Phil Galewitz, Arthur Allen, Author at KFF Health News https://kffhealthnews.org Fri, 31 Jan 2025 16:06:01 +0000 en-US hourly 1 https://wordpress.org/?v=6.6.2 https://kffhealthnews.org/wp-content/uploads/sites/2/2023/04/kffhealthnews-icon.png?w=32 Phil Galewitz, Arthur Allen, Author at KFF Health News https://kffhealthnews.org 32 32 161476233 At His HHS Job Interview, RFK Jr. Stumbles Over Health Policy Basics  https://kffhealthnews.org/news/article/the-week-in-brief-rfk-jr-hhs-nominee-senate-hearings/ Fri, 31 Jan 2025 19:30:00 +0000 https://kffhealthnews.org/?p=1979572&post_type=article&preview_id=1979572

Robert F. Kennedy Jr., the anti-vaccine activist President Donald Trump nominated to lead the nation’s top health agency, did little to win over his critics at two Senate confirmation hearings this week. 

Democrats argued he’s not qualified for the job. And by botching answers to basic questions about health policy, Kennedy supplied some evidence. 

It’s uncertain whether Kennedy will get enough votes in the Senate to be confirmed as the secretary of Health and Human Services. Every Democrat and independent is expected to vote against him, meaning he can afford to lose only three GOP votes. 

Sen. Bill Cassidy (R-La.), a physician who sits on the Finance Committee and chairs the Senate Health, Education, Labor and Pensions Committee, known as HELP, is seen as the crucial vote. 

He made a point of highlighting the successes of vaccination and questioned whether Kennedy, as HHS secretary, would champion the lifesaving medicines he has spent years attacking. 

Kennedy, 71, appeared before Finance on Wednesday, backed by dozens of supporters wearing “Make America Healthy Again” shirts and hats. Advocates also cheered him on at Thursday’s hearing of Cassidy’s HELP Committee. 

Over 3½ hours at Finance, Kennedy confused Medicare and Medicaid, the two largest government health insurance programs, which together cover more than a third of Americans but operate very differently. He also mistakenly said that Medicaid is funded solely by the federal government. In fact, nearly a third of costs are paid by the states

Kennedy, as recently as last year a supporter of abortion rights, said he agreed with Trump that “every abortion is a tragedy.” 

Kennedy also said he didn’t think HHS had “a law enforcement branch.” The agency can issue fines and penalties against health providers who break the law. 

He didn’t do much better Thursday at HELP, where he couldn’t correctly answer a question from Sen. Maggie Hassan (D-N.H.) about how Medicare works

Kennedy got kid-glove treatment from most Republicans on both Senate panels, with several seeking (and receiving) assurances that he would prioritize rural health care or leave alone federal policies that affect farmworkers. 

But Cassidy was an exception. At the Finance hearing, he unsuccessfully pressed Kennedy to say how he would improve care for people enrolled in Medicare and Medicaid, often called dual eligibles, for whom the government has struggled to coordinate care and control costs. 

Opening the HELP hearing, Cassidy made clear to Kennedy that he supports vaccines and that he expects the U.S. health secretary to support them as well, yet he couldn’t persuade the nominee to disavow debunked conspiracies that childhood vaccines cause autism

The Finance Committee plans a vote next week; HELP does not vote on HHS nominees. 

At the close of Thursday’s hearing, Cassidy said he would take the weekend to consider his vote. “Will you continue what you have been, or will you overturn a new leaf at age 70?” Cassidy said. 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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What RFK Jr. Might Face in His Nomination Hearings This Week https://kffhealthnews.org/news/article/rfk-kennedy-hhs-nomination-hearings-senate-finance-help/ Tue, 28 Jan 2025 10:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1976463 President Donald Trump has nominated Robert F. Kennedy Jr., an environmental lawyer with no formal medical or public health expertise, as secretary of Health and Human Services. Two Senate committees will question Kennedy this week on how his disproven views of science and medicine qualify him to run the $1.7 trillion, 80,000-employee federal health system.

Here are four considerations for lawmakers on the Senate Finance and Senate Health, Education, Labor and Pensions committees, which will host Kennedy for questioning on Wednesday and Thursday, respectively:

1) Kennedy’s unconventional health claims.

For decades, Kennedy has advocated for health-related ideas that are scientifically disproven or controversial. He created and was paid hundreds of thousands of dollars by Children’s Health Defense, a group that champions the false idea that vaccines cause autism and other chronic diseases and has sued to take vaccines off the market. Kennedy has said covid vaccines are the deadliest in history, antidepressants lead children to commit mass shootings, environmental contaminants may cause people to become trans, and HIV is not the only cause of AIDS. He also pushes the use of products that regulators consider dangerous, such as raw milk, and for broader use of some medicines, such as ivermectin and hydroxychloroquine, to treat conditions without FDA approval. He says public health agencies oppose their use only because of regulatory capture by big drug and food interests.

“He believes you can avoid disease if you have a healthy immune system. He sees vaccines and antibiotics as toxins,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Top Trump health nominees — Kennedy, Marty Makary for FDA commissioner, Jay Bhattacharya for National Institutes of Health director, and former U.S. Rep. Dave Weldon for Centers for Disease Control and Prevention director — are generally disdainful of the agencies they’ll be leading, Offit said.

“They think they are going to go into office, pull back the curtain, find all this bad stuff, and reveal it to the American public,” he said.

During a measles epidemic in 2019 and 2020 that killed 83 people, mostly children, in Samoa, Kennedy, as chairman of Children’s Health Defense, warned the country’s prime minister against measles vaccination. This behavior alone “is disqualifying” for an HHS nominee, said Georges Benjamin, executive director of the American Public Health Association.

Equally problematic, in Benjamin’s view, was Kennedy’s legal effort in 2021 to get the covid vaccine pulled from the market. “He can’t say he’s not anti-vax,” Benjamin said. “He wasn’t following the evidence.”

A Kennedy spokesperson did not respond to a request for comment.

2) Kennedy’s chances appear good, despite opposition.

Kennedy’s nomination has emerged in a moment when Trump is on a roll and mistrust of public health and medical authority in the wake of the pandemic has created an opening for people with unorthodox views of science to seize the reins of the country’s health system.

After former Fox News personality Pete Hegseth was confirmed as Defense secretary last week despite his controversial qualifications for the job and stark warnings from former top military brass, many Washington observers think RFK Jr. is going to be hard to defeat. In a meeting on the Hill with Democratic senators and their aides last week, Offit said, “the feeling was that he would likely be confirmed.”

Trump has demanded that Republican senators line up behind his nominees and has so far succeeded. It’s thought that Sens. Lisa Murkowski of Alaska and Susan Collins of Maine could oppose Kennedy, based on their opposition to Hegseth. Sen. Mitch McConnell (R-Ky.), the other Hegseth “nay” vote, is a polio survivor who has not spoken publicly about Kennedy but said in December that opposing “proven cures” was dangerous. Other senators whose Kennedy votes are said to be in question include Sen. Bill Cassidy (R-La.), the HELP Committee chair, a physician who gave a lukewarm response after meeting Kennedy.

Others have reported that Sens. Cory Booker (D-N.J.), who shares Kennedy’s concern with the spread of obesity and chronic illness, and Sheldon Whitehouse (D-R.I.), who attended law school with Kennedy, might vote for him. Neither senator’s office responded to a request for comment. Advancing American Freedom, a conservative advocacy group founded by former Vice President Mike Pence, has fought Kennedy’s nomination with a major ad buy.

3) The hearings are going to be heated.

Democratic senators are coming with plenty of ammunition. Sen. Elizabeth Warren (D-Mass.) sent Kennedy a 34-page letter containing 175 questions on everything from his anti-vaccine statements and actions to his waffling positions on abortion to his stances on Medicare, drug prices, and the cause of AIDS.

While public health and medical groups did not coordinate with Pence’s conservative organization, questions about Kennedy’s earlier stance in support of abortion rights could raise hackles on the GOP side of the aisle. Although his group is far from Pence on reproductive rights, Benjamin said, “if it helps derail him, I hope some senators are listening to Pence. Any shelter in a storm.”

“The hearings are going to be very difficult for him because he’s told a web of untruths as he’s marched across the offices,” said Leslie Dach, executive chair of Protect Our Care, a Democratic-aligned advocacy group.

Public opinion reflects leeriness of Kennedy on health, though not excessively. In a poll released Tuesday by KFF, 43% of respondents said they trusted him to make the right health recommendations. About 81% of Republicans in the poll said they trusted Kennedy — almost as many as trust their own doctor.

4) What happens if Kennedy takes office.

At the NIH, FDA, and other federal health agencies, nervous scientists speak of early retirement or jumping to industry should Kennedy and his agency heads take office.

The pharmaceutical industry has kept quiet on the nomination, as has the American Medical Association. Many patient advocacy groups are worried, but wary of creating friction with an administration they can’t ignore or defeat.

Kennedy’s comments on AIDS — suggesting that gay men’s use of stimulants, rather than the HIV virus, were its cause — are troubling to Carl Schmid, executive director of the HIV+Hepatitis Policy Institute. But “I don’t know if he’s going to get confirmed or not,” he said. “If he does, we look forward to working with him and educating him.”

At the J.P. Morgan Healthcare conference earlier this month, Emma Walmsley, CEO of GSK, a leading vaccine maker, said she’d “wait and see what the facts are” before predicting what Kennedy would do. Vaccines, she noted, are “not our biggest business.”

GSK is one of a handful of vaccine makers remaining on the U.S. market. That number could shrink further if the Trump administration and Congress undo a 1986 law that provided legal protection for vaccine makers — as Kennedy has advocated.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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How a Duty To Spend Wisely on Worker Benefits Could Loosen PBMs’ Grip on Drug Prices https://kffhealthnews.org/news/article/pbms-pharmacy-benefit-managers-erisa-lawsuit-mark-cuban-cost-plus/ Wed, 18 Dec 2024 10:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1953132 Ann Lewandowski knows all about pharmacy benefit managers, or PBMs, the companies that shape the U.S. drug market. Her job, as a policy advocate at drugmaker Johnson & Johnson, was to tell patient and physician groups about the PBMs’ role in high drug prices.

Armed with that knowledge, Lewandowski filed a potentially groundbreaking lawsuit in February. Rather than targeting the PBMs, however, she went after a big company that uses one — her own employer, Johnson & Johnson.

