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 Drug Use in the 60s, Two Snapshots

How pervasive was pregnancy drug use in the 1960s?  We can look at two cohorts, the CHDS (Child Health and Development Study) and the Collaborative Perinatal Project to get a sense of this vast history.  The top chart shows CHDS drug use throughout pregnancy, and the bottom two refer to drug CHDS and CPP drug use in roughly the first half of pregnancy.

Use of anti-nausea drugs, sedatives, hormones, painkillers and amphetamines were all common.  Which of these abnormal exposures entered the womb and fetal tissue? All of them.  Which of these affected fetal development? Most of them, though sometimes very subtly.  Which of them affected fetal germline?  Well, we hope to find out.




6 comments:

  1. Did you see you made Autism Speaks top ten blogs of 2013?

    http://www.autismspeaks.org/blog/2013/12/20/10-inspiring-and-informative-blogs-2013

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  2. Yes, I did. Thanks for noticing, it Roger!

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  3. Jill,

    I just listened to your interview from last year with Sean Croxton (http://undergroundwellness.com/podcasts/autism-the-plausible-cause-no-one-is-talking-about/) and I am so intrigued by your hypothesis! I do not have children with autism but thought of another connection that I hope will be studied.

    WHAT ABOUT FERTILITY? Have infertility issues not soared in recent years? I know you mentioned that IVF increases risk factors for ASD, but might that be because our reproductive organs, gametes, and the rest are possibly effected by prenatal exposures?

    I'm among the fortunate folks not exposed during my gestation in the 1970s, but there are people close to me with fertility issues, extremely painful periods, endometriosis, etc. There is one whose mother to an anti-nausea drug during her gestation in 1976. I understand it is all hypothetical but it is such an important topic to understand!

    I suppose there is nothing to do but hope for everyone's health and for studies that give us more answers.

    Also: Does this hypothesis possibly mean that there may be a die-off of ASD? Wouldn't that be amazing, if it is just a genetic epidemic of our time and two generations from now the incidence returns to the numbers of 40 years ago?

    I look forward to hearing your perspective.

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    1. There was a fair bit of research conducted on the effects of hormones on brain development in sheep. One of the things that came out of the research is that there's a critical period during prenatal brain development when exposure to external hormones can cause incorrect patterning of the part of the brain that controls hormones (the hypothalamus), resulting in fertility problems and endocrine disorders later in life.

      In the sheep experiments, most (70 percent) of the ewes affected in this way were fertile during their first breeding season, but there was a 100 percent failure rate during the second breeding season. The hypothalamus in the affected ewes was no longer able to generate the "LH surge" that causes maturation and release of the egg during ovulation. My reading of the reseach was that you end up with effects that look very similar to PCOS in humans (this makes me think that most cases of PCOS today are very likely a legacy of prenatal exposure to medical hormones, the number of people who were exposed to synthetic hormones before birth is huge).

      I couldn't find anything at all in the medical literature dealing with the effects of synthetic hormones on genetic males, but I think you end up with similar effects - incorrect control of hormones later in life, leading to fertility problems and endocrine disorders. In my case, I thinkt my hypothalamus ended up mostly or completely patterned as female, and throughout my life it's been attempting to regulate my hormones as if I were a woman rather than a man. This is because I've ended up developing bodily proportions (bone structure, limb and finger lengths etc) that are more like a woman's than a man's. My testosterone production certainly seems to have been below normal male all my life, and to have continued falling as I've got older, to the point where I started showing most of the symptoms of acute hypogonadism a few years ago. Since fertility and testosterone both originate in the same place in men, I'm fairly sure I'd be completely sterile by now, except I've started taking fertility drugs as a way of artificially boosting my testosterone production (I've been forced to self medicate because, under the NHS, it's nigh on impossible to get medical treatment for male hormonal problems).

      So yes, I think there must be literally millions of both women and men alive today who are suffering from fertility problems and endocrine disorders as a result of medical hormone treatment gone wrong. There's very likely a link to ASD too, it's a known fact that prenatal exposure to medical hormones can affect personality and behaviour later in life. There's an organization called Hhorages France that's currently trying to highlight high rates of suicides and psychiatric disorders among children who were prenatally exposed to synthetic hormones.

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    2. Hugh, I always appreciate your extraordinary intelligence and insight, you Brits seem to have a superior ability to articulate difficult concepts. Anyway, I agree that "there must be literally millions of both women and men alive today who are suffering from fertility problems and endocrine disorders as a result of medical hormone treatment gone wrong."

      What a tragedy that people, for the most part, have no idea whatsoever of their own prenatal exposures. But for the most serendipitous good fortune I would never, ever have had a clue that I was so heavily exposed in utero to these powerful, mind-bending, body-bending and gender-bending drugs.

      This is a silent epidemic, with an almost completely hidden cause.

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  4. Hi Ashley,

    Thanks for tuning into my podcast with Sean Croxton, it was a weird topic for his show but an episode of his podcast got me thinking about my own prenatal exposures nearly 3 years ago, so it was only appropriate!

    I definitely think that drugs and chemicals are playing a major role in declining fertility in both males and females. In fact there's a whole lot of animal studies on gestational exposure to endocrine-disrupting chemicals that demonstrates this effect.
    As for the anti-nausea drug to which your friend was prenatally exposed, yes, I believe those drugs can have various long-term adverse effects, based on what I've learned about molecular endocrine-disrupting impacts.

    You need to understand that the FDA DOES NOT TEST FOR LONG-TERM IMPACTS OF PREGNANCY DRUGS. The FDA limits testing to gross anatomical malformations, and in some cases, short-term neurodevelopment. No other testing is necessary. In fact, an anti-nausea drug called Diclegis was just granted an "A" safety rating with no concern for long-term impacts or, perhaps more importantly, germline impacts. It's just insane.

    As for a die-off of ASD. While I'm guessing rates will decline somewhat I doubt they will plummet, and that's because we are an increasingly medicated society -- statins, ADHD drugs, anti-depressants, painkillers, diabetes drugs, IVF drugs, hormonal contraceptives, you name it.

    ALL THESE DRUGS WILL HAVE AN ADVERSE MOLECULAR IMPACT ON HUMAN GERMLINE, yet neither the medical community nor the FDA has yet considered that an important issue to address. They are still clueless about germline epigenetics.

    Thanks for writing and being so alert to these urgent issues. Please stay in touch via my new website, germlineexposures.org.

    jill e

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