COVID-19 Data Dispatch

Tag: NIH

  • The NIH says it “inappropriately” censored Long COVID patients on social media

    The NIH says it “inappropriately” censored Long COVID patients on social media

    This Tweet, from the NIH’s Community Engagement Alliance, sparked criticism on social media—some of which was hidden by the NIH account.

    By Miles W. Griffis

    The National Institute of Health (NIH) is under fire for censoring comments from patients on social media — the latest in a trend of heavy criticism from people living with Long COVID for failing to listen to patients and implement their input into its $1.15 billion study, RECOVER. Patient concerns have been echoed by both scientists and healthcare professionals who have criticized the study’s lack of results, glacial pace, potentially harmful clinical trials, and wasted funds.

    Last month, the NIH Community Engagement Alliance (NIH CEAL) tweeted, “Some people don’t feel sick when they have #COVID19 but develop symptoms of #LongCOVID later on. If this sounds familiar, speak with your health care provider to find a treatment plan that works for you.” The controversial tweet received over one hundred responses, many from people with Long COVID and other infection-associated illnesses.

    Patients claimed the post contained misinformation about Long COVID treatments, as this debilitating multi-systemic condition affecting millions does not have any approved treatments or cures. Other commenters shared their negative experiences with their primary health care providers, who they say didn’t offer them any treatment plans or worse, gaslit them and wrote their symptoms off completely. Over 35 of these comments were hidden by the NIH CEAL account.

    When asked about this comment hiding, the NIH told me that their social media policy was “overapplied” and that comments on the post were “inappropriately hidden.”

    Olenka Sayko, a person with Long COVID whose comment was hidden, said the censorship added to a feeling of hopelessness: “Are we ever going to find solutions for Long COVID if patient voices aren’t being listened to?” She said the censorship is especially concerning since it came from an NIH account dedicated to community engagement. “Who are they engaging with? They’re hiding comments.” Lauren, another person with Long COVID who also was censored, said that the NIH CEAL’s tweet rhetoric sweeps Long COVID and the people experiencing it “under the rug.”

    NIH CEAL clarified their tweet earlier this month. “While there’s no cure for Long COVID,” the new post read, “there may be treatment options that can address one’s symptoms & may help people living with Long COVID have better days.” 

    Although there are no treatments or cures for Long COVID, there are some treatments for conditions associated with or triggered by COVID-19 or Long COVID, including dysautonomia, cardiac disease, diabetes, and others. Many healthcare professionals recommend that patients who have prolonged symptoms following COVID-19 should be screened for life-threatening medical events that can be caused by COVID-19 or Long COVID, including pulmonary embolisms, deep vein thrombosis, or strokes. Long COVID can be fatal. A CDC analysis found that more than 3,500 people have died of the condition, though many experts believe this is a vast undercount. 

    And while there are many Long COVID clinics around the country that may give the illusion of successful treatment plans, patients often don’t have successful experiences. In an article I wrote for Popular Science, I found that some clinics recommend potentially harmful treatments like graded exercise therapy. Others rejected and gaslit patients. Some only offered generic informational handouts.

    During an August 31 NIH RECOVER press conference, the director of the National Institute of Neurological Disorders and Stroke (NINDS), Walter Koroshetz, responded to my question about what Long COVID treatment plans the NIH CEAL account was referring to. He said that the NIH does not make treatment recommendations, adding that the NIH CEAL tweet might have been a misunderstanding. When I asked why the agency was censoring tweets from Long COVID patients, Lawrence Tabek, the acting director of the NIH, said he couldn’t speak to my question and said he has “no idea how social media works”.

    I later followed up with the NIH over email about the censored comments. The agency wrote that “The National Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Minority Health and Health Disparities (NIMHD) co-manage the NIH Community Engagement Alliance (CEAL) social media accounts and follow the NHLBI Privacy Statement and Comment Policy.” The policy states commenters should post “on topic,” “be respectful,” and “truthful.” It also prohibits spam and product endorsements.

    The NIH wrote over email that, in the case of the censored comments on the July 25th tweet, their policy was “overapplied” and that comments on the post were “inappropriately hidden.” They added that upon further review, comments on the post are now “public,” or unhidden. Some comments, however, were still hidden at the time of publication.

    But Eric Goldman, the co-director of the High Tech Law Institute at Santa Clara University School of Law, said this very policy may not be even constitutional. “Assuming that the NIH is a state actor, then anytime they take an action on social media to control the conversation, their decisions are governed by the First Amendment, which protects our right to free speech,” he said.

    Instances like the NIH censoring comments on social media are complicated, but upcoming Supreme Court cases may provide some clarity, Goldman said. 

    Two cases, Lindke v. Freed (from the 6th Circuit Court of Appeals) and Garnier v. O’Connor-Ratcliff (from the 9th Circuit Court of Appeals) may be heard by the Supreme Court this fall. Both involved government officials blocking members of the public on social media, but each led to a different result. The 9th Circuit found impermissible censorship, while the 6th Circuit did not. Due to the complexity of internet law, it’s unlikely Americans will feel good about the rule of law that will be articulated by the Supreme Court,” he said.

    Still, if the NIH is “selectively listening to people online, then that’s hugely problematic,” Goldman said. In particular, the NIH could be denying the patients’ ability to learn and talk with each other. “Selective intervention by the NIH takes away that potential,” he said.

    Advocates say the censorship has further eroded trust between the Long COVID community and the NIH. “It’s not just a one off,” Billy Hanlon, the director of advocacy and outreach for the Minnesota ME/CFS Alliance said, “It’s a pattern.” The agency fails to value the lived experience of patients with infection-associated illnesses, even though these illnesses have a quality of life worse than some advanced-stage cancers, Hanlon said.

    “I can see why people were furious,” said JD Davids about the censorship “It’s an insult upon injury.” As the co-director of the advocacy group Long COVID Justice, Davids said that if the NIH wants to truly work and engage with patients, they need to work closely with people living with Long COVID and certainly not silence their lived experience.

