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Good science takes what?

July 27, 2020

 

Humans, 

Let’s take a look at the conclusion paragraph on the NEJM article that said Hydrochloroquine isn't beneficial.

In this observational study involving patients with Covid-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with Covid-19 are needed. (Funded by the National Institutes of Health.)

See that last line? Randomized, controlled trials... are needed. Why? Because they were reporting on an observational study. Observational studies beget Randomized Control Trials (RTCs). RCTs, the gold standard of studies, is where you have two groups with only one variable that is different. The double-blind versions are the best. This means that the people providing treatment don’t know which of their patients received the treatment and the patients don’t know either. Yes, Double-Blinded RCTs are the hardest, most costly, and time-consuming trials.

Rapid-fire on the need for good science and RCTs:

  • I have three riffs from Dr. Daniel Griffen who provides the clinical updates on TWiV. I have heard him give clinical updates now for 3-4 months once a week. He is smart and well balanced.

    • In the May 31st episode, he explains (1 minute) that the medical mentality is to want to do something, but that we need to slow down for the RCTs.

    • In the May 2 TWiV, he riffs on the need for RCTs during this pandemic. Highly recommended.

    • Here he explains (1 minute) that 90% of phase 1 trials don’t result in the desired outcome. So, if you predict that a new drug or therapy will not work before the studies are done, you will be right 90% of the time. 

  • Jerry Hoffman MD, I have mentioned him before in the PS(s) in this and this letter, riffs (3 minutes) on the dangers of pre-published and non-peer-reviewed studies… aka Medicine by Press Release.

  • Loved this line "There is no room for placebos in engineering” by Seth Godin. Think of building a bridge - do you want to go on the placebo or the real one?

  • Conversations with Dr. Bauchner, Editor in Chief of JAMA, is about 30 min, is excellent, and discusses in depth the need for RCTs.

  • The Lancet and NJEM have retracted 2 papers in the last month. That is almost unheard of. These are two of the BEST medical journals. They were peer-reviewed papers. And, they basically said, “Well sorry, we got that wrong.” That is what happens when you rush science. And, yes, I am concerned about rushing the vaccine. We need to take our time and get this right. Here is a NY Times article on this situation.

  • Don’t take my word on this stuff. Please take 10 min and explore the links.

Stay emotionally connected and physically distant,

Greg

PS: A nice situational analysis from mid-June in the NY Times on the first 6 months of this global pandemic. 

PPS: A longer conversation on vaccines that I thought was interesting.

PPPS: TWiV folks talking about the Moderna vaccine paper. 

PPPPS: You know I'm a complete nerd when I admit to going back and re-listening to old TWiV episodes because I need a refresh. This one from April 29 with Jeff Shaman, a Columbia Univ Prof who studies infectious disease transmission and infectious disease forecasting, is solo good. Almost everything he says still applicable and I learned a ton on the second pass. And yes, I confess, I re-listened to more than one. Here is one with Jon Yewdell, MD PhD back on April 29th. They also discussed how this virus may become yet another coronavirus that causes a common cold after this passes through the population (the same topic from last Letter). Note, he mentions a mortality rate of 3%. We know from the April 30th letter that the term he really meant was “case fatality rate.” But, we also now know it is likely less than 1% and probably much lower than that. My prediction since February has been 0.6% and I believe this number will certainly be closer to the truth (hopefully its a bit lower). WHERE are the huge prevalence studies!!! It is the end of July. That will really give us the answer. OK, OK, I get it. Good science takes time. So I will end the PS section with a quote… “Take your time… hurry up.” - Rip