Dr.Anthony Fauci versus more than 2304 practicing physicians who are currently successfully treating their patients for the Covid-19 virus UTILIZING HYDROXYCHLOROQUINE
To: Michael Rich <mrich@rand.org>, natalie crawford <Natalie_W_Crawford@rand.org>
A. Dr.Anthony Fauci
Dr.Anthony Fauci has more than 50 years of extensive and impressive experience in medical research as well as in the financial, administrative and political realities of the sprawling US federal public health bureaucracy.
Dr. Fauci comes from Brooklyn where developed his “Street Smarts" in part by working (with the rest of his family) at his father's small pharmacy [ delivering prescriptions, sweeping the floor, waiting on customers and doing everything else necessary to keep a struggling family business alive].
He attended Cornell University Medical College where he graduated first in his class with a Doctor of Medicine in 1966. He then completed an internship and residency at the New York Hospital-Cornell Medical Center
In 1968, Dr. Fauci joined the National Institutes of Health as a clinical associate in the Laboratory of Clinical Investigation (LCI) at the National Institute of Allergy and Infectious Diseases.
Dr.Fauci was appointed director of National Institute of Allergy and Infectious Diseases in 1984. [The NIAID budget for fiscal year 2020 is an estimated $5.9 billion. —The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH)]
In addition to Dr. Fauci’s extensive technical and administrative responsibilities of overseeing complex organization [$5.9 billion annual budget ] Dr Fauci is very active in many technical organizations and as serving as a public face for the US government public health / public relations activities. Some examples:
* delivers major lectures all over the world
*recipient of numerous prestigious awards, including 45 honorary doctoral degrees from universities in the United States and abroad.
*is a member of the National Academy of Sciences, the National Academy of Medicine, the American Academy of Arts and Sciences, and the American Philosophical Society, as well as other professional societies including the American College of Physicians, the American Society for Clinical Investigation, the Association of American Physicians, the Infectious Diseases Society of America, the American Association of Immunologists, and the American Academy of Allergy, Asthma & Immunology
*serves on the editorial boards of many scientific journals; as an editor of Harrison's Principles of Internal Medicine; and as author, coauthor, or editor of more than 1,300 scientific publications, including several textbooks.
B. ON THE OTHER HAND
1. MORE THAN 2,304 PHYSICIANS WHO ARE CURRENTLY SUCCESSFULLY TREATING PATIENTS INFECTED WITH THE COVID-19 REPORTED THEIR "ANECDOTAL EVIDENCE" OF THEIR SUCCESS WITH THEIR PATIENTS UTILIZING HYDROXYCHLOROQUINE
"Hydroxychloroquine rated ‘most effective therapy’ by doctors for coronavirus: Global survey” (by Valerie Richardson Washington Tmes 4-2-20)
An international poll of more than 6,000 doctors released Thursday found that the antimalarial drug hydroxychloroquine was the most highly rated treatment for the novel coronavirus.
The survey conducted by Sermo, a global health care polling company, of 6,227 physicians in 30 countries found that 37% of those treating COVID-19 patients rated hydroxychloroquine as the “most effective therapy” from a list of 15 options.
The U.S. Food and Drug Administration gave chloroquine and its next-generation derivative, hydroxychloroquine, emergency-use authorization Monday for treating the novel coronavirus, although the drug was already being used off-label by some doctors and hospitals for COVID-19 patients.
The survey also found that the most commonly prescribed treatments are analgesics (56%), azithromycin (41%) and hydroxychloroquine (33%).
Azithromycin, known by the brand name Zithromax or Z-Pak, was rated the second-most effective therapy at 32%, followed by “nothing,” analgesics (including acetaminophen), anti-HIV drugs and cough medicine.
Hydroxychloroquine, which is sold under the brand name Plaquenil, was prescribed mainly in the United States for the most severe cases, but not so in other countries.
“Outside the U.S., hydroxychloroquine was equally used for diagnosed patients with mild to severe symptoms whereas in the U.S. it was most commonly used for high risk diagnosed patients,” the survey found.
The 30 nations surveyed included those in Europe, Asia, North America and South America, as well as Australia. No incentives were provided to participate in the poll, conducted March 25-27, according to Sermo.
Hydroxychloroquine usage was most widespread in Spain, where 72% of physicians surveyed said they had prescribed it, followed by Italy at 49%, and least popular in Japan, where 7% had used it to treat COVID-19.
The poll found 23% of U.S. medical professionals had prescribed the drug, which has been FDA-approved for malaria, lupus and rheumatoid arthritis.
Debate about hydroxychloroquine has raged in the United States since President Trump touted it two weeks ago as a potential “game-changer” in the fight against the deadly pandemic, prompting critics to accuse him of peddling unproven remedies, or “snake oil,” as USA Today put it.
Sermo CEO Peter Kirk called the polling results a “treasure trove of global insights for policy makers.”
“Physicians should have more of a voice in how we deal with this pandemic and be able to quickly share information with one another and the world,” he said. “With censorship of the media and the medical community in some countries, along with biased and poorly designed studies, solutions to the pandemic are being delayed.”
