By QUINTIN L. GUNN, SR.
There is an exciting development in China; Chinese hospitals are starting to sell experimental cell therapies... China is creating an emerging market for Regenerative Medicine, and Japan has already made significant investments to advance their global impact in this field.
Here is an update to this article and additional proof:
https://celltrials.org/news/response-new-cell-therapy-regulations-china
So, will the US fall behind in regenerative medicine advancements?
It is possible that the US will lag behind in Regenerative Medicine therapies due to over-regulation, and the overly critical view of advancements in regenerative medicine. Can our aging patient population afford to wait?
Effective Oct 1, 2019, Google has globally restricted advertiser use of most regenerative medicine and stem cell treatments being promoted:
Speculative and experimental medical treatment
The promotion of speculative and/or experimental medical treatments is prohibited.
Examples of products and services that will be prohibited (non-exhaustive)
Stem cell therapy, cellular (non-stem) therapy, gene therapy and similar forms of regenerative medicine, platelet-rich plasma, biohacking, do-it-yourself (DIY) genetic engineering products, and gene therapy kits.
Biologics such as PRP, Exosomes, A2M, Wharton's Jelly, Cord Blood, and Amino, to name a few, are cell assisted products that have the greatest opportunity to move the future of medicine forward. By being so restrictive or narrow in its thinking, could they be hurting medical innovations? Is it slowing down cures? Could it be destroying the financial aspects of what patients can afford and what doctors can recommend in treatment protocols?
Yes, the efficacy of these treatments needs to be documented and measured, but beyond that, who are the right types of doctors to administer these advancing technologies, and where are the best places for them to be educated or trained for the benefit of their patients?
There are several well-known organizations like IFATS, Boston BioLife, A4M, EmCyte, TOBI, World Stem Cell Summit, Perinatal Stem Cell Society, and the Interventional Orthopedic Foundation where doctors can get an introduction to stem cells or receive advanced training.
We also have many wonderful resources for doctors to gain access and information related to the latest in regenerative medicine innovations like BioInformant, Regenerative Medicine Foundation, and Regen Med
No doubt, we need advancements in healthcare. But what we really need is to have highly trained and skilled doctors who can administer new medical innovations and treatments. It is very likely the U.S. could actually stagnate and, unfortunately, fall behind the rest of the world as a result of over-regulation. This can only happen if we don't have enough doctors and speed up our acceptance of regenerative medicine alternatives. We get a glimpse of the future as we start to see U.S. citizens heading overseas to look for these emerging medical alternatives.
The urgency of this issue becomes even more concerning, as the global population has shifted to a more elderly population. Unfortunately, the data also shows that 71% of youth do not even have enough good health to qualify for military service due to obesity, drug use, and criminal records. How can they help manage the upcoming tsunami of aging patients?
Does this article become especially critical because data within actuarial studies show where the human population is headed? Global Aging In A Warming World
Who will take care of us if the youth are not even able to take care of themselves? Science and doctors have to work together to develop protocols that help to improve the health and well-being of our aging population in new and innovative ways.
What we know so far is the only prevailing methods for certain orthopedic procedures are surgery or non-surgical treatments using BMAC and PRP injections. PRP being the dominant and most approved way of treating patients for joint pain, back pain, hip pain, etc. What about other conditions or injuries such as MS, Spinal Cord Injuries, Autism, COPD, Strokes, just to name a few. We need more research to develop new therapies for these and other treatments.
It's the view of many physicians who are now actively pursuing an education in the field of Regenerative Medicine, Functional Medicine, and Integrative Medicine, as well as Age Management/Anti-Aging that they are constrained due to the limitations of accepting insurance. These doctors are awakening to the low cost and high benefits of regenerative medicine advancements. Using the Fee-For-Service model allows patients to choose for themselves and doctors to go with the best treatment plan that they see fit for their patients. When doctors attack the problems at the root cause via cell assisted therapies, nutrition optimization, and lifestyle changes, they give patients a fighting chance to see improvement.
Consider this, our current insurance-based model is causing burn out and job dissatisfaction due to too low reimbursements, too much regulation, overwork, and little pay. So, the once desired medical field is now becoming a second option for new college students.
We acknowledge that there has been a sharp uptick in the number of bad actors or profiteers who prey on the weak and elderly — however sharing within local medical boards, FDA regulations, and standardized protocols that meet regulatory guidelines for the safe use of cellular and regenerative medicine treatments. It’s the belief of many that the country should be a leading regenerative medicine industry for others to emulate.
Regulatory guidance has to be based upon scientifically documented findings and knowledge from physicians who are currently on the front line of treating real patients.
Scientists and doctors alike should provide a defense for an aging population. Without them both, our future progress in medicine gets impeded, and our healthcare system collapses under the weight of just too many patients and no new ways to treat them. Which could lead to a trail of untreated or untreatable patients?
Today the RMAT process via the FDA's TRG Rapid Inquiry Program (TRIP) allows studies for catastrophic injuries or illness and is certainly becoming an orderly way beyond the older IRB process. It provides doctors with the necessary framework to organize new treatment protocols and to move the needle of science and medicine further. This approach allows doctors to place their focus on where it belongs, and that's on the patient. Plus, it gives them a chance to ward off catastrophic medical problems by detecting and treating the onset of certain health issues earlier.
Regenerative Outcomes LLC has created a program to help doctors prepare for submission of their regenerative medical protocols so that doctors are not left in a lurch without guidance or Regenerative Outcomes Foundation resources.
Often online, we find disagreements between doctors within certain medical communities versus some PhD physicians related to 351 or 361 regulatory issues. In reality, it's in everyone's best interest to collaborate and work toward a common goal through data sharing that will provide clinical transparency and self-regulation using patient data management for the advancement of regenerative medicine as a whole.
Taking a personalized precision approach to medicine has mainly come from patients who are willing to pay out of pocket when traditional medicine has failed to give them results. Personalized Precision Medicine or WellCare seems to give the best options versus trying to keep up with insurance forms, billing codes, and the ongoing lowering of reimbursements and restrictions.
When you consider the rising cost of our current healthcare model, are we more focused on insurance approved treatments and payments than WellCare or preventative maintenance? The cost to care for certain age-related illnesses is outstripping our ability to meet the needs of this growing elderly demographic.
When science and doctors work together, both patients and doctors are happier and, subsequently, there’s less doctor burnout from volume patient care requirements related to the current insurance model. We have the technology, and we have a large pool of doctors who want to be trained, let's get with it!
So: Will the US Fall Behind in Regenerative Medicine Advancements?
Only time will tell but can the aging patient population afford to wait for the answer?
Quintin L. Gunn Sr. is a Practice Development Consultant with Social Media Solutions for Doctors. Visit www.SocialMediaSolutionsforDoctors.com
