The RECOVERY trial for COVID is the trial that keeps giving. Has already identified 3 life-saving treatments. Found 6 treatments to be not useful.
Publicly funded. Clinically relevant
Why are we not able to do such trials in the US?
1) Poor funding for RCTs 2) Too many cooks
The RECOVERY trial in reality is multiple randomized trials in one. Each trial will cost an order of magnitude more to run in the US. We simply do not have the public funding to support RCTs. Which is a tragedy given how much we spend, and how much we can gain. @NIH@NIHDirector
I have led several RCTs. Some through NIH. Some through Pharma.
The NIH trials were like pulling teeth. The Pharma trials were far easier to pull off. So besides lack of funding we also have a process problem for publicly funded trials. See below.
What we have learnt from the RECOVERY trial is not just about the specific treatments that work and that don't work. It's also the road map on how to initiate, fund, review, accrue, complete, disseminate, and publish clinically important RCTs @MartinLandray@NIHRresearch
We also have data that one dose of vaccine is only 33% effective against symptomatic COVID cause by delta variant (AZ or Pfizer). Versus 51% against alpha.
2 doses Pfizer 88% against delta versus 93% against alpha.
For those of you interested in multiple myeloma, here is a brief state of the science for treatment.
1/ For newly diagnosed patients, triplets, VRd or DRd, are the standard of care. Current RCTs are examining if we can improve outcome using quadruplets. Eg. PERSEUS trial.
2/ In newly diagnosed myeloma, another question given the cost & potential toxicity of quadruplets is to start with a triplet, and based on MRD status identify patients who need 4 drugs versus this who do equally well with 3 drugs. Eg: EQUATE trial. @myelomaMD@mtmdphd@eaonc
3/ Auto stem cell transplant is still standard of care for eligible patients. Current data indicate overall survival is similar whether the transplant is done early or delayed. But for many reasons we prefer early transplant for most patients.
The delta variant is the triple threat I have talked about. I am not saying this lightly. I take no pleasure in alarming people. It's just the facts after 2 months of being closely involved with the India COVID crisis. This is not last years COVID. Get vaccinated.
When the FDA approves a drug, it is not only approving the drug. Its actions provide prolonged monopoly protection to a drug in a country where the seller can set whatever price they want, the buyer cannot negotiate price, and competitors will face more severe barriers to entry
If like other Western countries we had a 2-step process for prescription drugs: regulatory approval followed by value based pricing determination, I would have less problem with an FDA that is more lenient.
If like other countries barriers to market entry to competition are not so hard, then I would have less problem with an FDA that is more lenient.
Vaccine hesitancy in alive and well in the US. And it is going to cost lives. The level of vaccination we have in the US is simply not sufficient against the delta variant.
Friends: tell unvaccinated friends to get vaccinated.
Leaders: lead. Talk to your constituents. Beg them
30 million people who got one dose of vaccine need second dose. One dose is not enough.
Another 60-100 million people need to be fully vaccinated.
Get vaccinated even if you had COVID before.
Im trying not to be alarmist even though I'm extremely worried.
The delta variant is a triple threat. It is here.
1) More transmissible: In India, If often if one family member had it, everyone got it.
2) Vaccine evasive: In UK study a single dose of Pfizer or AZ had only 33% protection against symptomatic COVID.
Incidental COVID positive test after full vaccination without COVID symptoms is not COVID.
Better still I have been calling for Reinfection COVID and Post vaccination COVID to have their own names, because the natural history and prognosis will be different.
COVID is the name of a disease: SARS CoV-2 infection in people without prior immunity to SARS CoV-2 infection. It carried a certain hospitalization / mortality rate.
SARS CoV-2 infection in people who previously had COVID or were fully vaccinated are different diseases.
You have to define the natural history of each separately because both for the individual patient and for public policy the implications are different.
It doesn't mean Post Vaccination COVID cant be serious: it means the prognosis from such diagnosis will be different from COVID