Objective: The Objective of this paper is to propose a new modality called Best Choice Medicine (BCM) to provide possible life-saving experimental treatments to patients suffering from Aging-Associated Non-Communicable Diseases (AA-NCDs) who would otherwise not survive without treatment. Likewise, BCM would expedite the drug approval process in the U.S. by generating immediate data from these patients. BCM resembles Medical Tourism in many ways except that it would be done within the U.S. To better appreciate Medical Tourism as a field patients were queried for their feedback on their own experiences with Medical Tourism.

Method: Thirteen people who spent significant time and money participating in Medical Tourism were queried in a non-randomized non-controlled survey to understand their perceptions of the Medical Tourism field.

Results: The thirteen people chose to participate in Medical Tourism mostly due to lack of treatments available through the regulatory system in their own countries. They also believed that they should be able to choose therapies for themselves. And all participants said that they would consider participating in medical tourism again.

Conclusions: Although this is a small study the researchers believe that this research shows the need for a new and more assessable regulatory route, such as BCM, in the United States. This preliminary study is a launchpad for doing more in-depth studies to develop and evaluate the concept of BCM further.

Aging; Aging-associated non-communicable disease; Regenerative medicine; Best choice medicine; Regulatory; FDA; Patient advocacy; Medical tourism

Everyday thousands of patients die from aging-associated non-communicable diseases (AA-NCDs) that might have been saved by new treatments that the United States Food and Drug Association (U.S. FDA) has no framework to allow them to try. The process of aging is accompanied by cellular level changes and leads to an increased risk of dying as age advances [1] though it is debated if it is a regulated or adaptive process [2]. Recognized by the United Nations as a “threat to global development” a mandate has been set to improve the consequences of such diseases [3]. As new drug candidates are developed to treat aging more people with money will escape the regulatory system for treatments abroad. The inequity of this access to medicine is emerging and likely to broaden. Understanding the medical tourism model is essential to understanding the broader impact that it offers and how it can be harnessed to meet people’s needs while benefitting future populations.

This paper proposes a new modality called “Best Choice Medicine” (BCM). This early access route would allow the same ease of access that Medical Tourism offers whilst creating cost-efficient safety and efficacy case studies within the United States. BCM will complement the U.S. FDA by giving thousands of patients access to cutting-edge medicine while concurrently expediting technological advancements to millions in need. Towards this end, several patients who have utilized the Medical Tourism route for their AA-NCDs were surveyed to learn about their experiences and perceptions.

Approval and marketing of new drugs in the U.S. today costs about $2.6 billion and takes over 12 years before the drugs can be provided to patients [4]. Meanwhile, millions of people die globally that could be saved by new drugs. To avoid being such a statistic many patients and their doctors are being driven to offshore locations to pioneer promising new technologies in a new trend called “Medical Tourism”.

The present study takes a look at how patients perceive medical tourism. The study also reviews the benefits and drawbacks of “Medical Tourism” versus creating a new regulatory route to bring new innovations back to the U.S. and maintain the country’s innovative edge. Understanding how the ease of access of the medical tourism model as an ethical case for biotechnology companies and governments to work together could help establish a new regulatory route within the U.S.Previous research studies based on customer choices regarding medical tourism came down to the patient’s perception of the country they were traveling to, price, quality of facilities, quality of care, and physician training [5].

The present “do no harm” mindset of the FDA might be causing more harm than it is meant to prevent. Numerous patients have fought for the legal authority to try new medicine, as seen in the "Right to Try Act" legislation; alas, these laws do not cover newer and more precise genetic therapies which are not currently in clinical trials [6]. A new regulatory designation Regenerative Medicine Advanced Therapy (RMAT) addresses regenerative medicine but not early access to the treatments in the ever-demanding aging patient population (Section 3033 of the 21st Century Cures Act) [7].

Understanding the medical tourism model as an ethical business case for biotech companies could also help establish new regulatory routes within the US. The BCM plan proposed here could give millions of patients access to technological advancements earlier in drug development than current legislation allows and enable biotech companies to legally do first-in-human studies based on patient consent and a medical doctor’s approval to treat. If such a new regulatory route was developed, these therapies could be given within the regulatory system and exponentially expedite therapeutic research and treatment in the United States.

