5 ms·

Publicity stunt instead of scientific paper in reviewed journal, "we don't care about FDA approval" attitude, undisclosed location in latin America - sounds tot

by JackuB 11y ago

Publicity stunt instead of scientific paper in reviewed journal, "we don't care about FDA approval" attitude, undisclosed location in latin America - sounds totally credible.

mcnamaratw 11y ago
What? Tech Review not credible? Surely you jest!
- JackuB 11y ago
  Tech Review just reports on news here - announcement came from Reddit thread by Parrish afaik.
  - mcnamaratw 11y ago
    I may have made my point too dryly for online. Tech Review sometimes veers towards Wired Magazine's airspace.
anonmeow 11y ago
If governments and FDAs of the developed world were more cooperative it wouldn't happen this way. Startups don't have a billion dollars for FDA trials.
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 ago
  Well written points, but I feel you should acknowledge your interests in this particular topic before discussing its merits.
pippy 11y ago
After the FDA started pressuring 23andme in to not giving data relating to diseases to customers, I lost of respect for them in the genetic arena. Customers have a right to know what's in their bodies. At the moment 23andme is only cleared to give out data from a single disease, which is pathetic. Clearing the way for more genetic diseases will likely be a bureaucratic nightmare and would harm more people in the long run. Given how conservative the FDA is in allowing companies to inform customers what's in their own bodies, it's unlikely companies will get any form of approval for modification.
- kbenson 11y ago
  I imagine the reasoning is that give people incorrect information about a disease they may have could be extremely damaging. Having models that predict the accuracy of each diagnosis to within a few percent and presenting this percentage would be better (maybe requiring it be over a certain percentage), but the FDA is conservative enough I can imagine them requiring 99% accuracy or better on everything.
  - TeMPOraL 11y ago
    I don't know the details of the particular case of FDA and 23andMe (I remember only the one when FDA asked 23andMe to fix their marketing, or else), but there is a known problem with giving medically-relevant information to people - that armed with such information, fully predictably, they go batshit insane. Most people are not properly equipped to handle such information. I see this as a failure of education, that could probably be easily fixed if e.g. high-school curriculum taught basic statistics and probability theory as applied to interpreting medical results. It's the simple things, like "just because you got a positive test on X doesn't mean you have X", "think of horses before zebras" and "if you read 'X causes cancer' or 'X increases risk of cancer by 1000%' in the news, take note if anyone is providing the base level - an increase of 0.00001% probability to 0.0001% means you can ignore the news and keep enjoying X", and "if commonly-used-in-food-X was really dangerous, you'd see people dying like flies around you; if you don't, it means it's mostly safe so don't panic".
    - 11y ago

by JackuB 11y ago

Publicity stunt instead of scientific paper in reviewed journal, "we don't care about FDA approval" attitude, undisclosed location in latin America - sounds totally credible.

mcnamaratw 11y ago

What? Tech Review not credible? Surely you jest!

JackuB 11y ago
Tech Review just reports on news here - announcement came from Reddit thread by Parrish afaik.
- mcnamaratw 11y ago
  I may have made my point too dryly for online. Tech Review sometimes veers towards Wired Magazine's airspace.

anonmeow 11y ago

If governments and FDAs of the developed world were more cooperative it wouldn't happen this way. Startups don't have a billion dollars for FDA trials.

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 ago
Well written points, but I feel you should acknowledge your interests in this particular topic before discussing its merits.

pippy 11y ago

After the FDA started pressuring 23andme in to not giving data relating to diseases to customers, I lost of respect for them in the genetic arena. Customers have a right to know what's in their bodies. At the moment 23andme is only cleared to give out data from a single disease, which is pathetic. Clearing the way for more genetic diseases will likely be a bureaucratic nightmare and would harm more people in the long run. Given how conservative the FDA is in allowing companies to inform customers what's in their own bodies, it's unlikely companies will get any form of approval for modification.

kbenson 11y ago
I imagine the reasoning is that give people incorrect information about a disease they may have could be extremely damaging. Having models that predict the accuracy of each diagnosis to within a few percent and presenting this percentage would be better (maybe requiring it be over a certain percentage), but the FDA is conservative enough I can imagine them requiring 99% accuracy or better on everything.
- TeMPOraL 11y ago
  I don't know the details of the particular case of FDA and 23andMe (I remember only the one when FDA asked 23andMe to fix their marketing, or else), but there is a known problem with giving medically-relevant information to people - that armed with such information, fully predictably, they go batshit insane. Most people are not properly equipped to handle such information. I see this as a failure of education, that could probably be easily fixed if e.g. high-school curriculum taught basic statistics and probability theory as applied to interpreting medical results. It's the simple things, like "just because you got a positive test on X doesn't mean you have X", "think of horses before zebras" and "if you read 'X causes cancer' or 'X increases risk of cancer by 1000%' in the news, take note if anyone is providing the base level - an increase of 0.00001% probability to 0.0001% means you can ignore the news and keep enjoying X", and "if commonly-used-in-food-X was really dangerous, you'd see people dying like flies around you; if you don't, it means it's mostly safe so don't panic".
  - 11y ago