Partisan fights delayed Zika funds for months. Will history repeat itself?

Public health experts have a warning for Congress: don’t treat emergency coronavirus aid like business as usual.
Partisan bickering has often frustrated lawmakers’ attempts to speedily approve emergency spending packages. Congress, for example, dawdled for seven months because of an acrimonious fight over funding for Zika in 2016. That left health departments around the country cash-strapped and forced to cut back on existing public health programs, like responding to STD outbreaks. The long delay left the federal government no choice but to plunder funds meant for cancer research, heart disease, and fighting HIV to pay for their response efforts.
No one knows if the debate over coronavirus funding, which has captivated Capitol Hill this week, will devolve quite as spectacularly as the one that took place around Zika funding. Bipartisan negotiations are ongoing in earnest.

But there’s no agreed-upon funding amount yet — and not even a draft of the legislation. The Trump administration has already suggested diverting funds from other public health initiatives to pay for at least half of its outbreak response, a move that Democrats vehemently oppose. And some Democrats have begun to talk about including more contentious requirements in the aid package — policies that might touch on partisan issues like drug pricing or border wall funding.
Public health experts warned that delaying coronavirus aid could have an even bigger impact on their ability to respond than it did during the height of the Zika outbreak. Already, Centers for Disease Control and Prevention officials have warned that the virus could spread rapidly in the U.S. and disruptions to daily life could be “severe.”
“Whenever these outbreaks happen in the middle of a political season, [emergency funding] gets delayed,” said J. Stephen Morrison, the senior vice president and director of the Global Health Policy Center at the Center For Strategic and International Studies, a Washington-based think tank.
“People are going to have to be very, very cautious and careful in trying to protect this response from getting stuck in toxic politics,” he added.
Tom Frieden, the former director of the Centers for Disease Control and Prevention under President Obama, suggested that past funding fights underscored the need for more permanent allocations.
“We can’t have this constant amnesia. We have cycles of panic and neglect,” he said.
Obama requested roughly $2 billion in Zika funding in February 2016, but it wasn’t until late September of that year that a funding bill finally made it to his desk.
Even before Obama’s request, the CDC had already warned pregnant women not to travel to the countries that had already reported outbreaks of the virus. The World Health Organization had declared a public health emergency. Blood banks were turning away donors that had traveled to Zika-impacted countries and photos were flooding news services of babies born in Latin America with microcephaly, a condition where the skull is smaller than normal.

Obama urged the House to reauthorize his relatively modest $2 billion package “expeditiously.” But the process was anything but.
Almost immediately, House Republicans, who then held the majority, insisted that the Obama administration should instead repurpose the millions of dollars they had appropriated for the U.S. Ebola response in December 2014.
Negotiations in the Senate seemed smoother. But when a final funding bill emerged in June, it was laden with provisions Democrats deemed “poison pills” — including a provision that would block Zika funding from going to Planned Parenthood clinics, despite the fact that many of these clinics were providing Zika-related services.
Senate Democrats were so enraged that they voted three separate times to block the Zika package from becoming law — depriving their own party’s president the funds desperately needed to fight Zika.
Underscoring how the conflict became so protracted and tense, then-House Speaker Paul Ryan (R-Wis.) penned an op-ed in USA Today that implored Democrats “to drop politics and put the public’s health first.”
Then-CDC Director Frieden and National Institute of Allergy and Infectious Diseases Director Anthony Fauci wrote their own op-ed in the Washington Post imploring Congress to pass a funding bill — an exceptionally political move from the country’s top public health officials.
Faced with a congressional stalemate, the federal government ultimately transferred more than $600 million in existing funds allocated to the National Institutes of Health and the CDC to pay for Zika response. In April, the CDC also took $44 million in promised funding for local health departments and redirected it toward Zika control measures. Even Michigan, which was responding to the Flint water crisis, lost funding.
All told, it took Congress seven months to allocate $1.1 billion dollars.
“This is why people hate Congress,” remarked Sen. Tim Kaine (D-Va.) at the time.

Experts said that such a similar delay, now, would have a greater impact on public health than the 2016 fight did.
There are already more than 60 cases of coronavirus spread across the U.S., including the first case that wasn’t linked to travel to an area that has already reported an outbreak or contact with an existing case. Federal officials have warned that the virus could begin to spread in the United States.
That stands in sharp contrast to the Zika outbreak, which primarily only impacted tropical climates. While there were 5,168 total cases of Zika reported in the U.S. in 2016, most were linked to travel outside the country. There were only 224 cases reported to be caused by mosquito bites in the U.S. and all of those cases were reported in two states: Florida and Texas.
In fact, when the Obama administration first requested funding to aid Zika response, there had only been a smattering of diagnosed Zika cases in the U.S.
“With Zika, we knew it was a very specific geographic location of where we were going to have to be focusing our efforts,” said Adriane Casalotti, chief of government and public affairs at the National Association of County and City Health Officials. “With Zika, there were a lot of areas that were really focused on it, but it wasn’t necessarily something that every community had to work on.”

