What doctors need to address about parents’ school reopening concerns

As state and local officials look to reopen schools in the fall, pediatricians and primary care doctors will likely field a lot of questions from worried parents about whether it’s safe to send their children back to classrooms amid the coronavirus.
Will children have to wear masks? What about sports and after-school activities? And how do you keep six-year-olds from hugging their friends and touching their faces?
The challenges of reopening K-12 schools in the fall was the subject of a recent viewpoint published in the Journal of the American Medical Association. The piece, which outlines measures that schools should take to minimize risk, was written by Joshua Sharfstein, M.D., vice dean for Public Health Practice and Community Engagement for the Johns Hopkins Bloomberg School of Public Health, and Christopher Morphew, Ph.D., of the Johns Hopkins School of Education.

“It’s important for people to understand that there’s nothing that is perfectly safe. No activity, including staying home, is perfectly safe,” Sharfstein told Howard Bauchner, M.D., editor-in-chief of JAMA, in a recent interview.

School, state and local officials need to be honest with parents about the risks and the measures being taken to keep the risk as low as possible, he said.
“At school, basic screening is probably appropriate,” Sharfstein said.
Schools should use paraprofessionals—such as nursing aides and other trained staff— to screen children quickly on arrival, make hand-washing and other supplies readily available and adopt schedules for cleaning high-touch areas and disinfecting classrooms with appropriate protective equipment for maintenance staff, the researchers said in the viewpoint.
Following guidelines from the Centers for Disease Control and Prevention, protocols at schools will likely involve spacing classroom desks six feet apart, keeping groups of children together throughout the day to limit mixing, staggering drop-offs and pickups, closing common areas and canceling extracurricular activities that require close contact.
Staff and older students should wear cloth face coverings, particularly when it is difficult to maintain distancing.
“In terms of masks, we need to recognize that some ages it’s just not possible,” he said. “There needs to be a strong understanding with parents that if anyone at home is sick then the child doesn’t come to school as the child could be asymptomatic.”
Parents need to do a check-in every morning to see whether their children have symptoms and whether other family members are ill at home.
The jury is still out on whether children are more or less contagious than adults, Sharfstein said, with recent research suggesting kids are less likely to spread the virus.
Sports and after-school activities will need to be considered on a case-by-case basis, with the understanding that after-school programs are beneficial to parents who need their kids to have supervision until they get off work.
“From a public health standpoint, each one has to be analyzed on its own and asked if it can be made safer. With choir practice, that activity may not be in the cards this year. Other types of clubs and activities could exist with social distancing in areas with a low level of community transmission,” Sharfstein said.

Despite the risks, reopening schools this fall is an urgent national priority, the researchers said.
“What kids get from schools is not just the three ‘Rs.’ With schools closed, children have lost access to health services through school-based health centers. More than 20 million children rely on school breakfast or lunch,” Sharfstein said.
Attending school impacts a child’s social and emotional development, he said.
“Teachers and other school officials recognize one in five cases of concern for child abuse. All those cases aren’t being reported now, he said.
School district leaders will need to consult with state and local officials, parents, teachers unions and other employees to develop a strategy for reopening. That strategy will need to focus on facility needs, transportation, staffing and education curricula.
“It’s like an emergency response decision-making structure that schools should adopt,” Sharfstein said.

School districts will need to be prepared to adopt a hybrid approach that combines physical in-class learning and remote learning, especially if there is a spike in COVID-19 cases in their communities, the researchers said.
Some parents and students will view the risk as too high and should have the opportunity for online learning, Sharfstein said.
There are many kids who lack access to broadband internet. School systems should make on-site education a high priority for kids who experience barriers to remote learning, students who receive special education services or nutritional support at school and younger children.
“One approach that districts need to think about is the idea that some children at some age levels learn better remotely. Think about high-schoolers versus elementary-age school children. We know elementary-age children don’t do as well with remote learning,” Morphew said.
Both researchers said massive funding from the federal government will be needed to give states and local school districts the resources needed to put all these measures in place.
“The staffing needs, the facility needs, the technological needs, all of these things are labor-intensive and resource-intensive. Keeping kids in different groups will require more teachers. We’ve seen evidence that this strategy works in Norway and Finland as they have reopened,” Morphew said.
https://www.fiercehealthcare.com/practices/what-physicians-need-to-know-about-schools-reopening-fall

Appeals court rejects AFL-CIO lawsuit over lack of COVID-19 labor protections

A federal appeals court on Thursday rejected the AFL-CIO’s emergency lawsuit against the Trump administration for failing to enact stronger labor protections amid the coronavirus crisis.
A three-judge panel on the D.C. Circuit Court of Appeals issued a two-page order saying that the Department of Labor’s Occupational Safety and Health Administration (OSHA) has the authority to decide whether to issue new rules during the pandemic.
“In light of the unprecedented nature of the COVID-19 pandemic, as well as the regulatory tools that the OSHA has at its disposal to ensure that employers are maintaining hazard-free work environments … the OSHA reasonably determined that an ETS [emergency temporary standard] is not necessary at this time,” the panel said in its order.

