Studies of breast cancer and other diseases threatened by new policy

A crystal sample, part of the research to eradicate malaria at the Vaccine Research Center of the N.I.H. in Bethesda, Md. on Wednesday, Dec. 8, 2021. Restrictions on payments to foreign partners may jeopardize studies of cancer and other conditions that would benefit Americans. (Shuran Huang/The New York Times)

By Roni Caryn Rabin

One of the studies threatened by a new administration policy regarding international research is focused on prolonging the lives of women with the most common kind of breast cancer.

Up to 1 in 5 women with estrogen-fueled breast cancer experiences a life-threatening recurrence after being in remission for 10 years or even longer. If those women could be identified in advance, doctors can treat them before the cancer comes back. The medicines already exist.

But the research project, conducted with scientists in Denmark, may well be shut down. The National Institutes of Health said this month that it will stop awarding grants to scientists if the projects include making a payment, called a sub-award, to a foreign collaborator.

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

Federal health officials said they had made the change because inconsistencies across internal systems and databases make it difficult to accurately track the sub-award payments, a problem documented in several reports by the Government Accountability Office.

The lack of accountability was unacceptable and necessitated the change in policy, an NIH official said in an email, even though stricter monitoring requirements were put in place in 2023, after a critical GAO report.

The breast cancer research cannot be done without European partners. The work relies on detailed cancer registries that have tracked patients for decades and samples from tumors that have been preserved in wax — resources that the United States does not have, and Denmark does.

“At the time we got the grant to do this, we looked throughout the United States to see if there is a similar resource, and there is not,” said Timothy Lash, professor of epidemiology at Emory University’s Rollins School of Public Health, who specializes in cancer prevention and predictors of recurrence.

Currently, foreign sub-awards are “nested” within the grant of the U.S.-based grant recipients. The new NIH policy would require international scientists who plan to work with American researchers to independently submit grant applications for review.

If awarded a grant, the funds would flow directly from NIH, rather than from the U.S. grant recipient.

The NIH initially said it would not “retroactively revise ongoing awards to remove foreign sub-awards at this time.” Yet the new policy will affect ongoing grants, which are typically awarded for periods of five years, and come up for so-called noncompeting renewal every year.

The new policy will be applied at the time of renewal, federal officials said, and so would threaten current research projects, such as the Denmark breast cancer study.

Thousands of international research projects already underway could be affected by the new policy, from studies of infectious diseases like malaria and HIV to research into chronic conditions common in the United States like cancer, cardiovascular disease and dementia.

Karestan Koenen, a professor of psychiatric epidemiology at Harvard University and a member of the Broad Institute, a biomedical and genomic research center in Cambridge, Massachusetts, receives NIH funding to study the genetics of psychiatric conditions like schizophrenia and post-traumatic stress disorder.

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

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

Much of the genomic data so far has come from populations with European roots, she noted.

“What we’ve realized is that if you develop tools based only on European ancestry, they don’t work well on African Americans or East Asians,” Koenen said. “So from a very practical point of view, we need to get more data from more populations.”

Dr. Jeremy Schwartz, an associate professor at Yale University, has been studying self-care relating to heart failure in Uganda. More than half his NIH grant goes to sub-awards supporting his international collaborators.

Heart failure strikes many Americans, but in sub-Saharan African, 3 in 10 people with the diagnosis die within a year. The study aims to improve the management of a heart failure, decrease hospitalizations and extend life.

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

The University of North Carolina at Chapel Hill has 105 federally funded research projects that include foreign sub-awards, including 12 with active clinical trials, according to a university spokesperson.

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

A new technology that couples artificial intelligence algorithms with a portable ultrasound device, thus reducing the need for trained staff to provide pregnancy ultrasounds, was originally created for use in developing nations.

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

Elizabeth Rogawski McQuade, an associate professor at Emory’s public health school, studies antibiotics used in the treatment of diarrheal disease caused by Shigella infection in children in developing countries like Tanzania.

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

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

The NIH policy says that foreign partners may be replaced with a domestic collaborators. If the project is no longer viable without the foreign sub-award, it may be terminated.

These options mean that huge investments already made in ongoing research could go to waste. Some researchers have also questioned 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 that he understood why the government may want to implement the accounting change.

But, he added, “it’s somewhat irresponsible not to have a system in place that you want to move to before you stop the system that does exist right now, and for the most part is working.”