Beyond evidence and regulation: Medical tourism
and the direct-to-consumer marketing of stem cell
therapies
Ubaka Ogbogu, LLB, BL, LLM
Adjunct Associate Professor of Law
Associate Director of Research and Education
Consortium on Law and Values in Health, Environment and the Life
Sciences & Joint Degree Program in Law, Health and the Life Sciences
University of Minnesota
Outline
• Media reports and examples of stem
cell offerings
• Research objectives/questions
• Research methodology
• Results
• Conclusion
• Current policy landscape
Stem cell cures: Ready for prime
time?
 Somatic stem cell research has reached the
clinical trial phase for diabetes mellitus, MS,
stroke, myocardial infarction, among others.
 Therapies remain unapproved and unavailable
outside of experimental trials due to knowledge
gaps, technical challenges, and regulatory hurdles.*
 Only one approved hESC therapy clinical trial,
currently on hold due to safety concerns.
Putative Stem Cell Therapies and
Offerings
“Our website is solely dedicated to providing you with
up to date and on target information on stem cells,
research and current treatments available in China”
“If you are interested in getting more information about
finding a treatment in China for a specific ailment, and
you are in North America, you can call us toll free...”
Research Objectives/Questions
 Review of media reports indicated that DTCA via the
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Internet plays an important role
Primary objective was to document and characterize a
novel occurrence of DTCA
What sorts of therapies are offered?
How are they portrayed?
Is there clinical/scientific evidence to support the use of
these therapies?
Are they regulated and in what way?
Study methods
 Two prongs:
 Content analysis of websites offering stem cell therapies
 EBM-based analysis of peer-reviewed clinical evidence for primary
human studies reporting clinical effects of any stem cell therapies*
 Websites identified through media reports and Google searches
(final sample:19) and coded for therapeutic offerings,
indications, claims, benefits, risks, cost of therapy, evidence,
location of clinic, etc.
 Clinical evidence identified through comprehensive PUBMED
search. 45 records met relevance criteria
 Inter-coder reliability testing completed on random sample
Content analysis results: Stem
cell types offered
Stem cell type
Frequency
Adult, autologous
9
Fetal
6
Cord Blood
4
Embryonic
2
Adult, allogeneic
2
Stem cell sources
Stem cell source
Frequency
Bone marrow
7
Blood or marrow donors
5
Peripheral blood
5
Fetuses
4
Fat
2
Unspecified
2
Other (animal sources (shark, sheep)
and skin stem cells)
3
Transplantation procedure
Procedure
Frequency
Intrathecal, into CSF
6
Intravenous
6
Subcutaneous or intramuscular
4
Surgical transplantation
4
Catheterization of deep body vessels (injection 3
deep into the brain via craniotomy or by
injection into the spinal cord parenchyma via
laminectomy)
By mouth
1
Topical
1
Treatment indications
Disease condition
Frequency
Neurologic (MS, Stroke, Parkinson’s, SCI, Alzheimer’s, etc)
16
Cardiovascular
12
Diabetes
11
Musculoskeletal
11
Cancer
7
Autoimmune (systemic), Blood (non-cancer), Gastrointestinal,
Ophthalmic, Sex-related
5, respectively
Blood, cancer
4
HIV/AIDS, Infectious (non-HIV), Dermatological, Respiratory
3
Allergies, Endocrine (non-diabetes), Nephrologic
2
PSYCHIATRIC
1
Benefits vs. Risks Mentioned
 All websites surveyed mentioned
improvement of disease state as main
benefit of treatment
 14 (74%) of the websites did not mention
any risks
 Few websites mentioned procedural risks,
and nonspecific fever and tingling as only
risks of procedure
Example statements
 “Of over 1800 patients we have treated, we estimate that
85% have gotten some kind of improvement and 80%
have been satisfied with the improvements that they have
gotten. We by no means guarantee improvement, but ...
we are extremely surprised when patients do not get
improvement”
 “Transplantation is a safe, painless procedure. It is
conducted in a sterile environment by professional
medical personnel”
 “List of contraindications against cell therapy is rather
limited. No negative side effects were observed”
Treatment portrayals
 Indications scored very or somewhat unclear or
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indeterminate in 68% of sites (websites use catch-all
categories like aging, ‘‘increased feelings of energy’’)
12 of 19 websites has indications which spanned 4 or more
broad disease categories
Benefits portrayed as somewhat or very relevant in 79% of
websites
Risks portrayed as very irrelevant in 74% of websites
17 of 19 websites portrayed treatments as routine or
somewhat routine
Credibility established through numerous patient
endorsements, patent claims, media reports, and publications
 “We have proved that the efficacy of autologous
stem cell therapy in minor spinal cord injury
ranges from 45 to 70%. Here everything depends
on the size of the lesion, the level of injury, and
the years post injury. The best results were
obtained in the patients with thoracic level of
injury; 2-5 years post injury and incompleteness
of SCI”
– Neurovita.ru
Location
Location
Number of clinics
Mexico
4
China
3
India, Philippines, Russia, Thailand 2
Puerto Rico, Holland, Ukraine,
Costa Rica, Barbados, Dominican
Republic, Turkey, Germany
1
Clinical evidence study:
Inclusion/exclusion criteria
 Targeted indications mentioned 10 or more times in top 2
disease categories: neurologic & cardiovascular
 MS, Parkinson’s disease, Stroke, Alzheimer’s disease, SCI, and
autologous hematopoietic stem cell transplantation (AHSCT)
for acute myocardial infarction (AMI)
 89 total records, of which 45 included. Excluded records
were unavailable (1), duplicative, non-stem cell
interventions, reviews, or non-English (2), or referenced no
clinical outcomes
 Study not focused on describing current state of stem cell
medicine
Results
 Evidence for stem cell therapies for SCI and stroke is
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generally underdeveloped: small size, low methodological
quality (e.g., no control group), and uncertain, negative, or
contradictory findings
No studies of stem cell therapy for Alzheimer’s or Parkinson’s
Some history of stem cell therapy for MS, but clinical
outcomes are variable and ‘‘not obviously better than the
natural history of patients with multiple sclerosis”
Treatment recommendations made on the basis of the
reviewed evidence likely to be low grade
Treatments offered by websites generally unsupported by
clinical evidence
Study Limitations
 Publicly available information is not indicative of
information actually shared with patients during
clinical encounters
 We did not analyze actual outcome data for
particular clinics. Instead we showed that high
quality supporting evidence is lacking
 Bias from exclusion of non-English studies.
However only 2 such studies were excluded
Conclusions
 DTC portrayal of current stem cell medicine appears
optimistic and unsupported by clinical evidence
 Patients may not be receiving proper or accurate
information, and are subject to inordinate risk and
financial burden
 Clinics may be contributing to stem cell hype
 Tourism aspect complicates post-treatment
monitoring, protection of patient rights and
regulatory scrutiny
Current policy landscape
 Supranational soft regulation and advocacy (ISSCR, JDRF
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Int’l, ALS Worldwide)
Statutory intervention through physician standard of care
rules?
Physician’s duty to report abuse, neglect, or situations of risk
under minor and incompetent adult welfare legislation
Truth in advertising rules (FTC)
Local regulation – stem cell clinics have been shut down by
regulators in the Netherlands, Ireland, US
Lobbying by research community for stricter national
regulation
Acknowledgments
 Co-authors: Darren Lau, Timothy Caulfield, Tania Stafinski,
Devidas Menon, Benjamin Taylor
 Canadian Stem Cell Network
 REMEDiE
 Linda Hogle