Vaccines<\/p>\n
Prescription drugs<\/p>\n
Disability issues<\/p>\n
Children’s health<\/p>\n
<\/a><\/p>\n Facebook<\/p>\n Tweet<\/p>\n <\/p>\n Email Link<\/p>\n \n This story<\/a> originally appeared on ProPublica, a nonprofit newsroom that investigates abuses of power. Sign up to receive their biggest stories<\/a> as soon as they\u2019re published.\n <\/p>\n \n Five months after taking over the federal agency responsible for the health of all Americans, Robert F. Kennedy Jr. wants to overhaul an obscure but vital program that underpins the nation\u2019s childhood immunization system.\n <\/p>\n \n Depending on what he does, the results could be catastrophic.\n <\/p>\n \n In his crosshairs is the Vaccine Injury Compensation Program<\/a>, a system designed to provide fair and quick payouts for people who suffer rare but serious side effects from shots \u2014 without having to prove that drugmakers were negligent. Congress created the program in the 1980s when lawsuits drove vaccine makers from the market. A special tax on immunizations funds the awards, and manufacturers benefit from legal protections that make it harder to win big-money verdicts against them in civil courts.\n <\/p>\n \n Kennedy, who founded an anti-vaccination group and previously accused the pharmaceutical industry of inflicting \u201cunnecessary and risky vaccines\u201d on children for profits, has long argued that the program removes any incentive for the industry to make safe products.\n <\/p>\n \n In a recent interview with Tucker Carlson<\/a>, Kennedy condemned what he called corruption in the program and said he had assigned a team to overhaul it and expand who could seek compensation. He didn\u2019t detail his plans but did repeat the long-debunked claim that vaccines cause autism and suggested, without citing any evidence, that shots could also be responsible for a litany of chronic ailments, from diabetes to narcolepsy.\n <\/p>\n \n There are a number of ways he could blow up the program and prompt vaccine makers to stop selling shots in the U.S., like they did in the 1980s. The trust fund that pays awards, for instance, could run out of money if the government made it easy for Kennedy\u2019s laundry list of common health problems to qualify for payments from the fund.\n <\/p>\n \n Or he could pick away at the program one shot at a time. Right now, immunizations routinely recommended for children or pregnant women<\/a> are covered by the program. Kennedy has the power to drop vaccines from the list, a move that would open up their manufacturers to the kinds of lawsuits that made them flee years ago.\n <\/p>\n \n Dr. Eddy Bresnitz, who served as New Jersey\u2019s state epidemiologist and then spent a dozen years as a vaccine executive at Merck, is among those worried.\n <\/p>\n \n \u201cIf his unstated goal is to basically destroy the vaccine industry, that could do it,\u201d said Bresnitz, who retired from Merck and has consulted for vaccine manufacturers. \u201cI still believe, having worked in the industry, that they care about protecting American health, but they are also for-profit companies with shareholders, and anything that detracts from the bottom line that can be avoided, they will avoid.\u201d\n <\/p>\n \n A spokesperson for PhRMA<\/a>, a U.S. trade group for pharmaceutical companies, told ProPublica in a written statement that upending the Vaccine Injury Compensation Program \u201cwould threaten continued patient access to FDA approved vaccines.\u201d\n <\/p>\n \n The spokesperson, Andrew Powaleny, said the program \u201chas compensated thousands of claims while helping ensure the continued availability of a safe and effective vaccine supply. It remains a vital safeguard for public health and importantly doesn\u2019t shield manufacturers from liability.\u201d\n <\/p>\n \n Since its inception, the compensation fund has paid about $4.8 billion<\/a> in awards for harm from serious side effects, such as life-threatening allergic reactions and Guillain-Barr\u00e9 syndrome, an autoimmune condition that can cause paralysis. The federal agency that oversees the program found that for every 1 million doses of vaccine distributed between 2006 and 2023, about one person was compensated<\/a> for an injury.\n <\/p>\n \n Since becoming Health and Human Services secretary, Kennedy has turned the staid world of immunizations on its ear. He reneged on the U.S. government\u2019s pledge<\/a> to fund vaccinations for the world\u2019s poorest kids. He fired every member of the federal advisory group that recommends which shots Americans get, and his new slate vowed to scrutinize the U.S. childhood immunization schedule. Measles, a vaccine-preventable disease eliminated here in 2000, roared back and hit a grim record \u2014 more cases than the U.S. has seen in 33 years, including three deaths. When a U.S. senator asked Kennedy if he recommended measles shots, Kennedy answered<\/a>, \u201cSenator, if I advised you to swim in a lake that I knew there to be alligators in, wouldn\u2019t you want me to tell you there were alligators in it?\u201d\n <\/p>\n \n Fed up, the American Academy of Pediatrics and other medical societies sued Kennedy last week, accusing him of dismantling<\/a> \u201cthe longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans.\u201d (The federal government has yet to respond to the suit.)\n <\/p>\n \n Just about all drugs have side effects. What\u2019s unusual about vaccines is that they\u2019re given to healthy people \u2014 even newborns on their first day of life. And many shots protect not just the individuals receiving them but also the broader community by making it harder for deadly scourges to spread. The Centers for Disease Control and Prevention estimates that routine childhood immunizations have prevented more than 1.1 million deaths<\/a> and 32 million hospitalizations among the generation of Americans born between 1994 and 2023.\n <\/p>\n \n To most people, the nation\u2019s vaccine system feels like a solid, reliable fact of life, doling out shots to children like clockwork. But in reality it is surprisingly fragile.\n <\/p>\n \n There are only a handful of companies that make nearly all of the shots children receive. Only one manufacturer makes chickenpox vaccines. And just two or three make the shots that protect against more than a dozen diseases, including polio and measles. If any were to drop out, the country could find itself in the same crisis that led President Ronald Reagan to sign the law creating the Vaccine Injury Compensation Program in 1986.\n <\/p>\n \n Back then, pharmaceutical companies faced hundreds of lawsuits alleging that the vaccine protecting kids from whooping cough, diphtheria and tetanus caused unrelenting seizures that led to severe disabilities. (Today\u2019s version of this shot is different.) One vaccine maker after another left the U.S. market<\/a>.\n <\/p>\n \n At one point, pediatricians could only buy whooping cough vaccines from a single company. Shortages were so bad that the CDC recommended doctors stop giving booster shots<\/a> to preserve supplies for the most vulnerable babies.\n <\/p>\n \n While Congress debated what to do, public health clinics\u2019 cost per dose jumped 5,000% in five years.\n <\/p>\n \n \u201cWe were really concerned that we would lose all vaccines, and we would get major resurgences of vaccine-preventable diseases,\u201d recalled Dr. Walter Orenstein, a vaccine expert who worked in the CDC\u2019s immunization division at the time.\n <\/p>\n \n A Forbes headline captured the anxiety of parents, pediatricians and public health workers: \u201cScared Shotless.\u201d So a bipartisan group in Congress hammered out the no-fault system.\n <\/p>\n \n Today, the program covers vaccines routinely recommended for children or pregnant women<\/a> once Congress approves the special tax that funds awards. (COVID-19 shots are part of a separate<\/a>, often-maligned<\/a> system for handling claims of harm, though Kennedy has said he\u2019s looking at ways to add them to the Vaccine Injury Compensation Program.)\n <\/p>\n \n Under program rules, people who say they are harmed by covered vaccines can\u2019t head straight to civil court to sue manufacturers. First, they have to go through the no-fault system. The law established a table of injuries<\/a> and the time frame for when those conditions must have appeared in order to be considered for quicker payouts. A tax on those vaccines \u2014 now 75 cents for every disease that a shot protects against \u2014 flows into a trust fund that pays those approved for awards. Win or lose, the program, for the most part, pays attorney fees and forbids lawyers from taking a cut of the money paid to the injured.\n <\/p>\n \n The law set up a dedicated vaccine court where government officials known as special masters, who operate like judges, rule on cases without juries. People can ask for compensation for health problems not listed on the injury table, and they don\u2019t have to prove that the vaccine maker was negligent or failed to warn them about the medical condition they wound up with. At the same time, they can\u2019t claim punitive damages, which drive up payouts in civil courts, and pain and suffering payments are capped at $250,000.\n <\/p>\n \n Plaintiffs who aren\u2019t satisfied with the outcome or whose cases drag on too long can exit the program and file their cases in traditional civil courts. There they can pursue punitive damages, contingency-fee agreements with lawyers and the usual evidence gathering that plaintiffs use to hold companies accountable for wrongdoing.\n <\/p>\n \n But a Supreme Court ruling, interpreting the law that created the Vaccine Injury Compensation Program, limited the kinds of claims that can prevail in civil court. So while the program isn\u2019t a full liability shield for vaccine makers, its very existence significantly narrows the cases trial lawyers can file.\n <\/p>\n \n Kennedy has been involved in such civil litigation. In his federal disclosures, he revealed that he referred plaintiffs to a law firm filing cases against Merck over its HPV shot in exchange for a 10% cut of the fees if they win. After a heated exchange with Sen. Elizabeth Warren during his confirmation proceedings, Kennedy said his share of any money from those cases would instead go to one of his adult sons, who he later said is a lawyer in California. His son Conor works as an attorney at the Los Angeles law firm benefiting from his referrals. When ProPublica asked about this arrangement, Conor Kennedy wrote, \u201cI don\u2019t work on those cases and I\u2019m not receiving any money from them.