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

Originally posted by jazzguy
with all these rediculous statements made by people in power, i am really starting to believe that people up top are systematically trying to create chaos in every part of our lives. seems like its all gonna come crashing down whether we try to stop it or not.

maybe they want to bring everything down and start from scratch, maybe its the whole order out of chaos theory and the new world order, its all becoming too much to handle


the one smartest thing ive ever heard Obama say was a day before the iowa caucus, a MSM reporter asked him if he is going to watch the debates on tv.. he replied.......i dont watch TV

edit on 2-2-2012 by jazzguy because: (no reason given)

I agree mate. The problem seems to be the human condition. We are all attracted to "shiny shiny". It seems that when you get to positions of power, everything appears as "shiny shiny" and therefore yours!

reply to post by TheMindWar


My sentiments exactly!

Or worse!

Thanks for the replies, EVERYone!

Am letting you guys help me vent. Thank you all!
Things like this tend to make me sick at my stomach - literally!

reply to post by tothetenthpower

Complete and utter insanity.

Really? Let's say you had chronic knee pain. Your doctor prescribes a mild, over the counter drug like Motrin. It helps a little, but you want the pain to go away completely, so you seek out alternatives. You undergo a procedure that a clinic claims is "stem cell therapy." They transplant a bit of bone marrow from your hip into your knee. Not only does this not make the pain go away, the joint gets inflamed and the pain becomes unbearable. What would you do? Say: I am responsible for my own choices and will accept a lifetime of pain? Or would you sue the clinic for malpractice? If you sued the clinic for malpractice, their defense would be: "We never claimed that the procedure was approved by either the FDA or the AMA; it is therefore not malpractice, but an experimental procedure performed with 'informed consent,'" The judge would necessarily rule: "You are responsible for your own choices, and must accept a lifetime of pain."

Does that hypothetical scenario make you feel any better? At least if you got a bad batch of Motrin, you could sue the manufacturer and have a chance at winning.

Originally posted by DJW001
Quite simply, the FDA is trying to bust a quack. The clinic is performing a medical procedure that has not been proven effective in clinical trials. They are stretching a bit with their rationalization for claiming jurisdiction in this matter, but if they can make it stick, they will be able to prosecute other greedy people claiming to be performing "stem cell therapy." Yes, it's about money. Quacks take money from gullible suckers who are desperate for a cure.

edit on 2-2-2012 by DJW001 because: (no reason given)

I don't believe that for one second, or maybe I just don't want to, either way its stupid.

The solution to saving people from "quacks" should be by simply educating the people to not be, as you put it "gullible suckers". The other part "desperate for a cure" just demonstates the complete failure of the current medical system put in place that the FDA considers "legitimate". The failure of the current system is what is making them "desperate for a cure", its what is pushing people more and more toward alternative medicine and for multiple reasons.

So the solution to this problem by anyone with a rational mind would be to educate people against the quacks, NOT "hey lets make the human body a drug so we can control what people do with it"...Thats the type of reach people are getting tired of seeing in government agencies, its Illogical, irrational, immoral, unethical and deplorable.

If I want to drink snake oil...I being the owner of my body, and the bearer of its consiquences, should be able to drink snake oil. The well-fare nanny state this country has fostered is what is justifying their involvement in every aspect of our lives, to the point that soon...our lives...won't be "our" lives. Maybe we should re-think the well fare nanny state before we all have an FDA approved stamp on our foreheads...

reply to post by DJW001


That has nothing to do with the issue at hand.

We aren't discussing whether or not the procedure is considered "medicine" and whether or not you can sue them for malpractice if the treatment doesn't go as planned.

What we are discussing is the FDA's claim that stem cells are medication, therefore they can regulate them, and that interstate commerce applies to any single item from out of state that is used in the making and performing of this proceedure.

The FDA has been trying to squash stem cell research for years, because there's no money to be made off of it for them. Considering you can't patent a natural substance, only the for of synthetic treatment derived from it, or proceedure, the FDA want to get paid for any and all proceedures concerning stem cells.

And they will go to any lenght to get it.

~Tenth

reply to post by miniatus


Thank yuh- honest, thats what I thought you meant but wanted to make sure. Takes another drink of coffee.

Originally posted by DJW001
reply to post by tothetenthpower

 

Complete and utter insanity.

Really? Let's say you had chronic knee pain. Your doctor prescribes a mild, over the counter drug like Motrin. It helps a little, but you want the pain to go away completely, so you seek out alternatives. You undergo a procedure that a clinic claims is "stem cell therapy." They transplant a bit of bone marrow from your hip into your knee. Not only does this not make the pain go away, the joint gets inflamed and the pain becomes unbearable. What would you do? Say: I am responsible for my own choices and will accept a lifetime of pain? Or would you sue the clinic for malpractice? If you sued the clinic for malpractice, their defense would be: "We never claimed that the procedure was approved by either the FDA or the AMA; it is therefore not malpractice, but an experimental procedure performed with 'informed consent,'" The judge would necessarily rule: "You are responsible for your own choices, and must accept a lifetime of pain."

