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The Complex Ethical Morass of COVID-19 Human Challenge Trials

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Two institutions in England have launched COVID-19 human challenge testing, where participants are deliberately infected with the SARS-CoV-2 virus. Despite the approval of these studies by European regulators, debates continued over whether the ethical justification was sufficient.

Studies conducted at Imperial College London and the University of Oxford are still in the early stages and have recruited participants aged 18 to 30 who have no risk factors for severe COVID-19 illness.

But the studies make a big difference. The Oxford study will look at how much protection is needed to avoid re-infection, which means participants have already had COVID-19. However, the trial at Imperial College London will infect people who have not previously been exposed.

Human challenge studies have been highly controversial since the pandemic began when they were published as studies that could speed up the development and production of vaccines. Such studies can provide critical insight into a pathogen faster than standardized clinical studies, which makes the case for conducting them during a public health emergency attractive.

However, some bioethicists say that the use of these studies to research COVID-19 is still not warranted due to the availability of vaccines to prevent infection, uncertainty about the long-term effects of the disease, and the lack of rescue treatment for participants who fall severely is sick.

Providing critical insights

Arthur Caplan, PhD, director of the department of medical ethics at NYU Grossman School of Medicine in New York City, said testing is required to quickly answer certain questions. For example, in regions where there are new outbreaks, these studies could be used to test the effectiveness of a vaccine against a new variant, answer questions about mixing vaccine doses, or test new immunizations.

“There are fundamental lessons we could learn from challenge studies on coronavirus,” Seema Shah, JD, bioethicist at Lurie Children’s Hospital in Chicago, told MedPage Today. The Oxford study, for example, could give scientists more information on who is protected from COVID-19 reinfection and how exactly they are protected.

Shah said that understanding protection, such as whether it is related to the lining of a patient’s nasal passage or the antibodies in their bloodstream, could be critical to developing better tests or vaccines. However, a solid ethical justification is required.

A “checkered” ethics story

Scientists have used challenge studies to study disease for hundreds of years. Prior to the COVID-19 pandemic, challenge studies helped researchers learn about and develop vaccines against diseases such as smallpox, malaria, cholera, and influenza.

But while appeal procedures have their place, they have not always been ethically justified. Daniel Sulmasy, MD, PhD, director of the Kennedy Institute of Ethics at Georgetown University in Washington DC, told MedPage Today that “Challenge Trials have a checkered history.”

Some studies, he said, have been widely condemned, such as the U.S. sexually transmitted disease experiments in Guatemala after World War II or the Willowbrook hepatitis experiments that tested vaccines on children with intellectual disabilities, which only ended in 1972.

Sulmasy found that we came a long way from these experiments using specific criteria to conduct challenge experiments. But in the face of a public health emergency like the COVID-19 pandemic, “we should be careful playing too quickly and too loosely on these criteria,” he said.

Prove social worth

In a position published in JAMA Internal Medicine, Sulmasy said the ethical justification for the COVID-19 challenge study at Imperial College London “is not sufficient”. He outlined an ethical framework for conducting Challenge Trials that includes considerations such as social and scientific justification, harmlessness, and justice.

One of the first ethical questions to consider before taking a Human Challenge test is whether or not it has any social value – that is, what kind of information will the study examine and how will it make a difference?

Sulmasy said evidence of social worth in the Imperial College London trial was not warranted. Although there is a societal and scientific justification for studying a disease like COVID-19, which has significant morbidity and mortality, he stressed that the availability of vaccines diminishes the power.

“We already have a number of effective vaccines available,” he said. “So why we have to hurry into a challenge process with all its problems seems questionable to me.”

Because the study is being conducted in young and healthy volunteers to minimize the risk of developing serious illness, the results may not be applicable to an older, higher-risk population, he said.

First of all, don’t be a pity

Sulmasy also said it was important to assess the risks to participants and whether or not those risks are justified. A main argument against conducting challenge studies is that the risks associated with the disease are still poorly understood.

“In some types of challenge studies, such as malaria, the disease has been around for thousands of years,” he noted. However, with COVID-19, we are only scratching the surface to understand the long-term consequences of disease.

“So we’re not just exposing people to the known risks of death. We are also not aware of the long-term consequences of infection, ”he said.

In addition, Sulmasy stressed that we do not have any rescue therapy that is ethically necessary.

