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OPINION | HEALTHCARE

August 30, 2018 - 01:54 PM EDT
Regenerative health is a door we can open together


BY DOUG OLIVER, OPINION CONTRIBUTOR
19
The views expressed by contributors are their own and not the view of The Hill

“I once was blind, but now I see” is an inspirational phrase we often hear sung in church, but it is very rare that anybody gets to declare it as literally true, especially if they’re talking about being restored from an untreatable, incurable disease. But I can, and even more amazingly, it turns out the treatment for my blindness came from within: Yes, my own adult stem cells gave my sight back.
I went from legally blind, walking with a stick and prohibited from driving, to getting my driver’s license once again and ceremoniously gifting my now-unnecessary walking stick to U.S. Sen. Lamar Alexander after we worked hard together to write and pass the 21st Century Cures Act into law.
This kind of regenerative medicine — healing from cells present within our bodies — is a miracle based upon science. With the stroke of the president’s pen, its impact on health policy could be profound 
Millions of people — whose diseases will not get attention or relief from their disabling conditions — will just have to wait to receive their “opportunity for healing” until big-ticket diseases get priority for fast-track clinical trials made possible by the Cures Act. Millions of Americans remaining dependent upon others and social supports.


This unfortunate failures of social policies doesn't have to be our reality. I know, because I am living in the alternative, and there is an answer here. A relatively simple one that could transform live 
Regenerative health is a door we can open together.
President Trump could take an executive action today that would open the floodgates of innovation currently being dammed up because of bureaucratic bottlenecks and a need to micromanage what Americans have access to here at home, while millions worldwide get healthier, and foreign companies draw business away from our economy into their own.

These roadblocks need to be removed. The executive order I am about to suggest would create jobs, propel medical miracles, generate economic growth, put people unable to work back into the labor force (saving billions of taxpayer dollars), and, most importantly, alleviate the kind of suffering I went through before my stem-cell-therapy procedure.
This executive order would result in a biotech boom like we’ve never seen in a new field of healing called regenerative medicine, the kind of innovation that gave me my sight back.
America has a lot more to lose in the global race for medical innovation if executive action isn’t taken soon. Despite the progress FDA has made so far in accelerating approval of treatments, we’re not moving fast enough to even keep up with the pace of our own advancement, much less the world’s. This unfortunately keeps us sicker and our workforce weaker.
Imagine more treatments, delayed surgeries, or slowing of progression for conditions like blindness, the frailty of aging, knee and hip surgeries, back pain and opioid dependence, diabetes (type 1 and 2), heart diseases like congestive heart failure, rare genetic disorders in children, strokes and heart attacks, MS, ALS – the list goes on.

Cast by our established (and comfortable) institutions as mere “possibilities” here in the U.S., treatments are already becoming fast realities in other countries, and we need to do more here at home if we want restore and maintain a healthy workforce.
President Trump has the authority to issue an executive order directing the U.S. Department of Health and Human Services to:
Direct Secretary of Health and Human Services Azar to automatically classify any disease or condition currently qualifying an American to receive Social Security disability payments as an “unmet medical need,” and certify these diseases and conditions as “serious” enough to qualify for FDA “fast track” clinical trials under what is called the “Regenerative Medicine Advanced Therapy” (RMAT) designation. RMAT is a new approval pathway for biologic therapies, and a key policy I helped craft within the 21st Century Cures Act signed into law in 2016.
Making this link between disability-benefits policy and access to effective treatments will help remove the impediment created by our large companies competing for the same small number of big-ticket markets in regenerative medicine. Because the majority of those markets involve treatment for “degenerative” conditions associated with aging, people already retired from the labor force, those able to potentially be reintroduced to the workforce will continue to languish, many needing support from disability payments for conditions not getting as much attention.
This executive action would instantly motivate not only large companies but, more importantly, incentivize small-shop biotechs and physician groups (many headed by early career, imaginative scientists and doctors to chase and achieve breakthroughs for all of these underdog conditions.
A Trump executive order would create wealth, instead of taking it — along with taxpayer money — from our economy, and most importantly, Americans would be healthier and happier, and we’ll once again lead the world in medical innovation.
Doug Oliver is the founder of Regenerative Outcomes, which is a nonprofit organization focused on advancing the science of regenerative medicine. The foundation’s primary objective is to help improve access to these cutting-edge “regenerative medicine” procedures and treatments by working both with patients seeking safe and effective help and the innovative providers and companies able to meet their medical needs. Oliver was legally blind from macular degeneration, and who, through adult stem-cell treatment, had his sight restored. He also helped to push the 21st Century Cures Act into law.

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