2. AS A PHYSICIAN ON THE FRONT LINES OF THIS COVID PANDEMIC, I AM SHARING MY THOUGHTS ABOUT HOW TO IMMEDIATELY END THE EPIDEMIC AND THE QUARANTINE PROTOCOLS. [from a board-certified physician with 30 years of experience in treating infectious diseases, including current Corona virus cases)
I can confirm that the vast majority of patients infected with Covid19 have minimal, mild or modest cold and flu-like symptoms, requiring little to no medical intervention. The planet is being systematically shut down because a very small percentage of those infected may have serious or grave reactions to the viral infection. When these seriously ill patients contract the disease over a short period of time, the healthcare system can become overwhelmed as was the experience in China, Korea and Italy.
The Chinese have largely completed their Covid19 experience and some significant science has come from their doctors and researchers as to the virology, epidemiology and treatment of Covid19. The most important of which is the recent study showing a 100% cure rate for Covid19 patients (n = 20) treated with the combination of chloroquine and azithromycin.
Now that a cure has been established (and is being confirmed in other areas hard hit with Covid19 — to my understanding), this new finding should be the antidote for public and political panic regarding any significant downside human costs (grave illness, casualties) of the pandemic.
As we no longer have the domestic capacity to manufacture these medications in the quantities needed on the timeline required, the Federal government should immediately work to re-tool US chemical factories that are capable of retrofitting to manufacture these two drugs. The raw materials of these medicines can then be shipped directly to vitamin manufacturers who have the capacity to conservatively and collectively make 5 - 10 millions pills daily. As a contract manufacturer of vitamins, I know first hand that these facilities follow strict FDA guidelines that are equivalent to the regulations of Big Pharma. Therefore, quality control will not be a concern. Compound pharmacies are also capable of participating in this effort.
If this protocol were to be adopted, some 150M doses of these life-saving medications would be available in the next two weeks to treat all patients in need and any first responder/front line healthcare worker.
While not scientifically proven, it has also been anecdotally observed that chloroquine may offer significant prophylaxis so that those most at risk (the vulnerable patients and front-line healthcare workers) may never develop a primary infection during the epidemic. This preventive intervention should be immediately offered to vulnerable populations and healthcare workers in an open-label, observational study.
With the cure in the hands of pharmacies, hospitals and first responders, the concern for the health and wellness of the vulnerable population (whose characteristics have been well described) can be assured. By treating these vulnerable patients in the early part of the 5 day prodrome (when mild symptoms begin), demands on hospital resources will be effectively countered.
Governmental authorities can then begin to immediately prepare the population for a systematic roll out of return-to-work orders while releasing the healthy, general public from quarantine.
It is my opinion, the vulnerable populations should remain quarantined for the next one month while the treatments are used and proven on a mass scale.
The concern of patients (and their providers) with an infectious disease is always the success and availability of the treatment for their condition. Now that a treatment has been Now that a treatment has been identified and can be made widely available at minimal cost (but with considerable public-private coordination issues) the End Game for this pandemic is within our collective reach.
3. MANY REPORTS OF BREAKTHROUGHS IN TESTING AND TREATMENT [WITH THE POTENTIAL FOR NEAR TERM APPLICATION] ARE BEING REPORTED IN THE GENERAL AND SCIENTIFIC MEDIA .NEARLY EVERY REPORT INCLUDES NEGATIVE REFERENCES TO THE CDC AND/OR THE FDA RELATING TO BUREAUCRATIC FOOT DRAGGING AND FOR IMPOSING UNNECESSARY CONDITIONS AND RESTRICTIONS. SOME [ UNEVALUATED]. FURTHER, MODELING AND FORECASTING EFFORTS HAVE COMPROMISED BY OBSOLETE MODELS, LACK OF TRANSPARENCY, MISREPORTING, ETC.
a. EXAMPLES ARE PRESENTED FOR YOUR INFORMATION:
Houston Methodist announced this week that it was the first hospital in the nation to treat a patient in the United States with the experimental method, following the Food and Drug Administration’s (FDA) announcing approval to test the therapy.
The first patient received plasma on March 27 and a second patient received it a day later, the hospital system said in a statement.
Plasma from recovered patients may have antibodies against the CCP virus that could potentially help patients recover, according to Dr. Eric Salazar, a physician scientist with Houston Methodist’s Research Institute. Salazar and his team recruited blood plasma donors who have been in good health for more than two weeks since being diagnosed with COVID-19. Each donor gave a quart of blood plasma. Medical workers transfused the plasma into the two critically ill patients.
MIGAL and IIBR are both testing potential COVID-19 vaccinations on mammals
MIGAL's biotechnology group's team is hard at work on a vaccine for COVID-19. (photo credit: COURTESY OF MIGAL)
MIGAL's biotechnology group's team is hard at work on a vaccine for COVID-19.
A team of Israeli researchers says that they are days away from completing the production of the active component of a coronavirus vaccine that could be tested on humans as early as June 1.
“We are in the final stages and within a few days we will hold the proteins – the active component of the vaccine,” Dr. Chen Katz, group leader of MIGAL’s biotechnology group, told The Jerusalem Post.
