4 part series published in Lamar University Press on evolving role of stem cell therapy in American medicine.

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Graphics by William Jones and Chelsea Henderson, Lamar University Press

Reported by Chelsea Henderson, named University Press editor at Lamar University in 2012, where her work has earned Excellence in Media awards. Chelsea has done a remarkable job of investigative reporting over the the past year on stem cell therapy. Interviews covered all stakeholders, including patients like PFSC members Claire Hooper and SammyJo Wilkinson, to explore the controversy that has arisen following the FDA’s determination that patients cannot utilize their own stem cells in the U.S., forcing them to resort to medical tourism abroad. Chelsea also tracked down regulators, doctors and scientific experts, to examine the scientific facts, and the restrictive regulations that no-option patients see as a death sentence.

The different types of stem cells are explained in clear language and illuminating graphics, starting with embryonic and man-made engineered induced pluripotent stem cells, which haven’t even entered human trials yet. Then autologous adult stem cells are examined, which have been in use for many years. The patient interviews she conducted reveal recoveries from conditions like multiples sclerosis and cerebral palsy, with positive results these patients had never been able to obtain with traditional medicine.

These reports represent the balanced reporting that Patients For Stem Cells has found to be lacking in much of the press stories on stem cells. This series stands as a comprehensive primer for anyone who needs to come up to speed on this important topic.

Stem cells spark controversy
October 23, 2013

FDA wary of ‘biological drugs’
October 30, 2013

Patients seek to reclaim stem cells
November 6, 2013

Handley leaves US for stem cells
November 13, 2013

Interview With The Author

PFSC How did this story come about, what caught your interest?

CH I began researching stem cells after my boss told me about his friend, an artist and Lamar University graduate, who was raising funds for stem cell treatment during the summer of 2012. She had multiple sclerosis, which I knew nothing about, so I wanted to educate myself about her disease, as well as how stem cells could be used as treatment. At this point in time, my research was only supposed to prepare me for that one article. But the more I discovered, the more gaps I found in the research and the less things made sense. I couldn’t understand how the scientific community could present the full potential of stem cells, there were patients all across the globe who were more than willing to use their own cells to heal their degenerating bodies, and somehow, the FDA had banned patients from doing so. That’s how my one story about an artist with MS turned into a two-piece story package and a four-part series.

PFSC What surprised you the most in your discovery research on stem cells?

PFSC When I began researching stem cells a year and a half ago, everything was new to me. I had no prior knowledge going in – I had never even heard of stem cells before. Once I became more educated, I was infuriated by how stem cells are regulated in the United States. The most surprising thing, however, was how the Food and Drug Administration handles inquiries about stem cells. Heidi Rebello, FDA Office of Media Affairs’ deputy director of operations, was the only FDA representative out of the 18 I contacted who agreed to answer my questions. Even then, all she did was paraphrase parts of the Code of Federal Regulations and send me a link to the full text. It was frustrating and complicated, and the only thing I could think during that lengthy process was, “Wow. If they’re making me jump through this many hoops just for some information, how are they treating sick patients who just want access to use their own cells?” This made me push even harder, and really helped turn writing this series into a civil rights issue.

PFSC Do you think you yourself will bank your stem cells, as insurance for future medical use?

CH I would love to bank my stem cells for future medical use. Without insurance coverage of such a procedure or any extra funds to speak of, however, this security is not an option for me at this time. If I ever needed to use my own stem cells, I would have to raise funds in order to travel abroad. I, like so many suffering Americans today, would be forced to engage in medical tourism just to access my own cells.

PFSC Knowing what you know now about the FDA regulations of our stem cells, do you agree or disagree with those regulations?