The labor group filed an emergency petition with the D.C. Circuit less than a month ago, accusing OSHA of ignoring calls for urgently needed labor rules to protect workers vulnerable to the coronavirus.
“COVID-19’s toll in mortality and morbidity among workers and the general public has exceeded the expectations of many prognosticators,” lawyers for the AFL-CIO wrote in their petition.
“Yet in a stunning act of agency nonfeasance in the midst of a workplace health emergency of a magnitude not seen in this country for over a century (if ever), OSHA has neither responded directly to, nor taken formal action on, either of the two pending ETS petitions, nor has it shown any inclination to adopt mandatory, legally-enforceable, COVID-19-specific rules to protect workers.”
But the lawsuit faced an uphill battle considering the amount of deference that the courts grant to federal agencies.
“We are very disappointed that three judges did not deem the lives of America’s workers worthy of holding an argument or issuing a full opinion,” AFL-CIO president Richard Trumka said in a statement responding to the decision.

“The U.S. Court of Appeals for the District of Columbia Circuit’s post-it length response to our petition acknowledges the ‘unprecedented nature of the COVID-19 pandemic’ but repeats the false claim by Big Business that the Occupational Safety and Health Administration already has done what is needed to protect workers,” he added.

The AFL-CIO and a coalition of labor unions had urged Labor Secretary Eugene Scalia in March to enact stronger rules for protecting workers and to require employers to report to the agency when their workers tested positive for the coronavirus.
Scalia responded in a letter saying that his agency had issued strong guidelines to protect workers and that the labor groups’ proposal would unnecessarily “burden employers and overwhelm OSHA with information.”
https://thehill.com/regulation/court-battles/502249-appeals-court-rejects-afl-cio-lawsuit-over-lack-of-covid-19-labor

DOJ invokes protests in urging Md. county to amend order for religious gatherings

The Department of Justice (DOJ) is calling on Maryland’s Montgomery County to amend a COVID-19 order to allow for religious gatherings after officials permitted protests over George Floyd’s death.
Assistant Attorney General Eric Dreiband of the DOJ’s Civil Rights Division sent a letter to the county’s executive and council on Wednesday expressing “civil rights concerns” about the enforcement of an executive order that prohibits gatherings of more than 10 people.
The letter begins by praising officials in the county, which sits just outside of Washington, D.C., for releasing a June 1 statement permitting “peaceful public protest” despite the order to limit gatherings during the coronavirus pandemic.

“Of no less importance, of course, is the First Amendment’s protection for religious exercise,” Dreiband wrote.
“Government may not discriminate against religious gatherings compared to other nonreligious gatherings that have the same effect on the government’s public health interest, absent compelling reasons,” he said.
The assistant attorney general called on the county’s leaders to adjust the executive order to allow residents to “gather peacefully to exercise the full range of rights protected by the First Amendment.”
The letter addressed to Montgomery County Executive Marc Elrich and the County Council encourages the county to “ensure that it imposes no more onerous conditions on gatherings for religious exercise than it does for other purposes.”
Dreiband acknowledged in the letter that protests are usually held outdoors and religious services are usually held indoors, but he cited reports of hundreds of people “packed into a library” in Bethesda on June 2 for demonstrations.
“We urge you to ensure that your Executive Orders and enforcement of them respect both the right of your residents to assemble to express their views and the right to practice their faith,” the letter reads.

Dreiband in a statement announcing the letter called it “important” for people to be able to practice religion “during a crisis.”
“Montgomery County has shown no good reason for not trusting congregants who promise to use care in worship the same way it trusts political protesters to do the same,” he said. “The Department of Justice will continue to take action if states and localities infringe on the free exercise of religion or other civil liberties.”
The executive order issued in Montgomery County on June 1 permits “drive-in religious services” with attendees staying in their cars and participating in services remotely.
Maryland Gov. Larry Hogan (R) later issued an executive order allowing churches, synagogues, mosques, temples and other religious facilities to open at 50 percent capacity.

