Wuhan Virus Watch: FDA Issues Emergency Authorization of Two Anti-Malaria Drugs for Coronavirus treatment
Novartis CEO says malaria drug is biggest hope against coronavirus
I reported yesterday that Italy and France officially authorized the use of chloroquine and hydroxychloroquine to treat severe cases of Wuhan coronavirus.
Now, the US Food and Drug Administration has issued its own emergency authorization.
The authorization came in a letter dated Saturday, but the US Department of Health and Human Services (HHS) acknowledged the FDA’s action in a Sunday news release. The FDA limited the scope of its authorization to drugs supplied from the Strategic National Stockpile. The HHS announced that two pharmaceutical companies — Bayer and a division of Novartis — had donated the drugs to the stockpile.
Do the drugs work? In its statement, HHS said:
“Anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients.
“The safety profile of these drugs has only been studied for FDA approved indications, not COVID-19.”
While there’s limited evidence on the efficacy of chloroquine, or hydroxychloroquine, the FDA said the drugs’ benefits outweighed their risk. In its letter, the FDA encouraged randomized clinical trials that could assess the effectiveness of the drugs. It also noted that the known and potential benefits outweigh the risks.
Who can the drugs be used to treat? The authorization is limited to patients who are currently hospitalized and weigh at least 50kg, or about 110 pounds. Under the emergency use authorization, health care providers must contact their local or state health department to access the drugs.
As a reminder, these “anecdotal reports” include 2 studies by a French team that had tremendous success using these drugs to ease the effects of the viral infection.
Novartis CEO says malaria drug is the biggest hope against coronavirus
One big name in the pharmaceutical industry supports the use of anti-malarial drugs as part of the COVID-19 treatment plans.
Novartis Chief Executive Vas Narasimhan said his Sandoz generics unit’s malaria, lupus and arthritis drug hydroxychloroquine is the company’s biggest hope against the coronavirus, Swiss newspaper SonntagsZeitung reported on Sunday.
Novartis has pledged to donate 130 million doses and is supporting clinical trials needed before the medicine, which U.S. President Donald Trump also has been promoting, can be approved for use against the coronavirus.
Other companies including Bayer and Teva have also agreed to donate hydroxychloroquine or similar drugs, while Gilead Sciences is testing its experimental drug remdesivir against coronavirus.
“Pre-clinical studies in animals as well as the first data from clinical studies show that hydroxychloroquine kills the coronavirus,” Narasimhan told the newspaper. “We’re working with Swiss hospitals on possible treatment protocols for the clinical use of the drug, but it’s too early to say anything definitively.”
Israeli doctor in Italy says innovative treatments offering hopes of recovery
An Israeli doctor in northern Italy says several new procedures appear to be helping some COVID-19 patients. Carmi Sheffer, a doctor at the University Hospital of Padua, told The Times of Israel’s Hebrew-language sister site, Zman Yisrael, that at the onset of the nation’s outbreaks, he had been pessimistic.
..One technique he said had yielded dramatic results was to have patients lie on their stomach instead of on their back while on a ventilator. “Suddenly the oxygen level in the blood jumped by hundreds of percents,” he said.
“I think the worst is behind us. We will control the virus and flatten the curve within a few weeks, but the closure will continue until June,” he predicted. “Italy is ahead of Israel by something like a month, so in my opinion, [in Israel] it will end only in July.”
Why Germany’s Coronavirus Death Rate Is Far Lower Than In Other Countries
Early testing is part of the success.
As Europe has become the epicenter of the global coronavirus pandemic, Italy’s fatality rate hovers around 10%. France’s is around 5%. Yet Germany’s fatality rate from COVID-19 has remained remarkably low since cases started showing up there more than a month ago. As of March 25, there were 175 deaths and 34,055 cases.
[Christian Drosten, director of the institute of virology at Berlin’s Charité hospital], whose team of researchers developed the first COVID-19 test used in the public domain, said Germany’s low fatality rate is because of his country’s ability to test early and often. He estimates Germany has been testing around 120,000 people a week for COVID-19 during the monthlong period from late February to now, when it’s reached epidemic proportions in the country, the most extensive testing regimen in the world.
Donations tax deductible
to the full extent allowed by law.
