The Future Path of U.S. Clinical Research: Bridging Geographic Diversity

In this era of the COVID-19 pandemic, norms have been upended in every aspect of society. A lesser known complication in the healthcare environment is the impact on clinical trials. There is an opportunity to rethink how trials are conducted and also implement much-needed changes for greater inclusion of diverse trial participants by building on the momentum of developments started prior to the Coronavirus pandemic. The scope of this review will focus on rural study subjects and their barriers to participation

By Nicole Jarosinski, MA

AllBe Health, Amsterdam, The Netherlands


 The Future Path of U.S. Clinical Research: Bridging Geographic Diversity


In this era of the COVID-19 pandemic, norms have been upended in every aspect of society. The media has paid particular attention to the challenges and demands on healthcare around the world as hospitals navigate a surge in patient census, pause elective procedures, and otherwise cope with new realities. A lesser known complication in the healthcare environment is the impact on clinical trials. Trials determine the treatments and best practices of the future. With the ongoing changes in healthcare and society at large, there is an opportunity to rethink how trials are conducted and also implement much-needed improvements for greater inclusion of diverse trial participants by building on the momentum of developments started prior to the Coronavirus pandemic.

In 2019, the US Food and Drug Administration (FDA) issued guidance[1] calling for greater diversity of clinical trial populations with the purpose of developing a full picture of the risk or benefit of an investigational medical product. Further, “experience has shown that there can be important differences in how people of diverse groups respond to medical products. Information on those differences can then be included in the product labeling to help doctors and patients make treatment decisions.”[2] Given that the majority of clinical trial participants in the United States tend to be affluent white males in urban and suburban locations, diversity in this context means more than racial factors. A diverse clinical trial would also include different ages, ethnic groups, genders, and geographic settings. Participants with diverse characteristics have vital information to contribute to a more complete scientific understanding of medicine. The scope of this review will focus on rural study subjects and their barriers to clinical trial participation. Rural populations are historically underrepresented in United States trials and face the possibility of being even less represented in this time of COVID.


Challenges of rural populations

Rural populations in the United States share a number of common challenges. According to the Pew Research Center, residents of rural areas have lower income and rates of employment.[3] They have problems accessing fast, reliable internet service, with 22% saying they never go online.[4] Rural Americans are also older, sicker, and less likely to be insured than their suburban and urban counterparts.[5] Twenty percent of Americans live in rural areas, but the proportion participating in clinical trials is far less. Fewer than five percent of studies funded through the National Institutes of Health National Cancer Institute (NIH NCI) demonstrate recruitment in rural populations.[6] Given these challenges, there are a number of reasons that rural populations are often overlooked as potential sources of research participants.

The Devil You Know

Sponsors tend to choose academic medical centers located in major metropolitan areas as study sites due to their dedicated investigative resources and research-based mission. Academic centers have reputations for cutting-edge medicine that also make them destination hospitals, drawing patients from across the country. It is expensive for a clinical trial sponsor to prepare sites to conduct clinical trials due to multiple on-site visits, inspections, and training. It’s not uncommon for a sponsor to invest $30,000 in each site at startup, but this investment does not guarantee that a site will ever enroll any subjects. Therefore, sponsors often return to sites that have delivered high enrollment and complete data in past studies. Sponsors are also reluctant to contract with new sites that may not have as large of a patient pool.

Transportation Roadblocks

Reliable transportation is a barrier for rural populations to participate in trials that have a heavy number of in-person follow-up visits. These types of visits have their advantages, including more complete data capture. In-person visits also allow an unbroken chain of custody for investigational drugs that are literally handed from the research team to the patient, thus eliminating the possibility of restricted medications being lost in the mail. Despite these advantages, on-site visits can place a heavy travel demand on study subjects. Demands are exacerbated for those who must traverse long distances, those who need assistance, such as the elderly or children, and those who have to miss work or other obligations in order to participate.

Technical Difficulties

Telehealth technologies that could potentially reach rural populations have been slow to develop in the United States. One barrier to telehealth is the lack of highspeed internet in rural communities, but arguably the biggest factor for slow telehealth development has been non-involvement from the Centers for Medicare & Medicaid Services (CMS). CMS is the largest payor of medical claims in the US and greatly influences the direction of healthcare. Even though telehealth technology was developed in the early 2000s, CMS strictly limited telehealth reimbursement until 2018. Without financial support from CMS, healthcare providers had little incentive to make investments in telehealth.


Overcoming the Challenges

Increasing participation of rural populations in clinical trials requires a three-pronged approach: 1) expanding the network of potential trial sites; 2) improving participants’ access to healthcare; and 3) providing flexibility for the method and frequency of trial follow-up visits.

Broader Site Networks

Reputation is important, so it is understandable that sponsors would return to high-enrollment research sites that they contracted with in the past. However, to meet FDA expectations of diverse enrollments, it is imperative for sponsors to extend their reach into new territories. To facilitate expanded connections in rural areas, sponsors can partner with organizations who have existing networks, such as the NCI Community Oncology Research Program (NCORP). With a mission to bring “cancer clinical trials and care delivery studies to people in their own communities,” NCORP is already conducting trials in rural and underserved areas.[7] By collaborating with NCORP or similar entities, sponsors may find new long-lasting partners while also bringing cutting edge treatments to areas of the country that otherwise wouldn’t have access.

Clearing the Road

Social infrastructure improvements in recent years have increased the mobility of rural populations. Clinical trial sponsors and sites can take advantage of these enhancements for patients that struggle with travel. For short distances, ridesharing services such as Uber and Lyft can bring patients to research sites. Lesser known services that specifically serve rural populations are shuttles offered by local counties. Community-based councils on aging or volunteers from elder care and/or disabled advocacy groups also offer rides to medical appointments for study participants who would otherwise be homebound. These agencies may offer multi-county transport options at low to no cost.

