A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals. There were more deaths among those given hydroxychloroquine versus standard care, researchers reported.
The nationwide study was not a rigorous experiment. But with 368 patients, it’s the largest look so far of hydroxychloroquine with or without the antibiotic azithromycin for COVID-19, which has killed more than 171,000 people as of Tuesday. The study was posted on an online site for researchers and has been submitted to the New England Journal of Medicine, but has not been reviewed by other scientists. Grants from the National Institutes of Health and the University of Virginia paid for the work.
Researchers analyzed medical records of 368 male veterans hospitalized with confirmed coronavirus infection at Veterans Health Administration medical centers who died or were discharged by April 11. About 28% who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone. About 22% of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival. Hydroxychloroquine made no difference in the need for a breathing machine, either.
Researchers did not track side effects, but noted hints that hydroxychloroquine might have damaged other organs. The drug has long been known to have potentially serious side effects, including altering the heartbeat in a way that could lead to sudden death.
Earlier this month, scientists in Brazil stopped part of a hydroxychloroquine study after heart rhythm problems developed in one-quarter of people given the higher of two doses being tested. (AP News)
————
This was not a rigorously designed experiment and from what I’ve seen, VA patients almost inevitably have multiple heath problems before they walk into the clinic or VA hospital. We’re a pretty banged up, broken down lot. However, the VA is skilled at doing this kind of evaluation of their vast patient population. Through their Million Veteran Program, they are conducting myriad studies involving genetic samples and health records. The results of this VA study is sobering and seems to help answer Trump’s question of what do you have to lose.
In response to this study and several prematurely ended studies, Fauci’s “National Institute of Allergy and Infectious Diseases recommends against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of potential toxicities.
Maybe those with lupus and rheumatoid arthritis will have an easier time getting their medication. We have to do something with our stockpiled 29 million pills. Still, more studies need to be done. Perhaps an effective treatment involving hydroxychloroquine will be developed when we understand Covid-19 better. We're still learning of the full range of damage this virus is capable of inflicting. Maybe it will be an effective prophylactic, not a magic shield or miracle potion, but a helpful prophylactic. There’s no reason to give up on this or any other proposed treatment or cure.
TTG
https://apnews.com/a5077c7227b8eb8b0dc23423c0bbe2b2
https://www.medrxiv.org/content/10.1101/2020.04.16.20065920v1.full.pdf
More studies, for sure. I always find it interesting other your take on VA matters...thank you for sharing your perspective to those of us without experience with the VA.
Posted by: Laura Wilson | 22 April 2020 at 02:56 PM
To be clear, the Institue guidance recommends agains the combination of HCQ and AZ. It makes to recommendation for or against HCQ by itself. These recommendations are only fo hospitalized pts. There are no recommendations for or against drugs for prophylaxis.
In our own internal studies we found higher rates of arrhythmias on HCQ and AZ, and found more problems related to AZ. We have stopped that. HCQ is no longer part of our standard protocol but docs may order it if they choose.
Steve
Posted by: steve | 22 April 2020 at 04:12 PM
The brazil study was of the Chloroquine diphosphate which has greater side effects than of the hydroxy form. The big trial is the one in NY state. Those results are not yet in.
The interesting news is that ventilators are not required in all cases and indeed my do more harm for some. BoJo was only on a cpap. The harm mechanism may be impaired hemoglobin. These medcram youtubes linked below are topnotch!
https://www.youtube.com/watch?v=qc6VV7ue4cE
Posted by: will.2718 | 22 April 2020 at 04:29 PM
My mail order pharmacy, Express Scripts via TriCare, will not dispense Hydroxychoroquine unless for Lupus and other rheumatoid diseases or Malaria if prescribed. Ditto for my local pharmacy. Jim the local pharmacist says that his pharmaceutical trade association is advising pharmacies to not dispense it for Covid19. They are worried about hoarding, which would cut off the supply to Lupus and Arthritis patients.
Regarding the cartoon at the top of your post: the "I only have a small stake in its manufacturer". Is that election propaganda? Snopes says it is mostly BS. But I would not put it past his son-in-law.
