Latest news with #RobertFKennedyJr
SBS Australia
6 hours ago
- Health
- SBS Australia
Former CDC staffers ring alarm bells over decisions of new US vaccine panel
Every week for a number of weeks, current and former employees of the US Centres for Disease Control and Prevention have been blowing whistles and banging drums at a street intersection near the group's headquarters in Atlanta, Georgia. They're protesting changes to the US Department of Health now led by Robert F Kennedy Jr, saying that he has brought his long history of vaccine scepticism into his role as the nation's top health official. Among the demonstrators is infectious diseases physician Peter Cegielski. "There have been rallies here every Tuesday maybe since March... The public needs to mobilise because, I mean, there's a clown show running this country and DHHS." The CDC protesters' appearance on the Atlanta corner this week was timed to coincide with the first meeting of the reconstituted US panel known as ACIP or the Advisory Committee on Immunisation Practices. Kennedy abruptly fired all 17 previous members earlier this month after accusing them without evidence of conflicts of interest, replacing them with seven handpicked others. Among them is new Committee chair Dr Martin Kulldorff, a biostatistician and epidemiologist who publicly criticised COVID-19 lockdowns and was fired from Harvard for refusing to take a COVID vaccine. Dr Kulldorff was one of five members at the meeting to vote for a recommendation that people aged 6 months and older get a flu vaccination only using a single dose formula which is thimerosal-free. "Even if the amount available in the vaccine, maybe that amount is safe - but does not amount for exposed to be exposed to mercury from other sources. So it's cumulative and there is a need. And if we care about public health we should try to minimise exposure to mercury." The reason why that's important is because the panel's recommendations influence the official US immunisation schedule, determine insurance coverage for vaccines, and act as an encouragement for people to get vaccinated. Thimerosal is widely used in lower income countries because they are more likely to use lower cost multidose containers that must be punctured repeatedly, raising the risk of contamination which thimerosal helps to prevent. But the preservative has also been at the centre of controversies and myths about vaccines for decades, with Robert F Kennedy involved in some of that debate. In 2014, when Kennedy was an environmental lawyer, he appeared on Fox 5 New York to promote a book he had published called 'Thimerosal' that alleged evidence had been covered up showing it could cause brain problems, including autism. "You know I've had all six of my children vaccinated. I want to see everybody taking their vaccines. We need full coverage. People don't take them (vaccines) because they no longer believe in the CDC. They can see the science." The CDC says it conducted nine separate studies since 2003 that found no link between thimerosal-containing vaccines and ASD or Autism Spectrum Disorder, and that multiple scientific studies have found no evidence of a link either. The CDC was not given an opportunity to present evidence before the committee's vote - but Lyn Redwood, the former president of what is now known as Children's Health Defense, an antivaccine group founded by Secretary Kennedy - did air her concerns about thimerosal. "Thimerosal is recognised as a developmental and reproductive toxicant, and is listed as a chemical in the California Proposition 65 list since 1990." Secretary Kennedy has maintained he has always just asked questions that are justifiable and necessary, arguing that the public's trust in vaccines has waned because those questions have not been answered satisfactorily. "We're living now in a time of upheaval, a time of popular revolt against established institutions that have lost the public trust - and that includes medicine. President Trump and I are committed to earning it back." But at least two CDC staff members have left over the changes, and major medical experts and former members of the panel have also expressed concern over its reconstitution. Georgia State Senator for District 42 Elena Parent says the panel is essentially embedding false information and vaccine scepticism into national policy. "This is the very body that has guided our nation's policies for vaccines for over 60 years. And by the way, this is what everyone said when they said 'do not confirm him'. Do not confirm him as the secretary of health. Anyone who knew anything about public health and vaccines said 'no'. These guy has peddled disinformation for years. And what did