Thursday, March 19, 2020

Has the FDA Approved a COVID-19 Treatment?

Before I note perhaps the most irresponsible comment from Donald Trump today, let me note I strongly support research into finding an effective treatment. Pardon me for saying the obvious as certain Trump cheerleaders are not accusing people like me as wanting massive deaths just to make their fearless “leader” look bad. Of course, these Trump sycophants have a long history of being utterly disgusting so let’s move on by noting a great post from Robert Waldmann:
I think that it is important to get the FDA out of the way (by executive order if necessary) ... I think there should be mass production and use of Remdesivir starting on the 5th of March
Robert notes that I have been following Gilead Sciences phase III trials of this potential treatment as well as their stock price, which can be seen as an indicator of the market’s view on the probability of eventual success. Its stock has been up somewhat of late but they note they are not quite there yet. Under Menzie Chinn’s place, I also provided this link:
French manufacturer Sanofi has said it could hypothetically offer enough doses of Plaquenil – a drug containing the molecule hydroxychloroquine – to treat up to 300,000 people if necessary. Chloroquine is normally used mainly to prevent and treat malaria, and also to treat auto-immune conditions such as Lupus and rheumatoid arthritis. In China, ongoing Covid-19 clinical trials have successfully used chloroquine phosphate and hydroxychloroquine to treat coronavirus patients. In France, renowned research professor Didier Raoult – who had been tasked by the French government to research possible treatments of Covid-19 – this week posted a video detailing “promising” results of a chloroquine trial of 24 Covid-19 patients in France. Professor Raoult – from infectious diseases institute l’Institut Hospitalo-Universitaire (IHU) Méditerranée Infection in Marseille (Bouches-du-Rhône, Provence-Alpes-Côte d’Azur) – said that the infected patients he had treated with the drug chloroquine (under the name Plaquenil) had seen a rapid and effective speeding up of their healing process. They also saw a sharp decrease in the amount of time they remained contagious, he said. Yesterday (Tuesday March 17), government spokesperson Sibeth Ndiaye said that similar clinical trials would now be extended to more patients, but said that there is currently no definite “scientific proof” that the treatment works. She said: “[New trials] will be completed by a team independent of Professor Raoult.” Some experts have warned of the dangers of authorising the use of chloroquine too quickly, in the absence of wider studies, and said that the side effects of chloroquine can be severe, especially in the case of overdose.
The last sentence is key in seeing why what Trump said today was beyond irresponsible:
President Trump confirmed Thursday morning the FDA’s rapid approval of a drug called ‘Chloroquine’ to be prescribed to help treat patients suffering from the Coronavirus.
Of course, the FDA has corrected this lie by noting that they have approved further clinical trials. But this important distinction is lost on people who listen to Sean Hannity as well as all those other Trump cheerleaders. Update: A report on the stock price movements yesterday for Gilead Sciences:
On the stock market today, GILD stock surged as much as 8.2% on Trump's statement during a press conference that its experimental coronavirus treatment is "essentially approved." But shares didn't hold after Hahn cautioned the testing process is far from complete. It's possible to have the "right drug" but the "wrong dose," Hahn said during the briefing at the White House. "That can cause more harm than good." Shares of GILD ended the day down 1.1% at 78.55.
The investors who paid $81 a share earlier yesterday should sue Donald Trump for his misleading statements.

14 comments: said...

I saw a link claiming that the French Minister of Health declared some of the reports about Raoult's work are "fake news" (not sure of the original French).

It looks that chloroquine is being used in South Korea on seriously ill patients who are doing poorly, but only on them due to the known bad side effects, especially serious on the eyes. it has had some positive effects in those cases, but not worthy of some of the jumping up and down going on in various quarters. Probably somewhat useful, especially for seriously ill patients, but no general panacea.

pgl said...

