Sunday, July 26, 2020, marks the 30th anniversary of the signing of the Americans with Disabilities Act.
About the public’s health
Renewal of Determination That A Public Health Emergency Exists: Starting tomorrow, HHS Secretary Azar will extend the COVID-19 public health emergency status for another 90 days.
U.S. coronavirus deaths top 1,100 for a third day in a row: Total cases have now reached 4 million.
Impact of self-imposed prevention measures and short-term government-imposed social distancing on mitigating and delaying a COVID-19 epidemic: A modelling study: “Based on our results, we conclude that handwashing, mask-wearing, and social distancing adopted by disease-aware individuals can delay the epidemic peak, flatten the epidemic curve, and reduce the attack rate. We show that the rate at which disease awareness spreads has a strong impact on how self-imposed measures affect the epidemic… For all measures, a large epidemic can be prevented when the efficacy exceeds 50%. Moreover, the effect of combinations of self-imposed measures is additive. In practical terms, it means that SARS-CoV-2 will not cause a large outbreak in a country where 90% of the population adopts handwashing and social distancing that are 25% efficacious (i.e., reduce susceptibility and contact rate by 25%, respectively)…
The potential second wave could be prevented altogether if the coverage of a self-imposed measure in the population and its efficacy are sufficiently high (e.g., 90% and 50%, respectively). Our sensitivity analyses showed that lower or higher efficacies can be required to prevent a large epidemic for countries with smaller or larger basic reproduction numbers…”
Estimated County-Level Prevalence of Selected Underlying Medical Conditions Associated with Increased Risk for Severe COVID-19 Illness — United States, 2018: This report from the CDC was published today and has a shocking revelation: “The median model-based estimate of the prevalence of any of five underlying medical conditions associated with increased risk for severe COVID-19–associated illness among U.S. adults was 47.2% among 3,142 U.S. counties. The estimated number of persons with these conditions followed population distributions, but prevalence was higher in more rural counties.” The five conditions are chronic obstructive pulmonary disease, cardiovascular disease, diabetes, chronic kidney disease, and obesity.
Why COVID-19 is killing U.S. diabetes patients at alarming rates: “At the microscopic level, high glucose and lipid counts in diabetes patients can trigger a ‘cytokine storm,’ when the immune system overreacts, attacking the body. Damaged endothelial cells, which provide a protective lining in blood vessels, can lead to inflammation as white blood cells rush to attack the virus and may cause lethal clots to form, emerging research suggests.”
‘It’s Like Groundhog Day’: Coronavirus Testing Labs Again Lack Key Supplies:”Pipette tips aren’t the only laboratory items in short supply. Dwindling stocks of machines, containers and chemicals needed to extract or amplify the coronavirus’s genetic material have clogged almost every point along the testing workflow.”
Neonatal management and outcomes during the COVID-19 pandemic: an observation cohort study:”Of 1481 deliveries, 116 (8%) mothers tested positive for SARS-CoV-2; 120 neonates were identified. All neonates were tested at 24 h of life and none were positive for SARS-CoV-2…. Our data suggest that perinatal transmission of COVID-19 is unlikely to occur if correct hygiene precautions are undertaken, and that allowing neonates to room in with their mothers and direct breastfeeding are safe procedures when paired with effective parental education of infant protective strategies.”
Coffee, Caffeine, and Health: Excellent article from the NEJM on this topic. (Can access by signing up for 3 free articles/month). Among the benefits: “coffee consumption was associated with a reduced risk of cardiovascular diseases, with the lowest risk for 3 to 5 cups per day. An inverse association has been observed between coffee consumption and coronary artery disease, stroke, and death from cardiovascular causes.” Filtered coffee is best, then espresso, then unfiltered. The article also discussed tea and “energy drinks.”
Evidence-based prevention of Alzheimer's disease: systematic review and meta-analysis of 243 observational prospective studies and 153 randomised controlled trials: A number of interventions are discussed with their recommendation confidence based on the scientific literature. “With credible though inconclusive evidence, the suggestions targeted 10 risk factors including diabetes, hyperhomocysteinaemia, poor BMI management, reduced education, hypertension in midlife, orthostatic hypotension, head trauma, less cognitive activity, stress and depression.”
