The Food and Drug Administration (FDA) is stepping up its oversight of companies peddling unproven and unlicensed stem-cell therapies. They have just released the stern warning letter they sent in September to Celltex, the controversial Texas company that became notorious after it treated Gov. Rick Perry and was entangled in a separate bioethics scandal. Summaries can be found at Pharmalot and at the Knoepfler Stem Cell Lab Blog (which had several earlier useful posts), while the letter itself is here.
The FDA's letter detailed its complaint that Celltex is illegally marketing an unlicensed drug, as well as reiterating a number of complaints about the company's manufacturing processes. In parallel, the FDA sent what is essentially a cease-and-desist letter (full text) to Texas Applied Biomedical Services, the review board that approved CellTex's activities.
Celltex has responded, disagreeing with the FDA's views on legality but promising to meet FDA requirements "no matter how high the hurdles may be, to ensure access to this technology." The 10-page letter is here, and a press release can be found here.
It certainly seems that the FDA is moving to take control of this nascent and regrettably scandal-ridden industry. By coincidence, they are also being forced to deal with a meningitis outbreak, traced to a pharmacy to which they sent a warning letter in 2006. However, a lack of regulatory clarity is said to have hampered the agency with, in that case, disastrous results. Let us hope that processes and procedures have improved. Stem cell treatments clearly need thorough oversight.
Previously on Biopolitical Times:
Posted in Pete Shanks's Blog Posts, Stem Cell Research, US Federal
Comments are now closed for this item.
Comment by Albert Salazar, Oct 23rd, 2012 11:14am
If autologous stem cell treatments were regulated by the state medical boards like thousands of other treatments there would be no need or consideration to risk going overseas. It is the train of thought that what happens overseas would likely occur here in the U.S., and that is not true.
As the narrative continues by researchers that stem cell treatments are unproven and dangerous and reporters continue to get duped by them as words of gospel, one would have to automatically assume if the FDA investigates any place, it has to be guilty before proven innocent? I guess we can throw out duo process along with all the conflicts of interests that researchers, Universities, and the FDA have. It is Dr. Burzynski all over again. If you do not know who he is I highly recommend looking into his story.
Comment by Albert Salazar, Oct 23rd, 2012 5:27am
Here is my concern with your report. Many of the PhDs/Researchers used as sources are not medical doctors. Medical doctors have different procedural protocols when conducting clinical trials which are based on patients’ unique conditions and the level of risks tied to the treatments considered. These new medical procedures usually fall under medical state boards’ jurisdiction and the discretion of medical doctors not researchers. Second and most importantly, many researchers are inherently compromised when stem cell medical treatments compete against their patented royalties and their continuous funding of stem cell research grants. Just like the large pharmaceutical companies, the progression and advancement of SCTs within the realm of possibilities can replace billions of dollars in drug sales, a frightening scenario for many of them. This potential threat conflicts with the interests of researchers, universities, non-profit organizations, and most of all the FDA’s control of the drug market. There is a growing collaboration between industry and researchers, since the enactment of the Bayh–Dole Act or Patent and Trademark Law Amendments Act of 1980. “The Act started out with the best of intentions; by clearing away the thicket of conflicting rules and regulations at various federal agencies, it set out to encourage universities to patent and license results of federally financed research. For the first time, academicians were able to profit personally from the market transfer of their work. For the first time, academia could be powered as much by a profit motive as by the psychic reward of a new discovery.”1 This is why many of the researchers tied to patents and government grants continue to disseminate false information to purposely stall the progression of autologous stem cell treatments. They masquerade under their altruistic intentions of protecting the interests of the general public, when in fact their motives are to protect their own interests. Many have claimed that autologous stem cell treatment can possibly cause cancerous tumors, when in fact, no published findings or evidence has been presented to prove that autologous stem cells manipulated within proper protocols cause cancer. We have posed the challenge in the past, and the only feedback we get “that certain contaminants in the manipulation field can cause undifferentiated stem cells to become tumors.” Medical doctors deal with contaminants in their everyday life from washing hands and sterilizing. Medical doctors are not strangers in preventing contaminations. Physicians have in their hands a remarkable way to deal with those that are frail, terminal, and disabled. All these patients want as the highest stakeholders are the rights to their own stem cells. We implore you to check patent registries and lists of recipients that receive federal grants as sources. This inherently poses as a conflict of interest, unless you balance your report with medical doctors or scientists that hold apposing views. Also, you may want to consider reporting how autologous stem cell treatments are not the same as chemical drugs, and why these stem cell procedures are unjustly being singled out as dangerous and unproven. Here is fact-check of autologous SCTs:
1 – There is no vested interest to research autologous stem cell treatments as a drug when they cannot be bottled or mass produced for profit.
