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
Even 1 drink a day elevates your cancer risk – an expert on how alcohol affects the body breaks down a new government report
Many people use the new year to reflect on their relationship with alcohol. Just-released government guidelines are giving Americans another reason to consider a “dry January.”
Over the past few decades, mounting scientific evidence has shown that as little as 1-2 alcoholic drinks per day can lead to increases in the likelihood of several cancers. This prompted the U.S. surgeon general, Dr. Vivek Murthy, to release a new Surgeon General Advisory on Jan. 3, 2025, warning about the link between alcohol and cancer. This report highlighted the evidence and included a call for new cancer warning labels on alcoholic beverages.
The association between alcohol and cancer isn’t new news – scientists have been trying to determine the link for decades – yet most people aren’t aware of the risks and may only associate drinking with liver disease like cirrhosis. In a 2019 survey from the American Institute for Cancer Research, less than half of Americans identified alcohol as a risk factor for cancer.
Alcohol is the third-most preventable cause of cancer in the U.S, putting it just behind tobacco and obesity. As the surgeon general’s report highlights, alcohol is associated with approximately 100,000 cancer cases and 20,000 cancer deaths every year, playing a role in breast, liver, colorectal, mouth, throat, esophagus and voice box cancer cases. Alcohol-induced cancer deaths outnumber alcohol-associated traffic crash fatalities every year.
The report included the suggestion to add warning labels to alcohol similar to what is already required for tobacco products – another substance of abuse known to cause cancer.
As a neuroscientist specializing in the neurobiological effects of alcohol use and binge drinking, I am glad to see the call to action for reducing alcohol consumption in the United States.
Key takeaways of the report
With so few people aware of the links between alcohol consumption and various cancers – and the fact that the vast majority of people consume some alcohol every week – it’s easy to see why the surgeon general is calling for greater awareness. The 22-page report highlights what scientists know about the relationship between alcohol and cancer, and suggests actions for moving forward. Those include label changes on alcohol, which have not been updated since they were created in 1988.
Somewhat strikingly, breast cancer carries a large portion of this risk – making it particularly worrisome in the face of increased alcohol use among women.
These numbers don’t only apply to heavy alcohol drinkers. While less alcohol is better, 25% of these cancer cases were in people classified as moderate drinkers – consuming, on average, fewer than two drinks per day. This means that anyone regularly drinking alcohol, even small amounts, should know about and understand the risks.
Surgeon general’s advisories are the primary way that the Department of Health and Human Services, where the Office of the Surgeon General resides, communicate health issues of great importance to the public. Surgeon general’s advisories are not necessarily breaking news, but they take the opportunity to bring public awareness to science surrounding big public health issues.
The science behind the link between alcohol and cancer
The relationship between alcohol and cancer has been clear to scientists for decades. In fact, it was highlighted in a 2016 surgeon general’s report as well, which focused on addiction more broadly.
The new report outlines the different types of evidence supporting this link. One way is through epidemiological science, which tries to understand patterns and relationships between the rates of cancer and how much alcohol people consumed. Another is through experimental animal studies, which allow scientists to understand the mechanism and causality of these connections as they apply to specific cancers. Together, studies conclusively show a link and pathway between alcohol consumption and cancer.
The surgeon general’s report highlights four key pathways through which alcohol can cause cancer. These largely focus on the ways alcohol can negatively affect your DNA, the building blocks of cells. While the healthy cells in your body divide all the time, their abnormal growth can be driven by aberrant factors like alcohol-induced DNA damage.
This DNA damage leads to uncontrollable growth of tissue instead of healthy, normal tissue growth. This abnormal tissue growth is cancer. The four pathways through which alcohol can lead to cancer highlighted in the report are:
- The body naturally breaks alcohol down into acetaldehyde. Acetaldehyde can damage and break DNA, leading to chromosomal rearrangements and tumors. This link is so strong that acetaldehyde has been classified as a carcinogen since 1999.
- Alcohol creates reactive oxygen species. Reactive oxygen species, sometimes called “free radicals,” are unstable molecules that contain oxygen and can further damage DNA, proteins and fats.
- Alcohol can influence hormones, like estrogen. Alcohol can raise the amount of estrogen in the body, which may explain its link to breast cancer. This increased estrogen can influence breast tissue by causing – you guessed it – DNA damage.
- Alcohol is a solvent, which means other things can dissolve in it. This makes it easier for carcinogens from other sources – like cigarettes and e-vapes – to be absorbed by the body when the two are consumed together.
