Read on Twitter
(1/ ) What the whistleblower complaint by Dr. Bright tells us about the N95 mask shortage: a thread. #medtwitter #GetMePPE #GetUsPPE #SoMeDocs
Link to full complaint here. https://www.kmblegal.com/sites/default/files/NEW%20R.%20Bright%20OSC%20Complaint_Redacted.pdf?fbclid=IwAR1yKIoYlEmThSZwWlK06GV3uU5kEA2yovnlQiMwm6U0CF2Z2TE-YYUQgC0
Link to full complaint here. https://www.kmblegal.com/sites/default/files/NEW%20R.%20Bright%20OSC%20Complaint_Redacted.pdf?fbclid=IwAR1yKIoYlEmThSZwWlK06GV3uU5kEA2yovnlQiMwm6U0CF2Z2TE-YYUQgC0
(2/ ) First, some hx about the Strategic National Stockpile (SNS). SNS used to be controlled by CDC. On 1/26/09, 11d after 1st US H1N1 infection, CDC authorized release of 39M masks, gloves, gowns, and face shields. That's how it's supposed to work. https://www.cdc.gov/h1n1flu/cdcresponse.htm
(3/ ) In 2018, control of the SNS was transferred away from the CDC to HHS, and placed under the Assistant Secretary for Preparedness and Response (ASPR) https://www.washingtonpost.com/news/to-your-health/wp/2018/04/24/inside-the-secret-u-s-stockpile-meant-to-save-us-all-in-a-bioterror-attack/
(4/ ) Dr. Kadlec is the current ASPR in charge of the SNS. His interest is in bioterrorism, not pandemic response. In 2011 he stated: "Mother Nature doesn’t develop highly virulent organisms that are resistant to our current stockpiles of antibiotics." https://www.washingtonpost.com/investigations/before-pandemic-trumps-stockpile-chief-put-focus-on-biodefense-an-old-client-benefited/2020/05/04/d3c2b010-84dd-11ea-878a-86477a724bdb_story.html
(5/ ) Dr. Bright, the complainant, has been the director of Biomedical Advanced Research and Development Authority (BARDA) since 2016. He has years of experience w flu, Ebola, Zika. Under his direction, BARDA helped fund development of 1st Ebola vaccine. https://endpts.com/the-head-of-barda-leaves-position-as-agency-enters-unprecedented-vaccine-campaign/
(5/ ) Back to the complaint. On Jan 18, Dr Bright became very worried about the threat COVID posed to US, and requested a disaster leadership group meeting (DLG) to plan response. Dr. Kadlec replied by email that he was “[n]ot sure if that is a time sensitive urgency.” (p. 16)
(6/ ) Dr Kadlec might not have thought COVID posed an urgent threat, but at least one govt agency did. On Jan 21 Mike Bowen, VP of mask manufacturer Prestige Ameritech
contacted Dr Bright to let him know that DHS had approached them about buying masks. (p. 17)
contacted Dr Bright to let him know that DHS had approached them about buying masks. (p. 17)
(7/ ) On Jan 22, Mr Bowen emailed Dr Bright again that they had 4 unused N95 manufacturing lines that could be reactivated “in a dire situation and with government help” and expressed concern that US reliance on mask imports could lead to a critical shortage (p. 17) #GetMePPE
emailed Dr Bright again that they had 4 unused N95 manufacturing lines that could be reactivated “in a dire situation and with government help” and expressed concern that US reliance on mask imports could lead to a critical shortage (p. 17) #GetMePPE
(8/ ) Jan 23: the DLG meeting Dr Bright requested on 1/18 finally happened. Dr Bright discussed imminent need for tests, drugs, vaccines, and N95s, but “Dr. Kadlec plowed through the abbreviated meeting... paying short shrift to the concerns that Dr. Bright raised.” (p. 18)
(9/ ) Jan 23-25, Mr Bowen repeatedly emailed Dr Bright that they were getting mask requests from China and Hong Kong, ~50% of US masks are imported, and “if the supply stops, US hospital will run out of masks". Dr Bright fwded to HHS Critical Infrastructure Protection (p. 19)
repeatedly emailed Dr Bright that they were getting mask requests from China and Hong Kong, ~50% of US masks are imported, and “if the supply stops, US hospital will run out of masks". Dr Bright fwded to HHS Critical Infrastructure Protection (p. 19)
(10/ ) Jan 25: Dr Bright notified Dr Kadlec and the directors of BARDA’s Influenza and Emerging Infectious Diseases and Medical Countermeasures programs of low mask supply in China/HK, and asked that they to request SNS funds to buy masks from Prestige Ameritech (p. 19)
(11/ ) Jan 26-27: Again, Mr Bowen warned that the “US mask supply is at imminent risk”. Again, Dr Bright urged HHS Critical Infrastructure Protection (CIP) and BARDA Medical Countermeasures (MCM) officials to act to prevent an the impending mask shortage (p. 19) #GetMePPE
warned that the “US mask supply is at imminent risk”. Again, Dr Bright urged HHS Critical Infrastructure Protection (CIP) and BARDA Medical Countermeasures (MCM) officials to act to prevent an the impending mask shortage (p. 19) #GetMePPE
