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Regulators explore new methods to evaluate vaccines for latecomers

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Who would willingly choose an untested vaccine produced by Shionogi & Co. over the already proven 95%+ efficacy vaccines produced by Pfizer and Moderna? 

This is all about ¥¥¥¥ — drug companies and associated parties trying to line their pockets with fat government vaccination contracts by rushing inferior vaccines to market without performing the established safety precautions.

5 ( +7 / -2 )

"evaluating COVID-19 vaccines swiftly"

While there may be a need for alternative evaluation methods, there is a much bigger need in Japan for eliminating unnecessary approval bureaucracy for vaccines that have already been tested, studied, approved and given to millions of people around the world with minimum side-effects.

9 ( +11 / -2 )

My friend’s company (in the drug field) had a meeting, where five people were supposed to “volunteer” for the shionogi vaccine trials. Nobody did….

4 ( +4 / -0 )

They need to add menstrual changes to the list of things to check because they apparently forget to check how it affects women's reproductive health: https://beta.ctvnews.ca/national/coronavirus/2021/4/16/1_5391236.html

1 ( +6 / -5 )

If the International Coalition of Medicines Regulatory Authorities finds other effective ways, drugmakers in Japan and other countries trailing the United States and European countries in COVID-19 vaccine development would be able to accelerate their development and production.

That depends on an assumption that is terribly wrong in Japan, and that is thinking the government would be interested or participating in a method that could accelerate approval of the developed vaccines, after all even now it requires completely useless local trials on top of the standard in the world.

One alternative is to figure out the relationship between the amount of antibodies generated after vaccination and its effectiveness in preventing symptoms of the disease using available data.

The problem is that antibody titers as a surrogate for protection can only work for some infections, not for all, for some extremely good protection can be obtained even if antibody levels never increase, and for others you could have long lasting antibodies at "good" levels but that would not provide proper protection. This is the main reason why this extremely easy to think approach has not been used until now.

They need to add menstrual changes to the list of things to check because they apparently forget to check how it affects women's reproductive health

There is no "forgetting" about it, there are endless amount of variants that could be examined for everything produced, but there is nothing wrong with only checking those things that have been found important before or that jump as significant during the trials, something that has not even been correlated with the vaccines and still is perfectly possible to be related with the stress of the pandemic itself is not something that could even be justified to be examined specifically during the trials (specially if it is not reported by the participants).

5 ( +8 / -3 )

Long term I’ll effects of the vaccine may be catastrophic, probably not but nothing is impossible. Nothing is impossible, through human history mankind has often played with fired and become badly burnt. This could happen again

-6 ( +3 / -9 )

Long term I’ll effects of the vaccine may be catastrophic, probably not but nothing is impossible. Nothing is impossible, through human history mankind has often played with fired and become badly burnt. This could happen again

"Nothing is impossible" is a terrible argument to avoid something that has proved to be safer than the alternative in every possible way until now. After all it is also "not impossible" that the vaccine have positive side effects or that survivors from COVID end up with long term problems that have not been identified until now, rejecting the vaccine would also be "playing with fire".

7 ( +9 / -2 )

So the tide turns and since most Japanese are not vaccinated as of today, the Japanese companies can test here and make better bucks rather than licensing a foreign product. Those sneaky LDP and CEO heads figured it all out.

3 ( +6 / -3 )

@virusrex

Nobody yet knows the answer and anyone who says they know there vaccine is safe long term is as deluded as the covid deniers. Both sides are like a cult and too quick to judge others. It’s the old seeing things in black and white without any middle ground that has held back mankind for so long

-10 ( +2 / -12 )

Japan was late to the party and is now desperate to find ways to catch up and get in on the action. Just hope they don’t put their people at risk trying to do so but this is a country that sacrificed many lives on a misguided strategy in WWII.

0 ( +3 / -3 )

Nobody yet knows the answer and anyone who says they know there vaccine is safe long term is as deluded as the covid deniers.

Of course not, because long term problems dont just randomly appear, if the disease already is causing long term and permanent health problems frequently in the patients, and the vaccine have not, that means the risk is much higher for non-vaccinated people.

Is like saying you don't know if you are safer wearing a seatbelt and having an airbag in your car, because maybe in the future they will contribute to your death. This is nonsense because it is easy to understand you are at a higher risk of death without them than with them, even if you cannot predict the future.

