Last Call For The FDA Goes Viral, Con't

The last shred of independent, objective authority in the Food and Drug Administration has been lit on fire in Health and Human Services Secretary Alex Azar's office trashcan, as the agency is now fully and totally under control of Azar and by default, under control of Donald Trump.

In a stunning declaration of authority, Alex M. Azar II, the secretary of health and human services, this week barred the nation’s health agencies, including the Food and Drug Administration, from signing any new rules regarding the nation’s foods, medicines, medical devices and other products, including vaccines.

Going forward, Mr. Azar wrote in a Sept. 15 memorandum obtained by The New York Times, such power “is reserved to the Secretary.” The bulletin was sent to heads of operating and staff divisions within H.H.S.

It’s unclear if or how the memo would change the vetting and approval process for coronavirus vaccines, three of which are in advanced clinical trials in the United States. Political appointees, under pressure from the president, have taken a string of stepsover the past few months to interfere with the standard scientific and regulatory processes at the health agencies. For example, a much criticized guideline on testing for the coronavirus was not written by C.D.C. scientists, and was posted on the agency’s public website over their objections. It was reversed on Friday.

Outside observers were alarmed by the new memo and worried that it could contribute to a public perception of political meddling in science-based regulatory decisions. Dr. Mark McClellan, who formerly headed the F.D.A. and now runs Duke University’s health policy center, praised the agency’s work on vaccine development but said the policy change was ill-timed.

“We’re in the midst of a pandemic, when trust in the public health agency is needed more than ever,” he said. “So, I’m not sure what is to be gained with a management change with respect to F.D.A. when they are doing such critical work.”

Dr. Peter Lurie, president of the Center for Science in the Public Interest and a former associate commissioner of the F.D.A., called the new policy “a power grab.”

Many rules issued by federal health agencies are signed by lawyers or by the heads of agencies, including the F.D.A., under the umbrella of H.H.S. The new memo requires the secretary to sign them, which Dr. Lurie said could lead to delays in the regulatory process.

“It will introduce an element of inefficiency within government operations that is wholly unnecessary and likely to gum things up,” he said.

Brian Harrison, chief of staff for Mr. Azar, described the new policy as “a housekeeping matter,” aimed at no agency in particular. He said it would have no bearing on how the agency dealt with coronavirus vaccines.

“This was simply pushing a reset button,” Mr. Harrison said. “This is good governance and should have no operational impact.”

The funny part is Brian Harrison is right: this won't have an "operational impact" on the FDA approval process for a COVID-19 or other vaccines going forward because the process was always going to be Azar approving a vaccine to help Trump politically no matter what FDA testing and protocols say.

 I practically guarantee you there will be a vaccine "approved" and distributed to medical personnel before the election. There's going to be a big fight about this and whether or not anyone takes the vaccine, but it will absolutely be announced in late October and will be made available "soon" for widespread use.

That "soon" part will be a lot trickier should Trump win, but the point is Azar and Trump believe it will win him the election. Actually having the vaccine work, well, that will come later.

Last Call For The GOP Goes Viral, Con't

As the Trump Depression becomes more apparent by the day and Trump needs a steady stream of villains to blame for it all, some Republican governors and senators are starting to get, well, pretty sick, of Dr. Anthony Fauci.

Anthony Fauci came to the Senate, virtually, to issue a dire warning against reopening the country too soon amid the deadly coronavirus pandemic. But his message fell flat with some of his intended audience. 

Republicans, led by President Donald Trump, are eager to revive the flailing economy. And resuming commerce at some level this spring and summer is central to the GOP’s message that it can turn around the economy before November. They’re also aiming to do so without adopting House Democrats’ plans for more multi-trillion-dollar stimulus bills. 

But Fauci’s Tuesday testimony clashes with the GOP’s vision, and it’s fueling growing fatigue among Republicans with one of the government’s most trusted public health leaders at a critical moment.

“There’s a spectrum of everything. And I think he’s on the overly cautious end of the spectrum,” Sen. Rand Paul (R-Ky.) said after parrying with Fauci at the hearing. “I don’t think he’s doing it because he’s a bad person, but if we’re overly cautious and we wait until all infectious disease goes away… we’ll wait forever and the country is going to be destroyed.” 

Sen. Mike Braun said Paul's view will be vindicated. 

“When we get this in the rearview mirror and do the dispassionate debrief, Sen. Paul’s going to be closer to right than Fauci,” said the Indiana Republican, who also attended the hearing. “I never did like the idea that you treated the entirety of the country, and even counties within a state, the same way.” 

