george cotsarelis has a patent in hair growth based on his PGD2 findings

[hellouser]

Regards the FDA bashing in this thread and elsewhere:

If regulations were not in place and a commercially available drug or treatment gave you cancer for example --- you would be the first to complain.

Testing of drugs is time consuming for a reason. Not only to assess efficacy, but also to ensure that they are SAFE.

Perhaps some people here are happy to slap untested chemicals that they bought off the internet on their head in the hope that it works, but to the general public, this is an unacceptable risk.

3 long ass phases are overkill. Then there's also the preclinical and post phase III approval process. FDA makes it an absolute nightmare. Phase I covers safety. Phase II covers efficacy and safety. That should be enough.

Watch these criticisms and methods for reform of the FDA:

https://www.youtube.com/watch?v=ccZLitYuWwQ
https://www.youtube.com/watch?v=Ww57tmmecDc

Regardless, there's not much positive that can be said about the FDA.

[walrus]

3 long ass phases are overkill.

Phase III is a large scale study. Phase I and II are carried out on smaller groups. Until a drug is demonstrated to be reasonably safe, larger trails can't be justified. However, short, small scale studies are not substantial enough to draw firm conclusions on the safety profile and effectiveness of a drug in the wider population over time.

[hellouser]

Phase III is a large scale study. Phase I and II are carried out on smaller groups. Until a drug is demonstrated to be reasonably safe, larger trails can't be justified. However, short, small scale studies are not substantial enough to draw firm conclusions on the safety profile and effectiveness of a drug in the wider population over time.

Yeah, but you could bump up the number of test patients in Phase II. Again, watch the videos I linked.

Japan is on the right track to expedite stem cell therapies. I dont even understand why we're relying on the FDA... USA isn't the only country in the world.

[locke999]

Yeah, but you could bump up the number of test patients in Phase II. Again, watch the videos I linked.

Japan is on the right track to expedite stem cell therapies. I dont even understand why we're relying on the FDA... USA isn't the only country in the world.

Because the FDA is a United States entity and you have to go through the FDA in order for the treatment to be approved in the United States.

Why would American based companies avoid the FDA and have their product approved everywhere else besides the United States. That is where they will make back their money. Unlike you, most people aren't going to do a shady procedure in some back of the woods place that isn't FDA approved because many people still believe in the FDA. Dude please, just stop rehashing your criticism of everything because we have heard it enough times already man.

[35YrsAfter]

Because the FDA is a United States entity and you have to go through the FDA in order for the treatment to be approved in the United States.

Why would American based companies avoid the FDA and have their product approved everywhere else besides the United States. That is where they will make back their money. Unlike you, most people aren't going to do a shady procedure in some back of the woods place that isn't FDA approved because many people still believe in the FDA. Dude please, just stop rehashing your criticism of everything because we have heard it enough times already man.

The FDA is a mixed bag. For example:

1.) Frances Kathleen Oldham Kelsey, Ph.D., M.D., a pharmacologist and reviewer for the U.S. Food and Drug Administration (FDA) refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved justified when thalidomide was proven to cause serious birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.

2.) Today as big money appears to run America, the FDA is not making it mandatory that all genetically modified foods (GMO) be labeled. That is very wrong IMO.

3.) Recently, deaths from legally prescribed drugs have surpassed deaths from illegal street drugs. So much for safety.

The legal status of prescribed medicine must make some people think their medication is safe from their abuse. When a baldness cure comes out some guys will guzzle the stuff, I guarantee you. Hopefully the FDA will do their job so their kids won't be born with three heads. As a consumer I am glad the FDA is tough. There is plenty of room for the FDA to do a better job.

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[rdawg]

Regards the FDA bashing in this thread and elsewhere:

If regulations were not in place and a commercially available drug or treatment gave you cancer for example --- you would be the first to complain.

Testing of drugs is time consuming for a reason. Not only to assess efficacy, but also to ensure that they are SAFE.

Perhaps some people here are happy to slap untested chemicals that they bought off the internet on their head in the hope that it works, but to the general public, this is an unacceptable risk.

It's the length and system that's the problem.

I agree that safety tests should be long, but how long is the problem here.

Phase I takes a year, which tests initial safety, but phase II can take up to an additional 2-3 years to complete. and then add another year or two for Phase III, so we have a minimum of 5 years of testing before anyone in the general public can even touch the stuff, why does it take 5 years to figure out the safety of a drug? Also not to mention the phases never start right away, so you're talking 7-8 years minimum with regulations, fees and preclinicals etc.

why not just do the 1 year phase I, 2 years of Phase II and then a limited release for a year in Phase III(i.e select cities or towns can test it out for a year) then full public release.

I also dislike the dose changing policies, if they want to change a dose they have to start an entirely new phase II(i.e like bimatoprost just did) which adds alot of time.

It should not take more than 2-3 years to figure out the long-term side-effects of a drug.

[burtandernie]

Yeah I agree with the above about the FDA taking longer then it needs to. There are other ways to go about it then just automatically taking 5+ years to figure if its safe or not.

Sure I agree people should have this choice. Most problems though go back to politicians not fixing things and this could be one I dont know
2.) Today as big money appears to run America, the FDA is not making it mandatory that all genetically modified foods (GMO) be labeled. That is very wrong IMO.

People abusing legal drugs doesnt mean they are not safe. The FDA has a very good safety profile better then most other countries I would guess.
3.) Recently, deaths from legally prescribed drugs have surpassed deaths from illegal street drugs. So much for safety.

[hellouser]

Yeah I agree with the above about the FDA taking longer then it needs to. There are other ways to go about it then just automatically taking 5+ years to figure if its safe or not.

Sure I agree.
2.) Today as big money appears to run America, the FDA is not making it mandatory that all genetically modified foods (GMO) be labeled. That is very wrong IMO.

People not following directions is 100 percent not the FDAs job at all. If someone takes more then the recommended dosage they get whatever happens to them. It speaks nothing about the safety of the drug
3.) Recently, deaths from legally prescribed drugs have surpassed deaths from illegal street drugs. So much for safety.

None of it matters though. USA isn't the only country in the world. Why should anyone treat it as the centre of attention?

Here's the timeline for Poland's clinical trials:



8 years total from phase I until launch.

[Scientalk56]

i Dont blame the FDA

Until now, i didn't hear about a company that got to phase 3.. they all get stuck in phase 2...
Histgoen has the ability to conduct its clinical trials in asia (no FDA) and still, no word from them until now...

[hellouser]

i Dont blame the FDA

Until now, i didn't hear about a company that got to phase 3.. they all get stuck in phase 2...
Histgoen has the ability to conduct its clinical trials in asia (no FDA) and still, no word from them until now...

The costs to run trials in USA are insane.... largely in part by the FDA. They definitely are at least partially to blame.