2 – The competition of individualized medical procedures that can potentially revolutionize medicine will ultimately replace various marketed drugs.
3 – Current and future stem cell FDA clinical trials are endangered becoming impractical.
3 – State medical boards have successfully approved riskier procedures in the past like open heart surgery, allogeneic transplants, etc.
4 – There are over 8,000 stem cell treatments performed around the world with only two reported deaths.
5 – Historically, many FDA approved drugs have resulted significantly worse adverse effects.
Therefore, why focus on autologous stem cell treatments as being dangerous, unproven, and justifiably regulated as a drug?
Source: 1 The New York Times: When Academia Puts Profit Ahead of Wonder by JANET RAE-DUPREE, September 7, 2008
Comment by Jennifer Ziegler, Oct 22nd, 2012 8:08pm
Nowhere in this adMSC debate do I hear the voice of a patient sited in an article. I see bioethicists, non-profits, medical researchers, and know it all's in genera,l all putting in their 2 cents, but where is the voice of the patient? In reality you are talking about ME. As a current patient of Dr. Jones with CellTex, I would like all the outspoken critics to understand I am informed and intelligent. There is somehow the misconception that Dr. Jones and CellTex are taking advantage of poor, sick, ignorant people. In fact I have found this to be the exact opposite description of the patients and CellTex. We are a group of patients that have been (for lack of a better word) "aroud the block" with mainstream medical MS treatments. Collectively we have tried EVERY FDA approved MS drug on the market with failing results. These are drugs have side effects that include brain infections, liver failure, chronic flu like symptoms, depression, anxiety, and even death. Big Pharma has turned the MS patients into risk takers of the highest degree. We are so used to trying the MOST dangerous drugs on the market and no one blinks an eye, but offer us our own adMSC with little risk factor, and the door is slammed shut? It just doesn't make sense. There are too many conflict of interests in the political/pharma/research/doctor side to even begin to list them here. I don't understand why the language change in 2006 by the FDA was done in such secrecy??? Why not let the public know that instead of transplant regulation of someone else's cells, that this language change now gave the FDA control over my own cells. Their actions speak louder than their words.
The word is out!!!! We want Adipose Mesenchymal stem cell therapy here in the US, not in 10 yrs., but NOW! Not one of us doesn't think that there shouldn't be regulation on this amazing new treatment, but to hold this quality of life sustainer, from the chronically ill is an outrage. So many people that I personally know in MS community, have become medical tourists (seeking treatment in foreign countries) So much so, that this is exactly why we are having this debate right now. This is a real treatment, with little to no side effects, and promising results.
Evidence based medicine is one way to look at this issue, but are we so stuck up in the US as to think that other countries including the UK, India, Israel, Mexico, Germany, Costa Rica, Panama and so on....don't have credible, viable experience that we can draw on to expedite this bio drug "tug of war" here in the states????
The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving humans:
35. In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.
Polite informational dialogue is always appreciated, but just remember that while we are having this little chat, many of my good friends who were set to receive this promising new treatment in Houston, are in the process of dying...And that's just WRONG! I don't care who you are!
Comment by Barbara , Oct 22nd, 2012 6:36pm
Your comments about oversight are interesting. Do you also believe that other medical treatments need oversight such as surgeries? What about IVF clinics? I would like your thoughts please.
I'm a little shocked at your comments because patients with little or no quality of life should be able to access experimental treatment if they choose. Most have exhausted all conventional medicine. I know several patients who have had excellent results after being treated at Celltex. You have chosen to ignore the patients. There is no celebrating the FDA’s decision for patients.
I have a terminal lung disease. I had autologous stem cell treatment last year that has improved the quality of life for me substantially. I am an adult. I am capable of making an informed decision about my health with my own doctor. I do not need a regulatory agency nor those in the research community who may have their own conflicts of interest contrary to my own, making these decisions for me. I have regained so much after my treatment that if you could see the difference and it was you or someone you loved, you would be doing everything in your power to make sure that other patients could also access similar treatment.
The problem with your stand is that with oversight comes years of lengthy clinical trials that many patients cannot qualify for and many cannot afford to wait for. Is the protection you so strongly advocate actually going to kill more patients who need treatment NOW than it protects? With so few examples of problems with treatments that utilize our own stem cells and so much already published about them, I think not. There simply is no evidence to support the regulation of our own stem cells as drugs. I am not advocating for non regulation of embryonic stem cells, iPS cells or other riskier types of therapy. A coordinated effort should be made by the research community, doctors and patients to find a solution that will allow patients access to their own stem cells as a practice of medicine that could also allow researchers access to information gathered from these patients.