However, in a recent comment in the BMJ, Seán O’Neill McPartlin, Abie Rohrig and Josh Morrison, representatives of 1Day Sooner, an advocacy group for participants in Human Challenge Trials, argued that rescue therapies are not a prerequisite for COVID. should be -19 challenge attempt. They suggested that there shouldn’t be a “standard of rescue therapy” as there are no rescue therapies for the flu and respiratory syncytial virus – both of which have been studied in challenge studies.

Equity and concerns about financial incentives

There are many important questions to consider when recruiting participants for challenge studies, Sulmasy said. The trial at Imperial College London does not appear to have any overt justice issues, such as conducting experiments in vulnerable populations. But it will pay attendees £ 4,500 for their time – about $ 6,300.

“I’m just a little worried about the amount of money they give people,” Sulmasy said. The concern is that greater financial incentive could attract people with economic adversity that could overlap with those at higher risk of disease, he added.

Shah said that when it comes to human challenge attempts, it is important “to ensure that people are adequately paid for the time and stress they take”. She acknowledged that there are concerns that high financial incentives could attract people who would sign up against their better judgment. However, she added that previous research suggested that people motivated by money are no less likely to consider and understand the risks of a challenge process than those motivated by altruism.

Avoiding ethical exceptions

Shah said the Oxford challenge study has different ethical considerations than the one at Imperial College London, as infecting people who have already had COVID-19 is likely safer than infecting people who have never been exposed. But the disease risks, she added, are still too unclear to make a good case for conducting challenge studies.

“The big problem for me is that there is still a lot of uncertainty about the risk of COVID,” said Shah. “That’s what makes me pause.”

For Sulmasy, adherence to principles and criteria for conducting challenge tests is essential. When difficult and urgent circumstances arise, such as the COVID-19 pandemic, the criteria for these studies allow researchers to know the limits of their ability and inability to do so. “I think we should be wary of ethical exceptionalism,” he said.

“The ends don’t justify the means,” he added. “We stick to these principles because that is exactly the kind of situation [in which] We need them.”

  • Amanda D’Ambrosio is a reporter on the MedPage Today corporate and investigation team. She covers obstetrics, gynecology and other clinical news and writes articles on the US healthcare system. consequences

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Colorado receives $94 million federal funding boost for behavioral health services – State of Reform

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The Colorado Department of Human Services, Office of Behavioral Health (OBH) will receive more than $ 94 million in additional federal block grants over the next four years to increase drug use and mental health services as the state relies on that higher demand responded to that caused by the Covid19 pandemic.

OBH has worked with stakeholders including the state health planning and advisory board and a diverse group of providers to set priorities for the stimulus funds. Out of dozens of projects, OBH will use the first round of stimulus dollars totaling more than $ 43 million to fund equity, diversity and inclusion efforts; Peer support and recovery services; and treating people with severe mental illness (SMI) and substance use disorders.

“As we struggle with heightened behavioral health needs in Colorado, this funding will help us meet the requirements caused by COVID and even expand services across the state,” said Robert Werthwein, director of OBH. “We are grateful to our federal partners for recognizing the importance of the problem and giving us the tools to deal with the crisis.”

As part of the Coronavirus Response and Relief Supplemental Appropriations Act (CRRSA), the federal government has Drug Abuse Management and Mental Health Services (SAMHSA) has awarded the OBH an additional $ 27.1 million for the state’s Block Grant Program for the Prevention and Treatment of Substance Abuse (SABG) and an additional $ 16.2 million for the Community Mental Health Services (MHBG) block grant program, which must be issued by March 14, 2023. The block grants are administered by the OBH and are non-competitive federal awards that fund behavioral health services in all 50 states.

In addition to that boost, OBH will receive an additional $ 23.4 million and $ 28.1 million, respectively, for the SABG and MHBG programs through the American Rescue Plan Act (ARPA) stimulus package. OBH has these dollars to spend by September 30, 2025 and is working on a spending plan to support programs that have seen increased demand during the pandemic. Many of the priorities from the CRRSA funds are expanded through the ARPA funds. The state’s plan for the ARPA fund is due on July 2nd.

The preliminary spending plan for the $ 43 million CRRSA fund includes the following allocations for the next two years. The funding amounts could change depending on the bills passed in the 2022 legislative period or on emerging priorities.

