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Whistle-Blower Exposes Infighting and Animus in Trump’s Coronavirus Response
The allegations suggest personal clashes influenced how the administration responded to the pandemic.
By Sheryl Gay Stolberg, Sharon LaFraniere, Michael D. Shear and Ben Protess
May 9, 2020
Source:https://www.nytimes.com/2020/05/09/...mp-coronavirus.html?smid=tw-nytimes&smtyp=cur
Dr. Robert Kadlec is a subject of a whistle-blower complaint by Dr. Rick Bright.Credit...Anna Moneymaker/The New York Times
WASHINGTON — The call in early February from the White House Situation Room came as a surprise to Rick Bright: Peter Navarro, President Trump’s trade adviser, wanted him to come present his ideas for fighting the coronavirus, alone.
Dr. Bright, whose tiny federal research agency was pursuing a coronavirus vaccine, had long been at odds with his boss at the Department of Health and Human Services, Robert Kadlec. His White House visits, twice in a single weekend, only exacerbated those tensions. “Weekend at Peter’s,” Dr. Kadlec quipped in the subject line of an email that expressed his displeasure.
The hostility between these two key officials in the government’s response to a pandemic that has claimed more than 75,000 American lives burst into public view Tuesday when Dr. Bright — who was abruptly dismissed last month as head of the Biomedical Advanced Research and Development Authority — filed a formal whistle-blower complaint. The document accuses Dr. Kadlec and other top administration officials of “cronyism” and putting politics ahead of science.
Whether or not the charges are ultimately proven, the 89-page complaint along with other documents and interviews expose troubling infighting at the Health and Human Services Department, the sprawling agency that includes BARDA, the Centers for Disease Control and Prevention, National Institutes of Health, the Food and Drug Administration and other arms of government, as officials there struggled to combat the worst public health crisis in a century.
“BARDA is the front edge of the global response, in terms of organizing the financing, laying down the bets on what’s coming forward as the options on vaccines and therapies,” said J. Stephen Morrison, a global health expert at the Center for Strategic and International Studies, adding that the infighting had consequences. “They need to move with incredible skill and judgment and speed.”
The internal clashes extend beyond Drs. Bright and Kadlec. Fierce battles have erupted between Alex M. Azar II, the health and human services secretary, and Seema Verma, the Medicare and Medicaid administrator. Mr. Azar has also clashed with a senior White House policymaker, Joe Grogan.
But the consequences of such clashes were vividly brought to life by Dr. Bright’s complaint. Email messages show that, as early as January, when President Trump was saying the outbreak was “totally under control,” Dr. Bright was pressing for the government to stock up on masks and drugs and to commence a “Manhattan Project” effort to develop a vaccine.
But Dr. Bright was largely sidelined by personal disputes with Mr. Kadlec and his aides, some of which long predated the coronavirus, the documents suggest. By the time the pandemic arrived in force, the relationship between them had become toxic, with Dr. Bright increasingly left out of key decisions. His ideas about battling the threat “were met with skepticism,” the complaint says, “and were clearly not welcome.”
On Friday, lawyers for Dr. Bright said the federal watchdog agency handling his complaint, the Office of Special Counsel, had notified them that it had found “reasonable grounds” to believe he was retaliated against and was seeking his reinstatement for 45 days while it investigated. On Thursday, he is scheduled to testify before a House committee.
Mr. Azar must now decide whether to reinstate Dr. Bright. An H.H.S. spokeswoman, Caitlin Oakley, declined to comment on a “personnel matter.” But, she said, the agency “strongly disagrees with the allegations and characterizations in the complaint from Dr. Bright.”
With a $1.6 billion annual budget, BARDA was created in the aftermath of the Sept, 11, 2001, attacks to partner with industry to develop “medical countermeasures” that could be stockpiled to combat a bioterror attack or pandemic threat. Dr. Bright had been in charge for less than a year when Dr. Kadlec was confirmed by the Senate as assistant secretary for preparedness and response in 2017.
The two men came from different worlds. Dr. Kadlec spent 20 years in the Air Force and helped write the legislation that created BARDA. He advised President George W. Bush on biodefense. Dr. Bright, who grew up in small-town Kansas, began his career at the C.D.C. An influenza expert, he considered a pandemic to be the nation’s biggest threat.
Dr. Bright’s allies say he was viewed with suspicion in the Trump administration as an “Obama holdover.” One of his earliest clashes with Dr. Kadlec centered on a long-running contract BARDA had with a small biotechnology company and a consultant who, Dr. Bright said, invoked Jared Kushner, Mr. Trump’s son-in-law and senior adviser, in an apparent effort to salvage that contract.
