FDA's New Claim: "Your Body Is a Drug—and We Have the Authority to Regulate It"

reply to post by tothetenthpower

But we all know the FDA is not interested in solving any medical problems or providing actuall solutions. They consistently favor Big Pharma, not only in allowing them to release un-tested drugs onto the market, but also by shutting down holistic medicines as their law states " Nothing but a drug, can cure, prevent or treat an illness".

Solving medical problems is not the FDA's job. Their job is simply to determine whether certain products are safe, and if they do what is claimed. The NIH is the government agency that concerns itself with actual medical research. I agree with you insofar as the FDA is far too lenient with certain pharmaceutical products. "Restless Leg Syndrome" is not a life threatening condition and is best treated with a decrease in caffeine consumption. On the other hand, the reason why many "alternative treatments," such as herbs, are not allow to market themselves as being 'Cures" or "preventatives" is because they cannot provide proper studies that prove that they work. When an herbal ingredient turns out to be efficacious, Big Pharma is quick to publish the proper studies and market it themselves.

Congress aren't the people to ask about this. They are incompetent fools, and having still issues with teaching evolution in a classroom, should be evidence enough that they aren't qualified to decide what the FDA should have jurisdiction over.

I know... there's that pesky Constitution again.

Well that first part is technically true, but we all know that money is the prime driver of all of Washington, including the FDA. Considering most people who work there are Big Pharma executives and government lobyists.

Yes, the FDA does have a vested interest in Big Pharma; I never said they don't. Because stem cell research is a new field, it is in Big Pharma's best interest to have the regulatory landscape laid out as soon as possible, so they can begin to map out their own plans. Hence, the lawsuit.

The FDA has NEVER been about the interest in the consumer, they want you buying drugs, which cause side effects so that you may buy more drugs to treat those side effects. They pocket money from Big Pharma and there's nothing that can refute those facts.

Those are allegations, not facts. The FDA needs to be responsible enough for consumer safety to avoid disasters like the Thalidomide scandal. Otherwise, they can avoid posing meaningful questions like: "Do we really need a medication that stops people from jiggling their feet?" That is not their job. They can rationalize this lack of philosophizing by claiming that they are providing consumers with a safe choice. This is why they have never taken the logical step of banning corn syrup as an additive. People can read labels. They are free to choose to eat those empty calories or not.

If it wasn't the case we would have a whole range of hollistic medicines available, that would be cheap, effective, and supported by the FDA. Far more so that big pharma's alternative medicines.

But there is a wide range of holistic medicines available. Go down to your nearest GNC or health food store and you will see shelves piled high with herbal "supplements." If you believe that St. John's Wort can heal depression, you can purchase it in capsules of varying sizes. The manufacturer simply can't claim that these capsules will cure depression, because they can't provide studies to support the claim. My hunch is that St. John's Wort is probably just as effective as some of the commercial psychotropics, but you really need to believe in it first. Remember, "alternative medicine" is a huge, for profit industry. They do everything they can to de-legitimize the FDA because the FDA won't let them market their product on their own terms.

reply to post by CastleMadeOfSand

I'm sorry but.....what dangers are you talking about? How can our bodies reject something that came from itself? There is no inflammation when there are no foreign bodies present. That is after all, what causes inflammation.en.wikipedia.org... So the exact opposite of your "knee" example will happen. Instead of causing inflammation, the cells would speed up the recovery. That's what stem cells do. It's just that there are more of them which speeds up the process. That is what this clinic is doing, multiplying the stem cells.

There would be no inflammation in a healthy body. There are auto-immune diseases that can result in white blood cells fighting the body's own healthy cells. The theory is that stem cells would accelerate the recovery. I'm not sure if this has been proven yet, or if the clinic is actually multiplying stem cells to begin with.

Now....with that said, the clinics that are performing this would need very strict guidelines during the processing of the stem cells to ensure that no foreign bodies are introduced or that the cells do no become damaged during the process. That's about the only place the FDA should have any influence.

....and yes, there ARE clinical trials going on:scholar.google.com...

