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It is a different way of going about bootstrapping funding for a new venture in medicine. The gene therapies used are well exercised in animal studies. At some
by reasonattlm 11y ago
It is a different way of going about bootstrapping funding for a new venture in medicine.
The gene therapies used are well exercised in animal studies. At some point you have to move to humans, but that costs money. This is one approach to raising the funding to perform small trials, you get the first trial member done first since that's what you have the funds for, and move on from there.
Parrish has been a member of the community interested in aging and biotech for some years. Look at the the advisory board of BioViva. You don't magically get George Church on your board without having paid your dues.
Meanwhile if you happen to be someone who disagrees with the existence and current practice of the FDA - and this may be a minority position, but it isn't a small minority position - then linking this all with regulatory arbitrage makes perfect sense. There is an enormous gap between what can be done safely (large set) and what the FDA permits (small set), and with the cost of biotechnology and medicine falling rapidly, sooner or later something has to give.
The FDA is all about maintaining the position of FDA bureaucrats. That's the only real way to interpret the 2.5x cost increase in trials over the past decade. They are willing to suppress as much medical progress as it takes in order to look like people who are doing a non-phony-baloney job. But medicine is inherently risky. There will always be people who die as a result of new therapies: it should be up to the patients to make informed decisions, not a matter of bureaucrats pushing the cost of development upwards to a point at which only a trickle of new treatments emerges on the other side. The public doesn't react to the invisible death toll of people who would have been saved by the medicines that are no longer cost-effective to develop.
It's a sad situation.
- PebblesHD 11y agoWell written points, but I feel you should acknowledge your interests in this particular topic before discussing its merits.