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New NIH policy threatens global science collaborations

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One of the studies that are threatened by a new administration policy with regard to international research is aimed at extending the lives of women with the most common type of breast cancer.

A maximum of one in five women with estrogen-driven breast cancer experiences a life-threatening recurrence after being in remission after 10 years or even longer. If those women can be identified in advance, doctors can treat them before the cancer returns. The medicines already exist.

But the research project, carried out with scientists in Denmark, can be closed very well. The National Institutes of Health said earlier this month that it will stop granting subsidies to scientists such as the projects, a sub-award, to a foreign employee.

The policy endangers thousands of active international research projects that depend on partnerships with scientists and universities in other countries.

Federal health officials said they had made the change because inconsistencies in internal systems and databases make it difficult to accurately follow the sub-competence payments, a problem that has been documented in various reports of the Accountability Office.

“This lack of visibility is unacceptable and is precisely why radical change is needed,” said a NIH officer in an e -mail, although stricter monitoring requirements were introduced in 2023, after a critical GAO report.

Breast cancer research cannot be done without European partners. The work is based on detailed cancer registers that patients have followed for decades and samples of tumors that have been preserved in – means that the United States does not have, and Denmark does that.

“The moment we received the subsidy to do this, we looked through the United States to see if there is a similar source, and that is not that,” said Timothy Lash, professor of epidemiology at the Rollins School of Public Health of Emory University, who specializes in cancer prevention and predictors of recurrent.

Currently, foreign sub-wounds are “nested” within the subsidy of the subsidy recipients based in the US. The new NIH policy would require international scientists who are planning to collaborate with American researchers to submit subsidies of subsidies for assessment.

If it is granted a subsidy, the funds would flow directly from NIH, instead of the American subsidy receiver.

The NIH initially said that “continuous prices with retroactive effect would not revise to remove foreign sub -wounds at the moment.” Nevertheless, the new policy influences current subsidies, which are usually awarded for periods of five years, and come every year for so-called non-competitive renewal.

The new policy will be applied at the time of renewal, said federal officials, and would therefore threaten the current research projects, such as the Denmark Breast Cancer Study.

Thousands of international research projects that are already underway can be influenced by the new policy, from studies of infectious diseases such as malaria and HIV to research into chronic disorders that occur in the United States, such as cancer, cardiovascular diseases and dementia.

Karestan Koenen, a professor in psychiatric epidemiology to Harvard and member of the Broad Institute, a biomedical and genomic research center in Cambridge, Mass., Receives nih financing to study the genetics of psychiatric conditions such as schizophrenia and post-traumatic stress disorders

But she has already informed colleagues in hospitals in Uganda and Kenya, who have helped to collect DNA samples from people with post-traumatic stress disorder that she can no longer work with them.

She was lucky, she said, because the researchers had been very efficient and had already collected enough samples for analysis, so the entire project will not be in vain.

Many of the genomic data so far come from populations with European roots, she noticed.

“What we have realized is that if you develop tools that only develop on European descent, they do not work well with Afro -Mamans or East Asians,” said Dr. Koenen. “So from a very practical point of view we need more data from more populations.”

Dr. Jeremy Schwartz, associate professor at Yale, has studied self -care with regard to heart failure in Uganda. More than half of his NIH subsidy goes to sub-homes to support its international employees.

Heart failure affects many Americans, but in African the Sahara die three out of 10 people with the diagnosis within a year. The study is intended to improve the management of heart failure, to reduce hospital admissions and to extend life.

“Our employees learn a lot from us, but we also learn a lot from them,” said Dr. Schwartz. “We think we can lift all the boats at the same time.”

The University of North Carolina in Chapel Hill has 105 federally funded research projects with foreign sub -wounds, including 12 with active clinical tests, according to a university spokeswoman.

Focus areas include eating disorders, genetics of diseases, cancer, infectious diseases and the improvement of prenatal care. Many of the projects benefit the state of North Carolina itself.

A new technology that links AI algorithms to a portable ultrasound, which originally developed the need for trained staff to offer ultrasound of pregnancy, was originally developed for use in developing countries.

But it can also be used in rural areas of the United States, including those in North Carolina, where one fifth of the provinces are so -called deserts for pregnancy care.

Elizabeth Rogawski McQuade, Assistantial Lecturer at the Emory’s Public Health School, Studies Antibiotics used in the treatment of diarrhea -disease caused by Shigella infection in children in developing countries such as Tanzania.

The idea is to better administer those antibiotics and to combat the rise of drug -resistant tribes of the bacteria. But Shigellose is also a problem in the United States and can threaten the lives of the elderly and the immunocomromized.

“When the resistance to medicines develops in Shigella, this can easily be transferred to other bacteria,” said Dr. McQuade, adding that more than half of the annual 450,000 Shigella cases in the United States are already drug resistant.

The NIH policy Says that foreign partners can be replaced by domestic employees. If the project is no longer viable without the foreign sub -guard, it can be terminated.

These options mean that huge investments can already be lost in ongoing research. Some researchers also wondered why the new restrictions were implemented before a replacement strategy was ready.

Carmen Marsit, Executive Associate Dean for Research Strategy at the Rollins School of Public Health at Emory, said he understood why the government might want to make the accounting change.

But he added: “It is somewhat irresponsible not to have a system you want to move to before you work the system that exists now and for the most part.”

The breast cancer study, a collaboration with the Danish Cooperative Group for breast cancerScientists from Aarhus University in Denmark and others is one of the approximately 35 scientific collaborations in which Rollins scientists are involved who can be affected by the new policy, he said.

Although the survival rates of cancer have improved, cancer becomes more often for young and middle age adults than in the past, especially women. Every year around 316,950 women in the United States are diagnosed with invasive breast cancer, and more than 42,000 die.

For the researchers who study late recurrences of estrogen -felt breast cancer, the Danish register and the repository of preserved tumors are invaluable.

“You could now start a new study, but it would be extremely expensive and you would have to wait 20 years,” said Dr. Lash, one of the researchers involved in the Danish register project. “We will have the answer in three or four years, and it is much more cost -effective.”

“I am convinced that the results of the study will be very important for cancer patients in the US,” he added.

Although the new policy suggests that recipients of American subsidies can easily remove foreign employees, “I think in many cases that is impossible,” said Dr. Marsit.

“The projects are specifically designed to record the foreign sites,” he said. “They can be central to the scientific question you ask and the work that is being done.”

In 2017, President Trump tried the Fogarty International Center of the NIH in Bethesda, MD. To eliminate that finances countless international scientific companies.

A commentary published in the New England Journal of Medicine at the time characterized the work of the center as “a critical investment in the health of the American people and the global community.”

It noted that scientists who were supported by the fogarty had studied how to prevent strokes and how to treat multi-drug-resistant tuberculosis and identified new cancer drugs “in waters for the Panama coast” and new ways to “reduce the number one murderer of young American travelers, traffic feelings”.

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