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Bird Flu Tests Are Hard To Get. So How Will We Know When To Sound the Pandemic Alarm?

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Amy Maxmen and Arthur Allen
Tue, 11 Jun 2024 09:00:00 +0000

Stanford University infectious disease doctor Abraar Karan has seen a lot of patients with runny noses, fevers, and irritated eyes lately. Such symptoms could signal allergies, covid, or a cold. This year, there's another suspect, bird flu — but there's no way for most doctors to know.

If the government doesn't prepare to ramp up H5N1 bird flu testing, he and other researchers warn, the United States could be caught off guard again by a pandemic.

“We're making the same mistakes today that we made with covid,” Deborah Birx, who served as former President Donald Trump's coronavirus response coordinator, said June 4 on CNN.

To become a pandemic, the H5N1 bird flu virus would need to spread from person to person. The best way to keep tabs on that possibility is by testing people.

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Scientifically speaking, many diagnostic laboratories could detect the virus. However, red tape, billing issues, and minimal investment are barriers to quickly ramping up widespread availability of testing. At the moment, the Food and Drug Administration has authorized only the Centers for Disease Control and Prevention's bird flu test, which is used only for people who work closely with livestock.

State and federal authorities have detected bird flu in dairy cattle in 12 states. Three people who work on separate dairy farms tested positive, and it is presumed they caught the virus from cows. Yet researchers agree that number is an undercount given the CDC has tested only about 40 people for the disease.

“It's important to know if this is contained on farms, but we have no information because we aren't looking,” said Helen Chu, an infectious disease specialist at the University of Washington in Seattle who alerted the country to covid's spread in 2020 by testing people more broadly.

Reports of untested sick farmworkers — as well as a maternity worker who had flu symptoms — in the areas with H5N1 outbreaks among cattle in Texas suggest the numbers are higher. And the mild symptoms of those who tested positive — a cough and eye inflammation, without a fever — are such that infected people might not bother seeking medical care and, therefore, wouldn't be tested.

The CDC has asked farmworkers with flu symptoms to get tested, but researchers are concerned about a lack of outreach and incentives to encourage testing among people with limited job security and access to care. Further, by testing only on dairy farms, the agency likely would miss evidence of wider spread.

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“It's hard to not compare this to covid, where early on we only tested people who had traveled,” said Benjamin Pinsky, medical director of the clinical virology laboratory at Stanford University. “That left us open to not immediately recognizing that it was transmitting among the community.”

In the early months of covid, the rollout of testing in the United States was catastrophically slow. Although the World Health Organization had validated a test and other groups had developed their own using basic molecular biology techniques, the CDC at first insisted on creating and relying on its own test. Adding to delays, the first version it shipped to state health labs didn't work.

The FDA lagged, too. It didn't authorize tests from diagnostic laboratories outside of the CDC until late February 2020.

On Feb. 27, 2020, Chu's research lab detected covid in a teenager who didn't meet the CDC's narrow testing criteria. This case sounded an alarm that covid had spread below the radar. Scaling up to meet demand took time: Months passed before anyone who needed a covid test could get one.

Chu notes this isn't 2020 — not by a long shot. Hospitals aren't overflowing with bird flu patients. Also, the country has the tools to do much better this time around, she said, if there's political will.

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For starters, tests that detect the broad category of influenzas that H5N1 belongs to, called influenza A, are FDA-approved and ubiquitous. These are routinely run in the “flu season,” from November to February. An unusual number of positives from these garden-variety flu tests this spring and summer could alert researchers that something is awry.

Doctors, however, are unlikely to request influenza A tests for patients with respiratory symptoms outside of flu season, in part because health insurers may not cover them except in limited circumstances, said Alex Greninger, assistant director of the clinical virology laboratory at the University of Washington.

That's a solvable problem, he added. At the peak of the covid pandemic, the government overcame billing issues by mandating that insurance companies cover tests, and set a lucrative price to make it worthwhile for manufacturers. “You ran into a testing booth on every other block in Manhattan because companies got $100 every time they stuck a swab in someone's nose,” Greninger said.

