Hydroxychloroquine study "does not meet the Society's expected standard."

The International Society of Antimicrobial Chemotherapy just issued the following statement:

I assume that proper studies are being conducted. This drug, possibly in combination with other drugs, may have some value. Nevertheless, junk science is junk science no matter who advocates for it. Let’s hope that we stop listening to people who don’t understand this.

Rolain’s lab just published another observational study today covering over a thousand patients together with their outcomes using hydroxychloroquine and azithromycin and showing very good outcomes. There are no control groups and no double blinding. Again just an observational study. People who, for whatever reason, don’t like this information put out there are put on notice:-)

Do you believe in the benefits of double blind studies with a control group?

There is an argument that good science sets the parameters in advance and follows through with it. Fiddling with your methodology after the fact is one way to create results out of nothing, because you can find the things that was, by random happenstance, an outlier variable.

Rolain’s methodology was to perform mouth swabs. He ignored people who he couldn’t swab - like people who died.

That he stuck to it is, in the previous sense, good. But it is, obviously, a bad methodology. Sticking to a bad methodology - particularly after people have pointed it out - is also bad science.

If his new study uses a better methodology then that would be good. If he stuck with the old one, then I would be pretty hesitant to accept his numbers until I knew more about what data went missing midway through.

Here’s the table final results. Again this is an observational study only. The control groups studies are still weeks away from producing their results. That said the mortality rate for older patients given hydroxychloroquine and azithromycin early was 0.5%. link below

Doesn’t include methodology.

Who’s in the sample set and who was excluded?

No you’re right only the abstract was published and so methodology isn’t shown. Looks like he’s interested in getting this information out as soon as possible. That said, the mortality rate of 0.5 percent for elderly patients certainly stands out. The medical profession can do with this information what they will. We’ll see how this pans out in a few weeks when the controlled studies finally come out.

The abstract is linked at the bottom of the page linked below – so you’ll have to scroll down.
https://www.mediterranee-infection.com/pre-prints-ihu/

Including transfers is promising (from a perspective of doing proper science). I don’t see your mortality rate in the document.

A 4.3% “poor outcome” rate includes ICU + Death. From the other thread, I believe that the odds of death after being sent to ICU was near 50%, implying that he saw a 2.15% fatality rate.

The expected fatality rate would depend on the ages of his patients (as well as lifestyle habits, etc.). But, in general, anyone under 50 should have something like a 0.1% fatality rate and anyone over should vary between 1% and 9% as you get older.

The average age in his group was 43.6 - it wasn’t just old folks. On the other hand, it was only people who went to a hospital.

Without a control group, it’s hard to say much from this data. It’s not clear to me whether 2.15% would be about right for a placebo or something that is mildly useful.

But certainly you don’t see 2.15% fatality (21.5x more fatal than the common flu) if the treatment is a miracle cure.

If the doctors are selecting patients that they feel are most likely to survive to receive the limited supply of the drug, then the lowered death rate is completely unremarkable.

Unless they also include and treat the patients that are on death’s doorstep when they present themselves for treatment, that statistic is worthless.

The study list 16 patients as still being hospitalized. That is roughly 1.5%. Stating a .5 percent death rate when the fate of these patients is still uncertain is dishonest.

But I think the real flaw is in the lack of a properly selected control cohort. Not exactly garbage, but it’s still not much. In normal times, this might be enough to get funding for a proper study with a control group. It doesn’t come close to proving anything.

Ah, I see that there were 5 deaths.

That could imply a 0.5% fatality rate (5x worse than the flu, but much better than current expectations for Covid-19).

HOWEVER

Yes, I say, HOWEVER…

When did the patients come in (e.g., first get infected)? How long did he track them after March 31?

These are metrics of patients who received treatment during those dates. It’s not clear that this is a set of patients who were all admitted to hospital on March 3rd and tracked for 28 days.

