LAST AMENDMENT (clxxxiii)

DR. RICK BRIGHT: NOT JUST ANOTHER WHISTLEBLOWER COMPLAINT*

Retaliating Against A Scientist Who Resisted The Administration’s Political Advocacy For Untested, Potentially Dangerous Drugs As Treatment For COVID19, Called Out Massive Corruption And Cronyism Within Trump’s HHS, And Exposed The Administration’s Unpreparedness And Refusal To Take Timely, Meaningful Preparation and Mitigation Measures

The Quest, Oil on Canvas, 31.5" x 24", Richard J Van Wagoner, Courtesy of Van Wagoner Family Trust**

I went through the 89-page whistleblower complaint (“Complaint”) Dr. Rick Bright filed with the United States Office of Special Counsel. The bulk of the Complaint comprises a 63 page, single-spaced Addendum in which Dr. Bright gives detailed support for his claims. He complains of illegal personnel practices in the form of retaliation against him for resisting, exposing and calling out massive corruption and cronyism, gross mismanagement and waste, violations of law, rules and regulations, abuses of authority, dangers to public health and safety and censorship related to scientific research.

Who is Dr. Bright? Until moved Dr. Bright was Director of the Biomedical Advanced Research and Development Authority (BARDA), Deputy Assistant Secretary for the Office of Preparedness and Response in the Department of Health and Human Services. For pandemic preparedness and response, his 25 years’ experience working in government, private industry and non-profit settings is impressive and nothing short of extraordinary. He has vast experience in research and development in the areas of new and emerging diseases, infectious diseases, virology, vaccines, anti-viral medications, and pandemic response capabilities here and abroad, including in developing countries.

Parenthetically, the Trump administration did to him what it always does when its misconduct is exposed. It undertook a campaign to attack and discredit Dr. Bright which, frankly, is belied by his extraordinary, well-documented service record at HHS.

https://context-cdn.washingtonpost.com/notes/prod/default/documents/6bfde4d6-4c3d-4671-8eeb-6b3d39e47c03/note/26f73d7a-d060-4c25-af4c-a58a167ee2c7.

The Office of Special Counsel found that Dr. Bright’s complaint “made a threshold determination,” establishing “reasonable grounds to believe” the Trump administration’s Department of Health and Human Services retaliated against him in violation of the Whistleblower Protection Act by removing “Dr. Bright from his position because he made protected disclosures in the best interest of the American public.” The Office of Special Counsel recommends reinstatement for 45 days while it investigates.

Think about that. If true, the Trump administration removed and retaliated against him in the middle of the worst public-health crisis in a century for pushing back against corruption and cronyism and renouncing unscientific and potentially harmful measures the administration and its propaganda machine advocated to make it through the next news cycle, all to the detriment of the American public.

Then again, Dr. Bright’s complaint simply brought to the fore what every fair-minded person who has paid any attention already knew—and knows—about how this administration operates. No substance or strategy, other than to spin its way through to the next news cycle. Misinformation. Disinformation. Deep-state conspiracies. Cronyism. Corruption. Whataboutism. Take no responsibility. Blame others. No short-term pain for long-term gain. No delayed gratification. And, in the face of a pandemic with a highly infectious disease, a willingness to sacrifice American lives at the whim of a malignant narcissist to make it through to that next news cycle.

Why? He has no other answer because he fails every measure of leadership and stewardship. Indeed, in response to a question posed by David Muir of ABC News on how voters should judge his performance in November in response to the pandemic, he said, “I think in a certain way maybe our best work has been on what we’ve done with COVID-19.” Given the unmitigated disaster that “work has been” with 80,000+ deaths and growing, an economy in the tank and no national strategy, it may or may not be his best work.

Below is the Index of the Addendum to Dr. Bright’s Complaint. It succinctly outlines and summarizes the content. Please go to the Complaint itself, linked above, for more detail. Also below is language from two parts of the Addendum itself, the Introduction and the last section in which he ties the protected conduct to the retaliation. I have attempted to remove legal citations where appropriate to make it more readable.

I. Introduction

II. Since 2017, Dr. Bright Has Objected to HHS Leadership’s Cronyism and Award of Contracts to Companies with Political Connections to the Administration.

A. ASPR Staff and John Clerici, an industry consultant and friend of Dr. Kadlec, exerted undue pressure on Dr. Bright to improperly extend a contract with Mr. Clerici’s client, Aeolus Pharmaceuticals.

