In 2010, I went to Nanjing, China for stem cell therapy (SCT). I have absolutely no regrets.
The therapy was to treat a debilitating, progressive neuro-muscular disorder I’d had since childhood. The condition had progressed to the point where my walking was unsteady and my swallowing was no longer functioning properly.
Two years prior, I had to endure the emotional and physical ordeal of having a feeding tube inserted into my stomach. At the time I was completing my Ph.D. in Political Science at the University of Pennsylvania. I detail my experience here. [Editor’s note: I highly recommend that you read Rahman’s extraordinary essay. It provides valuable background for this OP-ED.]
Determined to find a cure
Although neurologists told me there was nothing I could do but manage my condition, I was determined to find a cure. I began researching various emerging medical modalities and ran across SCT.
After studying the academic literature, I emailed some of the papers’ authors for their opinions on my case. I was told that there was no way to determine whether SCT would help me any, if at all. However, there was absolutely nothing in the literature that indicated the therapy could injure me in any way.
Thus, after serious study and earnest deliberation, I decided to try SCT. I knew the therapy would be expensive. And I knew it might not help me. I accepted those risks.
Conventional medicine had absolutely no answers for me. I decided that I owed it to myself to do whatever I could to save, or at the very least improve, my own life.
An informed decision
I researched several options and ultimately decided on a company that would treat me at a hospital in Nanjing, China. The representative from the company offering the therapy answered all of my questions thoroughly and professionally.
After all of the particulars were clarified, the booking was made. Soon afterward, I wired the funds to the company. I had absolutely no fear of traveling to China and no fear of the therapy itself.
Upon arrival at the Second Affiliated Hospital of Nanjing University, I completed some basic diagnostic tests. After, I was given several injections of umbilical-cord-derived stem cells. They were delivered intramuscularly (IM), intravenously (IV) and intrathecally. A team of neurologists handled my care.
My overall care was exceptional
My overall care was exceptional. Everyone, from the Chief Neurologist to the highly attentive nursing staff, translators, and custodians who attempted to teach me a few words in Mandarin contributed to my excellent care experience. Without question, the decision to go to Nanjing was one of the best I have ever made.
I got to enjoy a bit of China and its culture. I also met warm and caring hospital staff as well as fellow patients. And, the therapy helped me greatly.
The improvement “kicked in” approximately three months after I returned to the U.S. The Chief Neurologist advised me that this would be the case. The improvement was dramatic. My overall strength had significantly improved, my motor function had improved and my energy was clearly better.
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Did the therapy cure me?
Did the therapy cure me? No. And, its effects did diminish over time. However, I knew that with such a rare, aggressive long-standing condition, this could be the case.
If I had to do it again, I wouldn’t hesitate for an instant. I was so pleased with the overall outcome that after completing my Ph.D., I decided to advocate for all Americans to have affordable access to the therapy in the U.S.
I have written a number of online articles and a report entitled “Stem Cell Legislation in New Jersey: A Responsible Approach to the Costs of Disability and Disease.”
Both my research and my personal experience prompted me to consider SCT to be a paradigm shift in medicine and a therapy that everyone should have the chance to try.
The devolution of the stem cell debate
I had then, and still have now, exceptionally high hopes that SCT will be embraced as a new, powerful therapy. One that could help people with any number of disabling medical conditions achieve the physical freedom conventional medicine cannot offer them.
Sadly, almost ten years after I went to Nanjing, the current mainstream narrative about SCT in America is one of antagonism and conflict. It is characterized by
- scientists vs. practitioners
- government vs. clinics
- critics vs. patients
Hyper-critical statements from oft-cited scientist/ethicist “experts” reinforce the SCT story as being unruly, chaotic and wild.
The debate has devolved and become politicized. And, many in the scientific and journalistic communities seem to have lost sight of the needs of the patients themselves.
The arguments pro and con
Unlike the umbilical cord therapy I received, the current debate concerns primarily autologous stem cell modalities. These are treatments in which bone marrow or adipose tissue is extracted, then processed, then re-administered to the same person.
Stem cell proponents argue that SCT should be regarded differently than conventional drugs, and FDA regulations are
- stifle medical innovation and
- prevent patients from getting the life-saving therapy they need.
SCT critics argue, conversely, that the regulations are appropriate and necessary to safeguard safety and efficacy. And, they believe, that the FDA needs to do more to enforce them.
Privileging the patient perspective
Lost in the minutia and technicalities over policy is the patient perspective. In fact, the patient perspective is often implicitly dismissed, mocked or vilified even by supposedly-objective researchers.