Does that hypothetical scenario make you feel any better? At least if you got a bad batch of Motrin, you could sue the manufacturer and have a chance at winning.

Cmon man, people need to own up to their choices/decisions and take responsibility for them without resorting to "I'll SUE"

We were once all adults no? There was once a time being an adult meant something no? You were capable of making your own decisions and living by them, dying by them, prospering by them or suffering by them.

The answer is people need to be more careful, take responsibility for their actions/decisions, and educate themselves.

NOT

"Lets make the human body a "drug" that we can regulate..."

don't you see how absurd of a solution that is to this problem???

Originally posted by Sly1one
The solution to saving people from "quacks" should be by simply educating the people to not be, as you put it "gullible suckers"....

If I want to drink snake oil...I being the owner of my body, and the bearer of its consiquences, should be able to drink snake oil.

To let people be gullible suckers or not, that is the question.

Unfortunately our support system may end up caring for those gullible suckers who didn't educate themselves well enough and end up on disability, so then it's not just a matter of personal choice...we are already broke without adding to our costs by getting more people on disability.

Something doesn't add up in the OP article:

the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.

So according to the FDA, you still own your minimally manipulated cells...but the question seems to be whether ot not what the Regenexx clinic is doing is minimal manipulation or not, and I don't know the answer to that...the courts may have to decide.

Originally posted by Arbitrageur

Originally posted by Sly1one
The solution to saving people from "quacks" should be by simply educating the people to not be, as you put it "gullible suckers"....

If I want to drink snake oil...I being the owner of my body, and the bearer of its consiquences, should be able to drink snake oil.

To let people be gullible suckers or not, that is the question.

Unfortunately our support system may end up caring for those gullible suckers who didn't educate themselves well enough and end up on disability, so then it's not just a matter of personal choice...we are already broke without adding to our costs by getting more people on disability.

Something doesn't add up in the OP article:

the FDA stated that US policy is to allow the injection of stem cells that are treated with “minimal manipulation,” which federal regulations define as “processing that does not alter the relevant biological characteristics of cells or tissues”—which is certainly the case with the Regenexx clinic.

So according to the FDA, you still own your minimally manipulated cells...but the question seems to be whether ot not what the Regenexx clinic is doing is minimal manipulation or not, and I don't know the answer to that...the courts may have to decide.

Yea the well-fare state of government has got to GO! Otherwise its what will always be used to justify the inevitable "ownership" of people.

Government:
Well if we have to take care of you with "insert wellfare program" then we get to tell you what you can and can't do.

I don't think the goverment was ever intended to be the "parents" of the people. The relationship between the people and government is becomming increasingly parallel to the parent/child where they get to do whatever they want because
A) they pay the bills
B) cuz "i said so"

The horrible difference is that as a kid you can eventually move out and take care of your own and finally live your life "your way" ourside of your parents control.

With the government there is NO OPTION to do so without ridding yourself of your citizenship, which I might add is becomming more and more appealing. Just what other horrible country is worth moving to?

reply to post by tothetenthpower

That has nothing to do with the issue at hand.

It is the underlying issue. The FDA is responsible for consumer safety. Stem cell based therapies will eventually become a huge, and potentially dangerous, consumer market. The FDA is trying to establish its turf before it gets blamed for not doing enough to stop corporate abuses.

We aren't discussing whether or not the procedure is considered "medicine" and whether or not you can sue them for malpractice if the treatment doesn't go as planned.

Establishing whether or not the procedure is "medicine" is the substance of the case.

What we are discussing is the FDA's claim that stem cells are medication, therefore they can regulate them, and that interstate commerce applies to any single item from out of state that is used in the making and performing of this proceedure.

The FDA is not making a very strong case, but until the AMA pressures Congress to pass legislation that broadens the FDA's remit, it is probably the best they can muster. I cannot see a Congress that is still struggling with issues like teaching evolutionary theory in classrooms, and which seems increasingly inclined to view government regulation as inherently evil, taking the necessary steps.

The FDA has been trying to squash stem cell research for years, because there's no money to be made off of it for them. Considering you can't patent a natural substance, only the for of synthetic treatment derived from it, or proceedure, the FDA want to get paid for any and all proceedures concerning stem cells.

And they will go to any lenght to get it.

The FDA are a government agency, not a for profit organization like the clinic involved in the case. The FDA is not in it for the money. Because of the "revolving door" between the FDA and Big Pharma, they do tend to favor the pharmaceutical industry. The pharmaceutical giants, like Pfizer, are very active in stem cell research. They see the potential for great profit there. It is in their best interests, as well as the consumers', that the FDA establish explicit guidelines as early as possible. That's all that is going on here.