As for scandal-ridden industry, the research community has had its fair share lately. Do you suggest research be stopped and perhaps regulated?
Comment by Tracy Thompson, Oct 22nd, 2012 4:01pm
I wish we could for once view this from the opinion of the patient! I have lived with Multiple Sclerosis for 13 years. Unless you have walked one day in the shoes of someone battling a chronic disease, please don't pretend to know what is best for me. Risk? You want to talk about risk.......well I can take a Tier 4 biologic drug that costs in excess of $50,000 per year and has a 30% efficacy rate that carries a "Black Label" and major health altering side effects. I can and did for that matter. Once I exhausted all traditional medications where do you turn? All the drugs I took unfortunately did not work for me and carried harsh side effects. I decided on a stem cell treatment and saw amazing results. Better than any drug I had ever taken. Please tell me why this is so wrong? Deny me the right to battle my disease? Who exactly wins in that? I didn't ask to be "protected" from anything. I am of sound mind and made very educated choices about my treatment. Taunting me by denyng this right is a true injustice. I never asked an insurance company to pay. If I want to take my own money and invest it in sustaining my health that is my right. A cell that comes from my own body, who has the right to deny that to me? Every day I wake up wondering if this is the day I may lose my mobility, vision, speech among a mulitude of other possibilities. With everything else from insurance t quality of life please don't make me battle for a treatment that I believe in. Education and awareness is crucial. Meet the patients that you are "protecting". See the amazing results. Put a face to us and understand the full picture of why we make these choices. I was never guaranteed specific results. My whole life with MS is a risk. Can we ever talk about the success with stem cell therapy or do we have to run a smear campaign? What is the fear of telling the success stories? There are some credible companies that deserve to treat those in need. Why dismiss us as a bunch of desperate people seeking a miracle cure? So far from the truth!! Again, what would you do if you were in a fight for your life? You can judge me after you walk one day in my shoes!!
Comment by D5, Oct 22nd, 2012 2:57pm
And the FDA has killed thousands of people by approving unsafe drugs. I don't trust them!
Comment by Pete Shanks, Oct 22nd, 2012 12:34pm
Thanks for commenting. Regrettably, the stem cell field is rife with scams that play on the hopes of patients and their loved ones. I hope this is not one, but note that the FDA has saved many lives over the years through its insistence on caution.
Comment by sp, Oct 19th, 2012 4:18pm
I was diagnosed in 2010 with multiple sclerosis (MS). Prior to my diagnosis I was a nurse and active member of society. For the last two years I have not been able to walk, write, drive, speak clearly or feel with my hands. I also deal with constant fatigue and cannot think clearly.
My husband is an acive duty soldier in the US Army. He has had to take on all the responsibilies, including the care of our daughters.
I have tried the various FDA MS approved therapies recommended by my neurologist and have failed each one. The following are the therapies I have tried and thier possible side effects:
1)Tysarbi-There have been 14 new PML cases, bringing the total to 285. Of the 14 cases, 5 are in the US. The location for the others is unknown. There have been 3 more deaths, and the total is now 62 (still at 22%).
2) IV Steroids- Can cause diabetes and early osteoporosis.
3) Rebif-I lost 30 pounds in two months, flu-like symptoms, hairloss. A recent study came out that interferons DO NOT slow progression of disability.
4) Plasmaphoresis- can cause blood clots and exposure to Hepatitis B.
The MS has caused cerebellar ataxia. This causes me to have uncontrollable tremors, speech difficulty and balance issues. Nothing can be done for this except regenerative medicine.
I had my adipose tissue removed in September in Houston TX. A company by the name of Celltex grows a persons own adult mesechymal stem cells (MSC) from the adipose tissue that is extracted. MSC's have been shown to repair and regenerate the damage to tissues that several diseases can cause.
The FDA stopped all IRB trials through Celltex under the premise that a persons own stem cells are a drug, even though I had already begun the process. I am an educated patient, and there is hardly any risk in my own adult stem cells.
The FDA's interference of these IRB infusions have left me and my family feeling hopeless. I was wanting to receive this treatment in the US, but the FDA is forcing American citizen's to be medical tourists in other countries.
I have applied to several clinical studies, but never qualified. My heart cannot handle the chemo that Northwestern uses, and the Cleveland Clinic requires optic neuritis and the patient be ambulatory.
What would you do if this was you or a loved one?