In late February, MIGAL [The Galilee Research Institute] committed to completing production of its vaccine within three weeks and having it on the market in 90 days. Katz said they were slightly delayed because it took longer than expected to receive the genetic construct that they ordered from China due to the airways being closed and it having to be rerouted.
Doctors At University of Pittsburgh Medical Center: We've Developed a Vaccine Against CoronavirusDoctors and researchers at the University of Pittsburgh Medical Center have announced amazing news.
They are saying they’ve created a vaccine that can protect against developing COVID-19 and they want federal permission for human trials. They said they began working on it Jan. 21 and found mice had developed antibodies against COVID-19 about two weeks after receiving the vaccine. They said they based the vaccine on work previously done at UPMC that sought to create vaccines to protect against SARS and MERS, which they said are similar to the new coronavirus.
Not only that the doctors say the vaccine is easily deliverable in large quantities. They further said their vaccine is one that is easily scalable to produce in large quantities. It also includes a unique delivery method in which hundreds of tiny needles are in a patch similar to a Band-Aid, with the needles, made of sugar and protein particles, dissolving into the skin to deliver the vaccine.
The Mayo Clinic created its first-ever rapid response team. A third of the 15 members were devoted solely to the FDA’s data and paperwork demands. Like others on the team, they worked 15-hour days for three weeks.
“It’s unlike anything we’ve ever done before,” said Matt Binnicker, a director of clinical virology at Mayo.
At the University of Washington, Greninger and his fellow scientists were initially baffled by an FDA process they viewed as baroque. They had always worked under strict guidelines, aimed at protecting patients and guaranteeing quality. But the EUA was a bureaucratic puzzle they had never encountered.
“The most pernicious effect of the current regulatory environment is that it kneecaps our ability for preparedness should a true emergency emerge,” Greninger wrote to colleagues on Feb. 14.
Greninger channeled his energy into the paperwork problem, spending more than 100 hours filling out forms and collecting information needed for the application, he told The Post. But when he finally submitted the material, an FDA official told him the agency could not accept it — because he had emailed it.
“We received your email and attachments regarding the UW 2019-nCoV assay pre-EUA,” an FDA official wrote on Feb. 20. “However, we have not received the official submission through DCC.”
“What is the DCC?” Greninger wrote back.
“The Document Control Center,” came the reply.
“What is the Document Control Center?”
Greninger then learned about another requirement. Under FDA rules, he was supposed to digitally copy the electronic documents he had emailed to the FDA, burn the copies onto a disk and mail the hard disk to an office in suburban District of Columbia.
Greninger shared his exasperation in a Feb. 20 email to a colleague: “repeat after me, emergency.”
This New York Times story is a good place to get started.[ CAUTION: , for the most part ,reporters have friends and contacts who feed them information and thus, in return, the reporters do everything possible to steer blame away from their symbiotic associates and toward their rivals.Under the Obama administration ,US response to just about every outbreak was longer delayed.. Many of the laboratory and Association sources quoted are veterans of the Obama administration. They certainly will praise the Obama approach [their efforts] and attack those of Donald Trump. Also, the Centers for Disease Control explicitly allocated their budget to other” research” and declined the repeated and urgent requests from Harvard and other researchers to study this class of virus and to study the development of vaccines for this class of virus ]
For example,Dr. Nancy Messonnier, the director of the agency’s National Center for Immunization and Respiratory Diseases is very anti-Trump.
CDC Defends Its Handling Of Coronavirus Case In California…...The Centers for Disease Control and Prevention says there's been "confusion" about the handling of a coronavirus patient in California who is thought to represent the first case of the virus being transmitted in the general population, rather than through a known contact with someone who has been in China.
The case involves a woman who appears to have contracted the virus in California, apparently without having contact with anyone who had traveled abroad or was previously known to have the coronavirus.
On Friday, another patient believed to have similarly contracted the virus was reported in Santa Clara County in Northern California and a third in Oregon's Washington County was described by officials there as a "confirmed presumptive case" that also had no history of travel outside the country or close contact with an infected person.
The latest cases could be indicate a wider outbreak in the U.S.
*******The UC Davis Medical Center in Sacramento, Calif., where the woman was being treated, says its diagnosis of the patient's COVID-19, the disease caused by the novel coronavirus, was delayed for days because the patient didn't initially meet the CDC's criteria to approve a coronavirus test.
********The hospital says its staff requested a test from "public health officials" after the patient was transferred to its facility last Wednesday. However, UC Davis Medical Center added, "Since the patient did not fit the existing CDC criteria for COVID-19, a test was not immediately administered."
The Lost Month: How a Failure to Test Blinded the U.S. to Covid-19 By Michael D. Shear, Abby Goodnough, Sheila Kaplan, Sheri Fink, Katie Thomas and Noah Weiland March 28, 2020 New York Times
https://www.nytimes.com/2020/03/28/us/testing-coronavirus-pandemic.html?campaign_id=2&emc=edit_th_200329&instance_id=17044&nl=todaysheadlines®i_id=60743284&segment_id=23226&user_id=17e798e489b463910587c6144722778f
WASHINGTON — Early on, the dozen federal officials charged with defending America against the coronavirus gathered day after day in the White House Situation Room, consumed by crises. They grappled with how to evacuate the United States consulate in Wuhan, China, ban Chinese travelers and extract Americans from the Diamond Princess and other cruise ships.
