What if Lilly's monoclonal antibody trial was stopped due to futility? 1. A pause at 300 patients after 5 days of treatment was pre-specified in the protocol nytimes.com/2020/10/13/hea… by @KatherineJWu@katie_thomas
2. Trials have stopping rules for 3 main reasons:
—futility (further enrollment would not show benefit)
—safety (the intervention appears to have a hazard that precludes further enrollment)
—efficacy (the efficacy evidence is overwhelming and it would not be ethical to proceed)
3. Since the pause was pre-specified and Lilly announced a "potential safety concern," we don't know yet if it was for futility or safety. So far there have not been safety issues disclosed for the monoclonal antibody programs w/ now thousands of patients enrolled (Ab or placebo)
This is the 1st USA documented reinfection
Conclusion: "All individuals, whether previously diagnosed with COVID-19 or not, should take identical precautions to avoid infection w/ #SARSCoV2."
Several more global cases are in process of peer review now. Appears rare, but possible
Recall I had sent an open letter to him August 31 after the convalescent plasma "breakthrough" press conference, w/o any supportive evidence, and the prior EUA on hydroxychloroquine medscape.com/viewarticle/93…
He didn't take either option I suggested. He called me. 2/
We've since spoken several times and now I understand his intentions, what he's been through, the immense pressures that have been placed upon him. For me, the trust in him and the FDA has been restored. 3/
Dr. Conley does it again. He clears Trump for public engagements in 2 days, without evidence that he is not infectious, without viral load data, without providing when/timeline he became infected.
Yesterday Dr. Conley ordered & reported a positive IgG antibody test in a patient who received a massive dose of IgG antibodies.
Today, without even committing to simple PCR tests to verify Trump is not shedding virus, he's cleared to meet with large crowds of unmasked people.
BTW CDC Guideline of 10 days (this is 9 days) is a *guideline*. This is a unique individual (in many ways) who received monoclonal antibodies, not expected to achieve mucosal immunity. And the early dexamethasone would suppress T cell response.
Here's some of the things we discussed and learned from @cmyeaton 1. What prompted her to become an epidemiologist?
2. Dr. Yeaton and colleagues wrote the essential report in April providing guidance for reopening. @JHSPH_CHS centerforhealthsecurity.org/our-work/pubs_…
If only the states had adhered to the guidelines, we could have achieved containment of the virus
On today's message from Trump about his mAb treatment: "The gave me Regeneron" "at my suggestion" "I felt well immediately"
He now claims: "I call it a cure," "I've authorized the EUA" "Everyone will get them free"
All false. All predictable.