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FDA Bans Gender Selection Procedure

Edgar Dahl
By Edgar Dahl
Ethical Technology

Posted: May 17, 2011

The American Food and Drug Administration has required the Genetics and IVF Center in Fairfax, Virginia, to stop offering MicroSort for family balancing. Currently, the procedure is available only for “couples attempting to prevent sex-linked or sex-limited disease.”

spermMicroSort® is a device that allows the separation of X- from Y-bearing sperm. Thanks to MicroSort, more than one thousand couples have been able to have a baby of their choice. These couples include those who were at risk of transmitting a sex-linked genetic disorder as well as those who, say, after having three or four boys were longing for a girl.

Why is the FDA preventing the Genetics and IVF Institute from offering gender selection for family balancing? Well, the only reason given was that there is no “public health benefit” in offering gender selection for non-medical purposes.

Pardon my French, but I think this is total B.S.!

The only thing the FDA has a right to be concerned with is the safety and efficacy of the procedure. And by the FDA’s own admission, MicroSort is safe and effective. Whether or not it meets public health needs is, frankly, none of the FDA’s business. After all, there are countless pharmaceutical drugs and medical procedures which fail to meet “public health needs.”

Thus, whatever we think of the ethics of gender selection, one thing should be clear: if cosmetic surgery, such as liposuction, is worthy of approval, gender selection should be worthy of approval. In fact, the case for gender selection is much stronger than the case for liposuction.

Just as a woman may suffer from being overweight, a woman may suffer from not being able to have the daughter she was longing for all her life. Moreover, a woman not having a flat stomach DOES have alternatives while a woman not having a daughter DOES NOT. The chubby woman does not have to turn to medicine for help. In most cases, she can simply remedy herself by sports and diets. The daughterless woman, however, has no choice but to turn to medicine. And the FDA knows this.

So why doesn’t it just come out and tell the truth? Why can’t the FDA just be honest and say: MicroSort does not pose a medical problem, it poses an ETHICAL problem. Gender selection through sperm sorting may be safe and reliable, but it is widely seen as “immoral.”

Indeed, sex selection for non-medical reasons makes a lot of people uneasy. They somehow FEEL it is wrong. Even if they can’t quite put their finger on it, they just KNOW it is something we shouldn’t be doing.

For lack of an argument, they often claim that it is “unnatural.” Well, one doesn’t have to be a philosopher to see that it is entirely irrelevant whether an action is natural or unnatural. My personal hero, the Scottish philosopher David Hume, once stated that although something may be natural or unnatural, that doesn’t settle the question whether it is moral or immoral. This, he suggested, remains an open question.

It’s easy to see Hume’s point. Transplanting a heart to save a man’s life is certainly UNNATURAL. But who would claim that it is THEREFORE morally wrong?

The same applies to the notion that gender selection is “playing God.” By inoculating children against smallpox or other diseases they could die of, we are certainly “playing God.” But does this render all inoculations or vaccinations immoral? I don’t think so. 

Like the notion of gender selection being “unnatural,” so the notion of gender selection as “playing God” is not a considered response, let alone an argument. It is simply a gut reaction.

What would be a valid objection? I’m inclined to say: it would be justified to regulate gender selection if there was a clear and present danger of distorting our gender ratio.

We have all heard about countries like India, China, or South Korea where women are outnumbered by men. Nobel Prize winning economist Amartya Sen once famously wrote about Asia’s missing women. In their book Bare Branches, political scientists Valerie Hudson and Andrea den Boer point out that China soon will be faced with a “hoodlum army of 30 million bachelors” threatening the country’s security.

I don’t want to get into a debate about Asia’s demographic problems except to state that Chinese and Indian women do have religious and financial incentives for preferring boys over girls – incentives which are absent in America and the rest of the Western world.

Over the last ten years, I have surveyed the general population, pregnant women, and IVF couples in Germany, Britain, and the United States as well as in Pakistan, Jordan, and Trinidad & Tobago. The results for Germany, Britain and the United States are pretty much the same: First, there is no preference for children of a particular gender anymore. Second, if there is any preference at all, it is a preference for having children of both sexes. And third, only a small minority can envisage employing, undergoing and paying for gender selection to ensure the birth of a child of a particular sex. For example, in the US only 8% and in Germany only 6% of the general population could imagine using MicroSort.