CH I absolutely disagree with how autologous stem cells are regulated. I understand why embryonic and induced pluripotent stem cells are regulated the way they are, and the FDA is 100 percent correct in doing so. However, I see no reason for the FDA to regulate autologous stem cells they way it does. The only danger I can see in using autologous stem cells is in mixing them with potentially harmful substances. But after interviewing stem cell patients, I am confident in saying that the ones that want to use their own stem cells – not embryonic or induced pluripotent – do not want a stem cell cocktail. They want to use their cells, and I see no reason for the FDA to interfere with that.


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Court Battle: FDA vs. Your Stem Cells

Chris Centeno M.D. CEO at Regenexx

Chris Centeno M.D.
CEO at Regenexx

On October 21st, 2013 a very important case comes before the U.S. District Court. USA v. Regenerative Sciences will determine if physicians can use a patient’s own stem cells for life saving therapies here in the U.S. If this case is won, patients will no longer have to seek this therapy as medical tourists at offshore clinics.

Chris Centeno M.D. is the orthopedic doctor from Colorado, whose stem cell treatments for arthritis & injuries brought about the FDA’s regulatory over reaction. He has been standing up to the FDA in court for many years now, at great personal expense. Patients For Stem Cells caught up with Chris for some last minute thoughts before he heads off to court Monday. He will be tweeting the blow-by-blow court action, which you can follow on Twitter @CCentenoMD

PFSC: Dr. Centeno, what in simple terms is this case about, and why should folks pay attention?”

Centeno: Our case is about whether we want a society where some medical innovation is run by the guys in the trenches (physicians) treating patients. If that is beat out of existence by the FDA, will that negatively impact medical discoveries? In that case, we won’t get the best discoveries possible, just the ones that generate enough cold hard cash to pay the FDA piper.

This is about whether the FDA can pretend that a physician using autologous cells in his or her own patients can be regulated like a big pharma company, despite a century of legislation and case law that prohibits FDA from having any control over what a doctor does or how he or she does it. Physicians are already quadruple regulated (medical boards, public health depts, hospital privileges, tort system.) Can FDA quintuple regulate them as to when they use stem cells?

PFSC: What are the specific legal issues?

Centeno:
1. The FDA is prohibited by Congress from having any control over the practice of medicine. This extends right down to the congressional record for each of the FDCA versions (1938, 1962, and modern.)
2. A physician using cells in his own patients isn’t distributing anything and by definition can’t mis-brand (i.e. in US v. Evers a physician can’t fail to give himself proper instructions for use.)
3. Ever since Gonzales v. Oregon, state law trumps federal law when it comes to the practice of medicine-unless something is explicitly laid out by congress as an exception (Scalia – “Congress does not hide elephants in mouse holes…”)
4. The FDA’s midnight 2006 change to extend the 1271 regulations to autologous was ultra vires, as it went beyond the congressional authority outlined in the PHSA (i.e. they turned an organ transplant law into a drug regulation.)

PFSC: Midnight change, that sounds like they were trying to do this so no one would notice!

Centeno: With regard to cell manipulation, the FDA made up these distinctions out of thin air. When applied to allogeneic (donor cells, not your own) tissues grown in bioreactors, these regulations make sense. These tissues can be distributed to millions of individuals who are not consented for the risk of the widely distributed product. Prior to 2006 they didn’t even apply to autologous (your own) tissues. Then the FDA made a midnight change to the regulations without telling anybody (which violated the APA.) They literally changed one word in 1271 so that the regulation went from “into another human” to “into a human”. That one word midnight change is important, as it totally changed everything (Mary Anne Chirba from Boston College of Law has some good writing on this topic). This is because like all regulations, 1271 has to anchor in something congress passed or it’s ultra vires (literally in Latin “beyond the powers.”) There was no anchor law here. The FDA claims that the PHSA gave it authority to classify autologous tissues under certain circumstances (manipulation) a drug, but regrettably it doesn’t. In fact the PHSA exempts autologous tissue, as did the original versions of 1271. This is because the congressional intent of the law is to protect the public from communicable disease transmission in transplants.

PFSC: So what’s the most crucial issue?