Another obstacle is that the FDA has yet to allow companies to run their influenza A tests using eye swabs, although the CDC and public health labs are permitted to do so. Notably, the bird flu virus was detected only in an eye swab from one farmworker infected this year — and not in samples drawn from the nose or throat.

Overcoming such barriers is essential, Chu said, to ramp up influenza A testing in regions with livestock. “The biggest bang for the buck is making sure that these tests are routine at clinics that serve farmworker communities,” she said, and suggested pop-up testing at state fairs, too.

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In the meantime, novel tests that detect the H5N1 virus, specifically, could be brought up to speed. The CDC's current test isn't very sensitive or simple to use, researchers said.

Stanford, the University of Washington, the Mayo Clinic, and other diagnostic laboratories that serve hospital systems have developed alternatives to detecting the virus circulating now. However, their reach is limited, and researchers stress a need to jump-start additional capacity for testing before a crisis is underway.

“How can we make sure that if this becomes a public health emergency we aren't stuck in the early days of covid, where things couldn't move quickly?” Pinsky said.

A recent rule that gives the FDA more oversight of lab-developed tests may bog down authorization. In a statement to KFF Health , the FDA said that, for now, it may allow tests to proceed without a full approval process. The CDC did not respond to requests for comment.

But the American Clinical Laboratory Association has asked the FDA and the CDC for clarity on the new rule. “It's slowing things down because it's adding to the confusion about what is allowable,” said Susan Van Meter, president of the diagnostic laboratory trade group.

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Labcorp, Quest Diagnostics, and other major testing companies are in the best position to manage a surge in testing demand because they can process hundreds per day, rather than dozens. But that would require adapting testing processes for their specialized equipment, a process that consumes time and money, said Matthew Binnicker, director of clinical virology at the Mayo Clinic.

“There's only been a handful of H5N1 cases in humans the last few years,” he said, “so it's hard for them to invest millions when we don't know the future.”

The government could provide funding to underwrite its research, or commit to buying tests in bulk, much as Operation Warp Speed did to advance covid vaccine development.

“If we need to move to scale this, there would need to be an infusion of money,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories. Like an insurance policy, the upfront expense would be slight compared with the economic blow of another pandemic.

Other means of tracking the H5N1 virus are critical, too. Detecting antibodies against the bird flu in farmworkers would help reveal whether more people have been infected and recovered. And analyzing wastewater for the virus could indicate an uptick in infections in people, birds, or cattle.

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As with all pandemic preparedness efforts, the difficulty lies in stressing the need to act before a crisis strikes, Greninger said.

“We should absolutely get prepared,” he said, “but until the government insures some of the risk here, it's hard to make a move in that direction.”

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By: Amy Maxmen and Arthur Allen
Title: Bird Flu Tests Are Hard To Get. So How Will We Know When To Sound the Pandemic Alarm?
Sourced From: kffhealthnews.org/news/article/bird-flu-tests-pandemic-possibility-preparedness/
Published Date: Tue, 11 Jun 2024 09:00:00 +0000

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Harris, Once Biden’s Voice on Abortion, Would Take an Outspoken Approach to Health

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Stephanie Armour and Julie Appleby, KFF and Julie Rovner, KFF
Sun, 21 Jul 2024 21:30:00 +0000

Throughout Joe Biden's presidency, he leaned on the outspoken former prosecutor and senator he selected as his vice president, Kamala Harris, to be the White House's voice of unflinching support for reproductive health rights.

Now, as Democrats rebuild their presidential ticket just a few months before Election Day, Harris would widely be expected to take an aggressive stance in support of abortion access if she became the party's new presumptive nominee — hitting former President Donald Trump on an issue that could undermine his chances of victory. Biden endorsed Harris on Sunday when he announced his decision to leave the race.

While Biden sought to keep abortion center stage in his reelection bid, abortion advocates had harbored doubts that the president — a practicing Catholic who has said he is not “big on abortion” — could be an effective standard-bearer as Republican efforts erode access to abortion and other women's health care around the country.