However, counties and municipalities are given the option to delay entering the second phase of the state’s recovery plan if they feel like their areas have not hit needed metrics.
Elrich, the Montgomery County executive, tweeted Wednesday that “we continue to rely on the data to protect public health.” The official said the county could enter a second phase of reopening next week that would permit one congregant or family per 200 square feet of service space.
Despite some states having limitations on gatherings during the pandemic, widespread protests broke out within the past two weeks after video showed Floyd’s death in Minneapolis police custody.
https://thehill.com/homenews/administration/502303-doj-invokes-protests-in-urging-maryland-county-to-amend-order-for

With COVID-19 test tubes in shortage, Coca-Cola bottlers offer a solution

A group of independent soda bottle manufacturers working for Coca-Cola has pivoted to help produce the test tubes needed for COVID-19 diagnostic kits.

The efforts include a collaboration between the Oak Ridge National Laboratory (ORNL) and the U.S. Department of Health and Human Services to address this particular gap.

The coronavirus pandemic and a skyrocketing demand for diagnostics have strained nearly every piece of the supply chain—from the chemical reagents for processing the virus’s genetic material to the one-piece nasal swabs used to collect samples, as well as sterile containers for transport.

Finding this particular solution took a little luck. Before being heated, shaped and blown into their iconic curves, Coca-Cola bottles begin life as a simple, nondescript, mass-produced plastic tube—which happens to be the perfect size for holding a swab.

“Through a personal connection and discussions with Coca-Cola Consolidated, we determined the preform that goes into a blow molding machine to make Coca-Cola bottles looked exactly like the test tube needed for the COVID-19 testing kits,” said Lonnie Love, lead scientist at Tennessee-based ORNL.

Bottler Coca-Cola Consolidated worked with manufacturing cooperative Southeastern Container to produce over 7 million test kit tubes using their injection molding machinery.

“Coke bottlers have done what no other vialing company could do—In a few short days, they have fabricated a small, ruggedized vial from a plastic preform that does not leak, is large enough to hold any swab type, and importantly, they can make millions of tubes per week,” said Luke Daum, chief scientific officer at Longhorn Vaccines & Diagnostics, which tested the tubes’ viability.

“Within 24 hours Longhorn called us and said, ‘Coke is it!’” said Love. “Coca-Cola bottlers had an answer to a problem they did not know existed, and by connection with ORNL, they will now be supplying millions of preforms for COVID-19 testing kits throughout the U.S.”

Longhorn also partnered with Cenetron Diagnostics to produce sample-gathering kits using the preformed Coca-Cola bottle tubes and Longhorn’s PrimeStore Molecular Transport Medium, which is designed to inactivate microbial samples so they can be shipped and stored using less stringent biomedical precautions.
https://www.fiercebiotech.com/medtech/covid-19-test-tubes-shortage-coca-cola-bottlers-offer-a-solution

Gilead should get ‘real pricing,’ profit for remdesivir – Leerink’s Porges

Perhaps no other biopharma company has a tougher decision to make right now than Gilead Sciences does on the pricing of COVID-19 drug remdesivir amid a public health crisis. It’s not exaggerating to say the entire pharmaceutical industry’s reputation hinges on the company’s next moves.
Now, one Wall Street analyst is voicing his support for Gilead, arguing the Big Biotech shouldn’t be pressured to price remdesivir too low or be penalized for making a sizeable profit along the way.
“If you are going to war, or preparing for war in a capitalist country, you have to let business make money out of the process or business won’t work,” SVB Leerink’s Geoffrey Porges wrote in a Wednesday note to investors, quoting former U.S. Secretary of War Henry Stimson during World War II.

The COVID-19 pandemic is indeed a war against a pathogen, as the disease had infected over 7.4 million and claimed more than 417,000 lives globally as of Thursday morning.

Underestimated by cost-effectiveness analysis

What kind of a sticker price for remdesivir is acceptable? Around $5,000 per course, in Porges’ view. That was roughly the same as the $4,460 that drug cost watchdog the Institute for Clinical and Economic Review (ICER) came up with recently for the drug to be deemed cost-effective.
That price was reached on very stringent pharmacoeconomic standards, Porges noted. It’s based on the criterion of $50,000 per quality-adjusted life-year gained, rather than the more commonly applied $100,000/QALY or $150,000/QALY thresholds.
What’s more, the ICER analysis dismissed R&D and capital investment costs, arguing Gilead already got its money back by selling megablockbuster hepatitis C drugs. During a recent conference call with investors, Gilead CFO Andrew Dickinson said the “potential range” of investment in ramping up remdesivir development and manufacturing could reach $1 billion in 2020 alone.