The members of the coronavirus task force typically devoted only five or 10 minutes, often at the end of contentious meetings, to talk about testing, several participants recalled. The Centers for Disease Control and Prevention, its leaders assured the others, had developed a diagnostic model that would be rolled out quickly as a first step.
But as the deadly virus from China spread with ferocity across the United States between late January and early March, large-scale testing of people who might have been infected did not happen — because of technical flaws, regulatory hurdles, business-as-usual bureaucracies and lack of leadership at multiple levels, according to interviews with more than 50 current and former public health officials, administration officials, senior scientists and company executives.
The result was a lost month, when the world’s richest country — armed with some of the most highly trained scientists and infectious disease specialists — squandered its best chance of containing the virus’s spread. Instead, Americans were left largely blind to the scale of a looming public health catastrophe.
The absence of robust screening until it was “far too late” revealed failures across the government, said Dr. Thomas Frieden, the former C.D.C. director. Jennifer Nuzzo, an epidemiologist at Johns Hopkins, said the Trump administration had “incredibly limited” views of the pathogen’s potential impact. Dr. Margaret Hamburg, the former commissioner of the Food and Drug Administration, said the lapse enabled “exponential growth of cases.”
And Dr. Anthony S. Fauci, a top government scientist involved in the fight against the virus, told members of Congress that the early inability to test was “a failing” of the administration’s response to a deadly, global pandemic. “Why,” he asked later in a magazine interview, “were we not able to mobilize on a broader scale?”
Across the government, they said, three agencies responsible for detecting and combating threats like the coronavirus failed to prepare quickly enough. Even as scientists looked at China and sounded alarms, none of the agencies’ directors conveyed the urgency required to spur a no-holds-barred defense.
Dr. Robert R. Redfield, 68, a former military doctor and prominent AIDS researcher who directs the C.D.C., trusted his veteran scientists to create the world’s most precise test for the coronavirus and share it with state laboratories. When flaws in the test became apparent in February, he promised a quick fix, though it took weeks to settle on a solutio
The C.D.C. also tightly restricted who could get tested and was slow to conduct “community-based surveillance,” a standard screening practice to detect the virus’s reach. Had the United States been able to track its earliest movements and identify hidden hot spots, local quarantines might have confined the disease.
Dr. Stephen Hahn, 60, the commissioner of the Food and Drug Administration, enforced regulations that paradoxically made it tougher for hospitals, private clinics and companies to deploy diagnostic tests in an emergency. Other countries that had mobilized businesses were performing tens of thousands of tests daily, compared with fewer than 100 on average in the United States, frustrating local health officials, lawmakers and desperate Americans.
Alex M. Azar II, who led the Department of Health and Human Services, oversaw the two other agencies and coordinated the government’s public health response to the pandemic. While he grew frustrated as public criticism over the testing issues intensified, he was unable to push either agency to speed up or change course.
Mr. Azar, 52, who chaired the coronavirus task force until late February, when Vice President Mike Pence took charge, had been at odds for months with the White House over other issues. The task force’s chief liaison to the president was Mick Mulvaney, the acting White House chief of staff, who was being forced out by Mr. Trump. Without high-level interest — or demands for action — the testing issue festered.
At the start of that crucial lost month, when his government could have rallied, the president was distracted by impeachment and dismissive of the threat to the public’s health or the nation’s economy. By the end of the month, Mr. Trump claimed the virus was about to dissipate in the United States, saying: “It’s going to disappear. One day — it’s like a miracle — it will disappear.”
By early March, after federal officials finally announced changes to expand testing, it was too late. With the early lapses, containment was no longer an option. The tool kit of epidemiology would shift — lockdowns, social disruption, intensive medical treatment — in hopes of mitigating the harm. Now, the United States has more than 100,000 coronavirus cases, the most of any country in the world. Deaths are rising, cities are shuttered, the economy is sputtering and everyday life is upended. And still, many Americans sickened by the virus cannot get tested.
Dr. Bruce Aylward, a senior adviser at the World Health Organization, led an expert team to China last month to research the mysterious new virus. Testing, he said, was “absolutely vital” for understanding how to defeat a disease — what distinguishes it from others, the spectrum of illness and, most important, its path through populations.
“You want to know whether or not you have it,” Dr. Aylward said. “You want to know whether the people around you have it. Because you know what? Then you could stop it.”
“You can’t stop it,” he warned, “if you can’t see it.”
A Startling Setback
The first time Dr. Robert Redfield heard about the severity of the virus from his Chinese counterparts was around New Year’s Day, when he was on vacation with his family. He spent so much time on the phone that they barely saw him. And what he heard rattled him; in one grim conversation about the virus days later, George F. Gao, the director of the Chinese Center for Disease Control and Prevention, burst into tears.
Dr. Redfield, a longtime AIDS researcher, had never run a government agency before his appointment to lead the C.D.C. in 2018. Until then, his biggest priorities had been fighting the opioid epidemic and the spread of H.I.V. Suddenly, a man who preferred treating patients in Haiti or Africa to being in the public glare was facing a new pandemic threat.
