Not a political actor, just a former CEO of a decent sized ($200 mil) pharma company, bio major with a med school wife and on the board of a company researching COVID therapeutics: Word for word, although since he's talking to a cousin I doubt he's worried about complete accuracy.
"On the good side, finally someone did a randomized trial so that the baseline severity was well matched. The point of randomization is not to match the baseline, but to to reduce systematic bias.But, it was and open label study, which means both the doctor and the patient know what drug they are on. Without blinding (there are simple ways to blind) neither doctor nor patient are without biases for subjective endpoints (the lower portion of the scale and side effects).Blinding is always better, but in this case the outcomes were in/out of hospital, dead/alive - not a lot of room for bias. Patients on two placebos will always have more side effects than those taking one placebo. QT interval can be higher in HQC and AZT Its HCQ not HQC, and no one in medicine would use AZT for azithromycin because AZT is a different medication (to treat HIV). , so noting higher rates does not mean anything unless there are significant differences in things like arrhythmias. All that said, here are the two disqualifiers for this study. 1) ~50% of all patients in all groups were on HQC and/or AZT within 24 hours of starting the study. It's not 50%. It's 10% on HCQ and 30% on azithromycin.(Rafi's and I discussed this on the last page, this appears to be true). Think about that, 50% of patients that you randomize were already on the drugs before you randomize them. There is no mention of how long the 50% of each group of patients were on HQC and/AZT prior to starting the study, since they don't tell usThey explicitly mention this several times - it's less than 24 hours.. FDA would never let us submit a study with ANY level of study drug used prior to the starting the study (especially with long half life drugs like AZT). The reason is that patients may already have gotten enough of either or both drugs to be headed in the right direction.This is why you randomize. This makes the most important piece of information No, it's not at all." how many doses of both drugs were used prior to enrollment in the study. FDA would not let us use ANY patients like this and would laugh us out of a room where 50% were "prior users of potentially therapeutic amounts of any potentially effective therapy" So, disqualified, no need to read further. If you are a glutton for punishment, there is a second worse reason this study is broken. That is, they allowed up to 14 days of symptoms prior to enrollment!!! Half the patients were enrolled within 7 days. The Yale guy and everyone else told us before March that we needed to start treatment within 4 days. This has been further qualified to 24-48, with the recommendation to start treatment immediately/less than 24 hour from symptoms. We found in our Miami clinical trial that all 7 subjects that tested positive were resolved within 14 days. Again, they set this study up completely wrong if they wanted to fairly assess the potential of HQC.
The rest of this is where he just goes off into conspiracy theories that make no sense.Of Course, this is where the Yale doctor is exactly right. Many people do/did not want to study the potential of a therapeutic fairly. When you do undisciplined studies and have a bias, it's junk science. garbage in = garbage out. But also, think about my first point, 50% of the patients who showed up at the hospital were already on one or both of these drugs. That is the real truth behind the study. In second world countries 50% of patients with symptoms are getting these drugs and Americans are not, in a large part because the people made it political. The Yale doctor did a nice job of explaining the flaws in many of the early studies but did not cover this one. He also mentioned that a large share of the patients in developed and developing nations started receiving HQC with AZT or doxycycline in March. I can only imagine how many tens of thousands of lives could have been spared in the US, if patients and doctors were not deterred from prescribing them. Many of those front line doctors took either or both drugs for months in the hopes they would be protective or prophylactic. The Yale Doctor is right, everyone with a positive COVID test and symptoms and/or risk factors should be offered HQC. If they progress, they should get IV remdesivir."
Me: What I don't get is why can't someone simply do a trial under the scenarios you describe, Even with something being political that's not preventing someone from doing it, right? Getting someone within 24 hours is probably the hard part.
"Well most groups did not do a randomized, placebo controlled blinded study. The Henry Ford Hospital system in Michigan did a good on (large as in 2600 but not purely randomized) and showed a 50% benefit. Getting within 24 hours of symptoms starting is hard work, but that's what clinical trials are. That's why we spend hundreds of millions to do this. If you wanted to use the drug broadly to blunt COVID early on, that's what you would do. Lots of people try to do studies all the time to "prove their hypothesis" and some don't want to see a drug or therapy work. But with COVID ethics committees and IRBs let almost everything through (lots of junk and the junk overwhelmed the good studies) and then journals are letting almost anything be published at th eback end. You could ask yourself, if you were an acedmic who lives and dies by publications and whose whole department loathes the Trump Administration, why WOULD you spend the time and money to do it right and really see if it works"
Me: But I guess what I'm saying is right now politically if you support the trump admin, you'd fund the trial show the benefit and it may well sway the election. Oh and you'd spend the money to maybe save some lives? Presumable there's someone in the world that cares about saving lives, also probably plenty of people in different countries who don't care about american politics as much.
Him. "It's disgusting, and I think more of these authors should be punished (blocked from conducting trials/publishing for a few years or something) the studies they have pursued and then published. The Yale guy is right. Most of these people know better and have blood on their hands. Academics don't have the money to do blinded studies and closing the hospitals to wait for covid patients damn near bankrupted many. And if your buddy is going to get published quicker and easier for less money, where will the money come from. Yes ethics committees and IRBs should be sanctioned. They let almost anything through. Lots of it junk. There are good studies supporting HQC, you just have to look for them. When negative studies come along they are published as "pre print" before peer reviewed with the specious claims and the press picks them up. You never hear about the authors revoking their names, the corrections after peer review or the ultimate rejections. Everyone just remembers there are "so many" studies showing that HQC doesn't work. I have friends on Facebook say last year they hoped we had a horrible recession this year so Trump isn't re-elected. I responded that this would mean tens of millions of people would be out of work and lives imperiled. They responded that they would not be affected and the ends justify the means. Once the "ends justify the means" anything can be done if you hate Trump enough.
