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| Trump to Tap New Company to Make Covid-19 Drugs in the U.S. | Trump to Tap New Company to Make Covid-19 Drugs in the U.S. |
| (3 days later) | |
| WASHINGTON — The Trump administration will announce on Tuesday that it has signed a $354 million four-year contract with a new company in Richmond, Va., to manufacture generic medicines and pharmaceutical ingredients that are needed to treat Covid-19 but are now made overseas, mostly in India and China. | WASHINGTON — The Trump administration will announce on Tuesday that it has signed a $354 million four-year contract with a new company in Richmond, Va., to manufacture generic medicines and pharmaceutical ingredients that are needed to treat Covid-19 but are now made overseas, mostly in India and China. |
| The contract, awarded to Phlow Corp. by the Biomedical Advanced Research and Development Authority, meshes President Trump’s “America First” economic promises with concerns that coronavirus treatments be manufactured in the United States. It may be extended for a total of $812 million over 10 years, making it one of the largest awards in the authority’s history. | The contract, awarded to Phlow Corp. by the Biomedical Advanced Research and Development Authority, meshes President Trump’s “America First” economic promises with concerns that coronavirus treatments be manufactured in the United States. It may be extended for a total of $812 million over 10 years, making it one of the largest awards in the authority’s history. |
| “This is an historic turning point in America’s efforts to onshore its pharmaceutical production and supply chains,” Peter Navarro, Mr. Trump’s trade adviser, whose White House portfolio includes the global supply chain, said in a brief interview on Monday evening. The project, he said, “will not only help bring our essential medicines home but actually do so in a way that is cost competitive with the sweatshops and pollution havens of the world.” | “This is an historic turning point in America’s efforts to onshore its pharmaceutical production and supply chains,” Peter Navarro, Mr. Trump’s trade adviser, whose White House portfolio includes the global supply chain, said in a brief interview on Monday evening. The project, he said, “will not only help bring our essential medicines home but actually do so in a way that is cost competitive with the sweatshops and pollution havens of the world.” |
| It was unclear why the administration decided to award such a large contract to a new company when an entire industry exists — known as contract manufacturing — that makes drugs for other companies. However, manufacturers that operate in the United States generally make finished products using raw ingredients imported from elsewhere. They do not make the raw ingredients. | It was unclear why the administration decided to award such a large contract to a new company when an entire industry exists — known as contract manufacturing — that makes drugs for other companies. However, manufacturers that operate in the United States generally make finished products using raw ingredients imported from elsewhere. They do not make the raw ingredients. |
| And Phlow markets itself in boldly nationalist terms. “The United States’ drug supply chain is broken,” its website declares, “becoming dangerously dependent upon foreign suppliers for our most essential generic medicines.” | And Phlow markets itself in boldly nationalist terms. “The United States’ drug supply chain is broken,” its website declares, “becoming dangerously dependent upon foreign suppliers for our most essential generic medicines.” |
| In an interview, Dr. Eric Edwards, the chief executive and president of Phlow, described the company as a “public benefit corporation” that was dedicated to having a social impact, and he said his firm also intended to create “the nation’s first strategic active pharmaceutical ingredient reserve” — in essence, a stockpile for pharmaceutical ingredients to be used in the event of drug shortages or an emergency. | In an interview, Dr. Eric Edwards, the chief executive and president of Phlow, described the company as a “public benefit corporation” that was dedicated to having a social impact, and he said his firm also intended to create “the nation’s first strategic active pharmaceutical ingredient reserve” — in essence, a stockpile for pharmaceutical ingredients to be used in the event of drug shortages or an emergency. |
| “There are not a lot of people wanting to bring back generic medicine manufacturing to the United States that has been lost to India and China over decades,” said Dr. Edwards, who described himself as a “serial entrepreneur” as well as a physician. “You need someone like the federal government saying this is too important for us not to focus on.” | “There are not a lot of people wanting to bring back generic medicine manufacturing to the United States that has been lost to India and China over decades,” said Dr. Edwards, who described himself as a “serial entrepreneur” as well as a physician. “You need someone like the federal government saying this is too important for us not to focus on.” |
| In a statement that the Trump administration plans to release Tuesday morning, Mr. Trump’s health secretary, Alex M. Azar II, called the initiative “a significant step to rebuild our domestic ability to protect ourselves from health threats.” | In a statement that the Trump administration plans to release Tuesday morning, Mr. Trump’s health secretary, Alex M. Azar II, called the initiative “a significant step to rebuild our domestic ability to protect ourselves from health threats.” |
| Phlow will lead a team of private sector entities that includes Civica Rx, a nonprofit created in 2018 by American hospitals to alleviate drug shortages; Ampac Fine Chemicals, a custom manufacturer of pharmaceutical ingredients; and the Medicines for All Institute, a nonprofit arm of the Virginia Commonwealth University’s College of Engineering that also receives funding from the Bill and Melinda Gates Foundation. Dr. Frank Gupton, the founder and chief executive of Medicines for All, sits on Phlow’s board. | Phlow will lead a team of private sector entities that includes Civica Rx, a nonprofit created in 2018 by American hospitals to alleviate drug shortages; Ampac Fine Chemicals, a custom manufacturer of pharmaceutical ingredients; and the Medicines for All Institute, a nonprofit arm of the Virginia Commonwealth University’s College of Engineering that also receives funding from the Bill and Melinda Gates Foundation. Dr. Frank Gupton, the founder and chief executive of Medicines for All, sits on Phlow’s board. |
