America’s most prestigious medical journal makes a political statement

https://mailchi.mp/45f15de483b9/the-weekly-gist-october-9-2020?e=d1e747d2d8

In Rare Step, Esteemed Medical Journal Urges Voters To Oust Trump | KPCW

For its first 208 years, the New England Journal of Medicine has never endorsed a political candidate. But this week the journal published an editorial outlining its political position in the upcoming Presidential election, signed unanimously by all editors who are US citizens.

The editors did not explicitly endorse former Vice President Biden, but rather offered a scathing condemnation of the current administration’s performance during the COVID pandemic: “Reasonable people will certainly disagree about the many political positions taken by candidates.

But truth is neither liberal nor conservative. When it comes to the response to the largest public health crisis of our time, our current political leaders have demonstrated that they are dangerously incompetent. We should not abet them and enable the deaths of thousands more Americans by allowing them to keep their jobs.” (Formally endorsing Biden last month, Scientific American also made the first political endorsement in its 175-year history.)
 
Much of the media coverage of the NEJM statement has centered on the question of whether medicine should involve itself in politics, or “live above it”

Medicine has been drawn into political disputes before, but now the nature of the involvement has changed. In the past, debates largely centered around regulation, payment or policy—but now the science itself has become a fundamentally political issue. 

The very nature of the coronavirus has become a matter of political belief, not just an indisputable scientific fact.

Public trust in both scientific institutions and the government, and their ability to work together, has been damaged. We fear this will lead to poorer health outcomes regardless of who wins the upcoming election.

Medical ethics in pandemic times

https://www.axios.com/medical-ethics-clinical-trials-pandemic-eb77f819-76f1-45b0-af8a-cf181bc1607b.html

The Importance of Medical Ethics | Medical Ethics – theMSAG

The COVID-19 pandemic is rife with scientific and medical uncertainty, including debates about the ethics of using experimental treatments.

The big picture: As the global pandemic continues, the tension between providing the best available care for patients and performing trials to determine whether that care is effective risks complicating the medical response.

The big question: Is it unethical to withhold a possible treatment from someone who instead receives a placebo, or to continue to administer that treatment without having collected data on whether it works?

Driving the news: President Trump received an experimental monoclonal antibody cocktail via expanded access or “compassionate use,” which allows someone to access a treatment outside of a clinical trial before it is approved, provided their doctor, the drug company and the FDA agree.

  • Experts say his subsequent claims of the treatment being a cure risks reducing enrollment in clinical trials, flooding companies with requests for access to a limited number of doses and creating false hope for patients.
  • And the president’s treatment raised questions about fairness — would other COVID-19 patients have similar access?
  • “It’s important that we not say the president got access to a beneficial experimental intervention because we don’t know if it is beneficial or if there are adverse events associated with it, says Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University. 

He and other ethicists say the president’s treatment highlights a broader question about the ethical obligation doctors have to the science needed to determine if those treatments are effective.

Between the lines: Offering patients experimental COVID-19 drugs via emergency use authorizations, expanded access programs and compassionate use can slow needed clinical trials.

  • Researchers have struggled to enroll people in clinical trials in which they may receive a placebo if patients can access a drug directly.
  • One example: “There’s been some hiccups with the expanded access use for convalescent plasma, because it was something that precluded people from enrolling in a randomized control trial, so it took longer, and we still don’t quite know how well convalescent plasma works,” says Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins Center for Health Security.

More than 100,000 COVID-19 patients at almost 2,800 U.S. hospitals received convalescent plasma from people who survived the virus and developed antibodies to it.

  • “It’s easy for people to say you enrolled 100,000 people, there should have been a trial. But a small number of those 2,800 hospitals would have been capable of doing those trials,” says the Mayo Clinic’s Michael Joyner, who leads the program.
  • There are now smaller trials taking place to answer questions about the effectiveness of plasma in treating the disease in different stages.
  • But if this happens again, Joyner says programs at academic medical centers should be peeled off earlier to form clinical trials run in parallel.

The gold standard for determining whether a treatment works is through randomized controlled trials in which people are randomly assigned to receive a treatment or to be in a control group.

  • In the uncertainty and urgency of a pandemic, some physicians argue randomizing people to receive a placebo goes against physicians’ ethics and that it is better to do something to help patients than do nothing.
  • “That’s a false dichotomy because the question is, what should we do?” says London.

From a doctor’s perspectiveit’s important to weigh the collective value of theearly drug data and the individual needs of the patient, Adalja says.

  • “I do think you have to be extra careful when you’re thinking about drugs that you don’t have strong randomized control trial data for, or the data is incomplete or inconclusive,” he adds.
  • “What people have to ask themselves is what constitutes evidence or proof and where do you want to make the bets in a pandemic?” says Joyner.
  • “There is a moral, legal and public health obligation to do those trials before people use those products,” says Alison Bateman-House, a professor of medical ethics at NYU’s Grossman School of Medicine who co-chairs an international working group on pre-approval access to treatments.
  • She says she understands the emotional pull on doctors to help patients whose health is quickly deteriorating, “but it is not evidence-based medicine.”

“There is no ethical obligation to give anyone an unproven substance.”

Alison Bateman-House, NYU Grossman School of Medicine

In a forthcoming paper, London argues that when medical professionals don’t have the knowledge they need to treat patients, it is their responsibility “to band together and run studies to get evidence to discharge [their] very ancient medical obligation.”

  • Medical ethics should be updated to include a responsibility to learn in the face of uncertainty, says London, who was part of a committee that called for research to be incorporated into the response to the Ebola outbreak in West Africa in 2014.
  • The U.K.’s large randomized RECOVERY trial is based in part on the Ebola experience, says London. “Because of it, we know dexamethasone is effective and hydroxychloroquine is not.”

What to watch: How the FDA’s handling of treatments during the pandemic influences other drugs and diseases once the pandemic ends.

The bottom line: “Medicine doesn’t have a good handle on uncertainty, and that is a problem,” says London.

Election 2020: Trump and Biden’s starkly diverging views on healthcare

https://www.healthcaredive.com/news/presidential-election-2020-trump-biden-different-healthcare-policies-ACA-coronavirus/585184/?utm_source=Sailthru&utm_medium=email&utm_campaign=Issue:%202020-10-01%20Healthcare%20Dive%20%5Bissue:29992%5D&utm_term=Healthcare%20Dive

Spoiler: the 2 nominees differ on almost everything.

President Donald Trump and Democrat nominee Joe Biden’s starkly contrasting views on healthcare were laid bare during this week’s chaotic debate. But some major industry executives noted at a recent conference they’ve done relatively well under Trump and could likely weather a Biden presidency, given his moderate stance and rejection of liberal dreams of “Medicare for All.”

The former vice president stresses incremental measures to shore up President Barack Obama’s landmark Affordable Care Act. Trump’s campaign website has no list of healthcare priorities, making his record even more relevant to attempts to forecast his future policies.

“I think a lot of the president’s second term agenda will be extensions of things he’s done in his first term,” Lanhee Chen, domestic policy director at Stanford University’s Public Policy program, said at AHIP in September.

Either way, the impact of whoever lands in the White House next year still matters for the industry’s future.

And 33 seats in the Senate are also up for grabs in November, complicating the outlook. Two scenarios would likely lead to health policy gridlock, according to analysts and DC experts: Trump wins regardless of Senate outcome, or Biden wins and Republicans maintain control of the Senate. A third scenario, where Biden wins and Democrats retake the Senate, would be the most negative for healthcare stocks, Jefferies analysts say, while the other two outcomes would be a net positive or mostly neutral.

Here’s a look at where the candidates stand on the biggest healthcare issues: the coronavirus pandemic, the Affordable Care Act, changes to Medicare and Medicaid and lowering skyrocketing healthcare costs.

COVID-19 response

Trump

Of all wealthy nations, the U.S. has been particularly unsuccessful in mitigating the pandemic. The U.S. makes up 4% of the global population, but accounted for 23% of all COVID-19 cases and 21% of all deaths as of early September.

Public health experts assign the majority of the blame to an uncoordinated federal response, with the president electing to take a largely hands-off approach to the virus that’s killed nearly 207,000 people in the U.S. to date. That backseat stance is unlikely to change if Trump is elected to a second term.

In March, Trump said a final COVID-19 death toll in the range of 100,000 to 200,000 Americans would mean he’s “done a very good job.”