The nation’s top infectious disease expert testified to the Republican-controlled Senate that there could be “serious” consequences if states open up too early, and he urged them to follow federal guidelines to prevent a second wave of outbreaks. Fauci also downplayed the prospects of a quick vaccine or treatment for the disease this fall. 

Meanwhile, GOP senators and governors in both parties say that lifting stay-at-home orders can be done safely and have begun to crack open a diverse array of states before meeting federal benchmarks. 

Fauci’s testimony comes as House Democrats are preparing to pass a $3 trillion relief bill later this week. But rather than plunge immediately into talks with Speaker Nancy Pelosi, Senate Majority Leader Mitch McConnell (R-Ky.) and his members are banking on the idea that as states reopen, less money will need to come from Washington.

Asked whether Americans should be listening to Fauci’s caution or Trump’s economic-focused optimism, McConnell said they can do both. 

“We can’t spend enough money to prop this economy up forever. People need to be able to begin to be productive again,” McConnell told reporters. 

Fauci has served six presidents and knows how to offer advice in Washington without being thrown overboard. And aside from Paul, few senators took direct shots at him in interviews with a wide array of lawmakers on Tuesday afternoon. 

The director of the National Institute of Allergy and Infectious Diseases has been viewed by both parties as a plain-spoken, commonsense guide during the frightening coronavirus crisis even as Trump himself has oscillated between urging a quick reopening to adopting Fauci’s approach. 

Sen. Lindsey Graham (R-S.C.) called Fauci “the gold standard” and said he will “continue to listen to him.” And Sen. Richard Blumenthal (D-Conn.) said Fauci and other public experts have “spoken truth to power as best they can, obviously with some degree of diplomacy and qualification.” 

Yet as Americans grow weary of isolation, with some states’ shutdowns entering their third month, Paul showed that sentiment is extending toward Fauci himself in some parts of the GOP. 

At one point, Paul questioned Fauci’s methodology on coronavirus’ effects on children and said that he is not “the end all" of decison-making. Fauci responded that he has “never made myself out to be the end all and only voice on this.” 

“He has a very valuable voice in this discussion. He’s got a field of expertise that’s important to hear from,” said Sen. Pat Toomey (R-Pa.). “But it’s only one of many considerations we have to make as a society. Because we have to make trade-offs.”

Senate Republicans and governors don't want to go down with the SS Trumptanic in November, but they are starting to look at maybe Fauci as being a possible fall guy.  At the very least, Fauci still has support of most of DC, but some Senate Republicans are openly signaling that they won't be sad to see him go should Trump cut him loose.

We'll see how long he lasts.  My guess is much like Alex Azar, he won't be around much longer.  Azar has survived one storm at least, but again, Trump will need a constant stream of scapegoats, and November is a long, long way off as far as daily news cycles to be controlled.

Orange Meltdown, Con't

Trump is rolling back on the Traveling Snake Oil™ show from the White House briefing room podium, but this means he has more time for his second-favorite pastime, petty vengeance and scapegoating.

White House officials are weighing a plan to replace Health and Human Services Secretary Alex Azar, according to four people familiar with the discussions.

Among the names on the short list to replace Azar are White House coronavirus coordinator Deborah Birx, Medicare chief Seema Verma and deputy HHS Secretary Eric Hargan, said the four people familiar with the talks.

Senior officials’ long-standing frustrations with the health chief have mounted during the pressure-packed response to the Covid-19 outbreak, with White House aides angry this week about Azar’s handling of the ouster of vaccine expert Rick Bright. At a recent task force meeting, Azar assured Vice President Mike Pence that Bright’s move to the National Institutes of Health was a promotion — only for Bright and his lawyers to release a statement that he would soon file a whistleblower complaint against HHS leadership, blindsiding White House officials, according to three officials familiar with the meeting.

White House officials also have blamed Azar for long-running turmoil at the health department and a series of media reports that portrayed him as urging Trump to act on the Covid-19 outbreak in January, only for the president and his aides to disregard Azar’s warnings as alarmist. Azar has denied the reports, saying that Trump “never once rejected, turned down or dismissed a recommendation” of his or the task force’s.

The White House disputed that officials were considering a plan to replace Azar.

I told you two months ago that Azar was going to be the scapegoat for Trump's failed COVID-19 response.