China offers $1 billion loan to Latin America and the Caribbean for access to its Covid-19 vaccine:”The virtual meeting on Wednesday was led by Mexico's Foreign Affairs Minister, Marcelo Ebrard, and [Chinese Foreign Minister] Wang Yi. Their counterparts from Argentina, Barbados, Chile, Colombia, Costa Rica, Cuba, the Dominican Republic, Ecuador, Panama, Peru, Trinidad and Tobago and Uruguay also joined.”
About hospitals and health systems
General and Targeted Distribution Post-Payment Notice of Reporting Requirements Relief Fund (PRF) recipients that received one or more payments exceeding $10,000 in the aggregate from the PRF must report by Feb. 15, 2021 how they spent the relief grants. The reporting will be available strait October 1, 2020. Detailed instructions regarding these reports will be released by August 17, 2020.
About pharma
Trump likely to sign executive orders on drug pricing Friday:”The exact details of the orders remain unclear, but sources say one order is likely to include a version of a proposal to reduce some U.S. drug prices by tying them to the lower prices paid in other countries.
An idea that had been in the mix earlier in the week, to eliminate the rebates drugmakers pay to negotiators known as pharmacy benefit managers (PBMs), is now unlikely to be included, sources say.”
U.S. clears way for drugmakers to share COVID antibody capacity: “The U.S. Department of Justice on Thursday said it will not stand in the way of efforts by companies, including Eli Lilly and Co and Amgen Inc, to share information to help scale up capacity to manufacture antibody treatments for COVID-19, the disease caused by the new coronavirus….
The DOJ did not include Regeneron Pharmaceuticals Inc, which expects to have definitive trial results for its dual-antibody treatment by late summer or early fall. The Department of Health and Human Services in June awarded Regeneron a $450 million contract and the company has cleared the way for U.S. manufacturing of its antibody cocktail by moving production of its other products to a plant in Ireland.”
AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface:”Last week, Western intelligence officials pegged Russian hackers with an attempt to rip off leading research for a COVID-19 vaccine, linking the would-be thieves with the country's intelligence services.
Russia itself denies involvement in any of those attacks—and with a new licensing deal for AstraZeneca's COVID-19 shot, the country says it doesn't need the secrets anyway.
Russian drugmaker R-Pharm has signed a licensing deal with Britain's AstraZeneca to produce and distribute doses of its University of Oxford-partnered adenovirus-based COVID-19 shot, AZD1222.”
Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19: Do we really need another study showing lack of effectiveness? Here is one anyway (from Brazil): “Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care.”
U.S. sets global benchmark for COVID-19 vaccine price at around the cost of a flu shot:”The U.S. government has set a benchmark for COVID-19 vaccine pricing in a $2 billion deal announced on Wednesday with Pfizer Inc and German biotech BioNTech SE that will likely pressure other manufacturers to set similar prices, industry analysts told Reuters.
The deal, which is contingent on an approvable product, secures enough vaccine to inoculate 50 million Americans for about $40 a person, or about the cost of annual flu shots, and is the first to provide a direct window into likely pricing of successful COVID-19 vaccines.”
Biotech Startups Cash In With IPOs in First Half: “Drug startups capitalized on soaring interest in biotechnology to stage 26 initial public offerings globally in the first half of this year, putting 2020 on pace to be one of the strongest ever for new stock offerings in the sector.”
FDA Poses March Deadline for Reporting Unapproved Drug Use: “Drug companies would have until the end of March to tell the FDA which unapproved drugs they offered sick patients through the federal Right to Try law and whether they caused serious side effects under a proposed rule the agency released Thursday.
The rule is aimed to give the Food and Drug Administration a clearer picture of how patients are using experimental drugs through the law’s annual reporting requirements. It would also help provide the first comprehensive look at how effective the law has been at getting terminally ill patients access to the latest medications.”
