Doctors Break Down COVID Response and the Demonization of HCQ, DOCTORS TELL ALL

 

In this interview, Dr. Simone Gold and Dr. Dan Wohlgelernter discuss the country’s failure to protect the elderly from the coronavirus and also sort out information around Hydroxychloroquine.

TRANSCRIPT

Wohlgelernter: My name is Dan Wohlgelernter and I’m a cardiologist trained at Yale University School of Medicine here in New Haven, Connecticut and I’ve been a cardiologist here in Santa Monica, California for the last 30 years.

Gold: Hello good morning. I’m Dr. Simone Gold. I’m a board-certified emergency physician and I’m also an attorney. Please don’t hold that against me. I practice on the front lines whether or not there is a pandemic.

Interviewer: Dr. Wohlgelernter again, why have you decided to speak out?

Wohlgelernter: I think we are dealing with a tragic situation where the scientific process has been violated. Studies have been published that had not been adequately vetted and should not have been published. Those studies were used to terminate further evaluations of hydroxychloroquine.

I’ve decided to speak out because the political interference in the physician decision-making process is objectionable and should not be allowed to continue. There are lessons to be learned from this pandemic on many levels. We’ve spoken about the dangers and the irrationality of the lockdown process.

We’ve spoken about the violation of the scientific purity of investigation. We’ve spoken about media presentations and misrepresentations of data. This is injurious to the health of our population now.

And I don’t want to see this replicated in the future.

I think as physicians we have a moral responsibility to protect our patients. To protect the science behind our medical decisions. And to prevent intrusions into the purity of the scientific process by outside forces that may have bad intent. And it’s important to speak out. It’s a moral imperative for us to speak out and to protect our patients and to protect our professionals.

Interviewer: Dr. Gold, why did you decide to speak out?

Gold: I decided to speak out for one very specific reason. That was I was actually presented with a definite positive COVID patient and I prescribed hydroxychloroquine because I was very up on the literature on this and I got severely reprimanded for it. I also had received from the state board threatening all doctors, I was just one with a potential investigation into me for unprofessional conduct if I was to prescribe hydroxychloroquine.

This was so shocking to me and had never happened where the government told a physician if they had the right or not to prescribe an FDA medication. That is just an event that took me by surprise. I thought to myself if doctors don’t speak up than we are really all lost.

Wohlgelernter: Let me add one more thing if I may. I think it’s important in terms of people’s perspectives about the impact of COVID. That they understand that the data now shows that 99.7 percent of people infected with COVID will survive. Zero-point three percent die.

And the vast majority of those people who die as we’ve discussed are the elderly. The frail. Those that are at the end of life. It’s not to say that we don’t care about those deaths. On the contrary, we feel that many of those deaths could have been and should have been prevented had the proper precautions been taken as were taken in the state of Florida.

In contrast to how things were handled in the state of New York, the state of New Jersey and the state of Pennsylvania where the nursing homes were not protected and were forced to take people who were actively infected. What we needed to do was not lock down all of society. Not shut down schools. Not shut down all businesses. You needed to protect the elderly.

Particularly the elderly in the nursing homes. It’s a small segment of our population. We could have allowed the rest of the population to continue with their lives, take adequate precautions but not be completely shut down. The cost of the shut down in terms of the physical, emotional, and psychological health of people is enormous.

We’ve only seen the tip of the iceberg of people who have been shut-in. Who’ve lost their businesses. Who are facing depression. Who are facing issues of mental health because of the consequences. This should never happen again. If we ever face this situation again we need to learn the lessons from the mistakes and policies that were implemented.

Interviewer: So it recently came out that the coronavirus isn’t as contagious as they thought especially for asymptomatic carriers. Is this big news in the medical field? Have you guys known this? And what does that really mean for precautions they’ve been taking?

Gold: Whenever you review the CDC studies you could see that it wasn’t affecting young people. This has been a tragedy that we’ve locked down our young people. Again this data is widely available to anybody who wants to search it out. Go to CDC.gov and you can see people based on their ages. It hardly affects teenagers and youths. Under 20, 30, 40, or really under age 60 it does not have a higher lethality rate than common influenza. So I was not surprised.

