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About that Bill... - Karen's Musings
Random Rambling
estherchaya
estherchaya
About that Bill...
Ahem.   Now that I'm over my little hissy fit from last night.  And, um, this morning.  And, um, this afternoon...  Have I calmed down over the proposed Georgia legislation?  In a word?  Not so much.  It turns out, I'm a wee bit, shall we say, opinionated.
 
Let's review this proposed legislation, shall we?  In plain English, the Georgia so-called "Ethical Treatment of Human Embryos Act" (the title makes me want to vomit a little, how about you?) seeks to do the following:
 
1.  Limit the number of embryos transferred in an IVF cycle to 2, if under 40 (3 if 40 or over). 
2.  Limit the number of eggs fertilized (and therefore the number of embryos created) per IVF cycle to the number of embryos the woman is planning to transfer.  (e.g. no more than 2 in a woman under 40, 3 in a woman 40 or over).    If more eggs than that were retrieved in a cycle, those additional eggs could not be fertilized.
3.  If extra embryos are created, they may not be cryopreserved or destroyed; they must be transferred.  (In other words, if 2 are created, a woman may not opt to transfer a single embryo and cryopreserve the remaining embryo, she must transfer both of the the embryos to her uterus).
4.  The bill also bans all financial compensation for donor gametes (sperm, eggs, embryos). This would seriously limit the donor pool in Georgia.  It may, in fact, eliminate it entirely.
 
Note, of course, that the bill does not propose any financial relief or mandated insurance coverage (Georgia does not currently have an insurance mandate either) to help with the added financial burden of using less effective treatment. Patients will still have to pay out of pocket for less effective treatment.  
 
Here's the first thing, and let's get this out of the way right off the bat:  I am never going to support legislation that attempts to regulate what I believe needs to remain a discretionary decision between a doctor and a patient.  Should, under most circumstances, 2 embryos transferred in an IVF cycle be an appropriate course of action?   Absolutely.  Do most doctors today follow that guideline?  Statistics are showing that, yes, doctors are trending that direction quickly.  But are there ever circumstances of patient history, embryo quality, etc. that might suggest a different course of action may be appropriate?  Certainly.  And that's when legislation like this is inappropriate.    Think about it:  If a legislator can dictate how a doctor practices his/her field in infertility then there is no telling what may happen down the line with other specialties.  Would you want a politician telling your cardiologist when it's appropriate to do a cardiac catheterization?  Or when your neurologist can prescribe beta blockers?  Maybe only on alternate Thursdays?
 
So now that we've got out of the way that I have a blanket opposition to any sort of legislation like this, let's move on, shall we?
 
Let's think about the provisions a little more.
 
Limiting the number of embryos transferred.  Sure it seems sensible.  Gosh, I sure don't want to continue this epidemic of octomoms and HOMs, do you?  I mean, do you remember all those sextuplets that were all born a couple years ago?  Oh.   RIGHT!  Those were all from IUI!  That's RIGHT!  Octomom just happens to be the first case of octuplets born as the result of IVF well... ever.  And sextuplets?  Right, also generally not IVF.  In fact, most cases of quads and triplets even are the result, not of IVF, but of IUI.  Even twin statistics in IVF are going down because with the increasing popularity and success rates with eSET when used in an appropriate patient population, you can reduce your twin risk from upwards of 40% down to as low as 1%, without lowering your overall success rate.  So this epidemic of HOMs that the great state of Georgia is so concerned about happening in their state?  What was it Ralph T. Hudgens said?  "Nadya Suleman is going to cost the state of California millions of dollars over the years; the taxpayers are going to have to fund the 14 children she has ... I don't want that to happen in Georgia."  Oh because Nadya Suleman's pregnacy was, what?  Contagious?  Um.  No. 
 
In fact, limiting the number of embryos transferred in an IVF cycle may seem quite sensible.  And, in fact, the ASRM and SART do have guidelines that recommend doing exactly that.  They have, over the years, been dramatically lowering the number of embryos they recommend transferring in an IVF cycle and are recommending eSET with increasing frequency these days.  While they are guidelines, the statistics do show that by and large, doctors in the industry are following them.  And doctors who are found to be consistently in violation of these guidelines can have their SART membership revoked.  Think that's not such a big deal?  Well, think again, because many insurance companies will only cover doctors who are members in good standing with SART.  So legislation?  Just not necessary, and, honestly?  Quite possibly harmful because it takes away the discretionary ability of the doctor for the case-by-case determination of a patient's needs.
 
