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

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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22, arrived at the clinic, she learned why: The U.S. Agency for International Development, which funded the study, had withdrawn financial support and had issued a stop-work order to all organizations around the globe that receive its money.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.

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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.”

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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.

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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.

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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.

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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.

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Brain Health Challenge: Try the MIND Diet

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Brain Health Challenge: Try the MIND Diet

Welcome to Day 2 of the Brain Health Challenge. Today, we’re talking about food.

Your brain is an energy hog. Despite comprising about 2 percent of the average person’s body mass, it consumes roughly 20 percent of the body’s energy. In other words, what you use to fuel yourself matters for brain health.

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So what foods are best for your brain?

In a nine-year study of nearly 1,000 older adults, researchers at Rush University in Chicago found that people who ate more of nine particular types of food — berries, leafy greens, other vegetables, whole grains, beans, nuts, fish, poultry and olive oil — and who ate less red meat, butter and margarine, cheese, sweet treats and fried food had slower cognitive decline.

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Based on these findings, the researchers developed the MIND diet.

Large studies encompassing thousands of people have since shown that following the MIND diet corresponds with better cognitive functioning, a lower risk of dementia and slower disease progression in people with Alzheimer’s. People benefit from the diet regardless of whether they start it in midlife or late life.

Experts think the foods included in the MIND diet are especially good for the brain because they contain certain macro and micronutrients.

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Berries and leafy greens, for example, are rich in polyphenols and other antioxidants, said Jennifer Ventrelle, a dietitian at Rush and a co-author of “The Official Mind Diet.” Many of these compounds can cross the blood-brain barrier and help to fight inflammation and oxidative stress, both of which can damage cells and are linked to dementia.

Nuts and fatty fishes, like salmon and sardines, contain omega-3 fatty acids, which are important for building the insulating sheaths that surround the nerve fibers that carry information from one brain cell to another.

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Whole grains and beans both contain a hefty dose of fiber, which feeds the good microbes in the gut. Those microbes produce byproducts called short-chain fatty acids that experts think can influence brain health via the gut-brain axis.

You don’t have to revamp your whole diet to get these nutrients. Instead, think about “MIND-ifying” whatever you already tend to eat, said Dr. Joel Salinas, a neurologist at NYU Langone Health and the founder and chief medical officer of the telehealth platform Isaac Health. For instance, add a handful of nuts or berries to your breakfast.

Today’s activity will help you MIND-ify your own meals. Share your choices with your accountability partner and in the comments, and I’ll discuss the ways I’m adjusting my diet, too. For added inspiration, check out these MIND-approved recipes from New York Times Cooking.

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Measles outbreak explodes in South Carolina; multiple people hospitalized as cases surpass 200

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Measles outbreak explodes in South Carolina; multiple people hospitalized as cases surpass 200

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The South Carolina Department of Public Health (DPH) is sounding the alarm after 26 new measles cases were reported since Friday, bringing the total number of cases in the state’s latest outbreak to 211.

DPH first reported a measles outbreak Oct. 2 in the Upstate region. As of Tuesday, 144 people are in quarantine and seven people are in isolation.

Of the 211 cases, 45 involve children under 5, 143 cases involve children ages 5 to 17, 17 cases involve adults and six cases involve minors whose ages weren’t disclosed.

DPH said 196 of the 211 infected individuals were unvaccinated, four were partially vaccinated, one was vaccinated and 10 are either still being investigated or have an unknown vaccination status.

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MEASLES CASES CONFIRMED AT FOUR MAJOR US AIRPORTS ACROSS COUNTRY AMID PEAK HOLIDAY TRAVEL

Hundreds of people in South Carolina have contracted the measles, and a few have been hospitalized. (Jan Sonnenmair/Getty Images)

Officials said 19 of the new cases were associated with “exposures in known households and previously reported school exposures,” and four resulted from church exposures.

DPH identified public exposures at Sugar Ridge Elementary and Boiling Springs Elementary and began notifying potentially exposed students, faculty and staff Dec. 31. 

There are nine students in quarantine from the two schools.