Critics blame shortages of supplies like test materials, personal protective equipment and ventilators, especially in the crucial early days of the pandemic, on Trump’s approach. States and healthcare companies have also reported challenges with shifting federal guidelines on topics from risk of infection to hospital requirements for reporting COVID-19 caseloads.

Trump has also pushed unproven treatments for COVID-19, giving rise to concerns about political influence on traditionally nonpartisan agencies like the Food and Drug Administration and the Centers for Disease Control and Prevention.

These concerns have colored Operation Warp Speed, the administration’s public-private partnership to fast-track viable vaccines. The operation received $10 billion in funds from Congress, but administration officials have also pulled $700 million from the CDC, even as top health officials face accusations of trying to manipulate CDC scientific research publications.

Fears that political motivations, not clinical rigor, are driving the historically speedy timeline could lower public trust in a vaccine once it’s eventually approved.

Trump has also repeatedly refused to endorse basic protections like widespread mask wearing, often eschewing the face covering himself in public appearances. He’s consistently downplayed the severity of the pandemic, saying it’ll go away on its own while suggesting falsely that rising COVID-19 cases were solely due to increased testing.

While Trump’s list of priorities for his second term include “eradicating COVID-19,” the plan is short on details. His most aggressive promise has been approval of a vaccine by the end of this year and creating all “critical medicines and supplies for healthcare workers” for a planned return to normal in 2021, along with refilling stockpiles to prepare for future pandemics.

Biden

Biden, for his part, would likely work to enact COVID-19 legislation and dramatically change the role of the federal government in pandemic response first thing if elected.

The Democratic candidate says he would re-assume primary responsibility for the pandemic. He plans to “dramatically scale up testing” and “giving states and local governments the resources they need to open schools and businesses safely,” per an August speech in Wilmington, Delaware.

Biden says he’d take a backseat to scientists and allow FDA to unilaterally make decisions on emergency authorizations and approvals.

The candidate supports reopening an ACA enrollment period for the uninsured, eliminating out-of-pocket costs for COVID-19 treatment, enacting additional pay and protective equipment for essential workers, increasing the federal match rate for Medicaid by at least 10%, covering COBRA with 100% premium subsidies during the emergency, expanding unemployment insurance and sick leave, reimbursing employers for sick leave and giving them tax credits for COVID-19 healthcare costs.

Trump opposes most of these measures, though he did sign COVID-19 relief legislation that upped the Medicaid match rate by 6.2% and extended the COBRA election period, though without subsidies.

Biden has said he’d be willing to use executive power for a national mask mandate, though ensuring compliance would be difficult. He’d also rejoin the World Health Organization, which Trump pulled the U.S. out of in May.

Affordable Care Act

Trump

On his first day in office, Trump issued an executive order saying: “It is the policy of my Administration to seek the prompt repeal of the Patient Protection and Affordable Care Act.” But after the Republican repeal-and-replace effort floundered in 2017, the administration began steadily chipping away at key tenets of the decade-old law through regulatory avenues.

Trump has maintained he’ll protect the 150 million people with preexisting conditions in the U.S. But despite publicly promising a comprehensive replacement plan on the 2015 campaign trail (and at least five times this year alone), Trump has yet to make one public. The president did in September sign a largely symbolic executive order that it’s the stance of his administration to protect patients with preexisting conditions.

The president doesn’t mention the ACA in his list of second term priorities. The omission could have been intentional, as Trump is backing a Republican state-led lawsuit seeking to overturn the sweeping law, now pending in front of the U.S. Supreme Court and scheduled for oral arguments one week after the election.

The death of liberal justice Ruth Bader Ginsburg puts the law in an even more precarious position.

And Trump’s health agencies have enacted myriad policies keeping the law from functioning as designed.

The president signed legislation zeroing out the individual mandate penalty requiring people to be insured in 2017. The same year, he ended cost-sharing reduction payments to insurers, suggesting that would cause the ACA to become “dead.” But the marketplace generally stabilized.

The administration has also increased access to skimpier but cheaper coverage that doesn’t have to comply with the 10 essential health benefits under the ACA. The short-term insurance plans widely discriminate against people with pre-existing health conditions, even as a growing number of Americans, facing rising healthcare costs, enrolled, according to a probe conducted by House Democrats this year.

Trump has also encouraged state waivers that promote non-ACA plans, cut funding for consumer enrollment assistance and outreach, shortened the open enrollment period and limited mid-year special enrollments.

​Despite his efforts, the ACA has grown in popularity among voters on both sides of the aisle, mostly due to provisions like shoring up pre-existing conditions and allowing young adults to stay on their parent’s insurance until age 26.

Biden

If elected, Biden would likely roll back Trump-era policies that allowed short-term insurance to proliferate, and restore funding for consumer outreach and assistance, political consultants say.

Building on the law is the linchpin of Biden’s healthcare plan. The nominee has pledged to increase marketplace subsidies to help more people afford ACA plans through a number of policy tweaks, including lowering the share of income subsidized households pay for their coverage; determining subsidies by setting the benchmark plan at the pricier “gold” level; and removing the current cap limiting subsidies to people making 400% of the federal poverty level or below.

Biden maintains as a result of these changes, no Americans would have to pay more than 8.5% of their annual income toward premiums. They could save millions of people hundreds of dollars a month, according to a Kaiser Family Foundation analysis. Commercial payers mostly support these efforts, hoping they’ll stabilize the exchanges.

But a second prong of Biden’s health strategy is deeply unpopular with private insurers: the public option. Biden’s called for a Medicare-like alternative to commercial coverage, available to anyone, including people who can’t afford private coverage or those living in a state that hasn’t expanded Medicaid.

The rationale of the public plan is that it can directly negotiate prices with hospitals and other providers, lowering costs across the board. However, market clout will depend on enrollment, which is still to-be-determined.

Critics see the plan, which by Biden’s estimate would cost $750 billion over 10 years, as a down payment on Medicare for All. And the private sector worries it could threaten the very profitable healthcare industry, which makes up about a fifth of the U.S. economy.

Medicare

Trump

Neither Trump nor Biden supports Medicare for All, dashing the hopes of supporters of the sweeping insurance scheme for at least another four years.

“It has a pulse — it’s not dead — I just don’t see it happening in any near term,” John Cipriani, vice president at public affairs firm Global Strategy Group, said at AHIP.

Trump has promised to protect Medicare if elected to a second term, and it’s unlikely he’d make any major changes to the program’s structure or eligibility requirements, experts say.

But Medicare is quickly running out of money, and neither Trump nor Biden has issued a complete plan to ensure it survives beyond 2024. Political consultants think it’ll teeter right up to the edge of insolvency before lawmakers feel compelled to act.

The president’s administration has allowed Medicare to pay for telehealth and expanding supplemental benefits in privately run Medicare Advantage programs, efforts that would likely bleed into his second term — or Biden’s first, given general bipartisan support on both, experts say.

Under Trump, HHS did pass a site-neutral payment policy, cutting Medicare payments for hospital outpatient visits in a bid to save money. But Democratic lawmakers have argued Trump’s calls to get rid of the federal payroll tax, which partially funds Medicare, could throw the future of the cash-strapped program in jeopardy.

The president has also signed legislation experts say accelerated insolvency, including the Tax Cuts and Jobs Act of 2017, the Bipartisan Budget Act of 2018 and the Further Consolidated Appropriations Act of 2020, which repealed the ACA’s Cadillac tax — a tax on job-based insurance premiums above a certain level.

Nixing that tax lowered payroll tax revenue, also dinging Medicare’s shrinking trust fund.

Trump’s proposed budget for the 2021 fiscal year floated culling about $450 billion in Medicare spending over a decade. And repealing the ACA would also nix provisions that closed the Medicare prescription drug “donut hole,” that added free coverage of preventive services and reduced spending to strengthen Medicare’s winnowing Hospital Insurance Trust Fund.

Biden

Biden has proposed lowering the Medicare age of eligibility to 60 years, with the option for people aged 60-64 to keep their coverage if they like it. The idea is popular politically, though providers oppose it, fearful of losing more lucrative commercial revenue.

It would make about 20 million more people eligible for the insurance, but could also add even more stress onto the program, experts say. Biden’s campaign says it would be financed separately from the current Medicare program, with dollars from regular tax revenues, and will reduce hospital costs.

Biden also says he’d add hearing, vision and dental benefits to Medicare.

Medicaid

Trump

Trump’s tenure has also been defined by repeated efforts to prune Medicaid. The president has consistently backed major cuts to the safety net insurance program, along with stricter rules for who can receive coverage. That’s likely to continue.