Globally, 14-16 million people traveled for medical services in 2017; the area is growing at a CAGR of approximately 8.8% annually. Spending in 2015 alone was estimated at $70 million and predicted to climb upward of $28 billion by 2024 [8]. Bringing medical innovations back to the U.S. first requires finding ways to reduce research costs. This obstacle is due to the excessive standards set by the FDA and other regulatory agencies throughout the world. Providing humans with the opportunity to try potential drugs and treatments on themselves prior to pre-clinical results not only offers these patients a chance to survive their terminal illnesses, but it would also tremendously reduce research costs [9]. Medical Tourism offers the opportunity to test new drugs and therapies directly in humans who would otherwise die without the drug or therapy. Plus, investment for further testing, production, and marketing would be easier to obtain if biotech companies had the initial human data before seeking funding for expensive clinical trials.

Allowance for patients to participate under the BCM plan would be given to terminally ill patients and those with no other treatment options. These new routes to technological advancements would be proactive and could follow in the footsteps of recent AIDS treatments and COVID-19 vaccines in expediency and proficiency. During the present research, thirteen people answered questions about their experiences with the medical tourism platform to give insights on the process and the prospects of its future as a potential new route of regulated use within the United States. All thirteen participants were treated for aging-associated noncommunicable diseases (AA-NCDs) using technology not available in their current jurisdiction. Participants were queried for their reasons for participation, personal considerations, how they view personal choice, and their perception of how safe the process was in regard to COVID-19 exposure. The results of this research survey will allow biotech companies to get insight directly from the most critical stakeholders, the patients.

Further, the impact that BCM could bring to the business development side of biotech companies is discussed. Could a medical tourism-like structure in the USA lead to faster drug discoveries and an eventual radical shift in regulation for the medical benefit of humanity?

AA-NCDs are now the biggest killers globally and are responsible for 63% of deaths worldwide [10,11]. According to the 2019 Congressional Budget Office, AA-NCDs cost the US government about $1.5 trillion in 2018 alone. Promising solutions for treating these diseases can be found in novel experimental regenerative medicine protocols including gene therapies, stem cell and exosome treatments, small molecule drugs, regulated natural products, etc. But the high costs and tough regulations to take advantage of these protocols necessitates traveling to other countries to benefit from the lower costs and relaxed regulations provided by medical tourism. BCM would provide the same cost and regulatory benefits in the U.S.The US FDA does not consider aging a disease; this limits researchers from applying for grants to study aging directly. A trial cannot be conducted without a measurable endpoint, and though we all know what aging is, there is still no undisputed way to measure it. In 2013, a peer-reviewed paper in Cell called “The Hallmarks of Aging” was released, citing nine different cellular processes that change in humans as we age [12]. But a way to measure aging is still not clear. Clinical studies must still rely on treating limitless numbers of specific diseases associated with aging rather than just aging itself.

The United States Food and Drug Association (FDA) is a top-down power system established to help the government create food and drug standards for Americans. Built to protect the citizens of the USA, the FDA is built on precautionary principles. Personal risk aversions within the agency hinder development as commissioners can lose their careers if drugs harm the public. Restructuring the FDA has been considered, including changes allowing the agency to report directly to the President in the hope of alleviating exposure to political roadblocks [13]. Despite vast precautionary measures, some drugs approved by the FDA are still not safe for patients. Between 1998 and 2010, at least ten dangerous drugs, approved by the FDA, were recalled for causing liver damage, heart attacks, strokes, and multiple deaths [14]. According to the CDC, the opioid crisis alone has killed over 840,000 people since 1999, from opioids approved by the FDA. Likewise, clinical studies have even been approved by the FDA that have put patients at tremendous risks that the FDA should have been aware of and wasn’t. These include gene therapy studies, for example, in which proper precautions were not taken to protect the patients from cancer causing DNA alterations and deadly immune responses [15].

The purpose of this primary research is to determine if a radical paradigm shift in healthcare is warranted. This paper presents the combined pragmatic and humanistic approach to patient's feedback about their medical tourism experience and perceived outcomes. The research focuses on individuals who can use a self-directing agency and make decisions for themselves in a purposeful manner [13]. Earlier studies have shown trends that lead people to choose medical tourism over locally available care, that includes lower cost of therapies, enjoyable locations, and therapies not offered for their condition in their current location. Here we build on past research and narrow the focus to look at the reasons, considerations, and perceived safety of participants engaged in medical tourism to treat AA-NCDs during the COVID-19 pandemic. This research includes the participant's perceptions, experience, and personal insights and choices in using regenerative-based therapies. This action-based research consisted of a survey with a mixed-method approach (Creswell 2009). Quantitative data from participants was obtained from answers in the form of Likert scales, multiple-choice answers, and essay answers. From the essay answers, some of which were obtained from the participants’ multiple-choice answers, words were used to examine themes, narratives, and ideas that the participants had.

