POST 46. September 17, 2020. CORONAVIRUS. “Bill Gates used to think of the US Food and Drug Administration as the world’s premier public-health authority. Not anymore. And he doesn’t trust the Centers for Disease Control and Protection either….”

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“President Donald Trump continues to baselessly claim the coronavirus will simply “go away” even as the number of COVID-19 cases in the U.S. skyrocket under an administration fumbling its response to the pandemic.

“This is going to go away,” Trump said of the deadly virus at the White House on Tuesday. “And whether it comes back in a modified form in the fall, we’ll be able to handle it, we’ll be able to put out spurts, and we’re very prepared to handle it.”..

“It’s going to disappear,” he said of the coronavirus at the time as infection numbers began to trickle in. “One day it’s like a miracle, it will disappear.”” (J)

“Bill Gates used to think of the US Food and Drug Administration as the world’s premier public-health authority. Not anymore.

And he doesn’t trust the Centers for Disease Control and Protection either.

Both, in his view, are casualties of a presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. One recent example came when FDA Commissioner Stephen Hahn, speaking at one of President Donald Trump’s news conferences, exaggerated the benefit of blood plasma as a treatment for Covid-19, then backtracked the following day.

“We saw with the completely bungled plasma statements that when you start pressuring people to say optimistic things, they go completely off the rails. The FDA lost a lot of credibility there,” Gates, the billionaire philanthropist, said in an interview on Bloomberg Television.

“Historically, just like the CDC was viewed as the best in the world, the FDA had that same reputation as a top-notch regulator,” Gates said. “But there’s been some cracks with some of the things they’ve said at the commissioner level.”

At stake is nothing less than public confidence in the vaccine that could end the coronavirus pandemic, and which the FDA would have to approve. Polls conducted in the past two months show a majority of Americans worry development of the vaccine is being rushed and a third wouldn’t get inoculated.” (A)

“In an interview with STAT, Gates sounded exasperated at times as he described the badly bungled launch of Covid-19 testing, the enlisting of a neuroradiologist — rather than an epidemiologist or infectious diseases specialist — to help guide the White House’s response decisions, and the recent move to discourage testing of people who have been in contact with a known case but who aren’t yet showing symptoms.

“You know, this has been a mismanaged situation every step of the way,” Gates said in the wide-ranging interview. “It’s shocking. It’s unbelievable — the fact that we would be among the worst in the world.”

He leveled his harshest criticism at Food and Drug Administration Commissioner Stephen Hahn, who mischaracterized findings from a Mayo Clinic study on Covid-19 and said researchers had seen a 35% survival benefit with the use of convalescent plasma. “Many of you know I was a cancer doctor before I became FDA commissioner,” Hahn said at the time. “And a 35% improvement in survival is a pretty substantial clinical benefit.”

“This is third grade math. I mean, are you kidding?” Gates said. “The head of the FDA got up and said it was a 35% death reduction where it’s not even a 3% reduction based on just a tiny little subset that was nonstatistical. This is unheard of.”…

Early in the outbreak, as it was becoming clear the new coronavirus was spreading from China, experts from the Bill and Melinda Gates Foundation were in regular contact with the Trump administration, urging officials to come up with a plan for who to test and how to test them, and to get surveillance data up on the website of the Centers for Disease Control and Prevention.

Gates said from the start the foundation insisted that commercial laboratories should only be paid for their work if they returned test results within 24 hours — a target rarely reached in the U.S. response. Anything longer than that meant the tests were not useful for containing spread of the virus, he said, adding: “You get to write apology notes to the people you infected in the meantime.”

This advice still isn’t being heeded. “I’ve been saying this and I just don’t get why it hasn’t changed,” Gates said.

The CDC’s early missteps on testing — “they created this overly complicated test,” Gates said — was followed by a slow rollout of commercial tests. The commercial tests use polymerase chain reaction, or PCR, to look for small fragments of the genetic material of the virus in mucus swabbed out of the nasal passages of people who are tested.

“We have way more PCR machines than any country in the world. I mean, we are PCR central,” he said with emphasis. “So, the idea that we actually made it harder to get PCR tests approved by the commercial sector, it’s mind-blowing.”..

Likewise, Gates could not believe the administration’s recent move to rewrite CDC testing guidance to state that people who weren’t displaying symptoms didn’t need to be tested. Experts said the revised recommendations will make it harder to find and isolate people who are just becoming infectious — undermining efforts to limit spread of the virus. “It blows the mind,” Gates said.

