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February 20, 2009

Medical facts on octuplets and IVF from Yale Fertility Center blog

Since the Nadya Suleman gave birth to octuplets after undergoing in vitro fertilization, the procedure has been discussed at great length in the media, often without much grounding in medical fact.

The Yale Fertility Center blog has an excellent post about the existing professional standards and safeguards for fertility specialists who perform in vitro fertilization.
As you might have guessed, inserting 6 embryos into a 33-year-old patient would be a dramatic departure from accepted medical practice, according to the YFC blog. According to the post, most doctors wouldn't recommend more than one or two embryos for a patient like Suleman.

The Suleman case has prompted calls for tighter regulation of IVF. It would be a mistake to legislate based on this truly anomalous case. There are already civil and criminal penalties for physicians who flout accepted standards of care and endanger their patients. Doctors in California, the state where Suleman's doctor practices, have even gone to prison for criminal negligence.

[HT: Jill Zimon]

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A federal law which simply says that the limit is two embryos per try would be clearer and easier to enforce than a state trying to discern the "accepted standards of care."

The whole legal framework governing physicians is couched in standards of care and accepted medical practice. No responsible doctor would prescribe an leg amputation as a cure for a hangnail. We don't need a specific law against it, though. If a doctor does something that stupid, s/he can be sued, or lose their license, or face criminal charges for negligence. That's enough.

Laws governing IVF implantations would be impossible to enforce. Do you really want the feds sifting through womens' medical records if they give birth to a suspiciously large number of babies? No thanks.

It was extremely rare for a woman to give birth to 5 or more babies at once before IVF.

If we had a federal law that doctors could only implant two embryos per try, then I'd be OK with a government official investigating (looking a woman's medical records for about the previous nine months) to see if a doctor implanted more than 2 embryos for one try in cases in which a woman gave birth to 5 or more babies at once.

Higher-order multiples are still extremely rare. They're even extremely rare even among women who get IVF with multiple embryos. (And sometimes multiple embryos are medically appropriate, depending on the age of the patient and the type of infertility that IVF is supposed to resolve.)

One of the other odd risks of IVF is that every embryos is unusually prone to splitting and becoming twins. I've got a twenty-something friend who's considering IVF now, and the doctors have been very clear that prospective Mom and Dad should be prepared for twins or triplets.

FDA-approved fertility drugs were famous as a the cause of higher-order multiple births before IVF. Sometimes these massive multiple births happen without any medical intervention. The Dionne Quintuplets were celebrities in Canada in the 1930s, before fertility drugs or IVF.

It's ridiculous, and frankly offensive, to even consider asking all women to potentially submit their private medical records for FBI investigation just because they might give birth to "too many" babies.

Higher-order multiples are not a public health problem and they will never be, especially if abortion remains safe and legal--because most women who find themselves pregnant with more than two or three fetuses do the sensible thing and opt for selective reduction for the sake of their own health and that of their remaining future offspring. Guess what? Women and doctors are basically sane and unwilling to risk death or the loss of every much-wanted pregnancy for the sake of possibly carrying a massive multiple birth to term.


Lindsay,

Excellent analysis of the issues. I respect Right-to-Lifers who are genuinely concerned about mothers and children. The hypocrites, however, are engrossed in self-indulgent, self-righteous claptrap. Where is their concern (not to mention love) for the children, the overtaxed and stressed grandparents, preservation of the family, and possible mental disability of the mother? They are without shame as they thwart gifts from generous companies, intended for the benefit of the babies, because the mother doesn't deserve it. Can logic be more tortured than that?

Condemn the mother. Harass the doctor. Express outrage at lucrative book or media deals that might pay for the care of the new born infants. Focus on an irrelevancy like her plastic surgery. Ask why did she have to have so many UNINTENDED babies. Hatred of, and projection onto, the mother is OK for political posturing and self-serving hand wringing, even to the detriment of the babies.

Aside from making the care of the babies a priority, the fundamental question, here, is why so many denouncers with froth and venom are incited by the matter. That fact that they do so without all the facts, and no heart or compassion, suggests scapegoating in the midst of terrible human tragedies of a severe economic crisis. The suffering to be visited on people will only get worse over the next year. So will the contempt that will be heaped on the mother, her babies, and her family.


