POLICY BRIEFING – WEEK IN REVIEW
New plans to counter hoarding
Throughout the pandemic there has been a predictable pattern with medical therapies: announcement of potential efficacy is followed by a spike of "panic buying" and a subsequent national shortage. Novel therapies triggered less of this, as supplies tend to become allocated as they are produced. However, for treatments previously used for other conditions, like hydroxychloroquine for arthritis and lupus, or dexamethasone for a variety of conditions, hoarding of previously manufactured drugs can make them suddenly almost impossible to find.Early covid-19-related legislation created pharmaceutical reporting requirements to the Food and Drug Administration for any medication determined to be important during the pandemic. The rules require companies to track anticipated supply shortages. However, obscure supply chains and a lack of national coordination has made accurate accounting difficult. Similarly, while legislation required weekly updates from the Department of Health and Human Services (HHS) on medical supplies and disbursement in the National Stockpile, Congressional leadership has said they still do not know where everything is being sent.To increase transparency, many experts are calling for a more robust, centralized database with state and local-level granularity regarding supply allocation and use. They argue that this level of detail is necessary so that providers and hospitals can recognize the potential for local shortages and find additional sources to mitigate the tidaling levels seen so far. Bloomberg News. 23 July 2020.
The never-ending testing nightmare
As the numbers of covid-19 cases continue to rise across the U.S., testing continues to be an issue despite the rapid expansions that have occurred. In the upcoming weeks, demand is expected to continue to outpace capacity. In some areas, one-day results for covid-19 testing have been limited to hospitals, while others are experiencing 3-5 day delays before results come back—some areas even average 7 days. At the start of the pandemic in the US, testing kits were a rate-limiting step—now we lack the equipment needed to test samples. In response to this, the FDA reissued an emergency use authorization (EUA) for the Quest Diagnostics SARS-CoV-2 rRT-PCR test, which detects the virus's genetic material. This EUA also expands the use of pooled samples, enabling up to four samples to be tested at once. For example, if a family of four combines their tests into one vial, and the test is negative, the whole family is clear. While a positive pooled test doesn't identify who tested positive, it can be assumed that all have been infected until proven otherwise. Pooled sampling also cuts down on processing time since multiple tests can be run simultaneously rather than one after the other. However, this testing strategy is most feasible in areas with low prevalence of disease since a positive test usually requires the individually retesting each of the samples in the pooled batch. Nevertheless, pooled testing is a much-needed step in meeting the need for increased testing. So far, Quest is the first company obtain an EUA for pooled sample testing. Various. 22 July 2020.
CDC in the news. Three major developments
The United States Centers for Disease Control and Prevention (CDC) has been featured heavily in the news for its evolving role during the pandemic. Early on there were well-documented missteps, relating to testing errors, and inconsistent messaging. Three major recent developments are noteworthy and will be discussed here.
First, and most concerning, the White House announced last week that all data collected by hospitals related to coronavirus cases should now be sent directly to a system maintained by the US Department of Health and Human Services (HHS), bypassing the CDC. This policy has implications for data transparency that immediately worried experts. After the announcement was made last week, many state and local health entities claimed they no longer had access to aggregated data that had been made available by the CDC. There are also reports of hospitals having difficulties submitting newly acquired data to the CDC's system, run by the National Healthcare Safety Network (NHSN), making population-level health decisions and threat assessment more difficult. Back in March, Brief19 was the first media source to report on the creation of a nationwide reporting system run by the NHSN. Thousands of hospitals participated voluntarily. The system tracks case counts in hospitals as well as a number of other statistics, including the number of available hospital and ICU beds, information on the number of mechanical ventilators were in use, and data regarding emergency department overflow.
Separately, the CDC reported a delay in the release of its updated school reopening guidelines. While previously stating that recommendations would be made available by the end of last week, new tensions between the agency and the White House's drive for full reopening in the Fall has slowed the process. The CDC has said that the guidelines will be science and evidence-based recommendations with a goal of safely opening schools. President Trump called the circulating drafts "too tough" and Vice President Pence said the report should not be used as a reason to keep schools closed. The current timeline for the release of updated guidelines is projected for the end of the month.
Finally, in an effort to reduce the strain on limited supplies of test swabs, the CDC is finalizing recommendations on repeat testing, specifically emphasizing the avoidance of routine follow-up testing after quarantine (and before returning to work) of otherwise healthy individuals. Various. 20 July 2020.
Healthcare groups ask federal government to do more
In a series of recent letters, health organizations have asked Congressional leaders to include additional targeted funds in future relief bills. The first, directed at leaders of both the US Senate and the House of Representatives, focuses on the need to bolster contact-tracing efforts. Citing the importance of such efforts in tracking the spread of SARS-CoV-2, the letter warns that the $25 billion allocated in the CARES Act may not suffice. While local governments plan to increase contact tracers to 66,000, state funds are rapidly depleting. Estimates show that more 100,000 tracers are necessary to carry out effective tracing. In a separate letter, the American Hospital Association, American Medical Association and American Nursing Association requested that the next Senate relief package include provisions to strengthen the federal covid-19 response to marginalized communities, racial and ethnic minorities in particular. Data shows that these populations are disproportionately dying and account for a higher fraction of confirmed cases. To combat this, the groups request the collection and reporting of demographic and health inequity data, support for a workforce to aid and communicate with highly affected communities, improved testing access, health insurance coverage, more funding for research, and supporting social determinants of health. Various. 22 July 2020.