Predatory snake-oil peddlers have opened up shop right across the United States and Canada. They are literally salivating over the money they are raking in as they deviously promise miracle stem cell cures that have zero scientific evidence. Research is in its embryonic stage, as the U.S. government has spent $1.4 billion studying stem cells over the last 20 years. There are only 29 clinical trials worldwide involving stem cells (2018). Yet this hasn’t stopped these swindlers from making exaggerated or totally false claims, preying on sick people who are desperately looking for a treatment or cure that modern medicine is as yet unable to give. They claim stem cells can treat a long list of conditions, but in fact have only been proven to treat a few blood disorders and some burn victims.
Unapproved,
Fake Therapies
“‘Our belief is that there are many companies operating in the United
States that are selling fake stem cell therapies that are not legal under FDA regulations,’
says Dr. Sean Morrison, a stem cell biologist and researcher at The University
of Texas Southwestern, and past president of the International Society for Stem
Cell Research.
“‘One of the things that we see among people selling fake stem cell therapies
is they jump in early without testing whether something is safe and effective
and start selling it to desperate patients,’ Morrison said. ‘Our belief at
the International Society for Stem Cell Research is that there are many
companies operating in the United States that are selling fake stem cell
therapies that are not legal under FDA regulations.’”
Dangers of
Stem Cell Treatments
“And
according to the New England Journal of Medicine, a Massachusetts man was
completely paralyzed after stem cells injected into his spine to treat a
stroke-related disability morphed into a tumor. The article suggested that
known cases of patient harm may only be the tip of the iceberg. Owing to a lack
of reporting requirements, the paper’s authors wrote, adverse events associated
with unproven stem cell treatments are probably much more common than is
currently known.
“Paul
Knoepfler, Ph.D., a stem cell researcher and industry watchdog at the
University of California, Davis—who was not involved in the research promoted
in the school’s web video—says that consumers routinely underestimate the risks
associated with stem cell injections. ‘People think that since the cells come
from their own bodies, they must be safe,’ he says. ‘But oversight is so lax
that there’s no way to even know what you’re being injected with half the time.’”
Vision
Loss After Injecting Stem Cells (New England Journal of Medicine)
“Adipose
tissue–derived stem cells have been increasingly used by stem-cell clinics in
the United States and elsewhere to treat a variety of disorders. We evaluated
three patients in whom severe bilateral visual loss developed after they
received intravitreal injections of autologous adipose tissue–derived stem
cells at one such clinic in the United States. In these three patients, the
last documented visual acuity on the Snellen eye chart before the injection
ranged from 20/30 to 20/200. The patients’ severe visual loss after the
injection was associated with ocular hypertension, hemorrhagic retinopathy,
vitreous hemorrhage, combined traction and rhegmatogenous retinal detachment,
or lens dislocation. After 1 year, the patients’ visual acuity ranged from
20/200 to no light perception.”
Cancer Cells Are Yours As Well
“‘Stem cells
are basically blank checks,’ said Dr. Insoo Hyun, a professor of bioethics at
Case Western Reserve University’s School of Medicine and director of the CWRU
Stem Cell Ethics Center. ‘They can eventually become any kind of cell in the
human body ……… Just because they’re your
own cells doesn’t mean it’s good for you,’ he added. ‘Cancer cells are actually
your own cells, so just because something is your own cell doesn’t mean it’s
necessarily going to help you. It might actually hurt you.’”
How to Protect Yourself
“The FDA,
the International Society for Stem Cell Research, and CR’s medical experts
advise you to be cautious when considering stem cell therapy.
“Beware of the hype and hefty fees. Doctors testing stem cell treatments
in carefully controlled clinical trials usually don’t promote their offerings
with big, flashy advertisements that promise dramatic improvements or total
cures. They also don’t charge a lot. There may be some minor fees for travel or
other personal expenses, but the treatment itself should be free or low-cost to
participants. ‘A large price tag—especially in the range of thousands of dollars—should
be a major red flag,’ says Marvin M. Lipman, M.D., Consumer Reports’ chief
medical adviser. So should any doctor claiming to treat a wide range of medical
conditions, such as autism, arthritis, and erectile dysfunction, with the same
therapy. Different organs and body systems require different expertise—and
different medicine—to treat, which is why most doctors specialize.”
For two other ways to protect yourself, Ask questions and Read
the fine print, see:
FDA seeks
permanent injunctions against two stem cell clinics:
“The U.S. Food and Drug Administration, in two complaints filed today in
federal court, is seeking permanent injunctions to stop two stem cell clinics
from marketing stem cell products without FDA approval and for significant
deviations from current good manufacturing practice requirements.
