11th Aug, 2016
Dr John Waterstone, Medical Director of the Waterstone Clinic, tells Catherine Reilly about the challenges facing fertility services and the urgent need for regulation
The area of fertility is rapidly changing. Science is delivering new possibilities, but the efficacy and affordability of some treatments have created cause for concern.
Questions marks have recently surrounded pre-implantation genetic screening (PGS) or aneuploidy screening, for example, which is used by some clinics in Ireland and internationally to seek to identify chromosomally normal and abnormal embryos.
In an interview with the Medical Independent (MI), Waterstone Clinic’s Medical Director Dr John Waterstone said routine PGS is “not warranted”. He said PGS is often marketed in the US as a ‘standard’ element of IVF treatment, which he found disquieting.
Dr Waterstone, who is President of the Irish Fertility Society (IFS) but spoke in a personal capacity, said the Waterstone Clinic would only recommend PGS for a small cohort in particular clinical circumstances.
“Personally, I am worried about the role of PGS full-stop,” Dr Waterstone told MI. “I don’t know just how promising it is, I don’t know how beneficial it is.”
Mosaicism has recently emerged as a particular uncertainty in respect of PGS. Dr Waterstone noted that cases are being reported internationally of ‘mosaic embryos’ developing into healthy euploid newborns.
“When you do PGS on an embryo, you take out two-three-four-five cells from the embryo, usually from the part of the embryo that is going to form the placenta, and you do that at the blastocyst stage where there are maybe 150 cells present,” outlined Dr Waterstone.
“But some embryos contain a mixture of different cells; some of the cells are genetically normal and then other cells have an extra chromosome, or a chromosome too few.”
The growing evidence around mosaicism has thrown the area of PGS into confusion, he indicated.
“So for me, as Medical Director of Waterstone Clinic, we are proud that this is a technique we can do successfully but I am not at all certain right now, in 2016, about how the whole thing is going to pan-out with regard to PGS.”
Dr Waterstone said the centre was very happy with its pre-implantation genetic diagnosis (PGD) programme, which he said offers clear benefits.
“The couples are coming to you with a very real risk, usually a 25 per cent risk or a 50 per cent risk, that any baby they have would be affected by a very serious genetic condition. PGD is a good thing in my mind; there is no debate there.”
Dr Waterstone said the centre is doing a small number of PGD procedures. Waterstone Clinic is planning a relocation to a larger site that will facilitate a greater volume of work in this realm, he said.
“We are going to move to a new unit on the outskirts of Cork. We are opening there in January and our laboratory space is going to go from 300 square feet to about 1,400 square feet, so we will have a whole lot more space and a dedicated area for PGD.”
The centre has adopted the list of conditions approved for PGD by the UK fertility services regulator, the Human Fertilisation and Embryology Authority (HFEA). Dr Waterstone said there was a pressing need for long-awaited legislation and regulation around assisted human reproduction (AHR). The emergence of expensive ‘add-ons’ in IVF treatment is a particular concern.
In the UK, he noted, the HFEA has expressed alarm that certain IVF units are recommending extra treatments with the aim of “extracting more money from patients but without measurable benefits”.
Dr Waterstone said examples included intracytoplasmic morphologically-selected sperm injection (IMSI), which is not supported by data. He was also of the view that no additional cost should be associated with time-lapse incubators.
“What I have been saying to the Department of Health is we certainly need regulation of IVF, but the most pressing concern is the commercialisation of IVF. The regulations that are introduced must address that issue, because that is one of the most pressing concerns — that couples coming through are maybe being exploited commercially by clinics that just want to maximise profit, rather than just maximise the outcomes for their patients.
“That to me is something that urgently needs to be addressed but which hasn’t really been addressed by legislation and regulation in other countries… It is a very practical issue for couples who are cash-strapped and finding it hard to afford IVF anyway and meanwhile they are confused as they go through and are being offered these add-ons.”
Currently, it is unclear when the Department will publish its draft legislation on AHR. MI understands drafting of the bill’s General Scheme is ongoing and there will be consultation after its publication.
“I hope they are making progress but from a pragmatic point of view, I cannot see that the Government are going to be eagerly trying to legislate on a contentious area, seeing as they are not in a strong position anyway,” Dr Waterstone commented.
IVF stakeholders were invited to a meeting in Hawkins House in July 2015. At that point, recalled Dr Waterstone, the Department already had a “framework for legislation”. “We in the IVF community were slightly upset and surprised that the plans had advanced so far without them seeking advice from us,” said Dr Waterstone of this meeting.
Many felt there was also insufficient consultation on legislative AHR provisions in the Children and Family Relationships Act 2015, developed by the Department of Justice. The Act provides for a National Donor-Conceived Person Register and bans use of anonymous donor gametes in Ireland. These parts of the legislation have not yet commenced.
“I personally think it was bad legislation; I think it was a missed opportunity for good legislation. I think it is far too restrictive, it actually infringes people’s constitutional right to privacy and autonomy,” said Dr Waterstone.
Currently, many fertility clinics in Ireland use sperm from Denmark and the majority of donors choose to be anonymous.
“The initiative from the Department of Justice, which is in law but not actually introduced, tries to ban anonymous donation. In other words, every donor in the future has to be someone who could be identified. I personally think it is over-intrusive, it is too dogmatic. I think people should be allowed a choice.”
The majority of heterosexual couples using donor sperm have opted for anonymous donors. This option is also taken by a “significant minority” of single women and same-sex female couples, he outlined.
Dr Waterstone added that around 1,000 couples per year go abroad for egg donation, usually to Spain or the Czech Republic, where it is anonymous by law. The Department of Health, which will oversee implementation of this part of the legislation, has said the provisions relating to donor-assisted human reproduction, including those pertaining to non-anonymity and the National Donor-Conceived Person Register, will only apply where the donor-assisted human reproduction procedure takes place in Ireland.
The Department contends that the provisions reflect international best practice.
However, Dr Waterstone said the need to go abroad to access anonymous donor sperm or eggs would mitigate against less well-off people. There is also a possibility that people will not involve clinics in the process at all, he said.
“We are also concerned in the Irish Fertility Society about ‘do-it-yourself’ donor sperm treatment for women. Say, a single woman who wants to use donor sperm finds some man on the Internet who is saying ‘I am a sperm donor’ — it is completely uncontrolled and so they just deal with an individual and not with a sperm bank.
“Then you don’t have these safeguards of viral testing and there is a possibility of sexually transmitted disease… we have expressed concern that if donor sperm is restricted it will encourage unofficial, do-it-yourself sperm donors which, if you go on the Internet, apparently it is quite frightening; there are lots of men out there advertising their services as personal sperm donors. We think that is frightening… we have expressed that concern in communications to the Department of Health already.”
He acknowledged that donor anonymity is a contentious area and even people working within assisted reproduction hold different views. Nevertheless, the position of the IFS is that a ban is not warranted.
“There will always be debates about anonymity for gamete donation, is it good or is it bad… but while it is uncertain, people should have the freedom to choose anonymity or identifiability, and that is the situation that has obtained for a couple of decades and I think it has worked out very well.”