Wednesday, March 5, 2014

3rd Quarter Post Thursday 3/6/14 "FDA & 3 parent embryos"

Welcome back from vacation!  The post for this Thursday looks at a bioethical issue in the news this week concerning whether the FDA should approve a technique to enable researchers to produce human embryos from the cellular components of three parents.  Read the article and let us know what you think about what the FDA should do and why?


http://www.usatoday.com/story/news/nation/2014/02/24/fda-three-person-embryo-fertilization/5777869/

Best,

Mr. Clark

33 comments:

  1. I think the title is too sensationalized and misleading. Only a very small portion of the DNA used is from the donor, and it only affects mitochondrial function. I also think this procedure should be used, if it is shown that there are no adverse effects that arise. It would allow many children to live lives without debilitating conditions. After several decades of use, this might even be able to eliminate the genes that cause these mitochondrial disorders from the gene pool, assuming all embryos are screened for these mutations, because they would never be passed on to future generations.

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    1. I agree. Statistically speaking, the article stated that 0.02 % of U.S. children inherit this defect. Additionally, as you said, only a small portion of DNA must be donated to avoid this trait. I think that the journalist who labelled this technique as involving three "parents" made the wrong impression by doing so. Really, it's just a donation from a healthy third party, which is comparable to organ and blood donation in concept. However, I partially agree with the global agreement that prohibits scientists from playing with the human genome. As much as I would like to advocate for abiding to natural reproduction, I suppose that it's just like any other artificial medical treatment and should therefore be allowed. But if it were, then it would open the argument for other genetic screenings and tinkering, as we've discussed in class before.

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  2. Even though this procedure of having "3 parents" fertilize an egg to prevent mutations in mitochondrial DNA is a great thing, there is moral and ethical issues that go along with it. Just the same as things like gay marriage, it is considered a normal thing to have two parents. I know that in the article it says that only trace bits of DNA are used in fertilizing the embryo, but that still brings in different genes that will factor into what the baby will look like. Of the few babies that had the mitochondrial DNA correction via a donor, two of the children had irreversible birth defects and one had autism. Overall, I think this DNA correction process is a great idea to help women have babies that have this mutation/deficiency, but the FDA should put strict guidelines on checking the donors beforehand. Also there should be more testing and more media promoting the positive results (once confirmed as safe) of the procedure.

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    1. The procedure that produced children with birth defects was one to help infertile mothers back in the late 90s and was shut down in 2001 by the FDA. As of yet the mitochondrial replacement technique has no been tested in humans but is not showing any birth defects in the monkeys that were tested.

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  3. I think that if "gene correction" could help many women have children without debilitating conditions, then why not? After scientists do a little more research, I think that people will be more willing to do it, especially if they know they can't have healthy children without it. It surprised me that only a small amount of genes would be used to correct the mitochondrial DNA, and the rest of the DNA would be from the mother. I also think it's cool that the children will still inherit their mother's height and eye color from their mother's nucleus DNA. Overall, I think that gene correction would help many women with mitochondrial disease have healthy children, and if the women want to do it, then they should be able to.

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  4. With regards to the ethical dilemmas scientists and the public face surrounding the modification of the human genome, I think that we need to remember that this procedure is for purely medical purposes and can allow those afflicted with mitochondrial disease to lead a more normal life. It may not be a natural process, but the history of medical technology demonstrates that we as humans have decided that if we can do something like give medication or perform surgery on someone to help them live longer than that is better than leaving them alone and letting nature take its course. By taking a pill, getting a replacement organ, or inserting new mitochondrial DNA, we modify a biological process to make it work better.

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  5. I'm big on "precedent" -- what could happen if this door is opened? How large of a leap would it be, really, for some doctors/scientists to begin engineering PERFECT babies instead of HEALTHY babies? The Nazi's are salivating in their graves at this opportunity to scientifically create an FDA-approved master race under the guise of helping mothers have healthy babies. Yes, there would be a large amount of good that could be done with this technology. However, just as there are crack doctors who dole out medical marijuana prescriptions for no reason, or who clear athletes for concussions long after they should've told them to hang up the cleats, there will be scientists that will see this as a personal opportunity for gain. I'm also wary of allowing humans to take too much control over our own natural selection and evolution. Don't get me wrong, children are in no way mere pawns of Darwinian genetic change and adaptation, but the essence and ways of nature have their ethical bounds, too.