At first, Dr. Redfield’s agency moved quickly.
On Jan. 7, the C.D.C. created an “incident management system” for the coronavirus and advised travelers to Wuhan to take precautions. By Jan. 20, just two weeks after Chinese scientists shared the genetic sequence of the virus, the C.D.C. had developed its own test, as usual, and deployed it to detect the country’s first coronavirus case.
“That’s our prime mission,” Dr. Redfield said later in an interview, “to get eyes on this thing.”
Assessing the virus would prove challenging. It was so new that scientists had little information to work with. China provided limited data, and rebuffed an early attempt by Mr. Azar and Dr. Redfield to send C.D.C. experts there to learn more. That the virus could cause no symptoms and still spread — something not initially known — made it all the more difficult to understand.
To identify the virus, the C.D.C. test used three small genetic sequences to match up with portions of a virus’s genome extracted from a swab. A German-developed test that the W.H.O. was distributing to other countries used just two, potentially making it less precise.
But soon after the F.D.A. cleared the C.D.C. to share its test kits with state health department labs, some discovered a problem. The third sequence, or “probe,” gave inconclusive results. While the C.D.C. explored the cause — contamination or a design issue — it told those state labs to stop testing.
The startling setback stalled the C.D.C.’s efforts to track the virus when it mattered most. By mid-February, the nation was testing only about 100 samples per day, according to the C.D.C.’s website.
Dr. Redfield played down the problem in task force meetings and conversations with Mr. Azar, assuring him it would be fixed quickly, several administration officials said.
With capacity so limited, the C.D.C.’s criteria for who was tested remained extremely narrow for weeks to come: only people who had recently traveled to China or had been in contact with someone who had the virus.
The lack of tests in the states also meant local public health officials could not use another essential epidemiological tool: surveillance testing. To see where the virus might be hiding, nasal swab samples from people screened for the common flu would also be checked for the coronavirus.
The C.D.C. announced a plan on Feb. 14 to perform the screening in five high-risk cities: New York, Chicago, Los Angeles, San Francisco and Seattle. An agency official said it could provide “an early warning signal to trigger a change in our response strategy.” But most of the cities could not carry it out.
“Had we had done more testing from the very beginning and caught cases earlier,” said Dr. Nuzzo, of Johns Hopkins, “we would be in a far different place.”
The consequences became clear by the end of February. For the first time, someone with no known exposure to the virus or history of travel tested positive, in the Seattle area, where the U.S.’s first case had been detected more than a month earlier. The virus had probably been spreading there and elsewhere for weeks, researchers later concluded. Without a more complete picture of who had been infected, public health workers could not do “contact tracing” — finding all those with whom any contagious people had interacted and then quarantining them to stop further transmission.
The C.D.C. gave little thought to adopting the test being used by the W.H.O. The C.D.C.’s test was working in its own lab — still processing samples from states — which gave agency officials confidence. Dr. Anne Schuchat, the agency’s principal deputy director, would later say that the C.D.C. did not think “we needed somebody else’s test.”
And the German-designed W.H.O. test had not been through the American regulatory approval process, which would take time.
Throughout February, Dr. Redfield shuttled between Atlanta, where the C.D.C. is based, and Washington, holding multiple calls every day with Mr. Azar and participating in the coronavirus task force.
Mr. Azar’s take-charge style contrasted with the more deliberative manner of Dr. Redfield, who lacked the kind of commanding television presence that impressed Mr. Trump. He was “a consensus person,” as one colleague described him, who sought to avoid conflict. He relied heavily on some of the C.D.C.’s career scientists, like Dr. Schuchat and Dr. Nancy Messonnier, the director of the agency’s National Center for Immunization and Respiratory Diseases.
Under scrutiny from Congress, Dr. Redfield offered reassurances. Responding on Feb. 24 to a letter from 49 members of Congress about the need for testing in the states, he wrote, “CDC’s aggressive response enables us to identify potential cases early and make sure that they are properly handled.”
Days later, his agency provided a workaround, telling state and local health department labs that they could finally begin testing. Rather than awaiting replacements, they should use their C.D.C. test kits and leave out the problematic third probe.
Meanwhile, the agency’s epidemiologists were growing more concerned as the virus spread in South Korea and Italy. On Feb. 25, Dr. Messonnier gave a briefing with a much blunter warning than usual. “Disruption to everyday life might be severe,” she said.
Mr. Trump, returning from a trip to India, was furious, according to senior administration officials. Later that day, Mr. Azar seemed to be tamping down the level of concern. All Dr. Messonnier had meant, he said at a news conference, was that people should “start thinking about, in their own lives, what that might involve.”
“Might,” Mr. Azar repeated emphatically. “Might involve.”
Barriers to Testing
Dr. Stephen Hahn’s first day as F.D.A. commissioner came just six weeks before Mr. Azar declared a public health emergency on Jan. 31. A radiation oncologist and researcher who helped turn around MD Anderson in Houston, one of the nation’s leading cancer centers, Dr. Hahn had come to Washington to oversee a sprawling federal agency that regulates everything from lifesaving therapies to dog food.
