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Politico
5 days ago
- Health
- Politico
Understanding Trump's CVI diagnosis
Presented by Driving the Day WHAT IS CVI? President Donald Trump was recently diagnosed with chronic venous insufficiency, a medical condition that's the result of damaged leg veins struggling to pump blood to the heart. Sean Barbabella, the president's physician, said in a letter released to the public that Trump 'remains in excellent health' — but medical experts say the condition is important to monitor. White House press secretary Karoline Leavitt said Trump tested for other, more serious complications that sometimes go hand in hand with chronic venous insufficiency, but none were found. 'No signs of heart failure, renal impairment or systemic illness were identified,' she said. Here are some things to know about CVI. It's very common: CVI affects about 1 in 20 adults, according to the Cleveland Clinic. It's especially common in older adults, and the risk increases with age. Trump turned 79 last month. It's generally mild but can worsen over time: If left untreated, it can cause a range of symptoms, including swelling, cramps, skin changes, leg ulcers and varicose veins. 'What's interesting about this is that it runs the spectrum from very, very mild — where you might have a little bit of swelling, maybe a few varicose veins — to very severe, where you have very severe swelling, skin changes, hyperpigmentation, sort of fibrosis or leather appearance of the skin and even wounds,' said Dr. Thomas Maldonado, a vascular surgeon and medical director of the Venous Thromboembolic Center at NYU Langone Health, who is not involved in Trump's care. 'It's chronic, and over the course of a lifetime, especially as we age, this can be more severe.' Barbabella called CVI 'a benign and common condition, particularly in individuals over 70' in a letter released to the public. A range of treatment options: Barbabella, in his letter, didn't specify what treatments — if any — Trump would be undergoing. Lifestyle changes, like regular exercise, leg elevation and weight management, are typically the first steps in treating CVI, according to Maldonado. Compression therapy, which involves wearing tight stockings or bandages, is also an option. Oral anticoagulants are sometimes prescribed to prevent blood clots from forming, and in more severe cases, minimally invasive procedures and surgery are used. But those options are typically used only if the vein is 'superficial,' or close to the skin. In cases where deeper veins are damaged, treatment is more complicated. 'Sometimes the ultrasound will show it's mostly in the deep system. And unfortunately, those are sacred. We can't really do surgery or shut those veins down. They're critical for the circulation,' said Maldonado. WELCOME TO FRIDAY PULSE. Some nutrition experts argue that HHS Secretary Robert F. Kennedy Jr.'s push to remove synthetic dyes from ice cream won't move the needle on health. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. In Congress RESCISSIONS PACKAGE PASSES — House Republicans gave final approval just after midnight Friday to President Donald Trump's proposal to claw back $9 billion in public media and foreign assistance, green-lighting the Senate's changes to the measure that will bake in proposed DOGE cuts to public media and foreign aid. The package now heads to the president's desk. The House's 216-213 vote to clear the Senate-amended package comes less than 24 hours after the Senate voted to tweak the administration's original proposal that would have cut an additional $400 million from the global AIDS fighting program, the U.S. President's Emergency Plan for AIDS Relief, or PEPFAR. Senate Republicans also added language vowing that certain food-assistance programs would be protected and staved off impacts to other food aid, maternal health, malaria and tuberculosis-related initiatives. 'This bill tonight is part of continuing that trend of getting spending under control. Does it answer all the problems? No. Nine billion dollars is a good start,' said House Majority Leader Steve Scalise. In the House, the chamber's top Democratic appropriator, Connecticut Rep. Rosa DeLauro, said Republicans' approval of the clawbacks package was tantamount to 'a rubber stamp on the Trump administration's stealing' from the American people. 'This rescissions bill is another effort to subvert the Congress' power of the purse,'' she said. AROUND THE AGENCIES RISKY RESEARCH REBUKE — HHS accused its own staff of 'malicious compliance' in compiling a list of agency-funded experiments that President Donald Trump has ordered the agency to review and possibly halt because the administration believes they could endanger the public, POLITICO's Erin Schumaker reports. According to a Thursday post on the agency's official X account, staff at the National Institute of Allergy and Infectious Diseases had acted inappropriately by omitting certain grants while compiling a qualification list. On Wednesday, The Washington Post reported that NIH Principal Deputy Director Matt Memoli, the agency's No. 2 official, had added 11 new grants to the list career staff had compiled, overriding them in classifying tuberculosis studies NIH reviewers deemed safe as potentially dangerous gain-of-function research. 