There’s a great deal of promise and potential in stem cell research. There also has been a deluge of optimistic media coverage. However, presently there are only a limited number of evidence-based stem cell therapies available to consumers. This has not stopped numerous snake-oil swindlers from exploiting the public awareness on stem cells. They sell treatments with supposed health benefits and remedies “infused” with stem cells. Many are slick online marketing campaigns that avoid warnings from the FDA and ignore studies from the International Society of Stem Cell Research.
BMJ web analysis:
Researchers
for the British Medical Journal
conducted a comprehensive web analysis looking for companies that marketed
unsubstantiated and unproven stem cell therapies or therapies where stem cells
were part of the treatment. Not surprisingly, they found 243 companies
marketing these fraudulent therapies and 116 companies that publicised stem
cells as part of the treatment. The majority of the treatments were for: “pain/injury
relating to the bones, joints and muscles (182), illness (diseases or maladies
including autoimmune disorders, degenerative conditions, genetic disorders,
infectious diseases and environmental harms, other than chronic conditions
primarily affecting the bones, joints and muscles) (82), cosmetic concerns
(52), non-cosmetic ageing (44) and sexual enhancement (18).”
The following are the breakdown of
the countries and number of firms where the majority of the web sites/clinics originate.
Most sell internationally.
Everyone seems to be in on the scam, both web sites run by conventional medical doctors as well as the various alternative medical practitioners:
Just a few of the more interesting findings:
-----Only 18.93% admitted there was limited evidence that stem cell treatments actually work.
-----Only 33.33% admitted the treatment is experimental.
-----Only 24.69% mentioned possible risks, such as infection or an allergic reaction.
-----Only 5.76% cautioned of more serious risks, such as damaging a bone joint by injecting stem cells into it.
-----Only 30.86% mentioned whether the treatment was approved or not approved by the FDA or the regulatory body in their country.
-----31.69% boasted that their treatments were “breakthrough, revolutionary, cure, incredible, amazing, magical.”
Country
|
||
Total
|
%
|
|
USA
|
295
|
80.16
|
India
|
19
|
5.16
|
Canada
|
14
|
3.80
|
Australia
|
8
|
2.17
|
Mexico
|
7
|
1.90
|
UK
|
7
|
1.90
|
Thailand
|
6
|
1.63
|
China
|
3
|
0.82
|
Israel
|
2
|
0.54
|
Denmark
|
2
|
0.54
|
Practitioner
|
Full sample (n=368)
|
|
Total
|
%
|
|
Medical doctor
|
161
|
43.75
|
Naturopath
|
63
|
17.12
|
Chiropractor
|
61
|
16.58
|
Acupuncturist
|
36
|
9.78
|
Midwife
|
33
|
8.97
|
Homeopath
|
27
|
7.34
|
Massage therapist
|
13
|
3.53
|
Aesthetician
|
9
|
2.45
|
Registered nurse
|
7
|
1.90
|
Ayurvedic doctor
|
2
|
0.54
|
Other
|
74
|
20.11
|
Not specified
|
34
|
9.24
|
-----Only 18.93% admitted there was limited evidence that stem cell treatments actually work.
-----Only 33.33% admitted the treatment is experimental.
-----Only 24.69% mentioned possible risks, such as infection or an allergic reaction.
-----Only 5.76% cautioned of more serious risks, such as damaging a bone joint by injecting stem cells into it.
-----Only 30.86% mentioned whether the treatment was approved or not approved by the FDA or the regulatory body in their country.
-----31.69% boasted that their treatments were “breakthrough, revolutionary, cure, incredible, amazing, magical.”
Two examples of hyperbole in
advertising:
“Researchers
have finally found the ‘fountain of youth’ and it can regenerate your bodily
processes by ridding you of all sorts of degenerative diseases and aging
cells.”
“Breakthrough Healing for Degenerative Diseases and Chronic Ailments: Are you tired of trying traditional treatment options with little to no change? Do you want to avoid costly, painful surgery? Stem cell therapy could be the answer you’re looking for!”
Detailed updates on stem cell
research related to:
Cancer
Tissue
Regeneration
Heart
Disease
Peripheral
Arterial Disease
Ischemia
Stroke
Nervous
System and Neurodegenerative Diseases
Bone and
Cartilage
Dermatology
Pancreas and
Diabetes
Liver
Diseases
Urology and
Erectile Dysfunction
Retina
Hematology:
Preparation of Red Blood Cells
Heart
Lungs
Liver
Kidneys
…..can be
found at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4537770/
Risks for using unproven stem cell
treatments:
“Complications may create new short- and long-term health problems,
and/or may make your condition or symptoms more difficult to manage.
