Hydroxychloroquine for Coronavirus - Critical Information That You Won't Get Elsewhere

hi my name is rich Roberts I'm a medical doctor doctor biophysics and the former CEO for 24 years of a pharmaceutical company I'm going to get I'm going to give you information on treatments for the corona virus that you simply are not going to get anywhere else because people may not have had the same areas of exposure in in both medicine science but also pharmaceuticals and regulatory affairs that I've had lastly because I'm an Orthodox Jew I'm going to also address two videos that information that have been put that have been put out by two Orthodox Jewish physicians first I want to speak to you about hydroxychloroquine this is one of the leading candidates in in the press not necessarily scientifically but in the press to treat a current of virus infections and is a very hot topic of conversation hydroxychloroquine is used to treat rheumatoid arthritis and lupus it's a very common drug although you can't find it on shelves anywhere now because the American public have basically cleaned the shelves off of this product this is my second YouTube video on this subject and and if some parts of it please don't necessarily fit with your particular levels of understanding or areas of understanding and please bear with me cuz I will get back to two to two areas that are common to everybody I have a particular expertise in in this area of drugs because hydroxychloroquine is called a one amino Quinta line and it is a chemical modification of a drug called chloroquine which is a chemical modification of a drug called quinine and my company was the first one in the United States to get a FDA approval on it what you need to know is these are very old drugs they're the hydroxychloroquine and chloroquine were approved before 1982 if their drug has been approved and then if they're certain of years it goes generic there's no more money no more financial incentive and in in in selling that product anymore that will fund research and development on it so the research and development on hydroxychloroquine is has been very very little since 1982 but its precursor which is in the same chemical group as oxy chloroquine which is called quinine that was one that our company by an interesting twist of fate got approval for not too long ago I had to go back and check the records but I think the year was around 2007 something like that certainly we researched this drug up to modern standards and we made some discoveries on it which are critically important now to what you sing about hydroxychloroquine number one why do we have information about quinine that we don't have about hydroxychloroquine or chloroquine the reason is because y9 was being sold in the united states illegally for most of history up until our initial drug approval on it in like I said around 2007 the reason is because FDA has allowed a lot of old drugs that were never FDA approved and never fully researched to remain on the market because they were necessary medically necessary FDA started in started an initiative about 40 years ago to try to bring all of these old drugs up to modern standards so FDA had something called the trip the FDA's draft guidance on unapproved drugs and it said that if a company will do research on one of these old drugs and bring it up to modern regulatory and scientific standards then FDA will give a certain amount of exclusivity certain at a time of exclusivity so that company can make profits on it now here's the critical thing you need to know they're one of the there are several studies now showing that hydroxychloroquine might not does might work to treat coronavirus the most spoken about of those studies is from France and they use hydroxychloroquine along with z-pak where the generic name is a zipper Mason now virtually everybody you're going to see on the Internet medical including about including medical doctors will say that the reason why these probably work together is because the azithromycin works to stop pneumonia from bacteria whereas the hutch wears the hydroxychloroquine works by allowing zinc to go into cells I'm here to tell you that there's a very good chance that they're all wrong what we found was that quinine which again is chemically similar to hydroxychloroquine the way it's broken down in the body was best called metabolism the waste metabolized is with an enzyme in the liver called the cytochrome p450 system and it's these specific enzyme is 384 now that breaks down quinine that also breaks down hydroxychloroquine interestingly that also breaks down as the through Meissen and we have warnings on our quinine label about taking as if they're meisten and quinine together because the blood levels can shoot up dramatically of quinine now you can expect the same thing to happen front of hydroxychloroquine so you might say oh okay so taking is it through Meissen along with hydroxychloroquine caused much higher blood levels of hydroxychloroquine than what doctors would have thought that the patients had and that's what helped that's what helped the hydroxychloroquine to let a lot of zinc into the cells to kill the virus that may well be true but there's a downside to that quinine causes let me go back for a second every time your heart beats every time your heart beats to pump out blood there's an electrical signal that goes over the heart and that's what causes the muscles of the heart to contract and if you know an electrocardiogram you know it goes like Boop doot-doot-doot boop boop do do doop boop