Is PGD Being Regulated?

The Scoop on US and International PGD Regulation

Since PGD is a relatively new technology that involves moral, ethical and social matters, the issue of regulation is a hot topic. Internationally, PGD regulatory systems can be divided into four categories:

1) Non-Regulation: No law or regulatory process is enacted to limit the use of PGD.

The United States is currently a non-regulatory country, therefore the uses of PGD is left to the discretion of its providers (1). Although this sort of regulation avoids government interference in personal choices and the continuation of innovative scientific progress without regulation it has many questionable flaws. Not having regulation gives the authority to PGD clinics to make their own decision on moral and ethical issues concerning PGD. Each clinic will have their own separate policies and services. One clinic can allow using PGD to select the gender of the baby, while others will only use PGD to screen for severe genetic conditions. Is non-regulation giving too much power to the PGD clinics to make moral/ethical decisions? What can go wrong if PGD is not regulated? Interesting Fact: Since the US has no regulation on PGD, more than 2/3 of the 50 or so fertility clinics worldwide offering PGD are in the US (1).

2) Statutory Ban on PGD: PGD is not allowed to be performed.

Germany, Switzerland, Ireland, Western Australia, and Austria are some of the countries that have banned PGD. The ban on PGD could be for a number of ethical, moral and social reasons. Germany for example currently does not allow PGD based on the premise that the embryo has the right to life and performing PGD is unacceptable because it will likely result in the destruction of embryos that carry disease-linked genes (2). A ban on PGD and other regulations on PGD has given rise to "medical tourism." This is when couples who live where there are restrictive laws on PGD will travel to different areas, sometimes even a different country, to obtain treatment where it is permitted (2). In this case, do countries that ban PGD have the right to impose a single moral or ethical perspective on those who may have different views?

3) Statutory Mandatory Licensing: A section of government regulates PGD by requiring a clinic to obtain a license before performing PGD.

The UK and France are countries that regulate PGD through statutory mandatory licensing. In the UK, PGD is regulated by the Human Fertilization and Embryology Act of 1990. The UK allows for PGD to be performed to detect severe genetic diseases and tissue type matching for savior siblings under strict criteria, but does not allow for gender selection. The UK regulation requires the clinic to apply for a new license for every new genetic disease they would like to test for in the embryo (2). This form of regulation will create clear and legally enforceable rules, but is it fair to leave the decision of unacceptable vs. acceptable uses of PGD in the hands of another (3)?

4) Regulation by Professional Organizations: PGD is regulated through guidelines issued by professional organizations. Failure to abide by the guidelines can result in the withdrawal of a clinic's membership in the organization (2).

Japan is a country that regulates PGD through two professional organizations. Japans guidelines relating to PGD requires that it only be applied to "serious hereditary disorders," or in the case of sex selection, to "serious sex-linked recessive hereditary disorders." PGD clinics must get approval from the organization to perform PGD. With this form of regulation, what are the consequences if a clinic violates the guidelines without legal authority? What is the worst that can happen, not being supported by the organization? In Japan, a PGD doctor admits to allowing a couple to select the gender of their child even though it is not allowed by the professional organization guidelines (2). Is this kind of regulation enough to gain compliance from the PGD clinics?

POP QUIZ!!! - Just to see if you guys are paying attention ;)




OK one more...we're gonna give you an easy one.




PGD's Possible Affect on Society

So let’s talk about PGD and one of the possible future implications for our society. As previously discussed, the United States does not enforce PGD regulations currently. Instead our government promotes the laissez-faire approach to PGD practices, allowing the individual to determine for themselves whether PGD is an option for them dependent on their religious, cultural, and ethical values and beliefs. What other factor did I just leave out? Did you say wealth?? If so, you are correct! As you all know by now, PGD is a costly procedure in which the entire process of IVF and PGD will total about $16,000-$20,000. Therefore, it would be an easy correlation that IVF/PGD is a tool that is most likely utilized by the affluent population of our society. Which then leads some individuals to believe that PGD may “exacerbate the rift between the affluent and the underprivileged (4).” Some critics of PGD believe that in the future PGD will create a society where affluent children will be less likely to be stricken with diseases. Allowing these individuals who already are raised in “better” environments to have additional social advantages and ultimately increased opportunities for success. George Annas, a bioethicist states:

“to try to give your child a genetic head start would, I think, be irresistible for parents who could afford to pay for it…This could be very problematic for society. It's a road I don’t think we should go down. But it’s one I could see us going down very quickly as a result of advertising, peer pressure, and so on…and that parents who don’t “take advantage” of the new genetics will soon be seen as bad or even neglectful parents (4).”