Data from so-called “gender clinics” support these findings. The overwhelming majority of couples seeking gender selection—more than 90%—are couples who already have three or more children of the same sex longing to have at least one child of the opposite sex. When compared, couples with three or more boys are more likely to turn to a gender clinic than couples with three or more girls. And last but not least, it is typically the woman who initiates the contact to a fertility specialist.

familyHow many children are already born through social gender selection in the US? We don’t know! Still, we are in the position to make an educated guess. It is said that about 1% of children in the US are now conceived through in-vitro fertilization. This means that out of the four million children born every year, about forty thousand are “test-tube babies.” If, as has been claimed, 5% of IVF cycles are now combined with PGD (pre-implantation genetic diagnosis) for the sole purpose of social gender selection, we are talking about two thousand sex-selected children.

Two thousand out of four million children is almost nothing. It’s like a drop in the ocean. Even if this number were to grow by a factor of ten—which is conceivable as social gender selection may become more and more acceptable—we are still talking about only twenty thousand out of four million children per year. Given that these children are not always of one particular gender, but of both genders, selected to balance the composition of individual American families, there is no reason at all to be concerned about the gender ratio.

While a socially disruptive distortion of the natural gender ratio is not a problem in Western countries, it surely is a problem in some Asian countries. Hence it doesn’t come as a surprise that a few authors have called for a worldwide ban on social gender selection.

However, does the practice of social gender selection in, say, India really justify prohibiting social gender selection in the United States? The simple answer is: Most certainly not!

First, preventing American couples from choosing the gender of their children will not change the gender ratio of India. Second, even if it is only meant to “send a message,” it is simply naive to assume that Indian families will appreciate our gesture, well-meaning as it may be. As long as there are religious and economic incentives within a culture for preferring boys over girls, our moral plea will fall on deaf ears. Third, and most importantly, denying American couples the opportunity to have a daughter because Indian couples have killed theirs would amount to punishing the innocent. There is no moral justification whatsoever for punishing the people of one country for actions committed by the people of another.

Another objection to MicroSort claims that gender selection constitutes gender discrimination. While this claim may apply to, say, infanticide, it certainly does NOT apply to MicroSort. Discrimination is the violation of human or civil rights on the sole basis of race, gender, or religion. Thus it can only apply to already existing people, not to mere gametes, such as sperms or eggs. Entities that do not yet exist and do not yet have rights simply cannot be discriminated against. 

Another frequently advanced objection claims that gender selection is “sexist”. Some feminist philosophers even went so far as to call gender selection “the original sexist sin.” Gender selection, they argue, is deeply wrong because it makes “the most basic judgement about the worth of a human being rest first and foremost on its sex.”

However, this argument is deeply flawed. It is simply false that people who choose the gender of their children are motivated by the sexist belief that one gender is more “valuable” than the other. As already mentioned, almost all couples seeking gender selection are simply motivated by the desire to have at least one child of each sex. If this desire is based on any beliefs at all, it is based on the quite defensible assumption that raising a girl is different from raising a boy, but certainly not on the preposterous idea that one gender is “superior” to the other.

A further objection concerns the welfare of children born as a result of gender selection. Thus, it has been argued that gender-selected children may be expected to behave in certain gender-specific ways and risk being resented if they fail to do so. Although it cannot be completely ruled out, it is highly unlikely that children conceived after MicroSort are going to suffer from unreasonable parental expectations. Couples seeking gender selection to ensure the birth of a daughter are very well aware that they can expect a girl, not some Angelina Jolie; and couples going for a son know perfectly well they can expect a boy, not some Brad Pitt.

Last but not least, there is the widely popular objection that gender selection is the first step down a road that will inevitably lead to the creation of “designer babies.” Once we allow parents to choose the gender of their children, we will soon find ourselves allowing them to choose their eye color, their height, or their intelligence.

This slippery slope objection calls for three remarks. First, it is not an argument against gender selection per se, but only against its alleged consequences.

Second, and more importantly, it is based on the assumption that we are simply incapable of preventing the alleged consequences from happening. However, this view is utterly untenable. It’s perfectly possible to draw a legal line permitting some forms of selection and prohibiting others. Thus, if selection for gender is morally acceptable but selection for, say, intelligence is not, the former can be allowed and the latter not.

And third, the slippery slope argument presumes that sliding down the slope is going to have devastating social effects. However, in the case of selecting offspring traits, this is far from obvious. What is so terrifying about the idea that some parents may be foolish enough to spend their hard-earned money on genetic technologies just to ensure their child will be born with big brown eyes or black curly hair? I am sorry, but I cannot see that this would be the end of civilization as we know it.

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I agree.

By the same token, pre-natal vitamins should be banned too.

I can see how the FDA may have legitimate reasons to order a halt to the use of gender selection technologies.  However, I would guess that the “legitimate” reasons are not used in the FDA’s final decision.