Now what about this fertilization/embryo creation business?  I'm sorry, but this is utter crap.  The bill proposes limiting doctors/embryology labs to only fertilizing up to 2 eggs per IVF cycle for women under 40 (3 for women 40 or over).  The politicians/Right to Lifers who wrote this bill clearly have no grasp of the medical science at play here.  There is generally an attrition rate on embryos and it can be as high as 50-75%.  What do you do then?  It's too late now to make another, so now you're stuck.
 
So I'll give you a personal example.  In my last IVF cycle, I had 10 eggs retrieved, 9 were mature and miraculous, all fertilized and were 2 celled embryos the next day.  By Day 3 I had 7 crappy looking Embryos.  On Day 5, I had 4 "meh" looking morulas.  On Day 6 (transfer day), I had 2 decent looking blastocysts.  I transferred one. The other didn't make it to freeze (and neither did the other ones that had been lagging behind).  My cycle failed.  The Georgia politicians who were so worried that if I fertilized all 9 of my mature eggs I'd end up with 8 little human beings (and make no mistake, the language of the bill makes it clear that they believe that my embryos are living human beings) on ice indefinitely after I transferred my one blastocyst on day 6?  Needn't have worried.  Nothing made it to freeze.   If I'd only fertilized 2 eggs in the first place?  I may never have even made it to transfer, but I would have probably blown about $10K for nothing. 
 
Note, the bill provides for no additional financial relief, such as insurance coverage to help with the added financial burden of using less effective treatment. 
 
Further, note that if I made two embryos in the hypothetical scenario, and miraculously, both survived until transfer day - I would have to transfer both embryos to my uterus.  I would not be allowed to destroy it, per the language in the bill (actually, it's so poorly written, that there's a loophole there, but the INTENT of the bill is to keep people from destroying embryos, so let's go with that for the sake of argument, for the moment).  Nor would I be allowed to cryopreserve the embryo.  So me, who cannot under any circumstances risk having another multiple pregnancy, would have to transfer two embryos because of the way this law is written.  OR I would have to simply have fertilized only one egg in the first place, again risking that my one embryo ever made it to transfer. 
 
And banning all compensation for donor gametes?  That's just tacky.
 
What I hadn't realized was that there was a second bill being considered this morning.  SB 204/HB388 is an embryo adoption bill. It would subject embryo donation to all the same provisions as required by law for adoption of a child. This would subject infertility patients needing an embryo donation to go through the judicial proceedings, home visits, and other procedures required for an adoption.   Do you really think this is appropriate?  Is this really what you want? 
 
But back to SB169.... there's a lot of disturbing language in the bill:  In disputes arising between any parties regarding the in vitro human embryo, the judicial standard for resolving such disputes shall be the best interest of the in vitro human embryoYeah, what?  That's a custody standard used for custody disputes involving children.  How exactly is the judicial body going to apply that standard to an embryo?
 
Another example of disturbing language:  Nothing in this article shall be construed to affect conduct relating to abortion as provided in Chapter 12 of Title 16; provided, however, that nothing in this article shall be construed or implied to recognize any independent right to abortion under the laws of this state.  To hell if this isn't a reflection on abortion stance.  And this bill was written, in part, by the Georgia Right to Life Campaign.  You think that this wasn't written as a right to life issue?  WHATEVER.
 
More disturbing (emphasis mine):  A living in vitro human embryo is a biological human being who is not the property of any person or entity. The fertility physician and the medical facility that employs the physician owe a high duty of care to the living in vitro human embryo. Any contractual provision identifying the living in vitro embryo as the property of any party shall be null and void. The in vitro human embryo shall not be intentionally destroyed for any purpose by any person or entity or through the actions of such person or entity.
 
I'll let you figure out why that one bothers me.
 
 
Let's be clear.... either the politicians who drafted this law understand NOTHING about the medical science behind IVF and how it works and didn't care enough to consult a single doctor or embryologist while drafting this bill.  OR, alternatively, they DO understand the science, and they seek, instead, simply to eliminate IVF from Georgia entirely.  And in doing so, they'll shut down a $50million dollar (give or take) industry in Georgia and they don't care that they're doing so.
 
I don't want another set of HOMs.  I'd like to see fewer HOMs resulting from fertility treatment.  Truthfully, I think this piece of legislation could potentially INCREASE the number of HOMs because it will make IVF so difficult to effectively obtain in Georgia that people will instead turn to IUI with injectible gonadotropins.  And guess what happens then? 
 
So...  have I calmed down over this proposed piece of crap?  Not so much.  But I'm quite glad that it was sent to subcommittee for "further research."