Harris, on the other hand, became the first vice president to visit a clinic run by the Planned Parenthood Federation of America. She undertook a nationwide tour focused on reproductive rights. And when Sen. JD Vance of Ohio was named Trump's running mate, Harris used her next campaign appearance to criticize him for blocking protections for in vitro fertilization.

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“Most significantly, Harris would be the face of the drive to protect abortion rights,” Larry Levitt, executive vice president for health policy at KFF, a health information nonprofit that includes KFF Health News, said in an interview before Biden stepped aside. “Abortion access would likely be front and center in her campaign.”

A strong stance on abortion is not the only major contrast to the GOP that Harris offers: She is well versed in health policy. As a child, Harris often accompanied her mother to work on the weekends, visiting the lab where she was studying breast cancer.

While running for president in 2019, she backed “Medicare for All,” a single-payer insurance proposal that established her bona fides as a more progressive voice on health policy. And as California's attorney general, she fought against consolidation in the health industry over concerns it would drive up prices. 

She stumped for a Biden administration rule setting minimum staffing levels at federally funded nursing homes in April.

“She deserves credit, she's talked about them on the campaign trail. I don't see any change there in the priorities on what Democrats want to do on health care if she becomes the nominee,” said Debbie Curtis, vice president at McDermott + Consulting. 

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An intensified focus on women's health and abortion could help galvanize Democratic voters in the final sprint to the election. Since the three Supreme Court justices named by Trump helped overturn Roe v. Wade in 2022, public opinion has turned against Republicans on abortion, even contributing to an unexpectedly poor showing in the 2022 midterm elections.

Thirty-two percent of voters said they would vote only for a candidate for a major office who shares their views on abortion, according to a Gallup Poll conducted in May. That's a record high since Gallup first asked the question in 1992. Nearly twice as many voters who support abortion, compared with those who oppose abortion, hold that view. 

Sixty-three percent of adults said abortion should be legal in all or most cases, based on a poll conducted in April by Pew Research Center. Thirty-six percent said it should be illegal in all or most cases.

Republicans, in turn, have been eager to distance themselves from their own victory on the issue. Trump angered some members of his base by saying he would leave decisions on abortion to the states.

Regardless, advocates caution that the GOP's new moderation-by-omission on the issue masks their actual, more extreme stance. Vance has been clear in the past about his support for a national abortion ban. And while the GOP platform adopted during the party's convention last week may not explicitly call for a nationwide ban on abortion, party leaders' recognition of “fetal personhood,” the idea that as soon as an egg is fertilized it becomes a person with full legal rights, would create such a ban automatically if the Supreme Court found it constitutional.

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Those views stand in contrast to those of many Republicans, especially women. About half of Republican women voters think abortion should be legal in all or most cases, according to a recent national survey by KFF. And majorities of women who vote Republican believe abortion should be legal in cases of rape, incest, or a pregnancy emergency.

If Harris heads the ticket, she would be expected to hammer on those issues in the coming months. 

“It's been one of if not the main issue she's emphasized in the last year or two,” said Matthew Baum, Marvin Kalb professor of global communications at Harvard University. “Clearly the Republicans are trying to defang the issue. It's been a disaster for them.”

It is likely, though, that Republicans would paint Harris' views on abortion as extremist. During the presidential debate against Biden, Trump falsely claimed Democrats support abortions late in pregnancy, “even after birth.”

Shortly after news broke that Biden had endorsed Harris, Susan B. Anthony Pro-Life America issued a statement calling out Harris' record and offering evidence of what is to come. “While Joe Biden has trouble saying the word abortion, Kamala Harris shouts it,” said Marjorie Dannenfelser, the group's president.

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Some pollsters have said Harris would have to do more than just campaign against Republican efforts to roll back abortion access to truly motivate voters because so many issues, such as inflation, the economy, and immigration, are competing for attention.

“She has to say she is running for a federal law that will bring back Roe v. Wade,” said Robert Blendon, an emeritus public health professor at Harvard University. “She needs something very specific and clear.”

