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C.D.C. Labs Were Contaminated, Delaying Coronavirus Testing, Officials Say C.D.C. Labs Were Contaminated, Delaying Coronavirus Testing, Officials Say
(3 days later)
Sloppy laboratory practices at the Centers for Disease Control and Prevention caused contamination that rendered the nation’s first coronavirus tests ineffective, federal officials confirmed on Saturday.Sloppy laboratory practices at the Centers for Disease Control and Prevention caused contamination that rendered the nation’s first coronavirus tests ineffective, federal officials confirmed on Saturday.
Two of the three C.D.C. laboratories in Atlanta that created the coronavirus test kits violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly all of the 100 state and local public health labs, according to the Food and Drug Administration.Two of the three C.D.C. laboratories in Atlanta that created the coronavirus test kits violated their own manufacturing standards, resulting in the agency sending tests that did not work to nearly all of the 100 state and local public health labs, according to the Food and Drug Administration.
Early on, the F.D.A., which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health, to the C.D.C. labs to assess the problem, several officials said. He found an astonishing lack of expertise in commercial manufacturing and learned that nobody was in charge of the entire process, they said.Early on, the F.D.A., which oversees laboratory tests, sent Dr. Timothy Stenzel, chief of in vitro diagnostics and radiological health, to the C.D.C. labs to assess the problem, several officials said. He found an astonishing lack of expertise in commercial manufacturing and learned that nobody was in charge of the entire process, they said.
Problems ranged from researchers entering and exiting the coronavirus laboratories without changing their coats, to test ingredients being assembled in the same room where researchers were working on positive coronavirus samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.Problems ranged from researchers entering and exiting the coronavirus laboratories without changing their coats, to test ingredients being assembled in the same room where researchers were working on positive coronavirus samples, officials said. Those practices made the tests sent to public health labs unusable because they were contaminated with the coronavirus, and produced some inconclusive results.
In a statement on Saturday, a spokeswoman for the F.D.A., Stephanie Caccomo, said, “C.D.C. did not manufacture its test consistent with its own protocol.”In a statement on Saturday, a spokeswoman for the F.D.A., Stephanie Caccomo, said, “C.D.C. did not manufacture its test consistent with its own protocol.”
The F.D.A. confirmed its conclusions late this week after several media outlets requested public disclosure of its inquiry, which assuredly is part of a larger federal investigation into the C.D.C. lab irregularities by the Department of Health and Human Services.The F.D.A. confirmed its conclusions late this week after several media outlets requested public disclosure of its inquiry, which assuredly is part of a larger federal investigation into the C.D.C. lab irregularities by the Department of Health and Human Services.
Forced to suspend the launch of a nationwide detection program for the coronavirus for a month, the C.D.C. lost credibility as the nation’s leading public health agency and the country lost ground in ways that continue to haunt grieving families, the sick and the worried well from one state to the next.Forced to suspend the launch of a nationwide detection program for the coronavirus for a month, the C.D.C. lost credibility as the nation’s leading public health agency and the country lost ground in ways that continue to haunt grieving families, the sick and the worried well from one state to the next.
To this day, the C.D.C.’s singular failure symbolizes how unprepared the federal government was in the early days to combat a fast-spreading outbreak of a new virus and it also highlights the glaring inability at the onset to establish a systematic testing policy that would have revealed the still unknown rates of infection in many regions of the country. The blunders are posing new problems as some states with few cases agitate to reopen and others remain in virtual lockdown with cases and deaths still climbing.To this day, the C.D.C.’s singular failure symbolizes how unprepared the federal government was in the early days to combat a fast-spreading outbreak of a new virus and it also highlights the glaring inability at the onset to establish a systematic testing policy that would have revealed the still unknown rates of infection in many regions of the country. The blunders are posing new problems as some states with few cases agitate to reopen and others remain in virtual lockdown with cases and deaths still climbing.
While President Trump and other members of his administration assert almost daily that the U.S. testing capacity is greater than anywhere else in the world, many public health officials and epidemiologists have lamented the lack of consistent, reliable testing across the country that would reflect the true prevalence of the infection and perhaps enable a return to some semblance of normal life.While President Trump and other members of his administration assert almost daily that the U.S. testing capacity is greater than anywhere else in the world, many public health officials and epidemiologists have lamented the lack of consistent, reliable testing across the country that would reflect the true prevalence of the infection and perhaps enable a return to some semblance of normal life.
