Sgt. Howard wrote: ↑Mon Jun 15, 2020 11:50 am
???... and... HOW many decades has this drug been prescribed by VA and Civilian MD's, and NOW they need to run trials?
These drugs have been prescribed, for decades, for malaria and for lupus. These are diseases for which there is plenty of historical data (and lots of previous trials) to show that they are actually effective. Even in those applications, the trials showed that these drugs do come with some significant risks (in particular, heart problems) and the prescribing doctors have been well aware of those risks. For those diseases, the effectiveness and benefit usually outweighs the risks.
Over the last few decades, CQ and HCQ have been tried
experimentally as possible treatments against a number of viruses. If I recall correctly, there's long been some evidence that they have some anti-viral properties when used in vitro ("in the test tube"). However, they have not shown actual anti-viral benefits in vivo (when used in medical treatment of actual living patients). That's true of a lot of drugs - things that work in the lab often don't work out well in treatment trials. Sometimes the level of drug required to act as an antiviral is impossible to deliver in a human body, or the drug can't reach or penetrate the cells properly, or the body eliminates it too quickly, or it is unacceptably toxic.
When SARS-CoV-2 showed up, the old interest in the chloroquines arose again... since there was no effective drug treatment for this new virus at all, researchers pulled it off the shelf and started testing it to see if it might work better on this virus. There were one or two small, early, and poorly-controlled "field trials" which seemed to show some benefits. These early studies have received some serious criticism, and everybody agreed that bigger, longer, and more-carefully-controlled tests were required to know how much benefit (if any) CQ and HCQ show against CIVID-19.
(It's very common for early, small tests, and anecdotal reports to claim that drugs have a benefit, while larger, carefully-controlled "blind" tests later show that this benefit wasn't actually there, but was the result of random statistical jitter, bad reporting, pre-selection of patients, etc. That's why we do controlled tests. There's a huge corpus of knowledge about how you run a good controlled test, to make sure that you're measuring the thing you want to learn about, and aren't being confused or mislead by other factors.)
On the basis of those early trials, the FDA issued an "emergency use authorization" for broad-scale distribution and use of CQ and HCQ. This allowed the manufacturers to make and distribute the drugs
for the specific purpose of treating COVID-19 rather than for just the diseases which they'd previously been approved for. The FDA did this to allow for CQ/HCQ treatment (which might, possibly, save lives) while the longer tests were being run. This would (I believe) also create a presumption of legitimacy for doctors prescribing it. This might have saved lives,
if CQ/HCQ were actually effective in practice.
Well, a bunch of the longer and better-controlled tests have reported in. And, unfortunately, the results say "No significant benefit" - not for acutely-ill patients, and not for the mildly-ill either. As before, CQ/HCQ's anti-viral properties seem to work out better in the lab than they do in actual patients.
Some of the tests also showed that the death rate among seriously-ill patients was
higher for those who took CQ/HCQ than for those who took a placebo. This is
not what we wanted to hear.
So, the FDA has rescinded the "emergency use" authorization for the use of CQ/HCQ as a treatment for COVID-19. It is no longer recommended, and (if I understand correctly) its manufacturers can no longer claim that it's an effective treatment.
It can still be prescribed for the uses for which the FDA approved it as being effective (non-resistant malaria, lupus, etc.). And, individual doctors are free to prescribe it "off-label" to COVID-19 patients, if they choose to do so and if their patients want or agree to it (just as other "off-label" uses of most drugs are possible).
But, due to the lack of effectiveness, and the (known-for-decades) risks, it's not now considered a "mainstream" treatment. I imagine that many hospitals and health-care organizations will discourage their doctors from prescribing it off-label, due to the risk of liability if the patient becomes sicker or dies.
So, in the end, two drugs which had been touted as being a "game-changer" against COVID-19 didn't change the game in any good way. They don't work for this purpose. That's a damned shame. It's not a big surprise to the scientific community (they've been tried against related viruses in the past, and didn't work there either) but it's still a shame.
From what I can see, the FDA's decision to issue an EUA for CQ/HCQ against COVID-19 was a reasonable one. Their decision to revoke this EUA was also a reasonable one. The difference between the two, was the time required to go from "There are theoretical reasons to believe it might work, and some weak evidence that it does" to "More complete evidence shows that it does not work."