Asanda Zondi received a surprising phone call last Thursday, with orders to go to a health clinic in Vullindlela, South Africa, where she participated in a study that was testing a new device to prevent pregnancy and H.IV. infection.
The trial closed, said a nurse. The device, a silicone ring inserted in its vagina, was to be removed immediately.
When Ms. Zondi, 22, arrived at the clinic, she learned why: the American agency for international development, which funded the study, had withdrawn financial support and had issued a work order to all organizations of the world who receive their money. The steep decision followed a decree by President Trump freezing all foreign aid for at least 90 days. Since then, the Trump administration has taken measures to dismantle the agency entirely.
Ms. Zondi’s test is one of the dozens that have been abruptly frozen, leaving people around the world with experimental medicines and medical products in their bodies, cut off from researchers who monitored them and generating waves of suspicion and fear.
The State Department, which now oversees USAID, responded to a comment request by directing a journalist to USAID.GOVwhich no longer contains information, except that all permanent employees have been put on administrative leave. Secretary of State Marco Rubio said the agency was a waste and advances a liberal program contrary to President Trump’s foreign policy.
In interviews, scientists – who are prohibited by the terms of the order of judgment to speak with the media – described of the agonizing choices: violating the work orders and continuing to take care of the test volunteers, or the Leave alone to face a potential side effects and damage.
The United States is signatory to Helsinki’s declaration which presents ethical principles in which medical research must be carried out, demanding that researchers take care of participants throughout a test and signal the results of their results to the communities where trials have been conducted.
Ms. Zondi said she was disconcerted and frightened. She spoke with other women who had volunteered for the study. “Some people are afraid because we don’t know exactly what the reason was,” she said. “We don’t really know the real reason to take a break from the study.”
The work prescription was so immediate and radical that the research staff would violate him if they helped women withdraw the rings. But Dr. Leila Mansoor, a scientist from the Center for the Aids Program of Research in South Africa (known as Caprisa) and an investigator of the trial, decided that she and her team would do it anyway.
“My first thought when I saw this order was, there are rings in people ‘body and you can’t leave them,” said Dr. Mansoor. “For me, ethics and participants go first. There is a line.
In the communities where its organization works, people have volunteered for more than 25 years to test HIV treatment, prevention products and vaccines, contributing to many key breakthroughs in the field and benefiting people around the world .
This work was based on a carefully constructed confidence network that has now been destroyed, said Dr. Mansoor. The construction of this confidence has taken years in South Africa, where the apartheid diet has conducted medical experiences on blacks during the years of white diet. These fears are resolved in a long history of experimentation by researchers and pharmaceutical companies in developing countries and in marginalized populations in the United States.
Times identified more than 30 frozen studies that already had volunteers in the care of researchers, including tests of:
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Treatment of malaria in children under the age of 5 in Mozambique
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Bangladesh cholera treatment
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A screen and processing method for cervical cancer in Malawi
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Treatment of tuberculosis for children and adolescents 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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A mRNA vaccine technology for HIV in South Africa
It is difficult to know the total number of closed tests, or how many people are affected, because the rapid demolition of USAID in recent days has erased the public file. In addition to the disabled website, the agency no longer has communications service. And the order of stop labor prohibits any implementation agency from publicly talking about what happened.
In England, a hundred people were inoculated with an experimental vaccine on malaria in two clinical trials. Now they no longer have access to the personnel of the clinical trial if this vaccine was to cause an undesirable reaction in their bodies. The trial is an effort to find a new generation vaccine better than that now used in Africa; This blow protects children from around a third of malaria cases, but researchers hoped to find a vaccine that offered much more protection. Malaria remains one of the main world killers of children; 600,000 people died of the disease in 2023, the latest figure available.
If the trial had not been frozen, the participants came to a clinic regularly to be monitored for unfavorable physical effects and to take samples of blood and cells to see if the vaccine worked. Participants must be followed for two years to assess the safety of the vaccine.
A scientist who worked on the trial said that she hoped that the partners of the University of Oxford, where it was taking place, was breastfeeding the staff to answer if a participant fell ill. But she was dismissed last week and no longer has access to information on the trial. She spoke under the guise of anonymity because she feared compromising her ability to work on malaria research that the United States could lead to the future.
“It is contrary to ethics to test anything in humans without prevailing at the end of studies,” she said. “You put them in danger without reason.”
If the order of stop labor later came this year, the newly vaccinated volunteers could have been in an even more precarious position. They had to be deliberately infected with malaria to see if the experimental vaccine protected them from the disease.
Dr. Sharon Hillier, professor of reproductive infectious diseases at the University of Pittsburgh, was until this week, director of a trial of $ 125 million over five years funded by USAID to test security and the Efficiency of six new HIV prevention products. They included bimensual injections, vaginal inserts and vaginal rings.
With the suspended study, she and her colleagues cannot deal with biological samples, analyze the data they have already collected, or communicate results to participants or government partnership agencies in the countries where the tests have been conducted. These are requirements under the Helsinki agreement.
“We have betrayed the confidence of the ministries of health and regulatory organizations in the countries where we worked and women who agreed to be in our studies, who have been informed that they would be taken care of,” said Dr. Hillier. “I have never seen anything like this during my 40th anniversary of international research. It is contrary to ethics, it is dangerous and it is reckless. “”
Even the trials that have not been financed in whole or in part by the USAID were launched in disorders because they used medical or development infrastructure that were supported by the agency and are no longer operational. Millions of dollars of American taxpayers already spent to start these trials will not be recovered.
Closures also have commercial consequences. Many of these trials were partnerships with American pharmaceutical companies, testing products they hoped to sell abroad.
“This prevented pharmaceutical companies from doing research in these countries,” said Dr. Hillier.
Another HIV test, called Catalyst, has thousands of volunteers in five countries testing an injectable drug called prolonged action. Participants received bimensual injections to maintain a sufficient level of medication in their bodies to prevent HIV infection. Without regular injections, nor an end carefully managed to use the drug, participants will not have enough cabotravir to stop a new infection, but there will be enough in their systems which, if they were to contract the virus, that could easily mutate to become drug resistant, said Dr. Kenneth Ngure, elected president of the International AIDS Society.
This is an important threat to test volunteers and also for millions of people living with HIV because Cabotegravir is closely linked to a drug that is already used worldwide in the standard treatment of the virus. The development of resistance could be catastrophic, Dr. Ngure said: “It’s bad at so many levels – you can’t just stop.”
A clinical trial led by the FHI 360 development organization, which has implemented numerous health programs and studies funded by the USAID, was testing a biodegradable hormonal implant to prevent pregnancy. Women in the Dominican Republic had aircraft in their bodies when funding from USAID was cut. A spokesperson for the organization, who has known more than a third of its American staff this week, said that she had gathered other resources to ensure that participants continue to receive care.
Another test, in Uganda, was to test a new tuberculosis treatment diet for children. The order of arrest work reduces these children potentially vital drugs.
“You can’t get away from them, you can’t,” said a researcher at this trial.
