FAS Roundup: From Nuclear Secrets to Maternal Mortality and DARPA-H

By June 3, 2021

US Soldiers Expose Nuclear Weapons Secrets Via Flashcard Apps

“There are so many fingerprints that give away where the nuclear weapons are that it serves no military or safety purpose to try to keep it secret. Safety is accomplished by effective security, not secrecy,” Nuclear Information Project Director Hans Kristensen tells Bellingcat.

 

Deep Dive: Maternal Mortality and Clinical Trials

Each year about 700 women die from pregnancy or birth complications in the U.S., the worst maternal mortality rate out of all industrialized countries. Resolving this crisis is a top priority for the National Institutes of Health (NIH), along with bolstering research on the safety of prescription drugs for pregnant and lactating women. 

The rate of maternal deaths has been rising in the U.S. since 2000. More than half of maternal deaths occur after the day of birth, and one third occur during pregnancy. This crisis is also exacerbated by racial disparities: Black women are 2.5 times more likely to die than White women and three times more likely to die than Hispanic women.

Last year, the NIH established the Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE) Initiative. It aims to “mitigate preventable maternal mortality… and promote health equity” by using “an integrated approach to understand biological, behavioral, sociocultural, and structural factors.” The IMPROVE Initiative has already awarded over $7 million in grants to address disparities in maternal mortality.

Compounding maternal health issues, there is a significant lack of knowledge as to which drugs are safe for pregnant and lactating women to use. While this problem has existed for a long time, clinical trials for COVID-19 treatments brought more attention to the issue. Out of 927 clinical trials worldwide, only 16 evaluated the effectiveness of a treatment on pregnant women. More than half of those clinical trials excluded pregnant women specifically. 

The exclusion of pregnant women from clinical trials largely stems from the thalidomide and diethylstilbestrol (DES) tragedies of the 20th century. DES entered the market in 1938 and was promoted as a way to prevent miscarriages and premature births, but almost 40 years later, researchers found the drug caused rare cancers in the daughters born to mothers who took it, as well as infertility. Thalidomide was used during the late 1950s and early 1960s to treat morning sickness. Researchers found, however, that the drug caused devastating birth defects in babies. In response, the Food and Drug Administration (FDA) published guidelines in 1977 that prevented pregnant women from participating in phase I and phase II clinical trials.

Though it is now possible for pregnant women to enroll in clinical trials due to the passage of the NIH Revitalization Act of 1993, researchers may only recruit them if the clinical trials adhere to strict regulations. Current regulations require conducting preclinical studies with pregnant animals and clinical studies with nonpregnant women prior to enrolling pregnant women. Because these requirements add time and cost to clinical trials, as well as necessitate the recruitment of sufficient numbers of pregnant women, many researchers opt not to include them. 

The Centers for Disease Control and Prevention estimate that 70% of pregnant women take at least one prescription drug. Nevertheless, researchers rarely include pregnant women in clinical trials, resulting in these women not having clear information about what drugs are safe for them. One study found that 90% of drugs approved by the FDA between 1980 and 2000 had no data about the drugs’ potential effects on pregnant women and fetuses. Drug manufacturers now choose to track possible side effects after a drug’s release via self-reported registries, but self-reporting can skew the data toward only severe reactions, and omit any milder, but still clinically important, symptoms.

Adapted from FAS Science Policy Blog by Lindsay Milliken and Michael Fisher, Federally-supported initiatives aim to reduce maternal mortality and shed light on the effects of therapeutics on pregnant and lactating women.

 

Nuclear Secrecy: In Defense of Reform

“One might suppose that nuclear secrecy is merely incidental to the larger history of nuclear weapons, but Wellerstein demonstrates that the subject is rich and dynamic and consequential enough to merit a history of its own,” writes Project on Government Secrecy Director Steven Aftergood in a review of Alex Wellerstein’s Restricted Data.

 

Scoping a DARPA-like Initiative for Health Innovation

“Done right, the health-oriented ARPA-H would be created in the image of existing ARPAs – like DARPA – and be capable of mobilizing federal, state, local, private sector, academic, and nonprofit resources to directly address the country’s most urgent health challenges, such as the high cost of therapies for diseases like cancer, or antimicrobial resistance,” write Congressional Science Policy Initiative Director Michael Fisher and research assistant Lindsay Milliken in a new Science Policy blog.

 

Citizenship Agency Eyes Improved Service Without Plan to Pay

“When USCIS is plagued with problems and not delivering the services it is supposed to in a reasonable time, that’s not just bad news for immigrants, it is bad news for U.S. citizens navigating the system,” Technology and Innovation Initiative Director Doug Rand tells AP.

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