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.
(Family Features) Many people don’t think much about whether their blood is clotting properly. However, when you have a bleeding disorder, a condition that affects the way your body controls clots, it’s no small matter.
According to the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, abnormal clotting can lead to a host of problems, including excessive bleeding after an injury or during surgery.
About 3 million people in the U.S. have bleeding disorders. Some types, such as hemophilia, are inherited, meaning a person who has it is born with it. Inherited bleeding disorders are caused by certain genes passed down from parents to children. These genes contain instructions for how to make proteins in the blood called clotting factors, which help blood clot. If there is a problem with one of these genes, such as a mutation – a change in the gene’s instructions – the body may make a clotting factor incorrectly or not make it at all.
You can also have what’s called an acquired bleeding disorder, meaning you develop it during your lifetime. Acquired bleeding disorders can be caused by medical conditions, medicines or something unknown. Your risk of developing a bleeding disorder depends on your age, family history, genes, sex, or other medical conditions. If bleeding disorders run in your family, you may have a higher risk of developing or inheriting one.
Symptoms of a bleeding disorder may appear soon after birth or develop later in life and can include:
Excessive bleeding or bruising, such as frequent or long nose bleeds (longer than 15 minutes) or frequent or long menstrual periods
Petechiae, which are tiny purple, red, or brown spots caused by bleeding under the skin
Redness, swelling, stiffness, or pain from bleeding into muscles or joints
Blood in urine or stool
Excessive umbilical stump bleeding
Excessive bleeding during surgery or after trauma
If you believe you, or someone you care for, may have a bleeding disorder, talk to a health care provider. Your provider may make a diagnosis based on symptoms, risk factors, family history, a physical exam, and diagnostic tests. Health care providers typically screen for bleeding disorders only if you have known risk factors or before certain surgeries.
How your bleeding disorder is treated depends on its type. If your disorder causes few or no symptoms, you may not need treatment. If you have symptoms, you may need daily treatment to prevent bleeding episodes, or you may need it only on certain occasions, such as when you have an accident or before a planned surgery.
If you have been diagnosed with a bleeding disorder, it’s important to be proactive about your health and follow your treatment plan. To lower your risk of complications:
A Story of Bravery, Balance, and a Bleeding Disorder
There are lots of things that make Mikey White Jr. special. He’s a dedicated athlete. He’s determined, disciplined, and optimistic. He’s also living with hemophilia, a type of bleeding disorder.
Advertisement
White was diagnosed with hemophilia at age 3 after experiencing several severe bleeding episodes. He had to give up baseball and basketball, his passions, because of the high risk of injuries, but he found competitive swimming – and he’s been breaking records ever since.
“Competitive swimming is a noncontact sport, so it complements my hemophilia while still being an intense and rigorous sport,” White said.
Being an athlete with hemophilia requires support, White admits. He works with his healthcare team and coaching staff to make sure he safely manages his condition and balances it with his training. He hopes his story encourages others living with bleeding disorders to accept and appreciate their bodies the way they are.
(Family Features) Most people don’t want to think about death – let alone talk about it. When the time comes, families often find themselves overwhelmed, not only by grief but by the many decisions that need to be made quickly.
Funeral directors witness this every day. They see the stress and confusion that can come when there is no plan in place and the peace of mind that comes with thoughtful preparation.
After consulting funeral directors nationwide, the National Funeral Directors Association (NFDA) uncovered five things they wish families knew before a death occurs.
It’s Never Too Early to Start Planning
While everyone knows death and taxes are inevitable, conversations about death are often avoided.
Simply documenting your wishes and discussing your preferences with your family can alleviate the difficult decisions your loved ones will have to make in the future. Speak with a funeral director to explore the many options for planning a meaningful funeral.
Legal and Financial Details Can Cause Unexpected Issues
Families often don’t realize power of attorney ends at death, meaning a designated person can no longer make decisions or access bank accounts once an individual dies.
To avoid complications, consider adding a trusted loved one to your bank account and ensure life insurance beneficiaries are up to date. Too often, deceased individuals leave minor children, deceased spouses or former partners as beneficiaries, leading to legal and financial challenges.