Travel reimbursement can ease the burden of trial participation for all subjects regardless of distance from the study site, and it is a small cost to promote study enrollment. The FDA has clarified that it “does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues of undue influence.”[8] Such reimbursements are generally considered acceptable practice.

Another unique solution is to bring studies to rural subjects through collaboration with healthcare services that already interact with patients in remote settings. As an example, university researchers in Arkansas found great success in recruiting rural and minority participants by joining forces with traveling care teams, such as mobile mammography units. They also recruited by participating in community events, such as the Susan G. Komen Race for the Cure, church functions, and health fairs.[9]

Streamlined Follow-ups

There are many common sense and innovative ways sponsor can rethink the strategy for a follow-up visit schedule. First, reduce the frequency of visits to only those necessary for appropriate safety and efficacy monitoring. Not only would this reduce the burden of study participation for research subjects, it would also decrease costs for sponsors.

Another factor is to build flexibility for the method of follow-up visits so that they could be conducted at the research site, the patient’s home, or virtually. There are an increasing number of remote and mobile communication platforms that can accommodate clinical trials. Providing multiple options makes study participation more convenient to patients.

Finally, research sites can take advantage of incentive programs for the expansion of telehealth. The Federal Communications Commission (FCC) recently announced that it is offering telehealth startup funding through the COVID-19 Telehealth Program and Connected Care Pilot Program.[10] These programs will lower the initial investment needed from study sites to build telehealth infrastructure.


The Path Forward

Historically, the pharmaceutical industry has been extremely conservative, changing very slowly due to its risk-averse nature. However, clinical research is in tumultuous times as sponsors and sites hurry to figure out the path forward through complications brought on by COVID-19. It has been said that necessity is the mother of invention. In the midst of such great change there is also vast opportunity.

Sponsors can easily build on the momentum of recent innovations to both adapt ongoing clinical trials to the new 6-foot (1.5 meter) society and be more inclusive of rural participants. In fact, the above recommendations could be easily translated to increase diversity of all kinds, since concerns about transportation and low income span across all races, genders, ages, and geographic locations.

There will inevitably be speed bumps for a while as new best practices are established, technology is refined, and new bridges are crossed. But for the clinical trial industry, the COVID-19 pandemic is an inflection point. There is no going back to the way it has always been done. Patience, ingenuity, and a willingness to embrace change are what is needed in this time.



[1] U.S. Department of Health and Human Services, Food and Drug Administration. (2019). Enhancing the diversity of clinical trial populations: Eligibility criteria, enrollment practices, and trial designs. Draft Guidance. Retrieved from

[2] U.S. Department of Health and Human Services, Food and Drug Administration. (2018). FDA encourages more participation, diversity in clinical trials. Retrieved from

[3] Parker, K., Horowitz, J.M., Brown, A., Fry, R., Cohn, D., & Igielnik, R. (2018). What unites and divides urban, suburban and rural communities: Amid widening gaps in politics and demographics, Americans in urban, suburban and rural areas share many aspects of community life. Pew Research Center. Retrieved from

[4] Anderson, M. (2018). About a quarter of rural Americans say access to high-speed internet is a major problem. Pew Research Center. Retrieved from

[5] U.S. Centers for Disease Control and Prevention (2017). About Rural Health. Retrieved from,stroke%20than%20their%20urban%20counterparts.

[6] Blake, K.D., Moss, J.L., Gaysynsky, A., Srinivasan, S., & Croyle, R.T. (2017). Making the case for investment in rural cancer control: An analysis of rural cancer incidence, mortality, and funding trends. Cancer Epidemiol Biomarkers Prev. 26, 992-997.

[7] National Cancer Institute Community Oncology Research Program. (n.d.). About NCORP. Retrieved from

[8] U.S. Department of Health and Human Services, Food and Drug Administration. (2018). Payment and reimbursement to research subjects: Guidance for institutional review boards and clinical investigators. Final Information Sheet. Retrieved from

[9] McElfish, P.A, Su, L.J., Lee, J.Y., Runnells, G., Henry-Tillman, R., & Kadlubar, S.A. (2019). Mobile Mammography Screening as an Opportunity to Increase Access of Rural Women to Breast Cancer Research Studies. Breast Cancer: Basic and Clinical Research, 13, 1-6. DOI: 10.1177/1178223419876296.

[10] U.S. Federal Communications Commission. (2020). FCC Approves Emergency COVID-19 Telehealth and Connected Care Pilot Programs. Retrieved from



PEAH News Flash 388

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 388


Coronavirus: Commission unveils EU vaccines strategy 

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COVID Death: Direct Death or Excess Mortality Worth to Report in Low- and Middle-Income Countries? by Lemi Belay Tolu, Alex Ezeh, Garumma Tolu Feyissa

How to Survive COVID-19: Now and the Future by Subhash Hira, Sudhanshu Malhotra, Santosh Gupta, Kaamila Patherya

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New UNESCO report shows COVID-19 leaving vulnerable children behind 

Over 1,000 clinical trials involving children are missing results across Europe 

Health system’s response to the COVID-19 pandemic in conflict settings: Policy reflections from Palestine 

Webinar Registration: Sustainable Health Equity Movement Global Launch Event: “The Ethical Principle of Equity in the Response to the Pandemic and Beyond” Jul 2, 2020 08:00 AM 

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‘Alarming’ use of critical human antibiotics on crops 

MSF: Analysis and Critique of the Advance Market Commitment (AMC) for Pneumococcal Conjugate Vaccines 

