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President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.
Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.
The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @03:20AM
What wavelength a Gottlieb LED emits?
(Score: 5, Informative) by stormwyrm on Sunday March 12 2017, @03:23AM (19 children)
Here’s what Orac at Respectful Insolence has to say about him [scienceblogs.com]:
And in a bit more detail here [scienceblogs.com]:
So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).
Numquam ponenda est pluralitas sine necessitate.
(Score: 2) by c0lo on Sunday March 12 2017, @03:55AM
Just don't get seriously ill.
If you do... well, you are going to sell your house anyway; so probably it will be better for you to take the money and go Cuba [nytimes.com].
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 3, Informative) by Anonymous Coward on Sunday March 12 2017, @03:56AM (3 children)
So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).
So, the same choices that we got for all the heads of other agencies in the trump administration.
(Score: 2) by digitalaudiorock on Sunday March 12 2017, @07:26PM (2 children)
This...+10000. Who else has been waiting for a single pick by Trump that doesn't seem as though a lot of work went into finding the worst possibly candidate? It's getting to where you can only assume that the underlying motive is sabotage, plain and simple. How is anyone still defending this fucking guy?
(Score: 2) by Justin Case on Monday March 13 2017, @03:52AM (1 child)
I think this is called draining the swamp.
What makes people more furious than anything else is that he is keeping his promises.
(Score: 0) by Anonymous Coward on Monday March 13 2017, @04:27PM
> I think this is called draining the swamp.
Indeed. Sane people thought "draining the swamp" meant removing lobbyists working on behalf of the rich.
What he really meant was removing all the barriers that the lobbyists were hired to war with, so now the people who previously fertilized the swamp are directly in control. Swamp drained!
(Score: 1, Disagree) by khallow on Sunday March 12 2017, @05:19AM (13 children)
Here’s what Orac at Respectful Insolence has to say about him:
The third candidate (Scott Gottlieb) is the closest thing I’ve ever seen to a bona fide, honest-to-goodness pharma shill, who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died, defended the off-label marketing of Evista, and, when he was Deputy Commissioner of the FDA, harassed underlings when FDA scientists rejected Pfizer’s osteoporosis drug candidate Oporia, forecast to earn $1 billion a year.
That's a pretty huge point in favor of Gottlieb actually. Slowing medical treatments that the whole of humanity can benefit from just to save a few people in experimental treatment projects has to be one of the greatest evils of regulation ever just by body count. And if he does reduce the cost of bringing drugs to market via regulatory reduction, he will lower the barrier to entry for new pharmaceutical businesses, which will reduce the power of the current Big Pharma cartel. And current cost of drug development in the US is outright insane [tufts.edu] (what small start up can afford that kind of cost?) and needs to be curbed.
So the choice is now between a rapacious fox to guard the hen-house (Gottlieb) or someone who doesn’t believe in the hen-house and will demolish it the first chance he gets (O’Neill).
Kind of sad when Trump is the closest thing to a grown up in the house here with the first attempt in a while to curb the cost of approving new drugs. The point of drug regulation (and medical research regulation as a whole) isn't to protect a few people in a risky experimental program from serious injury or death. Nor is it to protect the Big Pharma cartel from competition. Sure, Gottlieb probably won't be a panacea. But we need to remember the big picture. Sure, we'll all die of something eventually, but there's no reason we can't extend our lives a great deal at a reasonable cost. Sane regulatory and competitive business environments should be part of that.
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @09:27AM (11 children)
(Score: 1) by khallow on Sunday March 12 2017, @01:45PM (10 children)
Someone who has a hankering for a return to the days of the FDA before 1938 looks like.
Just like rolling back some of the insane regulation on minimum wage laws and short work weeks is a roll-back to the days of sweat shops? This is a typical conservative argument. Change is a bad thing, even when the system is obviously broken.
(Score: 3, Informative) by c0lo on Sunday March 12 2017, @01:59PM (9 children)
FYI - the relevant Elixir sulfanilamide [wikipedia.org]
If that's a pretty huge point in favor of Gottlieb actually (who called the early termination of a multiple sclerosis drug study “an overreaction,” even though three participants had died), I think I understand a scared-shitless reaction whenever Gottlieb is mentioned.
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Sunday March 12 2017, @02:50PM (8 children)
(Score: 2) by c0lo on Sunday March 12 2017, @04:28PM (7 children)
So, Gottlieb says "stopping some trial after 3 deaths is an overreaction" and you ask me to trust him he'll rollback only some regulation which, presumably, are unnecessary, right?
Just what regulation do you think can be safely rolled-back?
---
In constructing your answer, on top of "elixir sulfanilamide", consider:
- homeopathy - pure non-toxic water. You don't die because of it, you die because the original illness is not addressed. In the same category, snake-oil from various snakes pushed by noisy markedroids, swamping out the signal of a good cure;
- Thalidomide [wikipedia.org] - non-toxic on short time span, on medium-long term causes malformed children with 40-50% chances of survival. After studies of efficacy/safety, it still have (FDA-)approved uses [wikipedia.org].