they do? Fell in line behind Trump and all the rest of them and put him in. And the worst fears are now coming true with this assault on the ACIP." The Secretary's views have also received a cool reception at a Brussels fundraising dinner for the GAVI global vaccine alliance, a group that facilitates immunisations in lower-income countries. In a video recording played to the gathering, Kennedy cast doubt on the diphtheria, tetanus and pertussis vaccines — which the World Health Organisation and other agencies have long deemed to be safe and effective. He also announced the US will be cutting its funding to GAVI, on the basis that they have allegedly silenced dissenting views and what he has described as legitimate questions about vaccine safety. "Consider the best science available even when the science contradicts established paradigms. Until that happens, the United States won't contribute more to GAVI." GAVI says that's ridiculous. Chairman of the Board Jose Manuel Barroso says the organisation has multiple safeguards and processes in place to prioritise the health and safety of children. "Gavi is indeed a unique organisation in global health with a public-private model that has brought together national governments, donors, vaccine manufacturers, scientific institutes and grassroot organisations to vaccinate more than 1 billion children in low income and middle income countries. And I have to say that Gavi has done it always following the best scientific advice." Doctors Without Borders is among the medical groups to say they believe countless children will die from vaccine-preventable diseases as a result of the U-S withdrawing support for Gavi. The charity's global health advocacy director, Mihir Mankad, has called it cruel and reckless to invoke misleading and inaccurate claims about vaccine safety as the pretext for cutting all global vaccine funding. But GAVI says it will be able to continue much of its work, and has plenty of other willing donors. Australia's Foreign Minister Penny Wong has said in a statement that Australia is sending $386 million over five years, while European Union President Ursula von der Leyen has also committed money. "Today I am pleased to pledge 360 million Euros to GAVI at this summit, and this is part of a total Team Europe pledge of 2 billion Euros or even more." Meanwhile, back in the US, some doctors are taking matters into their own hands. The influential American Academy of Paediatrics boycotted A-C-I-P's first meeting in protest, saying it will now publish its own vaccine schedule for children and do so independently of the vaccine panel, calling it 'no longer a credible process.' And the CDC demonstrators - which include former Division of Overdose Prevention public servant, Abby Tighe - say they will keep ringing their protest bells on that Atlanta corner for as long as they can. "Let's make it a non political conversation. We have to do the work to de-politicise public health. And I know it's hard and it sucks, but we have to do it because people's lives are at stake."
The Guardian
7 hours ago
- Health
- The Guardian
US supreme court rules key provision of Obamacare constitutional
The US supreme court has ruled that a key provision of 'Obamacare', formally known as the Affordable Care Act, is constitutional. The case challenged how members of an obscure but vital healthcare committee are appointed. The committee, the US Preventive Services Task Force (USPSTF), is a panel of 16 volunteer health experts who determine which evidence-based preventive health services private insurance companies must cover without cost for patients. The requirement is a provision of the ACA – and one of the few instances when privately insured American patients pay nothing for healthcare. The case, 'in line with other court decisions, strengthens the control of political appointees over the bureaucracy', said Dorit Reiss, a University of California San Francisco law professor and an expert in health law and vaccine policy. The case, formally called Kennedy v Braidwood Management, Inc, affirms that final decisions come by secretaries, in this case health secretary Robert F Kennedy Jr, a known vaccine skeptic. 