Booster divides grow

From: POLITICO Pulse - Tuesday Sep 14,2021 02:03 pm

Sep 14, 2021

Presented by

With Alice Miranda Ollstein, Erin Banco and Dan Goldberg

Editor’s Note: POLITICO Pulse is a free version of POLITICO Pro Health Care's morning newsletter, which is delivered to our s each morning at 6 a.m. The POLITICO Pro platform combines the news you need with tools you can use to take action on the day’s biggest stories. Act on the news with POLITICO Pro.

Quick Fix

— Two FDA regulators are speaking out on booster vaccines, further complicating the Biden team’s efforts to assemble a cohesive plan.

— Democrats are bristling at two moderate senators’ stranglehold on the reconciliation bill but desperate to make the package work with their razor-thin majority.

— Mississippi’s remaining abortion clinic is fighting a case to overturn Roe in arguments submitted to the Supreme Court Monday.

WELCOME TO TUESDAY PULSE. Pound the Alarm, Nicki is on a Bed of Lies with a recent slew of coronavirus vaccine tweets. The Night is Still Young as your authors write this, but Drake might have words about her only outing his breakthrough infection . Send health tips and playlist recommendations to sowermohle@politico.com and acancryn@politico.com.

A message from PhRMA:

While nine out of 10 Americans said in a recent Kaiser Family Foundation poll that they support drug price negotiation, opposition to the approach soared to 65 percent when respondents were told negotiation could limit people’s access to medicines or result in fewer new treatments and cures . Voters prefer commonsense, patient-centered solutions to address their true concerns.

Driving the Day

BOOSTER DIVIDES GROW — The government rift over how quickly people need boosters has widened even since you opened your last Pulse edition. Two top FDA vaccine regulators leaving the agency in the coming weeks say in a new Lancet paper that the current science doesn’t back giving a third dose to most Americans right now.

The paper ruffled feathers across the administration, where officials are already struggling to pull together a cohesive message on booster vaccines and when people will need them.

Pushback was also swift: “The article in The Lancet is conflating things that is understandable to conflate, but not appropriate to conflate,” Biden’s chief medical adviser Anthony Fauci told POLITICO’s Erin Banco. “If you can proceed with a program that's the third shot of a vaccine at the same time that you give a major push to get the developing world vaccinated, then you should not conflate those two things.”

Why it matters: Philip Krause and Marion Gruber, recently announced their pending retirements, a move two former FDA officials and a current senior health official have attributed to frustration with the CDC’s leadership on the booster discussion.

But they aren’t picking bones with the CDC in their paper: Krause, Gruber and other scientists bemoan the pitfalls of observational data and argue that Israel’s booster data isn’t all it’s cracked up to be. Namely, Israel followed up with booster patients in a week’s’ time, and “a very short-term protective effect would not necessarily imply worthwhile long-term benefit.”

The blowback: Many Biden officials want boosters rolled out soon — so do many governors and state health officials worried about breakthrough infections.

“The FDA needs to get out of their ivory tower and realize there is a real-life pandemic with 900 hospitalizations in Colorado, tens of thousands across the country,” Colorado’s Democratic Gov. Jared Polis said Monday. “We need to show the will to end it. And while the two-course vaccine is the primary way to do that, there is an added benefit to the booster shot.”

In a mark of rare across-the-aisle acknowledgment, Polis added: “There’s a lot that President Trump got wrong about the pandemic, but there is also something very important he got right. What he got right about the pandemic was Operation Warp Speed.”

DEMOCRATS STRUGGLE WITH MANCHIN/SINEMA STRANGLEHOLD — Joe Manchin (D-W.Va.) and Kyrsten Sinema (D-Ariz.) hold the reins on Biden’s $3.5 trillion social spending package, and their fellow Democrats are struggling with how to handle it, Burgess Everett and Marianne Levine write.

The two moderate senators are essentially dictating the final terms of what their colleagues have envisioned as a transformational package packed with health provisions. Manchin’s willingness to take his argument public, with an op-ed and a slew of Sunday TV appearances, has progressives seething and has made him the focal point of angst within the Democratic Party’s small majorities, Burgess and Marianne report.

But they’re still treading lightly, sitting with the reality that they need Manchin’s vote (and Sinema, who has been quieter on cost concerns) and criticizing doesn’t help them.

“We have 50 Democrats; we need all of them,” Sen. Elizabeth Warren (D-Mass.) said.

House check-up: The Energy and Commerce Committee didn’t get to health provisions in an all-day slog through potential amendments to the reconciliation bill. While they cleared a range of energy and telecom debates by the twilight hours of Monday, health should be next on the agenda.

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

MISSISSIPPI ABORTION CLINIC ASKS SCOTUS TO PRESERVE ROE V. WADE — Mississippi’s last remaining abortion clinic submitted arguments to the Supreme Court Monday for a case the justices will hear later this year on the state’s 15-week abortion ban and the fate of Roe v. Wade, Alice Miranda Ollstein reports.