MAKE IVF MORE ACCESSIBLE

There is an excellent article on Slate.com:

Pregnant Pause: Who should pay for in vitro fertilization?
By Darshak Sanghavi. Posted Friday, Feb. 13, 2009, at 6:52 AM ET

http://www.slate.com/id/2211151/

Sanghavi makes an excellent case, backed by substantial research and analysis, for making IVF more accessible. I quote from the article:

"The octuplets' birth has revived the debate about the proper means, if any, to regulate assisted reproduction. And though it's tempting to see Suleman's choices as nailing the case for making IVF less accessible, the data suggest such a strategy would have unintended consequences that would hurt children and families, and ultimately cost us all more money. We should be making IVF more accessible."

A theoretical federal law limiting implants to two embryos per try could...

a) Be civil, not criminal

b) Designate HHS as the only federal agency which can investigate, and only in cases of five or more babies being born at once

c) Designate the only punishment from HHS as a report to the state about the doctor

d) Allow a woman who gives birth to five or more babies at once to sue the doctor for child support over the next 18 years if the doctor implanted more that two embryos per try (the law would have to make any document she signed before the birth or within a year after the birth promising not-to-sue or limiting-monetary-awards null-and-void, because otherwise the doctor would just have her sign away that right.)


I'm still finding it hard to understand why proposals are being offered that include legislation, penalties, and invitations to litigation. I quote further from the above referenced Sanghavi article [http://www.slate.com/id/2211151/]:

"Taken together, America has selected a policy that encourages multiples. Since insurers aren't compelled to cover costs for IVF, self-paying women attempt to get pregnant in as few cycles as possible. As a result, officials find it hard to justify legally restricting how many embryos can be implanted. Since they're paying for it, the thinking goes, women should be free to implant as many embryos as they wish. The result? More multiples, more costs, poorer child health, and, on occasion, bizarre cases like that of Nadya Suleman.

"There's a cleaner way to handle the costs and regulation of IVF to reduce multiples, and that strategy was recently adopted by Sweden. In 2004, Scandinavian doctors reported that implanting one embryo at a time, repeatedly if necessary, resulted in the same final pregnancy rates as implanting several at once—with the incidence of multiples reduced to less than 1 percent of births in the sequential single-transfer group from 33 percent in the multiple-transfer group. The Swedes ran with the results: Their national health insurance now fully covers repeated IVF attempts with a single embryo but limits coverage if women instead choose to implant multiples embryos. It's too early to quantify the results, but the approach makes a lot of sense."

Norman Costa -

Do you want a federal law saying that health insurance companies have to cover single-embryo implants for any women in their system, but can't cover multiple-embryo implants?


Eric Jaffa,

Thanks for continuing the discussion. First, to the extent that federal legislation is required, I am thinking in terms of universal health insurance, preferably with a single payer. A single payer program, alone, would reduce overall health care costs.

Second, universal health insurance would be the vehicle for universal access to IVF.

Third, as argued by Sanghavi, wider access to IVF would, in fact, result in a number of significant benefits for society in general, and women and children in particular. The benefits include:

1. Reduction in overall costs of IVF;
2. Reduction in unintended multiple births to 1 percent;
3. No reduction in final intended pregnancy rates;
4. Reduction of risks, to women, that are related to carrying multiples to term;
5. Reduction of risks, to babies in utero, and after being brought to term;
6. Improved child health;
7. Reduction of overall costs in maintaining child health;
8. Improved postpartum options for parents (especially mothers) for education, employment, personal needs, preferred activities, and the reduction of stress;
9. Increased control, real and perceived, for parents (especially women) over their bodies and their lives.

Fourth, appropriate and acceptable levels of care and practice would emerge from an administrative process, rather than a legislative process. This is what we have today, in large part. An administrative process is one that arises from the insurer, the health care profession, the users of health care, and varied advocacy groups.

Fifth, legislation is always a part of the entire process. It's role, in part, arises from dealing with exceptions that cannot be adjudicated through an administrative process. It's role, in part, is to discipline or coerce the provider community that will not cede their profits to provide better care, more options, and improved services.

Sixth, Sanghavi cites the policy adopted in Sweden, backed by good research and analysis. Successive, repeated IVF attempts with a single embryo are fully covered. Coverage is limited (I do not read 'eliminated') for single attempts with multiple embryo implants. I could envision full coverage for multiple embryo implants as appropriate and acceptable under special circumstances. For example, a woman would choose multiple embryo implants if there is a probability of losing reproductive organs in the near future. The likelihood of a woman undergoing toxic therapies in the future could make a good case for multiple embryo implants.

