Damed Lies and Statistics

It has been said that there are three kinds of lies: lies, damned lies, and statistics. It has also been said that Trump lies like other people breathe. This habit unfortunately makes it difficult for him to be effective against Covid. The little strand of RNA doesn’t care about “alternate truths”. Years from now, Vivian and Evan, you will wonder why we faired so poorly against this bug. Why other countries did so much better. This New Yorker cover from March sums it up.

When you are faced with a tidal wave of shit heading towards the fan, it is hard to find the individual turds for proverbial forest. But here’s a story of a very small turd on its journey towards the air circulation device dangling from the ceiling: a damned lie about statistics! Stick with me for a few minutes while we skim through basic immunology and some arithmetic.

If you survive an infection, it is because your body’s immune system produced a type of protein called an antibody that helped you fight the infection. In the case of Covid, the antibodies stick to the coronavirus at the very same spikes that the virus uses to enter your cells, thus preventing the virus from entering your cells. Your immune system retains a memory of how to produce these antibodies. If you have a future infection, the production of antibodies ramps up quickly, helping fend off the infection. It takes time to recognize a foreign body and make an effective antibody. Someone who has a fresh infection of Covid may not yet have her own antibodies. If she could get some of your antibodies, she may be temporarily protected against the virus. If you donate your blood for helping others, the antibodies and the liquid part, called Covid-19 convalescent plasma (CCP), is separated from the rest of your blood and injected into a Covid patient in need.

Here’s a quote from Dr. Stephen M. Hahn, the commissioner of the FDA from Sunday. Not from a guy whose cousin knows a janitor at the FDA. The Head of the FDA.

“Many of you know I was a cancer doctor before I became FDA commissioner. And a 35 percent improvement in survival is a pretty substantial clinical benefit. What that means is — and if the data continue to pan out — 100 people who are sick with covid-19, 35 would have been saved because of the admission of plasma.”

This 35% number was repeated by the President. Yes – it would be criminal to not use CCP with these numbers. You would understand why the FDA issued an Emergency Use Authorization (EUA) for Covid convalescent plasma. EUAs are precisely designed for something as miraculous as this. The FDA is effectively saying: go ahead and start saving lives while the scientists keep checking on the safety and benefits. It’s too important to wait!

Last week the heads on two other government organizations, the National Institute of Health, and the National Institute of Allergy and Infectious Diseases (Doctors Collins and Fauci respectively) told the FDA not to issue the EUA. They said that the data to support plasma was too weak. How on earth could they say that about convalescent plasma when it is saving 35 people out of every 100 sick people?

Unfortunately there hasn’t been enough time or plasma to run a nice randomized clinical trial to test the safety and benefit of CCP anywhere in the world. If we had, we would be able say something like this: take 200 people who have Covid. Split them randomly into two groups of 100 each. The first group receives CCP treatment and second doesn’t. X people die in the first group by the time the study ends, and Y people in the second group. If X is heaps less than Y, and X doesn’t have other dangerous side effects, X gets FDA approval to become a drug (my brother, Alu, will tell you it’s a bit more complicated and requires three phases of trials with tens of thousands of test subjects, a small army of scientists and statisticians, and several thousand pages of documentation).

So where did Hahn and Trump’s 35% come from? From this study that hasn’t yet been peer reviewed https://www.medrxiv.org/content/10.1101/2020.08.12.20169359v1.full.pdf. I’ve highlighted the relevant part:

Because there are no randomized clinical tests to fall back on, we must rely on various weaker results. Mayo and other medical organizations around the world have been collecting data on CCP for a while. This data from the Mayo study says that people that received more concentrated plasma (plasma with more antibodies) did better than those who got plasma with lower amounts of antibodies. One week after receiving the high dose plasma, 8.9% had died, while one week after receiving the weaker plasma, 13.7% had died. So if I had two experiments with a 100 sick Covid cases in each, about 9 people die in the first group in 7 days and about 14 people die in the second group in the same time. Now let’s do some simple arithmetic: The first group did 13.7% – 8.9% = 4.8% better than the second. That is an improvement of (4.8/13.7)x100 = 35.04% between the first and second types of plasma treatment. Not, as Hahn stated: What that means is — and if the data continue to pan out — 100 people who are sick with covid-19, 35 would have been saved because of the admission of plasma.

Trump needs a miracle cure for Covid. It’s at least a bit ironic because he has spent the last seven months convincing his people that the disease doesn’t exist or isn’t very harmful. He needs a cure to this non-existent harmless disease before election day. He wishes he could be like Putin and start injecting people with a half baked vaccine that Jared made in the basement. So he has been pressuring the FDA for anything. Issue an EUA for plasma so I can hail it as “a major therapeutic breakthrough on the China Virus” and declare the pandemic over (again). When Collins and Fauci told the FDA that the data supporting plasma was too weak, Trump forced the FDA to act alone. Here’s a link to FDA’s website and a screen grab of the press release. Does this read like a scientific press release headline? How often do they normally mention anything about an “administration” :-)? https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-convalescent-plasma-potential-promising-covid-19-treatment

The scientific discussion about convalescent plasma will continue among researchers till enough data is available. CCP has been used on more than 70,000 patients in the US in the last few months. My friend was instrumental in building the first free plasma bank in Hyderabad to help Covid patients there. Scientists from Wuhan to the middle east are trying to figure out how and when to use plasma to fight Covid. At least one potential vaccine is taking this route. But this isn’t about how good plasma is. This isn’t even about Trump lying about how good plasma is (we’ve become somewhat immune to Trump lying). Our scientists and doctors from the best government scientific institutions are having to lie. Hahn tweeted today to half apologize.

Those that want to re-elect Trump heard him and a top doctor say that 35% fewer people will die now with convalescent plasma treatment. They also saw Trump’s tweet that the deep state is keeping therapeutics from the people. They don’t care about the details. Trump is more important than a few morals or what’s good for the country or scientific honesty.