Health
FDA Proposes Individual Risk Assessment for Blood Donations, While Continuing to Safeguard U.S. Blood Supply
The U.S. Food and Drug Administration today announced it is proposing a change from time-based deferrals to assessing blood donor eligibility using gender-inclusive, individual risk-based questions to reduce the risk of transfusion-transmitted HIV. This proposal is in line with policies in place in countries like the United Kingdom and Canada.
These draft recommendations are based on the FDA’s careful review of available information, including data from other countries with similar HIV epidemiology that have instituted this approach, as well as ongoing surveillance of the U.S. blood supply. Based on the available data, the agency believes the implementation of the proposed individual risk-based questions will not compromise the safety or availability of the blood supply.
“Whether it’s for someone involved in a car accident, or for an individual with a life-threatening illness, blood donations save lives every day,” said FDA Commissioner Robert M. Califf, M.D. “Maintaining a safe and adequate supply of blood and blood products in the U.S. is paramount for the FDA, and this proposal for an individual risk assessment, regardless of gender or sexual orientation, will enable us to continue using the best science to do so.”
Under the new proposed guidance:
- The time-based deferrals for men who have sex with men (MSM) and women who have sex with MSM would be eliminated.
- The current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months.
- Prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, would then be asked about a history of anal sex in the past three months.
- All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past three months would be deferred from donation.
- Under this proposal, a prospective donor who does not report having new or multiple sexual partners, and anal sex in the past three months, may be eligible to donate, provided all other eligibility criteria are met.
Other considerations in the guidance include:
- No change in the donor deferral time periods for other HIV risk factors, including for individuals who have exchanged sex for money or drugs or have a history of non-prescription injection drug use.
- Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently.
- Blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B and hepatitis C.
Proposed guidance related to pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP):
- Those taking oral medications to prevent HIV infection such as PrEP or PEP would be deferred for three months from their most recent dose.
- Those taking injectable PrEP to prevent HIV infection would be deferred for two years from their most recent injection.
- Some blood establishments currently have deferral policies related to the use of medications to prevent HIV infections.
- The available data demonstrate that the use of PrEP and PEP may delay detection of HIV by licensed screening tests for blood donations, potentially resulting in false negative results.
The agency recognizes that, while these draft recommendations, when finalized, will potentially increase the number of individuals eligible to donate blood, some individuals will still be deferred from donating blood. However, this does not mean that individuals taking PrEP should stop taking these medications to donate blood. The FDA will continue to track the latest data relevant to PrEP and blood donation.
“Our approach to this work has always been, and will continue to be, based on the best available science and data. Over the years, this data-driven process has enabled us to revise our policies thereby increasing those eligible to donate blood while maintaining appropriate safeguards to protect recipients,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We will continue to follow the best available scientific evidence to maintain an adequate supply of blood and minimize the risk of transmitting infectious diseases and are committed to finalizing this draft guidance as quickly as possible.”
To inform these draft recommendations, the FDA carefully reviewed numerous data sources, including data from the United Kingdom and Canada, countries with similar HIV epidemiology that have implemented this gender-inclusive, individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, and the performance characteristics of nucleic acid testing for HIV. Additionally, the agency funded the Assessing Donor Variability And New Concepts in Eligibility (ADVANCEExternal Link Disclaimer) study. This study examined several HIV risk factors, such as anal sex, rates of HIV infection and rates of PrEP and PEP use among MSM study participants.
As part of the FDA’s established process, today’s proposal will be open for public comment for 60 days. The agency will then review and consider all comments before finalizing this guidance, which would then be implemented by the nation’s blood collection establishments through an updated donor history questionnaire.
Related Information
- Keeping Blood Transfusions Safe: FDA’s Multi-layered Protections for Donated Blood
- Blood & Blood Products
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Lifestyle
Biden helped bring science out of the lab and into the community − emphasizing research focused on solutions
Arthur Daemmrich, Arizona State University
President Joe Biden was inaugurated in January 2021 amid a devastating pandemic, with over 24 million COVID-19 cases and more than 400,000 deaths in the U.S. recorded at that point.
