Asanda Zondi received a surprising phone call last Thursday, with orders to reach a health clinic in Vulindlela, South Africa, where he was participating in a research study that was testing a new device to prevent pregnancy and H.IV. infection.
The trial was closing, told her a nurse. The device, a silicone ring inserted in its vagina, had to be removed immediately.
When Mrs. Zondi, 22 years old, arrived in the clinic, learned why: the US agency for international development, which financed the study, had withdrawn financial support and had issued a stop-work order to all organizations all over the world who receive his money. The Brusca move followed an executive order of President Trump who freezed all foreign aid for at least 90 days. Since then, the Trump administration has taken measures to completely dismantle the agency.
The process of Mrs. Zondi is one of dozens who have been abruptly frozen, leaving people all over the world with experimental drugs and medical products in their bodies, cut off the researchers who were monitored them and generating waves of suspicion and fear.
The State Department, which now supervises Usaid, responded to a commentary request by directing a journalist to Usaid.gov, who no longer contains any information, except for the fact that all permanent employees were placed on administrative leave. State secretary Marco Rubio said that the agency is expensive and advances a liberal agenda in contrast with the foreign policy of President Trump.
In interviews, scientists-but are prohibited by the terms of the stop-work order to speak with the media-have described the agonizing choices: violate the stop -work orders and continue to take care of the volunteers or leave them alone to face the potential side effects and damage.
The United States are signatories of Helsinki’s declaration that exposes ethical principles on the basis of which medical research must be conducted, requesting that researchers take care of the participants during a test and refer to the results of their discoveries to the communities in which evidence was conducted .
Mrs. Zondi said she was bewildered and frightened. He spoke with other women who had offered themselves for the study. “Some people are afraid because we don’t know exactly what reason was,” he said. “We don’t really know the real reason to pause the study.”
The stop-work order was so immediate and wide that the research staff would violate him if they had helped women remove the rings. But Dr. Leila Mansoor, a scientist from the Center for The Aids research program in South Africa (known as Caprisa) and an investigator of the trial, decided that she and her team would have done it anyway.
“My first thought when I saw this order was, there are rings in people’s bodies and you cannot leave them,” said dr. MANSOOR. “For me ethics and participants come first. There is a line. “
In the communities in which his organization works, people have volunteers for more than 25 years to test HIV treatments, prevention and vaccine products, contributing to many of the main discoveries of the sector and benefit of people all over the world .
That work was based on a carefully built network of trust that has now been destroyed, said dr. MANSOOR. Building that trust required years in South Africa, where the apartheid regime has conducted medical experiments on blacks during the years of the white domain. These fears have taken up a long history of experimentation by researchers and pharmaceutical companies in developing countries and in the populations marginalized in the United States.
The Times has identified more than 30 frozen studies that already had volunteers in the care of researchers, including the studies of:
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Treatment of malaria in children under the age of 5 in Mozambique
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Treatment for cholera in Bangladesh
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A screen and treatment method for cervical cancer in Malawi
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Tuberculosis treatment for children and adolescents in Peru and South Africa
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Nutritional support for children in Ethiopia
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Development interventions of the first day in Cambodia
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Ways to support pregnant and stirring women to reduce malnutrition in Jordan
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A vaccine technology with MRNA 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 the last few days has canceled the public record. In addition to the disabled website, the agency no longer has a communication department. And the Stop-work order prohibits any implementation agency to speak publicly about what has happened.
In England, about 100 people were inoculated with an experimental vaccine for malaria in two clinical studies. Now, they no longer have access to the staff of the clinical experimentation if that vaccine should cause an adverse reaction in their bodies. The process is an effort to find a next generation vaccine better than the one now used in Africa; That shot protects children from about a third of the cases of malaria, but the researchers hoped to find a vaccine that offered much more protection. Malaria remains one of the best global children’s killers; 600,000 people died from illness in 2023, the last available figure.
If the experimentation had not been frozen, the participants would have come to a clinic usually to be monitored for adverse physical effects and to have blood samples and cells to see if the vaccine worked. Participants are designed to be followed for two years to evaluate the safety of the vaccine.
A scientist who worked on the trial said he hoped that the partners of the University of Oxford, where they were led, were mixing the staff to answer if a participant got sick. But it was fired last week and has no more access to any information on the test. He spoke on condition of anonymity because he feared that he jeopardizes his ability to work on the search for malaria that the United States could lead in the future.
“It is not ethical to test anything in man without bringing it to the complete completion of the studies,” he said. “You put them at risk without a good reason.”
If the stop-work order came by the end of the year, the newly vaccinated volunteers could 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, professor of reproductive infectious diseases at the University of Pittsburgh, has been director of a five -year process of 125 million dollars financed by Usaid to test the safety and effectiveness of six new products for the prevention of prevention of a five -year process of a five -year process ‘HIV. They included bimonthly injections, rapidly spread vaginal inserts and vaginal rings.
With the suspended study, she and her colleagues cannot elaborate biological samples, analyze the data that have already collected or communicate the results to the participants or government agencies partner in the countries where studies have been conducted. These are requirements provided for by the Helsinki agreement.
“We betrayed the trust of the health ministries and regulatory agencies in the countries in which we worked and women who agreed to be in our studies, to which it was said they would be treated,” said dr. Hillier. “I’ve never seen anything like this in my 40 years of international research. It is not ethical, it is dangerous and is reckless. “
Even the processes that have not been financed in whole or in part by USAID have been thrown in turmoil because they used medical or development infrastructures supported by the agency and are no longer operational. Millions of dollars of American taxpayers already spent to start these processes will not be recovered.
Arrests also have commercial consequences. Many of these studies were partnership with US pharmaceutical companies, testing products that hoped to sell abroad.
“This has made it impossible for pharmaceutical companies to do research in these countries,” said dr. Hillier.
Another process for HIV, called Catalyst, has thousands of volunteers in five countries that test an injectable drug called long -lasting cabotegravir. Participants were receiving bimonthly injections to maintain a sufficient level of the drug in their bodies to prevent HIV infection. Without regular injections or a thoroughly managed end for the use of the drug, the participants will not have quite cabotegravir to stop a new infection, but there will be enough in their systems which, if they contract the virus, could easily mute to become drug resistant , said dr. Kenneth Ngure, elected president of the International Aids Society.
This is a significant threat to the volunteers of the process and also for the millions of people who live with HIV because Cabotegravir is closely related to a drug that is already used all over the world in the standard treatment of the virus. The development of the resistance could be catastrophic, Dr. Ngure said: “It is wrong on so many levels – you cannot simply stop”.
A clinical experimentation conducted by the FHI 360 Development Organization, which implemented many programs and health studies financed by USAID, was testing a biodegradable hormonal system to prevent pregnancy. Now there are women in the Dominican Republic with devices in their bodies without continuous care.
Another study, in Uganda, was the test of a new treatment regime for tuberculosis for children. The stop-work order interrupts those children from potentially life-saving drugs.
“You can’t get away from them, you just can’t,” a researcher said in that process.