This preliminary one-time cross-sectional survey did not include controls and was open to participants for four weeks. It included a cohort of people aged 50 and over who had spent “significant time and money” on medical tourism and participated in international travel during the COVID-19 pandemic to participate in procedures to treat their AA-NCDs symptoms. “Significant time” was arbitrarily defined as more than 48 hours, and “significant money” was arbitrarily defined as spending more than $5,000. Thirty people were invited to participate in the study. Thirteen of them said they were willing and agreed that they understood that participation was voluntary, their personal data would not be shared, and the results would be shared in a research paper. It is unknown whether the other 17 chose not to participate because they did not agree with these features or if they simply did not receive the information asking them to participate.

The survey was closed to participants on the 25th of May 2021. The survey has 29 questions and allows a range of answers from positive to negative to create a fair representation of a variety of perceptions and provide quantification. The complete Survey can be found in Supplemental Information 1. It has two questions with checkboxes that allow the participant to check multiple answers and add information if they feel the available answers do not reflect their personal experiences. It contains 19 multiple-choice questions. Finally, there are four questions with a 10-point Likert scale. The survey was offered via an email from a medical tourism company they recently used and was presented as a link for those who wanted to participate.

The survey is broken into six separate sections for ease of understanding and to compartmentalize sections based on their focus:

1. Introduction-what the survey is about

2. Agreement to take part in research- voluntary and confidential

3. Reason for participation-why participate in medical tourism

4. Personal considerations-personal beliefs around disease and regulation

5. Perceived safety-how safe did they feel during medical tourism

6. Acknowledgment-answered to the best of their knowledge

No identification of participants was used in the questionnaire or final thesis. The research was conducted with respect, and all data was stored securely to reduce harm or prejudice that could arrive from the identification of the participants. No contact information was taken to participate in the survey. Google Forms was used as a software tool to form graphs and charts to show the survey outcomes. The answers to the survey were held in a password-protected document. Because all participants were allowed to answer the questionnaire anonymously over the internet there is no tracking of participants location, sex, ethnicity, or other background. The thirteen participants were asked to answer questions in an online questionnaire (supplemental information). Questions 1-3 related to why the subjects participated in medical tourism. Questions 4-11 related to their general beliefs about diseases and regulatory processes for obtaining treatment. Questions 12-25 related to safety concerns during their medical tourism. Finally, they were asked to acknowledge that they had answered all the questions to the best of their knowledge.

The Complete Results of the Survey can be found in Supplemental Information 2,3 and 4. Twelve of the thirteen participants said they pursued medical tourism for their treatment because there were no other options for their condition. This answer is consistent with past research into medical tourism. This “lack of other options" shows that the FDA is too slow to offer new treatment options. What was unexpected is that eleven of the thirteen wanted to play a part in developing technology for the future and two participants said they did it out of curiosity and because they wanted to try something new.

While four of the 13 specifically emphasized the aesthetic aspect of the therapy, this research shows that the primary motive is health rather than simply appearance. Over half of the participants claimed that they did much research before choosing the therapy, and the rest did enough research to conclude there was no other option for their disease. No participant claimed to have not researched their options. These answers point to this study having an educated group of participants. The participants general beliefs about diseases and regulatory processes for obtaining treatment contributed to their reasons for participation in medical tourism more so than other factors that were looked at. Over 90% of respondents considered aging a disease (Figure 1).

This answer is consistent with current trends in science and indicates that they thought aging is a condition and not just a natural untreatable process. It also displays the participants educated themselves in modern technology before partaking in offshore therapies. All respondents thought they, not the government, should choose their healthcare. Over half preferred medical tourism over standard care, possibly because medical tourism offers them more choices as well as medical doctors who will enthusiastically try new procedures in a timely manner. Again, this educated group of participants had time to assess their options, and their decisions led them to medical tourism.

Figure 1: Most participants considered biological aging itself to be a disease.

Over half of the respondents believed that regulated drugs were safer; the other half did not agree. This is consistent with the literature review findings that people are becoming less happy with traditional options and may view them as unsafe. Even those who thought regulated drugs were safer, due to no other options for their condition, still chose medical tourism. Most respondents were inclined to believe that their disease stemmed from their genes.Only two out of thirteen believed aging would be cured in their lifetime. This belief is interesting as 11 out of 13 stated they wanted to partake in the development of new technology in the reasoning section of the questionnaire. This answer may indicate altruism by the participants. When asked how their life had changed since therapy, 77% were the same or better than before; 23.1% claimed to feel worse. 100% of participants wanted these types of treatments to be allowed in the United States, supporting the need for BCM (Figure 2).

