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FDA Approves Malaria Drugs for COVID-19 Treatment – Update 2

It is a start, maybe. Remdesivir is being touted as a potentially more effective drug.

The Chinese had reported there were several pharmaceuticals which appeared to work also and in particular drugs for malaria, Chloroquine and HydoxyChloroquine. I had mentioned this earlier in the week (or even earlier) in a post and then again in two separate comments.

One small clinical test (preliminary trial with 24 -36 patients) in France had positive results recently as reported March 17, 2020. HydoxyChloroquine Would Be Effective According to Professor Roault of the IHU in Marseille,” after the first limited Test as reported by EN24 on March 17, 2020. With the use of the antibiotic Azithromycin to treat pneumonia a bacterial infection resulting from the virus infection, the test results were ~75% positive.

Remdesivir appears to have worked in a limited number of cases also. An issue which we are missing is bacterial infection following viral infection. The Chinese followed up their treatment using Chloroquine and HydoxyChloroquine (decades old drug) with antibiotics for Strep. The French study instead uses Azithromycin for treatment of the resulting pneumonia, etc. Although the French clinical test had a success rate of 75%, they are calling for a larger load testing. For Italy, it may present an opportunity sooner than Remdesivir.

And today, Trump is back on the air: Malaria Drug for Coronavirus Has Been Approved by FDA (?)

President Donald Trump announced Thursday the Food and Drug Administration (FDA) has approved hydroxychloroquine—a drug used to treat malaria, rheumatic diseases and other conditions—for COVID-19.

As the COVID-19 pandemic spreads around the world, scientists are scrambling to identify treatments that may be effective against the disease. Hydroxychloroquine—a common derivative of chloroquine—is among those touted as most promising by some experts.

HydoxyChloroquine Would Be Effective According to Professor Roault of the IHU in Marseille after the first limited Test,” EN24, March 17, 2020

Donald Trump Says Malaria Drug for Coronavirus Has Been Approved by FDA, Newsweek, Aristos Georgiou, March 19, 2020

Update 3/19:  As Trump claimed HydoxyChloroquine was approved, FDA Head Steven Hahn countered Trump’s claim, stating the president had “directed the FDA to take a closer took” at whether the drug could help people with coronavirus. Indicating the FDA had not approved HydoxyChloroquine for use on a Coronaviral disease/disorder yet, Mr. Hahn called for large clinical trials to ascertain HydoxyChloroquine’s  effectiveness in treatment.

FDA contradicts Trump on status of potential coronavirus drug,” Financial Times, Demetri Sevastopulo (Washington) and Hannah Kuchler (New York), March 19, 2020

Update 3/20: Robert Waldman – “MDs can prescribe chloroquine and hydroxychloroquine for Covid 19 right now. The FDA doesn’t and can’t regulate off label prescriptions. Large trials (with young subjects) might be OK, but that does NOT mean Drs should wait for the results before prescribing hydroxychloroquine. It has known side effects which are mild except if it is taken continuously for years (anti malaria profilassi). I think the current evidence is enough that it should be given to everyone who is not in the trials’ control group. I am quite confident of this and know of no arguably valid argument against doing so.”

Robert’s Comment is true and something I did not think of while writing.

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Let’s get real about coronavirus testing . . .

We do not know how severe the covid-19 epidemic will be or how much economic and social pain it will cause, but it clearly has the potential to kill hundreds of thousands or even millions of Americans, and the economic consequences could include a deep recession and even a financial crisis that will cause misery to tens of millions of people.

Testing is key to getting the epidemic under control, and it is not clear to me that policymakers are being nearly as aggressive about expanding testing capacity as they should be.  Think of two alternative testing strategies.  One strategy is to selectively test people who have symptoms or who may have been exposed to someone with the disease.  The alternative strategy is to develop the ability to do mass screenings for the virus among the general population.  (There are various intermediate strategies one can imagine, such as doing mass screenings in local areas with a high incidence of disease.)  Of course, selective testing is the place to start, but the ability to do mass screenings would allow us to pro-actively identify and isolate almost all carriers and would thus avoid the need for widespread social isolation which is wreaking havoc on the economy.  Selective screenings, in contrast, may or may not be able to contain the epidemic sufficiently to allow normal economic activity to resume.

I am not sure what is being done to expand our testing capacity, but if we want to develop the ability to do mass screenings, we need to make it a priority nowThe government will need to contract with equipment manufacturers and other suppliers (of reagents, swabs, protective gear, etc.) for large capacity commitments on a short timeline.  I have no idea what this would cost or even if it is feasible, but if there is even a small chance that the epidemic will last for six months or return next winter, it seems that a $10 or $20 billion investment in testing capacity would be short money.

The Democrats should jump on this as they take up the next coronavirus response bill.  Not only is it good policy, it will give them an opportunity to highlight the fumbling, timid response of the Trump administration to the crisis.