    “We need a government-wide response to Long COVID,” he said, describing the necessity for patients and complex chronic disease experts to be consulted on major decisions at the NIH and beyond. Tweeting that there is a treatment plan for a condition with no treatments or cures, Davids said, creates an illusion of a broader treatment plan for Long COVID, when there isn’t one. It confuses the public and creates doubt about people living with Long COVID. “It has huge unintended consequences,” Davids said.

    Editor’s note: JD Davids has donated to the COVID-19 Data Dispatch. This had no influence on the article, as the author talked to him before the CDD decided to publish it.

    Miles W. Griffis is an independent journalist based in Los Angeles, California. He’s written for High Country News, National Geographic, The New York Times, and many others.

    If you are able to contribute a tip for this reporting, please Venmo @miles-griffis.

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  • NIH RECOVER’s Long COVID trials unlikely to lead to successful treatments, experts say

    NIH RECOVER’s Long COVID trials unlikely to lead to successful treatments, experts say

    The NIH has primarily spent its funds for Long COVID research on observational studies rather than clinical trials, according to new data shared with my article this week.

    Last week, the National Institutes of Health and Duke University announced five Long COVID clinical trials as part of the NIH’s RECOVER initiative. This might sound like an exciting milestone for the millions of people dealing with long-term symptoms—but in fact, experts and long-haulers are disappointed by the trials, I learned when covering this news for MuckRock and STAT News.

    RECOVER is the largest Long COVID research effort in the world; the NIH received $1.15 billion for it, provided by Congress in late 2020. It’s also been plagued by delays and criticisms, as I’ve reported before. As we approach the three-year mark of the initial funding, long-haulers are becoming increasingly frustrated with RECOVER’s lack of results.

    My latest story for MuckRock and STAT focuses on the clinical trials, but connects to larger issues with RECOVER and with the federal government’s response to Long COVID in general. Read it on STAT’s site here or on MuckRock’s here.

    A few key points from the story:

    • RECOVER is only testing a handful of drugs for Long COVID, instead focusing on behavioral interventions that outside experts say are unlikely to address underlying causes of symptoms. There are several lists of potential drugs that should be (and aren’t) prioritized, including one compiled by members of an advisory committee to RECOVER.
    • Looking more closely at the drug trials, experts shared concerns about the study designs, suggesting that RECOVER’s choices of controls, outcomes measures, and other aspects of the studies may lead to inaccurate results. For example, dysautonomia expert Lauren Stiles told me that the trial testing drugs for autonomic symptoms may fail to accurately capture whether those drugs help with Long COVID.
    • At this point, the NIH has no plans for further Long COVID trials or other research going beyond RECOVER. The initiative has almost fully allocated all of its $1.15 billion in funding, and NIH officials haven’t shared details about how they will continue Long COVID research after this study concludes (though they acknowledge more research will be necessary).

    RECOVER failed to put much funding in clinical trials to begin with, focusing instead on observational studies aiming to track Long COVID symptoms over time. While such studies could be valuable for better understanding the condition, RECOVER has largely replicated other research and hasn’t contributed useful, new information to the field, experts have told me. In fact, over 40,000 people have petitioned the NIH to retract RECOVER’s first paper based on its observational research.

    Many of RECOVER’s errors, such as choosing the wrong treatments to prioritize and focusing on observational studies over clinical trials, could’ve been avoided if the initiative had listened more to long-haulers and learned from experts in other post-infectious diseases. Long-haulers have done plenty of research themselves in the last three years, ranging from informal tests of different treatments to formal studies conducted by the Patient-Led Research Collaborative; yet these studies have not informed RECOVER.

    Plus, scientists with expertise in ME/CFS, dysautonomia, HIV/AIDS, and many other similar diseases could share lessons with RECOVER—but they aren’t leading the initiative. I thought Todd Davenport, a rehabilitation expert at University of the Pacific who’s studied ME/CFS, put it well when he said that RECOVER scientists “have parachuted into post-infectious illness and are now trying these things for the first time, to them. But it’s clear they haven’t done the reading.”

    I hope to continue covering RECOVER and other issues with Long COVID research in the U.S. If you have any tips or stories to share with me on this topic, please reach out.

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  • The NIH has little to show for $1 billion allocated to Long COVID research

    The NIH has little to show for $1 billion allocated to Long COVID research

    Article header from STAT News; illustration by Mike Reddy.

    In December 2020, Congress gave the National Institutes of Health $1.2 billion to study Long COVID. That money was used to fund the RECOVER initiative, billed as a thorough study of this condition and an effort to help patients actually recover from the often-debilitating long-term effects of COVID-19.

    But it’s been more than two years, and the RECOVER initiative doesn’t have much to show for that money—besides a growing number of frustrated people in the Long COVID community. Clinical trials haven’t started yet, very limited research findings have been published, and some long-haulers involved with the initiative are losing faith in its ability to find answers.

    I collaborated with Rachel Cohrs, a reporter at STAT News, on a thorough investigation into RECOVER’s problems. We combed through documents and data, talked to a number of people involved with the initiative, and researched the broader context around RECOVER.

    This project was a collaboration between STAT and MuckRock, and you can read the full story on STAT’s website or on MuckRock’s. I also wrote a Twitter thread with some highlights:

    As I wrote on Twitter, I want to keep reporting on RECOVER, as I know there are other problems with the initiative that weren’t captured in this story. If anyone reading this has additional information to share, please shoot me an email or reach out on social media. (You can also reach out to ask for my number on Signal, a secure messaging platform.)

    Here’s the story’s introduction, to give you an idea of what we found:

    The federal government has burned through more than $1 billion to study long Covid, an effort to help the millions of Americans who experience brain fog, fatigue, and other symptoms after recovering from a coronavirus infection.

    There’s basically nothing to show for it.

