To protect Big Pharma, the FDA is coming after stem cell therapies. Don’t let the agency classify your body as a pharmaceutical drug. Action Alert!
In the next few months, the FDA will hold a public meeting to discuss its recent actions to clamp down on the use of autologous stem cell treatments. This is when a doctor removes adult stem cells from a patient, processes them, and returns the cells to the same patient.
The public meeting will discuss four guidance documents the agency has released over the last two years (here, here, here, and here). They are meant to clarify which treatments containing human cells, tissues, and cellular or tissue-based products (HCT/P) are considered the “practice of medicine” and therefore subject to minimal regulation and which therapies are considered unapproved biological drugs and subject to much more stringent regulation.
Unsurprisingly, the agency is claiming that even if your own stem cells are being used to treat you, if those cells are not directly related to the part of your body being treated, they constitute a drug and in effect can’t be used.
In fact, if a treatment utilizes a patient’s own stem cells to treat an ailment or chronic disease that is not directly related to the source of those stem cells, an Investigational New Drug (IND) application must be filed or the treatment must be pre-approved by the FDA—both of which are long, expensive processes that will likely eliminate these therapies.
This is an all-too-familiar power grab by the FDA that will effectively eliminate an entire industry—one that is on the cusp of some exciting discoveries. Mesenchymal stem cells, which can change into a variety of cell types such as muscle cells, fat cells, and bone cells, show incredible potential to treat a wide variety of chronic illnesses and autoimmune diseases—a powerful testament to the idea that the body possesses powerful mechanisms and tools with which to heal itself. A search of the National Institutes of Health (NIH) clinical trials database lists thousands of trials exploring the uses and benefits of adult stem cells, including improving cardiovascular function after a heart attack and treating multiple sclerosis and chronic heart failure. Other types of stem cells derived from adipose (fat) tissue also show great promise.
Even if stem cells are intended for homologous use (to treat an ailment or chronic disease that is directly related to the source of the stem cells), they must also meet the government’s definition of “minimally manipulated” to avoid being regulated like drugs. The regulation states that minimal manipulation is when the tissue is processed in a way that “does not alter the original relevant characteristics of the tissue.” The FDA has indicated that it views stem cells derived from adipose tissue as more than minimally manipulated and therefore a drug.
If the FDA goes through with its proposals, exciting discoveries that could alleviate the suffering of millions of patients could be delayed for years, be lost forever, or cost a fortune.
This power grab first revealed itself a number of years ago when the FDA sued a Colorado clinic over its Regenexx-C™ stem cell procedure. The FDA claimed it had the right to regulate the clinic’s procedure because stem cells are drugs and the clinic was engaged in interstate commerce. Now it appears the FDA is seeking to complete its takeover of stem cell treatment as drugs.
Why is this happening? We noted when the FDA made its first move, the agency stated outright in court documents that it wanted to protect the market for FDA-approved drugs—a statement rare in its level of candor about the agency’s real intentions. Stem cell clinics threaten the profits of large pharmaceutical companies—the FDA’s patrons—so they must be stopped.
The FDA has similarly declared other parts of our body to be “drugs.” You may remember our report on the agency’s attack on platelet-rich plasma (PRP) injections for bone and joint pain. PRP injections involve removing blood from a patient, spinning it in a centrifuge to separate the platelets, and injecting the platelets back into the patient. It is unclear, however, whether this treatment falls under the agency’s definition of a drug or whether it is exempted—meaning doctors are in the dark and perform the procedure at their own risk. The FDA often uses ambiguity like this as a form of intimidation.
At one point, the FDA even argued that a patient’s own feces or that of a family member, if used therapeutically to restart healing bacteria, would become a “drug” and would therefore be subject to FDA approval, although it later backed off this ridiculous claim.
Where will it end? We must forcefully oppose the government’s efforts to regulate what we can do with our own bodies.
Action Alert! Write to the FDA and protest their planned takeover of stem cell therapies. Please send your message immediately.
FDA: Your Own Cells Are a Drug!
Other articles in this week’s Pulse of Natural Health:
Next it will be blood donated that is used to save lives.