6 ( +8 / -2 )

@virusrex

Toyou it is nonsense be use your mind is made up regarding vaccinations and how to deal with Covid. Each nation is different, different approaches can work in different places. Some places Covid hit bad even with multiple lockdowns, in Japan far less. Nobody knows the answers, I don’t claim to, I assess the situation continually as things evolve.

-8 ( +2 / -10 )

Toyou it is nonsense be use your mind is made up regarding vaccinations and how to deal with Covid.

Of course not, it is nonsense because it has been scientifically proved so. In every nation of the planet the disease is correlated with more risks than the vaccines, "different approaches" make no difference about it anywhere. Lockdowns can be more or less useful because of particular situations, but vaccines have demonstrated to be safer everywhere. Your "assesment" is based on denying scientific information, which is not a valid approach.

4 ( +7 / -3 )

&@virusrex

The day humans or even scientists are infallible I will agree with you, however humanity is nowhere near that. I don’t deny anything, that’s the funny see, I’m taking a wait and see approach. One thing I do doubt though is that Covid is such a danger as it’s made out it is to your average health adult.

-7 ( +2 / -9 )

The day humans or even scientists are infallible I will agree with you, however humanity is nowhere near that.

That is irrelevant, science do not need to be infallible to be irrational to go against it without any basis. Your "wait and see approach" can be demonstrated to put yourself and others at a higher risk, the same as refusing antibiotics for a bacterial pneumonia or surgery for ruptured appendix. You are of course free to do it, but it doesn't make it less of an irrational choice based on prejudice.

Do you know what is hundreds or thousands times less dangerous than COVID for average healthy adults? the vaccines.

6 ( +9 / -3 )

The day humans or even scientists are infallible I will agree with you, however humanity is nowhere near that.

Not only are scientist not infallible, they are also not always all that honest. Especially when it comes to big pharma.

Do you know what is hundreds or thousands times less dangerous than COVID for average healthy adults? the vaccines.

And even less dangerous than vaccine are hydroxychloroquine and vitamin D, except for those irrational people that deny science.

-6 ( +1 / -7 )

Not only are scientist not infallible, they are also not always all that honest. Especially when it comes to big pharma.

"Big pharma" is just the excuse that antivaxxers desperately try to cling on when the whole scientific and medical consensus goes against their irrational beliefs, when not a single well recognized institution of medical science, hospital, university, etc. is against the well demonstrated reality that vaccines are safer than COVID then it is obvious there is no "big pharma" conspiracy, it is just science.

And even less dangerous than vaccine are hydroxychloroquine and vitamin D, except for those irrational people that deny science.

HCQ is more dangerous than the vaccine, so much that even those that tried to push for their adoption as therapy had to direct any patient with heart problems to the "no treatment" group because HCQ is a lethal risk for them, the worst part is that it is not even useful in the first place as demonstrated (again) by science and every medical and scientific institution of the world. Vitamin D has only value to correct (obviously) deficiency of vitamin D, the same as many other nutrients that have an effect on immunity, for people with normal levels there is no usefulness at all in getting more of it.

6 ( +9 / -3 )

@virusrex

Actually there are studies being done which show that Vitamin D above the recommended amount can make the risk of infection lower especially in black people. Limited study and in a short time so need further investigation as does the vaccine long term effects. Also studies have shown that exposure to sunlight reduces the severe symptoms in quite a large percent of people which makes the lockdowns seem more foolish.

-6 ( +3 / -9 )

Actually there are studies being done which show that Vitamin D above the recommended amount can make the risk of infection lower especially in black people.

People always say that, but when asked to produce those studies they never seem to be able to find them. A very important detail is that normal levels of the vitamin have been recently reviewed to higher levels, that means that what considered normal before actually should have been included as deficiencies. It is very different to find effects until deficiencies are corrected (only up to a certain level) another is to find a dose dependent effect (with more protection the more vitamin D there is, without relationship with normal levels). Interventional studies are also much less likely to discover spurious relationships than observational studies.

Also studies have shown that exposure to sunlight reduces the severe symptoms in quite a large percent of people which makes the lockdowns seem more foolish.

Show the studies then, and also understand that lockdowns do not consist on reducing exposure to sunlight that is still perfectly fine to get as long as people keep social distancing measures. This is the same argument from people saying that lockdowns make people get no exercise or eat worse, something that is extremely easy to avoid for anybody with a minimum of common sense.