The company, Aeolus Pharmaceuticals, was developing a drug to treat the effects of radiation from a potential nuclear attack when BARDA employees decided not to extend the contract in early 2017.
John L. McManus, the company’s chief executive, said in an interview that the decision was based on a flawed process, and appealed it directly to Dr. Bright. In August 2017, Dr. Bright’s complaint says, John M. Clerici, a consultant and Aeolus board member who is close to Dr. Kadlec, pleaded the company’s case to Dr. Bright over coffee and emphasized that Mr. McManus was “friends with Jared” and “has Hollywood connections.”
Mr. McManus said he did not know Mr. Kushner or anyone in his family, and he disputed nearly all of Dr. Bright’s claims about Aeolus. Mr. Clerici said the “conversation never happened.”
A review of corporate, political and nonprofit records shows only a distant and indirect connection between Aeolus and the Kushner family. Some of Mr. Kushner’s relatives have donated to National Jewish Health, a hospital that co-owned several patents licensed by Aeolus, and Mr. Kushner’s father and sister sit on the hospital’s council of national trustees.
Dr. Bright, though, said “the political pressure” from Dr. Kadlec and his underlings “became undeniable,” and “had no place in a system designed to award funding based on scientific merit.” In the end, he stood by BARDA’s decision to not extend the contact with Aeolus. The company folded within months. Mr. McManus lost his job.
In the fall of 2019, with Aeolus bankrupt, Mr. McManus landed at Partner Therapeutics, a Massachusetts-based company represented by Mr. Clerici that also appears in Dr. Bright’s complaint. Dr. Bright said that in September 2019, before Mr. McManus arrived, Dr. Kadlec handed out a $55 million, no-bid contract to the company to prevent it from going out of business.
Partner Therapeutics, with 200 employees, produces and sells a single drug, Leukine, that can be used to treat excessive exposure to radiation.
In 2018, the federal government decided to buy more anti-radiation drugs for the Strategic National Stockpile. Dr. Bright’s division, following the recommendation of a panel of experts, had chosen California pharmaceutical giant Amgen, which produces two similar drugs.
As Mr. Clerici pressed Partner Therapeutics’ case, Dr. Bright, alarmed by the consultant’s contacts with a former BARDA employee, pushed for — and got — an internal “procurement integrity investigation.” He asked investigators to examine Mr. Clerici’s and Mr. Kadlec’s phone records, the complaint said, and even called for an inspector general to investigate. After that, he says, he was cut out of meetings about the procurement inquiry.
There is no evidence that an inspector general investigation was ever conducted. Allies of Dr. Kadlec say he did make some changes that Dr. Bright had wanted, including supporting a directive by Congress to put the contracting team under BARDA’s jurisdiction. But the request for the investigation added to the bitterness between them.
Eventually Dr. Kadlec circumvented Dr. Bright and awarded a new sole-source contract to Partner Therapeutics “on the basis of industrial mobilization” — the interest of the federal government to keep more than one supplier of an important type of drug in business.
Bill McClements, the chief operating officer at Partner Therapeutics, said in an interview that Leukine “is the only drug shown to improve survival when given 48 hours after radiation exposure and without requiring whole blood transfusions.”
But Jessica Tillipman, a procurement expert at George Washington University Law School, said, “If a company is so desperate that one contract is going to keep them afloat, I would be concerned about their ability to perform.”
The clash between the two men intensified in late 2018, as Dr. Kadlec’s office moved to take custody of the Strategic National Stockpile from the C.D.C., asserting control over the drugs, medical equipment and other supplies that would be critical in responding to a pandemic or biological attack.
The dispute centered around a well-known anti-viral drug in the stockpile — Tamiflu — that was expiring just as the United States was entering flu season. A new anti-viral, baloxavir, marketed as Xofluza had just been approved by the F.D.A.
A panel of scientific experts recommended that the government maintain Tamiflu at “current inventory levels,” Dr. Bright says, while also diversifying the stockpile with Xofluza because a new flu strain had emerged that was resistant to Tamiflu.
But the stockpile’s managers, backed by Dr. Kadlec, decided to spend $40 million to purchase additional doses of oseltamivir, the generic — and much cheaper — version of Tamiflu, he said. Dr. Bright accuses Dr. Kadlec of trying to steer the purchase to Alvogen, a company that makes oseltamivir and is a client of Mr. Clerici. As the disagreement escalated, Dr. Bright said his boss ignored his objections, telling him he had “no choice” in the matter.
