Science

Analysis | Monkeypox is a new public health challenge for President Biden – The Washington Post

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Good morning and happy Wednesday! Your Health 202 researcher McKenzie is back again writing today’s newsletter top. 

Today’s edition: The Biden administration estimates it will need nearly $7 billion to fight monkeypox. An official at the FDA’s Center for Tobacco Products’s Office of Science is heading to a tobacco giant. But first …

Monkeypox is a challenge – but it’s hardly covid-19

After two years of a deadly pandemic that killed more than one million Americans, it’s not surprising that headlines about monkeypox are striking fear among some Americans.

Yes, cases are quickly rising around the country. Yet this latest infectious disease outbreak is vastly different from the coronavirus in key ways.

So far, virus has infected nearly 3,600 Americans, and cases have been overwhelmingly concentrated among men who have sex with men. Experts say it’s spread not through the air but through extended, close contact with an infected person (so you’re not going to get monkeypox from someone at the grocery store). Symptoms of monkeypox include fever, chills and a rash that can look like pimples or blisters. The illness typically lasts two to four weeks. No one has yet died from the illness in the United States, and a vaccine is available. 

And, unlike with covid-19, monkeypox has been around for decades. The Democratic Republic of the Congo recorded the first monkeypox case in 1970, and it has become endemic in roughly 10 countries in Central and West Africa since then. Researchers aren’t clear why the virus appears to have picked up steam now, and studies are underway to determine its epidemiology and transmission patterns. 

Challenges

Yet the Biden administration is under pressure to do more to stop the spread of monkeypox – and there have already been some flubs along the way.

The Centers for Disease Control and Prevention has no data on who has been vaccinated. Physicians had complained of facing daunting paperwork. The CDC briefly recommended that travelers wear masks, then quickly pulled back the guidance. 

In recent weeks, the administration has taken steps to expand testing and vaccine access to curb the outbreak — and is weighing whether to declare the virus a public health emergency. It has privately estimated to Congress that the federal government may need nearly $7 billion to mount a robust response to the record outbreak.

To learn more about monkeypox as cases increase across the country, The Health 202 turned to Fenit Nirappil, who has been covering the outbreak for The Post. 

The Health 202: Thousands of monkeypox vaccines have been distributed to state and local health officials nationwide. How are vaccination campaigns going so far?

Fenit: In the very early days of the outbreak, health authorities were only giving vaccines to confirmed or likely contacts of monkeypox patients. Now, as the federal government provides more doses, we’re seeing some localities broaden eligibility and it’s really uneven across the country.

You’re seeing a classic supply-and-demand crunch. And as institutions decide how to distribute their initial batches of vaccines, you’ll also see equity concerns. For example, if you have an online sign-up system, are you favoring those who have the flexibility to take off work in the middle of the day and who are more digitally connected? 

Monkeypox cases across the United States

The Health 202: Up until this point, monkeypox cases have predominantly affected gay and bisexual communities. How can officials ensure those most at risk are getting the resources they need without stigmatizing the disease?

Fenit: This is the big challenge for public health. This outbreak is concentrated among men who have sex with men. Men who have sex with men are not the only ones susceptible to monkeypox, and it’s not only spread by sex. But the health authorities and health care providers I talk to say we need to acknowledge reality when we are prioritizing who gets limited resources like vaccines

So the subtle messaging is key. Tell the population at risk that they face higher risk, but reminder the broader public that they are not immune to this emerging viral threat and that this is not a “gay disease” and that this is not something you contract by merely being around gay people.

The Health 202: Some public health officials have warned that the window to control monkeypox is closing. What would the virus becoming endemic here in the U.S. look like?

Fenit: The experts I talk to aren’t expecting something like coronavirus where millions are getting sick with no real end in sight. … An important caveat: We are still learning more about this latest outbreak and it’s possible something has changed about transmission.

If monkeypox becomes endemic, it could be like a host of other rare viruses where we see hundreds or thousands of cases a year with small clusters, but not necessarily a sprawling national outbreak, especially as more people get vaccinated and become familiar with the virus and its symptoms.

Tom Frieden, the Obama-era CDC director:

White House prescriptions

The U.S. may need $7B to respond to monkeypox, Biden officials estimate

The Biden administration privately estimated to Congress that it may need nearly $7 billion to craft a response to monkeypox that matches “the scope and urgency of the current situation,” The Post’s Dan Diamond and Tony Romm scoop.

The funding estimate isn’t a formal ask to Congress. But rather, the details contained in a memo — obtained by our colleagues — reflect early discussions between Democratic lawmakers and the White House. 

In the memo, officials detailed three different funding scenarios. The largest amount — $6.9 billion — would go toward vaccine manufacturing in the United States. The federal government could also secure 19 million new doses of vaccine for monkeypox, replenish 4 million doses for smallpox preparedness efforts and more.

