Science
The $8 Billion Children’s Vaccine Fund R.F.K. Jr. Would Oversee
When President Bill Clinton worked with a bipartisan Congress to enact a federal program to guarantee vaccines for poor children, they agreed that the authority over buying shots from drug makers should rest with the health secretary. The bill’s drafters did not consider that an extremely vocal critic of childhood vaccines would emerge as a nominee for the role.
That critic, Robert F. Kennedy Jr., comes before the Senate for confirmation hearings this week. If confirmed, he would have the power to limit or even cut off contracts with the makers of vaccines for more than half the nation’s children under the $8 billion dollar Vaccines for Children program.
The program has been credited with raising national vaccination rates and protects nearly 38 million low-income and working-class children from diseases like polio, measles, whooping cough and chickenpox.
Mr. Kennedy has said he would not take vaccines away from anyone, but he has a long history of questioning vaccine safety. The far-reaching authority he would wield over vaccine policy has become increasingly worrisome for public health experts, researchers and lawmakers from both parties.
Some architects of the program are trying to persuade senators to oppose his nomination.
“I think he’s dangerous to children’s health,” Donna E. Shalala, Mr. Clinton’s health secretary and a former Democratic congresswoman, said in an interview. She said she had spoken to Republican senators who expressed uneasiness about Mr. Kennedy, but would not name them.
Confirmation hearings for Mr. Kennedy will begin on Wednesday before the Senate Finance Committee, and continue on Thursday before the Senate Health, Education, Labor and Pensions Committee. The back-to-back sessions will give senators of both parties an opportunity to ask Mr. Kennedy pointed questions about how he would oversee the nation’s large health agencies and vaccine policies.
Lawmakers have already begun asking questions about what authority the health secretary would have over vaccines. At a round table on vaccine policy held by Senator Bernie Sanders, Independent of Vermont, last week, Senator Lisa Blunt Rochester, Democrat of Delaware, asked: “What are the protections and what are the ways that someone could come in and have an impact on reducing vaccines use?”
Experts told the senators that the authority included exerting power over vaccine approvals and using the prominent position possibly to raise fears or state things that are untrue.
A spokeswoman for Mr. Kennedy, Katie Miller, declined to respond directly to a question about Mr. Kennedy’s view of the children’s program.
For decades, Mr. Kennedy has sown doubts about the safety of vaccines and their ingredients. In 2021, he petitioned federal officials to revoke authorization of all coronavirus vaccines at a time when thousands of Americans were dying each week from Covid.
Mr. Kennedy has also worked for years on lawsuits claiming that Merck’s vaccine against HPV, a leading cause of cervical cancer, caused injuries. Records released in advance of the confirmation hearings also show that he plans to keep his financial stake in that vaccine litigation if he is confirmed.
His activism has made lawmakers in both parties uneasy. Several Republican senators, including Mitch McConnell of Kentucky, Lisa Murkowski of Alaska and Bill Cassidy of Louisiana, have suggested they are on the fence about how to vote.
Mr. McConnell, a polio survivor and former Republican leader, has said that anyone who engages in “efforts to undermine public confidence in proven cures” will face difficulty in getting Senate confirmation. Mr. Cassidy, a doctor and chairman of the HELP Committee, has not said how he will vote. Ms. Murkowski told CNN that she had concerns, adding, “Vaccines are important.”
The Vaccines for Children program was created in response to measles outbreaks that disproportionately affected poor children who could not afford vaccinations. It now protects against 19 diseases, according to the Centers for Disease Control and Prevention.
The law that established the program gives the health secretary power over contracts to buy millions of vaccine doses, including the authority to enter into, modify or decline the agreements. Drugmakers have delivered 71.5 billion doses to about 37,000 medical providers throughout the United States and its territories since the program’s inception.
Federal officials “control the whole means of supply and distribution,” according to Sara Rosenbaum, a professor emerita of health law and policy at George Washington University, who was asked by the Clinton administration to build the program.
“Who would have ever thought that it was a problem giving the secretary this kind of power?” she asked.
Some of the program’s defenders worry that just talking about the vaccines program might put it in jeopardy if Mr. Kennedy takes charge.
“Folks are very nervous about speaking these things out loud because they don’t want them to happen,” said Richard Hughes IV, a lawyer who represents vaccine makers and is a lecturer at George Washington University. “But these are things that could very well happen.”
