Stem cell tourism

Stem cell tourism, a form of medical tourism, is the internet based-industry in which stem cell procedures are advertised to the public as a proven cure.{{Cite journal|title=Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions|first1=Gerhard|last1=Bauer|first2=Magdi|last2=Elsallab|first3=Mohamed|last3=Abou-El-Enein|date=September 10, 2018|journal=Stem Cells Translational Medicine|volume=7|issue=9|pages=676–685|doi=10.1002/sctm.17-0282|pmid=30063299|pmc=6127222}} In the majority of cases, it leads to patients and families traveling abroad to obtain procedures that are not proven, nor part of a clinical trial approved by an authority like the Food and Drug Administration in the United States.{{Cite journal |pmid = 25945404|year = 2015|last1 = Turner|first1 = L.|title = US stem cell clinics, patient safety, and the FDA|journal = Trends in Molecular Medicine|volume = 21|issue = 5|pages = 271–3|doi = 10.1016/j.molmed.2015.02.008}} These procedures have not gone through the vetting process of clinical research and they lack rigorous scientific support.{{Cite journal |pmid = 25489841|year = 2015|last1 = Knoepfler|first1 = P. S.|title = From bench to FDA to bedside: US regulatory trends for new stem cell therapies|journal = Advanced Drug Delivery Reviews|volume = 82-83|pages = 192–6|doi = 10.1016/j.addr.2014.12.001|pmc = 4398607}} Although for the general public, this advertising in glossy websites, may sound authoritative, for translational doctors and scientists this leads to the exploitation of vulnerable patients. These procedures lack the reproducibility, the rigor that is required for successful development of new effective medications. Although the term may imply traveling overseas, in recent years, there has been an explosion of "stem cell clinics' in the US which has been well documented.{{Cite journal |pmid = 31456478|year = 2019|last1 = Knoepfler|first1 = P. S.|title = Rapid change of a cohort of 570 unproven stem cell clinics in the USA over 3 years|journal = Regenerative Medicine|volume = 14|issue = 8|pages = 735–740|doi = 10.2217/rme-2019-0064|doi-access = free}} These activities are highly profitable for the clinic but no benefit for the patients, sometimes experiencing complications like spinal tumors,{{Cite journal|title=Glioproliferative Lesion of the Spinal Cord as a Complication of "Stem-Cell Tourism"|first1=Aaron L.|last1=Berkowitz|first2=Michael B.|last2=Miller|first3=Saad A.|last3=Mir|first4=Daniel|last4=Cagney|first5=Vamsidhar|last5=Chavakula|first6=Indira|last6=Guleria|first7=Ayal|last7=Aizer|first8=Keith L.|last8=Ligon|first9=John H.|last9=Chi|date=July 14, 2016|journal=The New England Journal of Medicine|volume=375|issue=2|pages=196–198|doi=10.1056/NEJMc1600188|pmid=27331440|doi-access=free}} death, or financial ruin, all of which are documented in the scientific literature.{{Cite journal|title=Glioproliferative Lesion of the Spinal Cord as a Complication of "Stem-Cell Tourism"|first1=Aaron L.|last1=Berkowitz|first2=Michael B.|last2=Miller|first3=Saad A.|last3=Mir|first4=Daniel|last4=Cagney|first5=Vamsidhar|last5=Chavakula|first6=Indira|last6=Guleria|first7=Ayal|last7=Aizer|first8=Keith L.|last8=Ligon|first9=John H.|last9=Chi|date=July 14, 2016|journal=The New England Journal of Medicine|volume=375|issue=2|pages=196–198|doi=10.1056/NEJMc1600188|pmid=27331440|doi-access=free}} There is a great deal of interest in educating the public and patients, families and doctors who deal with patients requesting stem cells clinics.{{Cite journal|title=Responsibilities of Health Care Professionals in Counseling and Educating Patients With Incurable Neurological Diseases Regarding "Stem Cell Tourism": Caveat Emptor|first1=Michelle|last1=Bowman|first2=Michael|last2=Racke|first3=John|last3=Kissel|first4=Jaime|last4=Imitola|date=November 10, 2015|journal=JAMA Neurology|volume=72|issue=11|pages=1342–1345|doi=10.1001/jamaneurol.2015.1891|pmid=26322563}} In recent years, the FDA has become more active in overseeing stem cell clinics, taking a number of concrete steps including sending warning letters, putting out advisories, and in two cases filing suit in federal court to impose permanent injunctions on specific clinic firms.{{Cite journal|last=Commissioner|first=Office of the|date=2020-09-09|title=FDA Warns About Stem Cell Therapies|url=https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies|archive-url=https://web.archive.org/web/20190428194333/https://www.fda.gov/consumers/consumer-updates/fda-warns-about-stem-cell-therapies|url-status=dead|archive-date=April 28, 2019|journal=FDA|language=en}}{{Cite web|last=Commissioner|first=Office of the|date=2020-03-24|title=FDA seeks permanent injunctions against two stem cell clinics|url=https://www.fda.gov/news-events/press-announcements/fda-seeks-permanent-injunctions-against-two-stem-cell-clinics|archive-url=https://web.archive.org/web/20190618211704/https://www.fda.gov/news-events/press-announcements/fda-seeks-permanent-injunctions-against-two-stem-cell-clinics|url-status=dead|archive-date=June 18, 2019|access-date=2021-02-09|website=FDA|language=en}}

