WTF Community

🤮 Coronavirus (Community Thread)


So looking at this and thinking - Maybe this may be the fastest way for many journalists to be able to get a test.

(David Bythewood) #648

In a report published last summer, the Federal Emergency Management Agency (FEMA) warned that a nationwide pandemic would result in a shortage of medical supplies, hospitals would be overwhelmed and the economy would shut down.

(David Bythewood) #649

This is Trump’s doing. This was caused by his mad flooding of the airports in his botched travel ban.

The state of New York ON ITS OWN now leads every country in COVID-19 cases


Comments relating to today’s WH Presser with T, Pence - Fauci and Birx, and we want the last two to be the most reliable, the scientists…
But when you want a fact…everything seems negotiable.


This is where the stupids won…

Gov DeSantis (R-FL) discusses who is really affected by COVID-19 and says that no children have been affected. He wants children back in school for 2 weeks.


Among those with available information, 73% of pediatric patients had symptoms of fever, cough, or shortness of breath compared with 93% of adults aged 18–64 years during the same period; 5.7% of all pediatric patients, or 20% of those for whom hospitalization status was known, were hospitalized, lower than the percentages hospitalized among all adults aged 18–64 years (10%) or those with known hospitalization status (33%). Three deaths were reported among the pediatric cases included in this analysis. These data support previous findings that children with COVID-19 might not have reported fever or cough as often as do adults


:question:Should I start another tracking thread for the impending Congressional oversight, like I did for impeachment? House Speaker Pelosi has spoken about a special committee… I have the time again? What should I call it? I think I can make it even better this time, practice does make perfect.

Update: I think I will wait until a special committee is created and then title it after the committee.

(David Bythewood) #653

Trump Donor & 5-time winner of “Sounds Like A Sopranos Character” Award Joe Pizza, whose wife was serenaded by Trump at Mar-a-Lago, runs a pharmaceutical company that sells hydroxychloroquine sulfate, the primary active ingredient of Plaquenil.


Putting this here…it is a beautiful story and has a good ending.

Halleh Akbarnia

April 7 at 10:50 AM

I have been an Emergency Medicine Physician for almost 20 years. I have worked through numerous disasters, and I’m used to the daily grind of heart attacks, gunshots, strokes, flu, traumas, and more. It’s par for the course in my field. Yet nothing has made me feel the way I do about my “job” as this pandemic has—that knot-in-the-pit–of-your-stomach sensation while heading into work, comforted only by the empathetic faces of my colleagues who are going through the same. I am grateful for their presence, knowing they are both literally and figuratively with me, that they understand and accept so profoundly the risks we take each day. I also hope that my friends and family forgive me for my lack of presence during this time—precisely when we need each other most—and that they realize that their words, their encouragement, and their small gestures that come my way daily are the fuel that gets me through each day. This is a story for all of us.

I met my patient, Mr. C., on my first real “pandemic” shift, when what we were seeing that day was what we had been preparing for. He was classic in his presentation, his X-ray findings, his low oxygen levels… we just knew. And he was the nicest man I had met in a long time. Gasping for breath, he kept asking if we needed anything, and that it would all be okay. He told us he was a teacher but that he was learning so much from us, and how much he respected what we were doing. The opposite could not be more true.

We had to decide how long we would try to let him work through this low oxygen state before needing to intubate him. His levels kept falling and despite all our best efforts it was time to put him on the ventilator. He told us he didn’t feel great about this, “but Doc, I trust you and am putting myself in your hands.” That uneasy feeling in my stomach grew even more in that moment. But he, with his teacher’s steady voice, kept me grounded, where I was supposed to be. I saw his eyes looking at me, seeing the kindness in them, even as we pushed the medications to put him to sleep. To say this was an “easy” intubation is an understatement. It was not. He nearly left us a few times during those first minutes, but he kept coming back. We fought hard to keep him with us. The patience and strength of my team that day, truly remarkable.

