Dr. Brilliant, whose tiny federal analysis company was pursuing a coronavirus vaccine, had lengthy been at odds along with his boss on the Division
Dr. Brilliant, whose tiny federal analysis company was pursuing a coronavirus vaccine, had lengthy been at odds along with his boss on the Division of Well being and Human Companies, Dr. Robert Kadlec. His White Home visits, twice in a single weekend, solely exacerbated these tensions. “Weekend at Peter’s,” Dr. Kadlec quipped within the topic line of an e mail that expressed his displeasure.
The hostility between these two key officers within the authorities’s response to a pandemic that has claimed greater than 75,000 American lives burst into public view Tuesday when Dr. Brilliant — who was abruptly dismissed final month as head of the Biomedical Superior Analysis and Improvement Authority — filed a proper whistle-blower grievance. The doc accuses Dr. Kadlec and different high administration officers of “cronyism” and placing politics forward of science.
Whether or not the fees are in the end confirmed, the 89-page grievance together with different paperwork and interviews expose troubling infighting on the Well being and Human Companies Division, the sprawling company that features BARDA, the Facilities for Illness Management and Prevention, Nationwide Institutes of Well being, the Meals and Drug Administration and different arms of presidency, as officers there struggled to fight the worst public well being disaster in a century.
“BARDA is the entrance fringe of the worldwide response, by way of organizing the financing, laying down the bets on what’s coming ahead because the choices on vaccines and therapies,” mentioned J. Stephen Morrison, a world well being skilled on the Middle for Strategic and Worldwide Research, including that the infighting had penalties. “They should transfer with unbelievable talent and judgment and velocity.”
The inner clashes prolong past Drs. Brilliant and Kadlec. Fierce battles have erupted between Alex M. Azar II, the well being and human companies secretary, and Seema Verma, the Medicare and Medicaid administrator. Mr. Azar has additionally clashed with a senior White Home policymaker, Joe Grogan.
However the penalties of such clashes had been vividly delivered to life by Dr. Brilliant’s grievance. Electronic mail messages present 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.
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 drugs, vaccines and other “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 poor 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 that Dr. Bright believed was tied to Jared Kushner, Mr. Trump’s son-in-law and senior adviser.
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 deeply 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 does 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.
Dr. Bright was so alarmed about what he claimed were “inappropriate and possibly illegal communications” between Mr. Clerici, Dr. Kadlec, and other H.H.S. officials, the complaint says, that he called for an inspector general to “inspect their phone records.” After that, he says, he was cut out of meetings about the contract.
There is no evidence that an inspector general investigation was ever conducted and allies of Dr. Kadlec say he did make some changes that Dr. Bright had wanted, including putting the contracting team under BARDA’s jurisdiction. But the request for the investigation added to the bitterness between them. Eventually, Dr. Kadlec overruled him, Dr. Bright says, and awarded the 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 40 hours after radiation exposure and without requiring whole blood transfusions.”
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 quickly 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 and made by the pharmaceutical giant Roche, 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 in case a new flu strain emerged that was resistant to Tamiflu.
But Dr. Kadlec, he said, decided instead to spend $40 million to purchase additional doses of oseltamivir, the generic — and much cheaper —- version of Tamiflu. He 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 that could be called upon in 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, zeroed in on Dr. Bright’s 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 also 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.