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Deborah Leader, RN

FDA Stops Stem Cell Treatments in USA

By August 8, 2010

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Regenerative Science Inc., a US based clinic in Colorado issued a press release yesterday stating that the FDA has ordered them to stop treating patients with their own adult stem cells, a practice that the clinic says helps patients avoid other methods of invasive, orthopedic surgery. And, while the FDA is busy banning stem cell research in the USA, many patients with COPD and other health conditions are forced to go to other countries to get treatment, a practice that has many patients angry and frustrated.

Stem cell advocates believe that there is no better way to treat disease than enhancing the bodies own natural ability to heal itself. They also believe that the FDA is overstepping its authority and has no business trying to regulate stem cell treatment, and, are doing so in collaboration with pharmaceutical companies as a matter of self-interest.

Regenerative Science Inc. has been safely using adult stem cells since 2005 to treat patients who have arthritis and other orthopedic conditions. In 2009, the FDA visited the clinic and said they were not compliant with drug mass manufacturing guidelines, but, they failed to take further action at the time.

Currently, the battle will ensue in a Colorado courtroom, as Regenerative Science Inc. has filed two lawsuits against the FDA in an effort to force the agency to respond to questions about jurisdiction in this matter.  Last month, the clinic filed a Temporary Restraining Order against the FDA prompting them to take final action or leave the clinic alone.

To read more about this story, visit http://www.politicolnews.com/fda-stops-stem-cells-in-usa/

Also of interest:

The Pros and Cons of Stem Cell Treatment for COPD

Interview with Stem Cell Pioneer, Barbara Hanson

Comments
August 8, 2010 at 11:40 pm
(1) Nancy Lord, MD says:

This is a truly frightening example of the FDA’s propensity to invade both the power of congress to legislate and the right of a physician to practice freely.

While the Regenerex case may be touted as a victory for the FDA, the company’s complaint was dismissed only because the 1) case was held as not to be ripe for review, and 2) FDCA enforcement actions cannot be enjoined.

Similar to libel and slander, you cannot enjoin speech only punish it after it is made.

No Court has looked at these regulations and given them its blessing. The regulations were enacted without the delegated authority, relying on very general public health statutes in Title 42. The regulations ignore the explicit exemptions for physicians’ right to practice found in 21 USC 360(g)(2) and 369. The regulations ignore the lack of a scintilla of evidence to meet the element of introduction into interstate commerce required for a violation of 21 USC 333(a).

http://www.nancylordltd.org.

August 9, 2010 at 3:47 am
(2) Don Margolis says:

While everything that Deborah and Nancy have written here is true, I am afraid it may be too late to stop the final bars in our medical prison from sliding into place. As most people who can read already know, medical freedom is a thing of the past—you get what Big Medicine and its puppets want you to get, which is only what is profitable.

Big medicine owns the FDA and the sham stem cell society ISSCR. Both are committed to protecting the profits of Big Medicine all over the world by prohibiting the only stem cells that work wherever they can buy the politicians and regulators—which is everywhere. They already control 100% of the developed democracies, most of Latin America and most of Asia ex China and India.

Irv Weissman, protecting his own millions and those of Stanford, controls ISSCR while his Big Bosses control all the major media in North America, which is why 80% of us believe stem cells are snake oil. Corporations control both parties in Congress and the White House no matter who lives there, so there is no longer any legal remedy possible. Perhaps more importantly, American Medical Science is a money-making sham as the following paper, released yesterday, proves a hundred times over: http://www.americanthinker.com/2010/08/playing_politics_with_stem_cel.html

What actually helps patients is given zero consideration, as the FDA case mentioned here proves quite conclusively. Anything else is “not covered,” especially if it cures and takes patients off their drugs! It’s been 60 years since Salk & Sabin kayoed polio. Perhaps you haven’t noticed not one chronic disease cure has escaped the lab and made it to the clinic. Under this system, none ever will.

August 9, 2010 at 12:05 pm
(3) Don says:

More oversight of the established medical and pharmaceutical industries is needed . They must NOT BE ALLOWED to stifle research and development of new technologies/treatments.

