The University of Texas Southwestern Medical Center have announced new research and planning to see if Prozac (fluoxetine) can improve brain development, intellectual functioning, and behavior of children with Down Syndrome (DS) when given prenatally and postnatally during the first 2 years of life.
According to a breakdown of the study, found here, pregnant women and their unborn child will be assigned randomly to receive either fluoxetine or placebo in the study. Participants will have a 2 in 3 chance of receiving fluoxetine or placebo.
The study suggests...
During the prenatal study period, participants will take their assigned medication orally. After her child is born, the mother will stop taking the oral tablet of her assigned medication and her child will start a liquid solution of the medication to be taken orally. After birth, the fluoxetine dose will be adjusted as needed.
This, as far as I am aware, is a first as the ingestion of antidepressants by pregnant mothers has never been studied in a clinical trial before because, to date, it has always been deemed unethical. It throws up debate, much of it centered around antidepressants and the birth defect link, although this study's aim is not to prove whether or not antidepressant use in pregnancy can harm the fetus.
Very little has been mentioned in the press about this study save for a spattering here and there citing a study in mice whereby it was shown that mice with the extra copy of Down syndrome genes (like humans with DS), apparently improved the disturbed processes of brain development/function when treated with Prozac.
It's a tricky area as the target subject in this new study are both pregnant mothers and fetuses that have already been deemed to be carrying DS genes. Any help DS children can get in life should be applauded but is it right to put them at risk?
Half of the funds for the study have been raised by father, Paul Watson, who heard about the success of the studies in mice. Paul's son was born with Down syndrome.
Here's NBC reporting on the study... (If video does not load then it can be viewed here)
For years Prozac has been cited as one of the more safer SSRis on the market, in the UK, for example, it can still be prescribed to minors legally, the only SSRi that, apparently, does not show evidence of inducing suicidal thoughts in children and teenagers taking it. Surprisingly, the American drug regulator, the FDA, feel that Prozac should, just like the other SSRis on the market, carry a black box warning listing the dangers of its use in children and adolescents. As with all SSRis Prozac has never been deemed safe to give to pregnant mothers, that decision is left to both treating physician and the mother.
This study bothers me somewhat. Who has made this decision whereby it is now deemed ethical to study an antidepressant in a living fetus, end of the day a fetus with the down syndrome gene has just as much right to life as a "normal, healthy" human fetus.
Why has this study been given the green light, moreover, isn't this merely a guinea pig trial using a drug that can potentially cause more harm to the fetus on someone (the fetus) who has no say in the matter?
The study's lead author, Dr. Carol Tamminga, said, "the medical community has been giving Prozac to children with Down syndrome for years, but the effects of giving it to children in utero haven’t been tested." She added, "and this will really be the first controlled trial where we will get to test does this really work or not."
Tamminga's biography page shows that she has served as a Member and Chair of the Psychopharmacological Drugs Advisory Committee of the FDA. However, there is no mention of the payments made to her by Prozac manufacturers, Eli Lilly.
Jan. to Dec. 2011 - $1,574 for Business travel and other value.
Jan. to Dec. 2013 - $466 for Business travel and other value.
Jan. to Dec. 2013 - $267 for Business Meals.
Tamminga has also received research support from Sunovion and travel funds from Autiphony Therapeutics and has served as a consultant for Astellas, Kaye Scholer LLC for Pfizer, and Lundbeck.
According to Drugwatch it is estimated that thousands of people have filed Prozac lawsuits citing a variety of adverse events including mental, emotional and physical suffering. Early cases have claimed that Prozac has caused an increased risk of suicidal thoughts and violent behaviour. Drugwatch also claims that by the year 2000 Prozac manufacturer, Eli Lilly had reportedly paid out more than $50 million to settle more than 30 Prozac lawsuits related to murders or suicides.
Drugwatch also claims that Prozac has been linked with birth defects, including anencephaly, a fatal defect in the neural tube. Newborns also can experience septal defects, damaged hearts or cleft lip or palate.
Yet here we are in 2016 putting this powerful SSRi into the bodies of pregnant mothers who are carrying a fetus with DS genes. Furthermore, here we are in 2016 giving a newborn baby from the age of 0-2 years the liquid formulation of Prozac.
Background of the study can be read here. Results are expected to be available within 12 to 18 months.
I do hope all the participants are given all the information about Prozac, including the information about the $50 million paid out in Prozac lawsuits related to murders or suicides and also Prozac's link to birth defects.
I honestly don't know what to say anymore.
Bob Fiddaman.
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