Mental health and substance use funding plan for CRRSA funds

  • $ 5.28 million for peer-based recovery support services associated with SUD treatment providers, including those who have involuntarily committed to SUD treatment. Financing is provided by the state’s managed service organizations
  • $ 5 million for residential drug use treatment, withdrawal management (detox), and involuntary commitment services
  • $ 4.9 million to support the workforce, including training peer specialists and efforts to attract more blacks, indigenous and blacks (BIPOC) to behavioral health
  • $ 4.84 million for programs to support the mental health of children, adolescents and young adults
  • $ 3 million for assertive community or community-based treatment for adults with SMI
  • $ 2.8 million for Individual placement and support, a program to help people with mental illness and / or addictions find and keep a job
  • $ 2.6 million for programs that connect mothers, pregnant women and parents with behavioral health and recovery services
  • $ 2.35 million for the behavioral health crisis system, including safe transportation and marketing for diverse populations
  • $ 1.875 million for the state Forward together Prevention campaign
  • $ 1.875 million to expand school substance abuse screening
  • $ 1.68 million for drug abuse prevention programs among adolescents, particularly in BIPOC and LGBTQ communities
  • $ 1.5 million in peer-based mental health and drug use services across the state, including tribal and Latinx communities
  • $ 1.05 million for vacation homes and Housing assistance for people with SMI who are not housed
  • $ 700,000 in SUD services to tribal people across the state
  • $ 600,000 for a public awareness campaign on behavioral health related to the effects of the pandemic
  • $ 600,000 for a position as Director of Justice and Community Engagement, OBH form translation and branding materials, and public relations grants for organizations working with EDI populations
  • $ 450,000 for OBH’s bed capacity register

Approximately $ 2.3 million of the CRRSA grant will meet OBH’s administrative costs.

This news release was provided by the Colorado Department of Human Services.

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Get Ready for NORD’s Patient and Family Forum, Set for June 26-27

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Those who wish to acquire practical tools for living optimally with rare diseases are encouraged to attend the annual Living Rare Living Stronger Patient and Family Forum, hosted by the National Organization for Rare Disorders (NORD), and this year 26-26 June 27th takes place.

The conference brings together patients, families, healthcare professionals and other supporters to learn, share and connect.

Due to the ongoing COVID-19 pandemic, general sessions, breakout workshops and networking will again be virtual. The sessions, which provide perspectives from patients, caregivers and the medical community, are broadcast live and recorded for later viewing. Throughout the forum, participants can visit the exhibition hall and meet with other participants.

Also this year the Rare Impact Awards return as part of the program. This June 28 presentation honors individuals, organizations and industry innovators for their exceptional work benefiting the rare disease community.

“The health and well-being of people with rare diseases, their relatives and those who work to improve their lives continue to have top priority for all of us here at NORD,” said the forum message.

“The COVID-19 pandemic has given us new ways to connect with our community, and our 2020 virtual program has been the most successful forum to date! In 2021 we will continue to work hard to keep our community healthy and safe while we participate in this effective program, ”said NORD.

Registration for the “patient-centered” event costs US $ 39 for patients, nurses, students and representatives of the NORD patient organization. The cost is $ 75 for professional lawyers, scientists, doctors, and government officials and $ 500 for members of the NORD corporate council. For pharmaceutical, insurance, or other agents, registration is $ 650.

On the agenda is the opening discussion on the subject of “Patient-Professional Partnership” and includes three stories about the close bond between patients and their caregivers.

Breakout sessions for Saturday, June 26th, include “Coping with Graef and Anticipatory Grief”, “Shared Decision-Making with Your Care Team” and “Working While Rare”, followed by “Involving in Clinical Research: Finding” and Preparing for Clinical Trials, ”“ Navigating Insurance, Social Security Disability, and Patient Aid Programs, ”and“ The ABCs of Advocating Your Child’s Education ”in the second group of workshops.

This is followed by a plenary discussion on the subject of “Building resilience in a time of the unknown”. Speakers will examine how patients have coped while waiting for a diagnosis, how they fare while waiting for new treatments, and how they kept it together during the pandemic.

June 27th begins with an opening discussion in the plenum entitled “The Rare Sibling Experience”. Here, three siblings of rare disease patients will share their experiences, including how they became advocates.

Breakout sessions that day include “Fight Back and Fight Forward by Advocacy”, “Palliative Care: Unmasking the Myths”, “Rarely in the Family: Navigating the Roles of Patient, Parent, and Caregiver” in the early discussion groups. Later offerings this Sunday will include “Aging with a Rare Disease”, “Finding Your Community and Building Your Support Network” and “The Intersection of Race, Ethnicity and Equality with Access to Diagnosis and Treatment”.

The concluding plenary discussion, entitled “Rare Breakthroughs Now and on the Horizon”, will look at the latest advances in the diagnosis, treatment and care of rare diseases.