Centeno: This was really about the FDA trying to pretend a medical practice can be classified as a drug factory. This is the real issue for the courts to decide. I have discussed above some of the issues about why FDA can’t do this, in fact why they are prohibited by law from doing it.

PFSC: You’ve put many years into this, how do you feel on the eve of the case?

Centeno: I can’t predict how the DC Circuit will rule. I can say that there are many patients who are watching this case. They don’t want a paternalistic FDA telling them what risks they can or can’t take with their own bodies; they want to be able to have free and unfettered access to their own cells.


To find out the impact of what this means to patients, we asked some of our members for comment. Barbara Hanson is Co-Founder Stem Cell Pioneers and also a member of PFSC.

Barbara: Yesterday, I spoke with three terminally ill patients in the course of a two hour period. Emotionally, it leaves me a wreck, to be quite frank. They simply don’t understand how their own government could do this. It’s not as if they haven’t tried every conventional method of treatment either. No option patients should be able to opt for any type of experimental treatment they wish as long as there is informed consent. There is no guarantee that stem cell treatment will help everyone, but to not give patients the opportunity to at least try it does make the government the ultimate life or death decision maker. If Dr. Centeno wins this case, at least this decision will be back in the hands of patients and their physicians, not bureaucrats.

Claire Hooper is a member of PFSC, and moderates our discussion on LinkedIn, where you can join us to discuss this case.

Claire: I was injured in a car accident more than two decades ago. As my back and knees rapidly deteriorated, I began researching alternative ways of treating them. I have already spent a fortune over the last two decades on FDA approved, standard of care medications and treatments for my back and knees, to no avail. Moreover, many of my medications and approved treatments are invasive, risky, and typically lead to additional surgeries and life-long drug dependencies. I find those treatments to be unsafe and unethical. I also find it unethical that, under the current FDA overreach, I will be forced to travel outside the US for autologous stem cell treatments for my back and knee conditions. Dr. Centeno is fighting for our right to have this safe, effective therapy right here in the U.S. Patients everywhere will be rooting for him!


What are others saying about this case?
The Manhattan Institute, a respected legal think tank weighs in.
The FDA’s Misguided Regulation of Stem-Cell Procedures: How Administrative Overreach Blocks Medical Innovation

James Copland, director of the Center for Legal Policy at the Manhattan Institute, summarizes what’s at stake in this Washington Examiner piece.
FDA blocks innovation in adult-stem-cell research

In the Harvard Law Blog two judges, Mary Ann Chirba and Alice A. Noble discuss the case, and FDA regulatory boundaries.
Our Bodies, Our Cells: FDA Regulation of Autologous Adult Stem Cell Therapies

Following the hearing on Monday, it will take up to three months for the court to issue a ruling. But patients will be following Dr. Centeno’s tweets and his blog as if our lives depend upon the outcome – literally.


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The FDA vs. Patients: asking the government for permission to live

NPC-FDA1Presented Oct. 9th 2013 at the National Press Club.

Watch online here FDAvPatients.com

The FDA is aggressively moving past its lock on the approval of every medication and all medical equipment. It now seeks control of every procedure and treatment that your physician recommends – including your own stem cells.

Michael Phelan, a member of PFSC, spoke at this event about the FDA’s regulatory overreach in declaring our own stem cells are now drugs, precluding access to this life saving therapy in the U.S.

Mike Phelan, member of Patients For Stem Cells

Mike Phelan, member of Patients For Stem Cells

 

 

 

 

 

 

 

 

Frustrated by the limited effectiveness of standard drug therapy for MS, Michael, like many other patients who have run out of options, turned to medical tourism. You can read about his decision in this Forbe’s interview. In his talk he explores the history of the FDA’s encroachment, and what’s being done to win back the right of doctors and patients to utilize this therapy in the U.S.

Patients For Stem Cells would like to thank Americans for Free Choice In Medicine for sponsoring this event, and the Association of American Physicians and Surgeons (AAPS) for co-sponsoring.

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