*Accuses Kano Governor of laxity

*Demands inquiry to cause of death of elderly in the state

*Asks for 10 additional NCDC centers in Kano

By Malachy Uzendu

Former Governor of Kano State Alhaji Rabiu Musa Kwankwaso has tongue lashed the incumbent governor of the state, Alhaji Umar Ganduje, accusing him of laxity in the deaths recorded in the state recently.

In a letter addressed to President Muhammadu Buhari dated 27th April, 2020 which was submitted at the Pilot Gate of the Presidential Villa and received by one Blessing at 8:55am, the former governor alleged that the mysterious deaths recorded in Kano since last week was a direct consequemce of the mismanagement of issues relating to corona virus by the state governor.

According to him, rather than face reality, the governor politicised the issues and paid lip service to the fundamental things he ought to have done in the state to prevent the near crises situation in the state.

Although he did not pointedly state that it was corona virus that led to the death of mostly the elderly in the state recently, he argued that the failure of Ganduje to put up adequate measures against covid-19 was largely responsible for the deaths.

He offered five suggestions in the four-paged letter, asking for urgent intervention by the federal government in the state.

He accused the state government of unprofessionally handling covid-19 cases and expressed worry at what he described as near absence of cooperation between the state and federal government in that direction.

Kwankwaso warned that except emergency action is taken, the situation in the state could snowball to security emergency, stating with the large population of Kano, everything should be done to halt the pandemic and stem the rate people are dying in the state.

“At present and to all intent and purposes, the state has practically no covid-19 response committee”, claiming that what had existed was a contraption comprising of the governor’s cronies who were “both unqualified and incompetent”.

He lamented that since the disbandment of the committee, no further covid-19 tests had been carried out in the state, raising fears that some of those who died mysteriously may have been as a result of the dreaded virus.

“Mr. President, in times of crises like this, we require a robust and unifying leadership that will assure the citizens that it understands and shares it’s concerns; but unfortunately, the state government is even denying that there is unusual surge in the number of deaths in the state,” he said.

The former governor suggested the setting up of a task team of professionals to collect data in all cemeteries in the state and follow up with the cause of such deaths.

He also opines that people who prepared the dead for burial should be isolated and monitored in line with NCDC protocols.

“Mr. President, since is is undeniable that there is a spike in the number of deaths, and it is probable that these deaths are either as a result of covid-19 or some other illness, the state government is citizens should treat and consider all deaths as if they were caused by the virus, ” he stated.

He called on the federal government to send health experts to the state to assist and also to increase palliatives sent to the state as a result of the crises, but advised Governor Ganduje to stop politicising the distribution of palliatives in the state.

Reacting the state government dismissed Kwankwaso’s claims insisting that deaths in the state were caused by “complications arising from hypertension, diabetes, meningitis and acute malaria”.

The state Commissioner of Information, Muhammad Garba said, “although an investigation into the cause of the deaths is still ongoing, preliminary reports from the state Ministry of Health indicated that the deaths are not connected to the COVID-19 pandemic.

“Reports have shown that most of the deaths were caused by complications arising from hypertension, diabetes, meningitis, and acute malaria,” he maintained.

Garba stated the state government has three modern Isolation Centres where those tested positive to COVID-19 are being cared for.

“We are also hopeful of getting an additional two Isolation Centres soonest. The government has also hired a hotel where suspected cases are accommodated,” he said.

The Authority

A health worker checks the temperature of a traveller as part of the coronavirus screening procedure at the Kotoka Airport in Accra, Ghana on January 30, 2020 [File: Reuters/Francis Kokoroko]

By Robtel Neajai Pailey

In fact, Africa and the Global South can teach the rest some lessons.

It was inevitable that racism would rear its ugly head.

Having previously documented the long and shameful history of unethical drug testing on communities of colour across the globe, I was not surprised earlier this month when two French doctors proclaimed on national television that Africa would be the most appropriate location for a coronavirus vaccine trial. Never mind that this continent has the lowest recorded number of cases regionally.

For bigots who operate under the appalling assumption that black, brown, and other non-white bodies are easily expendable during times of crisis, COVID-19 presents the perfect storm. Yet, instead of expending energy on denouncing the doctors’ asinine comments, as so many have already done, we should be reflecting on what Africa and other regions of the so-called Global South have to teach the world in this collective moment of reckoning.

Call me naive in the heyday of apocalyptic projections about infections and deaths to come, but I prefer to focus on the silver lining. This is in some ways why I have been rolling my eyes at countless doomsday commentaries published by Western media outlets in which so-called Global North “experts” have argued that Africa, a continent of 54 diverse countries rumoured to be the final frontier of coronavirus, desperately needs saving. My response? Puh-lease!

Ordinary Africans, and their counterparts in Asia, Latin America and the Caribbean, are not navel-gazing or waiting around for the “mighty” Global North – itself in the bullseye of the virus – to come to the rescue. Even in the midst of constraints unheard of in Europe and North America, Global South folks are exemplifying the kind of ingenuity, generosity, solidarity, empathy and civility from which we all must learn. We should be borrowing from this playbook, not casting it aside.

Let’s start with my own country, Liberia, once destabilised by a 14-year intermittent armed conflict in the late 20th and early 21st centuries. During the deadliest ever Ebola outbreak of 2014-2016, which killed more than 11,000 in West Africa alone, 22-year-old Liberian student nurse Fatu Kekula single-handedly treated three family members at home when they fell ill. She transformed rubbish bags into aprons, gloves and masks which became her very own retrofitted personal protective equipment (PPE) – a technique that resource-strapped healthcare workers in Europe and North America are now replicating.

