On 16 February Ruth Faden and Nancy Kass for STATnews
wrote, "While the fate of USAID remains murky, one thing absolutely is clear. The abrupt termination of critical USAID-funded clinical trials, with insufficient time to safeguard the welfare of people who are participating, is profoundly unethical and utterly inexcusable. Such actions threaten the health and lives of thousands of patients. The stop-work orders affect research designed to answer important questions about HIV or TB treatments, where immediate withdrawal of drugs not only takes away what may be lifesaving treatments but also risks exacerbating or creating drug-resistant strains,
leaving participants potentially worse off than if they had never joined the study and creating additional, unacceptable risks for others in the community...Telling a medical researcher they must abruptly abandon study participants is akin to telling a surgeon they cannot treat a patient who has a post-operative infection that resulted from a surgery they performed the week before. All medical ethics codes forbid this." (bolding mine)
Last month The NYT
reported, "
The Declaration of Helsinki, a decades-old set of ethical principles for medical research that American institutions and others throughout the world have endorsed, lays out ethical guidelines under which medical research should 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....The Times identified more than 30 frozen studies that had volunteers already in the care of researchers...With the study suspended, she [Dr. Sharon Hillier] 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."
The Guardian reported, "A flagship programme to create malaria vaccines has been halted by the
Trump administration, in just one example of a rippling disruption to health research around the globe since the new US president took power...Some products, such as injectable HIV prevention drugs, are not yet available outside research settings, he said, leaving participants with no alternative source to continue treatment. If the level of drugs in a participant’s body falls to nonprotective levels, it not only puts them at risk of infection, but means their infection is more likely to
develop drug resistance. That makes their treatment more complicated, and if they then infect someone else, the resistance will spread."
Pharma's almanac
wrote, "The disruption of USAID-funded clinical trials also has significant consequences for the global pharmaceutical industry. Many biopharmaceutical companies rely on public-private partnerships to conduct trials in low- and middle-income countries, where diseases like malaria and tuberculosis are most prevalent. Without these studies, companies lose critical data necessary for advancing drug development and securing regulatory approval. The long-term economic ramifications include a slowdown in research pipelines, reduced pharmaceutical exports to affected regions, and increased costs for developing new treatments. Furthermore, clinical trials that depend on USAID-supported healthcare infrastructure — such as hospitals, laboratories, and supply chains — are now at risk, even if they were not directly funded by the agency."
Devex
wrote, "Arbuthnot was part of a group of researchers from eight African countries working to advance new HIV vaccine candidates, known as the BRILLIANT consortium — an initiative funded entirely by a
$45 million grant from USAID, which has now been terminated. As well as the mRNA vaccine, which was at the preclinical stage and was showing early promise, a protein-based vaccine, which was due to start clinical trials, has also been put on hold...Ultimately, the reduction in funding may end up costing more to the U.S. in the long run, [Claudia] Martínez [director of research at the Access to Medicine Foundation] said. “Investments that go into diseases that could potentially affect the world at large, they matter. They will be impacting the U.S. and the world more broadly,” she said. “If you don't have a healthy population, you cannot have a healthy economy.”"