But overnight, his mission — to manage 15,000 employees in a culture defined by precision and caution — was upended. A pathogen that Mr. Trump would later call the “invisible enemy” was hurtling toward the United States. It would fall to the newly arrived Dr. Hahn to help build a huge national capacity for testing by academic and private labs.
Instead, under his leadership, the F.D.A. became a significant roadblock, according to current and former officials as well as researchers and doctors at laboratories around the country.
Private-sector tests were supposed to be the next tier after the C.D.C. fulfilled its obligation to jump-start screening at public labs. In other countries hit hard by the coronavirus, governments acted quickly to speed tests to their populations. In South Korea, for example, regulators in early February summoned executives from 20 medical manufacturers, easing rules as they demanded tests.
But Dr. Hahn took a cautious approach. He was not proactive in reaching out to manufacturers, and instead deferred to his scientists, following the F.D.A.’s often cumbersome methods for approving medical screening.
Even the nation’s public health labs were looking for the F.D.A.’s help. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of C.D.C. for the vast majority of our member laboratories,” Scott Becker, chief executive of the Association of Public Health Laboratories, wrote to Mr. Hahn in late February. “We believe a more expeditious route is needed at this time.”
Ironically, it was Mr. Azar’s emergency declaration that established the rules Dr. Hahn insisted on following. Designed to make it easier for drugmakers to pursue vaccines and other therapies during a crisis, such a declaration lets the F.D.A. speed approvals that could otherwise take a year or more.
But the emergency announcement created a new barrier for hospitals and laboratories that wanted to create their own tests to diagnose the coronavirus. Usually, they faced minimal federal regulation. But once Mr. Azar took action, they were subject to an F.D.A. process called an “emergency use authorization.”
Even though researchers around the country quickly began creating tests that could diagnose Covid-19, many said they were hindered by the F.D.A.’s approval process. The new tests sat unused at labs around the country.
Stanford was one of them. Researchers at the world-renowned university had a working test by February, based on protocols published by the W.H.O. The organization had already delivered more than 250,000 of the German-designed tests to 70 laboratories around the world, and doctors at the Stanford lab wanted to be prepared for a pandemic.
“Even if it didn’t come, it would be better to be ready than not to be ready,” said Dr. Benjamin Pinsky, the lab’s medical director.
But in the face of what he called “relatively tight” rules at the F.D.A., Dr. Pinsky and his colleagues decided against even trying to win permission. The Stanford clinical lab would not begin testing coronavirus samples until early March, when Dr. Hahn finally relaxed the rules.
Executives at bioMérieux, a French diagnostics company, had a similar experience. The company makes a countertop testing system, BioFire, that is routinely used to check for the flu and other respiratory illnesses in 1,700 hospitals around the country. It can provide results in about 45 minutes.
“A lot of us said, you know, your typical E.U.A. is just much too demanding,” said Dr. Mark Miller, the company’s chief medical officer, referring to the emergency approval. “It’s going to take much too much time. And can’t you do something to shorten that?”
Officials at the F.D.A. tried to be responsive, Dr. Miller said. But rather than throw out the rules, the agency only modified the regulatory requirements, still requiring weeks of discussions and negotiations.
After conversations with the F.D.A. in mid-February, the company received emergency approval for its BioFire test on March 24. (The company also began talking to the F.D.A. in January about another type of test, but decided not to pursue it in the United States for now.) Dr. Miller said that while he was ultimately satisfied with the F.D.A.’s actions, the overall response by the government was too slow, especially when it came to logistical questions like getting enough testing supplies to those who needed them.
“You’ve got other countries — and I’m sorry, unfortunately, the U.S. is one of those — where they’ve been slow, disorganized,” he said. “There are still not enough tests available there to test everybody who needs it.”
In an emailed statement, Dr. Hahn maintained that his agency had moved as quickly as it safely could to ensure that tests would be accurate. “Since the early days of this pandemic,” he said, “the F.D.A.’s doors have always been and still remain open to test developers.”
A Lack of Trust
Alex Azar had sounded confident at the end of January. At a news conference in the hulking H.H.S. headquarters in Washington, he said he had the government’s response to the new coronavirus under control, pointing out high-ranking jobs he had held in the department during the 2003 SARS outbreak and other infectious threats.
“I know this playbook well,” he told reporters.
A Yale-trained lawyer who once served as the top attorney at the health department, Mr. Azar had spent a decade as a top executive at Eli Lilly, one of the world’s largest drug companies. But he caught Mr. Trump’s attention in part because of other credentials: After law school, Mr. Azar was a clerk for some of the nation’s most conservative judges, including Justice Antonin Scalia of the Supreme Court. And for two years, he worked as Ken Starr’s deputy on the Clinton Whitewater investigation.
As Mr. Trump’s second health secretary, confirmed at the beginning of 2018, Mr. Azar has been quick to compliment the president and focus on the issues he cares about: lowering drug prices and fighting opioid addiction. On Feb. 6 — even as the W.H.O. announced that there were more than 28,000 coronavirus cases around the globe — Mr. Azar was in the second row in the White House’s East Room, demonstrating his loyalty to the president as Mr. Trump claimed vindication from his impeachment acquittal the day before and lashed out at “evil” lawmakers and the F.B.I.’s “top scum.”