I handed him over to my friend and colleague, Dr. Beth Ginsburg, and her team in the ICU, and her calming voice reassured me that they had it from here. And then for the next twelve days, I waited and watched his progress, knowing the statistics, and how sick he was when he got to us. They did their magic, and just yesterday my new friend Mr. C was extubated. I decided to go “meet” him again.

Mr C. was in the COVID stepdown unit, recovering, without family. Nobody was allowed to visit him; even worse, his wife had been home alone in isolation for the past fourteen days, too. My heart broke thinking of how that must have been for her. I cautiously went into his room, donned in my PPE, and when he saw me, he stopped for a second. A moment of recognition.

I introduced myself. “I’m Dr. Akbarnia, Mr. C. I was the last person you saw in the ER. You told me you trusted us to get you to this side. Looks like you did just fine.” He started to cry. He said, “I remember your eyes.” And I started to cry. What he didn’t know is that, at that moment, I realized that we do what we do exactly for people like him, for moments like these. His strength, his kindness, his calming words to me meant everything. At that moment, my heart (which had been beating over 100 bpm since this pandemic began) finally slowed down.

I sat down and we talked. I told him that while he is here, we are his family. He will always have a place in my heart. And whether he knows it or not, he will be my silent warrior and guide as I take care of every patient, COVID or not. He will fuel me until the day I hang up my stethoscope.

(Picture and story posted with full permission from patient)

ETA: I was asked if this can be shared. Please do.


Confirming the stupid…

Florida Gov. Ron DeSantis falsely claimed Thursday that the novel coronavirus hasn’t killed anyone under 25 nationwide while discussing a timeline for reopening schools in the state.

“This particular pandemic is one where, I don’t think nationwide there’s been a single fatality under 25. For whatever reason it just doesn’t seem to threaten, you know, kids,” DeSantis said at an educators’ meeting to discuss distance learning.

“And we lose in Florida between five and 10 kids a year for the flu. This one, for whatever reason, much more dangerous if you’re 65 and plus than the flu, no doubt about that, if you’re younger it just hasn’t had an impact. So that should factor into how we’re viewing this.”

“I think the data on that has been 100% consistent,” he continued. “I’ve not seen any deviation on that.”

In reality, the CDC reports on its website that four people between the ages of 15 and 24 and one person between the ages of one and four have died. CNN has also reported on the death of a newborn in Connecticut on April 1 and an infant in Illinois last month whose death is being investigated as possibly caused by the virus.

(Lynn) #656

Face it…the GOP knows better, but they just don’t care! Only about money & power…trump has taken their souls -or perhaps they had none to lose, it just wasn’t so obvious before?

Why else would they insist that people vote IN PERSON despite serious health risks? Only because they want more people to catch COVID-19 & die, right? What’s up with that? WTF! :face_with_symbols_over_mouth:

(David Bythewood) #657

Why Does the President Keep Pushing a Malaria Drug?

What is actually known about hydroxychloroquine, the medication that Trump is fixated on recommending for COVID-19

Two weeks ago, French doctors published a provocative observation in a microbiology journal. In the absence of a known treatment for COVID-19, the doctors had taken to experimentation with a potent drug known as hydroxychloroquine. For decades, the drug has been used to treat malaria—which is caused by a parasite, not a virus. In six patients with COVID-19, the doctors combined hydroxychloroquine with azithromycin (known to many as “Z-Pak,” an antibiotic that kills bacteria, not viruses) and reported that after six days of this regimen, all six people tested negative for the virus.

