The FDA's Stem Cell Reformation Must Go Beyond COVID-19

barbara

Pioneer Founding member
"This reform must no longer be the subject of directionless academic debate or an issue for consideration by medical "ethicists" and self-proclaimed protectors of the common good. The time for debate and delay has ended. The time for decisive action has arrived." Brilliant!!

https://www.painnewsnetwork.org/stories/2020/5/11/the-fdas-stem-cell-reformation-must-proceed-beyond-covid-19
May 10, 2020
By A. Rahman Ford, PNN Columnist
The COVID-19 crisis has been a catalyst for new regulatory flexibility at the U.S. Food and Drug Administration. The FDA is pushing aggressively to develop new vaccines and treatments for coronavirus, including dozens of clinical trials of stem cell therapies on critically ill patients.

Mesoblast recently dosed its first patients on ventilators in a 300-patient trial using its Remestemcel-L stem cell product to treat acute respiratory distress syndrome (ARDS). Pluristem Therapeutics is using placenta-derived stem cells in another trial, while The Cure Alliance is using umbilical-cord derived stem cells. GIOSTAR has a trial approved for its mesenchymal stem cells under the FDA’s “compassionate use” program. And Athersys has begun a large trial using stem cells derived from bone marrow on patients with moderate to severe ARDS.

A stem cell reformation of sorts is underway at the FDA due to the coronavirus pandemic. But what about the chronic pain crisis? About 50 million American lives with chronic pain, as opposed to 1.3 million confirmed cases of coronavirus in the U.S. to date.

The reformation is not only the result of COVID-19, but due to the simmering pressure of the American people, who have long demanded greater democracy and autonomy in medical treatment. The voice of the people and the virulence of the pandemic have merged into a veritable stem cell Martin Luther, the German monk who rejected the teachings of the Catholic Church during the Protestant Reformation.

Like those told to wait for the promise of stem cell therapy to materialize while being inundated with propaganda about “unproven” cellular treatments, Christians in the Midieval era were told to wait for a salvation controlled by an entrenched religious establishment -- when the salvation they sought was always right inside of them.

One aspect of our current medical crisis is not new. Americans suffering with intractable chronic pain have endured perpetual crisis for a seeming eternity, waiting for the FDA to abandon its rigid, doctrinaire, one-size-fits-all approach to medical care in favor of more flexible, forward-thinking and tailored treatments.

The COVID-19 crisis — and Americans' consequent demand for solutions — has forced the FDA's hand. This demand compelled the FDA to reconsider its bureaucratic veneration of regulatory relics that denied the revolutionary novelty of stem cells.

The FDA deserves some credit for finally acknowledging the need for exploration and innovation in its clinical trial procedures. But now the agency must recognize that chronic pain - like COVID-19 - is a national medical crisis that necessitates a similar creative solution.

Stem cell regulatory innovation must not end with coronavirus. In fact, it must continue and accelerate. Yes, the current progress is heartening. However, more must be done. And needs to be done immediately. The chronic pain crisis demands it.

The FDA's current push for stem cell innovation must proceed beyond the therapeutic necessity of coronavirus. The agency needs to reform its restrictions on the use of our own stem cells for treating arthritis, neuropathy, degenerative disc disease and other chronic pain conditions.
This reform must no longer be the subject of directionless academic debate or an issue for consideration by medical "ethicists" and self-proclaimed protectors of the common good. The time for debate and delay has ended. The time for decisive action has arrived.

At the core of the matter are the cries of millions of Americans in a critical crisis of pain that existed well before the face masks, latex gloves, hand-washing, social distancing and trillions of dollars in federal appropriations that COVID-19 has spawned.

To the FDA and Commissioner Stephen Hahn, your effort in pursuing stem cell therapy for COVID-19 treatment has not gone unnoticed. Now it is time to relax FDA regulations on the use of our own stem cells. Devolve regulatory authority to the states and their oversight, and let physicians and patients decide when stem cell therapies are appropriate.

This is the next logical step in the FDA's reformation. It is a necessary step. It is the right step.
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. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.
 

barbara

Pioneer Founding member
This makes my blood boil and is a perfect example of what A. Rahman Ford, PhD is talking about in the article posted above.


Medical Xpress
May 7, 2020

Bioethicist calls out unproven and unlicensed 'stem cell treatments' for COVID-19

by Cell Press

As the COVID-19 pandemic enters its third month, businesses in the United States are marketing unlicensed and unproven stem-cell-based "therapies" and exosome products that claim to prevent or treat the disease. In Cell Stem Cell on May 5, bioethicist Leigh Turner describes how these companies are "seizing the pandemic as an opportunity to profit from hope and desperation."

"I'm concerned that individuals purchasing these supposed 'therapies' for COVID-19 will be scammed," says Turner, an associate professor at the University of Minnesota Center for Bioethics. "I'm also worried that they'll be injured as a result of being given products that haven't been adequately tested, or that they'll forgo measures like social distancing because they've paid for a product that they think will protect them from being infected or getting sick."

Many stem cell clinics have a history of selling unproven and unlicensed interventions for injuries and illnesses ranging from Alzheimer's disease to pulmonary disorders to spinal cord injuries. Since the COVID-19 pandemic began, some have added claims about "immune-boosting" therapies for treating COVID-19 and acute respiratory distress syndrome (ARDS) caused by infection with SARS CoV-2. These companies advertise stem cell interventions and exosome products derived from such sources as umbilical cords and amniotic fluid. Turner says uncritical news media accounts have compounded some of these claims by reporting on preliminary evidence and case studies.

Yet rigorous clinical trials on these stem cell products have not yet been done. "Randomized controlled trials are needed to establish whether particular stem cell products are safe and efficacious in the treatment of COVID-19-related ARDS," he explains.

Turner has studied the US direct-to-consumer marketplace for stem cell clinics for nearly a decade. "These businesses have a long history of claiming to treat diseases and injuries for which evidence-based therapies do not yet exist," he says. To find out what these businesses were promoting, he did Google searches on a variety of terms related to stem cell treatments, COVID-19, and ARDS. He also searched YouTube for promotional videos made by these clinics.

"I found more examples of businesses peddling stem cell products for COVID-19 than I had space to describe in detail," he notes. "I wasn't surprised at how quickly some of these companies began making these claims. For them, the COVID-19 pandemic is an opportunity to generate a new revenue stream."

In the paper, Turner also discusses the role of medical organizations, noting that while most are doing a good job of criticizing deceptive advertising, some have been promoting these interventions despite the lack of scientific evidence supporting their use.
"I want members of the public to know that some companies are trying to take advantage of them by selling supposed treatments that aren't backed by credible evidence," Turner concludes. "I'm also hoping that this paper will catch the attention of regulatory bodies like the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), as well as state medical boards and state attorney general offices. The FDA and FTC have issued letters to some businesses, but additional regulatory action is needed."
 

gh253

Member
I had to unfollow A. Rahman Ford. He's so naive I find it irritating. Regulators are badly intentioned and have only relaxed the rules for COVID treatments because the issue has reached mass public attention and the political impetus is to find treatments, not block them. But for everything other than COVID, regulators "must" do nothing. They WILL continue to regulate us to death because nobody gives a damn about pain patients.
 

SammyJo

Member
So what if the FDA suddenly said fine, you can have stem cells for anything your doctor thinks is reasonable?
Those who can afford to pay thousands of dollars will benefit. But this still doesn't get access to the vast majority, who can't afford it without insurance coverage. How does the process change so the insurers can pay? A few private corporations with self funded health plans have added coverage for stem cell therapy, without FDA approval. But would Medicare take this step? I have never seen a proposal for how we get over this hump.
 
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