I understand the argument, but the FDA has the responsibility to help ensure that a treatment works as advertised. There is a lot of quack medicine and some of it uses stem cells, a friend of mine was ready to go to Mexico for a scam treatment until I read an article about the scam and warned him about it, then there was the “60 Minutes” story about it. Valid science must back up use otherwise patients lose. Therefore, the “as-drug” label appears legitimate.
There is also a lot of scam-medicine patented as FDA-approved drugs. Companies don’t have to publish unfavorable studies, they are allowed to change the position of the goalposts in the middle of the game if it means they can profit from an ineffective drug, and they get off the hook when hundreds die from side effects they have hidden. I’ll buy the FDA’s interest in protecting the consumer when I see some transparency, some real science, and some even-handedness applied to the Pharma bros.
Ca. half of FDA-approved drugs are removed from the market due to injury or death from the officially prescribed use.
FDA is funded (user fees) by the corporations it’s supposed to regulated.
FDA still has some honest folks in quality control and research, but in general the political/industry appointees in key power positions ignore and censor the honest folks’ findings. (Consider GMO crops and GMO salmon, e.g.).
I trust FDA about as far as I can kick an anvil.
“I trust FDA about as far as I can kick an anvil.” A very wise (and health-enhancing) policy!
A couple of people I know have congestive heart failure. No stem cells treatment have been offered to them. They are going to die. So how does one get this treatment? Do they have to go to some special clinic?
Go and put a .45 in your doctors face and tell him to cure you properly or you’re going to “cure” him. Then shoot him. Whoopsie! Finger slipped! Oh well, that doctor has probably intentionally poisoned and murdered unborn children/infants/innocent people. So it is justified.
The drift of the article is that FDA doesn’t Want people to have stem cell treatment until Big Pharma has in some way cornered the market. – There’s some sort of program for people with officially declared terminal illness to be allowed experimental treatments or experimental drugs, but I don’t recall the name of it. I think it has rather strict requirements. Try an internet search.
The cheapest way to get stem cells is to do a 3 day fast. Your body will make them in response. No doctor required! Bonus!
Stem Cells used in the treatment of ALS has showed remarkable improvement in the lives of those who have participated in trials . Stem cells are the fountain of youth and where going to be used to re-grow kidneys , livers , lungs , hearts etc etc – but guess what the rat bastards known as Big Pharma put a stop to that by using their bought and paid for goons -The FDA scum bags
But you shouldn’t be HARVESTING the youth to keep some dirty old crooks alive, since all the old folks are doing is ruining all life on the planet and trying to take it over for themselves and their own petty gain of meaningless nonsense that humans made up. That is just how stupid old people are.
Your ignorance is beyond belief , do all a favor and try to educate yourself just a little ,
I understand that I know not all, do you? If you really think extending your life at the expense of the younger generations is a sustainable scenario, you’ve got another thing coming! I am not denying research in the slightest. I love R&D as long as it actually makes gains that aren’t intended for a system of manipulation and control/poisoning. People don’t have to be subjugated corporate slaves, everyone is a unique entity that is capable of different functions and each should be recognized for such. Poisoning your own contributors has no victory, even if you are an enemy combatant of said contributors. You still poison the same soil you exist on, the same air you breath, the same water and food you ingest… no matter how many filters you try to put before you and your perpetration’s.
When will the FDA get science? Part of the promise of stem-cell therapy is the ability of stem cells to differentiate in many different types, yet the FDA says if your stem cells didn’t come from the organ being treated, they are a drug???? Un-freakin’-believable. As is the hypocrisy and corruption of the all-to-obvious revolving door. But Big Pharma and their FDA lackeys are too arrogant to care if we see through their sham.
When we smash it through their craniums. Preferably with a howitzer.
@ AnnieLaurie: Well said and spot on.
My cells are a drug? The FDA is a criminal enterprise that intentionally makes people sick.
Do you want to be patented, people, or would you mind destroying these evil scumbags?
Seems everyone is too afraid of the violence that we are justifiably allowed to use.
It seems the FDA is trying to protect patients from unapproved therapies which have never been shown safe or effective