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Of the 211 cases, 45 involve children under 5 years old. (iStock)

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Exposures also happened at the Tabernacle of Salvation Church, Unitarian Universalist Church of Spartanburg, Slavic Pentecostal Church of Spartanburg and Ark of Salvation Church.

The source of one case is unknown, while two others are still being investigated.

Although complications from measles are not reportable, officials said four people, including adults and children, required hospitalization for complications from the disease.

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Officials recommend all children be vaccinated against measles. (Raquel Natalicchio/Houston Chronicle via Getty Images)

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Additional cases required medical care, but the infected individuals were not hospitalized.

Those infected with measles are contagious from four days before the rash appears and may be unaware they can spread measles before they know they have the disease, according to DPH.

DPH said it is important for those with a mild illness or those who are in quarantine to stay home to protect others.

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“We encourage employers to support workers in following DPH recommendations to stay out of work while ill or in quarantine, which also protects businesses, other workers and clients,” officials wrote in a statement.

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DPH said vaccinations continue to be the best way to prevent measles and stop the outbreak.

Though the CDC recently released new vaccine recommendations under Health and Human Services Secretary Robert F. Kennedy Jr., its guidelines still dictate all children should be immunized for measles, mumps, rubella, polio, pertussis, tetanus, diphtheria, Haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV) and chickenpox.

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Common pain relievers may raise heart disease and stroke risk, doctors warn

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Common pain relievers may raise heart disease and stroke risk, doctors warn

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Many might assume that over-the-counter (OTC) medications are generally safer than stronger prescription drugs, but research shows they can still present risks for some.

Certain common OTC painkillers have been linked to an increased risk of high blood pressure, stroke and heart attacks.

Potential risk of NSAIDs

Non-steroidal anti-inflammatory drugs (NSAIDs) — which are used to reduce pain, fever and inflammation — have been pinpointed as the class of medicines most linked to elevated cardiovascular risk.

NEW HEALTH WARNING ISSUED OVER POPULAR SLEEP AID MILLIONS TAKE NIGHTLY

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“This is because they reduce the production of certain chemicals called prostaglandins,” Maryam Jowza, M.D., an anesthesiologist at UNC Health in North Carolina, told Fox News Digital. “These chemicals are involved in inflammation, but they are also involved in other body functions, such as influencing the tone of blood vessels.”

Certain common OTC painkillers have been linked to an increased risk of high blood pressure, stroke and heart attacks. (iStock)

Dr. Marc Siegel, Fox News senior medical analyst, echoed the potential risk of NSAIDs. 

“They can lead to high blood pressure, heart attack and stroke via fluid retention and salt retention,” he told Fox News Digital. “This increases volume, puts a strain on the heart and raises blood pressure.”

DIABETES PATIENTS EXPERIENCE LOWER DEATH RATE WITH COMMON MEDICATION

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Common examples of NSAIDs include ibuprofen, naproxen, aspirin, diclofenac, indomethacin and celecoxib.

Randomized trials found that ibuprofen caused the biggest spikes in blood pressure, followed by naproxen and then celecoxib. 

“In general, the increase in blood pressure is more likely with higher doses and longer duration of treatment,” said Jowza, who is also an associate professor in the Department of Anesthesiology at the UNC School of Medicine.

COMMON VIRUSES LINKED TO ‘DRAMATIC’ SPIKE IN HEART ATTACK AND STROKE RISK

NSAIDs can also increase stroke risk, especially at high doses and with long-term use, the doctor added. 

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Diclofenac was linked to the highest cardiovascular risk, the doctor cautioned. Ibuprofen can also raise blood pressure and has been associated with a higher heart attack and stroke risk, but not as high as diclofenac. Naproxen carries a lower cardiovascular risk than ibuprofen or diclofenac, but is not entirely risk-free.

NSAIDs have been pinpointed as the class of medicines most linked to elevated cardiovascular risk. (iStock)

“The practical takeaway is that diclofenac is generally the least favorable choice in patients with elevated cardiovascular risk, and all NSAIDs should be used at the lowest effective dose for the shortest duration,” Dr. Nayan Patel, pharmacist and founder of Auro Wellness in Southern California, told Fox News Digital.