'Memoli corrected NIAID staff to assure that NIH was in compliance with the [executive order] by ordering them to submit the full list for temporary pause,' the agency's X post said. Contacted by POLITICO, an official at HHS described the behavior as 'malicious compliance' and said the administration wouldn't tolerate it. The list the agency ultimately adopted includes 40 experiments that the administration believes could constitute dangerous gain-of-function research, which involves altering pathogens to make them more transmissible or deadly to study them, according to a Washington Post report. Why it matters: Trump and many Republicans in Congress believe the Covid-19 pandemic was caused by a lab leak stemming from gain-of-function research in Wuhan, China, where the virus first emerged. The scientific community believes the virus most likely spilled over from animals into humans. The executive order banned federal funding to countries Trump said have insufficient research oversight and ordered a pause on U.S. research on 'infectious pathogens and toxins' that pose a danger to the public. What's next? The White House Office of Science and Technology Policy will decide whether to halt funding the experiments. Medicare WOUND-CARE CRACKDOWN — Some health providers are ecstatic that CMS is going after a billion-dollar Medicare scam — but they want regulators to guarantee they won't be hurt financially, POLITICO's Robert King reports. On Monday, the Centers for Medicare and Medicaid Services proposed to slash Medicare spending on pricey wound care treatments that have become a magnet for fraud. Accountable care organizations, which manage Medicare costs, first identified the fraud and lauded the move. But they don't want to be held responsible for the out-of-control spending caused by bad actors. 'The financial consequences of fraud should rest with those responsible for it, not with ACOs striving to uphold the integrity of value-based care,' said Nicole Bradberry, CEO of the advocacy groups the Florida Association of ACOs and the Texas Association of ACOs. ACOs are groups of doctors and hospitals that agree to keep their Medicare spending below a certain level. They receive a share of any savings but must pay Medicare for exceeding their targets. A few years ago, some ACOs noticed big spikes in Medicare spending on skin substitutes that mimic human skin and are used to treat burn victims. CMS' projected spending on the pricey treatments shot up from $256 million in 2019 to more than $10 billion in 2024. The increase stemmed largely from independent wound-care clinics billing for medically unnecessary treatments, according to CMS investigations. Beneficiaries can be treated at a home health or independent clinic not affiliated with an ACO, but costs are still attributed to the ACO responsible for those patients' care. The agency proposed reclassifying the treatments and slashing spending by 90 percent. But ACOs are worried they'll still be responsible for increased spending they had nothing to do with. CMS said in a statement that it understood the ACO's concerns but didn't comment on whether it would release a rule to address the issue. Industry Intel FIRST IN PULSE: FIGHT 340B FRAUD — Roughly 40 conservative leaders, including Grover Norquist, who heads Americans for Tax Reform, are calling on Republican congressional leaders to crack down on the 340B drug-pricing program, which provides discounted prices for certain so-called safety-net providers to purchase outpatient drugs. 'The 340B program is supposed to help hospitals provide care to indigent populations at low or no cost, but it is now routinely used fraudulently,' the leaders wrote in a letter. 'Hospitals serving low income areas receive the medicines at low or no cost, but then distribute them throughout a vast hospital network, specifically targeting affluent areas, and increasing the price for everyone.' Hospital groups have argued that 340B financially props up hospitals that serve low-income patients, and if the program were overhauled, it could mean closures and loss of access to care. In the spotlight: Congressional Republicans have long floated reforming 340B, arguing that it is frequently abused. But with Trump in the White House and Republicans holding both chambers of Congress, 340B reform has been top of mind in many conservative circles. In April, Sen. Bill Cassidy (R-La.), who chairs the Senate Health, Education, Labor and Pensions Committee, released a report calling for more transparency in the program, and the Trump administration has indicated it wants to move oversight of 340B from Health Resources and Services Administration to CMS, where the program could face more intense scrutiny. WHAT WE'RE READING Reuters' Diana Novak Jones reports on Democratic attorneys general suing to block HHS changes to ACA health insurance marketplaces. STAT's Olivia Goldhill reports on suicide rates rising in older men.