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  6. I think this issue really boils down to a more legal standoff. However unethical it may seem for someone to have a child from three parents, it is a woman's to decide whether she feels it ethical or unethical. The FDA shouldn't be allowed to tell a mother with mitochondrial disease that she cant correct her disease, that in itself is unethical. If said mother would like to attempt to have a child with this new technology, as long as she is made aware of the risks what should stop her? However from my own ethical standpoint i believe that even though the technology may be useful in eliminating many genetically linked diseases, it could cause irreparable harm to the human character. Who knows, with pioneering medical discoveries such as this we might just end up in a world that Albert Huxley foresaw in his book Brave New World.

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  7. Elizabeth CorsettiMarch 8, 2014 at 10:27 AM

    This is an incredible breakthrough for genetic engineering. However, I don't believe it is ethical to alter human genes. While this procedure provides huge initial benefits for families wishing to have a healthy child, I am concerned with what would occur later in that child's development. There is no known information about how this kind of procedure would affect a child past being healthy when born. As Reinhardt said, genes from a different nucleus and mitochondrion might not complement each other the way they do naturally. If this creates health risks for the child later on, this procedure may not be worth it in the first place. If the FDA believes this procedure is something that should become available to families, further research on its repercussions is necessary.

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  8. Although some may feel the procedure to be unethical, this new replacement of defective mitochondrial DNA offers great potential to help diminish the terrible conditions many face due to this issue. In this method, the altering of the DNA is purely in order to remove the deficient DNA, and help the offspring live a healthy life. If the alterations of the genome were for any purpose than medically aiding the baby I would agree that it is unnecessary and dangerous, but as long as further research is completed, I think that this method should absolutely be pursued. If we have an opportunity to eliminate such serious and horrible conditions such as blindness with such a simple procedure, as long as it is proven to be safe, it shouldn't be rejected on purely ethical issues regarding genetic engineering.

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  9. I am very undecided on whether I think this should happen or not. From one standpoint, this is so unethical. Science should not be messing with nature. Although it is horrible when babies are born with diseases that could be life-threatening, its nature. This might sound terrible, but if every single person lived the Earth would be way too overpopulated. I don't think that scientists should be messing with what is naturally occurring. From the other standpoint, this could completely revolutionize medicine. This could eliminate so many lethal diseases that are prevalent in society today. From an emotional standpoint, I think this is the right thing to do because it's horrible to see babies, along with their parents, suffering due to bad DNA, which is not their fault. This is a very hard topic for me to have a strong opinion either side because there are arguments behind both sides.

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  10. Upon first considering the concept it seems strange and I initially want to say that this shouldn't happen but after reading the whole article I don't feel like this method is unethical. It almost seems more unethical to declare that a baby must be born with a life-threatening disease rather than receive donor DNA. It doesn't seem all that different that a person receiving donor blood, organs, or bone marrow. What scares me is where something like this could lead not this method in particular. Could something like this lead the creation of "designer babies" manipulating the genome to create children with certain looks, athletic abilities, etc. As science advances its ability to alter genes it becomes more and more important for us to consider the ethical implications of what we are doing.

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  11. Although this scientific breakthrough could be massively beneficial, I don't believe that we should mess with the human genome. Even though it is only being used for medical purposes NOW, if this technology were to be approved it would only be a short time until it was used to create genetically "perfect" babies. The article also raises lingering issues as well, so I don't feel that the time is right to implement this science on the world. While I do wish for a way to save the lives of newborn babies, I truly believe that these things happen for a reason. If our race is allowed to run rampant with seemingly no population control, would we not become somewhat of a virus on the earth?

