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VA hydroxychloroquine study "garbage" "scientific misconduct"
Perhaps you've heard about the recent VA study on hydroxychloroquine. The MSM jumped on it with blaring headlines proclaiming failure and more deaths. It's no secret why they did.
There's also another big player in the war against hydroxychloroquine, Big Pharma. HCQ has no patent, is made all over the world, and is dirt cheap compared to the designer drugs they make billions from. Gilead's remdesivir is one of the covid 19 drugs being touted, and they might price it at $1000 per day like they did with Solvadi for Hep C So politics and billions of dollars are at play. You might think that after that VA study proclaiming death and failure that Doctors all over the world would stop using it. Actually no, in fact they are still using it at the VA Responding to the results during an appearance on MSNBC, Secretary of Veterans Affairs Wilkie said, “That’s an observational study. It’s not a clinical study. It was done on a small number of veterans; sadly, those of whom were in the last stages of life, and the drug was given to them.” The drug “has been working on middle-age and younger veterans,” Wilkie added. By that, he meant that it was “stopping the progression of” COVID-19" Dr Didier Raoult of France, who has treated over 1000 coronavirus patients, responded to the VA study with this letter. In the current period, it seems that passion dominates rigorous and balanced scientific analysis and may lead to scientific misconduct. The article by Magagnoli et al. (Magagnoli, 2020) is an absolutely spectacular example of this. Indeed, in this work, it is concluded, in the end, that hydroxychloroquine (HCQ) would double the mortality in patients with COVID with a fatality rate of 28% (versus 11% in the NoHCQ group), which is extraordinarily hard to believe. The analysis of the data shows two major biases, which show a welling to be convinced before starting the work : The first is that lymphopenia is twice as common in the HCQ groups (25% in the HCQ, 31% in the HCQ+AZ group versus 14% in the no HCQ group, p =.02) and there is an absolute correlation between lymphopenia (<0.5G/L) and fatality rate, which is well known (Tan, 2020) and confirmed here : 28% deaths, 22% and 11% in the HCQ, HCQ+AZ and No HCQ group, respectively. Lymphopenia is the most obvious criterion of patient severity (in our cohort, lymphocytes in dead individuals (n=22, mean ± standard deviation, 0.94 ± 0.45), versus in the living (n=2405, 1.79 ± 0.84, p < .0001)). As the authors acknowledge, the severity of the patients in the different groups was very different, and their analysis can only make sense if there is a selection of patients with the same degree of severity, i.e. the same percentage of lymphopenia. The second major bias is that in an attempt to provide meaningful data, by eliminating the initial severity at the time of treatment, two tables are shown: one table where drugs are prescribed before intubation, and which shows no significant difference in the 3 different groups (9/90 (10%) in the HCQ group, 11/101 (10. 9%) HCQ+AZ, and 15/177 (8.5%) in the group without HCQ, chi-square = 0.47, ddl = 2, p = 0.79), and one table, where it is not clear when the drugs were prescribed, where there are significant differences. These differences are most likely related to the fact that the patients had been intubated for some before receiving hydroxychloroquine in desperation. It is notable that this is unreasonable at the time of the cytokine storm, as it is unlikely that hydrochloroquine alone would be able to control patients at this stage of the disease. Moreover, incomprehensibly, the “untreated” group actually received azithromycin in 30% of cases, without this group being analyzed in any distinct way. Azithromycin is also a proposed treatment for COVID (Gautret, 2020) with in vitro efficacy (Andreani, 2020), and to mix it with patients who are supposedly untreated is something that is closer to scientific fraud than reasonable analysis. Altogether these 3 voluntary biases are all pushing to the idea of dangerosity of hydroxychloroquine safest drug as reported on nearly 1 million people (Lane, 2020). All in all, this is a work that shows that, in this period, it is possible to propose things that do not stand up to any methodological analysis to try to demonstrate that one is right. End of letter The cohort for this "study" was elderly