Politico
7 days ago
- Health
- Politico
Trump's next health nominee in the hot seat
Presented by With help from Simon Levien Driving the Day CHRISTINE FACES QUESTIONING — President Donald Trump's choice for a top post at HHS, Dr. Brian Christine, goes before senators today for a confirmation hearing. Christine will face questioning from the Senate Health, Education, Labor and Pensions Committee as lawmakers consider his nomination to be assistant secretary for health — one of the highest-ranking jobs at HHS and a position often held by admirals in the Commissioned Corps of the U.S. Public Health Service. Why it matters: If he advances through the committee and is eventually confirmed by the full Senate, Christine, a men's sexual health doctor and GOP donor, would oversee thousands of uniformed public-health service members and be charged with carrying out Health Secretary Robert F. Kennedy Jr.'s public health agenda, Simon reports. One of the highest-ranking positions at the agency, the assistant secretary for health advises the HHS secretary and recommends policy related to public health matters like disease prevention, vaccine programs and health disparities. He would also help lead a new HHS office called the Administration for a Healthy America, which consolidates existing agency offices to focus on primary care, maternal and child health, mental health, environmental health, HIV/AIDS and workforce development. Background: Christine, a urologic surgeon at Urology Centers of Alabama, has previously criticized the acceptance of transgender health care and the federal government's response to the Covid-19 pandemic. He's expressed opposition to trans athletes competing in women's sports and has said on his podcast — called 'Common Sense,' and last airing two years ago — that children experiencing gender dysphoria should seek counseling or 'pastoral care,' not gender-affirming treatments. He's also come under scrutiny after The Wall Street Journal reported in March that his Alabama urology practice advertised its work treating transgender men with erectile dysfunction. Christine has denied treating trans patients. Since taking office, Trump has directed HHS to restrict access to gender-affirming care treatments for children and teens. The Alabama GOP has praised Christine's nomination, calling him 'a longtime Conservative grassroots activist and dedicated supporter of the Alabama Republican Party.' In 2024, Christine contributed more than $8,500 to Trump's campaign. Key context: Dr. Rachel Levine, a pediatrician and the highest-ranking openly trans person to serve at the federal level, held the job during the Biden administration. Levine, who used the post to advocate gender-affirming care, was frequently the target of anti-trans attacks from Trump and his allies. WELCOME TO WEDNESDAY PULSE. Today marks the third anniversary of the 988 Suicide & Crisis Lifeline, and awareness of the hotline is up dramatically from 2022, according to a new National Alliance on Mental Illness poll. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. HAWLEY'S ABOUT-FACE — Just weeks after voting for massive cuts to Medicaid in the GOP's 'big, beautiful bill,' Missouri Republican Sen. Josh Hawley introduced a bill Tuesday that would walk back those cuts. Hawley repeatedly voiced his opposition to deep Medicaid cuts throughout the megabill negotiation process, specifically provisions that would hit rural hospitals. But he ultimately voted 'yes' on the recently enacted legislation, which contains more than $1 trillion in health care cuts and a provision that would cap state provider taxes — a move that hospitals have said could deeply reduce their revenue and limit access to health care for millions of Medicaid enrollees. Hawley said he voted for the bill's passage after negotiating for the inclusion of a $50 billion rural hospital fund but said at the time that he would 'continue to do everything in my power to reverse future cuts to Medicaid.' His new legislation, the Protect Medicaid and Rural Hospitals Act, would repeal the megabill's moratorium on taxes that states impose on providers to generate more Medicaid funding, which helps boost payments to hospitals. Hawley's bill would repeal megabill provisions that reduce state-directed payments — which enable states to increase the rates that privately run Medicaid managed care plans reimburse providers. His legislation would also double the megabill's investment in the rural hospital fund to $100 billion and extend the fund from five to 10 years. 'President Trump has always said we have to protect Medicaid for working people. Now is the time to prevent any future cuts to Medicaid from going into effect,' Hawley said in a news release. Global Health PEPFAR U-TURN — Senate Republicans on Tuesday stripped cuts to global AIDs funding from the White House's $9.4 billion spending clawback request, POLITICO's Jordain Carney and Cassandra Dumay report. Republicans will remove a $400 million cut to the global AIDS program known as PEPFAR, reducing the amount of cuts in the package to $9 billion, said Sen. Eric Schmitt (R-Mo.), who's leading the rescissions effort in concert with the White House. Senate Majority Leader John Thune said he expects the removal to be the only change made to the rescissions package, adding that there was a 'lot of interest' among Senate Republicans to address the cut to the program created under then-President George W. Bush and credited with saving tens of millions of lives. News of the change came after White House Budget Director Russ Vought briefed senators during a closed-door lunch Tuesday. Schmitt said the White House is on board with the change. 