'This makes it harder for Congress to isolate expert decisions from political review. So the stakes in appointing the political heads – in this case the secretary – are very, very high,' said Reiss. While the court affirms the constitutionality of the taskforce itself, it also held that members force can be removed at will by the health secretary, and that the secretary may review the taskforce's recommendations before they take effect. Kennedy used those powers only this June, when he unilaterally fired all sitting members of a critical vaccine advisory panel, and remade the panel with ideological allies. The new panel members then delivered Kennedy a victory by recommending against a vaccine preservative called thimerosal, despite a scientific consensus that the ingredient was safe. The court issued the opinion in a 6-3 ruling. The opinion was written by Justice Brett Kavanaugh, and joined by John Roberts, Sonya Sotomayor, Elena Kagan, Amy Coney Barrett and Ketanji Brown Jackson. In 2020 alone, an estimated 150 million Americans benefited from the preventive healthcare provision, according to the O'Neill Institute at the Georgetown University law center in Washington DC. Although the provision requires insurers to cover a wide range of services – from annual check-ups to cancer screenings and immunizations – the case centered on the provision of Prep, or pre-exposure prophylaxis for HIV. A small group of plaintiffs claimed provision of PrEP violated their religious beliefs. They were represented by Jonathan Mitchell, the former solicitor general of Texas who pioneered the state's 'bounty hunter' abortion law. Their arguments were backed by Republican and conservative groups, although the specific ACA provision was defended by both the Trump and Biden administrations. Major public health groups, hospitals, disease advocacy groups and Democratic attorneys general opposed ending the provision. Although the court affirmed the constitutionality of the panel, it also affirms that any health secretary, including Kennedy, could remake the panel with allies. The secretary could 'override experts' conclusions and remove things like PrEP', said Reiss. However, she added that the power was not 'absolute'. If the secretary's recommendation contravened the decision of an expert panel and there was a lawsuit, the secretary would still need to make 'a convincing case that there was a reason to deviate from the panel, if there is a lawsuit', said Reiss. That has left the Aids institute, and other groups who advocate for healthcare access for HIV and Aids patients, to say it 'celebrates' the decision while acknowledging uncertainty about the future. 'I think we have to be worried about what that means for future USPSTF decisions given what has happened with' the vaccine panel, said Rachel Klein, the deputy executive director of the Aids Institute. 'Knowing what preventive care is effective to keeping people healthy – and therefore cost-effective to cover – is crucial to helping people be as healthy as possible. That requires listening to medical and scientific experts. We hope that USPSTF will continue to be a body worthy of our trust to make scientifically sound decisions about preventive services going forward.'
CBC
10 hours ago
- Health
- CBC
U.S. vaccine panel rejects flu shots with a specific preservative, despite safety data
The Trump administration's new vaccine advisers on Thursday endorsed this fall's flu vaccinations for just about every American — but only if they use certain shots free of a preservative that has been safely used in vaccines for decades. What is normally a routine step in preparing for the upcoming flu season drew intense scrutiny after U.S. Health Secretary Robert F. Kennedy Jr. abruptly fired the influential 17-member Advisory Committee on Immunization Practices (ACIP)and handpicked replacements that include several vaccine skeptics. The seven-member panel bucked another norm Thursday as it discussed the safety of a preservative used in less than five per cent of U.S. flu vaccinations: It deliberated based only on a presentation from an anti-vaccine group's former leader — without allowing the usual public airing of scientific data from the U.S. Centers for Disease Control and Prevention. The preservative, thimerosal, has been used for decades in certain vaccines that come in multi-dose vials, to prevent contamination as each dose is withdrawn. Its controversy stems from containing a small amount of a particular type of mercury. However, the CDC's own data shows it is safe, and on Friday the World Health Organization stated in a press briefing that there was no evidence of risk. "Thimerosal has been reviewed multiple times by multiple agencies, including WHO, and it's clear from the evidence that there is no evidence of harm from the use of thimerosal," Dr. Katherine O'Brien from WHO told reporters in reaction to the U.S. panel decision. Thimerosal contains a minute amount of ethyl mercury, which breaks down quickly in the body and is swiftly removed, unlike methyl mercury, the type of mercury found in the environment which can build up in the body and cause harm. In Canada, a handful of multi-dose influenza vaccines approved for use by Health