\u201d\n <\/p>\n \n In March, a North Carolina federal judge overseeing hundreds of cases that alleged Merck failed to warn patients about serious side effects from its HPV vaccine ruled in favor of Merck<\/a>; an appeal is pending.\n <\/p>\n \n The Vaccine Injury Compensation Program succeeded in stabilizing the business of childhood vaccines, with many more shots developed and approved in the decades since it was established. But even ardent supporters acknowledge there are problems. The program\u2019s staff levels haven\u2019t kept up with the caseload. The law capped the number of special masters at eight, and congressional bills to increase that have failed. An influx of adult claims swamped the system after adverse reactions to flu shots became eligible for compensation in 2005 and serious shoulder problems were added to the injury table in 2017.\n <\/p>\n \n The quick and smooth system of payouts originally envisioned has evolved into a more adversarial one with lawyers for the Department of Justice duking it out with plaintiffs\u2019 attorneys, which Kennedy says runs counter to the program\u2019s intent. Many cases drag on for years.\n <\/p>\n \n In his recent interview with Carlson, he described \u201cthe lawyers of the Department of Justice, the leaders of it\u201d working on the cases as corrupt. \u201cThey saw their job as protecting the trust fund rather than taking care of people who made this national sacrifice, and we\u2019re going to change all that,\u201d he said. \u201cAnd I\u2019ve brought in a team this week that is starting to work on that.\u201d\n <\/p>\n \n The system is \u201csupposed to be generous and fast and gives a tie to the runner,\u201d he told Carlson. \u201cIn other words, if there\u2019s doubts about, you know, whether somebody\u2019s injury came from a vaccine or not, you\u2019re going to assume they got it and compensate them.\u201d\n <\/p>\n \n Kennedy didn\u2019t identify who is on the team reviewing the program. At one point in the interview, he said, \u201cWe just brought a guy in this week who\u2019s going to be revolutionizing the Vaccine Injury Compensation Program.\u201d\n <\/p>\n \n The HHS employee directory now lists Andrew Downing as a counselor working in Kennedy\u2019s office. Downing for many years has filed claims with the program and suits in civil courts on behalf of clients alleging harm from shots. Last month, HHS awarded a contract for \u201cVaccine Injury Compensation Program expertise\u201d<\/a> to Downing\u2019s firm<\/a>, as NOTUS has reported<\/a>.\n <\/p>\n \n Downing did not respond to a voicemail left at his law office. HHS didn\u2019t reply to a request to make him and Kennedy available for an interview and declined to answer detailed questions about its plans for the Vaccine Injury Compensation Program. In the past, an HHS spokesperson has said that Kennedy is \u201cnot anti-vaccine \u2014 he is pro-safety.\u201d\n <\/p>\n \n While it\u2019s not clear what changes Downing and Kennedy have in mind, Kennedy\u2019s interview with Carlson offered some insights. Kennedy said he was working to expand the program\u2019s three-year statute of limitations so that more people can be compensated. Downing has complained<\/a> that patients who have certain autoimmune disorders don\u2019t realize their ailments were caused by a vaccine until it\u2019s too late to file. Congress would have to change the law to allow this, experts said.\n <\/p>\n \n A key issue is whether Kennedy will try to add new ailments to the list of injuries that qualify for quicker awards.\n <\/p>\n \n In the Carlson interview, Kennedy dismissed the many studies and scientific consensus that shots don\u2019t cause autism as nothing more than statistical trickery. \u201cWe\u2019re going to do real science,\u201d Kennedy said.\n <\/p>\n \n The vaccine court spent years in the 2000s trying cases that alleged autism was caused by the vaccine ingredient thimerosal and the shot that protects people from measles, mumps and rubella. Facing more than 5,000 claims, the court asked a committee of attorneys representing children with autism to pick test cases that represented themes common in the broader group. In the cases that went to trial, the special masters considered more than 900 medical articles and heard testimony from dozens of experts. In each of those cases, the special masters found<\/a> that the shots didn\u2019t cause autism.\n <\/p>\n \n In at least two subsequent cases, children with autism were granted compensation because they met the criteria listed in the program\u2019s injury table, according to a vaccine court decision. That table, for instance, lists certain forms of encephalopathy \u2014 a type of brain dysfunction \u2014 as a rare side effect of shots that protect people from whooping cough, measles, mumps and rubella. In a 2016 vaccine court ruling, Special Master George L. Hastings Jr. explained, \u201cThe compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.\u201d\n <\/p>\n \n Hastings noted that when Congress set up the injury table, the lawmakers acknowledged that people would get compensated for \u201csome injuries that were not, in fact, truly vaccine-caused.