Moderna loses US patent challenge that could affect COVID-19 vaccine:”Shares in Moderna fell as much as 10% Thursday after the company failed in an attempt to invalidate a US patent on vaccine technology held by Arbutus Biopharma. SVB Leerink analyst Mani Foroohar suggested the decision by an administrative court run by the US Patent and Trademark Office opens the door to debate around Moderna's entire pipeline, with the near-term concern being its experimental coronavirus vaccine mRNA-1273, which is due to enter Phase III testing later this month.”
About health insurance
Aetna aims to offer alternative to high-deductible plans in 2 new benefit designs:”The new designs, called Upfront Advantage and Flexible Five, offer members coverage for some preventive services before they meet their deductibles. In Upfront Advantage, members will have access to services worth up to $500 for an individual and $1,000 for a family for free before their deductible is met.
In Flexible Five, members will instead be offered five coupons per person for these services; a family of four, for example, would receive 20 coupons that can be applied to services such as primary care visits, behavioral health visits, urgent care, lab tests or x-rays conducted during those visits and generic drugs.”
Nearly 11M paid premiums for ACA exchanges at beginning of 2020, a slight increase:”The Centers for Medicare & Medicaid Services (CMS) reported Thursday that 10.7 million ACA customers paid their premiums as of March 15, a slight increase from the 10.6 million who paid through February 2019. The data include both state and federally run insurance exchanges.”
Humana plans to send 1 million home screening kits to its members: “Humana said it will send 1 million test kits to its members to allow them to access preventive screenings at home. The insurer said it would send its Medicare Advantage members at-home colorectal cancer screenings and diabetic management test kits. Humana’s Medicaid members will also have access to the diabetic management test kits.” One advantage to the insurer is maintenance of quality scores for screening, which affects payment levels.
Association Between Switching to a High-Deductible Health Plan and Major Cardiovascular Outcomes: In a finding consistent with other studies on high deductibles and serious illness, the authors found that: “Mandated enrollment in high-deductible health plans with typical value-based features was not associated with increased risk of major adverse cardiovascular events.”
About healthcare IT
In Push for Better Cybersecurity, U.S. Energy Department Outlines a National Quantum Internet: While not strictly applicable to healthcare, this development can have profound benefits in the sector. For example, the public’s confidence in enhanced security would help allay fears of a unique patient identifier.
“A group led by the U.S. Department of Energy and the University of Chicago plans to develop a nationwide quantum internet that could be functional in about a decade and with the potential to securely transmit sensitive information related to national security and financial services…
The project will be funded by a portion of the $1.275 billion budget allocated as part of President Trump’s National Quantum Initiative, an effort to accelerate research and development in quantum information science, an area of study that includes quantum-based communication and quantum computing.”
Clinical, Legal, and Ethical Aspects of Artificial Intelligence–Assisted Conversational Agents in Health Care: With the rapid growth in telemedicine, this article is a great summary of the issues mentioned in the title. By way of definition: “Conversational agents (CAs) are artificial intelligence (AI) programs that engage in a dialogue with users by interpreting their questions or concerns and replying to them in a text message, image, or voice format. Conversational agents typically imitate human conversation by applying natural language processing and machine learning and stand in contrast to text-based engagement platforms that accept discretely formatted human inputs and reply with preset messages.”
Abbott receives FDA approval for neurostimulator-controlling iPhone app, for personalizing therapies for pain, Parkinson's disease: “The FDA approved a new smartphone app from Abbott allowing people to personalize their own neuromodulation therapies, including regimens for chronic pain and movement disorders such as Parkinson’s disease.
Compatible with Apple products, the devicemaker’s NeuroSphere Digital Care platform and its newly approved patient controller app are also designed to encourage more virtual connections with healthcare providers, and allow interactions to take place remotely in the face of the COVID-19 pandemic.”
Cerner inks partnership with point-of-care decision-making platform: “Cerner announced July 23 a new agreement to deploy Holon Solutions' point-of-care platform that can extract relevant patient information from Cerner's population health platform and deliver it into the clinician's EHR workflow.”
