1/🔥 Trump loyalists at HHS spent $1.2B of *Pentagon funds* on an unproven #COVID19 drug *after* NIH stopped its trial citing “lack of clinical benefit”

🔸Think: HCQ + convalescent plasma, but worse
🔸Raises ❓ re: FDA’s role, firing of Pentagon chief, delaying Biden transition
2/ 🗓 Timeline
🔸10/26: NIH stops the clinical trial for hospitalized #COVID19 patients early b/c it doesn’t work

🔸10/28: HHS ignores data and buys $375M of the drug anyway using Pentagon (DoD) funds

🔸11/3: Election
3/🗓 Timeline
🔸11/5-11/23: GSA slow-walks certification of Biden victory while…

🔸11/9-11/19: FDA cherry-picks data to issue EUA for drug that was already purchased w/ $375M of DoD funds…and DoD Chief is replaced w/ a Trump loyalist…Mnuchin shuffles COVID funds
4/🗓 Timeline, between 11/9 and 12/30:
🔸Doctors refuse to use the unproven #COVID19 drug citing lack of data

🔸HHS ignores doctors, ignores NIH, has no new data…but still purchases an additional $812M of the drug

🔸DoD and OMB called out for obstructing Biden @Transition46
5/🗓 Timeline, since 12/30/2020:
🔸HHS implements plan that intentionally misleads doctors and hospitals into using the unproven #COVID19 drug as standard of care, despite NIH expressly stating that it should *NOT* be used outside of a clinical trial.

Now, for the receipts…
6/
🔸10/26: NIH stopped its trial of bamlanivimab in hospitalized #COVID19 patients citing “lack of clinical benefit”
It also hinted that safety may have been a concern, but they couldn’t say for sure.

https://www.niaid.nih.gov/news-events/statement-nih-sponsored-activ-3-trial-closes-ly-cov555-sub-study
7/
🔸10/28: HHS ignores NIH statement and data, buys $375M of bamlanivimab anyway using Pentagon (DoD) funds

https://www.defense.gov/Newsroom/Releases/Release/Article/2396750/trump-administration-announces-agreement-to-purchase-eli-lilly-covid-19-investi/
ďżź
7/10/28: HHS ignores NIH statement and data, buys $375M of bamlanivimab anyway using Pentagon (DoD) funds https://www.defense.gov/Newsroom/Releases/Release/Article/2396750/trump-administration-announces-agreement-to-purchase-eli-lilly-covid-19-investi/ďżź
7/10/28: HHS ignores NIH statement and data, buys $375M of bamlanivimab anyway using Pentagon (DoD) funds https://www.defense.gov/Newsroom/Releases/Release/Article/2396750/trump-administration-announces-agreement-to-purchase-eli-lilly-covid-19-investi/ďżź
7/10/28: HHS ignores NIH statement and data, buys $375M of bamlanivimab anyway using Pentagon (DoD) funds https://www.defense.gov/Newsroom/Releases/Release/Article/2396750/trump-administration-announces-agreement-to-purchase-eli-lilly-covid-19-investi/ďżź
8/ Nov 9: FDA issues EUA for bamlanivimab in non-hospitalized patients, this EUA appears to be a foregone conclusion to justify $375M purchase.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibody-treatment-covid-19
9/ Nov 9: FDA’s EUA for bamlanivimab justified $375M purchase, but it was only possible through cherry-pickling of data.