black males with a variety of health issues and most of them were already intubated on ventillators, or about to be. And the HCQ group was biased towards the most critical patients as Dr Raoult says above. The death rate in NYC for coronavirus patients on ventillators has been reported at 88%. Most Doctors reporting success are using HCQ plus Zithromycin plus zinc and report the best results when the cocktail is used within a few days of symptoms start. A couple of personal anecdotes: An American friend who lives in Chapala, Mexico called me after he and his younger Mexican wife had both tested positive. She had light symptoms, and recovered easily without medications. He got very sick, high fever, cough, headaches etc and then his Doctor prescribed the HCQ + Zith + Zinc cocktail and after a few days recovered and is fine today. Yesterday I had a video appt with my cardiologist, we reviewed my heart health (I had heart ablation surgery recently) and then I asked him if I were to catch coronavirus would I be able to use the HCQ cocktail for treatment. He took a look at my most recent EKG and said yes you'd be a good candidate for that, we've had success with several patients, I would just have you stop taking one of the medications you're on. "What about that VA study" I asked. "It looks like it was designed to fail" |
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I hope we are all alive to see the hard facts and the tallies of why and how exactly people died. I personally am dreading what will happen when people are allowed to move about more, although I know that by not moving about more we are killing the entire mechanism of the economy that sustains all life functions...…….Eventually there is going to be a LOT of death due to Covid-19 and due to the economic shut down. There are no easy answers and not even any completely understandable questions. |
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That you would trot out Dr. Raoult to comment on data manipulation and small data sets is the height of hubris. This is the same Dr. Raoult whose paper on the success of HCZ contained 20 treated patients, and whose data deliberately ignored the 6 patients who deteriorated on his treatment. The doctor who the journal that published his report came back and said it was flawed by his inclusion criteria. He, who had 20 patients, is saying that a study of 368 is too small a sample. It is the largest collection of HCZ patients reported in any study so far. He criticizes the timing of administration of HCZ because the paper does not say when it was given. Then he jumps the shark to assert without any justification that it must have been given as a last desperate measure to men nearest to death. There is nothing in the study to support that statement. It is his wild guess. Lastly he criticizes that some patients also got azithromycin. Guess who did that in the study that made him recently famous. Yup, same Dr Raoult. He gave it to a few of his patients with no explanation in his paper as to why a few got it and most didn't. The outrageous gall of this man to criticize this paper for flaws he committed in this own work, with smaller numbers, is mind stunning. Quote:
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So FDA opinion, or that of a lawyer who is a political appointee about the drugs efficacy. I wrote a post about the VA study and noted its patient selection limitations. But the conclusion that the drug does not work on the most at risk patients is pretty clear. Older males with underlying illnesses. |
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Those of us who appreciate a lot of effort, facts, legitimate links and not personal anecdotal ramblings...are much appreciative. :ho: . |
Then don't go to the va.
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Blueash, I am most grateful for your responses. Please keep posting. You are needed in this wild world of disinformation.
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I think I'll stick with what the doctors are reporting
Lead author of the VA study, Joseph Magagnoli, has an MS in statistics. I wonder if he knows how to cook the books. |
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Who to believe?
So wait...was Secretary Wilkie ... outright lying and making things up? That's how it appears. If that's true about him, it will almost assuredly come out, and he'll have to face the consequences. It could probably be career ending.