The new advice reportedly had the support of Scott Atlas, a recent addition to the White House coronavirus task force. Atlas, a neuroradiologist and a public policy fellow at Stanford University’s Hoover Institution, has reportedly been advocating a policy of allowing the virus to spread unchecked so the country can reach herd immunity quicker.

Gates is not a fan. “The administration’s now hired this Stanford guy who has no background at all just because he agrees with their crackpot theories.” “ (B)

“The health department’s politically appointed communications aides have demanded the right to review and seek changes to the Centers for Disease Control and Prevention’s weekly scientific reports charting the progress of the coronavirus pandemic, in what officials characterized as an attempt to intimidate the reports’ authors and water down their communications to health professionals.

In some cases, emails from communications aides to CDC Director Robert Redfield and other senior officials openly complained that the agency’s reports would undermine President Donald Trump’s optimistic messages about the outbreak, according to emails reviewed by POLITICO and three people familiar with the situation.

CDC officials have fought back against the most sweeping changes, but have increasingly agreed to allow the political officials to review the reports and, in a few cases, compromised on the wording, according to three people familiar with the exchanges. The communications aides’ efforts to change the language in the CDC’s reports have been constant across the summer and continued as recently as Friday afternoon.

The CDC’s Morbidity and Mortality Weekly Reports are authored by career scientists and serve as the main vehicle for the agency to inform doctors, researchers and the general public about how Covid-19 is spreading and who is at risk. Such reports have historically been published with little fanfare and no political interference, said several longtime health department officials, and have been viewed as a cornerstone of the nation’s public health work for decades.

But since Michael Caputo, a former Trump campaign official with no medical or scientific background, was installed in April as the Health and Human Services department’s new spokesperson, there have been substantial efforts to align the reports with Trump’s statements, including the president’s claims that fears about the outbreak are overstated, or stop the reports altogether.

Caputo and his team have attempted to add caveats to the CDC’s findings, including an effort to retroactively change agency reports that they said wrongly inflated the risks of Covid-19 and should have made clear that Americans sickened by the virus may have been infected because of their own behavior, according to the individuals familiar with the situation and emails reviewed by POLITICO.

Caputo’s team also has tried to halt the release of some CDC reports, including delaying a report that addressed how doctors were prescribing hydroxychloroquine, the malaria drug favored by Trump as a coronavirus treatment despite scant evidence. The report, which was held for about a month after Caputo’s team raised questions about its authors’ political leanings, was finally published last week. It said that “the potential benefits of these drugs do not outweigh their risks.”

In one clash, an aide to Caputo berated CDC scientists for attempting to use the reports to “hurt the President” in an Aug. 8 email sent to CDC Director Robert Redfield and other officials that was widely circulated inside the department and obtained by POLITICO….

CDC officials have fought the efforts to retroactively change reports but have increasingly allowed Caputo and his team to review them before publication, according to the three individuals with knowledge of the situation. Caputo also helped install CDC’s interim chief of staff last month, two individuals added, ensuring that Caputo himself would have more visibility into an agency that has often been at odds with HHS political officials during the pandemic….

But public health experts told POLITICO that they were particularly alarmed that the CDC’s reports could face political interference, praising the MMWRs as essential to fighting the pandemic.

“It’s the go-to place for the public health community to get information that’s scientifically vetted,” said Jennifer Kates, who leads the Kaiser Family Foundation’s global health work. In an interview with POLITICO, Kates rattled off nearly a dozen examples of MMWR reports that she and other researchers have relied on to determine how Covid-19 has spread and who’s at highest risk, including reports on how the virus has been transmitted in nursing homes, at churches and among children.

“They’re so important, and CDC has done so many,” Kates said…

Caputo defended his team’s interventions as necessary to the coronavirus response. “Buried in this good [CDC] work are sometimes stories which seem to purposefully mislead and undermine the President’s Covid response with what some scientists label as poor scholarship — and others call politics disguised in science,” Caputo told POLITICO.

The battles over delaying or modifying the reports have weighed on CDC officials and been a distraction in the middle of the pandemic response, said three individuals familiar with the situation. “Dr. Redfield has pushed back on this,” said one individual. “These are scientifically driven articles. He’s worked to shake some of them loose.”

Kates, the Kaiser Family Foundation’s global health expert, defended the CDC’s process as rigorous and said that there was no reason for politically appointed officials to review the work of scientists. “MMWRs are famously known for being very clear about their limitations as well as being clear for what they’ve found,” she said.

Kates also said that the CDC reports have played an essential role in combating epidemics for decades, pointing to an MMWR posted in 1981 — the first published report on what became the HIV epidemic.

