About the public’s health
Deciding Who Should Be First in Line for the Coronavirus Vaccine: Here is the text of my NY Times letter published today:
“The debate in the article centers on who should get priority to receive the coronavirus vaccine when it first comes out. Another consideration is where it should first be deployed. Politics may dictate that it go to states that currently have the highest incidence, i.e., many red states. However, many places in those states are not prudently practicing quarantine, masking and social distancing.
Would it be fair to those states with sensible policies that they have to wait for the vaccine?”
The comment is meant to spur debate between two rationales for allocating the vaccine.
Recall that the vaccine is targeted to be 50-75% effective. Now that evidence points to the need for two injections, it may prove to be even less effective. This concern raises the further question of the overall effectiveness in a setting without social distancing and mask wearing. In other words, we need to ask: Would the vaccine be “wasted” in that setting? Would the vaccine be more useful in accomplishing the goal of zero infections if it were part of a portfolio of measures? To answer some of these questions, it is nice to see the following announcement: National Academies Launch Study on Equitable Allocation of a COVID-19 Vaccine – First Meeting July 24: “As part of the study, the committee will consider what criteria should be used to set priorities for equitable distribution among groups of potential vaccine recipients, taking into account factors such as population health disparities; individuals at higher risk because of health status, occupation, or living conditions; and geographic distribution of active virus spread. In addition, the committee will consider how communities of color can be assured access to COVID-19 vaccines in the U.S. and recommend strategies to mitigate vaccine hesitancy among the American public.”
HHS Coronavirus Data Hub:This dashboard replaces the CDC's National Healthcare Safety Network (NHSN) for reporting COVID-19 related data, such as intensive care unit capacity, ventilator use, personal protective equipment (PPE) levels, and staffing shortages.
Trump shifts rhetoric as he urges mask-wearing, warns of worsening pandemic: “President Donald Trump, in a shift in rhetoric and tone, encouraged Americans on Tuesday to wear masks if they cannot maintain social distance and warned that the coronavirus pandemic would get worse before it got better.”
Former CDC chief: Most states fail to report data key to controlling the coronavirus pandemic: “Not a single state reports on the turnaround time of diagnostic covid-19 tests…Six months after the first coronavirus case appeared in the United States, most states are failing to report critical information needed to track and control the resurgence of covid-19, the disease caused by the virus, according to an analysis released Tuesday” by former Centers for Disease Control and Prevention director Tom Frieden. “His team and other public health leaders are recommending that states and counties report 15 indicators they say are essential for an effective response.”
How long will immunity last after COVID-19 infection?While the data is not yet clear, here are a couple articles that try to answer the question:
Sweden Says Covid Immunity Can Last 6 Months After Infection: “Sweden’s top health authority says people who have had the novel coronavirus are likely to be immune for at least six months after being infected, whether they’ve developed antibodies or not…’We don’t see cases of people falling ill twice from Covid-19,’ state epidemiologist Anders Tegnell said during a press conference in Stockholm. ‘Hence, our assessment is that if you do get Covid-19 you are immune, even if you don’t develop antibodies.’”
Rapid Decay of Anti–SARS-CoV-2 Antibodies in Persons with Mild Covid-19: “The protective role of antibodies against SARS-CoV-2 is unknown… Given that early antibody decay after acute viral antigenic exposure is approximately exponential, we found antibody loss that was quicker than that reported for SARS-CoV-1… Our findings raise concern that humoral immunity against SARS-CoV-2 may not be long lasting in persons with mild illness, who compose the majority of persons with Covid-19. It is difficult to extrapolate beyond our observation period of approximately 90 days because it is likely that the decay will decelerate. Still, the results call for caution regarding antibody-based ‘immunity passports,’ herd immunity, and perhaps vaccine durability, especially in light of short-lived immunity against common human coronaviruses. Further studies will be needed to define a quantitative protection threshold and rate of decline of antiviral antibodies beyond 90 days.”
Genes May Influence COVID-19 Risk, New Studies Hint: A nice summary of this issue from Scientific American. “Combing through the genome, researchers have tied COVID-19 severity and susceptibility to some genes associated with the immune system’s response, as well as a protein that allows the disease-causing SARS-CoV-2 coronavirus into our cells. They have also turned up links between risk and a person’s blood type—A, B, AB or O. The findings are not cut-and-dried, however. “
Polio vaccination campaigns restart after modelers warn about risk of ‘explosive’ outbreaks:”In a sad knock-on effect of the COVID-19 pandemic, the Global Polio Eradication Initiative (GPEI) abruptly halted all mass vaccination campaigns in March, worried they could inadvertently spread the novel coronavirus. The move further imperiled the troubled 3-decade drive to wipe out polio.
But now, armed with new data and perspective, GPEI and the countries it supports are resuming vaccination campaigns.”
Poor diets threaten US national security — and it's serious: “Diet-related illnesses are a growing burden on the United States economy, worsening health disparities and impacting national security, according to a white paper published Monday in the American Journal of Clinical Nutrition.