Indeed, the Global South has both exported innovation and disseminated much needed “staff, stuff and systems“. While critiques abound, Cuba’s late March deployment of 52 medical workers to Italy was a stark and important exemplar of “South to North” medical humanitarianism. Once vilified for its socialist leadership and harshly sanctioned by the West, this island nation has a long history of dispatching health missions in times of calamity and tranquillity.

In keeping with Cuba’s efforts in Italy, Somalia followed suit by sending 20 doctors to aid the southern European country. Lest we forget, this Horn of Africa nation is recovering from protracted warfare, including current threats from al-Shabab armed fighters, which makes its intervention all the more admirable.

Though the United States has tightened sanctions against conflict-affected Iran and slammed crisis-prone Venezuela with narcoterrorism charges, countries across the Southern hemisphere have extended olive branches of support while the pandemic nears its peak.

Having faced virulent forms of Sinophobia as the initial epicentre of coronavirus, China has begun a global campaign to distribute medical supplies and expertise to African countries such as Algeria and Nigeria, with plans to deploy personnel to Europe, the Middle East and the Gulf in due course. Although not without controversy, such is the beauty of “South-South” cooperation.

Whereas others parroted early on the racist edict that COVID-19 was exclusively a Wuhan epidemic, Chinese philanthrocapitalist Jack Ma, of tech giant Alibaba fame, was one of the first billionaires to spring into action when he pledged $14m in late January to develop a vaccine to tame the virus. Regional heavyweight South Korea also proved its mettle by getting ahead of the curve with nation-wide testing and quarantining, earning international plaudits in the process.

In the likeness of South Korea’s proactive approach to virus prevention, Zimbabwe’s universities have shown that necessity is the mother of all inventions. As the country battles a chronic economic recession, including hyperinflation, with healthcare workers striking across the country, universities are manufacturing gloves, masks and hand sanitizers amidst a 21-day lockdown. Farther east, a factory in Kenya now produces 30,000 surgical masks a day to meet heightened national demand.

South Africa also has important lessons to impart. Because of the country’s experience researching and testing for HIV/AIDS and other communicable diseases, it has started developing locally-made COVID-19 tests and will embark shortly on a clinical trial for a vaccine.

It has been said a disease transported by upwardly mobile jet-setters – who have the wherewithal to huddle at homes and the resources to practice physical distancing when necessary – is now killing the poor and sedentary, who do not.

Yet, Global South traders in the so-called “informal sector” have defiantly dictated that one-size-fits-all coronavirus prevention measures will not work everywhere, that they hurt vulnerable populations in low-income countries, and that “top-down”, militarised lockdowns cannot be imposed on poor people without advanced warning or social protection schemes.

While some leaders in the Global South have unleashed physical brutality against their citizens under the guise of battling COVID-19, or blindly borrowed protocols from the North without understanding that context must drive policymaking, others, like Nigeria’s senators or senior members of Rwanda’s executive branch of government, have donated portions of their salaries for relief to poor households.

As Global North leaders jockey for power, undercutting each other in a bidding war over respirators, the Global South is unassuming in its instructions about the necessity of civility. Because whether rich or poor, black, brown, or white, young or old, man or woman, we are all in this existential catastrophe together. And while some of us may be more equipped than others to tackle it, the virus’ visa-free obliteration of borders and orders proves that no one is exempt from its ferocity.

Africa and other regions of the Global South have already demonstrated that they are far from passive centres for medical experimentation. Rather, they are the sites of home-grown solutions which should be transmitted globally.

As the celebrated Indian author and activist Arundhati Roy reminds us, coronavirus has not only exposed nature’s wrath against the crudeness of capitalism, but also forced us to imagine a better world beyond flattened curves, and, might I add, racist vitriol.

Editor’s note: An earlier version of this article  incorrectly claimed that 11,000 were infected during the Ebola outbreak in West Africa. It has been updated to clarify that 11,000 was the deathtoll from the outbreak. 

The views expressed in this article are the author’s own and do not necessarily reflect Al Jazeera’s editorial stance.

https://www.aljazeera.com/indepth/opinion/africa-saving-pandemic-200408180254152.html

A serving commissioner in Kogi State, Honourable Abudulmumuni Danga has been accused of abducting a lady, Queen NiNa, from Okene, took her to Lokoja, the state capital, assaulted her physically, made a pornography of her under duress while raping her.

The victim reportedly called Honourable Danga out via a post on social media accusing him of neglecting his family members  and asked him to begin his charity at home.

See screenshot of post below:

ElombahNews gathered that the Commissioner, thereafter, forcefully sent in thugs that kidnapped her and her son in Okene and then took her to Lokoja.

While at Lokoja, Danga allegedly molested and maltreated her and held her captive for a day, before her release after a nude apology according to a video obtained by ElombahNews.

Watch video below:

ABDUCTION, BRUTALITY & RAPE! #JusticeforElizabeth
A serving Commissioner in Kogi state Abdul Danga abducted this lady from Okene, took her to lokoja, assaulted her Physically, made her do a video under duress and Raped her. @ToyinSaraki @wfm917 @kikimordi @wipfng @unwomenNG https://t.co/iiODV4pHYW pic.twitter.com/zqSMU5nqb6

— Adiela Nwosu 💞 🔴 (@PrettieAdiela) April 2, 2020

After the nefarious action of violence, rape, intimidation, revenge porn and abuse of power, Danga extracted apology from her and her friend on tape.