https://www.nejm.org/doi/full/10.1056/NEJMoa2029849
9/ Nov 9: FDA’s EUA for bamlanivimab justified $375M purchase, but it was only possible through cherry-pickling of data. https://www.nejm.org/doi/full/10.1056/NEJMoa2029849
9/ Nov 9: FDA’s EUA for bamlanivimab justified $375M purchase, but it was only possible through cherry-pickling of data. https://www.nejm.org/doi/full/10.1056/NEJMoa2029849
9/ Nov 10: FDA’s EUA for bamlanivimab was a foregone decision— EUA would be granted regardless of what the data said. We know this b/c internal documents show that HHS developed a plan to distribute the drug ahead of time. This “playbook” acknowledges lack of data.
9/ Nov 10: FDA’s EUA for bamlanivimab was a foregone decision— EUA would be granted regardless of what the data said. We know this b/c internal documents show that HHS developed a plan to distribute the drug ahead of time. This “playbook” acknowledges lack of data.
9/ Nov 10: FDA’s EUA for bamlanivimab was a foregone decision— EUA would be granted regardless of what the data said. We know this b/c internal documents show that HHS developed a plan to distribute the drug ahead of time. This “playbook” acknowledges lack of data.
9/ Nov 10: FDA’s EUA for bamlanivimab was a foregone decision— EUA would be granted regardless of what the data said. We know this b/c internal documents show that HHS developed a plan to distribute the drug ahead of time. This “playbook” acknowledges lack of data.
10/ Nov 9-19: FDA cherry-picks data to issue EUA for drug that was already purchased w/ $375M of DoD funds…and DoD Chief is replaced w/ a Trump loyalist…Mnuchin shuffles COVID funds

see:
🔸 https://www.politico.com/news/2020/11/10/pentagon-top-policy-official-resigns-435693

🔸 https://www.forbes.com/sites/sarahhansen/2020/11/19/mnuchin-asks-fed-to-return-unused-cares-act-funds-nixes-emergency-programs/?sh=2082dcae305f

🔸 https://www.wsj.com/articles/ppp-was-a-fraudster-free-for-all-investigators-say-11604832072
10/ Nov 9-19: FDA cherry-picks data to issue EUA for drug that was already purchased w/ $375M of DoD funds…and DoD Chief is replaced w/ a Trump loyalist…Mnuchin shuffles COVID fundssee: https://www.politico.com/news/2020/11/10/pentagon-top-policy-official-resigns-435693 https://www.forbes.com/sites/sarahhansen/2020/11/19/mnuchin-asks-fed-to-return-unused-cares-act-funds-nixes-emergency-programs/?sh=2082dcae305f https://www.wsj.com/articles/ppp-was-a-fraudster-free-for-all-investigators-say-11604832072
10/ Nov 9-19: FDA cherry-picks data to issue EUA for drug that was already purchased w/ $375M of DoD funds…and DoD Chief is replaced w/ a Trump loyalist…Mnuchin shuffles COVID fundssee: https://www.politico.com/news/2020/11/10/pentagon-top-policy-official-resigns-435693 https://www.forbes.com/sites/sarahhansen/2020/11/19/mnuchin-asks-fed-to-return-unused-cares-act-funds-nixes-emergency-programs/?sh=2082dcae305f https://www.wsj.com/articles/ppp-was-a-fraudster-free-for-all-investigators-say-11604832072
10/ Nov 9-19: FDA cherry-picks data to issue EUA for drug that was already purchased w/ $375M of DoD funds…and DoD Chief is replaced w/ a Trump loyalist…Mnuchin shuffles COVID fundssee: https://www.politico.com/news/2020/11/10/pentagon-top-policy-official-resigns-435693 https://www.forbes.com/sites/sarahhansen/2020/11/19/mnuchin-asks-fed-to-return-unused-cares-act-funds-nixes-emergency-programs/?sh=2082dcae305f https://www.wsj.com/articles/ppp-was-a-fraudster-free-for-all-investigators-say-11604832072
10/ Nov 9-19: FDA cherry-picks data to issue EUA for drug that was already purchased w/ $375M of DoD funds…and DoD Chief is replaced w/ a Trump loyalist…Mnuchin shuffles COVID fundssee: https://www.politico.com/news/2020/11/10/pentagon-top-policy-official-resigns-435693 https://www.forbes.com/sites/sarahhansen/2020/11/19/mnuchin-asks-fed-to-return-unused-cares-act-funds-nixes-emergency-programs/?sh=2082dcae305f https://www.wsj.com/articles/ppp-was-a-fraudster-free-for-all-investigators-say-11604832072
11/ Nov 18: Infectious Disease Society recommends *AGAINST* routine use of bamlanivimab, citing lack of evidence

see:
🔸 https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-10
12/ Nov 24: After stalling for nearly 3 weeks GSA Administrator Emily Murphy finally certifies Biden’s victory. But Pentagon, OMB, and other agencies continue to slow-walk, stall, and obstruct the transition.

