Severe Hypoglycemia Linked With Over-the-Counter Supplement
An over-the-counter supplement promising male sexual enhancement led at least 17 men in Virginia to develop severe hypoglycemia in 2019, the CDC reported. (Source: JAMA)
Source: JAMA - August 11, 2020 Category: General Medicine Source Type: research

Emerging Drug-Resistant Meningitis Detected in the US
Although rare in the US, antibiotic-resistant strains of Neisseria meningitidis have been detected in a dozen states, according to a CDC report. (Source: JAMA)
Source: JAMA - August 11, 2020 Category: General Medicine Source Type: research

Virus Surveillance and Diagnosis With a CRISPR-Based Platform
A newly developed technology draws on the latest genome editing advances to detect viruses at scale —including the one that causes coronavirus disease 2019 (COVID-19)—for surveillance and diagnostic purposes. The innovation, recently described in Nature, uses clustered regularly interspaced short palindromic repeats (CRISPR) and CRISPR–associated protein 13 (Cas13), gene editing tools based on a bacterial defense system against invading viruses. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Correction to Data in Trial of Convalescent Plasma Treatment for COVID-19
This article was corrected online and a letter of explanation accompanies this correction. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Breast Cancer Drug Can Be Given at Home or in the Clinic
A formulation of pertuzumab and trastuzumab that health care professionals can administer by subcutaneous injection in a patient ’s home instead of intravenously in an infusion center has received approval for adults with certain types of breast cancer. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

First-in-Class HIV Drug Is Approved
A new medication has been approved for patients with HIV infection who, after receiving multiple treatments, have exhausted other options because of drug resistance, intolerance, or safety issues. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Immunotherapy Is Now First-line Therapy for Some Colorectal Cancers
Pembrolizumab is the first immunotherapy drug approved as a first-line treatment for patients with certain types of colorectal cancer that can be administered without initial chemotherapy. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Audio Highlights
Listen to the JAMA Editor ’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

COVID-19 and Massive Job Losses Will Test the US Health Insurance Safety Net
With massive and rapid job losses during the current economic crisis related to the coronavirus disease 2019 (COVID-19) pandemic, the US is at risk of a historic decrease in job-based health insurance. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

