The ugly truth

An explosive whistleblower report, released Tuesday, documents extensive corruption and dysfunction inside the Department of Health and Human Services (HHS) — both before and during the coronavirus pandemic. 

The report was submitted to the HHS Inspector General on Tuesday by Dr. Rick Bright, the former director of the Biomedical Advanced Research and Development Authority (BARDA), an agency within HHS that is responsible "for preparing the nation for influenza pandemics and coordinating production, acquisition, and delivery of medical countermeasures during a pandemic response."

Bright, who has decades of experience in vaccines and has worked for HHS since 2010, alleges that, from the start of the Trump administration, science and public health took a backseat. Instead, decisions were made to reward politically-connected pharmaceutical companies or secure political victories for the administration. The dynamic did not change when COVID-19 reached American shores.  

Bright pushed back against these efforts, with mixed success. He was ultimately removed from his position at BARDA and transferred to a position with less authority at the National Institute of Health. In his whistleblower report, Bright alleges his demotion was retaliation for refusing to play political games when lives were on the line. 

"Friends with Jared"

A recurring character in the whistleblower report is John Clerici, a pharmaceutical industry "consultant" who was also friendly with Bright's boss, Assistant Secretary for Preparedness and Response Dr. Robert Kadlec.

In 2017, BARDA decided to terminate a contract with Aeolus Pharmaceuticals, which was performing research for the agency on radiation-induced lung injury. Clerici, who served on the board of Aeolus Pharmaceuticals, requested to have coffee with Bright. During the conversation, according to Bright's report, Clerici warned Bright that the Aeolus' CEO, John McManus, was a "wildcard" and friends with Trump's son-in-law, Jared Kushner. Clerici also intimated that, unless BARDA reversed its decision, McManus would plant negative stories about Bright in the media.

On August 29, 2017, Mr. Clerici invited Dr. Bright to have coffee with him. During their meeting, Mr. Clerici clearly had the Aeolus contract in mind when he suggested that the BARDA review process was not always “fair.” He also remarked to Dr. Bright that “some of these CEOs are high maintenance,” and then referred specifically to Aeolus’s CEO John McManus, with whom Dr. Bright was scheduled to meet with the next day. Mr. Clerici warned that “McManus is a wildcard, and he is the kind of person who would write stories about you for the newspapers.” Dr. Bright knew this to be true from the articles that had appeared the previous spring. Mr. Clerici also emphasized that Mr. McManus is “friends with Jared [Kushner]” and “has Hollywood connections.” 

When Bright refused to cede to McManus' demands to continue with the contract, McManus directly appealed to Kadlec and his staff. Kadlec's chief-of-staff, Christopher Meekins — who "has no technical or scientific background" — then began advocating for "the merits of the science behind the Aeolus contract." 

Bright resisted this pressure, but it began to sour his relationship with Kaldec. "Mr. Clerici and ASPR staff continued to play an improper and outsized role in several BARDA contracts throughout the remainder of Dr. Bright’s tenure as Director."

$40 million for an inferior drug

In 2018, "Dr. Kadlec and Mr. Meekins instructed Dr. Bright to transfer $40 million to the SNS [Strategic National Stockpile] to purchase generic Oseltamivir, an influenza antiviral drug." Bright said he preferred "a different influenza antiviral drug, Xofluza" because it was recently approved by the FDA. Moreover, " a recent influenza virus had become resistant to Oseltamivir."

Bright then directed "the interagency Flu Risk Management Meeting" to "evaluate the SNS influenza antiviral drug holdings and recommendations." Experts from numerous government agencies validated Bright's intuition and recommended no additional purchases of Oseltamivir. 

Ultimately, the interagency recommendation was ignored, and generic Oseltamivir was purchased "from the pharmaceutical company Alvogen." Bright "learned that Mr. Clerici was representing Alvogen" in its pursuit of the contract. Clerici was communicating directly with Meekins, and possibly Kadlec to advocate for his client.

Kadlec diverted money from Bright's already strained budget to pay Alvogen. When Bright objected, Kadlec said Bright had "no choice" in the matter. 

Unmasked

Beginning on January 13, when COVID-19 spread from China to Thailand, Bright began to press Kadlec "to move quickly, hire more personnel, secure funding and obtain [samples of] viruses to get started on medical countermeasures." Bright's warnings were "repeatedly met with seeming indifference by Dr. Kadlec."

In a January 23 meeting about the pandemic, Bright "expressed concerns about the shortage of N95 masks, which he correctly anticipated would cause a health care crisis among first responders and health care providers." Bright's concerns were ignored, and the same day HHS issued a press release touting that SNS "holds millions of face masks as well as N95 respirators that could be used if needed in responding to a public health emergency when local supplies are exhausted and aren’t available from commercial suppliers.” Bright was excluded from the next high-level meeting on COVID-19. He was told by Bryan Shuy, Kadlec's new chief of staff, that his warnings on masks had caused "quite a shit storm." 

On January 25, Bright sent and email to Kadlec: "Hearing face mask supply is also getting very low as China and HK trying to procure... May need to consider options here also before things are gone." Nothing happened. 

In a February 7 meeting, Bright noted that models predicted "a need for up to 3.5 billion N95 masks to respond to a pandemic." The United States, Bright said, "had a significant shortage and raised concerns that the exportation of masks further depleted an already inadequate supply." In response, Bright was told that the CDC could conserve masks by updating "its guidelines to tell people who 'don't need' masks to not buy them." This is, of course, exactly what happened — to the detriment of Americans' health and safety.

HHS ultimately would not finalize procurement of additional N95 masks until March 12, nearly two months after Bright raised concerns. As a result, doctors and nurses were thrust into the middle of a pandemic without necessary protective equipment. 

Chloroquine chaos

Around March 10, Kadlec and his staff began pressuring Bright "to promote the malaria drug chloroquine as a therapeutic for COVID-19, despite a clear lack of scientific support." Bright believed it was an effort to "score a short-term political victory for the Administration during the escalating health crisis."

A week later, a member of Kadlec's staff emailed to say that Bayer had offered to donate 3 million doses of chloroquine to the SNS. Accepting the donation, the staff member said, "can be a BIG immediate win." Experts on Bright's staff, however, told him there was "no data available to support that chloroquine provides clinical benefit in the treatment or prevention of COVID-19." Accepting the donation, they said, would be a mistake. 

On March 23, Bright received a message from HHS' chief counsel, passed down from the White House, instructing Bright "to drop everything and make the chloroquine donated by Bayer widely available to the American public." 

Bright, however, was increasingly worried about dangerous side effects of chloroquine, "including dangerous irregular heart rhythms and even fatalities—risks that could increase if the drugs were used in combination with other drugs." 

No one with authority in the administration, however, would listen to Bright's concerns. Bright "felt powerless to protect the public from this potentially toxic chemical that HHS, at President Trump’s insistence, was touting as a safe treatment." Ultimately, he spoke to a journalist which "he felt was both a moral and a professional obligation to save lives and protect Americans."

Soon thereafter, Bright was removed from his post. 

Bright's view was ultimately vindicated. Subsequent studies found that chloroquine was ineffective and dangerous. 

In advance of Bright's complaint, Trump fires the HHS Inspector General

Bright's report was filed with the HHS Inspector General. Christi Grimm, who held the post since January, demonstrated her independence by releasing "a report on the shortages in testing and personal protective gear at hospitals during the coronavirus pandemic."

On Friday, however, as Bright prepared to submit his complaint, "Trump announced that he was firing the inspector general" and "nominating a handpicked replacement."

Photo by Kate Ter Haar

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