The Trump regime believes they have this election in the bag already, but they are publicly admitting the scenario where Trump gets crushed by any and every Democrat in November involves a big economic slump brought on by the Wuhan coronavirus.  They're so scared of this happening that they already have their scapegoat trussed and ready for the chopping block: HHS Secretary Alex Azar.

Azar was always going to have his card pulled, but not until the time was right.  After all, these Trump regime subgenii thought they were going to nail this "virus thing" out of the gate, and it was only a problem for them once it became clear that this time their incompetence was going to cost tens, if not hundreds of thousands of lives and trillions of dollars.

The funny thing is despite waiting two months to gank him, Azar's sacrifice probably won't even buy Trump a news cycle.  Not with the daily butcher's bill coming in right now.

Also note that Dr. Fauci has been largely AWOL this week.  That's not an accident.

Until this week, Dr. Anthony Fauci was a near-constant presence at the daily coronavirus task force briefings at the White House. As the head of the National Institute of Allergy and Infectious Diseases for 35 years, his expertise on the global pandemic has been a reassuring force for millions of Americans concerned about how COVID-19 has uprooted their lives.

Of the roughly 50 press conferences on the health crisis so far, Fauci had only missed a handful. But now, for the first time since regular press conferences began on the topic, Fauci was only present for one of seven briefings this week.

While Fauci gave media interviews throughout the week, his absence at the podium was notable given the president’s controversial remarks a day earlier about using light and disinfectants to possibly treat the deadly respiratory illness.

And though Fauci regularly shares his decades-long infectious disease knowledge publicly, one administration official suggested there’s a preference that Fauci do more of that behind closed doors so it doesn’t appear he’s on such a different page from the president.

“You are here in a certain role, you’ve got to give advice privately,” this official said.

And finally, the Trump regime is declaring full-on war against the World Health Organization.

President Trump and his top aides are working behind the scenes to sideline the World Health Organization on several new fronts as they seek to shift blame for the coronavirus pandemic to the world body, according to U.S. and foreign officials involved in the discussions.

Last week, the president announced a 60-day hold on U.S. money to the WHO, but other steps by his top officials go beyond a temporary funding freeze, raising concerns about the permanent weakening of the organization amid a rapidly spreading crisis.

At the State Department, officials are stripping references to the WHO from coronavirus fact sheets, and Secretary of State Mike Pompeo has instructed his employees to “cut out the middle man” when it comes to public health initiatives the United States previously supported through the WHO.

The United States will now attempt to reroute the WHO funds to nongovernment organizations involved in public health issues, according to interviews with U.S. officials and an internal memo obtained by The Washington Post.

“The Secretary has asked the State Department and USAID to identify and utilize alternative implementers for foreign assistance programs beyond the WHO,” read a memo sent to State Department employees in recent days.

At the United Nations Security Council, the Trump administration has delayed a resolution responding to the health crisis, which the French have been trying to advance for weeks, because it disagrees with draft language that expresses support for the WHO, European officials said.

U.S. opposition to the WHO also prevented health ministers at a virtual G-20 meeting from issuing a joint statement on the pandemic earlier this month.

The White House is imploring allies to question the organization’s credibility and push claims that its employees routinely go on excessive “luxury travel,” as one White House official, Sarah Makin Acciani, told a group of surrogates in a recent phone call without offering evidence, a transcript of which has been obtained by The Post.

“It has been impossible to find a common ground with the U.S. about the views on the work and role of WHO,” said a senior European official, who like others spoke on the condition of anonymity to describe diplomatic discussions.

WHO officials initially hoped they could stave off a halt in U.S. funding and a messy public confrontation by making a symbolic concession to Trump, but discussions between the organization and the U.S. ambassador to the WHO, Andrew Bremberg, failed to ease tensions. 

Azar's toast, Fauci is on his way out, and the WHO is being systematically dismantled.

Damn shame, that is.  On several levels.

Orange Meltdown, Con't

Last night, Donald Trump replaced Acting WH Chief of Staff Mick Mulvaney with retiring GOP Rep. Mark Meadows.

President Donald Trump announced late Friday that he was replacing his acting White House chief of staff, Mick Mulvaney, with Republican Rep. Mark Meadows of North Carolina, a shake-up in the top echelons of the West Wing just as the President confronts a growing public health crisis and girds for reelection. 

Meadows, who had previously announced he was leaving Congress, will become Trump's fourth chief of staff in a little more than three years in office. In a tweet, Trump did not denote him "acting," a designation Mulvaney never graduated from in the turbulent 14 months he spent in the job. 