COMMON VITAMIN COULD PROTECT SOME HEART ATTACK SURVIVORS, STUDY SHOWS

Aspirin is an exception — although it is an NSAID, it actually reduces the risk of clots when taken at a low dose for prevention, under a doctor’s guidance. However, it can increase bleeding risk and blood pressure at high doses.

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Non-NSAIDs safer, but not risk-free

Non-NSAID pain relievers are commonly used for everyday aches, headaches and fever, but not swelling. They act mainly on the brain’s pain signals, not inflammation, according to medical experts.

Acetaminophen, the most common non-NSAID pain reliever, is also linked to an increase in blood pressure, although to a lesser extent, according to Jowza. 

“All NSAIDs should be used at the lowest effective dose for the shortest duration.”

“Acetaminophen was once thought to have little to no cardiovascular effects, but more recent evidence suggests it can increase blood pressure, especially with higher doses used in the long term,” she said, emphasizing the importance of blood pressure monitoring. “Its effect on stroke risk is less clear.”

Which groups are most vulnerable?

The groups at greatest risk, according to doctors, are those with existing health conditions, such as high blood pressure, prior stroke or heart disease, diabetes or kidney problems.

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“These groups are also more likely to experience NSAID-related fluid retention and destabilization of blood pressure control,” Patel said.

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Cardiovascular risk is generally higher for people 75 and older, the doctors agreed.

“Age amplifies risk largely because baseline cardiovascular risk increases with age, and kidney function reserve tends to decline,” Patel said. “Older adults are also more likely to be on antihypertensives, diuretics, antiplatelets or anticoagulants, so NSAIDs can destabilize blood pressure control and add safety complexity.”

Warning signs

Anyone experiencing chest pain, shortness of breath, sudden weakness or numbness, severe headache, confusion, slurred speech or vision changes should see a doctor immediately, Jowza advised.

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“These symptoms can point to a heart attack or stroke,” she warned. “Other symptoms of concern that may not develop as rapidly, like new swelling in the legs, should also prompt medical attention.”

Anyone experiencing chest pain, shortness of breath, sudden weakness or numbness, severe headache, confusion, slurred speech or vision changes should see a doctor immediately, a doctor advised. (iStock)

“Patients should also seek medical advice if they notice signs of fluid retention or kidney stress, such as rapidly rising blood pressure, swelling in the legs, sudden weight gain over a few days, reduced urine output or worsening shortness of breath,” Patel added.

Safer alternatives

For those at higher risk, Patel recommends non-NSAID approaches whenever possible. 

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“For many patients, this means starting with non-drug strategies such as heat or ice, physical therapy and activity modification,” he told Fox News Digital. “If medication is needed, acetaminophen is generally preferred over oral NSAIDs from a cardiovascular standpoint, although regular use should still be monitored in people with hypertension.”

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For localized joint or muscle pain, the doctor said topical NSAIDs can offer “meaningful relief” with “far lower” risk.

“Overall, pain management in high-risk patients should emphasize targeted therapy, conservative dosing and close blood pressure monitoring.”

Bottom line

The doctors emphasized that the overall risk is “very low” for people taking OTC pain relievers on a short-term basis, but it rises with long-term, high-dose use.

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“I would not hesitate to use an occasional dose if it were a low-risk individual with no prior history of heart attack or stroke,” Jowza said. “I also think short-term use in diabetics and hypertensives who are well-controlled is acceptable.”

Although aspirin is an NSAID, it actually reduces the risk of clots when taken at a low dose for prevention, under a doctor’s guidance. (iStock)

For those taking NSAIDs, the doctor suggested using “guard rails” — such as regularly testing blood pressure and kidney function, and setting limits on dosing — to make treatment as safe as possible.

Patel agreed that for most healthy individuals, occasional NSAID use “does not carry a meaningful cardiovascular risk.”

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“The concern is primarily with repeated or chronic use, higher doses, and use in people with underlying cardiovascular, kidney or blood pressure conditions,” he confirmed to Fox News Digital.

“That said, large population studies show that cardiovascular events can occur early after starting NSAIDs, particularly at higher doses, which is why even short-term use should be approached cautiously in higher-risk patients.”  

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