Is any amount of alcohol safe?
The biggest question on people’s minds right now is likely “how much alcohol can I safely drink?” and the answer to that might disappoint you – probably none.
Alcohol use remains one of the most preventable risk factors for cancer. And even moderate alcohol consumption – one or fewer drinks per day – may elevate cancer risk for some types, such as breast, throat and mouth cancers.
But none of these studies can tell you what your individual risk for cancer is. The relationship between alcohol and cancer can be influenced by your genes, such as those that control the enzymes that metabolize alcohol, and other lifestyle factors that influence the rates of cancer broadly, like diet and inflammation. All of these lifestyle and personal health factors can influence how risky alcohol consumption is for you.
The Centers for Disease Control and Prevention notes that if you choose to drink, consider sticking to less than one, for women, or two, for men, standard servings of alcohol per day – which might be smaller than you think, and don’t binge drink alcohol at all. The surgeon general is also suggesting a rethinking of these guidelines to include updated limits on daily alcohol consumption and greater educational efforts around the link between alcohol and cancer.
The National Institute on Alcohol Abuse and Alcoholism has similar recommendations around limiting alcohol consumption and advises that for people who choose to drink alcohol, “the less, the better.”
The institute offers tips on its website for managing your alcohol consumption or abstaining from alcohol consumption altogether, including finding alternative hobbies and activities, identifying what leads to your urges to drink and having a plan to handle urges, and identifying a strategy for saying “no” to an alcoholic beverage in social settings.
Nikki Crowley, Assistant Professor of Biology, Biomedical Engineering and Pharmacology, Penn State
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.
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Consumer Corner
Defend Your Home from Harsh Winter Conditions: 7 pro tips to avoid long-term damage
(Family Features) Harsh winter elements like snow, ice and wind can wreak havoc on your home – if it’s not properly prepared and maintained. Make home maintenance both indoors and out a priority this winter to ensure it’s safe, warm, secure and operating efficiently.
While winterizing can be a daunting task, you don’t have to do it alone. Whether you need help installing gutter guards, sealing cracks in your concrete or ensuring your sump pump is ready for winter, the experts at Thrasher Foundation Repair provide precise repairs for every project.
They’ve seen it all through 50 years of serving more than 150,000 happy customers – from basement flooding to damaged concrete – and know how to prevent these issues before they start. Recognized with the International Torch Award for Ethics by the Better Business Bureau Midwest Plains, they set the standard for excellence in their field as a trusted industry leader in home protection.
“Winter can really take a toll on your home, but a few proactive steps now can save you headaches later,” CEO Dan Thrasher said. “At Thrasher Foundation Repair, we help protect what matters most – your home and peace of mind. We’re happy to share our pro tips to help you keep your home safe, dry and ready for whatever winter throws your way.”
It all begins with homeowners taking proactive steps to recognize small problems before they spiral out of control. Use this checklist from Thrasher’s experts to prepare your home for a warm, secure and stress-free winter season.
Clean and Maintain Gutters and Downspouts
When debris like leaves clog gutters, it causes water to overflow and freeze, leading to ice dams and roof leaks. These blockages can cause water to damage your roof, siding and foundation, meaning it’s critical to remove debris. Run water through gutters and check for proper water flow – if you notice pooling or slow drainage, there may be a blockage that needs attention. Make sure downspouts direct water away from the foundation and walkways by extending them at least 10 feet away from the home. Also be sure to inspect and tighten any loose gutter brackets and fasteners so they can withstand the weight of snow and ice.
Insulate Rim Joists
Rim joist insulation plays a big role in your home’s energy efficiency. If your insulation is more than 10 years old, consider upgrading to a more efficient material to reduce heat loss.
Protect the Basement and Foundation
Now is a good time to inspect your foundation for any cracks or damage. Bringing in the experts to address problem areas can help avoid larger issues when spring storms arrive. A working sump pump is critical for preventing basement flooding caused by snowmelt or winter storms, so it’s important to test it to ensure proper functionality. It’s also important to inspect discharge lines for potential freezing issues to avoid water backup into the basement. Consider grading soil to ensure the ground slopes away from your home, preventing water from seeping through.
Seal and Protect Concrete
Carefully inspect walkways, driveways and patios for cracking. During winter, water can seep into cracks, freeze then expand, causing long-term damage. Seal them with a penetrating sealant (rather than a topical one) for long-lasting protection from moisture, salt and other winter elements.