Canada contain thimerosal, but the vast majority of routine childhood vaccines do not. Single-dose flu shots unaffected Study after study has found no evidence that thimerosal causes autism, a myth long pushed by anti-vaccine groups, or poses any safety risks. Yet since 2001, all vaccines routinely used for U.S. children age 6 years or younger have already come in thimerosal-free formulas. The advisory panel voted to back the usual U.S. recommendation that nearly everyone age six months and older get an annual flu vaccination, but then voted 5-1 with one abstention that these had to be thimerosal-free formulations. This would include single-dose shots that already are the most common type of flu vaccination, and would rule out the subset of flu vaccine dispensed in multi-dose vials. "There is still no demonstrable evidence of harm," one panelist, Dr. Joseph Hibbeln, a psychiatrist formerly with the National Institutes of Health, said in acknowledging the committee wasn't following its usual practice of acting on evidence. But he argued that "we have to respect the fear of mercury" that he said might dissuade some people from getting vaccinated. Panel blocked CDC's analysis Lyn Redwood, formerly of the Kennedy-founded anti-vaccine group Children's Health Defense, gave the presentation on thimerosal in front of the panel, arguing that it was a neurotoxin. The version of Redwood's presentation posted to the CDC's website earlier this week initially included a reference to a study that does not exist. The report she gave to the committee was significantly shorter, removing a reference to that study and another slide saying she did not have any conflicts of interest. "With the vote on thimerosal this afternoon, the new committee has turned the ACIP process into a farce," said former CDC vaccine adviser Dr. Fiona Havers, who resigned last week over Kennedy's changes to vaccine policy. Medical groups decried the panel's lack of transparency in blocking a CDC analysis of thimerosal that concluded there was no link between the preservative and neurodevelopmental disorders, including autism. The data had been posted on the committee's website Tuesday, but was later removed — because, according to ACIP member Dr. Robert Malone, the report hadn't been authorized by Kennedy's office. Panel members said they had read it. The ACIP helps the CDC determine who should be vaccinated against a long list of diseases, and when, and its recommendations have a big impact on availability and insurance coverage of vaccines in the U.S. Normally the CDC's director would decide whether to accept ACIP's recommendation, but the Senate has not yet confirmed nominee Susan Monarez. Administration officials said Kennedy would make that decision. While Thursday's debate involved only a small fraction of flu vaccines, some public health experts contend the discussion unnecessarily raised doubt about vaccine safety. Already, fewer than half of Americans get their yearly flu vaccinations, and mistrust in vaccines overall is growing. "Selective use of data and omission of established science undermines public trust and fuels misinformation," said Dr. Sean O'Leary of the American Academy of Pediatrics (AAP). He said of the new panelists, "Nothing about their recent actions have been science-based or transparent." WATCH: Misinformation one of the factors behind decline in childhood vaccination globally: Decline in childhood vaccination fuelled by global conflicts, misinformation: Lancet 3 days ago Duration 2:01 A new study published in the Lancet medical journal suggests childhood vaccinations have stagnated or declined since 2010. The authors say geopolitical instability is fuelling the drop in some countries, but misinformation is largely driving the decline in high-income countries. The pediatrics group announced Wednesday that it would no longer be participating in the ACIP meetings, with president Sue Kressly saying in a video statement that "with the committee dismissals, it is no longer a credible process." The AAP will continue publishing its own vaccination recommendations. The flu votes marked the final step of a two-day meeting that alarmed pediatricians and other doctors' groups, who pointed to new panelists' lack of expertise in how to properly track vaccine safety — and a shift in focus which appears to boost anti-vaccine messaging. Of special concern was the announcement by panel chairman Martin Kulldorff to reevaluate the "cumulative effect" of the children's vaccine schedule — the list of immunizations given at different times throughout childhood. That reflects the scientifically debunked notion that children today get too many vaccinations for their immune systems.