In the legal filing, the clinic hits back at the state’s request that the court overturn Roe, saying there’s no justification for doing so. It also argues the 15-week plan places an unconstitutionally “undue burden” on people seeking abortions and makes a case that “the right to decide whether to continue a pregnancy before viability remains critical to women’s equal participation in society.”

“We are asking the Supreme Court to defend the precedent it has stood by for nearly 50 years,” said Nancy Northup, the president of the Center for Reproductive Rights, which is representing the clinic in the case.

An eye-grabbing footnote: In the wake of Texas enacting its six-week ban, Democrats have wrestled with what language to use in speeches and court documents when defending abortion rights. The new court brief straddles this divide, largely using “women” but emphasizing in a footnote that “people of all gender identities may also become pregnant and seek abortion care.”

What happens next: The court has not yet set a date for oral arguments in the case, but it’s expected to take place in November or December, with a decision issued next summer.

HAPPENING WEDNESDAY - POLITICO TECH SUMMIT: Washington and Silicon Valley have been colliding for some time. Has the intersection of tech, innovation, regulation and politics finally reached a tipping point? Join POLITICO for our first-ever Tech Summit to explore the evolving relationship between the power corridors of Washington and the Valley. REGISTER HERE.

FIRST IN PULSE: MORGAN HEALTH ADDS CMMI ALUMS — The new JPMorgan health venture is hiring Dawn Alley to lead its health care innovation team and Rivka Friedman as that team's executive director.

Alley was previously the chief strategy officer for the CMS Innovation Center, where she'd worked for much of the past seven years. She also did a stint during the Trump era as HHS' deputy senior adviser for value-based transformation. Friedman spent the past two years as group director for CMMI's State and Population Health Group.

Morgan Health is also adding Nelly Ganesan as executive director for community engagement. She spent the last decade at Avalere Health's Center for Healthcare Transformation.

SPOTTED: Joanne Kenen talked about our recent investigation into the high covid infection and fatality rate at state veterans’ homes with “Boots on the Air,” a vet-focused radio program at KOOP.

ALZHEIMER’S GROUPS PRESS FOR PREVENTION — Health and Human Services needs to add a sixth pillar to its National Alzheimer’s Project Act plan — preventing the disease and related dementia through reducing risk factors, UsAgainstAlzheimer’s and the Alzheimer’s Association wrote in a letter to Sec. Xavier Becerra Monday.

The NAPA’s advisory council this summer unanimously adopted a recommendation that would add that sixth goal, but the federal framework still needs an update. “A greater focus on prevention and risk reduction will show people across the country and the world that dementia is not an inevitable consequence of aging, but instead is a disease that can be prevented, treated, and ultimately cured,” the organizations said.

REPORT: 340B DRUG PRICES STAGNANT EVEN WITH PRICE CHANGES — Hospitals in the federal 340B program aren’t reducing prices when their own acquisition price declines and charges roughly 3.8 times the median of their purchase price — where data is available, according to an analysis by Ronny Gal’s Moto Bioadvisors and commissioned by the Community Oncology Alliance, an advocacy group for cancer patients.

“It is evident from the current situation that the drug price situation in 340B hospitals is problematic and relying on the current market structure to curb costs has not been effective,” Gal writes. “Making drug prices visible to a broader cohort of stakeholders ― primarily employers, but also regulators and the public, ― will create some pressure on hospitals to control their prices, notably those seeking advantages from the public purse.”

They add that a recent executive order instructing HHS to boost hospitals’ pricing transparency is a step in the right direction, but not enough. Reforms to the 340B program have been hotly contested in Congress, where Republicans press for more stringent oversight and Democrats argue those measures could squeeze already overburdened hospitals in poor areas with high-need populations.

A message from PhRMA:

Names in the News

Scott Mulhauser returned to Bully Pulpit Interactive. He most recently advised Commerce Secretary Gina Raimondo on topics like the Recovery Act rollout and was previously deputy chief of staff to then-VP Biden during the 2012 campaign.

What We're Reading

Barney Graham, a two-decade veteran of the National Institutes of Health and deputy director in vaccines, retired last month. Stat News’ Helen Branswell caught up with him about staving off retirement during the pandemic and what’s next.

West Virginia’s Covid-19 cases and hospitalizations hit record highs Monday as Gov. Jim Justice urged people to get vaccinated and warned of “inundated” hospitals, Newsweek’s Natalie Colarossi reports.

A message from PhRMA:

Proponents of government price setting often misrepresent voter opinion on support for allowing the federal government to “negotiate” drug prices. While nine out of 10 Americans said in a recent Kaiser Family Foundation poll that they support drug price negotiation, opposition to the approach soared to 65% when respondents were told negotiation could limit people’s access to medicines or result in fewer new treatments and cures.

Non-partisan, independent public polls have repeatedly demonstrated that once Americans understand what government negotiation is, and what the tradeoffs are, support drops dramatically.

76% of Americans oppose H.R.3-style “negotiation” if it causes delays in access to new prescription drugs, and 72% oppose it if it results in fewer new medicines developed in the future.

62% agree we should keep the current law that prohibits government interference in Medicare plan negotiations because it protects seniors and people with disabilities from losing access to their medicines.