this challenge head on and our approach in many ways serves as a template that other rare disease communities might consider.

From our earliest days, NNPDF has provided support services to patients living with Nieman-Pick Disease and their families. These efforts have focused on building broader awareness of the disease and helping to identify and expand the services and resources that families need.

We have also taken steps to keep families updated about the range of clinical research programs that have been initiated in recent years to try to develop new treatments. Our recent annual conference included a full schedule of presentations and updates on these clinical research programs, and we had more participants in our virtual meeting this year than ever before.

As we continue our focus on disease awareness and patient support, we have also in recent years had to expand our efforts to include both information and education to prepare the Niemann-Pick community to transition to an era when treatment might be available. In addition to helping families learn about and understand the process for developing and approving drugs in the US, we are also now providing resources to help them better understand and manage issues related to their healthcare coverage, reimbursement, patient access and industry-sponsored financial assistance programs.

We are helping them understand that there will be indications and eligibility criteria for different treatments and that NNPDF is working to ensure that access to treatment through healthcare coverage is available to as many patients as possible. We are also developing new resources that outline the important questions and topics that patients and families should discuss with their medical provider to empower them to take a more active role in often complex treatment decisions.

While availability of treatment is good news, many of the issues associated with patient access can cause stress and confusion. An important goal in developing programs related to the introduction of an approved treatment is to help reduce anxiety and outline a clear path forward in accessing care. For many rare disease communities, another daunting but welcome challenge for many families may be the need to reconsider many longstanding plans for the future once approved treatment is available.

In many cases, an approved treatment will mean major changes in how patients think about their own health, plan for their care, and engage with their medical teams. Treatment may present new challenges that require careful planning and monitoring. Patients and caregivers might need to reassess plans related to education, careers, job training, and living independently. Once again, our goal must be to provide the insights and support services that can help reduce any challenges associated with making important life decisions at every stage.

The final focus in supporting patients is often related to helping them manage expectations. In many cases, treatments for rare diseases will have some limitations in areas including efficacy, safety and cost. Advocacy leaders can play a role in helping their communities work with their healthcare teams to assess, understand, and address all the factors related to treatment so that patients and caregivers can make informed decisions.

In some cases, patients and caregivers may need very targeted services to support their psychological and emotional health. Peer-to-peer connections can be especially effective in helping patients handle the emotional impact of the transition to treatment.

Of course, none of these challenges should dampen the new hope that a first approved treatment can bring to a rare disease community. A first treatment is both a milestone and a sign that research is advancing and could lead to more personalized treatment options or combination therapies in the years ahead.

By recognizing the needs of patients and families whenever a new treatment becomes available, advocacy organizations can continue to lead in bringing them the targeted information and support they need to access care and thrive. The key is recognizing that an approved treatment and a new standard of care is not the end of the road in patient advocacy. It is a new direction and the beginning of a new era of hope that requires careful planning, new resources and very customized support.

Joslyn Crowe, MSW, MA, is executive director of the National Niemann-Pick Disease Foundation, Inc., a non-profit, unbiased patient advocacy and family support organization dedicated to supporting and empowering patients and families affected by Niemann-Pick disease, through education, collaboration and research.

The views expressed in this piece are those of the author, not necessarily those of the publication.

Healthcare experts and clinicians interested in contributing to HCPLive may contact the editorial staff 

Getting a Treatment Is Not the End of the Road in Rare Diseases

Joslyn Crowe

Previously, we reported the clinical and economic outcomes of an intent-to-treat analysis of the combined 10 years of the Diabetes Prevention Program/Diabetes Prevention Program Outcomes Study (DPP/DPPOS).

 In that analysis, participants were analyzed according to their randomized treatment group whether or not they adhered to their assigned treatment. In this paper, we report the results of an “on treatment” or “per protocol” analysis of DPP/ DPPOS. We assess outcomes by treatment group for participants who were adherent to their randomized assignments and compare the effectiveness and cost utility of the intensive lifestyle intervention (lifestyle) and the metformin intervention (metformin) with the placebo intervention (placebo).

Our previously published 10-year intent-to-treat analysis of DPP/ DPPOS used data from all randomized participants including those who did not adhere to their randomized treatments, and so likely underestimated both the effectiveness and the benefits of lifestyle and metformin. In real-world clinical practice, neither costs nor benefits are incurred by nonparticipants, but among participants, both intervention costs and benefits are likely to be greater. Our goal in this analysis of the DPP/ DPPOS is to extend our previous analyses to estimate the clinical effectiveness and cost-effectiveness of diabetes prevention among metformin participants who remained on treatment with metformin and lifestyle participants who succeeded in losing weight.

