This post is part of a series of quarterly roundups on scientific integrity.
During the last quarter of 2021, COVID-19 cases spiked once again as the Omicron variant swept the nation; CDC responded to resulting shortages of healthcare personnel and other workers by shortening the recommended isolation period for those who test positive, and the Occupational Safety and Health Administration announced it would withdraw its emergency temporary standard protecting healthcare workers. The Department of Health and Human Services withdrew non-evidence-based barriers to reproductive healthcare, while the Supreme Court ignored evidence and precedent regarding abortion. Congress took up new legislation to protect whistleblowers and combat corporate misinformation.
Agencies’ continued uneven response to COVID-19
Parents cheered FDA’s late October authorization of the Pfizer COVID-19 vaccine for children aged 5-11, and President Biden finally selected an FDA administrator: Dr. Robert Califf, who headed the agency in the last year of the Obama administration. Although Califf’s ties to the drug industry have generated some concerns about conflicts of interest, he seems likely to receive Senate confirmation.
In November, scientists in Botswana and South Africa detected a new variant of SARS-CoV-2. The first confirmed case of the Omicron variant was identified in the United States on December 1, and by late December it accounted for an estimated three-quarters of new COVID-19 cases. Omicron spreads more quickly than other variants, and both prior infection and vaccination offer less protection against it compared to Delta—though the combination of vaccines plus boosters still provides substantial protection and reduces disease severity. COVID-19 cases are soaring around the country, and although many of the cases are mild, the sheer number infected means hospitals are once again stretched to the limit. The problem isn’t just a spike in the number of people requiring hospitalization; it’s also that so many healthcare workers are sick.
To “address concerns about potential impacts on the healthcare system given a surge of SARS-CoV-2 infections,” CDC guidance updated on December 23 reduced the isolation period from ten days to seven days for healthcare personnel with mild to moderate illness whose symptoms have improved. It also allows vaccinated and boosted workers with COVID-19 exposures to continue working. Separate guidance on mitigating healthcare staffing shortages allows asymptomatic healthcare personnel to return to the job five days after their first positive test and those with mild to moderate illness and improved symptoms to return five days after symptoms first appeared; it also states that as a last resort during crises, personnel with confirmed infections can work. National Nurses United (NNU), the largest US union of registered nurses, urged the agency to maintain the old guidance in order to protect healthcare workers and their patients. A letter from NNU president Zenei Triunfo-Cortez pointed out, “There is no conclusive evidence that shortening the isolation time following a positive test will effectively prevent further transmission.”
Four days after updating its healthcare personnel guidance, the agency announced altered guidance for the public that reduced isolation periods from ten days to five days if people are asymptomatic or if their symptoms are resolving, provided that they wear a mask for an additional five days. “The change is motivated by science demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after,” their media statement explained. However, it’s not clear which studies they’re referencing here, and it seems likely that most (if not all) of them were conducted before Omicron was the dominant variant. None of the agency’s Science Briefs or Science Updates from December include information about the course of infection for individuals who tested positive for the Omicron variant.
In the wake of pushback against the new guidance, CDC director Rochelle Walensky explained that the reduced isolation period “really had a lot to do with what we thought people would be able to tolerate” and also aimed to “keep the critical functions of society open and operating.” Sara Nelson, president of the Association of Flight Attendants, said that the fact that the guideline change “aligns with the number of days pushed by corporate America is less than reassuring.” Days before CDC announced the new guidance, Delta Airlines’ CEO wrote to Walensky asking for a five-day isolation period, and the lobbying group Airlines for America echoed that request. CDC might help shore up fragile public trust in its guidelines by increasing the transparency around the studies it relied on in making this decision and demonstrating that it is tracking data on infectivity timelines as Omicron replaces Delta as the dominant variant.
Late December also saw the Occupational Safety and Health Administration (OSHA) announce that it would withdraw the non-recordkeeping portions of its COVID-19 emergency temporary standard (ETS) for healthcare workers. The standard, which it issued in June of 2020, required healthcare employers to provide their workers with N95 respirators or other personal protective equipment; adopt physical distancing and barriers; enhance ventilation and employee training; and develop and implement plans to mitigate the spread of COVID-19. The law requires that ETSs be replaced by permanent standards six months later, but Jordan Barab, who served as OSHA’s deputy assistant secretary of labor during the Obama administration, explains that courts are generally accepting of agencies’ failure to meet this impossible deadline. OSHA explained that it plans to work toward a permanent standard while vigorously enforcing the general duty clause of the Occupational Safety and Health Act, which requires employers to provide a safe and healthful workplace free from recognized hazards that are causing or likely to cause death or serious physical harm. A group of labor organizations and unions, including NNU and the American Federation of Teachers, have petitioned the United States Court of Appeals for the District of Columbia Circuit to order OSHA to issue a permanent standard requiring employers to protect healthcare workers against COVID-19. NNU has also launched a petition calling for a permanent OSHA standard (with the temporary standard retained in the meantime) and restoration of CDC’s 10-day isolation guidelines.