You've mentioned more than once that Secretary Wilkie is "a lawyer who is a political appointee". You're obviously trying to diminish the man - whether you'd admit to as much or not. ... See, what bothers me most about this Hydroxychloroquine subject is that there's a vested interest among many to hope that it doesn't work. And why? Because Trump mentioned it. It's a political play. It's tantamount to saying "please, please...don't let Trump get anything positive out of mentioning this drug!" Intellectually honest people would have to admit to as much. *** So who should we believe? The scientists at the FDA who say hydroxychloroquine should NOT be used outside of a medical study, OR a lawyer appointed by the President? Based on past experience (Dr. Bright), I wonder how long it will take before heads roll at the FDA. As for the conspiracy theory about Big Pharma opposing use of hydroxychloroquine because they won't profit much from it, please provide factual support. There are SO many conspiracy theories out there already surrounding Covid-19. Just once, I'd like to see facts instead of conjecture. The assertion that it could be career-ending for Mr. Wilkie to make a misstatement in support of the President, I almost lost my coffee laughing. In some circles, lying in support of Mr. Trump would be a badge of honor. |
The data is in — stop the panic and end the total isolation | TheHill
The above article is enlightening. There is a lot of MSM misinformation. The majority of reporters only report the information they need to prove their spin or bias. I know because I used to deal with them and watched my interview edited to say the exact opposite of what I actually said. That is why all politicians speak in short soundbites. That is why non-political speakers who are elected get roasted by a biased media. |
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Big Pharma conspiracy to protect profits? Too funny Big Pharma spends record millions on lobbying amid pressure to lower drug prices Big Pharma spends record millions on lobbying amid pressure to lower drug prices - CNN Proof that some scientific and medical studies are fraudulent or designed to produce a certain result? a survey of members of the American Association for the Advancement of Science (AAAS) in which 27% of the scientists reported having encountered some type of misconduct [13]; a survey of research coordinators in which 19% of respondents reported first-hand knowledge of misconduct within the previous year – and that only 70% of these were reported [14]; a study of Norway medical investigators in which 27% of investigators knew of instances of fraud [15]; a survey of members of the International Society of Clinical Biostatistics, in which over 50% of respondents knew of fraudulent reports [16]; a survey of medical institutions in Britain in which more than 50% of respondents knew or suspected misconduct among institutional colleagues [17]; and a survey of New Scientist readers, in which a remarkable 92% knew of or suspected scientific misconduct by colleague. a survey of NIH-funded scientists in which 33% of respondents said they had engaged in one or more of a list of ‘top 10’ questionable behaviors ranging from approximately 16% for ‘changing the design, methodology or results of a study in response to pressure from the funding source’ Data fraud in clinical trials |
Some here take things way out of context, and keep saying the same things over and over and over until they believe what they type is fact.
Steve |
Amen
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So FDA opinion, or that of a lawyer who is a political appointee about the drugs efficacy. I wrote a post about the VA study and noted its patient selection limitations. But the conclusion that the drug does not work on the most at risk patients is pretty clear. Older males with underlying illnesses.
Yes we now know that just about zero drugs (including HCQ) work once you go once you are intubated (88% died in NYC) Big whoop. FDA statement merely says be careful about prescribing these cocktails which I'm sure most Doctors are. Millions of doses of these drugs are currently being prescribed all over the world and we aren't hearing about 1000s or even 100s of deaths due to the drugs. Most Doctors who are using HCQ cocktail advise using it early. The VA study is garbage and was designed to fail. My own cardiac electrophysiologist, with 23 years experience, and who recently was inside my heart with a radio frequency probe for an hour zapping circles around the scar tissue advised me that if I were to catch the disease, I would be a good candidate if he stopped one of my medications. I think he knows what he's doing. |
Hydroxychloroquine is so yesterday. Lysol and sunlight is the new buzz.
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It's interesting that NOW there is a problem with the same medication that they gave EVERY military member in Vietnam. Never heard of any problem with it then, and I bet they do not want to publicize any of the side effects now, other than by using it as a political weapon against one side or the other. If this is so dangerous, with side effects, then why has it taken almost 50 years to come to this conclusion?
A dying person is not going to worry about side effects if that is the only lifeline offered. Kudos to those in our gov that are working hard to find some form of hope to offer all those that are currently suffering from the CHINA virus. Quote:
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Which ever drug is the cheapest is the drug the va will use , even if it kills us vets
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Sad when there are no repercussions for reporters putting out false or biased stories
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As soon as I see MSM I know the rest of the post was written by a cult member. No thanks.