The DPP enrolled 3234 participants with impaired glucose tolerance and fasting hyperglycemia who were at least 25 years of age and had body mass index of 24 kg/m

 The protocol and informed consent procedures were approved by all responsible institutional review boards. Participants signed written consent forms after discussion of all aspects of the study with study staff. For this analysis, we assigned costs related to finding the participants randomized to lifestyle and metformin but not the participants randomized to placebo. In estimating the costs of finding participants, we assumed that 10.4% of adults aged 45 to 74 years would be eligible to participate.

 We further assumed that potentially eligible subjects would be tested with a random capillary glucose level.

110 mg/dl, an oral glucose tolerance test (OGTT) would be performed

 and those with abnormal OGTTs would have a 15-minute visit with a physician to discuss the results. Based on the sensitivity, specificity, and reproducibility of the tests, we estimated that 12.8% of subjects screened would be eligible to participate in the DPP and that the average cost per eligible participant identified would be $173.

 of this article, which was originally published in 

Over 10 years, lifestyle intervention and metformin were cost-effective or cost saving compared with placebo.

Effectiveness and Cost-Effectiveness of Diabetes Prevention among Adherent Participants

Robert E. Ratner, MD

 available to physicians in numerous industries and sectors. An employee with a medical degree is an asset not just to hospitals and medical practices, but to any organization whose product or service relates to health, health care, or disease management.

Unfortunately, there is a tendency to think of nonclinical careers as a path taken only by physicians who are burned out, frustrated with clinical work, or unable to obtain a medical license. The phrase "nonclinical career" tends to be used interchangeably with "leaving medicine," which is far from accurate. There are many jobs that don't involve patient care activities but that do rely heavily on a doctor's medical knowledge, experience, and skills.

Nonclinical jobs come with many potential benefits. These depend on various factors related to the physician and the job; however, several tend to emerge frequently across the spectrum of nonclinical careers. This article covers five common benefits of nonclinical jobs for physicians.

Nonclinical jobs are often accompanied by a better work-life balance compared to clinical jobs. They tend to require fewer hours of work each week, and those hours are often regular and somewhat flexible. Most have no on-call duties and don't require work on weekends or holidays.

Some doctors, even when not at work, are burdened by worry about their patients. (

Did I make the right treatment decision? Did I miss an important clinical finding?

) While nonclinical work certainly comes with challenges, individual patient lives are not on the line, which can greatly decrease the amount of off-the-clock anxiety.

Taking a nonclinical job may mean that you exchange patient appointments for meetings and patient charting for emails; however, the pace of nonclinical work tends to be less hectic. You're be able to focus on a project without frequent interruptions.

Your annual salary in a nonclinical position is unlikely to be much more than you're used to making as an employed physician doing clinical work. The salary may even be significantly lower, depending on the job and your specialty. Despite this, a nonclinical career is a smart financial decision for many doctors.

Nonclinical careers tend have career advancement opportunities more so than clinical practice. Salary increases come with this. Additionally, some employers in the private sector offer nonclinical physicians bonuses based on company and individual performance.

Fewer work hours enjoyed by many doctors in nonclinical positions means that they have more free time and energy to dedicate to income-generating activities outside of their day jobs. These can be engaging in consulting or freelance work, starting a small business, or even 

Fear of malpractice suits is widespread among medical providers. This fear is not unjustified. More than 

 have a medical liability lawsuit filed against them at some point in their careers. The litigious environment of health care delivery has several consequences for physicians in addition to fear:

Practice time lost due to time spent on legal issues

Potential for loss of personal and professional assets

Liability and risk exist in any type of work, though risk tends to be far less in nonclinical jobs. Because you are not directly making management decisions for patients, there is limited potential for patients to sue you.

Physicians often see the same diagnoses and perform the same procedures repeatedly. Truly unique and interesting medical cases are sporadic among a primary care physician's cases of hypertension, back pain, and dermatitis.

Routine and tedious work happens in nonclinical jobs, as well; however, in many types of jobs, it is less frequent. Shifts in organizational priorities are commonplace and some companies regularly develop new products or lines of business. A nonclinical physician's activities within a pharmaceutical company may change significantly when a new drug enters the pipeline, for example.