Figure 2: 100% of participants wanted these types of treatments to be allowed in the United States.

The perceived safety section of the survey allowed the researcher to identify how risky the participants perceived medical tourism to be during the COVID-19 pandemic. Participants were asked if they identified as risk-takers. Only one participant strongly agreed that he/she strongly identified as a risk-taker. Four considered themselves moderate to low risk-takers, and eight were above average risk-takers. When asked, all the participants considered themselves well-informed about the process except one who wrote that they initially felt informed before treatment but no longer after treatment when the doctor gave short answers to their questions. Those short answers from the doctor left the participant feeling less informed about post-care but not treatment. These answers could point to medical tourism not just being for risk-takers and that even self-described low-risk-takers are interested in participating. Indeed, participants may have felt that not treating their disease and relying on traditional medicine was riskier than participating in medical tourism during COVID-19. No respondents recommended against others taking the same therapies (Figure 3). This desire to share information with others is a key finding.

Figure 3: All participants would at least consider suggesting that others take part in medical tourism.

The participants traveled to take part in medical tourism, so questions about the perceived safety of their travel experience were part of the questionnaire. All respondents said they felt safe traveling during the COVID-19 pandemic. All also felt safe during their procedure which dispels the perception that these types of therapies are done in precarious or haphazard situations. Twelve of the participants considered that their comfort level may have been “above average” throughout the process, while two participants strongly agreed that it had. One participant rated the comfort level at a 3 out of 10, but it is uncertain what part of the process was uncomfortable. Over half of the respondents preferred the medical tourism experience over their previous primary health care in the U.S.Approximately 78% would participate in medical tourism again, while 23% suggested they might participate again (Figure 4). No one selected that they would never participate in medical tourism again. Over 84% felt it was easy to communicate with the doctor after therapy, while 15% did not.Most of the participants felt that practical steps were taken to keep them from getting sick. None of the participants contracted COVID-19 during their medical tourism experience.

Figure 4: All participants either would participate in medical tourism again or consider it.

When asked what they most disliked about medical tourism, participants' most common answer was the cost. The third most disliked part of participation was anxiety relative to the therapy. And finally, logistics, travel, and the required pre- and post-testing were listed as disliked experiences. No participant chose the treatment as being the worst part of the experience. When asked what the best part of medical tourism was, most chose the travel. This choice is interesting as most, if not all, of these respondents traveled during the COVID-19 pandemic, a high-stress time for travel. The experience and the doctor tied for second place. These choices show that participants enjoyed the experience of trying new therapies and meeting new people.

Written feedback was about 50/50 in positive and negative feelings about the overall experience. Some felt a health improvement, others felt happy to try something that might help their condition, and a few felt anxiety during the process.

All participants acknowledged they answered the questionnaire to the best of their knowledge. The objective of this report is to evaluate the theoretical perceptions of medical tourism such as identifying if there is added value to patients to get faster access to new therapeutics, discussing biotech companies’ pain points and business landscape, and making suggestions for stakeholders about new paths for drug testing. The evaluation of “added value” to patients was achieved through the survey of the 13 participants. This primary research shows that the participants want to live with purpose and desire, as well as have an altruistic drive to give back to society. Most of the people in this survey (11 out of 13) said they wanted to be part of developing new technology to treat disease even though only two participants strongly believed aging diseases would be cured in their lifetime. Furthermore, participants felt when an individual is diagnosed with an end-stage disease, it may be unethical and immoral to let the individual die if research models have demonstrated success in treating a similar condition. Further research should be conducted to see how the data presented here compares to groups that didn’t seek medical tourism. The results of the survey, along with discussions about the limitations in biotech to provide treatments, leads to a proposal for a new medical tourism model allowed in the U.S. based on the “Best Choice Medicine” (BCM) route to drug development. Among other things the potential benefits of BCM to emerging biotech companies could leverage patient data to quicker clinical trial support. It is hoped that this work will attract other researchers to expand on the academic understanding of innovative drug access and further the cause of better healthcare. The findings apply to the medical tourism community, patients, patient advocates, biotechnology companies, government regulatory systems, and anyone interested in the development of new regulatory routes for terminal diseases, treating chronic conditions, and treating biological aging. Though the data shows an imperative to meet the needs of patients with a new regulatory route, the sample size is too small for statistical significance, and further development into this area is greatly needed.