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    1. I think it's a great idea that doctors want to enable women that are unable to naturally produce healthy babies, but I agree that this advance shouldn't be used to create genetically perfect babies (and knowing modern society, it is very likely that would eventually happen). While I believe every woman should be given the opportunity to have a healthy child without fearing issues like epilepsy or organ failure. I agree that we should wait before we introduce this as a regular practice because there is a very strong possibility that this breakthrough will become abused and used with the wrong intentions. In the future I think this could be very beneficial, but strict guidelines should be set so that this advancement isn't used to achieve perfection, only those who absolutely need this fertilization technique to reproduce a healthy child should be able to access it.

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  12. Well, depending on what this concept of mitochondrial transfer would later be used for if ever approved by the FDA, I would have two very different responses to the question of whether or not it’s a door that should be opened. If this DNA-donor system is more extensively researched (because it does seem very shaky at the moment), proven to do much less, if any, harm than good, and is applied strictly for, as Mitalipov himself promises, “gene correction” only and forever, than it is something that I would – although still with mixed feelings – support. On the other hand, if scientists and consumers were to eventually connect the dots and realize that if gene “correction” is as easy as it is (relatively speaking, of course), and there is certainly more demand for the technology than from just women with mitochondrial disease, then why not characterize any imperfection as an excuse for genetic improvement – I would more than regret that decision. So given that I can neither predict the distant future that will finally answer this much greater ethical question that scientists have been dancing around for years with people’s DNA, nor the immediate future that will reveal how much weight the “language gap” problem Klaus Reinhardt described toward the end of the article will make or break human testing, I would have to conclude that, for now, the FDA should not approve of the new technology. As much as I would like to see this road taken, it is simply too early, and likewise there is no guarantee that this process will be effective enough, let alone accepted. And for the hopeful mothers that do have mitochondrial disease that I feel I’ve now failed by saying this, I can only hope, myself, that they and their husbands can still find happiness, and start a healthy family through adoption.

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  13. This is yet another scientific topic that can cause a lot of controversy. By allowing people to donate their healthy mitochondrial DNA, it opens up the door to changing the human race and how we reproduce forever. I a few people accept this donor, and it is extremely successful, my guess is others would want this implantation also, eventually amplifying the process and ending up with a human-modified supreme human race. This would essentially go against all of Darwin's theories concerning natural selection.

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  14. I think that this is an ethical thing to do. While it may seem wrong to manipulate genes like this, the important thing to remember is that it's being done to benefit the baby, not to harm it. I think the main concern that people have is that one day, messing with genes will lead to unethical things such as designer babies, but right now that isn't what's being worked on, and I don't personally believe that it's worth abandoning all genetic research like this just because there's a possibility that people will go too far with it. If there are regulations in place over whether or not current testing and treatment like this can occur, there will certainly be many more regulations for things such as designer babies. Right now, what's important is curing diseases and helping people, and if there's an opportunity to do so, then it should be taken.

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  15. While genetically modifying humans is currently and will undoubtedly be a controversial topic for decades, if there are children suffering from such a destructive disease and gene modification is the best hope, how could we say no? I also agree with many of my peers who said the title and some of the accusations in the piece are overstated. Potentially, critics of this procedure may believe that this is the slippery slope and just the beginning of a new age of human genetic engineering, but the article specifically states "This is far from opening the floodgates to genetic engineering..." If we can successfully cure a destructive and painful disease with minimal effect on the human genome, why not do it?

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  16. Like Elizabeth, I also believe this new procedure is unethical, even if it may have the potential to allow mothers to have healthy babies. As Klaus Reinhardt noted, there is not enough research to know the long term effects of this procedure. Looking even more into the future, how would this affect the offspring of the genetically altered child? For this new procedure to be considered by the FDA, I think that a lot more research needs to be performed, but further on, the ethical issues have to be considered when the child grows up and learns of the procedure that brought them to being.