Posted by: Leith | 22 April 2020 at 04:33 PM
From Didier Raoult on twitter: https://twitter.com/raoult_didier
"The study published in pre-print on 04/21 on Medrxiv by Maganoli et al has three major biases which invalidate its conclusions, in any case absurd and incompatible with the literature. We have detailed these biases in the letter below."
https://www.mediterranee-infection.com/wp-content/uploads/2020/04/Response-to-Magagnoli.pdf
Posted by: A.S | 22 April 2020 at 05:19 PM
Thank you for your thoughtful post TTG. It may still be that the drug has a useful effect. I know Fauci is infuriating a lot of people, but he is right: a double blind placebo controlled trial is the only way to really know.
Off topic, but when my wife had breast cancer she took part in such a trial of a new drug. That involved extra free visits to hospital for testing. We guessed she was given the drug afterwards because her oncologist and surgeon surprisingly found that her lymph nodes had been scoured clean of the cancer. It’s now about four years of remission. The new drug is apparently going to be the new standard for treatment of that type of cancer.
Posted by: walrus | 22 April 2020 at 05:23 PM
Professor Didier Raoult has completed a further study of the efficacy of HCQ_AZ in treating COVID-19. The cohort size was 1061. https://www.mediterranee-infection.com/early-treatment-of-1061-covid-19-patients-with-hydroxychloroquine-and-azithromycin-marseille-france/
The conclusion was "The HCQ-AZ combination, when started immediately after diagnosis, is a safe and efficient treatment for COVID-19, with a mortality rate of 0.5%, in elderly patients. It avoids worsening and clears virus persistence and contagiosity in most cases."
Dr Zelenko, a US GP, had success with HCQ+AZ+zinc in treating his COVID-19 patients so that they did not need to be admitted to hospital http://archive.is/iBZFZ
Posted by: cirsium | 22 April 2020 at 05:24 PM
TTG,
"Fauci’s “National Institute of Allergy and Infectious Diseases recommends against doctors using a combination of hydroxychloroquine and azithromycin for the treatment of COVID-19 patients because of potential toxicities." No, sh##, I'm shocked, just shocked that based on this single world class study a national policy decision is being made. AP, Reuters, CNN Etc.: Yeee Haaa! Orange Man Wrong!
If I were a student in a medical school proposed a study with the following characteristics as reflective of the national population at risk :
1. All Male
2. Majority Black
3. Minimum age 59
4. Minimum BMI 29.6
5. Already hospitalized.
The instructor at that institution would respond with a word staring with the second letter of my nondeplume: R, as in redo this it is not acceptable. If I did not do so I would be graded with the first letter, "F".
"This work was supported by National Institutes of Health (USA) grants (R01EY028027 and R01EY029799), DuPont Guerry, III, Professorship, and University of Virginia Strategic Investment Fund to JA"
I want my tax money back, this thing is a joke.
References from the VA study:
Reference 1, French Study: Yes it works, small study.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7102549/
Reference 2, Chinese study. Yes it works, small study.
https://www.medrxiv.org/content/10.1101/2020.03.22.20040758v3
Reference 3, Chinese study. Yes it works.
Conclusions: The prognosis of common COVID-19 patients is good. Larger sample size study are needed to investigate the effects of HCQ in the treatment of COVID-19.
http://www.zjujournals.com/med/EN/10.3785/j.issn.1008-9292.2020.03.03
Reference 4.
https://www.medrxiv.org/content/10.1101/2020.04.10.20060699v1.full.pdf+html
"No, in patients hospitalised for COVID-19 infection and requiring oxygen
They buried info supportive of the usage and highlighted that which helped thier conclusion - We need more money! NIH is making national policy reccomendations based on this?
"Maybe those with lupus and rheumatoid arthritis...."