B. Over Dr. Bright’s objections, ASPR ignored expert recommendations and used BARDA funds to award contracts to Alvogen, one of Mr. Clerici’s clients.

C. ASPR overruled subject matter experts to award a lucrative contract to Partner Therapeutics, one of Mr. Clerici’s clients.

D. Dr. Bright resisted pressure from ASPR to fund a drug touted by Mr. Clerici and his client that lacked scientific merit.

III. With the Emergence of COVID-19, Dr. Bright pushed BARDA to innovate quickly, but within the bounds of the scientific review process.

A. Dr. Bright encountered opposition from Administration officials as he began pressing for necessary resources to begin vaccine, drug, and diagnostic development.

B. Dr. Bright Clashed with HHS Leadership About the Shortage of COVID-19 Testing Materials.

C. Dr. Kadlec and his staff increasingly circumvented Dr. Bright and BARDA in order to direct money without regard to scientific merit.

D. Dr. Kadlec’s animus toward Dr. Bright escalated markedly when Congress for the first time appropriated money directly to BARDA, making it harder for him to siphon off and control BARDA’s funds.

E. Dr. Kadlec tried to bypass Dr. Bright to access BARDA money over Dr. Bright’s objections.

F. Dr. Bright resisted pressure from HHS leadership to make potentially harmful drugs widely available, including chloroquine and hydroxychloroquine, and provided information to a reporter about the specific danger to the public health and safety caused by the Administration’s decision to release these untested drugs for use by the general public.

G. Dr. Bright achieved significant success as Director of BARDA and his removal was blatantly retaliatory.

IV. HHS’s involuntary transfer of Dr. Bright violated the Whistleblower Protection Act.

A. Dr. Bright made protected disclosures under the Whistleblower Protection Act.

B. HHS took a personnel action against Dr. Bright.

C. Dr. Bright’s protected disclosures were a contributing factor in the agency’s personnel action.

D. HHS would not have transferred Dr. Bright to NIH in the absence of his protected disclosures.

E. As a result of HHS’s illegal retaliation, the OSC should request HHS to stay its transfer of Dr. Bright.

“Dr. Rick Bright is an internationally recognized expert in the fields of immunology, therapeutic intervention, vaccine, and diagnostic development. He is also one of the nation’s leading experts in pandemic preparedness and response and in the design of diagnostic tools required to track pandemics, such as COVID-19, a virus that at this writing has infected more than a million people in the United States and has already killed [8]0,000 people in our country alone.

“Dr. Bright earned his PhD in Immunology and Molecular Pathogenesis (Virology) from Emory University, and has 25 years of experience working in government, industry, and nonprofit settings to research and develop drugs and vaccines responsive to emerging infectious diseases and to expand vaccine production capacity in the United States and around the world. He began his career researching viruses, immunology, vaccine development, and antiviral drugs at the Centers for Disease Control and Prevention (‘CDC’), then transitioned into the biotechnology industry to oversee vaccine and immunology programs as the Director of Immunology at Altea Therapeutics. In 2003, the CDC recruited Dr. Bright to return and he worked to evaluate the comparative merits of antiviral drugs and developed rapid tests for antiviral drug resistance to help combat avian flu. In recognition of his exemplary work, the CDC awarded Dr. Bright the Charles C. Shepard Science Award for Scientific Excellence – the most prestigious scientific award CDC confers. In 2006, Dr. Bright returned to the private sector as Vice President of Research and Development and Global Influenza Programs at Novavax, Inc., overseeing the development of new vaccines. In 2008, he joined the international health nonprofit PATH as the Scientific Director of the Influenza Vaccine Project in the Vaccine Development Global Program and the Director of the Influenza Vaccine Capacity Building Project in Vietnam, where he led efforts to accelerate the development and production of vaccines in developing countries.