Republican lawmakers maintain the program costs too much and discourages low-income Americans from getting job-based coverage, and have enacted policies trying to privatize Medicaid. The Trump administration took a step toward a long-held conservative dream earlier this year, when CMS invited state waivers that would allow states to deviate from federal standards in program design and oversight, in exchange for capped funding.

So far, no states have enacted the block grants.

The administration also aggressively encouraged states to adopt work requirements, programs tying Medicaid coverage to work or volunteering hours. A handful of states followed suit, but all halted implementation or rolled back the idea following fierce public backlash and legal ramifications.

And repealing the ACA would ax Medicaid expansion, which saved some 20,000 lives between 2014 and 2017, according to the Center on Budget and Policy Priorities.

Biden

Biden, however, wants to preserve expansion, and would take a number of other steps to bolster the program, including increasing federal Medicaid funding for home- and community-based services. The roughly 4.8 million adults in states that elected not to expand Medicaid would be automatically enrolled into his public option, with no premium and full Medicaid benefits.

Additionally, states that have expanded Medicaid could elect to move their enrollees into the public option, with a maintenance-of-effort payment.

Lowering costs of drugs and services

Trump

Efforts to lower prescription drug costs have defined Trump’s healthcare agenda in his first term, and been a major talking point for the president. That’s more than likely to continue into a second term, experts say, despite a lack of results.

Trump did cap insulin costs for some Medicare enrollees, effective 2021. He also signed legislation in 2018 banning gag clauses preventing pharmacists from telling customers about cheaper options.

But despite fiery rhetoric and a litany of executive orders, Trump has made little if any concrete progress on actually lowering prices. One week into 2020, drugmakers had announced price hikes for almost 450 drugs, despite small price drops earlier in Trump’s tenure.

Trump has proposed several ideas either dropped later or challenged successfully by drugmakers in court, including allowing patients to import drugs from countries like Canada, banning rebates paid to pharmacy benefit manufacturers in Medicare and forcing drugmakers to disclose the list prices of drugs in TV ads.

The president has signed recent executive orders to lower costs largely viewed as pre-election gambits, including one tying drug prices in Medicare to other developed nations and another directing his agencies to end surprise billing. Implementation on both is months away. Trump has also promised to send Medicare beneficiaries $200 in drug discount cards before the election, an effort slammed as vote-buying that would cost Medicare at least $6.6 billion.

Both Trump and Biden support eliminating surprise bills but haven’t provided any details how. That “how” is important, as hospitals and payers support wildly different solutions.

Biden

Biden also has a long list​ of proposals to curb drug costs, including allowing the federal government to negotiate directly with drug manufacturers on behalf of Medicare and some other public and private purchasers, with prices capped at the level paid by other wealthy countries. Trump actually supported this proposal in his 2016 campaign, but quickly dropped it amid fierce opposition from drugmakers and free market Republican allies.

Biden would also cap out-of-pocket drug costs in Medicare Part D — but wouldn’t ban rebates, as of his current plan, allow consumers to import drugs (subject to safeguards) and eliminate tax breaks for drug advertising expenses.

He would also prohibit prices for all brand-name and some generic drugs from rising faster than inflation under Medicare and his novel public option. Biden would create a board to assess the value of new drugs and recommend a market-based price, in a model that’s shown some efficacy in other wealthy countries like Germany.

Both Biden and Trump say they support developing alternative payment models to lower costs. But they diverge on the role of competition versus transparency in making healthcare more affordable. In a rule currently being challenged in court, Trump’s HHS required hospitals to disclose private negotiated prices between hospitals and insurers, with the hope price transparency will allow consumers to shop between different care sites and shame companies into lowering their prices.

Biden, by comparison, says he would enforce antitrust laws to prevent anti-competitive healthcare consolidations, and other business practices that jack up spending. Trump has been mum on the role of M&A in driving healthcare costs, and inherited a complacent Federal Trade Commission that’s done little to reduce provider consolidation. Until a contentious hospital merger in February this year, the FTC hadn’t opposed a hospital merger since 2016.

 

 

 

 

Administration Sketches Healthcare Plan, Signs Executive Order

https://www.medpagetoday.com/washington-watch/electioncoverage/88810?xid=fb_o&trw=no&fbclid=IwAR1OTD2FHXYsDzbKZ_H3MdTUNnvlxhe7kqEMtaZMXjRBpkHFksvvY-lHVGc

New Executive Order Applies to Foreign Third-Party Code | The Media Trust

Critics question value of provision addressing preexisting condition coverage.

President Trump presented his “America First Healthcare Plan” during a speech to healthcare professionals in Charlotte, North Carolina, on Thursday — a plan that mentioned preexisting condition coverage protections and surprise billing but did not seem to include comprehensive changes to the healthcare system.

“Under the America First Healthcare Plan, we will ensure the highest standard of care anywhere in the world, cutting-edge treatments, state-of-the-art medicine, groundbreaking cures, and true health security for you and your loved ones,” Trump said. “And we will do it rapidly, and it’s in very good order, and some of it has already been implemented.”

Executive Order Provisions

The president signed an executive order outlining the plan, but the order contained initiatives in only a few areas, including:

  • Preexisting condition coverage. The order says simply: “It has been and will continue to be the policy of the United States to ensure that Americans with preexisting conditions can obtain the insurance of their choice at affordable rates.” The order does not direct any government agency to enact a regulation nor request Congress to pass legislation. In August 2018, the Trump administration allowed the sale of “short-term, limited duration” insurance plans that could last for up to 3 years; these often exclude coverage for preexisting conditions but also typically cost less than comprehensive coverage.
  • Surprise billing. “Recognizing that both chambers of the Congress have made substantial progress towards a solution to end surprise billing, the Secretary of Health and Human Services (HHS) shall work with the Congress to reach a legislative solution by December 31, 2020,” the order says. “In the event a legislative solution is not reached by December 31, 2020, the Secretary of Health and Human Services shall take administrative action to prevent a patient from receiving a bill for out-of-pocket expenses that the patient could not have reasonably foreseen.”
  • Price transparency. “Within 180 days of the date of this order, the Secretary of Health and Human Services shall update the Medicare.gov Hospital Compare website to inform beneficiaries of hospital billing quality, including whether the hospital is in compliance with the Hospital Price Transparency Final Rule whether, upon discharge, the hospital provides patients with a receipt that includes a list of itemized services received during a hospital stay; and how often the hospital pursues legal action against patients, including to garnish wages, to place a lien on a patient’s home, or to withdraw money from a patient’s income tax refund,” the order reads.

Trump also announced another initiative, this one aimed at seniors. “Under my plan, 33 million Medicare beneficiaries will soon receive a card in the mail containing $200 that they can use to help pay for prescription drugs … The cards will be mailed out in coming weeks,” Trump said. The $6.6 billion cost of the cards will be paid for under the auspices of a Medicare demonstration program. These funds are ostensibly available via savings generated through Trump’s “most favored nation” executive order allowing Medicare to pay no more for certain prescription drugs than the price paid by other developed countries, a White House official said. That executive order has not yet been implemented, however, and court challenges are expected.

Final Rule Issued on Drug Importation

Trump also noted that the FDA issued a final rule on Thursday implementing the president’s July executive order earlier this month to allow for importation of certain less expensive prescription drugs from Canada. “This means a state or whatever — can go to Canada and buy drugs for a fraction of the price that they’re charging right now,” he said.

He also highlighted individual actions his administration had taken that mostly affected particular groups, including lowering insulin prices for certain Medicare beneficiaries, investing in childhood cancer research, and expanding health reimbursement accounts that employers can use to reimburse employees for medical expenses. The COVID-19 pandemic received scant mention other than a reference to slashing red tape to accelerate development of treatments for the disease, and a sentence about how the pandemic had greatly increased the use of telehealth.

During a telephone briefing with reporters Thursday afternoon, HHS Secretary Alex Azar highlighted the surprise billing provision. “The President is saying that all the relevant players — hospitals, doctors, insurance companies — had better get their act together and get legislation passed through Congress that protects patients against surprise medical bills from anybody — hospitals or doctors, doesn’t matter,” he said.

“Those special interest groups need to sort it out and figure out how that would work,” he continued. “There have been legislative packages that have come quite close on the Hill that are bipartisan, but…. the president is saying the time is now. And if they do not get legislation passed by January 1st, he is instructing me to use the full regulatory power of the U.S. government to protect patients against surprise medical bills.”