A technician transfers a sample to a tube for coronavirus testing at a lab in Seattle on March 27. (Jovelle Tamayo for The Washington Post)By Shawn Boburg, Robert O’Harrow Jr., Neena Satija and Amy Goldstein   

On a Jan. 15 conference call, a leading scientist at the federal Centers for Disease Control and Prevention assured local and state public health officials from across the nation that there would soon be a test to detect a mysterious virus spreading from China. Stephen Lindstrom told them the threat was remote and they may not need the test his team was developing “unless the scope gets much larger than we anticipate,” according to an email summarizing the call.

“We’re in good hands,” a public health official who participated in the call wrote in the email to colleagues.

Three weeks later, early on Feb. 8, one of the first CDC test kits arrived in a Federal Express package at a public health laboratory on the east side of Manhattan. By then, the virus had reached the United States, and the kits represented the government’s best hope for containing it while that was still possible.

For hours, lab technicians struggled to verify that the test worked. Each time, it fell short, producing untrustworthy results.

That night, they called their lab director, Jennifer Rakeman, an assistant commissioner in the New York City health department, to tell her it had failed. “Oh, s—,” she replied. “What are we going to do now?”

In the 21 days that followed, as Trump administration officials continued to rely on the flawed CDC test, many lab scientists eager to aid the faltering effort grew increasingly alarmed and exasperated by the federal government’s actions, according to previously unreported email messages and other documents reviewed by The Washington Post, as well as exclusive interviews with scientists and officials involved.

In their private communications, scientists at academic, hospital and public health labs — one layer removed from federal agency operations — expressed dismay at the failure to move more quickly and frustration at bureaucratic demands that delayed their attempts to develop alternatives to the CDC test.

“We have the skills and resources as a community but we are collectively paralyzed by a bloated bureaucratic/administrative process,” Marc Couturier, medical director at academic laboratory ARUP in Utah, wrote to other microbiologists on Feb. 27 after weeks of mounting frustration.

The administration embraced a new approach behind closed doors that very day, concluding that “a much broader” effort to testing was needed, according to an internal government memo spelling out the plan. Two days later, the administration announced a relaxation of the regulations that scientists said had hindered private laboratories from deploying their own tests.

By then, the virus had spread across the country. In less than a month, it would upend daily life, shuttering the world’s largest economy and killing thousands of Americans.

In a statement to The Post, the CDC said an investigation of the initial problems is ongoing. The test is now in use in every state and is “accurate and reliable,” the agency said.

Stephen Hahn, the commissioner of the Food and Drug Administration, which regulates testing, told The Post the agency is continuously adapting to an “unprecedented global public health crisis.”

“Right now, our efforts are focused on doing everything we can do to fight COVID-19, but we know there will certainly be a time to learn larger lessons from the agency’s response,” he said in a statement, referring to the disease caused by the novel coronavirus.

In an interview Thursday, Brett P. Giroir, a Public Health Service admiral who on March 12 was named the top administration official on the testing effort, acknowledged the government should have moved more decisively to detect and contain the virus.

“There was a clear need for a more aggressive posture,” said Giroir, an assistant secretary at the Department of Health and Human Services, adding that agency leaders named him to the new role because “unprecedented steps needed to take place.”

Asked who was responsible for the delays in the early stages of the crisis, he paused.

“A problem like this is bigger than any single agency,” he said. “Clearly, there needed to be a higher level of leadership and organization.”A hospital is constructed in January for coronavirus patients in Wuhan, China. (Getty Images)

The need for a test

The first reports about a strange, possibly unknown virus started leaking out of China in late December. Scientists and researchers in the United States and around the world began paying keen attention to the apparent epicenter of the spread, a sprawling industrial city in central China called Wuhan.

Among those keeping close track were virologists and other specialists at the CDC, the country’s flagship public health agency. Founded in 1946 to fight malaria in Southern states, the CDC is at the vanguard in the fight against infectious diseases throughout the nation. It employs some 22,000 epidemiologists, biologists, behavioral scientists and others. Recent successes include rapid responses to contain the Zika, MERS and Ebola viruses.

In early January, the CDC publicly treated the virus from Wuhan as a distant potential threat, issuing an advisory urging that the “usual precautions” be taken when traveling abroad.

The agency also began laying plans to protect the country. Led by Lindstrom, one team began considering the kinds of tests, technically called assays, that could identify the virus.

Lindstrom is a microbiologist with an impressive track record: He had helped develop a testing method critical to detecting the H1N1 virus in 2009. During a Jan. 7 conference call, he told public health officials that the CDC’s aim was to “plan for the worst, hope for the best,” according to an email exchange among scientists and others. Lindstrom, like several other officials named in this report, did not respond to requests for interviews.

On Jan. 10, CDC scientists received an important break when the Chinese government published the pathogen’s genetic sequence. The sequence, a long string of letters representing the RNA structure of SARS-CoV-2 described a coronavirus never before seen in humans. It also gave scientists a path to create a precise diagnostic test that could detect the virus.

CDC has long led the nation’s efforts to create diagnostic tests when a public health threat emerges. The agency usually distributes the tests to a network of state and county public health labs nationwide, using the results to track and contain new pathogens until large-scale commercial tests come on line.

But state and local public health labs juggle an immense array of responsibilities, including water and food safety, and government studies dating back two decades have found the public health labs often lack the money and resources to keep pace with the demands.