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  17. I disagree with a fair amount of the comments being made about how this is unethical and borderline human engineering. These scientists that are trying to help these mothers have healthy babies, not engineer them so they're one hundred percent perfect. Although, I don't if this should be allowed right away. I'd really like to see this tested over a generation or two to make sure that the people with modified genes could have healthy babies, just so people can know what they're getting into before they try this. The FDA still has some work to do with this, but I hope that this is something that can be offered in the future, since it could help out a lot of women looking to have healthy children that don't have any other options.

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  18. First off, I think that the idea needs to be tested and studied more. The human genome is already so incredibly unpredictable, there will never be any guarantee as to whether or not and to what extent procedures like this would help. I think it's incredible that the world is finding ways to try and change/prevent certain diseases, illnesses, or disabilities, but at the same time, it's scary to think of what unknown consequences may arise from using three sets (essentially) of DNA (even if one of the sets is just healthy mitochondrial DNA). I also personally dislike the idea of fertilization happening outside of the womb. After all, even if the egg is healthily fertilized and modified, there is no guarantee that it will attach to the uterine wall and that the woman will become pregnant - and that the baby will survive and grow. I would not have this approved yet because of the magnitude of unknowns, knowing that there is no way to eliminate every bad possible outcome.

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  19. While the title is technically true, it's clearly intended to get a reaction. This science isn't anything that sensational - new, not groundbreaking. The results, however, would be groundbreaking. I don't think there's much of a reason not to take advantage of this advancement, seeing as it would help mothers have healthy children. Yes, it is technically engineering a small part of the genome, but not in a radical way. It's a very simple procedure to help ensure the health of a child. However, this definitely needs more research before I would be comfortable with it being approved by the FDA. This development has a great potential benefit, so I think it should be approved if extensive testing finds no significant negative side effects.

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  20. I heard about this on NPR the other day. The fanfare over a "third parent" isn't rational at all. Baby's aren't doted upon with their "father's eyes, and mothers mitochondrial DNA!." If the procedure produces healthy babies with no side effects, who are fertile to live happy lives, the only conflict is a moral one. By outlawing this procedure, no children are given even a chance. Instead of doing everything they can fix the problem, we would roll the dice with their lives. The past has solid evidence that this does not work, so why would we dwell on it?

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  21. Like with most things, there are pros and cons to allowing the FDA to produce human embryos and fix DNA sequences. The pros would include allowing a mother whose child would otherwise be very unhealthy and sick, birth a child that is completely healthy. Every mother should be able to have their own healthy baby if wanted. On the other hand, is it ethical and right to allow this, and how will this affect the future in terms of human development and carrying capacity? Many think scientists shouldn't be able to tinker with DNA; a baby should be born the way it is even if he or she will be unhealthy. Also, it is common knowledge that the world is over populated already, so will fixing the DNA of these children even be worth it, or will new diseases that are more detrimental to human health arise and kill other healthy humans? There is a lot to think about when it comes to this issue. Ultimately, I think both the pros and cons should be thoroughly examined before allowing scientists to go forth with this.

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  22. Frankly, I don't believe this is much of a debate. As Chris noted, this method of gene modification is synonymous to an organ transplant, probably even more ethical. The child will not be of three parents but of their original two, with a small portion of DNA from a third party that could potentially save them from a life of disease. It would be unethical for the FDA NOT to approve this technique when it could save someone from a life of mitochondrial disease, and that disease from being spread to their children. If the mother of the child wants to save her child and knows what that entails, all the power to her. As long as there is enough research to ensure there are no serious long term repercussions, the FDA should approve this technique.

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  23. I think this has a lot of potential in the near future to prevent birth defects and help the babies that would have grown up with issues. It should be studied a little bit more, either on animals or willing humans that want to be experimented on mainly to observe and gather data on the offspring to see if any problems arise from this procedure. I don't think its too unethical because its changing the mitochondrial DNA, so the baby will still have its parent's traits. If the parents think this is the best thing for their unborn child, then they should be allowed to have it done.