The report caught the eye of the celebrity doctor Mehmet Oz, who has since appeared on Fox News to talk about hydroxychloroquine 21 times. As Oz put it to Sean Hannity, “This French doctor, [Didier] Raoult, a very famous infectious-disease specialist, had done some interesting work at a pilot study showing that he could get rid of the virus in six days in 100 percent of the patients he treated.” Raoult has made news in recent years as a pan-disciplinary provocateur; he has questioned climate change and Darwinian evolution. On January 21, at the height of the coronavirus outbreak in China, Raoult said in a YouTube video, “The fact that people have died of coronavirus in China, you know, I don’t feel very concerned.” Last week, Oz, who has been advising the president on the coronavirus, described Raoult to Hannity as “very impressive.” Oz told Hannity that he had informed the White House as much.
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Anthony Fauci is not among the impressed. The day the study came out, Fauci, the leading infectious-disease expert advising the White House’s coronavirus task force, downplayed the findings as “anecdotal.” The report was not a randomized clinical trial—one in which many people are followed to see how their health fares, not simply whether a virus is detectable. And Oz’s “100 percent” interpretation involves conspicuous omissions. According to the study itself, three other patients who received hydroxychloroquine were too sick to be tested for the virus by day six (they were intubated in the ICU). Another had a bad reaction to the drug and stopped taking it. Another was not tested because, by day six, he had died.

Nonetheless, the day after Raoult’s study was published, Donald Trump tweeted about it: “HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to be one of the biggest game changers in the history of medicine.” In the days since, Trump has repeatedly returned to this claim. On Saturday, he said that the term game changer wouldn’t even adequately describe the drug: “It will be wonderful. It will be so beautiful. It will be a gift from heaven, if it works.” After downplaying the value of ventilators and social distancing, measures that experts overwhelmingly agree are needed to overcome the virus, Trump said the country would procure 29 million doses of hydroxychloroquine for a national stockpile. He said he may start taking the drug himself.

Over the course of these two weeks, the president of the United States has become the world’s most prominent peddler of medical misinformation. While some very early evidence has shown that hydroxychloroquine may influence the course of COVID-19, Trump is overriding his top medical adviser and minimizing serious risks by encouraging Americans to try the drug right now. This brazen dispensation of medical advice from the president is dangerous in ways beyond the potential harm of the drug itself. A time of strict directives for personal behavior and hygiene requires tremendous trust in those giving the directives—and understanding the reality that this is a disease without a miracle cure. But instead of inspiring trust, Trump has pivoted from downplaying the number of cases in the United States to the extremely effective trick of quack medical providers: hyping an unproven treatment that entices desperate people with false confidence and confusing messaging.

It is unclear how hydroxychloroquine would work to treat COVID-19, but the drug is one of many now being urgently studied for the treatment of the disease. The drugs being tested include those that could block viral replication, such as remdesivir, and others that may target the way the virus binds to human cells. Still other drugs aim to modulate a person’s immune response, among them a class of drugs known as IL-6 inhibitors. Hydroxychloroquine has the theoretical potential to affect the virus itself or the immune response. In addition to treating malaria, hydroxychloroquine is important in the treatment of autoimmune diseases such as rheumatoid arthritis and lupus. In those specific conditions, the drug effectively serves to subdue an overactive immune response.

Slowing the immune system too far, though, could make people more susceptible to infection. Other drugs that suppress inflammation—steroids and ibuprofen—initially generated some enthusiasm as methods of controlling the immune response in COVID-19. They have since shown mixed results and are not widely recommended. Even in people without the disease, hydroxychloroquine’s potentially harmful effects range from vomiting and headaches to instances of psychosis, loss of vision, and even sudden cardiac death. The drug is to be used with caution in people with heart conditions and liver dysfunctionboth of which the coronavirus can itself cause.

Based on the limited evidence so far, giving hydroxychloroquine to people could very well be—as with most drugs that modulate the immune system—of some benefit in some circumstances. Some people will be made sicker by it, depending on underlying physiology, other medications they’re taking, timing, and dosing. Identifying who stands to benefit and why requires data, and several randomized controlled studies of hydroxychloroquine are under way.

But Trump has plunged ahead. On March 28, amid his constant enthusiasm, the FDA issued an emergency authorization allowing the use of hydroxychloroquine for treatment of COVID-19. Even still, the agency urged that the drug should be given only to patients “for whom a clinical trial is not available, or participation is not feasible.”

