LEGAL VICTORY! FDA loses landmark 1st Amend. case....

**Times Roman** · 06-13-2012, 03:43 PM

so the title goes in my new copy of life extension. there is a battle going on between the FDA and a marketer of green tea. the data supports the claim that green tea, when consumed daily, significanlty reduces the risk of getting cancer. It is in the July 2012 edition so no link yet to post to. But the FDA doesn't like it, as in the studies, what the FDA likes to see are half of the subjects taking green tea and the other half placebo. So because the study wasn't formatted correctly, the FDA doesn't want to allow it. But the courts stepped in, and agreed that the scientific data was valid, regardless if in the format the FDA likes or not, so we can now expect to see these claims on green tea containers here real soon.

talk about an archaic beauacracy! who's interests are being served by not allowing the claim, and therefore the public to know that green tea is a great way to reduce your cancer risk?!?!

**DanB** · 06-13-2012, 03:55 PM

Shhhhhhh or you will lose money for the pharmaceutical companys

**warchild** · 06-13-2012, 04:11 PM

gotta get me some green tea. any recommendations?

**Times Roman** · 06-13-2012, 05:29 PM

yeah, get the green kind...

**JohnnyVegas** · 06-13-2012, 06:09 PM

Well, science done without blind or double blind are oftentimes not considered stringent enough. Not only should there be a placebo group, but both subjects and the people doing the study should be in the dark as to who is getting what. Otherwise there are too many possible problems for the data to be trusted.

The green tea people should focus on doing their studies in a more widely accepted way if they want to do this right.

I am not saying green tea doesn't work but I am saying that their credibility is suspect if they refuse to do stringent testing. Especially with the track record that supplement companies have with making big claims.

**Times Roman** · 06-13-2012, 06:52 PM

Originally Posted by JohnnyVegas

Well, science done without blind or double blind are oftentimes not considered stringent enough. Not only should there be a placebo group, but both subjects and the people doing the study should be in the dark as to who is getting what. Otherwise there are too many possible problems for the data to be trusted.

The green tea people should focus on doing their studies in a more widely accepted way if they want to do this right.

I am not saying green tea doesn't work but I am saying that their credibility is suspect if they refuse to do stringent testing. Especially with the track record that supplement companies have with making big claims.

and here is the problem with that.....

these studies are very expensive! it's no prob for the deep pockets of the pharma industry, but green tea industry is very competitive and not so deep pockets. so if all the studies have to be very expensive, then only pharma will conduct, and then only on items with a very profitable chemical.

there has to be a better, more relaxed way....

**Far from massive** · 06-13-2012, 06:59 PM

The trouble is that once you open the door to allowing those sort of claims every vendor out there will be claiming health benifits with substandard testing. I think the current system works fine. That is if you do the legit stuff then you can claim it as such if not you can add the caveat ( this has not been approved bla bla bla) and people will still blindly buy it but the few with enough sense to know the difference will not be fooled.

**Times Roman** · 06-13-2012, 07:04 PM

there should be more than one standard.

one for new drugs being introduced into the market. this poses the biggest threat imo, and there should also be a 5 year moritorium on advertising on TV until really tested on the general population at large

another standard for "off label use" for drugs that are already deamed safe. the bar would be set lower and therefore make the testing less expensive.

another standard for general food stuffs that have been consumed by billions of people and we know safe. this standard could be met with sufficient scientific evidence from existing data. this would be the lowest standard, and the least expensive.

**MuscleScience** · 06-13-2012, 08:46 PM

Originally Posted by JohnnyVegas

Well, science done without blind or double blind are oftentimes not considered stringent enough. Not only should there be a placebo group, but both subjects and the people doing the study should be in the dark as to who is getting what. Otherwise there are too many possible problems for the data to be trusted.

The green tea people should focus on doing their studies in a more widely accepted way if they want to do this right.

I am not saying green tea doesn't work but I am saying that their credibility is suspect if they refuse to do stringent testing. Especially with the track record that supplement companies have with making big claims.

That is not necessarily true, there are many different experiment designs. There is a certain level of scrutiny that each program design is theoretically suppose to have. Just because you have a double blind, random control study on something doesnt mean that its better than say clinical data collected out in the field or observational study. In fact, in a lot of area's of science there is no way to do a double blind study but that does not mean that the data is any less valid.

I dont think that the case was based off one study. There are tons of studies done on green tea, its probably more of a matter of one study that the manufacture placed on the box.

As a matter of fact, a lot of public health policies are based off retrospective studies that take data from one or more different studies and statistically run the data for some other purpose than the data was collect for. There is no particular stringent design as the data could come from a number of unlike studies looking at different problems and compile the data to answer a new problem.

**charcold** · 06-13-2012, 09:03 PM

If you think thats bad, look at a Kaplan-mier curve of new cancer drugs. Drugs are getting accepted with lengthening life by like 6 months. Ask youself how you would feel to have a parent given a placebo or standard treatment and be on the shorter curve. Its a necessary process, I hate to admit. Yes, very expensive, and years of research.

the tea stuff falls in with herbals imo, some good things, some bad, all with poorly documented success.

Another note, each step, aka blinding, randomized each control for certain bias. Yet each study must be studied very critically before results evaluation, let alone changing practice.

**Razor** · 06-13-2012, 09:21 PM

Originally Posted by charcold

If you think thats bad, look at a Kaplan-mier curve of new cancer drugs. Drugs are getting accepted with lengthening life by like 6 months. Ask youself how you would feel to have a parent given a placebo or standard treatment and be on the shorter curve. Its a necessary process, I hate to admit. Yes, very expensive, and years of research.

the tea stuff falls in with herbals imo, some good things, some bad, all with poorly documented success.

Another note, each step, aka blinding, randomized each control for certain bias. Yet each study must be studied very critically before results evaluation, let alone changing practice.

Make sure it not coming from Japan otherwise its irradiated and give You cancer