see:
🔸 https://www.cnn.com/2020/11/23/politics/transition-biden-gsa-begin/index.html
🔸 https://www.wsj.com/articles/democrats-pressure-gsa-to-name-biden-winner-start-transition-11606172086
12/ Nov 24: After stalling for nearly 3 weeks GSA Administrator Emily Murphy finally certifies Biden’s victory. But Pentagon, OMB, and other agencies continue to slow-walk, stall, and obstruct the transition.see: https://www.cnn.com/2020/11/23/politics/transition-biden-gsa-begin/index.html https://www.wsj.com/articles/democrats-pressure-gsa-to-name-biden-winner-start-transition-11606172086
12/ Nov 24: After stalling for nearly 3 weeks GSA Administrator Emily Murphy finally certifies Biden’s victory. But Pentagon, OMB, and other agencies continue to slow-walk, stall, and obstruct the transition.see: https://www.cnn.com/2020/11/23/politics/transition-biden-gsa-begin/index.html https://www.wsj.com/articles/democrats-pressure-gsa-to-name-biden-winner-start-transition-11606172086
13/ Dec 7: HHS buys $812M more of bamlanivimab despite *no new data* and *opposition* from experts

HHS statements suggest shortages, but that claim is undermined by the drugmaker’s communications to its investors.

see:
🔸 https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda
🔸 https://www.biopharma-reporter.com/Article/2020/12/07/Lilly-UnitedHealth-team-up-on-COVID-19-antibody-study-US-government-secures-more-bamlanivimab-doses
13/ Dec 7: HHS buys $812M more of bamlanivimab despite *no new data* and *opposition* from expertsHHS statements suggest shortages, but that claim is undermined by the drugmaker’s communications to its investors.see: https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda https://www.biopharma-reporter.com/Article/2020/12/07/Lilly-UnitedHealth-team-up-on-COVID-19-antibody-study-US-government-secures-more-bamlanivimab-doses
13/ Dec 7: HHS buys $812M more of bamlanivimab despite *no new data* and *opposition* from expertsHHS statements suggest shortages, but that claim is undermined by the drugmaker’s communications to its investors.see: https://investor.lilly.com/news-releases/news-release-details/lillys-neutralizing-antibody-bamlanivimab-ly-cov555-receives-fda https://www.biopharma-reporter.com/Article/2020/12/07/Lilly-UnitedHealth-team-up-on-COVID-19-antibody-study-US-government-secures-more-bamlanivimab-doses
14/ Dec 18: AP reports that only 5-20% HHS’s $1.2B stockpile of bamlanivimab has been used— doctors and patients are (rightfully) skeptical of the data for this #COVID19 drug. Note: this drug was purchased using DoD funds.

see:
🔸 https://apnews.com/article/coronavirus-antibody-drugs-low-demand-05e84fe577459498d255cce8f35a9286
Demand is low for COVID-19 antibody drugs but shortages loom

U.S. health officials are seeing an astonishing lack of demand for COVID-19 medicines that may help keep infected people out of the hospital, drugs they rushed out to states over the past few...

https://apnews.com/article/coronavirus-antibody-drugs-low-demand-05e84fe577459498d255cce8f35a9286
15/ Dec 18: Trump loyalist at DoD abruptly halts Biden @Transition46 talks on the same day that the AP reports that doctors and patients are overwhelmingly refusing to use the unproven #COVID19 drug bamlanivimab. HHS purchased $1.2B worth of the drug using DoD funds. https://twitter.com/jonathanvswan/status/1339959470261215234
16/ Dec 23: NYT reports that the majority of HHS’s $1.2B stockpile of the #COVID19 drug bamlanivimab remains unused— HHS appears to pin the issue on state and local officials, who are busy trying to administer a *proven* drug: #COVID19 vaccines.

