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

IVF/PGD and Bone Marrow Transplant - Risks and Safety Issues

Thanks for joining us again this week! In our previous post, we looked at the moral/ethical dilemmas dealing with the discarded embryos in the process of in vitro fertilization (IVF) and preimplantation genetic diagnosis (PGD). Now lets go deeper and get into the risks and safety issues involved in IVF/PGD.

Risks of PGD

When we think of technology and science we typically do not think about what can go wrong, we believe that technology and science is the way of the future and there is not a lot of risks involved. In our minds, technology is solid, foolproof and can be trusted. For this reason, some experts in the field of PGD worry that patients may not fully grasp the potential risks involved in PGD. In a New York Times article, Dr. Hudson, the director of Genetic and Public Policy Center at John Hopkins University, interviewed PGD patients to see if they understood the potential risks and concluded that "while the information had been transmitted, it was not received (1)."

With PGD, there is a phenomenon called mosaicism. This phenomenon occurs when the eight cells that make up the early embryo are not identical. Therefore, if PGD is performed and the biopsied cell is deemed normal, there is still a potential risk that the other cells in the embryo could be defective. Mosaicism happens in about 30% of embryos (1). Dr. Santiago Munne, director of Reprogenetics, reports that about 4% of PGD will be misdiagnosed because of mosaicism and maybe 1% more are misdiagnosed due to technical error (1). According to Dr. Munne, his clinical error, which is when a defective embryo is implanted and thrives, is 6/5,000 cases. Of the 6 that are misdiagnosed and implanted, one spontaneously miscarried and the rest of the pregnancies were terminated. Another PGD doctor reported rates of error for single-gene testing. Of 250 babies, 5 were misdiagnosed; 2 were missed because of technical errors and 3 were because of human error - transferring the wrong embryos (1). Do these statistics and risks factors change your mind about PGD? Let's walk through an example in which PGD was unsuccessful.

• PGD Gone Wrong: Jordan Flynn was born with a rare genetic blood disorder called Fanconi Anemia (FA). With FA, Jordan has a 700-fold higher risk of getting cancer than other children. The disease will likely leave Jorden with some type of cancer, and without a bone marrow transplant the life expectancy for Jordan, an FA patient, is 20 years old (2). Similar to the Trebing case, the best hope for Jordan was to have a bone marrow transplant from an exact match sibling. The Flynn's decided to take the route of IVF/PGD to create a savior sibling for Jordan. During the PGD process they were given results that of the 4 viable embryos, 1 was disease free and an exact match with Jordan, another had a 99.9% chance of being disease free and an exact match with Jordan, and the last two were either diseased or not a match to Jordan (3). The Flynn's decided to implant the 2 embryos that were a match for Jordan. They ended up with a set of twin girls. After running blood work on the twins, it turned out they both had FA, just like Jordan. The devastating news still haunts Ms. Flynn till this day. She feels responsible for bringing two more innocent children into this world with FA (3). Currently, the Flynn family has placed the three girls on a bone marrow registry with hopes that they can find an exact match.

Below are pictures of Jordan, the twins and their brother.

Possible Safety Concerns of IVF/PGD

First, we will discuss safety issues for women who undergo IVF/PGD. With the use of IVF, hormones are given to these women in order to stimulate ovulation and in doing is correlated with a possible increased risk of an ectopic pregnancy (where the fertilized egg or embryo attaches to anything other than the lining of the uterus) (4). With IVF about 2-5% of clinical pregnancies are ectopic (5). On the other hand, in pregnancies without IVF, 1 out of 60 pregnancies may be ectopic (6). Another concern is in order to increase the probability of a successful IVF, more than 1 embryo is implanted in the uterus for each cycle resulting in an increased chance of multiples (twins, triplets, sextuplets…Jon and Kate plus 8). These women carry increased risk of pregnancy complications that may affect their health and the health of their unborn children (4).