    The National Institutes of Health hasn’t signed up a single patient to test any potential treatments — despite a clear mandate from Congress to study them. And the few trials it is planning have already drawn a firestorm of criticism, especially one intervention that experts and advocates say may actually make some patients’ long Covid symptoms worse.

    Instead, the NIH spent the majority of its money on broader, observational research that won’t directly bring relief to patients. But it still hasn’t published any findings from the patients who joined that study, almost two years after it started.

    There’s no sense of urgency to do more or to speed things up, either. The agency isn’t asking Congress for any more funding for long Covid research, and STAT and MuckRock obtained documents showing the NIH refuses to use its own money to change course.

    “So far, I don’t think we’ve gotten anything for a billion dollars,” said Ezekiel Emanuel, a physician, vice provost for global initiatives, and co-director of the Healthcare Transformation Institute at the University of Pennsylvania. “That is just unacceptable, and it’s a serious dysfunction.”

    Eric Topol, the founder and director of the Scripps Research Translational Institute, said he expected the NIH would have launched many large-scale trials by now, and that testing treatments should have been an urgent priority when Congress first gave the agency money in late 2020.

    “I don’t know that they’ve contributed anything except more confusion,” Topol said.

    Patients and researchers have already raised alarms about the glacial pace of the NIH’s early long Covid efforts. But a new investigation from STAT and the nonprofit news organization MuckRock, based on interviews with nearly two dozen government officials, experts, patients, and advocates, and internal NIH correspondence, letters, and public documents, underscores that the NIH hasn’t picked up the pace — instead, the delays have compounded.

    It’s difficult to pinpoint exactly why progress is so stalled, experts and patients involved in the project emphasized, because the NIH has obscured both who is in charge of the long Covid efforts and how it spent the money. The broader Biden administration has also missed opportunities for oversight and accountability of the effort — despite the president’s lofty promises to focus on the disease.

    The NIH’s blunders have massive ramifications for the more than 16 million Americans suffering from long Covid, in addition to those with other, similar chronic diseases. As the biggest government-funded study on this topic, the NIH initiative, dubbed RECOVER, sets precedents for future research and clinical guidelines. It will dictate how doctors across the country treat their patients — and, in turn, impact people’s ability to access work accommodations, disability benefits, and more.

    “The NIH RECOVER study is pointless,” said Jenn Cole, a long Covid patient based in Brooklyn, N.Y., who wanted to enroll in the study but found the process inaccessible. The research is “a waste of time and resources,” she said, and fails to use patients’ tax dollars for their benefit.

    In response to STAT and MuckRock’s questions, the NIH and an institute at Duke University managing the clinical trials defended the initiative, without providing a clear explanation for the delays.

    The NIH said it chose to fund a large-scale research program instead of small-scale studies to make sure data and processes could be shared across different groups of patients, adding that clinical trials will be launching soon. In these trials, standardized study designs will allow the agency to test multiple treatments across multiple sites. If there are signals a drug works, the agency said it can pivot to devote more resources there.

    A Department of Health and Human Services spokesperson said the agency has made progress over the last year in responding to long Covid, and that there are research efforts underway in addition to the RECOVER program.

    “The Administration remains committed to addressing the longer-term impacts of the worst public health crisis in a century,” HHS said.

    Read the full story on STAT’s website or on MuckRock’s.

    More Long COVID reporting

  • Sources and updates, April 9

    • Second Omicron boosters for high-risk adults: The FDA and CDC are planning to authorize a second round of bivalent, Omicron-specific vaccines for high-risk adults, the Washington Post reported this week. This decision will apply to Americans over age 65 and those who have compromised immune systems, with these groups becoming eligible four months after their initial bivalent boosters. It’s unclear exactly when the decision will become official; the FDA and CDC will make authorizations sometime “in the next few weeks,” according to WaPo.
    • HHS announces (underwhelming) Long COVID progress: This week marks one year since Biden issued a presidential memo kicking off a “whole-of-government response” to Long COVID. The Department of Health and Human Services (HHS) commemorated the occasion with a fact sheet sharing the federal government’s progress so far. Unfortunately, that progress has been fairly minor, mostly consisting of reports and guidance that largely summarize existing government programs or build on existing systems (such as Veterans Affairs hospitals). Many of the Long COVID programs that Biden previously proposed have not received funding from Congress; meanwhile, the National Institutes of Health’s RECOVER initiative, the one program that has been funded, has faced a lot of criticism.
    • RECOVER PIs recommend action on treatment: Speaking of RECOVER: this week, a group of scientists leading research hubs within the national study called for federal funding that would support treatment. The principal investigators (PIs) of these hubs have developed expertise in Long COVID through recruiting and studying patients, leading them to identify gaps in available medical care for long-haulers. To respond, the PIs recommend that Congress allocate $37.5 million to support Long COVID medical care at the RECOVER research sites. Their proposed budget includes patient outreach, telehealth support, educating healthcare workers on Long COVID, and more.
    • Ventilation improvements in K-12 schools: The CDC released a new study this week in its Morbidity and Mortality Weekly Report, sharing results of a survey (conducted last fall) including about 8,400 school districts representing 62% of public school students in the U.S. Research company MCH Strategic Data asked the districts about how they’d improved ventilation in their school buildings, along with other COVID-19 safety measures. About half of the districts reported “maintaining continuous airflow in classrooms,” one-third reported HVAC improvements, 28% reported using HEPA filters, and 8% reported using UV disinfectants. The results indicate that many districts have a long way to go in upgrading their indoor air quality.
    • Flu vs. COVID-19 mortality risk: Ziyad Al-Aly and his colleagues at the VA healthcare system in St. Louis have published another paper analyzing COVID-19 through the VA’s electronic health records. This study, published in JAMA Network, describes the mortality risk of COVID-19 compared to seasonal flu for patients hospitalized during the 2022-2023 winter season. The researchers evaluated about 9,000 COVID-19 patients and 2,400 flu patients, finding that risk of death for COVID-19 patients in the 30 days following hospitalization was about 1.6 times as high as the risk of death for flu patients. Despite great advances in vaccines and treatments, COVID-19 remains more dangerous than other seasonal viruses, the study suggests.
    • Biobot launches mpox dashboard: This week, leading wastewater surveillance company Biobot Analytics launched a new dashboard displaying its mpox (formerly monkeypox) monitoring. Biobot tests for mpox at hundreds of sewage sites across the U.S., largely through its partnership with the CDC, and will continue this monitoring through at least summer 2023. The new dashboard shows mpox detections nationally over time and monitoring sites by state; it also includes some information on how mpox surveillance differs from COVID-19 surveillance.

