The FDA is ********

[GoodGame]

The thing about the FDA is they also have responsibility to ensure the efficacy of any product.

So even if it's walnuts, if they make health claims above and beyond the obvious (e.g. this is food, food has calories, it has vitamins and fats, you need that), they better back them up.

It appears the company claimed some specific medical benefits---that the walnuts had anti-tumor effects. So I'd say the FDA was acting for the public good in this case.

 

[Berzerker]

Next year 50,000 people will live with the approval of this new medicine... FDA press release

So... last year 50,000 people died waiting for permission from the politicians to save their own lives. Yeah, there's yer friggin death panels... Land of the free my assterisk

 

[ori]

the approval process may have flaws - but without one a lot more people would die from taking drugs that either do not work or have deleterious effects.

 

[Berzerker]

So one group of people dies to save another? I'd call that a death panel...

 

[ori]

So you've decided to kill one group of people to save another? I'd call that a death panel...

Call it what you like - but without some proof that something actually works most of these people would get drugs that don't and die, and more would die / get unusable treatment. Its not a decision of letting some people die so that others may live - its a decision to ensure that there actually are drugs that work in the first place. If you abolish that you'll have all sorts of promises by companies but no new drugs that are actually tested. And everyone would suffer - those patients that benefit from a newly approved drug would not likely have benefited from using just any drug that a company markets as efficient without an approval process.
Also: this argument has another deep flaw, in that off-label use and pre-approval use are all possible (though attached with paperwork that makes it cumbersome, except for emergency situations where it is attached to a mandatory phone call.).

 

[sophie]

Yeah, just look at what the drug field looked like in the years before the FDA. Hate them or love them, the FDA is a good way to ensure that that medicine you're taken which is guaranteed to cure cancer isn't just a distillation of lead and arsenic .

 

[bhsup]

So one group of people dies to save another? I'd call that a death panel...

Would you rather have the 1800s with the snake oil salesmen going town to town selling God knows what to cure what ails ya? Course, we still need an amendment to make the FDA constitutional, but they do good work

 

[Bill3000]

Would you rather have the 1800s with the snake oil salesmen going town to town selling God knows what to cure what ails ya? Course, we still need an amendment to make the FDA constitutional, but they do good work

I would have thought the FDA would be pretty blatant regulation of interstate commerce?

 

[bhsup]

In most cases it probably does. But can you guarantee that every single thing it does involves something that crosses state lines (the REAL proper use of interstate commerce)?

 

[Narz]

The FDA is awesome. The last thing America needs is for hippies to be allowed to conflate food with medicine.

That's precisely what the FDA is doing.

 

[Narz]

LEF has stuff to sell, huh? The biased language in the LEF article is grating.

Everyone has stuff to sell. I know they have a bias but at least it's fairly transparent (unlike the FDA & WHO who are a bit too closely tied to pharmacutical companies which affects their judgment, there was story about this on NPR or a similar station this morning)

 

[SS-18 ICBM]

At least try to make the article sound unbiased, is all I'm saying.

 

[ori]

That's precisely what the FDA is doing.

Not in this instance at least - here its a company that tries to sell food as medicine and the FDA telling them if you want to sell it as medicine than get it approved as such - or stop selling it as medicine.

 

[Cutlass]

So one group of people dies to save another? I'd call that a death panel...

At least a public sector death panel doesn't maximize CEO bonuses by killing as many people as possible. Private death panels do. So which do you think will kill more?

 

[Narz]

Not in this instance at least - here its a company that tries to sell food as medicine and the FDA telling them if you want to sell it as medicine than get it approved as such - or stop selling it as medicine.

So anything with health benefits = medicine?

They aren't selling it "as medicine", they're saying it's healthy.

Processed junk like Honey Nut Cheeriors has all sorts of health claims on their box & no one's picking on them.

 

[ori]

So anything with health benefits = medicine?

They aren't selling it "as medicine", they're saying it's healthy.

Processed junk like Honey Nut Cheeriors has all sorts of health claims on their box & no one's picking on them.

they are not just saying its healthy
they are saying it slows tumor growth, prevents breast cancer, helps treat depression, prevents strokes, prevents heart attacks, helps treat other mental disorders, treats arthritis, treats inflammatory diseases, lowers cholesterol

now all of these may or may not be true - but they are specific claims regarding specific diseases and in some cases containing the claim that they can be used to treat those diseases. If you want to claim your [whatever piece of edible stuff] treats major depression - then you need to have [whatever piece of edible stuff] approved as a drug showing it is effective in treating major depression and it does not matter whether [whatever piece of edible stuff] is a pill or a banana.
Of course they could just as well cease to claim they can cure cancer, depression, arthirtis, strokes, heart attacks with just the use of walnuts (yeah I know I am exaggerating) and go with its healthy eat walnuts.
They chose to instead claim they can treat all sorts of diseases - so they better have studies showing this and that there are no harmful side effects and that double blind studies confirm this and whatever anyone else who wants to sell a drug has to show. Just because its a natural product doesn't mean its not a drug if you try to cure stuff with it.

