Although it has hardly been discussed in Japan, ever since President Trump commented on September 22 that pregnant women taking Tylenol (active ingredient: acetaminophen, an antipyretic analgesic) face a higher risk of having children with autism, the United States has been in an uproar.
Even just in the Nature News section:
- On September 23: “Trump team backs up an unproven drug for autism—but does it work?”
- On September 26: “What happens if pregnant women stop taking Tylenol?” and “US autism research gets $50 million funding boost—amid row over Tylenol.”
The September 23 article reported that the Trump team, with a little scientific basis, recommended leucovorin as a treatment for autism. Leucovorin is a drug used to counteract the side effects of methotrexate (an anticancer agent, but recently also used for rheumatoid arthritis). Leucovorin is a derivative of folate (vitamin B9). Folate is abundant in dark green vegetables (spinach, broccoli, Brussels sprouts, etc.), legumes, liver, and seaweed, so deficiency does not usually occur unless one has a highly unbalanced diet. However, it has been reported that pregnant women who avoid vegetables may suffer folate deficiency.
It is well known that folate deficiency in early pregnancy increases the risk of congenital abnormalities of the fetal brain and spinal cord. While not conclusive, some studies have reported an increased risk of autism as well. Many of my students who became pregnant in Chicago took folate supplements. There have been small studies reporting improvement of autism symptoms with leucovorin, but these were not of the scale to receive FDA approval. Nevertheless, Trump’s circle of loyalists seems to be moving in the direction of pushing it toward FDA approval. Of course, many physicians and researchers have voiced opposition.
Those who commented in Nature argued that the necessary dosage and safety are not yet established, that the drug will not work for everyone, and therefore that large-scale trials should be awaited. Yet, no drug in the world works for everyone, and since leucovorin is already marketed as a supplement, there is at least some safety data. To me, the criticism sounded more like an attempt to steer readers toward an anti-Trump stance. For patients and parents currently struggling with autism, waiting years is an unlikely option; if the product is already available as a supplement and some scientific evidence exists—even if based on small trials—then clinging to that hope seems reasonable.
I have seen many physicians who, blinded by their faith in “evidence,” tell terminal cancer patients with 3–6 months to live that they must wait for definitive proof of safety and efficacy—which in practice is no different from telling them to stay silent and wait for death. But the era has come when it is more important to identify who will respond and who will not, rather than to emphasize evidence that shows only a few months’ extension of survival in the statistical average.
The third Nature article reported that more than $50 million (about ¥7 billion) will be allocated to autism research, but I still find it puzzling why Tylenol is being singled out as the enemy. The article “What happens if pregnant women stop taking Tylenol?” explained that leaving a pregnant woman with high fever untreated poses significant risks to the fetus, and that there is no evidence that other antipyretic analgesics are safer than Tylenol. Therefore, Tylenol should be used in cases of high fever.
The age of equating “evidence” with nothing more than statistically significant differences is over. What matters now is cultivating the ability to truly see and understand the patient in front of you, beyond the numbers.