I did not reach 110 lbs until after I had my second baby. Why does this action discriminate against small, adult women?
It seems likely that the dose can be lowered to accommodate smaller people.
Oh, JD, so it’s OK to discriminate against small people and give them smaller doses? Large Privilege again! Haven’t you heard of the Me-2-Small Movement? You are cancelled.
That was a pretty good one. I always liked petite women, and would hate to see them disappear because they cannot handle a big dose.
“The authorization is limited to patients who are currently hospitalized and weigh at least 50kg, or about 110 pounds.” This hospitalization requirement is a ridiculous limitation, given the evidence. Anyone who tests positive should be given the chloroquine or hydroxychloroquine drug cocktail. In fact, doctors who treat corona virus patients have been prescribing it to themselves before testing positive,so they don’t get the disease in the first place. HHS is just trying to save face.
This is not a benign drug, a d should be reserved for moderate to severe cases, both because of the risk, and because we don’t want to run out of the drug.
This should be part of a widely available regimen to keep people at home, instead of having to be hospitalized.
Let’s not let our counter reaction to the ridiculous criticism launched at Trump, over his touting this potential treatment option, be as ridiculous.
FWIW, yes I am a physician.
I am not a doctor, but with withholding treatment because we may run out of the drug does not sound to me like the most ethical thing to do.
What about ramping up production?
Are we doing that already?
Not a doctor, but…..
F*ck doing these multiple blind studies.
They’ve approved it only for hospitalized cases – or in other words – those with a good (bad) chance of dying. If there was multiple anecdotal stories of improved survival rates and accelerated recoveries for any other killing disease it would be widely acknowledged as unethical to withhold a treatment from 50% of your patients.
Do multiple blind studies on the not-very-sick cases (for recovery times) and volunteer first responders who haven’t caught it (for preventive testing) as of yet.
For the serious life-threatened cases you can still compare results after treatment with the current known baseline of patients who never received the new treatment. Not as authoritative as a full blown blind study, but you’re not treating patients like they’re “only” African Americans with a deadly STD in the 50s and undeserving of more compassion than lab animals.
I had the (perhaps incorrect) impression that the earlier into the disease process they started these drugs, the better the outcomes.
Wouldn’t it be better to prevent patients from becoming sick enough to need hospitalization in the first place?
The problem is that almost immediately after this panic dies down, the lawsuits will begin. People who were cured of the Kung Flu (even those who’s lives were saved) will have maladies that may or may not be related to choloroqine; greedy lawyers will start shopping for class members – and doctors, hospitals and drug manufacturers will get sued for millions if not billions.
This will happen no matter what, but to at least have a fighting chance of defending themselves against these lawsuits, people in the medical profession cannot simply start prescribing drugs, even if they know they’d be saving lives.
In our ridiculously litigious society, people will die because of the legitimate fear of others taking advantage of the opportunity for a windfall.
Personally, I am tired of all the poor black drivel. People of most races were routinely enslaved, and the same applies to unsuspecting people being used as guinea pigs, one example being members of our military being intentionally exposed to nuclear tests and fallout.
In the case of fallout, their fate was in no way their own fault, in the case of STD, it was often their own fault.
I am not condoning what was done to black men, there should have been informed consent, this is another case where all lives matter, and all liars (such as BLM), do not matter quite as much. 🙂
Wow. Just wow.
I somehow hit a sore spot there.
My post in no way meant to reference BLM, in fact in my opinion a lot of BLM brouhaha is BS.
Trevon Martin was not some poor misunderstood candidate for sainthood with a bright future ahead as a doctor who would one day help cure cancer, the “wilding” Central Park Six were, by their own admissions, not out that night to play pickup basket ball games and rescue kittens stuck up in trees, in the vast majority of police shootings the citizen involved was not just reaching for his wallet or cell phone, and statistically there’s just not a strong case to be made for modern police shooting results to be race dependent – once you correct for who’s actually involved in actions likely to result in police involvement. Yup, I said it, if more X teens commit crime Y than overall teens do, it’s not discrimination in enforcement if more X teens are arrested for crime Y.
Oh, and O. J. did it, f*ck that jury.
I reference the black STD study because it’s the Classic instance of an American double-blind study that put rigidity of protocol in front of any consideration of patient wellbeing and ethics. “Double Blind” is a tool, and like any tool it’s use is not automatically appropriate or ethical.
