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Monday, August 10, 2020

Snapshot of the US contact-tracing workforce

As of the end of July, 45 states and the District of Columbia reported a total of 41,122 contact tracers, according to NPR‘s latest survey, done in collaboration with the Johns Hopkins Center for Health Security.
Five things to know:
1. Contact tracers help track COVID-19 cases and exposure. They call those who are infected and find their contacts to notify them of their exposure risk so they can take precautions.
2. Although NPR‘s latest survey found a total of 41,122 contact tracers, that count may be higher because not all U.S. states responded to the survey, and 12 states said their counts exclude county and local staff, NPR said.
3. According to NPR, more than two-thirds of states are using a bank of trained reserve staff for contact tracing as needed, and 11 said unpaid volunteers are part of their contact-tracing workforce.
5. Overall, CDC Director Robert Redfield, MD, estimated in June that as many as 100,000 contact tracers are needed nationwide to combat the pandemic.
Read more about the survey here.

Ligand to buy Pfenex for up to $516M deal value

Ligand Pharmaceuticals (NASDAQ:LGND) has agreed to acquire Pfenex (NYSEMKT:PFNX) at $12/share, equivalent to $438M in equity value, representing a 57% premium to Pfenex’s last close price of $7.66 on August 10.
Additionally, Ligand will pay $2/per share or $78M as a Contingent Value Right in the event a predefined regulatory milestone is achieved by December 31, 2021.
The acquisition expected to complete by next quarter, as well as expand Ligand’s technology offerings by adding a proprietary protein expression technology platform.
Ligand expects the transaction will be modestly dilutive to 2020 adjusted diluted EPS, will provide $0.10 to $0.30 of adjusted diluted EPS accretion in 2021, and will provide significant annual adjusted diluted EPS accretion thereafter with current forecast of $0.60 to $0.80 in 2022 and $1.25 to $1.50 in 2023.

Healthcare providers press White House for executive help on COVID-19

Providers were left out of President Trump’s flurry of executive orders on COVID-19 relief, as some groups turn to the White House for help.
Trump issued a series of executive orders on Saturday meant to address several sticking points in the negotiations with Congress, which broke down at the end of last week. The orders included a deferral of payroll taxes through the end of the year and an extension of enhanced unemployment benefits of $400 a month but only if states chip in.
But providers feel left out of the orders, which did not address a lingering financial crisis caused by low patient volumes from COVID-19.
What HHS has allocated out of aid funding
Congress has in total passed $175 billion in funding to help prop up providers. This is in addition to money from the Payroll Protection Program and the Medicare Advance and Accelerated Program.
Here is how much HHS has distributed so far of the $175 billion as of July 20, the latest date available from the agency’s website:
  • $50 billion in general distribution to all providers.
  • $13 billion to safety net and acute care providers.
  • $11 billion to rural providers. The agency gave $10 billion to rural hospitals and another $1 billion to specialty rural hospitals, urban hospitals with rural Medicare designations and hospitals in small metropolitan areas, HHS said on its website.
  • $5 billion to nursing homes and long-term care facilities.
HHS is also using the $175 billion fund to cover the tab for testing and treatment of the uninsured.
As of Aug. 6, HHS has paid out $167 million to cover testing costs for the uninsured and $382 million for treatment of uninsured individuals, according to data on the agency’s website.
The American Medical Association wrote to White House Chief of Staff Mark Meadows on Monday seeing help via an executive order to address issues with the Medicare Accelerated and Advance Payments Program.

The Centers for Medicare & Medicaid Services has given out $100 billion in advance payments to providers. But the payments are essentially loans and now the bill is coming due.
Some providers must start to repay the loans beginning this month, and CMS will start to garnish 100% of a provider’s Medicare payments until the loan is repaid.
But providers need much more time to repay the loans. While patient volumes plummeted in March and April, practices have reopened but are not able to recoup the volumes before the pandemic.
“There are a series of reasons, including: spacing of patients to comply with social distancing, additional costs due to personal protective equipment and an inability or unwillingness of many patients to engage in activities outside their home, including visiting their physicians,” the letter said.
The group wants Trump to also issue an order to postpone recoupment of the Medicare funds until 365 days after the payment was issued to a physician practice. It also wants CMS to only take 25% of a provider’s Medicare payment instead of 100%
“If the administration does not act many physician practices will fail,” the letter added.
The AMA and other provider groups have been pressing CMS and Congress to make such changes, but so far nothing has materialized.
The American Hospital Association, AMA and American Nurses Association asked Congress last month to pass another $100 billion in stimulus funding for providers. This would be in addition to the $175 billion that Congress has already passed.
The HEROES Act, a $3 trillion package that passed the House more than a month ago, included $100 billion. It has stalled in the GOP-controlled Senate as Republicans charge it is too partisan.
Senate Majority Leader Mitch McConnell released a package a few weeks ago that included $25 billion and liability protection from lawsuits.
Democrats blasted Trump’s executive orders, saying that they would not address longstanding economic issues created by the pandemic.
“Slashing unemployment benefits and forcing states to bear the burden when their budgets are already strapped is not a solution,” said House Majority Leader Steny Hoyer in a statement Saturday. “Words on paper that don’t provide rental assistance doesn’t cut it.”
The House is out until Sept. 14, but could come back if a relief deal is reached.

