Roy Exum: Yes Sir, Let’s Gamble

Saturday, March 21, 2020 - by Roy Exum
Roy Exum
Roy Exum
It was around about 50 years ago when the world started to recognize “Thalidomide babies.” A German pharmaceutical firm had developed a drug for morning sickness for expectant mothers and depression that was considered as a safe and efficient therapy. But there was no way for them to know that it also had a catastrophic side. Once in the human body, the good effects and the bad effects combined to have a devastating effect on a baby in the mother’s womb. When it was pulled from all drug regimens in 1961, there were over 10,000 children who had been born with disabilities such as the characteristic stunted arms or legs. Some babies were born with no limbs at all. Worse, just as many babies died at childbirth.

So, when you watched the pithy exchange between our president as he argued with Dr.
Anthony Fauci about the use of chloroquine to combat the coronavirus, you need the back story. Dr. Fauci has been the Director of the National Institute of Allergy and Infectious Diseases under six presidents and it is commonly believed he knows more about infectious disease than anybody in the world. He remembers the Thalidomide tragedy well and, in the sake of gilt-edged safety knows the proven process of scientific vitro testing and then human drug trials before a drug is approved. As basketball maven John Wooden would tell his UCLA players, “Never hurry, but always be quick.”

President Trump doesn’t have that luxury. Many Americans are about to die. The death rate in Italy two days ago from coronavirus was 480 in a 24-hour period. Yesterday it was about 800 for the same time period and this was on the same day a stunning 6,557 new cases were reported. On New Years Day, only a handful of Americans - all scientists - were the only Americans who had ever heard of CONVID-19. Yesterday the number of cases in the world toppled the 300,000 mark (304,000 at 8 p.m. Saturday) and the death rate is gaining at breakneck speed, 12,950 in the world. Once the coronavirus gets its head in our land of 330 million, the devastation will be unbelievable.

So I’m with Trump – let’s gamble. Here’s the exchange:

* * *

[NOTE: This pertains to the use of a malaria drug, chloroquine, to combat the coronavirus. Trump is pushing the immediate use instead of waiting for the trials’ data. Trump cites some results from the trials:]

Dr. Anthony Fauci: “That evidence is anecdotal evidence. As the president mentioned yesterday, we are trying to strike a balance between making something that has potential of an effect available, at the same time we do it under protocol that would give us the information to determine if it is truly saving effective. But the information is anecdotal, it was not done in a clinical trial, so we cannot make a definitive statement about it.”

President Trump: “Without saying too much, I am probably more of a fan of that than may be than anybody. But I am a big fan. We will see what happens. We understand what the doctor says is 100% correct, certainly. But I have seen things that are impressive. We will know soon. We will see. Including safety. But when you talk about safely, this has been prescribed for many years for people to combat malaria, which was a big problem. It is very effective. It is a strong drug. We will see...look, it may work, it may not work.

“I agree with the doctor. It may not work. But I feel good about it. That is all it is, just a feeling. You know, I am a smart guy. I feel good about it. We will see soon enough. We have big samples of people, if you look at the people. There are people in big trouble. This is not a drug that obviously I think I can speak for a lot of, from a lot of experience going because it has been out there for over 20 years. So it is not a drug that you have a huge amount of danger with.

“It is not a brand-new drug just created that may have a monumental effect, like kill you. We will know very soon. The FDA is working hard to get out. Right now in terms of malaria, if you want that you can get a prescription. By the way, it is very effective. It works. I have a feeling—I am not being optimistic or pessimistic. I think we should give it a try. There has been some interesting things that are happening. Some very good things. Let's see what happens. We have nothing to lose. You know that expression? What the hell do you have to lose?”

* * *

At yesterday’s coronavirus briefing, Trump was asked about the unfortunate exchange, which never should have been made in pubic because that just creates more angst replied …

“Well, I don’t know that it's resolved. I can say that it’s going to be distributed. I know New York is getting, I think, 10,000 units and numerous other people. It could be the malaria drug plus the Z-Pak, and we’re going to find out, we’re going to find out. I feel… look, I feel, as the expression goes, what do we have to lose? Because, you know, I feel very… I feel very good about it.

“Tony would feel like he’d like samples done in a certain way. And I understand that too. Many doctors agree with that. We don’t have much time. You know, we have a lot of very sick people right now in hospitals all over the place. And speaking with the governor of New York, Cuomo, I said, “How does it look?” He’s got a lot of sick people. So we’re going to be delivering a lot of samples to New York and other places and we’re going to find out very shortly whether or not it’s going to work.

“I feel very confident. I mean, I’ve seen things that surprise me, frankly. There are, as Tony said, there are other things we’re looking at too. Vaccine of course is incredible, but this is more immediate. Right now, this, to me, would be the greatest thing that could happen. This would be a gift from heaven. This would be a gift from God if it works. So we’re going to pray to God that it does work. It’d be a fantastic thing.”

* * *

In plain-speak, 10,000 units of the IV chloroquine on the way to New York would indicate a decision has been reached and – bully, bully – I can say without pause that is what the American people want. By rushing 10,000 units to New York for broad-spectrum use would indicate provisional approval.

Then again, last month Bruce Aylward, speaking on behalf of The World Health Organization (WHO), said in a presentation: “There is only one drug that we think may have real efficacy (means “a chance) and that’s remdesivir.” A promising anti-viral, Gilead’s treatment for coronavirus “could be approved for Covid-19 very soon,” a Piper Sandler analyst says.

“We now believe the Remdesivir clinical trial results are likely to be positive,” analyst Tyler Van Buren says of GILD's experimental medicine. If successful, it could be approved for broad use in the coming months considering it’s safe, the bar for efficacy in the context of the ongoing global pandemic is low.”

Not months … but now. On Friday Trump told the media that the FDA had given provisional approval to the drugs hydroxychloroquine, remdesivir, and favipiravir. Bayer announced Thursday it has donated 3 million tablets of Resochin, a chloroquine tablet, to the government response and is working with them to get authorization for emergency use.
I’m with Trump: “What the hell do we have to lose?”

* * *

THE FUSCO FAMILY in Freehold Township, NJ, has lost four members of its immediate family to the coronavirus. When the matriarch, “Miss Grace,” died on Wednesday, she had not been told two of her children, her oldest son, Carmine of Bath, PA, died five hours before and her daughter some five days earlier. The oldest of her 11 children, Roseann, died on Friday and three other family members are still critically ill. “It’s so pitiful,” said Paradiso Fodera, “We can’t even mourn the way you would.”

* * *

SOME STATES have closed all businesses except those deemed “essential”: In New York that includes liquor stores and, in California, marijuana dispensaries.

* * *

At 6:00 p.m. on Saturday, the United States had 25,045 confirmed cases (plus 6,924/24 hrs), 296 deaths (plus 63/24hrs), and 147 recovered.

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