Connect with us

Health

Dozens of Clinical Trials Have Been Frozen in Response to Trump’s USAID Order

Published

on

Dozens of Clinical Trials Have Been Frozen in Response to Trump’s USAID Order

Asanda Zondi received a startling phone call last Thursday, with orders to make her way to a health clinic in Vulindlela, South Africa, where she was participating in a research study that was testing a new device to prevent pregnancy and H.IV. infection.

The trial was shutting down, a nurse told her. The device, a silicone ring inserted into her vagina, needed to be removed right away.

When Ms. Zondi, 22, arrived at the clinic, she learned why: The U.S. Agency for International Development, which funded the study, had withdrawn financial support and had issued a stop-work order to all organizations around the globe that receive its money. The abrupt move followed an executive order by President Trump freezing all foreign aid for at least 90 days. Since then, the Trump administration has taken steps to dismantle the agency entirely.

Ms. Zondi’s trial is one of dozens that have been abruptly frozen, leaving people around the world with experimental drugs and medical products in their bodies, cut off from the researchers who were monitoring them, and generating waves of suspicion and fear.

The State Department, which now oversees U.S.A.I.D., replied to a request for comment by directing a reporter to USAID.gov, which no longer contains any information except that all permanent employees have been placed on administrative leave. Secretary of State Marco Rubio has said that the agency is wasteful and advances a liberal agenda that is counter to President Trump’s foreign policy.

Advertisement

In interviews, scientists — who are forbidden by the terms of the stop-work order to speak with the news media — described agonizing choices: violate the stop-work orders and continue to care for trial volunteers, or leave them alone to face potential side effects and harm.

The United States is signatory to the Declaration of Helsinki that lays out ethical principles under which medical research must be conducted, requiring that researchers care for participants throughout a trial, and report the results of their findings to the communities where trials were conducted.

Ms. Zondi said she was baffled and frightened. She talked with other women who had volunteered for the study. “Some people are afraid because we don’t know exactly what was the reason,” she said. “We don’t really know the real reason of pausing the study.”

The stop-work order was so immediate and sweeping that the research staff would be violating it if they helped the women remove the rings. But Dr. Leila Mansoor, a scientist with the Centre for the AIDS Programme of Research in South Africa (known as CAPRISA) and an investigator on the trial, decided she and her team would do so anyway.

“My first thought when I saw this order was, There are rings in people’s bodies and you cannot leave them,” Dr. Mansoor said. “For me ethics and participants come first. There is a line.”

Advertisement

In the communities where her organization works, people have volunteered for more than 25 years to test H.I.V. treatments, prevention products and vaccines, contributing to many of the key breakthroughs in the field and benefiting people worldwide.

That work relied on a carefully constructed web of trust that has now been destroyed, Dr. Mansoor said. Building that trust took years in South Africa, where the apartheid regime conducted medical experiments on Black people during the years of white rule. Those fears are echoed in a long history of experimentation by researchers and drug companies in developing countries and in marginalized populations in the United States.

The Times identified more than 30 frozen studies that had volunteers already in the care of researchers, including trials of:

  • malaria treatment in children under age 5 in Mozambique

  • treatment for cholera in Bangladesh

  • a screen-and-treat method for cervical cancer in Malawi

  • tuberculosis treatment for children and teenagers in Peru and South Africa

  • nutritional support for children in Ethiopia

  • early-childhood-development interventions in Cambodia

  • ways to support pregnant and breastfeeding women to reduce malnutrition in Jordan

  • an mRNA vaccine technology for H.I.V. in South Africa

It is difficult to know the total number of trials shut down, or how many people are affected, because the swift demolition of U.S.A.I.D. in recent days has erased the public record. In addition to the disabled website, the agency no longer has a communications department. And the stop-work order prohibits any implementing agency from speaking publicly about what has happened.

In England, about 100 people have been inoculated with an experimental malaria vaccine in two clinical trials. Now, they no longer have access to the clinical trial staff if that vaccine were to cause an adverse reaction in their bodies. The trial is an effort to find a next-generation vaccine better than the one now used in Africa; that shot protects children against about a third of malaria cases, but researchers hoped to find a vaccine that offered much more protection. Malaria remains a top global killer of children; 600,000 people died of the disease in 2023, the latest figure available.