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If you are here to accuse Joseph Magagnoli of fudging the data, please at least have the guts to directly accuse him and not just suggest it with no evidence. |
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Now, none of the reports yet presented has been a randomized study, those are coming. Most of them have been from doctors looking back on their patients, some of whom got HCZ, some didn't and using established statistical methods to see if the ones who got the drug did better. And the studies do balance for the age, gender, severity of illness at presentation, and many other factors when they can. All have weaknesses. The initial positive studies had more weaknesses than most others, and the fewest patients, and claimed the most benefit from very short courses of medicine. No one has been able to replicate Dr. Raoult's findings and it was his study that got the use of HCZ going. I agree a dying person is not going to worry about side effects. The finding of the VA study was that in their population there was no benefit of HCZ, and the most important side effect was that you were more likely to die than if you were not given HCZ. I find that conclusion bizarre and it is likely a statistical fluke, like flipping tails six times in a row. No other study has shown the drug kills you. But it is well known that HCZ can kill you if heart side effects are not monitored. The authors of this study, who were not bedside clinicians, did not extract or report on whether EKG's were being followed or not. If the conclusion is not a fluke, then HCZ is not a lifeline, it is a deathline for the patient population studied, older males ill enough to be hospitalized with COVID. |
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The authors are very clear about who they studied, men admitted all of whom were over 64. That was who they had because that is who got admitted. They didn't manipulate by throwing out younger men, none got admitted to the VA system. They did have a few women but too few to study independently. Their outcomes were not studied or reported. The question is : Does HCZ help our patients? How to answer it - Look at all the patients we have treated. How to do that? Use the electronic records across several hospitals and extract the data. What data? There are specific codes entered into the record that show if a patient did or did not get HCZ at some point in the hospitalization. One group did, one group did not. The people who got HCZ were then subdivided into whether they got it before they went on a vent or after. Now look at how they did with outcome data. The outcomes checked were Died, and needed a ventilator. Quote:
In the group who never needed a vent, which is 344 patients, there is no difference in outcome whether treated or not treated with HCZ. It did them no good at all. It did them no harm either. The drug was useless. In the group that progressed to needing a vent, those who had received HCZ at any time were more likely to die. The finding of increased death rate for the group as a whole is because of the increased deaths in ventilated drug recipients. This is why I have consistently written that the increased death rate may be a less reliable finding as it is a small sample size. Bu the overall finding that the drug was useless is the kindest interpretation possible. It clearly did not help at all in the population studied which was overwhelmingly COVID positive men who were not sick enough to need a ventilator. |
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From the VA A spokeswoman for the Department of Veterans Affairs said that the research findings should not be seen as definitive. "This was not a clinical trial. It is simply an analysis of retrospective data regarding hospitalized patients," she told Fox News, via email. "The findings should not be viewed as definitive because the analysis doesn’t adjust for patients’ clinical status and showed that hydroxychloroquine alone was provided to VA’s sickest COVID-19 patients, many times as a last resort." From the report itself BACKGROUND: Despite limited and conflicting data on the use of hydroxychloroquine in patients with Covid-19, the U.S. Food and Drug Administration has authorized the emergency use of this drug when clinical trials are unavailable or infeasible. Hydroxychloroquine, alone or in combination with azithromycin, is being widely used in Covid-19 therapy based on anecdotal and limited observational evidence. This sounds like it was written by CNN. Credible reports are started off with more neutral language and then provide conclusions with just the facts. Other issues that have been raised is that it was based on patients who had already been intubated and the study was not peer reviewed as of April 21. Proponents all say that it has limited benefits in late stages. It also neglected to mention the use of another drug on those who did not receive HCQ. There are several reasons to suspect this report was not credible enough to justify its bombastic coverage. |
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The death rates once you get admitted to a hospital are really bad for older patients. 11.5% for 65 to 74 and 25.5% for 75 plus Attachment 83839 lymphopenia is twice as common in the HCQ groups (25% in the HCQ, 31% in the HCQ+AZ group versus 14% in the no HCQ group, p =.02) and there is an absolute correlation between lymphopenia (<0.5G/L) and fatality rate, which is well known Looks like a stacked deck to me. If you want to see a drug fail, study hospitalized old black men with a host of pre existing maladies plus coronavirus. Stick more of the guys with lymphopenia in the drug group. I love to see a drug that cures people who are really sick, but even better would be one that cures people before they have to go to the hospital. Hopefully there will be a study using the correct cocktail, at the correct time. Until then there are a lot of Doctors reporting success who don't have time for full on clinical trials. |
Secretary Wilkie
There have been some comments in this tread about Secretary Wilkie and I’d like to offer a different perspective.