    All featured sources
  • How researchers track Long COVID’s impacts

    How researchers track Long COVID’s impacts

    The Census and CDC’s Household Pulse Survey provides one major source of data on Long COVID prevalence.

    I got an interesting question from a reader last weekend, asking if excess deaths might be one way to identify the impact of Long COVID. It’s an interesting idea: could the numbers of deaths from medical causes above what researchers expect in a given timeframe indicate some premature deaths tied to Long COVID?

    Based on my previous work with excess deaths (see MuckRock’s Uncounted project), I think this could be possible, though it’d likely be very hard to identify direct relationships between Long COVID and specific deaths. As far as I know, no researchers are working on this question; if you know of anyone who is, please reach out.

    Still, the reader’s question got me thinking about how, exactly, we track the impacts of Long COVID. Doctors, researchers, and long-haulers themselves have learned a lot about the condition over the last three years. We still don’t have clear estimates of exactly how many people in the U.S. are dealing with this chronic disease, but we’ve come much closer to understanding its impacts than we were when patients first began advocating for themselves in 2020.

    Tracking Long COVID is challenging because of uneven access to COVID-19 tests and to medical care, which means long-haulers with certain types of privilege are more likely to get an accurate diagnosis. A lack of knowledge about Long COVID, both among medical professionals and among the overall population of people who might get it, also contributes to this issue. (For more details, see this post from early December.)

    Still, some strategies have emerged for identifying people with Long COVID and tracking how the condition is impacting them. Here are a few.

    Following people who were hospitalized for COVID-19:

    In this strategy, researchers identify people who had COVID-19 and track how the virus impacts them over time. It’s often easiest for researchers to track people who were hospitalized, since hospitals keep detailed medical records of their patients, though this tactic leaves out long-haulers who initially had mild cases.

    Sometimes, researchers doing this type of follow-up study will directly survey COVID-19 patients, which can lead to more comprehensive data than using health records alone. One recent study in this category found that, among a group of 800 adults hospitalized for COVID-19, about half were still experiencing some financial issues and limitations in their ability to do day-to-day activities six months later. The study’s authors noted that financial issues were “reported more frequently” among patients who identified with demographic minorities.

    Following COVID-positive patients through electronic health records:

    In other studies, researchers use electronic health records to identify how people who had COVID-19 fare months later. Two recent studies associated with the National Institutes of Health’s RECOVER initiative fall into this category. One paper utilized records from New York City health centers, and found that Black and Hispanic adults were more likely to have potentially Long COVID-related health issues following a COVID-19 case. The other paper, which used records from 34 medical centers across the U.S., found that white, female, non-Hispanic patients living in areas with greater healthcare access were more likely to receive an actual Long COVID diagnosis.

    Angela Vázquez, president of the Long COVID group Body Politic, summarized the two new studies succinctly on Twitter, writing: “Black and Hispanic Americans appear to experience more symptoms and health problems related to #LongCovid than white people, but are not as likely to be diagnosed with the condition.” Vázquez also pointed out that the studies may have missed neurological symptoms among Black and Hispanic patients, due to less access to care for these groups.

    Broad surveys of potential patients:

    Electronic health records are far from perfect sources of Long COVID data, as they often present only sets of information that doctors are already compiling—and they are often biased towards the people who are able to access medical care for COVID-19 (or Long COVID) in the first place. As a result, some researchers track Long COVID through broader surveys, seeking to identify everyone who might have some long-term symptoms following a COVID-19 case, even if those people might not be calling their condition “Long COVID.”

    The Census and CDC’s Household Pulse Survey questions on Long COVID are one notable example of this strategy. Census researchers ask a random sample of Americans whether they’ve had “any symptoms lasting 3 months or longer” following a COVID-19 case, then follow up with questions about whether those symptoms are current and whether they impact the respondent’s ability to carry out day-to-day activities. The resulting data provide a broader view of Long COVID in the U.S., including people who may not have sought medical care for their symptoms.

    Biological studies of specific organs impacted by COVID-19:

    In order to better understand how a case of COVID-19 may lead to long-term, debilitating symptoms, some researchers focus on studying exactly what happens to different parts of the body after a coronavirus infection. This research sometimes focuses on testing for the continued presence of virus after a patient’s acute COVID-19 case is over or tracking changes to the immune system, as scientists test different theories into how Long COVID occurs.

    One major area of research has been the brain. Freelance journalist Stephani Sutherland recently published a major feature in Scientific American exploring how Long COVID impacts the brain and nervous system, summarizing research into the biological causes of common symptoms like fatigue and brain fog. Physician E. Wesley Ely, who cares for Long COVID patients, wrote an essay on the same topic that appeared in STAT News this week; Ely discussed what he’s learned from autopsy studies examining the brains of people who had COVID-19.

    Identifying trends in the labor market:

    Finally, researchers often seek to track the impacts of Long COVID indirectly, by looking at statistics on people who have left the labor market during recent years. It’s no secret that a lot of people have left their jobs during the pandemic; Long COVID experts argue that the chronic disease may be one major driver of the labor shortage. One often-cited Brookings Institution analysis suggested two to four million people may be out of work due to Long COVID.