6 ( +8 / -2 )

People always say that, but when asked to produce those studies they never seem to be able to find them.

That's strange, I have seen on JT several references on vitamin D over the past months, both for scientific studies as well as recommendations from health agencies.

-5 ( +1 / -6 )

That's strange, I have seen on JT several references on vitamin D over the past months, both for scientific studies as well as recommendations from health agencies.

And they always end up being references to correcting dietary deficiencies, not about an effect of vitamin D above recommended levels and specially not interventional studies, correcting problems from malnutrition is as "new" as controlling diabetes, hypertension or obesity. Is like saying that eating less protects you from COVID, it only applies when it corrects a problem, not as a general measure that will benefit anybody.

6 ( +8 / -2 )

@virusrex

https://www.sciencedaily.com/releases/2021/04/210408212954.htm

https://www.medicalnewstoday.com/articles/covid-19-high-vitamin-d-levels-may-protect-black-people

During lockdowns especially some may get zero sunlight, the elderly and those living in small apartments without garden or balcony, same applies for exercise.

Not claiming these are magic pills but they could help many as the studies show. The media and vaccine pushers solely focus on the vaccine and understand nothing for general well-being of people, especially the disadvantaged and those poorly educated regarding health and diet.They talk about caring but I don’t see that, just pushing the vaccine agenda and failing to see the big picture, terribly sad.

-6 ( +2 / -8 )

So as I said, observational studies without specific variable controls based principally into correcting deficiencies, a big hint would be the use of the word "suficcient" in the headings of the article you reference, which is exactly what I reference with normal levels not being the same now as before. Still no indication of dose-dependent relationship above adequate levels at all and no evidence from interventional studies to eliminate confounding factors (like people taking better care with other prevention measures together with their diets).

During lockdowns especially some may get zero sunlight, the elderly and those living in small apartments without garden or balcony, same applies for exercise.

And again this is in no way a fundamental part of the lockdowns nor specially difficult to correct without ever having to go against any of the social distancing measures even during lockdowns.

Vaccines are pushed because interrupting transmission has an effect not only in the vaccinated person but also in the public in general including those that are more vulnerable and those that cannot be vaccinated. Nothing in the promotion of vaccines and educating people that they are safe and effective goes against any of the other health recommendations because all can be done without problem together.

The big picture is that stopping spreading has a much bigger impact in the health of the whole community, and that there is plenty of access to measures to control or correct commodities for anybody that takes care of his own health. If people are protected from infection in the first place thanks to herd immunity then even imperfect control of their particular conditions will not make it easier to complicate or die from COVID.

4 ( +6 / -2 )

The media and vaccine pushers solely focus on the vaccine and understand nothing for general well-being of people, especially the disadvantaged and those poorly educated regarding health and diet.They talk about caring but I don’t see that, just pushing the vaccine agenda and failing to see the big picture, terribly sad.

Yes, that is very true. There are constant articles about vaccines as if that was the only solution to confront covid19 and avoid lockdowns. So many lives would be saved by educating the general public about the importance of vitamin D in overall health and specifically with regards to respiratory disease. Vitamin D is no longer just about having strong bones. People would be shocked to learn of the percentages of people with insufficient vitamin D levels, especially in winter and especially among those with dark skin. In India, the incidences of both vitamin D difficiency and insufficiency are shockingly high, but no mention.... we gotta sell those vaccines.

-6 ( +1 / -7 )

Yes, that is very true. There are constant articles about vaccines as if that was the only solution to confront covid19 and avoid lockdowns

That is as always a false strawman, vaccines are simply the best, most cost efficient way to relax social distancing measures. Much more than any treatment, including the limited effect of controlling any of the predisposing conditions for complications, after all without infection there is no possibility of complications from COVID.

4 ( +6 / -2 )

Vaccines are not the only way to achieve herd immunity.

We should focus on getting the general population to optimize their health to fight covid19. This includes simple, cheap, well established approaches (vitD, zinc, low carb, no seed oils,...) that will also do wonders for general health. Then while taking basic precautions and protecting the more vulnerable, we can let the virus run its course, and immediately treating everyone who tests positive with safe and effective drugs (e.g. HCQ). This will result in very few casualties while avoiding the known short term risks and unknown long term risks of the vaccines.

Yeah, vaccines could turn out to be exactly as they have been portrayed. But what cannot be denied is the extensive corruption in those involved in their creation and approval. If one has faith in them, go ahead, but I don't trust them and I don't need them...