I know that sounds a bit extreme but thought it was an interesting viewpoint that may to some extent become a reality. Next, we came across some interesting data from a study performed at a Massachusetts infertility clinic. This study showed that about half of the patients had advanced degrees and greater than 60% had an annual income of $100,000+. In addition, the highest level of education for these individuals was no less than a high school diploma. Also, the data indicated that Chinese and other Asian women over-utilized infertility services (why do you think that is? Maybe cultural importance placed on male children and therefore utilizing IVF/PGD for gender selection..???) but African-American and Hispanic women under-utilized infertility services. Lastly, affluent Caucasian women accessed infertility clinics the most (5). Is it ethically a problem that the educated, wealthy, Caucasian couples are able to provide additional social advantages to strengthen and enhance their progeny while the ‘have nots’ lack the same PGD availability? But can and will anything be reformed on this topic?…our country cannot even provide broad availability of general healthcare for all. Now this is just one implication of PGD that may affect our society but you have to come back next week to learn about the others…dum dum duuuum! :)

Our Thoughts:

Judy: I thought the information that we found this week was quite interesting. It was a great learning experience for myself and I was way excited about the opportunity to share this info with y’all! Well let’s get to it, what do I think about PGD regulation? Actually, I don't think any of the 4 categories of PGD regulatory systems listed above are or will be effective. However, I do believe that some kind of regulation needs to be enforced. In a perfect world, I think an international PGD guideline/regulation would be most efficient but we all know that’s not going to happen so let’s talk about fixing our country first. I believe that allowing the ultimate decision of morals and ethics on what procedures will be performed in a PGD clinic and accepting or denying a case, to be solely in the hands of the physicians and their clinics provide them with too much power. I believe this should be a cause of great concern for possible abuse of that power. I read somewhere in my research for this week that there was a fertility specialist with clinics in Los Angeles and Las Vegas that experienced an increase in the number of PGD procedures performed in their clinics, especially due to the influx of affluent Indian couples requesting male children. These Indian couples, known as “medical tourists” traveled to our country for gender selection PGD, since India banned such procedures in 1994. The issue I had with this article is that this PGD clinic “catered” to these couples by working with a clinic in India to oversee the fertility drug injections that is required prior to the initiation of the IVF/PGD process. Therefore, making the process more convenient for these couples by decreasing their stay in the U.S. to only a maximum of 5 days. Not only is this clinic “catering” to these individuals for business but also they are in a way encouraging citizens to escape the law enforced by their country and to flee to the Land of the Free. I’m not advocating our government to ban PGD but rather to be cognizant to the fact that PGD is a fairly new fertility technique and that providing sole ethical/moral decision-making to the hands of PGD physicians/clinics may be insufficient and problematic. Therefore, I believe some form of government oversight should be initiated to implement increased surveillance and supervision of such clinics, which in the end I believe would be beneficial for all parties involved.

Lili: It was shocking for me to find out that the US does not regulate PGD at all. In my mind, this is very dangerous and can raise a lot of social, moral and ethical concerns in the future. Although I do not believe in a complete ban on PGD, I don't believe the power should be given to the clinic and patient to decide about the moral and ethical issues dealing with PGD. Without at least guidelines, licensing procedures or regulation nationwide, people who have the money, will clinic shop until they find a clinic that will agree to what they want to have done. Do we trust that the people who work at the clinic will make the right decisions and uphold the principles of beneficence and non maleficence? For me, I wish I could completely say yes, but I think I am jaded and can't deny the fact that a lot of our society is run by greed, money and consumerism. I think when a lot of money is involved, some people can rationalize and be persuaded to go against their better judgment. The other issue in this weeks post deals with the implication that IVF/PGD will strengthen and enhance the progeny of the affluent society. I think this is another big concern that we need to think about. Is it fair that only the wealthy can afford access to IVF/PGD? I believe that it is definitely unfair and puts yet another division between the opposite ends of the socioeconomic spectrum. But what are we gonna do? provide IVF/PGD as a standard of care for those at high risk of passing on a genetic disease? I don't think that's ever going to happen.

Poll Question:

References:
1. The International Center for Technology Assessment. Pre-Implantation Genetic Diagnosis: Ethical Guidelines for Responsible Regulation. Available at:
www.icta.org/doc/pgd%20guidelines.pdf
2. Aron R. Fahrenkrog. A Comparison of International Regulation of Preimplantation Genetic Diagnosis and a regulatory suggestion for the United States. Available at: http://www.accessmylibrary.com/coms2/summary_0286-15444892_ITM
3. The Genetics and Public Policy Center. A Discussion of Challenges, Concerns, and Preliminary Policy Options related to the Genetic Testing of Human Embryos. Available at: http://www.dnapolicy.org/images/reportpdfs/PGDDiscussionChallengesConcerns.pdf
4. Jason Christopher Roberts. Customizing Conception: A Survey of Preimplantation Genetic Diagnosis and the Resulting Social, Ethical, and Legal Dilemmas. Available at: http://www.law.duke.edu/journals/dltr/articles/2002dltr0012.html
5. State of Fertility Report 2007. Available at: http://www.integramed.com/pdf/fertility.pdf