Final Wishes Shouldn’t Be In Your Will
Many people believe the best place to document their final wishes is in their will. However, wills are often not read until after funeral services take place, making them an unreliable way to communicate last requests. Instead, discuss and document your wishes with family members or a trusted funeral professional who can keep your wishes on file until there is a need.
There Are a Variety of Memorialization Options
End-of-life planning offers more choices than many realize. While burial remains a common preference, cremation is an increasingly popular choice and can even include a viewing and funeral service. Additionally, eco-friendly options, such as alkaline hydrolysis, natural burial and natural organic reduction are becoming more widely available for those seeking green memorialization. In fact, according to NFDA’s 2024 Consumer Awareness and Preferences Study, 68% of respondents expressed interest in green funeral options.
Exploring these possibilities with a funeral professional can help ensure your final arrangements reflect your values, traditions and personal wishes.
Funeral Directors Don’t Just Manage Funerals – They’re Trusted Guides In Honoring Life
Funeral directors play a vital role in helping families create meaningful services that reflect their loved one’s life, values and traditions. Whether planning ahead or facing a recent loss, funeral professionals provide expertise, compassionate care and personalized guidance during one of life’s most difficult moments.
Choosing the right funeral director is an important decision and finding someone who understands your needs can make all the difference in honoring your loved one in a personal and meaningful way.
Start the conversation today by talking about end-of-life planning. It isn’t easy, but it’s one of the most important conversations you can have with your loved ones. A little planning today can make a world of difference tomorrow.
Use comprehensive resources like RememberingALife.com, which is designed to guide families through every stage of the journey, including planning, funeral options and grief resources. The site offers valuable tools and support, such as the “Find a Funeral Home” tool to connect families with compassionate, local funeral directors and much more.
Photo courtesy of Shutterstock
SOURCE:National Funeral Directors Association
Workers who are in frequent contact with potentially sick animals are at high risk of bird flu infection.
Costfoto/NurPhoto via Getty ImagesRon Barrett, Macalester College
Disease forecasts are like weather forecasts: We cannot predict the finer details of a particular outbreak or a particular storm, but we can often identify when these threats are emerging and prepare accordingly.
The viruses that cause avian influenza are potential threats to global health. Recent animal outbreaks from a subtype called H5N1 have been especially troubling to scientists. Although human infections from H5N1 have been relatively rare, there have been a little more than 900 known cases globally since 2003 – nearly 50% of these cases have been fatal – a mortality rate about 20 times higher than that of the 1918 flu pandemic. If the worst of these rare infections ever became common among people, the results could be devastating.
Approaching potential disease threats from an anthropological perspective, my colleagues and I recently published a book called “Emerging Infections: Three Epidemiological Transitions from Prehistory to the Present” to examine the ways human behaviors have shaped the evolution of infectious diseases, beginning with their first major emergence in the Neolithic period and continuing for 10,000 years to the present day.
Viewed from this deep time perspective, it becomes evident that H5N1 is displaying a common pattern of stepwise invasion from animal to human populations. Like many emerging viruses, H5N1 is making incremental evolutionary changes that could allow it to transmit between people. The periods between these evolutionary steps present opportunities to slow this process and possibly avert a global disaster.
Spillover and viral chatter
When a disease-causing pathogen such as a flu virus is already adapted to infect a particular animal species, it may eventually evolve the ability to infect a new species, such as humans, through a process called spillover.
Spillover is a tricky enterprise. To be successful, the pathogen must have the right set of molecular “keys” compatible with the host’s molecular “locks” so it can break in and out of host cells and hijack their replication machinery. Because these locks often vary between species, the pathogen may have to try many different keys before it can infect an entirely new host species. For instance, the keys a virus successfully uses to infect chickens and ducks may not work on cattle and humans. And because new keys can be made only through random mutation, the odds of obtaining all the right ones are very slim.
Given these evolutionary challenges, it is not surprising that pathogens often get stuck partway into the spillover process. A new variant of the pathogen might be transmissible from an animal only to a person who is either more susceptible due to preexisting illness or more likely to be infected because of extended exposure to the pathogen.
