Asanda Zondi received an incredible call last Thursday, and was ordered to go to a hygiene clinic in Vulindlela, South Africa, and was involved in a research study that was testing new devices to prevent pregnancy. infection.
The trial had been closed, the nurse told her. The device, a silicone ring inserted into her vagina, had to be removed immediately.
When Zondi, 22, arrived at the clinic, she learned why: The US International Development Agency, which funded the research, withdraws its financial support and receives all organizations around the world that receives the money. A stop work order has been issued. . The sudden move followed an executive order by President Trump that freezes all foreign aid for at least 90 days. Since then, the Trump administration has taken steps to completely dismantle the agency.
Zondi's trial was one of dozens of people who were suddenly frozen, and was separated from researchers who were monitoring experimental medicines and medical products for people all over the world, leaving them in their bodies, and questioning and fear. It creates waves of
The State Department, which now oversees USAID, responded to a request for comment by directing reporters to USAID.gov. Secretary of State Marco Rubio said the agency is in vain and will advance a liberal agenda that violates President Trump's foreign policy.
In the interview, scientists, who are prohibited by the conditions of a halt work order to speak to news media, explain the painful choice. Effects and harm.
The United States is the signature of the Declaration of Helsinki, which sets out the ethical principles that medical research must be conducted, in which researchers take care of participants through trials and report the findings of the findings to the community where the trial was held. I'm requesting that.
Zondi said she was confused and frightened. She spoke to other women who volunteered for research. “Some people are afraid because they don't know exactly what the reason is,” she said. “We really don't know the real reason to pause our research.”
The order of stop work was cleaned very instantly, so if a woman helps remove the ring, the research staff will violate it. However, Dr. Leila Mansour, a scientist at the Centre for AIDS Research Programmes in South Africa (known as Caprisa), and a trial investigator, decided that she and her team would do so anyway.
“My first thought when I saw this order was that people's bodies have rings and you can't leave them,” Dr. Mansour said. “For me, ethics and participants come first. There's a line.”
In the community where her organization works, people have volunteered to test HIV treatments, preventive products and vaccines for over 25 years, contributing to many of the important breakthroughs in the field, and people all over the world is bringing benefits to.
The work relied on a carefully constructed web of trust that is currently being destroyed, Dr. Mansoor said. Building that trust took years in South Africa, when the apartheid regime conducted medical experiments on blacks during white control. These fears are reflected in a long history of experiments by researchers and pharmaceutical companies in developing countries, as well as marginalized groups in the United States.
The Times has identified more than 30 frozen studies where volunteers were already caring for researchers, including the following trials:
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Malaria treatment for children under the age of 5 in Mozambique
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Cholera treatment in Bangladesh
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Malawi cervical cancer screens and treatments
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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 growth interventions in Cambodia
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How to Support Pregnant and Breastfeeding Women to Reduce Malnutrition in Jordan
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South African HIV mRNA vaccine technology
As the recent rapid demolition of USAID has erased public records, it is difficult to know the total number of closed exams, or how many people will be affected. In addition to websites with disabilities, agents no longer have a communications department. Additionally, the order to stop work prohibits implementing agencies from publicly telling what happened.
In the UK, around 100 people have been vaccinated with the experimental malaria vaccine in two clinical trials. Currently, if the vaccine causes side effects in the body, they no longer have access to clinical trial staff. The trial is an effort to find a next-generation vaccine than what is currently being used in Africa. The shot protects children from about a third of malaria cases, but researchers wanted to find a vaccine that would provide far more protection. Malaria remains a global killer for children. 600,000 people died of illness in 2023, with the latest numbers available.
If the trial is not frozen, participants will be routinely monitored by the clinic to monitor the secondary physical effects and sample blood and cell samples to check if the vaccine is working. Participants aim to follow for two years to assess the safety of the vaccine.
Scientists involved in the trial said that Oxford University partners wanted it was being implemented and shuffled staff to respond to participants if they got sick. However, she was fired last week and has no access to information about the trial. She spoke on condition of anonymity because she feared she would endanger her ability to tackle malaria research that the United States might do in the future.
“It's unethical to test something in a human without completing the research completely,” she said. “You put them in danger without a valid reason.”
If the suspension work order came later this year, newly vaccinated volunteers could have been in an even more unstable position. They were planning to intentionally infect malaria to see if the experimental vaccines protected them from the disease.
Dr. Sharon Hillier, professor of reproductive infections at the University of Pittsburgh, said this week that the safety and effectiveness of six new HIV prevention products, up to the director of a five-year, $125 million trial funded by USAID this week. I tested it. They included injections of dimers, rapidly decomposed vaginal inserts, and vaginal rings.
When the study is suspended, she and her colleagues process biological samples, analyze data already collected, or investigate either participants or affiliated government agencies in the country where the trial was conducted. You cannot convey the results. These are requirements under the Helsinki contract.
“We have betrayed the trust of the country we worked in and the Ministry of Health and regulatory bodies of women who agreed to our research. “We have been conducting 40 years of international research, and we have a betrayal of the trust of the country we worked in, and the women's Ministry of Health and the regulatory bodies that agreed to our research. I've never seen anything like that. It's unethical, dangerous, and reckless.”
Even exams not funded in whole or in part by USAID were in disarray as they used healthcare or development infrastructure that was not supported and operated by the institution. The US taxpayer funds already spent to launch these trials will not recover millions of dollars.
Shutdowns also have business consequences. Many of these trials were partnerships with US pharmaceutical companies, testing products they wanted to sell overseas.
“This made it impossible for pharmaceutical companies to conduct research in these countries,” Dr. Hillier said.
Another HIV trial, called Catalyst, has thousands of volunteers in five countries testing an injectable drug called long-acting CaboteGravir. Participants were receiving second-class injections to maintain sufficient levels of drugs in the body to prevent HIV infection. Without a carefully controlled end to regular injections, or drug use, participants do not have enough cabotegravir to stop new infections, but their systems have the ability to contract to the virus. , there are enough that can be easily mutated. To become drug resistant, said Dr. Kenneth Nugure, president-elect of the International AIDS Association.
This is a major threat to the millions of people living with trial volunteers and HIV, as Cabotegravir is closely linked to the drugs already used worldwide as standard treatment for the virus. is. Development of resistance can be devastating, Dr. Ngure said: “It's wrong on so many levels. You just can't stop it.”
Clinical trials conducted by the development organization FHI 360, which has conducted many USAID-funded health programs and research, tested biodegradable hormone implants to prevent pregnancy. Currently, there are women in the Dominican Republic who have devices in their bodies without continuing attention.
Another trial in Uganda was testing a new regimen for treating tuberculosis in children. Orders for stopping work eliminate these children's potentially life-saving drugs.
“You can't leave them, you can't just,” the trial researcher said.