Next, safety issues of PGD children. Now, this topic has some controversy between experts regarding the possible long-term effects of children conceived by PGD. Some individuals believe that all babies born from PGD should be followed-up regularly to assess for any long term adverse effects that this technique may possess. As we have already introduced in previous posts, PGD was first introduced in 1990, and from its first use to 2005, it was estimated that 1,000+ babies were born worldwide from PGD. One of the UK centers offering PGD follow their PGD children regularly from 2 months of age until they are 5 years old and therefore questioned why other centers utilizing PGD are not upholding the same practice. Some experts strongly encourage close follow-up as they believe that PGD is still a fairly new procedure and like Dr. Siobahan SenGupta, from University College London, states, “it appears to be safe so far…but only time will tell” (7). On the flip side, others believe PGD is safe. For instance, the Reproductive Institute of Chicago studied 754 infants born after IVF/PGD pregnancies and the results showed that these children did not have increased incidence of birth defects than those born from natural pregnancies. However, we were unable to find information about possible long-term effects that PGD children may develop. We attribute this lack of data possibly due to the lack of regular check up of PGD children and also due to the current confidentiality legislations that prevents HFEA (Human Fertilization and Embryology Act) from distributing data on PGD children to the interested parties and specialists (7).

Interesting tidbit: In 2005, an experiment showed that those embryos that were deemed ‘defective’ (possessed abnormalities) detected via PGD were able to correct the defects as they matured. In this experiment, it was noted that half of the cells in the ‘defective’ embryos became normal by the blastocyst stage. This implied that the ‘defective’ embryo may be a source for embryonic stem cell donation and some of the embryos discarded as being defective could have potentially developed into a healthy fetus (8).

In the next section we wanted to give you more detailed information on bone marrow transplants and the complications and risks involved.

411 on Bone Marrow Transplant

Quick overview of bone marrow transplant

• The procedure of transfusing healthy bone marrow stem cells to the patient.
  
• Before transplantation of the new bone marrow cells, the patient undergoes high-dose chemotherapy and/or radiation to destroy dysfunctional bone marrow. Upon destruction of the patient's bone marrow, the healthy stems cells are transfused (transplanted) into the patient with the hopes that it will continue to produce new, healthy cells.

Where is bone marrow found?

• Bone marrow is spongy, fatty tissue that contains stem cells found inside certain bones. These stems cells develop into red blood cells, white blood cells, and platelets (don't know what these cells are? Just know that, these cells are all very important and are essential players in our bodies).

How do you get bone marrow stem cells from the donor? There are 2 options:

1. Bone marrow harvest = minor surgery under general anesthesia, where a needle is directly inserted in the donor’s hip bones to retrieve the bone marrow stem cells.

                                   

2. PBSCT (Peripheral Blood Stem Cell Transplant) = a more non-invasive technique, in which stem cells are retrieved through a process called apheresis (kind of like a transfusion). Apheresis is where blood is removed either through the donor's arm vein or through the use of a central venous catheter (a tube placed in a vein in the donor’s neck, chest, or groin area). The blood then goes through a machine that separates the stems cells from the donor’s blood. About 4 or 5 days before apheresis, the donor has to have an injection that will stimulate the increase of stem cells in their blood stream (10).
                                              
After bone marrow transplantation, what are some possible complications?

• Infections
  
• Bleeding
  
• Anemia
  
• Pain
  
• Inflammation/sores in the mouth
• Cataracts
• Graft failure, when the new stem cells do not produce new cells.
• Graft vs. host disease (GVHD), when the donor’s cells attack your body.
• In children, may experience delay in growth.

Health Problems in Long-Term Survivors after BMT (9)

Problem, Frequency, %

Immunodeficiency, 50-100%
Renal dysfunction (Parikh, 2002), >50%
Cataracts (Aristei, 2002), 20-50%
Chronic GVHD (Stem Cell Trialists' Collaborative Grp, 2005), 20-50%
Endocrine dysfuntion, 20-50%
Infertility (Sarafoglou, 1997; Dann, 2005), 20-50%
Delayed sexual development, 20-50%
Dental problems (Vaughn, 2005), 20-50%
Psychosocial stress (Gruber, 2003), 10-30%
2ndary malignant neoplasms (Ghelani, 2005; Shimada, 2005), <20%
Cognitive disorders (Simms, 2002), <20%
Avascular necrosis of hips and other joints (Stern, 2001), <20%
Ventilatory dysfunction, <20%

*50-100% very common, 20-50% common <20%>

Our thoughts:

Judy: This week we wanted to provide some background information on IVF, PGD, bone marrow donation and transplantation. Hopefully, you feel as if we didn't let you down on that objective! Anyhow to my conclusive thoughts! First, I believe that it should be known that with all scientific/medical procedures, there are pros and cons, benefits and risks because let's face it, nothing is perfect. Therefore, parents who elect IVF/PGD procedures for the creation of a 'savior sibling,' would assess the pros and cons of their situation and would only decide to go forward with the procedure if they believed in the end, the benefits outweighed the risks. Also, I believe that PGD appears safe thus far, with no indications of harm in the children developed with this technique. It has been 19 years since PGD was first utilized and from our research, we did not find any data proving increased risks of birth defects or long-term effects on PGD children. I know we stated above that a possible hinderance of such data may be due to upholding patient's confidentiality but I believe if something profound arose in PGD children, media would be all over it. I do understand that further research on PGD children would be beneficial but if in the future they were diagnosed with an illness, how would it be differentiated that it was due to PGD vs high-dose chemotherapy and/or radiation therapy vs genetics vs any other possible causes?

Lili: Sorry for the long post you guys! We wanted this week to be about risks and safety issues behind procedures that are involved in IVF/PGD and savior sibling cases. First, I wanted to talk about the thought that most of us have that science and technology is 'foolproof.' Isn't it crazy how we trust science and technology so easily? How many times have we trusted the results of a blood test or a chest x-ray without giving it a second thought? Although we are probably told about the % error in many of the procedures performed, we often choose to believe that technology will pull through, and it usually does...but, after reading about the Flynn family and the outcome of their story, it brings things back into perspective. The example of the Flynn family and the phenomenon of mosaicism reinforces my thoughts that despite what man can do, we can not completely defy nature. As for safety issues with PGD babies in the future, it seems that there is not enough data collection or incidences to be of concern. From what we researched, if there is any defect in a PGD baby, it is presented early in the pregnancy or when the child is born.

Regarding the bone marrow transplants, we wanted to give you statistics and make sure that you understood that the procedure is complicated. The process is more than just taking bone marrow from a savior sibling and putting it into the ailing child and all is well. We see the success story in the Trebing case but there have been unsuccessful stories as well. Keir Zangrando was born with Diamond Blackfan Anemia just like Katie Trebing. After his bone marrow transplant Keir's organs started to breakdown and soon after, he passed away. In a Newsday article, Ms. Zangrando comments that she knew that a transplant was going to be tough, but she "thought the odds of something going wrong were very, very remote (11)." Again, here we see that people often do not understand the magnitude of what risks mean...risks/complications means that it CAN happen to you. For me personally, I was swept away with the thought that technology has given me the option that if I had a child with a rare disease such as Katie, Jordan, and Keir, I would be able to create a savior sibling. But after reviewing the unsuccessful stories, the option of creating a savior sibling or doing a bone marrow transplant isn't just a 'yes' or 'no' question anymore...it's more like...are you willing to take a risk of doing harm to your sick child/PGD child every step of the way to potentially save your sick child?

References:
1. Laurie Tarkan. Screening for Abnormal Embryos Offers Couple Hope After Heartbreak. Available at: http://www.nytimes.com/2005/11/22/health/22gene.html
2. Jeannie Blaylock. Local Family Has Five Children, Three Facing Cancer. Available at: http://www.firstcoastnews.com/news/local/news-article.aspx?storyid=33355
3. Doreen Flynn. Our Personal Journey with PGD. Available at: http://www.fanconi.org/pubs/Newsletters/Family/FN42.pdf
4. Reproductive Health Technologies Project. Preimplantation Genetic Diagnosis. Available at: http://www.rhtp.org/fertility/pgd/default.asp
5. Advanced Fertility Center of Chicago. Tubal Ectopic Pregnancy and Fertility Problems. Available at: http://www.advancedfertility.com/ectopic.htm
6. American Pregnancy Association. Ectopic Pregnancy. Available at: http://www.americanpregnancy.org/pregnancycomplications/ectopicpregnancy.html
7. BBC News. Baby gene tests safety ‘unchecked.’Available at: http://news.bbc.co.uk/2/hi/health/4481839.stm
8. BioEdge. A second look at PGD. Available at: http://www.bioedge.org/index.php/bioethics/bioethics_article/a_second_look_at_pgd/
9. Girindra G Raval, John R Wingard, and Paulette Mehta. Bone Marrow Transplantation, Long-Term Effects. Available at: http://emedicine.medscape.com/article/989518-overview
10. National Cancer Institute. Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation. Available at: http://www.cancer.gov/cancertopics/factsheet/therapy/bone-marrow-transplant
11. Newsday. Losing a Battle With the Disease. Available at: http://www.newsdayinteractive.com/diamond-blackfan-anemia/main.html

The Embryo - Human Life vs. Collection of Cells?