'We're fine with adjustments,' Vought told reporters. 'This is still a great package, $9 billion, substantially the same package. The Senate has to work its will, and we've appreciated the work along the way to get to a place where they think they've got the votes.' Background: Several GOP senators, including Appropriations Chair Susan Collins of Maine, had raised concerns about the AIDS funding cuts. It's unclear whether the $400 million rollback will be enough to secure her vote, but it might placate enough Republicans to advance the package through the Senate. Other Republicans being watched closely are Alaska Sen. Lisa Murkowski, Kentucky Sen. Mitch McConnell and Kansas Sen. Jerry Moran. At the Agencies HOSPITAL PAY CUT — The Trump administration is proposing cutting $280 million in payments to certain hospital clinics for administering drugs to patients, POLITICO's Robert King reports. The Centers for Medicare and Medicaid Services said the cut would ensure that Medicare beneficiaries aren't charged more for the same service at a hospital than at an independent clinic. The proposed rule is likely to generate fierce pushback from the hospital industry, which has successfully fought similar congressional efforts. The rule also outlines 2026 Medicare payment rates for hospital outpatient services and ambulatory surgical centers and includes new changes to boost price transparency. 'These reforms expand options and enforce the transparency Americans deserve to ensure they receive high-quality care without hidden costs,' CMS Administrator Mehmet Oz said in a statement. Background: The first Trump administration adopted a policy in 2019 to lower payments for outpatient hospital clinics to align them with those of independent clinics. Now, CMS wants to expand that policy to include services for storing or administering pharmaceuticals to patients. The agency estimates the change will reduce Medicare spending by $280 million, with $210 million allocated to Medicare and $70 million to Medicare beneficiaries thanks to lower co-insurance rates, according to a fact sheet on the rule. Key context: Site-neutral payments — when Medicare pays the same amount for the same service regardless of where it's provided — have gotten bipartisan support on Capitol Hill. But packages have never made it across the finish line partly due to fervent lobbying from the hospital industry, which argues the payment cuts would imperil the finances of vulnerable hospitals. What's next: The rule has a 60-day comment period before final approval. WHAT WE'RE READING POLITICO's Lauren Gardner reports on Democratic Sen. Richard Blumenthal suggesting he's open to changing the federal vaccine injury program. KFF Health News' Darius Tahir reports in NPR that researchers fear a program that collects DNA data from millions of retired military service members could be in limbo. Endpoints News' Jared Whitlock reports on the Trump administration's disbanding of a newborn screening panel for rare conditions.
Politico
01-07-2025
- Business
- Politico
GOP megabill gets boost from parliamentarian
Presented by With help from Robert King and Lauren Gardner Driving the Day PAVING THE WAY — As the Senate GOP continues to struggle to pass its domestic policy megabill, several key decisions by the parliamentarian could help smooth the bill's path, Robert reports. Those include allowing provisions to cut Medicaid funding to Planned Parenthood for one year — a longtime GOP priority — and expand Medicare drug-price negotiation exemptions. If the Senate passes the megabill today, the House will still need to approve the changes before it heads to President Donald Trump's desk. Congress and Trump aim to pass the bill by Friday, a self-imposed deadline. Here are the key health care rulings from Senate Parliamentarian Elizabeth MacDonough: Planned Parenthood defunding: Republicans have tried to cut Medicaid funds to Planned Parenthood for years, and now they might get their wish. The Senate parliamentarian ruled that a policy to strip Medicaid funding for the women's health and abortion provider for one year doesn't violate the Byrd rule — which limits what can pass through the reconciliation process with a simple majority. That means it can pass the Senate as part of the larger megabill without needing 60 votes to break a filibuster. The bill would actually cost taxpayers money. The nonpartisan Congressional Budget Office estimated it would increase government spending by $52 million over the next decade. Planned Parenthood already can't use federal funds to cover abortions because of the Hyde Amendment, but it offers a collection of other