-6 ( +1 / -7 )

Vaccines are not the only way to achieve herd immunity.

They are the fastest, easiest and most effective way.

and immediately treating everyone who tests positive with safe and effective drugs (e.g. HCQ).

Hydroxychloroquine doesn't work on Covid-19.

https://www.nih.gov/news-events/news-releases/hydroxychloroquine-does-not-benefit-adults-hospitalized-covid-19

5 ( +7 / -2 )

Hydroxychloroquine doesn't work on Covid-19.

https://www.nih.gov/news-events/news-releases/hydroxychloroquine-does-not-benefit-adults-hospitalized-covid-19

Essentially all studies showing no effect have serious conflicts of interest with big pharma. There are many more studies showing clear positive effects of HCQ + azithromycin when given early. Your reference is from last November. Studies continue to come out showing positive effects, including recent studies from Iran, Saudi Arabia, France, Singapore... Roughly half of the world lives in countries where they use it to treat covid.

I find that the more one pushes vaccines, the more they criticize the use of HCQ, vitD, zinc,....

-6 ( +1 / -7 )

Essentially all studies showing no effect have serious conflicts of interest with big pharma. 

No they don't.

(By the way, who do you think produces hydroxycholoroquine if not "big pharma"?)

Studies continue to come out showing positive effects, including recent studies from Iran, Saudi Arabia, France, Singapore...

No they don't.

https://www.france24.com/en/20200527-france-revokes-decree-authorising-use-of-hydroxychloroquine-to-treat-covid-19

I find that the more one pushes vaccines, the more they criticize the use of HCQ, vitD, zinc,....

Because vaccines actually works, and the other solutions don't as much.

4 ( +6 / -2 )

Vaccines are not the only way to achieve herd immunity.

So after being told that "they are the only way" is just a false argument that only antivaxxers use you have no other option but to discuss against it anyway? If it has become so obvious even for your that you cannot refute the real argument (that vaccines are the best way, in safety and efficacy) maybe it is time to re-evaluate your beliefs.

Vaccines are much safer and efficient than any of the other measures to avoid complications, and the best thing is that it can be even done without having to sacrifice any of them. That is why is irrational to just reject vaccines because of irrational fears. It is not like you have to choose one or the other, but that you can use everything to reduce risk as much as possible, beginning with the measures that is fastest, easiest and more effective.

Everybody, from officials and experts from every country where it was tested to the hundreds of scientists that are involved in the examination of the safety and efficacy of the millions of doses already given vouches for their safety and efficacy, thinking that everybody is corrupt and that is why they push for a vaccine to be used in themselves and their families just because it fits your conspiracy is not logical at all.

we can let the virus run its course, and immediately treating everyone who tests positive with safe and effective drugs (e.g. HCQ

No, that is incorrect, even Didier Raoult (that invalidly tried to manipulate his own studies and is facing serious consequences about it) had to accept his own study proved HCQ has no effect protecting patients from complications and death. The "big pharma" excuse is too obviously nonsense, not only because studies from all around the world proved it false but because other drugs that are dirt cheap have been recognized as effective without problem, something that should be be impossible since they are "taking out profits from big pharma", the humble dexamethasone is enough to prove the conspiracy as false.

3 ( +5 / -2 )

I find that the more one pushes vaccines, the more they criticize the use of HCQ, vitD, zinc,....

You mean that the more one person tries to reject the scientific findings about the efficacy and safety of the vaccines the more they try to misrepresent other things as an option? and the more they end up exaggerating and inflating the importance of anything that has been demonstrated scientifically as not useful?

That would be natural, when a person rejects science when it contradicts their personal beliefs it becomes natural for them to do it for everything else that science says and they don't like, vaccines, social distancing measures, lockdowns, masks, the dangers of COVID-19 in the first place, etc. The common thing is to consider their own opinion as infallible and science mistaken.

3 ( +5 / -2 )

Studies continue to come out showing positive effects, including recent studies from Iran, Saudi Arabia, France, Singapore...

No they don't.

https://www.france24.com/en/20200527-france-revokes-decree-authorising-use-of-hydroxychloroquine-to-treat-covid-19

You do realize that your reference is almost 1 year old, right? Right around the time of Lancet Gate, regarding a fake study saying that HCQ was dangerous.