On the Jan. 15 call, Lindstrom told more than a dozen public health officials that the CDC planned to make its test available to all state and county public health labs. He assured them “there will not be pressure for everyone (at least from CDC) to implement unless the scope gets much larger than we anticipate right now,” according to the email summary written by Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories.

CDC scientists were not the only ones interested in creating a test. Commercial laboratories began to mobilize, and scientists at major hospitals and universities sprang into action to develop tests of their own.

One of them was Alex Greninger, 38, an assistant director of the University of Washington’s clinical virology lab. For Greninger, the chance to create a diagnostic test for a novel coronavirus was a rare opportunity.

Researchers at the University of Nebraska, Stanford University and elsewhere also began taking their first steps toward inventing tests for the virus to use in their own labs. These academic labs didn’t have the capacity to process the millions of tests that would be needed in the event of a pandemic, a scale that is achievable only by commercial labs, but their limited testing capabilities might have helped efforts to detect and slow the virus in its early stages.

On Jan. 16, the day Greninger started buying supplies for his test, a 35-year-old man who had recently visited Wuhan became ill with flu-like symptoms after returning to the Seattle area, according to a CDC incident report. The man went to his doctor, who swabbed his nose and sent the sample to the CDC, according to the report.

Four days later, using its newly developed test, the CDC confirmed that the man was the first person in the United States known to be infected with the novel coronavirus.

In a CNBC interview two days after that, President Trump downplayed the threat to Americans.

“We have it totally under control,” he said.

---

EARLY DECEMBERDEC. 31JAN. 7JAN. 8JAN. 10JAN. 15JAN. 16JAN. 17JAN. 20

Early December

The first presumed case of the novel coronavirus, which causes the disease covid-19, appears in Wuhan, China.

Dec. 31

China informs the World Health Organization about a strange pneumonia-like illness.

Jan. 7

The Centers for Disease Control and Prevention begins planning for tests. In an email, Stephanie Chester from the Association of Public Health Laboratories tells her colleagues that the CDC’s chief microbiologist said the agency’s aim is to “plan for the worst, hope for the best.”

Right now the pathogen is still unidentified, but if it is identified and is truly novel, they will be putting together an EUA assay. He said they are in a “plan for the worst, hope for the best” mode. A lot of their response efforts are contingent on being able to actually get data and info out of China. The main concern for the US PHLs is general travel and people returning from the Chinese New Year in the coming weeks. Will let you know if I hear more.

Jan. 8

The CDC issues an official health advisory recommending travelers to take the usual precautions.

 Read the full document

Jan. 10

China publishes the pathogen’s genetic sequence.

Jan. 15

The first known person in the United States to be infected with the virus arrives in Seattle from China. On the same day, CDC scientists say the agency will make its tests available to all state and county public health labs.

Jan. 16

Alex Greninger, a scientist at the University of Washington who was creating a coronavirus test, orders the necessary chemical reagents. He is one of several scientists across the country rushing to design their own test.

Jan. 17

Nancy Messonnier, a CDC official, says that “for a family sitting around the dinner table tonight, this is not something that they generally need to worry about.”

Since the outbreaks of MERS and SARS, we have made improved in our capacity in the United States and around the world. We’re now better poised to respond to this new threat quickly and collaboratively. Based on the information that CDC has today, we believe the current risk from this virus to the general public is low. For a family sitting around the dinner table tonight this is not something that they generally need to worry about.

Jan. 20

After developing a test over the weekend, the CDC in an internal incident report confirms the first positive case of the coronavirus in the United States.

 Read the full document

---

A significant moment

Designing the test took CDC scientists seven days — a stunningly short period of time for a health-care system built around the principles of medical quality and patient safety, not speed.

The CDC could use the test in its Atlanta labs but could not send it out to public health labs until it won approval from the FDA. On Jan. 28, Lindstrom and others at the CDC assured public health scientists in a conference call that “CDC’s goal is to get (FDA approval) as quickly as possible and expects the assay will be ready to deploy within two weeks, possibly sooner,” according to an Association of Public Health Laboratories’ summary of the call.

Although the CDC test was a priority, the FDA was also fielding inquiries from other test developers. At the end of January, about 20 companies and scientific groups were talking with the FDA about their plans to develop tests, according to two government officials familiar with those inquiries who like many others interviewed for this story spoke on the condition of anonymity to discuss sensitive matters.

At the same time, pressure on the Trump administration to take action was growing. The number of people who had died of the infection worldwide spiked to 200 by Jan. 30, when the World Health Organization declared the virus a public health emergency of international concern.

The next day, Health and Human Services Secretary Alex Azar announced a health emergency in the United States. At the time, Azar was the leader of the White House’s newly created coronavirus task force.Secretary of Health and Human Services Alex Azar speaks during a January briefing with members of President Trump’s coronavirus task force. (Jabin Botsford/The Washington Post)

The declaration was one of the most significant moments in the unfolding crisis. Such declarations provide the FDA flexibility to speed up approvals for critical medical products, including commercial diagnostic tests. But they also trigger strict limits on scientists in government-certified clinical labs at universities, research centers and hospitals.

Those labs are typically permitted by the FDA to make and use their own tests without government approval, including to make decisions about patient care, as long as they use them only in their own facilities and do not sell them.

But once Azar announced a public health emergency, tests created in such laboratories had to receive an “emergency use authorization,” or EUA, from the FDA. The additional regulation is intended to ensure the efficacy of tests in public health crises in which inaccurate results could be damaging.