He tells us how much of the medicine the people had in their blood on day 2. Does he have metrics for how much they had in their blood on day 3, or would that be impossible because his last patient came in on March 29?

Minus methodology, this paper is largely meaningless and it’s somewhat suspicious that it would be released without a methodology.

Sorry, just to save anyone from having to consider what I mean, imagine this case:

I have 100 people. If they drink from yonder water fountain then after exactly 25 days, each one of them will die.

On day 1, I ask one of them to drink from yonder water fountain. None of the others drink.

On day 2, I ask a second person to drink from yonder water fountain. None of the others drink.

And so on.

On day 26, the first drinker will die. On day 27, the second will die. And so on.

On day 30, I calculate my fatality rate. Five died. I have a 5% fatality rate.

On day 31, I have the 31st person drink from yonder fountain. He’ll die on the 56th day.

On day 125, the last person in the group perishes. All of them are dead. None of my 100 participants has survived yonder water fountain. Fortunately for me, I calculated the fatality rate on day 30.

My 86-year-old father called me this evening and said he was thinking about going to his doctor and asking for some hydroxychloroquine. :confused: I told him not to waste his time, his doctor’s time, and Medicare’s money, because he’s not going to get any, at least not this way.

As those who follow him might expect, pharma chemist Derek Lowe in his “In The Pipeline” blog has been addressing the hydroxychloroquine studies (and making a pointed effort to ignore the political controversy around the issue aside from occasional snide commentary that is an unavoidable consequence of having to view such a continuous waterfall of ignorance and misinformation). His latest entry from Saturday makes specific observations about the Marseilles IHU study in which it is clear that he considers the stated conclusions dubious even with respect to the reported outcomes, much less questions about the methodological approach and manner of reporting.

Stranger

It may not be garbage, but it will serve the same purpose until we get some actual garbage.

Well, it may not be garbage, but the raccoons have been feasting on it and encouraging their fellows to try out the delicious new treat.

NM, I give up.

“mortality rate for older patients given hydroxychloroquine and azithromycin early was 0.5%” …
Then its not the great treatment that can be used only on the seriously ill … its worth finding out if works better if used earlier ? I guess turning 1% to 0.5% does save lives, even of 20,30,40 year olds with no preexisting serious ailments.

Is Pharma Chemist Derek Lowe a doctor treating a sea of people dying from the virus? If the answer is yes then what is is his recommended treatment? If the answer is no then his opinion should go through a 2 year peer reviewed double blind study.

In the mean time we’re all passengers on the Titanic looking for objects that will float.

The drug in question has been around for 50+ years and it’s side effects are well known and easily monitored in a hospital. If there’s a better drug or drugs then step up and show your work because we’re digging trenches for the dearly departed who couldn’t wait for a 2 year study.

Lowe has been involved in pharmaceutical development and testing for nearly three decades and sits on the editorial board for ACS Medicinal Chemistry Letters. He has seen and written about many promising (or highly promoted) drugs that were not successful in actual trials, either because of unacceptable side effects or lack of observed efficacy.

In the case of the Marseilles IHU group hydroxychloroquine/azithromycin combination study, he is making informed and factual observations about deficiencies in the study and drawing the conclusion which is that outcomes are actually somewhat worse. Just because “drug in question has been around for 50+ years and it’s side effects are well known” does not mean that it is suitable for treating COVID-19 patients, which is what running these studies is about.

And treating patients with an ineffective and potentially harmful medication not only means that they are able to be treated with a more effective interventions (such as remdesivir which is tentatively showing promising results) but it also deprives people with other illnesses such as lupus who are dependent upon hydroxychloroquine for good health from having access to the drug when it is promoted as a “miracle cure” promoted by a non-expert influencer and quacktastic schemers leads to a rash of people (many of whom aren’t even experiencing symptoms of COVID-19) demand off-label prescriptions for it.

What expertise do you bring to the table that your opinion should weigh any merit whatsoever?

Stranger