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  24. I believe that this method shows promise and should be further researched and developed before being brought to a general market. A concern I have is that if we start engineering this, when would we draw the line? Could we enact a law that limits genetic modification to specific illnesses or diseases, or will this open the flood gates and allow people to create designer babies for themselves? I am in support of allowing the child to have an improved chance of life and reducing illness, but a line must be drawn.

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  25. Being able to create "healthy" babies could be a huge advantage to women with mitochondrial disease who are looking to have children. Although this may prevent the babies from inheriting certain diseases, I believe that it is morally wrong. I don't think it would be right to alter the genes to make sure that the baby will be almost perfectly healthy. I think this technique is unethical, but logically speaking, it will have a positive impact on the women that put the health of their children first. I think this may need some more trials before it is performed on humans, to be sure of any negative effects, but this could be a great way for women, who have defective mitochondrial DNA, to have kids who will not suffer from a certain illness or disease.

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  26. I believe the FDA should begin human trials, because it seems to me that the potential benefits of mitochondrial replacement would outweigh any risks. The idea that the procedure isn't ethical has no solid backing, and the skepticism about groundbreaking solutions such as this has no grounds in science, but rather in a fear of trying something new. It can't be said that there's no harm in trying, but to not try could be even worse in restricting many women from having a healthy child. Ethics should not be a concern here, and the fact that there is so much opposition to an idea that could save lives is ridiculous.

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  27. Yes, I think the FDA should approval the procedure to give a woman healthy mitochondrial DNA so she can have a healthy baby. According to the U.S. National Library of Medicine website,http://ghr.nlm.nih.gov/mitochondrial-dna, Mitochondrial DNA codes for enzymes used in oxidative phosphorylation and for creating tRNA and rRNA molecules. Problems in these genes cause many diseases. In my opinion, providing healthy genes for these functions does not rise to the ethical challenge of making "designer babies." Apparently, mitochondrial DNA is a weak link in our reproductive process because it is passed down from the mother without recombination, and does not have proofreading or repair capabilities, according to The National Forensic Science Technology Centerhttp://www.nfstc.org/pdi/Subject09/pdi_s09_m02_01.htm. This leads to more frequent mutations and as we know, most mutations are harmful. I wonder if they got the idea for this from viruses, since they reproduce by replacing host DNA with their own. Until it is possible to correct specific gene defects within the woman's own mitochondrial DNA let's be compassionate and give the gift of life and health.

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  28. The fact that mitochondrial DNA could produce a healthy baby who still inherits their mother’s normal nucleus DNA will supply tremendous amounts of relief for mothers suffering from these devastating diseases. While the possibility of every mother being able to have a healthy child sounds is a feat that should be strived for, I worry that if the FDA approves beginning these human trials there may be multiple ethical concerns.
    The procedure should be studied longer with macaque monkeys before being tried in people. During human trials you have families depending on producing a healthy child; however, what if these trials produce irreversible birth defects similar to the 1990s and early 2000s methods? Scientists suggest that it's still not clear that every mother can expect a definitely healthy child out of this. Producing children with defects could be detrimental for families and the resulting children.

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  29. The title of he piece is far enough off from the content to suspect the news is just trying to sensationalize the piece. Many people fear this idea of "human engineering" being preformed, but, this procedure is not any more unethical than say a blood transfusion or an organ transplant. The children would not really being born from three parents, but instead are simply having a third party donor donate part of their body (genetic material in this case) to help repair of the off spring giving them a fair chance at survival. I must however, agree with others that further study in other animals should be preformed first. No force in the universe is greater than human stupidity and ignorance, and I would not put it past scientists to rush ahead with no knowledge of what they're causing or risking. Long story short: The procedure isn't intrinsically unethical, but is new enough to fear human error and ignorance contaminating the process.

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  30. I think this discovery sounds like it could be very beneficial. Many people, it seems, are arguing that this process is "unethical" but I think if the treatment results in a healthy child as opposed to an unhealthy child, there is nothing wrong with it. In my opinion, it would be worse to have a treatment to prevent unhealthy children and ignore it. The risks seem to outweigh the benefits and giving a child a chance for a healthy life seems worth it.

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