(12/ ) Jan 27: Mr Bowen wrote Dr Bright to say he'd spoken to HHS CIP director Dr. Laura Wolf about the tenuous mask supply chain, but no action was taken. His email concluded “I think we’re in deep shit. The world.” (p. 19) #MedTwitter #GetMePPE #GetUsPPE
wrote Dr Bright to say he'd spoken to HHS CIP director Dr. Laura Wolf about the tenuous mask supply chain, but no action was taken. His email concluded “I think we’re in deep shit. The world.” (p. 19) #MedTwitter #GetMePPE #GetUsPPE
(13/ ) Also Jan 27: this story quotes an HHS spokesperson that SNS “holds millions of face masks as well as N95 respirators that could be used... in responding to a public health emergency when local supplies are exhausted.” Nothing to see here, folks. https://www.axios.com/coronavirus-surgical-face-masks-america-2cdae7d0-edf4-4d29-b24e-b10f16cbcd84.html
(14/ ) Jan 29: Mr Bowen told Dr Bright they'd already sent 1M masks to China, warned China might stop mask exports. "If so, US hospitals are going to have a very rough time, as up to half of the supply is made in China. A horrible situation will become unbearable." (p. 21)
told Dr Bright they'd already sent 1M masks to China, warned China might stop mask exports. "If so, US hospitals are going to have a very rough time, as up to half of the supply is made in China. A horrible situation will become unbearable." (p. 21)
(15/ ) Mr Bowen suggested going to the press to raise awareness of the impending mask shortage, since HHS wasn't taking it seriously. In this Feb 4 story, he warned that mask shortages in China and US dependence on imports could lead to a dire shortfall https://www.wired.com/story/amid-coronavirus-fears-a-mask-shortage-could-spread-globally/
suggested going to the press to raise awareness of the impending mask shortage, since HHS wasn't taking it seriously. In this Feb 4 story, he warned that mask shortages in China and US dependence on imports could lead to a dire shortfall https://www.wired.com/story/amid-coronavirus-fears-a-mask-shortage-could-spread-globally/
(16/ ) In the same story, Mr Bowen described his company's response to H1N1- production increased to 24h/day, adding a new building, hiring 150 people to staff a third shift. This is the experience he'd brought to HHS for 2wks, who still had taken no action to acquire masks.
described his company's response to H1N1- production increased to 24h/day, adding a new building, hiring 150 people to staff a third shift. This is the experience he'd brought to HHS for 2wks, who still had taken no action to acquire masks.
(17/ ) In early Feb, Dr Bright tried a different tactic, and added provisions for domestic mask production to BARDA’s budget request. Those provisions were removed after ASPR said that mask production should fall under the purview of their SNS budget (p. 22) #GetUsPPE
(18/ ) Feb 7. Another DLG meeting. Dr. Bright and Dr. Patel of CDC stressed urgency of mask acquisition, citing models projecting need for 3 billion N95s in a pandemic. ASPR leads maintained there was “no indication of a supply chain shortage or of issues with masks”. (p. 23)
(19/ ) Per ASPR leads, the plan was for CDC to tell people not to buy masks they don’t need. Dr Bright replied “Do you really believe that changing a CDC guideline to tell people not to wear masks would reduce the panic people would feel once this virus spreads?” (p. 23)
(20/ ) After dead ends w HHS, Dr Bright rec'd an email requesting a meeting w WH Trade Adviser Peter Navarro after a Trump insider read the Wired story and Mr. Bowen told them "you’re the guy who knows that I’m telling the truth... please don't let American down" (p. 23)
told them "you’re the guy who knows that I’m telling the truth... please don't let American down" (p. 23)
(21/ ) Dr. Bright met with Mr. Navarro on Feb 8, and the next day Mr Navarro sent a memorandum to the White House Coronavirus Task Force recommending that N95 export be immediately halted and domestic mask production be increased. (p. 24) #GetMePPE #GetUsPPE #MedTwitter
(22/ ) Apparently miffed by Dr Bright going over his head, Dr. Kadlec sent an email to HHS officials about the meeting w Mr Navarro derisively titled “Weekend at Peter’s”. Although Dr Kadlec did announce N95 procurement would be prioritized, no action was taken. (p. 25-26)
(23/ ) On Feb 14, Dr Kadlec briefed Mr Navarro on masks, acknowledging the need for up to 6 billion N95s, but concluding there were “no known immediate problems with supply chains”. Later that day, Dr Bright drafted a memo to WHTF again urging domestic N95 production (p. 26)
(24 ) ... to be continued momentarily, as I've reached Twitter's thread limit.