Lewandowski charges in her lawsuit that by contracting with the PBM Express Scripts, which is part of the insurance giant Cigna, Johnson & Johnson — which fired her in April — failed in its duty to ensure reasonable drug prices for its more than 50,000 U.S. employees.

By choosing an Express Scripts plan, she charged, J&J cost employees “millions of dollars in the form of higher payments for prescription drugs, higher premiums, higher deductibles, higher coinsurance, higher copays, and lower wages or limited wage growth.”

Lewandowski, 40, from outside Madison, Wisconsin, relies on an expensive multiple sclerosis drug. She brought the lawsuit, she said, because she “had trouble aligning the policy positions” she reported on as a J&J employee “with the actions I experienced as a health plan user.”

In recent years, the opaque business practices of PBMs have drawn fire. The Federal Trade Commission is conducting a lengthy investigation of the three biggest companies and sued them in September, accusing the firms of driving up insulin prices. Bipartisan bills in Congress would rein them in. And businesses such as Mark Cuban’s Cost Plus Drugs and smaller, “transparent PBMs” have tried to wean pharmaceutical companies and health plans from their reliance on the big PBMs.

But Lewandowski’s lawsuit goes to a sensitive spot that had been overlooked until recently: language in the 2021 appropriations bill that revised the 1974 Employee Retirement Income Security Act, known as ERISA. The original law focused on stopping fraudulent retirement plans.

Her lawsuit is based on congressional language specifying that the law’s requirement of prudent management covers health as well as retirement benefits. By providing workers with a health plan, employers aren’t “doing you a favor. They are holding your money and investing it in your health,” said Barak Richman, a George Washington University health law professor.

In July, a similar lawsuit was filed against Wells Fargo, and more suits are in the works.

PBMs demand discounts and rebates from drugmakers, which leads the manufacturers to charge higher list prices, which can drive up the price patients pay at the pharmacy. At the same time, retail pharmacies say PBMs are driving them out of business by paying them less than what the PBMs charge health plans — a practice known as spread pricing. Patients typically have no idea what they’ll pay for a drug, and neither do their employers, because many PBMs’ contracts contain nondisclosure clauses.

Dissatisfaction with the status quo and fear of liability are pushing employers to switch from the “Big Three” PBMs to “transparent PBMs,” which don’t shroud their pricing and drug choice decisions.

“We brought on nine Fortune 500s this year, 1.2 million patients,” said AJ Loiacono, CEO of New York City-based Capital Rx, a PBM founded in 2017. According to a recent survey, as many as half of U.S. employers are considering switching.

Cuban, in an interview with KFF Health News, said he has told hundreds of Fortune 500 executives, in one-on-one meetings and in groups, that they are overpaying on drug benefit plans skewed to fatten the wallets of big PBMs.

“You’re getting ripped off,” Cuban said he tells them. “You don’t really understand the elements, and that’s costing you money and costing you wellness. And now you are going to get sued. It’s not a question of if but a question of when.”

Pressuring a Purchasing Cartel

The billionaire, who launched Mark Cuban Cost Plus Drugs in 2022 to upend the byzantine $500 billion U.S. drug market, is convinced that the Lewandowski suit and others will end the dominance of the big PBMs, which control 80% of the business.

Cost Plus Drugs charges a straight 15% markup with small processing fees for the 2,500 drugs it sells, most of them generics, said co-founder Alex Oshmyansky. Its nearly 3 million customers — individuals, health plans, and transparent PBMs — appear to be saving money in many cases.

The big PBMs say their buying power and exclusive access to information enable them to save money for insurers, employers, and patients. Critics say they are skimming up to 25% from the drug market, perhaps $100 billion a year, according to Oshmyansky. The opaque strategies and conflicts of interest, critics say, often result in the poorest, sickest patients paying the most for medications.

The three PBMs amount to a “purchasing cartel,” Oshmyansky said in an interview at Cost Plus’ Dallas headquarters, once the office of broadcast.com, the internet radio company that made Cuban his first billion dollars when he sold it to Yahoo in 1999. “They buy all the drugs, they jack up the prices, and then they resell them.”

Richman and Amy Monahan of the University of Minnesota argued in a journal article this year that the Department of Labor, which has previously focused its ERISA oversight on retirement benefits, should issue standards for the use of health care dollars under the law.

When companies “enter into dumb contracts with insurers or PBMs, arguably they are in violation of ERISA,” Richman said. “Taking the law seriously would really require employers, who are spending half the health care dollars in the country, to spend that money in very different ways.”

Some drug market experts, however, doubt the ERISA lawsuits will succeed. Complex PBM money channels “make it hard to build a case,” said Stacie Dusetzina, a professor of health policy at Vanderbilt University School of Medicine. “You might think your company is overpaying, but relative to what?”

The ERISA Industry Committee, which lobbies Congress for some of the biggest U.S. companies, is asking Congress to give PBMs the specific duty to represent their clients’ financial interests, said Melissa Bartlett, the group’s senior vice president for health policy. That could require patients to sue the PBMs rather than their employers.

A few big employers are already changing their drug plans.

In 2019, Connecticut became CVS’ first PBM customer to negotiate a transparent fee structure. Its contract required 100% of drug rebates be passed along to the state and eliminated spread pricing.

The state decided to go further when it sought a new contract for its 214,000 employees this year, said Joshua Wojcik, director of health policy and benefits in the state comptroller’s office. Instead of discounts and rebates, it demanded the lowest net cost per employee.

Of the three big PBMs, only CVS bid on the contract. It edged out a few “transparent PBMs” — a sign, in Wojcik’s view, that CVS at least doesn’t want to be left out as more customers ditch the current PBM business model.

With the change, Wojcik estimates the state will save up to $70 million a year.

$13.40 vs. $2,500

Changing drug benefit policies at big companies takes time, said Oshmyansky of Cost Plus. Their PBM contracts last three to five years, so “you have to capture them in that one year where they are evaluating other options,” he said. PBMs pay benefit plan consultants and the brokers big companies hire to steer business their way.

“We have this weird structure where multiple sclerosis, cancer patients subsidize everybody else’s drugs,” Oshmyansky said. Instead of creating a pool that spreads costs to everyone with insurance, there’s a “disproportionate burden placed on the sickest members.”

Cost Plus generates the biggest savings for its customers on about 50 extraordinarily high-priced generic drugs. The poster child is imatinib, a generic cancer pill that Cost Plus sells for $13.40 for a 30-day supply, compared with the $2,500 it retails for at pharmacies. A study conducted by Dusetzina and colleagues found Medicare could save $662 million a year just by buying imatinib and six other generic cancer drugs from Cost Plus rather than through a big PBM.

Ironically, though, most generic drugs are cheaper in the U.S. than in Europe or Canada — so cheap, in fact, that they fall into shortages as companies get out of the business or stop making needed improvements to their production lines.

In response, Cost Plus has started a compounding pharmacy to make common generics and soon hopes to have a sort of “private reserve” of 70 to 80 products that it can make on short notice if they go into shortage, Oshmyansky said.

While the company hasn’t yet set up purchase agreements for most brand-name drugs, Oshmyansky and Cuban are hopeful. Drugmakers, through their trade group Pharmaceutical Research and Manufacturers of America, have lobbied fiercely to rein in PBMs in the past two years.

At a Sept. 24 hearing at which Sen. Bernie Sanders (I-Vt.) grilled Novo Nordisk CEO Lars Fruergaard Jørgensen over high prices for diabetes and weight loss drugs Ozempic and Wegovy, the executive expressed support for a more transparent pricing model.

“On average for our products we give 74% in rebates to PBMs” for every $1 the company charges, he said. If, instead, “we simply paid the PBMs a small fee for the limited risk and contribution they make, I think patients would be significantly better off.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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How Measles, Whooping Cough, and Worse Could Roar Back on RFK Jr.’s Watch https://kffhealthnews.org/news/article/rfk-jr-hhs-vaccine-policy-preventable-infectious-diseases-resurge/ Fri, 06 Dec 2024 10:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1952780 The availability of safe, effective covid vaccines less than a year into the pandemic marked a high point in the 300-year history of vaccination, seemingly heralding an age of protection against infectious diseases.

Now, after backlash against public health interventions culminated in President-elect Donald Trump’s nominating Robert F. Kennedy Jr., the country’s best-known anti-vaccine activist, as its top health official, infectious disease and public health experts and vaccine advocates say a confluence of factors could cause renewed, deadly epidemics of measles, whooping cough, and meningitis, or even polio.

“The litany of things that will start to topple is profound,” said James Hodge, a public health law expert at Arizona State University’s Sandra Day O’Connor College of Law. “We’re going to experience a seminal change in vaccine law and policy.”

“He’ll make America sick again,” said Lawrence Gostin, a professor of public health law at Georgetown University.

State legislators who question vaccine safety are poised to introduce bills to weaken school-entry vaccine requirements or do away with them altogether, said Northe Saunders, who tracks vaccine-related legislation for the SAFE Communities Coalition, a group supporting pro-vaccine legislation and lawmakers.

Even states that keep existing requirements will be vulnerable to decisions made by a Republican-controlled Congress as well as by Kennedy and former House member Dave Weldon, should they be confirmed to lead the Department of Health and Human Services and the Centers for Disease Control and Prevention, respectively.

Both men — Kennedy as an activist, Weldon as a medical doctor and congressman from 1995 to 2009— have endorsed debunked theories blaming vaccines for autism and other chronic diseases. (Weldon has been featured in anti-vaccine films in the years since he left Congress.) Both have accused the CDC of covering up evidence this was so, despite dozens of reputable scientific studies to the contrary.

Kennedy’s staff did not respond to requests for comment. Karoline Leavitt, the Trump campaign’s national press secretary, did not respond to requests for comment or interviews with Kennedy or Weldon.

Kennedy recently told NPR that “we’re not going to take vaccines away from anybody.”

It’s unclear how far the administration would go to discourage vaccination, but if levels drop enough, vaccine-preventable illnesses and deaths might soar.

“It is a fantasy to think we can lower vaccination rates and herd immunity in the U.S. and not suffer recurrence of these diseases,” said Gregory Poland, co-director of the Atria Academy of Science & Medicine. “One in 3,000 kids who gets measles is going to die. There’s no treatment for it. They are going to die.”

During a November 2019 measles epidemic that killed 80 children in Samoa, Kennedy wrote to the country’s prime minister falsely claiming that the measles vaccine was probably causing the deaths. Scott Gottlieb, who was Trump’s first FDA commissioner, said on CNBC on Nov. 29 that Kennedy “will cost lives in this country” if he undercuts vaccination.

