Move Fast and Break the Government; The Bulwark, January 28, 2025

SAM STEIN AND 

BENJAMIN PARKER

, The Bulwark; 

Move Fast and Break the Government

"A letter from the Office of Management and Budget, obtained last night by The Bulwark, instructed federal agencies that they were to “temporarily pause all activities related to obligation or disbursement of all Federal financial assistance,” effective “on January 28, 2025, at 5:00 PM.”

What, exactly, does this mean? The note was vague, stating that the pause was for activities that “may be implicated by [Trump’s] executive orders, including, but not limited to, financial assistance for foreign aid, nongovernmental organizations, DEI, woke gender ideology, and the green new deal.” But immediate speculation among those scrutinizing the letter was that things like food assistance, financial aid to students, grants for university-based research, and many other government functions could come to a stop. The scope of what could be impacted was honestly hard for them to comprehend.

“Nobody knows,” said one person on the receiving end of the memo, when asked the extent of the federal aid that would stop.

Perhaps that’s the point.

In recent days, agency officials and those dependent on government contracts have described being left in a state of darkness by the administration they now serve; like families cowering in their basement shelters waiting to go out to see the damage the tornado has caused. Getting guidance on what was now allowed and what was prohibited was hard to do, in part lobbyists and even Congress were no better informed.

Federal health and research agencies appear to be particularly confused. Over the weekend, several people posted online about their clinical cancer trials having come to an abrupt halt as the National Institutes of Health imposed restrictions on hiring, travel, communication, and other functions. The scientific and medical community was, rightfully, alarmed at the possibility that people suffering from deadly diseases would be denied treatment by their own government.

By Monday, the NIH finally issued some guidance. In another letter obtained by The Bulwark, acting NIH Director Matthew Memoli assured colleagues that, “Clinical trials at NIH or NIH-funded institutions are ongoing,” and that “travel restrictions do not apply to research participants traveling to NIH to participate in a clinical trial or protocol.”

A victory? Yes. But a limited one. In that same letter, Memoli said that no money would be available for “new studies, new equipment, or research services unrelated to the studies that were started prior to Jan. 20, 2025.” In other words, don’t make future plans.

And it’s not just at the NIH, either. Two people directly familiar with the matter told The Bulwark on Monday that the National Science Foundation abruptly canceled peer review panels. “All review panels scheduled for the remainder of this week, 1/28-1/31 will be rescheduled to a future date as appropriate,” read the guidance given. The NSF did not return repeated requests for comment. Nor has the White House over the past few days.

The breakneck speed of Trump’s orders could quickly turn into an acute constitutional crisis, with the executive branch essentially usurping the power of the purse from the legislative body. Certainly, it has already had profound political and psychological effects. Federal employees described utterly dispirited workplaces, where paranoia is creeping in. There is a belief that the new administration is set on turning the government into a tool for Trump and searching for the pretext to fire anyone unwilling to go along. It did not go unnoticed that the statement from the DOJ official announcing the firings on Monday noted that “Acting Attorney General James McHenry made this decision because he did not believe these officials could be trusted to faithfully implement the President’s agenda” (emphasis ours).

But it’s also not hard to see how the tremors being sent throughout the government could hurt Trump in the long run. It starts with small examples of over-compliance with the vague orders that the administration has to walk back, like the Air Force removing videos honoring the Tuskegee Airmen from training materials because they believe those videos violated the administration’s anti-DEI push. They move to larger problems, like prison guards who are responsible for securing ISIS militants no longer turning up for work because their salaries have been cut. And then they become disasters on your watch, like infants dying because water was cut off in the foreign aid freeze.

That’s the thing about moving fast and breaking things. Sometimes you end up breaking things you wish you hadn’t and can’t repair."

She worked in animal research. Now she’s blocked from commenting on it.; The Washington Post, May 6, 2024

 Rachel Weiner, The Washington Post; She worked in animal research. Now she’s blocked from commenting on it.

"For a long time, Madeline Krasno didn’t tell other animal rights advocates that she had worked in a monkey research lab as a college student. It had taken her years to understand her nightmares and fragmented memories as signs of post-traumatic stress disorder. And some activists could be vicious to former lab workers.

But four years after she graduated from the University of Wisconsin at Madison, Krasno started posting online about her experiences. Eventually, she started tagging the school in those posts and then commenting on its pages.

Many of those comments disappeared. As she would later learn, it was not a mistake or a glitch. Both the university and the National Institutes of Health were blocking her comments. Now with support from free speech and animal rights organizations, she is suing both institutions."

Addressing the epidemic of high drug prices; Harvard Law Today, January 5, 2024

Jeff Neal, Harvard Law Today; Addressing the epidemic of high drug prices

"The Biden administration is once again targeting high drug prices paid by Americans. This time, officials are focused on prescription medications developed with federal tax dollars. The United States government, through the National Institutes of Health (NIH), awards billions of dollars of research grants to university scientists each year to fund biomedical research, which is often patented. The universities in turn grant exclusive licenses to companies to produce and sell the resulting drugs to patients in need. But what happens if a drug company fails to make a medication available, or sets its price so high that it is out of reach for a significant percentage of patients?

To tackle this problem, the Biden administration recently released a “proposed framework” that specifies when and how the NIH can “march in” and award the rights to produce a patented drug to a third party if the patent licensee does not make it available to the public on “reasonable terms.” The plan is based on a provision included in the Bayh-Dole Act, a 1980 federal law which was designed to stimulate innovation by encouraging universities to obtain and license patents for inventions resulting from federally funded research.