Some hospitals in the U.S., including Massachusetts General Hospital, have begun incorporating hydroxychloroquine into treatment protocols, at the discretion of an infectious-disease specialist. Other institutions are more guarded. At the University of Washington, doctors are advised in official treatment policy that although the drug has been shown to inhibit replication of the virus in cultures of monkey kidney cells, “it has not been shown to be an effective antiviral” in living organisms. The University of Michigan Medical School advises its doctors that “the current body of literature and local experience does not support the routine use of any specific treatment regimen, including hydroxychloroquine, for patients with confirmed COVID-19 infection.”

Conclusions like these draw on the fact that the body of evidence remains small, and the results are mixed. A randomized trial of 30 patients with COVID-19 in Shanghai found no difference in detectable virus at day seven, with or without hydroxychloroquine. Another recent study suggested that the drug may help with COVID-19 symptoms, including coughing and fever, but it included only 62 people with mild cases of the disease, and excluded anyone with conditions that could be exacerbated by hydroxychloroquine. In mid-March, Italian and Israeli researchers concluded that there were sufficient grounds to continue doing research with the drug, but that any use should be closely monitored. The scientists advised against widely unleashing yet another medical variable during the pandemic.

In the U.S., Fauci continues to hold the same line as the rest of the medical community—cautious optimism, with a close eye on the many ongoing clinical trials. Trump, meanwhile, escalates as a peddler. “What do you have to lose?” the president said in a press conference on Saturday. “I’ll say it again: What do you have to lose? Take it. I really think they should take it. But it’s their choice. And it’s their doctor’s choice, or the doctors in the hospital.” At a briefing yesterday, he intercepted a question for Fauci about hydroxychloroquine and told the reporter that the doctor wouldn’t be answering it.

What do you have to lose? is a dark sentiment from a president managing a crisis that his administration failed to prepare for: It failed to develop testing, failed to communicate, and failed to have enough face masks for doctors. There is, in fact, much to lose. Americans also need hydroxychloroquine to treat serious immune conditions and parasitic diseases. Since Trump began promoting the drug, people have been hoarding it, and it has been added to the growing list of drug shortages. Two weeks ago, in an attempt to procure some, an Arizona couple ingested chloroquine, which is meant to be used in fish tanks. The man died.

In such moments, the appeal of any treatment that could offer a glimmer of hope is understandable. But even if hydroxychloroquine eventually proves to be safe and useful to some people with the disease, touting it constantly distracts from the immediate needs of the crisis. Now is not a time to abandon the tried and true systems that keep people safe and create order. It’s a time to double down on the systems developed over decades to help us find the best treatments for diseases, and make sure that they are safe and effective. What do you have to lose? follows the logic of removing stop signs because they might slow people trying to get to the hospital.

In his capricious responses to this pandemic, Trump has given little indication that he respects, or even comprehends, the reasons for the scientific process. Hydroxychloroquine could end up as part of the treatment approach that one day saves lives. Outside of a proper testing process and clear messaging, it could cost lives. Addressing a world in a collective state of despair, Trump offers exaggerated hope and endangers people as he rambles.

On Saturday, Trump suggested research exists that shows people with lupus don’t get the coronavirus, implying that their use of hydroxychloroquine protects them. “There’s a rumor out there that because it takes care of lupus very effectively, as I understand it, and it’s a, you know, a drug that’s used for lupus,” he said, “so there’s a study out there that says people that have lupus haven’t been catching this virus. Maybe it’s true; maybe it’s not.”

There is no such study.

Article Summary: Jan. 21st: “The fact that people have died of coronavirus in China, you know, I don’t feel very concerned.”

That is a quote from Dr. Didier Raoult, the French doctor who pushed hydroxychloroquine. He is also a climate change and evolution denier.

Raoult is a quack, who got a bigger quack, “Dr.” Oz, to push this drug to Sean Hannity, and on up to Trump, the biggest quack of all, who recently claimed a study shows lupus patients taking hydroxychloroquine don’t get coronavirus. There is no such study.

(David Bythewood) #658

And we have a mass grave now.

And this:


And the numbers bear out, that Captain Crozier’s warning as to the dire situation aboard the USS Theodore Roosevelt were true. Without some kind of quarantine, the sailors were ALL subject to getting the virus. Now there are 416 crew members who post positive for Coronavirus.