Sen. Lamar Alexander (R-Tenn.), outgoing chairman of the Senate Health, Education, Labor, & Pensions (HELP) Committee, praised the surprise billing announcement. “The president is right to call on Congress to pass legislation this year to end surprise medical billing,” Alexander said in a statement, adding that a bill currently going through the House and Senate addresses the issue effectively. “Ending surprise medical bills is a problem that requires a permanent solution passed by Congress this year. The American people can’t afford to wait any longer.”

Preexisting Condition Provision Panned

The preexisting condition provision drew scorn from Democratic legislators. The provision “offers no protection not already available through the existing Affordable Care Act (ACA) and no protection for millions of Americans with preexisting conditions if Trump is successful in packing the Supreme Court to destroy the ACA,” Rep. Lloyd Doggett (D-Texas), chairman of the House Ways & Means Health Subcommittee, said in a statement.

But Azar said during the briefing that the ACA’s clause requiring insurers to cover preexisting conditions does no good if people aren’t able to afford insurance in the first place. “If you’re a couple, aged 55, living in Missouri, making $70,000 a year, Obamacare is going to cost you $30,000 in premiums and a $12,000 deductible,” he said.

Azar promised that the administration “will work with Congress or otherwise to ensure” that people with pre-existing conditions are protected, but he did not indicate how that would be made affordable to individuals without government subsidies of the sort Republicans have long opposed.

Bob Laszewski, president of Health Policy and Strategy Associates in Alexandria, Virginia, questioned how much good the executive order’s preexisting condition provision would do. “Trump and the Republicans couldn’t pass an alternative to Obamacare in 2017 when they controlled the White House and both houses of Congress,” he wrote in a blog post. “But, now he can just sign an executive order and everything is fixed? He has signed a number of healthcare-related executive orders and just about all of them are tied up in the byzantine federal regulatory process, or have faded away. This is just an election-year gimmick in an attempt to persuade voters that Trump has healthcare policy under control. There are a lot of governments in the world that operate by executive fiat. Ours is not one of them.”

 

 

 

 

Medicare won’t cover coronavirus vaccines approved under emergency use authorization

https://www.beckershospitalreview.com/pharmacy/medicare-won-t-cover-coronavirus-vaccines-approved-under-emergency-use-authorization.html?utm_medium=email

Medicare Wouldn't Cover Costs of Administering Coronavirus Vaccine Approved  Under Emergency-Use Authorization - WSJ

Medicare won’t cover the cost of a COVID-19 vaccine if it is approved under an emergency use authorization, according to The Wall Street Journal. 

The White House recently concluded that Medicare’s exclusion of emergency-use drug costs could mean 44 million Americans, or 15 percent of the U.S. population, may have to pay out-of-pocket for a vaccine if it is approved under an emergency use authorization, the Journal reported.

HHS is now exploring coverage options, and a spokesperson told the Journal any vaccine doses bought by the government will be provided free.

The administration of President Donald Trump has pushed for a COVID-19 vaccine to be approved and distributed before the presidential election, which would likely only come with an emergency use authorization, since FDA approvals take more time.

In March, lawmakers passed the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, which ensures no out-of-pocket costs for COVID-19 vaccines for people on Medicare.

HHS also said in August that government health insurance programs, including Medicare and Medicaid, would cover the costs of administering a COVID-19 vaccine. 

 

 

 

 

COVID-19 vaccine verdicts loom as next big market risk

https://finance.yahoo.com/news/covid-19-vaccine-verdicts-loom-050615809.html

Optimism that vaccines are on the way to end the coronavirus pandemic has been a major factor in this year’s U.S. stock resurgence. That will face a critical test in coming weeks, as investors await clinical data on whether they actually work.

A UBS analysis found that about 40% of the market’s gains since May can be pegged to hopes for vaccines to protect against COVID-19, which has killed over 960,000 worldwide and rocked the global economy.

Global efforts to develop a vaccine are coming to a head, with late-stage data on trials by companies such as Pfizer Inc <PFE.N> and Moderna Inc <MRNA.O> possible as soon as October or November. Disappointing results could further shake markets that have recently grown turbulent on worries over fiscal stimulus delays and uncertainty around the Nov. 3 U.S. presidential election.

“The anticipation is that this stuff is going to work,” said Walter Todd, chief investment officer at Greenwood Capital in South Carolina. “So any news to the contrary could be a risk to the market.”

The number of vaccines in development could blunt the negative market impact of any single setback. More than a half-dozen vaccines globally are in late-stage trials out of over 30 currently being tested in humans, according to the World Health Organization.

“We are setting ourselves up for success in the sense of if you throw enough spaghetti at the wall, hopefully at least one noodle sticks,” said Liz Young, director of market strategy at BNY Mellon Investment Management.

That could explain why stocks overall barely reacted earlier this month, when AstraZeneca Plc <AZN.L> and partner Oxford University paused global trials of one of the leading vaccine candidates after a participant in its U.K. trial became seriously ill. The trials have resumed in Britain, Brazil and South Africa, but remain on hold in the United States.

Some forecasts on vaccine availability have grown less optimistic. Good Judgment, a company whose forecasters make predictions based on publicly available evidence, put the chances that a vaccine will be widely distributed in the United States by the end of March at 54%. That is up from an estimate of less than 20% in early July, but down from above 70% earlier this month.

Pfizer and Moderna could report initial efficacy results in October or November based on an early read of data, followed by data from companies such as AstraZeneca, Johnson & Johnson <JNJ.N> and Novavax Inc <NVAX.O>.

An approval or emergency use authorization this year could lead to a surge in travel, leisure and other stocks that have been decimated by pandemic-related shutdowns, while also fueling a long-awaited shift into value stocks from tech and other growth names that have led the market for years.

Even if a vaccine is approved, questions persist about how easily and quickly it can be distributed. President Trump and his health officials have issued conflicting predictions about when the general public could have access.

“The potential for market disappointment will likely come from the realization that manufacturing and broad distribution will take longer,” said Art Hogan, chief market strategist at National Securities.

An approved, broadly distributed and accepted vaccine could result in a gain of about 300 points to the S&P 500, or more than 8% at the index’s current level, according to Keith Parker, head of U.S. and global equity strategy at UBS.

If a vaccine is widely distributed in the first quarter, BofA Global Research projects global gross domestic product (GDP) growth of 6.3% in 2021, compared with 5.6% if that does not occur until the third quarter.

Disappointing clinical trial news could result in a loss of 100 points from the S&P 500, or about 3%, Parker estimates.

While the market might be able to handle one vaccine setback “reasonably well,” several setbacks could cause a rethink of the vaccine race, he said.

 

 

 

 

America Is Trapped in a Pandemic Spiral

https://www.theatlantic.com/health/archive/2020/09/pandemic-intuition-nightmare-spiral-winter/616204/

America Is Trapped in a Pandemic Spiral - The Atlantic

As the U.S. heads toward the winter, the country is going round in circles, making the same conceptual errors that have plagued it since spring.

Army ants will sometimes walk in circles until they die. The workers navigate by smelling the pheromone trails of workers in front of them, while laying down pheromones for others to follow. If these trails accidentally loop back on themselves, the ants are trapped. They become a thick, swirling vortex of bodies that resembles a hurricane as viewed from space. They march endlessly until they’re felled by exhaustion or dehydration. The ants can sense no picture bigger than what’s immediately ahead. They have no coordinating force to guide them to safety. They are imprisoned by a wall of their own instincts. This phenomenon is called the death spiral. I can think of no better metaphor for the United States of America’s response to the COVID-19 pandemic.

The U.S. enters the ninth month of the pandemic with more than 6.3 million confirmed cases and more than 189,000 confirmed deaths. The toll has been enormous because the country presented the SARS-CoV-2 coronavirus with a smorgasbord of vulnerabilities to exploit. But the toll continues to be enormous—every day, the case count rises by around 40,000 and the death toll by around 800—because the country has consistently thought about the pandemic in the same unproductive ways.

Many Americans trusted intuition to help guide them through this disaster. They grabbed onto whatever solution was most prominent in the moment, and bounced from one (often false) hope to the next. They saw the actions that individual people were taking, and blamed and shamed their neighbors. They lapsed into magical thinking, and believed that the world would return to normal within months. Following these impulses was simpler than navigating a web of solutions, staring down broken systems, and accepting that the pandemic would rage for at least a year.