Sorry Bob, I really dislike the crap pulled on George Zimmerman & Officer Wilson. Their civil rights were violated. It was nationally organized, and nothing has been done about it.
Not a doctor nor have I ever played a doctor on TV.
If I understand correctly, Germany’s death rate is low because they have been testing far more people than anyone else. I am assuming that they are trying to test everybody, not just those with symptoms.
This would suggest that Dr. Fauci’s prediction of a possible 100,000 to 200,000 US deaths is assuming at least half of the population will come down with symptoms and be tested?
My faith in Dr. Fauci is not where I would like it to be. I get the feeling he would shut down the entire country if he could. I’ll bet my prediction of 4-5,000 deaths will be far closer than his prediction.
“Anecdotal evidence” is nothing to get excited about. It’s more akin to rumor than actual evidence.
The two studies showed statistically significant results. the only reason they are not considered double-blind studies were that they treated the entire study group with the treatment, rather than having a section of them being given placebos. However, given the we are currently in the middle of a pandemic, it seems to me that there is a rather large an ongoing control group called “everyone else who has the disease at the same time.”
That is what makes the whole branding it as “anecdotal evidence” rather asinine. If Hospitals A B & C are having a 4% mortality rate, and Hospital D is having a <1% mortality rate, going in with the mindset that "Well we aren't really sure that what Hospital D is doing is really effective, so we need to do more studies, just to be safe before recommending that A, B, & C change anything," is a real pinhead move. However, it would be very in line with France's medical system, which seems to thrive on bureaucratic inertia.
Agreed, what the French did was not ‘anecdotal’ but rather what in medicine is called a ‘case series’. It’s the first step in figuring out what works — report what you see.
Next step is what we’re talking about, which is a “case-control retrospective trial” in which you try to match each case with a control by age, gender, ancestry, co-morbidities, etc., done after the fact.
To be clear (and pedantic! my specialty) the most rigorous control is the ‘randomized clinical trial’ (RCT) in which patients are randomized so that some receive the drug, some receive a placebo, and neither the patients nor the providers know who is who. Medicine does RCTs all the time because they best control a lot of the other variables, biases, and so on that come up. The key to an RCT is ‘equipoise’ — you have legitimate reason for thinking that the drug might work AND not work, and legitimate concerns about the risks.
Treatment with HCQ and azithromycin, or HCQ or chloroquine alone, would seem to meet this, and I’d really like to see a well-done RCT. Given the time and effort required to do an RCT (and I’ve participated as an investigator in a bunch of these), a retrospective case control trial is also perfectly fine and will CERTAINLY be a lot faster.
Adding to and agreeing with stevewhitemd above…
The case series (new vocabulary term for me) can be used to test a hypothesis of % mortality with treatment. For example, treat 10,000 patients presenting symptoms, and see what the mortality rate is, and how likely is the observed result given a hypothesis of 1% mortality.
In the same way, the case series can be used to establish statistics on any kind of outcome, be it mortality, ICU care required, days until virus-free, an so forth.
The non-controlled study will not determine the “effective” part of “safe and effective.”
This is just conventional scientific method and statistics.
Without the control group, one cannot rule out placebo effect.
At the present time, we would all be quite happy with total placebo that is observed to work.
“Anecdotal” is still real evidence….but limited in scope and not rumor. The larger the cohort in the study the better understanding of the distribution of positive to negative outcomes. New drugs coming to market usually wind up with different and sometimes poorer efficacy although they may be found to have expanded uses. In this case the actions are to blunt cytokine storm and ward off infection.
Who you going to believe, the skeptics or your lying eyes?
“Rumor” is what idiots spread when they tout drinking poisonous versions of alcohol (because hand sanitizer kills the virus, right?) or drinking fish tank cleaner (because chemicals with a few syllables in their name in common are the same chemical, right?) – or the Grand Daddy of stupid rumors that made the rounds in African nations back in the day – that raping an underage Virgin will cure AIDS.
Anecdotal evidence is STILL evidence. In fact, it’s normally the starting point for many sensible double-blind study – they don’t test random chemicals as treatments, they test either chemicals whose known properties could be beneficial vs the disease or which have been anecdotally spotted as possible causes for unexpected better than expected recoveries or resistance. These two chemicals qualify in both senses.