Maybe they are suffering from highly infectious conditions that may kill them in under 21 days, oh, wait, they are both chronic conditions and not highly contagious either. "We have to do something with our stockpiled 29 million pills. "
Yes, we sure do. What is the monthly need for Lupus and rheumatoid arthritis patients? Lets call that "X"
29,000,000 - X = Here you go, bought you another month treatment on top of what you have on hand for your chronic condition. In the mean time lets contact the Prime Minister of India and see if we can get some more. Here's my recommendation to Trump next time he speaks with Fauci about the world class work the career professionals at NIH are doing https://www.youtube.com/watch?v=WnS_5tR-K9U
Posted by: Fred | 22 April 2020 at 05:55 PM
I am surprised that "cloroquine phosphate", the name under which I know the drug, is now suddenly supposed to have serious side effects. When I was stationed in Egypt for one year with my family back in 1978, we all took cloroquine, as I remember it, once a week.
In my country, Denmark, drug regulation is pretty strict, so we assumed cloroquine was safe. Still, I went to ask my doctor when I had another one-year stationing to the Middle East coming up five years later. After looking at the guidelines, my doctor told me that cloroquine had been used for years without any side effects, and that the only side effects found after long trials on rabbits were some sort of residue settling in their eyes, though with no adverse effect on their eyesight.
Lars Moeller-Rasmussen
Posted by: Lars Moeller-Rasmussen | 22 April 2020 at 06:05 PM
This is not a controlled study. It is an analysis of medical records. It stands to reason that there were more fatalities amongst those who were given the drug, because it was desperation hour, so they therefore got the drug. The French guy says you have to use the drug early, not as a Hail Mary pass when the virus has done its work and left and all that remains in the pneumonia.
Oh the end-zone celebration on Morning Joe about this study! I guess you don’t need a double blind six month controlled trial to have absolute metaphysical certainty after all. People who were given hydroxycloriquine died, said Mika when she spiked the football.
Posted by: JMH | 22 April 2020 at 06:14 PM
From the CDC website right now: CDC information for travelers who want to avoid malaria:
CLOROQUINE
Drug Reasons that might make you consider using this drug Reasons that might make you avoid using this drug
Chloroquine
Adults: 300 mg base (500 mg salt), once/week.
Children: 5 mg/kg base (8.3 mg/kg salt) (maximum is adult dose), once/week. Begin 1-2 weeks before travel, once/week during travel, and for 4 weeks after leaving.
Some people would rather take medicine weekly
Good choice for long trips because it is taken only weekly
Some people are already taking hydroxychloroquine chronically for rheumatologic conditions. In those instances, they may not have to take an additional medicine
Can be used in all trimesters of pregnancy
Cannot be used in areas with chloroquine or mefloquine resistance
May exacerbate psoriasis
Some people would rather not take a weekly medication
For trips of short duration, some people would rather not take medication for 4 weeks after travel
Not a good choice for last-minute travelers because drug needs to be started 1-2 weeks prior to travel
Posted by: Deap | 22 April 2020 at 06:48 PM
The quote cirsium provided above from Didier Raoult is worth repeating with emphasis IMO: "The HCQ-AZ combination, when started immediately after diagnosis, is a safe and efficient treatment for COVID-19..". The price of treatment only beginning when sufferers are bad enough to be hospitalized seems to be a one to two orders of magnitude increase in mortality rate.
Test, trace contacts & quarantine like the South Koreans and prescribe Didier's magic elixir to all positives right away. If this isn't accepted medical practice, then change the accepted medical practice.
Posted by: Barbara Ann | 22 April 2020 at 07:12 PM
dont go to VA hospital
https://www.youtube.com/watch?v=dLSYRqcg0wo&feature=em-lsp
Posted by: parj | 22 April 2020 at 07:13 PM
TTG - on treatment of the disease this protocol from the Eastern Virginia Medical School is interesting -
https://www.evms.edu/media/evms_public/departments/internal_medicine/EVMS_Critical_Care_COVID-19_Protocol.pdf
They haven't found that much use for ventilators, seems.
On the wider question of how the pandemic should be tackled an article in the Jerusalem Post led me to wonder how they were tackling it in Israel-
On contact tracing via Smartphone monitoring -
https://techcrunch.com/2020...
"Details of exactly how the tracking will work have not been released — but, per the BBC, the location data of people’s mobile devices will be collected from telcos by Israel’s domestic security agency and shared with health officials."
Leads me to wonder whether the enthusiasm for smartphone tracking in the UK - HMG seems to be betting the farm on it - derives from the fact that GCHQ is geared up for that anyway.