Ebola in the Democratic Republic of the Congo 2020 

It is time to abandon “development” goals and demand a post-2030 Utopia 

Senegalese Women’s Participation in Energy Sector equals Empowerment 

CDI 2020: China’s Commitment to Development 

Tencent’s ‘smart city’ seen as model for post-coronavirus China 

Coastal fishing communities ‘facing disaster’ 

Lifting Livelihoods by Lifting Water 

UN says seeking to verify Arctic heat record 

Joint CSO Letter on the EIB Climate Bank Roadmap 









How to Survive COVID-19: Now and the Future

Having crossed the initial hurdle of accepting the present COVID-19 pandemic context and uncertainties that the future entails, we are now faced with answering how this ‘new normal’ should pan out across different sectors. As some human activities will become redundant, others will have to rapidly adapt. In essence, we are fast approaching the age where not just the ‘fittest’ will survive, but also those who are ‘quickest’ to adapt to this new way of life

Credit: Centers for Disease Control and Prevention (CDC)


Dr. Subhash HiraProfessor of Global Health, University of Washington-Seattle

Sudhanshu MalhotraSambodhi Research and Communications, New Delhi, India

Santosh Gupta, Indian Social Responsibility Network, New Delhi, India

Kaamila Patherya, Sambodhi Research and Communications, New Delhi, India

Addresses for correspondence:;

 How to Survive COVID-19: Now and the Future


It is now globally acknowledged that the COVID-19 pandemic has changed our world for good. People across the globe are navigating on a daily basis what the ‘new normal’ will look like. The initial denial, confusion and resentment has given way to gradual acceptance that the coronavirus is here to stay and it is up to communities to find ways of living with it by minimizing risk to the greatest extent, both in terms of health as well as social and economic life.

Having crossed the initial hurdle of accepting the present context and uncertainties that the future entails, we are now faced with answering how this ‘new normal’ should pan out across different sectors. As some human activities will become redundant, others will have to rapidly adapt. In essence, we are fast approaching the age where not just the ‘fittest’ will survive, but also those who are ‘quickest’ to adapt to this new way of life.

Social and Economic Restructuring

Epidemiologic Status of COVID-19 as of June 18, 2020



Figure 1: Slides 1-4 show global cases, deaths, sex and age distribution of deaths. Slides 5-6 depict Indian figures by mid-June 2020

Source: Worldometer, JHU


Wuhan, China being the epicenter, COVID-19 has developed into a pandemic with small chains of transmission in many countries and large chains resulting in extensive spread in a several countries, such as Italy, Iran, South Korea, USA, and Japan. While the number of cases in India is on the increase, we know that as epidemics progress the effective reproduction number (R0) declines until it falls below unity in value when the epidemic peaks and then decays, either due to the exhaustion of people susceptible to infection and/or the impact of control measures. With the governments gradually lifting lockdown measures, reducing transmission will primarily be an individual-level effort involving social distancing, mask-wearing, hand hygiene, and self-isolation. [1,2]

 Social and Mental Health Impacts of COVID-19

Countries across the globe are facing major social transformations that dictate their behaviors and interactions. These impacts are particularly staggering for Global South countries where marginalized populations are facing serious setbacks along vital SDG parameters such as gender equality, education, employment, refugees, and environmental protection. Historically, there has been a strong correlation between epidemics and increase in human trafficking. COVID-19 could offset gross human rights violations on women, refugees, and children, and could also disadvantage the elderly. Scaling in counseling services for lonely patients and families with COVID and accelerating community participation must be made a priority.

Equally important is the need to focus on mental health. Healthcare workers, those already dealing with mental health pre-COVID, and people with disabilities as those who are at greatest mental health risk during this period. It is important to destigmatize groups such as elderly people and healthcare workers, and to stress on the importance of basic care such as eating and sleeping. Helplines and deploying mental health professionals will be paramount in helping people deal with anxiety, resentment, depression, and trauma induced by lockdowns. Setting routines, meditation, expression of gratitude, and adaptability are useful practices in helping individuals cope with the volatile period.

Economic Impact


Figure 2: Mapping select countries based on comparative lockdown restrictions and socio-economic outcomes. Source: Boston Consulting Group (with modifications)


Figure 2 above shows various levels of lockdown restrictions in different countries represented by blue, pink, or red halos. Quadrant 1 where Vietnam and other countries show blue halo, meaning low restrictions. In Quadrant 2, India is seen with blue halo i.e. low restrictions, South Africa with pink halo i.e. moderate restrictions, and Argentina with red halo i.e. severe lockdown restrictions.

The quadrants are made up by vertical axis representing economic outcomes using GDP and industrial/agricultural production indicators, and horizontal axis shows Public Health (PH) outcomes using number of COVID cases detected, fatality rate, and social outcomes.

Quadrant 1 is characterized by high economic and high Public Health outcomes. The countries include China, Vietnam, Bangladesh, Indonesia, where low to moderate lockdown restrictions were used. Quadrant 2 shows low economic but high PH outcomes, including India, South Africa, Germany, Australia, South Korea, Taiwan, Japan. Low to high lockdown restrictions were used. Quadrant 3 displays low economic and low PH outcomes, including economies such as the USA, UK, Brazil, Saudi Arabia, Iran.. Moderate to high lockdown restrictions were instituted in these countries. Quadrant 4 has high economic but worse PH outcomes, including majorly of EU countries. Here, there were moderate restrictions, pictured with the pink halo.

It can be inferred that Quadrant 1 countries got the best socio-economic outcomes, and Quadrant 3 countries got the worst socio-economic outcomes.

