If you are in the placebo arm of a double blind trial and all the patients in the active arm completely recover in a timely manner - do you know what happens?
They “cut” the red tape that you are complaining about and give you the good stuff.
In an early trial of a targeted cancer drug, Gleevec, 53 of the 54 patients in the active arm went into remission. The trial was immediately suspended and all patients were give the active drug.
BUT THAT ALMOST NEVER HAPPENS. Usually, there is no more than the mildest observational effect at best from clinical studies. It’s not until all the data is analyzed that they may realize that maybe 10% more of the active arm patients got a little better a little faster than patients in the control group. This is often all that can be expected from even an effective drug.
This is particularly true in the classes of medical conditions that are historically intractable -solid tumor cancers, viruses, and autoimmune conditions. Any claims of a cure for any of these conditions should be viewed under the lens of extreme skepticism, especially if the cure is supposedly quick, easy and cheap.
That mentality, in fact, is how we ended up killing more people than we saved in the medical world until the beginning of the 20th century.
A witch doctor just waved some beads over you and sang. A doctor cut you open and made you drink poison.
But first step is and always should have been: First, do no harm.
You need to be certain that, that’s what you’re accomplishing. When doctors stopped healing their patients, a hundred years ago, they all started to get better faster and more consistently than when the doctors intervened.
For millenia, being a doctor was not just an invitation but a mandate to be a serial killer. I’d prefer to not return to that state.
I haven’t read it, but this looks like it might be a more serious look at the subject:
I would be distrustful of the usefulness of any book on medieval European medicine, due to medieval fantasism, hippies, wiccans, etc. Also, the Arabic territories were the first to start applying the scientific method to medicine. E.g.:
And now [this bullshit](The doctor who led the federal agency involved in developing a coronavirus vaccine said on Wednesday that he was removed from his post after he pressed for a rigorous vetting of a coronavirus treatment embraced by President Trump.).
I couldn’t make your link work, here’s another one.
It sounds like Dr. Bright was willing to try testing the drug in hospitals under controlled conditions but he resisted widespread distribution to non-hospitalized patients. Even though Trump used our tax dollars to purchase 29 million doses.
Trump’s not backing off this drug after the testing failures. He’s still going to be convinced it works based on his usual evidence of “what people are saying”. Plus his “evidence uncoverer extraordinaire” Rudy Guiliani has uncovered evidence that it works.
Trump was going to save the day by pushing this drug as a preventative. That was his big story arc. And I bet he’s not going to give up on that, he’ll fire people until he manages to get someone to rubber stamp handing it out en masse.
If you’re dying then there is no point in a double blind study of a single drug. Just take the drug and compare it to other people taking different drugs and see what direction to take.
The insistence of a double blind test in a global emergency automatically leaves out half the people. We should be pulling out all the stops and letting people trained in medicine use their best guess on what to try. yes, it’s a guess, but so is a double blind study.
I just came across a drug that was used on someone who was on a ventilator for 2 weeks. It required FDA approval to try it. Done and done. The person survived.
for those who insist on waiting for a double blind tested drug for treatment then best of luck. There is no cure for this disease and the clock is ticking.
The problem is figuring out who is going to be dying.
Most people who are diagnosed with COVID-19 don’t die; they get better. No, we don’t have a cure, but standard supportive therapies (IV fluids, supplemental oxygen, antibiotics for secondary infections, etc., etc.) can help the majority of patients fight off the disease themselves. In the Chinese data, even among those listed in critical condition slightly more than half survived.
Fatality rates vary wildly by country, and are probably more indicative of diagnosis and testing patterns than anything else, but as I write this, Worldometer is showing 184,235 deaths and 721,734 recoveries. If you had given HCQ to all of those 721,234 people, the odds are high that at least one or two of them, and maybe a whole bunch, would have died from the side effects. You would have killed people who would otherwise have recovered. You INCREASED the death rate.
Double-blind studies help figure out whether you’re doing any good at all; other kinds of studies will help to figure out who is going to recover and who isn’t, early enough in the disease process to change the outcomes of that latter group. Waiting until somebody is on death’s door is likely way too late, but giving the medication too early or to the wrong people may endanger somebody who didn’t need it in the first place. That’s a fine balancing act.
Whether they are, inevitably going to die or not, they are still a limited resource.
If you have 100 dying people, 5 different medicines to test, and you will NOT get useful data out of anything less than 50 on 1 medicine and 50 as a control, then which 1 medicine should you pick for your one test?
a) The medicine that is has previously shown to be likely to do good?
b) Randomly.
c) A medicine that has previously shown to be likely to do more harm than good?
d) Let 'em all die.
e) Test all five medicines, even though you’ll get no information from the results beyond what you already knew.
I think that a is the winning answer. Do you have some argument for one of the other options?
There’s little benefit on testing a drug with people who are literally gasping for their last breath. Nearly all of them are going to die no matter what you do, and wasting time and resources at that stage of the disease is of little use.
The real benefits of drug treatments happens when you test on people who are seriously sick but can recover. The majority of people severely sick with COVID-19 won’t die, unless you give them something that makes things worse. But a good drug treatment may provide early relief and save lives.
I’m tired of posting the same things over and over. Nonetheless, here goes: A doctor does not need FDA approval to prescribe a drug for any purpose (assuming the drug is currently marketed for some indication). Docs can be rightfully skittish about doing so, and many hospital systems will not allow their docs to do so, but docs have that authority.
All the “red tape” and all the need to do properly controlled trials are a direct result of past disasters. Nobody ever sat down and asked “how can we make this harder?” It’s always been “How do we prevent these bad outcomes moving forward?”
And, by the way, setting up a clinical trial isn’t actually that hard. It can be done fairly quickly. It’s phase 3 and the NDA (New Drug Application in the US) that takes a long time. Supply chains have to be in place and validated to submit an NDA- that can take a long time. But in early phases a lot of what takes so long isn’t necessary (supply chains, test methods, etc can be much less robust).
(I’m trying to avoid lots of jargon here; if people really want detail I can provide it, but I find myself rambling when I do that because each term such as method validation or stability studies seems to send me into another paragraph)