FDA say body is a drug and has the right to regulate it!

ANH read full article from link to alliance for natural health. Found this interesting figured I'd share and see what you all thought.

In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!

The FDA asserts in a court document that it has the right to regulate the Centeno-Schultz Clinic for two reasons: Stem cells are drugs and therefore fall within their jurisdiction. (The clinic argues that stem cell therapy is the practice of medicine and is therefore not within the FDA’s jurisdiction!) The clinic is engaging in interstate commerce and is therefore subject to FDA regulation because any part of the machine or procedure that originates outside Colorado becomes interstate commerce once it enters the state. Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

The Centeno-Schultz Clinic takes your blood, puts it into a centrifuge machine that separates the stem cells, and a doctor puts them back in your body where there is damaged tissue. The clinic has argued numerous times that stem cells aren’t drugs because they are components of the patient’s blood from his or her own body. The FDA says otherwise: “Stem cells, like other medical products that are intended to treat, cure, or prevent disease, generally require FDA approval before they can be marketed. At this time, there are no licensed stem cell treatments.” There they go again, saying that components of your body are drugs and they have the authority to regulate them! It’s the only way the agency can claim that adult stem cell therapy is within FDA’s purview. However, the agency seems to be of two minds. When ESPN magazine was doing a story on stem cell treatments, 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.

Mods move if need be I didn't see a "typical bs" forum




Starting a New Thread ?... Look Here First.

I think they're cracking down us this because stemcelltherapy has huge implications.

It could cure a variaty of things.

the FDA has to have its hands in the cookie-jar.

I was about to get mighty upset over this as just one more step in the Government trying to over-regulate everything imaginable. Then something occurred to me. I donated Plasma for a few years when I turned 18 and that money was the difference of playing bills or not.

Stem Cells and Plasma donation, separation, and return of red cells are quite similar to what your talking about...so I went to check that out. What do ya know? The FDA is well established as the authority for regulation of the Plasma industry, so I guess this is an extension of the same concept.

It's still probably over-reaching...but then again, how would we feel to be on the BAD end of a mistake with stem cells, and no fed agency was handy to file complaints with and shut down the center who may commit gross negligence? A trade off...I suppose..but at least this isn't something brand new and different. We have enough of that already, eh?

Originally posted by kn0wh0w
I think they're cracking down us this because stemcelltherapy has huge implications.

It could cure a variaty of things.

the FDA has to have its hands in the cookie-jar.

The FDA wants it so they can put a stop to it.....

There is no money to be made in curing ANYTHING

If that's the case they need to get to work regulating fecal matter infusions. It's a therapy gaining ground now too, and it seems to me that they can start with themselves.

Naturally Canada would be the first in line to fall in step with the USA's practices, I wonder...

Any product to be used in a clinical trial must be authorized by Health Canada under Division 5 of the Food and Drug Regulations to Canada’s Food and Drugs Act. Stem cells therapies qualify as biologics – drug products derived from biological sources and, as such, are included under the Food and Drug Act.

www.stemcellnetwork.ca...

So, it's a similar situation to Canada, Stem Cells are to be regulated by the government since they do qualify as a sort of drug derived from a biological source.

Sorry guys, it's not that the Government is right to remove your voice with a panel of objective experts on who gets to do what with Stem Cells, but of course this is a dangerous field of study; unchecked growth in the human body by improper application of any sort of stem cell treatment could turn cancerous. Stem cells are a final frontier of medicine, they're looking deeply in the complications that may arise because they'll be the ones held responsible if these complications arise with no oversight.

Uhhhhm, anyways, the body is not a drug, however for the same reason the waste treatment plants that handle sewage are under government control, the Stem Cell therapies that could save millions of lives are under the governments purvey.

I think that some people on ATS will over react to this thread, seeing it as TPTB trying to own them. Guys, it's not that simple, this technology is in safe hands as it is explored, they're doing their best to discover just how far this line of study can take us before we all try to be first to gain the benefits of stem cell treatments.

I didn't read any where about health concerns just money. And I agree that TPTB wouldn't want a cure let alone one we can get out of our own bodies

It says that their are court documents, yet no link to them? Can someone find these?

Don't get me wrong, I don't doubt this at all, but if its mentioned in a court document... well having the proof in the pudding will make some people react.