    This strategy for studying Long COVID may be the most difficult, as it’s hard to actually tie job loss numbers to the condition without more specific data. Most research surveys or electronic health records databases don’t ask people about their work situations; the recent study cited above is a notable outlier. Similarly, most unemployment claims and short-term disability datasets don’t ask people if Long COVID is contributing to their need for assistance.

    Still, I hope to see more studies in the future that examine Long COVID’s impact on work and other activities. Related: the U.S. Department of Labor recently published a report about the need for more assistance geared toward workers with Long COVID.

    More Long COVID data

  • Sources and updates, January 22

    • New CDC dashboards track respiratory illness hospitalizations: This week, the CDC released two new dashboards that combine COVID-19 data with data on other respiratory illnesses. First, the RESP-NET dashboard summarizes information from population-based hospital surveillance systems in 13 states for COVID-19, the flu, and RSV; it includes overall trends and demographic data. Second, the National Emergency Department Visits dashboard provides data on emergency department visits for COVID-19, the flu, RSV, and all three diseases combined; this dashboard includes data from all 50 states, though not all hospitals are covered.
    • Early results from NIH at-home test self-reporting: Last week, ABC News shared early results from MakeMyTestCount.org, an online tool run by the National Institutes of Health allowing Americans to self-report their rapid, at-home test results. Between the site’s launch in late November and early January, “24,000 people have reported a test result to the site,” according to ABC. (While the article says “people have reported,” I think this number actually represents the number of test results reported, given that the website doesn’t track when one person submits multiple test results over time.) The majority of results reported are positive and women are more likely to self-report than men, per ABC. It’s unclear how useful these early data may be for any analysis, but I’m glad to see some numbers becoming public.
    • New preprint updates county-level excess death estimates: A new preprint from Boston University demographer Andrew Stokes and colleagues, posted this week on medRxiv, shares updated estimates on excess deaths and COVID-19 deaths by U.S. county. According to the analysis, about 270,000 excess deaths were not officially attributed to COVID-19 during the first two years of the pandemic, representing 24% of all excess deaths during that time. And the analysis reveals regional patterns: for example, in the South and in rural patterns, excess deaths were less likely to be officially attributed to COVID-19. For more context on these data, see MuckRock’s Uncounted project (which is a collaboration with Stokes and his team).
    • Factors contributing to low bivalent booster uptake: Another notable paper from this week: results from a survey of Americans who were previously vaccinated about their reasons for receiving (or not receiving) a bivalent, Omicron-specific booster this fall, conducted by researchers at Duke University, Georgia Institute of Technology, and others. Among about 700 people who didn’t get the booster, their most common reasons were a lack of awareness that the respondent was eligible for this vaccine, a lack of awareness that the bivalent vaccine was widely available, and a perception that the respondent already had sufficient protection against COVID-19. This survey shows how governments at every level have failed to advertise the bivalent boosters, likely to dire results.
    • More wastewater surveillance on airplanes: And one more notable paper: researchers at Bangor University tested wastewater from three international major airports in the U.K., including samples from airplanes and airport terminals. About 93% of the samples from airplanes were positive for SARS-CoV-2, while among the airport terminal samples, 100% at two airports were positive and 85% at the third airport were positive. Similar to the study from Malaysia I shared last week, this paper suggests that there’s a lot of COVID-19 going around on air travel—to put it mildly. The paper also adds more evidence that airplane/airport wastewater can be a useful source for future COVID-19 surveillance.
    • Nursing home infections ran rampant early in the pandemic: A new report from the Health and Human Services Office of Inspector General examines how much COVID-19 spread through nursing homes in 2020. The report’s authors used Medicare data from about 15,000 nursing homes nationwide, identifying those with “extremely high infection rates” in spring and fall 2020. In more than 1,300 of these facilities, 75% or more of the Medicare patients had COVID-19 during these surges; the same facilities had way-above-average mortality rates. “These findings make clear that nursing homes in this country were not prepared for the sweeping health emergency that COVID-19 created,” the authors write in the report’s summary.

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  • COVID source shout-out: New NIH tool to report at-home test results

    COVID source shout-out: New NIH tool to report at-home test results

    Make My Test Count is a new NIH website for people to report at-home COVID-19 test results.

    This week, the National Institutes of Health launched a new website that allows people to anonymously report their at-home test results. While I’m skeptical about how much useful data will actually result from the site, it could be a helpful tool to gauge how willing Americans are to self-report test results.

    The website, MakeMyTestCount.org, puts users through a series of basic questions about their at-home test experience: your test result, the test brand you used, when you tested, and whether you have COVID-19 symptoms. The site also asks for basic demographic information, including your age, ZIP code, race, and ethnicity. After you report your test result, the website provides additional context on interpreting that result, such as suggesting a repeat test in the next two days if you have symptoms.

    These survey questions mimic the information that typically gets collected when someone receives a PCR test, and the resulting data could potentially be used to examine who is using at-home tests and what their results are. The NIH’s Rapid Acceleration of Diagnostics (or RADx) initiative, a program to speed up development and use of COVID-19 testing technologies, designed the website.

    Of course, there are a lot of potential issues here. This website was launched more than two years after the first COVID-19 rapid tests were authorized and almost one year after they gained widespread popularity during the first Omicron surge. No matter how many people report their results now, the NIH will miss a lot of data and a lot of opportunities to advertise the site.

    And how many people will report their results now? Pandemic safety measures like at-home testing are less popular than they were a year ago, and the launch of this website doesn’t seem to be paired with a public outreach campaign about using and reporting at-home tests. Basically, the results shared with the NIH are likely to be biased towards people who still care about taking precautions (and those who pay attention to federal COVID-19 resources). It’s also very easy to submit false results, as the website doesn’t ask for a photo of your test or anything similar.