The new regulatory hurdle stalled efforts like the one underway by Greninger at the University of Washington. Greninger and other scientists were located in some of the nation’s early coronavirus hot spots, where successful tests might have helped reveal the scope of the outbreak. Suddenly, their hands were tied.

Clinical scientists fumed about the new obstacle, according to exchanges in private online chat groups among academics and scientists.

“The EUA process is flawed, broken, and inefficient,” Couturier, the medical director and diagnostic specialist at ARUP Laboratories in Utah, wrote later on ClinMicroNet, a private message system for microbiology lab directors across the world.Alex Greninger, an assistant director of the University of Washington’s clinical virology lab, said his efforts to develop a test for coronavirus were stalled by an FDA regulation. (Jovelle Tamayo for The Washington Post)

In a statement this week, the FDA said its regulations “had not hindered or been a roadblock” to the rollout of tests.

“Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed,” the agency said.

But in his interview, Giroir offered a different analysis.

“If someone says they were a barrier, to me, you have to believe them,” he told The Post. “If they thought it was a barrier, it becomes a barrier.”

One person familiar with the emergency declaration told The Post that FDA career staff did not raise concerns about the EUA’s burdens on clinical labs to Azar or to FDA leaders. Azar oversees the FDA.

Hahn had been confirmed by the Senate as FDA commissioner on Dec. 12 — just seven weeks before Azar’s declaration. Before that, Hahn was a radiation oncologist and chief medical executive at the MD Anderson Cancer Center in Houston.

Hahn’s agency approved the CDC test on Feb. 4, making it the country’s only accepted test for the novel coronavirus. Public health officials in New York City, Nebraska, Colorado, Minnesota, New York State and elsewhere began receiving them four days later.

The test kits contain compact collections of chemicals known as reagents. The chemicals help isolate viral genetic material and then amplify it so that it can be detected by probes that also came with the kit.

Scientists in the local labs quickly recognized something was wrong. The assays often produced results that suggested the virus was present in samples in which scientists knew it was not.

On Feb. 8, when lab technicians for New York City’s health department ran the test on samples that contained the virus, they saw on their computer screens a logarithmic curve sloping upward, indicating the virus was present. The problem was, they saw something similar when they ran the test on distilled water that contained no trace of the virus.

When they finally gave up that evening, the technicians called their director, Rakeman. Shortly before midnight, she relayed the bad news in an email to local health authorities. “The issue will need to be investigated and could result in significant impact to testing availability at the CDC and across the country until the issue is resolved,” she wrote.

New York State lab officials also passed on the news, according to documents and interviews. “There is a technical problem in one of the reagents which invalidates the assay and will not allow us to perform the assay,” the lab director of New York State’s Wadsworth Center, Jill Taylor, wrote to state health officials in an email that same night.

“I am sorry to not have better news,” she wrote. “It is a bummer.”

Word that some labs were having problems with the test quickly made its way back to the CDC.

“Is this something to worry about?” Daniel Jernigan, a leader of the CDC’s coronavirus response, wrote to the Association of Public Health Laboratories the next morning as he prepared to board a plane.

It was, he was told.

Later that day, Scott Becker, chief executive of the association, raised concerns to another CDC official. “The states and their governors are going to come unglued,” he wrote, adding later, “If CDC doesn’t get ahead of this it will be a disaster.”

As they struggled to make the test kit work, many of the public health labs realized they might succeed by eliminating one of its three main chemical components. But under the FDA’s emergency rules, they could use the test only as it was approved. The flaw meant they could not use it at all.

“The silence from CDC … is deafening,” Joanne Bartkus, the Minnesota health department’s lab director, wrote to Becker on Feb. 10. “What is going on? We are getting questions from our governor’s office and other labs are getting media requests asking when we will be starting.”

By Feb. 12, a total of 2,009 tests had been conducted in the United States, according to CDC data.

“We’re screwed from a testing standpoint if this thing takes off in the US,” Susan Butler-Wu, director of medical microbiology at the Los Angeles County and University of Southern California Medical Center, warned in a Feb. 13 email to fellow scientists.Scott Becker, chief executive of the Association for Public Health Laboratories, raised concerns to the CDC about issues with its test. (Bill O’Leary/The Washington Post)

Falling behind

The United States was clearly falling behind in the fight against covid-19. Other countries such as Singapore and Taiwan were ramping up testing quickly. In South Korea, 1,000 people were being tested each day by mid-February, a number that would increase more than tenfold by the end of the month.

The Geneva-based World Health Organization, meanwhile, had already delivered 250,000 diagnostic tests designed and manufactured by a German lab to 70 laboratories around the world.

Academic and hospital researchers including Greninger eagerly experimented with the German lab design early on and found it workable, but U.S. health officials continued on their own path.

“To our knowledge, no discussions occurred between WHO and CDC (or other USG agencies) about WHO providing COVID-19 tests to the U.S.,” WHO spokesman Tarik Jasarevic told The Post.

Hahn defended the U.S. government’s approach at a news conference weeks later.

“In the U.S., we have policies in place that strike the right balance during public health emergencies of ensuring critical independent review by the scientific and public health experts and timely test availability,” he said in a White House press briefing. “What’s important here is that we have a test that the American people can trust.”

The FDA’s confidence in the flawed test was based in part on assurances from the CDC that it could be fixed easily, according to officials familiar with the agency’s deliberations.

In its statement to The Post, the CDC said it collaborated closely with the FDA and “encouraged our government partners to work with the private sector to develop diagnostic tests for commercial use and to remove restrictions for … labs in hospitals and universities across the county.”