Despite the great interest generated in the public for the use of stem cells, among all stem cell scientists, including the International Society for Stem Cell Research, the largest academic organization of scientist and advocates for stem cell research in the world.{{Cite web|url=https://www.isscr.org/news-publicationsss/isscr-news-articles/blog-detail/stem-cells-in-focus/2019/11/12/communicating-about-unproven-stem-cell-treatments-to-the-public|title=Communicating About Unproven Stem Cell Treatments to the Public|website=www.isscr.org}} Stem cell "therapy" is an aspirational goal, is still under development and although there is a great deal of research around the world.{{Cite journal|title=Ethical considerations when counseling patients about stem cell tourism|first=Amy|last=Tsou|s2cid=29862332|date=February 10, 2015|journal=Continuum (Minneapolis, Minn.)|volume=21|issue=1 Spinal Cord Disorders|pages=201–205|doi=10.1212/01.CON.0000461094.76563.be|pmid=25651226}} Rigorous stem cell trials are still ongoing and patients should be educated to be aware of the unethical clinics in the US or abroad, that offer stem cells procedures as a cure when it is still under investigation.{{Cite journal|title=Gordie Howe's "Miraculous Treatment": Case Study of Twitter Users' Reactions to a Sport Celebrity's Stem Cell Treatment|first1=Li|last1=Du|first2=Christen|last2=Rachul|first3=Zhaochen|last3=Guo|first4=Timothy|last4=Caulfield|date=January 10, 2016|journal=JMIR Public Health and Surveillance|volume=2|issue=1|pages=e8|doi=10.2196/publichealth.5264|pmid=27227162|pmc=4869214 |doi-access=free }}

Furthermore, there is confusion in the general public between the concept of the "right to try" (RTT) legislation to the right to pursue any"stem cell preparations'.{{Cite journal |pmid = 30231723|year = 2017|last1 = Shapiro|first1 = R. S.|s2cid = 52301267|title = Reconciling States' "Right to Try" Legislation and FDA's Expanded Access Program: Legal Issues|journal = Therapeutic Innovation & Regulatory Science|volume = 51|issue = 2|pages = 153–156|doi = 10.1177/2168479016683217}} These are different concepts. RTT is usually approved for promising pharmacological compounds that have earned a sound scientific or pre-clinical support. In contrast to stem cell tourism infusions that do not. One of the key elements in the RTT is the concept of promising, that is not just a theoretical possibility but a demonstrable and reproducible evidence obtained by scientific experimentation.{{Cite journal |pmid = 31933253|year = 2019|last1 = Speers|first1 = M. A.|s2cid = 109920343|title = Providing Patients with Critical or Life-Threatening Illnesses Access to Experimental Drug Therapy: A Guide to Clinical Trials and the US FDA Expanded Access Program|journal = Pharmaceutical Medicine|volume = 33|issue = 2|pages = 89–98|doi = 10.1007/s40290-019-00274-3}} The right to try legislation seek opportunities for incurables and often terminal patients to receive the compassionate use of experimental therapies that have passed phase I clinical trials that have not gone through all the checks and balances needed for approval.{{Cite journal |pmid = 31444643|year = 2019|last1 = Kim|first1 = O.|s2cid = 201285272|title = A Response to Meyerson's Defence of the American Right to Try : Experimenting with hope|journal = Journal of Bioethical Inquiry|volume = 16|issue = 3|pages = 463–466|doi = 10.1007/s11673-019-09918-0}} In contrast to the stem cell tourism, these trials have oversight by the FDA and there is no direct financial exploitation for the patient and families.{{Cite journal |pmid = 28968371|year = 2017|last1 = Simmons|first1 = Z.|s2cid = 43161837|title = Right-to-Try Investigational Therapies for Incurable Disorders|journal = Continuum (Minneapolis, Minn.)|volume = 23|issue = 5, Peripheral Nerve and Motor Neuron Disorders|pages = 1451–1457|doi = 10.1212/CON.0000000000000515}}