No Broad Autism Approval for Leucovorin, Despite FDA Commissioner’s Prior Suggestions

The Food and Drug Administration on March 10 changed the approval for a version of the prescription drug leucovorin to include people with a very rare genetic condition. FDA Commissioner Dr. Marty Makary had previously implied that the drug’s new label would cover a much broader group of people with autism, saying that “hundreds of thousands of kids” would benefit. 

The condition targeted in the FDA approval is a genetic version of cerebral folate deficiency, caused by mutations in a folate receptor gene. People with CFD — whether from genetic or other causes — have low levels of folate in their cerebrospinal fluid, which leads to reduced folate in the brain. This affects brain development. Patients with genetic CFD can experience developmental delays, movement disorders and seizures. Some behaviors are similar to those of people with autism.

However, this form of genetic CFD is estimated to occur in 1 in a million people, according to the FDA. That would translate to around 70 kids in the U.S. — far from “hundreds of thousands of kids.” Leucovorin had already been used for decades to treat genetic CFD via off-label prescribing, a common practice when evidence shows a drug approved for one condition improves another.

Despite this limited approval, Makary had initially implied a more substantial change. “Today the FDA is filing a Federal Register notice to change the label on an exciting treatment called prescription leucovorin so that it can be available to children with autism,” Makary said in a Sept. 22 press conference. “We are going to change the label to make it available,” he went on to say. “Hundreds of thousands of kids, in my opinion, will benefit.”

This was the same press conference in which President Donald Trump and others touted an unproven link between autism and the use of Tylenol, or acetaminophen, during pregnancy. 

Makary later referred to a subset of people with autism with antibodies that block their own folate receptors, called autoantibodies. Some researchers have hypothesized that a subset of people with autism have CFD caused by these autoantibodies, but this is not well-established, as we will explain.

How Iran Blocking the Strait of Hormuz Affects the U.S.

President Donald Trump claimed that Iran essentially shutting down the Strait of Hormuz “doesn’t really affect” the United States the way it does “other countries.” It’s true that a small share of U.S. oil imports comes from the Persian Gulf. But the U.S. has been affected by the global rise in oil prices.

Since the waterway has been effectively closed – significantly reducing crude oil exports from the Persian Gulf region – oil prices have increased by double-digit percentages, contributing to a 50-cent-plus spike in the average price of a gallon of gasoline in the U.S.

“The US is definitely affected,” Mark Finley, the nonresident fellow in energy and global oil at Rice University’s Baker Institute, told us in an email. Because it’s a global oil market, “if something goes wrong anywhere, the price goes up everywhere,” he said.

Iran has blocked the flow of oil and other goods through the strait in retaliation for joint U.S. and Israeli airstrikes that began on Feb. 28. Iran has threatened to shoot or bomb vessels that attempt to pass through the narrow body of water that separates Iran from Oman and connects the Persian Gulf with the Gulf of Oman and the Arabian Sea.

About 20 million barrels per day of crude and other oil products were transported through the strait in 2025. That has slowed “to a trickle” since the U.S.-Israeli conflict with Iran began, according to the International Energy Agency.

In a March 9 press conference, Trump talked about offering “risk insurance” to oil tankers operating in the region, possibly by having U.S. Navy ships escort the tankers, “because you have to keep the straits flowing.”

But then he said, “With all of that, it affects other countries much more than it does the United States. It doesn’t really affect us. We have so much oil. We have tremendous oil and gas, much more than we need.” And he added, “I mean, we’re doing this for the other parts of the world, including countries like China. They get a lot of their oil through the straits. So, we’re doing this.”

Is the U.S. at ‘War’? Politicians Disagree

Is the U.S. at “war” with Iran? Americans are getting conflicting messages from the Trump administration and congressional leaders.

“We are not at war. We have no intention of being at war,” House Speaker Mike Johnson said at a press conference on March 5, hours after Republicans in the House blocked a war powers resolution that would have required congressional approval for any further military action against Iran. Instead, Johnson called the military action a “limited operation.”

But in remarks to reporters on March 7 — and on other occasions — “war” is exactly how President Donald Trump has described it.

“We’re winning the war by a lot,” Trump told reporters on March 7. “The war itself is going unbelievably. It’s as good as it can be.”

While there are varying definitions of war, even among academics who study such things, the war-or-not political debate is mostly about the legal definition of war under the Constitution and the implications that come with such a designation.

While Article II of the U.S. Constitution designates the president as “Commander in Chief of the Army and Navy,” Article I, Section 8 of the Constitution gives Congress — and only Congress — the power “To declare War.” In other words, the president is obligated to seek authorization from Congress before he initiates a war.

But Congress hasn’t formally declared war since World War II. And it didn’t happen with the military attack initiated by Trump in Iran. Rather, in accordance with the 1973 War Powers Resolution, Trump provided a report to Congress on March 2 about the administration’s justification for the U.S.-Israeli joint strikes against Iran initiated on Feb. 28.

Trump’s Claim About the Obama Nuclear Deal and Iran’s Nuclear Development

President Donald Trump has claimed that the 2015 Iran nuclear deal was “a road to a nuclear weapon” and the country “would be sitting with a massive nuclear weapon three years ago” if he hadn’t withdrawn the U.S. from the deal in 2018 during his first term. The multilateral deal aimed to restrict Iran’s uranium enrichment program, and experts told us that after the U.S. withdrawal, Iran accelerated it instead.

It’s not possible to predict what would have happened if the agreement, called the Joint Comprehensive Plan of Action and negotiated by former President Barack Obama’s administration, had remained in place. In addition to imposing restrictions on Iran’s enrichment of uranium, the deal required international inspections of the country’s nuclear facilities.

On March 3, when speaking about the U.S. airstrikes on Iran that began Feb. 28, Trump said that Obama “made maybe the worst deal I’ve ever seen, because he gave all power in the Middle East to Iran, he went the exact opposite way, and I terminated that. If I didn’t terminate that deal, they would be sitting with a massive nuclear weapon three years ago, which would have been used already on Israel at least, and other countries also. And we wouldn’t be talking about it right now.”

The president went on to say that Obama “was giving them the right to have the path to a nuclear weapon,” saying that the deal “expired.”

The next day, Trump said: “If we didn’t terminate the worst deal, one of the worst deals ever made, the Obama nuclear deal … it was a road to a nuclear weapon. Bad things would have happened four years ago, because they would’ve had a weapon four years ago, if I didn’t terminate that deal.”