On Feb. 16, officials from the FDA and CDC met to discuss solutions, including the possibility of eliminating the component of the test that was causing problems, officials said. FDA officials said that would be a fast solution that could quickly get the public health labs up and running. But in the following days, the FDA learned that some public labs were reporting continuing problems with the test, the officials said.

As officials struggled to understand the test flaws, leading clinical labs were spending much of their time and energy on the FDA’s paperwork and data demands to win approval for their tests.

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.

He said they decided to persist because, in a worst-case scenario, the public health labs alone could not test on the scale that would be needed. “The public health infrastructure is really not set up to handle a pandemic,” he said.

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.”

In a statement, an FDA official said information sent by Greninger on Feb. 19 was promptly reviewed, despite not having been submitted properly, and was found to be insufficient to demonstrate that the test would work. The official said that after that interaction, “we immediately addressed how we receive applications.”

“The FDA is improving ways we interact with developers of products to address the pandemic, including those we don’t normally interact with,” the official said.

By the time Greninger sent his email, the FDA was in discussions with dozens of test developers, a number that was growing quickly. But none had managed to complete a formal application to the FDA, according to officials familiar with the agency’s actions. FDA officials interpreted the paucity of applications as a sign of limited ability or interest, the officials said.

Some private labs struggled to obtain samples of the virus necessary to verify their tests and complete their applications, according to government officials and lab representatives. An FDA official said that, at the time, the agency supported efforts to help those labs secure the necessary samples.

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JAN. 28JAN. 30JAN. 31FEB. 4FEB. 8FEB. 13

Jan. 28

HHS Secretary Alex Azar praises the CDC for developing a coronavirus test in one week: “This was really a historic accomplishment.”

Jan. 30

The World Health Organization declares a “public health emergency of international concern.”

It is important to note that as the situation continues to evolve, so will the strategic goals and measures to prevent and reduce spread of the infection. The Committee agreed that the outbreak now meets the criteria for a Public Health Emergency of International Concern and proposed the following advice to be issued as Temporary Recommendations.

Jan. 31

Azar declares a public health emergency, triggering tight restrictions on FDA approvals for tests called emergency use authorizations, or EUAs. Though meant to expedite approval of medical products, the EUAs added delays to the development of coronavirus tests at clinical labs at hospitals and universities.

Following the World Health Organization’s decision to declare the 2019 novel coronavirus a Public Health Emergency of International Concern, I have declared today that the coronavirus presents a Public Health Emergency in the United States.

Feb. 4

The CDC receives an emergency use authorization from the FDA to distribute its test to public health labs around the country. The CDC also announces it will start shipping test kits to around 100 public health labs. It is the only test kit available.

Feb. 8

CDC test begins arriving at labs in New York, Nebraska, Colorado, Minnesota and elsewhere. By the end of the day, public health lab directors tell the CDC it doesn’t work properly. Through the weekend, the lab directors share notes of the test not working and start to realize, “this could be really bad.”

The silence from CDC on the nCoVtest kit failures is deafening. What is going on? We are getting questions from our governor’s office and other labs are getting media requests asking when we will start testing. We need to be able to respond.

Feb. 13

Susan Butler-Wu, director of medical microbiology at the Los Angeles County and University of Southern California Medical Center, warns in an email to fellow scientists: “We’re screwed from a testing standpoint if this thing takes off in the US.”

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Anxiety intensifies

On Feb. 22, an FDA official named Timothy Stenzel flew to Atlanta. The director of a diagnostic office at the FDA, Stenzel was a key figure in the decisions about testing. The purpose of his visit was not clear to CDC officials, but he said he wanted to understand the testing development and help find a way to fix the troubled assay, according to three people familiar with the visit.

Stenzel spent much of the following week attending CDC meetings, touring the facilities and offering suggestions about how to cobble together viable tests from existing materials, the officials said.

At the same time, CDC officials, including Jernigan from the agency’s influenza division, urged Stenzel to convince the FDA to approve other tests under development in private laboratories.

Anxiety about the lack of widespread testing, meanwhile, was cresting among scientists and public health officials nationwide. Many felt the country could wait no longer.

On Feb. 24, the Association of Public Health Laboratories formally asked Hahn to loosen the FDA’s rules.

“We are now many weeks into the response with still no diagnostic or surveillance test available outside of the CDC for the vast majority of our member laboratories,” the association’s letter said. “While we understand that the EUA process is open to [public health labs], we believe a more expeditious route is needed at this time.”

Two days later, the FDA allowed public health labs to begin using the CDC test, with the troubled component eliminated.

On Feb. 27, Anthony S. Fauci, the government’s top infectious disease expert, added to the pressure to expand testing further. He spoke in person with Brian Harrison, Azar’s chief of staff, and underscored the urgent need to accelerate the approval of new tests, according to two people familiar with the call. At noon that day, Harrison convened a teleconference of officials from the FDA, CDC and other agencies.

In strong language, Harrison told the group to come up with a new test approval plan before they left the meeting. The participants scrambled to swap ideas. At the FDA and CDC, Stenzel, Jernigan and others worked on a memo into the evening that outlined a new strategy.

The memo, “A Plan to Increase Covid-19 testing in the U.S.,” frankly acknowledged that the original approach had not worked. The spread of the virus was “leading to significant impact on healthcare systems and causing social disruption,” it said.

“CDC has worked with FDA to assure that testing is available at Public Health Laboratories to support public health investigations and control efforts; however, a much broader interagency approach is needed to fill the greater need for diagnostics by commercial manufacturers and laboratories capable of developing their own tests.”

