NEJM, Lancet retract coronavirus studies

With help from Darius Tahir (@dariustahir)

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Quick Fix

— Top medical journals retract pair of studies: Both used data from controversial data firm Surgisphere.

— CDC head apologizes for lack of disparity data: Robert Redfield acknowledged that the agency’s reporting on racial disparities among Covid-19 patients has been “inadequate.”

— GAO cites ‘Mar-a-Lago 3' influence on VA: A report out this week stops short of backing charges that Trump’s social circle treated the agency as their personal fiefdom.

eHealth tweet of the day: Harley Lorenz Geiger @HarleyGeiger
My dad: Your son reminds me of you.
Me: How’s that?
Dad: Arguing so hard about little things.
My son, overhearing: WHY JUST LITTLE THINGS??

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Driving the Day

ACE INHIBITOR, HYDROXYCHLOROQUINE STUDIES RETRACTED — The New England Journal of Medicine retracted an analysis Thursday examining the impact of blood pressure drugs called ACE inhibitors on coronavirus patients, following The Lancet’s retraction of another study concluding that malaria drug hydroxychloroquine increases the risk of death in coronavirus patients.

"[A]ll the authors were not granted access to the raw data and the raw data could not be made available to a third-party auditor,” leaving them “unable to validate the primary data sources underlying our article,” the NEJM retraction note says. The Lancet retracted the hydroxychloroquine paper at the request of three of its four authors, who said the fourth co-author, Surgisphere CEO Sapan Desai, would not transfer data needed for a third-party peer review.

Desai, a co-author of both retracted papers, declined comment.

The quick retractions of two prominent studies could undermine the public’s — and politicians’ — trust of scientific research during a pandemic when knowledge is rapidly evolving and accumulating, Jennifer Kates, director of global health policy at the Kaiser Family Foundation, told Darius. “Some will question scientific findings, in an environment where misinformation and distrust of information is already a problem,” she said.

Also on hydroxychloroquine, our colleague Sarah Owermohle breaks down FDA’s struggle to remain independent during the search for a vaccine.

MORE ON EVIDATION/BARDA PARTNERSHIP — Evidation Health is working on an early warning algorithm for coronavirus symptoms, with funding from the Biomedical Advanced Research and Development Authority. The system will analyze sleep and activity patterns as well as self-reported information.

The project is “not only an early step in demonstrating the utility of models developed using person-generated health data but also may provide data to better understand the varied symptoms” of coronavirus, BARDA Acting Director Gary Disbrow said in a release.

E&C LEADERS WANT BETTER DATA MODELING — "[T]he better the infectious disease modeling, the better we can target our response to public health threats,” Committee Chair Frank Pallone, ranking member Greg Walden, and oversight subcommittee chair and ranking member Diana DeGette and Brett Guthrie said this week following a GAO report concluding that federal agencies could do a better job on their modeling efforts.

... The report found that HHS agencies did not “routinely monitor, evaluate, or report on the extent and success of coordination” on these efforts, leading them to “risk missing opportunities to identify and address modeling challenges” such as communicating and obtaining data during outbreaks. “There is potential for overlap and duplication of cross-agency modeling efforts, which could lead to inefficiencies,” the watchdog wrote.

COMING UP IN THE SENATE: TELEHEALTH HEARING — The Senate HELP committee is planning a hearing June 17 on telehealth in the coronavirus response and the “rapid shift from in-person doctor visits to health care being provided virtually — either on a phone call or through video conferencing,” according to a hearing notice.

REDFIELD CALLS DISPARITIES REPORTING ‘INADEQUATE’ — CDC director Robert Redfield addressed criticism that lack of data has hampered public health response in communities of color disproportionately affected by the virus, our colleague Brianna Ehley reports. “I want to apologize for the inadequacy of our response,” Redfield said during a House Appropriations subcommittee hearing.

Congress in its April relief package directed the CDC to report racial disparities data among coronavirus cases, deaths and hospitalizations. But the four-page report the agency released last week was ripped by lawmakers who said it was incomplete and outdated. The CDC has said its information is lacking because some states haven’t been reporting such data. Black and Latino Americans have been hit especially hard by Covid-19.

NEW LAB REPORTING GUIDELINES — HHS unveiled new guidance Thursday on what data laboratories must report to HHS along with coronavirus test results — including demographic information such as race, ethnicity, age and sex.

... Disparities could be reduced by health record interoperability, Howard Koh, former HHS assistant secretary for health under Barack Obama, told Morning eHealth. “The more we can get timely information that represents the impact of a crisis on a population, it shows where interventions can be directed in real-time,” he said.

Koh also said digital contact tracing apps, some of which notify people when they’ve been near someone who’s tested positive for the virus, will need to focus especially on building trust with underserved and disproportionately affected populations.

“For communities of color and for immigrant communities, the trust in the system may be less than for others in the United States,” Koh said. “I’m really hoping the contact tracing workforce that is ramping up now can be sustained and become a permanent local community health workforce for public health.”

In New York City, privacy concerns are already threatening contact tracing efforts, POLITICO’s Amanda Eisenberg writes. “People who were at these protests should be concerned that the government could use that data,” Public Advocate Jumaane Williams said in an interview. “I want to encourage [contact tracing], but it’s hard to when our executive leaders are not clarifying how that data will be used.”

... “Community members must have confidence that the information that they provide to contact tracers is truly confidential,” Bethsy Morales-Reid, senior director for health initiatives for the Hispanic Federation, said recently. “When you ask a Covid-19-positive person who they have come in contact with, you’re asking them to give up their undocumented tía [aunt] who helps them raise their children or their elderly mother who lives with them and may not be listed in their lease agreement.”

MORE ON CONTACT TRACING: PRIVACY VS. URGENCY — China has been experimenting with digital contact tracing, gathering vast amounts of user data including location. But that approach doesn’t quite work in the West, our colleagues Josh Ye, Coco Feng and Yujie Yu report for POLITICO and the South China Morning Post.

“The fears over surveillance could ultimately lead to a decrease in testing at precisely the time that we want people to trust public health authorities and go and get tested when the tests become widely available,” said Jennifer Daskal, faculty director of the tech, law and security program at American University.

REPORT: MAYO’S PATIENT DATA USE RAISES CONCERN — Sixteen companies have accessed de-identified Mayo Clinic patient data through licensing deals that “widened Mayo’s revenue stream and generated crucial insights for health tech firms eager to commercialize digital products and services,” Stat’s Casey Ross reports.

Mayo Clinic Ventures chair Andy Danielsen told Stat the clinic allows such access because it “will advance medicine and make care for patients in the future better,” but bioethicists warn that such agreements leave patients out.

...As University of Michigan Medical School bioethicist and lawyer Kayte Spector-Bagdady told Stat: “If your data and biospecimens are valuable, they are yours...There is a harm of respect for people to use your stuff without your permission, or make money from your stuff without giving some back to you.”

WATCHDOG: TRUMP’S CIRCLE CONSTANTLY INVOLVED IN VA BUSINESS — Another GAO report out this week concludes that Marvel Entertainment Chairman Ike Perlmutter, physician Bruce Moskowitz and lawyer Marc Sherman were involved in various aspects of VA operations including personnel changes and the department’s $16 billion EHR project, Darius writes.

What We're Reading

— In a NEJM perspective piece, Sirina Keesara, Andrea Jonas, and Kevin Schulman recommend policy changes to enable digital health.
— NHS’ test and trace system won’t be up and running till September, The Guardian’s Sarah Marsh writes.
— Hospitals are still a major target for ransomware attacks, Bloomberg Law’s Ayanna Alexander reports.