Why the CDC, NIH, and FDA shutdown has us worried


The US Congress and the White House didn’t agree on a new budget by midnight on Friday, and now the US government is officially shut down.

All furloughed federal employees can’t do their jobs — or even use their work emails or cell phones — and many government programs and research labs are grinding to a halt. And tens of thousands of them work at the agencies responsible for public health.

Half of the Department of Health and Human Services’ 80,000-member staff are furloughed, including people at the Centers for Disease Control and Prevention who monitor disease outbreaks like flu, researchers at the National Institutes of Health looking for disease cures, and inspectors at the Food and Drug Administration who oversee pharmaceutical and food safety.

But most alarming is the shutdown’s effects on patients: Families who have long awaited government-run clinical trials that were slated to start Monday won’t be able to enroll in them. That means the shutdown will keep them from potentially lifesaving procedures, and could be a factor in their deaths.

Here’s what we can expect for health and science during a shutdown. It’s making us anxious.

1) A government shutdown could mean we won’t know, as quickly, how deadly this year’s flu outbreak is

Right now, America is in the grips of one of the deadliest seasonal flu epidemics in recent memory. And the shutdown will slow operations on CDC’s seasonal influenza program.

As Buzzfeed reports, hours before the government shutdown Friday night, the agency released a contingency plan that said flu outbreak monitoring would continue during a shutdown, but that flu reports may be published on a slower schedule. (This was one of several signs of confusion at the agency going into the shutdown.) Still, the CDC has a limited capacity to communicate their findings, since their social media accounts are currently not posting updates.

During the 2013 shutdown, state labs continued to do the work of surveilling disease to detect outbreaks, but they weren’t able to call on CDC epidemiologists for help coordinating those investigations — and any samples sent to the agency piled up. Back then, the CDC also wasn’t able to update national disease trends or disease clusters in real time.

Tom Frieden, who was director of the agency for eight years, from 2009 to 2017, said the 2013 shutdown “was the only time I felt I couldn’t do my job of protecting Americans.”

He added: “It was the really the most anxiety-provoking time because it was like being blindfolded and having one hand tied behind your back.”

Even though the government says “activities related to the safety of human life” are supposed to continue in the event of a shutdown, Frieden said the way shutdowns work is “very irrational.”

“Because whether people are allowed to keep working or not doesn’t actually depend on how important their jobs are,” he said. “It depends on where the sources of funding come from and whether certain legal definitions are met.”

For example, in 2013, CDC employees working on tracking foodborne illness were furloughed — and then had to be put back on the job because of a severe salmonella outbreak, caused by raw chicken products. The outbreak sickened 278 people and hospitalized 76 across 18 states.

According to the government’s 2018 contingency plan for a government shutdown, 50 percent of staff across Health and Human Services agencies will be furloughed. The retention rates at specific agencies vary, but the plan suggests only 37 percent of the CDC’s 13,600 employees would be retained. At the two other key health agencies in the department, the NIH and FDA, the numbers are 23 percent and 58 percent, respectively.

In the 2013 shutdown, Frieden said, his agency didn’t know of any deaths that happened as a result of government public health services being shuttered — but he couldn’t be sure. “In practice it’s certainly possible,” he said. “We didn’t have our systems fully up and running to assess that.”

2) The NIH can’t enroll new patients in clinical trials, and research will grind to a halt

The NIH has hospital facilities to treat patients, but it’s also one of the major basic biomedical research institutions in the US, NIH research discovers new drugs and vaccines, and works to better understand the biology of illness. And not just at its campus in Bethesda — about 80 percent of its budget goes to awarding research grants for institutions across the United States. (Same goes for the National Science Foundation, which also won’t be able to approve new research grants.)

In 2013, the NIH had to turn down hundreds of patients (many of whom were children) who could have potentially benefited from experimental procedures.

The same would happen this time around, Anthony Fauci, the head of the NIH’s infectious disease division, told the Associated Press on Thursday.