| Martin van Trieste, the chief executive of Civica Rx, is also on Phlow’s board. And another board member, Rosemary Gibson, is a senior adviser at the Hastings Center, a nonpartisan bioethics institute, who has frequently written and testified about the dangers of the United States’ reliance on Chinese drug manufacturing. | Martin van Trieste, the chief executive of Civica Rx, is also on Phlow’s board. And another board member, Rosemary Gibson, is a senior adviser at the Hastings Center, a nonpartisan bioethics institute, who has frequently written and testified about the dangers of the United States’ reliance on Chinese drug manufacturing. |
| Dr. Edwards said his company would focus on “critical care medicines used to treat hospitalized patients with Covid-19,” including “medicines that are used for sedation to help patients requiring ventilator support, pain management and certain essential antibiotics.” Production has already begun at an Ampac facility, he said, while Phlow builds new plants. | Dr. Edwards said his company would focus on “critical care medicines used to treat hospitalized patients with Covid-19,” including “medicines that are used for sedation to help patients requiring ventilator support, pain management and certain essential antibiotics.” Production has already begun at an Ampac facility, he said, while Phlow builds new plants. |
| China is the main global supplier of the raw ingredients used in many common drugs, including antibiotics like penicillin and painkillers like ibuprofen and aspirin. | China is the main global supplier of the raw ingredients used in many common drugs, including antibiotics like penicillin and painkillers like ibuprofen and aspirin. |
| In recent years, observers like Ms. Gibson have warned about dependence on China for raw pharmaceutical ingredients, pointing to the widespread recalls in 2018 of the blood pressure drug valsartan that were traced to problems at a single Chinese factory that made the drug’s active ingredient, which was contaminated with a possible carcinogen. | In recent years, observers like Ms. Gibson have warned about dependence on China for raw pharmaceutical ingredients, pointing to the widespread recalls in 2018 of the blood pressure drug valsartan that were traced to problems at a single Chinese factory that made the drug’s active ingredient, which was contaminated with a possible carcinogen. |
| Dr. Edwards said Phlow was incorporated in January, though he began working on it last year, before the emergence of the coronavirus. The aim, he said, was “strengthening America’s supply chain and manufacturing American generic medicines at risk of shortage.” He planned at first to use advanced manufacturing technology to produce generic drugs for children. But he switched gears, he said, when the pandemic emerged, and responded to a request from the Biomedical Advanced Research and Development Authority for proposals to use advanced manufacturing to assist in the Covid-19 response. | Dr. Edwards said Phlow was incorporated in January, though he began working on it last year, before the emergence of the coronavirus. The aim, he said, was “strengthening America’s supply chain and manufacturing American generic medicines at risk of shortage.” He planned at first to use advanced manufacturing technology to produce generic drugs for children. But he switched gears, he said, when the pandemic emerged, and responded to a request from the Biomedical Advanced Research and Development Authority for proposals to use advanced manufacturing to assist in the Covid-19 response. |
| Updated June 12, 2020 | |
| 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. | |
| 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. | 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. |
| Dr. Edwards is also a founder of the pharmaceutical company Kaléo, which he created along with his twin brother, Evan Edwards, to sell the Auvi-Q, a competitor to the EpiPen, the emergency allergy treatment. The Auvi-Q, a talking auto-injectable pen, hit the market in 2013 as part of a partnership with the French pharmaceutical giant Sanofi, but Dr. Edwards’s company soon ran into roadblocks. | Dr. Edwards is also a founder of the pharmaceutical company Kaléo, which he created along with his twin brother, Evan Edwards, to sell the Auvi-Q, a competitor to the EpiPen, the emergency allergy treatment. The Auvi-Q, a talking auto-injectable pen, hit the market in 2013 as part of a partnership with the French pharmaceutical giant Sanofi, but Dr. Edwards’s company soon ran into roadblocks. |
| In 2015, the Auvi-Q was recalled after it turned out the product might not have been delivering the proper dosage of epinephrine, the medicine used to stop a dangerous allergic reaction. In 2016, Sanofi ended its relationship with Kaléo and returned the licensing rights. Kaléo relaunched the improved Auvi-Q in 2017. | In 2015, the Auvi-Q was recalled after it turned out the product might not have been delivering the proper dosage of epinephrine, the medicine used to stop a dangerous allergic reaction. In 2016, Sanofi ended its relationship with Kaléo and returned the licensing rights. Kaléo relaunched the improved Auvi-Q in 2017. |
| In 2016, Kaléo ran into a separate controversy with its other product, Evzio, which was similar to the Auvi-Q but delivered an injection of naloxone, which can stop a drug overdose. That year, Kaléo quintupled the price of Evzio, prompting letters from members from Congress who wanted to know why the company had raised the price in the middle of an opioid epidemic. (The company said it did so to cover the cost of a patient assistance program that lowered the out-of-pocket costs for people who could not afford it.) | In 2016, Kaléo ran into a separate controversy with its other product, Evzio, which was similar to the Auvi-Q but delivered an injection of naloxone, which can stop a drug overdose. That year, Kaléo quintupled the price of Evzio, prompting letters from members from Congress who wanted to know why the company had raised the price in the middle of an opioid epidemic. (The company said it did so to cover the cost of a patient assistance program that lowered the out-of-pocket costs for people who could not afford it.) |
| A spokesman for Phlow said Monday night that “Dr. Edwards departed Kaléo on good terms over one year ago and had no oversight of drug pricing during the end of his tenure.” | A spokesman for Phlow said Monday night that “Dr. Edwards departed Kaléo on good terms over one year ago and had no oversight of drug pricing during the end of his tenure.” |