Wohlgelernter: As Dr. Gold said, I think the focus should have been on protecting the high-risk population. And we knew from the data that it had come out from China and from Italy and from France that the people at risk were the elderly and frail and people who were immunocompromised.

As Dr. Gold said, young people had very little risk from this infection. They rarely got ill from it. So it was not a good decision to shut down schools and to shut down all businesses. It was certainly was not a good decision to send actively infected coronavirus patients to nursing homes. So the strategy was inverted.

We should have protected the people in the nursing homes and given those homes more resources to protect the people at risk. And the low-risk population should have been allowed to live their lives. We could have had some precautions in terms of social distancing and masks perhaps. But to close down the entire society when in fact, it’s just a small segment of that society that’s a risk. I think it was a tragic mistake.

Gold: I work in the emergency department so I see people of all ages. My heart would sink whenever I would see a nurse and her patient because I knew right behind that nurse and her patient were five more and 10 more behind that one. It flies through nursing homes. First of all, they are immune-compromised. You cannot be a nursing home patient unless you have a skilled nursing need. These are not just ordinary older people.

These are people who have one pretty serious medical condition. Many of them have three or four serious medical conditions. Obviously, they can’t fight it. So when I would see people with COVID-19 the ones who got really sick were the nursing home patients. Sometimes a person that wasn’t in a nursing home got sick. Very sick. But I almost never saw a younger person or a healthy person that was sick enough that had to be hospitalized or severely ill.

Always in life, there are limited resources and the resources need to go where they can be most useful. What we did is we spread all our resources out amongst society at large. That I thought was criminal and immoral. We needed to focus the resources on the people that needed it. Our nursing home patients. As a specific example off my head was in Pennsylvania, the average age of the person who died from COVID-19 was 79. At the same time, life expectancy was 78.7.

So of course all deaths are tragic. All of us have parents that we love. However, it’s in a different category when who’s passed the life expectancy passes versus a person who is 20 and passes. So when the average person sees these numbers that are calculated every day 100,000 Americans have died, they are not able to put that in context because the media is not giving the context.

Do you know how many Americans die every year? The average American doesn’t know. The question is how many more people died due to COVID-19 that were not going to already die let’s say within this year. That number is very low. I think there has to be some reckoning when this is all over how we really harmed and killed nursing home patients.

Wohlgelernter: Yes. The data certainly was known. We knew this as early as February from China and Italy that it was the elderly and frail who were most at risk. So why did Governor Cuomo and his health commissioner force the nursing homes to take patients? Well, it was part of the overall panic that occurred not just among society but in the healthcare industry.

The hospitals in New York and throughout the country were afraid that they would be overwhelmed with patients and they wouldn’t have sufficient capacity. And they wanted to offload patients that were no longer requiring in-patient high-intensity care. And they said we need to let those people go out of the hospital. And where can you send them?

Well, there were places in New York that they could have sent them. The Javits Center which had been equipped. The Navy ship Comfort that was sent into the New York east harbor. Instead, they were sent to the nursing homes where it created massive death. This was a tragic mistake. Just absolute negligence in terms of decision making.

Gold: Yes. So the Comfort and the Javits Center were shockingly empty. They were almost completely empty.  Which was amazing. The question of why Governor Cuomo did this is very unpleasant to speculate. One thing that’s for sure is that it was absolutely known when he made the decision to let the patients go back to the nursing homes. It was 100 percent known.

I understand looking back people would wonder was it known? You can go back and look at the dates of these things. It was absolutely known that it was risky to send nursing home patients back. The health commissioner of Pennsylvania really had an egregious situation where she took her own mother out of an assisted living facility but she told the rest of the state that it was perfectly safe to leave your grandparent in an assisted living facility. That’s just egregious. There’s no question that it was known at the time. I don’t know why this was the plan.

People always wondered why the deaths were so high in New York. There is no question that the nursing home’s death put them over the top. No question. And a fact that is often missed is that patients that got sick in the nursing home were often sent to the hospital and died. Those do not even count as COVID deaths attributable to the nursing home. That doesn’t even count. So whatever the number is, it’s higher.

