Re:CRISPR eliminates HIV-1 infection in live animals
by Fomite on Tuesday May 02, 2017 @06:25PM
(#14251190)
This is nowhere near the "This is getting tangled up in the FDA" phase. Funding speculative science is hard, and expensive, and this is the type of innovation we exchange for wanting more certain returns on investment, and nothing more than that.
Re:CRISPR eliminates HIV-1 infection in live animals
by Animats on Tuesday May 02, 2017 @05:44PM
(#14250914)
No, this hasn't gotten anywhere near human testing yet. The FDA isn't involved.
Re:CRISPR eliminates HIV-1 infection in live animals
by TaylorAlexander on Tuesday May 02, 2017 @07:01PM
(#14251470)
FDA rules increase barriers to entry to the market, resulting in fewer companies (especially fewer smaller companies) who would be interested in funding such a project.
Re:CRISPR eliminates HIV-1 infection in live animals
by johncolanduoni on Wednesday May 03, 2017 @02:13AM
(#14253443)
If you got DRACO to work in animals, there isn't a pharmaceutical company (or VC) on the planet that wouldn't buy you a small island just to get you to the table. This is probably the worst example you could choose for trying to demonstrate FDA regulations chilling development next to CRISPR.
It's the in vitro -> in vivo part that they're anxious about wasting money on, not the FDA process.
Re:CRISPR eliminates HIV-1 infection in live animals
by gozur88 on Friday May 05, 2017 @01:40PM
(#14275280)
But FDA rules loom large in every decision in medicine. Avenues of research that are going to produce results that will be difficult to bring to market are likely to be abandoned even before the government is involved by law.
That's not necessarily a bad thing.
Re:CRISPR eliminates HIV-1 infection in live animals
by dmix on Wednesday May 03, 2017 @02:41PM
(#14258779)
Obviously it will be in the future, which deters any small scale seed investment...
Re:CRISPR eliminates HIV-1 infection in live animals
by charlieflowers on Tuesday May 02, 2017 @04:39PM
(#14250352)
Are there other nations which have less demanding requirements, but still decent vetting? Why can't these kinds of ideas go there?
Re:CRISPR eliminates HIV-1 infection in live animals
by bdamm on Tuesday May 02, 2017 @04:43PM
(#14250382)
My scientist friends tell me China is paying well, making funding available, and has a lower go-to-market burden. Innovation appears to be literally moving to China as talent is being drained away from the US & Europe.
Re:CRISPR eliminates HIV-1 infection in live animals
by blackbagboys on Tuesday May 02, 2017 @10:08PM
(#14252472)
They have a lower go-to-market burden because the regulators don't much mind if you literally fabricate long-term clinical trial results out of whole cloth. The only innovation occurring is in the field of separating fools from their money.
Re:CRISPR eliminates HIV-1 infection in live animals
by hprotagonist on Wednesday May 03, 2017 @09:52AM
(#14255598)
Re:CRISPR eliminates HIV-1 infection in live animals
by sirtaj on Wednesday May 03, 2017 @01:16AM
(#14253227)
I've seen how clinical trials take place here in India and yes, it's not always pretty. There are plenty of people who mean well and do good work, but the pressure to reduce cost invariably leads to shortcuts.
Re:CRISPR eliminates HIV-1 infection in live animals
by Gtifn on Tuesday May 02, 2017 @04:59PM
(#14250516)
Just for biotech?
Re:CRISPR eliminates HIV-1 infection in live animals
by meric on Tuesday May 02, 2017 @06:19PM
(#14251150)
I'd count commodity electronics in there.
Re:CRISPR eliminates HIV-1 infection in live animals
by BurningFrog on Tuesday May 02, 2017 @05:12PM
(#14250654)
One factor is that by far the biggest profits are to be had in the US.
Maybe you can get approved in Australia or Sweden, but that will pay negligible sums compared to getting into the US market.
Re:CRISPR eliminates HIV-1 infection in live animals
by komali2 on Tuesday May 02, 2017 @05:59PM
(#14251015)
Could try for market pressure - for example, that male birth control being developed in India we keep hearing about. I bet it'll get approved here faster than normal because of how desired it is.
Re:CRISPR eliminates HIV-1 infection in live animals
by jpatokal on Tuesday May 02, 2017 @06:22PM
(#14251162)
Related anecdote: to this day, in Japan access to the Pill remains limited because of vague "safety" concerns, despite decades of use. However, when Viagra appeared, it was approved in months...
Re:CRISPR eliminates HIV-1 infection in live animals
by jliptzin on Wednesday May 03, 2017 @02:13AM
(#14253446)
Well, they do have a shrinking population problem...
Re:CRISPR eliminates HIV-1 infection in live animals
by lend000 on Tuesday May 02, 2017 @04:16PM
(#14250161)
> sense of absolute security
Well said -- the keyword is "sense" of security.
Re:CRISPR eliminates HIV-1 infection in live animals
by barrkel on Tuesday May 02, 2017 @04:37PM
(#14250336)
There's also the small matter of profiting from desperation with unproven remedies that do unknown, possibly permanent damage. There are good reasons and historical precedent for strong medicine safety regulations; it's not just bureaucracy.
Re:CRISPR eliminates HIV-1 infection in live animals
by WalterBright on Tuesday May 02, 2017 @07:23PM
(#14251617)
This was covered in Sam Peltzman's "Regulation of Pharmaceutical Innovation" book, where he goes over the statistics before/after the 1962 FDA Amendments. Statistically, the percentage of drugs that later prove to be ineffective or damaging is no different, just the aggregate amount of new drugs, good and bad, is way less.
Re:CRISPR eliminates HIV-1 infection in live animals
by lend000 on Tuesday May 02, 2017 @04:49PM
(#14250438)
Preventing fraud is one thing. Holding fraudsters responsible is a thing. However, barring access outright to (properly labeled) experimental medicine is completely different, and that's what the FDA does (as well as enforce a bunch of monopolies).
Most of these things die quietly or never get started so we never really see the true costs of what it takes to push the pharma world forward. It likely has a big effect on reinforcing existing monopolies as they are the only ones who can play that game (and pharma has been dominated by the same six companies since the 1800s). Usually R&D happens via a single trajectory which is either expensive internal labs at these companies or via anointed universities. There is very little variation on the source.
There's rarely an investment market between small scale seed stage and high growth phase. Which is where these bio R&D projects die.
Maybe there is an opportunity for a YC-style org to disrupt here. But I doubt it given the requirements to get to market.