see:
🔸 https://www.nytimes.com/2020/12/23/health/covid-antibody-treatment.html
Covid Antibody Drugs Go Unused as Need Soars

While such treatments are promising, their use has been slowed by testing lags, overwhelmed hospitals and a perception the therapies are only for well-connected people.

https://www.nytimes.com/2020/12/23/health/covid-antibody-treatment.html
17/ Dec 27: #COVID19 vaccines are #1 priority for doctors and public health officials — HHS is desperately trying to give away $1.2B bamlanivimab for free but has no takers.

Doctors say “they want more clinical trial data before using”

see:
🔸 https://www.wsj.com/articles/highly-touted-monoclonal-antibody-therapies-sit-unused-in-hospitals-11609087364
Highly Touted Monoclonal Antibody Therapies Sit Unused in Hospitals

Doses of monoclonal antibodies—Covid-19 therapies authorized for emergency use last month—are sitting unused in hospital pharmacies.

https://www.wsj.com/articles/highly-touted-monoclonal-antibody-therapies-sit-unused-in-hospitals-11609087364
18/ Dec 30-31: Biden’s @Transition46 express public frustration over ongoing obstruction by Trump loyalists at DoD and OMB— concerns over #COVID19 budgeting seem to be at the root of the problem.

see:
🔸 https://thehill.com/homenews/administration/532146-biden-frustration-grows-over-lack-of-trump-cooperation-in-transition
🔸 https://www.rollcall.com/2020/12/30/budget-process-covid-spending-being-undermined-by-omb-biden-transition-says/
Biden frustration grows over lack of Trump cooperation in transition

President-elect Joe Biden and his advisers are sounding the alarm about the lack of cooperation from the Trump administration with the transition process.

https://thehill.com/homenews/administration/532146-biden-frustration-grows-over-lack-of-trump-cooperation-in-transition
19/ Since Jan 1, HHS attempts to drive demand for the unproven #COVID19 drug bamlanivimab. HHS Sec. Azar tweets a daily PSA that includes a line that reads like drug promo:

“Ask your doctor about antibody therapies if you test positive & are 65+ or at risk for severe disease”
20/ Since Jan 1, HHS efforts to drive demand for the unproven #COVID19 drug bamlanivimab contradict experts: infectious disease doctors & NIH scientists agree that the drug should NOT be used outside of a clinical trial

see:
🔸 https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/
🔸 https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-10
20/ Since Jan 1, HHS efforts to drive demand for the unproven #COVID19 drug bamlanivimab contradict experts: infectious disease doctors & NIH scientists agree that the drug should NOT be used outside of a clinical trialsee: https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/ https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-10
20/ Since Jan 1, HHS efforts to drive demand for the unproven #COVID19 drug bamlanivimab contradict experts: infectious disease doctors & NIH scientists agree that the drug should NOT be used outside of a clinical trialsee: https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/ https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-10
20/ Since Jan 1, HHS efforts to drive demand for the unproven #COVID19 drug bamlanivimab contradict experts: infectious disease doctors & NIH scientists agree that the drug should NOT be used outside of a clinical trialsee: https://www.covid19treatmentguidelines.nih.gov/statement-on-bamlanivimab-eua/ https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/#toc-10
21/ An internal HHS training document show that HHS’s recent efforts to drive demand for the unproven #COVID19 drug bamlanivimab *intentionally* mislead doctors and hospitals into using the unproven #COVID19 drug as standard of care.
21/ An internal HHS training document show that HHS’s recent efforts to drive demand for the unproven #COVID19 drug bamlanivimab *intentionally* mislead doctors and hospitals into using the unproven #COVID19 drug as standard of care.
21/ An internal HHS training document show that HHS’s recent efforts to drive demand for the unproven #COVID19 drug bamlanivimab *intentionally* mislead doctors and hospitals into using the unproven #COVID19 drug as standard of care.
22/ Since Jan 1, Several HHS officials have made false and misleading statements on-the-record while promoting the use of bamlanivimab outside of a clinical trial:

HHS ASPR Dr. Robert Kadlec
HHS ASPR CMO Dr. Redd

see:
🔸 https://sunrisehospital.com/about/newsroom/hhs-sunrise-hospital-launch-federally-supported-monoclonal-antibody-infusion-clinic-to-treat-covid-19
🔸 https://www.reviewjournal.com/local/local-las-vegas/feds-and-las-vegas-hospital-partner-to-offer-new-covid-treatment-2246080/
22/ Since Jan 1, Several HHS officials have made false and misleading statements on-the-record while promoting the use of bamlanivimab outside of a clinical trial:HHS ASPR Dr. Robert KadlecHHS ASPR CMO Dr. Reddsee: https://sunrisehospital.com/about/newsroom/hhs-sunrise-hospital-launch-federally-supported-monoclonal-antibody-infusion-clinic-to-treat-covid-19 https://www.reviewjournal.com/local/local-las-vegas/feds-and-las-vegas-hospital-partner-to-offer-new-covid-treatment-2246080/
22/ Since Jan 1, Several HHS officials have made false and misleading statements on-the-record while promoting the use of bamlanivimab outside of a clinical trial:HHS ASPR Dr. Robert KadlecHHS ASPR CMO Dr. Reddsee: https://sunrisehospital.com/about/newsroom/hhs-sunrise-hospital-launch-federally-supported-monoclonal-antibody-infusion-clinic-to-treat-covid-19 https://www.reviewjournal.com/local/local-las-vegas/feds-and-las-vegas-hospital-partner-to-offer-new-covid-treatment-2246080/
23/ In the last week, HHS has gone even further by setting up infusion centers, which leverage federal resources in ways that they refuse to do for #COVID19 vaccines.

see:
https://www.phe.gov/newsroom/Pages/default.aspx
23/ In the last week, HHS has gone even further by setting up infusion centers, which leverage federal resources in ways that they refuse to do for #COVID19 vaccines.see: https://www.phe.gov/newsroom/Pages/default.aspx
23/ In the last week, HHS has gone even further by setting up infusion centers, which leverage federal resources in ways that they refuse to do for #COVID19 vaccines.see: https://www.phe.gov/newsroom/Pages/default.aspx
24/ Closing thoughts:
🔸 @COVIDOversight should compel Trump loyalists at HHS, FDA, GSA, Treasury, OMB, and DoD to explain their actions

🔸 FDA officials need to justify their rationale for the EUA issued to bamlanivimab
25/ Closing thoughts (cont):

🔸 HHS ASPR needs to explain why they promoted an investigational #COVID19 drug for use outside the context of a clinical trial —despite NIH and expert guidance explicitly contradicting its use as standard of care.
26/ Closing thoughts (cont):

🔥 HHS Secretary Azar must justify spending $1.2B on this drug. He must also explain why his agency has set up infusion centers for this drug instead of focusing on improving #COVID19 distribution and getting persons vaccinated.

/😷
Seems timely and relevant. https://twitter.com/gregggonsalves/status/1351316182691930113
Adding this here for posterity https://www.hhs.gov/about/news/2021/01/11/hhs-launches-web-based-locator-for-covid-19-outpatient-treatment-sites-for-monoclonal-antibodies.html
HHS Launches Web-Based Locator for COVID-19 Outpatient Treatment

A web-based COVID-19 outpatient treatment locator maintained by the U.S. Department of Health and Human Services (HHS) is now available to assist healthcare

https://www.hhs.gov/about/news/2021/01/11/hhs-launches-web-based-locator-for-covid-19-outpatient-treatment-sites-for-monoclonal-antibodies.html
https://twitter.com/erictopol/status/1351906916532830211
https://twitter.com/erictopol/status/1351963905535315968
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