August 9, 2010 at 2:11 pm
(4) Richard says:

I’m glad FDA is taking on unapproved therapies and drugs. Voodoo isn’t good in Haiti, it isn’t good here. We’re all safer for their efforts.

August 9, 2010 at 2:36 pm
(5) Sam says:

Again instead of the FDA doing their job for which they are mandated which is to protect the FOOD Supply and drugs, they are overstepping their authority here into regulating the practice of medicine. Instead we have a food supply that is full of drugs, chemicals, preservatives, dye and MSG, and the FDA allows this? We have industrialized farms and GMO frankenfoods and the FDA allows this, but when it comes to eliminating pain or helping the body to heal itself -which it can do- they stamp it out, divert, demonize the very scientists and doctors who are trying to help people. This is absurdity in the first degree-besides the fact that Pres. Obama was supposed to open the doors to Stem Cell Research and Treatments not close the doors. WHO is running the FDA – the US govt or drug companies trying to stop stem cell treatments because they are working? This stinks of a totalitarian state. The FDA should be overhauled like the EPA -they are full of corrupt corp interest CEO’s.

August 9, 2010 at 2:45 pm
(6) Barbara Hanson says:

Bring it on! Thanks to the defendants, the FDA must now fight this in court. Thank you Drs. Centeno and Schultz and Ms. Cheever. You speak for me and millions of others that believe our own stem cells are not drugs.

Colorado Medical Clinic Welcomes Opportunity to Fight FDA in Court
Clinic Claims FDA Has Repeatedly Overstepped Regulatory Authority

Denver, CO – August 9, 2010 – Regenerative Sciences, Inc., a Colorado medical practice that specializes in the use of a person’s own stem cells to help patients avoid more invasive orthopedic surgery, announced today that the US Food and Drug Administration (FDA) is seeking to enjoin the clinic physicians from practicing medicine using patients’ own stem cells. The lawsuit will allow Regenerative Sciences to question the FDA’s policy that adult stem cells can be classified as drugs when used as part of a medical practice.
“The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice,” said Christopher Centeno, M.D., Regenerative Sciences’ medical director.
The FDA claims that Regenerative Sciences is using an “adulterated” product because it fails to follow mass manufacture guidelines in its medical practice that is applied to drug factories producing millions of doses. Rather than mass producing drugs, Regenerative Sciences uses the patient’s own stem cells to treat common orthopedic problems.
“If physician practices and hospitals must now use the same standards as drug manufacturers, the public can almost certainly expect medical care costs to skyrocket without any measurable impact on safety,” stated Centeno. Regenerative Sciences has had an unblemished safety record, recently publishing a large study showing that its procedure is dramatically safer than the traditional surgical procedures it has helped many patients avoid.
Regenerative Sciences has been using its patients’ stem cells to treat orthopedic conditions since 2005 and received an untitled letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. The FDA inspected Regenerative Science’s facility in 2009, and found, at that time, that it was not compliant with drug mass manufacture guidelines, but failed to take any action.
Regenerative Sciences has filed two lawsuits against the FDA in an effort to force the organization to respond to questions about their jurisdiction in the matter. The medical practice filed a suit in Denver District Court in 2008 based on the issue that the FDA regulations regarding creating a drug out of the patient’s own stem cells exceeded the FDA’s congressional authority and that the Food, Drug, and Cosmetic Act contains exemptions for physicians using innovative therapies that do not go through FDA approval as part of their medical practice. Last month, Regenerative Sciences was forced to file suit against the FDA again, this time seeking a Temporary Restraining Order (TRO) to prompt the FDA to take “final agency action” or leave its medical practice alone following an exhaustive inspection of Regenerative Science’s facilities and taking no action.
“For two years we’ve been prodding the FDA to respond to our questions about how it has the ability to regulate a medical practice, so we’re encouraged that, as a result of this recent suit, the courts will decide if it the FDA has regulatory authority over the adult stem cells that live in everyone’s body,” stated Centeno. “This is an important case for everyone that suffers from any type of illness, not just patients with orthopedic problems. It will decide, once and for all, if the government has the right to restrict a patient and their doctor from using a person’s own stem cells to treat disease. Regenerative Sciences believes that stem cells are body parts and not the property of the government or big pharma.”
Adult stem cells are those found throughout the patient’s body. Recent medical research has indicated these important cells have as much clinical promise as the more controversial embryonic stem cells (cells taken from an embryo).
“What we’re doing in our Colorado medical practice is no different, in principle, than a fertility clinic that uses the in-vitro fertilization technique. The only difference is that we’re using stem cells and fertility clinics use fertilized eggs,” stated John Schultz, M.D., one of the founders of the Centeno-Schultz Clinic.
The FDA’s lawsuit is being closely monitored by the International Medicine Society (ICMS), a global nonprofit dedicated to patient safety and education in the medical use of adult stem cells that represents over 1,000 physicians, researchers and patients from over 35 countries on 6 continents. ICMS executive director, David Audley, stated “The Centeno-Schultz Clinic meets our strict criteria for the safe therapeutic use of adult autologous stem cells. There is more medical and scientific evidence supporting this type of medical therapy for orthopedic conditions, for example, than there is for many approved drugs that the FDA allows to be used in off-label or unconventional applications.”
About Regenerative Sciences
Headquartered in Colorado, Regenerative Sciences Inc. is an extension of the medical practice of the Centeno-Schultz clinic and is focused on the development of the Regenexx™ procedure, a breakthrough non-surgical option for people suffering from various orthopedic disorders. The physicians at Regenerative Sciences have developed a patent-pending procedure that uses a person’s own stem cells and blood growth factors to help regenerate bone and cartilage. Regenerative Sciences believes in educating patients, providing choices, offering options and encouraging people to take an active role in their own treatment. More information can be found at http://www.regenexx.com
__________________