I’m not the only person who is calling BS on Trump. This is from a medical doctor:

Today’s presser is unbelievable. I am an MD and member of our hospital executive administration in the thick of Covid preparation. Remdesivir is currently an infusion drug only- meaning you have to be in a hospital hooked to an IV. The ongoing clinical trials are all in hospitalized patients. The enrolled patients are those with evidence of lung disease, meaning that some damage is already present. There is no way that the infusion will ever be a practical solution for the vast majority of infected patients (not in hospitals). There is an oral preparation, but it is only now being tried in Phase 1 studies, meaning being determined if it is even safe for human consumption? I certainly hope that they do not rush the oral drug to market without even knowing if it is safe. Think Thalidomide, COX inhibitors, Gepants. We are at least a year away from effective treatment, unless some miracle cure in existing drugs is identified. said...

Remdesvir, the reason for Gilead's stock soaring, is newer and more unknown. At least with Chloroquine, it is an established pharmacuetical long used to combat malaria. We know about its bad side effects, and it is pretty widely avaiilable and does not need all this extensive testing. It probably is somewhat useful, as I noted, especially for seriously ill patients. But, again, it is not going to be a wonder drug that will stop SARS-CoV-2 in its tracks.

Anonymous said...

Remdesvir, the reason for Gilead's stock soaring, is newer and more unknown....

[ There are evidently important discouraging side-effects from the drug according to the Chinese. Here is the Japanese flu treatment drug the Chinese are now relying on:

March 17, 2020

China reports new progress in drug, therapies against COVID-19

BEIJING -- China has completed the clinical research of Favipiravir, an antiviral drug that has shown good clinical efficacy against the novel coronavirus disease (COVID-19), according to an official Tuesday.... ]

Anonymous said...


Here are some of the most promising COVID-19 treatments being explored today
By Omar Elwafaii

Companies from around the world are racing to find treatments for the deadly COVID-19 virus. According to a recent study by Chinese scientists, "Research thus far has revealed more than 30 agents including Western medicines, natural products, and traditional Chinese medicines that may have potential efficacy against COVID-19." Here are three treatments that medical professionals say may be effective.

1. Favipiravir

This Japanese influenza medication has been hailed by Chinese officials as being effective in treating coronavirus patients. According to Zhang Xinmin, an official at China's science and technology ministry, the medication showed positive outcomes after it was used in clinical trials in Wuhan and Shenzhen, China.

"It has a high degree of safety and is clearly effective in treatment," Zhang told reporters on Tuesday.

Patients treated with the drug showed negative results for COVID-19 after a median of four days after testing positive. That compares to a median of 11 days to test negative without the drug, according to Japanese public broadcaster NHK.

91% of patients in the trial also showed improved lung conditions, compared to 62% of those not treated with favipiravir.

2. Hydroxychloroquine

Developed over 50 years ago to treat malaria, this drug is being used in clinical trials to treat COVID-19 patients. According to a recent Chinese study, "the drug has a good potential to combat the disease." Now a French team has published initial results of a clinical trial of the drug in France.

They show that 50% of patients treated with 600mg of the drug each day tested negative for the virus after three days. By day six, the percentage climbed to 70%. More promising were the results among a smaller set of six patients given a combination of hydroxychloroquine and the antibiotic azithromycin. Five of them tested negative at day three. All six tested negative at day six....

[ On March 19, there were no new domestic cases of COVID-19 in ann mainland China. This makes 2 days at zero new domestic cases and zero suspected cases. There were 3 deaths and about 800 recoveries. ] said...

China ia apparently using chloroquine as well, with roughly similar results as what has been found in South Korea, where it has been used more extensively.

I have just seen David Ho on MSNBC, who was a major leader in the fight against HIV, and he said regarding chloroquine that what it seems to do is shorten the time one is ill who recovers, but that it does not reduce the mortality rate. Of course this is the one that Trump touted most vigorously and optimistically in his talk earlier today.

Anonymous said...

