The technology in question is mitochondrial replacement, also known as mitochondrial transfer, in which the mitochondrial DNA (mtDNA) from a donor mother is implanted into the embryo from two other parents; effectively giving the child three parents. Mutations in the mitochondrial DNA affect between 1,000 and 4,000 newborns each year in the U.S., leading to disabilities such as blindness, diabetes, dementia, epilepsy, or worse.
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee is to hold a public meeting on February 25 and 26 that will include discussion of requests by research teams to allow regulatory approval of clinical trials of these techniques.
One of the primary reasons given in the letter for opposing FDA approval is that it involves germline modifications, i.e. genetic changes that can be inherited by the descendants of those with the modifications. The CGS letter also claims that a safer alternative, preimplantation genetic diagnosis (PGD) exists. However, there are problems with this technique, as described in this Nature article.
One of the primary reasons given in the letter for opposing FDA approval is that it involves germline modifications, i.e. genetic changes that can be inherited by the descendants of those with the modifications. The CGS letter also claims that a safer alternative, preimplantation genetic diagnosis (PGD) exists. However, there are problems with this technique, as described in this On the same page as the letter is a more information link which contains an FAQ, Two paragraphs of which especially caught my interest. I'd like to respond to each in turn:
"Another concern with allowing germline modification, even in a limited form, is that it can create a "slippery slope"; if researchers are allowed to use it to limit the transmission of even a few specified diseases, why shouldn't its use be allowed to limit any disease? And if it is allowed to increase well-being by treating disease, why not allow it to increase well-being by "enhancing" non-disease traits? MtDNA plays a critical role in cellular energy production and it is conceivable that if mitochondria transfer were made legal that some would propose using it to increase the athletic ability, decrease the risk of obesity, or increase the longevity, for example, of their children."
Firstly, to forestall any questions or suspicions of hidden agendas, I will say up front that I don't really have a problem with germline modification. It seems to me a very strange position to take, as is apparent from the above paragraph, that the CGS believes that it is perfectly okay that future generations should be allowed, forced? to inherit diseases and disabilities that could be prevented. And as for longer life? Sounds great.
No actual reasons are given as to exactly why germline modification is wrong; it is simply asserted, as though everyone should know why it is wrong. Are there possibilities for abuse? Certainly, but it is hard to come up with many things involving human behavior that cannot be abused. So we regulate genetic treatments, just as we regulate other things that can cause harm when misused or abused such as prescription pharmaceuticals, motor vehicles, building construction, etc.
Elsewhere in the newsletter is an article about a new YouGov/Huffington Post poll, which claims to show that a strong majority of Americans are opposed to germline modifications. However, anyone who pays much attention to polls knows that the answers people give depend greatly on the wording of the questions; and that goes double for those who create these polls. Any poll that uses such loaded phrases as "playing God", as this one does, is highly suspect.
Elsewhere in the newsletter is an article about a new It is reasonable to ask how the numbers would skew if a question were asked more along the lines of "Would you favor a genetic modification that would prevent your children and grandchildren from inheriting genetic diseases or risks that you know you have such as diabetes, heart disease, or others?" Would a majority of Americans really answer "no" to such a question?
Even if a less obviously slanted poll were to show that a majority of Americans opposed germline modification, it should be remembered that public opinion can change with remarkable speed, as anyone who's run a political campaign can attest, or as shown by the rapid turnaround in the acceptance of gay marriage. With continually increasing knowledge and capabilities, more inheritable conditions will come under the umbrella of preventable, affecting an ever larger number of people. As this happens, the position of the CGS and those with similar views will become harder to defend. (I will return to the "playing God" phrase at the end of this essay.)
On their about us page, the CGS claims to be "for the rights of the disabled;". What does that mean in practice? Do those rights only begin at birth? Is it possible that people might have the right to come into the world free of diseases and disabilities? Well, certainly not right now, because there's no way of implementing or enforcing that right. But is it so inconceivable in the not too distant future? would a civilized society of that nottoodistant future really say to parents:
"We'll do what we can for your child after he or she has been born , but they have to be born with any and all disease risks and possible disabilities they were unlucky enough to inherit from you and your ancestors, even though we can prevent it, and even though we haven't yet figured out how to treat all of those diseases after birth."?
Certainly, we need to be careful with any new technology, especially one that can modify the genetic code. We should absolutely do a lot of testing before we approve it for general use. But the CGS' position is not that we should kick the can down the road a ways, study the matter further until we know more about what we're doing. Their view is no can, no road. I believe that is the wrong position.
The second paragraph I would like to address is under the title Implications for identity. I would like to take it in sections:
"A donation of mitochondrial DNA is certainly less of a genetic contribution than an entire egg or sperm, but it is likely to nonetheless have a very profound impact on a child’s life, including his or her sense of identity. If successful, this donation will allow them to live free of otherwise debilitating diseases. It is easy to imagine the human curiosity, gratitude, and connection one would feel to the person that made this possible. If the procedure is unsuccessful, the emotions and relationship between the child and parents, as well as the donor, could be particularly fraught."
