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FDA relaxes blood donation restrictions on gay men

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WASHINGTON – The U.S. is moving to ease restrictions on blood donations from gay and bisexual men and other groups traditionally at higher risk of HIV.

The Food and Drug Administration on Friday announced draft guidelines that would remove the current three-month abstinence requirement for donations from men who have sex with men. Instead, potential donors would be screened with a questionnaire that assesses their individual HIV risks based on sexual behavior, recent partners and other factors.

If complete, the postponement would be the FDA’s latest move to expand donor eligibility, with the potential to boost the U.S. blood supply.

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Gay rights groups have long opposed blanket restrictions on who can donate blood, saying they discriminate against the LGBTQ community. Medical societies, including the American Medical Association, have also stated that such exclusions are unnecessary given technological advances in testing blood for infectious diseases.

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“Current and past blood donation guidelines have made unfounded assumptions about gay and bisexual men and really tangled people’s identities with their likelihood of having HIV,” said Sarah Warbelow of the Human Rights Campaign, an LGBTQ advocacy group.

The United States and many other countries began blocking blood donations from gay and bisexual men during the AIDS epidemic in the early 1980s to prevent the spread of HIV through the blood supply.

In 2015, the FDA lifted the lifetime ban and replaced it with a one-year abstinence requirement. Then in 2020, the agency shortened the abstinence period to three months after donations plummeted during the COVID-19 pandemic.

Regulators said there have been no negative impacts on the blood supply as a result of these changes.

The FDA establishes requirements and procedures for blood banks across the United States. All potential donors answer questions about their sexual history, drug use, and recent tattoos or piercings, among other factors that may contribute to the spread of blood-borne infections. The donated blood is then tested for HIV, hepatitis C, syphilis and other infectious diseases.

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As part of the new questionnaire, men who have sex with men are asked about new or multiple partners in the last three months. Those who answered yes to both questions and also indicated having had anal sex would be barred from donating until a later date. The policy would also apply to women who have sex with gay or bisexual men.

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The policies reflect those used in Canada and the UK

The FDA based its latest proposal on a recent study of 1,600 gay and bisexual men. The FDA-funded study compared the effectiveness of a detailed, personalized sexual behavior questionnaire versus current time-based abstinence rules.

It will take several months for blood banks to make the changes, according to Cliff Numark, an executive at Vitalant, a blood center that participated in the study. The changes require new questionnaires, staff training and computer software updates.

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The Red Cross said it supports the FDA’s changes, but added that it’s too early to know if they will lead to more blood donations.

Lukas Pietrzak, of Washington DC, said he volunteered for the FDA study. He credits emergency blood transfusions with saving his father’s life after a bicycle accident in 1991.

Pietrzak donated blood in high school but was not admitted after becoming sexually active as a gay man.

“Until I fully came out to my friends, I had to play around with why I never went to donate blood with them,” says Pietrzak, 26, who now works for the federal government.

If blood donations are called, “we can now participate,” said Pietrzak.

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Too Much Time Online Might Raise Kids’ Odds for Mental Health Woes

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By Dennis Thompson

health day reporter

WEDNESDAY, March 29, 2023 (HealthDay News) — Children’s screen use could alter their developing brains as they enter puberty and increase their risk of mood disorders, a major new study finds.

Children ages 9 and 10 who spend more time on smartphones, tablets, video games and television showed higher levels of depression and anxiety at ages 11 and 12, researchers found.

Additionally, investigators linked some of these mood disorders to actual structural changes in the children’s developing brains, according to the report recently published online Behavioral Addiction Journal.

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“There were certain brain mechanisms that contributed in part to this relationship, meaning that statistically, over the two-year period, brain-based changes occurred that mediated the relationship between on-screen media activity in younger children and the internalization of concerns about depression and anxiety two years later,” said lead researcher Dr. Marc Potenza. He is Professor of Psychiatry at the Child Study Center at Yale School of Medicine in New Haven, Connecticut.

The proportion of mood disorders associated with structural changes in the brain is relatively small, “on the order of 2% to 3%,” Potenza noted.

However, child development experts hailed the study as an important step in fully understanding how excessive screen time affects children.

For the study, Potenza and his colleagues analyzed data from more than 5,100 children participating in the ongoing ABCD (Adolescent Brain Cognitive Development) study. The data included brain scans, psychological assessments and behavioral tracking in these children aged 9 to 10 years.

“This is the first time we’ve had this type of database to study problems of this magnitude, so this is groundbreaking,” said Dr. Cheryl Wills, director of child psychiatry at MetroHealth System in Cleveland. Wills was not involved in the study.

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“Basically, this study is the first to begin to examine, or better understand, the processes that may be related to the effects of screen media activity on mental health – how does screen media activity affect brain development and how does it affect the mental health out,” she said.

“Although the results are modest, this is the first structural association with these changes,” added Wills, who is also a board member of the American Psychiatric Association.

Too much screen time?