\u201d\n <\/p>\n \n Many disabling neurological disorders in children become apparent around the time kids get their shots. Figuring out whether the timing was coincidental or an indication that the vaccines caused the problem has been a huge challenge.\n <\/p>\n \n Devastating seizures in young children were the impetus for the compensation program. But in the mid-1990s, after a yearslong review of the evidence, HHS removed seizure disorder from the injury table<\/a> and narrowed the type of encephalopathy that would automatically qualify for compensation. Scientists subsequently have discovered genetic mutations that cause some of the most severe forms of epilepsy.\n <\/p>\n \n What\u2019s different now, though, is that Kennedy, as HHS secretary, has the power to add autism or other disorders to that injury table. Experts say he\u2019d have to go through the federal government\u2019s cumbersome rulemaking process to do so. He could also lean on federal employees to green-light more claims.\n <\/p>\n \n In addition, Kennedy has made it clear he\u2019s thinking about illnesses beyond autism. \u201cWe have now this epidemic of immune dysregulation in our country, and there\u2019s no way to rule out vaccines as one of the key culprits,\u201d he told Carlson. Kennedy mentioned diabetes, rheumatoid arthritis, seizure disorders, ADHD, speech delay, language delay, tics, Tourette syndrome, narcolepsy, peanut allergies and eczema.\n <\/p>\n \n President Donald Trump\u2019s budget estimated that the value of the investments in the Vaccine Injury Compensation Program trust fund could reach $4.8 billion this year. While that\u2019s a lot of money, a life-care plan for a child with severe autism can cost tens of millions of dollars, and the CDC reported in April that 1 in 31 children<\/a> is diagnosed with autism by their 8th birthday. The other illnesses Kennedy mentioned also affect a wide swath of the U.S. population.\n <\/p>\n \n Dr. Paul Offit, a co-inventor of a rotavirus vaccine and director of the Vaccine Education Center at Children\u2019s Hospital of Philadelphia, for years has sparred with Kennedy over vaccines. Offit fears that Kennedy will use flawed studies to justify adding autism and other common medical problems to the injury table, no matter how much they conflict with robust scientific research.\n <\/p>\n \n \u201cYou can do that, and you will bankrupt the program,\u201d he said. \u201cThese are ways to end vaccine manufacturing in this country.\u201d\n <\/p>\n \n If the trust fund were to run out of money, Congress would have to act, said Dorit Reiss, a law professor at University of California Law San Francisco who has studied the Vaccine Injury Compensation Program. Congress could increase the excise tax on vaccines, she said, or pass a law limiting what\u2019s on the injury table. Or Congress could abolish the program, and the vaccine makers would find themselves back in the situation they faced in the 1980s.\n <\/p>\n \n \u201cThat\u2019s not unrealistic,\u201d Reiss said.\n <\/p>\n \n Rep. Paul Gosar, an Arizona Republican, last year proposed the End the Vaccine Carveout Act<\/a>, which would have allowed people to bypass the no-fault system and head straight to civil court. His press release for the bill \u2014 written in September, before Kennedy\u2019s ascension to HHS secretary \u2014 quoted Kennedy<\/a> saying, \u201cIf we want safe and effective vaccines, we need to end the liability shield.\u201d\n <\/p>\n \n The legislation never came up for a vote. A spokesperson for the congressman said he expects to introduce it again \u201cin the very near future.\u201d\n <\/p>\n \n Ren\u00e9e Gentry, director of the George Washington University Law School\u2019s Vaccine Injury Litigation Clinic, thinks it\u2019s unlikely Congress will blow up the no-fault program. But Gentry, who represents people filing claims for injuries, said it\u2019s hard to predict what Congress, faced with a doomsday scenario, would do.\n <\/p>\n \n \u201cNormally Democrats are friends of plaintiffs\u2019 lawyers,\u201d she said. \u201cBut talking about vaccines on the Hill is like walking on a razor blade that\u2019s on fire.\u201d\n <\/p>\n","protected":false},"excerpt":{"rendered":"Vaccines Prescription drugs Disability issues Children’s health See all topics Facebook Tweet Email Link This story originally appeared…\n","protected":false},"author":2,"featured_media":276331,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4316],"tags":[105,4348,16,15],"class_list":{"0":"post-276330","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-health","9":"tag-healthcare","10":"tag-uk","11":"tag-united-kingdom"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/114883323639293327","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/276330","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=276330"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/276330\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/276331"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=276330"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=276330"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=276330"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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