Originally posted by Arbitrageur

Unfortunately our support system may end up caring for those gullible suckers who didn't educate themselves well enough and end up on disability, so then it's not just a matter of personal choice...we are already broke without adding to our costs by getting more people on disability.

If that is the criterion by which all activities should be judged acceptable in society then we should look at banning all potentially dangerous activities, like skateboarding, riding in automobiles, etc.

reply to post by Sly1one

Cmon man, people need to own up to their choices/decisions and take responsibility for them without resorting to "I'll SUE"

We were once all adults no? There was once a time being an adult meant something no? You were capable of making your own decisions and living by them, dying by them, prospering by them or suffering by them.

The answer is people need to be more careful, take responsibility for their actions/decisions, and educate themselves.

I agree with you 100%. Now, browse through some of the threads here on ATS at random and tell me: what do you think the odds are that will ever happen?

Originally posted by DJW001
reply to post by tothetenthpower

 

It is the underlying issue. The FDA is responsible for consumer safety. Stem cell based therapies will eventually become a huge, and potentially dangerous, consumer market. The FDA is trying to establish its turf before it gets blamed for not doing enough to stop corporate abuses.

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".

The FDA is not making a very strong case, but until the AMA pressures Congress to pass legislation that broadens the FDA's remit, it is probably the best they can muster. I cannot see a Congress that is still struggling with issues like teaching evolutionary theory in classrooms, and which seems increasingly inclined to view government regulation as inherently evil, taking the necessary steps.

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.

The FDA are a government agency, not a for profit organization like the clinic involved in the case. The FDA is not in it for the money. Because of the "revolving door" between the FDA and Big Pharma, they do tend to favor the pharmaceutical industry. The pharmaceutical giants, like Pfizer, are very active in stem cell research. They see the potential for great profit there. It is in their best interests, as well as the consumers', that the FDA establish explicit guidelines as early as possible. That's all that is going on here.

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.

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.

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.

~Tenth

I am farting right now. I wonder when the FDA is going to come regulate the length, odiousness, and gaseous content of my methane releases?

Craziness.

Originally posted by Erongaricuaro
If that is the criterion by which all activities should be judged acceptable in society then we should look at banning all potentially dangerous activities, like skateboarding, riding in automobiles, etc.

We have in fact passed laws requiring automobile occupants to wear seat belts, which doesn't remove all the risk of riding in the car but it does improve your chances of escaping serious injury.

Originally posted by tothetenthpower

Originally posted by DJW001
reply to post by tothetenthpower

 

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.

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.

~Tenth

I agree. They are sO regulating even the OTC (over the counter) drugs now and if I'm not mistaken are wanting to make our vitamins RX , making one go to doc to get the prescription. They tend to forget the sick folk who can't afford MORE out of pocket expensives , they will probably try to make ALL herbs- Gods gift to man- RX. Crazy fools.

Originally posted by antonia
I am farting right now. I wonder when the FDA is going to come regulate the length, odiousness, and gaseous content of my methane releases?

Craziness.

Hey,
Extra taxes the worse it stinks!
You think like moi!

reply to post by Arbitrageur


Understand where you are coming from but I have heard too of several cases where the drivers were NOT wearing a seat belt thankfully that would died IF belted!
So, I guess that is debatable and dependent upon circumstances.

Authority figures don't always choose what's best , sometimes they may , but I don't need parenting as both my parents did their jobs.

reply to post by DJW001


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.

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...

I'm all for folks making up their own mind about what they put in their bodies. If you elect injections of stem cells in your knee, even though not scientifically tested and proven and the clinic tells you there's no guarantee and tells you the possible side-effects, then you really don't have anyone else to blame but yourself.

Fraud is a whole different ballgame. If you go to a clinic that claims miraculous cures with using stem cells, claims they have the research and don't disclose side-effects, that's fraud and it becomes a criminal matter.

Say you buy snake oil from a guy that claims it'll make you grow a foot taller and you don't grow at all, but in fact you shrink a few inches. Should you sue the snake oil salesman?

What if he guaranteed his product and claimed he had proof it worked? What if he said he didn't have proof it worked and there could be a side-effect that would cause you to shrink instead? The first scenario is fraud and he can and should be prosecuted. The second--well, if you still decide to buy knowing there's no guarantee and you might shrink and you DO shrink, how is that the salesman's fault? Even surgeries and procedures we have, even routine ones, have no guarantees.

This is similar to this case where the man was selling his sperm to women who wanted to get pregnant.

My personal opinion is that it's his "stuff" and if women want to use it, why not? Why should anyone say he can't donate it and they can't use it? Why should that even be an FDA intervention?