Sadly, government, media, and scientific commentary are often permeated by an undercurrent of condescension, elitism and aristocratic thinking that denies the humanity and autonomy of patients. This makes the SCT picture sterile, clinical and mechanical. The human element – one that can only be provided by the patients – is what brings the issue into proper focus and gives it the depth of color it deserves.
Yes, patients can be desperate. And, in their desperation, they can be exploited by SCT bad actors. However, patients are not nearly as ignorant, infantile and docile as they have been portrayed. They need not be treated so paternalistically by ethicists or regulators.
The perceived flagrance of stem cell clinic operators and the perceived permissive FDA response has sparked the ire of certain recalcitrant, backward-thinking elements within the medical establishment that lodge unsubstantiated critiques of SCT writ large.
A patient-advocate’s perspective
From a patient-advocate perspective, these critics seek to maintain a monopoly on knowledge about what’s best for patients. At the same time, they usurp patients’ right and duty to perform their own due diligence and make the health decisions that they believe are best for them.
There is no question. There are important concerns over stem SCT that should be raised including,
- the training of clinicians and staff,
- compliance with health standards and manufacturing standards,
- fraudulent or misleading marketing practices,
- injuries occurring as a result of SCT
However, any robust debate must include the perspective of those most immediately affected.
Much to the dismay of SCT’s most ardent critics, the people’s voice has now gained predominance, as exemplified by the proliferation of SCT clinics. This proliferation has occurred despite the fact that the products and therapies offered by these clinics have not gone through the FDA clinical trial process.
A patient-centered way forward
The apparent ubiquity of physical disability and chronic illness amongst Americans from every geographic location, every socioeconomic class, every gender, every race, and every political ideology has fueled the growing interest in SCT.
The market has responded. And the government must respond as well. We all must recognize that the demand for SCT is urgent.
I believe that any broad crackdown on clinics that might occur will simply not be feasible or ethical. Working with clinics rather than against them is the optimal way forward.
Regenerative medicine generally, and SCT specifically, has reached its tipping point among the American people. Paradigm shifts are messy, disruptive and often turbulent enterprises.
Stem cell therapy is no different. However, amidst the turbulence, we must remember to put the needs of the patient first.
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The information in this article should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of The Doctor Weighs In.
A. Rahman Ford, J.D., PhD.
A. Rahman Ford, J.D., Ph.D., is a freelance researcher and writer on the issues of politics, policy and health. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor in Chief of the Howard Law Journal. He earned his PhD at the University of Pennsylvania. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.
Bone marrow transplantation to treat metastatic breast cancer came about at a time when there was not nearly as quick an access for patients to medical information as there exists today. The movement to treat breast cancer stricken women with bone marrow transplantation was essentially expert driven as opposed to patient driven. Expert opinion cannot always be relied upon. It can be bought. It seems to me that patients are finding out more and more about regenerative medicine clinics by searching the online information and making decisions and demands on their health care providers as opposed to just listening and following their advice anymore. There’s a saying that goes “When The People Lead…The Leaders (Politicians) Will Follow”. There are organizations that believe access to our own stem cells is THE civil rights issue of our time. That patient opinion is still being pooh poohed by the expert power players (academicians, FDA, drug companies, and others) seems very suspicious. People and organizations that held much power in previous generations are now struggling to keep that power under the guise of keeping patients safe. What they are more likely keeping safe are their own careers and the current power structures. And many patients at least suspect this. Cancer treatments with patented medicines foreign to the body are far and away much more complicated than the utilization of one’s own autologous stem cells to treat, for instance, bone and joint problems. As far as the man with the tumour on his spinal cord is concerned…my understanding is that it is questionable where his source of treatments originated. Were his treatments of the autologous variety, allogeneic, embryonic, induced pluripotent or perhaps a combination of the above? Failure needs to be tolerated in regenerative techniques as it is in other branches of medicine. What is intolerable is instead focusing on just the mistakes of autologous regenerative medicine and using that as propaganda against treatments. Treatments that are probably a lot more promising FOR PATIENTS than FOR PATENTS and the current pharmaceutical approach. The idea that the scientific community needs to find out the exact mechanism of action regarding autologous cellular therapy is a distraction at best. Rhetoric like “the science isn’t there just yet” “we don’t understand the mechanism of action fully” are all familiar refrains from the research industrial complex who make promises with words like hopeful and exciting yet rarely deliver on them in terms of therapies and treatments. Look at what happened recently in California and proposition 71 (The California Institute for Regenerative Medicine) Three Billion Dollars from the California tax payer and what they got in return was more of the same; essentially more research papers. No treatments and no cures. But that is not what was promised. And the lions share of the money went mostly to embryonic rather than adult stem cell research.
