Foreign threats to NIH research: Senate Finance Committee digs in
China, Russia and Iran were singled out in a Senate Finance Committee hearing on Wednesday as countries that are looking to either undermine or usurp scientific research conducted with US taxpayer funds.
Committee Chairman Chuck Grassley (R-IA) made clear that China is “by far the most prolific offender,” offering the example of attempts by Chinese researchers to steal genetically modified corn seeds in Iowa and send them back to China.
“Researchers who are secretly supported by a foreign government while working on US research projects can be more susceptible to the influence and control of the foreign parent. We must know who is financially supporting researchers to better understand whether they might be more dedicated to securing the interests of an adversary than to rigorous scientific and medical advancement,” Grassley said.
As part of efforts to combat such abuses, Sen. John Cornyn (R-TX) said he will introduce a bill next week, called “Secure Our Research Act,” which would establish an interagency working group to set up a compliance framework to protect federally funded research from foreign interference, espionage and exfiltration.
Capt. Michael Schmoyer, director of the Office of National Security (ONS) at the Department of Health and Human Services (HHS), explained the extent of the problem to the committee. Since the spring of 2017, ONS became “acutely aware of specific challenges relating to the threat of foreign influences on HHS, and specifically NIH, research integrity. We became involved in two whole-of-government working groups, led by the FBI, to address the challenges since some foreign governments have initiated systematic programs to unduly influence and capitalize on U.S.–conducted research, including that funded by NIH.”
More specifically, Louis Rodi, deputy assistant director of homeland security investigations in the Department of Homeland Security, pointed to China, Iran and Russia as being involved in the largest number of ongoing investigations related to either the transmission of technical data from the US or the transfer of foreign nationals to the US.
“As of May 2019, there are 357,863 F-1 [visa] Chinese students in the United States with 181,980 such students enrolled in STEM-related academic programs at U.S. institutions. There are also 11,323 F-1 Iranian students and 6,196 F-1 Russian students, with the respective STEM student breakdown of 9,057 for Iran and 2,008 for Russia,” Rodi wrote in written testimony.
He offered the hypothetical example of an Iranian student coming to the US to study civil engineering, but in reality that student might be working to study concrete to aid the Iranian nuclear program. “So that would be a concern to us, using our tech to build these bunkers,” he said. He also offered the example of an Iranian student coming to the US to learn how to weld titanium for aging Iranian airplanes.
Les Hollie, chief of investigative operations at HHS’ Office of Inspector General, explained how he’s overseen 16 allegations of noncompliance, which dealt with principal investigators that failed to reveal connections to foreign governments.
In written testimony, Hollie offered two examples of recently resolved research integrity investigative cases: One involved a doctor who worked in a laboratory at Iowa State University, which received research grants for an experimental HIV/AIDS vaccine. The doctor falsified scientific data to make it appear an experimental HIV/AIDS vaccine neutralized, or controlled, the HIV/AIDS virus in rabbits, and he contaminated rabbit blood samples with human antibodies to make it appear the rabbits produced neutralizing antibodies against the HIV/AIDS virus. The data were used in a grant application and progress reports to NIH. In 2015, the doctor was sentenced to 57 months in federal prison and required to pay more than $7 million in restitution.
The other example was a doctor who founded two companies, GenPhar and Vaxima, to perform research and produce vaccines for diseases such as Ebola, Marburg virus and Dengue virus. The companies received NIH funds for biodefense research and vaccine development, but actually used the funds for other purposes, including the construction of a commercial office building and to pay lobbyists and others who were seeking to secure more federal funding on the doctor’s behalf. In 2017, the doctor was sentenced to 70 months in federal prison and ordered to pay over $3 million in restitution.
Lawrence Tabak, principal deputy director at NIH, added: “The numbers are small but the problem is important. We’ve been working with 61 institutions, and that number will undoubtedly increase.”
But Tabak also pointed out how this issue is not always black and white and there are situations in which “honest mistakes were made by research investigators who were unaware of the requirement to disclose other funding sources (both domestic and international) or affiliations with foreign entities.”
Other senators and witnesses also noted the advancements made by foreign-born scientists in the US.
Sen. Lamar Alexander (R-TN) said in a statement: “Scientists from other countries have played an important role in research funded by the United States government—since 2000, 33 Americans who were born in other countries have won Nobel prizes in chemistry, medicine and physics. Unfortunately, attempts by foreign governments to influence our federally funded research and steal intellectual property from the United States threatens the integrity of scientific research.”
Sen. Steve Daines (R-MT) also expressed “real concerns” with China stealing research and commercializing that research. “China is opening its pharmaceutical market to better align with international standards, but you look at the Made in China 2025: they don’t want to build an open market but to build a domestic market. China is graduating eight times more STEM grads than what we produce in the US, and I think we’re underestimating the competitive threat,” he said.
The committee was expected to hold a classified briefing on the matter Wednesday afternoon.
First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.