Kennedy’s nomination validates and enshrines public mistrust of government health programs, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

“The notion that he’d even be considered for that position makes people think he knows what he’s talking about,” Offit said. “He appeals to lessened trust, the idea that ‘There are things you don’t see, data they don’t present, that I’m going to find out so you can really make an informed decision.’”

Targets of Anti-Vaccine Groups

Hodge has compiled a list of 20 actions the administration could take to weaken national vaccination programs, from spreading misinformation to delaying FDA vaccine approvals to dropping Department of Justice support for vaccine laws challenged by groups like Children’s Health Defense, which Kennedy founded and led before campaigning for president.

Kennedy could also cripple the National Vaccine Injury Compensation Program, which Congress created in 1986 to take care of children believed harmed by vaccines — while partially protecting vaccine makers from lawsuits.

Before the law passed, the threat of lawsuits had shrunk the number of companies making vaccines in the United States — from 26 in 1967 to 17 in 1980 — and the remaining pertussis vaccine producers were threatening to stop making it. The vaccine injury program “played an integral role in keeping manufacturers in the business,” Poland said.

Kennedy could abolish the CDC’s Advisory Committee on Immunization Practices, whose recommendation for using a vaccine determines whether the government pays for it through the 30-year-old Vaccines for Children program, which makes free immunizations available to more than half the children in the United States. Alternatively, Kennedy could stack the committee with allies who oppose new vaccines, and could, in theory at least, withdraw recommendations for vaccines like the 53-year-old measles-mumps-rubella shot, a favorite target of the anti-vaccine movement.

Meanwhile, infectious disease threats are on the rise or on the horizon. Instead of preparing, as a typical incoming administration might, Kennedy has threatened to shake up the federal health agencies. Once in office, he’ll “give infectious disease a break” to focus on chronic ailments, he said at a Children’s Health Defense conference last month in Georgia.

The H5N1 virus, or bird flu, that has spread through cattle herds and infected at least 55 people could erupt in a new pandemic, and other threats like mosquito-borne dengue fever are rising in the U.S.

Traditional childhood diseases are also making their presence felt, in part because of neglected vaccination. The U.S. has seen 16 measles outbreaks this year — 89% of cases are in unvaccinated people — and a whooping cough epidemic is the worst since 2012.

“So that’s how we’re starting out,” said Peter Hotez, a pediatrician and virologist at the Baylor College of Medicine. “Then you throw into the mix one of the most outspoken and visible anti-vaccine activists at the head of HHS, and that gives me a lot of concern.”

The share prices of drug companies with big vaccine portfolios have plunged since Kennedy’s nomination. Even before Trump’s victory, vaccine exhaustion and skepticism had driven down demand for newer vaccines like GSK’s RSV and shingles shots.

Kennedy has ample options to slow or stop new vaccine releases or to slow sales of existing vaccines — for example, by requiring additional post-market studies or by highlighting questionable studies that suggest safety risks.

Kennedy, who has embraced conspiracy theories such as that HIV does not cause AIDS and that pesticides cause gender dysphoria, told NPR there are “huge deficits” in vaccine safety research. “We’re going to make sure those scientific studies are done and that people can make informed choices,” he said.

Kennedy’s nomination “bodes ill for the development of new vaccines and the use of currently available vaccines,” said Stanley Plotkin, a vaccine industry consultant and inventor of the rubella vaccine in the 1960s. “Vaccine development requires millions of dollars. Unless there is prospect of profit, commercial companies are not going to do it.”

Vaccine advocates, with less money on hand than the better-funded anti-vaccine advocates, see an uphill battle to defend vaccination in courts, legislatures, and the public square. People are rarely inclined to celebrate the absence of a conquered illness, making vaccines a hard sell even when they are working well.

While many wealthy people, including potion and supplement peddlers, have funded the anti-vaccine movement, “there hasn’t been an appetite from science-friendly people to give that kind of money to our side,” said Karen Ernst, director of Voices for Vaccines.

‘He’s Serious as Hell’

“RFK Jr. was a punch line for a lot of people, but he’s serious as hell,” Ernst said. “He has a lot of power, money, and a vast network of anti-vaccine parents who’ll show up at a moment’s notice.” That’s not been the case with groups like hers, Ernst said.

On Oct. 22, when an Idaho health board voted to stop providing covid vaccines in six counties, there were no vaccine advocates at the meeting. “We didn’t even know it was on the agenda,” Ernst said. “Mobilization on our side is always lagging. But I’m not giving up.”

The kaleidoscopic change has been jarring for Walter Orenstein, who persuaded states to tighten school mandates to fight measles outbreaks as head of the CDC’s immunization division from 1988 to 2004.

“People don’t understand the concept of community protection, and if they do they don’t seem to care,” said Orenstein, who saw some of the last cases of smallpox as a CDC epidemiologist in India in the 1970s, and frequently cared for children with meningitis caused by H. influenzae type B bacteria, a disease that has mostly disappeared because of a vaccine introduced in 1987.

“I was so naïve,” he said. “I thought that covid would solidify acceptance of vaccines, but it was the opposite.”

Lawmakers opposed to vaccines could introduce legislation to remove school-entry requirements in nearly every state, Saunders said. One bill to do this has been introduced in Texas, where what’s known as the vaccine choice movement has been growing since 2015 and took off during the pandemic, fusing with parents’ rights and anti-government groups opposed to measures like mandatory shots and masking.

“The genie is out of the bottle, and you can’t put it back in,” said Rekha Lakshmanan, chief strategy officer at the Immunization Partnership in Texas. “It’s become this multiheaded thing that we’re having to reckon with.”

In the last full school year, more than 100,000 Texas public school students were exempted from one or more vaccinations, she said, and many of the 600,000 homeschooled Texas kids are also thought to be unvaccinated.

In Louisiana, the state surgeon general distributed a form letter to hospitals exempting medical professionals from flu vaccination, claiming the vaccine is unlikely to work and has “real and well established” risks. Research on flu vaccination refutes both claims.

The biggest threat to existing vaccination policies could be plans by the Trump administration to remove civil service protections for federal workers. That jeopardizes workers at federal health agencies whose day-to-day jobs are to prepare for and fight diseases and epidemics. “If you overturn the administrative state, the impact on public health will be long-term and serious,” said Dorit Reiss, a professor at the University of California’s Hastings College of Law.

Billionaire Elon Musk, who has the ear of the incoming president, imagines cost-cutting plans that are also seen as a threat.

“If you damage the core functions of the FDA, it’s like killing the goose that laid the golden egg, both for our health and for the economy,” said Jesse Goodman, the director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University and a former chief science officer at the FDA. “It would be the exact opposite of what Kennedy is saying he wants, which is safe medical products. If we don’t have independent skilled scientists and clinicians at the agency, there’s an increased risk Americans will have unsafe foods and medicine.”

Outbreaks of vaccine-preventable illness could be alarming, but would they be enough to boost vaccination again? Ernst of Voices for Vaccines isn’t sure.

“We’re already having outbreaks. It would take years before enough children died before people said, ‘I guess measles is a bad thing,’” she said. “One kid won’t be enough. The story they’ll tell is, ‘There was something wrong with that kid. It can’t happen to my kid.’”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Por qué el sarampión, la tos ferina y otras enfermedades graves podrían resurgir con RFK Jr. https://kffhealthnews.org/news/article/por-que-el-sarampion-la-tos-ferina-y-otras-enfermedades-graves-podrian-resurgir-con-rfk-jr/ Fri, 06 Dec 2024 09:45:00 +0000 https://kffhealthnews.org/?post_type=article&p=1955591 La disponibilidad de vacunas seguras y eficaces contra covid a menos de un año del inicio de la pandemia marcó un hito en los tres siglos de historia de la vacunación: comenzaba, aparentemente, una era de protección contra las enfermedades infecciosas.

Sin embargo, una reacción generalizada contra las intervenciones del estado en la salud pública permitió que el presidente electo Donald Trump nombrara a Robert F. Kennedy, el más conocido activista antivacunas del país como máximo responsable del área de Salud.

Ahora, expertos afirman que una confluencia de factores podría causar el resurgimiento de epidemias mortales de enfermedades como el sarampión, la tos ferina y la meningitis, o incluso de polio.

 “La cantidad de cosas que empezarán a desmoronarse es abrumadora”, dijo James Hodge, experto en derecho de salud pública en el Colegio de Derecho Sandra Day O’Connor de la Universidad Estatal de Arizona. “Vamos a experimentar un cambio crítico en la legislación y las políticas sobre vacunas”.

“Estas políticas harán que América vuelva a enfermarse”, afirmó Lawrence Gostin, profesor de derecho de la salud pública en la Universidad de Georgetown.

Los legisladores estatales que cuestionan la seguridad de las vacunas están preparados para presentar proyectos de ley que debiliten los requisitos de vacunación para ir a la escuela, o los eliminen por completo, señaló Northe Saunders, quien monitorea la legislación relacionada con vacunas para la SAFE Communities Coalition.

Incluso los estados que mantengan los requisitos que hoy existen podrán ser afectados por las decisiones que tome un Congreso controlado por los republicanos, Kennedy y el ex miembro de la Cámara Dave Weldon, en caso de que sean confirmados para dirigir el Departamento de Salud y Servicios Humanos (HHS) y los Centros para el Control y Prevención de Enfermedades (CDC), respectivamente.

Ambos —Kennedy como activista, Weldon como médico y congresista desde 1995 hasta 2009, y protagonista de documentales antivacunas desde entonces— han respaldado teorías ya desacreditadas que culpan a las vacunas del autismo y otras enfermedades crónicas. Los dos han acusado a los CDC de ocultar las pruebas que confirmarían sus postulados, a pesar de las docenas de estudios científicos de prestigio que demuestran lo contrario.

El equipo de Kennedy no respondió a los pedidos de comentarios o entrevistas.

En noviembre, Robert F. Kennedy Jr. declaró a NPR: “No vamos a quitarle las vacunas a nadie”.

Todavía no está claro hasta qué punto el nuevo gobierno buscaría desalentar la vacunación, pero si los niveles de inmunización caen bastante, las enfermedades y muertes prevenibles por vacunas podrían dispararse.

