The Trump administration tightens a drug called Leucovorin to reduce some symptoms of autism, but experts who are looking or treating autism are almost uniformly agreed that the drug should be studied more before it is presented to children or adults.
Leucovorin, also indicated as Folinic Aid, is an artificial form of vitamin B9 that requires a prescription. It is often administered for cancer patients as well as chemotherapy in the form of IV.
The Food and Drug Administration announced on Monday that it is in the process of approving the tablet version of some autistic patients.
Many researchers wondered whether the approval was premature, given that a handful of small experiences – mostly conducted outside the United States – indicated that ingovorin is effective in children with autism.
Several experts have told NBC News that the approval of the FDA may give wrong hope to families, because all children with autism may be eligible for a prescription, and even if they do so, the probability of seeing the results is inconceivable.
Scientists have searched for decades for a drug that can reduce the symptoms of autism in a useful way, but a few have achieved the strict threshold of safety and effectiveness that the Food and Drug Administration usually determines. Before Monday, the agency agreed to two drugs to treat irritation associated with autism, but no one addresses autism, social challenges or repeated behaviors.
“It is not as if scientists were staring at their abdominal buttons for 20 years, and they did not look at autism treatments. They have, but the criteria were very high.” Its organization, which funds autistic research based on, Leucovorin does not recommend as a treatment He says more studies are needed.
Lukovorin “has no criteria for the approval of the FDA, but this administration does this anyway. So I will not call this victory exactly.”
She added that the way the drug was promoted to surround the White House on Monday – as a penetration of autistic families – does not reflect the details of the FDA approval.
The FDA (FDA) said in a press statement that the drug is approved for patients with a lack of folic acid, a rare neurological condition characterized by low levels of vitamin B9 (folic acid) in the brain. Some researchers suspect that the condition is linked to autism, although not all patients with autism.
(Halladai estimated 10 % -30 % of autism patients who have the condition.)
Leucovorin folic acid can help reach the brain, which may improve verbal communication or reduce the symptoms of autism such as irritation or repeated behaviors. But there is no evidence that it completely removes symptoms.
“I am still optimistic that Leucovorin will be a tool in our toolbox that can help a group of patients,” said Dr. Rachel Fulmeer, a professor of assistant pediatrics at the Fennberg College of Medicine at North Western University. “But I do not know if we are at this stage, as we can say that this will definitely help all individuals with autism.”
President Donald Trump said that approval “gives hope to many parents who have autistic children that it may be possible to improve their lives.” Mohamed Oz, an official of medical care and medical care centers, described the work as a “savior of life.” “Hundreds of thousands of children, in my opinion, will benefit.”
However, in a press release after the briefing, the Ministry of Health and Humanitarian Services said that Leucovorin “is not a remedy” for autism and “may only lead to improvements in the deficit related to talk of a sub -group of children.”
David Mandel, a professor of psychiatry at the University of Pennsylvania, said that the Folic acid hypothesis is based on relatively weak science.
He said: “We do not have good, large -scale studies showing that any large part of people with autism suffers from a lack of folic acid.”
Leucovorin has turned out to have relatively small side effects in cancer patients, although high doses can cause digestive problems or increase the risk of seizures in people who take anti -activity medications. It is part of a common system of colon and rectum cancer and other digestive system cancers, as it is used to intensify the effect of chemotherapy 5-fluoril. In rare cases, it is used to relieve the side effects of another chemical drug called metotoxite a high dose.
Halladai said that Locovorin’s experiences of autistic music looked at the side effects, but did not specifically assess the safety of the drug. She said that the dose is also different from studying to study, and some of the experiment participants received behavioral treatment, which makes it difficult to determine whether Leucovorin is responsible for improving their symptoms.
Mandel said that the biggest of these experiences have 80 participants – very small to achieve final results.
“If you are looking for the approval of the FDA, for example, you want hundreds of children in these experiences,” he said.
Leucovorin should remove a last obstacle before it is available to some autistic patients. The FDA said it works with GSK, the brand name maker from Leucovorin, to update the drug poster. GSK said in a statement that the drug application is still to be presented to include the new signal of autism.
Oz said on Monday that the recipes of Leucovorin will be covered by Medicaid and that private insurance companies are likely to follow.
But Mandel said he was concerned that the expected discounts to Medicaid could force many families to pay from their pocket, and some of them were paid to buy Volinic acid supplements via the Internet without a prescription. It is unlikely to be tested online nutritional supplements, and it may be difficult to confirm the dose it contains.
Dr. William Dahout, chief scientific official at the American Cancer Association, said that the interest in Leucovorin can affect autism on the availability of drugs for cancer patients.
“We have seen a shortage of this medicine in the past, and if there is increasing interest, a shortage of the future may occur,” he said in an email.