You are correct about guidelines being required, but as things stand, it's not clear that the FDA has the power to regulate in this area; hence, the lawsuit.

reply to post by SeekerLou


I wonder if one could make the argument that the FDA position on this violated the Constituion, namely the amendment that prevents a person from owning another person as property.

If the FDA wants to regulate my cells, they are more than welcome to. First though they must sign a contract and agree to pay me 1 million dollars per cell that they want to control. In addition since they are my own cells they will be required to to pay for distribution rights since my cells are unique, making them intellectual propery under copyright / patent laws.

They must agree to pay me 1 million dollars for every cell of mine they use in medicine / treatment / insert catchall for all medical procedures.

They must sign an exclusive agreement with me and only me. The contract is null and void if the FDA performs the same practice on any other person / animal / hybrid / insert catch all term for life.

If they breach the contract, then all the money spelled out in the contract is due upon confirmation of the breach, and the FDA must shut down forever.

X_________________________ Sign here
X_________________________ Date and time

reply to post by SeekerLou


Another case of big government doing what it does best.

This FDA claim is insane:

Stem cells are drugs and therefore fall within their jurisdiction.

and this is a fact:

(The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!)

I hope a honest judge is hearing this case, or it guaranteed it will get appealed big time.

Starred and Flagged


and FDA :

reply to post by SeekerLou


This is a joke. These fools let industry contaminate our world with infectious disease-causing nanoparticles, and all kinds of disease-causing chemicals - but they draw the line where? With Open Access flu research and stem cell treatments.

It's all about protecting industrial monopolies. Pah.



Great catch. S&F&

Originally posted by soficrow
reply to post by SeekerLou

 

.... These fools let industry contaminate our world with infectious disease-causing nanoparticles, and all kinds of disease-causing chemicals - but they draw the line where? With Open Access flu research and stem cell treatments.

It's all about protecting industrial monopolies. Pah.

Thank you and Star! How I agree! For those not in the know, read your food's ingredients labels. Check out the poisoned food threads here at ATS - for a start.

reply to post by SeekerLou

Thank you and Star! How I agree! For those not in the know, read your food's ingredients labels. Check out our poisoned food threads here on ATS.

What evil organ of government forces corporations to list ingredients on processed food packages?

Lol wut? The FDA is a joke has been a joke and will always be a joke. It should be renamed BPI as in Big Pharma Inc.

reply to post by DJW001


I ask , what evil organization ALLOWS poisons in our foods?
Most people are too trusting and never read the label of course. Then again, if they do, the majority do not realize what the ingredients are, nor will they take the time to educate themselves!
Some do get it though!

Jesus tits!

Why? .... Just Why?

Reading, even a little, about this case makes me feel like Alice in Wonderland.

I've come up with a better idea. Nix the FDA and a host of other regulatory agencies. Make deliberate fraud illegal and establish courts for haring fraud cases. Allow third parties to investigate and prosecute cases of fraud.

*throws something across the room in a display of frustration and violence*

reply to post by SeekerLou

I ask , what evil organization ALLOWS poisons in our foods?
Most people are too trusting and never read the label of course. Then again, if they do, the majority do not realize what the ingredients are, nor will they take the time to educate themselves!
Some do get it though!

So you are saying that you want the government to ban substances you personally don't believe are healthy. No corn syrup, no EDTA... where do you draw the line? Why would you trust the government to make these decisions for you?

reply to post by Aim64C


Isn't deliberate fraud already illegal? Who would regulate in their place? When you say 3rd party do you mean private institutions or non profit? How would you stop the profit incentive or conflict of interest that is bound to come up?

I certainly agree that this is totally bogus and some change needs to be done, but the answer as to what will replace the FDA is a bit complex.

Originally posted by DJW001
reply to post by SeekerLou

 

I ask , what evil organization ALLOWS poisons in our foods?
Most people are too trusting and never read the label of course. Then again, if they do, the majority do not realize what the ingredients are, nor will they take the time to educate themselves!
Some do get it though!