Welcome back! Hopefully we are now "learned" about savior siblings and upon being exposed to the "success" of PGD and IVF evidenced by the Trebing story, we are all ready to delve deeper into what some of the techniques like in vitro fertilization (IVF) and preimplantation genetic diagnosis (PGD) are.

If you don't have time to read what we wrote about IVF and PGD below, don't worry! The next two videos will inform you about the processes...trust us...you want to at least watch the second video below for some awesome background music :) Enjoy!



The 411 on IVF and PGD

We're sure most of you all are aware of what IVF entails but here's a little refresher for you to brush up your knowledge on the topic. IVF was primarily utilized for infertile couples. About 6.1 million people in the U.S. are unable to become pregnant by natural methods. IVF is an assisted reproductive method, that combines a man's sperm with a woman's egg in a laboratory dish for fertilization. Then the embryos (usually 2-4, but as we have all noticed sometimes a lot more, look at the recent controversy with the "Octuplet mom") are placed in the woman's uterus for implantation. Just FYI, the cost of one IVF cycle is about $12,400. Each cycle of IVF may result in a successful pregnancy about 10-35% of the time (depending on maternal factors). Also, there may be a slight increased risk of genetic defects in IVF children according to a study (1). So with all this new technology, what can be done to identify these genetic deformities?

If you were thinking PGD, you are correct! PGD is a costly technique (an additional $4,000-$7,500 to each IVF cycle) to detect defects in IVF embryos prior to uterine implantation (2). It is currently the only option to test your future child who may be at a high risk of carrying a genetic abnormality. PGD assists in eliminating genetic disease before implantation which would prevent the need of termination of the pregnancy upon the diagnosis of a prenatal disorder. This is accomplished by removing a single cell, taking a biopsy, of the developing IVF embryo. Then genetic testing is done on the biopsied tissue for certain sex-linked disorders, single gene defects, or chromosomal disorders (3). Most commonly PGD is used to prevent the transmission of chromosomal abnormalities onto one's child but since the first savior sibling case in 2000, IVF and PGD may be utilized to find a genetically perfect match for an ailing sibling, as the Trebings family did.

What happens to the left over embryos from IVF and PGD?

Many of you have been asking us via e-mail what happens to the embryos that are not used during the process of IVF/PGD. You guys raise a good question that is definitely a controversial issue. It is believed that about 12 embryos are created (give or take) during each IVF cycle and not all of them are used (3). According to a recent study by researchers at Yale University School of Medicine, results show that only 5 out of every 100 eggs fertilized by IVF will result in a live birth. So, 95% of IVF embryos are discarded, either die in the Petri dish or in the womb (4). For the embryos that are 'non-viable' by IVF standards or determined 'affected' by PGD standards the embryo is either discarded or donated for research. For the embryos that are viable and not used during the IVF/PGD process, the donor can choose from the following:

• Freeze the embryo for future use (in case the first round of IVF doesn't work or they want kids through IVF in the future). About 25% of the embryo's stored this way do not survive (5).


• Discard the embryos (flush the embryos down the sink or throw it away in the bio-hazard bin). Approximately 50% of donors choose this option if they do not freeze their embryo (6).


• Allow the embryos to become non-viable on its own in the petri dish in which they were created (usually takes 3-4 days). Roughly 46% of donors choose this option if they do not freeze their embryo (6).


• Donate embryos to research (possibly stem cell research)


• Donate embryos for training purposes (training those who work in the IVF/PGD field)


• Donate embryos to another person

Next question you may want to ask yourself is, what is an embryo to you? Is it a human being or just a collection of cells?
As with the topic of abortion, the fate of the discarded embryos during the process of IVF/PGD is a hot topic in the ethical realm. People who are pro-life view the discarded embryos in IVF/PGD as throwing away a life while others consider the discarded embryos as part of the process of creating life. The overarching moral/ethical question to ask ourselves when looking at IVF/PGD is 'do we believe an embryo is a human life?'

For those that believe life begins at conception, the embryo is a human being with a soul, and therefore has a right to live. Scientifically, the embryo has the genetic make-up to become a living, breathing human being. With this perspective in mind, discarding embryos would be morally wrong. The discarding of the embryos can even be considered murder to most people who believe in pro-life. Some believe that IVF/PGD may be worse than termination of a pregnancy due to the fact that more embryos are discarded and destroyed in the process of IVF/PGD than termination. These views are closely associated with the Christian faith regarding the sanctity of human life in which, "human life should be valued and protected from conception to natural death (7)." Another issue to be raised in this perspective is the ethical principle of nonmaleficence, "to do no harm." If an embryo is considered a human being at conception, the process of discarding the viable embryos is doing unnecessary harm to a life.