Seres Soars On Positive Pivotal Study Results For Microbiome Therapeutic

Cambridge, Massachusetts-based Seres announced positive topline results from a pivotal Phase 3 study, dubbed ECOSPOR III, that is evaluating its investigational oral microbiome therapeutic SER-109 for recurrent C. difficile infection.
The study met the primary endpoint of showing a statistically significant absolute decrease of 30.2% in the proportion of patients who experienced a recurrence in CDI within eight weeks of administration of SER-109 versus placebo, the company said.
Additionally, 11.1% of patients in the treatment arm experienced a CDI recurrence versus 41.3% in the control arm, Seres said.
“The study results were equally compelling when characterized by the alternative metric of sustained clinical response, where 88.9% of patients in the SER-109 arm achieved this objective,” according to the biopharma.
With the study’s efficacy results exceeding the previously established regulatory statistical threshold, this single clinical study will likely fulfill efficacy requirements for a BLA submission, the company said.
The investigational asset’s safety results were favorable.
Why It’s Important: Recurrent CDI, a bacterial infection that causes symptoms ranging from diarrhea to life-threatening colon inflammation, is a serious disease that affects the quality of life of patients and could eventually lead to death in cases of severe infection.
Today’s treatment options leave much to be desired in terms of efficacy, safety and route of administration, Seres said.
“Based on these highly positive SER-109 ECOSPOR III results, we believe that this novel microbiome therapeutic candidate could potentially provide a much-needed effective oral treatment option for the approximately 170,000 patients in the U.S. that suffer from recurrent CDI annually,” Chief Medical Officer Lisa von Moltke said in a statement.
What’s Next? Seres said it aims to meet with the FDA to discuss the regulatory path for SER-109.

Window of opportunity to beat back Covid-19 closing?

