The United States Food and Medicines Administration is directing their attention to selective serotonin reuptake inhibitors, a class of antidepressant drugs criticized for a long time by the Secretary of Health and Human Services Robert F. Kennedy Jr.
On Monday morning, the FDA organized a 10 person Expert panel On use during pregnancy of the ISRs, which include medications such as fluoxetine (prozac), sertraline (zoloft) and citalopram (celexa), among others.
Nine of the 10 panel members were researchers, doctors or psychologists who previously questioned the security of the SSRIs publicly or have spoken against the use of antidepressants in general.
In the course of the discussion, several members of the panel cited studies that lacked appropriate controls, said doctors not involved with the panel. In other words, there was no way of being safe on the basis of studies if the health problems observed were caused by the SSRIs, the underlying mood disorder or some other factor.
Other participants described the study findings in an inaccurate or incomplete way, they said external experts. For example, few panelists considered the risks of the use of SSRs in relation to the risks associated with unrelated depression, which also contributes to bad results for children and Mothers. In the United States, suicide is a main cause of maternal death In the first year of a baby's life.
An FDA spokesman said that the panel was part of the “broader efforts of the agency to apply rigorous standards based on evidence to the safety of ingredients and modernize regulatory supervision” and did not respond to new consultations on the possible upcoming steps of the agency.
But health professionals expressed concern that the panel could prevent women from receiving the attention they need.
“I was surprised and disappointed as the amount of erroneous information that was presented,” said Dr. Katie Unverferth, a reproductive psychiatrist and medical director of UCLA's Maternal mental health program.
“When we look at the data body … we found that there are no consistent associations [of] Irs with heart defects, pulmonary hypertension or neurological development problems in the offspring, “he said, naming some of Harms panelists attributed to drugs.” This erroneous information simply creates intrusive thoughts. It is not useful. “
The panel included only a specialist in maternal mood disorders: Dr. Kay Roussos-Ross, an obstetrician-ginologist and director of the Perinatal General Staff Disorders Program at the Florida University of Medicine Faculty, which argued that the SSRIs are for most patients a safe treatment option for serious mental health disorders in pregnancy.
“Mental health disorders are not different from medical disorders,” Roussos-Ross said.
“I want to emphasize that treating mental illness in pregnancy is not a luxury. It is a necessity,” he said. “We are not asking [pregnant] Women will not take their antihypertensives and risk death or their baby. We are not asking women to stop their diabetes medications. We should not retain the SSRs as a possible treatment for women who need it. ”
The FDA did not answer the questions about how experts for the panel were selected. The participant, Dr. Josef Witt-Dorring, directs a private clinic that helps patients highlight psychiatric medications. Another panelist, Dr. Roger McFillin, is a prolific podcast and a skeptic of theory of germBelief, widely sustained as a fundamental truth in medicine since the nineteenth century, that infectious diseases are caused by microorganisms.
The panelist Dr. David Healy, a Wales psychiatrist, made a series of confusing and mislead One 2011 Study, not the general public). Healy also declared that “any medication that causes birth defects will also cause autistic spectrum disorder”, an affirmation that has no basis in any scientific research.
Dr. David Urato, Chief of Maternal and Fetal Medicine at the Metawest Medical Center in Framingham, Massachusetts, was the only panelist in addition to Rousssos-Doss who cares directly with pregnant patients. He spoke strongly about the potential damage that drugs represent for developing babies.
“Never before in human history we have chemically altered babies like this,” he said during the discussion. “Now there is more than enough evidence to support strong warnings of the FDA on how drugs interrupt fetal development and impact mothers.”
Roussos-Ross argued that the greatest risk of birth defects for babies exposed to SSRs in pregnancy was statistically insignificant, and that children of mothers with unrelated depression were more likely to have subsequent behavioral problems than those of mothers who took medication for the disease.
“Have that [medication] Not being available for women who need it really would be harmful, ”he said.
In this, the Moderator of the Tracy Beth Høeg panel, a sports medicine doctor who is now the main advisor of Clinical Sciences in the FDA, said: “I'm going to do something unconventional. I regret playing favorites, but Dr. Urato, I want you to weigh now.”
In response, Urato questioned the idea that depression can be relieved with antidepressant medication.
“This idea about depression – [that it] can cause damage and, therefore, we treat [it] With these chemicals, and when we obtain treatment we see improved results, this is something we all want. It's an illusion, “he said.” But it is not what the data shows. ”
It was not clear to what data he meant. In 2019, the most recent year for which data is available, One in eight adults us He had a recipe for antidepressant medication. Although drugs do not work for all people with major depression, multiple studies have consistently found that they are significantly better than placebos to relieve disease symptoms.
Drugs have been the goal of Kennedy Healthy Again's Make America Movement, along with vaccines and food dyes. In its confirmation and apparitions in Podcast, Kennedy has incorrectly stated that drugs are linked to school shootings and more difficult to stop heroin. There is no evidence of any of the claims.
In February, President Trump placed Kennedy at the head of the Make America feel healthy again commissionA group in charge of, among other things, evaluate “the prevalence and threat raised by the prescription of selective serotonin reuptake, antipsychotics, mood stabilizers, stimulants and medications for weight loss.”
Health professionals expressed their frustration with the FDA approach.
“There is already so much shame and stigma that surrounds these diseases. There is also a lot of shame and stigma around taking medications during pregnancy or postpartum period,” said Paige Bellenbaum, a perinatal mental health therapist and attached professor of social work at Hunter College. “We are giant step back in many ways. This will restore the fear that was there to start with [and] Finally it will result in the loss of lives. “
Alexandre Bonnin, associate professor of pathology at the USC, has studied the effects of prenatal exposure to the SSRIs on the fetal brain in development for years.
The most recent great studies in the field have not found a statistically significant association between the SSRIs and fetal damage, he said. “Our finding, at least at the basic science level, suggests that the use of SSRs in pregnancy can be beneficial if the mother is under important stress, anxiety or depression, because maternal stress actually has many negative effects on the development of the fetal brain,” he said.