Dr. Robert R. Redfield, the director of the C.D.C., and other health experts have long suggested that contamination in the labs might have been the culprit. But even as several officials at the F.D.A. late this week cited contamination as the cause, a spokesman for the C.D.C., Benjamin Haynes, asserted that it was still just a possibility and that the agency was still awaiting the formal findings of H.H.S.Dr. Robert R. Redfield, the director of the C.D.C., and other health experts have long suggested that contamination in the labs might have been the culprit. But even as several officials at the F.D.A. late this week cited contamination as the cause, a spokesman for the C.D.C., Benjamin Haynes, asserted that it was still just a possibility and that the agency was still awaiting the formal findings of H.H.S.
In a statement, however, he acknowledged that the agency’s quality control measures were insufficient during the coronavirus test development. Since then, he said, “C.D.C. implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”In a statement, however, he acknowledged that the agency’s quality control measures were insufficient during the coronavirus test development. Since then, he said, “C.D.C. implemented enhanced quality control to address the issue and will be assessing the issue moving forward.”
Initially, the C.D.C. was responsible for creating a coronavirus test that state and local public health agencies could use to diagnose Covid-19 in people, and then isolate them to prevent the spread of the disease.Initially, the C.D.C. was responsible for creating a coronavirus test that state and local public health agencies could use to diagnose Covid-19 in people, and then isolate them to prevent the spread of the disease.
“It was just tragic,” said Scott Becker, executive director of the Association of Public Health Laboratories. “All that time when we were sitting there waiting, I really felt like, here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing.”“It was just tragic,” said Scott Becker, executive director of the Association of Public Health Laboratories. “All that time when we were sitting there waiting, I really felt like, here we were at one of the most critical junctures in public health history, and the biggest tool in our toolbox was missing.”
Mr. Becker said that public health laboratories started receiving the C.D.C. kits on Feb. 7, and by the next day members were already calling him to report that the test was not working accurately. He alerted both the C.D.C. and the F.D.A., which regulates medical devices, including laboratory tests.Mr. Becker said that public health laboratories started receiving the C.D.C. kits on Feb. 7, and by the next day members were already calling him to report that the test was not working accurately. He alerted both the C.D.C. and the F.D.A., which regulates medical devices, including laboratory tests.
Updated June 5, 2020 Updated June 12, 2020
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.So far, the evidence seems to show it does. A widely cited paper published in April suggests that people are most infectious about two days before the onset of coronavirus symptoms and estimated that 44 percent of new infections were a result of transmission from people who were not yet showing symptoms. Recently, a top expert at the World Health Organization stated that transmission of the coronavirus by people who did not have symptoms was “very rare,” but she later walked back that statement.
A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.A study by European scientists is the first to document a strong statistical link between genetic variations and Covid-19, the illness caused by the coronavirus. Having Type A blood was linked to a 50 percent increase in the likelihood that a patient would need to get oxygen or to go on a ventilator, according to the new study.
The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.The unemployment rate fell to 13.3 percent in May, the Labor Department said on June 5, an unexpected improvement in the nation’s job market as hiring rebounded faster than economists expected. Economists had forecast the unemployment rate to increase to as much as 20 percent, after it hit 14.7 percent in April, which was the highest since the government began keeping official statistics after World War II. But the unemployment rate dipped instead, with employers adding 2.5 million jobs, after more than 20 million jobs were lost in April.
Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.Mass protests against police brutality that have brought thousands of people onto the streets in cities across America are raising the specter of new coronavirus outbreaks, prompting political leaders, physicians and public health experts to warn that the crowds could cause a surge in cases. While many political leaders affirmed the right of protesters to express themselves, they urged the demonstrators to wear face masks and maintain social distancing, both to protect themselves and to prevent further community spread of the virus. Some infectious disease experts were reassured by the fact that the protests were held outdoors, saying the open air settings could mitigate the risk of transmission.
Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.Exercise researchers and physicians have some blunt advice for those of us aiming to return to regular exercise now: Start slowly and then rev up your workouts, also slowly. American adults tended to be about 12 percent less active after the stay-at-home mandates began in March than they were in January. But there are steps you can take to ease your way back into regular exercise safely. First, “start at no more than 50 percent of the exercise you were doing before Covid,” says Dr. Monica Rho, the chief of musculoskeletal medicine at the Shirley Ryan AbilityLab in Chicago. Thread in some preparatory squats, too, she advises. “When you haven’t been exercising, you lose muscle mass.” Expect some muscle twinges after these preliminary, post-lockdown sessions, especially a day or two later. But sudden or increasing pain during exercise is a clarion call to stop and return home.
