Tuesday, August 04, 2015

Indication Creep in IVF - why PGS can be bad for patients



One of the common problems we see in IVF is what I call indication creep. This means a particular treatment is introduced in order to treat a specific problem and then, as doctors gain more experience with this particular procedure, they start using it for lots of other indications as well, simply because they have the expertise and the technology to be able to do so.

Thus, for example, when ICSI was first introduced , it was a major advance over standard IVF technology . It was done for treating patients with extremely low sperm counts, where their sperms couldn’t fertilise their wives’ eggs in a regular IVF cycle, which is why the sperm needed a helping hand and the embryologist had to inject a single sperm in the egg to fertilise it.

ICSI was an amazing advance, which revolutionised the way we treated the infertile man.  However, once doctors started doing ICSI, they started deciding to do it for everyone, irrespective of whether the man had a low sperm count or a normal sperm count.

It is quite easy to justify this kind of indication creep.  After all with ICSI, fertilisation is guaranteed and we’re good at doing it, so why not just make sure that we do it for everyone, so this way we don’t risk the possibility of unexpected total fertilisation failure.  Now in a good clinic where the embryologist is skilled, this makes sense because you will get extremely good fertilisation rate , and lots of additional information about the egg quality as well by doing ICSI.  But the trouble is that when all doctors in all IVF labs start copying some of these recommendations , which are based on the experience of expert embryologists who are experienced because they do lots of cycles, the results in real life with a lot of the IVF clinics is extremely poor, because most embryologists are not good at doing ICSI.  Some of them are clumsy, some of them don’t have enough expertise and lots of them will actually end up killing the eggs in the IVF lab ! You cannot extrapolate the results obtained from centers of excellence to the average IVF clinic. The poor patient doesn’t understand the damage which is being done to their chances of getting pregnant.

We are interestingly seeing exactly the same problem today with PGS .  PGD was first introduced to reduce the risk of genetic diseases - to prevent couples with a genetic defect from transmitting that disease to their baby. Doctors soon realised to their dismay that there weren't enough patients with genetic diseases they could find to treat. This meant that they needed to expand their potential pool of patients for PGD - after all, doctors also need to justify their investment in expensive equipment !
When you invest all that time, money and expertise in learning how to do PGD, what do you do with that expertise if there aren’t enough patients?  The answer is simple - create more patients ! Why not do PGD for all older women ? After all, IVF clinics treat lots of older women ! And it's possible to justify this logically , since  we know that the risk of chromosomal abnormalities ( such as aneuploidy)  in the eggs of older women is increased, which is why their success rate is lower and their miscarriage rate is higher.  It makes a lot of scientific sense to do PGD for all older women, doesn't it ? This also allows IVF clinics to increase their workload and profits, because you can now justify the reasons for doing PGD tenfold ! You no longer doing PGD, you’re doing PGS, which is pre implantation genetic screening, which can be applied for every infertile woman who is over the age of 35 who needs IVF !

You can now guess what the logical progression of this line of thought will be in the future. If PGS works so well for older woman and it allows us to select a chromosomally normal embryo which has a very high chance of implanting, then why not just offer it to everyone who is doing IVF ?  In fact, there are already some clinics where the standard for IVF treatment is to do an IVF PGS cycle for all couples ! It's easy to bulldoze patients into this, because the doctor can say - PGD will allow us to remove the genetically abnormal embryos - and which patient is going to want genetically abnormal embryos to be transferred back ? If you are spending so much for IVF, why not spend a little more ?

Now this is great for these clinics , and it makes a lot of logical sense.  After all, isn’t it better to transfer a chromosomally normal blastocyst rather than a chromosomally abnormal blastocyst. ? No one can argue with this kind of logic , and that is perhaps the Holy Grail for IVF. However, in real life , we forget that all these additional technical procedures add to the cost, as well as the time which the patient needs to spend on the treatment . Many of these procedures may sound great on paper, but are not cost effective.

What's worse is that once these influential world leading clinics present their data at conferences, other IVF clinics want to start copying them, partly because they want to be the " first " in their particular country so they can show that they are the "best"; and partly because patients read about these so called advances in press releases and newspaper articles , and they push their IVF doctor to do the same for them. IVF doctors are happy to comply, because want to remain at the cutting edge; they like doing new stuff ; and this is especially true when this increases their income, because they can charge more for these new advances.

The reality is that what sounds good in theory, may not always work in real life.  We learned this from the real life experiences of implementing PGD FISH one decade ago. PGD was supposed to revolutionise IVF treatment and improve pregnancy rates, but it actually ended up reducing pregnancy rates for a lot of these patients, who never even needed it in the first place. This is because there is a steep learning curve involved with mastering these technically complex procedures - and it's the patients who serve as uninformed guinea pigs in these clinics.

Too much technology can cause unintended harm , and the trouble is that IVF doctors don’t seem to learn from their experiences . They seem to repeat the same mistakes every decade, perhaps because the new set of technologies come with the promise that they are better and more advanced !

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