Harris' elevation to the top of the ticket would come at a critical juncture in the fight over reproductive rights.

The Supreme Court heard two abortion cases in the term that ended this month. But the justices did not address the merits of the issues in either case, ruling instead on technicalities. Both are expected to return to the high court as soon as next year.

In one case, challenging the FDA's 2000 approval of the abortion pill mifepristone, the justices ruled that the group of anti-abortion medical professionals who challenged the drug lacked standing to sue because they failed to show they were personally injured by its availability. 

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But the Supreme Court returned the case to the district court in Texas where it was filed, and the GOP attorneys general of three states — Idaho, Kansas, and Missouri — have joined the case as plaintiffs. Whether the courts accept the states as viable challengers remains to be seen, but if they do, the justices could soon be asked again to determine the fate of the abortion pill.  

The other abortion-related case pitted a federal law requiring hospitals to provide emergency care against Idaho's strict ban, which allows abortions when a pregnant patient's life is in danger — but not in cases in which it is necessary to protect her health, including future fertility.

In that case, the justices apparently failed to reach any majority agreement, declaring instead that they were premature in accepting the case and sending it back to the lower court for further consideration. That case, too, could return in relatively short order.

Harris would also have substantial leeway to talk about what are considered to be the Biden administration's core health policy accomplishments. These include enhanced Affordable Care Act tax credits aimed at helping consumers get health insurance coverage, which were extended through the Inflation Reduction Act into 2025, the $35 monthly cap on copays some patients pay for insulin, and drug price negotiation in Medicare.

“I think she is well positioned. She is core to the administration and will be able to take credit for those things,” said Dan Mendelson, CEO of Morgan Health, a subsidiary of J.P. Morgan Chase.

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That said, it may be hard for any candidate to get voters to focus on some of those accomplishments, especially drug price efforts.

While the administration has taken some important steps, “new expensive drugs keep coming out,” Mendelson said. “So if you look at the perception of consumers, they do not believe the cost of drugs is going down.”

Joseph Antos, of the American Enterprise Institute, said Harris would likely say the Biden-Harris administration “is already saving people money” on insulin. But she will have to go beyond these accomplishments and double down on drug pricing and other cost issues — not talk solely about reproductive rights.

“She's got to concentrate, if she wants to win, on issues that have a broad appeal,” Antos said. “Cost is one and access to treatments is another big issue.”

Samantha Young of KFF Health News contributed to this report.

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By: Stephanie Armour and Julie Appleby, KFF Health News and Julie Rovner, KFF Health News
Title: Harris, Once Biden's Voice on Abortion, Would Take an Outspoken Approach to Health
Sourced From: kffhealthnews.org/news/article/kamala-harris-health-agenda-abortion-womens-health-2024-election/
Published Date: Sun, 21 Jul 2024 21:30:00 +0000

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Biden Administration Tightens Broker Access to Healthcare.gov To Thwart Rogue Sign-Ups

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Julie Appleby, KFF
Fri, 19 Jul 2024 20:05:54 +0000

The Biden administration on Friday put in place stringent curbs aimed at thwarting rogue insurance brokers from switching consumers' Affordable Care Act plans without their consent.

The announcement came in response to mounting complaints from consumers. The Centers for Medicare & Medicaid Services said Friday that, in the first six months of the year, more than 200,000 people reported to the agency that they were either enrolled in Obamacare plans or switched from one plan to another without their permission.

KFF Health News began reporting on Affordable Care Act enrollment schemes this spring.

CMS said insurance agents will be blocked from making changes to any Obamacare enrollments made through the federal marketplace, healthcare.gov, unless the agent is already “associated” with a consumer's policy.

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Additionally, agents who can't prove an association — which is undefined in the agency directive — will have to take additional steps to make changes even if they have a consumer's consent.