Wohlgelernter: You have an interesting contrast between the state of New York and the state of Florida. In the state of New York, the nursing homes were not protected. They were not given adequate PPE equipment. They were not given adequate resources. And they were forced by the governor, the health commissioner, by the mayor of New York City to accept people who were discharged from the hospital and were still actively infected with the coronavirus.

And guess what happened? Just as what you would predict would happen. You had thousands of deaths. It estimated as many as 40 or 50 percent of the deaths in New York were nursing home patients. This was preventable. The proof of it was the state of Florida. Governor DeSantis said let’s protect the nursing homes.

And his health commissioner said let’s work on protecting the nursing homes and not allowing visitors. Checking everyone who comes in and to make certain that there is no evidence of infection. Giving them adequate resources and certainly not allowing any people with an active infection to go into the nursing homes. So the mortality rate in the nursing homes in Florida was small.

And Florida, as most people know, has a large percentage of elderly people. Not just in nursing homes but throughout the society and all the snowbirds who come down from the northeast. It shows you with good policies and with rational thinking, you can protect people. And we could have had a much lower death rate and death count in this country had people followed the policies that were used in the state of Florida.

Interviewer: And there is a lot of talk going around now about hydroxychloroquine. People are saying it’s really dangerous. The news is really hammering it. Dr. Dan is hydroxychloroquine dangerous?

Wohlgelernter: I’ve prescribed it. I’ve also recommended it to people. I’ve had conversations with people literally around the world in Israel and Italy and England and the east coast of the United States. And I’ve read the literature extensively. So hydroxychloroquine definitely has a role. That role is specific.

It’s an anti-viral agent that is effective in the early stages of infection. When used in that context it is effective and it is safe. Unfortunately, there have been studies that have looked at hydroxychloroquine but have looked at it in the wrong context. They looked at it for severely and critically ill people in the hospital setting.

At that point, the antiviral is not effective because you’ve gone beyond viral infection to a new mediated widespread inflammatory reaction. So that was the wrong population to look at hydroxychloroquine in. And that kind of study, that sabotages the whole story about hydroxychloroquine. I’m not certain why they were designed that way.

But it was obvious hydroxychloroquine would fail in that context. Hydroxychloroquine has been reported to have heart toxicity. As a cardiologist, I’m intimately aware of this literature and I’m familiar with hydroxychloroquine and the study that was most specific in looking at the cardiac issues.

Specifically, with rhythm abnormalities, there was a study done on the East Coast in the New York area where they looked at 200 patients and carefully monitored their EKG’s and looked for arrhythmias and the found no serious arrhythmias in any of those patients. Some of the reports about the danger of the heart and the dangerous effects of hydroxychloroquine are based on a misinterpretation of data or on faulty data.

Interviewer: Interesting. We did see the World Health Organization ordered countries to stop using hydroxychloroquine recently and they’ve also stopped trial testing on it as well. Was this decision based on those studies from the Lancet and the New England Journal of Medicine and JAMA?

Gold: Yes. The World Health Organization stopped the hydroxy trials based specifically on the faulty studies that were printed in the Lancet and printed in the New England Journal of Medicine. Also, the European Union stopped it and it has had headlines all across the world that we should stop using it.

I do want to clarify for the audience that they did restart the trials once the Lancet and New England Journal of Medicine retracted those faulty studies. However, it’s not so easy to just restart a trial. You have all these patients that were in the trial that had to start and stop and gather new patients. And the damage has certainly been done.

In addition to those studies, there has been so much negative press that it’s even difficult to enroll patients in hydroxy studies. That’s been well documented. There was a professor of Columbia who said that it’s tough for him to even get patients in the study because they hear about hydroxychloroquine and they think it’s so negative.

I want to remind people that this is an FDA approved drug for 65 years. It’s generic. It’s cheap. We give it to pregnant women. We give it breastfeeding women. We give it to elderly patients. We give to patients who are immune-compromised.

Most of those patients are on it for decades. There was never a controversy about hydroxychloroquine right up until March 20, 2020. So I would look at the studies before them. The early studies before Trump said he kind of liked the drugs were uncontroversial from China and France. However, I do find that the data after Trump thought it was possibly helpful is suspect.

Interviewer: Absolutely. A lot of people are saying that the JAMA study is the most flawed out of the three. Why is it so controversial. Can you kind of touch on how they collected the data and how it was a little skewed?