“In 2010, Dr. Bright joined the Department of Health and Human Services (‘HHS’) as a Program Lead within the Biomedical Advanced Research and Development Authority (‘BARDA’) Influenza Division International Program. In this role, he was responsible for expanding pandemic preparedness capacity to 12 developing countries, providing each with tools and capabilities to respond to a pandemic. In these countries, he led the expansion of vaccine production capacity from less than 1 million doses to a nearly 1 billion dose capacity during his tenure. In 2014, Dr. Bright became the Director of BARDA’s Influenza and Emerging Diseases Division. In this role, he was responsible for preparing the nation for influenza pandemics and coordinating production, acquisition, and delivery of medical countermeasures during a pandemic response. In November 2016, after HHS completed a global competitive selection process, Dr. Bright was appointed Deputy Assistant Secretary for Preparedness and Response and Director of BARDA. Since 2008, Dr. Bright has also served in scientific advisory roles for the U.S. Department of Defense and the World Health Organization (‘WHO’), working to advance vaccines and public health around the world.

“Throughout his tenure as BARDA Director, Dr. Bright provided much needed leadership to this critical government agency and helped turn around an office that previously had high turnover and morale problems. Dr. Bright transformed BARDA into a larger, more stable, and better funded organization, hyper-focused on the single mission of developing drugs and vaccines to save lives. Dr. Bright worked tirelessly to lead a highly skilled technical team of government and industry partners in this mission. His efforts and successes were recognized and reflected in performance appraisals in which he was consistently given the highest possible ratings. See Bright Performance Evaluations . . . . Dr. Bright and his team responded to the Zika and Ebola outbreaks and developed diagnostic tests, therapeutics, and vaccines that are being used today. When COVID-19 emerged as a global threat, Dr. Bright was uniquely positioned to lead BARDA in its crucial work of combating this existential public health threat. However, Dr. Bright repeatedly clashed with his supervisor Dr. Robert Kadlec, Assistant Secretary for Preparedness and Response (‘ASPR’), who took orders from HHS Secretary Alex Azar. Their relationship had been tense since approximately 2018, when Dr. Bright began raising repeated objections to the outsized role Dr. Kadlec allowed industry consultants to play in securing contracts that Dr. Bright and other scientists and subject matter experts determined were not meritorious. Once the COVID-19 pandemic hit, however, Dr. Bright became even more alarmed about the pressure that Dr. Kadlec and other government officials were exerting on BARDA to invest in drugs, vaccines, and other technologies without proper scientific vetting or that lacked scientific merit. Dr. Bright objected to these efforts and made clear that BARDA would only invest the billions of dollars allocated by Congress to address the COVID-19 pandemic in safe and scientifically vetted solutions and it would not succumb to the pressure of politics or cronyism.

“As detailed below, despite Dr. Bright’s efforts to ensure that the U.S. government dedicated the appropriate resources and expert personnel to combat this deadly virus, HHS political leadership leveled baseless criticisms against him for his proactive efforts to invest early in vaccine development as well as in critical supplies such as masks, respirators, and swabs, which were in short supply and would be necessary to combat COVID-19. Thereafter, HHS political leadership retaliated against Dr. Bright for his objections and resistance to funding potentially dangerous drugs promoted by those with political connections and by the Administration itself. Specifically, as detailed in the attached emails and other documentary evidence, Dr. Bright opposed the broad use of chloroquine and hydroxychloroquine as lacking scientific merit, even though the Administration promoted it as a panacea and demanded that New York and New Jersey be “flooded” with these drugs, which were imported from factories in Pakistan and India that had not been inspected by the FDA.

“Dr. Bright felt an urgent and compelling need to inform the American public that there was insufficient scientific data to support the use of these drugs for COVID-19 patients – particularly given their importation from factories abroad that had not been inspected by the FDA. Dr. Bright believed that Americans needed to have this critical information available to them to better inform them of the risks before taking the medicine. He also felt that he had exhausted all avenues to alert government officials, who refused to listen or take appropriate action to accurately inform the public. He concluded that his only remaining avenue was to share his concerns with a journalist who had contacted him and understood the specific issue and risks associated with these drugs and who had already gathered substantial information from multiple sources. Accordingly, Dr. Bright confirmed information for the reporter and provided corroborating documentation. He knew that providing this information to the reporter would place him at odds with HHS leadership. However as the death toll mounted exponentially each day, Dr. Bright concluded that he had a moral obligation to the American public, including those vulnerable as a result of illness from COVID19, to protect it from drugs which he believed constituted a substantial and specific danger to public health and safety.