The two chemicals being discussed both have known past anti-viral history, both have known past side effects which are NOT death in reasonable doses, and both have been observed by working medical professionals to have an apparent correlation with otherwise unexpected and unexplained faster than normal recoveries from the Hunan Flu.
I can’t help but attribute some of the reluctance some people have to acknowledge that these are possible and even probable treatment regimens to TDS.
Taking hydroxychloroquine long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking this medicine and call your doctor at once if you have trouble focusing, if you see light streaks or flashes in your vision, or if you notice any swelling or color changes in your eyes.
Ah, and I remember when the press ridiculed Trump for saying it was a “promising” treatment.
So the FDA limiting the use to donated pills, sent to the national stockpile, and then to be used only by a hospitalized patient means that the FDA is still a major limiting factor to the treatment.
I mentioned this on another post, but the clinical trials should be done considering the timing of the administration of the drugs. Groups could be preventive option for health professionals, positive test with mild symptoms and sheltering at home, positive test & hospitalized, positive test and on a ventilator.
One of the “known unknowns” is the long term effects of having C19 and recovering. Is this corona virus like the zika virus with an effect on the unborn? We won’t know that for many months. What is the LT effect on the lungs? Anything else?
OK doctors – do you have an opinion why putting a person on a ventilator on their stomach improves the O2 levels? I know this is just “anecdotal evidence”. But, the theory is easily tested by having the patient in both positions and checking O2 levels.
The ventilator is providing oxygen under pressure to get more O2 throughout the lung and into the bloodstream. Right?
It seems that being on your back, the lungs are expanding, but there is no strong external pressure as an assist. Being on your stomach, your body weight is providing some additional pressure to get more oxygen into your blood stream.
Yes (I’m a pulmonary physician). “Proning” a patient for periods of time (2 hours prone, 2 hours supine, etc) leads to better matching up of ventilation (air going into the lungs) and perfusion (blood going through the lungs). We refer to this as the V/Q ratio (Q for perfusion because ‘P’ was already taken for pressure).
If V/Q is too high, we ventilate lung that isn’t being perfused.
If V/Q is too low we perfuse lung that isn’t being ventilated.
So we want a proper blend.
Right now you and I sitting in our chairs have a blend of all three regions, but most of our lung is of the proper V/Q ratio. That’s how we get oxygen into our blood.
A critically ill person with ARDS has damaged lungs, and more of the lung has V/Q ratios that are off (too high and too low). Leaving them supine all the time makes that worse. Proning them helps to fix that. It’s well demonstrated in clinical trials in ICUs and is now standard practice.
Thanks for the explanation. The doctor referenced in the article was an Israeli taking care of people in Italy. So, I wonder if the advice is just a reminder for the rest of the world.
I checked out some training videos about how to move a patient on the ventilator from prone to supine positions. The process included changing out the linens and used three people for the head and both sides. So, very labor and supply intensive process. I wonder if that is impacting patient care in some countries?
I have a question – does the FDA approval override the threat to the MI Doctors by their governor?
How can a governor block drug use in a state. I guess they can do that since there was no federal law being applied here?
Ponder how the vicious, deranged and truly contemptible American mainstream media, Dhimmi-crat prostitute-propagandists immediately leaped to condemn Trump, for merely expressing an aspiration, born of optimism, that anti-malaria drugs MIGHT be of some use.
If the sainted Obama had stated the same thing, these utterly vile hypocrites would be swooning at his feet and singing hosannas to his alleged sagacity, for giving people hope.
Note that the limitations on the FDA authorization don’t mean you can’t use it for anything else. Doctors are entitled to prescribe it for anything they like, if they believe it can help. They don’t need the FDA’s permission.
I don’t understand how a state governor can interfere with that. If someone can explain that, please do.
Note that Dr Zelenko has been treating people before they are hospitalized, and has so far had 100% success in keeping people from needing to be hospitalized. This authorization doesn’t help with that.
HOWEVER. Watch this video from an expert on chlorinique, warning of a risk that Dr Zelenko and some others pushing this cocktail seem unaware of. The combination of chlorinique and Z-Pak can cause heart attacks. Still, at a time like this that may be a risk people are willing to take.