“We still take care of them,” he said of patients currently enrolled in NIH hospitals for treatment. But new patients would be turned away.

As The Conversation reported, “This is one of the few places where the shutdown could result in fatalities. Many patients only participate in medical studies when conventional medicine has failed. It’s possible that some would-be patients, who would have received potentially lifesaving medical care, will die without these lifesaving treatments.”

Not being able to enroll new patients may also hurt ongoing studies. Sometimes, patients die or drop out of clinical trials. With the shutdown, researchers wouldn’t be able to enroll new patients in ongoing studies, which could affect the studies’ strength.

During the 2013 shutdown, 73 percent of its staff couldn’t go to work. That means research projects were put on hold at the Bethesda facility, and new grants couldn’t go out to outside scientists awaiting funding since the NIH (and National Science Foundation) have to stop processing grants.

The NIH kept on essential staff to ensure the safety of critical cell lines, and to keep research animals (mice and primates) alive.

But some research can’t survive a pause. “You have experiments that have been going on for months if not years, and then all of a sudden you’ve got to stop — you can’t do that,” Fauci told the AP. “You can’t push the pause button on an experiment when you inject an animal with a particular substance to see what the response is and then you have to go home for a week.”

And even PubMed, the widely-used health science database run out of NIH, will stop being updated for as long as the shutdown lasts. Researchers from around the world trying to access the system for their work won’t get the most up-to-date results.

The shutdown also throws a wrench into international and disciplinary science collaboration. During a shutdown, government scientists can’t attend conferences.

3) The FDA’s food inspection work is imperiled

The Food and Drug Administration not only regulates pharmaceuticals and monitors their safety after they get on the market; it also regulates most of the food supply. And one of the scariest aspects of the government shutdown is that the agency would likely to have to put its food safety inspections on pause.

In the 2013 shutdown, according to Food Safety News, FDA food safety inspectors were “asked to turn in their government cell phones and not even check their work email until Congress passes a budget.”

This didn’t mean all food safety inspections in America stopped; private companies continued with their own monitoring practices, and inspectors at the US Department of Agriculture, which oversees inspections of meat, poultry, and eggs, were allowed to continue working. But the federal oversight the FDA provides — of 80 percent of the food supply — was shuttered.

During this year’s shutdown, the FDA will operate in a limited capacity. According to a memo on the FDA’s website, the agency will continue to monitor and respond to food-borne disease outbreaks, manage product recalls, and “screening the food and medical products that are imported to the U.S. to protect consumers and patients from harmful products, and addressing other critical public health issues.”

The FDA is also currently dealing with a saline IV bag shortage. These essential medical devices are in short supply due to a double whammy: Hurricane Maria disrupted production of IV saline bags in factories in Puerto Rico, and the ongoing severe flu season has increased their demand. The FDA memo reports it will still work on this issue during the shutdown.

In an excellent story on the 2013 government shutdown’s impact on health, STAT reported that FDA staff who worked on research that would inform public health decisions stopped, as did “the agency’s efforts to keep drug labelling information up to date and accurate.”

In addition to programs and services that are halted, we can also expect a more sluggish FDA in shutdown mode. Again, the government’s 2018 contingency plan for a government shutdown would keep only 58 percent of the FDA’s 17,000 staff members on the job. So drug approvals would slow down, for example (but they wouldn’t necessarily stop, because they are partly funded by the private sector).

Overall, the government shutdown isn’t an apocalypse. But it means the government is less able to carry out critical research, address issues like drug and device shortages, and monitor and respond to disease outbreaks.

Do you have stories about how the shutdown affecting your work/patients?

Reach Julia at [email protected], on KeyBase at jbelluz, or through PGP: F65A 5539 A081 B01E 1E8D 498D 6489 E570 AEAB E972

Reach Brian at [email protected], on KeyBase at bresnick, or through PGP: 229A C31B 8C89 63C6 BD03 A36C 5888 5415 AFD9 EFC9

Sourse: vox.com

Why the CDC, NIH, and FDA shutdown has us worried

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