Media reports in recent weeks suggest top White House officials overruled CDC on guidelines concerning the reopening of schools and cruise line operations. Meanwhile, former FDA commissioners are raising concerns about reports the White House could try to intervene on vaccine standards for the new coronavirus.

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US new coronavirus cases top 7.2M, deaths surpass 205K

U.S. officials as of Wednesday morning reported a total of 7,219,800 cases of the novel coronavirus virus since the country’s epidemic began—up from 7,176,500 cases reported as of Tuesday morning.

According to data from the New York Times, the rates of newly reported coronavirus cases are “staying high” in Puerto Rico and 22 states that have had a daily average of at least 15 newly reported cases per 100,000 people over the past week. Those states are Alaska, Arkansas, Idaho, Illinois, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Wisconsin, and Wyoming.

Meanwhile, the rate of newly reported cases over the past seven days is “going down” in Alabama, which had previously seen elevated case rates.

Six states that have had comparatively low case rates are now seeing those rates “going up,” according to the Times. Those states are Colorado, Massachusetts, New Jersey, New Mexico, Oregon, and Washington.

In the 24 remaining U.S. states and territories, rates of newly reported coronavirus cases are “staying low,” according to the Times‘ analysis.

U.S. officials as of Wednesday morning also reported a total of 205,859 deaths linked to the coronavirus since the country’s epidemic began—up from 204,941 deaths reported as of Tuesday morning.

White House’s role in CDC’s scientific process under media scrutiny

As coronavirus cases and related deaths continue to rise throughout the country, reports have emerged of political interference with CDC’s guidelines, orders, and scientific reports.

For example, the Times on Monday reported that documents and interviews with current and former government officials showed top White House officials had pressured the CDC to downplay the risk of sending children back to school amid the epidemic.

Olivia Troye, one of Vice President Mike Pence’s former top aides on the White House’s coronavirus task force, said that Marc Short, the Pence’s chief of staff, repeatedly asked her and other members of the vice president’s staff to find data that would support the White House’s position on reopening schools—even if that meant going around the CDC.

“I was appalled when I found out that Marc Short was tasking more junior staff in the office of the vice president to develop charts” for White House briefings, Troye said. According to the Times, Troye ultimately left the White House because “the strain was too much for her to do the job.”

In addition, the Times found documents that showed Deborah Birx, the coordinator for the White House’s coronavirus task force, asked CDC Director Robert Redfield to incorporate information from a document developed by HHSSubstance Abuse and Mental Health Services Administration (SAMHSA) into CDC guidelines on reopening schools as background in the guidance’s introduction section. According to the Times, the information from SAMSHA had a less cautious tone than CDC’s draft guidance on children’s risk of infection, stating “very few reports of children being the primary source of Covid-19 transmission among family members have emerged,” and asymptomatic children “are unlikely to spread the virus.”

CDC scientists identified several errors in the document from SAMSHA and raised concerns about incorporating the information into CDC’s guidance because it appeared to minimize the risk the new coronavirus posed to school-aged children, according to an edited version of the document obtained by the Times. CDC in mid-July distributed a copy of its proposed guidance on reopening schools to the White House and other health agencies, but those guidelines were formally rejected.

SAMSHA officials told CDC that the guidance contained “too much information” that was “presented in a negative way,” according to an email obtained by the Times. CDC scientists later updated the guidance, which was then cleared by the White House’s Office of Management and Budget. However, on July 23, hours before the guidelines were set to be published, the White House staff secretary emailed the guidance to top White House officials to ask for any “‘critical edits’ by 1 p.m.,” the Times reports. By the time the guidelines were published to CDC’s website, they contained information that CDC scientists had opposed, including claims that the new coronavirus was less deadly than the flu among children, the Times reports.

Brian Morgenstern, a White House spokesperson, said the coronavirus task force has brought together public health officials “who offer different expertise and views on a variety of issues” concerning policies related to the novel coronavirus. He added, “President Trump relies on the advice of all of his top health officials who agree that it is in the public health interest to safely reopen schools, and that the relative risks posed by the virus to young people are outweighed by the risks of keeping children out of school indefinitely.”

CDC did not immediately respond to the Times‘ request for comments.

Separately, Axios on Tuesday reported that the White House overruled CDC Director Robert Redfield when he pushed to extend CDC’s “no-sail” order for cruise ships until Feb. 15, 2021. Axios attributed the information to two people with direct knowledge of a conversation concerning the order during a meeting in the White House’s Situation Room on Tuesday.

Redfield during the meeting recommended the federal government’s ban on cruise ships, which is scheduled to expire on Wednesday, be extended until February 2021 because of the new coronavirus’ severity and the high probability of transmission on cruises.

However, Axios reports that two members of the coronavirus task force said that Pence, who chaired the meeting, rejected that plan. Instead of following Redfield’s recommendation, the administration now plans to extend the no-sail order for cruise ships until Oct. 31, which coincides with the end of the cruise industry’s self-imposed ban, Axios reports.

A task force member who participated in the meeting said the administration hopes the cruise industry will be able to develop plans to ensure “ships can sail in a safe and responsible manner and that the companies assume the burden of dealing with any possible outbreaks” by the Oct. 31 date.

A White House official said cruise industry representatives are scheduled to meet with the administration on Friday to discuss lifting the government’s “no-sail order” for passenger cruises.

White House deputy press secretary Brian Morgenstern dismissed claims that politics played a role in the administration’s decision. “The president, the vice president and the task force follow the science and data to implement policies that protect the public health and also facilitate the safe reopening of our country,” he said. “It is not about politics. It is about saving lives.”

CDC did not respond to a request for comment on the order, Axios reports.

Former FDA commissioners urge FDA to not politicize vaccine approval

Separately, seven former FDA commissioners in a Washington Post opinion piece published Tuesday urged the White House against politicizing the approval of a coronavirus vaccination.

Former FDA Commissioners Robert Califf, Scott Gottlieb, who serves on the board of Pfizer, Margaret Hamburg, Jane Henney, David Kessler, who is an adviser for former Vice President Joe Biden’s presidential campaign, Mark McClellan, who serves on the board of Johnson & Johnson, and Andy von Eschenbach penned the opinion piece.

“With our country having passed the grim milestone of 200,000 Covid-19 deaths …, the [FDA] might soon face one of its most important decisions in our lifetimes: the authorization of a coronavirus vaccine,” they wrote. “But a safe and effective vaccine will not be enough; people will also have to choose to take it. This depends on widespread confidence that the vaccine approval was based on sound science and not politics. If the White House takes the unprecedented step of trying to tip the scales on how safety and benefits will be judged, the impact on public trust will render an effective vaccine much less so.”

According to the former commissioners, the administration’s actions—including “acts of political influence on the FDA’s coronavirus communications, significant misstatements by the secretary and other political leaders about the benefits of hydroxychloroquine and convalescent plasma, and the overruling of FDA scientists on the regulation of Covid-19 laboratory tests”—are already “eroding the public’s confidence” and putting “at risk … FDA’s ability to make the independent, science-based decisions that are key to combating the pandemic and so much more” (Mazzetti et al., New York Times, 9/28; Swan, Axios, 9/29; Hines, USA Today, 9/29; Califf et al., Washington Post, 9/29; New York Times, 9/30).

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