The Trump administration just announced a program of actions to tackle the so-called “autism epidemic”, a term that is disputed by many within the autistic community. As well as seeking Food and Drug Administration (FDA) approval for a new drug treatment, safety label changes are being pursued for acetaminophen (paracetamol) due to a “potential association” between its use in pregnancy and neurodevelopmental conditions.
The rest of this article is behind a paywall. Please sign in or subscribe to access the full content. They told us way back in April that they would “know” the causes of autism by September. As predicted, the new announcements from the US Department of Health and Human Services (HHS) cannot go as far as that, but they do bring forth a suite of “bold actions” that many scientific experts say are not supported by any quality data and that, in short, are going too far, too fast. The first announcement relates to a drug called leucovorin, which is already used as a medical treatment in the US. It’s similar to folic acid and is used to counteract some of the toxic effects of methotrexate, which is a medication used to treat inflammatory diseases and some types of cancer. The FDA has announced that it has initiated the approval process for a new use for leucovorin: treating cerebral folate deficiency (CFD), a condition where the essential vitamin folate is not transported efficiently into the brain. “Individuals with cerebral folate deficiency have been observed to have developmental delays with autistic features,” the agency said in a statement. “While promising,” HHS emphasized, “it is important to note that leucovorin is not a cure for [autism] and may only lead to improvements in speech-related deficits for a subset of children.” They say the drug will only be given under strict medical supervision and in combination with non-pharmacological treatments. The second part of the announcement relates to acetaminophen, one of the most widely used drugs in the world. You may know it as paracetamol, or under brand names like Tylenol®. The FDA says it has started the process of updating the label, as well as publishing a letter to alert doctors to the upcoming changes. President Trump himself was far less measured in his language when addressing the media, stating repeatedly – and against the best available scientific data – “Don’t take Tylenol.” There have been a number of studies that have linked use of acetaminophen in pregnancy to conditions like autism and ADHD. However, as the FDA notes in its announcement, there are also studies that say the opposite, and as yet no causal link has been established. In addition, acetaminophen is the only option currently available to treat fever during pregnancy, as other over-the-counter pain relievers like aspirin are known to have adverse effects. “It remains reasonable [..] for pregnant women to use acetaminophen in certain scenarios,” said FDA Commissioner Marty Makary, MD, MPH. “Today, we are taking bold action – opening the door to the first FDA-recognized treatment pathway, informing doctors and families about potential risks, and investing in groundbreaking research,” said HHS Secretary Robert F. Kennedy, Jr. in a statement yesterday about both announcements. “We will follow the science, restore trust, and deliver hope to millions of American families.” “Following the science”, however, is the last thing these policies are doing, according to some experts. “The best available evidence is that paracetamol use in pregnancy is not linked to autism,” Dr Edward Mullins, Clinical Associate Professor at Imperial College London, told the Science Media Centre. “In the absence of any new evidence, the reported press release from the Trump administration claiming it is would appear to be an unsubstantiated theory which is likely to lead to an essential treatment for fever and pain being denied to women in pregnancy without good reason, contrary to US and European medical guidance.” “The fear mongering will prevent women from accessing the appropriate care during pregnancy,” said Dr Monique Botha, Associate Professor at Durham University. “Further, it risks stigmatising families who have autistic children as having brought it on themselves and reinvigorates the long pattern of maternal shame and blame as we’ve seen re-emerge repeatedly over the last 70 years where we try to pay the fault of autism at the mother’s door one way or another.” The makers of Tylenol, Kenvue, pushed back strongly as well, telling the BBC that they are “deeply concerned with the health risk this poses for expectant mothers.” On leucovorin, Dr Botha added, “Any evidence available at this point is exceptionally tentative and would not be considered to be robust. Similarly, whilst medications may help with very specific aspects, there is no medication or treatment that actively cures or erases autism, though it might adjust behaviour, or reduce co-occurring symptoms which contribute towards distress for autistic people.” In an article for The Conversation, Professor Nial Wheate of Macquarie University and pharmacist and PhD candidate Jasmine Lee of the University of Sydney discussed the evidence base around leucovorin. “While promising, none of these trials are at the level to change medical practice. We’d need further, larger studies before doctors can make a proper recommendation,” they said. Those at the heart of the Trump administration continue to insist that they’re following “gold standard science”. The final part of yesterday’s statement from HHS announced more than $50 million of funding for 13 projects to “transform autism research”. But autism has been and continues to be studied extensively. It’s because of years of rigorous research that we can confidently state that vaccines do not cause autism. The current scientific consensus is that autism is extremely complex and likely has a huge number of primarily genetic causes. The fact there isn’t a simple answer is not evidence of a conspiracy or cover-up. More to the point, in the eyes of many experts and autistic people themselves, this rhetoric is actively unhelpful. “The incessant misinformation about autism from President Trump and Robert F Kennedy Jr risks undermining decades of research by respected experts in the field,” said Mel Merritt, Head of Policy and Campaigns at the UK’s National Autistic Society, in a response to the latest news. “This is dangerous, it's anti-science and it's irresponsible.” Leucovorin
Acetaminophen
“Gold standard science” – or is it?
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