Trump suggests FDA slowing vaccine trials
Worldwide virus deaths pass 800,000
The world hit a grim coronavirus milestone Saturday by topping 800,000 confirmed deaths and more than 23 million confirmed cases, according to a tally kept by Johns Hopkins University.
Meanwhile, President Donald Trump criticized the Food and Drug Administration, suggesting that employees at the agency are attempting to sabotage his reelection by slowing down coronavirus research.
In a tweet, Trump said members of “the deep state” at the FDA are making it hard for drug companies to “get people in order to test the vaccines and therapeutics” and “obviously” want to delay progress until after Nov. 3, Election Day. He tagged FDA Commissioner Stephen Hahn, appointed by Trump in 2019, in the tweet.
The “deep state” is a term used by Trump and others to describe employees of government agencies they believe are manipulating policy to work against the country’s interests.
Trump’s comments Saturday follow a gradual buildup of criticism aimed at the agency over the course of the pandemic.
Last week, Trump suggested that health and science officials inside the administration were delaying an emergency measure to
expand access to blood plasma from covid-19 survivors as a treatment.
And for months, Trump has touted what he claims are the benefits of the malaria drug hydroxychloroquine — including criticism of the FDA after the agency revoked a measure encouraging the drug’s use.
The FDA didn’t immediately respond to a request for comment on Trump’s remarks.
House Speaker Nancy Pelosi, D-Calif., in remarks on Saturday said Saturday’s tweet “was a very dangerous statement on the part of the president.”
An effective vaccine is considered pivotal to ending the pandemic. It would provide protection from the virus to healthy people, allowing them to go back to work, go to restaurants, return to school and resume most aspects of normal life. To speed development, the White House started Operation Warp Speed, signing agreements with drugmakers worth more than $4 billion.
In the U.S., health officials believe there may be 10 times more cases than the confirmed 5.6 million. The U.S. also leads the world in deaths, with more than 176,000 as of Saturday.
VACCINE TESTING
The drug industry has embarked on what’s likely the most ambitious research and development effort in its history. The biggest drugmakers in the world, as well as a number of innovative biotechnology companies, have developed vaccine candidates in record time and are putting them into human trials. Thirty vaccines are now in human testing, according to a Thursday summary by the World Health Organization.
The FDA, too, has been moving far faster than normal. The agency has tentatively scheduled an Oct. 22 meeting to consider a potential vaccine, and health officials across government are working on guidelines for who would first get any vaccine and how it would be distributed.
Any shot likely would be used first in a narrow group of high-risk people, like health workers, before being rolled out to the public in phases next year. But that timeline is still a fraction of the years it typically takes to develop, test and review a new inoculation.
Hahn has, in public, walked a line of deference to Trump while occasionally pushing back against some of the president’s claims. After Trump suggested in April that chemical disinfectant could be used to clean the virus from people, Hahn said that Americans shouldn’t ingest or inject bleach. But he’s declined to remark on some comments Trump has made, such as saying in July that 99% of all virus cases are “totally harmless.”
One of the leading vaccines is being developed by New York’s Pfizer Inc. The company’s trial has been enrolling patients rapidly, with more than 9,000 volunteers as of Wednesday, according to Philip Dormitzer, Pfizer’s vice president of viral vaccine research.
“Things are going very quickly,” Dormitzer said earlier this month. “We remain on target” to have results ready to submit to regulators in October. Another vaccine, being developed by Moderna Inc., has enrolled about 13,000 people in its 30,000-person trial. The company is “on track” to complete enrollment in September, said Moderna spokeswoman Colleen Hussey.
“We have no comment on the tweet,” said Hussey. Pfizer didn’t immediately respond to a request for comment.
MEDICINE AND POLITICS
Saturday’s Twitter message from Trump was the latest in a growing drumbeat from the president aimed at his health agencies.
Last week, Trump suggested the delay in an emergency measure supporting blood plasma was a political one.
“I hear great things about it, that’s all I can tell you,” Trump said at a White House news conference Wednesday, talking about blood plasma. “It could be a political decision because you have a lot of people over there that don’t want to rush things because they want to do it after Nov. 3.”
And while some in the medical community have, in general, lost interest in hydroxychloroquine as a treatment for the virus after some trials failed to show that it works, Trump pointed out Saturday that there is still some support for it.
Reacting to the FDA’s months-old decision in June to revoke its emergency backing of the drug, Trump tweeted that “Many doctors and studies disagree with this!”
While Trump’s tweets are likely the most public recent efforts by a president to influence the FDA, the agency has never been immune from political pressure.
“One of Commissioner’s jobs is to protect this critical independence of judgement of the Center Directors and their staffs. It is naive to believe that politics aren’t part of the picture — both Dems and Reps,” former FDA Commissioner Robert Califf said Saturday in a tweet. Califf served in the Obama administration in 2016 and 2017.