Advertisement

Had the trial not been frozen, the participants would be coming to a clinic routinely to be monitored for adverse physical effects, and to have blood and cell samples taken to see whether the vaccine was working. The participants are meant to be followed for two years to assess the vaccine’s safety.

A scientist who worked on the trial said she hoped that partners at the University of Oxford, where it was being conducted, were shuffling staff to respond if any participant fell ill. But she was fired last week and no longer has access to any information about the trial. She spoke on condition of anonymity because she feared jeopardizing her ability to work on malaria research the U.S. might conduct in the future.

“It’s unethical to test anything in humans without taking it to the full completion of studies,” she said. “You put them at risk for no good reason.”

Had the stop-work order come later this year, the newly-vaccinated volunteers might have been in an even more precarious position. They were scheduled to be deliberately infected with malaria to see if the experimental vaccine protected them from the disease.

Dr. Sharon Hillier, a professor of reproductive infectious diseases at the University of Pittsburgh, was until this week director of a five-year, $125 million trial funded by U.S.A.I.D. to test the safety and efficacy of six new H.I.V. prevention products. They included bimonthly injections, fast-dissolving vaginal inserts and vaginal rings.

Advertisement

With the study suspended, she and her colleagues cannot process biological samples, analyze the data they have already collected, or communicate findings to either participants or the partnering government agencies in countries where the trials were conducted. These are requirements under the Helsinki agreement.

“We have betrayed the trust of ministries of health and the regulatory agencies in the countries where we were working and of the women who agreed to be in our studies, who were told that they would be taken care of,” Dr. Hillier said. “I’ve never seen anything like it in my 40 years of doing international research. It’s unethical, it’s dangerous and it’s reckless.”

Even trials that were not funded in whole or part by U.S.A.I.D. have been thrown into turmoil because they were using medical or development infrastructure that was supported by the agency and is no longer operational. Millions of dollars of U.S. taxpayer funds already spent to start those trials will not be recouped.

The shutdowns have business consequences as well. Many of those trials were partnerships with U.S. drug companies, testing products they hoped to sell overseas.

“This has made it impossible for pharmaceutical companies to do research in these countries,” Dr. Hillier said.

Advertisement

Another H.I.V. trial, called CATALYST, has thousands of volunteers in five countries testing an injectable drug called long-acting cabotegravir. Participants were receiving bimonthly injections to maintain a sufficient level of the drug in their bodies to prevent H.I.V. infection. Without regular injections, or a carefully-managed end to use of the drug, the participants will not have enough cabotegravir to stop a new infection, but there will be enough in their systems that, if they were to contract the virus, it could easily mutate to become drug-resistant, said Dr. Kenneth Ngure, president-elect of the International AIDS Society.

This is a significant threat to the trial volunteers and also to the millions of people living with H.I.V. because cabotegravir is closely related to a drug that is already used worldwide in standard treatment of the virus. Development of resistance could be catastrophic, Dr. Ngure said: “It’s wrong on so many levels — you can’t just stop.”

A clinical trial run by the development organization FHI 360, which implemented many U.S.A.I.D.-funded health programs and studies, was testing a biodegradable hormonal implant to prevent pregnancy. Women in the Dominican Republic had the devices in their bodies when U.S.A.I.D. funding was cut off. A spokeswoman for the organization, which furloughed more than a third of its staff this week, said that it had pulled together other resources to ensure that participants continue to receive care.

Another trial, in Uganda, was testing a new regimen of tuberculosis treatment for children. The stop-work order cuts those children off from potentially lifesaving medication.

“You can’t walk away from them, you just can’t,” a researcher in that trial said.

Advertisement

Health

Man’s extreme energy drink habit leads to concerning medical discovery, doctors say

Published

on

Man’s extreme energy drink habit leads to concerning medical discovery, doctors say

NEWYou can now listen to Fox News articles!

Eight energy drinks per day may lead to serious health consequences, recent research suggests.

A relatively healthy man in his 50s suffered a stroke from the overconsumption of unnamed energy beverages, according to a scientific paper published in the journal BMJ Case Reports by doctors at Nottingham University Hospitals in the U.K.