Operation Warp Speed, initiated by the Trump administration in May 2020, meant an effective vaccine was becoming available. Biden quickly announced a plan to immunize 100 million Americans over the next three months. By the end of April 2021, 145 million Americans – nearly half the population – had received one vaccine dose, and 103 million were considered fully vaccinated. Science and technology policymakers celebrated this coordination across science, industry and government to address a real-world crisis as a 21st-century Manhattan Project.
From my perspective as a scholar of science and technology policy, Biden’s legacy includes structural, institutional and practical changes to how science is conducted. Building on approaches developed over the course of many years, the administration elevated the status of science in the government and fostered community participation in research.
Raising science’s profile in government
The U.S. has no single ministry of science and technology. Instead, agencies and offices across the executive branch carry out scientific research at several national labs and fund research by other institutions. By elevating the White House Office of Science and Technology Policy to a Cabinet-level organization for the first time in its history, Biden gave the agency greater influence in federal decision-making and coordination.
Formally established in 1976, the agency provides the president and senior staff with scientific and technical advice, bringing science to bear on executive policies. Biden’s inclusion of the agency’s director in his Cabinet was a strong signal about the elevated role science and technology would play in the administration’s solutions to major societal challenges.
Under Biden, the Office of Science and Technology Policy established guidelines that agencies across the government would follow as they implemented major legislation. This included developing technologies that remove carbon dioxide from the atmosphere to address climate change, rebuilding America’s chip industry, and managing the rollout of AI technologies.
Instead of treating the ethical and societal dimensions of scientific and technological change as separate from research and development, the agency advocated for a more integrated approach. This was reflected in the appointment of social scientist Alondra Nelson as the agency’s first deputy director for science and society, and science policy expert Kei Koizumi as principal deputy director for policy. Ethical and societal considerations were added as evaluation criteria for grants. And initiatives such as the AI bill of rights and frameworks for research integrity and open science further encouraged all federal agencies to consider the social effects of their research.
The Office of Science and Technology Policy also introduced new ways for agencies to consult with communities, including Native Nations, rural Americans and people of color, in order to avoid known biases in science and technology research. For example, the agency issued government-wide guidance to recognize and include Indigenous knowledge in federal programs. Agencies such as the Department of Energy have incorporated public perspectives while rolling out atmospheric carbon dioxide removal technologies and building new hydrogen hubs.
Use-inspired research
A long-standing criticism of U.S. science funding is that it often fails to answer questions of societal importance. Members of Congress and policy analysts have argued that funded projects instead overly emphasize basic research in areas that advance the careers of researchers.
In response, the Biden administration established the technology, innovation and partnerships directorate at the National Science Foundation in March 2022.
The directorate uses social science approaches to help focus scientific research and technology on their potential uses and effects on society. For example, engineers developing future energy technologies could start by consulting with the community about local needs and opportunities, rather than pitching their preferred solution after years of laboratory work. Genetic researchers could share both knowledge and financial benefits with the communities that provided the researchers with data.
Fundamentally, “use-inspired” research aims to reconnect scientists and engineers with the people and communities their work ultimately affects, going beyond publication in a journal accessible only to academics.
The technology, innovation and partnerships directorate established initiatives to support regional projects and multidisciplinary partnerships bringing together researchers, entrepreneurs and community organizations. These programs, such as the regional innovation engines and convergence accelerator, seek to balance the traditional process of grant proposals written and evaluated by academics with broader societal demand for affordable health and environmental solutions. This work is particularly key to parts of the country that have not yet seen visible gains from decades of federally sponsored research, such as regions encompassing western North Carolina, northern South Carolina, eastern Tennessee and southwest Virginia.
Community-based scientific research
The Biden administration also worked to involve communities in science not just as research consultants but also as active participants.
Scientific research and technology-based innovation are often considered the exclusive domain of experts from elite universities or national labs. Yet, many communities are eager to conduct research, and they have insights to contribute. There is a decades-long history of citizen science initiatives, such as birdwatchers contributing data to national environmental surveys and community groups collecting industrial emissions data that officials can use to make regulations more cost effective.