February 17, 2020

Clinical evidence suggests antimalarial drug is effective on COVID-19 patients
By Pan Zhaoyi

Chloroquine phosphate, an antimalarial drug that has been on the market for many years, has proved to be effective against the novel coronavirus, according to Sun Yanrong, deputy director of the biological center under China's Ministry of Science and Technology (MST).

Sun said that the clinical evidence from over 10 hospitals in Beijing, Guangzhou and Hunan Province shows the cure rate of patients who are negative in nucleic acid tests after treatment with the antimalarial drug is higher than in the controlled group. "Over 100 patients have shown no signs of side effects," she added.

Experts from the MST, the National Health Commission (NHS) and the State Food and Drug Administration unanimously agreed that chloroquine phosphate is a safe drug and called for its inclusion in the new edition of clinical guidelines for doctors fighting against the novel coronavirus....

pgl said...

Thanks for the information on Favipiravir. The world scientists are working hard on this issue. Would it be ironic if our miracle cure has to be imported from Asia?

Anonymous said...

March 20, 2020

These last 2 days there have been zero new domestic COVID-19 cases on the Chinese mainland. There are now zero new domestic suspected cases on the Chinese mainland. Recovery rates are very high with 6,569 cases remaining of what were 58,097 on February 17. There were 3 mainland deaths on March 19.

Hubei-Wuhan new cases

Chinese mainland recovered and new cases

Chinese mainland total remaining cases

Anonymous said...

We need to be looking to, learning from and working with China on COVID-19. This is a desperate need. Please, please let us do so.

Anonymous said...

Forty-two thousand medical workers went to Hubei to support the efforts against COVID-19. None contracted the viral illness. *


March 20, 2020

12,000 medical workers supporting Hubei have left the province

As of Friday, 12,000 medical workers who headed to support Wuhan from other parts of China have finished their work and left Hubei in batches, an official from the National Health Commission said at a press conference held in Beijing on Friday.

Guo Yanhong said the majority of these medical workers used to work in temporary hospitals and designated hospitals treating non-critical patients in Hubei.

But experts and teams for critically-ill patients will continue their work in Hubei until all patients are recovered, the official added.

China sent a total of 42,000 medical workers to Hubei to combat the epidemic and none of them caught the coronavirus, Guo told reporters.

Also, as the situation cools down in Hubei, where no new cases have been recorded for two consecutive days, 43 hospitals in the capital city of Wuhan have resumed normal operations accepting non-COVID-19 patients. said...

BTW, for the record, my comments were about hydroxychloroquine, not the simpler type.

In today's presser Trump was at it again, making exaggeratedly positive statements about this and denouncing a reporter for "fake news" who questioned him about possibly being overly optimistic.

He then has the gall when asked about senators possibly selling stocks based on inside information to reply by mentioning Feinstein "and some others," and then when a reporter asked, "What about Burr and Loeffler" (there is also apparently Inhofe as well) he angrily gave this reporter a hard time for not mentioning Feinstien also. "Why did you not mention her?"

Right, this is our supposedly Chuurchillian wartime leader rising above partisanship. Gag,

Anyway, hopefully one of these drugs will get developed properly and be useful.

pgl said...

'In today's presser Trump was at it again, making exaggeratedly positive statements about this and denouncing a reporter for "fake news" who questioned him about possibly being overly optimistic.'

Thanks for noting what STARTED this back and forth. Trump went on to berate this reporter very unfairly which seems to be the only thing the news is focused on. His dishonest claim that the FDA had a cure was the beginning of this exchange and it turned out to be Anthony Fauci who noted precisely what the real science has shown so far. Fauci was standing behind Trump during this tirade looking very uncomfortable - understandably.

Anonymous said...

Anonymous said...
Forty-two thousand medical workers went to Hubei to support the efforts against COVID-19. None contracted the viral illness. *

Thanks for this and the rest of your informative comment. It shows hope for nations that do this right. China made some mistakes early on but then they got serious. Alas our nation is led by a China hating racist who seems bound to do everything wrong.