that's electrocardiogram now the distance between two of those beeps two of those Peaks it's called the QT interval if that gets too long people get too much duration between them people can get a disruption of the electrical rhythm of the heart called torsades t o RS t o art SI des and it can cause heart attack and death so when people are running around saying oh there's a French study as if they're Meissen and and hydroxychloroquine take them together well whoa whoa whoa wait one second wait one second that all sounds nice we don't know for sure that it works and we do know that it can cause unpredictably high levels of hydroxychloroquine again because the azithromycin interferes with your livers ability to break down hydroxychloroquine and this can lead to the QT interval that's electrical activity to be prolonged and it can lead to heart attacks and death so that's why this should not be done lightly and this should not be done without being supervised or under the care of a licensed medical doctor and everything I'm saying here you should check with your licensed medical doctor but it could tell your medical doctor the information I just told you tell him or her to go look it up they probably don't know this they probably don't know about these different mice and interference with hydroxychloroquine metabolism and blood levels and tell them they should check a koala qin qu a la hue UI n that's the brand name of the drug that we had in the company that i used to be the CEO of it was sold and then I retired there's you check that out and understand that they need to make an assessment on whether they should be checking your your electrocardiogram before enduring treatment now president Trump has said that FDA is fast tracking a study on hydroxychloroquine ditch treat coronavirus now I'm going to tell you how the government really works in when it comes to agencies of the government there's all kinds of different agencies that do all kinds of different things the number one priority of agencies is to protect their own jobs I'm sorry to say it now this is I don't think this is true about the military military people are willing to risk the lives and limbs and be injured or potentially died protecting our freedom but when it comes to these agencies the number one priority of agencies in general workers and those agencies is to protect their jobs so what you need to know is in regulatory agencies in the government there are two types of employees one are called career employees and the other are political appointees almost all the people that work in all of the agencies of the government are career employees they work there for example at FDA they work as a chemist they work as a reviewer of applications they work as an inspector and they expect to work there for 20 30 40 years and they'll retire from there presidents come and go presidential administrations come and go Republican Democrat come and go these people stay and they can and they're they are very very careful that they that not to lose their jobs that's their their number-one priority so they want to help the public yeah sure but they don't want to lose their jobs and they know that they will not lose their jobs if they go by the regulations and by the way this was all over government for example a criminal enforcement agencies like they like the Department of Justice they know when they open up an investigation that the the investigators the lawyers that open up an investigation in DOJ and spend a half a million a million to three million dollars out of do J's budget they know very well that if they don't get a conviction and if they get fines or high-profile people in prison they know that's gonna look bad on their records so I'll give you an interesting story with our company and FDA firts and and human health the Department of Health and Human Services after the World Trade Centers came down there was an ant threat there were anthrax attacks on the United States and it turned out that the drug that worked to treat anthrax infections is doxycycline and our company was one of the companies that made doxycycline and we had plenty of it so the government some days a group called the Metropolitan rapid deployment force which is which was was I know if it still is an agency in the department in the Department of Health and Human Services HHS contacted us and said that they want to stop by stockpile doxycycline so that if there's an attack a major attack and people didn't know maybe somebody with an airplane with a with an insecticide spray who's gonna fly over a city and just spraying it with anthrax they want to have a certain number of millions or tens of millions of doses available so that so that the the rapid deployment force could rush doxycycline into into that city like like overnight and start to treat people so at the time we made on a bottle of 100 tablets 100 capsules of doxycycline this is a pharmaceutical a manufactured sophisticatedly manufacture product we made like 20 cents per bottle of 100 capsules it was ridiculously low and we really could have charged anything that we wanted at that point because people were all around the country like they did with hydroxychloroquine we're just wiping it off the shelves but I said you know what we're not going to raise the price and as a matter of fact for the government the government wanted to buy it at a price even below that where we didn't make any money at all I mean the 20 cents a bottle is pathetic but we make no money at all I said you know what we're