What is one to do when the equivalent of the Surgeon General of the UK calls one’s concerns about something, in this case 3-person IVF, “bunk”?
It sure gave me some pause. What’s going on?
First, some brief background.
The debate over 3-person IVF/mitochondrial transfer technology has been getting more heated.
The epicenter for the discussion is the UK where the technology is part way through getting Parliamentary approval. In fact, it could be approved by the House of Lords as soon as tomorrow after it was approved by the House of Commons a few weeks back.
The FDA held a committee hearing on this technology in the US a few months ago and it could eventually be approved in the US in say 3-5 years if more data turn out to be more supportive. Very similar to the FDA, my view is also one that we need more data.
If ground zero on this debate is in the UK, why am I as an American scientist involved?
I happen to be one of the few scientific publicly outspoken opponents of approval of this technology for use now. Note again that I could eventually back it in the future, however, if more data supported safety and efficacy. My concerns relate primarily to the risks of creating children with birth defects and human genetic modification (a third person’s mitochondria).
Even though I’m across the ocean from the UK, my position that we need more time and data and in particular an article in the UK press, which quoted me on my concerns, have ruffled some feathers in the UK
In fact, Professor Dame Sally C. Davies, the UK Chief Medical Officer (roughly the equivalent of the US Surgeon General) went so far as to call my assertion that 3-person IVF could yield children with a higher risk of cancer “bunk” in the House of Lords.
That’s a strong word.
So, again, what to do? This was a few weeks ago.
I decided to write to her indirectly via a letter to Lord Alton, a member of the House of Lords also concerned about approval of this technology. I indicated in the letter why I didn’t think my position was bunk and what were my concerns were on this experimental technology.
Now she has written a letter intending to rebut my concerns again. Lord Earl Howe also signed the letter.
She and I still disagree, which is not unusual in biomedical science, right? For context, as best as I can tell she and I probably agree on 99% of other issues.
I respect her even though we disagree about this one issue. Hopefully that is mutual.
I’m going to write more about the specifics of her most recent letter, which I think is quite surprising in some ways, in a post to come.
Paul, in reading her letter, has anyone picked up on her message that “debunks” Prof. Mitalipov? Prof. Mitalipov’s application to the FDA is for two clinical trials licences: (1) treating mitochondrial disease and (2) for age-related infertility. In her letter, Prof. Davies states women who carry mitochondrial DNA mutations have normal fertility and there is no evidence they have chromosomal abnormalities. However, she clearly illuminates the fact older infertile women are at risk due to having higher chromosomal abnormalities.
Hi Paul,
I start with the premise that HFEA acts in good faith. I’d anticipate that HFEA would carefully guard the privacy of the “tri-parents”. But I doubt that outcomes like 10 miscarriages with developmental disorders could be kept secret for long. Perhaps I’m naive.
Paul, as I’m sure you already know, with any new drug or treatment you can always call for more data to be accrued before starting human trials. But you’ve got to have a cost benefit analysis at some point, with the risks being weighed against the potential benefits.
As a pessimist you cannot be disappointed. But then will your reputation really be damaged if mitochondrial donation turns out to work well? I don’t think so. It is this lack of you having real skin in the game that makes me suspicious that you haven’t really sat down and examined this rigorously from all perspectives, and are letting caution get the better of you.
I’d feel more inclined to listen to you if you somehow got some skin in the game. Maybe make a public bet by taking whatever odds you think there are of mitochondrial donation going horribly wrong, and then bet an amount at those odds so that you stand to lose $100,000 if things don’t go wrong.
Hi Jim,
I think betting on the outcomes of a human experiment would likely ruin someone’s career. Besides, I’d rather be wrong about mitochondrial transfer and have it work perfectly.
Hi Paul,
It seems to me that Dame Davies isn’t suggesting the writing a blank cheque for this 3P-IVF. More like she’s advocating moving it onto the next stage — which would seem to be letting HFEA approve (or not approve) application for specific “tri-parents”. Presumably, HFEA won’t go hog wild. Would your concerns be allayed if HFEA started cautiously, with small numbers and careful followup?
My own ethical sense is that 3P-IVF is like the Burj Khalifa, a monument to vanity. There is no need to procreate and the person who would have the highest burden of risk need never even exist. But I’d be the last person to deny another — in this case 3 others — their vanity.
With respect to matters of vanity, I’m happy to defer to Lords, Earls and Dames.
Hi Brian,
Yeah, a careful, entirely-data based approach from an entirely independent HFEA would at least be a step in the right direction if (once) the House of Lords approves this tomorrow, but I’m skeptical.
The proponents of this technology already think they have HFEA on their side and realistically they seem to have them.
The proponents want a mitochondrial conception to happen this year and I have little doubt that HFEA will comply for the rush.
I’d also feel better if there was a mandate that all data on pregnancy outcomes from this technology be reported publicly and promptly, but apparently that is not going to happen either based on what I’ve heard. I hope I’m wrong on that.
For example, if there are 10 miscarriages and 1 live birth, will the public get to know that? If the 10 fetuses that failed have developmental disorders, will the public get to know that too?
Or will this be wrapped up in secrecy and only the possible “good news” make it through the filter?
I’m a skeptic on this and I’m conscious of that. Most scientists who have voiced opinions on this are on the other side and that puts me in an awkward position, but maybe it’s good to sometimes be the contrarian one. It’s not easy though.
Paul
I’m impressed. Your opinions are being noticed! Keep it up.
Thanks, Jeanne.
Even if I’m wrong in my concerns on 3-person IVF, which I fully concede is possible, this situation surely benefits from a more thorough debate and airing of the possible risks.
I’d also tip my hat to the proponents if they would simply admit that this is in reality a high-risk human experiment and drop the false assurances that they just know it will work and be safe.
I feel like there is much hubris and a disquieting sense of one-sidedness to this issue instead.
If nothing else I hope I have sparked a more balanced discussion by going out on a limb on this one.