\n<\/p>\n
W<\/span>hen Donald Trump and Robert F Kennedy Jr stood up at the press conference in September to tout leucovorin, a vitamin B derivative, as a treatment for autism, some neurodevelopmental doctors were shocked \u2013 and they braced themselves. There was little evidence to suggest the folinic acid helps with autism, yet there was an immediate flood of parents calling and scheduling visits to talk about the medication.<\/p>\n \u201cThe average parent who maybe wasn\u2019t getting the right information said, \u2018Well, to be good parents, we need to try this,\u2019\u201d said William Graf, a professor of pediatrics and neurology at Connecticut Children\u2019s Medical Center. Outpatient leucovorin prescriptions for children ages five to 17 in the US rose by 71% in the weeks following the announcement, new research shows.<\/p>\n But on 10 March, the FDA approved leucovorin only for cerebral folate deficiency, in an apparent walk-back from officials\u2019 statements about autism. The treatment seems to help treat \u201cdevelopmental delays with autistic features\u201d, Marty Makary, commissioner of the US Food and Drug Administration (FDA), said in a statement \u2013 a reference to the ways cerebral folate deficiency, a very rare condition, can appear similar to autism.<\/p>\n Only months ago at the September press conference, Makary was much more explicit about folinic acid as the first FDA-recognized treatment for autism.<\/p>\n \u201cHundreds of thousands of kids, in my opinion, will benefit,\u201d he said, stating that being autistic \u201cmay be entirely preventable\u201d. The drug \u201cmay help 50 to 60% of kids with autism\u201d, Makary claimed on C-SPAN. He also said on Becker\u2019s Healthcare Podcast that \u201cin the right population of children with autism, two-thirds of kids can see a clinical improvement and some a dramatic improvement in their autism symptoms\u201d.<\/p>\n Other officials also spoke to the potential benefits of leucovorin for autism.<\/p>\n \u201cThis gives hope to the many parents with autistic children that it may be possible to improve their lives,\u201d Trump said. Kennedy, the secretary of the US Department of Health and Human Services (HHS), said it was \u201can exciting therapy that may benefit large numbers of children who suffer from autism\u201d.<\/p>\n Graf noted that \u201cpredictably,\u201d this rhetoric \u201ccaused a ruckus\u201d.<\/p>\n At a national meeting for neurodevelopmental specialists, it was a hot topic of debate \u2013 should families try the medication for a month and see if a benefit emerged? Should every child go through a spinal tap to see if they had a folate deficiency? There wasn\u2019t even solid evidence on what kind of dose a child should get, since the medication has not undergone a major clinical trial, Graf said, adding: \u201cNobody really knew.\u201d<\/p>\n Some of the families in his clinic had pediatricians who prescribed leucovorin, but \u201cI haven\u2019t seen anybody respond to it,\u201d Graf said. \u201cThis is not a panacea. This is not a wonder drug that was out there but no one knew about it. It was just propagated from a government that, at the same time, doesn\u2019t want to fund ACA, isn\u2019t supporting research and is vaccine hesitant.\u201d Congress is also making massive cuts to Medicaid and other services for autistic people.<\/p>\n With the FDA approving the drug only for folate deficiency, \u201cit\u2019s almost like they\u2019re backtracking now, they\u2019re trying to get out of it\u201d, Graf said.<\/p>\n The biggest study on leucovorin for autism \u2013 which only followed 77 children \u2013 was retracted in January after re-analyses of the data failed to find the same results. The only other studies have faced criticism for small sample sizes and improper blinding. The American Academy of Pediatrics (AAP) said in October that it does not recommend leucovorin for autistic children because of limited evidence.<\/p>\n Even Richard Frye, the Arizona physician who said he told officials about the possibility of using leucovorin, was surprised regulators didn\u2019t require more research before making their announcement.<\/p>\n \u201cSo we were kinda surprised that they were just approving it right out of the gate without more studies or anything,\u201d Frye told the Associated Press.<\/p>\n Leon Epstein, chief of neurology at Lurie Children\u2019s hospital of Chicago, told the Guardian that \u201cscience is a matter of facts and data. It\u2019s not a matter of just making something up and declaring it. Physicians are obligated to act in the best interest of their patients, which means they have to act with science-based studies and science-based therapies.\u201d<\/p>\n Giving anyone a treatment without evidence is \u201cjust wrong. It\u2019s unethical,\u201d Graf said. In fact, a vitamin-based approach to autism was already attempted decades ago, but it showed no results.<\/p>\n \u201cIf a B vitamin were a cure for neurodevelopmental disorders, everyone would already have known this,\u201d Graf said.<\/p>\n Other purported cures have been dangerous, including chelation, a process for extracting heavy metals, and hyperbaric oxygen. In December, the FDA pulled a warning against dangerous, unproven \u201ctreatments\u201d for autism like these.<\/p>\n \u201cThere\u2019s a whole history in autism of people coming up with therapies that they claimed work, and some have been actually dangerous to patients,\u201d Epstein said.<\/p>\n Misinformation about autism is already rampant. \u201cThe role of government is not to put gasoline on the misinformation fire,\u201d Graf said. \u201cIt\u2019s selling false hope. It was almost like public deception.\u201d<\/p>\n The consequences are likely to spread beyond this treatment and even autism generally, Epstein said, before adding: \u201cThe problem here is you cannot trust our public health officials because they are not following science,\u201d and making claims like this can \u201ccreate disbelief in the system\u201d.<\/p>\n \u201cWhen public officials, especially those who are not physicians, make statements like this \u2013 this is a big setup, ultimately, to really put everything the government says in question,\u201d Graf said.<\/p>\n","protected":false},"excerpt":{"rendered":" When Donald Trump and Robert F Kennedy Jr stood up at the press conference in September to tout leucovorin, a vitamin B derivative, as a treatment for autism, some neurodevelopmental doctors were shocked \u2013 and they braced themselves. There was little evidence to suggest the folinic acid helps with autism, yet there was an immediate<\/p>\n","protected":false},"author":1,"featured_media":47284,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[51],"tags":[5814,249,3194,14381,554,789,23943,2384,81,21256],"class_list":{"0":"post-47283","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-health","8":"tag-autism","9":"tag-fda","10":"tag-healthcare","11":"tag-leucovorin","12":"tag-quietly","13":"tag-rfk","14":"tag-touted","15":"tag-treatment","16":"tag-trump","17":"tag-walked"},"_links":{"self":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/47283","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=47283"}],"version-history":[{"count":0,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/posts\/47283\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=\/wp\/v2\/media\/47284"}],"wp:attachment":[{"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=47283"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=47283"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/naijaglobalnews.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=47283"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}