"I am pleased to announce that Congressman Mark Meadows will become White House Chief of Staff. I have long known and worked with Mark, and the relationship is a very good one," Trump tweeted Friday just after arriving at his Mar-a-Lago estate in Florida. 

Trump, who did not immediately offer an explanation for the swap, thanked Mulvaney and said he said would become special envoy for Northern Ireland. 

"I want to thank Acting Chief Mick Mulvaney for having served the Administration so well. He will become the United States Special Envoy for Northern Ireland," Trump added. "Thank you!" 

It was an abrupt announcement of news that had been anticipated for weeks. It continues a churn of staffing changes that followed Trump's impeachment acquittal a month ago. 

Trump offered the position to Meadows on Thursday, people familiar with the matter said. Mulvaney was on a personal trip and not at work Friday, two officials said. Some staffers found it odd that the acting chief of staff would leave Washington during such a critical time while the administration is dealing with the coronavirus crisis. 

But Mulvaney also did not attend several of Trump's recent trips -- including a campaign swing in the Western United States and his state visit to India -- which is a pattern his predecessors also followed before they were dismissed. 

Though Mulvaney had been a fixture of Trump's administration in various roles over the past three years, the President effectively lost confidence in him months ago, a combination of personality conflicts and frustration at his handling of the impeachment ordeal. 

Trump, who had considered dismissing Mulvaney at various junctures, was convinced not to act by close aides, who argued that a leadership change in the White House during impeachment could cause unnecessary chaos.

Booting Mulvaney out to be envoy to Northern Ireland isn't firing him, but it's close.  Firing him of course would mean he's no longer protected by executive privilege should Dems get the wild idea to subpoena Mulvaney again.

I figured Mulvaney would be the scapegoat for COVID-19, but apparently Trump has Alex Azar in mind still for that one, so we'll see what happens with Mark Meadows, the fourth WH Chief of Staff in three years.

Rand Paul Goes Viral

As usual, Republican glibertarian asshole Rand Paul has decided that being the lone vote against anything that would actually prove the federal government should help people in a time of national crisis by voting against a coronavirus emergency funding package in the Senate yesterday will somehow endear him to the people here in Kentucky.

Kentucky Sen. Rand Paul voted against an emergency response coronavirus bill Thursday afternoon after his proposed amendment to the bill was turned down.

The bill had already received more than 60 affirmative votes, which was more than it needed to pass, when Paul voted against it. The bill passed 96-1.

"Earlier today on the Senate floor, I said that while I support an all-hands-on-deck response to the coronavirus, we should cut out waste and take money from less urgent spending, such as what we are wasting overseas, to put into that response effort," Paul said in a statement after his vote. "We don’t have to borrow more money. We just have to start setting our own priorities."

We can't afford coronavirus testing because GOP tax cuts, which Rand Paul voted for, knowing they would cost the federal government trillions in revenue.  I'm sure that will help.

The U.S. Senate voted earlier Thursday to table an amendment from Paul after the junior senator from Kentucky threatened to hold up the legislation if his amendment did not receive a vote.

The House of Representatives voted overwhelmingly to approve $8.3 billion in emergency aid Wednesday to combat the novel coronavirus, which has caused 11 deaths in the United States so far.

Before a scheduled Thursday afternoon vote on the bill, Paul put forth the amendment, which proposed cuts to State Department Cultural Exchange programs and reduces funding for the United States Agency for International Development, among other things.

The amendment died screaming, but Paul continues to remain in office. If Amy McGrath can't beat Mitch in November, I sincerely hope she goes for Paul's seat in 2022.

Meanwhile in DC, the Trump regime's response continues to be bafflingly inadequate and incompetent to the point of venality.

There will be a notable omission when Vice President Mike Pence visits Washington state Thursday as part of the Trump administration's coronavirus response: health Secretary Alex Azar.

The White House on Wednesday also benched Azar from a coronavirus task force press briefing, the latest sign of diminished standing for an official who was the face of the U.S. response to the disease just a week ago.

Four of Azar’s deputies — including Medicare chief Seema Verma and Food and Drug Administration Commissioner Steve Hahn, who were both added to the task force after Pence took over the federal response — joined the vice president and other officials at the White House on Wednesday.

Azar's absence didn't go unnoticed by allies worried about his standing in the administration and the way he's catching more flak for missteps. Azar was front and center Thursday at a Capitol Hill briefing with House members, during which he took heat from some lawmakers over transparency and whether his department is adequately prepared for the stealthy disease.