    Still, I’m excited to see this website launched—collecting some at-home test results is better than no test results! I hope lots of people use it, and I look forward to seeing any data the NIH eventually releases from the tool.

    more source spotlights

  • Sources and updates, October 9

    • Household Pulse Survey updates, expands Long COVID data: This week, the CDC and Census released an update of their Household Pulse Survey results on how Long COVID is impacting Americans. In addition to more recent data on Long COVID prevalence, the update includes new information on how adults with the condition find it limiting their day-to-day activities. The data shows that, out of all adults currently experiencing Long COVID symptoms, over 80% have some activity limitations and 25% have “significant” activity limitations. (For more context on this dataset, see my post from June.)
    • NIH shares update on RECOVER study: Speaking of Long COVID, the National Institutes of Health’s Directors Blog shared a post this week with updates on its flagship RECOVER study to learn more about the condition. Major updates include: RECOVER’s current recruitment goal is 17,000 adults and 18,000 children; the NIH recently awarded more than 40 grants to research projects examining the condition’s underlying biology; and RECOVER is utilizing electronic health records to track patients over time. While this is all valuable progress, patient advocates have expressed concerns about limited involvement by post-viral chronic illness experts in RECOVER so far.
    • Paxlovid is going under-utilized, study finds: A new report from the health records company Epic Research provides evidence that Paxlovid reduces severe COVID-19 outcomes: patients over age 50 who received the antiviral drug were about three times less likely to be hospitalized, compared with those who didn’t. The study also found, however, that eligible Americans aren’t taking advantage of this treatment. Out of about 570,000 people who “could have received Paxlovid” between March and August 2022, only 146,000 (about one in four) actually got prescriptions. Paxlovid needs to be better advertised and easier to access.
    • New COVID-19 pill added to Medicines Patent Pool: And a new COVID-19 treatment option is becoming available internationally. Shionogi, a Japanese pharmaceutical company, recently signed an agreement with the Medicines Patent Pool, an international public health organization that facilitates increased drug access in low- and middle-income countries. The agreement allows other drug companies to make Shoinogi’s antiviral COVID-19 pill, called ensitrelvir fumaric acid, which has seen some promising results in clinical trials so far. Paxlovid and Molnupiravir (Merck’s antiviral pill) are already licensed by the pool.
    • Patient access to electronic health records expands: This past Thursday, new federal rules took effect requiring healthcare companies to “give patients unfettered access to their full health records in digital format,” as STAT News reporter Casey Ross put it. This is a major milestone for the democratization of health data, as patient records have historically been locked in a labyrinth of private databases—though more public education is needed to help people actually take advantage of the new rules. Personally, I hope this is a first step towards more record-sharing between health institutions, which could be a key step for more comprehensive analysis in the future.
    All featured sources

  • Five reasons why Long COVID research in the U.S. is so difficult

    Five reasons why Long COVID research in the U.S. is so difficult

    Medical and research institutions participating in the NIH’s Long COVID study are, unsurprisingly, concentrated in states with more scientific resources. Chart via Grid; see the full story for the interactive version!

    In December 2020, Congress provided the National Institutes of Health (NIH) with over $1 billion to study Long COVID. A couple of months later, the agency announced it would use this funding for an initiative called RECOVER: a large clinical trial aiming to enroll 40,000 patients, designed to answer long-standing questions about Long COVID and, eventually, identify potential treatments.

    At the time, Long COVID patients and researchers were thrilled to see this massive investment. Long COVID patients may suffer from hundreds of possible symptoms, many of them debilitating; reports estimate that millions of people are out of work as a result of the condition. To anyone who has experienced Long COVID or talked to patients, as I have in my reporting, it’s clear that we need treatment options, and we need them yesterday.

    But that promising NIH study is floundering: it’s moving incredibly slowly (with treatment trials potentially years off); it’s enrolled a tiny fraction of the 40,000 patients originally planned; it’s failing to meet the needs of patients from the communities most vulnerable to COVID-19; and it has been critiqued by patient advocates on concerns of trial setup, transparency, engagement, inclusion of other post-viral illnesses, and more.

    I explored the concerns around RECOVER for a story in Grid, published last Monday. My piece highlights critiques from patient advocates and Long COVID researchers outside of RECOVER, while also discussing some of the broader problems that make it difficult for an initiative like this to succeed in the first place.

    In the COVID-19 Data Dispatch today, I’d like to dig deeper into those broader problems and share some material from my reporting for the Grid story that didn’t make it into the final piece. Here are five reasons why the U.S. is not set up for success when it comes to Long COVID research, based on my interviews and research for the piece.

    The NIH is designed for stepwise research, not “disruptive innovation.”

    One of my favorite quotes in the story comes from David Putrino, who directs a lab at Mount Sinai focused on health innovations and was one of the first scientists in the U.S. to begin focusing on Long COVID. Putrino described how the NIH’s usual mode of operation does not work when it comes to novel conditions like Long COVID:

    “What the NIH does very well, better than most national research organizations around the world, is supporting research that slowly develops small innovations in scientific knowledge,” Putrino said. The agency normally supports series of stepwise trials, climbing from one tiny aspect of research into a condition or treatment to the next.

    This method is good for “long-term innovations that take 20 years,” Putrino said, but not for “disruptive innovation.” Treatments for long covid fall into the latter category: higher-risk, higher-reward science that may be viewed as a waste of government funding if it doesn’t pay off.

    The same day as my Grid story was published, last Monday, STAT News published a story by Lev Facher discussing an oversight board at the NIH that was supposed to improve efficiency at the agency… and has not met for seven years. While this story doesn’t discuss Long COVID specifically, it provides some pretty clear context for why a study like RECOVER—which is different from anything the agency has done before—may be hard to get off the ground.

    Here’s the final quote in Facher’s story, from Robert Cook-Deegan, founding director of the Duke Center for Genome Ethics, Law and Policy:

    “About every 10 years, the National Academies [of Sciences, Engineering, and Medicine] are asked to review NIH, and they make recommendations, most of which are ignored,” he said. The agency’s “large, inertial, and ponderous bureaucracy,” he added, is “not terribly open to criticism as a whole.”