According to Casalotti, in response to the coronavirus outbreak, Chicago has already spent $350,000 on the response, and expects to spend $150,000 more each week. Riverside, Calif., which recently quarantined roughly 200 people, spent $1.3 million. And Los Angeles has estimated it will need $7.5 million over the next year to respond to coronavirus.
State and county health officials insist that they need new funding and that existing funds simply can’t be used to respond to coronavirus.
“We still have flu, we still have people with tuberculosis, we still have restaurants that need inspecting, people still have STDs, pulling from those programs to fund coronavirus … does strain a system that is already pretty strained,” said Michael Fraser, the executive director of the Association of State and Territorial Health Officials.
Casalotti said it’s critical funding comes in soon.
“People are operating day-to-day with a question mark,” she said. “Public health is used to getting stuck in political crossfires. … What we really hope is that people can come together.”
State and local health officials made their own plea to the government for additional funding earlier this week.
“We would like to think that public health can be pretty nonpartisan,” said Fraser.
His group and three others wrote to Capitol Hill earlier this week warning that any delay in funding would “severely impact the necessary response to this public health emergency and delay efforts to appropriately secure the public health of our nation.”

In Washington, top appropriators have said they’re hoping to hold a vote on a coronavirus aid package early next week. Congressional leaders are eyeing a package that falls much closer to the $8.5 billion funding level suggested by Senate Minority Leader Chuck Schumer than to the Trump administration’s much lower $2.5 billion request. Trump also said at a press conference this week he’d accept whatever level Congress appropriated.
Trump proposed spending about $535 million in funding that had previously been allocated to fight Ebola. Schumer, in contrast, detailed entirely new spending, including $1.5 billion in funding for the CDC, $3 billion for the Public Health and Social Services Emergency Fund, $2 billion for state and local health departments, $1 billion for USAID emergency funds, and $1 billion for vaccine development.

Partisan bickering delayed Zika funding for months. With coronavirus, experts worry history will repeat itself

‘Speed is critical’: Health officials face daunting task of tracing case contacts

Last weekend, as it became clearer and clearer that Covid-19 has been spreading stealthily through the Pacific Northwest, the task facing health officials has become more and more monumental. To try to stop the virus’ transmission and restrain the outbreak, they need to identify every single person with whom patients have come into contact, isolate those at risk of harboring the illness, and monitor the entire network of people for symptoms.
That’s hard even if you know how each patient became infected. If you don’t, it can be downright herculean. The fact that the pathogen is passing through people without making them sick enough to seek care means that they may have unwittingly transmitted it for weeks before it came to the attention of authorities. Once a case is discovered, epidemiologists still need to figure out whom the patient might have exposed. But they also need to look in the other direction, too, to figure out by what unseen route the virus reached that person in the first place.
“The question is, what is their source of exposure?” said Laurence Burnsed, state epidemiologist for Oklahoma’s health department. “Who are we missing?”

Answering such questions requires state and county health agencies — overworked as they already are — to ramp up their efforts as fast as possible.
“Speed is critical. Speed is absolutely critical. Every country that is receiving their first cases needs to act robustly and aggressively. … Look for this virus,” said Maria Van Kerkhove, head of the emerging diseases and zoonoses unit for the World Health Organization’s global infectious hazard preparedness team, in an interview with STAT.

Controlling the outbreak means getting ahead of the virus — and that’s no mean feat in a situation shifting so rapidly.
On Friday night, there were reports of four people — two in California, one in Oregon, and one in Washington State — who’d tested positive for the virus but had neither a known history of traveling outside the U.S. nor any identified contact with previously diagnosed patients. By Saturday afternoon, officials reported an outbreak of the virus in a long-term care facility outside of Seattle as well as the first death in the U.S. due to the illness — but it wasn’t clear whether those two events were related.
“That’s the kind of thing that we’re trying to answer now,” said Jeffrey Duchin, health officer for public health for Seattle and King County in a Saturday press briefing. “We’re doing an investigation as we speak to try and understand all the potential exposures that that patient may have had and if there’s any potential commonalities … but at this point we don’t have links.”
By Saturday night virologists had sequenced samples from one of the mysteriously acquired Covid-19 cases in Washington State, and found that the pathogen looked like a descendent of the virus swabbed from the first reported case in the U.S., identified way back on January 16. But there was no known contact between the two patients.
“There are some enormous implications here,” tweeted Trevor Bedford, a researcher at Fred Hutchinson Cancer Research Center in Seattle, who studies how viruses evolve and spread. “This strongly suggests there has been cryptic transmission in Washington State for the past 6 weeks.”