(25/ ) On Feb 15, Mr Bowen rec'd a 5 pg form from the FDA to explain his ability to produce N95s. He responded that BARDA was the only agency who recognized mask shortage as a national security problem, and if they’d been listened to, they’d already have the masks. (pp. 27-28)
rec'd a 5 pg form from the FDA to explain his ability to produce N95s. He responded that BARDA was the only agency who recognized mask shortage as a national security problem, and if they’d been listened to, they’d already have the masks. (pp. 27-28)
(26/ ) Feb 25, after being briefed several times about billions of masks needed in a pandemic, Sec Azar testified to the Senate Appropriations Committee that 300M N95s were needed and the SNS had 30M. Feb 26 he clarified that SNS only had 12M N95s https://www.cnn.com/asia/live-news/coronavirus-outbreak-02-26-20-intl-hnk/h_d18cf0c9f803033ffdeff947ad1bae26
(27/ ) At the end of February, HHS still had placed no orders for masks. On March 2, the NY Times reported that the Commerce Department had advertised to industry that relaxed Chinese regulations would make it easier for masks to be exported. #GetMePPE https://www.nytimes.com/2020/03/02/business/stock-market-today.html
(28/ ) Indeed, this report from @RepKatiePorter shows a staggering increase in exports during the period Dr Bright & others advocated for increased domestic production. Mask exports in Feb 2020 were valued at nearly $84M, up 1094% from 2019 monthly avg https://porter.house.gov/uploadedfiles/everyone_but_us.pdf
(29/ ) On Mar 4, HHS finally issued a RFP for N95s, and closed a contract on Mar 12, over 7 weeks after Mr Bowen first offered a domestic N95 production site. Rep. Porter's report indicates most PPE contracts will not be completed until July-Sep 2020.
https://www.hhs.gov/about/news/2020/03/04/hhs-to-procure-n95-respirators-to-support-healthcare-workers-in-covid-19-outbreaks.html
first offered a domestic N95 production site. Rep. Porter's report indicates most PPE contracts will not be completed until July-Sep 2020.https://www.hhs.gov/about/news/2020/03/04/hhs-to-procure-n95-respirators-to-support-healthcare-workers-in-covid-19-outbreaks.html
(30/ ) In Dr Bright's complaint, Mr Bowen, an industry figure, futilely urged HHC to increase domestic mask production. Meanwhile Commerce Dept advertised opportunity for exports that were a windfall for industry. And there's more than a hint of petty office politics throughout
, an industry figure, futilely urged HHC to increase domestic mask production. Meanwhile Commerce Dept advertised opportunity for exports that were a windfall for industry. And there's more than a hint of petty office politics throughout
(31/ ) QTNA: Did industry lobby against halting exports? Did anyone with decision making capacity in HHS have financial ties to companies benefiting from the surge in PPE exports in Jan/Feb? Why did it take 7 weeks of meetings and briefings for ASPR to close a RFP for N95s?
(32/ ) Meanwhile, HCWs are falling sick by the thousands and no one is even systematically counting us. A month ago, there were over 9K HCWs with COVID, from only 16% of reports. Spare us the banners and flyovers. Just #GetUsPPE
#MedTwitter
END https://www.theguardian.com/us-news/2020/apr/15/coronavirus-us-health-care-worker-death-toll-higher-official-data-suggests
#MedTwitter
END https://www.theguardian.com/us-news/2020/apr/15/coronavirus-us-health-care-worker-death-toll-higher-official-data-suggests