In fact, Alvogen was the only generic manufacturer that bid for the contract, which was open to any company, including Roche, the maker of Xofluza, which submitted a bid that was rejected as “nonresponsive” by the department’s independent contracting division.
Allies of Dr. Kadlec say he did not steer the contract in any direction and merely pushed for the more cost-effective drug because it was needed to replenish a stockpile ahead of what was expected to be a particularly bad flu season. Several officials, who spoke on condition of anonymity, said that scientific advisers assigned to the stockpile, while open to acquiring baloxavir, differed with the earlier panel, believing it was important to replace the expiring stock of generic Tamiflu quickly.
Nicole Lurie, who held Dr. Kadlec’s job when Barack Obama was president and chose Mr. Bright to lead BARDA the day after Mr. Trump was elected, zeroed in on his description of political appointees overriding the decisions of scientific experts.
“What I find most troublesome is the description of repeated attempts to subvert scientific assessments — the disregard for scientific judgments and the dismantling of the checks and balances that keep you from spending money either illegally or wrongly,” Ms. Lurie said.
The relationship between Dr. Bright and Dr. Kadlec broke last month when Dr. Bright objected to the widespread use of a malaria drug, hydroxychloroquine, that Mr. Trump had promoted as a treatment for Covid-19, and then leaked emails on the subject to a Reuters journalist.
Dr. Bright began sounding alarms on coronavirus within weeks of its emergence in January, expressing a sense of urgency that he felt his superiors and the president did not share. On Jan. 18, the complaint said, he pushed Dr. Kadlec to convene high-level meetings about the virus, but Dr. Kadlec “initially rejected” the request.
Dr. Bright had been in contact with Mike Bowen, an executive at Prestige Ameritech, a mask manufacturer, who had been warning for years that the United States was too dependent on China for its mask supply.
Mr. Bowen, who in an interview called Dr. Bright a “great public servant who didn’t have the authority to do anything,” told Dr. Bright on Feb. 5 that a “Trump insider” had heard his pleas.
“Please ask your associates to convey the gravity of this national security issue to the White House,” Mr. Bowen wrote, two days before Mr. Navarro invited Dr. Bright to meet with him at the White House. “I’m pretty sure you’ll get the chance.”
Kitty Bennett contributed research.
The allegations suggest personal clashes influenced how the administration responded to the pandemic.
By Sheryl Gay Stolberg, Sharon LaFraniere, Michael D. Shear and Ben Protess
May 9, 2020
Source:https://www.nytimes.com/2020/05/09/...mp-coronavirus.html?smid=tw-nytimes&smtyp=cur
Dr. Robert Kadlec is a subject of a whistle-blower complaint by Dr. Rick Bright.Credit...Anna Moneymaker/The New York Times
WASHINGTON — The call in early February from the White House Situation Room came as a surprise to Rick Bright: Peter Navarro, President Trump’s trade adviser, wanted him to come present his ideas for fighting the coronavirus, alone.
Dr. Bright, whose tiny federal research agency was pursuing a coronavirus vaccine, had long been at odds with his boss at the Department of Health and Human Services, Robert Kadlec. His White House visits, twice in a single weekend, only exacerbated those tensions. “Weekend at Peter’s,” Dr. Kadlec quipped in the subject line of an email that expressed his displeasure.
The hostility between these two key officials in the government’s response to a pandemic that has claimed more than 75,000 American lives burst into public view Tuesday when Dr. Bright — who was abruptly dismissed last month as head of the Biomedical Advanced Research and Development Authority — filed a formal whistle-blower complaint. The document accuses Dr. Kadlec and other top administration officials of “cronyism” and putting politics ahead of science.
Whether or not the charges are ultimately proven, the 89-page complaint along with other documents and interviews expose troubling infighting at the Health and Human Services Department, the sprawling agency that includes BARDA, the Centers for Disease Control and Prevention, National Institutes of Health, the Food and Drug Administration and other arms of government, as officials there struggled to combat the worst public health crisis in a century.
“BARDA is the front edge of the global response, in terms of organizing the financing, laying down the bets on what’s coming forward as the options on vaccines and therapies,” said J. Stephen Morrison, a global health expert at the Center for Strategic and International Studies, adding that the infighting had consequences. “They need to move with incredible skill and judgment and speed.”
The internal clashes extend beyond Drs. Bright and Kadlec. Fierce battles have erupted between Alex M. Azar II, the health and human services secretary, and Seema Verma, the Medicare and Medicaid administrator. Mr. Azar has also clashed with a senior White House policymaker, Joe Grogan.