According to Harvard Law School intellectual property expert Ruth Okediji LL.M. ’91, S.J.D. ’96, although the Biden administration’s proposed framework for using government march-in rights to lower drug costs is an important development, whether it will be successfully implemented and result in meaningful drug price reductions remains to be seen. Harvard Law Today recently spoke to Okediji, the Jeremiah Smith, Jr. Professor of Law and faculty director of Global Access in Action(GAiA) at the Berkman Klein Center, about the new proposal and the legal challenges it might face."

The NIH and Moderna Are Fighting Over Who Owns Their Vaccine; Intelligencer, November 10, 2021

Matt Stieb, Intelligencer; The NIH and Moderna Are Fighting Over Who Owns Their Vaccine

"While last year the government was calling the shot the “NIH-Moderna COVID-19 vaccine,” the biotech giant filed a patent made public this week in which it found that “only Moderna’s scientists” designed the vaccine. The patent, filed in July, is specific to the genetic sequence creating spike proteins, which allow vaccine recipients to build antibodies to block the virus when the body is actually exposed. As the New York Times reports, the NIH was surprised by the attempt at a solo effort. If the two parties cannot figure out a way to split the credit, the government will have to determine if it will take the expensive step of going to court. Already, the U.S. has paid $10 billion in taxpayer funds for Moderna to help create the vaccine, test its efficacy, and provide shots for the federal government."

All of Us program wants to change the face of medicine; University of Pittsburgh: University Times, January 8, 2019

Susan Jones, University of Pittsburgh: University Times; All of Us program wants to change the face of medicine

"Dr. Steven Reis wants all of you to become part of All of Us.

Pitt received a $46 million award in 2016 from National Institutes of Health to build the partnerships and infrastructure needed to carry out the All of Us initiative, which seeks to gather health information from 1 million people nationwide to create a database to study different diseases and other maladies, and in the process change the face of medicine.

In Pennsylvania, Pitt is responsible for recruiting 120,000 participants and by early this week had reached 11,610. Nationally, there are more than a dozen other organizations now gathering participants and more than 80,000 people have enrolled nationwide. There are between 40 and 50 people working on the project at Pitt...

The institute “supports translational research, meaning how to get research from the bench to the bedside, to the patient, to practice, to the community, to health policy,” Reis said...

The information will be stored in a secure central database created by Vanderbilt University Medical Center, Verily Life Sciences (a Google company) and the Broad Institute in Cambridge, Mass. Volunteers will have access to their study results, along with summarized data from across the program."

Open-data contest unearths scientific gems — and controversy; Nature, March 8, 2017

Heidi Ledford, Nature; 

Open-data contest unearths scientific gems — and controversy

"Now one-third of the 60 papers that Wright's team had planned to publish are in jeopardy of being scooped. “I think the incentives to do these trials will be dramatically lessened if this is going to be the expectation going forward,” he says. “It's a huge time commitment.”

But others favour making data from trials publicly available as soon as possible. Doing so, they argue, opens up the possibility of a wide range of additional analysis, and speeds up analyses that can yield important clinical insights. “Clinical trial data are quite valuable, but usually they're kept locked away,” says Sandosh Padmanabhan, a participant in the competition who researches cardiovascular genomics at the University of Glasgow, UK. “Everybody who does clinical trials needs to open up their data for everybody to use.”"

Henrietta Lacks’s family wants compensation for her cells; Washington Post, February 14, 2017

Andrea K. McDaniels, Washington Post; Henrietta Lacks’s family wants compensation for her cells

"Francis Lanasa, the attorney who will represent the family, said that he would use a “continuing tort” argument, alleging that Hopkins had continued to violate the “personal rights, privacy and body parts” of Henrietta Lacks over time.

“They are literally the foundation of modern medical science,” Lanasa said of the cells."

The Institutional Animal Care and Use Committee; NIH, 2011

NIH; The Institutional Animal Care and Use Committee:

"Responsibilities

The IACUC is responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide). Link to Non-U.S. Government Site - Click for Disclaimer Its oversight functions include an ongoing assessment of animal care and use. IACUC responsibilities include:

Review, at least semiannually, the institution's program for the humane care and use of animals;

Inspect, at least semiannually, the institution's animal facilities (including satellite facilities);

Prepare reports to the Institutional Official (IO) of the IACUC evaluations;

Review animal welfare concerns;

Make recommendations to the IO on any aspect of the animal program, facilities, or personnel training;

Review and approve, those components of PHS conducted or supported activities related to the care and use of animals;

Review and approve, proposed significant changes to the use of animals in ongoing activities; and

Be authorized to suspend an activity involving animals.

Membership

[Five People]The IACUC membership must consist of at least 5 members and includes:

one veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution;

one practicing scientist experienced in research with animals;

one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); and

one member who is not affiliated with the institution other than as a member of the IACUC."

Pitt faces animal rights scrutiny; Pittsburgh Post-Gazette, 3/2/14

Anya Sostek, Pittsburgh Post-Gazette; Pitt faces animal rights scrutiny:

"An animal rights group has filed a letter of complaint against the University of Pittsburgh, asking that the school be fined for violations against the federal Animal Welfare Act in its research labs.

The group, Stop Animal Exploitation Now, charges two rabbits died while being used in Pitt experiments and that there were several instances of primate escapes and other infractions, based on information Pitt voluntarily reported to the National Institutes of Health.

The group is asking the U.S. Department of Agriculture, which enforces the Animal Welfare Act, to fine Pitt $80,000 -- the maximum for what it counts as eight infractions.

Pitt acknowledges that "minor violations" occurred but said the violations already had been investigated by the NIH and that the agency did not find cause for further action."