The Future of the Physician
(Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Prevalence, Characteristics, and Costs of Urgent Care Center Membership Programs
This study uses simulated patient phone calls to a random selection of US urgent care clinics (UCCs) to describe the proportion that offer membership programs with access to discounted visits for recurring fees and the characteristics (affiliations, accreditations, population income) and fees and charges of those that do. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Intravenous Interferon β-1a for Severe ARDS
To the Editor Dr Ranieri and colleagues found that intravenous interferon (IFN) β-1a administered for 6 days, compared with placebo, did not result in significant improvement in a composite score that included death and ventilator-free days over a total of 28 days in patients with acute respiratory distress syndrome (ARDS). Some important issues remain to be discussed. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Research and Development Costs of New Drugs
To the Editor Using publicly available data, Dr Wouters and colleagues estimated a mean cost for research and development of 63 products of $1335.9 million. This finding is noteworthy given that DiMasi and colleagues estimated a mean research and development cost of $2800 million based on data for 106 products developed by 10 large firms. Wouters and colleagues attributed this difference, among other reasons, to higher clinical costs incurred by larger pharmaceutical firms in the sample of DiMasi et al. The sample used by Wouters and colleagues contained 41% of US pharmaceutical firms with a market capitalization greater t...
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Research and Development Costs of New Drugs
To the Editor The study by Dr Wouters and colleagues estimated the cost of pharmaceutical research and development using publicly available data. However, the discussion failed to address certain salient factors. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Research and Development Costs of New Drugs
To the Editor The article by Dr Wouters and colleagues compared their estimate of the mean cost of developing a new drug with that found in a study by myself and colleagues. Their base case mean cost per approved new drug of $1.3 billion (in 2018 US dollars) stands in contrast to our estimate of $2.8 billion (2018 US dollars). The authors acknowledged that their sample was nonrepresentative in a number of drug characteristics (including therapeutic class) and by firm size (primarily small firms). Given that our sample consisted of midsized to large firms, their results could be viewed as complementary. Wouters and colleagu...
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Errors in Trial of Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
To the Editor My coauthors and I recently undertook a review of the Original Investigation “Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial,” published online in JAMA on June 3, 2020. In this trial, we assessed the effect of convalescent plasma therapy in addition to standard treat ment vs standard treatment alone among 103 patients with coronavirus disease 2019 (COVID-19), stratified by disease severity. The primary outcome was time to clinical improvement within 28 days. We found that among patients with s...
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Intravenous Interferon β-1a for Severe ARDS—Reply
In Reply Drs Zhou and Tang comment that the survival curves crossed each other in our study, and thus they questioned whether the proportionality assumption was met. Although the 1-year survival curves in the Kaplan-Meier plot overlapped at some points, the lines were generally distinct and there was no actual line crossing except at the very end, when there were few patients left in follow-up. In a diagnostic graph of log( −log[survival]) vs log of survival time, there was visible crossing of lines only in the very beginning of the log-time axis. Thus, overall, the time proportionality assumption seemed to hold well...
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Research and Development Costs of New Drugs —Reply
In Reply The correspondents raise concerns about the nonrepresentativeness of our sample, which arose because we restricted ourselves to publicly available data. Other studies have relied on confidential data that companies agreed to share. To the best of our knowledge, none of the previous studies on this topic, including that by DiMasi et al, which involved only 10 midsized to large companies, are representative. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Tafamidis (Vyndaqel; Vyndamax) for Transthyretin Amyloid Cardiomyopathy
This Medical Letter review describes how tafamidis prevents transthyretin protein complexes from disocciating into amyloid fibrils, and its recent approval in 2 different formulations (Vyndaqel and Vyndamax) for treatment of adults with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Diagnosis Coding and Differences in Mortality Between Critical Access Hospitals (CAHs) and Non-CAHs
This study uses Medicare data to estimate mortality differences for common medical conditions (pneumonia, heart failure, chronic obstructive pulmonary disease, urinary tract infection, others) at US critical access vs non –critical access hospitals between 2007 and 2017 with vs without adjustment for discharge diagnosis counts to assess the extent to which coding practices rather than illness severity might account for observed mortality differences. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Effect of Vitamin D 3 Supplementation vs Placebo on Risk of Depression or Relevant Depressive Symptoms
This randomized clinical trial compares the effects of vitamin D ₃ supplementation vs placebo on depression risk and mood scores in men and women aged 50 years or older. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Remains
Gone is the body (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Heart Failure With Reduced Ejection Fraction: A Review
This narrative review summarizes the epidemiology, pathophysiology, diagnosis, management, and prognosis of heart failure with reduced ejection fraction. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Jama
(Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Airborne Transmission of SARS-CoV-2 —Theoretical Considerations and Available Evidence
This Viewpoint discusses physical and epidemiological evidence supporting droplet vs aerosol transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and concludes on balance that aerosol transmission seems unlikely to be the dominant mode of coronavirus disease 2019 (COVID-19) spread. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Safeguards Needed for Development of COVID-19 Vaccines
This Viewpoint lists 4 safeguards policy makers should consider before release of a COVID-19 vaccine, including ensuring effectiveness through clinical trials, providing evidence of safety, requiring informed consent before vaccination, and establishing comprehensive adverse effects monitoring systems. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Academic Medicine and Black Lives Matter —Time for Deep Listening
In the context of the Black Lives Matter movement, this Viewpoint considers the demand that academic medicine address its own structural racism, and concludes on the basis of its history, culture, role, and influence that the institution can, should, and must make racial justice a part of its work and mission. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