These conceptual errors were not egregious lies or conspiracy theories, but they were still dangerous. They manifested again and again, distorting the debate around whether to stay at home, wear masks, or open colleges. They prevented citizens from grasping the scope of the crisis and pushed leaders toward bad policies. And instead of overriding misleading intuitions with calm and considered communication, those leaders intensified them. The country is now trapped in an intuition nightmare: Like the spiraling ants, Americans are walled in by their own unhelpful instincts, which lead them round and round in self-destructive circles.

“The grand challenge now is, how can we adjust our thinking to match the problem before us?” says Lori Peek, a sociologist at the University of Colorado at Boulder who studies disasters. Here, then, are nine errors of intuition that still hamstring the U.S. pandemic response, and a glimpse at the future if they continue unchecked. The time to break free is now. Our pandemic summer is nearly over. Now come fall, the season of preparation, and winter, the season of survival. The U.S. must reset its mindset to accomplish both. Ant death spirals break only when enough workers accidentally blunder away, creating trails that lead the spiraling workers to safety. But humans don’t have to rely on luck; unlike ants, we have a capacity for introspection.

The spiral begins when people forget that controlling the pandemic means doing many things at once. The virus can spread before symptoms appear, and does so most easily through five P’s: people in prolonged, poorly ventilated, protection-free proximity. To stop that spread, this country could use measures that other nations did, to great effect: close nonessential businesses and spaces that allow crowds to congregate indoors; improve ventilation; encourage mask use; test widely to identify contagious people; trace their contacts; help them isolate themselves; and provide a social safety net so that people can protect others without sacrificing their livelihood. None of these other nations did everything, but all did enough things right—and did them simultaneously. By contrast, the U.S. engaged in …

1. A Serial Monogamy of Solutions

Stay-at-home orders dominated March. Masks were fiercely debated in April. Contact tracing took its turn in May. Ventilation is having its moment now. “It’s like we only have attention for only one thing at a time,” says Natalie Dean, a biostatistician at the University of Florida.

As often happens, people sought easy technological fixes for complex societal problems. For months, President Donald Trump touted hydroxychloroquine as a COVID-19 cure, even as rigorous studies showed that it isn’t one. In August, he switched his attention to convalescent plasma—the liquid fraction of a COVID-19 survivor’s blood that might contain virus-blocking antibodies. There’s still no clear evidence that this century-old approach can treat COVID-19 either, despite grossly misstated claims from FDA Commissioner Stephen Hahn (for which he later apologized). More generally, drugs might save some of the very sickest patients, as dexamethasone does, or shorten a hospital stay, as remdesivir does, but they are unlikely to offer outright cures. “It’s so reassuring to think that a magic-bullet treatment is out there and if we just wait, it’ll come and things will be normal,” Dean says.

Other strategies have merit, but are wrongly dismissed for being imperfect. In July, Carl Bergstrom, an epidemiologist and a sociologist of science at the University of Washington, argued that colleges cannot reopen safely without testing all students upon entry. “The gotcha question I’ve handled most from reporters since is: This school did entry testing, so why did they get an outbreak?” he says. It’s because such testing is necessary for a safe reopening, but not sufficient. “If you do it and screw everything else up, you’ll still have a big outbreak,” Bergstrom adds.

This brief attention span is understandable. Adherents of the scientific method are trained to isolate and change one variable at a time. Academics are walled off into different disciplines that rarely connect. Journalists constantly look for new stories, shifting attention to the next great idea. These factors prime the public to view solutions in isolation, which means imperfections become conflated with uselessness. For example, many critics of masks argued that they provide only partial protection against the virus, that they often don’t fit well, or that people wear them incorrectly. But some protection is clearly better than no protectionAs Dylan Morris of Princeton writes, “X won’t stop COVID on its own is not an argument against doing X.” Instead, it’s an argument for doing X along with other measures. Seat belts won’t prevent all fatal car crashes, but cars also come with airbags and crumple zones. “When we layer things, we give ourselves more wiggle room,” Dean says.

Several experts I’ve talked with have been asked: What now? The question assumes that the pandemic lingers because the U.S. simply hasn’t found the right solution yet. In fact, it lingers because the familiar solutions were never fully implemented. Despite claims from the White House, the U.S. is still not testing enough people. It still doesn’t have enough contact tracers. “We have the playbook, but I think there’s a confusion about what we’ve actually tried and what we’ve just talked about doing,” Dean says. A successful response “is never going to be one thing done perfectly. It’ll be a lot of different things done well enough.” That resilience disappears if we create…

2. False Dichotomies

A world of black and white is easier to handle than one awash with grays. But false dichotomies are dangerous. From the start, COVID-19 has been portrayed as a disease that mostly causes mild symptoms in people who quickly recover, and occasionally causes severe illness that leads to hospitalization and death. This two-sided caricature—severe or mild, sick or recovered—has erased the thousands of “long-haulers” who have endured months of debilitating symptoms at home with neither recognition nor care.

Meanwhile, as businesses closed and stay-at-home orders rolled out, “we presumed a trade-off between saving lives and saving the economy,” says Danielle Allen, a political scientist at Harvard. “That was foolishness of the most profound degree.” The two goals were actually aligned: Epidemiologists and economists largely agree that the economy cannot rebound while the pandemic is still raging. By treating the two as opposites, state leaders rushed to reopen, leading a barely contained virus to surge anew.  

Now, as winter looms and the pandemic continues, another dichotomy has emerged: enter another awful lockdown, or let the virus run free. This choice, too, is false. Public-health measures offer a middle road, and even “lockdowns” need not be as overbearing as they were in spring. A city could close higher-risk venues like bars and nightclubs while opening lower-risk ones like retail stores. There’s a “whole control panel of dials” on offer, but “it’s hard to have that conversation when people think of a light switch,” says Lindsay Wiley, a professor of public-health law at American University. “The term lockdown has done a lot of damage.” It exacerbated the false binary between shutting down and opening up, while offering …

3. The Comfort of Theatricality

Stay-at-home orders saved lives by curtailing COVID-19’s spread, and by giving hospitals some breathing room. But the orders were also meant to buy time for the nation to ramp up its public-health defenses. Instead, the White House treated months of physical distancing as a pandemic-ending strategy in itself. “We squandered that time in terms of scaling up testing and contact tracing, enacting policies to protect workers who get infected on the job, getting protective equipment to people in food-processing plants, finding places for people to isolate, offering paid sick leave … We still don’t have those things,” says Julia Marcus, an infectious-disease epidemiologist at Harvard Medical School and regular Atlantic contributor. The country is now facing the fall with many of the same problems that plagued it through the summer.

Showiness is often mistaken for effectiveness. The coronavirus mostly spreads through air rather than contaminated surfaces, but many businesses are nonetheless trying to scrub and bleach their way toward reopening. My colleague Derek Thompson calls this hygiene theater—dramatic moves that appear to offer safety without actually doing so. The same charge applies to temperature checks, which can’t detect the many COVID-19 patients who don’t have a fever. It also applies to the porous and inefficient travel bans that Trump and his allies still tout as policy successes. These tactics might do some good—let’s not conflate imperfect with useless—but they cause harm when they substitute for stronger measures. Theatricality breeds complacency. And by emphasizing solutions that can be easily seen, it exacerbated the American preference for …

4. Personal Blame Over Systemic Fixes

SARS-CoV-2 spread rapidly among America’s overstuffed prisons and understaffed nursing homes, in communities served by overstretched hospitals and underfunded public-health departments, and among Black, Latino, and Indigenous Americans who had been geographically and financially disconnected from health care by decades of racist policies. Without paid sick leave or a living wage, “essential workers” who earn a low, hourly income could not afford to quarantine themselves when they fell ill—and especially not if that would jeopardize the jobs to which their health care is tied. “The things I do to stay safe, they don’t have that as an option,” says Whitney Robinson, a social epidemiologist at the University of North Carolina at Chapel Hill.

But tattered social safety nets are less visible than crowded bars. Pushing for universal health care is harder than shaming an unmasked stranger. Fixing systemic problems is more difficult than spewing moralism, and Americans gravitated toward the latter. News outlets illustrated pandemic articles with (often distorted) photos of beaches, even though open-air spaces offer low-risk ways for people to enjoy themselves. Marcus attributes this tendency to America’s puritanical roots, which conflate pleasure with irresponsibility, and which prize shame over support. “The shaming gets codified into bad policy,” she says. Chicago fenced off a beach, and Honolulu closed beaches, parks, and hiking trails, while leaving riskier indoor businesses open.