“Es una fantasía pensar que podemos reducir las tasas de vacunación y la inmunidad colectiva en Estados Unidos sin sufrir la reaparición de estas enfermedades”, dijo Gregory Poland, co-director de la Atria Academy of Science & Medicine. “Uno de cada 3,000 niños que desarrolla sarampión va a morir. No hay tratamiento para evitarlo. Van a morir”.

En noviembre de 2019, una epidemia de sarampión causó la muerte de 80 niños en Samoa. En esa oportunidad, Kennedy escribió al primer ministro de ese país afirmando falsamente que la vacuna contra el sarampión probablemente estaba causando esas muertes.

Scott Gottlieb, que fue el primer comisionado de la Administración de Drogas y Alimentos (FDA) bajo la administración Trump, declaró en CNBC el 29 de noviembre que Kennedy “va a costar vidas en este país” si sabotea la vacunación.

La nominación de Kennedy valida y consagra la desconfianza pública en los programas de salud del gobierno, asegura Paul Offit, director del Centro de Educación sobre Vacunas del Hospital Infantil de Philadelphia.

“La idea de que se considere para ocupar un puesto tan importante hace que la gente piense que sabe de lo que habla”, dijo Offit. “Y él apela a generar desconfianza, a la idea de que ‘hay cosas que no ves, datos que no presentan, que yo voy a averiguar para que realmente puedas tomar una decisión informada’”.

Qué quieren los grupos antivacunas

Hodge ha elaborado una lista de 20 acciones que la administración podría llevar a cabo para debilitar los programas nacionales de vacunación, desde difundir información errónea hasta retrasar las aprobaciones de la FDA sobre vacunas. O retirar el apoyo del Departamento de Justicia a las leyes de vacunación que buscan impugnar grupos como Children’s Health Defense, que Kennedy fundó y dirigió antes de postularse para la presidencia.

Kennedy podría eliminar el Comité Asesor sobre Prácticas de Inmunización de los CDC, cuyas recomendaciones sobre el uso de una vacuna determinan si el gobierno la financia a través del programa Vacunas para Niños, que se creó hace 30 años y ofrece inmunizaciones gratuitas a más de la mitad de los niños del país.

Otra opción es que Kennedy coloque en el comité a aliados suyos que se oponen a nuevas vacunas y, al menos en teoría, retire las recomendaciones para vacunas como la triple viral (sarampión, paperas y rubéola), que se usa desde hace 53 años y cuya anulación es uno de los principales objetivos del movimiento antivacunas.

Mientras tanto, siempre hay amenazas de enfermedades infecciosas. Pero en lugar de prepararse para enfrentarlas, como haría una administración entrante común, Kennedy ha amenazado con reestructurar las agencias federales de salud. En una conferencia de Children’s Health Defense en noviembre, en Georgia, declaró que, cuando asuma el cargo, les dará “un respiro a las enfermedades infecciosas” para ocuparse de las afecciones crónicas.

El virus H5N1, o gripe aviar, podría estallar y convertirse en una nueva pandemia. No solo se ha propagado entre el ganado sino que ha infectado por lo menos a 55 personas. El dengue, que se transmite por mosquitos, es otra de las enfermedades que aumenta en el país.

Las enfermedades tradicionales de la infancia también están manifestándose con mayor frecuencia, en parte debido a la baja en la vacunación. Este año hubieron 16 brotes de sarampión —el 89% de los casos en personas no vacunadas— y la epidemia de tos ferina fue la peor desde 2012.

“Así es como estamos empezando”, dijo Peter Hotez, pediatra y virólogo del Baylor College of Medicine. “Y a esta situación se suma el nombramiento a la cabeza del HHS de uno de los activistas antivacunas más contundente y visible, lo que me provoca mucha preocupación”.

Los precios de las acciones de las compañías farmacéuticas con grandes portfolios de vacunas se han desplomado desde la designación de Kennedy. Incluso antes de la victoria de Trump, la escasez de vacunas y el escepticismo habían hecho caer la demanda de las más nuevas, como las vacunas contra el Virus Respiratorio Sincitial (VSR) y el herpes zóster de GSK.

Kennedy tiene varias maneras para retrasar o directamente detener el lanzamiento de nuevas vacunas. También para reducir las ventas de vacunas existentes. Por ejemplo, puede exigir estudios adicionales después que las vacunas ya están en el mercado o difundir estudios que sugieren posibles riesgos de seguridad, aunque esa afirmación sea errónea o no esté comprobada.

Kennedy, quien ha apoyado teorías conspirativas como que el VIH no causa el sida y que los pesticidas provocan disforia de género, declaró a NPR que existen “enormes déficits” en la investigación sobre la seguridad de las vacunas. “Nos aseguraremos de que esos estudios científicos se realicen y de que las personas puedan tomar decisiones informadas”, dijo.

El nombramiento de Kennedy “es un mal pronóstico para el desarrollo de nuevas vacunas y la aplicación de las que están actualmente disponibles”, dijo Stanley Plotkin, quien desarrolló la vacuna contra la rubéola en la década de 1960 y ahora es consultor de la industria de vacunas. “El desarrollo de vacunas requiere millones de dólares. A menos que haya perspectivas de obtener beneficios, las empresas comerciales no van a interesarse en invertir en esas investigaciones”, reflexionó.

Los defensores de las vacunas, que disponen de menos recursos que los grupos antivacunas, mucho mejor financiados, consideran que será muy difícil la batalla para defender la necesidad de la inmunización en los tribunales, las legislaturas y la opinión  pública. Las personas rara vez valoran la ausencia de una enfermedad erradicada, lo que dificulta promover las vacunas, incluso cuando son altamente efectivas.

Una situación muy grave

“Para mucha gente, RFK Jr. era motivo de burla, pero él está absolutamente decidido, habla totalmente en serio”, afirmó Ernst. “Tiene mucho poder, dinero y una vasta red de padres antivacunas que aparecerán en cualquier momento”. Nada similar ha ocurrido en los grupos a favor de las vacunas, dijo Ernst.

El 22 de octubre pasado, cuando una junta sanitaria de Idaho votó a favor de dejar de suministrar vacunas contra covid en seis condados, no había defensores de las vacunas en la reunión. “Ni siquiera sabíamos que esa discusión estaba en el orden del día”, aseguró Ernst. “La movilización por nuestra parte siempre está más retrasada. Pero no me rindo”, concluyó.

Este giro multifacético e impredecible ha sido desconcertante para Walter Orenstein, quien como jefe de la división de inmunización de los CDC entre 1988 y 2004 convenció a los estados de que endurecieran los requisitos de vacunación escolares para luchar contra los brotes de sarampión.

“La gente no entiende el concepto de protección comunitaria y, si lo entiende, no parece importarle”, afirmó Orenstein. Como epidemiólogo de los CDC en la India, Orenstein fue testigo de algunos de los últimos casos de viruela en la década de 1970. También atendió con frecuencia a niños con meningitis causada por la bacteria H. influenzae tipo B, una enfermedad que ha desaparecido casi totalmente gracias a una vacuna introducida en 1987.

“Yo era muy ingenuo”, dijo. “Pensaba que la vacunación contra covid consolidaría la aceptación de las vacunas, pero sucedió todo lo contrario”.

Los legisladores que se oponen a las vacunas podrían presentar leyes para eliminar los requisitos de acceso a la escuela en casi todos los estados, explicó Saunders.

En Texas se ha presentado un proyecto de ley de estas características, donde lo que se conoce como el movimiento de elección de vacunas ha estado creciendo desde 2015 y se intensificó durante la pandemia, fusionándose con los grupos de defensa de los derechos de los padres y grupos antigubernamentales opuestos a medidas como las vacunas obligatorias y el uso de máscaras.

“El genio ya está fuera de la botella y no se puede volver a meter”, dijo Rekha Lakshmanan, directora de estrategia de Immunization Partnership en Texas. “Se ha convertido en un problema con muchos ángulos con el que tenemos que lidiar”, agregó.

En el último año escolar completo, más de 100.000 alumnos de las escuelas públicas de Texas fueron eximidos de aplicarse una o más vacunas, dijo Lakshmanan, y se cree que muchos de los 600.000 niños en el estado que reciben su educación en sus casas tampoco están vacunados.

Los planes del presidente electo Donald Trump, que se propone eliminar las protecciones del servicio civil de los trabajadores federales, podrían ser la mayor amenaza para las políticas de vacunación existentes. Una decisión de ese tipo pondría en peligro a los empleados de las agencias federales de salud cuyo trabajo diario es prepararse para luchar contra las enfermedades y epidemias.

“Si se desmantela el aparato administrativo del estado el impacto en la salud pública será a largo plazo y grave”, dijo Dorit Reiss, profesora de la Facultad de Derecho Hastings de la Universidad de California.

El multimillonario Elon Musk, una persona con gran influencia sobre el presidente electo, planea recortes de gastos que también se consideran una amenaza.

“Dañar las funciones más importantes de la FDA, es como matar a la gallina de los huevos de oro, tanto para nuestra salud como para la economía”, afirmó Jesse Goodman, director del Center on Medical Product Access, Safety and Stewardship de la Universidad de Georgetown y ex director científico de la FDA.

“Sería exactamente lo contrario de lo que Kennedy dice que quiere, que son productos médicos seguros. Si en la agencia carecemos de científicos y clínicos calificados e independientes, el riesgo de que los estadounidenses tengan alimentos y medicamentos inseguros se incrementa.”

Los brotes de enfermedades prevenibles con vacunas podrían ser alarmantes, pero ¿serían suficientes para impulsar de nuevo las tasas de  vacunación? Ernst, de Voices for Vaccines, no está convencido.

“Ya estamos teniendo brotes. Tendrían que pasar años antes de que murieran suficientes niños como para que la gente dijera: ‘Supongo que el sarampión es algo realmente peligroso’”, afirmó. “La muerte de un niño no será suficiente. La historia que contarán será: ‘A ese niño le pasaba algo. A mi hijo no le puede pasar’”.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Scientists Fear What’s Next for Public Health if RFK Jr. Is Allowed To ‘Go Wild’ https://kffhealthnews.org/news/article/trump-rfk-maha-federal-health-agencies-takeover/ Thu, 14 Nov 2024 16:36:48 +0000 https://kffhealthnews.org/?post_type=article&p=1942166 Many scientists at the federal health agencies await the second Donald Trump administration with dread as well as uncertainty over how the president-elect will reconcile starkly different philosophies among the leaders of his team.

Trump announced Thursday he’ll nominate Robert F. Kennedy Jr. to be secretary of the Health and Human Services Department, after saying during his campaign he’d let the anti-vaccine activist “go wild” on medicines, food, and health.

