Petitioning Food and Drug Administration and 1 other

FDA, acknowledge that hormone treatment during pregnancy can cause intersex and transgender!

0

0 have signed. Let’s get to 200.

This petition is to ask the FDA to acknowledge that, when a pregnant woman is given medical treatment with synthetic hormones, these substances can cross the placenta and cause abnormalities of sexual development in her unborn child, including both physical intersex conditions and transgender.

There are a variety of situations in which medical treatments involving high doses of synthetic hormones are given to pregnant women. Many of these treatments would, if given in the same dose to an adult man, suppress his testosterone production and have other feminising effects on him. Based on my own experiences and what I’ve seen of the effects of an artificial estrogen called DES, they can do the same thing to a male foetus, the main difference being that the effects are permanent. Due to the way foetal development takes place and the fact that most medical use of these drugs tends to be during the second half of the pregnancy, brain development is more likely to be affected than physical development.


Background

Synthetic hormones were first developed during WW2. Since that time, their use has expanded to the point where they’re now probably the most widely used type of pharmaceutical product there is in the entire field of medicine. Among the different types of synthetic hormones, there are two classes of artificial female hormone: estrogens and progestins. These female hormone derivatives tend to be mainly used in women’s medicine, because in men, they suppress testosterone production and have other feminising effects at quite modest doses (well below those commonly used for medical treatment in women).

The main uses for estrogens and progestins in men are for chemical castration of sex offenders; suppression of testosterone production in prostate cancer patients; in experimental hormonal contraception for men (none of which ever went beyond the clinical trials stage), and as part of the hormone treatment for turning a man into a woman.

There's one other situation in which a male person can be exposed to high doses of artificial female hormones: before birth, if his mother is in danger of going into premature labour. Both estrogens and progestins have long been used during difficult pregnancies where there's thought to be a risk of miscarriage, in doses that would be more than sufficient to shut down testosterone production and have other strong feminising effects on an adult man. Most treatment with these drugs tends to happen during the second and third trimester of the pregnancy, which is after the genitals have completed their development but during the time the permanent structure of the brain is being built. Commonsense says that there's an obvious risk that, where the unborn baby happens to be male, you could end up creating a person with male genitals but whose brain developed as female instead of male. Based on my own experiences and what I've seen of the effects of the earliest of these drugs, the artificial estrogen DES, that's exactly what can happen in real life too.

Among "DES sons", there seem to be 3 main types of commonly experienced problems:
* intersex-related genital abnormalities (DES was often started in the first trimester, early enough to affect genital development)
* damage to the hormone regulating regions of the brain (the hypothalamus and pituitary), leading to problems such as impaired spermatogenesis and abnormally low testosterone production later in life
* psychological effects, including gender dysphoria, as well as seemingly non gender related problems such as depression, ADHD and autism spectrum disorders.

Based on what I've seen of the effects of DES, I think it's quite likely that the whole transgender phenomenon of recent times is largely being driven by people who were exposed to DES or other female hormone derivatives before birth.

Although DES was withdrawn from use 40 years ago, other treatments involving high doses of other female hormone derivatives are still in use. One example is "Proluton Depot", an injectible progestin (the same type of synthetic hormone as is used to chemically castrate sex offenders!). The standard dose for prevention of miscarriage or premature birth is either 250mg or 500mg a week, which if you know anything about hormones, looks like a very high dose indeed.

http://www.drugs.com/cons/hydroxyprogesterone-intramuscular.html

This is just one example I've found; there are probably many others. That these drugs could cause intersexed or partial female development in a male foetus doesn't part of their safety testing or assessment for suitability of use during pregnancy, and I for one think it should!

If you or your partner are planning on having children, or you know someone who is, then I'd urge you to sign this petition. You never know whether your pregnancy could take a turn for the worse, resulting in an unexpected hospital visit during which you're administered one of these drugs.

Please sign this petition!