When researchers looked at the first round of data for 9- and 10-year-olds, they found an association between high screen use and mood disorders, as well as “externalizing” behaviors like aggression and discipline, Potenza said.

They also observed brain structure patterns in these children that were similar to those previously associated with underage drinking, he added.

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They then followed the children as they got older to see if the mental health problems persisted and if they correlated with more brain changes.

As 11 and 12-year-olds, the children continued to suffer from depression and anxiety associated with heavy screen use, and their brains had changed in ways that would explain some of these mood disorders.

However, the study did not link the same brain changes to heavy screen use and behavioral problems such as aggression, bullying or defiance.

The observed brain changes affected both the cortical brain regions involved in higher-level processes such as attention or emotional regulation, and subcortical regions related to a person’s drives, Potenza said.

“Given that this pattern of structural variation in the brain has been associated with early engagement in addictive behaviors, it suggests that there may be some elements shared between addictive behaviors in substance use and non-substance use domains – in this one.” Fall screen media activity,” Potenza added.

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The ABCD study will continue to track the same children as they age, and future reports should provide even more insight into the effects of screens on brain development, said Mitch Prinstein, chief science officer of the American Psychological Association.

“I don’t think most people realize how important puberty is to brain development,” Prinstein said. “We all know that infant brains develop in really important ways, but we may not remember that brain development from ages 12 to 16 is also an incredibly sensitive time.”

Brain changes associated with addiction

Will agreed.

“This is the first step and we’ll see how it goes, whether or not it’s consistent throughout the developmental process as children mature into adults, or if this stops at a certain age or gets worse at a certain age,” said Wills. “It helps us understand that this can affect mental health and brain development. And only time will tell how sustainable the changes are, whether or not they change over time and what the results are.”

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The post-pandemic world has made it more important than ever to understand the impact screen-based media is having on children, Wills said.

“During the COVID period, much education has shifted to computers and screen media. Although the kids are mostly back in school, teachers are using screens to a greater extent than before,” Wills said. “In the past, you would usually let your child come home and then worry about on-screen media activity, but they are already coming home from school after being exposed at school more than before.”

Many parents try to limit children’s screen activity by using timers to turn off devices when the kids have had enough, Wills said. They also set up other activities, “basically trying to get their kids to focus on things other than the screens.”

In the meantime, Prinstein recommends that parents set a firm 9 p.m. screen time limit.

“We just need that as a rule. We can’t disturb sleep. Sleep is incredibly important for brain development, and the number one reason kids don’t get the recommended amount of sleep is their screens,” Prinstein said.

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Parents should also use timers and controls to ensure they limit what kids can do on devices and for how long. “They’re not perfect, but at least it’s a start,” said Prinstein.

Finally, parents need to be open with their children about whether the children themselves feel they are using too much screens.

“We’re seeing a remarkable amount of problematic screen time use,” Prinstein said. “In other words, using screen time looks a bit like an addiction.”

More information

The European Network for Problematic Usage of the Internet looks at the effects of excessive screen use in more detail.

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SOURCES: Marc Potenza, MD, PhD, Professor, Psychiatry, Yale School of Medicine Children’s Study Center, New Haven, Connecticut; Cheryl Wills, MD, Director of Child Psychiatry, MetroHealth System, Cleveland, Ohio; Mitch Prinstein, PhD, Chief Science Officer, American Psychological Association; Behavioral Addiction JournalMarch 20, 2023 online

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Zorro Launches with $11.5M to Revolutionize Employee Health Benefits

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What you should know:

ZoroA digital health Company that optimizes the healthcare experience for employees, employers and brokers announced its launch from stealth with an $11.5 million seed funding round co-led by Pitango And 10D.

– The process of providing employee benefits is complicated, opaque and onerous. For employers and agents, offering benefits often results in unpredictable budgets, endless administration, and a distraction from core business. For employees, health benefits are universal and all too often completely out of their control.

– Zorro plans to use the seed funding to further expand R&D efforts and scale customer operations.

How Zoro works

Zorro analyzes employers’ performance targets to create a top-down predictable budget and performance allowances per employee or group of employees. It also offers an end-to-end insurance management solution that offers a single, comprehensive platform that makes managing claims seamless and effective. In addition, Zorro acts as a financial companion, analyzing employees’ health needs, family situation, risk tolerance and other personal characteristics. It then generates a recommended service package consisting of health insurance, supplementary insurance, specialized digital health solutions and other value-added financial services.

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Here is where the debate on Social Security and Medicare stands in Congress

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As lawmakers near an impending debt ceiling deadline, the battle over what to do with entitlement programs like Medicare and Social Security continues to be fought across party lines.

Republicans have demanded commitments from Democrats to cut spending in exchange for raising the debt ceiling, but said entitlement programs aren’t on the chopping block.

President Biden and the Democrats have still tried to frame the GOP’s desire for spending cuts as an attack on Medicare and Social Security. At current rates, Medicare funding is expected to hit a deficit in 2028, with Social Security following in 2032.

Social Security, Medicare, and Medicaid currently make up nearly half of the entire federal budget, at a total annual cost of $2.7 trillion.