August 9, 2010 at 3:43 pm
(7) Mary says:

The FDA has no authority to regulate the practice of medicine. If they did, they would have personnel following every doctor in the US. My stem cells are just that- mine. They do not have the authority over what is in my bone marrow nor in my veins as long as it is returned to me and not someone else. It is the same principle as a heart surgeon taking a vein out of a patient’s leg and using it in his heart. There is no difference. It is the practice of medicine. Wake up people. This is the reason why our medicine costs so much and heals nothing – FDA regulation. What a joke.

August 9, 2010 at 3:57 pm
(8) Jeannine Richardson says:

What really sickens me are these constant warnings about sick Americans seeking treatment overseas. What are they supposed to do? Just sit home and wait to die while physicians hands are tied here in the US?

One other point – other countries are way ahead of us and many of the worthwhile stem cell clinical trials going on in the world (see http://clinicaltrials.gov ) are happening in other countries.

Someone has to expose what’s happening. It’s all about government funding for embryonic stem cells even though nothing has been proven to work while zero attention is paid by the NIH to adult stem cell treatment research which has already proven to improve many diseases especially, heart damage, MS and Cerebral Palsy. It is truly appaling.

August 9, 2010 at 5:28 pm
(9) Jan says:

The FDA and big pharmaceutical companies do not want it to be proven that the body can heal itself using our own stem cells to do it. They want us to continue buying expensive drugs, not meant to heal until we die. Where does it state that the FDA has the power to regulate the practice of medicine? The FDA has no authority to do this and has yet to prove that autologus stem cells from our own body cannot heal diseases. They want us to not have the opportunity to cure diseases and live a healthy life so they can continue to profit, big time, selling drugs to us. Now they want to designate our own stem cells as a drug. Why? I am glad this will be settled in a court of law. There is no way that my stem cells are a drug an d the FDA will never own them.

August 9, 2010 at 8:26 pm
(10) Eric says:

Great comments – I don’t really know what to add. The FDA has admitted that their boss is the pharmaceutical industry and they serve not to protect the American people. This is illustrated by Vioxx, Celebrex, Phen phen, and numerous others that have had or currently have class action lawsuits due to the negative side effects that were known before the FDA approved them. The drug company gets sued, as they should, but where is the accountability to this government agency that was supposed to protect us? Then when something comes around that has great potential and no side effects as demonstrated by thousands of clinical trials and they want to ban it indefinitely. Things that make you go hmmmm.