My story

From a young age I've been aware of somehow being different from other people, but it's only a couple of years ago that I figured out what that difference might be: somehow, part of my brain development seems to have gone down the female pathway instead of the male one. I spent most of 2011 trying to figure out how this could have happened, looking at how sexual development takes place in the unborn child, and the kinds of things that can go wrong with that process.

A not widely appreciated fact is that androgenic hormones (primarily testosterone and its derivative DHT) play a crucial role in driving male development, and if for whatever reason these hormones aren’t produced, the foetus will develop as female, irrespective of whether they are genetically male or female (there’s a condition called Complete Androgen Insensitivity Syndrome which basically proves this to be so).

In my case, something seems to have catastrophically disrupted my endocrine system partway through the pregnancy, so that for a time I stopped producing any testosterone. Since (apart from a hydrocele) my genitals aren't affected, this must have been after my genitals had essentially finished their development. Judging by which brain functions seem to be female, it must have been fairly early in the process of wiring up the permanent structure of my brain though. Going on the timing of these developmental events, whatever it was seems to have happened somewhere between 15 and 20 weeks into the pregnancy - at or soon after the time when my mother would have first felt me moving inside her, and close to the point where ending the pregnancy would no longer have been a miscarriage but would have become a stillbirth instead.

Given my mother’s history of depression and knowing that my parents had used birth control pills for contraception, my immediate thought was that perhaps she was in the midst of a depressive episode when she first felt me moving inside her and had taken an overdose of contraceptive pills in an attempt to end the pregnancy. Obviously that’s not a pleasant thought to leave hanging around unresolved, so I went to quite a lot of trouble to try to figure out if that’s what actually happened.

A bit of snooping on maternity forums soon confirmed that an overdose of birth control pills is indeed the first thing most unhappily pregnant women seeking a DIY method for ending their pregnancy seem to think of. Apparently, it isn't all that unusual for hospital ERs to see pregnant women who've done that very thing. It’s treated as a minor poisoning incident. These cases don’t normally result in a miscarriage, so I was expecting to find plenty of research documenting the aftereffects of such incidents on male development. Much to my surprise, I couldn’t find anything in the publicly accessible medical literature. Worse, I couldn’t find any acknowledgement at all of the possibility that exposure to synthetic hormones (or any other drugs capable of suppressing testosterone production), might interfere with normal male foetal development.

However, I did discover that the first mass-produced synthetic hormone, a potent artificial estrogen called diethylstilbestrol (or DES), had, from about 1940 until the mid-1970s, been widely used in the US and worldwide as a treatment to prevent miscarriages. Unfortunately, when the extent of the damage caused by this substance started to become apparent, medical records went missing, doctors practices and apparently even entire countries (the UK) claimed they never used the stuff, and so the total number exposed isn’t known with any degree of certainty. Most estimates seem put the number of mothers given the drug at around 5 million, with there being between 2 and 3 million "DES daughters" and an equal number of "DES sons" being exposed to the drug in the womb.

DES made the ideal candidate to study  the effects of testosterone-blocking drugs on male foetal development for a number of reasons:
· In adult men, DES is highly effective at suppressing testosterone production. The dose required to completely shut down testosterone production in prostate cancer patients is 3mg per day. The doses being used for miscarriage prevention were always higher than this. Under the standard "Smith and Smith" treatment plan, the mother was given 125mg per day towards the end of the pregnancy, more than 40 times the dose used to chemically castrate prostate cancer patients! That sort of extreme dosage makes it virtually inevitable that testosterone was being suppressed for at least part of the pregnancy.
· I’d read about a study of teenage boys who were prenatally exposed to DES. They showed a characteristic pattern of very shy, socially passive behaviour, being bullied and ostracised by their classmates, regarded as sissies and having no interest in sport. The parallels with my own teenage years were striking.
· While the DES mothers and daughters are acknowledged to have suffered a whole range of devastating effects as a result of their exposure, the official line is that the DES sons came through virtually unscathed. Given that, over the course of a typical DES pregnancy, they were exposed to roughly as much artificial estrogen as is contained in 500,000 birth control pills, that seemed a little too good to be true. I wanted to know whether we’re being told the full facts about what synthetic hormones can do to a developing foetus. If DES could cause intersexed development and that fact not be acknowledged, that makes it far more likely that other synthetic hormones are doing the same thing.