The good news: The United States has a window of opportunity to beat back Covid-19 before things get much, much worse.
The bad news: That window is rapidly closing. And the country seems unwilling or unable to seize the moment.
Winter is coming. Winter means cold and flu season, which is all but sure to complicate the task of figuring out who is sick with Covid-19 and who is suffering from a less threatening respiratory tract infection. It also means that cherished outdoor freedoms that link us to pre-Covid life — pop-up restaurant patios, picnics in parks, trips to the beach — will soon be out of reach, at least in northern parts of the country.
Unless Americans use the dwindling weeks between now and the onset of “indoor weather” to tamp down transmission in the country, this winter could be Dickensianly bleak, public health experts warn.
“I think November, December, January, February are going to be tough months in this country without a vaccine,” said Michael Osterholm, director of the Center for Infectious Diseases Research and Policy at the University of Minnesota.
It is possible, of course, that some vaccines could be approved by then, thanks to historically rapid scientific work. But there is little prospect that vast numbers of Americans will be vaccinated in time to forestall the grim winter Osterholm and others foresee.
Human coronaviruses, the distant cold-causing cousins of the virus that causes Covid-19, circulate year-round. Now is typically the low season for transmission. But in this summer of America’s failed Covid-19 response, the SARS-CoV-2 virus is widespread across the country, and pandemic-weary Americans seem more interested in resuming pre-Covid lifestyles than in suppressing the virus to the point where schools can be reopened, and stay open, and restaurants, movie theaters, and gyms can function with some restrictions.
“We should be aiming for no transmission before we open the schools and we put kids in harm’s way — kids and teachers and their caregivers. And so, if that means no gym, no movie theaters, so be it,” said Caroline Buckee, associate director of the Center for Communicable Disease Dynamics at Harvard’s T.H. Chan School of Public Health.
“We seem to be choosing leisure activities now over children’s safety in a month’s time. And I cannot understand that tradeoff.”
While many countries managed to suppress spread of SARS-CoV-2, the United States has failed miserably. Countries in Europe and Asia are worrying about a second wave. Here, the first wave rages on, engulfing rural as well as urban parts of the country. Though there’s been a slight decline in cases in the past couple of weeks, more than 50,000 Americans a day are being diagnosed with Covid-19. And those are just the confirmed cases.
To put that in perspective, at this rate the U.S. is racking up more cases in a week than Britain has accumulated since the start of the pandemic.
Public health officials had hoped transmission of the virus would abate with the warm temperatures of summer and the tendency — heightened this year — of people to take their recreational activities outdoors. Experts do believe people are less likely to transmit the virus outside, especially if they are wearing face coverings and keeping a safe distance apart.
But in some places, people have been throwing Covid cautions to the wind, flouting public health orders in the process. Kristen Ehresmann, director of infectious disease epidemiology, prevention, and control for the Minnesota Department of Health, points to a large, three-day rodeo that was held recently in her state. Organizers knew they were supposed to limit the number of attendees to 250 but refused; thousands attended. In Sturgis, S.D., an estimated quarter of a million motorcyclists were expected to descend on the city this past weekend for an annual rally that spans 10 days.
Even on smaller scales, public health authorities know some people are letting down their guard. Others have never embraced the need to try to prevent spread of the virus. Ehresmann’s father was recently invited to visit some friends; he went, she said, but wore his mask, elbow bumping instead of shaking proffered hands. “And the people kind of acted like, … ‘Oh, you drank that Kool-Aid,’ rather than, ‘We all need to be doing this.’”
Ehresmann and others in public health are flummoxed by the phenomenon of people refusing to acknowledge the risk the virus poses.
“Just this idea of, ‘I just don’t want to believe it so therefore it’s not going to be true’ — honestly, I have not really dealt with that as it relates to disease before,” she said.
Buckee, the Harvard expert, wonders if the magical thinking that seems to have infected swaths of the country is due to the fact many of the people who have died were elderly. For many Americans, she said, the disease has not yet touched their lives — but the movement restrictions and other response measures have.
“I think if children were dying, this would be … a different situation, quite honestly,” she said.
Epidemiologist Michael Mina despairs that an important chance to wrestle the virus under control is being lost, as Americans ignore the realities of the pandemic in favor of trying to resume pre-Covid life.
“We just continue to squander every bit of opportunity we get with this epidemic to get it under control,’’ said Mina, an assistant professor in Harvard’s T.H. Chan School of Public Health and associate medical director of clinical microbiology at Boston’s Brigham and Women’s Hospital.
“The best time to squash a pandemic is when the environmental characteristics slow transmission. It’s your one opportunity in the year, really, to leverage that extra assistance and get transmission under control,” he said, his frustration audible.
Driving back transmission would require people to continue to make sacrifices, to accept the fact that life post-Covid cannot proceed as normal, not while so many people remain vulnerable to the virus. Instead, people are giddily throwing off the shackles of coronavirus suppression efforts, seemingly convinced that a few weeks of sacrifice during the spring was a one-time solution.
Osterholm has for months warned that people were being misled about how long the restrictions on daily life would need to be in place. He now thinks the time has come for another lockdown. “What we did before and more,” he said.
The country has fallen into a dangerous pattern, Osterholm said, where a spike in cases in a location leads to some temporary restraint from people who eventually become alarmed enough to start to take precautions. But as soon as cases start to plateau or decline a little, victory over the virus is declared and people think it’s safe to resume normal life.
“It’s like an all or nothing phenomenon, right?” said Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases. “You all locked down or you get so discouraged with being lockdown that you decide you’re going to be in crowded bars … you can have indoor parties with no masks. You can do all the things that are going to get you in trouble.”
Osterholm said with the K-12 school year resuming in some parts of the country or set to start — along with universities — in a few weeks, transmission will take off and cases will start to climb again. He predicted the next peaks will “exceed by far the peak we have just experienced. Winter is only going to reinforce that. Indoor air,” he said.
Buckee thinks that if the country doesn’t alter the trajectory it is on, more shutdowns are inevitable. “I can’t see a way that we’re going to have restaurants and bars open in the winter, frankly. We’ll have resurgence. Everything will get shut down again.”
Fauci favors a reset of the reopening measures, with a strong messaging component aimed at explaining to people why driving down transmission now will pay off later. Young people in particular need to understand that even if they are less likely to die from Covid-19, statistically speaking, transmission among 20-somethings will eventually lead to infections among their parents and grandparents, where the risk of severe infections and fatal outcomes is higher. (Young people can also develop long-term health problems as a result of the virus.)
“It’s not them alone in a vacuum,” Fauci said. “They are spreading it to the people who are going to wind up in the hospital.”
Everyone has to work together to get cases down to more manageable levels, if the country hopes to avoid “a disastrous winter,” he said.
“I think we can get it under much better control, between now and the mid-to-late fall when we get influenza or we get whatever it is we get in the fall and the winter. I’m not giving up,” said Fauci.
But without an all-in effort “the cases are not going to come down,” he warned. “They’re not. They’re just not.”