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'War On Vaccines Has Begun' Under RFK Jr And Trump

'War On Vaccines Has Begun' Under RFK Jr And Trump

National Institutes of Health officials have urged scientists to remove all references to mRNA vaccine technology from their grant applications, two researchers said, in a move that signaled the agency might abandon a promising field of medical research.

The mRNA technology is under study at the NIH for prevention and treatment of infectious diseases, including flu and AIDS, and also cancer. It was deployed in the development of covid-19 vaccines credited with saving three million lives in the U.S. alone — an accomplishment President Donald Trump bragged about in his first term.

A scientist at a biomedical research center in Philadelphia wrote to a colleague, in an email reviewed by KFF Health News, that a project officer at NIH had “flagged our pending grant as having an mRNA vaccine component.”

“It’s still unclear whether mRNA vaccine grants will be canceled,” the scientist added.

NIH officials also told a senior NIH-funded vaccine scientist in New York state, who does not conduct mRNA vaccine research but described its efficacy in previous grant applications, that all references to mRNA vaccines should be scrubbed from future applications.

Scientists relayed their experiences on the condition of anonymity for fear of professional retaliation by the Trump administration.

A senior official at the National Cancer Institute confirmed that NIH acting Director Matthew Memoli sent an email across the NIH instructing that any grants, contracts, or collaborations involving mRNA vaccines be reported up the chain to Health and Human Services Secretary Robert F. Kennedy Jr.’s office and the White House.

Memoli sent a similar message ahead of the agency canceling other research, such as studies of vaccine hesitancy.

Memoli’s email on that topic bluntly stated that NIH was not interested in learning why people shun vaccines or in exploring ways to “improve vaccine interest and commitment.”

The National Cancer Institute official, who also spoke on the condition of anonymity for fear of reprisals, said that “it is reasonable to assume mRNA vaccine work is next.”

The official said a similar memo also went out regarding NIH-funded work in South Africa, which the White House has targeted over false claims that the country’s government is persecuting white people. More recently, another one went out regarding all global research collaborations, the official said.

Political conservatives in the U.S. have promulgated conspiracy theories, unsupported by scientific evidence, that the shots and their relatively new technology are dangerous. This has undermined public support for covid vaccinations and mRNA research.

“There will not be any research funded by NIH on mRNA vaccines,” the scientist in New York said in an interview. “MAGA people are convinced that these vaccines have killed and maimed tens of thousands of people. It’s not true, but they believe that.”

Meanwhile, hundreds of other vaccine-related studies are in limbo. Kawsar Talaat, a vaccine researcher at the Bloomberg School of Public Health at Johns Hopkins University, has been waiting since the fall for money needed to recruit subjects for a study of an antidiarrheal vaccine.

“NIH approved our funding,” she said, “and now we’re waiting, and we don’t know if it’s going forward or going to be killed.”

The scientist in Philadelphia signaled that he believes Kennedy, a longtime anti-vaccine activist, is responsible for the NIH’s turn against mRNA research.

“Kennedy’s war on vaccines has started,” the scientist told his colleague.

The scientist in New York said that it was “ridiculous” to remove mRNA language from the grant applications. But “if my grant is rejected for any reason,” the scientist said, “people in my lab will lose their jobs.”

“I’ve worked with some of them for 20 years,” the scientist added. “They have children and families. There is a real climate of fear in academia about this now, especially among vaccine scientists.”

“My grant does not involve a request for funds to conduct mRNA vaccine experiments,” the scientist said, “so my principal concern was to avoid word-search flags that, at minimum, would lead to delays in any funding.”

While tenured research professors at universities generally receive a salary from their institution, the staffers who work in their labs and offices are often paid through NIH grants. The 2023 Nobel Prize in physiology or medicine was given to two scientists for developing mRNA vaccines, through work that relied on pharmaceutical companies and on NIH scientists working under infectious disease specialist Anthony Fauci.

According to Sen. Bill Cassidy, a Louisiana Republican who chairs the chamber’s Health, Education, Labor and Pensions Committee, Kennedy promised during his Senate confirmation process that he would protect “the public health benefit of vaccination” and “work within the current vaccine approval and safety monitoring systems, and not establish parallel systems.”

Cassidy, a physician, had expressed reservations about confirming Kennedy to the HHS post and challenged his anti-vaccine views during a confirmation hearing. He ended up voting for him, he said, because Kennedy had agreed to work closely with Cassidy and his committee.

However, Kennedy has faced scrutiny in his first weeks in office for his handling of a large measles outbreak among mostly unvaccinated people in Texas that has led to the death of a child, the first U.S. measles death in more than a decade. A patient who tested positive for measles died in New Mexico, but the cause hasn’t been confirmed. Instead of urging vaccination against the disease, an almost surefire way to prevent infection, Kennedy has blamed malnourishment for the outbreak, promoted unproven treatments for measles, and falsely claimed in one Fox News interview that the vaccine is ineffective and even dangerous.