In July 2011 I joined an online support group for DES sons (which had originally been set up by a social scientist, Dr Kerlin, as part of a study looking at the effects of DES on gender identity). One thing that immediately struck me was that it was supposed to be a group for DES sons, yet around half of the people posting seemed to be using women’s names! I soon discovered that these people were actually DES sons at birth, but now identified as women (in my case, not enough of me is female for me to identify as a woman, I just have a strong sense of not being one sex!). Aside from that, many of the life experiences being talked about closely paralleled my own, including the shyness as a teenager, being relentlessly bullied at school, learning to create a fake male identity, and a period of very self destructive behaviour as a young adult.

Physically there were similarities too. Although gender identity seemed to be the main gripe for most members, looking at the life stories many of them posted on joining the group, it became clear that they had very high rates of intersex-related genital abnormalities at birth. I too was born with a genital abnormality. Among those that hadn’t opted for reassignment, it seemed that chronically low testosterone was a widespread problem, as it has been for me. Some mentioned being easily mistaken for girls, and I got the impression that a high percentage have the same "eunuchoid" body structure that I have (this is the result of having below normal male levels of testosterone during childhood and puberty, and as an adult makes you look a bit like a cross between a man and a woman).

There’s been almost no research into DES sons, and based on what I saw in that group, it’s easy to see why. All the bodies who would normally carry out the research (the FDA, the pharmaceutical companies, doctors organisations) were implicated to some extent in the DES disaster. I think they must have taken one look at what had happened to the DES sons, and  decided that the numbers affected were so large and the effects so horrific, that their only option was to try to pretend that the whole thing never happened. Amazingly enough it worked, no doubt helped to a large extent by the shame and secrecy that surrounds intersex conditions and transsexuality.

Everyone looking at the aftermath of the DES disaster seems to have assumed that, just because it’s such a powerful estrogen and was given in such high doses, that all the harm it caused was through estrogenic effects, and that now it’s been withdrawn from use, the problems it produced are past history. If I’m right about what happened to me then that clearly isn’t the case, and other synthetic hormones are capable of producing similar effects. If most of the effects on the DES sons are actually due to their testosterone production being shut down during the second and third trimester of their foetal development, then it means that any drug capable of interfering with testosterone production could potentially do most of the same things.

Until recently I’d been living my life under the illusion that I was just an ordinary man, and if I’ve have done it, so can others. The impression I get is that most transgender people go through a long phase of denial in which they try to fit in as their assigned sex, and that even after they’ve admitted to themselves that there is a problem, personal circumstances often mean that they can’t do anything about it. The true number affected by some sort of gender variance is probably much higher than the numbers opting for reassignment surgery would suggest.

For anyone who's wondering whether they might have been DES-exposed, here's a list of things that seem to commonly affect DES sons (note that most of these can also be the result of other types of intersex condition too):

Born between 1940 and 1971 (US) or 1980 (elsewhere)
Mother with a previous history of miscarriages; diabetes; other risk factors such as being in her 40s

Birth defects:
Undescended testicles
Micropenis - a fully formed but considerably shorter than normal penis
Hypospadias
Epididymal cysts of the testicles (these are apparently Mullerian remnants - fragments of female tissue that would have been absorbed in normal male development)
Vestigial female organs or organ remnants
Intersexed genitals similar to grade 3 PAIS
Other genital abnormalities (in my case a hydrocele)