Lawyers who specialize in vaccine policy pointed to other areas where the nation’s health secretary has authority over vaccines. One is the Vaccine Injury Compensation Program, which was set up in 1986 to shield vaccine makers from liability and to create a court system to compensate people harmed by vaccines.
Though Mr. Kennedy has suggested the liability shield provides incentives to vaccine makers to cut corners, he would not have authority to remove it — that lies with Congress. However, the health secretary can add injuries to a table of harms presumed to be caused by vaccines. The secretary can also add or remove vaccines from the court’s purview.
As an official above the Food and Drug Administration in the executive chain of command, the secretary could push the agency to pause or revoke the approval of established vaccines or to withhold approval from those seeking authorization.
“Those are real possibilities,” said Denise Hill, an Iowa lawyer who specializes in vaccine law. “And if you’d asked me five, 10 years ago, I would say it’s never going to happen, but now I can’t say that with any certainty.”
Ms. Hill said it would also be possible for the Trump administration to try to place conditions on the funds for the children’s vaccine program, such as dropping its mandate for students entering kindergarten to be immunized.
The secretary would also have the authority over an influential advisory panel at the C.D.C. called the Advisory Committee on Immunization Practices or A.C.I.P. The committee could be disbanded, according to Mr. Hughes. The secretary could also revisit vaccine-safety matters and reject the committee’s recommendations.
That committee tends to influence state-level policy, doctors and private insurers. But it has more direct authority over which vaccines are distributed by the children’s program. Dr. Walter Orenstein, who ran the C.D.C.’s immunization programs when the children’s program was started, said he was concerned that Mr. Kennedy could change the makeup of the committee.
“There is the potential that they could really put into the A.C.I.P. a substantial number of anti-vaccine people, and that would then have some potentially negative effects, in terms of changing current recommendations,” Dr. Orenstein said. “It could mean vaccines wouldn’t be provided through the Vaccines for Children program.”
Ms. Rosenbaum, who helped create the system, said Medicaid covered vaccines and the cost of administering them decades ago. But even so, many doctors did not want to go to the trouble to pay in advance to keep vaccines stocked in their offices.
Ms. Rosenbaum said the system they built was revolutionary in that it empowered the health secretary to negotiate prices with vaccine makers and have the doses shipped directly to thousands of providers.
The program has been expanded to cover working class families above the Medicaid income limits who rely on CHIP, or the Children’s Health Insurance Program. Those programs cover about 38 million infants, children and adolescents, including those who rely on Native American health systems.
Thirty years on, Ms. Rosenbaum said, as Mr. Kennedy faces confirmation, people familiar with the program have assumed it may be a target if he is confirmed. “People haven’t reacted with alarm for no reason,” she said.
Science
Infant formula recalled after California baby sickened with botulism
Nara Organics recalled its whole milk baby formula after a California child and two others were sickened by potentially fatal infant botulism, federal officials said.
Parents should immediately stop giving the formula to their children, said officials from the U.S. Centers for Disease Control and Prevention. Unopened cans should be returned or thrown away.
All three infants, who ranged in age from 2 to 5 months, were hospitalized and given a drug to treat infant botulism, officials said. No deaths have been reported.
Parents should quickly seek medical care for an infant who has difficulty swallowing, poor feeding, loss of head control or decreased facial expression, the CDC said. Other symptoms include constipation, drooping eyelids, sluggish pupils and a weak cry.
Because symptoms of infant botulism can take several weeks to begin, officials said, parents of children who have consumed the formula should monitor their child for signs for a month after the product was last consumed.
Nara Organics formula is sold online and at Target stores. The two other infants who were hospitalized were from Pennsylvania and Washington.
The New York company said in a statement that so far its product had not tested positive for the bacterium Clostridium botulinum. Nevertheless, the company said, it decided to recall all products currently on the market.
“We sincerely apologize for the concern and distress this announcement causes our customers,” the company said. “We are committed to leading with transparency and accountability throughout this process as we work to identify further information.”
Consumers can find refund information on the company’s website at nara.com.
Infant botulism happens when swallowed spores from the bacterium infect a baby’s large intestine and make a toxin in it. If not treated, the child can experience a progressive paralysis that can lead to breathing difficulties and require weeks of hospitalization.
Last year, another manufacturer recalled its product — ByHeart Whole Nutrition Infant Formula — after an outbreak of infant botulism sickened dozens of babies across the country.