August 10, 2010 at 8:13 pm
(11) Cyndi says:

Is this the same FDA that approved Tylenol and Vioxx as well as many other drugs that hurt and killed people?

It’s pretty obvious they still don’t know what they are doing.

I know the Colorado Medical Clinic will send them home with their tail between their legs.
How dare the FDA try and dictate the right of a doctor to practice safe medicine? Especially in this case where the results are positive and benefical to the patient.

Is there a legal defense fund set up to help CMC take on these clowns oops I mean FDA?

August 10, 2010 at 9:31 pm
(12) Connie says:

It is about time someone stood up to the FDA. They have abused their power for far to long. I should have the right to use my own body to heal myself and should not be forced to leave my country to get the treatments I need to keep me alive.

If you do not want stem cell treatments don’t get them but don’t stand in my way when I go to get the treatments I feel could heal me.

August 13, 2010 at 12:08 am
(13) Ausanta Adams says:

Nice to know I am paying the FDA to do a job on protecting the food supply and they are suing doctors conducting stem cell research in court instead. Go figure that one out. I thought there was an executive order to promote stem cell therapy and treatments within the US =not make patients have to go to a foreign country. What the hell is going on here -this needs to be investigated by an outside impartial group.

August 20, 2010 at 6:11 pm
(14) Gail Steen says:

I want to know how I can join the lawsuit. I’ve been a quadriplegic for 13 years and think I should have a say in how I use my own stem cells. Why should the FDA have a right to decide? I think we the people should start a lawsuit of our own.

August 20, 2010 at 6:11 pm
(15) Gail Steen says:

I want to know how I can join the lawsuit. I’ve been a quadriplegic for 13 years and think I should have a say in how I use my own stem cells. Why should the FDA have a right to decide? I think we the people should start a lawsuit of our own.

August 24, 2010 at 11:14 am
(16) Bruce Bennion says:

One can only hope that this is just a continuation of the previous administrations war on science and that more logical minds will prevail and stop this lunacy soon. This battle was undoubtably concieved to fan the hysteria of those who minds cannot think after seeing the words “stem cell”. Thanks to doctors like these, this procedure is now no more mysterious than the invitro fertilization procedure it mimics. It infuriates me to know my tax dollars are now being used to protect the interests of big pharma against the interests of the citizens.

August 30, 2010 at 12:10 am
(17) Al says:

The FDA and the Patent process must be rebuilt from the ground up.
The FDA has become a dictator .
The Patent process should be only 5 years,

December 22, 2010 at 5:01 pm
(18) Rosie says:

I know people here in Australia who have travelled to this clinic in Denver to receive this treatment to joints The results are fantastic One wonderful man only got to begin his treatment before the FDA stepped in. His pain is now excrutiating and I am watching a strong active healthy man waste away. His choices are now only one, open surgery for various joint replacements. Painfull, costly, long recovery, life threatening infections RISKY ! How can he go back to the States and simply get HIS cells BACK ?

April 26, 2011 at 1:02 pm
(19) brenda says:

come on people china is having great results has any of you stop to think if it can bring sight to some how much money the govt would save on disability checks and drs not to mention all the therapists my grand daughter sees .WAKE UP

December 3, 2011 at 8:11 pm
(20) juanita sievert says:

I am a 65 yr old woman suffering with Parkinson dicease and I was hoping to qualify for the stem cell treatment, Now I am devastated because is no hope for me to go to another country to do it. United States Gov should really look into this issue, I dont agree with abortion, but Iam sure we could use cells from other sources. I hope there is a way to get this to pass. Thanks juanita sievert

March 25, 2013 at 1:07 pm
(21) Ed Rodriguez says:

With so many abortions, both legal and illegal, going on in this country they should at least use the stem cells to help regenerate other people or just make abortion of any kind illegal and punish both the doctor and the woman.

March 25, 2013 at 1:15 pm
(22) copd says:

Ed, punish the woman???? For what? Making a choice that she has the right to make because it is, after-all, her body? What if she was raped? Abortion is, and most likely always will be, legal in this country. Roe vs Wade ensured that. God help us if we ever go back to the archaic way of thinking that took place in America before this landmark case.

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