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Global report: Germany may extend lockdown as Covid cases in Italy soar

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Record daily infections in Germany; Naples hospitals at risk of being overwhelmed; France reports slowdown in rate of new cases

Jon HenleyKate Connolly in Berlin and Angela Giuffrida in Rome

Fri 13 Nov 2020 12.14 ESTLast modified on Fri 13 Nov 2020 23.36 EST
Source: The Guardian

  • Germany’s partial lockdown could be extended beyond the end of the month and hospitals in parts of Italy are near breaking point as Covid-19 cases continued to surge in both countries, despite positive signs elsewhere in Europe.

New daily coronavirus cases in Germany hit a record of 23,542 on Friday, the Robert Koch Institute for infectious diseases reported, prompting government spokesman Stefan Seibert to say measures “were not expected to be relaxed” by next week.

Federal and regional leaders are due to meet on Monday to discuss whether the country’s closure of all gyms and entertainment venues has slowed the disease’s spread, but the health minister, Jens Spahn, said it was too early to say.Advertisementhttps://cfc55da519ed832fe459f46ba8c59744.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html

“We will see in the next few days whether they are making a difference,” Spahn said. Winter gatherings and festivities such as office Christmas parties were in any event unlikely to go ahead.

Christmas markets, traditional St Martin’s Day parades and Germany’s carnival season, which should have started this week, have all been cancelled, while more than 300,000 school pupils are in quarantine along with about 30,000 teachers.

The southern Italian city of Naples, meanwhile, was braced for further restrictions as hospitals risked becoming overwhelmed by new cases, with medics forced to bring oxygen tanks outside to treat desperate patients waiting in their cars.

“The situation in Campania is out of control,” the Italian foreign minister, Luigi Di Maio, said after a video emerged showing an 84-year-old man dead in a hospital bathroom where he had been waiting for a Covid test. “We need urgent restrictions… people are dying.”

Hundreds of people from Campania have been travelling to neighbouring Lazio in search of urgent medical help as political wrangling continues over whether to impose a total lockdown in the region.Advertisement

Campania is expected to be upgraded to the “red zone” from Sunday, meaning people will have to stay home unless going out for work, shopping or medical reasons, and bars, restaurants and most shops will close.

Italy’s alternative approach to the crippling nationwide lockdown it imposed during the first wave this spring has had little apparent success so far, with total infections passing the million mark this week and cases rising at more than 30,000 a day.

Confirmed cases in Portugal pushed past 200,000 with new daily infections reaching a record high of 6,653 and a new record of 2,799 Covid patients in hospital. A state of emergency due to last until 23 November is likely to be extended.

“When we reach the peak of the disease, it will still take weeks to see a drop in demand for hospitals and even more weeks to reduce the fatality count,” the health minister, Marta Temido, told a news conference.

The French prime minister, Jean Castex, on Friday said upcoming regional elections due in March should be delayed until June, a day after confirming the country’s two week-old lockdown would not be eased for at least another fortnight.

While the rate of increase continues to slow significantly, France has the fourth highest number of confirmed cases in the world, at almost 1.9 million, and the number of people in hospital with the coronavirus has reached a new all-time high of 32,638.

Castex said France could start to loosen restrictions from 1 December providing case numbers continue to fall, first by allowing non-essential shops to re-open. But bars and restaurants would not be permitted to resume operating until later still, he said.

Several European countries including France, Belgium, the Netherlands, the Czech Republic and Ireland have reported a slowdown in new infections since introducing strict new measures last month, but hospital services remain under severe pressure.

Ireland’s prime minister, Micheál Martin, said on Friday the country may embark on a staged approach after 1 December, with the aim of having restrictions eased by the run-up to Christmas “because I do get that people will want to meet with family”.Advertisement

Elsewhere, however, infections continue to soar. Sweden recorded a record 5,990 new cases on Friday, its highest since the start of the pandemic, the national health agency said, as well as 42 new deaths taking its overall toll to 6,164.

The Scandinavian country, which has a Covid death tally per million inhabitants many times higher than its Nordic neighbours, is battling a second wave that health officials had hoped its light-touch, anti-lockdown approach would mitigate.

Russia, which has the world’s fifth largest number of cases, also reported a record 21,983 infections as Moscow prepared to close restaurants, bars and nightclubs on Friday between 11pm and 6am until mid-January in an effort to contain the pandemic.

Officials warned of raids and fines for establishments that do not comply. The capital has also moved university and college students to online learning and recommended that school children, already learning from home, keep travel to a minimum.

Beyond Europe, the virus is returning to New York City after it was in effect banished over the summer, with the city’s seven-day average of positive Covid-19 tests climbing to 2.6% on 11 November.

The governor, Andrew Cuomo, urged New Yorkers to “do their part” and “take this seriously” as officials started rolling back some reopenings, prompting fears of more dramatic lockdowns loom and possibly schools closures.

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Many health care professionals warned about a second wave. We can now see that numbers are on the rise any many parts of the world and even here in Virginia. Where are you? Have the number of COVID 19 cases risen in your area? Why?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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As virus cases rise, Navy limits sailors’ travel, activity

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By BEN FINLEY, November 17, 2020
Source: AP News

NORFOLK, Va. (AP) — U.S. Navy bases and personnel in Virginia’s Hampton Roads region were ordered Tuesday to limit travel and other activities as coronavirus cases rise.

The Navy said in a statement that the order was issued by Rear Adm. Charles W. Rock of Navy Region Mid-Atlantic. It impacts the world’s largest Navy base in Norfolk and several other installations throughout the region, including a large air station in Virginia Beach.

Sailors’ travel will be restricted to commuting from home to work, with stops only for essential goods and services such as food, medicine and child care. Dining inside restaurants is not allowed. Neither is using off-base gyms and barber shops.

The order also prohibits participation in team sports and bans social gatherings in sailors’ homes that have more than 10 guests who don’t live there.

“The health and safety of our Navy family is our number one priority,” Rock said in a statement. “We’ve been fighting this virus for a long time, but we’ve still got some more work to do and can’t give in to fatigue.”

The region’s Navy installations were operating at a less restrictive level since Sept. 23.

The Navy’s order follows one by Virginia Gov. Ralph Northam that took effect Sunday at midnight and implemented new restrictions across the state. They include reducing the cap on gatherings from 250 people to 25 people and prohibiting alcohol sales at dining and drinking establishments after 10 p.m.

“COVID-19 is surging across the country, and while cases are not rising in Virginia as rapidly as in some other states, I do not intend to wait until they are. We are acting now to prevent this health crisis from getting worse,” Northam, who is a physician, said on Friday.

Over the past two weeks, the rolling average number of daily new cases in Virginia has increased by more than 20%, according to an Associated Press analysis of data from the COVID Tracking Project.

There also were nearly 250 new cases per 100,000 people in Virginia, which ranks 46th in the country for new cases per capita, according to AP’s analysis. One in every 763 people in Virginia tested positive for the virus in the past week.

Where are you located? Where does your state rank with regard to COVID 19 cases? Why?

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Opinion: For now, it’s unethical to use human challenge studies for SARS-CoV-2 vaccine development

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Source: Proceedings of the National Academy of Sciences of the USA


 View ORCID ProfileJeffrey P. Kahn,  View ORCID ProfileLeslie Meltzer Henry,  View ORCID ProfileAnna C. Mastroianni,  View ORCID ProfileWilbur H. Chen, and  View ORCID ProfileRuth MacklinPNAS November 17, 2020 117 (46) 28538-28542; first published October 29, 2020; https://doi.org/10.1073/pnas.2021189117

The prospect of a widely available severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine is an increasingly high priority for an effective response to the coronavirus disease 2019 (COVID-19) pandemic and an area of intense interest and attention for professionals, politicians, and the public alike. The understandable desire for such a vaccine has led to significant discussion and even some planning for the possibility of human challenge studies (HCS) as a tool for accelerating the process for identifying, testing, and developing an effective vaccine (13).

Typically, undertaking HCS in vaccine development requires that the disease for which a challenge would be introduced either has an available rescue therapy to treat those who become infected or the disease is known to be self-limiting. There is no rescue therapy for SARS-CoV-2 infection, and proponents of HCS have claimed that the infection is likely to be self-limiting and mild in young, healthy volunteers based on current understanding of the infection. If accurate, the basic requirements for undertaking an HCS could be met if conducted with that population. Proponents further argue that such HCS are ethically acceptable in the current pandemic. Most critically, they contend that these studies are likely to speed the development of effective vaccines.

But based on our assessment of these arguments, we disagree. We believe it is unethical to move forward with such trials at the current time. Whereas proponents of these studies suggest that such studies will accelerate the time to approved vaccines, the facts fail to support these claims. HCS to address SARS-CoV-2 face unacceptable ethics challenges, and, further, undertaking them would do a disservice to the public by undermining already strained confidence in the vaccine development process.

Accelerating Vaccine Approval

There is general consensus among researchers, ethicists, and oversight bodies that HCS can be ethical, provided certain conditions are satisfied (46). Key among those criteria is the requirement that HCS generate sufficient social value to justify exposing healthy volunteers to uncertain risks with no prospect of direct benefit. Proponents of SARS-COV-2 HCS, notably a nonprofit called 1DaySooner started in April to advocate for such trials (7), contend that such studies will provide “enormous social value” by accelerating the timeframe for vaccine development and distribution, thereby saving thousands of lives (8).

The acceleration argument relies on several interconnected assumptions that prove problematic under deeper scrutiny. The first is that SARS-CoV-2 HCS can provide vaccine efficacy data faster than the standard vaccine pathway. Although comparative speed is an accepted scientific justification for conducting HCS, its conventional application is to circumstances in which conducting field studies would be prohibitively difficult because the target pathogen is rarely transmitted in the natural local environment (9). The opposite is true of conducting HCS in a pandemic environment. During the Zika pandemic, for instance, the ability to conduct field trials played a prominent role in a federal ethics committee determination that it was premature to proceed with Zika virus HCS (10). Widespread transmission of SARS-CoV-2 is already facilitating close to 10 active Phase III trials of SARS-CoV-2 vaccine candidates (11). With more field studies likely to follow, the necessity and relative speed of HCS becomes even less compelling.

Technical and logistical aspects of developing and implementing HCS further undercut the assumption that SARS-CoV-2 HCS would result in a viable vaccine faster than the traditional vaccine pathway. Before initiating definitive SARS-CoV-2 efficacy HCS, researchers must develop a suitable challenge model. This requires carefully selecting the challenge strain, manufacturing it in a BSL-3 laboratory that adheres to current Good Manufacturing Practice (cGMP), receiving regulatory approval from the Food and Drug Administration (FDA) or other regulator to administer it to human volunteers, and conducting dose-escalation studies to determine the target dose of the challenge agent that will elicit the level of illness necessary for determining the primary outcome of the efficacy studies. Vaccine experts estimate that in the context of SARS-CoV-2 HCS those steps will collectively take one to two years to complete, leading them to conclude that such studies are “unlikely to accelerate the establishment of vaccine efficacy” (12).

Ultimately, the social value of SARS-CoV-2 HCS (in terms of deaths averted) hinges on the premise that people at greatest risk of COVID-19–related mortality will receive a safe and efficacious vaccine sooner than they would without HCS.

Even if SARS-CoV-2 HCS were to accelerate vaccine development, it is unclear that the FDA will consider data from HCS in its licensing decision. Although the FDA’s recent approval of a cholera vaccine based on efficacy data from HCS might signal the agency’s willingness to make similar determinations in the future (13), the agency is not likely to do so in the context of SARS-CoV-2. The FDA’s latest Guidance for Industry on developing SARS-CoV-2 vaccines not only omits HCS from its discussion of expedited trial designs but also states that to meet vaccine approval standards, “late phase clinical trials…will likely need to enroll many thousands of participants,” including “adequate representation of elderly individuals and individuals with medical comorbidities” (14). Although it is conceivable that HCS initiated 12–24 months from now could generate efficacy data to support the necessary Phase III results for licensing (12), those HCS would not accelerate the current pathway, in which multiple Phase III trials are underway and a licensed vaccine is possible within 6 months.

Ultimately, the social value of SARS-CoV-2 HCS (in terms of deaths averted) hinges on the premise that people at greatest risk of COVID-19–related mortality will receive a safe and efficacious vaccine sooner than they would without HCS. Those high-risk groups include older adults and people who are immunocompromised or have comorbidities, as well as members of Black, Latinx, and Native American communities—groups who are, as emerging evidence demonstrates, at disproportionate risk of serious COVID-19–related outcomes (15). Current proposals and guidelines for conducting SARS-CoV-2 HCS, however, recommend only enrolling young, healthy adults (781617). Although that strategy arguably reduces the risks associated with HCS, it jeopardizes the generalizability of trial results (1819).

Because the safety and efficacy of vaccine formulations and dosing may differ between populations (e.g., based on age), the social value of HCS—in terms of reducing mortality among those at greatest risk—is likely limited. Moreover, the social value of vaccines depends in large part on whether people get vaccinated (20). Ongoing, standard SARS-CoV-2 vaccine trials, however, are currently struggling to recruit participants from some communities of color, and in recent polls respondents who self-identified as Black were more than twice as likely as white respondents to be leery of taking a SARS-CoV-2 vaccine (21). Well-intentioned recruitment from communities of color into HCS may nevertheless evoke historical mistrust over discrimination in research and elicit concerns of exploitation, either of which could detrimentally impact vaccine uptake in at-risk communities.

Acceptable Risk–Benefit

For research to be ethically sound, the relationship between risks and potential benefits must be reasonable. IRBs are charged with making that assessment, but in the case of human challenge studies, knowledge about infection with SARS-CoV-2 and potential resulting COVID-19 illness continues to evolve; many unknowns remain. Despite the earlier belief that young, healthy adults (the proposed subjects) experience a mild form of COVID-19 and recover quickly, recent data have revealed that this population can experience significant adverse effects when they become infected (2224). An additional shortcoming of HCS is that some risks of the vaccine itself may emerge only when a larger number of individuals have been vaccinated.

Because the proposed HCS will enroll only young adults, the result is a much narrower potential benefit than proponents have assumed. Vaccine trials using the standard methodology would still be needed to ensure safety and efficacy for the vast numbers of people who do not fit the narrow inclusion criteria of HCS.

Taken together, these considerations make it virtually impossible for IRBs to make an appropriate assessment of the risk–benefit balance. If the potential benefit is low because Phase III field efficacy studies would still be necessary, and larger numbers of participants would be needed to obtain adequate safety data, this would call into question an acceptable balance of benefits over the risks to participants in HCS.

The uncertainty of information about risks to participants from both the infection and the vaccine makes adequate disclosure next to impossible in the informed consent process. Along with the unknown potential benefits to groups other than the age cohort in the study, accurate, detailed information in informed consent documents is bound to be limited. Despite acknowledgment in consent forms that participants may not experience direct benefits from the experimental intervention, it is entirely possible that volunteers may labor under a “preventive misconception” that they will receive some protection from infection by their participation. This is analogous to the so-called “therapeutic misconception” in research on experimental therapies, in which research subjects agree to participate in part based on the misconception that they are likely to gain some therapeutic benefit as a result.

Very little has been said so far in the literature about payment or other incentives to potential HCS volunteers (2526). A misconception about immunological protection is only one of several such incentives, which could include monetary payments, a common inducement in HCS for other diseases. More information is needed about such incentives or misconceptions before IRBs can meaningfully assess the ethical acceptability of proposed HCS for COVID-19.

Resources Required

Current arguments in favor of SARS-CoV-2 HCS fail to account for the pandemic realities of global, national, and local resource constraints and the extent to which diversion of scarce health care resources could compromise local pandemic response.

We find such HCS proposals to be flawed in their core claim about speeding vaccine development, and we believe that the risk–benefit balance for such HCS is both too uncertain and likely to be unacceptable, even with greater information.

Any proposed SARS-CoV-2 HCS would necessarily provide all medical care for study participants who become infected during the trial. Some have even advocated that participants receive “priority” access to critical care resources (clinical support, ventilators, drugs, and other interventions) “notwithstanding the possibility of severe shortages” (16). Others who have closely examined the ethical requirements for these trials, in contrast, argue convincingly that HCS sponsors should be required to show that HCS do not “unduly compete for scarce resources” that affect local pandemic response (5).

As part of a risk minimization strategy, trial sites should be geographically located in high prevalence areas to reduce the risk associated with intentional infection [i.e., recruiting those who have an otherwise high baseline risk of exposure (16)]. Unfortunately, these are areas with the most demands on essential public health resources.

The reality is that essential supplies for conducting SARS-CoV-2 HCS are already limited because of the pandemic (18), with communities, states, and even national governments competing for access (e.g., personal protective equipment, ventilators, oxygen, supportive care, treatments such as remdesivir and convalescent plasma, and even testing). Human resources are similarly strained by the pandemic, and HCS may remove critical trained personnel from provision of urgent health care: Highly sought-after health care workers on the study team must have training in biocontainment and infection control, and planning must further account for worker quarantine and medical treatment if they test positive.

We believe that the unique impact that a SARS-CoV-2 HCS places on scarce and already strained resources during a pandemic must be given considerable weight in any justification of these trials. In contrast to community-based field studies, which are effectively outpatient rather than inpatient trials, a SARS-CoV-2 HCS will place greater demands on medical resources, including specially trained personnel, biocontainment units, and dedicated hospital rooms. Decisions to further burden an already battered public health system with intentional infection—including the potential for unintentional release—will involve hard choices and consultation with, and buy-in from, affected stakeholders, including public health authorities, regulators, regional and local institutions, health care providers, and communities already hard hit by infection. Coordination is essential to ensure that decisions are not made unilaterally (27). These efforts will take time, further slowing any hoped for promise of acceleration.

HCS and Public Mistrust

Undertaking an HCS in the context of this pandemic risks fueling and potentially worsening levels of public mistrust. All aspects of the public health response to the pandemic have been politicized, feeding concerns across a wide spectrum of the population (20). This includes those traditionally skeptical about vaccine policy (so-called anti-vaxxers) as well as proponents of vaccine development and drug discovery who fear that approval will be hasty in response to intense political pressures, a concern only reinforced by both Russian and Chinese “approval” of candidate vaccines that had not gone through a phase III trial. Concerns within the science community have prompted hundreds of medical and public health experts to issue an open letter to the FDA calling for assurances that full and transparent review of vaccine candidates will be undertaken, and nine pharmaceutical companies have felt the need to make a collective pledge “to uphold the integrity of the scientific process” (2829). Introducing HCS that do not meet basic principles of research ethics and vaccine development are likely to play into concerns that shortcuts are being taken and that science is being politicized, further undermining public trust (19).

In sum, the severity of COVID-19, and the lack of a cure or effective treatment, make it unethical, at this point in time, to institute HCS for the development of a SARS-CoV-2 vaccine. We think proponents’ core claim about speeding vaccine development is flawed, and we believe that the risk–benefit balance for such HCS is both too uncertain and likely to be unacceptable, even with greater information. In addition, issues of resource allocation are critically important and difficult to justify. Vaccine trials aiming to undertake risky and uncertain steps in human subject research—particularly those that depart from standard approaches to protection of subjects in HCS—risk further exacerbating increasing levels of public mistrust related to SARS-CoV-2 vaccine development. Taken together, we believe that these arguments make undertaking SARS-CoV-2 HCS both unwarranted and unethical. At this critical moment in the response to the pandemic, it would do more harm than good.

Footnotes

  • The authors declare no competing interest.
  • Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and have not been endorsed by the National Academy of Sciences.

Published under the PNAS license.

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View Abstract

Like many things, there are different opinions regarding COVID 19 trails and the vaccines that are produced from them even within the medical and science communities. Will you take the vaccine? Why? Why not?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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Portland VA: Human Experiments Unethical, No Consent

Asthma and Diet Shidonna Raven Garden and Cook

Source: Disabled Veterans
A consumer group named Public Citizen filed ethics complaints against Portland VA for unethical kidney transplant trails at the facility that lacked consent.

The trial paperwork indicated the kidney transplant trial subjects were deemed “nonhuman” despite kidneys being transplanted into live humans. The study failed to seek informed consent through normal channels because of the “nonhuman” classification.

The Portland VA Medical Center and University of California, San Francisco (UCSF) were involved in the study. Drs. Daren Malinoski and Claus Niemann led the study. Dr. Malinoski works at Portland VA. The Institutional Review Board (IRB) was conducted by UCSF.

The complaint from Public Citizen said participants in the study were not informed of the nature of the transplanted kidneys. Those kidneys came from brain dead donor bodies where the body was cooled prior to removal of the kidney as part of a study. The kidney gathered at experimental temperatures was then placed into a live human for research.

The purpose of the study was to gauge whether colder kidneys would result in quicker acceptance of the organ. The meta-goal of the study was to find cheaper ways to transplant kidneys.

PORTLAND VA / UCSF STUDY ERRORS

The recipients were apparently not informed. According to the Public Citizen complaint, the organizations failed to reach a few obvious and common sense related conclusions prior to the study being conducted:

  • Failure to recognize trial as involving human subjects research
  • Failure to satisfy IRB review and approval requirements

Not surprisingly, these two researchers and the IRB panel failed to recognize the subjects of the study were human. While the donors were brain dead, the recipients of the kidneys subject to the cooling experiment were most certainly human.

Should we be surprised that Ivory Tower type researchers would erroneously conclude recipients of experimentally harvested kidneys are not human? Do you ever wonder if VA at large considers us humans with rights, at all?

The complaint indicates that the error of judgment about the humanness of the study resulted in the participant doctors failing to seek informed consent from the 572 recipients.

This news made me wonder an obvious question:

How many more similarly mistaken IRB reviews have concluded veterans are not humans where informed consent is required?

In the name of conducting human experiments to save money, researchers apparently concluded humans were not humans. How many of these “nonhumans” were veterans?

Source: https://www.citizen.org/documents/2315.pdf

What are the benefits to medical professionals Not to obtain informed consent? What are the financial benefits to the medical professoinals Not to obtain informed consent? Do the ends justify the means?

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The End of the Pandemic Is Now in Sight

covid 19 shidonna raven garden and cook

A year of scientific uncertainty is over. Two vaccines look like they will work, and more should follow.
SARAH ZHANG, NOVEMBER 18, 2020
Source: The Atlantic

Editor’s Note: The Atlantic is making vital coverage of the coronavirus available to all readers. Find the collection here.

For all that scientists have done to tame the biological world, there are still things that lie outside the realm of human knowledge. The coronavirus was one such alarming reminder, when it emerged with murky origins in late 2019 and found naive, unwitting hosts in the human body. Even as science began to unravel many of the virus’s mysteries—how it spreads, how it tricks its way into cells, how it kills—a fundamental unknown about vaccines hung over the pandemic and our collective human fate: Vaccines can stop many, but not all, viruses. Could they stop this one?

The answer, we now know, is yes. A resounding yes. Pfizer and Moderna have separately released preliminary data that suggest their vaccines are both more than 90 percent effective, far more than many scientists expected. Neither company has publicly shared the full scope of their data, but independent clinical-trial monitoring boards have reviewed the results, and the FDA will soon scrutinize the vaccines for emergency use authorization. Unless the data take an unexpected turn, initial doses should be available in December.

The tasks that lie ahead—manufacturing vaccines at scale, distributing them via a cold or even ultracold chain, and persuading wary Americans to take them—are not trivial, but they are all within the realm of human knowledge. The most tenuous moment is over: The scientific uncertainty at the heart of COVID-19 vaccines is resolved. Vaccines work. And for that, we can breathe a collective sigh of relief. “It makes it now clear that vaccines will be our way out of this pandemic,” says Kanta Subbarao, a virologist at the Doherty Institute, who has studied emerging viruses.

The invention of vaccines against a virus identified only 10 months ago is an extraordinary scientific achievement. They are the fastest vaccines ever developed, by a margin of years. From virtually the day Chinese scientists shared the genetic sequence of a new coronavirus in January, researchers began designing vaccines that might train the immune system to recognize the still-unnamed virus. They needed to identify a suitable piece of the virus to turn into a vaccine, and one promising target was the spike-shaped proteins that decorate the new virus’s outer shell. Pfizer and Moderna’s vaccines both rely on the spike protein, as do many vaccine candidates still in development. These initial successes suggest this strategy works; several more COVID-19 vaccines may soon cross the finish line. To vaccinate billions of people across the globe and bring the pandemic to a timely end, we will need all the vaccines we can get.

But it is no accident or surprise that Moderna and Pfizer are first out of the gate. They both bet on a new and hitherto unproven idea of using mRNA, which has the long-promised advantage of speed. This idea has now survived a trial by pandemic and emerged likely triumphant. If mRNA vaccines help end the pandemic and restore normal life, they may also usher in a new era for vaccine development.

The human immune system is awesome in its power, but an untrained one does not know how to aim its fire. That’s where vaccines come in. They present a harmless snapshot of a pathogen, a “wanted” poster, if you will, that primes the immune system to recognize the real virus when it comes along. Traditionally, this snapshot could be in the form of a weakened virus or an inactivated virus or a particularly distinctive viral molecule. But those approaches require vaccine makers to manufacture viruses and their molecules, which takes time and expertise. Both are lacking during a pandemic caused by a novel virus.

mRNA vaccines offer a clever shortcut. We humans don’t need to intellectually work out how to make viruses; our bodies are already very, very good at incubating them. When the coronavirus infects us, it hijacks our cellular machinery, turning our cells into miniature factories that churn out infectious viruses. The mRNA vaccine makes this vulnerability into a strength. What if we can trick our own cells into making just one individually harmless, though very recognizable, viral protein? The coronavirus’s spike protein fits this description, and the instructions for making it can be encoded into genetic material called mRNA.

Both vaccines, from Moderna and from Pfizer’s collaboration with the smaller German company BioNTech, package slightly modified spike-protein mRNA inside a tiny protective bubble of fat. Human cells take up this bubble and simply follow the directions to make spike protein. The cells then display these spike proteins, presenting them as strange baubles to the immune system. Recognizing these viral proteins as foreign, the immune system begins building an arsenal to prepare for the moment a virus bearing this spike protein appears.

This overall process mimics the steps of infection better than some traditional vaccines, which suggests that mRNA vaccines may provoke a better immune response for certain diseases. When you inject vaccines made of inactivated viruses or viral pieces, they can’t get inside the cell, and the cell can’t present those viral pieces to the immune system. Those vaccines can still elicit proteins called antibodies, which neutralize the virus, but they have a harder time stimulating T cells, which make up another important part of the immune response. (Weakened viruses used in vaccines can get inside cells, but risk causing an actual infection if something goes awry. mRNA vaccines cannot cause infection because they do not contain the whole virus.) Moreover, inactivated viruses or viral pieces tend to disappear from the body within a day, but mRNA vaccines can continue to produce spike protein for two weeks, says Drew Weissman, an immunologist at the University of Pennsylvania, whose mRNA vaccine research has been licensed by both BioNTech and Moderna. The longer the spike protein is around, the better for an immune response.

All of this is how mRNA vaccines should work in theory. But no one on Earth, until last week, knew whether mRNA vaccines actually do work in humans for COVID-19. Although scientists had prototyped other mRNA vaccines before the pandemic, the technology was still new. None had been put through the paces of a large clinical trial. And the human immune system is notoriously complicated and unpredictable. Immunology is, as my colleague Ed Yong has written, where intuition goes to die. Vaccines can even make diseases more severe, rather than less. The data from these large clinical trials from Pfizer/BioNTech and Moderna are the first, real-world proof that mRNA vaccines protect against disease as expected. The hope, in the many years when mRNA vaccine research flew under the radar, was that the technology would deliver results quickly in a pandemic. And now it has.

“What a relief,” says Barney Graham, a virologist at the National Institutes of Health, who helped design the spike protein for the Moderna vaccine. “You can make thousands of decisions, and thousands of things have to go right for this to actually come out and work. You’re just worried that you have made some wrong turns along the way.” For Graham, this vaccine is a culmination of years of such decisions, long predating the discovery of the coronavirus that causes COVID-19. He and his collaborators had homed in on the importance of spike protein in another virus, called respiratory syncytial virus, and figured out how to make the protein more stable and thus suitable for vaccines. This modification appears in both Pfizer/BioNTech’s and Moderna’s vaccines, as well as other leading vaccine candidates.

The spectacular efficacy of these vaccines, should the preliminary data hold, likely also has to do with the choice of spike protein as vaccine target. On one hand, scientists were prepared for the spike protein, thanks to research like Graham’s. On the other hand, the coronavirus’s spike protein offered an opening. Three separate components of the immune system—antibodies, helper cells, and killer T cells—all respond to the spike protein, which isn’t the case with most viruses.

In this, we were lucky. “It’s the three punches,” says Alessandro Sette. Working with Shane Crotty, his fellow immunologist at the La Jolla Institute, Sette found that COVID-19 patients whose immune systems can marshal all three responses against the spike protein tend to fare the best. The fact that most people can recover from COVID-19 was always encouraging news; it meant a vaccine simply needed to jump-start the immune system, which could then take on the virus itself. But no definitive piece of evidence existed that proved COVID-19 vaccines would be a slam dunk. “There’s nothing like a Phase 3 clinical trial,” Crotty says. “You don’t know what’s gonna happen with a vaccine until it happens, because the virus is complicated and the immune system is complicated.”

Experts anticipate that the ongoing trials will clarify still-unanswered questions about the COVID-19 vaccines. For example, Ruth Karron, the director of the Center for Immunization Research at Johns Hopkins University, asks, does the vaccine prevent only a patient’s symptoms? Or does it keep them from spreading the virus? How long will immunity last? How well does it protect the elderly, many of whom have a weaker response to the flu vaccine? So far, Pfizer has noted that its vaccine seems to protect the elderly just as well, which is good news because they are especially vulnerable to COVID-19.

Several more vaccines using the spike protein are in clinical trials too. They rely on a suite of different vaccine technologies, including weakened viruses, inactivated viruses, viral proteins, and another fairly new concept called DNA vaccines. Never before have companies tested so many different types of vaccines against the same virus, which might end up revealing something new about vaccines in general. You now have the same spike protein delivered in many different ways, Sette points out. How will the vaccines behave differently? Will they each stimulate different parts of the immune system? And which parts are best for protecting against the coronavirus? The pandemic is an opportunity to compare different types of vaccines head-on.

If the two mRNA vaccines continue to be as good as they initially seem, their success will likely crack open a whole new world of mRNA vaccines. Scientists are already testing them against currently un-vaccinable viruses such as Zika and cytomegalovirus and trying to make improved versions of existing vaccines, such as for the flu. Another possibility lies in personalized mRNA vaccines that can stimulate the immune system to fight cancer.

But the next few months will be a test of one potential downside of mRNA vaccines: their extreme fragility. mRNA is an inherently unstable molecule, which is why it needs that protective bubble of fat, called a lipid nanoparticle. But the lipid nanoparticle itself is exquisitely sensitive to temperature. For longer-term storage, Pfizer/BioNTech’s vaccine has to be stored at –70 degrees Celsius and Moderna’s at –20 Celsius, though they can be kept at higher temperatures for a shorter amount of time. Pfizer/BioNTech and Moderna have said they can collectively supply enough doses for 22.5 million people in the United States by the end of the year.

Distributing the limited vaccines fairly and smoothly will be a massive political and logistical challenge, especially as it begins during a bitter transition of power in Washington. The vaccine is a scientific triumph, but the past eight months have made clear how much pandemic preparedness is not only about scientific research. Ensuring adequate supplies of tests and personal protective equipment, providing economic relief, and communicating the known risks of COVID-19 transmission are all well within the realm of human knowledge, yet the U.S. government has failed at all of that.

The vaccine by itself cannot slow the dangerous trajectory of COVID-19 hospitalizations this fall or save the many people who may die by Christmas. But it can give us hope that the pandemic will end. Every infection we prevent now—through masking and social distancing—is an infection that can, eventually, be prevented forever through vaccines.

Will you take the vaccine? How do you think the vaccine will impact the pandemic? How has the pandemic impacted you and yours?

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Studies that intentionally infect people with disease-causing bugs are on the rise

Source: Science Magazine
By Jon Cohen May. 18, 2016 , 3:00 AM

Vibrio cholerae, a comma-shaped bacterium that contaminates water and food, can kill fast. Acids in the stomach can wipe out billions of the bacteria, but if a person swallows as few as 1000 with food, some may survive the swim to the small intestine. There, the invaders will release enzymes to penetrate a thick mucous layer that lines the epithelium. Once through, the bacteria will attach to epithelial cells and begin dividing, establishing microcolonies that secrete toxins. Then the death clock begins ticking.

Irritated by the main cholera toxin, the intestine will gush fluid, and a person will develop cramping, vomiting, and, most notoriously, diarrhea that rapidly becomes a staggering volume of “rice-water” stool: a watery liquid filled with mucous flakes and epithelial cells. In severe cases, people lose a liter of rice-water stool per hour and, without rehydration to replace lost body water and electrolytes, can die within half a day.

In 1976, at the behest of a U.S. government panel, Myron “Mike” Levine of the University of Maryland School of Medicine in Baltimore began intentionally giving humans V. cholerae. He is still doing so today.

Forty years ago Levine was one of a tiny cadre of researchers doing so-called human challenge studies—intentionally infecting people with V. cholerae and other pathogens to test drugs and vaccines. But in the past few decades, this practice, which has a long and checkered past, “has become much more mainstream,” Levine says. Stricter safety procedures and new ways to weaken pathogens to reduce their risks are leading investigators in industry, universities, and government to take a new look at human challenge trials, which offer a powerful tool for studying diseases and potential therapies. There’s even a commercial company, hVIVO in London, that specializes in human challenges. Today, people are being deliberately infected with malaria, influenza, shigella, dengue, norovirus, tuberculosis, rhinovirus, Escherichia coli, typhoid, giardia, and campylobacter.

The risks are obvious: Otherwise healthy people can suffer harm and, if the disease is contagious, potentially sicken others. But if done right, the benefits are compelling, a growing number of researchers say. The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected. Human challenge studies, which only involve a few dozen volunteers, speed the process of deciding whether to scrap or pursue a promising lead, saving time and money. And tests that intentionally infect people can quickly and efficiently flag potential side effects, advocates say. “You certainly can’t do a $100 million study for every candidate vaccine that appears safe and immunogenic,” says Mark Mulligan, a molecular virologist who heads the vaccine center at Emory University in Atlanta and does human challenges with norovirus and tuberculosis.

Insights from human challenges reach far beyond drugs and vaccine development. Christine Moe, another Emory University researcher, has shown that norovirus more readily transmits via vomit than diarrhea, and that this “Ferrari of viruses,” famous for the speed at which it races through vacationers on cruise ships, is impervious to alcohol-based hand sanitizers and to power-washing the oysters that carry it. She notes that “sometimes human challenge studies are the only way to answer critical questions.”

Checkered past

Human challenges date back to the 18th century and the first vaccine, when English physician Edward Jenner attempted to persuade the world that infecting a person with harmless cowpox could prevent disease from its dreaded cousin, smallpox. Jenner scraped “matter” taken from a cowpox sore on a dairymaid’s hand into the skin of 8-year-old James Phipps, the son of his occasional gardener, and then repeatedly tried to infect him with smallpox. “Poor Phipps,” as Jenner later referred to the boy, never came down with smallpox. Jenner reported that some 6000 other people were vaccinated and then the “far greater part of them” were challenged with smallpox. Two centuries later, the vaccine Jenner pioneered eradicated the virus from the human population.

Vaccine pioneer Edward Jenner put cowpox fluid into James Phipps’s arm in 1796, then challenged him with smallpox.
Vaccine pioneer Edward Jenner put cowpox fluid into James Phipps’s arm in 1796, then challenged him with smallpox. UNIVERSITY OF MICHIGAN HEALTH SYSTEM, GIFT OF PFIZER INC. UMHS.23

Intentionally infecting a human—let alone a child—with a disfiguring and even deadly disease would never pass ethical muster today. But as recently as the early 20th century, intentional infection was seen as cutting-edge: Austrian psychiatrist Julius Wagner-Jauregg won the 1927 Nobel Prize in Physiology or Medicine for injecting blood from people with malaria into patients with neurosyphilis, which putatively cured them of insanity and paralysis. As journalist Lawrence Altman documented in his book Who Goes First?, many investigators have challenged themselves with pathogens to prove the worth of their own experimental medicines or theories. Some died.

In the 1940s, the University of Chicago in Illinois and the U.S. Army collaborated on challenge experiments that tested malaria drugs in 400 Illinois prisoners. Nazi doctors, who horrified the world with their own medical experiments, including malaria tests that killed several hundred people, cited the U.S. studies in their defense when they were put on trial in Nuremberg, Germany, in 1947. This led to the Nuremberg Code, which spells out what are now the standard research principles of informed consent, voluntary participation, and the freedom to quit a study.

Yet U.S. experiments on prisoners continued, leading to investigative journalist Jessica Mitford’s 1973 exposé in The Atlantic Monthly, “Experiments Behind Bars.” Levine, who was just starting his career, was then challenging humans with shigella and typhoid at the Maryland House of Correction in Jessup—experiments he insists were conducted ethically. “The studies done at Jessup were 2 decades ahead of their time in terms of the methods of informed consent,” he says. But in 1976, the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research—the country’s first bioethics policy effort—issued a report that effectively brought human challenge experiments in prisons to a halt.

The first question I ask is, ‘Would I want my kids … to participate?’Myron “Mike” Levine, University of Maryland School of Medicine

Outside of prisons, however, research continued. In 1974 the U.S. National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, awarded the University of Maryland a half-million dollars to create a new vaccine testing center, headed by Levine, that would recruit volunteers from colleges and church groups. The center began with influenza challenges, which were conducted in refurbished rooms at the University of Maryland Hospital that had bunk beds for 22 people and an isolated air system. The researchers had little trouble recruiting volunteers, who received the same fee as jurors ($20 a day), which the researchers deemed fair but not coercive. Volunteers had to take a written test to prove that they understood the risks.

Two years later, at the request of NIAID’s Cholera Panel, Levine’s group added challenges with V. cholerae to test cholera vaccines. “One of the really big questions was, ‘Would anyone be willing to participate?’” Levine recalls. “It’s one thing doing flu, which most people experience every other year or so, and it’s another thing to take this exotic tropical infection and set that up.”

Maryland required that the hospital fly a yellow flag to warn of a cholera quarantine area. Again, finding volunteers presented few obstacles. “These were the same young people who would go down the hairiest parts of rivers on rafts,” Levine says.

The cholera studies led to the scuttling of a leading vaccine candidate, a finer understanding of effective immune responses, and, ultimately, compelling evidence that a different cholera vaccine worked. In June, the U.S. Food and Drug Administration (FDA) will consider licensing a cholera vaccine for travelers based largely on Levine’s work. This is the most influential role the human challenge model has ever played in the FDA approval process.

Modern volunteers

Over the next decade, Levine’s group expanded to challenges with Salmonella typhiE. coli, and rotavirus. The only other substantial human challenge operation was the Common Cold Unit established by the Medical Research Council in Salisbury, U.K. Then in 1985, a team led by Ripley Ballou began human challenges with malaria at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, Maryland. That program pioneered advances that have lowered the risks of human malaria challenges and increased the benefits, opening the way to the trials flourishing today in several places.

Ballou, who now heads vaccine R&D in the United States at GlaxoSmithKline (GSK), and his team bred mosquitoes in an insectary, and then fed them on human blood infected with the malaria parasite Plasmodium falciparum. He and five other Army colleagues each took a candidate malaria vaccine and then let five infected mosquitoes—which their group had determined was the number needed to reliably transmit the parasite—lunch on their arms. “I got a full-blown case of malaria and was never so sick in my life,” Ballou says, even though he was promptly treated. “It made a huge impression on me and I was committed to finding a way to stop this disease.”

In WRAIR’s first vaccine trial, all the participants were “my friends in the laboratory or from down the hall,” says Ballou, and they went home after being infected. Now, WRAIR recruits civilians—special policies govern participation of people serving in the military—who for up to 10 days stay in a hotel together, where they receive regular checkups. Technology has also made the experiment safer than when Ballou infected himself: The polymerase chain reaction test can detect minute amounts of parasite DNA and identify an infection 2 days earlier than traditional microscopy, and if volunteers receive immediate treatment, they rarely suffer any symptoms.

The Army’s malaria challenge studies have yielded impressive dividends. “We trashed a whole bunch of vaccines,” Ballou says. They also contributed to the development of GSK’s RTS,S, the only malaria vaccine that has so far demonstrated efficacy, albeit modest, in a large-scale field trial.

The resurgence

Trials launched more recently face greater regulatory scrutiny than Levine’s and Ballou’s did. Since the mid-1990s, FDA has deemed that organisms used in challenge studies are experimental medicines, and the agency has required researchers to submit Investigational New Drug applications before conducting trials. Institutional reviews have intensified, too.

Human challenge studies with influenza provide a glimpse of the new landscape. In the 1980s and 1990s, for example, Frederick Hayden of the University of Virginia School of Medicine in Charlottesville conducted challenge studies with influenza that helped speed the development of Tamiflu and Relenza, drugs that have become the mainstays of treatment. But the work ground to a halt in 2000 after a volunteer in one of Hayden’s studies experienced what FDA calls an “adverse event.” A 21-year-old man testing a flu drug developed heart abnormalities after being challenged with the virus. “I still don’t know what caused that episode,” Hayden says. “There were a lot of sleepless nights.” No long-term harm occurred, but the incident has led to a thorough review of cardiac events in other influenza challenge studies.

So there was considerable concern when NIAID’s Matthew Memoli proposed new human challenge studies with influenza in 2011, which ultimately aimed to test novel treatments and vaccines. Some of his colleagues were so wary that the ethics department at the National Institutes of Health (NIH), NIAID’s parent, was asked to conduct a formal review of the protocol. “We went through a lot of steps,” Memoli says. The ethicists were particularly concerned about the proposed “high levels of payment”—up to $4000—but deemed this was not an “undue influence” because no one had an obligation to accept the offer.

Volunteers were “meticulously” screened, Memoli says: They had to be under 45 and undergo a battery of tests, including electrocardiograms. Memoli and colleagues also worked with FDA to grow a strain of the virus that met the agency’s good manufacturing practices, and they precisely calculated the minimum dose needed to cause disease in most volunteers.

In ongoing studies, the researchers spray influenza virus into the noses of volunteers via a mist, created by an atomizer that only produces particles larger than 10 microns. These relatively fat particles can cause infections in the upper respiratory pathway but do not reach the lungs, where influenza virus can cause life-threatening pneumonia. To avoid infecting others, participants remain in hospital isolation rooms for 9 days. “I’ve challenged nearly 200 people and have had no serious complications,” Memoli says. “The worst thing that happened is a guy slipped in a shower.”

Memoli stresses that intentionally infecting people is an odd pursuit for a doctor. “We’re purposefully making people sick,” Memoli says. “It’s a different idea than what you originally go to medical school for. But over the course of the next few years I think we’re going to get information that’s going to be tremendously helpful.” In a study published online in mBio on 19 April, Memoli and his co-workers reported that their challenge studies indicated that a widely ignored antibody response to influenza vaccines might be a better predictor of effectiveness than the antibody routinely analyzed today.

Five years ago, the small community that studies dengue began discussing challenge trials, which made some people nervous, says Anna Durbin of Johns Hopkins Bloomberg School of Public Health in Baltimore. The mosquito-borne infection can trigger a high fever, serious joint pain, and intense rashes; in rare cases, it can lead to hemorrhaging and death. No drugs specifically target dengue virus. “We heard, ‘You can’t treat dengue so you can’t do a human challenge model,’” Durbin says. Human challenges with dengue date back a century, but the last intentional infections of volunteers took place at WRAIR in 2001, and a few of the participants developed dengue fever.

In 2011, WRAIR and NIH sponsored a workshop to discuss “reintroducing” the human challenge model for dengue. Several attendees, including Durbin, argued that the trials could be done safely and would speed development of a badly needed vaccine for this disease.

With the blessing of FDA, Durbin in June 2013 began challenging volunteers who had received a dengue vaccine made by NIAID. Instead of using wild-type dengue virus, Durbin and her Hopkins team infected people with a naturally weak isolate of the virus that had been further attenuated in the lab. “I don’t think you need to make people sick” to see whether they develop an infection, Durbin says.

As she and her group reported online on 16 March in Science Translational Medicine, none of the 21 people who received the vaccine became infected after the challenge, but all 20 controls had the virus in their blood, and 16 developed a rash. Based in part on these results, the Butantan Institute in São Paulo, Brazil, this year launched an efficacy trial of the vaccine that plans to enroll 17,000 people. 

Regulations of human challenge studies differ from place to place. In the United Kingdom, for example, challenge agents are not considered drugs, and experiments with them thus don’t require regulatory approval. A group at the University of Oxford led by pediatrician Andrew Pollard has conducted a challenge study of experimental vaccines against typhoid and paratyphoid. Although both diseases are contagious, the researchers allow volunteers to go home instead of staying in isolation. “They’re potentially shedding organisms that are going into a flush toilet,” says Levine, who collaborates with the Oxford group. “That’s something that’s not amenable to being carried out in the USA.”

The United Kingdom is “much more permissive,” agrees Pollard, but he says the trials go through extensive ethical reviews, and the risk of transmission is “near zero” if people have good hygiene.

The human challenge model has its limits, Levine stresses, noting that his group declined to participate in an experiment done elsewhere that put Neisseria gonorrhoeae in a penile catheter to study gonorrhea transmission. “The first question I ask is, ‘Would I want my kids, siblings, or spouse to participate?’” Levine says. “If the answer is ‘no,’ we don’t do it.” And he worries that even though researchers today address risks more carefully than ever before, someone could push too far and undo the gains the field has made. “This should not be a Wild West show,” he says. “Some newcomers may not be totally aware of the burden the pioneers went through. It has taken a lot of time to get buy-in from everyone imaginable.” 

Have you ever heard of informed consent? The use of prisoners for unethical and unauthorized medical trials remains an issue today and has been of topic for COVID 19 trails. What has changed since these past reported unethical issues? Why?

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Health Benefits of Cherry Tomatoes

Seedling Shidonna Raven Garden and Cook

Delightfully sweet, cherry tomatoes deliver a burst of flavor as a snack, in salads, or in a surprising variety of both savory and sweet dishes. Although typically used as a vegetable, they are officially a type of fruit because they come from flowers.

The cherry tomato was first cultivated in South America and eventually found its way into European and Israeli gardens. They were finally commercialized by British grocery chain Marks & Spencer during the 20th century. The store’s owner sought a new take on commercialized tomatoes to entice customers.

Now popular as both a snack or primary meal ingredient, cherry tomatoes are one of the most well-loved types of produce you can find in grocery stores today.

Health Benefits

Cherry tomatoes are chock full of vitamins and minerals that promote excellent health. They are packed with vitamin C, which plays a major part in many body functions. The nutrient levels in cherry tomatoes can vary based on when you harvest them, but they can still be an important part of a healthy diet any time of the year.

Other health benefits of cherry tomatoes include:

Stroke Prevention

Like other types of tomatoes, cherry tomatoes are a wonderful source of lycopene. This compound can help with issues like inflammation and blood clotting. These benefits may minimize your risk of ischemic strokes, which occur when blood clots form and prevent blood flow to the brain.

Prostate Cancer Prevention

Several compounds in cherry tomatoes are associated with a lower risk of multiple diseases, including many types of cancer. Research suggests that a higher intake of tomatoes and tomato products may reduce your risk of prostate cancer in particular.https://647a12498aa581b9bf416fe05a5f411b.safeframe.googlesyndication.com/safeframe/1-0-37/html/container.html

Bone Health

The lycopene in cherry tomatoes may support bone health, especially in women at risk of osteoporosis. A study found that women who consumed tomato products saw lower rates of bone density loss compared to those who consumed less lycopene.

Nutrition

Cherry tomatoes are rich in lycopene, which is great at fighting free radicals that cause disease. Lycopene can also limit UV damage to your skin from sun exposure and promote better heart health.

Cherry tomatoes are also an excellent source of:

Nutrients per Serving

A one-cup serving of cherry tomatoes contains:

  • Calories: 25
  •  Protein: 1 gram
  • Fat: 0 grams
  • Carbohydrates: 6 grams
  •  Fiber: 2 grams
  • Sugar: 4 grams

Things to Watch Out For

Eating too many cherry tomatoes can give you acid reflux and other negative digestive side effects. This may be due to the malic acid in cherry tomatoes.

How to Prepare Cherry Tomatoes

You can find cherry tomatoes year-round in grocery stores, co-ops, farmer’s markets, and several other locations. They are also notoriously easy to grow in backyard gardens — or even as potted plants. Expose them to plenty of sun and water, and you’ll be rewarded with a healthy treat you can enjoy right off the plant.

Most recipes that use cherry tomatoes call for raw ones, but they can also be steamed, sauteed, or roasted. Cooking them can reduce the amount of vitamin C they contain, but it may actually boost the other antioxidants your body can absorb.

Try some of these ways to add cherry tomatoes in your diet:

  • Enjoy cherry tomatoes as a snack with hummus or spinach dip.
  • Include them with carrot sticks, celery, and slices of bell pepper on a veggie tray.
  • Add sliced cherry tomatoes to a stir fry.
  • Toss them with parmesan cheese and olive oil in a pesto-flavored pasta.
  • Combine cherry tomatoes with chopped red onion, jalapeño, and lime juice to create pico de gallo.
  • Fold them into an omelet with your favorite types of cheese.
  • Add them with lemon juice and Feta cheese to a couscous salad.
  • Use heirloom cherry tomatoes in a tasty fruit salad.

WebMD Medical ReferenceReviewed by Dan Brennan, MD on September 02, 2020

SOURCES

© 2020 WebMD, LLC. All rights reserved.

Which recipe will you try? How will cherry tomatoes contribute to your healthy diet? Why?

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Roasted Cherry Tomato Pasta

Seedlings Shidonna Raven Garden and Cook

by HOLLY March 19, 2018 · Updated July 7, 2020
Source: Spend with Pennies

Easy Cherry Tomato Pasta

Fresh cherry tomato pasta is a dish I make all year long.  It’s crazy-easy and so loaded with flavor that everyone raves over it! Sometimes the simplest dishes make the best meals.

Don’t let the simplicity of this recipe fool you, it’s not a super saucy heavy dish but the juices of the tomatoes create the most beautiful delicate sauce for this dish, reminiscent of the meals I ate in Italy.

I’m not much of a gardener, I hate weeding and I can’t keep a houseplant alive for the life of me. That being said, the one thing I grow every year is cherry tomatoes. There is a little local garden store that sells plants and we often end up with more tomatoes than we can even eat!

Of course this means we’re always in search of the best ever cherry tomato recipes (like this one).

Our summers consist of bowl upon bowl of Garden Fresh Bruschetta, our favorite Greek Tortellini Salad loaded with veggies and this pasta with cherry tomatoes and basil.

How to Make Cherry Tomato Pasta

This recipe is insanely easy.  I start with fresh cherry tomatoes (obvs) and slice them in half.  I toss it all with a good dose of fresh garlic, some olive oil, salt and pepper… and a splash of balsamic vinegar.  The vinegar has natural sugars which helps it to caramelize adding tons of rich flavor.

Once it’s all tossed I put it on a foil lined pan.  I used to use parchment paper but I truly find things caramelize better either directly on the pan or on foil (hello… easy clean up).

While the tomatoes are getting all roasty-toasty, I boil up some pasta… most often spaghetti or linguine but whatever you have will work.  Make sure you DO NOT RINSE your pasta for this dish.  You want the starches in it to mix with the juices to make a fresh tomato pasta sauce.

Finally a sprinkling of parmesan, some chopped fresh basil and freshly ground pepper.

I often make this on nights my daughter has soccer because by the time the pasta has cooked, the tomatoes are ready to serve! It tastes fancy but it’s pretty effortless!

This recipe is so simple and the better quality your tomatoes are, the better your dish will be.  You can certainly use any type of tomatoes in this recipe but grape tomatoes or cherry tomatoes give the best results.  Please don’t skip the fresh basil for garnish in this cherry tomato pasta, it adds such incredible flavor!

One last thing about the pasta, I try to buy refrigerated pasta if I can for this dish since the ingredients have such a fresh flavor. If you don’t have it on hand, you can use boxed pasta cooked al dente.  If you want to add a little protein, grilled chicken or shrimp are perfect options!

This pasta is fuss free, quick and easy and a go-to around here. Add in some bread and Homemade Garlic Butter and a side salad for the perfect meal!

Fresh Tomato Pasta

Ingredients

  • ▢6 cups cherry tomatoes halved
  • ▢4 cloves garlic minced
  • ▢3 tablespoons olive oil
  • ▢2 tablespoons balsamic vinegar
  • ▢½ teaspoon dried basil
  • ▢½ teaspoon oregano
  • ▢salt and freshly ground pepper to taste
  • ▢1 pound refrigerated pasta or use boxed if you prefer
GARNISH
  • ▢¼ cup sliced fresh basil
  • ▢⅓ cup parmesan cheese

Instructions

  • Preheat oven to 425°F.
  • Gently toss all ingredients (except the pasta).
  • Place on a foil-lined pan and roast at 425°F for 15 minutes or until softened. Broil 1-2 minutes to add a little bit of char/color once softened.
  • Meanwhile, in large pot of boiling salted water, cook pasta until tender but firm. Drain (do not rinse) and place in a large bowl.
  • Add tomatoes (and any pan juices) to the pasta and toss to combine.
  • Serve and garnish with fresh herbs and parmesan cheese.

NUTRITION INFORMATION

Calories: 504, Carbohydrates: 73g, Protein: 18g, Fat: 15g, Saturated Fat: 3g, Cholesterol: 88mg, Sodium: 190mg, Potassium: 711mg, Fiber: 1g, Sugar: 6g, Vitamin A: 1210IU, Vitamin C: 51.9mg, Calcium: 152mg, Iron: 5.8mg

After growing your own cherry tomatoes, enjoy this simple recipe. What did you think of the recipe? Did you use your own indoor or outdoor grown cherry tomatoes? Why not?

Share your comments with the community by posting them below. Share the wealth of health with your friends and family by sharing this article with 3 people today. As always you are the best part of what we do. Keep sharing!

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The Long, Strange History of Bill Gates Population Control Conspiracy Theories

Source: Type Investigation
How the billionaire philanthropist displaced George Soros as the chief bogeyman of the right.
MAY 12, 2020 By KATHRYN JOYCE

PHOTO BY WILLIAM WEST/AFP VIA GETTY IMAGESAnti-vaccine protesters in Melbourne, Australia on May 10, 2020.

Three months into the global pandemic, Bill Gates has displaced George Soros as the chief bogeyman of the right.

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In April, dozens of Texans crowded around Infowars host Alex Jones at an anti-shutdown demonstration in Austin, Texas, chanting “arrest Bill Gates.” A New York-based tech nonprofit falsely rumored to be working with the Bill and Melinda Gates Foundation to implant vaccine microchips in people received so many death threats that it contacted the FBI. And a White House petition demanding the billionaire’s foundation be investigated for “medical malpractice and crimes against humanity” amassed half-a-million signatures in three weeks.

Gates, who has announced that his $40 billion-foundation will shift its “total attention” to fighting COVID-19, has been accused of a range of misdeeds, from scheming to profit off a vaccine to creating the virus itself. On April 8, Fox News host Laura Ingraham and Attorney General Bill Barr speculated about whether Gates would use digital certificates to monitor anyone who got vaccinated.

KEY FINDINGS

  • Accusations that Bill Gates has sinister plans to control or experiment on the public under the guise of medical charity date back at least a decade, in part to an obscure political fight in Ghana. 

A Christian Right broadcaster, Brannon Howse of “Worldview Watch,” warned that Gates and the “medical globalist deep state” were using the crisis to regulate people’s fertility depending on their worldview, through “procreation tickets” and microchips. On Instagram, anti-vaccination activist Robert F. Kennedy, Jr., posted a video featuring a “1984”-style audience listening to Gates, with text declaring that the Microsoft Corp. co-founder “is conducting global social and medical experimentation,” via the World Health Organization. The New York Times noted that misinformation about Gates has become “the most widespread of all coronavirus falsehoods” trending online.ARINDAM SHIVAANI/NURPHOTO VIA GETTY IMAGES

An anti-lockdown rally in Toronto, Canada, on April 25, 2020.

But while these themes have fed the imagination of QAnonPizzagate and anti-vaccination proponents since January, conspiracy theories involving Gates actually have a much longer history. Accusations that he has sinister plans to control or experiment on the public under the guise of medical charity date back at least a decade, including to an obscure and different political fight in Ghana.

A New War Over Birth Control In Africa

In 2010, a former staffer with a government health initiative in Ghana made a shocking claim: a project partially funded by the Gates Foundation had tested the contraceptive Depo-Provera on unsuspecting villagers in the remote region of Navrongo, as part of an illicit “population experiment.” The woman making the charge was the Ghanian-born, U.S.-educated communications officer for another Gates-funded initiative by the Ghanaian government and Columbia University to use mobile phones to improve health care access for rural women and children. She had previously attempted to sue her employer for a multi-million dollar settlement when, after repeated clashes with her boss, her contract wasn’t renewed.

The lawsuit fizzled, but with help from a small U.S. nonprofit called the Rebecca Project for Human Rights, she shopped a series of stories to Ghana’s tabloid press. The Depo-Provera story caused a national scandal. Although it was denounced by Ghanaian health professionals and traditional leaders as libelous—the Navrongo project hadn’t tested any medications— so many death threats were directed at the project that some staff had to be evacuated across the Burkina Faso border.

  • The new narrative was that Gates was waging “chemical warfare on poor women” in a neocolonial effort to suppress African births. 

The episode would mark the opening shot in a new war over birth control in Africa. It also reflected an evolution in the U.S. anti-abortion movement’s strategy in which it started to co-opt the language of women’s and civil rights used by progressives. There were fewer bloody fetus posters and more talk about how abortion and contraception violated women’s safety and impeded racial justice.

Anti-abortion groups hired black activists and highlighted uglier aspects of the history of reproductive health care — in particular, the courting of the eugenics movement by Planned Parenthood founder Margaret Sanger in the early part of the 20th century. A right-wing documentary, Maafa 21: Black Genocide in 21st Century America, used a Swahili word that refers to the holocaust of African enslavement to denounce Planned Parenthood as racist. Billboards in Atlanta and Manhattan carried messages like, “The most dangerous place for an African American is in the womb.” And federal and state legislators proposed a series of bills banning race- and sex-selective abortions in order to insinuate that abortion providers deliberately target communities of color.

KEY FINDINGS

  • Thinly sourced research from a small nonprofit, The Rebecca Project, suggested a massive international conspiracy, led by the Gates Foundation, to push dangerous contraceptives on poor black women as a means of decreasing African births. 

As black feminists pointed out, these groups cared little for women’s or civil rights in general, or black women’s well-being in particular. (A 2009 U.S. House bill titled the “Susan B. Anthony and Frederick Douglass Prenatal Nondiscrimination Act” was co-sponsored by a champion of the Confederate flag.)

But the strategy exploited the real and painful history of medical abuses against people of color in the U.S., from compulsory or coercive sterilization campaigns from the 1910s to ’60s (including the sterilization of a third of all Puerto Rican mothers between 20 and 49 years old by 1965) to unsafe contraceptives marketed to poor women of color from the 1970s to ’90s. And the legacy of those abuses could be profound. One 2016 study found that the notorious Tuskegee Study, wherein hundreds of black men were left with untreated syphilis so U.S. government researchers could track the progress of the disease, led to such mistrust of the medical establishment that it reduced the life expectancy of a generation of black men by more than a year.

The Rebecca Project, a small, Washington-based nonprofit focused on issues disproportionately affecting women of color, hadn’t been involved on either side of the abortion fight. But in 2011, the group released a thinly-sourced report titled “Non-Consensual Research in Africa: The Outsourcing of Tuskegee,” outlining what it claimed was a series of unethical U.S.-backed medical experiments in Africa.

Some of the examples were documented stories of legitimate concern — for instance, HIV-positive women in southern Africa had been pressured into sterilization procedures by local health care entities. The report attempted to link them to shakier allegations of USAID funding being used for coercive sterilization campaigns in other countries. But the report’s real target, it seemed, was the Gates-backed health initiative in Navrongo. Later, the report’s lead author would suggest that people involved with the project should be charged with attempted genocide.

The report had numerous factual problems. Its author ― the Rebecca Project’s chief financial officer, Kwame Fosu ― also hadn’t disclosed a significant conflict of interest: The employee who’d leveled the charges against the Ghana project was the mother of his child. The fallout wound up splitting the organization, as one of its founders and several staff departed, taking with them all the Rebecca Project’s funding. Left with the group’s name, Fosu doubled down on his conspiratorial claims.

In 2013, Fosu published another report, “Depo-Provera: Deadly Reproductive Violence Against Women.” Drawing heavily on unnamed sources, paranoid accusations and the rhetoric of right-wing anti-abortion groups, this report used the Ghana story to anchor claims of a massive international conspiracy, led by the Gates Foundation, to push dangerous contraceptives on poor black women as a means of decreasing African births and advancing “population control ideology.” Fosu brought the Rebecca Project into alliance with a network of conservative Catholic nonprofits, like C-Fam and the Population Research Institute (PRI), that had long focused on fighting reproductive rights in developing nations or at the United Nations.REBECCA PROJECT FOR JUSTICE

A portion of the title page from The Rebecca Project for Justice’s 2013 report.

His new allies began publicizing Fosu’s claims to a large audience of conservative activists, arguing that he had uncovered the smoking gun confirming their long-held suspicions. As the head of PRI put it, “The population controllers will stop at nothing to stop African women from having children.” By 2014, the Rebecca Project was focusing full-time on the scourge of Depo-Provera. At the same time, the Gates Foundation was undertaking a new mission to radically expand contraceptive access to women in Africa, including with a new, low-dose adaptation of Depo-Provera.

The foundation’s family planning campaign had already drawn predictable backlash from religious groups. But as U.S. anti-abortion groups and websites circulated the Rebecca Project’s allegations, the opposition was no longer dominated by complaints that Gates was tempting African women to defy their faith. The new narrative was that Gates was waging “chemical warfare on poor women” in a neocolonial effort to suppress African births.

Soon, powerful figures across Africa were making similar claims, undermining vital public health projects in the process. In 2014, Zimbabwe’s Registrar General, Tobaiwa Mudede — the official responsible for overseeing the country’s dubious elections — warned women to avoid modern contraceptives because they caused cancer and were a Western ploy to limit African population growth. In 2015, Mudede told parliamentarians, “Western countries are bent on curtailing the population of the darker races of the world.” According to a parliamentary committee, Mudede’s campaign panicked Zimbabwean women, who flooded into clinics to have contraceptive implants removed.

KEY FINDINGS

  • Recently, these claims have grown to suggest that a Gates-backed vaccine against COVID-19 — in which the foundation has invested $300 million — could be a stealth attack on African populations. 

In Kenya, all 27 members of the nation’s Conference of Catholic Bishops declared that a WHO/UNICEF campaign to administer neonatal tetanus vaccines to women of childbearing age was really “a disguised population control programme.” According to the bishops, the vaccines were laced with a hormone that would cause repeated miscarriages and eventual sterility.

The same conservative Catholic network the Rebecca Project had allied itself with published numerous stories amplifying the bishops’ accusations and casting doubt on the government’s response. The Kenyan Parliament was forced to have the vaccine tested repeatedly. But by the time the claims were debunked, priests around Kenya had already instructed their congregants to refuse the vaccine.

Back in the U.S., Fosu also worked with C-Fam to lobby delegates from African nations, with some success. After a meeting of the Commission on the Status of Women, a regional grouping of African countries released an unprecedented statement expressing concerns over “harmful contraceptives,” echoing specific claims by Fosu and his allies. The next month, at the Commission on Population and Development, delegates couldn’t agree on an outcome document for the first time in the commission’s 48 years — the result, conservative advocates claimed, of African and other developing nations’ frustration with “the profusion of references to population control, adolescent sexual activity, abortion, and comprehensive sexuality education.”

Undermining Confidence In A Coronavirus Vaccine

The Rebecca Project has long since faded into obscurity. But the current attacks on Gates and his foundation are now broadcasting the same themes to a massive global audience.

In April, Trump boosters Diamond & Silk vowed they would never take a vaccine created by Gates because he’d sought to make Africans “guinea pigs.” (This claim was helped along by erroneous media reporting that falsely suggested Gates planned to test his vaccine in South Africa.) “I have a problem receiving any vaccine from any entity, especially anybody like Bill Gates who pushed for population control. The same thing that Margaret Sanger pushed for,” Diamond said. “Abortions! Genocide!” Silk explained.

In response to these and other conspiracy theories, including their contention that the virus was a “plandemic,” Fox Nation reportedly cut ties with the pair. But Diamond and Silk weren’t alone.

Conservative commentator Candace Owens tweeted in April that “vaccine-criminal Bill Gates” had used “African & Indian tribal children to experiment w/ non-FDA approved drug vaccines.” Last week, she declared “that under no circumstances will I be getting any #coronavirus vaccine that becomes available. Ever. No matter what.”

  • In the U.S. alone, nearly a third of Americans say they’ll refuse a coronavirus vaccine. 

An Infowars video suggested that Gates was the successor of eugenicist population controllers from Sanger to Nazi collaborators, and asked whether viewers would “allow your government to impose forced vaccines.” In a viral sermon, Rev. Danny Jones, the pastor of a 250-member Georgia church, predicted that Gates would use vaccines to usher in a new world order under which Christians might be forced to accept biometric tattoos.

On Twitter, hundreds of posts claimed that the billionaire had publicly said that vaccines could be used to lower the population by 10% to 15%. This was an old misrepresentation of Gates’ suggestion that increasing vaccination rates in the developing world could slow population growth, since families in which more children survive to adulthood might have fewer children overall.

Doctored photographs falsely suggesting the Gates Foundation runs a “Center for Human Population Reduction” spread so widely that both Reuters and Snopes published articles debunking them. Anti-vaxxer and Pizzagate proponents began sharing old C-Fam articles as proof that Gates “Thinks There Are Too Many Africans.” And the White House petition resurrected the old Kenyan controversy, informing new believers that Gates has “already been credibly accused of intentionally sterilizing Kenyan children through the use of a hidden HCG antigen in tetanus vaccines.”

By Saturday, the Gates-population control narrative had made its way onto conservative network One American News, quoting an anti-social distancing protester who charged,“This is not about COVID or about a virus. This is about gaining control over the human race and limiting population.”

Anti-Gates theories have resurfaced in Africa, as well. Unfounded rumors that Gates had bribed Nigerian lawmakers to pass a compulsory vaccination bill sparked a legislative investigation there. African Twitter influencers posted threads linking him not just to population control but the entire history of colonialist medical violence. One described the foundation’s family planning work “as genocide in Sub-Saharan Africa.” Another suggested that Gates would turn to “toxic Covid-19 vaccines” to depopulate South Africa next, since it had become “clear that this Depo is not working fast enough.”

Nancy Rosenblum, author of “A Lot of People are Saying: The New Conspiracism and the Assault on Democracy,” said that some people may simply see the proliferation of these conspiracy narratives as a vehicle to advance their agenda, exploiting the swirling outrage around Gates to introduce fringe arguments to a much larger audience. To Quassim Cassam, author of the book “Conspiracy Theories,” the anti-Gates attacks reflect a larger global trend towards populism, characterized by profound distrust of the establishment and experts.

“If you say it’s Gates or big corporations who are responsible for developing coronavirus via 5G, these are all ways of expressing anti-elitist sentiment,” Cassam said. “They’re fantasies, but they’re fantasies that give expression to real things in their lives.”

The potential impact of such fantasies could be dire. The legacy of medical abuses against people of color helped give rise to HIV/AIDS conspiracy theories, Rosenblum noted, from claims that it was a government-crafted bioweapon to charges that life-saving medications were poison. After the latter theory was adopted by South Africa’s former president, Thabo Mbeki, Harvard University researchers found it was responsible for more than 330,000 unnecessary deaths.

The Gates Foundation has already committed $300 million to fighting the coronavirus and finding a vaccine. Tens of millions of that sum are dedicated to ensuring that vaccines are distributed in poor countries. Conspiracy theories suggesting an eventual vaccine is part of a nefarious plot could leave many of the world’s most vulnerable at greater risk; in the U.S. alone, a late April survey found, nearly a third of Americans say they’ll refuse a vaccine.

Of course, the same side that is accusing Gates of planning an imminent eugenicist attack is also loudly pushing to reopen the economy, even though this will almost undoubtedly come at the cost of thousands of lives, overwhelmingly people of color. Rather than reckon with that reality, Republican leaders have argued that “there are more important things than living” and the public will “have to accept” massive new casualties.

Wisconsin’s chief justice dismissed superclusters of infection in the minority-staffed meatpacking industry as distinct from the threat posed to “regular folks.” One local California official mused that allowing the virus to “run rampant” through the ranks of the homeless, the old, the sick and the poor, represents a “natural” process of culling the “herd” that could lighten Social Security and health care burdens and free up jobs and housing.

Against this backdrop, right-wing claims of eugenics or population control begin to seem not just disingenuous, but like the most amoral form of projection.

Unethical medical experiments are not new and without past apologies. What are your thoughts on the information in this article? Why? What are your thoughts on COVID 19? Why?

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Should COVID-19 vaccine testing be done on prisoners? Some researchers say we should ask them.

covid 19 shidonna raven garden and cook

September 4, 2020 by Hannah Critchfield
Source: North Carolina Health News

Is it time to reconsider restrictions on using prisoners in medical experiments? Some experts say we should ask incarcerated people themselves.

By Hannah Critchfield 

As the COVID-19 infection toll inside United States prisons and jails reaches 100,000, some researchers are wondering if it’s time to reconsider bans on using prisoners in medical trials, such as the vaccine trials currently underway across the country.

Though often in the center of the discussion of a contentious topic, prisoners have had little input into the conversation. The researchers say it’s time to ask prisoners what they might want.

In the past, prisoners were used as medical study subjects, sometimes against their will. Prisoners were paid hundreds of dollars — far more than what a person normally receives doing prison labor, even today — to undergo studies involving everything from the toxic substance in Agent Orange, dioxin, to Johnson & Johnson bubble bath products (which reportedly led one prisoner to break out in painful blisters) to skin viruses like herpes.

Since 1978, however, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research has heavily restricted most research involving incarcerated people. The regulations followed reports of widespread abuse in drug and vaccine testing on prisoners in places like Holmesburg Prison in Philadelphia, where inmates were exposed to radioactive, carcinogenic and hallucinogenic chemicals without independent oversight or obtaining informed consent.

“I was in prison with a low bail,” former Holmesburg prisoner Leodua Jones told Executive Intelligence Review in 1999. “I couldn’t afford the monies to pay for bail. I knew that I wasn’t guilty of what I was being held for. I was being coerced to plea bargain. So, I thought, if I can get out of this, get me enough money to get a lawyer, I can beat this. That was my first thought.”

An exposé of the prison experiments in 1974 came on the coattails of the public’s discovery and the subsequent shutdown of the Tuskegee Study of Untreated Syphilis in the Negro Male, a 40-year study commissioned by the U.S. Public Health Service in which researchers withheld and concealed the existence of widely available, effective treatment for syphilis from its all-Black participants in order to study the long-term effects of the disease.

“You can make a strong argument that Holmesburg was as bad, if not worse,” said Allen Hornblum, who worked as a literacy instructor at the prison at the time and later wrote the book Acres of Skin about the experiments. “Because it’s not happening in the backwoods of Alabama, it’s happening in the third-largest city in the nation. A city loaded with universities, and medical schools, and very sophisticated people. Yet nobody seemed bothered or perturbed by it.”

In the time of pandemic 

Today, research in correctional settings is only permitted in limited conditions. Two of the categories of potentially permissible research are “research on conditions particularly affecting prisoners as a class” and “research on practices intended and deemed likely to improve the health or well-being of participants.”

Federal law requires that the secretary of the U.S. Department of Health and Human Services must convene a panel of experts before any trial takes place, a barrier that drastically reduces the likelihood that studies of this kind would occur.

With present regulations, vaccine trials for COVID-19 will not include currently-incarcerated people. But the novel coronavirus has ravaged the very places where incarcerated people live, leading some researchers to ask if now is the time for convening a DHHS panel. Inmates are more likely to contract COVID-19 than the general population, and to have chronic conditions that increase risk of severe illness from the virus, such as diabetes and heart conditions.

Outbreaks have ravaged North Carolina prisons, infecting thousands and killing 10 in the state correctional system alone. The facilities have been likened to petri dishes for the virus, as incarcerated people are housed in close, crowded conditions that make it difficult to social distance.

In a report released earlier this month in the Journal of the American Medical Association, health experts from the schools of medicine at Yale, Johns Hopkins and the University of North Carolina asked DHHS to consider if a Phase 3 vaccine trial for COVID-19 might meet the criteria for study of a condition “particularly affecting” prisoners.

“We’re just calling into question whether we’re taking away the agency of people who are in these settings,” said Lauren Brinkley-Rubinstein, a public health researcher at UNC-Chapel Hill and co-author of the report. “A majority of cluster outbreaks in this country are happening in these settings, and so why wouldn’t you give people that live there the option of participating or not?”

Trial participation would need to be voluntary, according to the authors, and couldn’t be tied to any condition, such as release from incarceration or special treatment

It would also require approval from an Institutional Review Board, those bodies that oversee the ethics of drug trials, that would need to include a prisoner representative.

Prisoner participants shouldn’t make up more than 50 percent of the test subjects to avoid exploitation and would need to be adequately briefed on risks, including “potentially the unique risks in the correctional health system of obtaining aftercare.”

“What we tried to communicate in that article is not that we definitely should be doing [correctional testing],” said Brinkley-Rubinstein. “But we tried to create a framework that could be used, if we were to consider it, that tries to center the voice of people who have been incarcerated.”

Oversight and equitable access

Clinical vaccine trials involving incarcerated people must ensure their correctional facilities have the resources to provide adequate treatment for vaccine complications, as well as funding for an incarcerated person’s aftercare in a community setting upon release.

The report also emphasizes that clinical trials should guarantee that incarcerated people have universal access to vaccines once one is proven successful. They also call for the federal government to pass legislation guaranteeing this universal access.

“I think once vaccines are proven that they work, the first places they should be deployed are nursing homes, prisons and jails,” said Brinkley-Rubinstein. “So that’s a part of [considering research with incarcerated people] too — if we are to do that, we need to understand how best to implement vaccine programs in the settings.”

The authors emphasize the need for a Federal Oversight Board in addition to an IRB, regardless of whether the trials are funded by the U.S. government, to monitor any clinical COVID-19 trials in prisons and jails.

Is consent possible behind bars?

Still, some people like Hornblum, the former Holmesburg worker, remain skeptical about whether it’s possible to ethically implement any medical trial behind bars.

“A lot of people in high positions do not want to ruffle the feathers of the medical-industrial community,” he said. “Can you imagine what ‘federal oversight’ would be with the Trump administration?

“I see the argument that is being made, and there is merit to it,” Hornblum added. “But I’m not just an academic who has read this in a journal, I witnessed it. I saw the lies, I saw the deceit. I saw inmates trusting their doctors, who were from an Ivy League institution, yet people were being damaged on an industrial scale.

“When it can happen at prison in a major sophisticated city, just think what can happen in smaller-scale facilities.”

Central to this debate is the issue of free and informed consent.

Some researchers believe that a person who cannot leave their present environment due to incarceration cannot truly give “informed consent” — that incarceration itself is too great a power dynamic to surmount. Many cite the Nuremberg Code, a set of research ethics principles drafted in the aftermath of the Nuremberg Trials at the end of World War II.

“Prisoner testing flies in the face of the first principle of the Nuremberg Code, which argues that if you’re confined or in a facility that lacks freedom, if you can’t walk out, you should not be used as a test subject,” said Hornblum.

‘A million ethical landmines’

Brinkley-Rubinstein conceded that there would be “a million ethical landmines” to navigate in vaccine trials inside prisons and jails.

“I do think the entire critique of whether it should happen or not really rests on that power dynamic, and that can manifest in a million different ways,” she said. “It would take a lot of time to figure out how to do it well.”

But the authors of the JAMA report said a blanket bar on research involving prisoners lacks nuance — in this moment, researchers must ask if it’s also unethical to not allow incarcerated people to participate.

“While the history of clinical trials in US prisons suggests that there is potential and opportunity for coercion in correctional settings, research on this issue in the contemporary era is limited,” the report states, noting that while prisoners need protection from coercion and exploitation, respect for prisoners requires “recognition of their autonomy in decision-making.”

“An ethical position that could be considered is that because of the epidemiology of this disease, it may be unethical to not provide clinical trial opportunities to these groups,” it adds.

“There are definitely places in which I would be terrified if they tried to do something like this,” said Brinkley-Rubinstein, who researches addiction treatment for incarcerated people in North Carolina, Rhode Island and Pennsylvania facilities. “But I think there are some systems, like Rhode Island’s, that are primed for this and have demonstrated their ability to properly take care of people in their custody.

“It’s context dependent, and lots of different voices should be at the table,” she added.

Considering the inclusion of incarcerated people in vaccine testing, according to Brinkley-Rubinstein, would signal a shift away from what she called “patriarchal” ideas about prisoners in research.

“We [on the outside] may all agree that this could never ethically happen in these settings, but like it’s not for us to decide,” Brinkley-Rubinstein said. “There needs to be this paradigm shift where people who have lived in those settings, and experienced the risks to their health from COVID, get to decide if this is a prevention activity that they want to engage in.”

Is it ethical to include unknowing people in medical experiments in or out of jail? Informed consent is not always received by people not in prison. What is the difference? Would you recognize health care fraud when you see it?

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