Also group testing for speed -
https://www.tabletmag.com/s...
Plus what seems to be an extensive programme of testing both for antibodies and for detection of currently infected cases -
https://www.jpost.com/israe...
This seems to be a version of the American approach to containing local outbreaks after lockdown has been lifted -
“When we have more tests, we can open the economy in an aggressive way without any danger and without being surprised – and the moment there is an outbreak in a residential building or a school, you can go there [and close it] and not the whole city,” Bennett said.
Also containing a reference to the progress made in ensuring the various tests are more accurate -
"There have been more than 20 rapid serological tests that have been developed worldwide – mainly in China – many of which have been found to provide inaccurate results.
"However, Roche and a handful of companies, such as US-based Abbott Laboratories and Becton Dickinson and Co., have created more sophisticated serological tests, which are expected to be validated.
"Ofer said that, “If we run these tests in conjunction with the molecular test, then we will get a full picture” – and as Bennett explained, “the closures will end.”
Those are the roughly the references I put together to submit to an English site. On another English site I read a reference to how one Canadian area (unnamed) geared up for the pandemic -
We live in an Ontario health district, about the size of Connecticut (with 200,000 population), in a small city with a medical school. Our public health officer in January alerted nursing homes and hospitals to prepare, e.g. get supplies and train staff for higher hygiene standards. Example, auditing handwashing practices in nursing homes. As a result, we have 50 total positive cases, almost all cases traceable to travel. No nursing home outbreaks. No deaths. No ICU care. Two people currently in hospital."
So they got going on this back in January. If only ...
Posted by: English Outsider | 22 April 2020 at 07:21 PM
TTG - Apologies - those links in full-
Eastern Virginia Medical School -
https://www.evms.edu/media/evms_public/departments/internal_medicine/EVMS_Critical_Care_COVID-19_Protocol.pdf
On Smartphone monitoring -
https://techcrunch.com/2020/03/18/israel-passes-emergency-law-to-use-mobile-data-for-covid-19-contact-tracing/
on test pooling -
https://www.tabletmag.com/sections/science/articles/pooling-covid-19-israel
Jerusalem post -
https://www.jpost.com/israel-news/coronavirus-testing-expected-to-increase-diversify-by-mid-may-625375
Posted by: English Outsider | 22 April 2020 at 07:35 PM
Everything in the EVMS outline is stuff that we have known for quite a while. Everyone tries to avoid intubation. We use steroids like they do so would agree on that. We also use a lot of self proning and proning once intubated. Between the steroids and proning w have cut the number of people going on to intubation by over 50%. Need to double check our stats but we have had decent success at getting people extubated.
Steve
Posted by: steve | 22 April 2020 at 08:41 PM
Another discussion of chloroquine: only does any good if used early in the disease progress and with zinc.
https://www.youtube.com/watch?v=dLSYRqcg0wo
Posted by: LJ | 22 April 2020 at 09:46 PM
As others has observed, this retrospective analysis (this is not a study at all) of seriously ill patients, hospitalized and perhaps intubated, is seriously limited in its value to the discussion. These patients were administered the hydroxychloroquine, sometimes in conjunction with azithromycin, at an advanced stage of the viral infection, that one poster characterized as a Hail, Mary pass, and not at the earlier, inception stage of the infection which other clinicians have found to be a far more efficacious time to administer HCL or the "cocktail" including azythromycin. Also, the omission of zinc as an element to the treatment weakens the conclusions to be drawn, as other clinicians have not only stressed early treatment, but the inclusion of zinc as being an important element in the therapy.
May I bring to your attention also a post found on a thread at the Conservative Tree House from a retired doctor named John, in which he conveys some important information about the different likelihoods of heart arhythmias depending upon which class of antibiotic is used in the "cocktail".
https://theconservativetreehouse.com/2020/04/21/fauci-resurfaces-nih-panel-recommends-against-hydroxychloroquine-treatment/comment-page-3/#comment-8111040
This jumped out at me. Also, it occurs to me, that if the treatment with a "cocktail" is begun early on, instead of at an advanced state of infection, the course of drugs may be shorter, and consequently the potentially QT-altering characteristics of some antibiotics being limited in duration, this thereby may lessen the danger to cardiac health. This only stands to reason.