Communicating Science in the Time of a Pandemic
This Viewpoint uses the example of rapid changes to public reporting on the efficacy of hydroxychloroquine and remdesivir for COVID-19 to illustrate how misinformation damages the public ’s trust in science and medicine, and urges accuracy and circumspection in news reports of developments in the pandemic. (Source: JAMA)
Source: JAMA - August 4, 2020 Category: General Medicine Source Type: research

SARS-CoV-2 Positivity Rate for Latinos in the Baltimore –Washington, DC Region
This study characterizes the trends in rates of SARS-CoV-2 positive test results among individuals in the Baltimore –Washington, DC area by self-reported race/ethnicity. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Figure Error
In the Original Investigation titled “Effect of a Chikungunya Virus–Like Particle Vaccine on Safety and Tolerability Outcomes: A Randomized Clinical Trial,” published in the April 14, 2020, issue of JAMA, a decimal was missing in the lowest number on the y-axis of Figure 3. The number “75” should have been “7.5.” This art icle was corrected online. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Menopausal Hormone Therapy and Long-term Breast Cancer Risk
Reports from the Women ’s Health Initiative (WHI), first published in 2002, have informed and complicated the narrative of the relative benefits and potential harms of menopausal hormone therapy (HT) over the past 20 years. Prior to the initiation of the WHI trials, hormone therapy had already experienced a tumultuous p ublic stature. Initially heralded as the cure for menopause in the 1960s, unopposed estrogen therapy was vilified when its association with increased risk of endometrial hyperplasia and cancer emerged. The discovery that the addition of progesterone to estrogen therapy mitigated this risk propelled ho...
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Better HHS Planning Needed for National Disaster Medical System
The US Department of Health and Human Services (HHS) needs better strategic planning to ensure it has enough physicians, nurses, and other health care professionals enrolled in the National Disaster Medical System (NDMS), according to a recent report from the US Government Accountability Office (GAO). (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Higher Rate of Opioid-Related Stays in Urban Than Rural Hospitals
In most parts of the country, hospitals in metropolitan areas had a higher average rate of opioid-related inpatient stays than hospitals in rural areas, according to a recent analysis of 2016 data by the Healthcare Cost and Utilization Project (HCUP), which is sponsored by the Agency for Healthcare Research and Quality. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

NIH Launches Platform to Serve as Depository for COVID-19 Medical Data
The National Institutes of Health (NIH) recently launched the National COVID Cohort Collaborative (N3C) to store and study medical record data from people across the country who have been diagnosed with coronavirus disease 2019 (COVID-19). (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Audio Highlights
Listen to the JAMA Editor ’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Prescribing Paid Sick Leave —An Important Tool for Primary Care During the Pandemic
“Fourteen days—no work, no outings. Please stay home.” (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

