First, Dr Vladimir Zelenko speaks:
While, the Governor blocks:
Sisolak signed an emergency order earlier Tuesday barring the use of anti-malaria drugs for someone who has the coronavirus. But Sisolak’s order does not apply to patients who are hospitalized with coronavirus. The order restricting chloroquine and hydroxychloroquine came after President Donald Trump touted the medication as a treatment and falsely stated that the Food and Drug Administration had just approved the use of chloroquine to treat patients infected with coronavirus. Sisolak said in a statement that there’s no consensus among experts or Nevada doctors that the drugs can treat people with COVID-19.
Actually, as Pharmacy Times reported, Thu March 19:
FDA Announces Two Drugs Given ‘Compassionate Use’ Status in Treating COVID-19
Kristen Coppock, MA, Managing Editor
Two drugs, chloroquine and remdesivir, are being designated for Expanded Access, or “compassionate use,” by the FDA to address the novel coronavirus (COVID-19) pandemic, according to FDA Commissioner Stephen Hahn, MD, and President Donald Trump.1
Chloroquine and remdesivir are not FDA-approved for a COVID-19 indications, but Expanded Access allows patients with serious or life-threatening cases of the virus to have access to them as investigational medicinal products.2
Chloroquine, or hydroxychloroquine, is currently approved by the FDA for treatment of malaria, lupus, and rheumatoid arthritis, although not for COVID-19. A heme polymerase inhibitor, the drug is being tested for possible COVID-19 use to improve virologic clearance.3
Remdesivir is an investigational nucleotide analog with broad-spectrum antiviral activity, according to its maker, Gilead Sciences, and it is not approved by the FDA nor any other countries for any use. However, remdesivir has demonstrated activity against MERS and SARS, indicating that it may have potential activity against COVID-19. The drug has been used in a small number of patients with COVID-19 in an experimental manner, according to Gilead.4
During a White House press conference on Thursday, Hahn said that although remdesivir is still in its investigational phase, the unprecedented pandemic warranted action. “Remdesivir is [still] going through the normal process. We do need to know about the safety and effectiveness,” he said.1
According to Hahn, the FDA is providing regulatory flexibility and guidance, but is also continuing to ensure products are safe. He said the agency has been working with the CDC since January on combating the virus.1
“An important part of that work is expanding therapeutic options for the coronavirus,” Hahn said.1
Trump said these medications will be made available by prescription. Hahn declined to say when both drugs would become available for use in patients with COVID-19.1
For up-to-date information on COVID-19 for pharmacy professionals, visit Pharmacy Times’ coronavirus resource center.
Coronavirus Task Force. White House Press Conference. Presented: March 19, 2020. Accessed March 19, 2020.
FDA. Expanded Access. FDA website. https://www.fda.gov/news-events/public-health-focus/expanded-access Updated May 6, 2019. Accessed March 19, 2020.
Bulloch M. Potential Pipeline Medications May Help Patients with Novel Coronavirus. Pharmacy Times. https://www.pharmacytimes.com/news/potential-pipeline-medications-for-the-coronavirus Published March 11, 2020. Accessed March 19, 2020.
Gilead Sciences. Gilead Sciences Update On the Company’s Ongoing Response to COVID-19. Gilead Sciences website. https://www.gilead.com/purpose/advancing-global-health/covid-19 Updated February 26, 2020. Accessed March 20, 2020.
So, we clearly have a case of half-truth here. FDA has not given FULL approval, but per Pharmacy Times, it has given permission for compassionate, exploratory use. Dr Zelenko has on his own professional responsibility gone ahead to use the drugs for early stage cases and has seen full success for “hundreds” of cases. From his description, he is operating in a community of 36,000 some 50 mi from NYC, where he estimates 20,000 are or have been infected with the Covid-19 virus.
At the same time, Nevada’s Governor claims lack of consensus and bans use (there seems to be a hospitalisation exemption). Fair comment, this last does not seem responsible (and may lead to needless loss of life), on readily accessible global evidence.
What do I mean?
Exhibit 1, Guandong, China [i.e. Canton]:
Zhonghua Jie He He Hu Xi Za Zhi. 2020 Mar 12;43(3):185-188. doi: 10.3760/cma.j.issn.1001-0939.2020.03.009.
[Expert consensus on chloroquine phosphate for the treatment of novel coronavirus pneumonia].