The U.S. Navy confirmed Thursday that 416 crew members onboard the USS Theodore Roosevelt, a U.S. Navy aircraft carrier docked in Guam, have now tested positive for the coronavirus. The number of confirmed cases jumped by 130 people in one day with more than 1,000 tests still pending.

On Wednesday, the Navy released a statement that said 93% of the crew had been tested for COVID-19, the disease caused by the coronavirus, resulting in 2,588 negative and 286 positive results. Over 2,000 sailors on the ship were subsequently moved to a base on the island, which is a U.S. territory.

The situation on board the USS Theodore Roosevelt first gained attention after its captain, Brett Crozier, went outside his chain of command and sent a memo to more than 20 people pleading for help, and describing the carrier’s dire conditions — when only dozens of sailors had tested positive. That memo quickly made its way to The San Francisco Chronicle, which first reported the story on March 31.

In his memo, Crozier suggested that most of the 4,000 crew members on board should be removed from the ship and put into 14-day individual quarantines, in keeping with the CDC’s recommended guidelines for preventing infection. “We are not at war. Sailors do not need to die,” he wrote. “If we do not act now, we are failing to take care of our most trusted asset — our Sailors.”

The situation on board the USS Theodore Roosevelt first gained attention after its captain, Brett Crozier, went outside his chain of command and sent a memo to more than 20 people pleading for help, and describing the carrier’s dire conditions — when only dozens of sailors had tested positive. That memo quickly made its way to The San Francisco Chronicle, which first reported the story on March 31.

In his memo, Crozier suggested that most of the 4,000 crew members on board should be removed from the ship and put into 14-day individual quarantines, in keeping with the CDC’s recommended guidelines for preventing infection. “We are not at war. Sailors do not need to die,” he wrote. “If we do not act now, we are failing to take care of our most trusted asset — our Sailors.”

Crozier was later relieved of his command by the Navy. Acting secretary of the Navy, Thomas Modly, said he fired Crozier after losing confidence in his ability to lead under the stress of dealing with the viral outbreak. Modly went on to harshly criticize Crozier in front of his crew.
thx @rusticgorilla

And really…it does matter about the safety of naval crew…way beyond rank, as seen in this reversal posted in today’s WTFJHT am recap. WTF


This is an example of how out-of-whack the for-profit hospital systems can exasperate all of us, with these large medical staffing operations bilking the government and misappropriating lesser funding to doctors and staff in the name of profits.

I don’t think Medicare-for-All is an easy answer to taming this, but it would certainly help in gaining oversight into where the money goes. How else can we stop the grift and unwieldy nature of doing business with large corporate hospitals and staff and managed by hedge-funders or big investment firms hell bent on profits.

Medical staffing companies — some of which are owned by some of the country’s richest investors and have been cutting pay for doctors on the front lines of the coronavirus pandemic — are seeking government bailout money.

Private equity firms have increasingly bought up doctors’ practices that contract with hospitals to staff emergency rooms and other departments. These staffing companies say the coronavirus pandemic is, counterintuitively, bad for business because most everyone who isn’t critically ill with COVID-19 is avoiding the ER. The companies have responded with pay cuts, reduced hours and furloughs for doctors.

Emergency room visits across the country have fallen roughly 30%, and the patients who are coming tend to be sicker and costlier to treat, the American College of Emergency Physicians said in an April 3 letter to Health and Human Services Secretary Alex Azar. The professional group asked the Trump administration to provide $3.6 billion of aid to emergency physician practices.

Without immediate federal financial resources and support separate from what is provided to hospitals, fewer emergency physicians will be left to care for patients, a shortfall which will only be further exacerbated as they try to make preparations for the COVID-19 surge,” the organization said in the letter.

The American College of Emergency Physicians’ 38,000 members include employees of large staffing firms as well as academic medical centers and small doctor-owned practice groups. The letter was signed by the group’s president, William P. Jaquis, whose day job is as a senior vice president at Envision Healthcare, a top staffing firm owned by private equity giant KKR.