ICER also based its calculation on an outside study that estimates the manufacturing cost of the drug is $10 per 10-day course, though Dickinson recently told Porges the actual number is “an order of magnitude greater than” that. Consumer advocacy group Public Citizen is calling for a manufacturing cost recovery price of $1 per day.
In addition, ICER used hospital medical costs of hospitalization for non-COVID pneumonia, “which likely underestimates the cost of care for COVID pneumonia, with likely longer hospital stays, greater complexity, highly infectious nature and isolation requirements,” Porges said.
He noted that those medical costs also don’t account for other secondary economic effects such as loss of productivity, though he acknowledged that adding those factors in would push up the drug’s price and create a “massive burden” on society. Instead, “[p]ricing at a proportion of medical costs saved would be a terrific deal for payers and consumers,” he said.
A recent study in Health Affairs by researchers at the City University of New York found the median cost of a hospitalized COVID-19 patient during admission was $14,366. Another report, by America’s Health Insurance Plans, estimates that the hospital cost per non-ICU patient is about $11,000, and the cost could exceed $30,000 for each person admitted into intensive care.

For context, remdesivir has shown it can cut the duration of hospital stays by 30% compared with placebo. Shaving 30% off an average cost of $15,000 means a $5,000-per-course price for remdesivir is fair, regardless of potential benefit on post-hospital costs and other individual benefits, Porges argues.

Negative impacts from distorted pricing

The technical analysis aside, Gilead should be allowed to make money off remdesivir from a societal perspective, according to Porges.
Compared with the $5.5 billion Gilead spent last year in R&D and external deals, the $1 billion investment in remdesivir represents a large proportion of its capital allocation. For 2019, Gilead reported operating cash flow of $9.1 billion. After paying investors dividends and upgrading its physical assets, only $2.4 billion was left for any unplanned portfolio development.
“Were it not for this investment in remdesivir, Gilead could perhaps be investing more capital into developing their oncology franchise, or in expanding other aspects of their antiviral or hepatology franchises,” Porges said.
Granted, Gilead has a social obligation to develop remdesivir to help fight a deadly disease, but it shouldn’t be punished for doing that when it could potentially enjoy better profitability elsewhere, he figures. High pricing pressure and “absence of the expectation of any profit” could discourage further investment in COVID-19, Porges said.

Anti-infectives and non-COVID vaccines are already attracting increasingly less interest, as cash is being allocated to high-return oncology and rare diseases. Taking away the profits such investments could reap is, as Porges put it, “exactly the wrong signal to send to industry participants if we are trying to encourage the development of such medicines and the expansion of the industrial capacity to amount rapid responses to events such as COVID-19.”
Large companies such as Gilead may be able to absorb the cost of a zero-profit program, and some have suggested the rewards for the development of COVID treatments will be non-financial but rather reputational. However, Porges finds such goodwill difficult to value and hard to count on. Even if it materialized, it could lead to a slippery slope where regulatory and commercial favoritism is given to the company.
What’s more, biopharma companies shouldn’t be singled out in response to COVID-19, Porges contends. Admittedly, scrutiny on the pharma industry comes from years of distrust—Gilead itself was lambasted for high pricing on hepatitis C drugs Sovaldi and Harvoni. But the same expectations of zero profit aren’t being applied to developers of diagnostic kits, to manufacturers of protective gears, or to grocery stores that are supplying necessary household supplies during lockdown.
Some large drugmakers have come out to say that they will provide COVID medicines or vaccines at zero profit. As Porges sees it, these statements were made in the heat of the crisis “obviously done to capture public and political favor.” Such behaviors, namely announcing pricing before a product’s profile is understood, “distorts” both the internal incentives and other investors’ motivation to continue to finance the area.
All things considered, pricing for COVID-19 products “should reflect some proportion of the value they will create,” Porges said. Even that approach will still be a “special situation” for a pandemic. For remdesivir, the $50,000/QALY ICER used to reach the $4,460 price is already a tighter standard utilized for a public health emergency.
https://www.fiercepharma.com/pharma/gilead-should-be-allowed-remdesivir-real-pricing-and-sizeable-profit-covid-19-says-analyst

‘Boom and bust’ pandemic response isn’t working – Sanofi exec

With much of the world caught up in responding to COVID-19, experts and lawmakers are again underscoring the need to prepare for the next pandemic, as distant a concern as it may seem.

Historically, the biopharma industry and public health groups have gone through “boom and bust” funding cycles in response to pandemics, “where we throw resources and money at a problem when the horse is out of the barn,” Sanofi chief scientific officer Gary Nabel said on a BIO Digital panel this week.