So you are saying that you want the government to ban substances you personally don't believe are healthy. No corn syrup, no EDTA... where do you draw the line? Why would you trust the government to make these decisions for you?

Hi DJ,

Can't answer where the line should be drawn now after allllll of these years. but yes, I DO think they should not ALLOW poisons!

and honestly, NO, I do NOT trust the gov anymore to make good decisions for me - now they want to OWN me! .

reply to post by Chewingonmushrooms

Isn't deliberate fraud already illegal?

Depends upon who you ask. Which is why I say we need to nix a lot of the regulatory agencies and their circle-jerk policies and simply go with: "Look, deliberately and knowingly creating or perpetuating fraud is illegal." You may need to add some specifics in there to minimize the way lawyers and judges like to make them spill over into each other; but you get the idea.

Who would regulate in their place?

That was one of the original purposes of labor unions (in certain segments of industry).

However, it would largely be third parties. If a company suspects it has been the victim of fraud, it will launch an investigation (as is often done, already). If an individual suspects they have been the victim of fraud - they can contact a lawyer. Lawyers already do plenty of counseling on the legitimacy of a case for free. With a clearly defined law against fraud - they will be able to secure an out-of-court settlement very easily; or could even go for trial if the party decides to.

When you say 3rd party do you mean private institutions or non profit?

Both. Either. Any. Doesn't matter. We don't need an agency to go around and make up its own policies outside the due process of law. We already have a system of law designed to prosecute people for committing crimes (which can be made to include a lot, if we want).

How would you stop the profit incentive or conflict of interest that is bound to come up?

No different than it is, now. Agencies like the FDA will selectively regulate businesses they know are likely to pay out a fine. Many institutions operate consistently in violation of regulatory codes and simply pay the fines (because non-compliance with a fine is more cost-effective than compliance).

Corporate lobbyists also come in and manipulate the policies of regulatory agencies to stifle small business development. Large corporations cannot innovate at the rate small businesses can. The further back in history you go, the more instances you see of small businesses coming up with some random new little must-have gadget or technology - booming out of nowhere to challenge century-old institutions.

There are "conflicts of interest" no matter how you go about it. We may as well select the system that offers the least amount of intrusion and requires interpretation of law developed under its due process.

I certainly agree that this is totally bogus and some change needs to be done, but the answer as to what will replace the FDA is a bit complex.

We don't need the FDA. We're in a different age. Large food market retailers will handle a lot of their own food quality controls in the absence of the FDA.

You will also see the start-up of third-party rating commissions. Much like how there are sites dedicated to game reviews. Or how you have the IEEE and ISO that serve as the closest thing to an international regulatory committee (if you want to do business with anyone serious about doing business - you comply with those standards; because you'll be hard-pressed to win a contract without compliance).

Nothing needs to replace many of the things the government is currently doing. Just get rid of them, bite the bullet for about five years, and watch things improve significantly by the ten and fifteen year marks. (Could be three, nine, and twelve - but I'm erring on the side of caution).

reply to post by DJW001


I sum it up to this, the FDA is corrupt and they let drugs and food additives into the market that many here know are poisons or highly dangerous. I cant even believe some of the commercials for meds on tv, the side effects on most big pharma meds are horrific.

For someone like me who believes in a malevolent global conspiracy involving alot of "elites" moves like this make perfect sense according to what their plan seems to be. Which I think is holding our true potential for actual medical advances back many years for the non elites.

The FDA is another bureaucratic nightmare along with many other letter names that seems to do the opposite of what its supposed to.

I wonder if the idiot who comes up with this crap realizes they are including themselves in these results too.

I'd like them to just try this crap on me in person because it would be over my dead body that they have rights over it and I will KILL anyone who attempts to tell me different.

Who does the FDA think they are, Gods?

Well I got new for them because I don't believe in any God or Gods...

Guess that means I'm exempt like the president

The FDA is NOT our friend. Oh, they used to be, back in their early days, but a constant revolving door of employees that go from Big Pharma to the FDA and vice versa have completely corrupted this agency to the point where they cannot be trusted.