Gold: Let me just back up first. The Lancet study and the New England Journal of Medicine study both were retracted. I want to emphasize that that’s a very rare thing for a world-famous journal to do. To be published in the Lancet and the New England Journal is no easy feat. It’s the world-class editors and journal and people all over the world listen to these journals. There are a handful of journals in that category. Those are probably the number one and two.

So to have them do a retraction is a major story which is why you heard about it in the headlines. The reason their story was retracted was that the data that went into those studies could not be independently verified. You can draw conclusions from that if you will. Was the data even gathered? Was the data faulty? Was it fabricated?

We don’t know because we asked the company that provided the data a company called Surgisphere Corp. who’s been quite secretive to reveal their data and they have absolutely refused. Because they wouldn’t reveal their data their studies had to be retracted from the journals. That’s the problem with those. A story that hasn’t been discussed in the media is a third world premiere class medical journal known as JAMA also is severely flawed.

There are a number of flaws with this. The first major flaw in the JAMA study is what I would call pseudo randomization. To do an effective medical study you have randomized the patients into different groups. Groups that have this character and that character.

And the point being is that the groups should be generally similar so you know if the drug actually made a difference. If you give the drug here but not here. It doesn’t really help if the groups themselves are pretty different. So you kind of make them even in terms of age and risk factors of heart disease etc.

When you look at the study itself as it’s printed right now I encourage your viewers to go and look this up yourself on page seven of the study you can look and see the groups are not equal. The higher dose group is seven years older and they have almost eight percent heart disease. The other group is seven years younger and has zero percent heart disease. There are a number of these flaws that are different in the two groups.

By itself that is cherry-picking of patients that would make any data through this study suspect. So I want to make clear that the JAMA used a drug called chloroquine which is really a precursor to hydroxychloroquine and sometimes we use those names interchangeably. But in America we only use hydroxychloroquine.

The JAMA study was in Brazil. They used chloroquine. The lethal dose of chloroquine has been established for more than 30 years. In 1988 the New England Journal of Medicine established that the lethal dose of chloroquine is five grams. The JAMA study had two groups.

In the high dose chloroquine group, they gave them one point two grams a day which means by the fourth day they had almost five grams. Now most of us think of a drug as going through your system kind of quickly and you’re thinking it’s been four or five days.

That’s not the case with chloroquine and hydroxychloroquine. Hydroxychloroquine and chloroquine sits in your body for a very long time. At least a month perhaps two months. Somewhere between 30 and 60 days is its half-life. So to give somebody four point eight grams in four days is a very large dose.

People would often possibly call that a lethal dose. The study went on for ten days which meant the people in that group got 12 grams. Again, the New England Journal of Medicine in 1988 established five grams as a lethal dose.

If you don’t think it’s lethal, you would at least say it’s very toxic. And patients would be expected to have a lot of neural or cardiovascular symptoms, and you could expect them to be vomiting. Mind you, these are elderly and critically ill patients that are incubated with several respiratory distresses.

You don’t want these people to be vomiting. That’s a huge risk factor. It’s not just speculation or the science data that says it’s a very high toxic dose. So many patients died in the high dose group that they halted that study early. They quit the high dose group because so many patients died. That’s extremely dramatic for a scientific study.

It’s very unusual for a study to have given such a large dose of a medication because all of the scientific studies have to be overseen by an ethics board. The scientist that did this study presented the paper to JAMA saying that they went through an ethics board however that is in doubt. The Brazilian Ministry of Justice is actually investigating.

There is actually no proof that there was an ethics board. I can’t speak to whether they had it or not. But what I can say is that there is no proof that they had it. They normally have a certain committee number that is stamped on the paperwork and they don’t have that. We have written to them and tried to get it. And there has been no response on that. So the Ministry of Justice is investigating the deaths of all those patients that died in the high dose chloroquine group.

Interviewer: Dr. Dan in your opinion why do you think hydroxychloroquine has been so politicized after hearing all this and seeing how the media has been portraying it?