For those that believe that the embryo is not a human being, discarding the embryos in IVF/PGD is not a hard task to do. In this perspective, the embryo is not living because it "has no brain, central nervous system, mouth, heart, lungs, or other internal organs. It has no organs to see, hear, touch, taste; it lacks a body, head, arms, legs; it has no self awareness, memory, thought processes, or consciousness (6)." The embryo in this view is not considered a human being, but it has the potential to be one (8). The discarded embryos are therefore, a collection of cells that has a potential for life but is not living. Since the embryos are not regarded as living, IVF/PGD is not doing harm and is in line with the principle of nonmaleficence. Instead, IVF/PGD can be viewed as techniques used to increase the possibility of developing healthy human beings. In an article from the San Francisco Chronicle, fertility specialists point out that a small percentage of embryos survive the natural reproductive cycle, "out of all the embryos created by sexual intercourse, roughly 3 out of 4 do not last long enough to produce a baby. About half of the fertilized eggs are lost even before the woman misses her first period following conception (5)." Therefore, IVF/PGD is not doing anything different from the natural reproductive process other than taking part of the process out into the laboratory?

OUR THOUGHTS

Judy: So now we’re getting into nitty gritty of the ethics surrounding IVF/PGD and savior siblings. Try to contain your excitement and let us dive into my thoughts :) I would like to comment on how amazing it is to see the advancements in medicine and in technology in our society today. However, putting my nerdiness about medicine aside, I do have ethical concerns regarding IVF/PGD and savior siblings. Let me start by addressing our question to you all, “what an embryo is to me?” I do believe that life begins at conception and therefore, the embryo should be considered a human being from day 1. It may scientifically be described as a collection of cells with no vital organs at that time, but if we let nature take its course, then that collection of cells will eventually become a fetus…a human being, right? Then I feel like that leads into a discussion about how people are playing “creator.” With IVF and PGD, we are the ones creating these embryos, bringing them into the world and therefore we must feel entitled to have the right to take them out of it as well. It is easy to not think about the possible moral ramifications of our acts but to rather turn our attention to all the great things that may be accomplished with the use of IVF and PGD. Such as, the success stories of savior siblings, to assist in reproduction of infertile couples, to possibly eliminate genetic disorders to future generations, and the use of excess IVF embryos in research to assist in finding cures of diseases like Alzheimer’s and Diabetes. But, if our society continues to leave such procedures unregulated, as many fail to address the moral dilemmas associated with such practices, what do you all think may be the “slippery slopes” of PGD? If you’re drawing a blank…we’ll discuss this in future posts, so stay tuned!

Enough about that, another issue I wanted to discuss briefly is about the ethical principle of nonmaleficence, “ to do no harm.” I want to try to apply that principle to the savior siblings. In general, parents are solely responsible for making decisions for their children up to a certain age, as they are not competent to make decisions for themselves. That sounds about right for all of us but I believe predicaments arise in situations such as the Trebings and other cases of savior siblings. In such cases, the parents decide what “sacrifices” of one child must be made for the benefit of another. However, is that ethical? To have a child be put through procedures that may pose harm to a certain extent to them in order to possibly save the life of another child. I believe it is evident that the parents are unable to uphold the principle of nonmaleficence for the savior siblings. However, if the parents are unable to make the best decisions for these individuals and their wellbeing, who will?

Lili: I'm just gonna get right into it and say that I believe life begins at conception. The embryo has the genetic makeup to become a human being...it's dividing, growing, living. To put it into perspective in my mind...I remind myself that I was once an embryo. Does that mean that I'm considered a human being now, but not at the beginning? Who determines when life starts and who determines when you are officially a human being? If there is a clear beginning and an end, you can't really tag a place in between and call it the beginning, right? I know my thoughts sound psychedelic, but that's what I honestly think. People may say that during the natural reproductive cycle the woman looses many embryos anyway, so what is the harm in taking it to the laboratory? I think the harm is thinking that IVF/PGD mimics the natural reproductive cycle, because there is nothing that screams 'natural' to me about it. I believe that things happen for a reason and that we should let nature take it's course. Although IVF/PGD has given us success stories, such as the Trebings, there are documented stories about IVF/PGD gone wrong as well...we will discuss this in a later post, so stay with us :) Disclaimer: I would like to add that I am pro-life, but I respect the right that every person has to make their own decisions...so if you were wondering...no, I do not picket outside of fertility clinics ;)

WHAT DO YOU THINK?