“‘Cell-based regenerative medicine holds significant medical
opportunity, but we’ve also seen some bad actors leverage the scientific
promise of this field to peddle unapproved treatments that put patients’ health
at risk. In some instances, patients have suffered serious and permanent harm
after receiving these unapproved products. In the two cases filed today, the
clinics and their leadership have continued to disregard the law and more
importantly, patient safety. We cannot allow unproven products that exploit the
hope of patients and their loved ones,’ said FDA Commissioner Scott Gottlieb,
M.D.”
Warning
Letter
“The U.S.
Food and Drug Administration today posted a warning letter issued to US Stem
Cell Clinic of Sunrise, Florida, and its Chief Scientific Officer Kristin
Comella for marketing stem cell products without FDA approval and for
significant deviations from current good manufacturing practice requirements,
including some that could impact the sterility of their products, putting
patients at risk.
“‘Stem cell
clinics that mislead vulnerable patients into believing they are being given
safe, effective treatments that are in full compliance with the law are
dangerously exploiting consumers and putting their health at risk,’ said FDA
Commissioner Scott Gottlieb, M.D. ‘As the FDA takes new steps to advance an
efficient, modern approach to the regulation of cell based regenerative
medicine, at the same time we will be stepping up our enforcement actions
against clinics that abuse the trust of patients and, more important, endanger
their health with unsanitary conditions or by purporting to have treatments
which may not provide any benefit.’”
Class Action Lawsuit
“Defendant is essentially a marketing company masquerading as a medical ‘institute.’
Defendant intentionally circumvents FDA regulation by purporting to inject
patients’ own ‘stem cells’ back into their bodies. During the course of its
operation, Defendant has offered at least three purported ‘stem cell’
treatments to the general public under the representation and auspices that these
procedures are effective. Specifically, Defendant has offered ‘venous’
procedures, ‘bone marrow’ procedures, and ‘adipose’ procedures.
“(a) In the ‘venous’ procedure, Defendant takes a blood draw from the
patient, runs the blood through a centrifuge, and then reinjects the very same
blood into the patients’ blood stream.
There is no evidence that any stem cells are extracted from the peripheral
blood and no evidence that the very same cells extracted from the patient’s
body have any beneficial effect on any pulmonary disease.
“(b) Similarly, Defendant’s ‘bone marrow’ procedure involves the removal
of a small amount of the patient’s bone marrow fluid, along with the patient’s
blood, which is then re-injected into the patient’s own body. Defendant solely
relies on ‘anecdotal’ evidence in support of the efficacy of its procedures.
Not a single double blind, placebo-controlled study and not a single piece of
medical literature supports the efficacy of any of Defendant’s ‘stem cell’
procedures.
“(c) In the ‘adipose’ procedure, adipose tissue, composed predominately
of body fat, is removed from the patient. Defendant purported to isolate ‘stem
cells’ from the patient’s adipose tissue, which is then reintroduced into the
patient’s body. Defendant no longer administers this procedure and at least one
clinic in Florida unrelated to Defendant has been shut down for providing
so-called adipose stem cell therapy.”
Additional
Info
Stem Cells: Latest Marketing Buzz Words Used To Dupe and Deceive http://www.mybestbuddymedia.com/2018/03/stem-cells-latest-marketing-buzz-words.html
Shot in the Dark: Gordie Howe & Stem Cell Optimism http://www.mybestbuddymedia.com/2015/07/shot-in-dark-gordie-howe-stem-cell.html
Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry https://www.cell.com/cell-stem-cell/pdf/S1934-5909(16)30157-6.pdf
Tool to easily search for a stem cell clinical trial for your disease: https://ipscell.com/find-a-clinical-trial/
Nine Things To Know About Stem Cell Treatments http://www.closerlookatstemcells.org/stem-cells-and-medicine/nine-things-to-know-about-stem-cell-treatments
Tyler Graham, “The Cure-All: Are New Stem Cell Therapies Miracles In A Bottle – Or Just A Dangerous Form of Snake-Oil?” http://www.popsci.com/cure-all
Reeves Wiedeman, “The Gordie Howe Protocol” http://nymag.com/daily/intelligencer/2015/06/gordie-howe-protocol-stem-cells.html
Judy Illes and Fabio Rossi, “Opinion: No Miracle Therapy for Stroke” http://www.vancouversun.com/health/Opinion+miracle+therapy+stroke/10787468/story.html
David Gorski, “Stem Cells Versus Gordie Howe’s Stroke” Parts one and two https://www.sciencebasedmedicine.org/stem-cells-versus-gordie-howes-stroke/
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Photo: https://www.futurity.org/iron-carbon-monoxide-snake-venom-1571692/
Jerry De Luca is a Christian freelance writer who loves perusing dozens of interesting and informative publications. When he finds any useful info he summarizes it, taking the main points, and creates a (hopefully) helpful blog post.
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