going to give here of our production to the to the rapid deployment force so we agreed to do it great we did it now two stories come off of this the next thing we know we get contacted by the human relations department of the government and they and they said now that we are a contractor for the government they have to inspect our Fermin of action plan so I went ballistic I said just look at this we don't want the government business work we have people clamoring begging for it all the major warehousing drug chains the number names you know they were begging us for the product we were pouring it out as quickly as we could and I said we've handed it to the government well we will make no profit even though we made a little profit on the other business and now we're getting an inspection about this by the Labor Department so for our Fuhrman of action policy so I just want ballistic now we haven't from we had an affirmative action policy but we had an affirmative action policy and the truth is I felt good internally and I prided myself on the fact that we were a meritorious company merit based company if employees performed they got they got promoted and I was very happy that there were many minority employees from racial minorities that went up up the ladder in management and there were also a number of employees who graduated from the the local Catholic girls high school never had any college education and they moved up into management why because they performed because they were smart they were capable dedicated hard-working they were loyal they were they were reliable so I had a lawyer one of our law firms write a letter to the Labor Department and say this is absolutely atrocious this is absolutely ridiculous you know that the one inspect us now nevertheless they can't about contact the Labor Department contact our attorney and said look we have no choice the computer spit out your name because your government tractor now we understand the situation just have your formative action policy on a table while Kidman will look at it we'll go and to the Labor Department's credit and this is rare that you see government do this the inspector came in to the office looked at the policy for five minutes and left and that was the end of it there's another story though which doesn't have as as happy of an ending and this is what gets to FDA so we said to FDA I mean then we wrote to FDA we had a product another product and the antibiotic that we made that is extremely stable meaning it doesn't break down with heat yet we might have but we've had approval to you know maybe a two or three year shelf life on it but in fact we tested five years out it was still perfectly good rock stable solid with a great manufacturing process said FDA normally you would make us to scale if we said okay we can scale we can use the same equipment but bigger sized for that product then we'll be able to to free up um I forget the number I think is about a hundred or two hundred million tablets of production for doxycycline so we can get more of this product out to H did to HHS of which FDA was an agency as well as this Metropolitan rapid deployment force you get much more out and we said we will so normally you have to make a batch in the bigger equipment you have to put it on three months of accelerated stability which is higher temperatures higher humidity than usual then test it and then send indefinite FDA asked if you can scale up the equipment you'll do tests all kinds of other tests on it and then six months or a year though they'll likely give you approval as I said it's a rock-solid product let us scale it up into other equipment and and and then we'll be able to make much more doxycycline for HHS and FDA said no why because they live and die by the regulations the guy in FDA or the guys at FDA said Isaac of my Senate generically could be men or women who make that decision if they go by the regulations they won't lose their jobs if they go contrary to the regulations and something goes wrong they can lose their jobs they didn't care about the science they cared about protecting their jobs and I'm here to tell you that is how mature the majority of government works so when President Trump says that FDA has fast-tracked studies on hydroxy koala Quinn don't hold don't hold your breath that's not the way FDA works FDA people know that if they don't do complete studies and get all the proper data in and go look at how the testing methods to test what you know in different tests for whether people in effect are not affected how they were where they were validated or not validated what was the certification on the equipment that was used how was the certification actually certified who tricked you who checked the certifiers and on and on and on FDA their inclination is if they don't get all that information then they don't want to lose their jobs by approving something and proving something that could be false so don't count on FDA to come through anytime soon with hydroxy koala Quinn study now that's the bad news here's the good news we don't need FDA approval if this was a new drug to the market that would need FDA approval before the company could ever send it out but this drug is already approved for rheumatoid arthritis and is used for lupus also it's all over the place it's already out there what this study would do is it would cause a it would allow FDA to then officially approve the drug to also be used for coronavirus but that isn't needed it never has been approximately half the usage of drugs in the