But genetic sequencing data come from already diagnosed cases. That can’t help you find people whose infections have gone undetected.
For that, you need the old-fashioned detective work of contact tracing.
It begins with an in-depth interview. An official sits down with a patient, and together, they reconstruct exactly where that person has been and with whom, day by day, hour by hour, for the entire window of potential contagion. The conversation often lasts hours. “That would be having the case pull out their personal calendar, going through their phone,” Burnsed said. “They might even have to go through their social media feed to see where they were tagged and what they did, to kind of jog their memory.”
The officials try to identify every single person who might have been unwittingly exposed to the pathogen. They start with family members and close friends — but then, as Burnsed put it, “the next level is identifying all of the contacts in shared airspaces.” Did you go to restaurants? What time were you there? Did you go to work or school? Did you take your child to daycare? Did you go see a doctor?
It’s already enough work to try to identify everyone who might have been at a hospital at the same time as that person — pulling rosters of on-shift workers, asking for appointment times of other patients, trying to figure out if they were there with family members. Other public spaces can be harder, because there are less meticulous records of who was where when.

Once officials have reached everyone they can reach, they still need to monitor them, and if they are at risk of spreading the illness, make sure they isolate themselves. Even for a handful of cases, it’s an unwieldy operation: When Oklahoma identified four measles diagnoses last year, the health department had to assess 300 individuals, Burnsed said.
While Covid-19 is less contagious than measles, the effort required for contact tracing investigations last year illuminates the sort of scramble Washington state officials are facing now. In a single nursing facility alone, some 50 people —including both staff and residents — have symptoms and are undergoing testing for the virus, and those aren’t the only potential cases.
The sheer number of people to reach won’t be the only issue. “Challenges in any large outbreak involve fully identifying all contacts including those that may have been exposed in a more public setting (and who are not known by name), insufficient or incorrect contact information given that hinders finding contacts, and lack of compliance by identified contacts,” Sharon Watkins, Pennsylvania’s state epidemiologist, wrote in an email to STAT.
That issue can be especially prevalent for vulnerable groups, such a undocumented immigrants, who worry that identifying themselves to health authorities might make their situations even more precarious.
In American Samoa, for instance, during the measles outbreak that began late in 2019, some people from the nearby Independent State of Samoa, as well from Tonga, Fiji, the Philippines, China, and Korea, were worried that participating in contact investigations might jeopardize their immigration status .

“Some of these population groups are close knit and will not easily reveal who in their community are or were sick with measles,” explained American Samoa Health Department Epidemiologist Aifili John Tufa, in a text message. “They are afraid that if they tell our team they may be ‘incriminating’ their own.”
Yet, to the WHO’s Van Kerkhove, in spite of these challenges, it’s imperative that public health officials in the US and around the world race to track and control the virus’ spread. “What worries me the most is people feeling like there’s nothing that they can do and they just have to give up and surrender to this virus … and we just have to let the wave pass through,” she said.
She is hopeful that by identifying and isolating potential Covid-19 patients, health departments can restrain the outbreak. “Every single country has the possibility to contain [transmission],” she said. “I’m not suggesting that this is easy. … But it can be controlled.”

‘Speed is critical’: As coronavirus spreads in U.S., officials face daunting task of tracing case contacts

California Warns Investors Virus May Affect its Finances

California, home to the world’s fifth-largest economy, warned investors that the coronavirus and the concurrent global market declines could hit its finances.

“There can be no assurances that the spread of a novel strain of coronavirus called COVID-19 will not materially impact the state and national economies and, accordingly, materially adversely impact the general fund,” California said in documents circulated to investors for its bond sale next week. “While the effects of COVID-19 on the state may be temporary, it appears to be altering the behavior of businesses and people in a manner that may have negative impacts on global and local economies.”

California is selling $2.2 billion in general-obligation bonds next week, with a retail order March 9 and pricing March 10.
While California has enjoyed a robust recovery from the recession, with credit ratings the highest in nearly 20 years and unemployment at a record low, it is vulnerable to market declines because of its reliance on the wealthy to fund its services.