It recommended giving clinical laboratories, such as the University of Washington, leeway to create and begin using their own tests while seeking FDA approval. The memo was forwarded to top government officials, including Azar, who supported loosening the regulations.

The next day, Greninger and scores of other clinical scientists appealed to Congress in a letter of their own. They complained that “significantly more stringent” FDA rules had nearly frozen the country’s fight against the virus.

“Notably, no test manufacturer or clinical laboratory has successfully navigated the EUA process for SARS-CoV-2 to date,” the Feb. 28 letter said. “Therefore, the CDC test remains the only test available with EUA status, and it has not been made available to hospital laboratories.”A laboratory test kit for coronavirus that was developed by the Centers for Disease Control and Prevention. (CDC/AP)

FDA’s turnaround

On Feb. 29, the FDA finally reversed course, opening the way for clinical labs outside the government to begin testing for coronavirus. Under a revised policy Hahn announced at a White House briefing, the labs would have to notify the FDA when testing began, but they would not have to submit paperwork for 15 days.

“The FDA recognized the urgent need for even faster testing availability,” the agency said in a statement this week. “Although laboratories could use the EUA pathway, many were hesitant or didn’t know the pathway was available to them.”

Giroir told The Post that the FDA was right to reverse itself but could have done so sooner.

“In retrospect, it might have been useful earlier, right?” he said. “I mean, it was the right decision to make.”

On March 2, Greninger and his colleagues at the University of Washington went live, testing 30 patients in a single day. Two days later, they tested 202 people. That number soon soared to over 2,800 per day, roughly the equivalent of a quarter of tests done by all state and federal public health labs on the same day.

About two weeks after the FDA loosened its grip on testing, two major manufacturing giants, Roche and Thermo Fisher Scientific, won approval. By then the number of confirmed cases in the United States had grown to more than 2,000.

On March 12, Fauci, who runs the National Institute of Allergy and Infectious Diseases, told lawmakers the problem was not simply the failure of the CDC test. The coronavirus testing debacle had exposed deep structural problems in the nation’s public health system, he said.

“Yeah, it is a failing, let’s admit it,” he said. “The idea of anybody getting it easily the way people in other countries are doing it, we’re not set up for that. Do I think we should be? Yes, but we’re not.”

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FEB. 14FEB. 18FEB. 24FEB. 26FEB. 27FEB. 28FEB. 29MAR. 11MAR. 12

Feb. 14

As of this date, more than three dozen public health labs are having problems with the CDC test. Greninger writes a message to his colleagues about the bureaucratic difficulties for clinical labs at universities trying to make their own tests.

The most pernicious effect of the current regulatory environment is that it kneecaps our ability for preparedness should a true emergency emerge, as Susan notes. Why bother getting ready as a clinical lab if you think that you won’t ever be allowed to do anything until May or June (per the time frame on the prior Zika virus EUAs).

Feb. 18

The CDC warns clinical laboratories around the country against testing on their own without FDA approval. Meanwhile, it has still not provided public health labs with instructions on how to modify its test to make it work properly.

Feb. 24

A coalition of public health labs asks the FDA for permission to make their own tests: “We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories.”

We are now many weeks into the response with still no diagnostic or surveillance test available outside of CDC for the vast majority of our member laboratories. While we understand that the EUA process is open to PHLs, we believe a more expeditious route is needed at this time.

 Read the full document

Feb. 26

The FDA commissioner sends a letter to the coalition of public health labs that had asked for permission to make tests: “False diagnostic test results can lead to significant adverse public health consequences — not only serious implications for individual patient care but also serious implications for the analyses of disease progression and for public health decision-making.

 Read the full document

Feb. 26

The CDC announces to public health labs that a workaround for the test has been approved.

Feb. 27

CDC Director Robert R. Redfield testifies to the House Foreign Affairs subcommittee on Asia, the Pacific and nonproliferation that the “CDC believes that the immediate risk of this new virus to the American public is low.” Privately, the CDC concluded that a “much broader” effort to testing is needed.  An internal memo titled,“A Plan to Increase Covid-19 testing in the U.S.,” frankly acknowledged the approach was not working. The spread of the virus was “leading to significant impact on healthcare systems and causing social disruption,” it said. “A much broader interagency approach is needed to fill the greater need for diagnostics by commercial manufacturers and laboratories capable of developing their own tests.”

 Read the full document

Feb. 28

Dozens of clinical laboratory scientists from across the nation write to Congress asking for more leeway to create new tests, saying “this regulatory process is significantly more stringent than that required for every other virus we test for.”

Feb. 29

The FDA reverses course and announces it will permit clinical labs to develop tests with less stringent review. By this date, the CDC and public health labs have tested 3,999 people nationwide.

March 11

WHO declares the coronavirus outbreak a pandemic.

March 12

Anthony S. Fauci, the nation’s top infectious diseases expert, testifies to Congress about coronavirus testing and the nation’s response to the outbreak: “The system does not, is not really geared to what we need right now,” he said. “Yes, it is a failure, let’s admit it.”

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Emily Rauhala, Yasmeen Abutaleb and Josh Dawsey contributed to this report.

The Washington Post

By Sarah Kaplan Reporter

Noela Rukundo sat in a car outside her home in Melbourne, Australia, watching as the last few mourners filed out. They were leaving a funeral — her funeral.

Finally, she spotted the man she’d been waiting for. She stepped out of her car, and her husband put his hands on his head in horror.

“Is it my eyes?” she recalled him saying. “Is it a ghost?”