 

[Narz]

Should jogging have to get approved as a drug? What about support groups? Should you have to get a prescription before you start walking twice a day or meditating?

At the end of the day it's not a drug & as long as it's not making true claims it should be able to say whatever it wants on it's label.

Just because its a natural product doesn't mean its not a drug if you try to cure stuff with it.

I think it's less about trying to "cure stuff" than trying to prevent stuff that needs curing.

Seems like 99% of medicine today is about curing rather than prevention. Which is understandable considering how much more profitable it is.

 

[ori]

Should jogging have to get approved as a drug? What about support groups? Should you have to get a prescription before you start walking twice a day or meditating?

At the end of the day it's not a drug & as long as it's not making true claims it should be able to say whatever it wants on it's label.


I think it's less about trying to "cure stuff" than trying to prevent stuff that needs curing.

Seems like 99% of medicine today is about curing rather than prevention. Which is understandable considering how much more profitable it is.

read the FDA letter - they mostly jump on the treatment claims. Stating that, if you say you can treat disease X ,then you have to provide dosage information on the label and proof of efficacy. If disease X happens to be one which a lay person cannot diagnose, like major depression you have to market it through doctors as a prescription drug.
You say its about prevention - very well - the company selling these walnuts claimed treatment (as well as prevention), so they are held to their own claims. Again, if you claim your product is a drug you need to accept being held to this claim.

Edit: the other thing they got hit for was the claim about omega fatty acids - which the FDA says is not proven and thus they should not make that claim - again had they said Walnuts help prevent strokes - great, but they went out on their limb and say Walnuts contain a certain component and that is the one that helps prevent strokes - and then advertise with how much of this compound their walnuts have. Cool if it were true. Really this whole thing is just about a company that crossed a line into claims that they couldn't hope to substantiate and then whining about being held accountable for those misleading claims.

Edit2: the whole of the letter can be summarized with these two sentences

Your walnut products are also new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act [21 U.S.C. § 355(a)], they may not be legally marketed with the above claims in the United States without an approved new drug application.

The FDA telling them you can market your Walnuts, just don't claim these specific things - or have them registered and approved as drugs. They just cannot have it both ways.

 

[Narz]

read the FDA letter - they mostly jump on the treatment claims. Stating that, if you say you can treat disease X ,then you have to provide dosage information on the label and proof of efficacy. If disease X happens to be one which a lay person cannot diagnose, like major depression you have to market it through doctors as a prescription drug.
You say its about prevention - very well - the company selling these walnuts claimed treatment (as well as prevention), so they are held to their own claims. Again, if you claim your product is a drug you need to accept being held to this claim.

I agree they should be held to their claims.

Edit: the other thing they got hit for was the claim about omega fatty acids - which the FDA says is not proven and thus they should not make that claim - again had they said Walnuts help prevent strokes - great, but they went out on their limb and say Walnuts contain a certain component and that is the one that helps prevent strokes - and then advertise with how much of this compound their walnuts have. Cool if it were true. Really this whole thing is just about a company that crossed a line into claims that they couldn't hope to substantiate and then whining about being held accountable for those misleading claims.

Edit2: the whole of the letter can be summarized with these two sentences

The FDA telling them you can market your Walnuts, just don't claim these specific things - or have them registered and approved as drugs. They just cannot have it both ways.

I understand. They should just make the claims about the omega-3's rather than the walnuts themselves unless they have firm evidence that walnuts alone (as part of a healthy diet) vs. a control group (with a similar diet minus wlanuts) had an improved lipid profile & thus the associated benefits. I still don't think they should have to market their product as a drug though.

 

[GoodGame]

Everyone has stuff to sell. I know they have a bias but at least it's fairly transparent (unlike the FDA & WHO who are a bit too closely tied to pharmacutical companies which affects their judgment, there was story about this on NPR or a similar station this morning)

Narz, the FDA is required by law, that came down through the democratic process, to regulate the efficacy of product claims.

There's nothing fishy about it.