Cassidy did not respond to a request for comment on the NIH’s potential abandonment of mRNA vaccine research.

As part of the Trump administration’s push to examine spending on mRNA vaccines, health officials are reviewing a $590 million contract for bird flu shots that the Biden administration awarded to Moderna, Bloomberg News has reported. Legislation introduced by GOP lawmakers in at least seven states is aimed at banning or limiting mRNA vaccines. In some cases, the measures would hit doctors who give the injections with criminal penalties, fines, and the possible revocation of their licenses.

Stephanie Armour and Céline Gounder contributed to this article.

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.

Reprinted with permission from Alternet

Patients See Drug Savings From Biden Law -- As Pharma Prepares To Sue

Patients See Drug Savings From Biden Law -- As Pharma Prepares To Sue

Last year alone, David Mitchell paid $16,525 for 12 little bottles of Pomalyst, one of the pricey medications that treat his multiple myeloma, a blood cancer he was diagnosed with in 2010.

The drugs have kept his cancer at bay. But their rapidly increasing costs so infuriated Mitchell that he was inspired to create an advocacy movement.

Patients for Affordable Drugs, which he founded in 2016, was instrumental in getting drug price reforms into the 2022 Inflation Reduction Act. Those changes are kicking in now, and Mitchell, 73, is an early beneficiary.

In January, he plunked down $3,308 for a Pomalyst refill “and that’s it,” he said. Under the law, he has no further responsibility for his drug costs this year — a savings of more than $13,000.

The law caps out-of-pocket spending on brand-name drugs for Medicare beneficiaries at about $3,500 in 2024. The patient cap for all drugs drops to $2,000 next year.

“From a selfish perspective, I feel great about it,” he said. But the payment cap will be “truly life-changing” for hundreds of thousands of other Medicare patients, Mitchell said.

President Joe Biden’s battle against high drug prices is mostly embodied in the IRA, as the law is known — a grab bag of measures intended to give Medicare patients immediate relief and, in the long term, to impose government controls on what pharmaceutical companies charge for their products. The law represents the most significant overhaul for the U.S. drug marketplace in decades.

With Election Day on the horizon, the president is trying to make sure voters know who was responsible. This month, the White House began a campaign to get the word out to seniors.

“The days where Americans pay two to three times what they pay for prescription drugs in other countries are ending,” Biden said in a February 1 statement.

KFF polling indicates Biden has work to do. Just a quarter of adults were aware that the IRA includes provisions on drug prices in July, nearly a year after the president signed it. He isn’t helped by the name of the law, the “Inflation Reduction Act,” which says nothing about health care or drug costs.

Biden’s own estimate of drug price inflation is quite conservative: U.S. patients sometimes pay more than 10 times as much for their drugs compared with people in other countries. The popular weight loss drug Wegovy lists for $936 a month in the U.S., for example — and $83 in France.

Additional sections of the law provide free vaccines and $35-a-month insulin and federal subsidies to patients earning up to 150% of the federal poverty level, and require drugmakers to pay the government rebates for medicines whose prices rise faster than inflation. But the most controversial provision enables Medicare to negotiate prices for certain expensive drugs that have been on the market for at least nine years. It’s key to Biden’s attempt to weaken the drug industry’s grip.

Responding to Pressure

The impact of Medicare’s bargaining over drug prices for privately insured Americans remains unclear. States have taken additional steps, such as cutting copays for insulin for the privately insured.

However, insurers are increasing premiums in response to their higher costs under the IRA. Monthly premiums on traditional Medicare drug plans jumped to $48 from $40 this year, on average.

On Feb. 1, the Centers for Medicare & Medicaid Services sent pharmaceutical makers opening bids for the first 10 expensive drugs it selected for negotiation. The companies are responding to the bids — while filing nine lawsuits that aim to kill the negotiations altogether, arguing that limiting their profits will strangle the pipeline of lifesaving drugs. A federal court in Texas dismissed one of the suits on Feb. 12, without taking up the substantive legal issue over constitutionality.

The nonpartisan Congressional Budget Office predicted the IRA’s drug pricing elements would save the federal government $237 billion over 10 years while reducing the number of drugs coming to market in that period by about two.

If the government prevails in the courts, new prices for those 10 drugs will be announced by September and take effect in 2026. The government will negotiate an additional 15 drugs for 2027, another 15 for 2028, and 20 more each year thereafter. CMS has been mum about the size of its offers, but AstraZeneca CEO Pascal Soriot on Feb. 8 called the opening bid for his company’s drug Farxiga (which earned $2.8 billion in U.S. sales in fiscal year 2023) “relatively encouraging.”