Going further, the Biden administration carried out experiments to create research projects in a way that involved community members, local colleges and federal agencies as more equal partners.
For example, the Justice40 initiative asked people from across the country, including rural and small-town Americans, to identify local environmental justice issues and potential solutions.
The National Institutes of Health’s ComPASS program funded community organizations to test and scale successful health interventions, such as identifying pregnant women with complex medical needs and connecting them to specialized care.
And the National Science Foundation’s Civic Innovation Challenge required academic researchers to work with local organizations to address local concerns, improving the community’s technical skills and knowledge.
Frontiers of science and technology policy
Researchers often cite the 1945 report Science: The Endless Frontier, written by former Office of Scientific Research and Development head Vannevar Bush, to describe the core rationales for using American taxpayer money to fund basic science. Under this model, funding science would lead to three key outcomes: a secure national defense, improved health, and economic prosperity. The report, however, says little about how to go from basic science to desired societal outcomes. It also makes no mention of scientists sharing responsibility for the direction and impact of their work.
The 80th anniversary of Bush’s report in 2025 offers an opportunity to move science out into society. At present, major government initiatives are following a technology push model that focuses efforts on only one or a few products and involves little consideration of consumer and market demand. Research has repeatedly demonstrated that consumer or societal pull, which attracts development of products that enhance quality of life, is key to successful uptake of new technologies and their longevity.
Future administrations can further advance science and address major societal challenges by considering how ready society is to take up new technologies and increasing collaboration between government and civil society.
Arthur Daemmrich, Professor of Practice in the School for the Future of Innovation in Society, Arizona State University
This article is republished from The Conversation under a Creative Commons license. Read the original article.
The science section of our news blog STM Daily News provides readers with captivating and up-to-date information on the latest scientific discoveries, breakthroughs, and innovations across various fields. We offer engaging and accessible content, ensuring that readers with different levels of scientific knowledge can stay informed. Whether it’s exploring advancements in medicine, astronomy, technology, or environmental sciences, our science section strives to shed light on the intriguing world of scientific exploration and its profound impact on our daily lives. From thought-provoking articles to informative interviews with experts in the field, STM Daily News Science offers a harmonious blend of factual reporting, analysis, and exploration, making it a go-to source for science enthusiasts and curious minds alike. https://stmdailynews.com/category/science/
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Health
Know These 4 Core Factors to Avoid a Heart Health Syndrome
(Family Features) In the U.S., 1 in 3 adults is at risk for a newly recognized syndrome that comes from a combination of heart disease, kidney disease, type 2 diabetes and excess body weight. This cluster of conditions, called cardiovascular-kidney-metabolic (CKM) syndrome, is an example of how problems in one part of your body can affect other parts.
To avoid CKM syndrome, health experts suggest paying close attention to four of the American Heart Association’s Life’s Essential 8 – blood pressure, lipids, body weight and blood sugar level – which are core health factors that impact your metabolic health.
Good metabolic health means your body uses energy well and keeps these factors in a normal range. However, when numbers are off in one area, it can affect others, raising your risk for heart disease, stroke, kidney disease and diabetes.
Consider these tips from the American Heart Association to help keep your core health factors under control.
Blood Pressure
High blood pressure, also known as hypertension, happens when the force of your blood pushing against the walls of your blood vessels is too high. High blood pressure is a leading cause of heart disease, stroke and kidney disease.
Because high blood pressure doesn’t have symptoms, the only way to know you have it is to get your blood pressure checked. Healthy blood pressure is below 120/80. If your blood pressure is 130/80 or higher, talk to your doctor about checking your other core health factors.
Lifestyle changes can help reduce high blood pressure. One example is a Dietary Approaches to Stop Hypertension (DASH) eating pattern that’s low in fat and rich in fruits, vegetables, whole grains and low-fat dairy products. Losing 10 pounds and reducing alcohol consumption can also reduce blood pressure.
Cholesterol
Cholesterol is a waxy substance your liver makes then circulates in the blood where your body uses it to build cells and make vitamins and hormones. You may also get cholesterol from eating animal products. If there’s too much cholesterol circulating, your risk of type 2 diabetes, heart disease and stroke may increase.