Envision, which has 27,000 clinicians, said it’s cutting doctors’ pay in areas that are seeing fewer patients, as well as delaying bonuses and profit-sharing, retirement contributions, raises and promotions. The company also cut senior executives’ salaries in half and will impose pay cuts or furloughs for nonclinical employees. However, Envision said that it’s adding doctors in hard-hit New York and other coronavirus hot spots.

Thx. @rusticgorilla for pointing this out.

(David Bythewood) #661

The Terrifying Story of an Unwitting Potential ‘Super-Spreader’ in Chicago

Before social distancing set in, a funeral, birthday party, and some hugs helped kick off a disastrous cluster, according to a new federal report.

Across the country Trump is confiscating PPE, Ventilators, and other supplies from states and hospitals and handing them out as patronage to political allies and favorites.

More on the blocking of private labs from helping develop tests:

A weeks-long testing delay that effectively blinded public health officials to the spread of the coronavirus in the US might have been avoided had federal agencies fully enacted their own plan to ramp up testing during a national health crisis.

The plan, which is spelled out in an April 2018 agreement between the Centers for Disease Control and three of the biggest associations involved in lab testing, called for boosting the capacity of public health labs, bringing big commercial labs into the testing process early, and making sure labs would have whatever they needed to mount a rapid, large-scale response.

But over January and February, agencies within the Department of Health and Human Services not only failed to make early use of the hundreds of labs across the United States, they enforced regulatory roadblocks that prevented non-government labs from assisting, according to documents obtained by CNN, and interviews with 14 scientists and physicians at individual laboratories and national laboratory associations.

When the CDC stumbled out of the blocks in early February, releasing a flawed test that took it weeks to correct, labs across the country had been effectively sidelined. Many public health labs were waiting for the revised CDC tests, while commercial and clinical labs were barred from conducting their own tests unless they went through a complex, slow process of applying for their own “emergency use authorization” from the US Food and Drug Administration.

As a result, the government squandered a critical month during which aggressive and widespread testing might greatly have reduced the speed and scale of the pandemic.

“We really were… basically on a pause for a few weeks within the public health system,” said Scott Becker, executive director of the Association of Public Health Laboratories. “And meanwhile, the academic laboratories who had developed their own tests also were not able to test because the regulations didn’t allow it at that time.”

In a written response to CNN’s inquiries about why the 2018 agreement wasn’t fully implemented, the CDC confirmed that it didn’t seek to bring commercial labs quickly into the testing mix. Rather, the agency said it decided to “prioritize the nation’s public health laboratories” but keep the commercial labs “well informed.” Critics charge that the CDC and other federal agencies weren’t quick enough to recognize the need for emergency action.

Bureaucratic inertia and disinterest

Public health labs are run by local, county or state governments and typically focus on detecting and providing surveillance of significant diseases, among other work.

The federal government “made it very difficult for private labs, for university labs to make their own test based on certain regulatory hurdles,” said Amesh Adalja, a physician and infectious disease expert at the Johns Hopkins University Center for Health Security.

It shouldn’t have been that way, Adalja and other scientists said.

The CDC’s 2018 plan, created following the Zika outbreak two years earlier, was meant to prevent the very testing shortfalls and obstacles that have been unfolding since Covid-19 arrived in the US.

The agreement, obtained by CNN, calls for extensive coordination, planning, exercises and constant communication between the CDC, the public labs and the commercial sector. It was designed to leverage the full weight of the nation’s wide-ranging scientific community, and rapidly boost “national laboratory testing and strengthen future responses to public-health emergencies.”

But, smothered by bureaucratic inertia and disinterest at the highest levels of the Trump Administration in pandemic preparation, that agreement, known as a memorandum of understanding, today remains far from being fully realized, scientists say.

“What we needed was extremely aggressive leadership at the CDC level and at the national level to say, okay, these are all our plans… I don’t think there was really a realization of the magnitude of the problem,” said Glenn Morris, director of the Emerging Pathogens Institute at the University of Florida.