health services. Orphan drug exemption: The Senate's parliamentarian reversed a ruling that language expanding Medicare's drug-price negotiation exemption for orphan drugs to include medicines that treat multiple rare diseases violated the Byrd rule. The decision means the policy, sought by the pharmaceutical industry, can remain in the bill. The provision would exempt additional drugs from Medicare drug price negotiations. That's a win for drugmakers, which argue the policy would incentivize research for rare conditions. The Congressional Budget Office previously estimated the policy, as written in the House-passed megabill, would cost nearly $5 billion over 10 years. WELCOME TO TUESDAY PULSE. We've made it to July. I hope everyone who was up late because of the vote-a-rama gets a nap today. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. AROUND THE AGENCIES COVID TRACKING MANDATE TO END — The Labor Department is promising to do away with a remaining requirement for health care workplaces that was intended to help the government track Covid-19 cases, POLITICO's Nick Niedzwiadek reports. DOL seeks to withdraw the rule that required employers to record and report when their workers tested positive for Covid, as well as any related hospitalizations or fatalities. The requirements went into effect as part of a broader effort then-President Joe Biden put forward within months of taking office in 2021. Additionally, DOL's Occupational Safety and Health Administration issued an emergency temporary standard mandating protections for workers against the virus using a rarely exercised provision of federal law. DOL ultimately withdrew the standard by the end of that year, drawing criticism from labor unions and congressional Democrats concerned about health care workers' safety. OSHA formally killed off the standard in the final days of Biden's tenure and paused enforcement of the record-keeping requirements in February. As such, the rule's withdrawal now is largely a symbolic measure by the Trump administration to close the book on the pandemic. Key context: The new proposed rule is part of the Labor Department's deregulatory overhaul released Monday. The department estimates it will save close to $1.6 million annually, according to the regulatory filing. Separately, DOL proposed rolling back an expansion of minimum wage and overtime protections for certain health aides, which has been on the books for more than a decade. In the courts DOUBLE DEFEATS FOR CHD — Federal courts have rebuffed two attempts by anti-vaccine activists to challenge past losses, Lauren reports. The Supreme Court also denied on Monday a bid by Children's Health Defense — the group founded by Health Secretary Robert F. Kennedy Jr. — to have its censorship case against social media giant Meta heard. The group alleged that the owner of Facebook and Instagram colluded with the federal government to deplatform its content. And the U.S. Court of Federal Claims denied CHD attorney Rolf Hazlehurst's motion to reopen his son's case claiming that childhood vaccines caused his autism. Judge Edward H. Meyers signed the order Thursday, according to the court docket, but the document is not yet public due to court rules that embargo the release of decisions until parties decide whether to request the redaction of any medical or otherwise private information. Mary Holland, CHD's president and CEO, said the group is disappointed by both decisions. 'It is our understanding that Mr. Hazlehurst is already evaluating the next steps,' she said in a statement. Separately, she said 'the problem' the organization presented in its Meta case 'has lessened' — seemingly a nod to Kennedy's ascension to power within the federal government. 'The censorship-industrial complex agreements of the past seem to have gone by the wayside, at least for now, and for that I am grateful,' she said. Industry Intel NURSES TO PROTEST MEGABILL — Nurses across the country plan to protest at congressional Republicans' district offices today, to oppose Medicaid cuts in the 'big, beautiful bill,' according to a statement from National Nurses United, the country's largest professional association of registered nurses. 'Not only does Medicaid provide lifesaving, safety-net care to patients who would otherwise unnecessarily suffer and die, but it also is a powerful engine of local economies that employs tens of thousands of people,' Nancy Hagans, an NNU president, said. Demonstrations will be held at the district offices of Reps. Juan Ciscomani (R-Ariz.), Michael Cloud (R-Texas), Ron Estes (R-Kansas), Kevin Kiley (R-Calif.), Nicole Malliotakis (R-N.Y.), Jay Obernolte (R-Calif.) and Mike Turner (R-Ohio) and Sens. Bill Cassidy (R-La.) and Susan Collins (R-Maine). Names in the News Shara Selonick has been tapped to serve as the Senior Care Pharmacy Coalition's vice president of strategy and government affairs. She was previously a public health adviser at the FDA. WHAT WE'RE READING POLITICO's Maya Kaufman reports on New York's new road map for the state's aging population. KFF Health News' Julie Appleby reports on a family that was billed more than $1,400 for an MMRV shot.