“Dr. Bright provided the reporter with emails between HHS officials that were not privileged or classified or otherwise legally restricted from dissemination, which discussed the drug’s potential toxicity and demonstrated the political pressure to rush these drugs from Pakistan and India to American households. Dr. Bright hoped that by shining a light on HHS’s reckless and dangerous push to make these drug available, American lives would be saved. HHS leadership, including Secretary Azar and Dr. Kadlec, were already gunning for Dr. Bright’s removal because of other issues he had raised about fraud, waste, and abuse, but they chose to remove him as BARDA Director within days of publication of the article about chloroquine because they suspected that he was the source. Coincidentally, on the very day that they involuntarily removed Dr. Bright from his position, the U.S. Food and Drug Administration (‘FDA’) issued a warning that hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.

“Dr. Bright was removed as BARDA Director and Deputy Assistant Secretary for Preparedness and Response in the midst of the deadly COVID-19 pandemic because his efforts to prioritize science and safety over political expediency and to expose practices that posed a substantial risk to public health and safety, especially as it applied to chloroquine and hydroxychloroquine, rankled those in the Administration who wished to continue to push this false narrative. Similarly, Dr. Bright clearly earned the enmity of HHS leadership when his communications with members of Congress, certain White House officials, and the press – all of whom were, like him, intent on identifying concrete measures to combat this deadly virus – revealed the lax and dismissive attitude HHS leadership exhibited in the face of the deadly threat confronting our country. After first insisting that Dr. Bright was being transferred to the National Institutes of Health (‘NIH’) because he was a victim of his own success, HHS leadership soon changed its tune and unleashed a baseless smear campaign against him, leveling demonstrably false allegations about his performance in an attempt to justify what was clearly a retaliatory demotion.

“Here, the documentary evidence makes clear that Dr. Bright’s removal as BARDA Director was in retaliation for his whistleblowing activity . . . which protects employees who disclose information that reveals ‘any violation of any law, rule, or regulation,’ or ‘gross mismanagement, a gross waste of funds, an abuse of authority, or a substantial and specific danger to public health or safety.’ . . . Securing a stay of Dr. Bright’s reassignment will ensure that during the pendency of the OSC investigation, he will be able to continue to lead BARDA as the agency does its critically important work of partnering with industry to develop life-saving drugs and vaccines and combating the COVID-19 pandemic. . . .

“Dr. Bright has engaged in numerous instances of protected activity under the WPA. First, in objecting to pressure from HHS leadership to ignore scientific merit and expert recommendations and instead to award lucrative contracts based on political connections and cronyism (as he did with the Aeolus, Alvogen, and Partner Therapeutics contracts), Dr. Bright conveyed information he reasonably believed evidenced an abuse of authority or gross mismanagement. As such, these communications were protected disclosures . . . .

“Indeed, Dr. Bright was so concerned about the improper role Mr. Clerici and a former employee turned consultant played in promoting a particular drug and their improper influence with Dr. Kadlec and HHS leaders that he requested the HHS Office of General Counsel initiate a procurement integrity violation investigation. This was a protected disclosure . . . .

“Dr. Bright also engaged in protected activity when he insisted that BARDA funds be apportioned in accordance with their expected benefit. As noted above, Dr. Bright objected to extending a contract that subject matter experts concluded had lost its value to the government (Aeolus), and he resisted the ASPR’s efforts to fund drugs that subject matter experts concluded were inferior to other options (Oseltamivir), or which had not yet been properly tested (EIDD2801). By insisting BARDA allocate money to projects that aligned most closely with the mission of the agency to ‘save lives and protect Americans,’ and refrain from funding projects unsupported by experts in the field, Dr. Bright made protected disclosures of ‘a gross waste of funds.’

“Following the emergence of COVID-19, Dr. Bright engaged in protected activity when he implored HHS leadership to take urgent measures to prepare for the spread of this deadly virus. From January to March 2020, he repeatedly objected to the Administration’s strategy of attempting to contain the virus outside of the United States; its failure to take action to devote resources to vaccine, drug, and diagnostic development; and its failure to secure and produce potentially promising drugs such as Remdesavir, and supplies such as respirators, masks, swabs and syringes. Dr. Bright’s advocacy for these appropriately aggressive measures constitutes protected disclosures of a ‘substantial and specific danger to public health or safety’ . . . because Dr. Bright reasonably believed that the information disclosed “evidence[d] a danger . . . even if the alleged danger was created by a policy decision.” . . .