“Pseudodoxia Pediatrica”
Under the heading “pseudodoxia pediatrica” Bakwin calls attention to a number of doubtful practices in current use among pediatricians. The worst offender among these, he believes, is indiscriminate tonsillectomy. The American Child Health Association, some ten years ago, surveyed a group of 1,000 children 11 yea rs of age from the public schools of New York City; 61 per cent had had their tonsils removed. The remaining 39 per cent were subjected to examination by a group of physicians who, in turn, selected 45 per cent of these for tonsillectomy and rejected the rest. The rejected children were reexamined b y ...
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Trends in HIV PrEP Prescribing in the US, 2012-2018
This study uses national pharmacy claims data to describes trends in prescriptions for HIV preexposure prophylaxis (PrEP) overall and by specialty between 2012 and 2018. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Drug Prices, Rebates, and Discounts
To the Editor Dr Hernandez and colleagues found that list and net prescription drug prices have increased out of proportion to inflation, and that the gap between list and net prices has widened. Most prominently, among non-Medicaid patients (who are mostly covered by Medicare Part D or commercial insurance plans), rebates and other price concessions increased from 23% in 2007 to 51% in 2018. The authors used estimates of discounts (including manufacturer rebates) calculated by SSR Health, which uses a proprietary algorithm to estimate net prices by dividing publicly reported manufacturer revenue by the volume of filled pr...
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Pathogenic Variants in Breast Cancer Susceptibility Genes in Older Women
To the Editor The advent of sequencing technologies has brought genetic information to the forefront of clinical decision-making for cancer patients. Universal germline testing for hereditary cancer is not yet recommended; rather, there are guidelines on who to test based on certain features suggestive of hereditary predisposition, such as early age at diagnosis and family history. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Drug Prices, Rebates, and Discounts
To the Editor The analysis of prescription drug net price growth by Dr Hernandez and colleagues has 2 methodological issues that affect the interpretation of results. First, the authors overestimated the increase in discounts provided by drug manufacturers to non-Medicaid payers and underestimated the increase in discounts to Medicaid. Second, their methodology for estimating the mean growth in prices and discounts cannot be linked to drug spending. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Drug Prices, Rebates, and Discounts —Reply
In Reply In our study, we estimated changes in list prices, net prices, and discounts for branded drugs from 2007 to 2018. We found that discounts offset 62% of increases in list prices, and that after discounts, net prices still increased by 60% from 2007 to 2018, or 4.5% per year. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Pathogenic Variants in Breast Cancer Susceptibility Genes in Older Women —Reply
In Reply We wish to emphasize that we did not in fact recommend that all postmenopausal breast cancer patients undergo multiple gene panel testing. Instead, we commented that the prevalence of BRCA1/2 PVs among patients with breast cancer diagnosed at age 64 years or younger was 2.2%, comparable with that of people of Ashkenazi Jewish ancestry (2.5%), for whom BRCA1/2 testing is supported by guidelines. This result, together with our finding that the prevalence of any breast cancer –associated PV was 3.55%, led us to conclude that prevalence in postmenopausal breast cancer patients “may be high enough to warran...
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Telehealth Reduces Excess Weight Gain in Pregnancy
A telehealth lifestyle intervention substantially decreased excess gestational weight gain (GWG) among pregnant women who were overweight or obese and improved insulin resistance markers, a trial in The Lancet Diabetes& Endocrinology reported. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Rivaroxaban Reduces Complications of PAD Revascularization
Daily rivaroxaban and aspirin significantly reduced major limb and cardiovascular events among patients with peripheral artery disease (PAD) who had undergone lower-extremity revascularization, a trial in the New England Journal of Medicine reported. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Intervention Improves Kids ’ Attitudes About Mental Disorders
A school-based intervention reduced mental health stigma among preadolescent students and resulted in more children seeking treatment, according to a trial in Pediatrics. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Novel Therapy Eradicates H pylori
Antimicrobial resistance to existing therapies has made Helicobacter pylori infection increasingly difficult to treat. In a phase 3 trial published in the Annals of Internal Medicine, a 3-drug combination of amoxicillin, omeprazole, and rifabutin in 1 capsule achieved high eradication rates of H pylori infection. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Wellness Program Failed to Improve Employee Health
A comprehensive workplace wellness program did not improve health outcomes, a trial in JAMA Internal Medicine reported. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

Association of Menopausal Hormone Therapy With Long-term Breast Cancer Incidence and Mortality
This study reports 20-year breast cancer incidence among participants in Women ’s Health Initiative (WHI) trials randomized to conjugated equine estrogen (CEE) alone or with medroxyprogesterone acetate vs placebo. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research

The Healthy, Hunger-Free Kids Act and Dietary Quality Among Children in the US School Lunch Program
This national survey study assesses the dietary quality of lunch for students participating in the National School Lunch Program (NSLP) before and after implementation of the Healthy, Hunger-Free Kids Act, which, in 2012, aligned school lunch nutrition standards with the 2010 Dietary Guidelines for Americans. (Source: JAMA)
Source: JAMA - July 28, 2020 Category: General Medicine Source Type: research