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Sunday March 12 2017, @04:50PM (6 children)
So, Gottlieb says "stopping some trial after 3 deaths is an overreaction" and you ask me to trust him he'll rollback only some regulation which, presumably, are unnecessary, right?
Just what regulation do you think can be safely rolled-back?
First of all, why should the trial have been halted? Gottlieb made an important point [time.com] at the time that the deaths could have been due to MS complications rather than the drug:
"Just seems like an overreaction to place a clinical hold" on the trial, he wrote. An FDA scientist rejected his analysis and replied that the complication "seems very clearly a drug-related event."
Even if the latter was true, that still means that the medication could be adjusted to attempt to reduce such drug-related events.
Second, a significant part of the problem is that pre-clinical trials (testing before testing on humans occurs) are notoriously ineffective at weeding out drugs that have problems in clinical (human) trials. We need some serious innovation in coming with with better pre-clinical trials. FDA is a solid roadblock to that.
(Score: 2) by c0lo on Sunday March 12 2017, @05:00PM (5 children)
Exactly how FDA roadblocks pre-clinical trials?
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Sunday March 12 2017, @06:24PM (4 children)
Exactly how FDA roadblocks pre-clinical trials?
Let me first demonstrate that this is a huge problem [sciencemag.org] (speaking of :
So how is everyone doing in the clinic? Sheesh, you had to ask. The overall Likelihood of Approval” (LOA) from Phase I is 9.6 per cent. So no, if you were hoping for an upturn in the more recent numbers, it doesn’t seem to be there. Somewhere around ten per cent success has been the estimate for some time now [sciencemag.org], and here it is again [sciencemag.org]. The worst therapeutic area is oncology, with a 5.6% LOA. That reflects some of its traditional features: lower barrier to entry, which brings in a lot of marginal ideas, difficult diseases to target once you’re in the clinic, and a corresponding willingness to try some fairly out-there stuff.
These numbers shouldn’t be too surprising to folks in the industry itself. What I’ve found while writing this blog, though, is that people who don’t know drug discovery tend to be very surprised indeed. It bears repeating: ninety per cent of all drugs that go into the clinic fail. And ninety-five per cent of all cancer drugs. That’s the central problem of the whole industry, right there. If you can make those numbers look better, hundreds of millions of grateful patients (and untold billions of dollars in revenue) are waiting for you.
The point here is that approval of pharmaceuticals, medical technologies, and other treatments is a sort of inverted pyramid system where expense increases substantially with each step forward. When you get to the point of FDA rejection (one of the very last steps before marketing), it tends to be a huge financial disaster at present. It should be a huge warning sign to us that we're seeing a 90% failure rate (which gets worse as one goes into certain areas like cancer treatments with particularly bad animal models) from human testing (with apparently still a 40% failure rate going into the last and by far most expensive phase of testing before FDA consideration). So right here, the formal testing regime currently approved by the FDA has a huge, rear-loaded failure mechanism and introduces considerable delay in the system.
It appears that final stages of human testing are for the foreseeable future unavoidable [sciencemag.org], due to human biology being ridiculously hard and conflicts of interest often being less than ideal, meaning we will have considerable regulation, delay, and expense even under the best of circumstances. But what we have is this lengthy, expensive, risky, remarkably unreliable process for doing anything to improve peoples' lives and health. That needs to change. The FDA has shown little interest in doing so.
(Score: 2) by c0lo on Sunday March 12 2017, @10:56PM (3 children)
Ok, I got the numbers. What I don't get is: what you see as "FDA roadblocks pre-clinical trials" which need to be removed?
The only way that I see the higher chances of a new drug to be proven effective and safe with reduced costs is to have the drugs failing the process as soon as possible thus removing extra cost in advanced steps.
Do you see some other way here?
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Monday March 13 2017, @06:42AM (2 children)
(Score: 2) by c0lo on Monday March 13 2017, @07:26AM (1 child)
Those hoops, added or removed?
If removed: how this is going to drive down the costs if the drug turns out to be toxic? Given that human testing is much expensive than testing on model animals, I believe its their interest of doing the best the pharmas can in pre-clinical trials, when the costs are lower.
If added: how's this removing roadblocks from pre-clinical trials?
I'll let aside we are barely at the level of cloning organs (from stem cells), much less at the level of cloning humans without brains.
What stops them from using any line of immortal cells [wikipedia.org]? At least the toxicity can be (partially) evaluated on a cell closer to human than any model animal.
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 1) by khallow on Monday March 13 2017, @02:59PM
If removed: how this is going to drive down the costs if the drug turns out to be toxic?
It allows the drug company to solve that problem as they see fit before it gets to human testing.
What stops them from using any line of immortal cells?