Moralistic thinking jeopardizes health in two ways. First, people often oppose measures that reduce an individual’s risk—seat belts, condoms, HPV vaccines—because such protections might promote risky behavior. During the pandemic, some experts used such reasoning to question the value of masks, while the University of Michigan’s president argued that testing students widely would offer a “false sense of security.” These paternalistic false-assurance arguments are almost always false themselves. “There’s very little evidence for overcompensation to the point where safety measures do harm,” Bergstrom says.

Second, misplaced moralism can provide cover for bad policies. Many colleges started their semester with in-person teaching and inadequate testing, and are predictably dealing with large outbreaks. UNC Chapel Hill lasted just six days before reverting to remote classes. Administrators have chastised students for behaving irresponsibly, while taking no responsibility for setting them up to faila pattern that will likely continue through the fall as college clusters inevitably grow. “If you put 10,000 [students] in a small space, eating, sleeping, and socializing together, there’ll be an explosion of cases,” Robinson says. “I don’t know what [colleges] were expecting.” Perhaps they fell prey to …

5. The Normality Trap

In times of uncertainty and upheaval, “people crave a return to familiar, predictable rhythms,” says Monica Schoch-Spana, a medical anthropologist at the Johns Hopkins Center for Health Security. That pull is especially strong now because the pandemic’s toll is largely invisible. There’s nothing as dramatic as ruined buildings or lapping floodwater to hint that the world has changed. In some circles, returning to normal has been valorized as an act of defiance. That’s a reasonable stance when resisting terrorists, who seek to stoke fear, but a dangerous one when fighting a virus, which doesn’t care.

The powerful desire to re-create an old world can obscure the trade-offs necessary for surviving the new one. Keeping high-risk indoor businesses open, for example, helps the virus spread within a community, which makes reopening schools harder. “If schools are a priority, you have to put them ahead of something. What is that something?” says Bill Hanage, an epidemiologist at Harvard. “In an ideal world, they would be the last to close and the first to open, but in many communities, casinos, bars, and tattoo parlors opened before them.” A world with COVID-19 is fundamentally different from one without it, and the former simply cannot include all the trappings of the latter. Cherished summer rituals like camps and baseball games have already been lost; back-to-school traditions and Thanksgiving now hang in the balance. Change is hard to accept, which predisposes people to …

6. Magical Thinking

Back in April, Trump imagined the pandemic’s quick end: “Maybe this goes away with heat and light,” he said. From the start, he and others wondered if hot, humid weather might curb the spread of COVID-19, as it does other coronavirus diseases. Many experts countered that seasonal effects wouldn’t stop the new virus, which was already spreading in the tropics. But, fueled by shaky science and speculative stories, people widely latched on to seasonality as a possible savior, before the virus proved that it could thrive in the Arizona, Texas, and Florida summer.

This brand of magical thinking, in which some factor naturally defuses the pandemic, has become a convenient excuse for inaction. Recently, some commentators have argued that the pandemic will imminently fizzle out for two reasons. First, 20 to 50 percent of people have defensive T-cells that recognize the new coronavirus, because they were previously exposed to its milder, common-cold-causing cousins. Second, some modeling studies claim that herd immunity—whereby the virus struggles to find new hosts, because enough people are immune—could kick in when just 20 percent of the population has been infected.

Neither claim is implausible, but neither should be grounds for complacency. No one yet knows if the “cross-reactive” T-cells actually protect against COVID-19, and even if they do, they’re unlikely to stop people from getting infected. Herd immunity, meanwhile, is not a perfect barrier. Even if the low thresholds are correct, a fast-growing and uncontrolled outbreak will still shoot past themPursuing this strategy will mean that, in the winter, many parts of the U.S. may suffer what New York City endured in the spring: thousands of deaths and an untold number of lingering disabilities. That alone should be an argument against …

7. The Complacency of Inexperience

When illness is averted and lives are spared, “nothing happens and all you have is the miracle of a normal, healthy day,” says Howard Koh, a public-health professor at Harvard. “People take that for granted.” Public-health departments are chronically underfunded because the suffering they prevent is invisible. Pandemic preparations are deprioritized in the peaceful years between outbreaks. Even now, many people who have been spared the ravages of COVID-19 argue that the disease wasn’t a big deal, or associate their woes with preventive measures. But the problem is still the disease those measures prevented: The economy is still hurtingmental-health problems are growing, and educational futures have been curtailed, not because of some fearmongering overreaction, but because an uncontrolled pandemic is still afoot.

If anything, the U.S. did not react swiftly or strongly enough. Nations that had previously dealt with emerging viral epidemics, including several in East Asia and sub-Saharan Africa, were quick to take the new coronavirus seriously. By contrast, America’s lack of similar firsthand experience, combined with its sense of exceptionalism, might have contributed to its initial sloppiness. “One of my colleagues went to Rwanda in February, and as soon as he hit the airport, they asked about symptoms, checked his temperature, and took his phone number,” says Abraar Karan, an internist at Brigham and Women’s Hospital and Harvard Medical School. “In the U.S., I flew in July, and walked out of the airport, no questions asked.”

Even when the virus began spreading within the U.S., places that weren’t initially pummeled seemed to forget that viruses spread. “In April, I was seeing COVID patients in the ER every day,” Karan says. “In Texas, I had friends saying, ‘No one believes it here because we have no cases.’ In L.A., fellow physicians said, ‘Are you sure this is worse than the flu? We’re not seeing anything.’” Three months later, Texas and California saw COVID-19 all too closely. The tendency to ignore threats until they directly affect us has consigned the U.S. to …

8. A Reactive Rut

In March, Mike Ryan at the World Health Organization advised, “Be fast, have no regrets … The virus will always get you if you don’t move quickly.” The U.S. failed to heed that warning, and has repeatedly found itself several steps behind the coronavirus. That’s partly because exponential growth is counterintuitive, so “we don’t understand that things look fine until right before they’re very not fine,” says Beth Redbird, a sociologist at Northwestern. It’s also because the coronavirus spreads quickly but is slow to reveal itself: It can take a month for infections to lead to symptoms, for symptoms to warrant tests and hospitalizations, and for enough sick people to produce a noticeable spike. Pandemic data are like the light of distant stars, recording past events instead of present ones. This lag separates actions from their consequences by enough time to break our intuition for cause and effect. Policy makers end up acting only when it’s too late. Predictable surges get falsely cast as unexpected surprises.

This reactive rut also precludes long-term planning. In April, Michael Osterholm, an epidemiologist at the University of Minnesota, told me that “people haven’t understood that [the pandemic] isn’t about the next couple of weeks [but] about the next two years.” Leaders should have taken the long view then. “We should have been thinking about what it would take to ensure schools open in the fall, and prevent the long-term harms of lost children’s development,” Redbird says. Instead, we started working our way through a serial monogamy of solutions, and, like spiraling army ants, marched forward with no sense of the future beyond the next few footsteps.

These errors crop up in all disasters. But the COVID-19 pandemic has special qualities that have exacerbated them. The virus moved quickly enough to upend the status quo in a few months, deepening the allure of the hastily abandoned past. It also moved slowly enough to sweep the U.S. in a patchwork fashion, allowing as-yet-untouched communities to drop their guard. The pandemic grew huge in scope, entangling every aspect of society, and maxing out our capacity to deal with complexity. “People struggle to make rational decisions when they cannot see all the cogs,” says Njoki Mwarumba, an emergency-management professor at the University of Nebraska at Omaha. Full of fear and anxiety, people furiously searched for more information, but because the virus is so new, they instead spiraled into more confusion and uncertainty. And tragically, all of this happened during the presidency of Donald Trump.

Trump embodied and amplified America’s intuition death spiral. Instead of rolling out a detailed, coordinated plan to control the pandemic, he ricocheted from one overhyped cure-all to another, while relying on theatrics such as travel bans. He ignored inequities and systemic failures in favor of blaming China, the WHO, governors, Anthony Fauci, and Barack Obama. He widened the false dichotomy between lockdowns and reopening by regularly tweeting in favor of the latter. He and his allies appealed to magical thinking and steered the U.S. straight into the normality trap by frequently lying that the virus would go away, that the pandemic was ending, that new waves weren’t happening, and that rising case numbers were solely due to increased testing. They have started talking about COVID-19 in the past tense as cases surge in the Midwest.

“It’s like mass gaslighting,” says Martha Lincoln, a medical anthropologist at San Francisco State University. “We were put in a situation where better solutions were closed off but a lot of people had that fact sneak up on them. In the absence of a robust federal response, we’re all left washing our hands and hoping for the best, which makes us more susceptible to magical thinking and individual-level fixes.” And if those fixes never come, “I think people are going to harden into a fatalistic sense that we have to accept whatever the risks are to continue with our everyday lives.”