“Surprise! I’m still alive!” she replied.

Far from being elated, the man looked terrified. Five days earlier, he had ordered a team of hit men to kill Rukundo, his partner of 10 years. And they did — well, they told him they did. They even got him to pay an extra few thousand dollars for carrying out the crime.

Now here was his wife, standing before him. In an interview with the BBC on Thursday, Rukundo recalled how he touched her shoulder to find it unnervingly solid. He jumped. Then he started screaming.

“I’m sorry for everything,” he wailed.

But it was far too late for apologies; Rukundo called the police. The husband, Balenga Kalala, ultimately pleaded guilty and was sentenced to nine years in prison for incitement to murder, according to the Australian Broadcasting Corp. (the ABC).

The happy ending — or as happy as can be expected to a saga in which a man tries to have his wife killed — was made possible by three unusually principled hit men, a helpful pastor and one incredibly gutsy woman: Rukundo.

Here is how she pulled it off.

Rukundo’s ordeal began almost exactly a year ago, when she flew from her home in Melbourne with her husband, Kalala, to attend a funeral in her native Burundi. Her stepmother had died, and the service left her saddened and stressed. She retreated to her hotel room in Bujumbura, the capital, early in the evening; despondent after the events of the day, she lay down in bed. Then her husband called.

“He told me to go outside for fresh air,” she told the BBC.

But the minute Rukundo stepped out of her hotel, a man charged forward, pointing a gun right at her.

“Don’t scream,” she recalled him saying. “If you start screaming, I will shoot you. They’re going to catch me, but you? You will already be dead.”

Rukundo, terrified, did as she was told. She was ushered into a car and blindfolded so she couldn’t see where she was being taken. After 30 or 40 minutes, the car came to a stop, and Rukundo was pushed into a building and tied to a chair.

She could hear male voices, she told the ABC. One asked her, “You woman, what did you do for this man to pay us to kill you?”

“What are you talking about?” Rukundo demanded.

“Balenga sent us to kill you.”

They were lying. She told them so. And they laughed.

“You’re a fool,” they told her.

There was the sound of a dial tone, and a male voice coming through a speakerphone. It was her husband’s voice.

“Kill her,” he said.

And Rukundo fainted.

Rukundo had met her husband 11 years earlier, right after she arrived in Australia from Burundi, according to the BBC. He was a recent refugee from Congo, and they had the same social worker at the resettlement agency that helped them get on their feet. Since Kalala already knew English, their social worker often recruited him to translate for Rukundo, who spoke Swahili.

They fell in love, moved in together in the Melbourne suburb of Kings Park, and had three children (Rukundo also had five kids from a previous relationship). She learned more about her husband’s past — he had fled a rebel army that had ransacked his village, killing his wife and young son. She also learned more about his character.

“I knew he was a violent man,” Rukundo told the BBC. “But I didn’t believe he can kill me.”

But, it appeared, he could.

Rukundo came to in the strange building somewhere near Bujumbura. The kidnappers were still there, she told the ABC.

They weren’t going to kill her, the men then explained — they didn’t believe in killing women, and they knew her brother. But they would keep her husband’s money and tell him that she was dead. After two days, they set her free on the side of a road, but not before giving her a cellphone, recordings of their phone conversations with Kalala, and receipts for the $7,000 in Australian dollars they allegedly received in payment, according to Australia’s The Age newspaper.

“We just want you to go back, to tell other stupid women like you what happened,” Rukundo said she was told before the gang members drove away.

Shaken, but alive and doggedly determined, Rukundo began plotting her next move. She sought help from the Kenyan and Belgian embassies to return to Australia, according to The Age. Then she called the pastor of her church in Melbourne, she told the BBC, and explained to him what had happened. Without alerting Kalala, the pastor helped her get back home to her neighborhood near Melbourne.

Meanwhile, her husband had told everyone she had died in a tragic accident and the entire community mourned her at her funeral at the family home. On the night of Feb. 22, 2015, just as the widower Kalala waved goodbye to neighbors who had come to comfort him, Rukundo approached him, the very man whose voice she’d heard over the phone five days earlier, ordering that she be killed.

“I felt like somebody who had risen again,” she told the BBC.

Though Kalala initially denied all involvement, Rukundo got him to confess to the crime during a phone conversation that was secretly recorded by police, according to The Age.

“Sometimes Devil can come into someone, to do something, but after they do it they start thinking, ‘Why I did that thing?’ later,” he said, as he begged her to forgive him.

Kalala eventually pleaded guilty to the scheme. He was sentenced to nine years in prison by a judge in Melbourne.

“Had Ms. Rukundo’s kidnappers completed the job, eight children would have lost their mother,” Chief Justice Marilyn Warren said, according to the ABC. “It was premeditated and motivated by unfounded jealousy, anger and a desire to punish Ms. Rukundo.”

Rukundo said that Kalala tried to kill her because he thought she was going to leave him for another man — an accusation she denies.

But her trials are not yet over. Rukundo told the ABC she’s gotten backlash from Melbourne’s Congolese community for reporting Kalala to the police. Someone left threatening messages for her, and she returned home one day to find her back door broken. She now has eight children to raise alone and has asked the Department of Human Services to help her find a new place to live.

And lying in bed at night, Kalala’s voice still comes to her: “Kill her, kill her,” she told the BBC. “Every night, I see what was happening in those two days with the kidnappers.”

Despite all that, “I will stand up like a strong woman,” she said. “My situation, my past life? That is gone. I’m starting a new life now.”

The Washington Post