In many companies, nonclinical physicians are able to transition between teams. For instance, a physician doing utilization management for a health insurance company may have the chance to shift to the insurer's population health and analytics division. Physicians with nonclinical careers can easily transition between companies using their blend of medical expertise and industry knowledge.

The benefits of a nonclinical job are not just benefits to the physicians holding those jobs. In many cases, the work of a nonclinical doctor positively impacts the overall health of an entire population of patients or consumers. Rather than treating individual patients, nonclinical roles allow physicians to use their medical skills in a broader way. Here are several examples:

A Health Officer in a county or state health department promotes and protects the health of the population in a geographic area.

 impacts the health of plan's entire membership.

An entire customer market is influenced by the work of a physician in a company that develops any type of health-related technology, whether the customers are individuals, healthcare systems, or physician practices.

Physicians can undoubtedly be influential without directly treating a panel of patients.

A nonclinical job may have other benefits to you

These are only five potential benefits to nonclinical jobs for physicians. There may be several more that apply to you, depending on your interests and the value you can offer in a nonclinical work setting. Perhaps you'd benefit from doing less administrative work, being able to travel, or having the opportunity to work with a specific population demographic. Your career is your own, and how you choose to use - and benefit from - your medical training and experience is up to you.

Sylvie Stacy received her MD from the University of Massachusetts Medical School and completed a residency in preventive medicine at Johns Hopkins, obtaining an MPH along the way. She has held nonclinical jobs in medical writing, medical education, utilization management, and clinical documentation improvement. Her blog and online community, 

, aims to equip medical professionals with the information and knowledge needed to take charge of their professional fulfillment and earn income doing work they enjoy. She recently published the book 

The phrase "nonclinical career" tends to be used interchangeably with "leaving medicine," which is far from accurate.

5 Benefits to Having a Nonclinical Job as a Doctor

Sylvie Stacy, MD, MPH

Takeda Pharmaceuticals

This article was originally published on 

 were more likely to experience the neurological complications, including bleeding in the brain and stroke, that come with the virus.

Based on CT and MRI images, investigators from the Perelman School of Medicine at the University of Pennsylvania determined that these chronic conditions could play a role in which patients are impacted by more than just the hallmark lung inflammation that comes with viral infection.

“COVID-19’s effects extend far beyond the chest,” said lead study author Colbey W. Freeman, M.D., chief resident in the Penn Medicine radiology department. “While complications in the brain are rare, they are an increasingly reported and potentially devastating consequence of COVID-19 infection.”

Freeman’s team will present their findings during this year’s Radiological Society of North America (RSNA) annual meeting. 

In an effort to better understand how COVID-19 impacts the body, they examined head CT and/or MRI images for patients positive for the virus who presented to the University of Pennsylvania health system from January 2020-April 2020.

A total of 81 of the 1,357 COVID-19-positive patients who were admitted underwent a brain scan prompted by either altered mental state or focal neurological deficits, including speech and vision problems.

Based on the team’s analysis, 18 patients – slightly over 20% – had findings that were considered critical, such as strokes, brain bleeds, or blocked blood vessels. And, of that group, at least half also had a pre-existing history of high blood pressure or type 2 diabetes.

“COVID-19 is associated with neurological manifestations, and hypertension and type 2 diabetes mellitus are common in individuals who develop these manifestations,” Freeman said. “These populations may be at higher risk for neurologic complications and should be monitored closely.”

The team also found that two-thirds of the patients who had critical findings were African American, indicating COVID-19 positive patients in that minority group should be monitored more closely. And, among the entire group of 18 with emergent findings, three died while in the hospital, the team said.

Although this study revealed a role for high blood pressure and type 2 diabetes in the neurological impact of the virus, investigators still do not know exactly what causes those complications.

The mechanisms could be multi-factorial, and the generally accepted belief is that infection-associated inflammation is responsible, they said. In this study, in particular, they reported blood markers for inflammation were high in patients who had critical results.

“When your body is in an inflammatory state, it produces all these molecules called cytokines to help recruit the immune system to perform its function,” Freeman said. “Unfortunately, if cytokines are over-produced, the immune response actually starts doing damage.”

Using data from this study, the team is also looking at the how frequently COVID-19-positive patients on extracorporeal membrane oxygenation (ECMO) – a pump system that circulates and replenishes oxygen in the blood – experience neurological complications. Many patients included in this study required ECMO during hospitalization.

About 20% of 81 positive patients experienced critical neurological complications; further, half had a pre-existing history of high blood pressure or type 2 diabetes.

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