Emergency Physician, Dr. Simone Gold and Cardiologist, Dr. Dan Wohlgelernter are two brave doctors who join Austen Fletcher of the Fleccas Talks YouTube channel with very important infor-mation, countering the breathtaking skullduggery coordinated worldwide across governments and health agencies against the drug, hydroxychloroquine. Furthermore, they say the lockdowns were and are completely unnecessary.
Dr. Wohlgelernter says, "I've decided to speak out, because I think that we're 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 and those studies were used to terminate further evaluations of hydroxychloroquine."
He says, "I have 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 protect our profession."
Dr. Gold says, "I decided to speak out for one very specific reason. I was actually presented with a definite COVID-positive patient and I prescribed hydroxychloroquine and zinc, because I was very up on the literature on this - and I got severely reprimanded for it. I also had received a letter from the State Board, threatening all doctors - I was just one - with potential investigation into me for unprofessional conduct if I was to prescribe hydroxychloroquine.
"This was so shocking to me," says Gold, who is also an attorney. "It had never happened, where the government told a physician if they had a right or not a right to prescribe an FDA-approved medication. I mean, that was just a sui generis [unique] event, that took me by surprise. And I thought to myself, 'If doctors don't speak up we've really all lost."
Dr. Wohlgelernter says, "The cost of the shutdown, 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 kind of situation again, we need to learn the lessons from the mistakes in policy that were implemented...
"I think that the focus should have been on protecting the high-risk population. And we knew from the data that had come out from China and from Italy and from France, that the people at risk were the elderly and frail; people who are 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, to shut down all businesses and it certainly was not a good decision to send actively-infected coronavirus patients to nursing homes.
"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..."
Thousands of infected patients were sent to nursing homes, leading to massive death when there were plenty of new beds set up at great expense, between the Javits Center and the USNS Comfort. This was unconscionably negligent.
Dr. Gold says, "The question of why Governor Cuomo did this is very unpleasant to speculate but one thing that...was absolutely known when he made the decision to let the patients go back to the nursing homes - it was 100% known...that it was risky to send the 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 [the danger] was known, at the time...
Dr. Wohlgelernter says, "It's estimated that as many as 40%, even 50% of the deaths in New York were nursing home patients. This was preventable."
Austen asks Dr. Wohlgelernter about reports that hydroxy-chloroquine is dangerous. He replies, "I've prescribed it. I've also recommended it to people and I've had conversations with physicians literally around the globe; in Israel and Italy and England and the East Coast of the United States and and I've read the literature extensively.
"Hydroxychloroquine definitely has a role. That role is specific. It's an antiviral agent that is effective in 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; looked at it and severely critically ill people in the hospital setting. At that point, the antiviral isn't effective, because you've gone beyond viral infection to an immune-mediated widespread inflammatory reaction, so that was the wrong population to look at hydroxychloroquine in.
"And that kind of study sabotages the whole story about hydroxy-chloroquine..I'm not quite certain why they were designed that way, but it was obvious that hydroxychloroquine would fail in that context.
"Hydroxychloroquine has been reported to have heart toxicity - and 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 in the East Coast, in the New York area, where they looked at 200 patients and carefully monitored their EKGs and looked for arrhythmias and they found no serious arrhythmias in any of those patients.
"Some of the reports about danger to the heart and dangerous effects of hydroxychloroquine are based on misinterpretation of data or on faulty data."
Austen asks, "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 Lancet, New England Journal of Medicine and JAMA?"
Dr. Gold responds, "The World Health Organization stopped the hydroxychloroquine 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 was 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... restart a trial. You have all these patients, they were in the trial that had to stop and start and gather new patients and the damage has certainly been done.
"And in addition to those studies, there's been so much negative press about hydroxychloroquine, that it's actually difficult to even enroll patients in hydroxychloroquine studies. That's been well-documented. There's a professor at Columbia who said it's hard for me to even get patients in this study, because they hear about hydroxychloroquine, they think it's so negative.
"I always want to remind people, this is an FDA-approved drug for 65 years. It's generic. It's cheap. It's widely available. We give it to pregnant women. We give it to breastfeeding women. We give it to elderly patients. We give it to patients who are immune-compromised.
"Most of those patients are on it for decades! There was never controversy about hydroxychloroquine, right up until March 20th, 2020. So, I would look at the studies before then. The early studies, before Trump said he kind of liked the drug were uncontroversial, from China and from France. It looked promising.
"I don't know what the final data will show, however, I do find that the data after Trump thought it was possibly helpful is suspect...
"To be published in The Lancet and to be published in the New England Journal Medicine is no easy feat...to have them do a retraction was a major story, which is why you heard about it in the headlines. The reason their study was retracted is the data that went into those studies could not be independently verified...