Health officials also estimated what a “medium” second option of $2.2 billon in funding could do, as well as a more modest option of $500 million. 

Meanwhile … the Biden administration also called for as much as $31.4 billion in new funding to combat the coronavirus as additional pandemic aid has languished on the Hill for months.

Agency alert

Key federal tobacco official heads to tobacco giant

Matt Holman — who served in the Food and Drug Administration’s tobacco office — is stepping down immediately to head to Philip Morris International, a major tobacco company.

Holman has worked at the FDA for more than 20 years and served as the head of the Center for Tobacco Products’ Office of Science since 2017. He recused himself, “consistent with agency ethics policies,” from his work while he was pursuing jobs outside of the government, CTP director Brian King wrote in an email to staff, per our colleague Laurie McGinley. 

An FDA spokesperson didn’t specifically answer a question on when the recusal began, noting instead that King’s letter said Holman has been recused since before King began working at CTP this month. He has been recused from tobacco-related regulatory decision-making, the spokesperson wrote. 

When asked for comment by The Health 202, Sen. Dick Durbin (D-Ill.) — a critic of the FDA’s tobacco work and who hadn’t yet heard the news — said: “Huh. You can’t make this up, can you?”

Stat’s Nicholas Florko:

CMS rolls out plan aimed at improving maternal health

The Centers for Medicare and Medicaid Services unveiled its Maternity Care Action Plan to implement the Biden administration’s blueprint for addressing the maternal health crisis released earlier this year. The agency also approved the extension of postpartum care for up to 19,000 people across Connecticut, Kansas and Massachusetts, who will now have access to Medicaid and Children’s Health Insurance Program coverage for a full year — instead of just 60 days — after pregnancy. 

FDA agrees to review Biogen ALS therapy

In a surprising move, the FDA accepted a treatment for a rare form of ALS developed by Biogen for review. The announcement from the biotechnology company comes months after the drug didn’t meet the goal of a late-stage study, Reuters reports. The drug, called tofersen, will undergo a priority review with a decision from federal regulators expected by Jan. 25. If approved, the drug would be the first of its kind to treat a genetic cause of ALS.

In the courts

Teva agrees to tentative $4.25B settlement over opioids

The Israeli drugmaker agreed to the proposed $4.25 billion to resolve thousands of lawsuits from states, other jurisdictions, and in a first for a national settlement, Native American tribes, over allegations about its role in the opioid epidemic, our colleague Meryl Kornfield reports.

Such a deal would end a protracted legal battle for Teva Pharmaceuticals, as cities and counties argued the company misled doctors about its addictive fentanyl products for cancer patients. The agreement doesn’t include an admission of wrongdoing, and the company has denied allegations raised during the lawsuit.

If finalized, Teva would pay roughly $3 billion in cash and $1.2 billion in donations of the overdose-reversing drug Narcan over 13 years. About $100 million would go to tribes. 

Coronavirus

Scientists hone argument that coronavirus came from Wuhan market

The coronavirus pandemic began in at least two viral spillovers — but could be as many as two dozen — from live animals sold and butchered in late 2019 at the Huanan seafood market in Wuhan, China, according to two papers published yesterday in the journal Science

A natural origin of the virus has long been the favored theory among scientists because most pandemics have started that way, but the publication of the peer-reviewed papers is unlikely to quell the ongoing debate about whether the virus emerged from a Chinese laboratory, our colleague Joel Achenbach writes. 

While many questions remain unanswered, the study’s authors argue that multiple lines of evidence — including the clustering of early covid-19 cases and subsequent geographic spread — make a market origin not only a likely scenario but the only one that fits the data.

In other health news

  • President Biden’s physician Kevin O’Connor gave him the greenlight yesterday to resume physical exercise as his symptoms from covid-19 have “almost completely resolved” after completing the full five-day course of the antiviral treatment Paxlovid.
  • South Carolina can continue enforcing its ban on abortions after fetal cardiac activity is detected, around six weeks of pregnancy, after a judge yesterday declined a request to temporarily block it while the state Supreme Court considers a case challenging the law, according to the Associated Press.
  • The 30-day countdown in Texas for its trigger ban on abortion officially began yesterday, following the Supreme Court’s decision in June that overturned Roe v. Wade. Texas already has abortion restrictions on the book, the Dallas Morning News reports.

Health reads

‘What can we do?’: Pharma lobbyists face their biggest test in a decade, as Democrats barrel toward a vote on drug pricing (By Rachel Cohrs | Stat)

Viral Infections and Gene Variant Are Linked to Child Hepatitis Cases (By Emily Anthes | The New York Times)

Med students walk out mid-ceremony to protest speaker’s antiabortion views (By María Luisa Paúl | The Washington Post)

Sugar rush

Thanks for reading! See y’all tomorrow.

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