June 20, 2021 Liz Borkowski, MPH 2Comment

I didn’t expect to agree with everything the Biden administration does. But some of the developments over the past several weeks have been especially disheartening because they’re at odds with the administration’s stated commitment to equity and evidence-based policymaking.

A narrow look at evidence for mask guidance

On May 13, CDC abruptly altered its guidance for vaccinated individuals to advise that people who are fully vaccinated against COVID-19 no longer need to wear masks in most indoor settings (healthcare and public transit are exceptions). Just days earlier, the agency had finally issued a long-awaited scientific brief acknowledging that the novel coronavirus spreads via aerosols (tiny droplets that can hang in the air for hours)—a statement that, while it didn’t take the next logical step of making ventilation recommendations, was an important recognition of the scientific consensus. The fact that the brief on aerosol transmission took such a long time seemed to reflect a careful and deliberative process, but such a process was not in evidence with its guidance for fully vaccinated people.

The May 13 guidance was based on several studies indicating that fully vaccinated individuals are at low risk of developing symptomatic COVID-19 and spreading the disease to others, plus a small number of modeling studies—most described as preliminary—that project the likely impact of relaxing other preventive measures in the context of vaccination. In a critique of the CDC guidance, National Nurses United cautions that a large proportion of the studies CDC cites are preprints, which generally means they haven’t gone through a journal’s peer-review process yet, and that some of the studies’ investigators are funded by vaccine manufacturers.

The larger problem, though, is that CDC seemed to treat this as a question of vaccine effectiveness rather than a question of how best to equitably protect public health. Consultation with social scientists likely would have indicated that this guidance would result in state and local governments as well as businesses lifting their mask requirements (which is indeed what happened), and that even if policies continued to require masks for those not fully vaccinated, many of them would likely stop wearing masks, too. Such circumstances then make it harder for those who are at greatest risk to spend time in public spaces, and increase risks for workers.

Children under 12 are not yet eligible for vaccination, and people with compromised immune systems may not become immune even after they receive the shots. And not every eligible person has been able to get the vaccinations they desire. “Many low-wage workers are not vaccinated because they cannot afford the time off of work to be vaccinated or recover from post-vaccination adverse effects,” former OSHA head current George Washington University Milken Institute School of Public Health professor David Michaels told Tom Philpott of Mother Jones. Lack of access is still a problem for many people. KFF reports that racial/ethnic gaps in vaccinations have narrowed in recent weeks, but as of June 14 the distribution is still inequitable: 45% of the total White population has been vaccinated, compared to 32% of the Black population and 36% of the Hispanic population. When CDC issued its guidance, University of Illinois director of social emergency medicine Marina Del Rios tweeted, “If the USA’s overall vaccination rates were as low as they currently are among Latinx and Black people, the CDC would NOT have changed their guidelines.”

In TIME, maternal and child health epidemiologist Theresa Chapple-McGruder and Duke University physician and professor Gavin Yamey decry CDC’s narrow focus on the health of vaccinated individuals as opposed to the public:

The Biden Administration and the CDC have adopted a new rhetoric of personal responsibility that does not match the reality of the pandemic today. The government is abandoning its responsibility to keep the population healthy. It has eliminated guidance meant to protect the public’s health and placed the onus on individuals to protect themselves. Vaccination is being promoted as the only nationwide approach to prevent COVID-19. Instead of adopting a population-based strategy, in which we as a community would work together in solidarity to drive down transmission by universal masking indoors, Biden and the CDC are telling individuals that it is up to them to lower their risk. The CDC director now says “your health is in your hands” and President Biden says “The choice is yours.”

Ed Yong, who just won a Pulitzer for his COVID-19 reporting, notes in The Atlantic that this approach is at odds with CDC’s stated commitment to equity:

The CDC’s own website lists the 10 essential public-health services—a set of foundational duties arranged in a colorful wheel. And at the center of that wheel, uniting and underpinning everything else, is equity—a commitment to “protect and promote the health of all people in all communities.” The CDC’s critics say that it has abandoned this central tenet of public health. Instead, its guidelines centered people who had the easiest and earliest access to vaccines, while overlooking the most vulnerable groups.

As NNU’s brief emphasizes, vaccines are not 100% effective, and we don’t know how well they will protect against the newest variants of the virus; therefore, multiple layers of protection are still advisable. With its focus on a narrow scientific question instead of an examination of broader public health evidence, CDC is contributing to the continued inequitable risk for those who are already marginalized.

Limited COVID protections for healthcare workers only

The OSHA standard to protect workers from COVID-19 (which one of Biden’s first executive orders instructed the agency to consider issuing) had already run into substantial resistance, and CDC’s failure to issue public health-protective guidance seems to have doomed it.