But the consequences of such clashes were vividly brought to life by Dr. Bright’s complaint. Email messages show that, as early as January, when President Trump was saying the outbreak was “totally under control,” Dr. Bright was pressing for the government to stock up on masks and drugs and to commence a “Manhattan Project” effort to develop a vaccine.
But Dr. Bright was largely sidelined by personal disputes with Mr. Kadlec and his aides, some of which long predated the coronavirus, the documents suggest. By the time the pandemic arrived in force, the relationship between them had become toxic, with Dr. Bright increasingly left out of key decisions. His ideas about battling the threat “were met with skepticism,” the complaint says, “and were clearly not welcome.”
On Friday, lawyers for Dr. Bright said the federal watchdog agency handling his complaint, the Office of Special Counsel, had notified them that it had found “reasonable grounds” to believe he was retaliated against and was seeking his reinstatement for 45 days while it investigated. On Thursday, he is scheduled to testify before a House committee.
Mr. Azar must now decide whether to reinstate Dr. Bright. An H.H.S. spokeswoman, Caitlin Oakley, declined to comment on a “personnel matter.” But, she said, the agency “strongly disagrees with the allegations and characterizations in the complaint from Dr. Bright.”
With a $1.6 billion annual budget, BARDA was created in the aftermath of the Sept, 11, 2001, attacks to partner with industry to develop “medical countermeasures” that could be stockpiled to combat a bioterror attack or pandemic threat. Dr. Bright had been in charge for less than a year when Dr. Kadlec was confirmed by the Senate as assistant secretary for preparedness and response in 2017.
The two men came from different worlds. Dr. Kadlec spent 20 years in the Air Force and helped write the legislation that created BARDA. He advised President George W. Bush on biodefense. Dr. Bright, who grew up in small-town Kansas, began his career at the C.D.C. An influenza expert, he considered a pandemic to be the nation’s biggest threat.
Dr. Bright’s allies say he was viewed with suspicion in the Trump administration as an “Obama holdover.” One of his earliest clashes with Dr. Kadlec centered on a long-running contract BARDA had with a small biotechnology company and a consultant who, Dr. Bright said, invoked Jared Kushner, Mr. Trump’s son-in-law and senior adviser, in an apparent effort to salvage that contract.
The company, Aeolus Pharmaceuticals, was developing a drug to treat the effects of radiation from a potential nuclear attack when BARDA employees decided not to extend the contract in early 2017.
John L. McManus, the company’s chief executive, said in an interview that the decision was based on a flawed process, and appealed it directly to Dr. Bright. In August 2017, Dr. Bright’s complaint says, John M. Clerici, a consultant and Aeolus board member who is close to Dr. Kadlec, pleaded the company’s case to Dr. Bright over coffee and emphasized that Mr. McManus was “friends with Jared” and “has Hollywood connections.”
Mr. McManus said he did not know Mr. Kushner or anyone in his family, and he disputed nearly all of Dr. Bright’s claims about Aeolus. Mr. Clerici said the “conversation never happened.”
A review of corporate, political and nonprofit records shows only a distant and indirect connection between Aeolus and the Kushner family. Some of Mr. Kushner’s relatives have donated to National Jewish Health, a hospital that co-owned several patents licensed by Aeolus, and Mr. Kushner’s father and sister sit on the hospital’s council of national trustees.
Dr. Bright, though, said “the political pressure” from Dr. Kadlec and his underlings “became undeniable,” and “had no place in a system designed to award funding based on scientific merit.” In the end, he stood by BARDA’s decision to not extend the contact with Aeolus. The company folded within months. Mr. McManus lost his job.
In the fall of 2019, with Aeolus bankrupt, Mr. McManus landed at Partner Therapeutics, a Massachusetts-based company represented by Mr. Clerici that also appears in Dr. Bright’s complaint. Dr. Bright said that in September 2019, before Mr. McManus arrived, Dr. Kadlec handed out a $55 million, no-bid contract to the company to prevent it from going out of business.
Partner Therapeutics, with 200 employees, produces and sells a single drug, Leukine, that can be used to treat excessive exposure to radiation.
In 2018, the federal government decided to buy more anti-radiation drugs for the Strategic National Stockpile. Dr. Bright’s division, following the recommendation of a panel of experts, had chosen California pharmaceutical giant Amgen, which produces two similar drugs.
