The Mother of All FDA Fails

The FDA has never required drug safety assessment for fetal germline impact, even though FDA staff understand that gestational exposures can adversely affect developing germ cells. We must end this catastrophic omission, while also granting all Americans access to their own prenatal medical records.

Prenatal Exposures: Should You Be Worried?

by Jill Escher (@Autism_Exposed)

My 14 year-old son Jonny, in SF today. Like all of us, Jonny developed from a single egg and single sperm. But something very odd happened to the JonnyEgg, before I was even born—evolutionarily unprecedented bombardment by synthetic hormone drugs that, unbeknownst to anyone at the time, impaired epigenetic synthesis of the all-important germ cell.  Now, having differentiated into 100 trillion cells or so, Jonny is so handsome, and, with a brain that really does not know how to connect, so autistic. Gee, thanks, docs! Thanks epigenetics!

With more people learning about the potential connections between my own prenatal drug exposures and my children's autism (via unintended epigenetic damage to my eggs), I'm hearing many worried, no, panicked, questions from a number of corners. 

I'd like to try to address some of these questions, knowing that my hypothesis has profound practical implications, but with the caveat that these responses are based on the "as far as I can tell from the research" basis, and that I do not speak with any sense of perfect authority on the subject.  So here goes.

Q:  My husband and I used IVF to get pregnant with twins, and the fertility clinic gave me several medications both before and after conception. Should I worry that any of these medications may have damaged the eggs of my daughter and sperm of my son?

I recommend that you contact the fertility clinic as soon as possible to obtain all records, both written and electronic, of your medication use, both before and during pregnancy.  The people who will most benefit from these documents are your son and daughter, who should at some point be given the opportunity to know of their prenatal pharmaceutical exposures, particularly before they contemplate having children of their own.

Depending on the drugs used, dosages, and timing, you and your children should have some level of concern about the impact of the drug exposures on their germ cells, and therefore, your future grandchildren. That said, most of the drugs used in an IVF cycle address the pre-ovulation and early implantation stages, so to the extent they have adverse impacts (and many, including myself, believe they do), those impacts would be seen in the health and development of your children themselves.

Early IVF cycle drugs include a wide variety of chemicals to facilitate production and retrieval of eggs.  Commonly used drugs include agonists and antagonists like Lupron, Synarel, Antagon, Cetrotide, gonadotropins such as Gonal F, Bravelle, Follistim, Menopur, Pergonal and Repronex, HCGs such as Pregnyl, Profasi, Ovidrel and Novarel, corticosteroids such as Medrol, and antibiotics such as doxycycline. It is worth noting that corticosteroids are known to have epigenetic effects on DNA, yet early embryos are routinely exposed to these very genotoxic drugs.

However, your children's primordial germ cells (future gametes) develop from the cluster of cells exposed to the various early-IVF drug regimen, and may be further affected by exposures to drugs, such as hormone preparations, given during the first half of pregnancy. Progesterone is often given from the beginning of pregnancy, under the belief that additional progesterone will encourage implantation and prevent miscarriage.  There is extremely little data to support this contention, however, but since the 1950s it has remained an unshakeable myth perpetuated by the drug companies and a subset of medical doctors.  Administration is via vaginal suppositories, intramuscular injections or by mouth.

I was exposed in utero to heavy doses of synthetic progesterones (along with other hormones), via injection of my mother, throughout the first two trimesters of my gestation.  I advise strongly against the prenatal use of most exogenous hormones, including progesterone, as excess hormones can not only affect the physical and behavioral sexual development of the exposed individual, they can affect epigenetic synthesis of the baby's germline, which can lead to developmental abnormalities in the grandchild generation.

One notable exception, where benefit certainly appears to outweigh risk, is thyroid hormone where mother or baby are hypothyroid and require supplementation to reach normal levels to facilitate healthy fetal brain development.

Q: I took antidepressants (20 mg of Paxil per day) throughout my pregnancy.  My son seems to be okay, but is there a risk of permanent damage to his sperm?

Antidepressants such as SSRIs have been shown to elevate the risk for autism in an exposed fetus, so your son is fortunate to have escaped damage. As for the next generaion, a male fetus develops his spermatogonial stem cells (SSCs) while in utero, cells that go through additional processes of division and maturation, resulting in mature sperm beginning at the time of puberty.  Sperm continue to develop from the SSCs throughout the male's life, spermatogenesis taking about 2 months time.

So the question is, can the in utero exposure to SSRI chemicals impair epigenetic synthesis of the SSCs? Animal models have repeatedly shown epigenetic changes, such as reduced methylation of DNA, in response to exposure to endocrine disrupting chemicals. SSRI drugs are known to interfere with normal hormonal functioning and should be considered endocrine disrupting chemicals. So, though no study has ever been conducted to examine the question directly, the research suggests a possible connection between SSRI exposure and epigenetic fetal gamete impairments.  I strongly urge precaution and recommend against any use of antidepressant drugs during (or several months before) pregnancy.

As an alternative to drugs to elevate mood, women should consider natural alternatives, including a mood-boosting Paleo-type diet packed with micronutrients and healthy fats, and free of processed food, sugars, and inflammation-causing grains. What causes depression in the first place? Often hormone disruption caused by birth control pills, impaired neurological function caused by low-fat diets (tragically, the misguided nutrition advice for the past half-century), and impaired blood sugar control and neurotransmitter function caused by high-carb and processed food diets.

Exercise and talk therapy have also shown to be helpful. But food makes mood, and women should strive to adopt a highly nutritious mood-boosting diet, free of low-fat and processed crap, well before becoming pregnant.

Distressingly, many women report staying on SSRIs during pregnancy because they had become chemically dependent on them over the years and feared suffering through withdrawal.  This represents a dramatic side effect of the drug that is never disclosed or reported. It underscores the importance of resisting all temptation to start taking these drugs if you think you might ever choose to have children.

Again, it is urgent that you obtain copies of all medical records from your pregnancy, so that your son can later have the opportunity to learn of his in utero drug exposures.

Q:  Diclegis, a drug to prevent morning sickness, was just approved as a Category A drug for pregnancy by the FDA.  Are there risks the FDA has not disclosed?

Category A drugs are described as drugs that have been tested and shown to be safe during pregnancy.  However, while Diclegis has not demonstrated increased risk for fetal malformations, it has never been tested for potential impacts to fetal germ cells, which, though subtle and submicroscopic, could result in subtle or catastrophic disability in the next generation. Please do not consider taking Diclegis or any other morning sickness medication until such epigenetic germline testing has been completed. Details on the topic can be found in my Citizen's Petition to the FDA.


  1. I'm curious if you've considered heritable epigenetic damage from vaccines, apart from drugs. This seems to me to be a huge potential problem, and may explain the "official" lack of evidence of direct vaccine damage in autistic children.

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