The Guardian
12 hours ago
- Health
- The Guardian
US supreme court ruling sets stage for more politicized science under RFK Jr
A US supreme court decision affirming the constitutionality of Obamacare sets the stage for more politicized science in the future, health law experts said about the court's decision. The court's majority opinion in Kennedy v Braidwood Management found that an expert panel – the preventive services taskforce – convened under the Affordable Care Act is under the direct oversight of the health secretary. 'This is your classic good news, bad news,' said Lawrence Gostin, a professor of global health law at Georgetown Law. 'In a sane world, with a secretary of health that believes in science and doesn't bring in conspiracy theories and agendas, you would applaud this decision.' With health policy now in the hands of the Trump administration, 'it gives Secretary [Robert F Kennedy Jr] complete power about what to recommend and what not to recommend,' Gostin said. The court issued the opinion only hours after an expert vaccine advisory panel (ACIP) handpicked by Kennedy subverted the scientific consensus by recommending against thimerosal-containing vaccines, a preservative overwhelmingly considered safe. Thimerosal has been a subject of misinformation and anti-vaccine advocacy for decades. Much like the expert panel in question in the Braidwood case, the recommendations of the vaccine advisory committee are a key link in the treatment distribution pipeline. Recommendations from both panels are typically affirmed by the leadership of the health department, and then become the basis on which insurers base coverage decisions. In the case of the ACIP, those recommendations typically concern vaccines. In the preventive taskforce context, they include a wide range of treatments – from statins to cancer screenings to HIV prevention. It was widely recognized that Kennedy had the authority to hire and fire people for the vaccine panel – but legal controversy existed about whether health secretaries have the same power over the preventive services taskforce. 'The president and the Senate are accountable 'for both the making of a bad appointment and the rejection of a good one,'' wrote Justice Brett Kavanaugh for the six-vote majority. In other words, the court said, if you don't like it, go to the ballot box. MaryBeth Musumeci, an associate professor of health law management at the George Washington University Milken Institute of Public Health, told the Guardian: 'We have that structure in place – and that is a really great structure if the folks in charge are actually deferring to the experts and the science and what the evidence says.' She added: 'To the extent that we are going to make decisions based on bad science – that has really serious public health implications.' The panel at the center of the vaccine decision is the ACIP vaccine panel. Until June, the advisory panel was made up of 17 experts vetted by CDC career scientists. Their recommendations, while not binding, were almost always approved by CDC leadership. Kennedy fired all 17 members unilaterally in June and stocked the panel with eight ideological allies – including vaccine skeptics and medical professionals with little experience in vaccines. One panelist withdrew after a government financial review, and after it was widely publicized that the secretary's claims about the panelist's affiliation with two universities was false. Wayne Turner, a senior attorney for the National Health Law Program, which advocates for the medically underserved, said that he and others were 'certainly breathing a sigh of relief with the court's decision today' because a key provision of Obamacare was found to be constitutional. 'But that sigh of relief is really short-lived,' Turner said. 'We have long-anticipated with the appointment of RFK Jr, and certainly with his actions with the ACIP, that we can fully expect the preventive services taskforce to be the next battleground in the ideological war this administration seems to be waging. And the war is against science.' The subject of the Braidwood case provides a salient example. Plaintiffs were suing the government to claim that the taskforce was wrongly appointed. Although their legal argument was thorny, one treatment they specifically cited as wrong was insurance coverage of pre-exposure prophylaxis (Prep), an HIV prevention drug. Although the plaintiffs' claim that the taskforce was unconstitutional was swatted down, it provides activists with a roadmap to get what they want – if they can convince Kennedy to appoint more ideological allies to the taskforce. The preventive services taskforce may have one protective mechanism: a requirement that they be guided by evidence written into Obamacare, the legislation that impaneled them. Gearing up for another fight, Turner said: 'That's going to be an important thing for us to point to in the weeks and months ahead, and years, quite frankly.'
Health Line
12 hours ago
- Health
- Health Line
Is Thimerosal in Flu Shots Safe? Experts Discuss CDC Vaccine Decision