Should Kennedy win Senate confirmation, his critics say a radical antiestablishment medical movement with roots in past centuries would take power, threatening the achievements of a science-based public health order painstakingly built since World War II.

Trump said in a post on the social platform X that “Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” echoing Kennedy’s complaints about the medical establishment. The former Democratic presidential candidate will “end the Chronic Disease epidemic” and “Make American Great and Healthy Again!” Trump wrote.

Vaccine makers’ stocks dipped Thursday afternoon amid news reports ahead of Trump’s RFK announcement.

If Kennedy makes good on his vision for transforming public health, childhood vaccine mandates could wither. New vaccines might never win approval, even as the FDA allows dangerous or inefficient therapies onto the market. Agency websites could trumpet unproven or debunked health ideas. And if Trump’s plan to weaken civil service rights goes through, anyone who questions these decisions could be summarily fired.

“Never has anybody like RFK Jr. gotten anywhere close to the position he may be in to actually shape policy,” said Lewis Grossman, a law professor at American University and the author of “Choose Your Medicine,” a history of U.S. public health.

Kennedy and an adviser Calley Means, a health care entrepreneur, say dramatic changes are needed because of the high levels of chronic disease in the United States. Government agencies have corruptly tolerated or promoted unhealthy diets and dangerous drugs and vaccines, they say.

Means and Kennedy did not respond to requests for comment. Four conservative members of the first Trump health bureaucracy spoke on condition of anonymity. They eagerly welcomed the former president’s return but voiced few opinions about specific policies. Days after last week’s election, RFK Jr. announced that the Trump administration would immediately fire and replace 600 National Institutes of Health officials. He set up a website seeking crowdsourced nominees for federal appointments, with a host of vaccination foes and chiropractors among the early favorites.

At meetings last week at Mar-a-Lago involving Elon Musk, Tucker Carlson, Donald Trump Jr., Kennedy, and Means, according to Politico, some candidates for leading health posts included Jay Bhattacharya, a Stanford University scientist who opposed covid lockdowns; Florida Surgeon General Joseph Ladapo, who opposes mRNA covid vaccines and rejected well-established disease control practices during a measles outbreak; Johns Hopkins University surgeon Marty Makary; and Means’ sister, Stanford-trained surgeon and health guru Casey Means.

All are mavericks of a sort, though their ideas are not uniform. Yet the notion that they could elbow aside a century of science-based health policy is profoundly troubling to many health professionals. They see Kennedy’s presence at the heart of the Trump transition as a triumph of the “medical freedom” movement, which arose in opposition to the Progressive Era idea that experts should guide health care policy and practices.

It could represent a turning away from the expectation that mainstream doctors be respected for their specialized knowledge, said Howard Markel, an emeritus professor of pediatrics and history at the University of Michigan, who began his clinical career treating AIDS patients and ended it after suffering a yearlong bout of long covid.

“We’ve gone back to the idea of ‘every man his own doctor,’” he said, referring to a phrase that gained currency in the 19th century. It was a bad idea then and it’s even worse now, he said.

“What does that do to the morale of scientists?” Markel asked. The public health agencies, largely a post-WWII legacy, are “remarkable institutions, but you can screw up these systems, not just by defunding them but by deflating the true patriots who work in them.”

FDA Commissioner Robert Califf told a conference on Nov. 12 that he worried about mass firings at the FDA. “I’m biased, but I feel like the FDA is sort of at peak performance right now,” he said. At a conference the next day, CDC Director Mandy Cohen reminded listeners of the horrors of vaccine-preventable diseases like measles and polio. “I don’t want to have to see us go backward in order to remind ourselves that vaccines work,” she said.

Stocks of some the biggest vaccine developers fell after news outlets led by Politico reported that the RFK pick was expected. Moderna, the developer of one of the most popular covid-19 vaccines, closed down 5.6%. Pfizer, another covid vaccine manufacturer, fell 2.6%. GSK, the producer of vaccines protecting against respiratory syncytial virus, hepatitis A and B, rotavirus, and influenza, fell just over 2%. French drug company Sanofi, whose website boasts its products vaccinate over 500 million annually, tumbled nearly 3.5%.

Exodus From the Agencies?

With uncertainty over the direction of their agencies, many older scientists at the NIH, FDA, and Centers for Disease Control and Prevention are considering retirement, said a senior NIH scientist who spoke on the condition of anonymity for fear of losing his job.

“Everybody I talk to sort of takes a deep breath and says, ‘It doesn’t look good,’” the official said.

“I hear of many people getting CVs ready,” said Arthur Caplan, a professor of bioethics at New York University. They include two of his former students who now work at the FDA, Caplan said.

Others, such as Georges Benjamin, executive director of the American Public Health Association, have voiced wait-and-see attitudes. “We worked with the Trump administration last time. There were times things worked reasonably well,” he said, “and times when things were chaotic, particularly during covid.” Any wholesale deregulation efforts in public health would be politically risky for Trump, he said, because when administrations “screw things up, people get sick and die.”

At the FDA, at least, “it’s very hard to make seismic changes,” former FDA chief counsel Dan Troy said.

But the administration could score easy libertarian-tinged wins by, for example, telling its new FDA chief to reverse the agency’s refusal to approve the psychedelic drug MDMA from the company Lykos. Access to psychedelics to treat post-traumatic stress disorder has grabbed the interest of many veterans. Vitamins and supplements, already only lightly regulated, will probably get even more of a free pass from the next Trump FDA.

Medical Freedom’ or ‘Nanny State

Trump’s health influencers are not monolithic. Analysts see potential clashes among Kennedy, Musk, and more traditional GOP voices. Casey Means, a “holistic” MD at the center of Kennedy’s “Make America Healthy Again” team, calls for the government to cut ties with industry and remove sugar, processed food, and toxic substances from American diets. Republicans lampooned such policies as exemplifying a “nanny state” when Mike Bloomberg promoted them as mayor of New York City.

Both the libertarian and “medical freedom” wings oppose aspects of regulation, but Silicon Valley biotech supporters of Trump, like Samuel Hammond of the Foundation for American Innovation, have pressed the agency to speed drug and device approvals, while Kennedy’s team says the FDA and other agencies have been “captured” by industry, resulting in dangerous and unnecessary drugs, vaccines, and devices on the market.

Kennedy and Casey Means want to end industry user fees that pay for drug and device rules and support nearly half the FDA’s $7.2 billion budget. It’s unclear whether Congress would make up the shortfall at a time when Trump and Musk have vowed to slash government programs. User fees are set by laws Congress passes every five years, most recently in 2022.

The industry supports the user-fee system, which bolsters FDA staffing and speeds product approvals. Writing new rules “requires an enormous amount of time, effort, energy, and collaboration” by FDA staff, Troy said. Policy changes made through informal “guidance” alone are not binding, he added.

Kennedy and the Means siblings have suggested overhauling agricultural policies so that they incentivize the cultivation of organic vegetables instead of industrial corn and soy, but “I don’t think they’ll be very influential in that area,” Caplan said. “Big Ag is a powerful entrenched industry, and they aren’t interested in changing.”

“There’s a fine line between the libertarian impulse of the ‘medical freedom’ types and advocating a reformation of American bodies, which is definitely ‘nanny state’ territory,” said historian Robert Johnston of the University of Illinois-Chicago.

Specific federal agencies are likely to face major changes. Republicans want to trim the NIH’s 27 research institutes and centers to 15, slashing Anthony Fauci’s legacy by splitting the National Institute of Allergy and Infectious Diseases, which he led for 38 years, into two or three pieces.

Numerous past attempts to slim down the NIH have failed in the face of campaigns by patients, researchers, and doctors. GOP lawmakers have advocated substantial cuts to the CDC budget in recent years, including an end to funding gun violence, climate change, and health equity research. If carried out, Project 2025, a policy blueprint from the conservative Heritage Foundation, would divide the agency into data-collecting and health-promoting arms. The CDC has limited clout in Washington, although former CDC directors and public health officials are defending its value.

“It would be surprising if CDC wasn’t on the radar” for potential change, said Anne Schuchat, a former principal deputy director of the agency, who retired in 2021.

The CDC’s workforce is “very employable” and might start to look for other work if “their area of focus is going to be either cut or changed,” she said.

Kennedy’s attacks on HHS and its agencies as corrupted tools of the drug industry, and his demands that the FDA allow access to scientifically controversial drugs, are closely reminiscent of the 1970s campaign by conservative champions of Laetrile, a dangerous and ineffective apricot-pit derivative touted as a cancer treatment. Just as Kennedy championed off-patent drugs like ivermectin and hydroxychloroquine to treat covid, Laetrile’s defenders claimed that the FDA and a profit-seeking industry were conspiring to suppress a cheaper alternative.

The public and industry have often been skeptical of health regulatory agencies over the decades, Grossman said. The agencies succeed best when they are called in to fix things — particularly after bad medicine kills or damages children, he said.

The 1902 Biologics Control Act, which created the NIH’s forerunner, was enacted in response to smallpox vaccine contamination that killed at least nine children in Camden, New Jersey. Child poisonings linked to the antifreeze solvent for a sulfa drug prompted the modern FDA’s creation in 1938. The agency, in 1962, acquired the power to demand evidence of safety and efficacy before the marketing of drugs after the thalidomide disaster, in which children of pregnant women taking the anti-nausea drug were born with terribly malformed limbs.

If vaccination rates plummet and measles and whooping cough outbreaks proliferate, babies could die or suffer brain damage. “It won’t be harmless for the administration to broadly attack public health,” said Alfredo Morabia, a professor of epidemiology at Columbia University and the editor-in-chief of the American Journal of Public Health. “It would be like taking away your house insurance.”

Sam Whitehead, Stephanie Armour, David Hilzenrath, and Darius Tahir contributed to this report.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Qué le depara a la salud pública si se confirma Robert F. Kennedy Jr. como secretario de Salud https://kffhealthnews.org/news/article/que-le-depara-a-la-salud-publica-si-se-confirma-robert-f-kennedy-jr-como-secretario-de-salud/ Thu, 14 Nov 2024 16:36:00 +0000 https://kffhealthnews.org/?post_type=article&p=1945608 Científicos de las agencias federales de salud esperan la segunda administración de Donald Trump con incertidumbre y temor, preguntándose cómo el presidente electo conciliará filosofías radicalmente diferentes entre los líderes de su equipo.