Figure 3: IMF World Economic Outlook


Figure 3 above provided by the IMF in April 2020 shows real GDP of major countries and how this has comparatively changed over 2019 and 2020 due to the impacts of COVID-19.The real GDP of the United States will fall to 1/4th of what it was the last year.EU countries will collectively lose their GDP to 1/7th of what it was. Japan GDP will drop to 1/8th of what it was the last year. The Indian GDP will drop from 4.2 to 1.9, which is almost like one half. On a comparative scale, Indian GDP still survives with significantly lesser drop than countries such as South Africa or Brazil or even China to that extent.

Based on these trends across countries that are at various stages of lockdown, it seems that the economic slump will be varied and different from recessions in the past. Unlike past recessions, the economy should recover more swiftly, and the scenario should start inching towards business-as-normal within the next 6-8 months. Adopting a protectionist stance will have to be viewed with some caution, as developed economies imposing high tariffs could negatively impact some of the emerging economies. Economic reforms accompanying the rollout of stimulus packages, similar to the approach adopted by India, might be a useful mechanism to put countries back on the path of speedy economic recovery.

With the above major changes happening in the world, the following five concepts define the ‘new normal’ areas for our survival:
Acceptance that the world has changed forever with onset of COVID-19 pandemic.
Adaptation is required in all spheres of human life.

It will be survival of the “quickest”; not survival of the ‘fittest’.

Accept “forced entrepreneurship” as the way to survive in the industry of your choice.

In order to avoid making mistakes, drop your ‘ego’ and accept changes as they come.
Sectoral Changes

Personal Protection

While governments are actively taking steps for prevention and containment, protection is primarily the individual’s responsibility. Mask wearing, frequent hand washing, and maintaining 6 feet physical distance are becoming ingrained in our social behaviors. [3] Mask wearing, in fact, has long been a tradition in many countries such as Japan as a precautionary step against respiratory diseases. Other countries would do well to similarly adopt these measures as a way of life. According to research studies, the cotton mask is as effective as a medical mask for protection. [3,4] In developing countries including India, owing to socio-economic disparity, homemade masks or cloth coverings that protect the nose and mouth are sufficient and practical solutions. Figure 5 shows findings of a mathematical modeling study, wherein there is an average of 30-50 contacts/day for individuals <18 years of age, and an average of 100 contacts/day for individuals >=18 years of age. [4]

Figure 4: Probability of contagion at various levels of protection

Figure 5: Effectiveness of various protection measures in reducing transmission [4] 

Travel, Hospitality Industry, and Vacations

The delayed closing of international flights and borders was not only the primary cause for global transmission of the virus that deemed it a pandemic, but it is also the most alarming aspect that sets it apart from other epidemics of the past. In the case of SARS in Hong Kong or Ebola in Africa, shutting down flights and closing borders was the first governmental response measure to contain the spread of infections. Needless to say, the lack of these measures for COVID-19 is what has transpired into the current state of affairs.

As borders gradually open and certain flight routes resume, we will have to continue to approach travel with some caution till some time to come. Tourism and non-essential travel must be stalled. While airlines are enforcing strong protection measures, air travel should only be resorted to when absolutely essential.

The Future of Work from Home

We are transitioning not just in terms of how we work, but also in the very nature of work itself. Occupations which demand close contact, such as in restaurants, hospitality, malls, salons etc., are the most impacted. However, the economy is fast adapting to a new way of doing business. The ‘digital economy’ has been infused with new vigor, and one can foresee emerging demand for a host of new services. Online teaching, for example, is emerging. The work from home model is now largely accepted as the way of the future. [2]

Apart from digital businesses, the health sector and alternative medicine will both see a surge. Investments in this space will also increase. Startups focusing on how technology and Data Science can optimize public health are also appearing on the horizon.

Entertainment and Leisure

The old ways for entertainment and leisure will probably not resume for some time to come. Cinema halls, malls, and restaurants, though gradually opening up, continue to pose some risk. However, this need not necessarily result in the stalling of entertainment activities. Home-based streaming services are providing access to films and media at nominal costs, and video conferencing software are ensuring that people are connected for meetings and consultations. Adapting to new mode of enjoyment, as opposed to its altogether disbandment, is how we need to reorient our thinking.


While the economy may have momentarily halted in the last few months, learning and education across the globe has remained largely unaffected at least in private and university settings. The mode of instruction has moved to the virtual space, and it will be so for some time to come. The challenge will now be to navigate how public schools and establishments in remote areas and villages that lack access to technology can be resumed. Testing at end-of-course is another concern that institutions across the world are currently finding solutions to. Virtual teaching, which had been gathering momentum, is now going to be indispensable. The benefits offered in terms of access, reach, and innovative methods are fast convincing education professionals as well as students of the efficacy of this medium of instruction.

Treatments, Vaccines and Herd Immunity

A variety of approved treatments are being used by the Government of India to treat COVID-19 patients. Hydroxychloroquine (HCQ), Azithromycin, Oseltamivir, Vitamin C tablets, among other drugs, are being administered depending on specific patient conditions. Convalescent plasma therapy, which has successfully treated other infectious diseases in the past, is being used for severe COVID-19 cases and the initial results have been favorable. [5,6,7]

There has been some debate on the usage of Hydroxychloroquine (HCQ) in the treatment of COVID-19. Despite claims, there is no conclusive evidence against is usage as yet and in-vitro studies have shown that HCQ reduces viral shedding and also hampers replication. The only concern is that of cardiotoxicity and ECG baselines have to be done to determine usage. [8]

While we continue to remain hopeful for a vaccine for COVID, we must learn and be cognizant of realities and of our experiences with vaccines throughout the course of history. The Smallpox vaccine took almost 200 years to develop and the Polio vaccine took almost 60 years. Several rounds of animal and human level testing are involved in developing vaccines and taking shortcuts in this regard can be dangerous. We need to wait at least 18 months before we reach any conclusions regarding a potential COVID vaccine. Even after discovery, administering it to a global population will not be an easy task. Instead of pinning hopes on the vaccine, it is important to reorient our thinking to how we can adapt and live with coronavirus. Wishful thinking of vaccine as a magic bullet could be misleading at this stage.