Optimize Humidity
Turn on your furnace’s humidifier to maintain proper indoor humidity levels and adjust your dehumidifier settings to match winter’s low humidity. This helps keep your home comfortable while preventing moisture-related issues.
Clear Debris Around the House
Along with cleaning gutters and downspouts, it’s important to clear window wells and clean up around the foundation, too. Debris in window wells can block drainage, causing water from snowmelt to pool near the foundation then seep into the basement.
Manage Snow and Ice
Leaving snow and ice on concrete surfaces can erode and weaken the material over time. Regularly shoveling snow from driveways, sidewalks and patios helps prevent ice buildup and protects the concrete from long-term damage.
Find more winter home maintenance tips and contact the pros for assistance by visiting GoThrasher.com.
Photo courtesy of Shutterstock (teens shoveling snow)
Photo courtesy of Thrasher Foundation Repair (contractor checking gutters)
SOURCE:
Thrasher Foundation Repair
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Lifestyle
Expert Tips for Keeping Loved Ones Healthy This Winter
(Family Features) Winter can bring plenty of opportunities for cozy gatherings with loved ones and these moments can be bright spots during cold months. However, sp ending more time indoors means more chances for respiratory viruses to spread.
Flu, COVID-19 and RSV viruses can make people sick enough that they need to go to the doctor or hospital.
“Getting sick from these viruses can happen more often in the winter months,” said Dr. Manisha Patel, chief medical officer of the Centers for Disease Control and Prevention’s (CDC) National Center for Immunization and Respiratory Diseases. “This season’s flu and COVID-19 vaccines, as well as the RSV vaccine, are the best way to avoid serious illness so people can spend time with friends and family.”
How Can You Protect Loved Ones?
Millions of people have already gotten vaccinated this fall or winter. In fact, more people are getting vaccinated for COVID-19 and flu this year compared to this time last year, according to the CDC. Vaccines are the best protection against serious illness. To help keep your loved ones healthy this winter, offer to take them to get vaccinated. Make sure they know it’s safe to get more than one vaccine at the same appointment.
The CDC recommends everyone 6 months and older get flu and COVID-19 vaccines. In addition, everyone 75 and older – and those 60 and older with certain health conditions or who live in nursing homes – should get one dose of an RSV vaccine if they haven’t before. Pregnant people who are 32 through 36 weeks pregnant during the winter months should get an RSV vaccine to help protect their baby during the first 6 months.
Are Your Loved Ones at High Risk?
According to the CDC, some people face higher risks of getting very sick from respiratory viruses, including:
- People not up to date on their vaccines: Vaccines cut your risk of needing hospital care for flu or COVID-19 by about half. In 2023, 90% of adults admitted to the hospital for COVID-19 were not up to date on their COVID-19 vaccines. People who skipped their flu shot were twice as likely to need to visit a doctor for flu.
- Older people: Most flu, COVID-19 and RSV hospitalizations and deaths are in people ages 65 and older. If you help care for an older friend or loved one, let them know their risk for getting very sick from these viruses – and that vaccines can help protect them from needing to go to the hospital.
- Those who live in long-term care facilities: Respiratory viruses can spread among people in long-term care who may be older or have health conditions that raise their risk of severe flu, COVID-19 and RSV.
- Pregnant people: Getting flu and COVID-19 vaccines during pregnancy provides protection against severe illness for you and your baby during their first 6 months. An RSV vaccine during pregnancy also protects your baby from severe RSV in their first 6 months.
Urge Loved Ones to Get Vaccinated
Flu, COVID-19 and RSV vaccines are the best way for you – and your friends and family – to risk less and do more of what you enjoy this winter.
Visit cdc.gov/RiskLessDoMore or talk to your doctor to learn more about flu, COVID-19 and RSV vaccines. Visit vaccines.gov to find a nearby pharmacy.
Additional High-Risk Groups
In the U.S., some additional groups of people are at higher risk of respiratory viruses, according to the CDC.
- People in rural parts of the country: People who live in rural areas face a higher risk of getting very sick from flu, COVID-19 and RSV. In these regions, less than half of adults got a flu vaccine last year. Fewer than 1 in 5 got an updated COVID-19 vaccine. Serious illness can be even more dangerous in rural areas with less available medical care.
- Black and Hispanic people: At the peak of last year’s respiratory virus season, Black people were more likely than white or Hispanic people to be hospitalized for flu, COVID-19 or RSV. By season’s end, Hispanic people were more likely than non-Hispanic white people to have been hospitalized for flu.
Photos courtesy of Shutterstock
SOURCE:
U.S. Department of Health and Human Services
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