Even then, the pathogen might not be able to break out of its human host and transmit to another person. This is the current situation with H5N1. For the past year, there have been many animal outbreaks in a variety of wild and domestic animals, especially among birds and cattle. But there have also been a small number of human cases, most of which have occurred among poultry and dairy workers who worked closely with large numbers of infected animals.
Pathogen transmission can be modeled in three stages. In Stage 1, the pathogen can be transmitted only between nonhuman animals. In stage 2, the pathogen can also be transmitted to humans, but it is not yet adapted for human-to-human transmission. In Stage 3, the pathogen is fully capable of human-to-human transmission.Ron Barrett, CC BY-SA
Epidemiologists call this situation viral chatter: when human infections occur only in small, sporadic outbreaks that appear like the chattering signals of coded radio communications – tiny bursts of unclear information that may add up to a very ominous message. In the case of viral chatter, the message would be a human pandemic.
Sporadic, individual cases of H5N1 among people suggest that human-to-human transmission may likely occur at some point. But even so, no one knows how long or how many steps it would take for this to happen.
Influenza viruses evolve rapidly. This is partly because two or more flu varieties can infect the same host simultaneously, allowing them to reshuffle their genetic material with one another to produce entirely new varieties.
Genetic reshuffling – aka antigenic shift – between a highly pathogenic strain of avian influenza and a strain of human influenza could create a new strain that’s even more infectious among people.Eunsun Yoo/Biomolecules & Therapeutics, CC BY-NC
These reshuffling events are more likely to occur when there is a diverse range of host species. So it is particularly concerning that H5N1 is known to have infected at least 450 different animal species. It may not be long before the viral chatter gives way to larger human epidemics.
Reshaping the trajectory
The good news is that people can take basic measures to slow down the evolution of H5N1 and potentially reduce the lethality of avian influenza should it ever become a common human infection. But governments and businesses will need to act.
People can start by taking better care of food animals. The total weight of the world’s poultry is greater than all wild bird species combined. So it is not surprising that the geography of most H5N1 outbreaks track more closely with large-scale housing and international transfers of live poultry than with the nesting and migration patterns of wild aquatic birds. Reducing these agricultural practices could help curb the evolution and spread of H5N1.
Large-scale commercial transport of domesticated animals is associated with the evolution and spread of new influenza varieties.ben/Flickr, CC BY-SA
People can also take better care of themselves. At the individual level, most people can vaccinate against the common, seasonal influenza viruses that circulate every year. At first glance this practice may not seem connected to the emergence of avian influenza. But in addition to preventing seasonal illness, vaccination against common human varieties of the virus will reduce the odds of it mixing with avian varieties and giving them the traits they need for human-to-human transmission.
At the population level, societies can work together to improve nutrition and sanitation in the world’s poorest populations. History has shown that better nutrition increases overall resistance to new infections, and better sanitation reduces how much and how often people are exposed to new pathogens. And in today’s interconnected world, the disease problems of any society will eventually spread to every society.
For more than 10,000 years, human behaviors have shaped the evolutionary trajectories of infectious diseases. Knowing this, people can reshape these trajectories for the better.Ron Barrett, Professor of Anthropology, Macalester College
This article is republished from The Conversation under a Creative Commons license. Read the original article.
Privacy & Cookies: This site uses cookies. By continuing to use this website, you agree to their use.
To find out more, including how to control cookies, see here:
Cookie Policy
(Family Features) Most people don’t want to think about death – let alone talk about it. When the time comes, families often find themselves overwhelmed, not only by grief but by the many decisions that need to be made quickly.
Funeral directors witness this every day. They see the stress and confusion that can come when there is no plan in place and the peace of mind that comes with thoughtful preparation.
After consulting funeral directors nationwide, the National Funeral Directors Association (NFDA) uncovered five things they wish families knew before a death occurs.
Ron Barrett, Professor of Anthropology, Macalester College
This article is republished from The Conversation under a Creative Commons license. Read the original article.