Those who are praising the FDA as the guardians of our health and safety are failing to properly read the article, in which the FDA states quite plainly that it doesn't like the idea of people coming from out-of-state to get treated because it affects the pharmaceutical market's bottom line. In other words, if these patients get the treatment offered in Colorado, they won't buy expensive drugs in their own state.

The FDA is guilty of allowing dangerous drugs to be put on the market without proper testing, and are continually caught with their pants around their ankles when people end up dying or disabled in droves and launch a class-action lawsuit against the offending drug. But before that happens, the FDA happily puts its stamp of approval on it with very little testing, allows the drug companies to throw out tests which show negative or negligible effects of their latest potion, allows the drug companies to market the hell out of it, allows their drug reps to visit doctors and fill their heads with lies about its efficacy and safety profile, allows those reps to give docs nice little perks for pushing the drug (my step-sister reps for Pfizer, she gives away trips to Hawaii and expensive lobster and steak dinners at the finest restaurants in town), and allows commercials to be run to hypnotize uneducated people to ask their doctor for the drug (each drug commercial on TV ends with "Ask your doctor about...").

They allow a box of Cheerios to state that it is good for your heart, but doesn't allow a vitamin or herb company to say the same thing on their bottles. To me, the FDA has become the regulatory goon for the pharmaceutical industry, the heavy for the mob.

Of all the governmental agencies which currently star in the Hall of Shame, the FDA is the one I distrust the most, and hate with a purple passion. As somebody with an incurable auto-immune disorder which used to cause me unbelievable amounts of pain and almost total disability, I have gone through the gauntlet, from using pharma's drugs, which only made me sicker and more disabled, to a near-normal life thanks to diet, herbs and vitamins.

I used to worship and admire the whole medical establishment, until I needed them and found them to be not only in daily violation of their Hippocratic oath, but shameless drug pushers whose only concern is emptying my bank account for their poisonous concoctions, while I suffer, lay in bed and wish I was dead. Yet they disparage and slander the very things which have given me my life back. Health and safety take a back seat to pharma's profits. The constant stream of litigation and class action lawsuits against the drugs the FDA certified as "safe" tell the whole story.

Whatever good the FDA has done in the past is more than mitigated by their unfathomable corruption and deceit. There should be a special place in hell for these bastards, and they are the last people on Earth I would trust with my health.

Well, the FDA does regulate and oversee blood as it relates to blood transfusions, so isn't this basically an extension of that?

Granted, they could have phrased it differently, but the notion is the same. If blood is subject to standards and quality tests, why wouldn't the process by which stem cells are isolated and then re-instituted?

FDA Link

Not that i think the government should keep butting into every facet of our lives, or that the human body (or blood) should be considered a "drug."

Pretty soon, everything that causes any change on the body (food, water, etc), will be considered a drug, and regulated. Oh wait, it already pretty much is regulated anyway.

All about the $.

ETA:

FDA: the same folks who allow pink ammonia slime in hamburgers. Yes, pink ammonia slime IS the official name.

Although not technically adulteration because use of pink slime is sanctioned by the FDA
[...]
The FDA classified ammonium hydroxide as Generally Recognized as Safe (GRAS) in 1974

Link

reply to post by SmArTbEaTz


Starred your posts and agree to all except for the part re God.
I believe there IS a Supreme God.

Agree with the rest!

To everyone:
Thank you for your comments- you all are bringing up a lot of good points.
I don't know the solution to the ''mess'' we are in , we are definitely caught between a rock and a hard place.
But I'd say we are better off without the FDA!

The New World Order is trying to figure out how to thin the population. They don't need fancy new treatments that may cure life threatening illnesses, that will keep people alive. The argument about getting stem cells from aborted fetuses was easier for them to argue away, it was a bad policy. Now doctors have figured out a new way to harvest these cells without the dead fetus, so the Gov figured out a new argument to shut it down.

And to comment on the "Quackery". If you are dying you will try any treatment including things healthy people might deem as "Quackery"