Trump anunció hace pocos días que nominará a Robert F. Kennedy Jr. (RFK) como secretario del Departamento de Salud y Servicios Humanos (HHS), después de decir durante la campaña presidencial que dejaría que el activista antivacunas implementase “sus locuras” en materia de medicamentos, alimentos y salud.

Si el Senado confirma a Kennedy, sus críticos dicen que un movimiento médico radical antisistema, con raíces en siglos pasados, tomaría el poder, amenazando los logros de un orden de salud pública basado en la ciencia y construido con esfuerzo desde la Segunda Guerra Mundial.

Trump dijo en un post en la red social X que “los estadounidenses han sido aplastados por el complejo industrial alimentario y las compañías farmacéuticas que se han dedicado al engaño, la información falsa y la desinformación cuando se trata de salud pública”, haciéndose eco de las quejas de Kennedy sobre el establishment médico.

RFK, ex candidato presidencial demócrata, “acabará con la epidemia de enfermedades crónicas” y “¡Hará que Estados Unidos vuelva a ser grande y saludable!”, escribió Trump.

Las acciones de los fabricantes de vacunas cayeron en medio de las noticias previas al anuncio de Trump sobre RFK.

Si Kennedy hace realidad su visión de transformar la salud pública, los mandatos de vacunación infantil podrían debilitarse. Las nuevas vacunas podrían no ser aprobadas nunca, incluso si la Administración de Alimentos y Medicamentos (FDA) permite la comercialización de terapias peligrosas o ineficaces.

Los sitios web de la agencia podrían diseminar ideas sobre la salud no probadas o desacreditadas. Y si el plan de Trump de socavar los derechos de los funcionarios sigue adelante, cualquiera que cuestione estas decisiones podría ser despedido de inmediato.

“Nunca nadie como RFK Jr. se había acercado a la posición en la que podría estar para dar forma real a estas políticas”, dijo Lewis Grossman, profesor de Leyes en la American University y autor de “Choose Your Medicine”, una historia de la salud pública estadounidense.

Kennedy y su asesor Calley Means, un empresario del sector de la salud, afirman que se necesitan cambios drásticos debido a los altos niveles de enfermedades crónicas en Estados Unidos. Según ellos, las agencias gubernamentales han tolerado o promovido, de forma corrupta, dietas poco saludables, y medicamentos y vacunas peligrosos.

Means y Kennedy no respondieron a las solicitudes de comentarios. Cuatro miembros conservadores que formaron parte de la primera burocracia de la salud de Trump hablaron bajo condición de anonimato.

Recibieron con entusiasmo el regreso del ex presidente, pero expresaron pocas opiniones sobre políticas específicas. Días después de las elecciones, RFK Jr. anunció que la administración Trump despediría y reemplazaría inmediatamente a 600 funcionarios de los Institutos Nacionales de Salud (NIH). Creó un sitio web en el que buscaba candidatos por crowdsourcing para nombramientos federales, con una gran cantidad de enemigos de las vacunas y quiroprácticos entre los primeros favoritos.

En reuniones celebradas recientemente en Mar-a-Lago, la residencia de Trump en Florida, en las que participaron Elon Musk, Tucker Carlson, Donald Trump Jr, Kennedy y Means, según Politico, entre los candidatos a los principales puestos en el área de salud estaba Jay Bhattacharya, un científico de la Universidad de Stanford que se opuso a los cierres durante covid. También el cirujano general de Florida, Joseph Ladapo, que se opone a las vacunas de ARNm contra covid-19 y rechazó prácticas de control de enfermedades bien establecidas durante un brote de sarampión; el cirujano de la Universidad Johns Hopkins Marty Makary; y la hermana de Means, la cirujana formada en Stanford y gurú de la salud Casey Means.

Todos ellos pueden ser calificados de inconformistas, aunque sus ideas no son uniformes. Sin embargo, la posibilidad de que puedan dejar de lado un siglo de políticas de salud basadas en la ciencia es profundamente preocupante para muchos profesionales. Ven la presencia de Kennedy en el corazón de la transición de Trump como un triunfo del movimiento de “libertad médica”, que surgió en oposición a la idea de la Era Progresista de que los expertos son los que deben guiar la política y las prácticas de atención de salud.

Podría representar un alejamiento de la expectativa de que los médicos convencionales sean respetados por sus conocimientos especializados, dijo Howard Markel, profesor emérito de pediatría e historia en la Universidad de Michigan, que comenzó su carrera clínica tratando a pacientes con sida y la terminó tras sufrir un año de covid de larga duración.

“Hemos vuelto a la idea de ‘cada uno es su médico’”, comentó, refiriéndose a una frase que se impuso en el siglo XIX. Era una mala idea entonces y es aún peor ahora, agregó.

“¿Cómo afectará eso a la moral de los científicos?”, se preguntó Markel. Las agencias de salud pública, en gran medida un legado posterior a la Segunda Guerra Mundial, son “instituciones notables, pero se pueden echar a perder estos sistemas, no sólo quitándoles financiación, sino desmoralizando a los verdaderos patriotas que trabajan en ellas”.

El Comisionado de la FDA, Robert Califf, declaró en una conferencia el 12 de noviembre que le preocupaban los despidos masivos en la agencia. “No soy imparcial, pero creo que la FDA está en una especie de pico de rendimiento en este momento”, expresó.

Al día siguiente, en una conferencia, la directora de los Centros para el Control y Prevención de Enfermedades (CDC), Mandy Cohen, recordó los horrores de las enfermedades prevenibles mediante vacunación, como el sarampión y la poliomielitis. “No quiero que tengamos que dar marcha atrás para recordarnos que las vacunas funcionan”, afirmó.

Las acciones de algunos de los principales fabricantes de vacunas cayeron después que los medios de comunicación, encabezados por Politico, informaran de que se esperaba la elección de RFK.

Moderna, creadora de una de las vacunas más populares contra covid-19, cerró con una baja del 5,6%. Pfizer, otro fabricante de vacunas contra covid, cayó un 2,6%. GSK, que produce la vacuna contra el virus respiratorio sincitial, la hepatitis A y B, el rotavirus y la gripe, cayó algo más del 2%. La farmacéutica francesa Sanofi, cuyo sitio web presume de que sus productos vacunan a más de 500 millones de personas al año, cayó casi un 3,5%.

¿Éxodo de las agencias?

Ante la incertidumbre sobre la dirección de sus agencias, muchos científicos de edad avanzada de los NIH, la FDA y los CDC consideran la posibilidad de jubilarse, contó un científico de alto nivel de los NIH que habló bajo condición de anonimato por temor a perder su trabajo.

“Todo el mundo con quien hablo respira hondo y dice: ‘Esto no pinta bien’”, explicó el funcionario.

“Sé de muchas personas que están preparando sus currículums”, dijo Arthur Caplan, profesor de bioética en la Universidad de Nueva York. Entre ellos se encuentran dos de sus antiguos alumnos que ahora trabajan en la FDA, dijo Caplan.

Otros, como Georges Benjamin, director ejecutivo de la American Public Health Association, han han dicho que esperarán y verán qué pasa. “Trabajamos con la administración Trump la última vez. Hubo momentos en que las cosas funcionaron razonablemente bien”, explicó, “y momentos en que las cosas fueron caóticas, particularmente durante covid”.

Cualquier esfuerzo de desregulación al por mayor en la salud pública sería políticamente arriesgado para Trump, señaló Benjamin, porque cuando las administraciones “arruinan las cosas, la gente se enferma y muere”.

En la FDA, al menos, “es muy difícil hacer cambios sísmicos”, dijo Dan Troy, ex consejero jefe de la FDA.

Pero la administración podría conseguir fáciles victorias de tinte libertario, por ejemplo, diciendo a su nuevo jefe de la FDA que revierta la negativa de la agencia a aprobar el fármaco psicodélico MDMA de la empresa Lykos. El acceso a los psicodélicos para tratar el trastorno de estrés postraumático ha despertado el interés de muchos veteranos.

Las vitaminas y los suplementos, que ya sólo están ligeramente regulados, probablemente recibirán aún más carta blanca de la próxima FDA de Trump.

Libertad médica o Estado niñera

Pero los “influencers” de la salud en la futura administración Trump no son monolíticos. Los analistas ven posibles enfrentamientos entre Kennedy, Musk y las voces más tradicionales del Partido Republicano.

Casey Means, un médico holístico en el centro del equipo “Make America Healthy Again” de Kennedy, pide que el gobierno corte los lazos con la industria y elimine el azúcar, los alimentos procesados y las sustancias tóxicas de las dietas estadounidenses. Los republicanos tacharon estas políticas de “Estado niñera” cuando Mike Bloomberg las promovió como alcalde de Nueva York.

Tanto el ala libertaria como el de la “libertad médica” se oponen a aspectos de la regulación. Pero los partidarios de la biotecnología de Silicon Valley que están con Trump, como Samuel Hammond de la Foundation for American Innovation, han presionado a la agencia para que acelere la aprobación de medicamentos y dispositivos. Mientras tanto, el equipo de Kennedy dice que la FDA y otras agencias han sido “capturadas” por la industria, lo que resulta en medicamentos, vacunas y dispositivos peligrosos e innecesarios en el mercado.

Es probable que algunos organismos federales sufran cambios importantes. Los republicanos quieren reducir los 27 institutos y centros de investigación de los NIH a 15, y recortar el legado de Anthony Fauci dividiendo el Instituto Nacional de Alergias y Enfermedades Infecciosas, que dirigió durante 38 años, en dos o tres partes.

Numerosos intentos anteriores de reducir los NIH han fracasado frente a las campañas de pacientes, investigadores y médicos.

Legisladores republicanos han defendido recortes sustanciales del presupuesto de los CDC en los últimos años, incluido el fin de la financiación de la investigación sobre la violencia con armas de fuego, el cambio climático y la equidad en salud. De llevarse a cabo el Proyecto 2025, un proyecto político de la conservadora Heritage Foundation, dividiría la agencia en dos ramas: la de recopilación de datos y la de promoción de la salud. Los CDC tiene una influencia limitada en Washington, aunque ex directores y funcionarios de salud pública defienden su valor.

“Me sorprendería que los CDC no estuvieran en el radar” de posibles cambios, dijo Anne Schuchat, ex subdirectora principal de la agencia, que se jubiló en 2021.

El personal de los CDC es “muy empleable” y podría empezar a buscar otro trabajo si “su área de interés va a ser recortada o modificada”, opinó Schuchat.