I believe it was around the same time that the EU purchased about 1 billion Euros worth of Remdesivir a day before it was declared ineffective by the WHO to treat covid.

BTW, your reference mentions Dr. Didier Raoult, one the world's greatest experts of infectious diseases. He was subjected to severe harassment right after he announced the positive effects of HCQ, including death threats that were eventually discovered to come from Prof Raffi, who was heavily funded by Gilead....

It is vital that all regulators openly declare their conflicts of interest.

-5 ( +1 / -6 )

BTW, your reference mentions Dr. Didier Raoult, one the world's greatest experts of infectious diseases. He was subjected to severe harassment right after he announced the positive effects of HCQ, including death threats that were eventually discovered to come from Prof Raffi, who was heavily funded by Gilead....

No, he was subjected to perfectly valid criticism for conducting unethically human trials, fabricating data, falsifying results and ethical approvals and manipulating protocols to make it appear as if HCQ had an effect, something that was determined to be scientific malpractice. Eventually he recognized that his own study proved the contrary.

How do you explain that every well recognized medical and scientific institution of the world says HCQ is useless for COVID? is the whole world in the conspiracy? and what about dexamethasone? I mean, it clearly proves that a dirt cheap drug can be easily recognized as effective by the scientific consensus without any harrasment for any of the scientists that proved it, even if it means no profit can be made from hugely more costly alternatives.

2 ( +5 / -3 )

You do realize that your reference is almost 1 year old, right?

Yup, and the situation in France hasn't changed since then : French hospitals and doctors do not use hydroxychloroquine to treat covid-19 patients. Because it's ineffective.

You want to believe all doctors and hospitals in France are in on a huge conspiracy against one single doctor? Please do. But don't be surprised if that sounds completely insane to everyone.

3 ( +5 / -2 )

No, that is incorrect, even Didier Raoult (that invalidly tried to manipulate his own studies and is facing serious consequences about it) had to accept his own study proved HCQ has no effect protecting patients from complications and death.

Are you still going there? Do I need to paste his exact words again? All he admitted is that the number of patients tested was too low show an effect on mortality. But his study showed a very clear effect on viral load. That was the first small scale study, there have been over a hundred studies since then.

How do you explain that every well recognized medical and scientific institution of the world says HCQ is useless for COVID?

That is clearly false. Roughly half of the world lives in countries where they use it to treat covid.

-5 ( +1 / -6 )

 That was the first small scale study, there have been over a hundred studies since then.

And all those studies proved HDC was ineffective.

https://www.cochrane.org/news/chloroquine-or-hydroxychloroquine-useful-treating-people-covid-19-or-preventing-infection

This is from last month.

Roughly half of the world lives in countries where they use it to treat covid.

No, they don't.

3 ( +5 / -2 )

All he admitted is that the number of patients tested was too low show an effect on mortality. But his study showed a very clear effect on viral load. That was the first small scale study, there have been over a hundred studies since then.

No, he also admitted the re-analysis was valid, expected and necessary, making his previous declarations mistaken. The study proved that HCQ had absolutely no importance in the risk of patients going to ICU or dying from the disease, even when previously he invalidly tried to hide this analysis in the study.

That is clearly false. Roughly half of the world lives in countries where they use it to treat covid.

And also where viral colds are treated with antibiotics, what do you think that proves? nothing but that not all doctors act according the scientific consensus and make mistakes. If you think this proves HCQ has any value (or that antibiotics should be used to treat viral colds) you need to understand better what it means scientific evidence.

Again, what do you think no recognized institution says HCQ is of any value, (but dexamethasone is)? is the whole world in the conspiracy?

0 ( +3 / -3 )

No, he also admitted the re-analysis was valid, expected and necessary, making his previous declarations mistaken. The study proved that HCQ had absolutely no importance in the risk of patients going to ICU or dying from the disease, even when previously he invalidly tried to hide this analysis in the study.

I'm quite surprised you are still pushing this misrepresentation of Raoult's views.

His published statements in response to criticisms include the following:

"When COVID-19 starts around the world the Editor-In-Chief of the International Journal of Antimicrobial Agents (JM. Rolain) asked colleagues (D.Raoult, PR.Hsueh, and S.Stefani) to launch a special issue in the journal to create a real-time rapid debate around this emerging disease with special regards to therapeutic options. Our preliminary paper in this way was relatively trivial i.e. reported, in an emergency situation, a comparative analysis between a small group treated with hydroxychloroquine and another small group not treated with hydroxychloroquine showing a significant decrease of viral shedding after 6 days of therapy.