Firstly, I wonder how the child would feel if he or she contracts one of the possible disabilities, and learns that a treatment was within the capabilities of modern science to have cured them even before they were born, but that treatment was denied them because of things such as the CGS letter and paragraphs like the one above. Parents have to make decisions about how to care for their children all the time. They do the best they can with the knowledge they have. They recognize that there are tradeoffs, risks, in whatever choices they make.
Firstly, I wonder how the child would feel if he or she contracts one of the possible disabilities, and learns that a treatment was within the capabilities of modern science to have cured them even before they were born, but that treatment was denied them because of things such as the CGS letter and paragraphs like the one above. Parents have to make decisions about how to care for their children all the time. They do the best they can with the knowledge they have. They recognize that there are tradeoffs, risks, in whatever choices they make.To make efforts to persuade the legal and regulatory bodies that have the power to decide such things to continue to ban an entire domain of research and application that could help untold numbers avoid the suffering of serious disability and disease not only denies parents the opportunity to do the best they can for their children, but is lacking in compassion both for parents and their disabled children.
"Even if the procedure is successful, however, the child will be aware that his or her genetic make-up is, in some fundamental sense, different from that of childrenconceived from two parents."
I am doubtful that this would be a major issue. If the treatment were successful, how likely is it really that the child would be hung up on having gotten genetic material from a third person—material that saved them from serious misery or even an early death?
"Further, it will be difficult to ever really know if the procedure was completely successful. Children who result from mtDNA procedures will need to be monitored throughout their lives for possible unanticipated effects. They will be, and will know themselves to be, test subjects of scientific experiments."
My experience with children, (although I do not have any myself), is that they can be remarkably empathic and altruistic, (much more so than the adults who wrote the above seem to be). If they were told the truth by their parents, which is that their being a subject of scientific study is benefiting thousands of other children like them, I strongly doubt most of them would mind very much. They may even be glad to be helping other kids all over the country. And of course, we will never really know whether the procedure was completely successful. But if those who've been treated continue to be free of the diseases and disabilities associated with mitochondrial mutations, then we can take a pretty good stab at an answer, can't we?
My experience with children, (although I do not have any myself), is that they can be remarkably empathic and altruistic, (much more so than the adults who wrote the above seem to be). If they were told the truth by their parents, which is that their being a subject of scientific study is benefiting thousands of other children like them, I strongly doubt most of them would mind very much. They may even be glad to be helping other kids all over the country. And of course, we will never really know whether the procedure was completely successful. But if those who've been treated continue to be free of the diseases and disabilities associated with mitochondrial mutations, then we can take a pretty good stab at an answer, can't we?"Finally, they will be aware of the possibility that undetected genetic anomalies will be passed to their own children."
Well, this is certainly true! But this statement borders on the tautological. Many children with untreated (and for now at least untreatable) genetic diseases, and a lot of adults in this country, are aware of that possibility already. Even further, many are aware not just of the possibility, but of the certainty of passing on currently untreatable genetic disorders to their offspring.
As a person with a disability myself, (blindness, although not genetic), I take this kind of callousness a bit personally. What are the goals of the authors of this letter? Is it to benefit society as a whole? How does denying treatment to between 1000 and 4000 potential victims a year here in the U.S. and therefore allowing untold suffering of children (and their families of course) benefit society as a whole?
Finally, the "playing God" phrase mentioned earlier in the poll on Americans' views regarding germline modifications. I'd like to turn that around a bit: Who is "playing God" with the lives of thousands by making efforts to deny them possible treatments and therefore allowing great suffering? When a capability is only speculative, then the positions one takes, either for or against, have no repercussions. But when something moves from speculative to fact, then both the decision to use it and not to do so have real consequences for real people.
Finally, the "playing God" phrase mentioned earlier in the If I argue for a position that results in harm to many people, preventable harm, is it not legitimate to ask me for a good explanation? What about moral complicity here? Once again the question arises as to what "greater good" the CGS is advocating with their view that this form of genetic therapy should be denied. No reasons are given in the first paragraph I quoted above, and the reasons for denying treatment given in the second paragraph are flimsy at best.
It is true, as stated in the CGS letter, that the numbers for this treatment are relatively small. So it is highly unlikely that members of the CGS, their children and grandchildren, and those who hold similar views will have to live with the consequences of their position. But that relatively small number is still in the thousands, and those children and their parents certainly will have to live with the consequences of a decision to deny them mitochondrial replacement therapy. If the CGS letter has its desired effect, those victims and their relatives will know at whom to point the finger.
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