CHECK OUT OUR VIDEO! We went out and asked random people their thoughts on issues we've been discussing on our blog.

Hope you guys learned something from this post and leave us a comment already!!! :)

References
1. Jairo E Garcia MD. In Vitro Fertilization. Available at: http://www.emedicinehealth.com/in_vitro_fertilization/article_em.htm
2. Reproductive Health Technologies Project. Preimplantation Genetic Diagnosis (PGD). Available at: http://www.rhtp.org/fertility/pgd/default.asp
3. Molina B Dayal MD, MPH and Shvetha M Zarek MD. Preimplantation Genetic Diagnosis. Available at: http://emedicine.medscape.com/article/273415-overview
4. Bioedge. How many embryos are destroyed in IVF? Available at: http://www.bioedge.org/index.php/bioethics/bioethics_article/8552/
5. Carl T. Hall. The Forgotten Embryo. Available at: http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2001/08/20/MN58092.DTL
6. B.A Robinson. Are Pro-Life Leaders Ignoring the Real Problem? Available at: http://www.religioustolerance.org/abo_inco.htm
7. Biblical Bioethics Advisor. Preimplantation Genetic Diagnosis: A Pro-Life Choice? Available at: http://www.bfl.org/documents/BibBiov11no1.pdf
8. Kathryn Ehrich. The Embryo as Moral Work Object: PGD/IVF staff views and experiences. Available at: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2592482

The Gamble? - The Katie Trebing Story

Lets get started by looking into the story of the Trebing family. You can either watch the video and/or visit the Newsday link below in which reporters recount and discuss the Katie Trebing story. Enjoy!

Click on the Newsday link below to read about the Katie Trebing Story: http://www.newsday.com/news/specials/ny-katie-sg,0,1414219.storygallery

PERSPECTIVES:
We thought it would be interesting to discuss possible perspectives of the key players that were involved in the Trebing case. Please share your thoughts here and anything you feel that we missed

• Parents: For parents of children who are chronically ill, in this case, Stacy and Steve Trebing, it is hard to sit back and be helpless to the sufferings of your own child. As a parent, you want to make things better for your children, to take care of them and to be able to say at the end of the day that ‘everything will be ok.’ For Katie, she will not be ok because she has a rare disease that requires her to have monthly blood transfusions or she will not survive. Even with monthly transfusions the major side effect is that it will slowly destroy her organs and most likely take her life by the age of 40. What if you, as a parent, found a way to help your child by scientifically conceiving a child that can possibly cure your ill child? The thought of creating a life to save a life doesn’t seem so bad right? The choice is to do nothing to try to cure your child or to take action with the support of the latest scientific reproductive technology. It is a tough decision to make as a parent to decide whether or not to take the gamble. However, for parents that want more children, the gamble might not be so difficult. Where is the harm in creating a child that you already planned on having in the future, especially if that child will be a perfect match for your sick child.

• Physicians: For the physician, using the latest scientific technology to save a chronically ill child is not a tough decision to make. From the Newsday report on the Trebing story, Alan Fleishman, a pediatrician and member of the New York State Task Force on Life and the Law, states that physicians in the situation of savior siblings “often make sacrifices for one child, especially one with a chronic illness.” What is the harm in creating a child who can save their sister or brother’s life? If the physician is not causing harm to the savior sibling and the parents want another child anyway and will love the child the same, is it wrong to allow the process to happen?

• Katie: For the chronically ill child, such as Katie and her diagnosis with Diamond Blackfan Anemia, the decision to perform a bone marrow transplant versus monthly blood transfusions does not appear to be a difficult decision. Mandatory monthly blood transfusions that carry the risk of a shortened life span OR a bone marrow transplant that will possibly cure her condition allowing her to live as normal of a life as she can. Sounds like a no brainer right? But what about the complications associated with the bone marrow transplant and from the chemotherapy that Katie will have to undergo? There are many complications from these procedures such as: her hair falling out, infertility, increased risk of fatal infections, increased risk of cancerous tumors in the future, graft rejection, organ poisoning, veno-occlusive disease, or even death. 1 out of every 10 children who receive a bone marrow transplant from a matched sibling will not survive the procedure. Therefore, the question must be raised, where's the harm of taking the conservative route? What if future research unveils a new treatment that may cure this disease without a procedure with so many associated complications?