An actual legitimate reason for not using gender selection technologies is that there are no studies on long term effects on humans.  While there have been great strides in the genetics, there is still a great deal that is unknown.  It would be tragic to bring a seemingly healthy child into the world that may suffer horribly, some unintended mutation, throughout there life due to mishaps from genetic tampering.  This is also one of the few legitimate arguments against human cloning.  “We just don’t know enough to make it work perfectly.”

Further, piggy backing off of the slippery slope argument, maybe creating designer babies will lead to a lack of genetic diversity and make human kind more susceptible to some random virus that will wipe out the entire human race.

I’ve seen episodes of “The Outer Limits” about this stuff.  Believe me…  It’ll scare the crap out of you.

So, there are more pertinent reasons to keep these technologies on the back burner.  But again, I would wager that the FDA’s final decision is not based fully on these reasons but more on idealism.

Gender selection is “Playing God” and “Unnatural”.  But that doesn’t make for a sound statement of hindrance.

The idea that gender selection does not fill a “public health need” is also trite.  Do the majority of plastic surgeries fill a “public health need”?  Should we start closing plastic surgery centers and orthodontic offices?  Sure they make people pretty, but are most cosmetic procedures medically necessary?

I think that the FDA stands on wobbly legs here.  Standing alone in the argument that gender selection is not a “public health need” is a cop out.

Ultimately, time will tell what the effects of gender selection are on those who are born from its technologies.  More will become known about the human genome and how to manipulate it.  It will become safer, cheaper, more reliable, and more accessible.  But it is easier to fall back on rhetoric of “public health needs” when the technologies can be shown to be safe and provide benefit.  The evidence of benefit can too easily stack up against rhetorical nonsense.

We need to stop worrying about how genetic engineering is “unnatural” and “steals you soul”.  We need to make strides in scientific and medical advancement.

The U.S. health care system is continuing to gear itself toward preventative medicine in order to cut out catastrophic disease costs.  Genetic engineering can play a key factor in prevention, lower drug development and retail costs, and greater access to treatment.

Why are we shooting ourselves in the foot when it comes to progress?

“It would be tragic to bring a seemingly healthy child into the world that may suffer horribly, some unintended mutation, throughout there life due to mishaps from genetic tampering.”

Traditional sexual reproduction already does that.

Agreed.  It’s an argument that is easily refuted.

While it is a much more relevant argument than stating that gender selection is not a public health need.  Long term, the technology will most likely prove to be a safe and relevant to scientific advancement.

Again, the probability of the long term benefits of the technology may refute any legitimate concern.

I find it kind of fun to argue about government interference.

In my long term view, I don’t care that much about biotech, as I think that we will transcend biology completely within 25-30 years or so.

So things like genetic engineering and cloning and such don’t truly make an impact on me, as much as the issue that the government is stepping in to regulate it.

The challenge is to truly understand the opinions/feelings/concerns of those that differ from our own. So hard, so painful; sometimes nearly impossible.
The challenge of the new technologies are individual choices that present large societal shifts. We run the risk of societal inequalities and prejudices becoming biological and not simply social.
Is this move a call for never using the technology or moving ahead more slowly? Is it ethical for one nation or a handful of nations alone, without global input, to make decisions that can change the face of humanity?
Today it is gender, but iPan is right—the issue will likely extend across a variety of the emerging technologies.
We need to learn intercommunication skills and develop ethical standards across domains: personal, societal, national and global.

The problems arising from an excess of males (e.g., China, India) simply do not arise when there are more females than males.  In fact, having more females than males might well have very positive effects on society.

Would the FDA have any say if women aborted the “wrong” sex child? That is what they do in China. Microsort is vastly more moral than that

I’ve milled over this subject during the last few months & I have a firmer stance now.  At this point in history gender selection without regulation is a bad idea.  For instance, areas of the world such as China have preferences for males over females.

When there is an increase in males over females, as previous commenters have posted, societal issues can arise.  Dominant male populations can lead to things like increased violence against women and sex trafficking.

Now, I do not like the “We’re Just Not Ready For It” argument.  I do not think that the issue is that simple.  But, one must look at social trends when determining standards for gender selection.  Gender selection is not amoral nor is it sexist.  Gender selection could prevent social tragedies such as abortion for gender selection or gender based child abandonment.

Ultimately, there are huge potential consequences which must be evaluated & regulated before permitting gender selection.  While there may be parts of the world that can effectively regulate gender selection clinics; there are many other parts of the world that will be unable to establish or enforce regulation standards.

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