As public attention on the virus threat intensified in January and February, Mr. Azar grew increasingly frustrated about the harsh spotlight on his department and the leaders of agencies who reported to him, according to people familiar with the response to the virus inside the agencies.
Described as a prickly boss by some administration officials, Mr. Azar has had a longstanding feud with Seema Verma, the Medicare and Medicaid chief, who recently became a regular presence at Mr. Trump’s televised briefings on the pandemic. Mr. Azar did not include Dr. Hahn on the virus task force he led, though some of the F.D.A. commissioner’s aides participated in H.H.S. meetings on the subject.
And tensions grew between the secretary and Dr. Redfield as the testing issue persisted. Mr. Azar and Dr. Redfield have been on the phone as often as a half-dozen times a day. But throughout February, as the C.D.C. test faltered, Mr. Azar became convinced that Dr. Redfield’s agency was providing him with inaccurate information about testing that the secretary repeated publicly, according to several administration officials.
In one instance, Mr. Azar appeared on Sunday morning news programs and said that more than 3,600 people had been tested for the virus. In fact, the real number was much smaller because many patients were tested multiple times, an error the C.D.C. had to correct in congressional testimony that week. One health department official said Mr. Azar was repeatedly assured that the C.D.C.’s test would be widely available within a week or 10 days, only to be given the same promise a week later.
Asked about criticism of his agency’s response to the pandemic, Dr. Redfield said: “I’m personally not focused on whether they’re pointing fingers here or there. We’re focused on doing all we can to get through this outbreak as quickly as possible and keep America safe.”
For all Mr. Azar’s complaints, however, he continued to defer to the scientists at the two agencies, according to several administration officials. Mr. Azar’s allies said he was told by Dr. Redfield and Dr. Fauci that the C.D.C. had the resources it needed, that there was no reason to believe the virus was spreading through the country from person to person and that it was important to test only people who met certain criteria.
But even in the face of a crescendo of complaints from doctors and health care researchers around the country, Mr. Azar failed to push those under him to do the one thing that could have helped: broader testing.
In a statement, Caitlin Oakley, Mr. Azar’s spokeswoman, said that the secretary had “empowered and followed the guidance of world-renowned U.S. scientists” on the testing issue. “Any insinuation that Secretary Azar did not respond with needed urgency to the response or testing efforts,” she said, “are just plain wrong and disproven by the facts.”
By Feb. 26, Dr. Fauci was concerned that the stalled testing had become an urgent issue that needed to be addressed. He called Brian Harrison, Mr. Azar’s chief of staff, and asked him to gather the group of officials overseeing screening efforts.
Around noon on Feb. 27, Dr. Hahn, Dr. Redfield and top aides from the F.D.A. and H.H.S. dialed in to a conference call. Mr. Harrison began with an ultimatum: No one leaves until we resolve the lag in testing. We don’t have answers and we need them, one senior administration official recalled him saying. Get it done.
By the end of the day, the group agreed that the F.D.A. should loosen regulations so that hospitals and independent labs could move forward quickly with their own tests.
But the evening before, Mr. Azar had been effectively removed as the leader of the task force when Mr. Trump abruptly put Mr. Pence in charge, a decision so last-minute that even the top health officials in the White House learned of it while watching the announcement.
A Tacit Acknowledgment
Previous presidents have moved quickly to confront disease threats from inside the White House by installing a “czar” to manage the effort.
During an outbreak of the Ebola virus in 2014, President Barack Obama tapped Ron Klain, his vice president’s former chief of staff, to direct the response from the West Wing. Mr. Obama later created an office of global health security inside the National Security Council to coordinate future crises.
“If you look historically in the United States when it is challenged with something like this — whether it’s H.I.V. crises, whether it’s pandemic, whether it’s whatever — man, they pull out all the stops across the system and they make it work,” said Dr. Aylward, the W.H.O. epidemiologist.
But faced with the coronavirus, Mr. Trump chose not to have the White House lead the planning until nearly two months after it began. Mr. Obama’s global health office had been disbanded a year earlier. And until Mr. Pence took charge, the task force lacked a single White House official with the power to compel action.
Since then, testing has ramped up quickly, with nearly 100 labs at hospitals and elsewhere performing it. On Friday, the health care giant Abbott said it had received emergency approval for a portable test that could detect the virus in five minutes. Yet hospitals and clinics across the country still must deny tests to those with milder symptoms, trying to save them for the most serious cases, and they often wait a week for results. In tacit acknowledgment of the shortage,
Public health experts reacted positively to the increased capacity. But having the ability to diagnose the disease three months after it was first disclosed by China does little to address why the United States was unable to do so sooner, when it might have helped reduce the toll of the pandemic.