Politico
30-06-2025
- Health
- Politico
How MAGA learned to love psychedelics
Presented by Driving the Day THE PSYCHEDELICS FLIP-FLOP — Historically, the Republican Party hasn't jumped to embrace cutting-edge medical treatments that involve drugs commonly used recreationally (see: 'Marijuana'). But things are shifting when it comes to psychedelics for PTSD — and HHS Secretary Robert F. Kennedy Jr. could be just the person the movement has been looking for, POLITICO's Erin Schumaker reports. Driven by a desire to help ex-servicemembers with post-traumatic stress disorder and other mental illnesses, GOP lawmakers led a failed campaign last year to persuade the Biden administration to approve psychedelic drugs. The campaign ended when, in August, the FDA rejected drugmaker Lykos Therapeutics' application to offer ecstasy, alongside therapy, as a PTSD treatment. FDA advisers expressed concern that the company's researchers were more evangelists than scientists and determined they'd failed to prove the regimen was either safe or effective. The advisers also raised concerns that ecstasy had the potential to damage the heart and liver. But Kennedy has been known to embrace medical treatments that fall well outside of the mainstream. A friend in MAHA: A longtime believer in psychedelics' potential to help people with illnesses like PTSD and depression, Kennedy is ramping up government-run clinical studies and telling the disappointed lawmakers that doctors would soon be prescribing the drugs, even though Biden officials found no evidence of their effectiveness. 'These are people who badly need some kind of therapy; nothing else is working for them,' Kennedy said at a House hearing Tuesday. 'This line of therapeutics has tremendous advantage if given in a clinical setting. And we are working very hard to make sure that that happens within 12 months.' The shifting political landscape: The GOP's embrace of psychedelics is another — and perhaps one of the more jarring — examples of cultural transformation that President Donald Trump's populist politics have brought. Veterans seeking cures for mental illnesses associated with combat, combined with the Kennedy-backed Make America Healthy Again movement's enthusiasm for natural medicine, have strengthened a libertarian strain on the right in favor of drug experimentation. Meanwhile, the left, where hippies are giving way to technocrats, has become more skeptical. Key context: Earlier this month, Texas' Republican governor, Greg Abbott, signed a law to put $50 million into clinical trials of the psychedelic ibogaine as a mental health treatment. Like ecstasy, ibogaine also poses heart risks. The Drug Enforcement Administration lists both drugs on its schedule of drugs with no currently acceptable medical use and a high risk of abuse. That would have once been enough to make law-and-order Republicans say no. But top Kennedy adviser Calley Means says not anymore. 'Ten years ago, nobody expected the Republican Party as the party of healthy food, as the party of exercise, as the party of questioning pharmaceutical companies, as the party of psychedelic research — but that's where we are,' Means said. WELCOME TO MONDAY PULSE. The GOP's massive domestic policy bill could pass today. For the latest coverage, check out POLITICO's Inside Congress Live blog. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @kelhoops and @sophie_gardnerj. In the courts OBAMACARE SCOTUS RULING FALLOUT — On Friday, the Supreme Court upheld a provision in the Affordable Care Act that mandates insurance companies cover preventive health services at no cost to patients, POLITICO's Lauren Gardner reports. The ruling hinged on the U.S. Preventive Services Task Force — an independent advisory panel of experts who recommend what preventive care should be covered free of charge. The court, in a 6-3 decision, ruled that the USPSTF is constitutional because the HHS secretary has the power to appoint and fire members and to reject their screening and drug recommendations. Some public health experts, including Kathy Hempstead, senior policy officer at the Robert Wood Johnson Foundation, expressed concern about how Health Secretary Robert F. Kennedy Jr. may use that power. The lawsuit was brought by individuals and businesses with religious objections to covering preexposure prophylaxis drugs, which are key to preventing HIV. Key context: Kennedy's recent decision to remove all members of the CDC's vaccine advisory panel and reconstitute it with individuals skeptical of immunizations illustrates the extent of that authority. 'It's sort of the end of one threat but the beginning of another,' Hempstead said. Kennedy said that the decision was needed to root out 'persistent conflicts of interest.' It's unclear whether Kennedy plans to alter the task force's membership, too. But federal law stipulates that policy decisions stemming from both groups' advice be based on science, said Andrew Pincus, a Supreme Court attorney at the law firm Mayer Brown who represented public health groups that filed a brief supporting the government's defense in the case. 