Here is the Capitol debate on the future of the programs.

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A scattered Republican embassy

A number of policy options have been proposed by GOP lawmakers in both the House and Senate for what to do with the future of entitlement programs. Options ranged from not touching the programs, to raising age requirements, to having the programs shut down on a regular basis, which would require renewed approval from Congress.

Sen. Rick Scott (R-Fla.) caused a stir last year when he released his 12-point Rescue America plan, which originally proposed scrapping all federal legislation after five years and prompting Congress to consider whether the Law “worth observing”.

But after intense heat from Democrats and some in his own partyScott changed his plan “to make specific exceptions to Social Security, Medicare, national security, veterans’ benefits, and other essential services.”

Other policy options put forward by Republicans include a plan by the Republican Study Committee, which includes more than 75 percent of the House GOP conference, to raise the age for individuals to qualify for Social Security and Medicare.

Other prominent Republicans, including former Vice President Pence, have advocated partial privatization of Social Security. “I think we can replace the New Deal programs with a better deal,” he said in an interview earlier this year.

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But the party’s leadership in Congress has revealed relatively little about their plans for the future of Social Security and Medicare.

Senate Minority Leader Mitch McConnell (R-Ky.) and Speaker Kevin McCarthy (R-Calif.) have both said the entitlement programs are off the table in the debt ceiling negotiations, but they have avoided details about how they will want to achieve their desired spending cuts.

Democrats position themselves as protectors

Biden has led the charge in Democrats’ efforts to portray themselves as protectors of the entitlement programs in the face of what they characterize as GOP threats.

Democrats and the White House leaned against the frame as strategy ahead of the midterms and warns of what a Republican majority could mean for the 65 million Americans who depend on Social Security and Medicare benefits.

Republicans have insisted their proposals to keep the programs solvent aren’t cuts, but that’s largely what the debate boils down to what makes a cut.

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Democrats have claimed they don’t want to touch Social Security or Medicare at all, and Biden has suggested taxing the wealthy to prop up the programs — something that has little chance of gaining traction among Republicans.

The president’s budget proposal aims to increase the Medicare tax rate on earned and unearned income over $400,000 from the current 3.8 percent to 5 percent.

“This modest increase in Medicare contributions for those with the highest incomes will help keep the Medicare program strong for decades to come,” he wrote in a New York Times Commentary.

Biden’s budget proposal doesn’t detail plans to keep Social Security afloat.

Biden leaning towards messaging before 2024

In his State of the Union address last month, Biden drew heckles from Republican lawmakers when he accused some in the GOP of trying to target federal entitlement programs as part of spending cuts.

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Rep. Marjorie Taylor Greene (R-Ga.) shouted “liar” at the President’s remarks.

Playing off the dissent, he joked, “Well folks, it seems we can all agree, Social Security and Medicare are off the books now, right?”

The White House has targeted Scott with his harshest criticism and called the Florida Senator national flagship for Republican attacks on Medicare and Social Security benefits.

Scott hit back after Biden’s SOTU speech, urging the president to resign over “lying about Republicans” trying to cut programs.

The attacks on Republicans over the programs have emerged as part of a broader narrative strategy the GOP as extreme while Biden prepares for a possible re-election run in 2024.

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The latest polls have confirmed this again The popularity of Social Security and Medicare, even as many Americans tend to rein in overall government spending.

Biden has also attempted to highlight the House Freedom Caucus, the conservative group that includes Greene and Rep. Jim Jordan (R-Ohio), to create greater contrast between the parties in their overall vision for the country ahead of 2024.

The White House approved the caucus’ budget proposal “Five Alarm Fire”, and Biden has argued that the plan would cut non-defense spending across the board by 25 percent, though the group has disputed that claim.

Republicans are trying to reverse the script

While the GOP has fended off attacks from Democrats, Republicans have tried to do the same Turn the debate around on their opposition and accused the Democrats of not having their own vision to keep the programs afloat.

Sen. Bill Cassidy (R-La.) grilled Treasury Secretary Janet Yellen earlier this month over the government’s plan to support Social Security.

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“Of the $4.5 trillion in taxes he’s proposed, not a dime will support Social Security,” Cassidy said at a Senate hearing.

Yellen responded that Biden “cares very, very much,” before Cassidy interjected to ask about the president’s plan to extend Social Security solvency.

Yellen said Biden was “ready” to work with Congress on the matter, but Cassidy called the statement a “lie,” adding that he and other senators had tried unsuccessfully to meet with the president on the matter.

Sen. Marco Rubio (R-Fla.) told The Hill earlier this month that Congress needed “the president’s leadership” to secure the programs long-term and said Biden was “doing nothing.”

Biden has fired back that GOP proposals would only undermine programs.

“Only in Washington can people say they’re saving something by destroying it,” he wrote in his Times op-ed.

Copyright 2023 Nextstar Media Inc. All rights reserved. This material may not be published, broadcast, transcribed or redistributed.

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