The emergency temporary standard that OSHA released on June 10 applies only to healthcare settings; as Government Executive’s Courtney Bublé reports, its requirements for employers include “develop and implement coronavirus safety policies; limit and monitor entrance to areas where there is direct patient care; ensure employees are wearing masks inside and when in a vehicle for work purposes; maintain physical distancing; screen employees before coming into work; keep a log of employee COVID-19 cases; inform employees of their rights under the temporary standard; and do not retaliate against them for exercising such rights and provide time off and paid leave for employees to get vaccinated.”

Although these steps are welcome in healthcare settings, they leave unprotected many other essential workers, including those in meatpacking, agriculture, food service, retail, transportation, warehouses, childcare, hospitality, and other industries that require in-person interactions. Workers in these essential jobs are disproportionately likely to be Black and Hispanic, and this inequitable distribution of jobs—a manifestation of systemic racism—is one of the factors placing Black and Latinx people at greater risk of COVID-19.

Former senior OSHA official and current National Employment Law Project worker health and safety program director Debbie Berkowitz told Mother Jones’s Philpott, “We know that less than one half of all the adult population is vaccinated—and unvaccinated workers remain at risk and must be protected, especially in low wage industries like meat processing that disproportionately employ Black and brown people.” Philpott notes that three of the states with the highest concentrations of poultry workers (Arkansas, Alabama, and Mississippi) have some of the lowest vaccination rates.

Michaels also explained to Noam Schieber of the New York Times how CDC’s weak guidance affected the OSHA rule: To justify issuing this as an emergency standard, rather than going through the usual multi-year notice-and-comment rulemaking process, OSHA had to show that danger to workers outside healthcare settings remains grave. CDC taking an unwarrantedly rosy view of current hazards makes it much harder for OSHA to defend a multi-sector rule against inevitable court challenges.

Drug approval that flies in the face of evidence and scientific advice

On June 7, FDA made what now-former advisory committee member Aaron Kesselheim said “might be the worst approval decision that the F.D.A. has made that I can remember.” None of the members of the relevant scientific advisory committee recommended approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab), so it was a shock when FDA gave it the green light. Three advisory committee members have resigned in protest: Joel Perlmutter of Washington University School of Medicine in St. Louis, David Knopman of the Mayo Clinic, and Kesselheim of Harvard Medical School and Brigham and Women’s Hospital. “With the three resignations, the federal panel has now lost a third of its members who come from outside the government,” notes NPR’s Bill Chappell.

The two clinical trials of Aduhelm did not find convincing evidence that it could slow cognitive decline, the advisory committee noted. The trials did, however, show a risk of serious side effects like brain swelling and bleeding. In making its decision, FDA moved the goalpost: instead of looking for improvements in symptoms, they decided that reductions in the beta amyloid plaques that are present in the brains of Alzheimer’s patients was enough to merit approval. However, we don’t actually know that reducing beta amyloid in the brain will improve cognitive function in Alzheimer’s patients; as authors from the National Center for Health Research explained in the journal BMJ, other drugs that have been found to reduce beta amyloid have failed to achieve cognitive improvements in clinical trials.

In another inappropriate move given the evidence, FDA approved the drug for all Alzheimer’s patients, even though the trials only enrolled patients with mild disease. The trials also failed to enroll a patient population that looks like the population of US Alzheimer’s patients, where Black and Hispanic people are overrepresented—STAT’s Usha Lee McFarling notes that “For the global aducanumab trials, information released by Biogen includes only Asian people, who made up roughly 10% of participants, and white individuals, who made up 80%.”

FDA went against the advice of its entire advisory committee to approve a drug that hasn’t shown significant clinical benefit but has shown alarming side effects, and they approved it for populations in whom it hasn’t been studied. It appears that they might have been swayed by Alzheimer’s patient groups, who are desperate for something they can count as good news after years of disappointing trial results. But is it really serving patients to make a decision based on hope rather than science, when the drug might well have devastating physical and financial consequences without any noticeable benefit? It certainly seems likely to harm already shaky public trust in FDA.

In the future, I hope CDC, OSHA, FDA, and the White House leadership that shapes their actions do a better job considering all of the relevant evidence and advancing equity. Lives and public confidence in our government are at stake.

2 thoughts on “With COVID-19 Policies and Alzheimer’s Drug Approval, Biden Administration Lets Us Down

Leave a Reply

Your email address will not be published.

This site uses Akismet to reduce spam. Learn how your comment data is processed.