Robert was one of my students at the Joint Forces Staff College. He was a Reserve Officer in the Navy then and an advisor to Condoleezza Rice. We had many discussions and remained friends for many years and as is typical in the military we drifted apart due to orders and moves. I was extremely pleased though when I heard he was assigned to head the VA. I couldn’t think of a better candidate. Robert has the highest integrity of any officer I have ever had the honor of serving with, and while he has a law degree, he is first and foremost a veteran. He represents and fights for all veterans. He is incredibly intelligent and has served his country with honor and tremendous professionalism for many, many selfless years of personal sacrifice. Robert is the kind of fellow that would leave Washington and drive 3 hours to have lunch with me, just to “catch up” and I was really no one, not a dignitary and not a flag officer. I was just his teacher. So, I hope before anyone passes judgement on a “political appointee” that you’ll stop and consider that there are those few men and women who rise above politics. I trust Robert. He is one person I’d gladly have next to me in the worst situation, working through challenges and finding solutions. As this thread has mentioned, he most recently went on camera to clear up the misunderstanding of a report that was released from the VA. Some of you are questioning if you can believe a lawyer and a political appointee. That’s up for you to decide, but for me, I know him and I know that he would resign before he would let anyone force him to make a false statement. |
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Hydroxychloroquine nay-sayers
I wonder how many people bad-mouthing hydroxychloroquine on this site would be begging their doctors to prescribe it for them at the first signs of the virus? I would bet almost all of them!
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Remember what he did? He treated patients sick enough to be in the hospital, not treated early. He treated 14 with HCZ and reported that with six days almost all were better compared to less than 20% better without HCZ. No zinc given, not given early. The only mentions of zinc helping have been by a couple doctors on TV who made the "you need zinc claim" and have disappeared since making those claims, not published anything, not come back with follow up data. There are studies being done, none have reported any findings. We should of course take special note, as you did of Dr. Cardillo Quote:
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He says that HCZ is useless unless given with zinc and that he is treating outpatients with the combination and all got better. He didn't say in the video it was 5 patients. And that he never treated anyone without zinc. Funny how the literature has zero reports of zinc being needed for HCZ to "work" and you have "most doctors" If you treat your COVID patients really really early you will get a terrific cure rate. I understand that 99% of symptom free COVID patients recover if treated with properly rearranging their furniture. Here's the point. Dr. Raoult's study claimed that hospitalized patients given just HCZ got better significantly more often and rapidly than those that did not. Nothing about zinc. Now people trying to replicate Raoult's data find it is not verifiable. In their data, HCZ fails. Either it works on its own or it doesn't. Nobody in any scientific paper has claimed HCZ plus zinc has shown benefit over just HCZ, or over no treatment. Nobody. |
It's important to remember, unless we have a crystal ball, everything is speculation, this is a Newal Virus,