The theme of herd immunity is also being deliberated. Sweden, after a couple of weeks of lockdown, has adopted a stance of minimal restrictions and eventual herd immunity as a means of responding to the pandemic. However, this is still widely contested with inconclusive evidence, particularly since the parameter to judge the herd immunity raises challenges. [7] Normally, it is known that once the body fights a disease, antibodies are produced in the bloodstream which protect against future infections. However, antibodies can be created in the body for various reasons, rendering it not the best parameter to judge herd immunity. In some animal models, it may take 6-8 months for herd immunity to develop. Neutralizing antibodies take very long to develop, and more research is needed in this space. [9]

Alternative Medicine

While we continue to protect ourselves from COVID through safety measures, strengthening our innate mechanisms to fight infections is an equally important aspect that deserves attention. Alternative medicine, in particular Ayurveda and homeopathy, hold some potential in this regard. As a prophylactic measure, homeopathic treatments have been known to boost immunity and the body’s natural defenses against infections. In fact, homeopathic treatments have been widely used during past epidemics such as cholera, Spanish flu etc. While they may not be able to scientifically prevent infection, they do not pose any harm or side-effects. [10]


The COVID-19 pandemic has transformed the social and economic fabric of our lives. While on the one hand the effects have been catastrophic in terms of lives and livelihoods lost, the speed and optimism with which communities and businesses have responded holds testament to the innate adaptability of human beings as a species. Adapting, the very quality that ensures our survival on earth, will prove most instrumental in how we meet the challenges and demands of ‘new normal’ in the future.


  1. Roy M Anderson, Hans Heesterbeek, Don Klinkenberg, Déirdre Hollingsworth. How will country-based mitigation measures influence the course of the COVID-19 epidemic?
  2. Mark Barnes, Paul E. Sax. Challenges of “Return to Work” in an Ongoing Pandemic. The New England Journal of Medicine.
  3. Derek K Chu, Elie A Akl, Stephanie Duda, Karla Solo, Sally Yaacoub, Holger J Schünemann, on behalf of the COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis.
  4. Stadnytskyi V, Bax CE, Bax A, Anfinrud P. The airborne lifetime of small speech droplets and their potential importance in SARS-CoV-2 transmission. Proc Natl Acad Sci U S A. 2020;117(22):11875‐11877. doi:10.1073/pnas.2006874117
  5. Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services (EMR Division). Clinical Management Protocol: COVID-19.
  6. World Health Organization. Clinical management of COVID-19: Interim guidance, May 2020.
  7. World Health Organization. Key criteria for the ethical acceptability of COVID-19 human challenge studies. Reference number: WHO/2019-nCoV/Ethicscriteria/2020.1
  8. Anwar M. Hashem,Badrah S. Alghamdi,Abdullah A. AlgaissiFahad S. Alshehri, Abdullah BukhariMohamed A. Alfaleh, and Ziad A. Memish. Therapeutic use of chloroquine and hydroxychloroquine in COVID-19 and other viral infections: A narrative review.
  9. Haley E. Randolph, Luis B. Barreiro. Herd Immunity: Understanding COVID:19.
  10. Government of India, Ministry of AYUSH. GUIDELINES for HOMOEOPATHIC PRACTITIONERS for COVID 19.


PEAH News Flash 387

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 387


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PEAH News Flash 386

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 386


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Switching the poles of infectious diseases outbreaks: Time for a new gaze? 

Equity, Trust and Accountability Vital in Preventing Pandemics 

Why working together on global migration is vital to pandemic recovery 

Diagnosing and Treating Systemic Racism 

Europe should do more for a tobacco-free generation 

Tobacco exposed: Protecting young people from deceptive tobacco industry advertising 

A review of policies and programmes for human organ and tissue donations and transplantations, WHO African Region 

UN chief urges fast action to avoid `global food emergency’ 

New Euro 7 standards: the final nail in the coffin for polluting vehicles? 

How a Global Ocean Treaty Could Protect Biodiversity in the High Seas 










An Economic Prescription for U.S. Healthcare: On Combining Capitalism, Socialism and Sports Competition

...the U.S. federal government has many options and capabilities for meeting financial challenges facing state & local governments, businesses and regular folks too as a result of COVID-19...

...In doing over things to improve U.S. healthcare, what is there not to like about using forms of socialism especially the form of socialism that is practiced by the NFL which is enjoyed by millions of Americans every year?

By Larry J. Pipes, Ph.D.

Management Strategist and Consulting Professional, Los Angeles, CA

An Economic Prescription for U.S. Healthcare

On Combining Capitalism, Socialism and Sports Competition


Rewinding time is not possible, but do overs are, sometimes we get another chance to do something right the second time that we got wrong the first time.


Suddenly in 2020, COVID-19 devastated economies and overwhelmed healthcare systems throughout the world. In the U.S., healthcare has been hit hard on several fronts resulting in damages to system finances, providers, employees, suppliers, lifesaving procedures and equipment and to patients. COVID-19 impacts demonstrate severe vulnerabilities of so-call “free market” enterprise economic systems that many say are based on capitalism with most importantly competitive markets wherein savvy consumers & suppliers interact. But pure capitalism doesn’t exist anywhere in the world — never has existed or will!