Los ataques de Kennedy contra el HHS y sus agencias como herramientas corruptas de la industria farmacéutica, y sus demandas de que la FDA permita el acceso a medicamentos científicamente controversiales, recuerdan mucho a la campaña de los años 70 por parte de los conservadores que defendían el Laetrile, un peligroso e ineficaz derivado de la semilla de albaricoque promocionado como tratamiento contra el cáncer.

Al igual que Kennedy defendió fármacos sin patente como la ivermectina y la hidroxicloroquina para tratar covid, los defensores del Laetrile afirmaron que la FDA y una industria con fines de lucro estaban conspirando para suprimir una alternativa más barata.

A lo largo de las décadas, el público y la industria se han mostrado escépticos ante las agencias reguladoras de la salud, afirmó Grossman. Los organismos tienen más éxito cuando se les pide que solucionen problemas, sobre todo cuando un medicamento defectuoso mata o lastima a un niño.

La Ley de Control Biológico de 1902, que creó el precursor de los NIH, se promulgó en respuesta a vacunas contra la viruela contaminadas que mataron al menos a nueve niños en Camden, Nueva Jersey. Las intoxicaciones infantiles relacionadas con el disolvente anticongelante de un medicamento con sulfamidas impulsaron la creación de la FDA moderna en 1938.

En 1962, la agencia adquirió la facultad de exigir pruebas de seguridad y eficacia antes de la comercialización de medicamentos tras el desastre de la talidomida, cuando los hijos de mujeres embarazadas que tomaban el medicamento contra las náuseas nacieron con extremidades terriblemente malformadas.

Si las tasas de vacunación caen en picada y proliferan los brotes de sarampión y tos ferina, los bebés podrían morir o sufrir daños cerebrales. “Sufriremos las consecuencias si la administración ataca abiertamente la salud pública”, afirmó Alfredo Morabia, catedrático de Epidemiología de la Universidad de Columbia y director del American Journal of Public Health. “Sería como quitarte el seguro de tu casa”.

Sam Whitehead, Stephanie Armour, David Hilzenrath y Darius Tahir colaboraron con este artículo.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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What’s at Stake: A Pivotal Election for Six Big Health Issues https://kffhealthnews.org/news/article/health-policies-pivotal-changes-election-results-6-issues/ Fri, 01 Nov 2024 19:24:16 +0000 https://kffhealthnews.org/?post_type=article&p=1936774 In the final days of the campaign, stark disagreements between Vice President Kamala Harris and former President Donald Trump over the future of American health care are on display — in particular, in sober warnings about abortion access, the specter of future cuts to the Affordable Care Act, and bold pronouncements about empowering activists eager to change course and clean house.

Trump and his campaign have been vague about plans on health care policies, though current and former Trump aides have published blueprints that go well beyond reversing programs in force under the Biden administration, to overhauling public health agencies and enabling Trump to quickly fire officials who disagree.

Harris, on the other hand, has staked out positions primarily preserving and protecting existing health care access — on abortion, transgender health care, insurance coverage, and more.

Here are some of the most consequential changes in health policies that could hinge on who wins the White House.

ACA Premiums

The election is likely to affect the cost of health insurance for millions who buy coverage on the Affordable Care Act marketplaces.

That’s because extra, pandemic-era subsidies that lower the cost of premiums will expire at the end of 2025 — unless Congress and the next president act.

Harris has pledged to make the enhanced subsidies permanent, while Trump has made no such commitment.

Letting them expire “would reduce fraud and waste,” said Brian Blase, a former Trump adviser who is president of the Paragon Health Institute, a conservative policy research firm.

About 19.7 million people with ACA coverage benefit from a subsidy — 92% of all enrollees. The expanded subsidies, started in 2021, helped increase ACA enrollment to a record high and reduce the uninsured rate to a record low.

They have also cut premium payments by an estimated 44%. Many pay no premiums at all.

Without congressional action, almost all ACA enrollees will experience steep increases in premium payments in 2026, according to KFF. The Urban Institute estimates 4 million people could wind up uninsured.

Letting the subsidies lapse could cause blowback for Republicans in 2026, said Jonathan Oberlander, a health policy expert at the University of North Carolina’s School of Medicine: “Is it worth the pain politically?”

— Phil Galewitz

Abortion

When he was president, Trump promised — and delivered — Supreme Court justices who would vote to overturn the constitutional right to an abortion. In the event of a second term, he has promised to leave abortion policy to the states — though he would have significant leeway to reduce access nationwide.

Harris has promised to restore the protections of Roe v. Wade, though doing so would require Congress’ help. At the very least, a Harris presidency would mostly preserve existing protections and prevent new federal restrictions.

Trump’s first actions would likely mirror those of many Republican presidents since the 1980s: defunding Planned Parenthood and the United Nations’ family planning agency, and, more recently, allowing employers with religious or moral objections to contraception to decline coverage through job-sponsored health plans.

But Trump could go considerably further, effectively banning abortion even in states where it is legal. For instance, the FDA could reduce availability of the abortion pill mifepristone or cancel its approval. This has been the subject of numerous lawsuits, including one before the Supreme Court that was recently revived.

Trump could also order the Justice Department to enforce the Comstock Act, an 1873 law that bans mailing “every article or thing designed, adapted, or intended for producing abortion, or for any indecent or immoral use.” That could apply not just to abortion pills, but also to supplies for abortion procedures.

— Julie Rovner

Drug Prices

Both campaigns say they are committed to lowering drug prices. Trump has offered few specifics, though the America First Policy Institute, a think tank led by close Trump allies, has put forward policies that are considerably less aggressive than Harris’ proposals.

Harris has said she would expand drug pricing negotiations and out-of-pocket drug spending caps enabled by the Inflation Reduction Act. She has also called for more transparency requirements for pharmacy benefit managers, or PBMs, the powerful drug-industry middlemen.

America First’s plan would cut costs by lowering reimbursements to doctors for some expensive infused drugs, using trade policy to force other developed countries to increase what they pay for drugs, and making more prescription medications available over the counter.

The plan makes no mention of bipartisan legislation under consideration in both chambers of Congress that seeks to achieve lower drug prices through new transparency requirements for PBMs.

— Arthur Allen

Trans People’s Health

The presidential election could determine whether transgender Americans hold on to broad protections ensuring access to gender-affirming medical care. Trump has said he would seek to ban hormone replacement therapy, gender-affirmation surgery, and other treatments for minors — and make the services more difficult for adults to receive.

In the closing days of the campaign, Trump and his political action committees have leaned into divisive ads attacking Harris for past comments supporting access to care for transgender people who are incarcerated.

Backed by Republicans eager to stoke culture-war social issues, Trump has pledged to repeal Biden policies affecting transgender health care, including rules prohibiting federally funded providers and insurers from discriminating based on gender identity.

As some states passed legislation that opposed transgender rights, the Biden administration expanded coverage for gender-affirming care and increased research funding for the National Institutes of Health.

In a video on his campaign site, Trump vowed to order federal agencies to “cease all programs that promote the concept of sex and gender transition at any age” and bar government programs such as Medicare and Medicaid from paying for gender-affirming care.

Trump also said he would strip federal funding from hospitals that provide such care, create a right to sue doctors who perform gender-affirming procedures on children, and investigate whether the pharmaceutical industry and hospitals have “deliberately covered up horrific long-term side effects” of transition treatments.

Harris has been largely silent on the Trump campaign’s rhetoric targeting trans people. But she has said she would “follow the law” in providing transgender Americans the same right as others to access medically necessary care.

— Daniel Chang

Medicaid

Though the word “Medicaid” was barely uttered on the campaign trail this year, the election will determine future benefits for its 80 million primarily low-income and disabled enrollees.

“The stakes are very high,” said UNC’s Oberlander.

While Harris has described Medicaid as a key program to improve health, Trump has framed it as a broken welfare program in need of cuts.

Nearly half of Medicaid enrollees are children, and the program pays for about 40% of births nationwide.

The ACA expanded Medicaid coverage to nearly all adults with incomes up to 138% of the federal poverty level, or $20,783 this year. All but 10 states, which are GOP-led, have opted to expand their program.

The Biden administration has largely focused on efforts to protect and expand Medicaid to reduce the number of uninsured people.

The Trump administration, and GOP proposals since then, sought to reduce Medicaid spending by stiffening eligibility standards, such as adding work requirements, and by changing federal financing to a block grant, which would put more burden on states.

— Phil Galewitz

Shaking Up Biomedical Agencies

Trump said at an Oct. 27 rally in New York City that he would give anti-vaccine activist Robert F. Kennedy Jr. free rein to “go wild” on health and food policy in a second term.

Even a Republican-controlled Senate would be unlikely to confirm Kennedy for any top government position. Regardless of whether he had a specific role, RFK Jr.’s influence could be powerful, said Georges Benjamin, executive director of the American Public Health Association.

Kennedy said Trump promised to give him “control” of public health, including naming leaders of the NIH, FDA, and the Centers for Disease Control and Prevention. He has advocated for a doctor who made a name for herself as a right-wing health guru, Casey Means, to head the FDA. This week, in a discussion on CNN during which he put forward the debunked theory that vaccines cause autism, Trump transition team co-chair Howard Lutnick said Kennedy wanted data on vaccines “so he can say these things are unsafe,” at which point “the companies will yank the vaccines right off … the market.”

Numerous Trump allies have urged disempowering public health agencies — stripping the CDC of much of its research and promotional authority while streamlining NIH and adding congressional oversight over its grant-making.

Project 2025, the Heritage Foundation blueprint disavowed by Trump but whose authors include many former Trump officials, says the drug industry and other corporations have “captured” regulatory agencies: “We must shut and lock the revolving door” between agencies like the NIH, CDC, and FDA, and the industries they regulate, it states.

Kennedy recently posted on the social platform X that “FDA’s war on public health” — by which he meant restrictions on disproven therapies and cure-alls like raw milk and ivermectin — “was about to end.”

He warned FDA employees who are “part of the corrupt system” that they should “1. Preserve your records, and 2. Pack your bags.”

— Arthur Allen

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Post-Helene, Patients Who Rely on IV Nutrition Face Severe Shortages https://kffhealthnews.org/news/article/health-brief-helene-aftermath-iv-nutrition-patients/ Tue, 29 Oct 2024 13:49:05 +0000 https://kffhealthnews.org/?p=1935000&post_type=article&preview_id=1935000 Hurricane Helene, which struck North Carolina last month, wrecked a Baxter International factory that produced 60 percent of the country’s IV fluids, according to the American Hospital Association. The company is rationing its products, and some hospitals have delayed or canceled surgeries that require large amounts of IV hydration.