The unnamed man was described as “normally fit and well,” but was experiencing left-side weakness, numbness and ataxia, also known as poor coordination or unsteady walking. 

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

Advertisement

When the man sought medical attention, it was confirmed via MRI that he had suffered an ischemic thalamic stroke, the report stated.

The patient’s blood pressure was high upon admission to the hospital, was lowered during treatment and then rose again after discharge, even though he was taking five medications.

The 50-year-old man (not pictured) admitted to drinking eight energy drinks per day. (iStock)

The man revealed that he consumed eight cans of energy drink per day, each containing 160 mg of caffeine. His caffeine consumption had not been recorded upon admission to the hospital.

CLICK HERE FOR MORE HEALTH STORIES

Advertisement

Once the man stopped drinking caffeine, his blood pressure normalized, and he was taken off antihypertensive medications.

High caffeine content can raise blood pressure “substantially,” a doctor confirmed. (iStock)

Based on this case, the authors raised the potential risks associated with energy drinks, especially regarding stroke and cardiovascular disease.

CLICK HERE TO DOWNLOAD THE FOX NEWS APP

They also highlighted the importance of “targeted questioning in clinical practice and greater public awareness.”

Advertisement

The authors say this case draws attention to the potential dangers of over-consuming energy drinks. (iStock)

Fox News senior medical analyst Dr. Marc Siegel reacted to the case study in an interview with Fox News Digital.

“This case report illustrates the high risk associated with a large volume of energy drink consumption, especially because of the high caffeine content, which can raise your blood pressure substantially,” said Siegel, who was not involved in the study.

TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ

“In this case, the large amount of caffeine appears to have led directly to very high blood pressure and a thalamic stroke, which is likely a result of that soaring blood pressure.”

Advertisement

Fox News Digital reached out to the case study authors and various energy drink brands for comment.

Continue Reading

Health

5 Surprising Ozempic Side Effects Doctors Are Finally Revealing (Like Back Pain and Hair Loss)

Published

on

5 Surprising Ozempic Side Effects Doctors Are Finally Revealing (Like Back Pain and Hair Loss)


Advertisement


Surprising Ozempic Side Effects Doctors Want Women To Know | Woman’s World




















Advertisement











Advertisement




Use left and right arrow keys to navigate between menu items.


Use escape to exit the menu.

Advertisement

Continue Reading

Health

Relationship coach blames Oprah for pushing family estrangement ‘for decades’

Published

on

Relationship coach blames Oprah for pushing family estrangement ‘for decades’

Join Fox News for access to this content

You have reached your maximum number of articles. Log in or create an account FREE of charge to continue reading.

By entering your email and pushing continue, you are agreeing to Fox News’ Terms of Use and Privacy Policy, which includes our Notice of Financial Incentive.

Please enter a valid email address.

Having trouble? Click here.

NEWYou can now listen to Fox News articles!

Oprah Winfrey is shining a light on family estrangement, which she calls “one of the fastest-growing cultural shifts of our time” — but one expert says the media mogul helped fuel that very culture.

Advertisement

“A Cornell University study now shows that almost one-third of Americans are actively estranged from a family member,” Winfrey said on a recent episode of “The Oprah Podcast,” referring to adult children going “no-contact” with parents, siblings or entire family systems.

Winfrey said the trend is a “silent epidemic” that can be especially relevant during the holidays.

ONE TOXIC BEHAVIOR KILLS RELATIONSHIPS, LEADING HAPPINESS EXPERT WARNS

But family and relationship coach Tania Khazaal, who focuses on fighting “cutoff culture,” took to social media to criticize Winfrey for acting as if the estrangement crisis appeared “out of thin air.”

“Now Oprah is shocked by the aftermath of estrangement, after being one of the biggest voices pushing it for decades,” Canada-based Khazaal said in an Instagram video, which drew more than 27,000 likes and 3,000 comments.

Advertisement

Oprah Winfrey recently discussed what she called a “silent epidemic” of family estrangement on her podcast. (Theo Wargo/Getty Images)

Khazaal claimed that Winfrey’s messaging started in the 1990s and has contributed to a cultural shift where walking away became the first resort, not the last.