For years, healthcare insurers, payers, providers, researchers and governments have debated how best to organize and supply healthcare.1 There are many facets to the debate but one of the most intensely argued is the appropriate role of competition in healthcare markets. Claims are made at each end of the spectrum: some see competition as having no place in services aimed at protecting the sick2; and others that competition is the antidote for bloated, inefficient services and even “saves lives.”3

As the U.S. tackles the challenges of reopening and expanding the economy in the light of COVID-19, it is prudent for economic educators/researchers and political leaders to consider and agree on implementing changes to our badly damaged healthcare system along with other business and consumer sectors. For healthcare, damages and concerns include:

  • Hospitals, health systems and doctors forced to lay off staff and cut otherwise essential services and costs.
  • As a result of treating COVID-19 patients, the American Hospital Association estimates that U.S. hospitals and health systems will collectively lose more than $200 billion from March 1, 2020 to June 30, 2020. This includes factors like lost revenue from postponed surgeries, or an average of nearly $51 billion per month.4 These loss estimates don’t include costs of the physical and mental harm to health personnel.
  • Low payment rates from government payers, which in part led the Congressional Budget Office to project that between 40% and 50% of hospitals, could have negative margins by 2025 prior to the pandemic. 5
  • COVID-19 worries have kept patients away from doctors’ offices and forced the postponement and cancellation of non-urgent surgeries. The pandemic also has shut down large portions of the American economy, leaving many would-be patients without insurance or in a financial pinch that makes them curb spending.
  • Health care provided the biggest drag on the U.S. economy in the first quarter. Spending on care fell at an annual rate of 18%, the largest drop for that sector among records going back to 1959.6

Now I’m not suggesting anything extreme that would be equivalent to “throwing out the baby with the bathwater”, but obviously Adam Smith whose “free market” ideas in Wealth of Nations opened the world to capitalism didn’t consider or offer solutions to cases of economic ravages caused by pandemics.

Generally, conservatives in Congress and throughout the U.S. are strongly against socialism in any form — arguing it’s an anathema to personal freedoms and economic prosperity. Well, $1.8 trillion in loan and paycheck protection legislation quickly and overwhelmingly passed by Congress and immediately signed into law by the POTUS which by the way added over $2 trillion to the U.S. National Debt is not the stuff of pure capitalism. And by all indications, there is more federal government stimulus to come.

Getting back to where we were pre-COVID-19 — the good or great days as some say –  aren’t realistic. In fact, talk of making America great again begs the question what is the specific time period to which proponents of this want to return. Since the beginning of the 13 colonies and the establishment of the Republic, the U.S. has always faced non-trivial challenges on several fronts. Regardless, competition by and among healthcare providers and suppliers will remain. And Congresses and Presidents will have plenty of opportunities to influence and shape things going forward to improve healthcare and reopen/expand the economy.

Principles embedded in American Sports can serve as guides — me thinks. That is, in a Jan 29, 2012 CBS 60 Minutes interview that aired before Super bowl XLVI, NFL Commissioner Roger Goodell said that the NFL combines capitalism & socialism “…by sharing our revenue in a way that will allow every team the ability to compete.”7 So a relevant question for those who criticize socialism is: do they also have problems with the socialism practiced by American Professional Football? As the biggest sports entertainment enterprise in the World, the NFL, a cartel (exempt from anti-trust laws by Congress for 50 years), is a form of socialism that:

  • Operates a draft for new players and has salary caps;
  • Depends on public tax money and/or tax breaks to help fund stadiums;
  • Is composed of 32 teams owned by billionaires that contract with unionized millionaires;
  • Shares 80% of annual revenues (estimated at $15 billion for the 2018 season) among teams.

Goodell (no leftist shield) said “One of the things we want every fan to feel in the country is hope when the season starts that their team can end up holding that Super Bowl trophy. And one of the stats we’re most proud of in the last 9 years we’ve had at least one team go from last to first.” In the NFL, the result is a financially engineered equality that allows a small town team in Green Bay, Wisconsin, to compete with a metropolis like New York. It produces lots of close games and those unscripted dramas that are essential to the NFL’s appeal.

Installing government economic policies that give hope to average Americans that they can succeed would be a good guiding principle as the U.S. reopens and expands the economy. Immediately some will raise questions about the cost and wisdom of capitalism and socialism combination schemes. Re costs, as already demonstrated with the Federal stimulus packages, the U.S. federal government has many options and capabilities for meeting financial challenges facing state & local governments, businesses and regular folks too as a result of COVID-19. Congress & the Trump Admin need only think-outside-the-box and avoid partisanship to achieve this (although avoiding partisanship may be very tough). One option is for the U.S. Treasury to mint a series of “$1 trillion platinum coins.” The coins would be created by Treasury and then sold to the Federal Reserve, which would credit the U.S. Mint’s account at the Fed with trillions in reserves (depending on the number of coins minted).

This approach could produce enough funds for State & Local governments and for businesses and individual citizens too. This would be legal, as U.S. law gives the Treasury Secretary the power to mint new coins “in qualities and quantities that the Secretary determines are sufficient to meet public demand.”

One challenge would be the potential for runaway inflation which would destabilize the U.S. financial system. Sharp-witted economists and financial wizards should be called upon to  come up with policies to avoid inflation. However, this is a workable short-term solution. At some future point, bonds bearing interest above the near zero rate the Fed has currently established should be sold to repay or recover the account credits.

Finally, the literature is replete with thought provoking articles on the subject of organizing healthcare, competition and competitive sports to positively affect service delivery, patient safety and outcomes.8 9 10 I’ll say on this subject in the future. For now, I’ll end by asking this question: In doing over things to improve U.S. healthcare, what is there not to like about using forms of socialism especially the form of socialism that is practiced by the NFL which is enjoyed by millions of Americans every year?