States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.States are reopening bit by bit. This means that more public spaces are available for use and more and more businesses are being allowed to open again. The federal government is largely leaving the decision up to states, and some state leaders are leaving the decision up to local authorities. Even if you aren’t being told to stay at home, it’s still a good idea to limit trips outside and your interaction with other people.
Touching contaminated objects and then infecting ourselves with the germs is not typically how the virus spreads. But it can happen. A number of studies of flu, rhinovirus, coronavirus and other microbes have shown that respiratory illnesses, including the new coronavirus, can spread by touching contaminated surfaces, particularly in places like day care centers, offices and hospitals. But a long chain of events has to happen for the disease to spread that way. The best way to protect yourself from coronavirus — whether it’s surface transmission or close human contact — is still social distancing, washing your hands, not touching your face and wearing masks.
Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)If air travel is unavoidable, there are some steps you can take to protect yourself. Most important: Wash your hands often, and stop touching your face. If possible, choose a window seat. A study from Emory University found that during flu season, the safest place to sit on a plane is by a window, as people sitting in window seats had less contact with potentially sick people. Disinfect hard surfaces. When you get to your seat and your hands are clean, use disinfecting wipes to clean the hard surfaces at your seat like the head and arm rest, the seatbelt buckle, the remote, screen, seat back pocket and the tray table. If the seat is hard and nonporous or leather or pleather, you can wipe that down, too. (Using wipes on upholstered seats could lead to a wet seat and spreading of germs rather than killing them.)
Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.Taking one’s temperature to look for signs of fever is not as easy as it sounds, as “normal” temperature numbers can vary, but generally, keep an eye out for a temperature of 100.5 degrees Fahrenheit or higher. If you don’t have a thermometer (they can be pricey these days), there are other ways to figure out if you have a fever, or are at risk of Covid-19 complications.
The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.The C.D.C. has recommended that all Americans wear cloth masks if they go out in public. This is a shift in federal guidance reflecting new concerns that the coronavirus is being spread by infected people who have no symptoms. Until now, the C.D.C., like the W.H.O., has advised that ordinary people don’t need to wear masks unless they are sick and coughing. Part of the reason was to preserve medical-grade masks for health care workers who desperately need them at a time when they are in continuously short supply. Masks don’t replace hand washing and social distancing.
If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.If you’ve been exposed to the coronavirus or think you have, and have a fever or symptoms like a cough or difficulty breathing, call a doctor. They should give you advice on whether you should be tested, how to get tested, and how to seek medical treatment without potentially infecting or exposing others.
If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.If you’re sick and you think you’ve been exposed to the new coronavirus, the C.D.C. recommends that you call your healthcare provider and explain your symptoms and fears. They will decide if you need to be tested. Keep in mind that there’s a chance — because of a lack of testing kits or because you’re asymptomatic, for instance — you won’t be able to get tested.
“This is consistent with what we said was plausible when we found the problem at the beginning,” Mr. Becker said. “When we found the problem, it seemed to our community that it was a contamination issue that would cause a problem to this extent.”“This is consistent with what we said was plausible when we found the problem at the beginning,” Mr. Becker said. “When we found the problem, it seemed to our community that it was a contamination issue that would cause a problem to this extent.”
The F.D.A. concluded that C.D.C. manufacturing issues were to blame and pushed the agency to shift production to an outside firm. That company, I.D.T., accelerated production of the C.D.C. test and says no more issues were reported.The F.D.A. concluded that C.D.C. manufacturing issues were to blame and pushed the agency to shift production to an outside firm. That company, I.D.T., accelerated production of the C.D.C. test and says no more issues were reported.
Meanwhile, the F.D.A. also came under fire for not initially allowing commercial labs like Quest and LabCorp and others to begin ramping up production of their own tests.Meanwhile, the F.D.A. also came under fire for not initially allowing commercial labs like Quest and LabCorp and others to begin ramping up production of their own tests.
More than two months later, nearly 700,000 Americans have become infected and close to 40,000 have died. Testing is still rationed in some states and uneven in others, and it can take days before doctors and patients receive results. Many infectious disease and public health experts say testing is nowhere near widespread enough to reopen the country or return to some semblance of normal.More than two months later, nearly 700,000 Americans have become infected and close to 40,000 have died. Testing is still rationed in some states and uneven in others, and it can take days before doctors and patients receive results. Many infectious disease and public health experts say testing is nowhere near widespread enough to reopen the country or return to some semblance of normal.