Surprisingly, despite the very small size of the group, the addition of azithromycin made a difference on the endpoint we chose, which is the disappearance of the viral load in the pharynx that is the only data that can be analyzed on a small group. Indeed, neither mortality, nor the passage in intensive care unit, nor the duration of the treatment can be evaluated on such a small group. This preliminary information was essential in our opinion especially as it confirmed the preliminary in vitro and in vivo results against SARS-28CoV-2 announced by the Chinese, also confirming previous in vitro reports on the anti-29SARS-CoV-1 coronavirus activity dating back to 2004. This preliminary report paved the way for work testing its reproducibility.

So your comment is a complete misrepresentation, when you interpret "neither mortality, nor the passage in intensive care unit, nor the duration of the treatment can be evaluated on such a small group" as meaning "The study proved that HCQ had absolutely no importance in the risk of patients going to ICU or dying from the disease".

I have explained this to you already many times and for you to continue to misrepresent his views like this is...

-2 ( +1 / -3 )

His published statements in response to criticisms include the following:

And that could be grounds for the retraction of that paper, because he signed the re-analysis of the report that said the numbers were adequate enough to assess difference of risk and ICU need of the patients and that it was wrong not to have included those numbers on the first place, something not justified and that should be corrected.

He accepted this when he signed of conformity with the re-analysis, now he is going back on his position, which means there is an authorship problem and now the Journal has grounds for a correction where he is is eliminated as an author or the paper is retracted completely.

Every other fault of his are still confirmed and invalidate his papers completely independently from him going back and forth in his declarations, and HCQ is still useless for COVID according to every recognized medical and scientific institution of the world, while other cheap drugs like dexamethasone are still perfectly accepted as effective and safe in their use to prevent and correct complications of the disease.

0 ( +2 / -2 )

You do realize that your reference is almost 1 year old, right?

Yup, and the situation in France hasn't changed since then : French hospitals and doctors do not use hydroxychloroquine to treat covid-19 patients. Because it's ineffective.

You want to believe all doctors and hospitals in France are in on a huge conspiracy against one single doctor?

Because of widespread complaints from doctors, the French authorities were force to backtrack and allow doctors to use HCQ. Many do use HCQ in France. And HCQ is widely used worldwide. In the west, where HCQ is prohibited or strongly discouraged, the death rate is very high...

-2 ( +1 / -3 )

Discussion seems interesting but I'm just here to solicit comments on a different but related topic:

https://journals.lww.com/americantherapeutics/Fulltext/2021/00000/Review_of_the_Emerging_Evidence_Demonstrating_the.4.aspx?WT.mc_id=HPxADx20100319xMP

2 ( +2 / -0 )

Because of widespread complaints from doctors, the French authorities were force to backtrack and allow doctors to use HCQ. Many do use HCQ in France. And HCQ is widely used worldwide. In the west, where HCQ is prohibited or strongly discouraged, the death rate is very high...

That does absolutely nothing to prove HCQ is in any way useful, only that misinformed people can demand useless things as treatment and unprofessional doctors prescribe it even when knowing it does nothing, exactly as I said about antibiotics and viral colds. This is a problem to be corrected, not something you can use to justify the value of a drug.

Discussion seems interesting but I'm just here to solicit comments on a different but related topic:

Ivermectin is a very complicated issue, at this point it seems to have some effect, but the problem is that reviews that include studies of low quality are the only ones that find a clinically important effect. The more controls are put in place (randomizing patients, making it double blind or interventional instead of observationa, etc.) the effect is reduced very importantly and in limited cases it even disappears completely. This means that if there is an effect is not something that can apply in every case.

So the situation is not as bad with HCQ that already has been eliminated as even a possibility, but more research is necessary and unfortunately that has become more and more difficult because in many places people now refuse to be randomized, or have already began to take the drug before being hospitalized (since it is easy to get veterinarian versions) or the researchers play loose with the safety and ethical controls of the studies. So for the moment it cannot be recommended outside of trials.

0 ( +2 / -2 )

And that could be grounds for the retraction of that paper...

I have so far disproven all of your accusations towards Didier Raoult, and now you are bringing up a "signing of reanalysis". Do you have any reference to support your continued accusations towards him?