As Mr. Clerici pressed Partner Therapeutics’ case, Dr. Bright, alarmed by the consultant’s contacts with a former BARDA employee, pushed for — and got — an internal “procurement integrity investigation.” He asked investigators to examine Mr. Clerici’s and Mr. Kadlec’s phone records, the complaint said, and even called for an inspector general to investigate. After that, he says, he was cut out of meetings about the procurement inquiry.
There is no evidence that an inspector general investigation was ever conducted. Allies of Dr. Kadlec say he did make some changes that Dr. Bright had wanted, including supporting a directive by Congress to put the contracting team under BARDA’s jurisdiction. But the request for the investigation added to the bitterness between them.
Eventually Dr. Kadlec circumvented Dr. Bright and awarded a new sole-source contract to Partner Therapeutics “on the basis of industrial mobilization” — the interest of the federal government to keep more than one supplier of an important type of drug in business.
Bill McClements, the chief operating officer at Partner Therapeutics, said in an interview that Leukine “is the only drug shown to improve survival when given 48 hours after radiation exposure and without requiring whole blood transfusions.”
But Jessica Tillipman, a procurement expert at George Washington University Law School, said, “If a company is so desperate that one contract is going to keep them afloat, I would be concerned about their ability to perform.”
The clash between the two men intensified in late 2018, as Dr. Kadlec’s office moved to take custody of the Strategic National Stockpile from the C.D.C., asserting control over the drugs, medical equipment and other supplies that would be critical in responding to a pandemic or biological attack.
The dispute centered around a well-known anti-viral drug in the stockpile — Tamiflu — that was expiring just as the United States was entering flu season. A new anti-viral, baloxavir, marketed as Xofluza had just been approved by the F.D.A.
A panel of scientific experts recommended that the government maintain Tamiflu at “current inventory levels,” Dr. Bright says, while also diversifying the stockpile with Xofluza because a new flu strain had emerged that was resistant to Tamiflu.
But the stockpile’s managers, backed by Dr. Kadlec, decided to spend $40 million to purchase additional doses of oseltamivir, the generic — and much cheaper — version of Tamiflu, he said. Dr. Bright accuses Dr. Kadlec of trying to steer the purchase to Alvogen, a company that makes oseltamivir and is a client of Mr. Clerici. As the disagreement escalated, Dr. Bright said his boss ignored his objections, telling him he had “no choice” in the matter.
In fact, Alvogen was the only generic manufacturer that bid for the contract, which was open to any company, including Roche, the maker of Xofluza, which submitted a bid that was rejected as “nonresponsive” by the department’s independent contracting division.
Allies of Dr. Kadlec say he did not steer the contract in any direction and merely pushed for the more cost-effective drug because it was needed to replenish a stockpile ahead of what was expected to be a particularly bad flu season. Several officials, who spoke on condition of anonymity, said that scientific advisers assigned to the stockpile, while open to acquiring baloxavir, differed with the earlier panel, believing it was important to replace the expiring stock of generic Tamiflu quickly.
Nicole Lurie, who held Dr. Kadlec’s job when Barack Obama was president and chose Mr. Bright to lead BARDA the day after Mr. Trump was elected, zeroed in on his description of political appointees overriding the decisions of scientific experts.
“What I find most troublesome is the description of repeated attempts to subvert scientific assessments — the disregard for scientific judgments and the dismantling of the checks and balances that keep you from spending money either illegally or wrongly,” Ms. Lurie said.
The relationship between Dr. Bright and Dr. Kadlec broke last month when Dr. Bright objected to the widespread use of a malaria drug, hydroxychloroquine, that Mr. Trump had promoted as a treatment for Covid-19, and then leaked emails on the subject to a Reuters journalist.
Dr. Bright began sounding alarms on coronavirus within weeks of its emergence in January, expressing a sense of urgency that he felt his superiors and the president did not share. On Jan. 18, the complaint said, he pushed Dr. Kadlec to convene high-level meetings about the virus, but Dr. Kadlec “initially rejected” the request.
Dr. Bright had been in contact with Mike Bowen, an executive at Prestige Ameritech, a mask manufacturer, who had been warning for years that the United States was too dependent on China for its mask supply.
Mr. Bowen, who in an interview called Dr. Bright a “great public servant who didn’t have the authority to do anything,” told Dr. Bright on Feb. 5 that a “Trump insider” had heard his pleas.
“Please ask your associates to convey the gravity of this national security issue to the White House,” Mr. Bowen wrote, two days before Mr. Navarro invited Dr. Bright to meet with him at the White House. “I’m pretty sure you’ll get the chance.”
Kitty Bennett contributed research.