“Receipt of one unproven or experimental treatment may make you
ineligible for future clinical trials or treatment options.
“Out-of-pocket expenses could be enormous. In addition to treatment
costs, there may be accommodation charges or other fees. In most cases,
insurance companies and government health programs do not cover the cost of
experimental treatments.
“If travel is involved, there are additional considerations, including
time away from friends and family.”
Stem cells are a unique type of drug:
“Yeah, stem cells can be extremely unusual drugs, but they are often drugs even if some argue they aren’t. The FDA considers them drugs in many cases. Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it. You have no way to stop it. Also because stem cells are alive they can grow inside your body, move around, and change. This can be helpful or harmful, but the big point is that it is not something that is controllable or reversible.”
“Yeah, stem cells can be extremely unusual drugs, but they are often drugs even if some argue they aren’t. The FDA considers them drugs in many cases. Unlike other drugs, once a patient receives a stem cell drug, it will not necessarily simply go away like other drugs because a stem cell drug consists of living cells that often behave in unpredictable ways. What this means is if the stem cells are doing bad things your doctor has no way to stop it. You have no way to stop it. Also because stem cells are alive they can grow inside your body, move around, and change. This can be helpful or harmful, but the big point is that it is not something that is controllable or reversible.”
Be wary of testimonials:
“Clinics
peddling unproven stem cell treatments frequently overstate the benefits of
their offerings and use patient testimonials to support their claims. These
testimonials can be intentionally or unintentionally misleading. For example, a
person may feel better immediately after receiving a treatment, but the
perceived or actual improvement may be due to other factors, such as an intense
belief that the treatment will work, auxiliary treatments accompanying the main
treatment, healthy lifestyle changes adapted in conjunction with the treatment
and natural fluctuations in the disease or condition. These factors are complex
and difficult to measure objectively outside the boundaries of carefully
designed clinical trials.”
Advice for People Considering Stem
Cell Therapies:
“Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask the clinical investigator to give you the FDA-issued Investigational New Drug Application number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment—even if the stem cells are your own.
“Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.”
“Ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask the clinical investigator to give you the FDA-issued Investigational New Drug Application number and the chance to review the FDA communication acknowledging the IND. Ask for this information before getting treatment—even if the stem cells are your own.
“Request the facts and ask questions if you don’t understand. To participate in a clinical trial that requires an IND application, you must sign a consent form that explains the experimental procedure. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Make sure you understand the entire process and known risks before you sign. You also can ask the study sponsor for the clinical investigator’s brochure, which includes a short description of the product and information about its safety and effectiveness.”
A stem
cell professor and researcher visits a stem cell patient recruitment seminar:
“The growing direct-to-consumer, stem cell clinic industry in the U.S.
uses a number of strategies for patient recruitment, including self-styled
educational seminars, which may reach thousands of members of the public
annually. Here I report on a first-hand experience at such a seminar that I
recently attended. Numerous specific medical claims were made at the seminar:
no potential for rejection; no side effects, including no pain; proven efficacy
for a variety of conditions, including in particular arthritis and pain; and
U.S. Food and Drug Administration approval. I discuss the potential impact of
these kinds of seminars on the public and on the stem cell field.”
The many downsides of stem cell marketing:
“Given the growing realization that there are hundreds of stem cell
clinics in the U.S. today in 2016 and the observation that many hold
recruitment seminars, it is possible that thousands of members of the public
each year are attending infomercial seminars that provide misleading or even
outright factually incorrect information about stem cells and questionable
medical claims. This could not only lead many patients to receive unnecessary,
unsafe, or ineffectual treatments, but it may also contribute to public
confusion about stem cells and the field of stem cell clinical research. These
seminars represent only one type of an assortment of recruitment methods,
including Internet, radio, newspaper, and television ads for various clinics,
which may also contain dubious statements. I believe that such stem cell clinic
marketing poses a significant threat to public perception and understanding of
the legitimate stem cell translational medicine field.”
Additional Info
Tool
to easily search for a stem cell clinical trial for your disease: https://ipscell.com/find-a-clinical-trial/
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Photo:
https://www.lifesitenews.com/opinion/the-late-great-stem-cell-debate-why-pro-lifers-were-right
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