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Remdesivir II

This is, in fact, another post on Coronavirus, but it will take me a while to get to the point. To put the conclusion here, I think that it is important to get the FDA out of the way (by executive order if necessary).

The Food and Drug Act, as currently interpreted, requires the assumption that people should (generally) not be treated with pharmaceuticals which haven’t been proven to be safe and effective. The rule is first do no harm, second do no harm. This only makes sense if results with current standard of care are acceptable. In this case, they aren’t. I think there should be mass production and use of Remdesivir starting on the 5th of March, based on one case where it seems to have cured a patient overnight.

To be honest, I think it should have been approved based on evidence that it is safe (from failed efforts to treat Ebola) and evidence that it inhibits the RNA dependent RNA polymerase of the MERS Coronavirus

Obviously one case is not proof. Still more obviously a pre-clinical study of a related organism isn’t strong evidence about the novel coronavirus.

So ?

It isn’t as if the current approach is working so well, that we should stick with it until there is proof that a new approach works better.

I think the trace of information is enough that, given almost no knowledge and a very diffuse posterior, one can conclude that the expected welfare of a patient treated with Remdesivir is higher than of one not treated with Remdesivir.

At this point, the standard ethical rule that decisions should be made in the patients’ intererests would mandate use of Remdesivir
(I personally do not accept that rule)

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To Slow Spread Of Coronovirus, End Iran Sanctions

To Slow Spread Of Coronovirus, End Iran Sanctions

On 3/13/20 in Foreign Policy Focus, Ariel Gold and Medea Benjamin argue that to improve the global coronavirus problem, sanctions on Iran should be lifted, quite aside from the fact they should never have been imposed in the first place as Iran was adhering to the JCPOA nuclear deal.

The effect of the sanctions has been to tank the Iranian economy, including its health care sector, much worsening the coronavirus epidemic in Iran, thus making it more likely to spread to the global pandemic. The Iranian rial has fallen by 80 percent, making it far harder to purchase medical equipment from abroad.  This has not only aggravated the coronavirus situation but also that of many other diseases as well. As of March 13, there were 11,362 reported cases and 514 deaths.

Of course this is aggravated by the Iranian regime imitating those of China (initially) and the US (until very recently) in denying the conditions in their country and being slow to act with testing and other measures. But the bad behavior of the regime does not justify the US and others acting to worsen the health crisis in Iran, which makes it more likely to spread its problems elsewhere as well.

Barkley Rosser

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Shelter in place

The San Francisco Chronicle reports “shelter in place” restrictions.  My daughter lives in Santa Clara county, where schools are closed till April 13.

Six Bay Area counties announced a “shelter in place” order for all residents on Monday — the strictest measure of its kind in the country — directing everyone to stay inside their homes and away from others as much as possible for the next three weeks as public health officials desperately try to curb the rapid spread of coronavirus across the region.

The directive begins at 12:01 a.m. Tuesday and involves San Francisco, Santa Clara, San Mateo, Marin, Contra Costa and Alameda counties — a combined population of more than 6.7 million. It is to stay in place until at least April 7. Three other Bay Area counties — Sonoma, Solano and Napa — were not immediately included.

The order falls just short of a full lockdown, which would forbid people from leaving their homes without explicit permission, and it wasn’t immediately clear how, or to what degree, it would be enforced. The order calls for the sheriff or chief of police to “ensure compliance.” In Italy and other places that have instituted lockdowns, travel outside the home has been restricted without permission and police have been ordering people back home if they don’t have a reason to be in public.

“The scientific evidence shows that at this stage of the (coronavirus) emergency, it is essential to slow virus transmission as much as possible to protect the most vulnerable and to prevent the health care system from being overwhelmed,” the order states. “One proven way to slow the transmission is to limit interactions among people to the greatest extent practicable.”

The Bay Area orders are the most restrictive yet in the U.S……

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Reporting from Germany: “Welt am Sonntag”

Welt am Sonntag is reporting our honorable President is attempting to bribe lure a German company CureVac to develop a vaccine  to be used only in the US.

Germany’s Health Ministry confirmed a report in the newspaper “Welt am Sonntag”, which said President Donald Trump had offered bribes funds to lure the German company CureVac to the United States, and the German government was making counter-offers to tempt it to stay.

Welt am Sonntag quoted an unidentified German government source as saying Trump was trying to secure the scientists’ work exclusively, and would do anything to get a vaccine for the United States, “but only for the United States.”

CureVac’s chief production officer and co-founder Florian von der Muelbe told Reuters the company had started with multitude coronavirus vaccine candidates and was now selecting the best two to send into clinical trials.

The privately-held company based in Tübingen, Germany hopes to have an experimental vaccine ready by June or July to then seek the go-ahead from regulators for testing on humans.