    Clinical trials are difficult and time-consuming to set up, especially when they involve new drugs.

    My story also discusses the red tape that U.S. researchers face when they attempt to test potential treatments on human subjects. For such a clinical trial, researchers need to get approval from an Institutional Review Board (or IRB), an oversight board that ensures a study’s design protects the rights and welfare of people who participate in the trial.

    In the U.S., this approval can take months, and may have extra steps for government-funded research. Researchers in other countries often have much shorter processes, Lauren Stiles, president of the research and advocacy organization Dysautonomia International, told me. She gave the example of a researcher in Sweden studying a potential Long COVID treatment with funding from her organization: for this researcher, the equivalent of IRB approval took a few hours rather than a few months.

    Clinical trials in the U.S. also face extra hurdles when they involve studying new drugs, as our research system makes it easier for companies that develop these drugs to do new clinical trials than for outside academics to undertake similar studies. For example, Putrino told me that he would love to study the potential for Paxlovid, the antiviral drug for acute COVID-19, to treat Long COVID patients. But, he said, “I physically don’t have the bandwidth to fill out the hundreds of pages of documents” that would be required for such a trial.

    A recent story in The Atlantic from Katherine J. Wu focuses further on Paxlovid’s potential as a Long COVID treatment—and how hard it is to study. Quoting from Wu:

    The company is “considering how we would potentially study it,” Kit Longley, a spokesperson for Pfizer, wrote in an email, but declined to clarify why the company has no study under way. That frustrates Putrino, of Mount Sinai, who thinks Pfizer will need to spearhead many of these efforts; it’s Pfizer’s drug, after all, and the company has the best data on it, and the means to move it forward… When asked to elaborate on Paxlovid’s experimental status, the NIH said only that the agency “is very interested in long term viral activity as a potential cause of PASC (long COVID), and antivirals such as Paxlovid are in the class of treatments being considered for the clinical trials.”

    The NIH has historically underfunded and undervalued research into other post-viral conditions.

    When I shared my Grid story on Twitter this week, a lot of patients with myalgic encephalomyelitis (ME), dysautonomia, and other post-viral illnesses said that the issues outlined in my piece felt very familiar.

    https://twitter.com/sshabein/status/1524114628740993024

    After all, the NIH has been failing to fund research into their conditions for decades. Pots, one type of dysautonomia, received less than $2 million a year in NIH funding before the pandemic, Stiles told me. As a result, scientists and clinicians in the U.S. have fairly limited information on these other chronic conditions—in turn, limiting the sources that Long COVID researchers may use as starting points for their own work.

    Long COVID patients share a lot of symptoms with ME, dysautonomia, and other chronic post-viral illness patients; in fact, many Long COVID patients have been diagnosed with these other conditions. According to one study by the Patient-Led Research Collaborative, almost 90% of Long COVID patients experience post-exertional malaise, the most common symptom of ME.

    Despite the historical underfunding, post-viral illness researchers have still made major strides in studying this condition that could provide springboards for RECOVER. But the NIH trial isn’t using them, say experts I talked to. Here are a few paragraphs from an early draft of the story:

    “NIH is approaching Long COVID as a brand-new phenomenon,” said Emily Taylor, an advocate at Solve ME, even though it has extensive overlaps with these other conditions. “We’re starting at square one, instead of starting at square 100.”

    Long COVID patients and those ME have already come together organically to share tips and resources, she said. For example, Long COVID patients versed in medical research have educated ME patients on potential biological mechanisms for their chronic illness, while ME patients have shared methods for resting, pacing, and managing their conditions.

    Experts in conditions like ME were not included in the trial’s leadership early on, and are now outnumbered in committees by cardiologists, respiratory experts, and others who have limited existing knowledge about post-viral illness. “Right now, there are three people with [dysautonomia] expertise on these committees,” Stiles said.

    With the other two experts, Stiles has advocated for autonomic testing—a series of tests measuring the autonomic nervous system, believed to be a key driver of Long COVID symptoms—to be conducted on all RECOVER patients. A few of these tests have been added to the protocol, she said, but not the full list needed to get a comprehensive reading of patients’ nervous systems.

    America’s fractured medical system and lack of broad knowledge on Long COVID have contributed to data gaps, access issues.

    How does a Long COVID patient know that they have Long COVID? Ideally, more than two years into the pandemic, the U.S. medical system would have developed a consistent way of diagnosing the condition. Instead, patients are still getting diagnoses in a variety of ways, including (but not limited to):

    • A positive PCR test, followed by prolonged symptoms.
    • A positive rapid/at-home test, followed by prolonged symptoms.
    • Prolonged symptoms, perhaps later associated with COVID-19 via a positive antibody test.
    • Self-diagnosis based on prolonged symptoms.
    • An official diagnosis of Long COVID from a doctor.
    • An official diagnosis of ME, pots, mass cell activation syndrome, and/or other conditions from a doctor.

    Patients also continue to face numerous barriers to formal Long COVID diagnoses, compounded by the fractured nature of the medical system. A lot of doctors and other medical providers—especially at the primary care level—still don’t know about the condition, and may make it hard for patients to learn that their prolonged fatigue is actually Long COVID. PCR or lab-based COVID-19 testing is also getting harder to access across the country, and many doctors won’t take a positive antigen test as proof of infection.

    All of this means that the U.S. does not have a good estimate of how many Americans are actually suffering from Long COVID. There’s no central registry of patients who can be contacted for potential trials; there aren’t even basic demographic estimates of how many Long COVID patients are Black, Hispanic, or otherwise from marginalized communities. These data gaps make it hard for researchers studying Long COVID to set goals for patient recruitment.