2 Pollock A, Macfarlane A, Kirkwood G. et al. No evidence that patient choice in the NHS saves lives. Lancet. 2011;378(9809):2057–2060. doi: 10.1016/S0140-6736(11)61553-5.

3 Gaynor M, Moreno-Serra R, Propper C. Death by market power: reform, competition, and patient outcomes in the National Health Service. Am Econ J Econ Policy. 2013;5(4):134–166.

4 due

5 Moody’s Investor Service (2019). “Medians – Revenue growth rate inches ahead of expenses as margins hold steady.” Accessed on April 29, 2020 at https://www.






PEAH News Flash 385

News Flash Links, as part of the research project PEAH (Policies for Equitable Access to Health), aim to focus on the latest challenges by trade and governments rules to equitable access to health in resource-limited settings

News Flash 385


WHO: public health round-up 

WHO: Coronavirus disease (COVID-2019) situation reports 

Sign the open letter to governments on ISDS and COVID-19 

United Nations Human Rights: Joint questionnaire on COVID-19 and human rights 

Post-Corona online course by Global Labour University 

China delayed releasing coronavirus info, frustrating WHO 

MSF: Any future COVID-19 vaccines must be sold at cost and accessible to all

COVID-19 Vaccine Global Access (COVAX) Facility: Key considerations for Gavi’s new global financing mechanism 

The Lancet Retracts Study Finding Higher Mortality In COVID-19 Patients Taking Hydroxychloroquine 

WHO to resume hydroxychloroquine trial 

How The Rapid Shift To Telehealth Leaves Many Community Health Centers Behind During The COVID-19 Pandemic 

Looking at healthcare workers only as heroes does them a disservice 

What Do Coronavirus Racial Disparities Look Like State By State? 

Can veterinarians save us from the next pandemic? 

Watch: END Fund CEO on pandemic impact on NTDs 

New Ebola Outbreak in Congo, Already Hit by Measles and Coronavirus 

A survey of nongovernmental organizations on their use of WHO’s prequalification programme 

João Aprígio Guerra de Almeida: supporting breastfeeding mothers 

Health Care Reform in The United States: a Call to Action by Susan M. Severance

On Reforming U.S. Healthcare by Larry J. Pipes

Labour Migrants in Russia and their Needs by Chamid Sulchan

COVID-19 and refugees, asylum seekers, and migrants in Greece 

Lancet Commission on migration 

Transforming International Cooperation 

Q&A: New UN guidelines target ‘out of whack’ food systems 

World Food Safety Day 2020: UN experts in Facebook live event on 5 June 2020 

Despite protest, standards group backs use of horseshoe crab blood to test for bacteria in drugs 

No let-up in global rainforest loss as coronavirus brings new danger 

Two-thirds of tropical forests ‘under threat in next decade’ 

Q&A: Oceanography should be a core discipline in Africa 




On Reforming U.S. Healthcare

...there is a novel straightforward way to reduce U.S. healthcare costs and increase choice at the same time: 

- Require all U.S. Federal & State government agency and employer payments for healthcare to go directly to the beneficiaries of those payments on a per person or per- family basis that is tax-free. 
- Permit insured persons to decide how and which insurer and providers to pay for healthcare.

Doing this alone will bend the cost curve downward, reduce the healthcare bureaucracy and enable folks to freely select their own doctors as so-called conservative thought claim to champion. For persons unable to handle this responsibility on their own, say, due to their medical or mental limitations, the government (e.g., Medicare/Medicaid) would be the decision-making backstop...

By Larry J. Pipes, Ph.D.

Management Strategist and Consulting Professional, Los Angeles, CA

On Reforming U.S. Healthcare


Healthcare is the largest industry in the world, and in the U.S. healthcare absorbs nearly 20% of annual GDP. In 1960, U.S. Healthcare’s take out of our GDP was 5.01%.1  Today other developed countries with which the U.S. companies compete spend less than 13% of their GDP on healthcare. Just think for a moment how better off the U.S. economy would be if U.S. healthcare costs were in line with healthcare spending by other developed nations (i.e., it would mean more money for worker salaries, business investments and shareholder profits to say the least). By this measure the U.S. pays a premium of about 7% of GDP for healthcare. A contributing factor for increases in healthcare consumption by U.S. citizens is subsidies2 by employers and government agencies that arrange/pay-for healthcare service for employees & beneficiaries of government programs. Among other things, these subsidies affect consumers’ consumption choices re healthcare.

Now nowhere in the world has healthcare ever been produced or operated under a free market competitive system, so let’s quickly dismiss notions of capitalism as a sole solution. In 1963, economists Kenneth Arrow who later won a Nobel Prize offered a simple explanation for why free markets won’t work in healthcare:

  • Huge information & power mismatch between the buyer and seller.

Although economic theory of competitive markets rightly implies that if a seller, say, wants to sell a particular TV, a buyer can accept, choose another brand or simply walk away. But if  physicians order particulars medicines, procedures or operations, patients are far less likely to just walk away thinking about it.

Now there is a novel straightforward way to reduce U.S. healthcare costs and increase choice at the same time:

  • Require all U.S. Federal & State government agency and employer payments for healthcare to go directly to the beneficiaries of those payments on a per person or per- family basis that is tax-free.
  • Permit insured persons to decide how and which insurer and providers to pay for healthcare.

Doing this alone will bend the cost curve downward, reduce the healthcare bureaucracy and enable folks to freely select their own doctors as so-called conservative thought claim to champion. For persons unable to handle this responsibility on their own, say, due to their medical or mental limitations, the government (e.g., Medicare/Medicaid) would be the decision- making backstop.