• Christopher: For the savior siblings, they are brought into this world being "engineered," created by man and by science in order to save their future brother or sister. Their life has an objective, to be a savior sibling and they do so without a choice in the matter. The dilemma continues as whether the cord blood will be sufficient to fulfill their "duties," a painless, non-traumatic procedure. However, what if cord blood is not enough and bone marrow transplant is necessary? Then a more invasive procedure is performed in which bone marrow is extracted from the child's hip under general anesthesia. Not only is this procedure painful to the child but one may wonder, how often will procedures like this be warranted? Or perhaps, what other procedures may be asked of the savior sibling to save their ailing sibling? Where do you draw the line in what these children must endure? When will enough be enough? And who will put their needs above the needs of others?

OUR THOUGHTS:

Judy: When I first heard of this topic, I was trying to sound wise stating, "you never know how you'll react or the decisions you may make until you are actually put in that situation." Noble right? Then I thought about it a little bit more and I hypothetically thought that I wasn't opposed to the possibility of going through IVF and PGD to create a child in order to save a child. However, I thought I would have to draw the line somewhere and I would do so by consenting only to cord blood transplant. It is tough though. Even as I was just typing that last comment, I was like "what if that doesn't work and my ill child is not cured, I can't stop there, what's one more procedure?" That's what is so scary to me. You get so consumed in the entire process and the emotions involved in saving your sick child, that you may loose the ability to know when to stop. In the book My Sister's Keeper, Jodi Picoult portrays a family where the savior sibling was created to save the life of her sister by undergoing cord blood donation, blood and bone marrow transfusions, and the last straw being the donation of one of her kidneys. When faced with an extreme, situation as this, where do you draw the line to uphold ethics and human rights of the savior sibling?

Lili: Last year Judy lent me a book called My Sister’s Keeper by Jodi Picoult. The book was a tear-jerker and made me think about the ethical issues behind savior siblings, but once I put the book down I didn’t give it a second thought. It is interesting how one can easily brush aside ethical matters especially if that issue does not pertain to them or their lives. However, as I started to do research for this project, the issues portrayed in Jodi Picoult’s novel and my thoughts on savior siblings came rushing back to me. I remembered thinking how awful the savior sibling must feel knowing the fact that they were conceived specifically to save their sibling. That the savior sibling may possibly believe that they were a second thought in the scheme of things. In the book, the parents, especially the mother was obsessed with saving the ill child that it seemed that the other children were just shadows in the family. My view’s against the idea of engineering a savior sibling has been slowly changing as I learn more about the successful outcome of the Trebing family. The Trebing’s took the gamble and now Katie is predicted to have a long and full life. However, at the end of the day, I still struggle with the thought of “things happen for a reason” and that maybe we should not be playing the role of the creator. Stick with me as I begin to break down my thoughts over the next couple of weeks.

Welcome!

We are two Physician Assistant students who elected to do our Master's degree tracks in bioethics. We did not know what we were getting into when we chose bioethics, but we both wanted to challenge ourselves to step outside our comfort zones and learn about something that we knew very little about. With the same philosophy of doing something "different" and "out of the box" in mind, we decided to explore a bioethics topic that was interesting, controversial, and something we were passionate about. In our search for a topic, we came upon the subject of savior siblings. Savior siblings are children who are scientifically conceived to be a donor to their sibling who is ill. Specifically, the Katie Trebing story captured our hearts and has propelled us to want to learn more. Don't worry, we will share more than you want to know about the Trebing case in our next post, so stay tuned. We hope that as we uncover information regarding the Trebing story, savior siblings, preimplantation genetic diagnosis (PGD), and the ethical issues surrounding this topic, you may be engaged and that you may share your thoughts with us.

Also, check out this movie coming out June 26th. It is based on the novel, My Sister's Keeper by Jodi Picoult. The movie deals with the trials and tribulations dealing with savior siblings. We are excited that this movie is premiering during our blog! Hopefully, the movie trailer will serve as a teaser to possible topics we will discuss and make you want to come back for more :)

My Sister's Keeper - 2009 Movie Trailer