Science
What COVID is teaching doctors about the relationship between viruses and cancer
In early 2022, around the time the Omicron variant started driving a new surge in COVID-19 cases, researchers at James DeGregori’s University of Colorado Anschutz lab noticed something unusual: When lab mice with dormant breast cancer cells were infected with either influenza or SARS-CoV-2, the animals were significantly more likely to develop aggressive lung tumors.
What’s true for a mouse isn’t always true for a human. But when the team examined healthcare databases, they were surprised to find that something similar appeared to be going on in the human population.
Analysis of records from the U.K. Biobank showed that cancer survivors who contracted COVID in 2020 — when the virus was new and no vaccine was available — were significantly more likely to die of recurring cancer than patients who didn’t get the virus, particularly within the year after their COVID infection.
Analysis of a separate U.S. breast cancer database found that breast cancer patients in remission who got COVID were significantly more likely to develop metastatic lung tumors than patients who did not contract the virus.
The University of Colorado researchers couldn’t analyze influenza’s effects as thoroughly — most flu infections don’t make it into medical charts, as patients often ride out routine cases at home. They also weren’t able to take into account whether the severity of a patient’s COVID infection influenced the likelihood of a cancer recurrence. But COVID’s novelty gave the team the data it needed to track the effects of viral inflammation on cancer recurrence. Their results were published last year in the journal Nature.
“When [cancer] comes back, it comes back with a fury,” DeGregori said. “We think that these virus infections can be almost like fuel for the fire.”
Unwelcome as COVID’s emergence was, the sheer scale of its spread has vastly deepened science’s understanding of the ways that viruses can continue to affect a human body long after the initial illness has passed.
Scientists need a critical mass of data to be able to identify statistically significant patterns. In the case of a global pandemic “where the whole population gets infected, basically you have a denominator of 7 billion people,” said Dr. Stanley Perlman, a University of Iowa microbiologist who studies coronaviruses.
The rapid increase in patients suffering from long COVID supercharged research on post-viral syndromes — the complex collection of lingering symptoms doctors have long observed in some patients infected with pneumonia, flu or other viruses.
Now, as more years of post-pandemic data have accumulated, scientists are also able to look more closely at the complicated relationship between COVID and cancer, a disease that takes significantly longer to make itself known.
“This is something that merits more attention,” said Dr. Aditya Bardia, director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center. Bardia’s lab has also observed associations between COVID infection and breast cancer recurrence; that research has not yet been submitted for peer review.
There isn’t sufficient evidence to indicate that COVID is an oncogenic, or cancer-causing, virus, a half-dozen researchers contacted for this article said. The virus has some significant structural differences from known oncogenic viruses such as human papilloma virus, which is linked to cervical cancer, and hepatitis B and C, which are associated with liver cancer.
But the pandemic has left some evidence that viral infection may play a role in reawakening dormant cancer cells present in a patient’s body before infection.
“COVID and influenza do not cause cancer under themselves, but if you have cancer and you have dormant cancer cells that are normally under control by your immune system, getting a severe case of COVID can help reactivate those existing cancers,” said Dr. Patrick Moore, a virologist and epidemiologist at the University of Pittsburgh.
A sharp increase in metastatic breast cancer cases in the pandemic’s early years was largely attributed to care delayed by pandemic restrictions, rather than a real increase in incidence.
More recent work suggests that “it’s not just the logistics of the pandemic, but it’s really something inherent to infection” behind the association with cancer recurrence, said Melanie Ott, director of the Gladstone Institute of Virology and a professor of medicine at UC San Francisco.
The effect isn’t specific to COVID, as DeGregori’s Nature paper shows, Ott pointed out. One of the body’s natural defense mechanisms against a virus like COVID or influenza is the release of cytokines, proteins that act as chemical messengers helping to coordinate the immune system’s response.
But in some cases of severe infection, the immune system can overcorrect and send out an excess amount of these proteins, a serious and potentially fatal reaction called a cytokine storm.
Research in the early months of the pandemic showed that patients with severe COVID who died or required hospitalization were much more likely to have runaway levels of cytokines, including a particular protein called interleukin-6, or IL-6.
Chronically high IL-6 levels have also been linked to recurrence and metastasis of multiple types of cancer.