Poor nutrition is the leading cause of illnesses in the US, with unhealthy diets killing more than half a million people each year, a group of experts who have formed the Federal Nutrition Research Advisory Group wrote in the paper.
About 46% of adults in the country have an overall poor-quality diet, and this number goes up to 56% for children…
The paper's authors called for the expansion of federal investment in nutrition science by creating a new Office of the National Director of Food and Nutrition or a new US Task Force on Federal Nutrition Research, with the goal of improving coordination within the agencies that budget for research in this topic.”
Physicians’ progress toward ending the nation’s drug overdose and death epidemic: A couple important takeaways from the report:
—”37.1% decrease in opioid prescriptions from 244.5M in 2014 to 153.7M in 2019…
—Despite these efforts, illicitly manufactured fentanyl, fentanyl analogues and stimulants (e.g. methamphet- amine, cocaine) are now killing more Americans than ever. The use of these illicit drugs has surged and their overdose rate increased by 10.1% and 10.8%, respectively.”
US signs contract with Pfizer for COVID-19 vaccine doses: “The Trump administration will pay Pfizer nearly $2 billion for a December delivery of 100 million doses of a COVID-19 vaccine the pharmaceutical company is developing, Health and Human Services Secretary Alex Azar announced Wednesday.
The U.S. could buy another 500 million doses under the agreement…”
About health insurance
Are Employers Satisfied that Their Health Plans Drive Quality, Safety, and Value?:This report from the Leapfrog Group polled “174 employers representing an estimated 4 million insured lives… Respondents cited their experience with health plans including Aetna, Cigna, UnitedHealthcare, as well as a range of BlueCross and BlueShield (BCBS) plans, including Anthem and over a dozen state BCBS plans.” The results were divided over 4 criteria:
“Responsiveness of the health plan to employer concerns;
Transparency in helping employers and employees choose the best providers;
Payment reform initiatives that incentivize excellence in the market; and
Value strategies driven by health plans.”
You should read the whole study but here are some pertinent facts:
”The final question asked of the employers was to grade their health plan, from A to F, on their ability to direct their employees to high-quality health care. Overall, employer respondents gave their plans a C-plus (2.57 GPA). The larger employers were tougher on the health plans than the mid-size to small employers….
Among the plans reported in the survey, Cigna was a clear leader in the movement for value. Employers gave UnitedHealthcare the lowest ratings, with the most room for improvement in driving for value, reducing costs and improving quality. Aetna led among plans for putting a focus on quality.”
California Blues earned $1B ACA risk adjustment payment last year. Here's how other insurers fared:”Risk adjustment transfers totaled $10.8 billion in 2019, with some insurers on the ACA's exchanges earning substantial payouts, according to new data from the Trump administration.
The Centers for Medicare & Medicaid Services released (PDF) its annual look at the Affordable Care Act's risk adjustment program, and said that 561 insurers participated in 2019. The $10.8 billion was split evenly between payments made to insurers and payments to CMS to maintain budget neutrality.
The individual market accounted for the largest share of transfers, or about $7.98 billion.”
Insurers worry drug companies could game changes to Medicaid rebate program in new rule:”Several insurer groups commented on the proposed rule that the Centers for Medicare & Medicaid Services (CMS) released last month to get states and drugmakers to create more value-based payment arrangements.
If finalized, the rule would relax some of the requirements for the average manufacturer price and best price that manufacturers must provide for Medicaid. Under the new rule, a manufacturer could report multiple best prices for a therapy under the Medicaid Drug Rebate Program, but any best price has to be tied to a value-based purchasing agreement.
A manufacturer could also use a ‘bundled sales’ approach that allows a manufacturer to calculate a weighted average for discounts across a drug class. If there is a performance-based failure for the drug, it is allocated proportionally for all products sold in the bundle.
But payers were concerned manufacturers could game the new multiple “best price” provision. For instance, the manufacturer could offer a variety of rebates based on a patient’s response to a drug, but questions remain on how states will track those outcomes.”
About pharma
How COVID-19 could be crippled by an age-old blood thinner:Scientists at Rensselaer Polytechnic Institute “discovered that SARS-CoV-2 binds tightly to heparin, making the drug a potential ‘decoy’ that could serve as a way to neutralize the virus before it can infect healthy cells. They reported the finding (PDF) in the journal Antiviral Research.”
Novartis' second-quarter sales, profit fall as COVID-19 stockpiling reverses: Many healthcare institutions stockpiled medications in the first quarter. Now pharma performance results will show the effect of reduced 2nd quarter purchases.
10 most valuable R&D projects in the pharmaceutical industry pipeline: The headline is self explanatory.
COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines:”EMA has now set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. This is underpinned by three contracts for observational research that EMA has signed with academic and private partners over recent months, to be ready to effectively monitor vaccines in the real world as soon as they are authorised, and support the safe and effective use of COVID-19 vaccines and medicines.
The latest contract was finalised in mid-July with Utrecht University and the University Medical Center Utrecht as coordinators of the CONSIGN project (‘COVID-19 infectiOn aNd medicineS In preGNancy’).”
Do we have a similar entity in this country?