As late as January 28, in an email obtained by CNN, CDC Director Robert Redfield told state public health directors that “the virus is not spreading in the U.S. at this time and CDC believes the immediate health risk from 2019-nCoV to the general American public is low.”

But lab directors and epidemiologists said the likely magnitude of the problem was crystal clear to them much earlier.

“We certainly said on many conference calls with the CDC during those times that we really needed to expand lab testing,” in January and early February, said Dr. Jeffrey Engel, a senior adviser on Covid-19 for the Council of State and Territorial Epidemiologists “Our members were telling the CDC that we needed testing capacity for a public health surveillance because we felt that the virus might be circulating in the US as early as January and we should be testing for that now.”

A week before Redfield’s email, on January 21, officials in Washington state confirmed that the first case on US soil had been detected there two days earlier.

Becker said the intent behind the 2018 coordination plan was “a good thing” that did improve communication between the government and commercial labs, but that there was a failure to get those outside the government launched on the testing effort early in process.

“You can add this,” he said, “…to the list of things that could have been better in this response.”

Reports of an “unknown pneumonia”

On January 8, Jana Broadhurst was in Kansas City, having a glass of wine and celebrating her second wedding anniversary with her husband, when she got a message from a colleague back in Omaha, Nebraska, about “news coming out of China.”

Chinese scientists had identified “unknown pneumonia” in Wuhan as a novel coronavirus. Within days, Chinese authorities announced the first death in Wuhan from the disease. That weekend, they released the full sequence of the coronavirus genome.

For Broadhurst, the director of a clinical laboratory at the University of Nebraska Medical Center, the message might as well have been an emergency flare. Soon she was on the phone with her colleagues, talking logistics about travel screening and virus detection from her hotel room. Within days, her laboratory would dive into developing its own coronavirus test.

Her lab gained special permission February 4 to use that test on quarantined passengers from the Diamond Princess cruise ship. It would take until February 29, though, for the FDA to give her lab permission to offer tests to residents of Omaha and the surrounding area.

Hers was not the only lab in that situation.

“We had a feeling something was coming, based on what was happening in China,” said Karen Kaul, chair of pathology at the NorthShore University HealthSystem in Illinois. “We started looking at developing our own in-house laboratory test in January… We contacted the CDC because CDC had the assay,” or test.

Kaul was so anxious to get the test she looked for a way to get her hospital lab certified as a public-health lab, since they would be the first to get the CDC test. But, she said, CDC officials told her “I could not, because there was no pathway for that to happen” in the regulations.

Then, in early February, a friend forwarded to her a memo from the Centers for Medicare & Medicaid Services, or CMS, which oversees clinical laboratories.

Alphabet soup of overlapping authority

Three federal agencies – CMS, the CDC and the FDA – have overlapping authority over laboratories and lab testing. Before the CDC could distribute its own test to public health labs, for example, it had to get FDA approval for an “emergency use authorization,” or EUA, which the FDA issued to the CDC on February 4.

The same regulations prevented clinical laboratories from immediately developing and conducting their own tests, said Dr. Jordan Laser, a pathologist for Northwell Health in New York and a member of the Clinical Laboratory Improvement Advisory Committee, a committee managed by the CDC that advises on clinical laboratory standards.

On February 6, CMS sent out a memo to state health officials who survey labs, asking them to notify the agency if they found out about any labs working to conduct a coronavirus test without an emergency use authorization.

When a friend passed the memo along to her, “that definitely gave us pause,” Kaul said. “No one wants to spend the time and money and manpower developing a test they wouldn’t allow you to use… and this shutting down of that avenue severely hampered our ability to test patients.”

CMS told CNN that the memo was meant to confirm that “laboratories are following protocols to ensure accurate testing and patient safety.”

For some labs, developing the coronavirus test was the easy part. What was not easy was getting approval from the FDA and the CDC.

“Within several weeks of the [DNA] sequence being published, we had what we felt was a reasonably good test for detection of the virus,” said Morris, at the University of Florida.