At the beginning of the year, NORD called on people to report on their practical experiences with rare diseases at the conference. A total of around 55 speakers will attend the conference, including doctors, nurses and other health professionals. Access to the virtual program will be provided by email during the week of the event.

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Never ignore these 6 signs in your pets

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From Dr. Cynthia Maro

There are times when your pets are begging for extra treats, attention, or play time and it’s safe to ignore, but some signs that can start out as simple nuisances can be leading indicators of very serious health problems.

Knowing which signs require your attention and action can be life saving for your companion. The sooner you alert your veterinarian to these symptoms, the more likely they are to make a diagnosis and get your furry friend on the road to restoring health.

Below are some key indicators of illness.

1. Panting, Increased Breathing Rate, Open-Mouth Breathing: Panting can be a sign of pain, heat stroke, fever, or respiratory or cardiovascular problems.

A pet’s respiratory rate will increase as the need for oxygen increases, which can occur with all of the aforementioned diseases.

Cats always prefer to breathe through their nose. So if you breathe with your mouth open it is a sure sign of stress that can be the result of extreme stress, asthma, upper airway obstruction, heart or lung disease, or even cancer.

Increased respiratory rates also occur in infections that cause very high fevers or hyperthermia from heat stroke.

Wheezing that persists after a game of play and adequate rest should be taken seriously.

Conditions such as congestive heart failure, anemia, pneumonia, or pleural effusion (a condition where fluid fills the chest cavity and compresses the lungs) all need to be diagnosed through blood tests and x-rays.

All of these disorders can be life-threatening, and in cases such as heat stroke, immediate treatment through an emergency room visit is needed.

2. Salivation: This may be a sign of gastrointestinal discomfort, nausea, a foreign body in the mouth or throat, an oral tumor or infection, a sialocele (disorder of the salivary glands), a lymphoma or a tooth root abscess.

Diagnosis may include sedated oral inspection and x-rays.

3. Increased thirst: Thirst will increase slightly in hot weather or with an increase in salty snacks (think jerky, bully sticks, and rawhide). Prolonged increases in water consumption must be considered as it may be due to diabetes mellitus, diabetes insipidus, kidney disease or kidney failure, VBD (vector-borne disease, such as Lyme disease), an endocrine or hormonal imbalance such as Cushing’s disease or thyroid disease.

Diagnosis requires urinalysis, blood chemistry tests, and in some cases, more expensive hormone tests and ultrasounds.

4. Odor Change: Although pets can sometimes have an odor when it rains, a persistent or foul odor is often the first sign of illness.

“A smelly pet” can indicate something as small as a superficial skin or ear infection, or something much more serious, including an infected anal gland or a deep ear infection. These diseases can be treated very effectively by your veterinarian.

Some other worrying issues include odors from oral infections or tumors, deep skin infections, hormonal imbalances, diabetes, internal or external yeast or bacterial infections, anal gland narrowing, ulcerated skin tumors, or sinus infections.

5. Appetite Change: Lack of or increased appetite in pets should never be ignored.

Often times a pet has an increased appetite when they develop diabetes, but this sign can also be associated with certain types of cancer or tumors such as insulinoma, hyperthyroidism, Cushing’s disease, or adrenal cancer.

Pets often have a decreased appetite when battling infections, in pain, or having gastrointestinal disorders. The list of diseases that affect appetite is quite long.

6. Vomiting and diarrhea: Bowel discomfort or intermittent gastrointestinal symptoms (such as spitting once a week or even once a month) are signs that some part of the digestive process is not working properly.

Diagnoses such as intestinal parasites, food sensitivity, liver, gallbladder, and pancreatic diseases can all be treated with medication, but require a visit to the vet for appropriate treatment.

Your pet’s vet will know what tests to order to get insight into the cause of any of the signs mentioned.

If your fears of a negative or poor diagnosis are preventing you from taking action, please discuss this with your veterinarian. It’s always best to investigate early.

If you are concerned about high costs, your vet will want to know both your time and financial budget to care for your companion.

Not only can your quick attention to the warning signs of illness help your pet get better, but they can also reassure you, knowing that your companion will be comfortable, pain-free, and well-cared for.

Dr. Cynthia Maro is a veterinarian at Ellwood Animal Hospital in Ellwood City and Chippewa Animal Hospital in Chippewa Township. She writes a bi-weekly column on animal care and health issues. If you have a topic you’d like to address, email ellwoodvet@msn.com.

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