As an aging population grows, it is both socially responsible and economically sound to address the diseases of aging. But, due to the slow regulatory process and enormous costs of preclinical animal studies, most Biotech companies go out of business before reaching clinical trials. Medical tourism provides biotech an alternative. BCM, in the U.S. would allow a faster and more thorough understanding of innovative drugs and better outcomes for the patients, even more so than medical tourism outside the U.S. BCM associated therapeutics would be defined as therapeutics that perform better in basic research and meta-analysis than current regulated therapeutics.

BCM would be housed under the Department of Health and Human Services as an agency separate from the U.S. FDA (Figure 5). This disconnect from the U.S. FDA would allow both agencies to have their own order and rules but still communicate to transfer data when a successful drug candidate was found. Successful drug candidates would then be passed on to the U.S. FDA for fast-track approval without the added costs associated with the Prescription Drug User Fee Act (PDUFA). The U.S. BCM would consist of U.S. government representatives who manage a patient database, ensuring that each patient signs off on two documents. One document of their current medical diagnosis/condition signed by both themselves and their treating physician. The second document would express written “informed consent” as acceptance to participate in experimental medicine that indemnifies all parties of adverse outcomes. Unlike the Right to Try Act, drugs through the BCM will not need to have passed a Phase I trial; they can be based on critical meta-analysis, reproducible basic research, more advanced development, and/or primary evidence based on proof of principle under similar or related conditions.

Figure 5: Organization Chart for Drug Testing and Approval in the U.S. including Best Choice Medicine (BCM).

Through BCM first-in-human data would be generated quicker. This could drive more innovation, jobs, and public interest into the sector. Government, society, industry, researchers, and most importantly patients, the most prominent stakeholders, would all benefit.

BCM is strongly needed for those with no curative options and for those that are terminally ill. Terminally ill patients are defined as patients given a diagnosis with no available “regulated” curative treatment. These patients, or their caregivers who have power of attorney, would register on a website overseen by the United States government BCM task team while pharmaceutical companies, biotechnology companies, and device companies would also register their technologies and protocols. The task team would then network them together (Figure 6). All companies would be allowed to participate regardless of their previous experience in FDA trials. Over 41 million people will die this year of aging diseases that have been significantly slowed or halted in animal models. A social and moral position must be considered for the benefit of humanity. Currently, the idea of "safe drugs" tends to override the ability to achieve them. No drugs are inherently safe or efficacious in all people through today's regulatory body, as shown by multiple drugs historically being removed from the market after approval.

Figure 6: The BCM Process includes therapeutic feedback.

Several genetic treatments have shown significant benefits in aging diseases in animal models. However, advancing these treatments to humans is stalled because of complex regulatory procedures and the lack of funding to follow these procedures.

The total cost of drug development at $2.6 Billion is too high and has not produced the needed results of medical cures. AA-NCDs are now the biggest killers on the planet. Through smarter regulations, millions of lives and enormous amounts of money could be saved (Figure 7).

Figure 7: Comparison of FDA and BCM.

BCM will bring about six areas of business opportunity:

1. A reduction in research costs via condensed regulation criterion.

2. Reduction in supply expenses due to front-end scaling.

3. Reduction in delivery costs therapies would be systematically closer to manufacturers.

4. Reduction in bench-to-patient time giving consenting patients the dignity to participate.

5. Modernization of marketing achieved by open-access information.

6. Improved investor participation due to knowing how the drugs work in humans.

Many of the roadblocks to new and innovative therapies lie within social norms and cognitive biases. BCM offers flexibility to roadblocks by giving the patient the role of primary decision maker. This concept of BCM needs further research including controls and larger sample sizes to expand further upon the initial findings of this study.

Conceptualization, investigation, visualization, methodology, data curation, formal analysis, project administration, and writing-original draft preparation based on Elizabeth Parrish’s MBA Thesis. Validation, investigation, methodology, writing review and editing, visualization, supervision; by William Andrews; All authors have read and agreed to the published version of the manuscript.

This research received no external funding.

The study was conducted in accordance with the Declaration of Helsinki and approved by Ethics Committee at its inception via Bucks New University, via the faculty Ethics Committee and signed by the module leader, Sambal Manzoor on the 28th day of March 2021. Module name and number-MB759-20SBAMC: Dissertation-20SBAMC.

Informed consent was obtained from all subjects involved in the study.

Data can be found in the supplemental section of this journal.

We would like to thank those who participated in this study for the benefit of future patients who may benefit from their time and efforts.

Both Elizabeth Parrish and Williams Andrews work for companies whose goal is to treat aging associated non-communicable diseases, therefore this finds them both in a position of authority to speak to the matter of the subject.

I, Elizabeth L Parrish, author of a student paper submitted to Buckinghamshire New University give my consent to publish the work in the Journal of Biomedical and Allied Research.

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