About 70% of the state’s general fund comes from personal income-tax receipts and the top 1% of taxpayers accounted for 47% of such collections in 2017, the bond documents say. Such people have their fortunes tied to the stock market — capital gains accounts for about 10% of the state’s annual revenue this year. That leads to volatility generally, and “stock markets in the U.S. and globally have seen significant recent declines that have been attributed to coronavirus concerns,” California said in the documents.
The state told investors that while the impact is “currently uncertain,” it may become a factor in Governor Gavin Newsom’s updated budget for the next fiscal year, to be released in May.
https://www.bloomberg.com/news/articles/2020-03-02/california-warns-virus-could-affect-its-finances

J&J gene therapy nabs accelerated review status in Europe for vision loss disorder

The European Medicines Agency has granted PRIME and Advanced Therapy Medicinal Product designations to Johnson & Johnson (JNJ +1.9%) unit Janssen Pharmaceutical Companies’ AAV-RPGR gene therapy for the treatment of X-linked retinitis pigmentosa, an inherited eye disorder that causes progressive vision loss in boys and young men.

The company is developing the candidate with licensor MeiraGTx Holdings (MGTX +5.2%).

PRIME, akin to Breakthrough Therapy status in the U.S., provides for more intensive guidance on development and accelerated review of the market application.

Advanced Therapy Medicinal Product status allows for, among other things, centralized regulatory approval based on a single clinical trial.

https://seekingalpha.com/news/3547547-j-and-j-gene-therapy-nabs-accelerated-review-status-in-europe-for-vision-loss-disorder

Schrödinger teams up with Google to speed up drug discovery platform

High flying recent IPO Schrödinger (SDGR -3.9%) announces a three-year deal with Google Cloud aimed at increasing the speed and capacity of its physics-based computational platform for drug discovery. Terms are undisclosed.

Although shares are down today, they are up ~160% from the $17 IPO price on February 6.

https://seekingalpha.com/news/3547566-schrodinger-teams-up-google-to-speed-up-drug-discovery-platform

FEMA preparing for Trump emergency declaration on coronavirus

The Federal Emergency Management Agency (FEMA) is preparing for President Trump to potentially make an emergency declaration regarding the coronavirus outbreak, NBC News reported Monday.
The agency is readying itself in case Trump makes an “infectious disease emergency declaration,” which would allow states and local governments to receive disaster relief funding and federal assistance to combat the virus, according to internal planning documents obtained by NBC.
The declaration would allow FEMA to distribute this funding under the 1988 Stafford Act, which is more often used to provide money for natural disaster relief but can also be used for diseases. The Stafford Act was also used to help fund the fight against the West Nile virus in New York and New Jersey in 2000.

“To me this is another indication that the president and the White House are finally aware of the gravity of the situation,” Michael Coen, who was FEMA chief of staff during the Obama administration, told NBC News.
The funding would authorize FEMA to provide support such as disaster medical assistance teams, mobile hospitals and military transport. Currently, the agency’s disaster relief fund has $34 billion, according to a Jan. 31 report, which a former FEMA official told NBC News is “sitting there and ready.”
But an emergency declaration would differ from a “major disaster” declaration, which is wider reaching and usually used for major natural disasters.
FEMA spokeswoman Lizzie Litzow said the agency is working on supporting the Department of Health and Human Services (HHS), which declared a separate “public health emergency” on Jan. 31.
“At this time, there isn’t anything additional to the HHS public health emergency,” Litzow told NBC.
Concern over the coronavirus is increasing as two deaths were reported in Washington state this weekend, the first two in the U.S. The U.S. has confirmed 86 cases, according to data from Johns Hopkins University.
Researchers say the coronavirus could have been spreading undetected in the country for weeks.
https://thehill.com/policy/healthcare/public-global-health/485467-fema-preparing-for-trump-emergency-declaration-on

FDA OKs Sanofi drug for previously treated multiple myeloma

The FDA approves Sanofi’s (SNY +4%) Sarclisa (isatuximab-irfc), combined with Bristol-Myers Squibb’s (BMY +1.7%) Pomalyst (pomalidomide) and dexamethasone, for adult multiple myeloma (MM) patients who have received at least two prior lines of therapy, including lenalidomide (Revlimid) and a proteasome inhibitor. The agency’s action date was April 30.

Isatuximab is a monoclonal antibody that promotes programmed tumor cell death via targeting a specific epitope on the CD38 receptor. CD38 is a protein found on the surface of white blood cells.

Related product: Johnson & Johnson’s (JNJ +2.4%) Darzalex (daratumumab), also a C38-directed cytolytic antibody used to treat MM.

https://seekingalpha.com/news/3547590-fda-oks-sanofi-drug-for-previously-treated-multiple-myeloma