Never mind, I see the link and have downloaded it. Unfortunately its going to take me forever to wade through it to verify

reply to post by Sachyriel

I agree that people will over react, but none the less if you had the ability to heal yourself with your own biological material instead of perscription drugs that usually cause worse side effects and are usually addictive you shouldn't be stopped because of the government. I don't typically care for government oversight though as they usually mess things up! And from this article they don't seem to be concerned about regulating. I'm going to look for more info.

Originally posted by calnorak
It says that their are court documents, yet no link to them? Can someone find these?

Don't get me wrong, I don't doubt this at all, but if its mentioned in a court document... well having the proof in the pudding will make some people react.

edit on 1-2-2012 by calnorak because: (no reason given)

I found a filing in the OP's article. Here is the link. It's in pdf format.

Originally posted by DIRTYDONKEY
reply to post by Sachyriel

 

I agree that people will over react, but none the less if you had the ability to heal yourself with your own biological material instead of perscription drugs that usually cause worse side effects and are usually addictive you shouldn't be stopped because of the government. I don't typically care for government oversight though as they usually mess things up! And from this article they don't seem to be concerned about regulating. I'm going to look for more info.

Well, see the Government has a vested interest in controlling how Stem Cell Therapy research plays out, it will be a big part of the medical branch for the armed forces, or at least Veterans as they come home begin wounded. Stem Cell Therapies are not just for civilians, the Military would have a right to those technologies as well, so I'm saying that the government doesn't need to be overly zealous on regulating them, but it does need a bit of regulation to prevent it from being a quagmire; Veterans deserve the Stem Cell Therapies as well, they will get those from Government programs designed to help them heal after their tours of duty. Because the government of the USA needs to regulate it for its own soldiers, it will obviously try to regulate the civillian side as well, to ensure that any civilian procedures are not harmful to their veterans.

There is a gray area in too much government involvement in something like this, but on the other hand without the Government being involved in regulating Stem Cell Therapy they would not let the Veterans have it using tax-payer funded programs designed to help them.

You can see that when people over-react to something like this they are only thinking of themselves, rather than those who would need it the most, the fastest, and the cheapest.

reply to post by Wrabbit2000


The FDA is not there to protect you..they protect 'big pharma' There is a revolving door between the executive round table and FDA headquarters.

reply to post by webpirate


Thanks, I found it.

Just another day on planet earth. Next thing you know they will start regulating how much water you drink because your body needs water to produce certain chemicals to maintain organ and muscular function.

You watch and see if they don't. This is just the beginning of the rise of an extremely nasty monster.

Wow seriously FDA, next you'll have to have a prescription to blow your nose, or process waste. The Fascist Reich moves onward.

Filereply to post by calnorak
best I can find for now

reply to post by Sachyriel


I see your point with the soilders and veterans, but when has government made anything cheaper or better? Lol I think this is a major advance in technology and it should be explored and study for the better of us all.

I love the way America is going at the moment, makes you wonder what it will be like in 20 years, rise of the brown shirts all over again. Death of the Internet, cities in ruins while billions are spent fighting countries that couldn't threaten their neighbours never mind our countries. #e times indeed

You missed this statement?
"'Moreover, interstate commerce is substantially affected because individuals traveling to Colorado to have the Regenexx procedure would “depress the market for out-of-state drugs that are approved by FDA.”

One more time for the hard of seeing:

DEPRESS THE MARKET FOR OUT-OF-STATE DRUGS

Their motives are not so honorable. $$$$$

Originally posted by DIRTYDONKEY
reply to post by Sachyriel

 

I see your point with the soilders and veterans, but when has government made anything cheaper or better? Lol I think this is a major advance in technology and it should be explored and study for the better of us all.

Well, the government regulating the industry prevents it from being over run by frauds. :/ I mean, anyone can sell you your own stem cells, but only a few people know what they're doing. Preventing those who would scam the unknowing from their money by investing in false hope or usefulness treatments, keeps the courts less clogged from malpractice suits and the hospitals less filled with botched stem cell therapy victims.

They're speedy researchers, they've covered a ton of ground but it's not enough to the man on the street to say "Oh, those cells you have, they're like powerful pharmaceutical drugs and if you misuse them you can be seriously screwed through your own enthusiasm".

The moderate speed of research and regulation is like preventative medicine, don't buy into the snake oil of anyone who promises big things from stem cells, these procedures are so complicated and the scientific background to study them is literally years of research and peer review of well-intentioned scientists and doctors.