Seventh, recovering damages in a civil tort action is always understood as an option. In fact, most of the time it is not. The average citizen labors under the delusion that the payout of millions of dollars in damages is only one trial lawyer away. The idea that frivolous cases can yield big payouts is a fiction. The woman who recovered a large settlement from McDonalds, because hot coffee was spilled on her, is an oft cited example of this fiction. Investigate the case and you'll find out it is not the frivolous suit you think it is. What about the multi-million dollar jury verdicts that make the news? Juries tend to award plaintiffs all the gold in Fort Knox. Almost all jury awards are substantially reduced, if not thrown out, when they go to appeal. They all go to appeal.

This entire matter has, at its base, a number of simple policy issues. Understand what those policies are and the policies that should replace them. That's the definition of structural change - a simple (sometimes subtle) change that has a profound impact on outcomes.

A federal civil law would presumably give some group or groups of people grounds to sue doctors who introduce more than the standard number of embryos. Why would we need such a law? A woman can already sue her doctor for malpractice for "overdosing" her on embryos, just as she can sue over an overdose of medication. If the screw-up is bad enough, criminal charges can be brought against the doctor, especially if the embryo overdose was part of a pattern of negligent behavior. At the very least the woman can file a complaint against him with the state medical board and the board will investigate and determine whether the doctor should lose his or her license.


Lindsay,

There is a lot with which I disagree in your latest comment. I have the sense that tort and case law in the medical arena may be sufficient, already. I don't think our first move should refelct the approaches of 'there outta be a law', or 'one false embryo and I'll throw you in jail'.

Rather than argue, myself, I wonder if there are any attorneys among your readers, familiar with such matters, who could contribute to the discussion. Any medical ethicists in Majikthise cyberspace?

I acknowledge that my position, stated above, assumes wide access to IVF, funded through all insurance plans, and modeled on the Sweden plan.


Lindsay,

Whoops! I misread your latest comment. I agree with you. My fault. I apologize.

Still, I would like to hear from others attorneys, doctors, and ethicists on the matter.

It's important to keep in mind that massive multiple births are a very small problem, whereas infertility is widespread.

IVF has been around for 30 years and Suleman is the first woman in history to give birth to a set of live octuplets.

The vast majority of doctors and prospective parents actively seek to avoid multiple births for a host of obvious reasons.

Enhancing access to IVF would help way more people than any law against implanting too many embryos at once.

The law should be clear.

A legal limit of two embryos per try would be clear.

Trying to take a vague law about medical malpractice and apply it to a woman who received IVF giving birth to a large number of babies isn't a good approach. It leaves the matter vague enough for doctors to continue implanting six embryos at once.

The standards must be open to case-by-case interpretation because individual physicians should have broad discretion about how to practice medicine. It's all about the best interest of the individual patient. That's the logic of regulating the whole medical profession: Give doctors a lot of training and a lot of discretion and hold them legally and professional liable if they screw up.

We're not doctors. We can't anticipate all the possible medical circumstances that might affect the number of embryos that's appropriate in any given case. It's not up to society to decide what the magic number is.

The medically appropriate number depends on the age of the patient and other factors like the underlying cause of the infertility that led her to seek IVF. For example, if the problem is that embryos don't implant properly, then it makes sense to implant more embryos at once.

The odds of getting even one pregnancy increase proportionately with the number of embryos, and statistically, most of them won't implant. Using fewer embryos increases the risk that the IVF cycle will fail completely. Even for a couple that can afford more cycles, that's not a trivial thing to ask of them.

If you're concerned about multiple births, an arbitrary 1-2 embryo limit isn't really going to solve the problem because IVF embryos are prone to splitting naturally. Twins or triplets can result from using even one embryo. So, it's not like an upper limit of 2 embryos would rule out the possibility of higher-order multiple births.

The other consideration is that there's another straightforward solution to multiple conceptions: Selective abortion. A woman is not obliged to carry to term any embryo that happens to implant itself in her uterus. What if a woman and her doctor decide that the best chance to get her pregnant even once is to use a lot of embryos first and selective reduction in (the astronomically unlikely) event that a medically unsafe number of pregnancies results? That seems like a reasonable choice to me, if the alternative is a higher likelihood that the IVF will fail completely.

Please, are in Sweden the governemental insurance does cover the IVF (In-vitro Fertilization)?

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