A CDC advisory panel voted 5–1 to recommend only flu vaccines without the preservative thimerosal. Thimerosal is a mercury-containing compound used as a preservative in vaccines and other drugs. Doctors and physician advocacy groups warn that the decision could lead to more confusion and vaccine hesitancy. A CDC advisory committee voted 5-1 on Thursday to recommend only single-dose formulations of flu shots that do not contain the preservative thimerosal. The vote follows a shakeup of the Advisory Committee on Immunization Practices (ACIP), in which Health Secretary Robert F. Kennedy Jr. dismissed all 17 members of the panel and hand-picked their replacements. The ouster and subsequent ACIP vote have caused alarm among doctors and physician advocacy organizations—including the American Medical Association (AMA) and the American Academy of Pediatrics (AAP) — who claim the committee is stoking confusion and distrust in vaccines. 'It further undermines vaccine confidence. And they're doing this despite a massive amount of data that confirms that thimerosal is a safe and effective preservative,' said Jake Scott, MD, clinical associate professor of infectious diseases at Stanford Medicine. Thimerosal, a mercury-containing preservative, has been used since the 1930s in vaccines and other drugs. Since the 1990s, it has been the target of intense speculation and debate due to claims — now debunked — that linked it to autism and neurotoxicity. ACIP's new recommendations contradict numerous studies and decades' worth of data showing no link between thimerosal and autism or other neurological conditions. 'This decision does not appear to be data-driven at all,' said Saahir Khan, MD, PhD, an infectious disease specialist with Keck Medicine of USC. 'This will sow a lot of distrust and probably lead to reduced vaccine uptake rates because they are sending a message that indirectly says that we don't think vaccines with thimerosal are safe, whereas the evidence shows that they are safe,' Khan said. What is thimerosal? Thimerosal, which contains about 50% mercury by weight, is one of the most widely used preservatives in vaccines. Every time a drug vial is pierced, it is susceptible to bacterial and fungal contamination. Thimerosal prevents microbial growth and contamination. Today, the use of thimerosal-containing vaccines has declined due to the advent of single-dose vaccine formulations. All routinely recommended vaccines for U.S. children ages 6 and younger are available in formulations without thimerosal. The vast majority of flu shots administered last flu season, about 96%, were also free of thimerosal. ACIP's recommendation this week against thimerosal-containing flu shots applies only to vaccines packaged in multi-dose vials. While multi-dose vials make up only a small subset of flu shots, the format is important for public health. 'Multi-dose vials are cheaper, easier to deploy, and essential for equitable access. They're especially important during pandemics. They proved to be essential during the H1N1 pandemic when single-dose supplies run out a lot faster,' said Scott. Following a review in 1999, conducted as part of the FDA Modernization Act (FDAMA), the FDA, National Institutes of Health (NIH), CDC, and others recommended that thimerosal be removed from childhood vaccines as a precautionary measure. That recommendation was based on 'scientific uncertainty' at the time and sought to reduce total mercury exposure in infants. That review found ' no evidence of harm ' caused by thimerosal in vaccines beyond localized reactions. However, it noted that some infants' cumulative mercury exposure in their first six months exceeded EPA recommendations, and that removing thimerosal could reduce this overall exposure. At vaccine concentrations, thimerosal delivers roughly 25 micrograms of mercury per 0.5 mL dose — about the same amount found in a three-ounce can of tuna. However, there's also an important distinction between the mercury found in thimerosal and tuna. Certain kinds of fish contain methylmercury, which can be toxic. Thimerosal contains ethylmercury, which, in contrast, is eliminated far more rapidly from the body and thus is far less likely to persist and cause harm. Revisiting the thimerosal controversy In the lead-up to this week's vote, Lyn Redwood, a retired nurse practitioner and president emeritus of Children's Health Defense — a group formerly chaired by Robert F. Kennedy Jr., whose mission is 'ending childhood health epidemics by eliminating toxic exposures' — reiterated many claims against thimerosal in an ACIP presentation. However, those claims — especially the alleged link between thimerosal and neurotoxicity — have been extensively debunked. 'There have been multiple well-controlled studies, randomized meta-analyses, and trials comparing vaccines with thimerosal to vaccines without thimerosal to see if there was any difference in neurological outcomes, and these trials generally did not find any connection between thimerosal at the doses used in vaccines and neurological conditions,' said Khan. An often-cited Danish study that included over half a million children found no causal relationship between thimerosal and the development of autism. Another large study of more than 100,000 children in the United Kingdom also found no evidence to support a link between thimerosal and neurodevelopmental disorders. A 2010 study found that exposure to thimerosal in prenatal or infant stages did not increase the risk for autism spectrum disorder (ASD). Perhaps most telling, Scott points out, is that even after thimerosal has been removed from vaccines, autism rates continued to rise. Such was the case for Denmark, which removed thimerosal in 1991, and the United States in 2003. Doctors warn that ACIP's recommendation fails to consider these studies and the large body of evidence supporting vaccine safety. And that will inevitably have consequences for the health of Americans. 'Our studies show that vaccines are safe and effective. I recommend them based on my medical experience, but some people are going to refuse. And unfortunately, they're going to put themselves at higher risk of infection and they're going to put the people around them at higher risk of infection,' said Khan.