practice of medicine is for diseases that the drugs are not FDA approved for this is completely legal this is completely regular and this is what's known as the practice of medicine this is the history this is a historical distort the historical art of practicing medicine so as more and more studies that are done informally come in by the way I don't know what they're gonna shall they make sure that hydroxy koala Qin addressed hydroxychloroquine works for treating Kovach 19 coroner corn virus they might show it doesn't work they'll make sure its people are dropping dead of QT prolongation heart attacks I don't know if the studies going to show but the study is going to start rolling in from all over the place all kinds of hospitals big ones small ones doctors writing in their experience to the journals and there will be a weight of eminence now this is not perfect evidence all things being ideal we would wait until a full proper study can be done and all the systems to be validated and when that happens a year from now they're built there gonna be a lot of people who are dead who could have been saved if this drug worked so you need to know that this FDA FDA fast-tracking it as President Trump said that's all nice and good it's unnecessary I don't think anybody's going to wait for for it but we are waiting for good data so now I'm going to talk about some of the data one of the Orthodox Jews Jewish doctors from a Harvard Hospital I also was there at one I was one year at a Harvard Hospital this guy is way way behind be way way beyond me in his medical training but he said that we need to wait for a double-blind placebo-controlled clinical study date blah blah blah that is standard medical science but the fact is people are dying now we need to have some idea or indication of whether the drug really works or not and and the idea of waiting for FDA that's a standard medical doctor physician who doesn't know how things really work that's their that's their position but the fact is as data comes in positive or negative I don't know which helping or maybe hurting patients I don't know the answer physicians if the data is good if the safety looks good even though it's not fully proven but they have patients who are deathly ill you have a high rate of you know it was an unacceptably high rate of patients that are not surviving this there are medical doctors that will start to use the drug and let's start to use it you know pretty widely so we don't have to wait for FDA to get the answer we can work with interim answers now again I don't make the medical decisions for you you're licensed medical doctor makes decisions for you but that's just what you need to know so this doctor from Harvard is a very seems like a very bright and respectable and reliable guy he just doesn't know about how the FDA works and the approval process now there's a different medical doctor Orthodox Jew from Muncie who is who is saying things that I'm really quite shocked to hear first of all in one of his videos he called zinc a vitamin it's not a vitamin it's a mineral they may say it's a small error is a small error for the public a medical doctor should know that difference he also put out a letter thanking President Trump for approving hydroxychloroquine for for coronavirus that's what he wrote he's wrong President Trump doesn't approve drugs the FDA approves drugs but and what dr. Falchi explained publicly is the doctor Falchi is is a hard science expert in virology and he's the leader on this he explained that President Trump is trying to be a cheerleader and that's good you want the president to give hope to people you want him to rally people but you don't take president Trump's scientific analysis or regulatory analysis explicitly you have to listen to the scientific experts so for that doctor from Muncie I would encourage people to be very careful about listening what he says he's wrong zinc is not if I do minutes of mineral he's wrong President Trump did not approve hydroxychloroquine for a coronavirus the FDA did not approve a drug see chloroquine for coronavirus and he'd be very careful this guy also put out a regimen of zinc azithromycin a night roxy chloroquine to treat coronavirus is no mention of the fact that as if from iceland that's in his regimen will can interfere with the livers ability to metabolize or breakdown hydroxychloroquine potentially causing dangerously high levels of hydroxychloroquine and therefore potentially causing heart attacks so be very careful about that Muncie doctor now back to the Harvard doctor very good legitimate guy he said the only evidence that we have fried chicken fried roxy chloroquine is a study from france that by the way used it with the zipper Meissen and he pointed out major major errors in that study major reasons why we should bury beet why we should be very cautious about the information that studies correct about that but he's not correct that that's the only place that we've been getting information from there is an excellent youtube site called med cram a needy CRA M and if you look at the coronavirus update number 34 he goes through data of coronavirus use of I'm sorry of hydroxychloroquine used to treat karana virus from China and from South Korea as so there's additional information now I don't know how well we can trust the studies from China but we have additional information there some of it looks pretty decent I would not depend on it but I can tell you now there are all kinds of informal studies and formal studies going on all around the