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Comments
allah_sulu From: allah_sulu Date: March 6th, 2009 02:35 am (UTC) (Link)
under 40 / over 40...

What about women who are 40? Can they do whatever they want?
estherchaya From: estherchaya Date: March 6th, 2009 02:39 am (UTC) (Link)
sorry, that was my sloppy writing, the bill itself talks about under 40 and women who are 40 and over.
From: boobalah Date: March 6th, 2009 02:41 am (UTC) (Link)
I think that, ideologically, this is basically a "life begins at conception" sort of piece. I find these issues fascinating, because I am a donor sperm baby. For the most part, I trust doctors to make the best decisions for their patients. There's really only one law WRT to reproductive technology that I want passed, and that's only due to personal experiences I've had.
estherchaya From: estherchaya Date: March 6th, 2009 02:48 am (UTC) (Link)
it is both a "life begins at conception" bill and a "we are terrified of having another octomom here in our backyard" bill.

It's a ridiculous, and poorly written, piece of crap bit of legislation. I hope it never makes it out of subcommittee.
estherchaya From: estherchaya Date: March 6th, 2009 02:49 am (UTC) (Link)
(and what law WRT to ART do you want passed?)
arosoff From: arosoff Date: March 6th, 2009 02:49 am (UTC) (Link)
Most of the bill is BS and a horrendous overreaction, but I really don't have a problem with the transfer limit. It's the law in several European countries, including the UK.

It's nice to say "but there should be flexibility" but there needs to be some kind of stick involved. Given the number of insurers who won't pay for ART and the number of people on self-pay, having membership revoked is not necessarily a disincentive for unethical REs. The octuplets showed that voluntary regulation has holes. (I'm sure that ethical REs are really, really pissed off at this idiot, too.)
estherchaya From: estherchaya Date: March 6th, 2009 02:56 am (UTC) (Link)
It's the law in the UK and several European countries. What you're leaving out of your statement here is: AND THERE THEY HAVE COVERAGE FOR IVF UNDER THE HEALTHCARE SYSTEM. HERE THEY DO NOT.

Using the octuplets as an example is a piss-poor example, by the way. Nadya Suleman had the FIRST set of live-born octuplets EVER born as a result of IVF in this country (possibly in the world). She is the ABERRATION. Legislating against the aberration is a great tradition in our country, but it's a stupid and ridiculous tradition.

By and large the ASRM and SART guidelines DO work. And the statistics DO prove it, if you look carefully at the CDC statistics over the last 5 years you'll see an amazing trend downward in even the triplet trend and you'll soon see a beautiful trend downward even in the twin rate. My clinic's twin rate is down significantly because they have a very strong eSET program. As more clinics across the country adopt eSET as the standard, you'll see twin rates drop dramatically in CDC stats.

If transfer rates are legislated, then insurance mandates must also be legislated. And I'm all for insurance mandates, believe me. Speaking as someone who is seeking eSET specifically to avoid another multiple pregnancy, I can tell you that I'm all for avoiding transferring 4,5,6,7,8 embryos in a single IVF cycle. But this law was drafted by the wrong people.
(Deleted comment)
estherchaya From: estherchaya Date: March 6th, 2009 03:52 am (UTC) (Link)
I hate her. For a long time I was defending her, but she's done so much damage to the image of HOM mothers and ART patients everywhere that I just, plain, hate her.
marag From: marag Date: March 6th, 2009 03:37 am (UTC) (Link)
Thank you so much for writing this, so I don't have to try to summon the brainpower to write it. Now I can just point people here.

Because...yes, what you said. Exactly.

I'm trying to remember my IVF stats. I think it was 30 follicles, 20 eggs (hi, ovarian hyperstimulation!), 11 fertilized, 8 made it to day 3, we transferred 2 on day 3, and froze 6.

As it happens, we were extraordinarily lucky that every single one of the one that made it was high quality. But...that's pretty rare.
estherchaya From: estherchaya Date: March 6th, 2009 03:51 am (UTC) (Link)
it's especially rare with hyperstimulation.
journeytoernie From: journeytoernie Date: March 6th, 2009 12:50 pm (UTC) (Link)
HOM?

i forsee a lot of people in ga driving to other states to do this....

and they wont pay donors? so an egg donor is supposed to go through that hell and headache for fun? they're not going to get any donors anymore.
estherchaya From: estherchaya Date: March 6th, 2009 02:06 pm (UTC) (Link)
HOM = High Order Multiples. Anything over twins is considered High Order Multiples (e.g. my triplets).