Wohlgelernter: I think one of the serious casualties of the COVID pandemic has been scientific truth. We rely on the scientific process to be pure and untainted by political influence. The fact that as Dr. Gold said, two of the world’s most prestigious journals Lancet and the New England Journal of Medicine published studies hastily without an adequate peer view. And studies that were based on data that had no transparency.

That creates widespread skepticism about the reliability of medical journals to give information that can be trusted. And we’re going to need to look into that whole process and into the forum of the process of publication so that we never see that violation of scientific truth. Why did this become politicized?

The fact is that President Trump first mentioned hydroxychloroquine and advocated for its use as a non-physician in mid-March. But we had data from China and from France and well before that in February showing the significant beneficial impact of hydroxychloroquine.

Yet we saw physicians, politicians, journalists, saying that hydroxychloroquine is all hype, and it’s all due to the President pushing it. And that’s revisionist history. The fact is there was a great deal of excitement in the medical community internationally a month before President Trump ever mentioned it.

Because they reported it from China and from Dr. Raoult in France and it is sad that people used whatever political animosity they had towards the President to attack the medication that in fact had helped many people with coronavirus and could have helped many more had it reputation not been so sullied by political accusations and by poorly designed studies and by medical journals allowing publications that were negative as far as their conclusions. Publications that never should have reached print because they hadn’t been adequately vetted.

Interviewer: Interesting.

Gold: I get asked a lot of questions about the VA study of hydroxychloroquine. And my immediate instinct is to wonder why hydroxychloroquine keeps getting studied at the later stages of the disease. I can’t emphasize enough that the mechanism and action of a drug and the path of the physiology of a disease is the number one factor when you are structuring a scientific study. So the disease early in the course is all about viral replication.

How much virus can be produced and how quickly? That’s the problem in the early setting. In the late setting, the problem is your body’s over-response trying to cure itself. And that’s called a cytokine storm. And in this setting, it affects all of your organs including your lungs failing.

The first group which is the early group you would like a drug that is very good at preventing the viral replication. That’s what hydroxychloroquine with zinc is very very good at. So I was always a bit confused why we kept getting study after study after study about hydroxychloroquine being studied in the late-stage disease population and kind of like it doesn’t snow in August it wasn’t working very well.

So to me the VA study and Lancet study, JAMA all of those studies, I’m not that surprised because I already know it doesn’t snow in August. I’m waiting to see the data about hydroxychloroquine and zinc and how it works early on. The mechanism of action would indicate it would work well. Before the hydroxychloroquine got politicized, the preliminary data we have from China and France was very promising.

Wohlgelernter: As Dr. Gold mentioned, hydroxychloroquine and chloroquine have been around since the 1950s. Azithromycin which is an agent used with hydroxychloroquine has been around for 30 years. These agents have been shown to be safe and effective. Again we needed to understand which context it worked in. It wasn’t going to work with the critically ill hospitalized patients on ventilators with multi-organ system failure.

That is not what it should have been used for. It works in early-stage where the antiviral effect can terminate the infection and prevent people from getting critically ill. And it’s sad that many people to this day have been deprived of the potentially beneficial use of an agent that in fact is safe and that is inexpensive and widely available.

Interviewer: Dr. Gold, what is your message to the media?

Gold: My message to the media is I understand that you have a point of view and God bless you and you can say it. Free speech is very important. But don’t have an opinion on the science of a medication. Think of your own family and your own loved ones and relegate to the scientists the purity of the scientific result because one day you could suffer the harm of having polluting that process.

My message to the scientists is I understand that there is a lot of pressure out there maybe coming from big pharmaceutical companies or journal editors to come to specific results. I implore scientists to stand the line. If us scientists don’t stand the line and hope for truth and accuracy nobody will. Certainly not the media. Certainly not the politicians. I’m very distressed on two levels about the JAMA study.

The first level is that the scientist that ran that study actually doesn’t seem as though it was done in the correct scientific manner. The other part I’m upset about is the journal itself – which I don’t think vetted it in the manner that a world-class medical journal is supposed to vet it.

My message to the scientists and the editors is to please ignore the media. And please ignore the politicians. Please focus on the science. All of humanity depends on you doing that.

Interviewer: Perfect. That was awesome.

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Photo “Dr. Simone Gold and Dr. Dan Wohlgelernter” by Fleccas Talks.

 

 

 

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