Asked why Azar didn’t attend Wednesday's televised briefing, a Pence spokesperson said that Azar left for his office after the task force meeting, and officials wanted to make room on stage for Ben Carson, the Housing and Urban Development secretary and also a task force member. A spokesperson for Azar said that members of the task force will be “rotating through as necessary” now that the group is doing daily briefings.

Azar is being kept on until he can take the maximum amount of blame for the failed response, and everyone knows it.  It won't be long until the epidemic phase kicks in, end of the month at best.  April is going to be a nightmare.

And again, Trump is in charge.

Trump Goes Viral

The Trump regime believes they have this election in the bag already, but they are publicly admitting the scenario where Trump gets crushed by any and every Democrat in November involves a big economic slump brought on by the Wuhan coronavirus.  They're so scared of this happening that they already have their scapegoat trussed and ready for the chopping block: HHS Secretary Alex Azar. 

Trump himself took a break from his two-day trip to India to weigh in on coronavirus, tweeting that the virus was under control in the United States. “We are in contact with everyone and all relevant countries. CDC & World Health have been working hard and very smart. Stock Market starting to look very good to me!” he wrote late Monday afternoon.

But inside the White House, officials have been quietly studying models of the pandemic’s potential effect on both the U.S. and the global economy, said one Republican close to the White House. Among policy aides, there‘s widespread concern that the spread of the coronavirus will hit a slew of industries including manufacturers, airlines, automakers and tech companies, slowing down both the U.S. and Chinese economies. Aides fear the White House has few economic tricks it can deploy to lessen the impact.

Meanwhile, officials like acting chief of staff Mick Mulvaney and domestic policy chief Joe Grogan have turned their fire on HHS Secretary Alex Azar, who’s leading the coronavirus response, arguing that Azar has poorly coordinated the strategy, failed to escalate the potential risks to Trump and pushed for a multibillion-dollar emergency-funding request that they initially viewed as extreme, said four individuals familiar with the matter.The Trump administration on Monday night announced a request for $2.5 billion in emergency coronavirus cash, which would also shift at least $535 million in previously committed funds.

Funding the response had been a major sticking point between the White House and Azar, who lobbied to request additional funds from Congress before he makes four separate hearings on the Hill this week. Officials had spent days jockeying over the final figure for the emergency package, veering anywhere between $1 billion to $5 billion. The package also is expected to face resistance from Democrats, who have warned the Trump administration against shifting money away from existing commitments.

The White House and HHS both maintained that the task force is working in tandem and defended Azar’s leadership.

“There is zero disagreement between HHS, [National Security Council], the White House, and other members of the task force,” Mulvaney said in a statement. “Secretary Azar is the right person to lead this effort, and any reporting to the contrary is just false.”

"OMB and HHS have been in lockstep throughout this entire process," said Derek Kan, a top White House budget deputy who's also working on coronavirus efforts. An HHS spokesperson denied that the White House and Azar had disagreed over the emergency-funding request.

But the pressure-packed coronavirus fight has reopened year-old cracks between the White House and Azar, who has few allies in the White House and was seen as weakened by his own recent feud with Medicare chief Seema Verma. Two of Azar’s allies said they worried that the secretary’s job is at risk if the coronavirus response goes poorly.

Administration officials also have traded blame over the evacuation of 14 Americans from a cruise ship who were confirmed to have coronavirus, fueled by Trump’s anger over the episode. The decision to evacuate the Americans — who were placed on a plane with other Americans, over the objections from the Centers for Disease Control and Prevention — has sparked finger-pointing and second-guessing for days. Japanese officials didn’t inform their U.S. counterparts that the 14 had tested positive until they were already aboard buses with the other American cruise ship passengers heading for the airport.

Some officials worry that the U.S. is missing potential coronavirus infections of its own, especially as clusters of cases emerge in countries like Iran, prompting that nation's neighbors Turkey, Pakistan and Armenia to close their borders. The U.S. surveillance effort has been hampered by the failure of the health department’s tests, with public health labs on Monday asking for permission to use their own homegrown tests rather than wait on the CDC.

“If we have an outbreak in the United States and didn’t pick it up, that’s going to be a public health mistake of historic proportion,” said a former senior HHS official.

How competent do you think the Trump regime will be at handling something that can't be blocked by Mitch McConnell or shouted down by FOX News state TV or Rush Limbaugh?  Something that Trump can't intimidate on Twitter or threaten with his lawyers?

Oh, I imagine the Trump regime will botch the inevitable US outbreak badly.  Unfortunately it's going to be deadly when it happens.