“When his calls for urgent action fell were dismissed and ignored, Dr. Bright sought political support outside of HHS. He met with White House Trade Advisor Peter Navarro in February 2020 to discuss actions necessary by HHS to combat COVID-19. His disclosures to Mr. Navarro about missteps by HHS were protected disclosures of gross mismanagement, and a substantial and specific danger to public health or safety. . . . The following month, Dr. Bright disclosed to various members of Congress—including Senator Steve Daines (R-MT), Senator Chris Coons (D-CT), Senator Roy Blunt (R-MO), Congresswoman Anna Eshoo (D-CA) and Congresswoman Rosa DeLauro (D-CT)—that, among other things, HHS leadership delayed and withheld money from BARDA allocated by Congress, which hampered diagnostics, drug and vaccine development. These disclosures were protected . . . .

“Dr. Bright additionally engaged in protected activity when he resisted efforts to fall into line with the Administration’s directive to promote the broad use of chloroquine and hydroxychloroquine, even though these drugs lacked scientific merit and had not received prior scientific vetting. In March 2020, scientific experts within BARDA and across HHS through the MCM TF concluded that data to date had shown no clinical benefit of chloroquine and hydroxychloroquine, and that there were “scientific liabilities” associated with Bayer’s donation of chloroquine tablets that came from foreign manufacturers that were not approved by the FDA. When Dr. Kadlec and others in the Administration spoke of ‘flood[ing]’ New York and New Jersey with these drugs, Dr. Bright and his staff repeatedly voiced their concerns. Nevertheless, HHS publicly announced its acceptance of Bayer’s donation, and lauded chloroquine and hydroxychloroquine as ‘potential therapeutics for COVID-19.’ The HHS press release claimed that ‘both drugs have shown activity in laboratory studies against coronaviruses,’ and ‘[a]necdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID19 patients.’ By making public disclosures contrary to the conclusions of its experts, and by failing to disclose the known risks of unapproved foreign drugs, HHS muzzled its experts and instead published information that was politically expedient. When Dr. Bright objected to HHS leadership’s censorship of expert opinion in favor of a political ‘win,’ he engaged in protected activity . . . .

“Finally, Dr. Bright engaged in protected activity when – concerned that his objections were not getting any traction within HHS and lives were at stake – he confirmed to a reporter that HHS had accepted a donation of drugs from Pakistan and India that had not been approved by the FDA and were potentially toxic. Dr. Bright was concerned that HHS actions would seriously harm, or even kill, members of the American public. He agreed to speak with a reporter and confirm this information about the dangers of chloroquine, which was neither classified nor confidential, because he believed transparency on this issue would save lives. The disclosed danger was ‘sufficiently substantial and specific to warrant protection under the WPA’ because it identified an ‘objectively significant and serious danger to public health and safety’ – namely, the mass consumption of unvetted and potentially toxic drugs. . . . With each of these actions, Dr. Bright sought to advance public health and safety by advocating for measures that he and other subject matter experts concluded would best protect the American public. Dr. Bright certainly had a reasonable belief that his disclosures were protected because ‘a disinterested observer with knowledge of the essential facts . . . could reasonably conclude’ that overriding the recommendations of public health experts poses ‘a substantial and specific danger to public health.’”

*My brother the very talented fiction writer and novelist, Robert Hodgson Van Wagoner, deserves considerable credit for offering both substantive and technical suggestions to https://medium.com/@richardvanwagoner and https://lastamendment.com

**Richard J Van Wagoner is my father. His list of honors, awards and professional associations is extensive. He was Professor Emeritus (Painting and Drawing), Weber State University, having served three Appointments as Chair of the Department of Visual Arts there. He guest-lectured and instructed at many universities and juried numerous shows and exhibitions. He was invited to submit his work as part of many shows and exhibitions, and his work was exhibited in a number of traveling shows domestically and internationally. My daughter Angela Moore, a professional photographer, photographed more than 500 pieces of my father's work. On behalf of the Van Wagoner Family Trust, she is in the process of compiling a collection of his art work. The photographs of my father's art reproduced in https://medium.com/@richardvanwagoner and https://lastamendment.com are hers

ravchief

Natural US Citizen. Caucasian. Shamed into blogging by DSM-V Cluster B 9/9-led regime, Utah's most embarrassing congressperson, and Newton's Third Law of Motion. The views expressed are mine.

USA, Utah, Salt Lake City

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