Yesterday's article on the Times online site gave voice to Thomas Okarma (CEO of Geron) who was making the case that embryonic stem cells are the only viable source of stem cell-based treatments. Geron, you may know, are preparing to enter clinical trials with the first human embryonic stem cell treatment in SCI. The ethical debate on the use of embryonic/fetal stem cells will probably not go away and for this and other reasons other sources of stems cells are being investigated. One of these is induced pluripotent stem cells (IPS) which is a technology that takes cells from the adult (say a skin cell) and drives these using biochemical and molecular biological techniques to become stem cell-like.
Okarma's argument is a simple one and goes; since it has taken tens of $millions to develop, produce and gain approval for the ES for their SCI trial, should it be necessary to replicated these costs for every patient-tailored treatment the costs and time would be unviable.
The article stimulates a very interesting debate. Obviously, Okarma sees medicine from a profit making angle. The current "product" they have ready to enter clinical trial in SCI will not break even financially and this hurts them and their shareholders. Nevertheless, they need to show the investment made so far was worth it and that the technology is medically viable. If they can do that they might have a chance of validating a platform which can be handle turned in other indications and recoup development costs and see a profit. The interview would have been given with more than half an eye on Geron's shareholders who probably want to be reassured new technologies such as IPS aren’t about to steal the market.
As ever the Americans (perhaps I'm being unfair) don't see beyond finance and assume there cannot be a non-profit approach that sees improving peoples’ lives as a motivation in itself. It also assumes that regulatory authorities will not change their own model of approval. The authorities are not there to impede science but to ensure the process safeguards the public. If this primary objective can be met by another model of regulatory approval that fits with "designer drugs" they will move towards that, eventually. But there will have to be justification, which can only be established by demonstrating what I call "advantages rather than features."
But let's not be naive. It will come down to what drives technology - heavily biased to financial reward at present - and what does the market want. These are often aligned, not always.
Things may shift: increasingly, the market involves government who are footing the bill for an ageing society and its associated ailments. Anything that can reduce the financial and socio-economic burden will be seen as a good thing and worth investing in. Right? The government's shareholders are the people and people don't demand a profit, just better lives. In this case, then, a profit does not have to be turned at the point of sale but later when measured in terms of well fare.
So, which is best ES or IPS? We can't know yet, but competition is a very good thing.
Posts