The changes are effective immediately, an unusually rapid move by the agency that may reflect the urgency of the problem. Republicans have alleged that enhanced subsidies backed by the Biden administration provide incentive for brokers or consumers to fraudulently misstate their incomes to qualify for ACA tax credits, while some Democrats have also been critical of CMS, saying the agency needs to take a tougher stand against rogue brokers who are switching people without their consent in order to gain commissions.

Consumers, meanwhile, can face higher out-of-pocket costs for medical services or unexpected tax bills if they get signed up for subsidized plans they're not eligible for.

To show they have consumers' consent for enrollment changes, CMS said, unassociated agents must do three-way calls with the healthcare.gov call center or ask their clients to make changes themselves, either through healthcare.gov or one of the private sector enrollment websites allowed to link with it.

“CMS anticipates these updates will help block unauthorized changes by agents and brokers,” the agency said in a notice posted on its website Friday afternoon.

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Ellen Montz, a deputy administrator at CMS and the director of its Center for Consumer Information and Insurance Oversight, in a written statement to KFF , said “CMS will do everything it can to protect consumers from bad actors and will assist consumers who have experienced a change that they didn't authorize.” She added that the “consumer experience” would not change for people who continue to work with agents who are already associated with their policies.

The rules drew concern as well as some cautious optimism from agents and their professional associations, which have been calling on CMS to act for months.

“On paper, it protects consumers, so that's a good thing,” said Joshua Brooker, founder of PA Health Advocates in Pennsylvania, who has followed the issue closely. But he and others said the directive raises many questions about how it will work in practice, especially during the busy open enrollment period at the end of the year.

The requirements will be a burden on consumers, predicted Ronnell Nolan, president of the agent trade group Health Agents for America.

“They will be responsible for calling the marketplace call center, which is a nightmare in itself, to change their agent,” Nolan said. “Why is it their responsibility?”

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The directive applies only to existing coverage, not brand-new ACA enrollments.

Complaints about unauthorized enrollment or plan-switching are not new but accelerated during the last open enrollment period for the ACA. President Joe Biden has boasted of record enrollment for 2024 ACA plans. More than 21 million people signed up nationally during the most recent open enrollment period.

The agency said Friday it has resolved more than 97% of the reported complaints about enrollment or switching.

For the first time, the agency also reported on enforcement action, saying that between June 21 and July 10 it had suspended 200 agents or brokers “for reasonable suspicion of fraud or abusive conduct related to unauthorized enrollments or unauthorized plan switching.”

The new rules don't apply to the 18 states, and the District of Columbia, that run their own Obamacare insurance marketplaces. Many of them use security procedures that healthcare.gov does not, including two-factor authentication.

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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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By: Julie Appleby, KFF Health News
Title: Biden Administration Tightens Broker Access to Healthcare.gov To Thwart Rogue Sign-Ups
Sourced From: kffhealthnews.org/news/article/biden-administration-aca-obamacare-rogue-agents-cms-new-rules/
Published Date: Fri, 19 Jul 2024 20:05:54 +0000

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At Trump’s GOP Convention, There’s Little To Be Heard on Health Care

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Phil Galewitz, KFF
Fri, 19 Jul 2024 13:12:10 +0000

No talk of Obamacare. Or abortion.

At the Republican National Convention in Milwaukee this week, where delegates officially nominated Donald Trump as the party's 2024 presidential candidate, care issues received little attention from prime-time speakers.

The silence is surprising, given health care makes up the largest chunk of the federal budget, nearly $2 trillion, as well as 17% of U.S. economic output.

It also stands in stark contrast to the GOP's priorities when it first nominated Trump.

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In 2016, the last time Republicans gathered en masse for a presidential convention, repealing the Affordable Care Act was a favorite topic. So was overturning Roe v. Wade and its constitutional protections for abortion.

The change in tone reflects Trump's political sensitivities. The failed attempt under the former president to repeal Obamacare in 2017 contributed to a crushing GOP defeat in the 2018 congressional elections, and the law now enjoys broad support. Abortion, too, has become a treacherous topic for Republicans since Roe was overturned in 2022, with most Americans opposed to a national ban.