Later in life:
Feminine-looking facial features, developing a body structure that's more like the female members of your family than the male ones
Other symptoms of low testosterone such as a lack of body hair, gynecomastica and an inability to build upper body muscle
Very shy, socially passive behaviour as a teenager
Difficulty forming friendships with boys; having a special affinity with girls
Being bullied a lot; having an inability to fight back
Having no interest in sport
People tending to assume you're gay; lots of men being attracted to you
Identifying as a woman, or part of you identifying as a woman while another part identifies as a man

Further reading:

One instance where synthetic hormones are known to have caused abnormalities of sexual development in human beings:
http://en.wikipedia.org/wiki/Progestin-induced_virilisation

A series of experiments in sheep, in which exposure to external hormones caused them to partially develop as the wrong sex. Some of the reported effects include genital abnormalities, impaired fertility and opposite sexed behaviour:
http://dev.biologists.org/content/36/1/87.long
"Effects of testosterone implants in pregnant ewes on their female offspring", August 1976 J Embryol Exp Morphol 36, 87-99.
http://www.reproduction-online.org/content/49/2/311.long
"The sexual behaviour of prenatally androgenized ewes observed in the field", J Reprod Fertil. 1977 Mar;49(2):311-5
http://press.endocrine.org/doi/full/10.1210/en.2002-220965
"Prenatal Programming of Reproductive Neuroendocrine Function: Fetal Androgen Exposure Produces Progressive Disruption of Reproductive Cycles in Sheep", Endocrinology 2003 144:4, 1426-1434

"DES Voices: from Anger to Action", an ebook about the DES disaster by DES mother Pat Cody and available as a free download at the following link:
http://www.lulu.com/shop/pat-cody/des-voices-995/ebook/product-17522743.html

A study documenting high rates of gender dysphoria (and other problems, including genital abnormalities and impaired fertility) among DES sons:
http://www.shb-info.org/sitebuildercontent/sitebuilderfiles/desexposedhbs.pdf

Some research documenting high rates of serious mental disorders and suicide in people exposed to synthetic hormones before birth:
http://www.intechopen.com/books/state-of-the-art-of-therapeutic-endocrinology/behavioral-and-somatic-disorders-in-children-exposed-in-utero-to-synthetic-hormones-a-testimony-case#article-front

This last study is quite important, because it's a completely separate group of hormone-exposed people  from Drs Kerlin and Beyer's DES sons research group, and independently confirms much of what I saw in Dr Kerlin's group. If I've read that paper correctly, of 740 exposed children, 279 had somatic disorders (primarily genital abnormalities). This ties in with what I saw in Dr Kerlin's group, where about a third mentioned having intersex-related genital abnormalities. Since these are two completely independent groups, it's likely that the same applies to DES sons in general.

Table 1 is a good example of the colossally high doses of these drugs that were often administered during the first few decades after synthetic hormones were developed. The second woman in the study (whose son developed schizophrenia and then committed suicide aged 27) was given 500 milligrams per day of ethinyl estradiol for part of the pregnancy. By way of comparison, all birth control pills containing 100 micrograms of ethinyl estradiol or more were discontinued due to high rates of blood clots, strokes and heart attacks among those taking them.  In other words, the daily dose that mother was being given, was 5,000 times higher than contained in the birth control pills that were withdrawn from use! There must have been quite a few fatalities amongst the mothers given these treatments if these doses were in any way typical (and it appears they were).

Incidentally, this is the fault of the pharmaceutical companies rather than the doctors prescribing these treatments, since it's the pharmaceutical company that promotes a drug for a particular use and provides the dosing guidelines.

This petition will be delivered to:

    Hugh Easton started this petition with a single signature, and now has 191 supporters. Start a petition today to change something you care about.




    Today: Hugh is counting on you

    Hugh Easton needs your help with “The US Food and Drug Administration: FDA, acknowledge that hormone treatment during pregnancy can cause intersex and transgender!”. Join Hugh and 190 supporters today.