“Physicians recognized there was some kind of pattern and disseminated it around the country and the world,” Kates said. “We can now see how important it was to have that publication, in that moment.”” (C)

“White House officials are advising Dr. Anthony Fauci, the nation’s top infectious disease expert, to promote messages that prioritize political positions over scientific findings, an attempt to bolster Donald Trump’s misleading claims about the coronavirus. The pressure is apparently coming from Paul Alexander, a Trump appointee at the Department of Health and Human Services who, in emails reported by Politico, has repeatedly tried to edit Fauci’s planned responses to outlets including Bloomberg News, BuzzFeed, HuffPost, and the science journal Cell. Just this week, Alexander reportedly sent a message to Fauci’s press team urging him not to promote mask-wearing by children in an MSNBC interview.

“Can you ensure Dr. Fauci indicates masks are for the teachers in schools. Not for children,” Alexander wrote. “There is no data, none, zero, across the entire world, that shows children especially young children, spread this virus to other children, or to adults or to their teachers. None. And if it did occur, the risk is essentially zero,” he said, adding—without evidence—that children “take influenza home but do not take COVID home.” The advice prompted long email threads between Alexander and some of Fauci’s aides pushing back against the misleading claims. Alexander is a senior adviser to Michael Caputo, an ally of the president who currently oversees HHS’s media strategy and who said in a statement that he “hired Dr. Alexander for his expertise and not to simply resonate others’ opinions.”…

Fauci told Politico he had not seen the emails, nor had his staff advised him to minimize the risk coronavirus poses to kids or the need for mask-wearing. “No one tells me what I can say and cannot say,” Fauci said. “I speak on scientific evidence,” a point he reiterated in a pair of interviews on Friday. Asked by CNN’s Wolf Blitzer whether the public should listen to Fauci or Trump—who on Thursday claimed “we’re rounding the corner” of the pandemic—Fauci remarked, “You don’t have to listen to any individual” if you “look at the data. The data speak for themselves,” he said. “We’re still getting up to 40,000 new infections a day and 1,000 deaths. That is what you look at. Look at the science, the evidence and the data and you can make a pretty easy conclusion.”  (D)

“Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies confirmed on Saturday a report in Politico late Friday that the C.D.C.’s public Morbidity and Mortality Weekly Reports have been targeted by senior officials in the Health and Human Services’ communications office.

The reports, which one former top health official called the “holiest of the holy” in agency literature, are written largely for scientists and public health experts, to update them on trends in infectious diseases, not only the coronavirus but also other outbreaks around the country. They are guarded so closely by agency staff members that political appointees only see them just before they are published.

The reports became the subject of intense scrutiny this summer by Michael Caputo, a Republican political operative and former Trump campaign official the White House installed as the top spokesman at the department in April, despite his having no background in health.

Mr. Caputo himself said on Saturday that Politico’s report was largely accurate, but he denied that there was any overt pressure involved. He said that the primary person involved in critiquing the reports, Paul Alexander, an assistant professor of health research at McMaster University in Canada whom he hired to advise him on the science of the pandemic, simply offered direct reactions to the drafts of the C.D.C.’s Morbidity and Mortality Weekly Reports.

“He digs into these M.M.W.R.s and makes his position known, and his position isn’t popular with the career scientists sometimes,” Mr. Caputo said of Dr. Alexander. “That’s called science. Disagreement is science. Nobody has been ever ordered to do anything. Some changes have been accepted, most have been rejected. It’s my understanding that that’s how science is played.”

In an email obtained by Politico and confirmed to The Times by a health official with direct knowledge of the message, Dr. Alexander accused C.D.C. scientists of trying to “hurt the president,” referring to the weekly reports as “hit pieces on the administration.” Dr. Alexander asked Dr. Robert R. Redfield, the C.D.C. director, to edit reports that had already been published, which he believed overstated the risks of the virus for children and undermined the administration’s efforts to encourage school reopenings.

The meddling from Washington concerned Dr. Redfield, according to one former senior health official, who often pushed back when Mr. Caputo called to pester him about the reports.” (E)

“The MMWR Weekly reports are authored by scientists and published by the CDC. Their purpose is to inform doctors, medical professionals and researchers and offer statistics, data and trends on all aspects of health issues in the United States. The MMWR Weekly report is also in the public domain and can be reprinted without permission – all reports dating back to 1982 are available on the CDC’s online database. Notable MMWR Weekly articles included a report on AIDS in 1981 and an alert on lead-contaminated drinking water in Washington in 2001. The MMWR Weekly reports have always been published without any kind of interference from political parties – until now.