“The problem was that CDC was insisting on being the sole source for the assay [or test] to be used here in the United States… CDC basically said everything has to come through us.”

In a statement to CNN, the FDA said there was nothing wrong in its process.

Instead, it blamed individual lab delays “where labs did not understand the FDA process and mistakenly believed there was more work involved, or just did not even realize that they could develop a test in the first place.”

‘Seemed like the right thing to do’

In Seattle, researchers for the University of Washington-sponsored Seattle Flu Study had taken thousands of swabs from people with flu symptoms across the region. But, during February, federal and state officials repeatedly rejected their requests to let them retest those swabs for coronavirus, as first reported by The New York Times. The CDC said the project’s test would need FDA approval; the FDA said the lab would need to be certified first under CMS regulations, which would take months; and the project wasn’t certified to share results with state public health officials or anyone else outside the study.

At the end of February, scientists at the study decided not to wait. They began testing swabs and quickly found another coronavirus case. When they shared that fact with the FDA and the CDC, those agencies initially ordered them to stop testing the swabs.

The scientists hurriedly conferred with Karen Moe, the director of the university’s institutional research board office, which ensures research meets regulatory and ethical standards. On March 2, she said they had to share the information, regardless.

“Every once in a while, the ethics and the regulations don’t match up,” Moe told CNN. “Ethically, it sure seemed like the right thing to do.”

On February 29, the FDA loosened its regulations, allowing clinical labs to test for coronavirus using tests they developed and validated, so long as they notified the FDA and submitted EUA requests within 15 days.

Julie Khani, the president of the American Clinical Laboratory Association, a partner in the plan, said that it was the FDA’s updated guidance at the end of February that was the “federal call to action for commercial laboratories.”

The FDA made further changes March 16, to “reflect FDA’s constant assessment of benefits and risks over the course of the evolving emergency.”

Those actions came after weeks of pressure from labs across the country.

Broader testing, Morris said, “Should have been an absolute top priority and should have been aggressively pursued by CDC using all avenues possible.”

South Korea’s success story

The actions taken in South Korea offers a useful comparison, Morris said.

Both countries reported their first coronavirus case within a day of one another. Officials in South Korea gave permission just a week later for their commercial labs to develop coronavirus tests. Within two weeks, South Korea was shipping thousands of test kits daily. By mid-March, South Korea was testing at a per-capita rate 40 times higher than the US.

On March 13, when the total number of US coronavirus tests finally cracked 10,000, South Korea was doing that many tests daily. The results: South Korea was able to “flatten the curve” of coronavirus cases by late March, without having to resort to a nationwide shutdown.

Morris also said the opportunity of having the combined power of many U.S. labs working together was essentially squandered. “To tackle something like this, you need the big huge commercial machines that are operated by large medical centers, by commercial labs like LabCorp and Quest. You need to get those guys on board.”

And that, he said, happened way too late.

A leading model now estimates tens of thousands fewer covid-19 deaths by summer

Good news — that carries asterisks


Navarro publicly said Americans had ‘nothing to worry about’ while privately warning coronavirus could cost lives and dollars

Well, Navarro did get his job in the White House because Jared googled China and his ebook came up. :roll_eyes: #thesefuckingpeople




Compelling article on how we are going to be messaged to believe so many things…GASLIGHTING 101

Prepare for the Ultimate Gaslighting*

You are not crazy, my friends

You are not crazy, my friends. And so we are about to be gaslit in a truly unprecedented way. It starts with a check for $1,200 ( Don’t say I never gave you anything) and then it will be so big that it will be bigly. And it will be a one-two punch from both big business and the big White House — inextricably intertwined now more than ever and being led by, as our luck would have it, a Marketer in Chief. Business and government are about to band together to knock us unconscious again. It will be funded like no other operation in our lifetimes. It will be fast. It will be furious. And it will be overwhelming. The Great American Return to Normal is coming.

(Eleanor) #665

Under the bus :bus:


Read: the “Red Dawn” emails