That might, indeed, be Trump’s next solution. The Washington Post reports that Trump’s new adviser—the neuroradiologist Scott Atlas—is pushing a strategy that lets the virus rip through the non-elderly population in a bid to reach herd immunity. This policy was folly for Sweden, which is nowhere near herd immunity, had one of the world’s highest COVID-19 death rates, and has a regretful state epidemiologist. Although the White House has denied that a formal herd-immunity policy exists, the Centers for Disease Control and Prevention recently changed its guidance to say that asymptomatic people “do not necessarily need a test” even after close contact with an infected personThis change makes no sense: People can still spread the virus before showing symptoms. By effectively recommending less testing, as Trump has specifically called for, the nation’s top public-health agency is depriving the U.S. of the data it needs to resist intuitive errors. “When there’s a refusal to take in the big picture, we are stuck,” Mwarumba says.

The pandemic is now in its ninth month. Uncertainties abound as fall and winter loom. In much of the country, colder weather will gradually pack people into indoor spaces, where the coronavirus more readily spreads. Winter also typically heralds the arrival of the flu and other respiratory viruses, and although the Southern Hemisphere enjoyed an unusually mild flu season, that’s “because of the severe precautions they were taking against COVID-19,” says Eleanor Murray, an epidemiologist at Boston University. “It’s not clear to me that our precautions will be successful enough to also prevent the flu.”

Schools are reopening, which will shape the path of the pandemic in still-uncertain ways. Universities are more predictable: Thanks to magical thinking and misplaced moralism, the U.S. already has at least 51,000 confirmed infections in more than 1,000 colleges across every state. These (underestimated) numbers will grow, because only 20 percent of colleges are doing regular testing, while almost half are not testing at all. As more are forced to stop in-person teaching, students will be sent back to their communities with COVID-19 in tow. “I expect this will blow up outbreaks in places that never had outbreaks, or in places that had outbreaks under control,” Murray says. Further spikes will likely occur after Thanksgiving and Christmas, as people who yearn to return to normal (or who think that the country overreacted) travel to see their family. Despite that risk, the CDC recently dropped its recommendation that out-of-state travelers should quarantine themselves for 14 days.

But many of the experts I spoke with thought it unlikely that “we’ll have cities going full New York,” as Bergstrom puts it. Doctors are getting better at treating the disease. States like Massachusetts, New York, and New Jersey have managed to avoid new surges over the summer, showing that local leadership can at least partly compensate for federal laxity. A new generation of cheap, rapid, paper-based tests will hit the market and make it easier to work out who is contagious. And despite the spiral of bad intuitions, many Americans are holding the line: Mask use and support for physical distancing are still high, according to Redbird, who has been tracking pandemic-related attitudes since March. “My feeling is that while things are going to get worse, I’m not sure they’ll be catastrophic, because of situational awareness,” Bill Hanage says.

Meanwhile, Trump seems to be teeing up a vaccine announcement in late October, shortly before the November 3 election. Moncef Slaoui, the scientific head of Operation Warp Speed, told NPR that it’s “extremely unlikely” a vaccine will be ready by then, and many scientists are concerned that the FDA will be pressured into approving a product that hasn’t been adequately tested, as Russia and China already have. Many Americans share this concern. A safe and effective vaccine could finally bring the pandemic under control, but its arrival will also test America’s ability to resist the intuitive errors that have trapped it so far. Vaccination has long been portrayed as the ultimate biomedical silver bullet, separating an era when masks and social distancing mattered from a world where normality has returned. This is yet another false dichotomy. “Everyone’s imagining this moment when all of a sudden, it’s all over, and they can go on vacation,” Natalie Dean says. “But the reality is going to be messier.”

This problem is not unique to COVID-19. It’s more compelling to hope that drug-resistant bacteria can be beaten with viruses than to stem the overuse of antibiotics, to hack the climate than to curb greenhouse-gas emissions, or to invest in a doomed oceanic plastic-catcher than to reduce the production of waste. Throughout its entire history, and more than any other nation, the U.S. has espoused “an almost blind faith in the power of technology as panacea,” writes the historian Howard Segal.* Instead of solving social problems, the U.S. uses techno-fixes to bypass them, plastering the wounds instead of removing the source of injury—and that’s if people even accept the solution on offer.

A third of Americans already say they would refuse a vaccine, whether because of existing anti-vaccine attitudes or more reasonable concerns about a rushed development process. Those who get the shot are unlikely to be fully protected; the FDA is prepared to approve a vaccine that’s at least 50 percent effective—a level comparable to current flu shots. An imperfect vaccine will still be useful. The risk is that the government goes all-in on this one theatrical countermeasure, without addressing the systemic problems that made the U.S. so vulnerable, or investing in the testing and tracing strategies that will still be necessary. “We’re still going to need those other things,” Dean says.

Between these reasons and the time needed for manufacturing and distribution, the pandemic is likely to drag on for months after a vaccine is approved. Already, the event is exacting a psychological toll that’s unlike the trauma of a hurricane or fire. “It’s not the type of disaster that Americans specifically are used to dealing with,” says Samantha Montano of Massachusetts Maritime Academy, who studies disasters. “Famines and complex humanitarian crises are closer approximations.” Health experts are burning outLong-haulers are struggling to find treatments or support. But many Americans are turning away from the pandemic. “People have stopped watching news about it as much, or talking to friends about it,” Redbird says. “I think we’re all exhausted.” Optimistically, this might mean that people are becoming less anxious and more resilient. More worryingly, it could also mean they are becoming inured to tragedy.

The most accurate model to date predicts that the U.S. will head into November with 220,000 confirmed deaths. More than 1,000 health-care workers have died. One in every 1,125 Black Americans has died, along with similarly disproportionate numbers of Indigenous people, Pacific Islanders, and Latinos. And yet, a recent poll found that 57 percent of Republican voters and 33 percent of independents think the number of deaths is acceptable. “In order for us to mobilize around a social problem, we all have to agree that it’s a problem,” Lori Peek says. “It’s shocking that we haven’t, because you really would have thought that with a pandemic it would be easy.” This is the final and perhaps most costly intuitive error …

9. The Habituation of Horror

The U.S. might stop treating the pandemic as the emergency that it is. Daily tragedy might become ambient noise. The desire for normality might render the unthinkable normal. Like poverty and racismschool shootings and police brutalitymass incarceration and sexual harassmentwidespread extinctions and changing climate, COVID-19 might become yet another unacceptable thing that America comes to accept.

 

 

 

 

Why Your Hand Sanitizer May Be Ineffective Or Tainted By Cancer-Causing Chemicals

https://www.forbes.com/sites/ericmack/2020/09/10/why-your-hand-sanitizer-may-be-ineffective-or-tainted-by-cancer-causing-chemicals/?utm_source=newsletter&utm_medium=email&utm_campaign=coronavirus&cdlcid=5d2c97df953109375e4d8b68#115d2e346241

Since the start of the coronavirus pandemic, hand sanitizers have become a sought-after staple of life in a Covid-19-afflicted world. But supply chains have been turned upside down in our new normal, and some sketchy suppliers have at times stepped in to fill the vacuum. The result for consumers could be hand sanitizer that doesn’t work as advertised and might even be filled with impurities that can cause cancer.

When the pandemic set in during the spring, New Mexico’s Rolling Still Distillery began switching gears from making its trademark green chile vodka and other spirits to producing hand sanitizer for sale and free distribution during the early days of lockdown.

In the middle of May, Rolling Still founder Dan Irion (disclosure: Irion and I have lived in the same small town for years and occasionally hang out socially) began to receive a number of emails from bulk ethanol producers, offering up the alcohol for sanitizer production at prices as low as $1.60 a gallon, quite a deal over the $9 per gallon or more Rolling Still normally pays for its key ingredient.

To take advantage of the steep discount, Rolling Still would need to come up with $60,000 and take possession of a huge tank of the stuff.

Irion balked at the offer after he couldn’t get a straight answer about the quality of the ethanol. He asked one of the suppliers if organic alcohol was available and was told simply: “It’s all good. Don’t worry about it.”

He called Brian Coutu from Rolling Still’s regular alcohol supplier, Greenfield Global, who warned him away from what he says is fuel-grade ethanol potentially loaded with chemicals that are known to cause cancer.