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As far as zinc being used with HCQ and other drugs, here are a few reports. No CTs yet but they are being done. First, the reason Doctors are trying it is probably based on this invitrio study. Zn2+ Inhibits Coronavirus and Arterivirus RNA Polymerase Activity In Vitro and Zinc Ionophores Block the Replication of These Viruses in Cell Culture For a less technical explanation a video by Dr Seheult Coronavirus Epidemic Update 34: US Cases Surge, Chloroquine & Zinc Treatment Combo, Italy Lockdown - YouTube Dr Zelenko in New York (has treated 900 patients) New updates from Dr. Vladimir Zelenko: Cocktail of Hydroxychloroquine, Zinc Sulfate and Azithromycin are showing phenomenon results with 900 coronavirus patients treated - Must Watch Video | Tech News | Startups News DR Smith in New York is also reporting good results with HCQ + zithromycin + zinc Dr. Cardillo with Mend Urgent Care in Sherman Oaks says using hydroxychloroquine with zinc appears to be working in the handful of patients he has prescribed it to. "It was actually the hydroxychloroquine opening up a channel in the cellular membranes allowing zinc to come into the cells," he said, "And we do know high levels of zinc inside of the cell that's infected with the virus shuts down that viral replication machinery." He also gave patients azithromycin, an antibiotic most of us know as a Z-pack, to treat possible subsequent bacterial infections. Dr Sabine Hazan of Progenabiome is doing a clinical trial on HCQ + zinc A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection - Full Text View - ClinicalTrials.gov An interesting interview with DR Hazan here https://www.youtube.com/watch?v=XCVPwm2jVIo PS these are not asymptomatic patients the above Doctors are treating. PS2 If 99% of people can recover by rearranging their furniture, why are we arguing about drugs? I have some heavy items, come on over and I'll cure you. |
A preprint of a Brazilian study using HCQ and azithromycin shows promising results
Of the 636 symptomatic outpatients, 412 started treatment with hydroxychloroquine and azithromycin and 224 refused medications (control group). Need for hospitalization was 1.9% in the treatment group and 5.4% in the control group (2.8 times greater) and number needed to treat was 28 (NNT = 28). In those who started treatment before versus after the seventh day of symptoms, the need for hospitalization was 1.17% and 3.2% Conclusion Empirical treatment with hydroxychloroquine associated with azithromycin for suspected cases of COVID 19 infection reduces the need for hospitalization Dropbox - 2020.04.15 journal manuscript final.pdf - Simplify your life |
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Perhaps you don't understand the meaning of NNT. It means you have to give the drugs to 28 people to have 1 person benefit. So if only one out of every 28 "sick" patients had an underlying bacterial illness this is exactly what your data should result. This study has absolutely zero meaning in treatment of COVID and by the way, these people forgot to add the zinc which is so important per your posts. |
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Such intellectual dishonesty!!! Maybe they have a shortage of tests in Brazil, or maybe they bought a load of faulty tests from China. And maybe, just like all over the USA hospitals and Doctors are treating many patients at home until they can't breathe. Never examined? From the paper: Chest CT was performed in 251 (60.9%) subjects in the treatment group and showed that 70.1% had COVID 19 suggestive images; 150 (59.7%) patients had mild lung involvement, 26 (10.4%) moderate and none (0%) showed severe lung compromising. Only 54 (24.1%) chest CT were performed in the control group and of those 40,7% had COVID-19 suggestive images (Table 2) . All patients from both groups who needed hospitalization presented COVID -19 pattern at Chest CT Some think Chest CT best for covid 19 diagnosis CT Provides Best Diagnosis for Novel Coronavirus (COVID-19) | Imaging Technology News Next? Review the links I provided above about zinc. Not all Doctors are using it, but many are and think it's important. When I said most Doctors I meant of the several I was reporting on. My mistake, as someone we know said "it happens" |
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I'm waiting for actual peer reviewed studies that are backed by major universities and/or the CDC. |
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