[Article in Chinese; Abstract available in Chinese from the publisher]
multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia.
Abstract in English, Chinese
At the end of December 2019, a novel coronavirus (COVID-19) caused an outbreak in Wuhan, and has quickly spread to all provinces in China and 26 other countries around the world, leading to a serious situation for epidemic prevention. So far, there is still no specific medicine. Previous studies have shown that chloroquine phosphate (chloroquine) had a wide range of antiviral effects, including anti-coronavirus. Here we found that treating the patients diagnosed as novel coronavirus pneumonia with chloroquine might improve the success rate of treatment, shorten hospital stay and improve patient outcome. In order to guide and regulate the use of chloroquine in patients with novel coronavirus pneumonia, the multicenter collaboration group of Department of Science and Technology of Guangdong Province and Health Commission of Guangdong Province for chloroquine in the treatment of novel coronavirus pneumonia developed this expert consensus after extensive discussion. It recommended chloroquine phosphate tablet, 500mg twice per day for 10 days for patients diagnosed as mild, moderate and severe cases of novel coronavirus pneumonia and without contraindications to chloroquine.
Similarly, Exhibit 2, on the French trials — and, recall, France is where co-discoverers of the HIV virus worked:
24 march 2020
A renowned research professor in France has reported successful results from a new treatment for Covid-19, with early tests suggesting it can stop the virus from being contagious in just six days.
Professor Didier Raoult from infection hospital l’Institut Hospitalo-Universitaire (IHU) Méditerranée Infection in Marseille (Bouches-du-Rhône, Provence-Alpes-Côte d’Azur), published a video explaining the trials on Monday March 16.
Professor Raoult is an infectious diseases specialist and head of the IHU Méditerranée Infection, who has been tasked by – and consulted by – the French government to research possible treatments of Covid-19.
He said that the first Covid-19 patients he had treated with the drug chloroquine had seen a rapid and effective speeding up of their healing process, and a sharp decrease in the amount of time they remained contagious.
Chloroquine – which is normally used mainly to prevent and treat malaria – was administered via the named drug, Plaquenil.
The treatment was offered to 24 patients, who were among the first to become infected in the south east of France, and who had voluntarily admitted themselves to hospital for the process.
Patients were given 600mcg per day for 10 days. They were closely monitored, as the drug can interact with other medication, and cause severe side effects in some cases.
Professor Raoult said: “We included everyone who was in agreement [to be treated], which was almost everyone. Two towns in the protocol, Nice and Avignon, gave us [infected] patients who had not yet received treatment.
“We were able to ascertain that patients who had not received Plaquenil (the drug containing hydroxychloroquine) were still contagious after six days, but of those that had received Plaquenil, after six days, only 25% were still contagious.”
Chloroquine phosphate and hydroxychloroquine have previously been used to treat coronavirus patients in China, in ongoing Covid-19 clinical trials . . . .
A new academic study, published on Friday March 13 by US scientific researchers, also said that chloroquine appeared to be an effective treatment, and appears to align with the findings in France.
It said: “Use of chloroquine (tablets) is showing favorable outcomes in humans infected with Coronavirus including faster time to recovery and shorter hospital stay…
“Research shows that chloroquine also has strong potential as a prophylactic (preventative) measure against coronavirus in the lab, while we wait for a vaccine to be developed.
“Chloroquine is an inexpensive, globally available drug that has been in widespread human use since 1945 against malaria, autoimmune and various other conditions…[it] can be prescribed to adults and children of all ages.
“It can also be safely taken by pregnant women and nursing mothers [and] has been widely used to treat human diseases, such as malaria, amoebiosis, HIV, and autoimmune diseases, without significant detrimental side effects.”
As further fair comment, it seems that the overwrought rhetoric over endorsement of the drug by US President Trump may be distorting our ability to reasonably assess the degree of warrant that it is credible that the drug is a potentially useful treatment for Covid-19. That may needlessly cost lives.
So, while indeed, we must be cautious about premature full endorsement, it is only reasonable to take on board evidence that the drug is effective, allow for significant use in the face of an emergency and by carrying out further trials, regularise the use [or, show that it is no better than the notorious placebo sugar pill].
We of course, are following up from an earlier UD Sci-Tech news watch post, here [which points to evidence from as long ago as 2005].
Perhaps, we need less cumbersome approaches in the face of a pandemic. END