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The head of the US food administration and US drugs, Marty Makari in the White House on September 22.Credit: Andrew Harnik/Getty
On September 22, senior public health officials in the United States stood with President Donald Trump in the White House and in an instant transmitted a message that took place around the world. The US Sanitary Supervision of the US products and medicines (FDA) said this intends to change his leadership on acetaminophene – Also known as paracetamol – homemade anesthesia sold in the United States as Tylenol. The FDA published a statement stating that the agency initiates a change in its marking “reflecting evidence indicating that the use of acetaminophen with pregnant women may be associated with an increased risk of neurological conditions, such as autism and autism and autism and [attention deficit hyperactivity disorder] in children “. What confuses is that this proposed action from the US drug regulator does not accurately reflect the spectrum of research results, as well as consensus among researchers. This consensus should be expressed with a nuance of uncertainty, which always exists in scientific research. Weapons that uncertainty to the detriment of public healthcareField
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During pregnancy, paracetamol is usually recommended for pain and fever, in a minimum possible dose and in the shortest possible time under the guidance of a qualified medical worker. It is recommended because it relieves pain with minimal risks, and because Unprocessed fever can harm unborn childrenThe regulators of drugs in the vast majority agree that there is no constant evidence to assume that this leadership should change. And last week they quickly said.
National regulators and public health authorities are in no hurry to change their leading principles. Against, World Health Organization has issued a statement They say that “at present there is no convincing scientific evidence confirming the possible connection between autism and the use of acetaminophen during pregnancy.” A The European Medicon Agency stated that its leadership is also invariably – What is: “There is no evidence that the adoption of paracetamol during pregnancy causes autism in children.” This was the same message from national regulators around the world, from Australia to the UK, as well as from state bodies in the United States, as well as professional societies that represent researchers and clinicians in the field of autistic spectrum disorder, obstetrics and gynecology.
This is the long -awaited development that public health organizations have quickly opposed these inaccurate statementsThe field correction of misinformation now matters more than when -libs from the speed with which it spreads. The fact that the United States speak and is important for people both inside and beyond, out of its significant influence on the health care policy and science. Thus, for trusted organizations with experience and for those who are responsible in global public healthcare, it is extremely important for quickly correcting the recording and strengthen their messages.
The choice of cherries
Although a small number of studies reports the relationship between paracetamol and autism, public healthcare bodies around the world agree that these conclusions are not final and outweighed by other, more reliable conclusions that have not found the appropriate connection. In the statement, FDA recognizes that “a causal relationship was not established, and opposite studies are conducted in the scientific literature.” However, in a statement by the White House, published on the same day, this is not mentioned.
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One of the largest research1Including the data of almost 2.5 million children born in Sweden, did not find convincing evidence of the association. The study of public healthcare Viktor Alquist at the Carolinskaya Institute in Stockholm and his colleagues studied medical records for children born from 1995 to 2019. Researchers studied data on the use of paracetamol during pregnancy and subsequent diagnoses of autism among children. They also analyzed the couples of brothers and sisters, in which one was exposed to paracetamol, and the other was not to control the mixed factors. There was no evidence of the association in the study of brothers and sisters.
Research of a fertility costume2 In Japan (also including brothers and sisters) I also did not find a convincing link. Yusuka Okubo, a public health researcher at the National Health and Development Center in Tokyo, and his colleagues studied the records of about 200,000 children.
A study of the White House provides a study3 Epidemiologist Diddieier Prada at the Ikan Medical School on Mount Sinai in New York and his colleagues. Nevertheless, he does not mention that the study says that the connection between acetaminophen and autism “requires caution”. The authors of the study also “recommend the rational use of acetaminophen – the lowest effective dose, the shortest duration – under the medical leadership.”
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How do we have written on these pages beforeThe regulation of drugs always requires a thorough calculation of risk and benefits. Preparations are never at risk. When medicines and other therapy are approved by regulatory authorities, precisely because researchers and other specialists working in regulatory authorities took time to evaluate all the evidence of safety and efficiency, and believe that the advantages outweigh the risks.
In the field of public healthcare, as in science, decisions are made by regular assessment of all available evidence, taking into account the quality of research, and not only referring to those statements that support one opinion on others. If new evidence appears, recommendations are reviewed and, if necessary, revised. That is how the bodies in the world of public health work work because they agree that there is no better way to improve healthcare and reduce risks. The fact that the federal agencies of the United States currently evade this approach is a real danger to the health of people living there and around the world.
Public health authorities everywhere must continue to correct the record and do it quickly when necessary. The risks of inaction are too great. In science, there is almost always uncertainty. Responsible what needs to be done is the communication of research in such a way that this is the fullness of their conclusions; And in public healthcare, in order to ensure decision -making in accordance with the consensus of experts.