According to the relationship coach, millennials, some of whom grew up watching Oprah, are the leading demographic cutting off family members — and even if it wasn’t intentional, “the effect has absolutely been harmful,” Khazaal told Fox News Digital.

FAMILY BREAKUPS OVER POLITICS MAY HURT MORE THAN YOU THINK, EXPERT SAYS

The coach, who has her own history with estrangement, questioned why Winfrey is now treating the issue as a surprising crisis.

Advertisement

“Now she hosts a discussion with estranged parents and estranged kids, speaking on estrangement like it’s some hidden, sudden, heartbreaking epidemic that she had no hand in,” she said in her video.

Nearly one-third of Americans are estranged from a family member, research shows. (iStock)

Khazaal said she believes discussions about estrangement are necessary, but insists that people shouldn’t “rewrite history.”

“Estrangement isn’t entertainment or a trending conversation piece,” she added. “It’s real families, real grief, parents dying without hearing their child’s voice.”

JENNIFER ANISTON, KATE HUDSON, HEATHER GRAHAM’S SHOCKING REASONS THEY BECAME ESTRANGED FROM THEIR PARENTS

Advertisement

Winfrey reportedly responded in the comments, writing, “Happy to have a conversation about it — but not on a reel. Will have my producer contact you if you’re interested.” But the comment was later deleted due to the backlash it received, Khazaal told Fox News Digital.

“I would still be open to that discussion,” Khazaal said. “The first thing I’d want her to understand is simple: Setting aside cases of abuse or danger, the family unit is the most sacred structure we have.” 

Experts emphasize that estrangement should be a last resort. (iStock)

“When children lose their sense of belonging at home, they search for it in the outside world,” she added. “That’s contributing to the emotional fragility we’re seeing today.”

Her critique ignited a debate online, with some social media users saying Khazaal is voicing a long-overdue concern.

Advertisement

PSYCHIATRIST REVEALS HOW SIMPLE MINDSET SHIFTS CAN SIGNIFICANTLY REDUCE CHRONIC PAIN

“The first time I heard, ‘You can love them from a distance’ was from Oprah … in the ’90s,” one woman said.

My son estranged himself from us for five years,” one mother commented. “The pain, hurt and damage never goes away.”

TEST YOURSELF WITH OUR LATEST LIFESTYLE QUIZ

Others, however, argued that Winfrey’s podcast episode was empathetic and that estrangement shouldn’t be oversimplified.

Advertisement

Mental health experts say the conversation around estrangement is more complex than any single celebrity influence, and reflects broader cultural shifts.

Experts say today’s focus on boundaries and emotional well-being has reshaped family expectations. (iStock)

In the episode with Winfrey, Joshua Coleman, a California-based psychologist, said, “The old days of ‘honor thy mother and thy father,’ ‘respect thy elders’ and ‘family is forever’ has given way to much more of an emphasis on personal happiness, personal growth, my identity, my political beliefs, my mental health.” 

Coleman noted that therapists sometimes become “detachment brokers” by unintentionally green-lighting estrangement.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

Advertisement

Jillian Amodio, a licensed master’s social worker at the Maryland-based Waypoint Wellness Center, told Fox News Digital that while public figures like Winfrey help normalize these conversations, estrangement might just be a more openly discussed topic now.

“Estrangement used to be handled privately and quietly,” she said.

Winfrey’s take on family estrangement is prompting a broader discussion amid the holiday season. (iStock)

But even strained relationships can be fixed with the right support, experts say.

CLICK HERE FOR MORE HEALTH STORIES

Advertisement

Susan Foosness, a North Carolina-based clinical director of patient programs at Rula Health, said families can strengthen their relationships by working with a mental health professional to improve communication, learn healthier conflict-resolution skills, and build trust and empathy through quality time together.

“No family is perfect,” Foosness told Fox News Digital.

Khazaal agreed, saying, “Parents need to learn how to listen without slipping into justification, and children need help speaking about their pain without defaulting to blame or avoidance.”

Fox News Digital reached out to Winfrey for comment.

Advertisement

Continue Reading
Advertisement

Trending