    And then, beyond receiving a diagnosis, actually getting care for Long COVID may require patients to wait weeks for appointments with specialists, contact many different doctors, and generally advocate for themselves in the medical system—while dealing with chronic, debilitating symptoms. As a result, as I wrote in the story:

    The long covid patients who are believed by their doctors, who garner media attention, who serve on RECOVER committees — they’re more likely to be white and financially better-off, said Netia McCray, a Black STEM entrepreneur and long covid patient who has enrolled in the trial.

    So far, RECOVER has not been doing much to combat this inherent bias in the patients who know about the trial (and about their own condition) and are able to sign up for participation.

    Clinical trials in the U.S. are not typically set up in a way that prioritizes patient engagement, especially chronically ill patient engagement.

    One major concern from Long COVID patient advocates involved with RECOVER is that the trial has not prioritized patient engagement—which should be a priority, considering all the medical bias that patients have faced while they’ve become experts in their own condition over the last two years.

    Here’s a bit more detail on this issue, taken from an early draft of my Grid story:

    Patients serving on the committees are dramatically outnumbered by scientists, creating an “intimidating” environment that makes it hard to speak up about their needs, said Karyn Bishof, founder of the COVID-19 Longhauler Advocacy Project. This feeling is exacerbated when scientists on the committees are misinformed about Long COVID and dismiss patients’ experiences, she said.

    Some scientists on the committees are receptive to patient input, representatives told me. Still, the structure is not in their favor: not only are patents outnumbered, it’s also a challenge for them to simply show up to committee meetings. Many Long COVID patients are, by definition, dealing with chronic symptoms that are not conducive to regular meeting attendance. Some are managing a barrage of doctors appointments, jobs, caregiving responsibilities, and more.

    For instance, a second patient representative on a committee with Lauren Stiles—who serves as a representative because she has suffered from Long COVID in addition to other forms of dysautonomia—once missed a meeting because she had to go to the hospital. “If I wasn’t there, no patient would have been represented at all,” Stiles said.

    Patients are compensated for their time in meetings, but not for hours spent doing other research outside those calls. And there’s no structure for patient representatives to coordinate more broadly; patients are operating in silos, with limited information about what representatives on other committees may be doing.

    The NIH has potential models for improving this structure; it could draw from past HIV/AIDS clinical trials that had oversight from that patient community, advocate JD Davids told me. And leaders of RECOVER have acknowledged that they need to improve: as I highlighted in the story, trial leadership met with patient advocates earlier this month to discuss potential changes:

    [Lisa McCorkell, advocate and researcher from the Patient-Led Research Collaborative] said that the meeting made it clear that the NIH and RECOVER leadership understand that improving patient engagement is key to the study’s success. “We agreed to work together to strengthen trust, improve representation of patients, and ensure greater accountability and transparency,” she said in an emailed statement.

    The pressure is on for the NIH and RECOVER leadership to follow up on their promises. I, for one, intend to continue reporting on the trial (and on Long COVID research more broadly) as much as possible.

    More Long COVID reporting

  • Sources and updates, April 10

    • Lessons learned from the non-superspreader Anime NYC convention: Last fall, one of the first Omicron cases detected in the U.S. was linked to the Anime NYC convention, a gathering of more than 50,000 fans. Many worried that the event had been a superspreader for this highly contagious variant, but an investigation from the CDC later found that, in fact, Omicron spread at the convention was minimal. My latest feature story for Science News unpacks what we can learn from this event about preventing infectious disease spread—not just COVID-19—at future large events. I am a big anime fan (and have actually attended previous iterations of Anime NYC!), so this was a very fun story for me; I hope you give it a read!
    • States keep reducing their data reporting frequency: Last Sunday, I noted that Florida—one of the first states to shift from daily to weekly COVID-19 data updates—has now gone down to updating its data every other week. This is part of an increasing trend, writes Beth Blauer from the Johns Hopkins COVID-19 data team in a recent blog post. “As of March 30, only eight states and territories (AR, DE, MD, NJ, NY, PA, PR, and TX) report case data every day of the week,” Blauer says. And it seems unlikely that states will increase reporting frequencies again without a major change in public health funding or the state of the pandemic.
    • Biden administration announces Long COVID task force: This week, the Biden administration issued a memo addressing the millions of Americans living with Long COVID. The administration is creating a new, interagency task force, with the goal of developing a “national research action plan” on Long COVID, as well as a report laying out services and resources that can be directed to people experiencing this condition. It’s worth noting that recent estimates from the U.K. indicate 1.7 million people in that country (or one in every 37 residents) are living with Long COVID; current numbers in the U.S. are unknown due to data gaps, but are likely on a similar scale, if not higher. 
    • New scientific data sharing site from the NIH: Not directly COVID-related, but an exciting new source: the National Institutes of Health (NIH) has created an online data repository for projects funded by and affiliated with the agency. The site currently includes over 100 datasets, including scientific data, genomic data, and clinical data; it also includes information on data management and sharing for researchers working on these projects. This press release from NIH has more info. (H/t Liz Essley Whyte.)
    • Study indicates continued utility for COVID-19 testing in schools: During the Omicron surge, testing programs in a lot of schools collapsed, simply because institutions didn’t have enough resources to handle all of the students and staff getting sick. The surge led some schools to consider whether school testing programs are worth continuing at all. But a new study, released last week in The Lancet, suggests that yes, surveillance testing can still reduce transmission—even when schools are dealing with highly contagious variants. (Note that this was a modeling study, not a real-world trial.)
    • Preprint shows interest in self-reporting antigen test results: Another interesting study released recently: researchers at the University of Massachusetts distributed three million free rapid, at-home antigen tests between April and October 2021, then studied how test recipients interacted with a digital app for ordering tests and logging results. About 8% of test recipients used the app, the researchers found; but more than 75% of those who used it did report their antigen test results to their state health agency. The results (which haven’t yet been peer-reviewed) suggest that, if institutions make it easy and accessible for people to self-report their test results, the reporting will happen.

    All featured sources