Stem cell therapy is in its early stage of development. More research is essential to learn more about the stem cell therapy and I appreciate the efforts you have made to get public support towards the stem cell therapy. Stem cell therapy has the ability to cure many diseases which could not be treated by conventional medications. However, there are a lot of drawbacks are also associated with such kind of therapy which needs to be controlled to make it a more effective way of treatment.
Thank you for your comment. I generally agree with you. More research and data collection will make SCT more effective. However, this data collection can occur in controlled trials as well as in clinics – twin tracks that are mutually reinforcing, not antagonistic. Right now, progress on both tracks is proceeding rapidly, and that’s a great thing.
This is a new way of evaluating efficacy, but that doesn’t mean it’s bad. Novel treatments require novel approaches. The one-size-fits-all approach is losing its viability. In the case of SCT, multiple avenues of establishing “proof” can co-exist and even harmonize. At some point the twin tracks will converge and I believe the point of convergence will be cure.
The two-track approach has been tried before. Here is one example:
For many years oncologists used bone marrow transplantation to treat metastatic breast cancer. Anecdotal reports of “success” were self-reinforcing, and practitioners felt that it would be unethical to deny a woman such an effective therapy. Until a double-blind, controlled study showed that the treatment actually increased mortality, sending hundreds women to their death from the treatment -not from their disease. Food for thought.
Great post, Rahman. But I have to admit that as a retired physician/biologist/ cancer researcher, I have mixed feelings. On the one hand, stem cell therapy is to regenerative medicine as CRISPR to genetic therapy of inherited diseases and cancer. Both promise, nay, will(!) revolutionize medicine as we know it.
The prospect of replacing defective genes that code for defective neurons or replacing such neurons with healthy ones is nothing short of breathtaking. But are these technologies ready for prime time?
The answer, in my humble opinion, is not yet. Are the patients that went blind after receiving Retinal Pigment Epithelium stem cell transplant worth the price of getting it to ‘market’ ASAP? Should the FDA turn a blind eye to shady operators who promise a stem cell cure to desperate gullible MS victims? And what about the unfortunate patient who received neural stem cell transplant and developed a tumor on his spinal cord?
This is exactly why the FDA insists on stringent quality and efficacy criteria. Not because they are in some kind of conspiracy with the pharmaceutical industry or with physicians who are loath to change the old ways of treating patients. I still remember the outcry of advocacy groups, including the pharma company that manufactured the drug, when the FDA “dragged its feet” in approving thalidomide as an antiemetic for pregnant women. It spared us an epidemic of “thalidomide kids”.
As a developer of a cancer vaccine, I was chafing under the FDA insistence on Laboratory Good Practices (GLP) and Good Manufacturing Practices (GMP). When we discovered a minute flaw in the manufacturing procedure that could have ended up in a disaster for the patients, I was eternally grateful to FDA”s uncompromising insistence of quality.
So no, I am not a stooge of the medical establishment or the pharmaceutical industry. I have practiced in a medical school and never made a penny out of delivering medical treatment. I spent a career in both research, medicine and drug development – the latter at a biotechnology company.
I feel qualified to say that your view of the sociology of medical research is akin to describing a whole room viewed through a peephole. The field is populated with earnest, well-meaning, dedicated people whose ethics are above reproach. They deserve our gratitude.
Thanks for the thoughtful comment. I really appreciate the time you took to make such a reasoned analysis. I’m always open to rethinking my positions and it’s refreshing to learn of of your practical experience.
I have absolutely no doubt that there are well-meaning people in medical science. In my health journey I’ve had the pleasure of meeting some unbelievably competent and professional people. I’ve also had the displeasure of meeting some unbelievably incompetent, unprofessional people, some of whom worked at prestigious institutions. There’s definitely a mix there.
I have to disagree with your initial premise. Stem cell therapy and CRISPR may be equally revolutionary, but their safety profiles are not equal – autologous SCT is simply not comparable to gene editing. There’s a reason why every article critical of SCT uses the same case of the people being blinded. It’s because – try as they might – they can’t find any others.
Now we have the new case of a young man with a tumor on his spine. This is a terribly sad and unfortunate case, and I’m glad it was reported. However, in my opinion the report was overly political, indicting an entire stem cell industry based on one very unique case. I’ve written on this case for the Pain News Network. Check it out if you’re so inclined.
At the end of the day, I believe in regulation. But not every innovation should be regulated the same. And the FDA has acknowledged as much in its guidance. As you astutely pointed out, we’re in uncharted territory with these cellular therapies, and the FDA is confronted with a very difficult balancing act. My main concern is that patients have a voice in the discussion because far too often we don’t.
Thanks again for the comment and all of your years of research.
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