"We asked the company that provided the data, a company called Surgisphere, which has been quite secretive to reveal their data and they have absolutely refused. Because they refused to reveal their data, those studies HAD to be retracted by the journals...
"In addition, a story that hasn't been discussed really in the media is a third world premier class Medical Journal, the Journal of the American Medical Association, known as JAMA...
"The first major flaw in the JAMA study is what I would call "pseudo randomization". To do an effective medical study, you have to randomize the patients into different groups; groups that have this character and that character - and the point being that the group should be generally similar, so that you know if the drug actually made the difference...
"When you look at the study itself, as it's printed right now in JAMA, your listeners - I encourage you and viewers to go and look this up, yourself - on Page 7 of the study. You can look and see that the groups are not equal. The higher-dose group is seven years older, they have almost 80% heart disease. Those are just two of the differences. The other group is seven years younger and has 0% heart disease and there's a number of these flaws that are different in the two groups.
"By itself, that's cherry-picking of patients that would make any data that comes from such a study suspect. So I want to be clear that the JAMA study used not exactly hydroxychloroquine, they used a drug called chloroquine which is really a precursor to hydroxychloroquine. Sometimes, we use those drugs, 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 well-established for more than 30 years in 1988 a New England Journal Medicine. Again, one of the world premier journals established and everyone accepts that the lethal dose of chloroquine is 5 grams. Well, the Jama study had two groups. In the high-dose chloroquine group, they gave them 1.2 grams a day which means by the fourth day, they had almost 5 grams...
"Hydroxychloroquine and chloroquine sit in your body for very long time, at least a month, perhaps 2 months; somewhere between 30 and 60 days is its half-life. So, to give someone 4.8 grams in four days is a very large dose; people would often possibly call that a lethal dose.
"The study went on for 10 days, which meant that the people in that group got 12 grams. Again, New England Journal of Medicine in 1988 established 5 grams as a lethal dose...Mind you, these are elderly, critically-ill patients that are intubated or in severe respiratory distress...
"It's not just my 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 the scientific studies that involve human subjects have to be overseen by an ethics board. The scientists that did this study and presented the paper to JAMA are saying that they went through an ethics board - however, that's in doubt.
"The Brazilian Ministry of Justice is actually investigating. There's no proof that there actually was an ethics board...
"They normally have a certain committee number that's 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 actually investigating the deaths of all those patients who died in the high-dose chloroquine group."
Austen asks Dr. Wohlgelernter why hydroxychloroquine has become so politicized and he responds, "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. Gould said two of the world's most prestigious journals, Lancet and the New England Journal of Medicine published studies hastily, without adequate peer review and studies that were based on data where there was 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 to and to reform the process of publication so that we never see that kind of violation of scientific truth.
"Now, 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 well before that in February, showing a significant beneficial impact of hydroxychloroquine.
"Yet you saw physicians, politicians, journalists saying that hydroxychloroquine is 'all hype', 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 of the data reported from China and from Dr. Raoult in France and it's 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 its 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."
"I got 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 of action of a drug and the pathophysiology of a disease is the number one factor when you're structuring a scientific study. 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 to trying to cure itself and that's called a 'cytokine storm' and in that setting, that affects all of your organs, including your lungs failing.
"In 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 doing study after study after study but hydroxychloroquine - we studied it 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, The 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 but hydroxy-chloroquine and zinc, how well it works early on. Mechanism of action, when indicated would work well and before hydroxy-chloroquine got politicized, the preliminary data that we have from China and from France, it was very promising."
"As Dr. Gold mentioned, hydroxychloroquine and chloroquine had been around since the 1950s. Azithromycin, which is an adjuvant agent used with hydroxychloroquine has been around for 30 years. These agents have been shown to be safe and to be effective. And again, you needed to understand which context it worked in. It wasn't going to work in the critically-ill, hospitalized patients on ventilators with multi-organ system failure. That was 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 that's widely available."
Dr. Gold says, "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 polluted that process.'
"My message to the scientists is, 'I understand that there's a lot of pressure out there, maybe from big pharmaceutical companies or journal editors to come to a specific result. I implore scientists to stand the line. If US scientists don't stand the line and hold for truth and accuracy, nobody will - certainly, not the media, certainly not politicians.
"I'm very distressed on two levels about the JAMA study. The first level is that the scientists who read that actual study it, 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 supposed to vet it.
"So my message to the scientists and the editors is, 'Please ignore the media and please ignore the politicians. Please focus on the science. All of humanity depends on you doing that.'"
Running Time 47 mins: |
|
No comments:
Post a Comment