To better prepare for future threats, he called for a “global biosecurity network” to anticipate threats and better prepare. The effort could include surveillance, “banks of antibodies” to quickly deploy in response to outbreaks, and “ready-to-go” diagnostic tests.

“Let’s use modern technologies and let’s never be put in this position ever again,” he said.

COVID-19 is the worst pandemic in generations, leaving hundreds of thousands of dead and millions more infected worldwide. But the world has faced six global outbreaks in the last 20 years, including Ebola, Zika and MERS.

None of those grew to the level of deadliness across the world as COVID-19, but that doesn’t mean future outbreaks can’t.

“I guarantee you if we are lucky enough to get through this relatively unscathed,” there will be other pandemics, Nabel said during the panel. “And there can be worse pandemics.”

Scientific and health communities have been working for years to better prepare for outbreaks and pandemics, including with the 2017 formation of the Coalition for Epidemic Preparedness Innovations. The group has committed hundreds of millions of dollars to fund research in emerging diseases, and it got involved early in COVID-19 vaccine work.

Nabel isn’t alone in outlining the need for better pandemic preparation. In fact, just this week, Senate health committee Chairman Lamar Alexander called on Congress to “act on needed changes this year in order to better prepare for the next pandemic.” Takeda’s CEO Christophe Weber has urged a global shift to be “more proactive than reactive” in pandemic responses. Over the years, other biopharma execs have spoken up on the issue as well.

In a new white paper, Alexander’s office outlined five areas of focus for U.S. pandemic preparations—better R&D for tests, treatments and vaccines, plus surveillance, stockpiling, stronger public health infrastructure and better cooperation within the federal government during a crisis.

Another challenge is manufacturing. The vaccine industry operates “more or less” at capacity, Merck’s vaccine president John Markels said on a BIO panel this week. That poses significant challenges when companies need to scale up for global immunization efforts for billions of people. On that panel, Moderna CEO Stéphane Bancel said health communities should build new factories to help deal with that capacity shortfall.

https://www.fiercepharma.com/pharma/bio-boom-and-bust-pandemic-response-isn-t-working-sanofi-exec-says-it-s-time-to-get-ready

Docs don’t think Biogen Alzheimer’s drug should get OK, but they’d still prescribe it

When Biogen disclosed a filing delay for its closely watched Alzheimer’s disease drug candidate aducanumab back in April, analysts were puzzled and pushed for answers. But no matter when the drug makes its way to regulators, controversy will follow, J.P. Morgan analysts wrote in a recent note, pointing to results from a survey of experts.

Among 30 Alzheimer’s doctors who are “very familiar” with aducanumab’s data—20 academic doctors and 10 community docs—most said the drug should not be approved, the analysts wrote. Even still, many of the doctors will prescribe the drug if it is, the firm’s expert survey found.

The survey results “pretty clearly” outline “why the ultimate regulatory fate of [aducanumab] stands to be controversial,” J.P. Morgan analyst Cory Kasimov wrote in a note to clients.

An overwhelming majority of docs surveyed—94%— see the drug as at least “somewhat tolerable” for patients, according to the note. But the experts are split on whether the phase 3 data that will support Biogen’s FDA application are “clinically meaningful.”

The doctors treat about 7,000 Alzheimer’s patients each year, and the group said they would prescribe aducanumab for about 20% of patients at launch, growing to about 40% after two years, Kasimov wrote.

“Although it is difficult to take these utilization rates at face value, our survey results imply that there will be strong initial demand for aducanumab, if approved,” Kasimov wrote.

After teaming up on aducanumab in 2017, Biogen and its partner Eisai in March 2019 disclosed the drug had failed phase 3 testing. Biogen planned to write off the effort entirely. But in a stunning development that fall, Biogen said a review of a larger dataset justified an FDA filing. Within a year after Biogen’s discontinuation news, the company’s share price had recovered as it pushed forward, toward an FDA filing.

At the J.P. Morgan Healthcare Conference earlier this year, execs said they were already gearing up for launch. The company has finished construction on a plant in Switzerland that will produce the drug, CEO Michel Vounatsos told analysts April.

In another move that surprised analysts earlier this year, Biogen said it was pushing its FDA filing to the third quarter of 2020. That means an approval could come in 2021 or 2022, analysts wrote. Biogen execs insisted the delay wasn’t caused by problems with the data, but instead the complexity of the application and challenges from COVID-19. The company is “prioritizing quality of submission versus the timing,” Vounatsos said at the time.

https://www.fiercepharma.com/pharma/docs-don-t-think-biogen-s-aducanumab-should-be-approved-but-they-would-still-use-it-analyst