'To the extent that they don't rest on science, I think they would be subject to being set aside by the courts,' he said. PHARMA WATCH WHO's WEIGHT-LOSS DRUG WARNING — The World Health Organization is cautioning health care professionals and regulatory authorities that weight-loss and diabetes drugs containing semaglutide have caused rare cases of sudden blindness, POLITICO's Carmen Paun reports. The WHO pointed to a recommendation earlier this month from the European Medicines Agency — the EU's drug regulator — which found that taking Novo Nordisk's Ozempic, Rybelsus and Wegovy could cause a condition known as nonarteritic anterior ischemic optic neuropathy in up to 1 in 10,000 users. The condition is typically characterized by sudden, painless vision loss in one eye that's generally irreversible and for which no effective treatment is available, the WHO said. What's next: The WHO's drug-safety advisory committee evaluated the evidence and concluded that the risk-management plan for semaglutide drugs should be revised to include sudden blindness as a potential risk. Novo Nordisk didn't immediately respond to a request for comment. In Congress TILLIS WON'T RUN FOR REELECTION — Sen. Thom Tillis — who voted 'no' on advancing the GOP's massive domestic policy bill partly because of concerns over Medicaid cuts — will not run for reelection, the North Carolina Republican announced Sunday. The move comes after President Donald Trump said he would explore backing a primary challenger to the senator. The bill contains many of Trump's campaign promises. Key context: While Trump's Truth Social attacks might have accelerated Tillis' announcement — Trump called him, among other things, 'a talker and complainer, NOT A DOER!' — he had already shown ambivalence about his ability to win reelection while squarely backing Trump's agenda, POLITICO's Jordain Carney reports. He privately warned colleagues in a Senate Republican lunch last week that the megabill's approach to Medicaid would cause him to lose his race next year, remarks first reported by POLITICO. GOP colleagues chalked up Tillis' private warnings to his fears of a tough general election in the swing state, where popular former Democratic Gov. Roy Cooper could be a formidable candidate. Names in the News Anindita 'Annie' Saha will take on the lead policy role on artificial intelligence at the Food and Drug Administration's drug division, according to an internal email reviewed by POLITICO. Saha is a 20-year agency veteran who will also keep her role as associate director for strategic initiatives at the Digital Health Center of Excellence within the FDA's device division. Saha replaces Tala Fakhouri, who is leaving the FDA. WHAT WE'RE READING The Wall Street Journal's Dominique Mosbergen reports on researchers' hopes that preemptive treatment for early-onset Altzhimer's could slow or even halt a disease that has no cure.
Politico
20-06-2025
- Health
- Politico
RFK Jr.'s past claims shadow vaccine panel agenda
Presented by With help from Amanda Chu and Danny Nguyen Driving the Day ACIP AGENDA CHANGE — The agenda for next week's Advisory Committee on Immunization Practices meeting includes some notable differences from the notice posted in the Federal Register earlier this month, Sophie reports with POLITICO's Lauren Gardner. Most notably, the panel will hold two separate votes for the flu shot: one on influenza vaccines and another on influenza vaccines that contain thimerosal. In 2014, before he became health secretary, Robert F. Kennedy Jr. wrote a book in which he alleges the vaccine preservative thimerosal likely caused autism and should be banned — a claim that health agencies now under his control have said is unfounded. Thimerosal continues to be used as a preservative in multidose vaccine vials to inhibit germ growth. But its use in FDA-licensed flu vaccines has declined over the past 25 years as manufacturers reformulated their products and shifted to single-use vials. Most of those contain little or no thimerosal, according to the CDC. The meeting marks the first for Kennedy's revamped ACIP roster — following the firing of the previous 17 members — which includes several vaccine skeptics. No Covid vote: The agenda does not include a vote on Covid-19 vaccines, despite the Federal Register notice saying a vote is planned. Last month, Kennedy updated the CDC's Covid recommendations without a vote from the panel, breaking from tradition. Kennedy removed the recommendation that pregnant women get the shot, and the CDC changed the recommendation for healthy children to 'shared clinical decision making' — meaning children 'may' get vaccinated if their doctors and parents want them to. The HPV vaccine and meningococcal vaccine were also slated for a vote according to the meeting's Federal Register notice but aren't included in the draft agenda. Cut short? The agenda for the advisory committee's meeting includes only two days, June 25 and 26, but the initial Federal Register notice said the panel would also meet on June 27. A spokesperson for HHS did not comment on the thimerosal vote or why the agenda for the 27th wasn't included. WELCOME TO FRIDAY PULSE. For more on what next week's ACIP agenda holds, keep reading. Send your tips, scoops and feedback to khooper@ and sgardner@ and follow along @Kelhoops and @sophie_gardnerj. Vaccines 'THEY CROSSED THE LINE' — Dr. Fiona Havers, a CDC scientist who collected and compiled data on Covid-19 and respiratory syncytial virus before stepping down this week, told POLITICO that HHS Secretary Robert F. Kennedy Jr.'s overhaul of the agency's outside panel of vaccine experts was her final straw. 'I knew at that point that they had crossed the line,' Havers said. 