As I recall, for a time, certain lines were banned from federal funding by the Bush administration. And the higher level Department of Health and Human Resources was for a time the means by which a ban on the funding of anything derived from human fetuses was enforced. There is a history of interference here.
(Score: 2) by sjames on Sunday March 12 2017, @03:30PM
The part you're missing is that the drug in testing was killing the research subjects, and would have continued doing that on a much larger scale if it was approved for marketing.
The trial wasn't halted just to save a few research subjects, it was halted because it had become clear that the new drug was unacceptable. That is, it failed.
(Score: 4, Interesting) by Azuma Hazuki on Sunday March 12 2017, @04:06AM (8 children)
Well, not "we" as in all of us as individuals, but God *damn* it, maybe all the historically-illiterate know-nothing RWNJs need to suffer (and perhaps die in large numbers) because of their choices so this doesn't happen again. Then again, things are *so* bad that there might not BE a next time. So thanks for that, R voters. Yeah Hillary sucked nuts, but not like this.
I am "that girl" your mother warned you about...
(Score: 2) by c0lo on Sunday March 12 2017, @04:30AM (3 children)
Remember that "We came we saw he died?"
I'm afraid she'd be sucking more than nuts.
Something like the marrow bones of those killed in escalating wars that controlling, authoritarian bitch would think she will win.
(is it agent orange better? nope, tough luck, he's as bad but in other ways)
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 3, Insightful) by Anonymous Coward on Sunday March 12 2017, @05:25AM
escalating wars that controlling, authoritarian bitch would think she will win.
Also perfectly describes Trump, only turned up to 11 :/
(is it agent orange better? nope, tough luck, he's as bad but also in other ways)
FTFY
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @11:48AM (1 child)
When North Korea nukes Tokyo you'll still be going on about how Trump saved lives.
(Score: 2) by c0lo on Sunday March 12 2017, @12:43PM
Idiot, mate, you're an idiot if you think I like Trump better than Hillary.
I'm not, and is also true I don't like the russian Agent Orange better than that bitch. Both of them are made from shit, except that one is donkey shit, the other is elephant dung.
IMHO, you should have elected anybody else but those two.
Being non-USian as I am though, I'll respect your right to shoot yourself in both feet with a weapon the calibre you think will inflict the maximum damage.
https://www.youtube.com/watch?v=aoFiw2jMy-0 https://soylentnews.org/~MichaelDavidCrawford
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @06:57AM (3 children)
Shortening the approval process for new drugs will save lives in the long run.
You're welcome.
(Score: 2) by aristarchus on Sunday March 12 2017, @09:20AM (1 child)
Shortening the approval process for new drugs will save lives in the long run.
Unless they kill more people in the short run to the extent that they also kill more people in the long run. Do you not remember the 1950's? https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation [northwestern.edu] Yeah. And why is Peter Thiel, that vampire, involved in health care at all? Why should government be involved in safety, as opposed to effectiveness? Unless we have some proven drug, in double-blind objective studies, and can cure Republican Libertarian Really Creepy Gay Billionaire syndrome. (Do we, yet? What? No funding? OMG!) I say let the market decide. If a company sells drugs the kills their customers, they will just go out of business when the mechanism of the market kicks in! Right, khallow! That is why you just cannot by street heroin these days. Just can't do it. Can't buy Epi-pens, or AIDS medication, either, but that is a different issue.
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @01:15PM
Hero-in.
I'm afraid the kills customers will go out of business before the mechanism of the market kicks in.
Ah, I see now, you were taking about a (as in "one") company going out of business.
Sorry, this singulars and those plural pronoun is making my non-native english head spin.
I'd better go to sleep now.
See you to morrow, buy-bye. Hero-out!
(Score: 4, Informative) by Thexalon on Sunday March 12 2017, @01:40PM
Shortening the approval process for new drugs will save lives in the long run.
... unless they don't work, or they kill more people than they help, or they work but have crippling side effects, or they work but not as well as competing products.
Which, in order to determine, we'd have to do extensive trials of the drug on humans who have whatever the drug is supposed to cure, and wait long enough after the subjects got the pills in order to check on longer-term effects.
The only thing that stops a bad guy with a compiler is a good guy with a compiler.
(Score: 2) by gringer on Sunday March 12 2017, @08:19AM (2 children)
O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works
And how is this different from the current situation?
Ask me about Sequencing DNA in front of Linus Torvalds [youtube.com]
(Score: 0) by Anonymous Coward on Sunday March 12 2017, @01:46PM (1 child)
I have a hunch currently the drugs need to be both safe and effective.
May have something to do with the harm on the pocket of vulnerable people caused by plain water marketed as a cancer cure.
(Score: 2) by Immerman on Sunday March 12 2017, @03:49PM
In theory, but sadly only just barely in practice. There's fair number of drugs on the market that have been shown to be roughly as effective as placebos in independent testing. But so long as the manufacture can also manufacture tests showing how effective they are, they tend to get approved.