Another avenue for agencies to protect workers is by requiring vaccinations and testing. In November, the Centers for Medicare and Medicaid Services (CMS) published a rule requiring that healthcare providers that participate in Medicare and/or Medicaid ensure their staff are fully vaccinated against COVID-19; courts quickly blocked it in the face of legal challenges. At the same time, OSHA issued a rule requiring that employers with 100 or more employees adopt policies that require employees to be vaccinated or to show weekly negative COVID tests. The Fifth Circuit blocked that rule, but the Sixth Circuit lifted the stay–and then the Supreme Court struck down the requirement.
Looking ahead: In January, the Supreme Court allowed a rule on healthcare worker vaccination to remain in force but blocked OSHA’s vaccinate-or-test rule. However, the Court’s decision left the door open for a more traditional risk-based rule, and advocates are calling on OSHA to pursue that avenue.
Steps forward and far back for reproductive health
While federal agencies have been reversing reproductive health rules that weren’t based on evidence, the Supreme Court has been ignoring evidence and precedent regarding abortion.
In October, the US Department of Health and Human Services issued a final rule undoing the Trump administration’s domestic gag order—a rule that prohibited providers that received Title X family planning funds from discussing abortion as an option for pregnant patients or providing abortion referrals. In December, the Food and Drug Administration completed a review of evidence related to restrictions on the abortion drug mifepristone and, in light of extensive data regarding the drug’s safety, lifted the requirement that patients receive the drug in person (a requirement that FDA had suspended for the duration of the public health emergency). Removing this aspect of mifepristone’s Risk Evaluation and Mitigation Strategy (REMS) will increase access while bringing regulation closer to what the science indicates is appropriate, but unwarranted REMS requirements for providers to be certified to prescribe the drug, and for patients to sign an agreement, remain in place.
While FDA was taking an evidence-based step toward improving access to abortion, the Supreme Court majority was hurtling backwards. Back in September, Texas SB 8 took effect and began allowing private vigilantes to collect $10,000 bounty payments if they successfully sue someone who helps a pregnant person obtain an abortion after six weeks’ gestation. The Supreme Court declined to block the law when it took effect but agreed to consider whether lawsuits against it can proceed. In December, they decided that abortion providers’ suits can continue only against state medical licensing officials—a move that effectively leaves the law in place until the Court eventually hears the case to decide whether it is constitutional. By then, the Court might have already gutted Roe v. Wade in their decision about Mississippi’s 15-week abortion ban in Dobbs v. Jackson Women’s Health Organization. For the moment, they have effectively overturned in Texas the precedent set by Roe v. Wade to protect the right to abortion before fetal viability—and opened the door to any state evading federal laws it dislikes with this same bounty-hunting structure. Justice Sonia Sotomayor warned of that danger in her dissent in the SB 8 decision, and she asked during the Dobbs oral arguments, “Will this institution survive the stench that this creates in the public perception that the constitution and its reading are just political acts?”
Looking ahead: The Supreme Court will issue its decision in Dobbs v. Jackson Women’s Health Organization by the time its term ends in the summer.
Congress considers legislation to protect whistleblowers
In December, the House passed the Protecting Our Democracy Act, which includes the Whistleblower Protection Improvement Act (WPIA). As Dana Gold of the Government Accountability Project explained in an op-ed, the WPIA would “strengthen protections for federal employees by prohibiting federal officials from interfering with an employee’s ability to share information with Congress, prohibit retaliatory investigations, expand whistleblower protections to political appointees in the Senior Executive Service, and also provide much-needed access to jury trials for whistleblowers.” In addition, Representative Al Green (D-Tex.) introduced the Whistleblower Protection Reform Act, which would protect corporate employees who raise concerns about waste, fraud, or abuse. At a hearing on transparency and accountability in rulemaking held by the House Committee on the Judiciary Subcommittee on Antitrust, Commercial, and Administrative Law, Representative Pramila Jayapal introduced the Stop Corporate Capture Act. This bill would require that scientific research results submitted for rulemaking disclose funding sources and entities that reviewed, and create an Office of the Public Advocate whose duties will include conducting research on social equity impacts of the rulemaking process.
Looking ahead: The Senate must now vote on the Protecting Our Democracy Act.
- EPA Official Prevented Staff from Warning Public about Widely Used Carcinogen
- Emails Reveal New Details of Trump White House Interference in CDC COVID Planning
- Oil Execs Spout Disinformation at House Climate Disinformation Hearing
- As Omicron Spreads, Studies Suggest That Travel Bans Alone Don’t Do Much Good
- Concern Over President’s Choice to Head Federal Wildlife Agency
- Climate Science Legal Defense Fund and Union of Concerned Scientists resource: What to Expect When You’re an Expert Witness, Part 2: Ways to Engage and How to Avoid Common Pitfalls
- Environmental Data & Governance Initiative report: Crossing the Line: Analyzing EPA news releases under Trump and ensuring trust in federal information in the future
- Equity Forward profile of Robert Califf
- Revolving Door Project report: Climate Capacity Crisis: Attrition at Climate Agencies and Immediate Steps to Address It