In 2011, for example, the Obama administration’s top health official overruled the agency, and said that the “morning after” birth control pill should be available to teens without a prescription.
‘LISTEN TO THE SCIENTISTS’
Meanwhile, the Democratic nominee for president, Joe Biden, said he would listen to government scientists on the coronavirus — even if it means shutting the country down.
“I would be prepared to do whatever it takes to save lives, because we cannot get the country moving until we control the virus. That is the fundamental flaw of this administration’s thinking to begin with,” the former vice president told ABC News on Friday. “I would shut it down. I would listen to the scientists.”
Trump has urged state and local governments to ease virus-related restrictions on schools and businesses in order to boost the economy. In other developments: ■ More cases of coronavirus have been traced to a recent wedding reception in Maine. Health officials say 53 cases have been linked to the Aug. 7 reception in Millinocket.
A hospital said one person associated with the outbreak has died. The reception at the Big Moose Inn exceeded the state’s indoor gathering limit, among other violations of state rules. About 65 people attended the event. The limit was 50.
Thirty-two new cases and one additional death were announced Saturday by the Maine Center for Disease Control and Prevention. Maine has reached nearly 4,320 cases and 131 deaths.
■ A Middleton, Wis., coffee shop has lost its lease after violating Dane County’s mask mandate. The Wisconsin State Journal reported that Helbachs Coffee Roasters and Kitchen will close on Aug. 31.
The shop said in an Instagram post Thursday that its landlord has refused to renew its lease, and the decision to close comes on the heels of “enforcement action, negative public statements and continued vindictive and hostile behavior” by county health officials toward the shop.
Health authorities issued the shop three citations for violating the order. The shop was facing revocation of its food and drink license because of its refusal to abide by the order.
The shop responded with a lawsuit, declaring itself “a mask-free zone.”
FLORIDA CRISIS
Florida recorded 4,300 new cases and 106 coronavirus deaths on Saturday.
The state is registering an average of 156 coronavirus deaths per day this month, which likely makes covid-19 the state’s No. 1 killer during that period. Cancer and heart disease each average about 125 deaths per day, according to the Florida Department of Health.
The number of new cases continues a downward trend from more than 10,000 cases per day a month ago. During the past week, the state’s positivity rate on tests has been 10.8%.
Hospitalizations from covid-19 have been declining. On Saturday, 4,773 patients were treated for the disease in Florida hospitals compared with Friday’s 4,909 and Thursday’s 5,340. That number has fallen from a peak above 9,500 on July 23.
Overall, the state has nearly 600,000 confirmed cases since March 1 and 10,410 deaths.
The Arizona Department of Health Services reported 996 new cases and 68 confirmed coronavirus deaths on Saturday.
That increased the state’s totals to 197,895 cases and 4,756 deaths, as reports of infections and deaths continued to slow.
The coronavirus hospitalization numbers from the health department showed a downward trend, posting levels from late May and early June before Arizona became a national hot spot. New case and death reports have dropped since mid-July.
The seven-day rolling average of new daily cases dropped from 1,578 on Aug. 7 to 740 on Aug. 21. The rolling average of deaths per day dropped from 55 to 38.
In Washington, state health officials say more than 30 coronavirus cases have been reported in an outbreak at a Bremerton hospital.
The state health department said the outbreak has affected several units at St. Michael Medical Center, which is part of the CHI Franciscan system. Officials say the outbreak involves hospital staff and employees.
VACATIONERS INFECTED
Elsewhere, vacationers returning to the Italian mainland from Sardinia helped push Italy’s daily new coronavirus caseload far past 1,000 on Saturday, reaching the high for the first time since early May.
Confirmed cases increased from 947 on Friday to 1,071 on Saturday, with many infections confirmed in travelers who were tested as they disembarked from airplanes or ferries.
While the average age of the infected early in the outbreak hovered near 70, it’s now 30.
Italy has more than 258,000 confirmed cases. With three more deaths, the known total has reached 35,400.
South Korea, once considered a coronavirus success story, banned large gatherings, shut nightspots and churches and banned fans from professional sports to slow a viral resurgence.
Germany, which also initially slowed the virus, reported a four-month high of more than 2,000 cases on Saturday. Schools there reopened two weeks ago, and at least 41 schools last week reported students or teachers were infected.
India recorded nearly 70,000 new coronavirus infections as the disease spreads across the country’s southern states after plateauing in the capital and the financial center of Mumbai.
India’s Health Ministry reported 69,878 new cases on Saturday, raising the total to 2,975,701. Globally India has been reporting the biggest daily rise in cases for 18 consecutive days.