It is not uncommon for drugs to have this effect. Last year, I was given an MRI exam, and a contrast agent was going to be administered to me; but before proceeding with the MRI, I was sent to get an EKG which was analysed by a cardiologist to ascertain if there were any red flags that would contraindicate the use of that contrast agent. This is also a known factor with many clinical drugs, and vigilance regarding heart function is often mandatory when those otherwise useful drugs are part of a therapeutic regime.
I also rather suspect that, as failure of the oxygen supply is common in advanced cases of the virus, that oxygen starvation to the heart almost inevitably would lead to heart failure. How can you blame HCQ for this, when these problems don't seem to be seen in prophylactic administration of HCQ for lupus or RA? Bad logic on attribution of such failures in patients far down the spiral of collapse suffering from the virus to HCQ.
Posted by: JerseyJeffersonian | 22 April 2020 at 10:42 PM
The question is moot. Anybody who wants to take the drug(s) can take them. But Ingraham has stopped promoting it, as have Carlson and Hannity, so I might think twice about it. They are the ones who know what they're talking about, not Fauci et al.
Posted by: Stephanie McEnery | 22 April 2020 at 10:46 PM
Stephanie McEnery,
Really, where can a get a set without a prescription?
Posted by: Fred | 22 April 2020 at 11:14 PM
Stephanie McEnery,
This just in, Ingraham is very much reporting on the topic, as well as the scientific misconduct related to this “study”.
https://www.youtube.com/watch?v=RexUJeWmzSE
Posted by: JMH | 23 April 2020 at 12:10 AM
Leith,
Yes, all the hype about Trump invested in HCQ is just that, hype. Trump is invested in some funds which have some small investment in the manufacturer of HCQ. I doubt Trump would ever be aware of that fact. No normal person would. I'm not sure what caused him to fixate on HCQ over all other possible treatments, but it wasn't about making money.
Posted by: The Twisted Genius | 23 April 2020 at 12:40 AM
Fred,
The entire population in this study are old, broke down vets including those who did not receive HCQ treatment. In the end, the group of old, broke down vets who didn't get the HCQ had a better chance of avoiding the ventilator and walking out of the hospital than the old, broke down vets who did get the HCQ. Given all the problems these vets had, they probably would have had better outcomes if they took black licorice rather than HCQ.
If the study population consisted of young, healthy people, the outcome surely would have been different. Most would recover just fine with or without the HCQ given the actual morbidity of the virus. The HCQ probability would have shaved a day or so off the recovery period. Side effects would have been much less in a generally healthy patient population. Since the virus is capable of causing heart damage, blood clotting and neurological damage as well as lung damage we don't know how HCQ interacts with these other viral effects.
No one in the VA system is in the peak of health. If they were, they wouldn't be in the system. All the patients' physical failures were taken into account. Just for laughs, I'm going to compare my test reading with those in the study just so I can see where I stand. This song goes through my head every time I visit the VA hospital in Richmond.
https://www.youtube.com/watch?v=wwQjy_ZTaRM
Posted by: The Twisted Genius | 23 April 2020 at 01:21 AM
English Outsider,
Your last point about the Ontario health district reminds me of how effective an aggressive application of basic hygiene practices reduced infections in our local hospital to zero. Everyone from a doctor to a nurse to a visitor was required to wash their hands with soap and water upon entering a patient's room. I know NY, Maryland and Virginia are recruiting an army of contact tracers to help control the spread of the virus. It's a simple thing that just requires discipline and persistence. I also hope this heightened cleaning of stores and restaurants continues long after this virus is under control and we return to something closer to normal life.
Posted by: The Twisted Genius | 23 April 2020 at 01:30 AM
Didn't the VA cast doubt on what the AP said, after the AP damage was done? That was the VA response to Fox News Lou Dobbs April 21
"The findings should not be viewed as definitive because the analysis doesn't adjust for patients clinical status and showed that hydroxcloroquine alone was provided to VA's sickest COVID-19 patients..."
Posted by: J | 23 April 2020 at 03:18 AM