How the FDA Can Help Solve the Overdose Crisis
/By A. Rahman Ford, Columnist
As the U.S. Food and Drug Administration prepares to issue new guidelines on stem cell therapy, it must give due consideration to the ever-increasing number of Americans who suffer from intolerable chronic pain.
According to the National Institutes of Health, over 25 million American adults suffer from chronic pain and nearly 40 million have severe levels of pain. To alleviate that pain, many turn to addictive opioid medications, sometimes with deadly consequences.
Under former FDA Commissioner Robert Califf, the agency took several steps to reduce opioid addiction, including improved warning labels, enhanced education for prescribers, and the development of abuse-deterrent drug formulations.
Unfortunately, those initiatives have had negligible success in stemming the tide of opioid overdose, perhaps because, as Califf himself put it, “financial incentives in the (pharmaceutical) industry can lead to a focus on short-term profits instead of patient well-being.”
Indeed, although opioid addiction has seeped into the public consciousness and ascended to the top of many politicians’ agendas, the attention has been largely rhetorical -- practical, immediate-term solutions to the overdose crisis remain few and far between. Clearly, new approaches are needed.
Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths. The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years.
Stem cell therapy can be a meaningful intervention in the effort to eradicate chronic pain and end opioid deaths. The fact is that many physicians are already using stem cells to treat chronic pain safely and effectively, and have been doing so for years. But with the issuance of new guidelines, which are expected this fall, the FDA could very well limit access to stem cell therapy, even to stem cells that come from our own bodies.
Current FDA Commissioner Scott Gottlieb recently said stem cells hold “significant promise for transformative and potentially curative treatments,” but some unscrupulous stem cell clinics were preying on sick people desperate to find cures. While cracking down on these bad actors, Gottlieb must not lose sight of the fact that stem cell therapy is a potential solution to everyday Americans’ chronic pain.
Science Supports Stem Cells for Pain
Let’s take a brief look at some of the recent scientific literature about stem cell therapy, and how it can attenuate or even eliminate the chronic pain that results from a myriad of medical conditions.
A 2014 study in the Journal of Pain Research made the case for the use of adult stem cells to treat neuropathic pain. Due to the "scarce response to the conventional analgesic therapy,” the authors said it was “mandatory to identify and propose novel approaches" to neuropathic pain. They noted the “fast onset and long-lasting effect on pain relief that one injection (of stem cells) could provide,” an outcome far superior to drugs which require chronic administration, have side effects, and require periodic dose increases.
That same year, an editorial in the British Journal of Medical Practitioners entitled “Stem Cell Therapy: The Future of Pain Medicine” claimed that “recent advancements for SCT (stem cell therapy) for pain due to degenerative diseases in the spine and joints are promising and indicative that SCT will undoubtedly play a major role in the future.”
A 2015 review in the World Journal of Stem Cells examined the plausibility of using stem cells to treat acute, chronic and neuropathic musculoskeletal pain, concluding that stem cells “show promise for several chronic non-life-threatening yet disabling conditions.”
Just this year, in a review published in Frontiers in Immunology, researchers said stem cells derived from a patient’s bone marrow “may provide efficient, long-term, and safe therapy for patients with painful diseases” such as osteoarthritis, degenerative disc injuries, inflammatory bowel disease, neuropathic pain, and pain associated with cancer and radiotherapy.
Stem cells can alleviate pain in a myriad of ways. A recent study published in Military Medicine found that a low-dose stem cell injection significantly attenuated neuropathic pain in injured rats, regardless of whether the cells were derived from bone marrow or adipose (fatty) tissue. The authors concluded that the therapy “has great potential to emerge as an innovative, safe, efficacious, and cost-effective therapy for the treatment [of] neuropathic pain or other chronic pain conditions.”
A 2016 study published in International Orthopaedics followed 26 patients who suffered from chronic discogenic lower back pain who were injected with their own bone marrow concentrate. All 26 patients had a significant decline in their pain and disability scores, and were able to avoid surgery.
Stem Cells Can be a Remarkable Solution
As the above sampling of literature suggests, stem cells can treat chronic pain caused by several illnesses. It is important to note that no subjects in any of the referenced studies experienced significant adverse effects. Safety was simply not an issue. The results regarding the use of autologous stem cells – a patient’s own stem cells -- are especially noteworthy because, so long as the cells are “minimally manipulated,” under current FDA regulations approval is not required.
If this were to change due or be restricted under new FDA guidelines, many patients would be left with no viable pain treatment options. Let us not forget that former Texas governor and current Secretary of Energy Rick Perry once suffered from chronic back pain, and found no answer in surgery or pills. Perry found relief in his own stem cells. All of us deserve that chance.
On June 13 of this year, Commissioner Gottlieb made it clear that “everyone at the FDA is committed to focusing on all aspects of the [opioid] epidemic” and promised to seek input from the public “to share additional steps and information that the FDA should consider in addressing these challenges.”
Commissioner Gottlieb, a growing number of Americans like Secretary Perry are already using stem cells to solve problems that current treatment modalities have failed to cure. They're traveling to clinics at home and abroad because their pain is disabling and insufferable.
Commissioner Gottlieb, by adopting a forward-thinking policy on stem cell therapy – specifically autologous stem cell therapy – you can fulfill your promise to the American people.
A. Rahman Ford, PhD, is a lawyer and research professional. 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.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.