DeGregori’s team found that breast cancer cells in mice whose dormant cancers returned after a COVID infection reactivated in response to high levels of IL-6. Their research couldn’t prove that the same biological process happens in humans, DeGregori said. But the fact that a review of real-life patient data showed a high correlation between COVID infection and cancer recurrence makes him think they are on to something.
It’s not a settled question, even among the paper’s authors. Dr. Doug Wallace, director of the Center for Mitochondrial and Epigenomic Medicine at Children’s Hospital of Philadelphia and a co-author on the Nature paper, said he has a “slightly different interpretation” of the data.
IL-6 also inhibits mitochondria, the parts of a cell that generate energy. Wallace thinks that this suppression of the cells’ powerhouses is actually what’s encouraging cancer growth. (Mitochondrial dysfunction is also a prime suspect in the cause of long COVID.)
Other viruses shut down mitochondrial function too, Wallace said. SARS-CoV-2 seems to be particularly good at it, which could be the reason an infection leads to the lingering misery of long COVID in some people or an unexpected recurrence of cancer in others.
Researchers stressed that this area of study is still in its early days, and there is no definitive causal link between COVID infection and cancer recurrence.
“It’s fair to say that [COVID infection] could be added to the long list of theoretical reasons that cancer might be more likely to come back, [but] I’m on the skeptical side of all things. Prove it to me,” said Dr. Eric Winer, director of the Yale Cancer Center. “This is one where I’d say, interesting finding, let’s look more.”
The evidence to date suggests simply that the question is worthy of more study, researchers said. If there is any action people with vulnerable immune systems should take as a result, it’s to continue reasonable precautions against viral infections of all kinds.
“There’s a very, very, very compelling reason for those patients who have chronic diseases to avoid getting a severe case of influenza or COVID or respiratory syncytial [virus] — all of these diseases for which good, safe, effective vaccines exist,” Moore said.
Science
Oliver Tree, musician and Santa Cruz native, dies in helicopter crash
Oliver Tree, a genre-defying singer-songwriter and Santa Cruz native, was one of six people killed when two helicopters collided Sunday morning in Brazil, according to the Associated Press. He was 32.
Tree, a quirky artist known for his highly theatrical music videos and crisp bowl cut, had been traveling through South America as a part of his world tour. CNN Brazil reported Argentinian YouTuber Gaspar Prim, also known as Gaspi, was among those killed in the crash.
The mid-air collision occurred in Rio de Janeiro, with one of the helicopters landing in the parking lot of a car dealership, the AP reports. Local authorities have launched an investigation into the cause of the crash.
Tree, born Oliver Tree Nickell, broke out in the electronic music world first performing as, simply, Tree. He released an e.p., “Demons,” in 2013, which included a cover of Radiohead’s “Karma Police” that caught the ear of Thom Yorke. He later attended CalArts north of Los Angeles, and signed to Atlantic Records for his major-label debut e.p. “Alien Boy” in 2018.
To find his distinct look, he told the Santa Cruz Sentinel that “I was making a statement with it. Everybody’s trying to look so beautiful and sexy nowadays. It was my way of rebelling against that. So, I tried to make myself look as silly and ridiculous as possible.”
Tree was an instant hit on the festival circuit for his outlandish stage productions and outsider charisma, performing at Lollapalooza, Coachella and Outside Lands. He collaborated with Skrillex, David Guetta and Zeds Dead, and was fiercely protective of his meticulously weird visual identity and video concepts, telling Rolling Stone that “That’s kind of my signature. The people who do f- with me know me because of my videos..Music is my day job but my real dream is to be making feature films.
He released his major label debut LP, “Ugly Is Beautiful,” in 2020. His hit song “Life Goes On” and collaboration “Miss You” with German DJ Robin Schulz earned him international recognition and climbed onto the Billboard Hot 100. He released four full length albums as Oliver Tree, most recently April’s independent LP “Love You Madly Hate You Badly.”
Tree had performed in Buenos Aires on June 4.
From July to October, he had shows scheduled throughout Europe, Australia and China. This year, he performed at the Coachella Valley Music and Arts Festival this year as a special guest of electronic producer Subtronics. In one of his last social media posts, he made a point to spotlight an upcoming show on Aug. 9 in his hometown at the Quarry Amphitheater at UC Santa Cruz.
“I can’t believe Oliver is gone,” Schulz posted on Instagram. “You were such a lovely soul and a one of a kind character. Working with you on ‘Miss You’ was an honor. My deepest condolences to his family, friends and everyone who loved him.”
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