country now when I talk to you about some of this but the nature of some of those studies something else you may not know I've mentioned previously about the art of medicine the practice of medicine were not computers medical doctors you're allowed to use any drug for any reason if you have a rational scientific reason to think that it might work and you and you you as a medical doctor you assess that the benefits at risk outweigh the risks now if you really mess up when that the lawyers will probably destroy you but that's the ability there's another aspect to the art of medicine and that is medical doctors taking unknown drugs themselves Sigmund Freud was the was the originator of modern psychiatry and he was the founding father of psychoanalysis which is really the basis for most of psychology psychiatrists psychologists that we have today he was wrong about some things he was right about many but he was a pioneer do you know that he was the one to introduce cocaine into medical practice and how did he introduce it he did it used it himself it was a new drug people didn't know about it and he tried it himself I'm not telling if you could take cocaine heaven forbid what I'm trying to tell you is that there's a long history of medical doctors using themselves as pigs to try new drugs that are not proven yet just like there's a long history of medical doctors putting themselves in the win in harm's way to treat sick people and many times medical doctors died they sacrificed themselves treating patients I said for those there's really no more noble cause they're like American soldiers putting themselves in harm's way and there have been doctors now that have died from corona virus so you should know that when you do clinical studies patients have to sign all kinds of forms that they understand their risks and and and blah blah blah well medical doctors and I would think nurses also because because nurses know quite a bit of medicine and they're also very very dedicated I'm sure a general kotoba everybody generally very dedicated to their patients and also put themselves in harm's way and there were studies going on by medical doctors and nurses who are being exposed to corona virus where some of them are taking hydroxychloroquine and some are taking a sugar pill and they don't know which and they're putting themselves on the line so a lot of this data is going to start coming in and when it does we're going to be able to get a much a lot more information so that medical doctors to start to make much more informed decisions about whether or not they want to take a chance when using a Troxy chloroquine or if they want to take the risk of not using it because if it does work for coronavirus and visions don't get it and they succumb or they're permanently damaged that's also bad that's the art of medicine that's the practice of medicine and it's not being done by some artists be done by people of extensive who have extensive scientific training and they have a world of communication of that scientific information through scientific journals so that's what's coming you do not have to wait for FDA to come up with the answer now some other they get when people talk about a vaccine vaccines are not drugs the drug is it looking for a drug is a drug you want to go in to the body and kill a bacteria or kill a virus a vaccine is is an injection that will hopefully cause your immune system to start to make I'd only get to come pick antibodies start to attack that virus and to get a vaccine approved which is not on the market yet not like hydroxychloroquine it's already on the market or not like some other antiviral drugs that are already on the market for other uses that are now being tested but the new vaccine is not on the market yet that will that will require FDA approval before you can even get your hands on it or doctors before doctors can get their hands on it and that's gonna require extensive testing and you might say oh well you know people are dying just to prove it what could what could be worse a lot they could cause I mean illogic reactions of course people to die they could cause they coat of glue Murray cause agglomerations that settle into basement membranes of the glomerulus and cause the kidneys to fail there's a lot that could go wrong there is no way a vaccine is going to be approved by the FDA before it's fully and extensively tested in all the traditional ways so don't count when any vaccine being approved at least until a year from now and maybe much longer by that time this catastrophe will have hit and be gone so when a year great nose great news vaccine you know give it a break don't tell FDA about it also the companies say we're screaming drugs are screening a thousand chemicals well if these are chemicals that are not already on the market approved by FDA it will be at least a year of not years until FDA approves them because they will have to go through full testing good there are real true risks to them and until you know what those risks are the FDA is simply not going to take those risks all right I think I'm smoking long enough I'm sorry this was boring to you but this is a real catastrophe we're dealing with and what I wanted to make sure that people have the full information thank you and if you liked it it was helpful okay I want you to know I'm not commercializing this I don't want anybody's money but if you can send it to other people who might also find it helpful or useful please do so I'm in this just to help others and I hope that you will too thank you