This novel idea would require health care suppliers (insurers, providers and product manufacturers) to compete directly for consumers/customers/patients business. For example, life, auto, home insurance markets aren’t dependent on third-parties to direct or limit which insurer consumers can or must select. Third-party interventions into market decisions via subsidies to consumers usually increase prices for not the best reasons.

Letting folks decide how to spend their own money is the sort of freedom actual conservatives and liberals alike should abide — right? Now this idea is not to imply the U.S. should do away with Medicare, Medicaid and employer sponsored healthcare plans as those who work for these government agencies and human resource departments are not trivial actors in the whole scheme of things.

On the other hand, if Americans want the current healthcare system fixed, they have only to elect and unambiguously direct political representatives to do so forthwith. What threatens the health insurance of Americans is stubborn, intractable refusal by one party to make reasonable fixes or improvements to the Affordable Care Act (Obamacare). The nation would be better served if politicians abandoned repeal & replace screeches, and focused their time and attention to fixing/improving Obamacare, including:

  • Obamacare’s mandate that large-and medium-sized employers provide insurance to workers applies only to workers employed 30 or more hours a week. Repubs correctly criticized the design of this mandate. It should be corrected.
  • Some proposed replacing the 40% excise tax on high-cost health plans, the so-called Cadillac tax, with a requirement that people include the cost of employer-financed health insurance above certain thresholds in their personal taxable income. There is a reasonable compromise to be made re this.
  • 19 states have been unwilling to extend Medicaid coverage, partly from a fear that the Fed government will cut payments and leave states holding the bag (like what McConnell’s has proposed doing). Congress should reassure states re this which would help all states regardless of the party in control of legislatures.
  • Politicians on both sides have decried the provision of Obamacare authorizing the creation of the Independent Payment Advisory Board, an un-elected group empowered to hold down growth of Medicare spending by proposing cost-reducing changes that would take effect unless both houses of Congress mustered majorities to block them. So, agree to change or eliminate it.

If Congress Republicans proposed these straightforward types of Obamacare repairs or fixes, Democrats would want something in return. For instance, Democrats may well seek to raise, rather than lower, assistance for those who currently face high out-of-pocket medical costs. Now these are the kinds of trade-offs Donald J. Trump, the supposed deal maker supreme, should proudly strike — right?

A major challenge for this generation of US politicians particularly on the right is understanding and accepting the true nature of our democracy and of our politics which involve marrying principle to a political process that means neither the majority nor the minority gets 100% of what they want — ever! For example, Slavery was one of the most divisive issues in U.S. history. Abraham Lincoln didn’t believe in slavery, but his 1st priority as President was keeping the Union intact. Most of Lincoln’s Emancipation Proclamation deals with States and areas where emancipation didn’t apply because those folks were allied with the Union so they were allowed to keep their slaves. Wartime President Lincoln made this compromise around the greatest moral issue that the US faced because he understood that his job was to win the war and maintain the Union.

The U.S. made compromises to get past slavery — one of the most morally divisive issues we faced. Political compromise is the reason why major legislation benefiting the Country is passed by Congresses and signed into Law by Presidents. Those who do not understand and accept this principle of compromise are undeserving of serving in Congress or the Presidency.



1 Healthcare was 5.01% of US GDP in 1960, 6.05% in 1970, 7.88% by 1980, 12.09% in 1990, 13.3% in 2000, 17,3% in 2010, 17.56% in 2015 and 17.73% in 2018 (over 4 times defense spending).

2 Supply-Side and Demand-Side Cost Sharing in Health Care, Randall P. Ellis and Thomas G. McGuire, American Economic Journal, 1993:











Health Care Reform in The United States: A Call to Action

A call to action for clinicians and all the rest of us, here's a brief book review for Dr. Marty Makaray's recently published book focusing on Health Care Reform in the United States.

On the same issue, PEAH is going to post a couple of companion articles by Larry Pipes:

- On Reforming U.S. Healthcare
- An Economic Prescription for U.S. Healthcare: On Combining Capitalism, Socialism and Sports Competition 

By Susan M. Severance, MPH

Forward Channel LLC


Health Care Reform in The United States: A Call to Action


I have been sheltering in place at home along with Dr. Marty Makary’s recently published book, The Price We Pay – What Broke American Health Care – And How To Fix It. I got the book from the library, read it, and then COVID-19 hit. The library asked that we hold onto our borrowed books for now. I am glad for that because I have it handy here with me. Dr. Marty Makary is a surgeon with the great ability to write in plain language; this is a book for all to read.

I highly recommend Dr. Makary’s book as an enlightening read into understanding the complicated health care system in The United States. Dr. Makary addresses public health care in The United States and does not hold back. Some of what he uncovers seems criminal in nature and unbelievable in our society. The areas covered in the book include: public health fairs, treatment of unpaid medical bills, overtreatment, health insurance, medications and the pharmacy, and overwellness. Dr. Makary encourages all in The United States to action with specific direction – a disruption movement that all can be a part of.

In a similar call to action, I want to share 5 books with you about patient safety and The United States health care system. All are written by surgeons. I read these fairly recently. Here are the books:

  • Flatlined by Guy L. Clifton, 2009
  • Unaccountable by Marty Makary, 2012
  • Being Mortal by Atul Gawande, 2014
  • The Checklist Manifesto by Atul Gawande, 2009
  • Better by Atual Gawande, 2007

I have had an interest in patient safety since being the project coordinator for an evidence-based medicine report on The Effect of Healthcare Working Conditions on Patient Safety published in 2003.  The work was performed at the Oregon Health & Science University and funded and published by The Agency for Healthcare Research and Quality part of The United States Department of Health and Human Services. This large report is in the public domain and you can find a summary here. A structured abstract is also available below: