Connect with us

Spread & Containment

COVID: why people who refuse to get vaccinated should not have lesser healthcare rights

Prioritising COVID patients who are vaccinated – or charging unvaccinated patients for treatment – isn’t the right thing to do.

Published

on

ORION PRODUCTION/Shutterstock

As winter pressures have mounted on the NHS, both health staff and politicians have grown increasingly frustrated with the number of unvaccinated patients needing treatment for COVID. The risk of being hospitalised with COVID is substantially greater for those that haven’t had a vaccine. The latest data suggests that more than 60% of COVID patients requiring critical care in England haven’t been vaccinated.

Nevertheless, despite debates over whether COVID vaccines should be mandatory – given that they clearly protect a person’s health and have wider social benefits – uptake has largely remained voluntary in England. Vaccines are obligatory only for those working in the care and (from April 2022) health sectors.

Even with omicron sending cases surging, Sajid Javid, the UK health secretary, dismissed universal mandatory vaccination, saying that “ethically it’s wrong”. What, though, should the consequences be for a person who comes to suffer ill health with COVID having chosen not to be vaccinated?

In Singapore, the answer is that they must pay for their treatment. A proposal along the same lines has been debated in New South Wales in Australia. Limiting care for unvaccinated patients has also been a publicly debated question in the UK. But should choosing not to be vaccinated really result in a person being deprioritised or charged by the NHS?

Using policies to influence the decisions people make in response to the pandemic is not problematic in itself. Indeed, some coronavirus-related responsibilities – such as lockdown restrictions and self-isolation rules – have been supported by the threat of legal punishment to ensure they are met.

Meeting other responsibilities has been encouraged through “softer” measures. Information campaigns and public guidance have been used to promote vaccine uptake. And having to show a COVID pass to attend particular events or venues has been an indirect way of increasing rates of vaccination.

The perceived threat of negative consequences may therefore serve as a “stick” to encourage compliance. But the threat of any negative consequences must not just be effective; it must also be ethical and fair when the policy comes to be applied.

Is limiting healthcare rights ethical?

In a context of having finite healthcare resources to allocate, there’s an intuitive pull to the idea that someone who has made a clear, poor decision regarding their health shouldn’t be prioritised – and that they should be responsible for the costs.

But, as I have argued previously, there are strong reasons, based in medical ethics, to resist the attraction of such an argument. Such a policy would undermine two of the seven principles underpinning the NHS: that treatment is provided to all who need it; and that the provision of treatment is based on clinical need, not ability to pay.

Just by refusing vaccines, a person cannot be deemed to have also refused consent to receive treatments for COVID. People who are unvaccinated have not waived their positive right to healthcare. Rather, the NHS would be denying treatment that unvaccinated patients are due.

A policy to deprioritise unvaccinated patients for care, or to charge them for such care, would not be about denying a privilege or preference. It would be punitively discriminatory, denying a fundamental and universal positive right. And crucially, despite the apparent starkness of vaccine refusal, such a policy shows too little subtlety in understanding responsibility for health.

Beyond individual responsibility

For better and for worse, as individuals alone we are demonstrably not responsible for many of our health opportunities and outcomes. Policies that would punitively pinpoint responsibility to individuals – with significant costs to them – therefore need careful justification. This includes policies in relation to apparently straightforward choices that are harmful to health, such as smoking, poor diet or refusing vaccines.

The evidence indicates that when it comes to choices people make about their health, there are systemic influences in the background – factors that may themselves be changed, such as the social advantages or disadvantages that people experience. But these are beyond the influence of individuals acting alone. Looking just at individual responsibility and vaccine uptake requires us to deny that there’s any meaning or relevance, for example, to systemic influences that explain lower levels of vaccination among some ethnic minority communities.

And would a punitive “responsibilising” policy, with its moral undertones in justice, be coherent with other individual and social responsibilities that we have? Given how stark the choice is between having a vaccine or not, refusing may be interpreted as being obviously irresponsible in the context of trying to control COVID. But so too could other choices, some of which are also quite stark, such as choosing not to socially distance, for example.

A sound reason would be needed for singling out vaccine refusal. And even if that could be found, and the government did want to punish or otherwise treat people who refuse to be vaccinated differently, the NHS is not the right place to do that. “The punishment fits the crime,” it might be said. But the firm reality is that vaccine refusal is not crime, and even if it were, denial of healthcare is not a fair or humane punishment.

At the extreme (which I would resist), parliament could criminalise non-vaccination. Yet even then, we would be right to punish offenders through the criminal justice system rather than by denying healthcare; just as we would do a person who comes to harm as a result of, for example, drink-driving.

Sajid Javid may be right to declare that mandatory vaccination is ethically wrong. But so would be denial of healthcare rights where that care is clinically needed – even if a person may (at least in some senses) be responsible for that need having arisen.

John Coggon is an honorary member of the UK Faculty of Public Health, a member of the Nuffield Council on Bioethics and sits on the BMJ's ethics committee. He also is (and has been) a member of a number of national expert groups, convened by NHS England and NHS Improvement, to determine the commissioning position around treatments for COVID across the NHS in England, Northern Ireland, Scotland and Wales. Within the past 36 months Professor Coggon is or has been on research projects funded by the UK Arts and Humanities Research Council, the UK Economic and Social Research Council, the UK Prevention Research Partnership, and the Wellcome Trust, and he has a grant from the Wellcome Trust to provide scholarships on the University of Bristol’s LLM in Health, Law and Society. The work on which this piece is based was supported by the UK Ethics Accelerator Grant, reference UKRI/AHRC:AH/V013947/1. All views expressed in this piece are personal to the author and should not be taken as being held by any of the above organisations or other organisations with which the author may be associated.

Read More

Continue Reading

Spread & Containment

Why are clinical trials struggling with diversity?

In the diverse world we live in, the products we produce, the services we create and the places
The post Why are clinical trials struggling with diversity?…

Published

on

In the diverse world we live in, the products we produce, the services we create and the places we work should be as equally representative. In recent years this has seen diversity, equity, and inclusion (DEI) become a big focus for industries to get right.

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening.

Fair and timely access to efficacious medicine is one of the vital tenets of the healthcare industry and is a critical building block of the sector’s environmental, social and governance (ESG) objectives. But historically there are groups that are typically neglected due to the current systems in place. Racial disparities are still commonplace in many clinical trials with white-ethnic groups often overrepresented amongst trial participants.

Factors such as ethnicity, gender, sexual orientation and age can contribute to interindividual differences in treatment responses and risks of adverse events. Inadequate clinical trial representations of all populations can therefore leave underrepresented groups vulnerable due to the lack of subgroup-specific data.

While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. The good news is that technology is being harnessed to promote a DEI-conscious agenda within the clinical trial space, making diversity more attainable than it ever has been.

To understand why improving diversity, mitigating bias, and reinforcing inclusion in clinical trials is such a big task, it’s important to understand the challenges currently at play.

Unpacking the status quo

Traditional Randomised Control Trials (RCTs) continue to form the backbone of clinical efficacy and safety data submitted to health authorities for regulatory review. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.

It is well-established that safety and efficacy data is highly influenced by internal (intrinsic: ethnicity, sex, age, genetic background) and external (extrinsic: climate, education, access to healthcare) factors. The challenge for regulators and pharma companies is that safety and efficacy data from an RCT may not always translate to the real world ‘effectiveness’ of a medicine (how efficacious the drug is in patients once marketed) which is governed by these complex intrinsic and extrinsic factors.

To mitigate against potentially lower drug efficacy or a different drug safety profile in a wider population vs those findings evidenced in RCTs it is important for companies to include ‘patient-orientated’ outcomes (relief of symptoms) alongside traditional endpoints (blood pressure, glucose concentrations). The diversity of clinical trial patients in the context of disease prevalence is key to capturing ‘patient-orientated’ outcomes in populations. For example, with skin conditions, textbooks, studies, and trial photos often present lighter-skinned individuals’ symptoms, which are bound to differ in darker skinned individuals.

The pandemic brought imbalances into sharp focus

The race to produce a vaccine which could protect the world against COVID-19 brought the topic of diversity in clinical trials, or lack of it, into sharp focus.

Vaccines approved for public use require comprehensive RCTs to establish their safety and efficacy. The demographics of vaccine trial participants should reflect the vulnerable groups to whom infection with the disease presents the greatest risk of harm and mortality. However, this did not happen to the extent it could have during trials for the COVID-19 vaccine.

Research has shown a disproportionately higher rate of COVID-19 infection and mortality among the elderly and minority ethnic groups who are more likely to be negatively impacted by social and economic deprivation linked to pre-existing health conditions. In the UK, during the first wave of the COVID-19 pandemic, ethnic minority groups (except for women in “Chinese” or “White Other” categories) had higher rates of death post-exposure compared with the “White British” population.

These issues are not confined to the UK; in the US, some minority groups including Black, Latino, Pacific Islander and Indigenous peoples have been shown to have twice the COVID mortality rate of Caucasian people.

Despite policies, guidelines, and regulations to promote the diversification of clinical trial groups by the European Medicines Agency (EMA) and FDA, the inclusion of key demographic populations within clinical research continues to be less than proportionate to their representation in society.

Why are certain ethnic groups underrepresented?

Redressing the imbalance in trial participation is not a simple task. Throughout the pandemic, the issue of vaccine hesitancy was compounded by ethnic disparities. This is underpinned by historical mistrust in healthcare organisations, governments, and clinical research, which is still prevalent in some communities.

Factors influencing trust vary between ethnic groups. Reported experiences of discrimination, perceived structural inequalities impacting the access to and quality of healthcare, and concerns of trial under-representation are likely to influence trust issues, of which the latter is within the remit of companies to acknowledge and address with appropriate measures to effect change. Without diverse participation in clinical research there is a lack of breadth in safety and efficacy data. Certain groups of individuals may then not trust that the medicines have been produced with them in mind and may be highly sceptical of the resulting evidence base and prescribing label of medicines.

In the second half of this article, we’ll look at how technology is being used to make clinical trials more diverse and consider some of the lessons learned during the COVID-19 pandemic.

About the authors

Tanya Chambers is an ex-MHRA (Medicine and Healthcare Regulatory Agency) Senior Assessor with over 15 years’ experience principally evaluating preclinical data packages (small molecules and biologics) accompanying clinical trial applications, EU & UK marketing authorization applications (MRP/DCP/Centralised submissions) and variations across all therapeutic areas. Most recently, Tanya led the preclinical rolling review for COVID anti-viral applications resulting in national roll-out, and was product lead for the review of a vast array of development programmes via UK innovative licensing pathways: iLAP and EAMs. In addition, Tanya has working knowledge of the collaborative review of promising oncology treatments alongside Australia (TGA), Canada (Health Canada), UK (MHRA), Singapore (HSA), Switzerland (Swissmedic) and Brazil (ANVISA): ‘Project ORBIS’.

Liam Johnstone has six years of toxicology experience working across regulators in the UK, developing expertise in medicine, consumer product and agrochemical safety whilst working at the MHRA, OPSS and HSE, respectively. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. He has provided scientific advice to companies both nationally and as part of the Scientific Advice Working Party (SAWP) on the suitability of non-clinical data packages and study plans, as well as generating guidance for the European Medicines Agency (EMA)

 

The post Why are clinical trials struggling with diversity? appeared first on .

Read More

Continue Reading

Government

After mass shootings like Uvalde, national gun control fails – but states often loosen gun laws

After mass shootings, politicians in Washington have failed to pass new gun control legislation, despite public pressure. But laws are being passed at…

Published

on

A girl cries outside the Willie de Leon Civic Center in Uvalde, Texas, on May 24, 2022. Allison Dinner/AFP via Getty Images

Calls for new gun legislation that previously failed to pass Congress are being raised again after the May 24, 2022, mass shooting at an elementary school in the small town of Uvalde, Texas.

An 18-year-old shooter killed at least 19 fourth grade students and two teachers at Robb Elementary School, marking the deadliest school shooting in the U.S. in a decade.

The U.S. has been here before – after shootings in Tucson, Aurora, Newtown, Charleston, Roseburg, San Bernardino, Orlando, Las Vegas, Parkland, El Paso, Boulder, and 12 days earlier at a grocery store in Buffalo, N.Y.

Gun production and sales in the U.S. remain high, following a purchasing surge during the COVID-19 pandemic. In 2021, the firearms industry sold about six guns for every 100 Americans.

Senator Chris Murphy of Connecticut was among the Democratic politicians who pleaded for action on gun control as horrifying details of the Uvalde school shooting unfolded.

“What are we doing?” Murphy asked other lawmakers, speaking from the Senate floor on the day of the shooting. “Why are you here if not to solve a problem as existential as this?”

Congress has declined to pass significant new gun legislation after dozens of shootings, including those that occurred during periods like this one, with Democrats controlling the House of Representatives, Senate and presidency.

This response may seem puzzling given that national opinion polls reveal extensive support for several gun control policies, including expanding background checks and banning assault weapons.

In October 2021, 52% of people polled by Gallup said that they thought firearm sales laws should be made more strict.

But polls do not determine policy.

I am a professor of strategy at UCLA and have researched gun policy. With my co-authors at Harvard University, I’ve studied how gun laws change following mass shootings.

Our research on this topic finds there is legislative activity following these tragedies, but it’s at the state level.

A Democratic senator and Sandy Hook parents and teachers at a press conference in the US Capitol in 2013.
U.S. Senator Richard Blumenthal (D-Conn.) speaks to the media as teachers, parents and residents from Newtown, Conn. – where the Sandy Hook school massacre happened – listen after a Capitol Hill hearing on Feb. 27, 2013, on the Assault Weapons Ban of 2013. Alex Wong/Getty Images

Restrictions loosened

Stricter gun laws at the national level are more popular among Democrats than Republicans, and major new legislation would likely need votes from at least 10 Republican senators. Many of these senators represent constituencies opposed to gun control.

Despite national polls showing majority support for an assault weapons ban, not one of the 30 states with a Republican-controlled legislature has such a policy.

U.S. Texas Senator Ted Cruz said on May 24 that more gun control laws could not have prevented the Uvalde attack, explaining “that doesn’t work, it’s not effective, it doesn’t prevent crime.”

The absence of strict control policies in Republican-controlled states shows that senators crossing party lines to support gun control would be out of step with the views of voters whose support they need to win elections.

But a lack of action from Congress doesn’t mean gun laws are stagnant after mass shootings.

To examine how policy changes, we assembled data on shootings and gun legislation in the 50 states between 1990 and 2014. Overall, we identified more than 20,000 firearm bills and nearly 3,200 enacted laws. Some of these loosened gun restrictions, others tightened them, and still others did neither or both – that is, tightened in some dimensions but loosened in others.

We then compared gun laws before and after mass shootings in states where mass shootings occurred, relative to all other states.

Contrary to the view that nothing changes, state legislatures consider 15% more firearm bills the year after a mass shooting. Deadlier shootings – which receive more media attention – have larger effects.

In fact, mass shootings have a greater influence on lawmakers than other homicides, even though they account for less than 1% of gun deaths in the United States.

As impressive as this 15% increase in gun bills may sound, gun legislation can reduce gun violence only if it becomes law. And when it comes to enacting these bills into law, our research found that mass shootings do not regularly cause lawmakers to tighten gun restrictions.

In fact, we found the opposite. Republican state legislatures pass significantly more gun laws that loosen restrictions on firearms after mass shootings.

In 2021, Texas Governor Greg Abbott signed a new law that eliminated a requirement for Texans to obtain a license or receive training to carry handguns. This came two years after a 2019 mass shooting at a Walmart in El Paso.

That’s not to say Democrats never tighten gun laws – there are prominent examples of Democratic-controlled states passing new legislation following mass shootings.

California, for example, enacted several new gun laws following a 2015 mass shooting in San Bernardino. Our research shows, however, that Democrats don’t tighten gun laws more than usual following mass shootings.

After the Buffalo shooting in early May 2022, New York Governor Kathy Hochul said that she would work to increase the age for legal gun purchasing from 18 to 21 “at a minimum.”

'Change gun laws or change Congress' reads a sign at a 2018 rally in New York City.
In August 2018, Moms Demand Action hosted a rally at New York City’s Foley Square to call upon Congress to pass gun safety laws. Erik McGregor/LightRocket via Getty Images

Ideology governs response

The contrasting response from Democrats and Republicans is indicative of different philosophies regarding the causes of gun violence and the best ways to reduce deaths.

While Democrats tend to view social factors as contributing to violence, Republicans are more likely to blame the individual shooters.

Cruz, for example, has said that stopping individuals with criminal records from committing violence could help prevent mass shootings.

Politicians favoring looser restrictions on guns following mass shootings frequently argue that more people carrying guns would allow law-abiding citizens to stop perpetrators.

In fact, gun sales often surge after mass shootings, in part because people fear being victimized.

Democrats, in contrast, typically focus more on trying to solve policy and societal problems that contribute to gun violence.

For both sides, mass shootings are an opportunity to propose bills consistent with their ideology.

Since we wrote our study of gun legislation following mass shootings, which covered the period through 2014, several additional tragedies have energized the gun control movement that emerged following the December 2012 shooting at Sandy Hook Elementary School in Connecticut. These include the May 2022 shooting at the Tops grocery store in Buffalo, as well as the Uvalde school massacre.

While President Joe Biden issued executive orders in 2021 with the goal of reducing gun violence, action in Congress remains elusive. States, meanwhile, have been more active on the issue.

Student activism following the 2018 shooting at Marjory Stoneman Douglas High School in Parkland, Florida, did not result in congressional action but led several states to pass new gun control laws.

With more funding and better organization, this new movement is better positioned than prior gun control movements to advocate for stricter gun policies following mass shootings. Public outcry and devastation over the Uvalde shootings will likely provide fuel to this advocacy work.

But with states historically more active than Congress on the issue of guns, both advocates and opponents of new restrictions should look beyond Washington for action on gun policy.

This is an updated version of an article originally published on March 21, 2021.

Christopher Poliquin does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Read More

Continue Reading

Spread & Containment

Lactation Lab receives FDA Breakthrough Device designation for breast-milk-testing device that allows mothers to test for key nutritional elements in their milk

Los Angeles, May 25, 2022 –Lactation Lab, which offers the most scientifically advanced breast milk testing available, has announced today that the…

Published

on

Los Angeles, May 25, 2022 –Lactation Lab, which offers the most scientifically advanced breast milk testing available, has announced today that the U.S. Food and Drug Administration (FDA), has granted the company Breakthrough Device designation for its latest device Emily’s Care Nourish Test System that tests and provides a nutritional analysis of breast milk. 

Credit: Dr. Stephanie Canale

Los Angeles, May 25, 2022 –Lactation Lab, which offers the most scientifically advanced breast milk testing available, has announced today that the U.S. Food and Drug Administration (FDA), has granted the company Breakthrough Device designation for its latest device Emily’s Care Nourish Test System that tests and provides a nutritional analysis of breast milk. 

This first-of-its-kind breast-milk (point of care)-test allows mothers to test for key macronutrients (fat, protein, carbohydrates and adjust their nutritional intake accordingly. The test was developed for use in the NICU, hospital clinics, milk banks and home use. 

“The FDA Breakthrough Device designation for Emily’s Care Test System is a critical step in serving the most vulnerable infant population,” says Dr. Stephanie Canale, CEO of Lactation Lab. “Research in the past five years demonstrates how important key nutrients are for babies in the first five weeks of life. Nutrition is the only modifiable factor for preterm babies, and our Emily’s Care device provides potentially life-saving data, especially for those at risk of life-threatening conditions.”

The FDA Breakthrough Device designation will expedite regulatory review of Emily’s Care to provide patients and health care providers with quicker access. The designation is only awarded to breakthrough technologies that have the potential to provide effective treatment and diagnosis for life-threatening or irreversible debilitating diseases or conditions.

Founded in 2017 by CEO Dr. Stephanie Canale, Lactation Lab’s proprietary tests were developed by a team of practicing physicians, Ph.D. chemists and toxicologists. The startup company is housed at the Magnify Incubator at the California NanoSystems Institute at UCLA, which provides access to one of the most advanced research labs in the world. 

Lactation Lab is pioneering academic research in breast milk composition, also publishing findings in several prominent scientific journals, including Breastfeeding Medicine and Clinical Lactation.

Canale, a physician formerly at UCLA whose practice largely consisted of new mothers and babies, started Lactation Lab to provide parents with scientific and evidence-based insights, resources, and guidance. As a mom with an infant diagnosed with “failure to thrive,” also known as growth faltering. Canale wondered why there was no way to know what was in her own breast milk. 

“The time is now to empower moms with the kind of information and peace of mind I needed during my own breastfeeding journey. During the Covid-19 pandemic, amid the anxiety of leaving the home and going to doctor’s visits, we decided to bring Emily’s Care directly to mothers and take the guesswork out of breastfeeding,” said Canale. 

Lactation Lab’s breast-milk-test surpasses the creamatocrit breast milk test first developed in 1978. This rudimentary test is still widely used in hospitals, NICUs and support centers. Lactation Lab’s Emily’s aims to replace the existing test with Emily’s Care, which provides more accurate data than infra-red human milk analyzers. The company also just launched Emily’s Care infant supplement, which is the first infant supplement to receive Clean Label Project Certification and will support breastfeeding babies.

“We would like to continue advancements in women’s health to remove the current stigma around postpartum care and breastfeeding,” said Canale. “The data supports objective, evidence-based decision-making not only for hospitals and NICUs, but also for mothers at home. These are revolutionary steps to improve the standard of care surrounding breast milk for mom and baby.” 

Currently in the seed round of funding. Those interested in investing in Lactation Lab may reach out to scanale@lactationlab.com. To learn more, visit lactationlab.com and join the conversation @lactationlab.

About Lactation Lab

Founded by CEO Stephanie Canale, a doctor and mother of two, Lactation Lab is a first-of-its-kind breast-milk-testing kit. Lactation Lab analyzes your breast milk for basic nutritional content like calories and protein, as well as vitamins, fatty acids, and environmental toxins. Results are delivered in a user-friendly report that reads like a food label. Lactation Lab explains how results affect children, offers suggestions for enhancing the quality of milk, and offers personal consultation. Other products include mastitis screening test strips and the company will soon be launching a Clean Label certified infant supplement. Learn more at www.lactationlab.com.

About the FDA Breakthrough Device Program

The FDA Breakthrough Device program enables expedited regulatory assessment of novel technologies with the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.

About Magnify Incubator at the California NanoSystems Institute at UCLA 

Centrally located at UCLA’s Court of Sciences, Magnify strives to enhance the vibrant culture of entrepreneurship at UCLA and the broader Los Angeles region. Magnify was built with one goal in mind: to help startups succeed by vastly accelerating their access to facilities while increasing their capital efficiency and market opportunities.

Related Links

www.lactationlab.com
magnify.cnsi.ucla.edu

Learn more about Lactation Lab from CEO Dr. Stephanie Canale
https://www.youtube.com/watch?v=3t4Q1OX05lg


Read More

Continue Reading

Trending