Explanatory: Can leucorine be considered a treatment for autism, as Trump suggested? An expert says the evidence is “very, very weak”

On Monday, the US Food and Drug Administration (FDA) has published an announcement in the federal register before the speech of US President Donald Trump, approving a version of Leucorine produced by Glaxosmithkline (GSK), which the pharmaceutical company had previously retired from the FDA evaluation process when the production of the drug ceased.

The FDA has invoked an analysis of the use of leukorine in 40 patients with a rare metabolic disorder called cerebral folate deficiency, which can lead to a number of neurological symptoms, some of them being observed in people with autism.

Here's what is known about leukorine and autism.

What is leukorine

Leucovorina, also known as folinic acid, is a form of folate, an essential vitamin (or B9).

Leukovorina has been approved by the US Food and Medications Administration (FDA) to counteract the toxic effects of certain cancer drugs, such as methotrexate, which blocks the use of folate by the body.

Leukorine is also used to enhance the effects of other chemotherapeutic drugs and to treat certain types of anemia. The drug can be administered orally or intravenously.

According to the FDA website, Leucovorina is produced by more than six companies.

Why is the folate important

The folate helps the cells to grow and divide. It also supports the immune system and helps to produce healthy red cells. In developing girls, an inadequate level of folate leads to a type of serious congenital malformation called “defects of the neural tube”.

The center for control and prevention of diseases in the US recommends to all women who may become pregnant to complete their diet with 400 mcg of folic acid every day, to prevent the defects of the neural tube.

Some studies, but not all, also discovered an association between low levels of maternal folate during early pregnancy and an increased risk of autism in children.

The folate, the natural form of vitamin B9, is an essential nutrient involved in cell growth, DNA synthesis and the formation of red blood cells, being necessary for optimal functioning of the body. A folate deficiency can increase the risk of heart disease through high levels of homocysteine ​​and can lead to serious congenital malformations in the fetus, as well as to an increased risk of cancer. The folate is present in many vegetables with green, legume and citrus leaves, while folic acid is the form of synthesis.

Why can leucorine use for treating autism can be considered

Doctors prescribed leukorine for autism outside the approved indications or reused an approved drug for a condition to treat another condition.

Studies conducted by researchers at Suny Dowstate Medical Center in Brooklyn, New York, and other parts have suggested that up to three quarters of children with autism have genetic variations that affect their body's ability to process folate or autoimmune disorders that block folate transport to the brain.

Other small studies have associated these discoveries with more severe forms of the disorder and have suggested that leukorine treatment can improve verbal skills, social skills and irritability to these young people.

However, the scientific progress on leukorine and autism “is still in an early stage and more studies are needed before it can be reached a definitive conclusion,” Autism Science Foundation (Foundation for Autism Science), in a statement.

The data in favor of leukorine treatment come from four small controlled studies, all using different doses and having different results, and in one case, based on a specific genetic version “, notes the Foundation, on its website.

Dr. David Mandell, a professor of psychiatry and autism expert at the University of Pennsylvania, told Reuters that Leucorina could be a possible treatment for some children with autism, but the evidence we have in support of it … are very, very weak. “

President Donald Trump said on Monday, in an announcement at the White House, that there is a connection between the use of a popular analgesic without a prescription, Tylenol (which contains Paracetamol), and the development of autism, during pregnancy, a statement challenged by many doctors. “Avoid taking” Paracetamol, the American leader repeated during an event at the White House dedicated to autism, a complex disorder with a very broad spectrum and whose origin has long been the object of medical research.

Trump also suggested the use of leukorine as a treatment for the symptoms of autism.