Food and Drug Administration of the United States turns its attention to selective inhibitors of the reupercake of serotonin, a class of antidepressant drugs criticized by the Secretary of Health and Social Services Robert F. Kennedy Jr.
Monday morning, the FDA welcomed a person of 10 people jury On the use during the pregnancy of the ISRS, which include drugs such as fluoxetine (prozac), sertraline (zoloft) and citalopram (Celexa), among others.
Nine of the 10 members of the panel were researchers, doctors or psychologists who previously questioned the safety of SSRIs publicly or expressed against the use of antidepressants in general.
During the discussion, several members of the panel quoted studies that lacked appropriate controls, said doctors not involved in the panel. In other words, there was no way to be certain on the basis of studies if the health problems observed were caused by the SSRIs, the underlying mood disorder or another factor.
Other participants described the results of the study in an inaccurate or incomplete way, said external experts. For example, few panelists have considered the risks of ISSRs used in relation to the risks associated with untreated depression, which also contributes to poor results for children And mothers. In the United States, suicide is A main cause of maternal death During the first year of a baby’s life.
An FDA spokesperson said the panel was one of the agency’s “wider efforts to apply rigorous standards based on ingredients safety and modernize regulatory surveillance” and has not answered new questions about the next potential stages of the agency.
But health professionals have expressed their concern that the panel can ultimately prevent women from receiving the care they need.
“I was surprised and disappointed by the quantity of disinformation presented,” said Dr. Katie Unverferh, reproductive psychiatrist and UCLA medical director Maternal mental health program.
“When we look at the body of the data … we find that there are no coherent associations [of] ISRS with cardiac anomalies, pulmonary hypertension or neurodevelopmental problems in offspring, “she said, appointing some of the damage panelists attributed to drugs.” This disinformation simply creates intrusive thoughts. It is not useful.
The panel included a single specialist in maternal humor disorders – Dr. Kay Roussos -Ross, obstetrician -gynecologist and director of the perinatal program for mood disorders at the college of medical university of Florida – which argued that the SSRIs are intended for most patients a safe treatment option for serious mental health disorders during pregnancy.
“Mental health disorders are not different from medical problems,” said Roussos-Ross.
“I want to point out that the treatment of mental illness during pregnancy is not a luxury. It is a necessity, ”she said. “We don’t ask [pregnant] Women do not take their anti-hypertensives and risk death to them or their baby. We do not ask women to stop their drugs against diabetes. We must not retain SSRIs as a possible treatment for women who need them. »»
The FDA did not answer questions about how experts were selected for the panel. The participant, Dr. Josef Witt-Derring, leads a private clinic that helps patients wean psychiatric drugs. Another panelist, Dr. Roger McFillin, is a prolific and skeptical podcastor of germ theory, belief – widely considered a fundamental truth in medicine since the 19th century – that infectious diseases have been caused by microorganisms.
The Panelist, Dr. David Healy, psychiatrist of Wales, has made a number of confusing and misleading declarations, insisting that “mothers who take IsRers during pregnancy have a risk of 10 times higher to have a baby with a fetal alcohol syndrome” (This figure describes the population of the subjects of the population One 2011 Study, not the general public). Healy also said that “any medication that causes congenital malformations will also cause autism spectrum disorder”, an affirmation that has no basis in scientific research.
Dr. David Urato, head of maternal and fetal medicine at the Metrowst Medical Center in Framingham, Mass., Was the only panellist in addition to Roussos-Ross who directly cares about pregnant patients. He spoke with force the potential damage that drugs pose to the development of babies.
“Never before in human history, we have chemically changed babies like this,” he said during the discussion. “There is now more than enough evidence to support solid warnings from the FDA on how drugs disrupt fetal development and have an impact on mothers.”
Roussos-Ross argued that the increased risk of congenital malformations for babies exposed to SSRIs during pregnancy was statistically insignificantand that Children of mothers with untreated depression were more likely to have subsequent behavioral problems than those of mothers who took medication for the disease.
“To have that [medication] Not being available for women who need it, it would be really harmful, “she said.
To this, the moderator of the Panel Tracy Beth Høeg – a sports medicine doctor who is now the main advisor for the clinical sciences at the FDA – said: “I will do something unconventional. I’m sorry to play the favorites, but Dr. Urato, I want you to weigh now. ”
In response, Urato questioned the idea that improving a mother’s depression symptoms leads to better results for babies.
“This idea of depression – [that it] can harm and therefore we treat [it] With these chemicals, and by obtaining treatment, we see improved results – this is something we would all like. It’s a pious wish, “he said.” But that’s not really what the data shows. “”
It was not clear to what data he was referring. In 2019, the most recent year for which data is available, One in eight American adults had a prescription for antidepressant drugs. Although drugs do not work for all people suffering from major depression, Analysis of several studies have always found them significantly better than placebos to the attenuation of the symptoms of the disease.
Medicines were a target of the Make America Healthy movement again, as well as vaccines and food dyes. In his confirmation audiences and on the appearances in the podcast, Kennedy has affirmed – with inaccuracy – that drugs are both linked to school fire and more difficult to stop than heroine. There is no evidence for one or the other complaint.
In February, President Trump placed Kennedy at the head of Make the Commission in good health of AmericaA group responsible, among other things, to assess “the prevalence and threat posed by the prescription of selective inhibitors of serotonin reuptake, antipsychotics, mood stabilizers, stimulants and weight loss drugs.”
Health professionals expressed their frustration at the FDA approach.
“There is already so much shame and stigmatization that surrounds these diseases. There is also a lot of shame and stigmatization concerning the taking of drugs during pregnancy or the postpartum period, “said Paige Bellenbaum, perinatal therapist in mental health and assistant social work professor at the Hunter College. “We take a giant step back in many ways. It will restore the fear that was there to start [and] will ultimately lead to the loss of life. »»
Alexandre Bonnin, an associate professor of pathology at the USC, studied the effects of prenatal exposure to ISRS on the fetal brain in development for years.
The most recent studies in the field have not found a statistically significant association between SSRIs and fetal damage, he said. “Our observation, at least at the fundamental scientific level, suggests that the use of SSRIs during pregnancy can be beneficial if the mother is under stress, anxiety or major depression, because the Maternal stress in fact itself Has many negative effects on the development of the fetal brain, “he said.
