Ethical debates on the use of stem cells to treat human conditions have been raging since the late 1990s when President Clinton directed the formation of a National Bioethics Advisory Commission. Over time, stem cell research issues have been another political football with politicians and religious leaders debating funding and research issues.
It finally appeared that in 2009, when President Obama relaxed the rules on lines of research that more experimental stem cell therapy options could finally be explored. Indeed, there has been exponential growth in stem cell clinics and therapies.
Stem cell therapies are being explored for degenerative eye diseases, the production of human skin, heart conditions, joint repair and arthritis. Some scientists predict that stem cells may be used to treat diabetes and conditions such as Parkinson’s and blood diseases. Stem cells are able to become any kind of cell that the body needs. The therapy could become the wave of the future where a person’s own cells could heal the patient.
It is all very exciting stuff, but the problem occurs when promised therapies simply don’t work and clinics are unregulated. Therapies are expensive. While all the promise is there, in many cases the promise is not delivered – not yet, in any case. Stem Cell Clinic Crackdown and Treatment Ethics.
FDA Reacts
While most of the research being done in the area of stem cell therapy is generally responsible, there are clinics applying questionable therapies to patients and charging them big bucks to do it. Lately, the US Food and Drug Administration has stepped up its enforcement of unproven and even dangerous stem cell treatments.
For example, in August 2017 the USDA went after U.S. Stem Cell Clinic of Sunrise, Florida and an outfit called StemImmune Inc. of San Diego, California.
In the case of the Florida clinic, they have been warned about treating patients with unapproved and nonsterile (!) stem cell treatments and then injecting them both intravenously or directly into patients’ spines. This runs against every responsible treatment modality.
In the case of the San Diego clinic the FDA sent US marshals seize live smallpox vials. The smallpox was mixed with stem cells and then it was injected into the tumors of cancer patients. The injections were being made at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California. This potentially implicates not only the clinic but the “treatment centers.”
In both cases, the clinics have mounted serious public relations efforts. With the Florida clinic, they have stated (in part):
“It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures.”
That may all be well and true, but my question from an ethical point of view is if the therapy works and what the record of efficacy may be. I am fairly certain the FDA has expressed similar concerns.
As to the San Diego clinic and their treatment centers, the founder of the California Stem Cell Treatment Center, said it was “voluntarily participating” in “studies for late-stage, no-options cancer patients.”
Their claim is that they provided their services for free. They claim the treatments are safe and no adverse effects. However, could other therapies have been tried and explored? Is it ethical to use unproven therapies on patients? Isn’t that akin to using the very sick patients as Guinea pigs, using hope instead carrots?
Ethical Policies Needed
At this juncture, many of the clinics who are taking yet unproven stem cell research and are bypassing extensive trials to treat patients are downright unethical. The most unethical of all of them are those who treat patients who are terminal or who require immediate intervention.
The FDA has not stepped up to regulate and it has not established strict policies and guidelines. It is shocking that given the FDA’s scrutiny for so many treatments, pharmaceuticals and equipment that “stem cell products” remain largely unregulated.
At issue here is knowledge.
The FDA is allowing desperate patients to seek out stem cell “cures,” that are unapproved and quite expensive (not covered by insurance plans) without the patients realizing the treatments may not only be dangerous, but that they don’t work.
If the FDA has taken bold steps to approach “regulation,” why shouldn’t that regulation at least offer a warning that the therapies are highly doubtful at best? It is unethical to say and do nothing. Stem Cell Clinic Crackdown and Treatment Ethics.
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