For optimal CKM health, your LDL cholesterol should be below 100 and triglycerides below 150. Triglycerides are the most common type of fat in the body. If your triglyceride level is 135 or higher, talk to your doctor about decreasing your risk.
Losing body weight and increasing physical activity decrease triglyceride levels. In addition, DASH and Mediterranean (plant-based, high-fiber, low-fat) eating patterns support healthy LDL and triglyceride levels.
Body Weight
Healthy weight may be determined by body mass index (BMI), a number that represents your weight in relation to your height. Extra body fat can mean a higher risk for many health problems, including heart disease, stroke, high blood pressure, high cholesterol and diabetes.
CKM syndrome starts when BMI is 25 or higher and waist circumference is 88 centimeters or higher for women and 102 centimeters or higher for men. Aim for a BMI between 18.5-25.
To lose weight and keep it off, start by setting realistic goals. Understand how much and why you eat, manage portion sizes, make smart snack substitutions and be physically active.
Blood Sugar
High blood sugar can slowly damage the kidneys. In fact, diabetes is the leading cause of kidney disease, and it increases the risk of heart attack and stroke.
Blood sugar is measured in two ways: a fasting blood glucose test (short term blood sugar) and an A1C test (long term blood sugar control). A normal fasting blood glucose level is 70-99 and a normal A1C level is below 5.7%. Fasting blood glucose above 125 and A1C of 6.5% or higher means you have diabetes.
Habits that help you avoid high blood pressure, weight gain and high cholesterol also keep your blood sugar in check. These are especially important if you have a family history of diabetes.
Learn more about CKM syndrome and how to manage your risk at heart.org/CKMhealth.
Photos courtesy of Shutterstock
SOURCE:
American Heart Association
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Lifestyle
Expert Pregnancy Tips for Staying Healthy This Winter
(Family Features) Staying up to date on recommended vaccines is important during pregnancy. This is especially true during the winter months when more people tend to get sick from flu, COVID-19 and RSV. These viruses can be especially dangerous for pregnant people and babies.
Vaccines are an important part of routine pregnancy care, both for you and your baby. Getting vaccinated against flu and COVID-19 can cut your risk of hospitalization by about half.
Now is the time to get vaccinated if you haven’t already. Flu vaccines help protect you from getting the flu and getting seriously ill, so it’s a good idea to schedule an appointment now. The latest COVID-19 vaccines are important too because they lower your risk of serious illness. An RSV vaccine may also be recommended for when you are 32-36 weeks pregnant. Be sure to talk to your doctor.
“Right now, we are seeing a concerning increase in cases of respiratory diseases, such as the flu, COVID-19 and RSV,” said Adm. Rachel Levin, MD, assistant secretary for health at the U.S. Department of Health and Human Services. “I encourage all pregnant people to take preventive action to protect their health and the health of their baby. The best and safest way to do this is to get vaccinated. Getting vaccinated is easy and is usually covered by insurance.”
Help Protect Your Baby
When you get flu, COVID-19 and RSV vaccines, you’re helping protect your baby by passing your immunity on to them. Getting vaccinated against flu, COVID-19 and RSV during pregnancy can protect your baby during the first 6 months of life. These viruses can be very harmful to newborns. In fact, RSV is the leading cause of hospitalization in infants
Talk to Your Doctor About Timing
Millions of people in the U.S. have already gotten vaccinated against flu, COVID-19 and RSV this season. If you haven’t gotten your vaccines yet, be sure to talk with your doctor. They can help you choose the right vaccines and determine the best timing to help protect you and your baby.
Get the Facts
Getting vaccinated can give you peace of mind, ensuring you have done everything you can to protect yourself and your baby from serious respiratory illness. Information can give you power and comfort, especially when you’re pregnant.
Go to cdc.gov/RiskLessDoMore to learn more about flu, COVID-19 and RSV vaccines, or go to vaccines.gov to get started today.
Photo courtesy of Shutterstock
SOURCE:
U.S. Department of Health and Human Services
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