Among the worst-hit patients are those who rely on parenteral nutrition — IV liquids containing amino acids, lipids, sugars, vitamins and electrolytes. These patients often get the fluid through a port connected to a vein near their heart because they can’t digest food through the intestines due to conditions ranging from autoimmune diseases to cancer.

In addition, two weeks after the hurricane hit, CVS Health, which owns one of the biggest home infusion pharmacies in the country — a subsidiary called Coram — began warning patients that it was getting out of the parenteral nutrition business.

With Baxter providing limited supplies of IV fluid to the remaining infusion pharmacies, many Coram patients are starting to run out of supplies. For some, hospitalization is the only answer.

We caught up with Lisa Trumble, a 52-year-old Pittsfield, Massachusetts, grandmother who was slammed by this double whammy. After entering Berkshire Medical Center with a respiratory illness on Oct. 1, she was ready to be discharged Oct. 9. But then Coram alerted her doctor that it could no longer supply her with home IV nutrition.

“I was dropped between Tuesday night and Wednesday morning with no care for my life or my health,” Trumble told me by phone after another week in the hospital.

Although another supplier stepped up for Trumble a few days after we talked, she isn’t the only one facing critical problems. Several IV nutrition patients we spoke with said they were running low on supplies and worried about getting sick. A couple of days without electrolytes can make you ill. Without sufficient carbohydrates, you starve. Some patients say they’ve had trouble getting enough of the special syringes and tubing needed to administer their fluids since the hurricane.

Even before the Baxter and Coram troubles, pharmacies were suffering shortages and low reimbursement rates. They have barely been able to care for existing patients, and the Baxter rationing left them no way to take new ones dropped by Coram, said David Seres, director of medical nutrition at Columbia University Medical Center in New York.

The Biden administration has triggered the Defense Production Act, under which it can commandeer supplies and labor to get the Baxter plant running at full speed again. Meanwhile, the FDA is allowing emergency imports of IV fluids wiped out by Helene as well as production of some of the fluids by U.S. compounding pharmacies.

But it’s unclear how long it will take to replenish supplies, said Manpreet Mundi, a Mayo Clinic endocrinologist who is a board member of the American Society for Parenteral and Enteral Nutrition. “We’re trying to raise awareness that this could get worse before it gets better,” he said.

Baxter says on its website that, “barring any unanticipated developments,” it expects to restart “the highest-throughput IV solutions manufacturing line” this week.

This article is not available for syndication due to republishing restrictions. If you have questions about the availability of this or other content for republication, please contact NewsWeb@kff.org.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Helene and CVS Land Double Whammy for 25,000 Patients Who Survive on IV Nutrition https://kffhealthnews.org/news/article/hurricane-helene-cvs-coram-parenteral-iv-fluids/ Fri, 18 Oct 2024 09:00:00 +0000 https://kffhealthnews.org/?post_type=article&p=1931278 The CVS representative popped into Lisa Trumble’s third-floor Berkshire Medical Center hospital room in Pittsfield, Massachusetts, to announce that everything was arranged for Trumble to return home, where she relies on IV nutrition because of severe intestinal problems that leave her unable to eat.

That was on Tuesday, Oct. 8. The next morning a social worker and a doctor woke Trumble to say her discharge was canceled. CVS would no longer provide her home nutrition, and she had to stay in the hospital. “I was dropped between Tuesday night and Wednesday morning with no care for my life or my health,” Trumble said from her hospital bed eight days later.

After this article was published, on Oct. 18, Trumble said she was being discharged, after her caregivers found a replacement service. “I’m just afraid their supplies will run out,” she said. “My backup plan is always to go back to the hospital.”

Trumble is among 25,000 U.S. patients whose survival depends on parenteral nutrition, or PN — IV bags containing life-sustaining amino acids, sugars, fats, vitamins, and electrolytes. Hurricane Helene wrecked a factory in North Carolina that produced 60% of the fluids their sustenance is mixed from. About two weeks later, CVS announced that its Coram division, a leading infusion pharmacy, was exiting the PN and IV antibiotics business.

The hurricane led Baxter International to ration its dwindling supplies. Pharmacies that supply Trumble and other patients like her were already plagued by shortages, and the rationing means the remaining infusion pharmacies can’t take on the customers cut off by CVS, said David Seres, director of medical nutrition at Columbia University Medical Center in New York.

At the Mayo Clinic in Rochester, Minnesota, seven or eight patients were ready to go home Tuesday but couldn’t be discharged because no infusion company would accept them, said Manpreet Mundi, a Mayo endocrinologist. The patients would fall ill within a day or two without this nutrition, he said.

By Oct. 18, home supplies had been located for all but a few of them, Mundi said. “A lot of public pressure” on Coram was starting to have an effect, he said.

Although the FDA is allowing emergency imports of IV fluids wiped out by Helene, as well as production of some of the fluids by U.S. compounding pharmacies, it’s unclear how long it will take to replenish supplies, said Mundi, who is a board member of the American Society for Parenteral and Enteral Nutrition and medical adviser to the Oley Foundation, which advocates for PN patients. “We’re trying to raise awareness that this could get worse before it gets better,” he said.

The patients who rely on PN have a variety of conditions that render them unable to digest food. Some have congenital abnormalities or disorders like Crohn’s disease that led to surgical removal of bowel sections. Others were scarred by cancer, car accidents, or gunfire, or are preemies born with underdeveloped intestines. In most patients, the fluid is pumped through a catheter into a large vein near the heart.

A crisis hit this community two years ago when CVS Health announced that it was shutting half of the 71 Coram pharmacies.

CVS, which recently announced nearly 3,000 layoffs amid reports of a possible restructuring, on Oct. 8 began telling its remaining 800 to 1,000 PN customers that they would have to find other infusion pharmacies. A news release provided to KFF Health News suggested the phaseout would last into January, but for patients like Trumble, the impact was immediate.

Highly specialized infusion medicine is “a challenging environment” for all companies “and Coram has not been immune to these challenges,” the CVS release said. “As such, we have reevaluated our service offerings.”

When asked about Trumble’s case, CVS Health spokesperson Mike DeAngelis said the company would “try to resolve it.” The next day, a company called Optum stepped in to replace Coram, Trumble said.

It’s hard enough normally for such patients to find new suppliers for their materials, which can include 120 pounds of IV fluid per week.

Coram’s departure “made a big crisis that much worse,” Mundi said. “It’s become kind of a double whammy.”

The Baxter International North Cove plant produced most of the country’s high-concentration dextrose, a major source of energy for PN patients, as well as saline solution and sterile water, also vital supplies. A week after Helene hit, Hurricane Milton threatened sterile IV fluid supplier B. Braun Medical’s facility in Daytona Beach, Florida. The federal government helped truck 60 loads of the company’s inventory to a safe location, but the plant was spared the storm’s worst. It restarted production on Oct. 11.

That was a huge relief for Beth Gore, CEO of the Oley Foundation. She, her husband, and their six adopted children braved the storm’s seven hours of lashing wind in their home near Ruskin, Florida. Milton wrecked a car and part of the roof, but the family prayed through it all and somehow never lost power, though their neighbors did, Gore said. That kept the IV fluids fresh and the internet on, which calmed the kids.

Coram has supplied her youngest son, 15-year-old Manny, with PN for 13 years, and the family will need to find another supplier, she said.

“There’s been no relief” since Coram reduced its services in 2022, Gore said. “Now there’s this new twist.”

Her son gets care through Medicaid, whose reimbursement provides barely break-even margins for many infusion pharmacies, she said. Insurance limits, state licensing differences, and highly specific nutritional needs pose challenges for patients seeking new IV suppliers in the best of times, she said.

The FDA announced Oct. 9 that it would allow Baxter to import emergency supplies from Canada, China, Ireland, and the U.K. In the meantime, Baxter is prioritizing hospital patients over the home infusion companies — which lack backup supplies, Mundi said.

“We’re all on the phone 24/7,” said Kathleen Gura, president-elect of the American Society for Parenteral and Enteral Nutrition and pharmacy clinical research program manager at Boston Children’s Hospital. Her team is struggling to find new suppliers of IV nutrition at home for the 20 Coram patients among the 150 she sees.

“Some kids have a situation where they can’t absorb at all through their intestines and will die of dehydration if they can’t get IV,” Gura said.

The IV fluids lost in the Baxter disaster are key to all kinds of inpatient care. Many U.S. hospitals are conserving fluid by giving some patients oral hydration instead of IVs, or by delaying surgeries, said Soumi Saha, senior vice president of government affairs at Premier, which negotiates group hospital purchases.

President Joe Biden has invoked the Defense Production Act, which will enable the government to order companies to prioritize rebuilding the Baxter plant.

The military is flying in supplies from Baxter plants overseas, Saha said. Premier has also asked the FDA to put additional PN ingredients on its shortage list, which would allow large compounding facilities to produce the materials.

Ellie Rogers, 17, of Simpsonville, South Carolina, fears the worst if she can’t get her supplies. She suffers from a host of immunological and neurological ailments that require her to get four liters of IV fluid daily to stay alive, she said.

Her supplier, an Option Care Health pharmacy in South Carolina, informed the family Oct. 14 that instead of her weekly supply it was sending her enough bags for a day or two. “They really don’t know when they’re going to get what they need,” she said. Reducing the infusions in the past has led to dizziness, nausea, and pooling of her blood that “felt like my veins were going to explode.”

On Oct. 7, Crohn’s disease patient Hannah Hale’s infusion pharmacy called and said it couldn’t fill her standing weekly order of IV bags, urging her to find a new pharmacy.

“I called 14 infusion pharmacies and haven’t been able to find anyone to take me,” said the Dallas 37-year-old. She suffers from weight loss and low blood sugar, and rationing her supplies raises dangers of seizures or coma, she said.

Trumble, 52, who started on PN 13 months ago because of colon cancer and severe intestinal issues, said she was grateful to the hospital and gets excellent care there, but missed her mother, son, and 8-year-old grandson, Jordan — and her cats — during her 17-day hospitalization.

What’s worse, Trumble said, her mother and son, who get Medicaid payments to care for her, weren’t paid while she was away.

But without IV nutrition at home, she said, “I’d starve.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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