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September 18, 2020

Controversial coronavirus testing guidelines bypassed CDC scientific review, reports say

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    HHS officials skirted CDC's scientific review process last month when they wrote and published CDC guidelines that did not recommend testing asymptomatic people who had been exposed to the novel coronavirus, according to reporting in the New York Times.

    How Covid-19 is changing the future of the health care industry

    US new coronavirus cases near 6.7M, deaths approach 198K

    As of Friday morning, U.S. officials reported a total of 6,698,700 cases of the novel coronavirus virus since the country's epidemic began—up from 6,653,200 cases reported as of Thursday morning.

    According to data from the Times, the rates of newly reported cases are "staying high" in 15 states that have had comparatively high case rates, meaning a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Arkansas, Idaho, Iowa, Kansas, Kentucky, Missouri, Nebraska, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, and Wisconsin.

    Meanwhile, the rates of newly reported cases over the past seven days are "going down" in Alabama, Georgia, Guam, and Mississippi, which had previously seen elevated case rates.

    In nine states that have had comparatively low case rates, rates are now "going up," according to the Times. Those states are Arizona, Colorado, Connecticut, Michigan, New Hampshire, New Jersey, Rhode Island, West Virginia, and Wyoming.

    In the remaining states and U.S. territories, rates are "staying low," according to the Times' analysis.

    U.S. officials as of Friday morning also reported a total of 197,529 deaths linked to the coronavirus since the country's epidemic began—up from 196,680 deaths reported as of Thursday morning.

    HHS published coronavirus testing guidelines without CDC's scientific review

    On Thursday, the New York Times reported that HHS officials last month wrote and published coronavirus testing guidelines without going through CDC's ordinary scientific review process.

    The guidelines, which HHS officials published to CDC's website last month, state that people who have been in close contact with a person infected with the coronavirus "do not necessarily need a test" if they're not exhibiting symptoms of Covid-19. The agency said such individuals instead should monitor themselves for Covid-19 symptoms and "strictly adhere to CDC mitigation protocols, especially if [they] are interacting with a vulnerable individual."

    CDC's guidelines previously recommended coronavirus testing "for all close contacts" of people infected with the novel coronavirus, irrespective of whether those contacts were showing symptoms of Covid-19. CDC in the earlier guidelines had noted that "the potential for asymptomatic and pre-symptomatic transmission" is a critical component in the novel coronavirus' spread.

    In an interview with the Times, a federal official familiar with the matter said the updated guidelines "came from the top down, from the HHS" and the White House's coronavirus task force. "That policy does not reflect what many people at the CDC feel should be the policy."

    A senior CDC scientist who spoke with the Times on the condition of anonymity said the guidelines contain "elementary errors"—such as referencing "testing for Covid-19," which is the disease caused by the new coronavirus, rather than testing for the virus itself.

    In an interview with the Times on Thursday, HHS Assistant Secretary for Health Brett Giroir said CDC wrote the document's original draft, but he "coordinated editing and input from the scientific and medical members of the task force."

    Giroir said the draft recommendations went through about 20 revisions—with feedback from CDC Director Robert Redfield; Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; Deborah Birx, the White House's coronavirus response coordinator; and Scott Atlas, a special advisor to President Trump on the coronavirus.

    At least eight versions of the updated guidelines were circulated within CDC in August and the agency's scientists raised concerns over the document, but in an email obtained by the Times, a senior CDC official told the scientists, "We do not have the ability to make substantial edits."

    Giroir said the members of the White House's coronavirus task force also presented the document to Vice President Mike Pence, who leads the task force.

    Giroir said he was unsure why the document bypassed CDC's ordinary scientific review process. "I think you have to ask Redfield about that. That certainly was not any direction from me whatsoever," he said.

    In a statement emailed to the Times, Redfield said, "The guidelines, coordinated in conjunction with the White House Coronavirus Task Force, received appropriate attention, consultation, and input from task force experts."

    A federal official told the Times that new testing guidelines are expected to be posted on Friday, but the recommendations have not undergone CDC's scientific review and are being revised by HHS officials.

    Pfizer, Modern release clinical trial plans for coronavirus vaccine candidates

    Separately, Pfizer and Moderna on Thursday released comprehensive plans detailing how they intend to evaluate their vaccine candidates.

    The move comes as Americans' trust in FDA and other health agencies has eroded. A recent Kaiser Family Foundation poll found 62% of respondents said they were concerned FDA would rush authorizing a coronavirus vaccine because of political pressure.

    To ease the public's concerns, the companies shared their plans, which explain how they are selecting and monitoring clinical trial participants; what conditions and problems would drive researchers to stop a clinical trial; and what evidence researchers will use to determine a vaccine's effectiveness.

    Moderna's plan provided a timetable of when the drugmaker could determine whether its vaccine candidate is effective. According to the plan, Moderna's timeline could stretch into next year.

    Pfizer's plan did not appear to include a prediction on when its results could become available, but Pfizer's CEO Albert Bourla has repeatedly said the company expects to have data on its vaccine candidate as soon as next month.

    Both companies acknowledged that it is unusual for drugmakers to release detailed information on their clinical trials before their studies are complete, but they said the need to win the public's trust and the unique nature of America's coronavirus epidemic warranted transparency.

    Eric Topol, a clinical trial expert at Scripps Research in San Diego, applauded Moderna for sharing it trial plan, but expressed disappointment over Moderna's proposal to include participants who develop mild cases of Covid-19, in its data. Topol said Moderna could provide more compelling evidence on its vaccine candidate's effectiveness if it included only data on participants who developed moderate to severe cases of Covid-19.

    According to Topol, Moderna's plan would allow the company to stop its clinical trial early after a relatively small number of cases develop, which could inflate the vaccine's effectiveness and result in researchers missing safety problems.

    Topol also raised concerns over Pfizer's plan, which would give the company opportunities to stop clinical trials early based on milder cases than Moderna would under its plan.

    "Take the time, the extra weeks," Topol said. "No shortcuts. Nobody will regret it. I've been doing clinical trials for decades. I don't know if there's ever been a more important one than this one. I'd like to see it done right, and not stopped early" (Coleman, The Hill, 9/17; Mandavilli, New York Times, 9/17; Grady/Thomas, New York Times, 9/17; New York Times, 9/18).

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