Related Biden administration efforts, as well as legislation with bipartisan support, could complement the Inflation Reduction Act’s swing at drug prices.

The House and Senate have passed bills that require greater transparency and less self-serving behavior by pharmacy benefit managers, the secretive intermediaries that decide which drugs go on patients’ formularies, the lists detailing which prescriptions are available to health plan enrollees. The Federal Trade Commission is investigating anti-competitive action by leading PBMs, as well as drug company patenting tricks that slow the entry of cheaper drugs to the market.

‘Sending a Message’

Months after drug companies began suing to stop price negotiations, the Biden administration released a framework describing when it could “march in” and essentially seize drugs created through research funded by the National Institutes of Health if they are unreasonably priced.

The timing of the march-in announcement “suggests that it’s about sending a message” to the drug industry, said Robin Feldman, who leads the Center for Innovation at the University of California Law-San Francisco. And so, in a way, does the Inflation Reduction Act itself, she said.

“I have always thought that the IRA would reverberate well beyond the unlucky 10 and others that get pulled into the net later,” Feldman said. “Companies are likely to try to moderate their behavior to stay out of negotiations. I think of all the things going on as attempts to corral the market into more reasonable pathways.”

The IRA issues did not appear to be top of mind to most executives and investors as they gathered to make deals at the annual J.P. Morgan Healthcare Conference in San Francisco last month.

“I think the industry is navigating its way beyond this,” said Matthew Price, chief operating officer of Promontory Therapeutics, a cancer drug startup, in an interview there. The drugs up for negotiation “look to be assets that were already nearing the end of their patent life. So maybe the impact on revenues is less than feared. There’s alarm around this, but it was probably inevitable that a negotiation mechanism of some kind would have to come in.”

Investors generally appear sanguine about the impact of the law. A recent S&P Global report suggests “healthy revenue growth through 2027” for the pharmaceutical industry.

Back in Washington, many of the changes await action by the courts and Congress and could be shelved depending on the results of the fall election.

The restructuring of Medicare Part D, which covers most retail prescription drugs, is already lowering costs for many Medicare patients who spent more than $3,500 a year on their Part D drugs. In 2020 that was about 1.3 million patients, 200,000 of whom spent $5,000 or more out-of-pocket, according to KFF research.

“That’s real savings,” said Tricia Neuman, executive director of KFF’s Medicare policy program, “and it’s targeted to people who are really sick.”

Although the drug industry is spending millions to fight the IRA, the Part D portion of the bill could end up boosting their sales. While it forces the industry to further discount the highest-grossing drugs, the bill makes it easier for Medicare patients to pick up their medicines because they’ll be able to afford them, said Stacie Dusetzina, a Vanderbilt University School of Medicine researcher. She was the lead author of a 2022 study showing that cancer patients who didn’t get income subsidies were about half as likely to fill prescriptions.

States and foundations that help patients pay for their drugs will save money, enabling them to procure more drugs for more patients, said Gina Upchurch, the executive director of Senior PharmAssist, a Durham, North Carolina-based drug assistance program, and a member of the Medicare Payment Advisory Commission. “This is good news for the drug companies,” she said.

Relief for Patients

Lynn Scarfuto, 73, a retired nurse who lives on a fixed income in upstate New York, spent $1,157 for drugs last year, while most of her share of the $205,000 annual cost for the leukemia drug Imbruvica was paid by a charity, the Patient Access Network Foundation. This year, through the IRA, she’ll pay nothing because the foundation’s first monthly Imbruvica payment covered her entire responsibility. Imbruvica, marketed jointly by AbbVie and Janssen, a subsidiary of Johnson & Johnson, is one of the 10 drugs subject to Medicare negotiations.

“For Medicare patients, the Inflation Reduction Act is a great, wonderful thing,” Scarfuto said. “I hope the negotiation continues as they have promised, adding more drugs every year.”

Mitchell, a PR specialist who had worked with such clients as the Campaign for Tobacco-Free Kids and pharmaceutical giant J&J, went to an emergency room with severe back pain in November 2010 and discovered he had a cancer that had broken a vertebra and five ribs and left holes in his pelvis, skull, and forearm bones. He responded well to surgery and treatment but was shocked at the price of his drugs.

His Patients for Affordable Drugs group has become a powerful voice in Washington, engaging tens of thousands of patients, including Scarfuto, to tell their stories and lobby legislatures. The work is supported in part by millions in grants from Arnold Ventures, a philanthropy that has supported health care policies like lower drug prices, access to contraception, and solutions to the opioid epidemic.

“What got the IRA over the finish line in part was angry people who said we want something done with this,” Mitchell said. “Our patients gave voice to that.”

Arnold Ventures has provided funding for KFF Health News.

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.


Reprinted with permission from Alternet.