Caputo, a former Republican operative who comes from neither a medical nor a scientific background, has allegedly modified MMWR reports to play down the health risks associated with Covid-19 or sometimes block certain articles from being included at all. In an email sent to CDC Director Robert Redfield which Politico has gained access to, Paul Alexander, a member of Caputo’s team accused CDC scientists of deliberately using the reports “as hit pieces to hurt the President”. In the same email, Alexander asked Redfield to make changes to two reports which had already been published online, claiming that they were “misleading” and wrongly inflated Coronavirus’ risks to children – consequently hindering Trump’s plans to reopen schools.

Alexander also requested that publication of all future MMWR reports should be halted “immediately” adding that the publication process should be completely revamped to enable him to review and edit reports before they were published. “The reports must be read by someone outside of CDC like myself; and we cannot allow the reporting to go on as it has been, for it is outrageous. Its lunacy,” Alexander wrote in one email to Redfield. “Nothing to go out unless I read and agree with the findings how they CDC, wrote it and I tweak it to ensure it is fair and balanced and complete”.

When Politico approached Caputo to ask why he and his team were demanding changes to MMWR reports, Caputo responded with a statement in which he heaped praise on Alexander, who he hailed as “an Oxford-educated epidemiologist who specializes in analysing the work of other scientists”.” (F)

“Scientists and physicians reacted with words such as “aghast,” “despicable” and “outrageous” over the weekend as news spread that White House appointees interfered with a basic national public health report when it conflicted with President Donald Trump’s coronavirus messaging.

Michael Caputo, the Health and Human Services assistant secretary for public affairs, acknowledged Saturday that since June, he and an adviser have scrutinized and at times pushed for changes to a weekly health report distributed by the U.S. Centers for Disease Control and Prevention.

The meddling, first reported by Politico, included efforts to stop the publication of a report last week on the use of hydroxychloroquine, a malaria drug often touted by Trump, delay a 10-state study of COVID-19 infection statistics in June and another on the spread of coronavirus at a Georgia sleep-away camp….

The Morbidity and Mortality Weekly Report is a series of dry and sometimes dense brief updates on public health incidents that come out on Thursdays. They typically describe events or topics and are an important way for doctors and health officials to get the latest data.

Dr. William Schaffner, who is on the publication’s editorial board, said he was “aghast” and “appalled” by the reported attempts to delay, stop or change reports. He described the publication as a vital part of the global conversation among public health officials who track diseases and dangers.

“It has been the voice of the U.S. government’s health system, of integrity and scientific rigor, for years,” said Schaffner, a professor and infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee. “Indeed, the MMWR has been a model for other countries’ ministries of public health for creating similar newsletters in their countries.”

The interference is not just anti-science but disinformation intended to deceive the American public, said Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California.

“This is outright egregious. It’s despicable,” Topol said, accusing Redfield and other leaders of allowing the agency to be hijacked by politics.

“What we’re seeing is multiple actors, important people who are just laying down, who are complicit with the anti-science machinations of the Trump administration,” he said….

On Twitter, Dr. Sherri Bucher, a global health researcher, wrote, “There are no words to articulate how horrific this is. Trust & credibility, shattered, overnight. MMWR has been, for a long time, one of the most reliable, steadfast, scientific resources; unquestioned veracity, impeccable reputation for quality of data/analysis. No longer.”” (G)

“On Saturday, members of the public health community aired frustration over the report, which has not been confirmed by CNBC. Dr. Carlos Del Rio, an infectious disease specialist at Emory University, called the reports “incredibly concerning.”

“It’s very upsetting also for those of us in public health and medicine. The MMWR is a landmark CDC publication,” he said in an interview with CNN’s Fredricka Whitfield. “I think that MMWR are still trying to get the information out there, but certainly now, I will start reading with a degree of skepticism.”

Marc Lipsitch, an epidemiologist at Harvard University, said on Twitter that the move is “outrageous and dangerous” to public trust in the CDC. He added that the move is “unsurprising.”..

Dr. Atul Gawande, a professor in the Department of Health Policy and Management at Harvard, said on Twitter that political appointees “should have no role in scientific publications. None.”

Natalie Dean, a biostatistician at the University of Florida, urged the Trump administration to give career professionals at the CDC more freedom so speak.

“It remains unthinkable to me that during a global pandemic that has so severely impacted the United States, we hear so little from the CDC,” she said on Twitter. “The expertise is there. Let the scientists speak.”

Through MMWR, the CDC has continued to regularly publish important studies about Covid-19, including one this week that emphasized the risk of spread associated with dining at a restaurant and another demonstrating kids’ ability to spread the virus despite not becoming severely sick with the disease.