In one of the only pieces of health policy in the GOP's 2024 platform, the former president vows not to cut Social Security or Medicare, the health program for older and disabled Americans, or change the federal retirement age.

In his speech accepting the nomination Thursday night, Trump promised to protect Medicare and find cures for Alzheimer's disease and cancer. But he did not outline any health care proposals for a second term. “Democrats are going to destroy Social Security and Medicare,” he said.

Health care isn't a winning subject for Republicans, said Charles Coughlin, CEO of a Phoenix public affairs firm who was a longtime GOP political operative before he became an independent in 2017.

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Speakers at the convention have instead focused on inflation, crime, and immigration. “They have the tried-and-true polling data to show those are winning issues for them, and that's where they want to keep the narrative focused,” he said.

Immigration has bled into a few health issues, including the U.S. opioid crisis and public insurance coverage. Some Republicans — including Georgia U.S. House Rep. Marjorie Taylor Greene, who addressed the convention on July 15 — have claimed an increase in people crossing the southern border has caused a surge of drug overdoses and deaths.

However, most fentanyl seized at the border with Mexico enters through legal ports of entry, according to the Cato Institute, a libertarian think tank, and most people sentenced in the U.S. for fentanyl trafficking are American citizens, according to the U.S. Sentencing Commission.

Speaking on July 17, U.S. House Rep. Monica De La Cruz of Texas claimed Democratic policies allow people who come into the country without authorization to receive government benefits, even though they are largely not eligible for federal health programs.

De La Cruz also said the Biden administration had cut Medicare Advantage for seniors. While the Biden administration this year modestly cut spending on the private plans, the federal government still spends more money per beneficiary on Medicare Advantage than for those in the traditional Medicare program.

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The paucity of convention speakers focused on health care reflects the new GOP platform, a document hewing closely to both the substance and tone of Trump's views. Along with its promise to protect Medicare, the 28-page document vows that Republicans will expand veterans' health care choices, as well as access to “new Affordable Healthcare and prescription drug options” more broadly, without elaboration.

On abortion, the party stripped from the platform its decades-old call for federal limits, including instead language suggesting the 14th Amendment prohibits abortion. The platform also says the party supports state-level elections on abortion policy and opposes “Late Term Abortion.” Only about 1% of abortions in the U.S. occur after 21 weeks of pregnancy, according to KFF, a health information nonprofit that includes KFF Health .

In contrast, the 2016 platform — a 66-page document — also called for shifting open-ended federal Medicaid funding into block grants and introducing a Medicare “premium-support model” to cap spending. It also called for limiting payouts from medical malpractice lawsuits and combating drug abuse.

The word “abortion” appears 32 times in the 2016 platform, compared with once in the 2024 document.

“The GOP is in a headlong sprint away from that issue,” Coughlin said.

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During the week of the convention, of a call between independent presidential candidate Robert F. Kennedy Jr. and Trump appeared online. In the video, Trump is heard sharing disproven claims about childhood vaccines, saying falsely that the shots can cause a baby to “change radically” and dismissing their health benefits.

As a candidate, Kennedy has repeatedly made false claims about the safety and efficacy of vaccines. Trump has long entertained vaccine skeptics. (Before Trump took the oath of office in 2017, Kennedy told reporters Trump had invited him to chair a presidential commission on vaccines, though the commission never materialized.) But as president, Trump ordered the creation of the “Operation Warp Speed” program in 2020 that helped drive development of covid-19 vaccines.

Since the start of the pandemic, however, vaccine skepticism has blossomed in the Republican Party. Just 36% of Republicans say they're confident covid vaccines are safe, and 44% of Republicans and Republican-leaning independents say parents should be able to decide not to vaccinate their children against measles, mumps, and rubella “even if that may create health risks for other children and adults,” according to KFF polling.

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By: Phil Galewitz, KFF Health News
Title: At Trump's GOP Convention, There's Little To Be Heard on Health Care
Sourced From: kffhealthnews.org/news/article/donald-trump-gop-convention-platform-health-care-abortion/
Published Date: Fri, 19 Jul 2024 13:12:10 +0000

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