Health
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22, arrived at the clinic, she learned why: The U.S. Agency for International Development, which funded the study, had withdrawn financial support and had issued a stop-work order to all organizations around the globe that receive its money.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.
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.”
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:
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malaria treatment in children under age 5 in Mozambique
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treatment for cholera in Bangladesh
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a screen-and-treat method for cervical cancer in Malawi
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tuberculosis treatment for children and teenagers in Peru and South Africa
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nutritional support for children in Ethiopia
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early-childhood-development interventions in Cambodia
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ways to support pregnant and breastfeeding women to reduce malnutrition in Jordan
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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.
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.
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.
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.
Health
Dementia risk signals could lie in simple blood pressure readings, researchers say
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Simple measurements taken during routine blood pressure checks could predict dementia risk years before symptoms appear.
That’s according to new research presented this week at the American College of Cardiology’s Annual Scientific Session in Louisiana.
The findings draw on two studies led by researchers at Georgetown University, which suggest that monitoring how blood vessels age and stiffen over time can provide a window into future cognitive health.
LURKING DEMENTIA RISK EXPOSED BY BREAKTHROUGH TEST 25 YEARS BEFORE SYMPTOMS
Data shows rates of dementia and aging-related cognitive decline are expected to increase as populations age, and half of U.S. adults have high blood pressure (hypertension).
Scientists believe that efforts to better address hypertension, a key contributor to heart disease and a risk factor for dementia, could affect both cardiac and brain health.
Data shows rates of dementia and aging-related cognitive decline are expected to increase as populations age. Meanwhile, half of U.S. adults have high blood pressure. (iStock)
“Blood pressure management isn’t just about preventing heart attacks and strokes; it may also be one of the most actionable strategies for preserving cognitive health,” Dr. Newton Nyirenda, the study’s lead author and an epidemiologist at Georgetown University in Washington, said in a press release.
The research focused on two metrics, the pulse pressure-heart rate index and estimated pulse wave velocity. Both were calculated using data collected during standard doctor visits, such as heart rate, age and blood pressure.
“Blood pressure management isn’t just about preventing heart attacks and strokes; it may also be one of the most actionable strategies for preserving cognitive health.”
Researchers examined five years of data patterns for more than 8,500 people in the SPRINT trial, a large study of adults 50 years and older with hypertension. In the follow-up, 323 of the participants developed probable dementia.
HIDDEN BRAIN CONDITION MAY QUADRUPLE DEMENTIA RISK IN OLDER ADULTS, STUDY SUGGESTS
In one study, the team found the pulse pressure-heart rate index was a strong independent predictor of dementia risk in adults over 50. For participants under 65, every one-unit increase was associated with a 76% higher risk of developing dementia.
For participants under 65, an increase in the pulse pressure-heart rate index was associated with a 76% higher risk of developing dementia. (iStock)
The second study found that adults with consistently elevated or rapidly increasing pulse wave velocity were more likely to develop dementia than those with stable velocity, even after accounting for factors like smoking, gender and cardiovascular history.
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“Our findings suggest that vascular aging patterns may provide meaningful insight into future dementia risk,” said Nyirenda. “This reinforces the idea that managing vascular health earlier in life may influence long-term brain health.”
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The team emphasized that clinicians should tailor risk assessments and treatment strategies to the individual.
Further studies are needed to confirm these parameters and determine whether changing vascular aging trajectories reduces dementia risk. (iStock)
“You don’t want to wait until a patient starts manifesting cognitive decline before you act,” said senior study author Sula Mazimba, an associate professor at the University of Virginia.
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Researchers noted the study could not establish causation. Other limitations included the fact that participants already had hypertension and elevated cardiovascular risk, meaning the findings may not apply to people without those conditions.
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Further studies are needed to confirm these findings and to determine whether improving blood vessel health over time could reduce dementia risk.
Health
Everything You Need To Know About Zepbound for Weight Loss, Including Costs
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Health
‘Gas station heroin’ banned in another state amid nationwide crackdowns
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A dangerous substance dubbed “gas station heroin” continues to alarm medical professionals, with more states making moves to restrict or ban tianeptine.
Fourteen states have officially classified the tricyclic antidepressant as a Schedule I controlled substance.
Connecticut is the latest state to crack down, officially banning the sale and use of the substance starting on Wednesday.
HEALTH OFFICIALS WARN OF DANGEROUS SUBSTANCE AVAILABLE IN STORES ACROSS THE NATION
Tianeptine, which can produce euphoria in higher doses, can be more potent than morphine and addictive opioids, according to the U.S. Food and Drug Administration.
Some countries have taken steps to restrict how tianeptine is prescribed or dispensed, and have even revised the labels to warn people of its potential addictive qualities.
Tianeptine can be more potent than morphine and addictive opioids. (iStock)
Misuse of tianeptine can cause severe adverse health effects, including respiratory depression, severe sedation and death, according to the Drug Enforcement Administration.
Some companies market the drug as an aid for pain, anxiety and depression, or as a means of improving mental alertness in a pill, powder, salt or liquid form.
The products are typically sold at convenience stores, gas stations, vape shops and online retailers, and go by names like Tianaa, ZaZa, Neptune’s Fix, Pegasus and TD Red.
Connecticut is the 15th state to classify tianeptine as a Schedule I controlled substance. (Markus Scholz/picture alliance via Getty Images)
Connecticut Lt. Gov. Susan Bysiewicz said in a press release that the schedule change is a necessary step to combat addiction.
“With false marketing that led consumers to believe these are safe products, and with candy-like flavor options, these substances posed a clear threat to those battling substance-use disorder and our youngest residents,” she added.
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The Nutmeg State also added Mitragyna speciosa (kratom), 7-hydroxymitragynine, Bromazolam, Flubromazolam, Nitazenes and Phenibut to the schedule classification.
Earlier this month, FDA Commissioner Martin Makary penned a letter sounding the alarm on what he called a “dangerous and growing health trend.”
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“I am very concerned,” Makary wrote. “I want the public to be especially aware of this dangerous product and the serious and continuing risk it poses to America’s youth.”
New York-based Robert Schwaner, M.D., vice chair of system clinical affairs at Stony Brook Emergency Medicine, told Fox News Digital that the FDA has never approved tianeptine as a dietary supplement.
“As with heroin and other opioids, significant mu-opioid receptor stimulation ultimately results in a loss of respiratory drive and subsequent cardiac arrest.” (Dekalb County Sheriff’s Office)
“The euphoria at low doses is primarily due to increased serotonergic activity from its serotonin reuptake effects. With increasing doses, the mu-opioid receptor stimulation may become lethal,” said Schwaner. “As with heroin and other opioids, significant mu-opioid receptor stimulation ultimately results in a loss of respiratory drive and subsequent cardiac arrest.”
Schwaner said he believes the substance requires national regulation due to its addictive qualities.
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“Acting at the same receptor as opioids, tianeptine has the potential for an individual to develop tolerance, subsequent dependence and withdrawal from its use,” he cautioned.
Fox News Digital reached out to the FDA for comment.
Fox News Digital’s Greg Wehner and Melissa Rudy contributed to this report.
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