HHS Secretary Alex Azar, in a statement to CNBC, said Trump has always been receptive to “the data and science.” The CDC falls under the responsibility of HHS. 

“As the Secretary of Health and Human Services, I have briefed President Trump alongside the nation’s top doctors and I have insisted that he have direct access to these doctors throughout the COVID-19 pandemic,” Azar said. “He has always been receptive to the data and science presented by me and other members of the task force. President Trump’s science-based decision making has saved lives.”” (H)

“As acting director of the CDC at the dawn of the H1N1 pandemic in 2009, I felt the natural tensions that can occur between political appointees and career public health officials at CDC. During my tenure, the science was always—without exception—the driving force in the review process and in our communications to the public. Indeed, in the many decades I’ve spent in public health, including 13 years at CDC, science has been the arbiter of truth and carried the day no matter the administration or the political party. That must remain the case today.

The MMWR is among the most sober and least political public health communiques one can imagine. The name itself—Mortality and Morbidity Weekly Report—could only have been conceived by scientists rather than professional communicators. I’ve reviewed hundreds and co-authored several of these reports, which are notoriously meticulous, built on foundations of data and notably devoid of adjectives. The just-the-facts approach could be frustrating, in fact, because any public health guidance that carried even a whiff of the subjective would be expunged from the reports by science-driven editors. This is as it should be for public health communications written for the public health community, and it’s why the integrity of these reports has been second to none.

In 2009, the first communications from CDC about H1N1 were included in the MMWR. Two cases in California detailed in an MMWR in April of that year gave us an early indication that the virus first reported in Mexico had crossed into the United States. From that point forward—much as we’re seeing today—the MMWRs would serve as a valuable tool in filling in the gaps in knowledge while informing public health officials in every state in the country, and in real time, what they might be facing. These reports are the keepers of the latest statistics and allow for sharing of information to be used in planning and response during a public health crisis.

Because the voice of the CDC has largely been silenced during the coronavirus pandemic and unable to regularly reach the public, the MMWRs have become an even more critical conduit for the latest information and data. Produced like clockwork and driven by scientific rigor, they have detailed everything from COVID-19 spread at church events to outbreaks among college students to a comprehensive look at who is dying from COVID-19 in the U.S. The latest report, issued the day the Politico story broke, detailed COVID-19 outbreaks at three Utah childcare facilities. Each report is an important puzzle piece in helping on-the-ground public health officials better understand the virus and emerging epidemiological learnings….

The landmark of 200,000 deaths that is fast approaching reflects a scale of tragedy that the United States did not have to bear. CDC science should not be undermined nor the voices of its experts muted, or our nation will suffer a crisis of confidence and trust that will continue to hamper our recovery from this pandemic and open the door for more death and more suffering.

We cannot let this happen.” (I)

“Testifying before Congress on Wednesday, Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention, strongly disputed that his agency’s scientific research has been influenced by political appointees attempting to bring those findings in line with President Trump’s views.

“We’re not going to let political influence try to modulate” the agency’s scientific conclusions, Redfield said. Those conclusions are customarily conveyed in a regular CDC publication called the Morbidity and Mortality Weekly Report, or MMWR…

“The scientific integrity of the MMWR has not been compromised,” Redfield said in his Senate testimony on Wednesday. “It will not be compromised on my watch.” He added that he would “stand by” his agency’s “scientific experts” and ensure that their work is free of political taint.” (K)

“President Trump on Wednesday rejected the professional scientific conclusions of his own government about the prospects for a widely available coronavirus vaccine and the effectiveness of masks in curbing the spread of the virus as the death toll in the United States from the disease neared 200,000.

In a remarkable display even for him, Mr. Trump publicly slapped down Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, as the president promised that a vaccine could be available in weeks and go “immediately” to the general public while diminishing the usefulness of masks despite evidence to the contrary.

The president’s comments put him at odds with the C.D.C., the world’s premier public health agency, over the course of a pandemic that he keeps insisting is “rounding the corner” to an end. Mr. Trump lashed out just hours after Dr. Redfield told a Senate committee that a vaccine would not be widely available until the middle of next year and that masks were so vital in fighting the disease caused by the coronavirus, Covid-19, that they may even more important than a vaccine….

The public scolding of Dr. Redfield was only the latest but perhaps the starkest instance when the president has rejected not just the policy advice of his public health officials but the facts and information that they provided. Public health officials are in strong agreement about the value of masks even as Mr. Trump generally refuses to wear one, mocks his opponent for doing so and twice in the past two days questioned their utility based on the advice of restaurant waiters.” (L)


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