Earlier this month CureVac CEO Daniel Menichella met Trump, Pence, members of the White House Coronavirus Task Force, and senior representatives of pharmaceutical and biotech companies to discuss a vaccine.

Professor of Health Economics and Epidemiology Karl Lauterbach, a senior lawmaker with the Social Democrats and a junior partner in Chancellor Angela Merkel’s coalition stated:

“The exclusive sale of a possible vaccine to the USA must be prevented by all means. Capitalism has limits.”

Germany tries to stop US from luring away firm seeking coronavirus vaccine, CNBC, March 15, 2020

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Europe’s Response to Coronavirus and the Implications for the U.S.

Europe’s Response to Coronavirus and the Implications for the U.S.

As I listened to the morning news about the coronavirus crisis, I was reminded of this critique of the Eurozone:

In a recent conference, the distinguished economist Paul Krugman repeated the oft-heard critique that the eurozone is not an optimal currency area. Waltraud Schelkle disagrees with this characterisation, and argues that no country or group of countries represents an optimal currency area – one region or country always loses out from a single monetary policy. But countries can use fiscal, social and regulatory policies to overcome these difficulties. When Americans criticise the eurozone’s currency policies, she writes, they are forgetting the US dollar’s shaky start and the adjustments which had to be made to the financial system in the 19th century.

Why mention the optimal currency area debate in reference to this health crisis? This morning I heard statements like this one:

By contrast, the coronavirus crisis has started to look more like the European migration and financial crises: a symptom of globalization that can’t be held back where it started. The exploding outbreak around the Continent — officially declared a pandemic by the World Health Organization on Wednesday — highlights both the promises and limitations of the European Union: a single, largely borderless market made up of 27 countries, each with their own governments, electorates, bureaucracies, health care systems and, as has become painfully obvious, national interests. For weeks, officials in Brussels and national capitals have called for pan-European coordination. Yet even as Italy, the bloc’s third largest economy, embraces a made-in-China solution — putting the entire country under preventative lockdown — the modus operandi across the EU remains fragmented and reactive.

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Benefit-Cost Analysis and the Coronavirus

Benefit-Cost Analysis and the Coronavirus

We are in the middle of a flurry of decision-making on how to deal with COVID-19.  After much resistance, officials are now canceling public events, closing schools and discouraging other activities that put us in contact with each other.  Travel restrictions and possible shutdowns of workplaces, as we’ve seen in Italy, may be up next.

It’s interesting we haven’t heard anything about benefit-cost analysis in all this.  Nearly all economists profess to think that BCA is the single best decision method.  Almost every introductory economics textbook is built around benefit-cost thinking, and for decades federal regulations have mandated BCA for proposals with significant economic impacts.

But now we are facing immense choices—what could have a more drastic impact than shutting down most of the economy by fiat?—and BCA is nowhere to be found.

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Three related metrics of coronavirus

Three related metrics of coronavirus

Here are three different but ultimately related updates about the coronavirus pandemic.

1. It is 100x more lethal than the 2009 H1N1 swine flu

The latest right-wing disinformation is that Obama waited 6 months to declare the 2009 swine flu an emergency, and 1000 people died. As others have pointed out, his Secretary of Health and Human Services did so only 11 days into the US outbreak.

So why don’t we remember a big health emergency in 2009? Because the swine flu was 100x less lethal than coronavirus. According to the CDC’s final estimates:

from April 12, 2009 to April 10, 2010 approximately 60.8 million cases (range: 43.3-89.3 million), 274,304 hospitalizations (195,086-402,719), and 12,469 deaths (8868-18,306) occurred in the United States [were] due to pH1N1.

That is a mortality rate of 0.02%, or 2 in 10,000. The total number of deaths, spread out over a year, were 10% of average seasonal influenza deaths.

By contrast, coronavirus appears to have a 2% (some estimates are coming in more like 3%) mortality rate. If 60.8 million Americans were to contract coronavirus, that would mean about 1,200,000 deaths.

2. Exponential projections of the spread of the virus are holding up so far.

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Coronavirus update: reason for alarm; (small) reason for hope

Coronavirus update: reason for alarm; (small) reason for hope

This weekend has continued the discouraging news: reports just about everywhere that the Young Invulnerables packed the bars Friday night; the Petri dishes of airport security lines packed with Americans returning from Europe; and personally, two friends who I have known for almost 40 years getting very sick this past week and not able to be tested for coronavirus (one of whom by the way went in to work Friday to drive school buses full of kids because so many other drivers called out). All of these are going to be vectors for continued transmission of the virus.

In that regard, let me repost the graph from Jim Bianco that I ran last week. Because we are now 4 days into his linear projection of an exponential curve of coronavirus transmissions. Here’s the graph:

And here is how his projections compare with the actual numbers I pulled each day from the Johns Hopkins site:

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