'As a physician and a scientist, and for my own personal integrity, I did not feel like I could stay and legitimize this process.' The Advisory Committee on Immunization Practices votes on vaccine recommendations, playing an integral role in developing childhood and adult vaccine schedules. Last week, Kennedy fired the entire panel and replaced them with members he hand-selected. The first meeting of the new members is scheduled for next week. Havers often presented data to the panel to inform its decisions. I spoke with Havers about her decision to resign and what she will be watching for at next month's meeting. Here's our conversation, edited for length and clarity. What made you resign? [It was a] culmination over the last one to two months of RFK Jr. trashing the vaccine policy recommendation process at CDC. This has been building for a while. Several events have really undermined the vaccine policy process. One was in late May, when FDA officials released this regulatory framework suggesting that only those 65 years older and people with underlying medical conditions should receive [updated] Covid-19 vaccines. Then the following week, the HHS secretary announced on X that the Covid vaccines for healthy children and healthy pregnant women had been removed from the CDC recommended vaccine immunization schedule … Basically, RFK Jr. was making CDC vaccine policy on X without involving CDC. And that was pretty shocking, because there's a very rigorous process in place. Then last week, when they announced the firing of all 17 ACIP members, I knew I was done. Can you share any thoughts on Kennedy's replacement picks? These people are, for the most part — with very few possible exceptions — not the people that should be sitting on ACIP. What will you be watching at the meeting next week? If CDC is presenting the data … the data coming out of CDC is still solid. As of now, I can speak to the fact that the COVID-NET and RSV-NET data is high-quality evidence and can be believed. How those data get used to make vaccine policy decisions is really what's in question right now. Seeing the kind of questions that they ask and what they say may give some clue as to how they may vote in the future. I am very concerned that there's going to be a restricting of access to vaccines for people that otherwise should be getting them, and we'll get some sense of if that's actually going to happen. HHS response: HHS spokesperson Andrew Nixon told POLITICO that HHS is 'committed to following the gold standard of scientific integrity,' and 'vaccine policy decisions will be based on objective data, transparent analysis and evidence — not conflicts of interest or industry influence.' AROUND THE AGENCIES GAIN-OF-FUNCTION CUTS — The National Institutes of Health is cutting and suspending funding for gain-of-function research, a move that will impact biomedical projects conducted globally, Danny reports. The NIH's directive, released Wednesday, will immediately terminate funding and other support for gain-of-function research conducted by 'foreign entities in countries of concern or foreign countries where there is no adequate oversight.' The order didn't explicitly name the targeted groups and countries. The NIH did not respond to a request for comment. The agency will also suspend funding and additional support for all other gain-of-function research and has asked researchers who receive NIH funds to identify other projects not yet identified by the agency that fit the category by June 30. Gain-of-function research involves genetically altering biological organisms to enhance transmission or other functions, which can help scientists identify therapeutic targets. Key context: The move comes months after the Trump administration marked gain-of-function research as dangerous. Earlier this year, the administration said the Covid pandemic was caused by a lab leak from gain-of-function research at a virology research institute in the Chinese city of Wuhan, where the virus first appeared. Many scientists, however, believe the disease was caused by natural spillover from an animal to a human. The Trump administration's theory, memorialized in a glossy website unveiled in April, prompted President Donald Trump to issue an executive order last month to eliminate federal funding for gain-of-function research in countries such as China, which Trump has criticized for inadequate research oversight. The NIH's latest missive delivers on this executive order. In other research news: The FDA announced Wednesday it would immediately review new clinical trials that 'involve sending American citizens' living cells to China and other hostile countries for genetic engineering and subsequent infusion back into U.S. patients — sometimes without their knowledge or consent.' The order, endorsed by the NIH, is another swipe at foreign research — particularly studies performed in China, which the administration has characterized as poorly regulated. Industry Intel BURR'S LOBBYING GIG — The Biotechnology Innovation Organization, the world's largest biotech organization, has tapped former Republican Sen. Richard Burr (R-N.C.) to lobby on issues related to drug pricing and supply chains, Medicare and Medicaid and reauthorization of the Pandemic and All-Hazards Preparedness Act, Amanda reports. Now health policy chair at law firm DLA Piper, Burr was the top Republican on the Senate Health, Education, Labor and Pensions Committee and was a champion of reforming the FDA. Jamie Gregorian, a former senior policy adviser at the FDA and assistant to Burr in the Senate, will also represent BIO at DLA Piper, according to the law firm's disclosure submitted today. The outside hire from BIO marks the third for the group this year and comes as the biotech industry faces a steep drop in investor funding amid President Donald Trump's cuts to regulatory agencies. Earlier this week, BIO hired former Trump White House adviser Matt Mowers and Trump's campaign deputy director Bill Killion, who both now work at Valcour, a Washington-based lobbying firm. WHAT WE'RE READING POLITICO's Jordain Carney and Robert King report that Senate Republican leaders are seeking ways to tamp down moderates' worries about the megabill's possible impact on rural hospitals. The New York Times' Roni Caryn Rabin reports on the Trump administration's travel restrictions impacting medical residents.