Coutu knew this because Greenfield was getting the same cold calls Irion received, but as a large corporation, it could easily test samples.

“They send us a sample and it’s just God awful…it’s got acetaldehyde and benzene and all kind of nasty stuff in it; it’s not pure,” Coutu told me over the phone. “What (fuel producers) are trying to do is dump it off to these companies that run it through charcoal and try to do a million other things to make it USP grade (safe for food, drug or medicinal use), which it’s still not.”

Irion and Coutu both told me that the cold calls had largely stopped by the end of June. The price of ethanol cratered at the end of March as the pandemic took hold and fuel demand dropped. It stayed low through May before edging back near pre-pandemic levels at the end of June.

“Because of the fast and furious nature of the hand sanitizer industry at that time, we might have done it,” Irion says. “I’m sure there are others who saw this as a way to do something good and make money.”

And this is the big question for right now. How much of the sanitizer that made it to warehouses, store shelves and ultimately into our homes, cars and hands was produced from industrial fuel-grade ingredients rather than safe medical or food grade alcohol?

“You’re seeing less pure forms get into the market because there is a shortage of ethanol,” says Mike Sandoval, President and Chief Operating Officer of Santé Laboratories. “We see tert-butyl impurities, we see methanol, we see benzene in many of the hand sanitizers we test… We’ve seen some tequila grade ethanol that when you open the bottle it smells terrible, unless you like tequila… we’re seeing a lack of transparency in this space.”

 

Not just distilleries

Santé Labs works primarily in the hemp and CBD markets, providing quality testing and other services. CBD manufacturers can work with large amounts of ethanol and also turned to making hand sanitizers in the spring.

Sandoval says he began seeing CBD manufacturers and related companies using “untraditional sources” of ethanol from places like Mexico, Guatemala, South America and the fuel industry. The raw alcohol often came with a certificate of authenticity claiming 100 percent purity, but in reality it might actually contain chemical impurities and a significant amount of water.

“They come from a price sensitive market where no one wants to pay for high quality tests… They’re not used to operating in sophisticated manufacturing where you are required to test incoming raw material. For example the ethanol or isopropyl alcohol that goes in a hand sanitizer. You’re supposed to test (according to Food and Drug Administration rules) the purity of that ingredient before you formulate it, and that’s just not happening.”

For its part, the FDA has recently made public guidance on a testing method to detect impurities in hand sanitizers like those seen by Greenfield and Sante Labs.

“The agency’s investigation of contaminated hand sanitizers is ongoing,” the FDA said in an email. “Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated.”

The takeaway from all this is that the ethanol market for manufacturers new to the production of hand sanitizer was flooded with sketchy raw alcohol that could be diluted or tainted with carcinogens. If that raw material isn’t tested on the front end, the resulting final product can come out with those impurities and an alcohol concentration that doesn’t meet the claims stated on the label.

The FDA maintains a list of hand sanitizers to avoid because they’ve been found to contain dangerous amounts of methanol, or an insufficient amount of its actual sanitizing ingredient, such as ethanol or isopropyl alcohol. However, the FDA’s enforcement powers are limited. A new waiver program created in response to the pandemic makes it easier for manufacturers to get around substantiating their label claims.

“Nine out of ten people are not meeting the label claim,” Sandoval says. “So most of the hand sanitizer you’re using from stores – and I even saw one from Wal-Mart that was a big brand… their hand sanitizers were crystallizing and turning green. I guarantee that they’re at 50 percent ethanol when they need to be at 70 percent.”

This brings up yet another concern, which is the shortage of proper plastic bottles and containers for sanitizer. Sandoval suspects that some manufacturers may have resorted to using the wrong type of containers, which then react with the alcohol, leaching chemicals into the sanitizer and turning its color.

“This entire supply chain is upside down because there’s a shortage of everything.”

 

Covering the stink of subpar sanitizer

Coutu at Greenfield Global says he’s aware of companies that have purchased their alcohol from unconventional sources, lured by prices as much as 90 percent lower than what Greenfield would charge.

The FDA relaxed the allowable limit of impurities like acetaldehyde and benzene that can make it into hand sanitizer, but Coutu says the limits still only allow a very small amount, whereas the samples Greenfield was testing had levels of contamination ten to 100 times higher than the new limits.

“And the odor on it is just not acceptable. It smells like burnt tequila… there’s some pretty nasty stuff out there and it’s dangerous.”

New services have even popped up this year, with fragrance manufacturers offering up products to help reduce the bad odor of some ethanol-based hand sanitizers.

Irion feels like he dodged a bullet by not jumping at the deeply discounted supply of ethanol others may not have been able to resist.

Rolling Still continued buying the organic alcohol it uses in both its spirits and sanitizer. It’s now ramping up production of sanitizer, which Irion says has no need for added fragrances to mask any ethanol odors, but some local osha and sage is infused to lighten the scent.

The alcohol used is also distilled five times just to make sure all impurities are removed.

 

 

 

 

Fauci Says It Will Be ‘Well Into 2021’ Before U.S. Returns To Normal From Coronavirus

https://www.forbes.com/sites/sarahhansen/2020/09/11/fauci-says-it-will-be-well-into-2021-before-us-returns-to-normal-from-coronavirus/#4eb5a0862f7c

Dr Anthony Fauci disagrees with Trump over the coronavirus says US has not  turned the final corner | Daily Mail Online

TOPLINE

Dr. Anthony Fauci, the country’s top infectious disease official, told MSNBC on Friday that because of the timeline for manufacturing and distributing a coronavirus vaccine, it will be well into next year before American life returns to normal.

 

KEY FACTS

President Trump suggested this week that a vaccine will be ready in time for November’s election, but Fauci has said such an accelerated timeline is not realistic. 

Fauci said Friday it’s possible that a vaccine could be available by the end of this year or early 2021.

Manufacturing the vaccine in large quantities and distributing it to the majority of the population will take significantly longer, however, meaning that returning to “normal” life—including indoor and enclosed activities like movie theaters—won’t happen until the middle or end of next year. 

Fauci on Friday also refuted Trump’s comments Thursday that the U.S. is “rounding the corner” on coronavirus, characterizing the current data on the virus, which shows about 40,000 new cases and 1,000 deaths a day, as “disturbing.”

During a discussion with doctors from Harvard Medical School on Thursday, Fauci said the U.S. needs to prepare to “hunker down” this fall and winter and warned against looking only at the “rosy side of things,” CNBC reported

 

CRUCIAL QUOTE

“If you’re talking about getting back to a degree of normality, which resembles where we were prior to COVID, it’s gonna be well into 2021,” Fauci said. “Maybe even towards the end of 2021.”

 

KEY BACKGROUND

According to a New York Times tracker, there are 38 coronavirus vaccine candidates being tested on humans in clinical trials. This week, pharma giant AstraZeneca announced it had paused a late-stage vaccine trial after a participant developed what is suspected to be an adverse reaction to the drug. The heads of nine pharma companies have also pledged that they would not submit their coronavirus vaccine candidates to regulators until they are shown to be safe and effective in large critical trials. 

 

 

 

 

Nearly half of Americans hesitant to get a COVID vaccine

https://mailchi.mp/365734463200/the-weekly-gist-september-11-2020?e=d1e747d2d8

The race for a COVID-19 vaccine is well underway, with dozens of vaccine candidates being tested worldwide. Because vaccines typically take a decade to get to market, the pace of Operation Warp Speed—which aims to deliver a COVID vaccine by January 2021—has raised concerns that the government will sacrifice vaccine safety and efficacy for speed.

Shown in the graphic above, a survey conducted by Jarrard Phillips Cate & Hancock and Public Opinion Strategies found nearly half of American adults are on the fence about getting a COVID-19 vaccine, with over 20 percent saying they are unlikely to get one at all.

This hesitancy is greater among both female and Black respondents—with the latter doubly concerning given that Blacks have been disproportionately impacted by the disease. The top reasons given for skepticism include concerns about side effects (47 percent) and the risk of becoming infected by the vaccine (22 percent).

A related survey from STAT and the Harris Poll found that 78 percent of Americans worry the vaccination approval process is being driven more by politics than science.

Whom do consumers trust for information? Their doctors. Physicians must be prepared to answer questions about how they have evaluated a vaccine, why they believe it to be safe and effective, and whether they have chosen to take it themselves.

As providers prepare to deliver millions of vaccine doses once one is approved and available, leveraging the trust inherent in physician-patient relationships will be essential, especially among vaccine-hesitant populations.