“Testing is the crack that split apart the rest of the response, when it should have tied everything together,” said Dr. Nahid Bhadelia, the medical director of the Special Pathogens Unit at Boston University School of Medicine. “It seeps into every other aspect of our response, touches all of us,” she said. “The delay of the testing has impacted the response across the board.”
b. CDC GUIDANCE [ ON HOW TO REPORT CORVID-19 DEATHS ] MAY RESULT IN SUBSTANTIAL OVER REPORTING, CORRUPTING BOTH THE BASIS FOR OPERATIONAL DECISIONS AND ALL ANALYSES RELATING TO PREVENTION, DETECTION AND TREATMENT
1. CDC Tells Hospitals To List COVID as Cause of Death Even if You're Just Assuming or It Only Contribute https://www.cdc.gov/nchs/data/nvss/vsrg/vsrg03-508.pdf
The problem with making informed decisions about coronavirus is that we don’t have a whole lot of data on it at the moment.
The data that we do have, meanwhile, could end up being terminally skewed, particularly the data that’s been coming out of China.
The Centers for Disease Control and Prevention’s guidance on determining COVID-19 as a cause of death isn’t going to help those numbers.
Issued March 24, the guidance tells hospitals to list COVID-19 as a cause of death regardless of whether or not there’s actual testing to confirm that’s the case.
Instead, even if the coronavirus was just a contributing factor or if it’s “assumed to have caused or contributed to death,” it can be listed as the primary cause.
The International Statistical Classification of Diseases and Related Health Problems, or ICD, has established the code U07.1 for death by coronavirus infection. There’s a secondary code, U07.2, “for clinical or epidemiological diagnosis of COVID-19 where a laboratory confirmation is inconclusive or not available,” according to the CDC guidance.
“Because laboratory test results are not typically reported on death certificates in the U.S., NCHS is not planning to implement U07.2 for mortality statistics.”
Therein lies the problem.
“The underlying cause depends upon what and where conditions are reported on the death certificate. However, the rules for coding and selection of the underlying cause of death are expected to result in COVID- 19 being the underlying cause more often than not,” the guidelines read.
Is this new CDC guidance problematic?
“COVID-19 should be reported on the death certificate for all decedents where the disease caused or is assumed to have caused or contributed to death. Certifiers should include as much detail as possible based on their knowledge of the case, medical records, laboratory testing, etc.,” the guidance continued.
“If the decedent had other chronic conditions such as COPD or asthma that may have also contributed, these conditions can be reported in Part II.”
Author and former New York Times reporter Alex Berenson, one of the few well-known figures to question some of the statistics on COVID-19, questioned the new CDC guidelines as well.
It doesn’t help that data when the guidelines for determining who’s actually died of the coronavirus are profoundly vague.For instance, what happens when an elderly person with numerous underlying conditions comes into the hospital and dies?
2. IN ADDITION, USE OF FOREIGN DATA FOR MODELING AND FORECASTING HAS BEEN A MAJOR CONTRIBUTOR TO THE HIGHLY MISLEADING AND CONSTANTLY CHANGING PREVALENCE AND DEATH ESTIMATES AND TO THE CONFUSING.AND OFTEN CONFLICTING GUIDANCE GIVEN TO THE AMERICAN PUBLIC.
For example, Dr. Fauci and many others kept repeating: “we are only two weeks behind Italy." In fact, only 3% of the “coronavirus deaths” reported by Italy are actually caused by it…..97% of deaths are due to Other Serious Health conditions which are agravated by the coronavirus.
As of Wednesday morning , Italian reported data stated 31,506 confirmed cases of coronavirus in Italy and 2,503 deaths. But new data from the Italian government shows that the people dying from the coronavirus are either the elderly or have other complications. 50% of those who died from coronavirus had THREE DIFFERENT SERIOUS HEALTH CONDITIONS and the average per person had 2.7 serious health conditions. Only 12 coronavirus fatalities had NO previous health concerns before coming down with the coronavirus.
Via Agenzia Nova from March 18: (rough translation)
Rome, 18 Mar 09:29 – (Agenzia Nova) – Only 12 deaths caused by coronavirus have been ascertained so far. The data, however, emerges from the analysis of just 355 medical records, out of 2,003 received by the Higher Institute of Health (ISS). All the other 343 patients who fell victim to the epidemic, according to the ISS, had other serious diseases, which caused their death. Almost 50 percent of the deceased had 3 previous pathologies, and the average of the 343 deaths from secondary causes is 2.7 pathologies per person. The 12 deceased patients, equal to 3.38 per cent of the sample examined, did not present any previous pathology , which means that their death was caused, precisely, by Covid-19.
Among the other victims, 84, equal to 23.7 percent of the sample, had 1 pathology; 90 patients, equal to 25.4 percent of the sample, had 2; and 169, equal to 47.6 percent, had 3 or more pathologies. Respiratory failure is the most common complication observed. The ISS, in fact, found the disease in 97.2 percent of cases; the second cause is acute kidney damage, in 27.8 percent of cases; followed by acute myocardial injury, with 10.8 percent; and from superinfection, with 10.2 percent.
The Institute also reports on the age groups of patients. As of March 17, seventeen those who died and were positive at Covid-19 under the age of 50. Specifically, 5 of these were less than 40 years old: these are male subjects between the ages of 31 and 39 with serious pre-existing diseases. Among these, cardiovascular, renal, psychiatric diseases but also diabetes and obesity.