Yes, if this bill were to pass, which it probably will not, it would shut down the GA IVF industry - a $50 million dollar industry.

It would also mean that they would be nearly completely incapable of getting egg donors (and possibly sperm donors) in the state of Georgia. People would have to seek donors from other states.
ichur72 From: ichur72 Date: March 6th, 2009 04:35 pm (UTC) (Link)
I can't speak in any detail about ART, but as far as I can tell, this is sloppy, ignorant legislation (and I say this as a chagrined Republican voter). Sadly, I think it's much of a piece with some other goings-on in the Georgia legislature -- e.g., an attempt to ensure insurance coverage for autism treatment. I'm not entirely sure what that is supposed to do, given that there is already a law on the books here mandating insurance coverage for autism. This first law has a convenient loophole that allows insurers to get out of it most of the time, if they are acting as a contractor for the employer rather than providing coverage directly. Maybe this law is supposed to close the loophole? Dunno. Meanwhile, there's plenty of infighting among the families who stand to benefit because the language of the bill is designed to ensure coverage for behavioral treatments and there are people who want all other types of treatments covered too. Yippee. My point is, yes, the Georgia legislature ought to be more careful and do more research.
estherchaya From: estherchaya Date: March 8th, 2009 12:19 am (UTC) (Link)
It was sloppy - but I don't think it was ignorant. I think it was intentionally written the way it was written. It was drafted, in part, by the Georgia Right to Life campaign. The parts of it that offended me the most were clearly drafted by them.
eyelid From: eyelid Date: March 6th, 2009 04:53 pm (UTC) (Link)
And sextuplets? Right, also generally IVF.

I think you mean IUI.

And of course you know exactly how I (and every other woman who has EVER gone through IVF) feels about this legislation. Too furious for words.

Edited at 2009-03-06 04:57 pm (UTC)
estherchaya From: estherchaya Date: March 6th, 2009 05:13 pm (UTC) (Link)
Er, right. Sloppy on my part. Running on very little sleep this week. Funny part is, I wrote IVF, deleted it, wrote IUI, deleted it, wrote IVF. I think I meant to write "not IVF" there. Gah.
yeishlitikvah From: yeishlitikvah Date: March 6th, 2009 05:24 pm (UTC) (Link)
thank you for making a concise policy, had you not I honestly would not have bothered to even understand the aspects and nuances let alone the agenda based upon the language.

What is HOM?

Completely random if they are establishing in the langugage they are using that the embryo is a 'biological human being' chv can someone who miscarries after poor judgement be charged with murder. SOrry maybe it's a random thought as I do not attempt to grasp let alone fully understand the complexities both emotionally and medically of IVF.
estherchaya From: estherchaya Date: March 6th, 2009 05:41 pm (UTC) (Link)
HOM = High Order Multiples. Anything over twins is considered High Order Multiples (triplets, quads, quintuplets, sextuplets...etc.).

Miscarriages are rarely caused by a person's actions, so I'm not sure how "poor judgment" could equal a miscarriage. But if you could give me an example where someone's poor judgement really could be traced to an actual miscarriage then YES, if the legislature WERE to define an embryo as a living human being, then YES they could make the leap and charge that person with the embryo's death (whether it be manslaughter murder, etc, I can't tell you).

There was actually a curious law either proposed in Virginia about 4 years ago that would have required women who experienced fetal death (at any gestational age) to report the fetal death to law enforcement agencies within 12 hours of the loss occurring. They would have had to file such information as the date of the last normal menses, weight of the products of conception in grams, number of prenatal visits, when the fetus died (they didn't acknowlege that early gestational loss would be embryonic loss, not fetal loss), events of labor and delivery, place of occurrence, name of patient, age of patient, education of patient, etc. Failure to report fetal death within 12 hours (regardless of gestational age), had the law passed, would have resulted in a class one misdemeanor. So anyone who had an early miscarriage without really realizing it and failed to report it would have been guilty of a misdemeanor.

Lawmakers get really, really stupid when it comes to matters of reproduction.
From: boobalah Date: March 6th, 2009 07:21 pm (UTC) (Link)
I think you will like this article about the bill.

http://www.slate.com/id/2212876/
estherchaya From: estherchaya Date: March 6th, 2009 08:47 pm (UTC) (Link)
finally a Slate article about Embryos that doesn't piss me off! (I've been avoiding the slate articles on this topic because the last few Slate articles on anything to do with IVF have really pissed me off because they've been written by so-called "pro-choice moralists")
From: have_inner_lady Date: March 6th, 2009 10:06 pm (UTC) (Link)
Thank you for demonstrating just how scary this one is. I saw it come up in the paper and thought it sounded very wrong, but being finals week, I was not able to research further.

As much as the octuplet situation offends me (which may be unfair, but it does), I earnestly do believe that fertility treatments are still such a new process that we've still got a long learning curve ahead. If a lot of people are upset about HOMs, well, a lot of people are upset that we can't cure cancer yet either. But medical science gets more accurate all the time. It's a lot LESS likely to do so if our politicians tie the hands of our doctors and researchers.
estherchaya From: estherchaya Date: March 6th, 2009 10:14 pm (UTC) (Link)
The octuplet situation is not remotely the norm for fertility treatments, and certainly beyond even an aberration for IVF. High order multiples generally are the result, not of IVF, but of IUI, especially multiples of that magnitude (though you'll note that she has only the second set of octuplets this country has ever had and hers are only the first set ever resulting from IVF).

The numbers of HOMs resulting from fertility treatment is on a steady decline. This is an important fact to note.

Nadya Suleman? Is a nut job. Worse, her doctor was a crack pot. Of 500 or so fertility clinics in the country, his success rates and statistics were in the BOTTOM TEN in the country. How he had ANY business is beyond me. He took risks with her that stepped well beyond the line of malpractice. He should lose his license. And I say he should be shot, but Seth says he's no good to society if he's shot - he should be financially responsible for those kids - all 14 of them.

The Suleman situation should NOT under any circumstances be used as the example against which to build new legislation. Period.
tigerbright From: tigerbright Date: March 7th, 2009 02:21 pm (UTC) (Link)
I am somewhat confused by the IVF/IUI distinction that you make... My cousin Lauren's triplets, now college students, were the survivors of five implanted embryos, and I was given to understand that this is common when it happened. Help?
estherchaya From: estherchaya Date: March 8th, 2009 12:13 am (UTC) (Link)
First, I'm going to clarify - the triplets were the survivors of five implanted embryos. Meaning your cousin was originally pregnant with quintuplets and two did not survive the pregnancy? And the pregnancy was the result of IVF? So five embryos were transferred and all five implanted in her uterus? Or five were transferred and only three implanted? (Sorry for my confusion, but since the media refuses to use the proper terminology - in IVF embryos are transferred to the uterus, not implanted... doctors can't implant anything, they can only hope that embryos will implant after transfer - I have to make sure I'm understanding you before I answer your question).

Assuming what you mean is that your cousin had IVF and had five embryos transferred and the triplets were the result... let's back up.

If your cousin Lauren's triplets are now college students, your cousin Lauren had IVF nearly (or more than) 20 years ago. IVF is only a little over 30 years old. A lot has changed in the world of IVF in the last 20 years. A lot has changed in the world of IVF even in the last 10 or 5 years.

5 or 10 years ago it wasn't possible to consider routinely and electively transferring a single embryo to a uterus in an IVF procedure, even in a woman under the age of 35. But that is becoming increasingly the recommendation in this country - and several countries actually mandate it. The embryology laboratory science has come a long way in their ability to culture the embryos, to grow them, select the best ones, enable them to surivive for longer in the lab in order to find the strongest, most likely to implatnt embryos. 20 years ago, I'm not sure if they even waited until the third day after egg retrieval to transfer embryos to the uterus, or if they transferred them immediately after fertilization. 10 years ago, they transferred embryos on the third day. Today, 5 day blastocyst transfers are quite common because embryologists have developed what is called a "blastocyst media" which enables to embryologist to culture the embryo for even longer in the laboratory before transferring the embryo to the uterus. Though fewer embryos survive to the Day 5 stage, usually these are the strongest embryos that are the most likely to implant and become successful pregnancies.

So, while 20 years ago a larger percentage of high order multiple pregnancies (triplets in particular) resulted from IVF, TODAY, very few do. Today, the vast majority of high order multiple pregnancies that result from fertility treatment result not from IVF, but from the less technologically advanced, ovulation induction with IUI. Ovulation induction involves taking medications which stimulate follicle development of the ovaries to produce one or more eggs (usually more). The goal is to have 1 or 2, but ultrasounds aren't perfect, and sometimes you can't see everything, and sometimes you have smaller follicles you don't think will have a viable egg in it and *whoops*! (that's what happened with me)

IUI with ovulation induction uses some of the same medications that IVF uses, but less of them. And doesn't involve egg retrieval or embryo culture and development in the lab. It's a much cheaper process, but not one I'm ever going to do again, because, frankly, I don't want another set of triplets. Much as I love mine... one set is enough.

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