-2 ( +1 / -3 )

I have so far disproven all of your accusations towards Didier Raoult, and now you are bringing up a "signing of reanalysis". Do you have any reference to support your continued accusations towards him?

You have disproved not eve a single one, not the heavy ethical and methodological flaws of his study, nor that he signed the reanalysis of his report where it is clearly written that analysis of deaths and ICU need is valid, necessary and perfectly possible. All the authors signed of conformity, and none of them went back on that, only Raoult did, that means the re-analysis is still valid and Raoult either lied to the journal or he signs things without reading.

Here is where he signed (with all other authors) that the re-analysis is necessary and correct, nothing about the excuse of not having enough numbers

https://www.sciencedirect.com/science/article/pii/S0924857920304611?via%3Dihub

And the many different problems with his studies

https://www.the-scientist.com/news-opinion/journal-publisher-concerned-over-hydroxychloroquine-study-67405

https://scienceintegritydigest.com/2020/03/24/thoughts-on-the-gautret-et-al-paper-about-hydroxychloroquine-and-azithromycin-treatment-of-covid-19-infections/

It is extremely easy to find other kinds of analysis of the many problems of his reports.

0 ( +2 / -2 )

@virusrex

I looked at your first link. It just says they accepted that the paper should also include the clinical results and they concluded that they should pay special attention to the possibility of arrhythmias, but I don't see why his previous paper should be retracted, since their original goal according to Raw Beer's quote was to look at the effect on viral shedding. That result is still valid, HCQ greatly reduced viral shedding.

So your comment is a complete misrepresentation, when you interpret "neither mortality, nor the passage in intensive care unit, nor the duration of the treatment can be evaluated on such a small group" as meaning "The study proved that HCQ had absolutely no importance in the risk of patients going to ICU or dying from the disease".

I can't see how one can misunderstand prof Rault's statement like that, seems intentional.

-2 ( +1 / -3 )

I can't see how one can misunderstand prof Rault's statement like that, seems intentional.

There is no misunderstanding, his paper was purposefully and invalidly manipulated not to report data that proved his theories wrong with excuses, so he and the rest of the authors agreed that a re-analysis was not only possible but necessary to do

"We agree with colleagues that clinical outcomes are also key elements to consider when assessing the effect of hydroxychloroquine-azythromycin (HCQ-AZ) combination. To this end, we reanalyzed our data on all patients enrolled in our study (n=42) and, in addition to viral clearance over time, we analyzed clinical outcomes, including the need for oxygen therapy, transfer to intensive care unit (ICU), death and length of stay at hospital."

He and every other author signed this re-analysis, explicitly accepting what is written there as true, and contradicting his previous position that this was not possible. Now he is going back on this saying that exactly what you wrote (...accepted that the paper should also include the clinical results) is now false, which is not acceptable, if that were the case he should have not signed the acceptance of the re-analysis, but he did, so he is going back and forward on what is or not valid without any valid excuse, that makes him a terribly bad scientist.

0 ( +2 / -2 )

No, that is incorrect, even Didier Raoult (that invalidly tried to manipulate his own studies and is facing serious consequences about it)

Has he faced serious consequences? All your links are about one year old. If any of those criticisms were valid, there must have been at least one concrete consequence by now. Or were they all baseless pharma-led accusations.

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Has he faced serious consequences?

Yes, on many fronts. And the criticisms are so valid that you could not do anything to disprove them. The links were about an specific case, but others can be readily found.

For example the complaint he faces from the Order of Physicians of France against him

https://www.leparisien.fr/societe/sante/le-professeur-didier-raoult-poursuivi-par-l-ordre-des-medecins-12-11-2020-8407949.php

Or a compilation of very serious problems that apparently are beginning to catch him:

https://forbetterscience.com/2021/03/23/didier-raoult-fraud-je-ne-regrette-rien/

For the rest of the world it was enough that he was proved wrong about HCQ and was forgotten, but in France his problems are multiple and not going away. Once again "pharma" is the excuse used to try to disguise the fact that his peers are the ones accusing him, and with clear evidence of unethical practices that he has never refuted.

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Thanks @virusrex, much appreciated

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Has he faced serious consequences?

Yes, on many fronts....

That's sort of what I expected. There have not been any serious consequences for Didier Raoult, only complaints from a bunch of gamma ankle biters. One that has faced serious consequences is Prof Raffi, the prof heavily funded by Gilead who was found guilty of harrassing and issuing death threats towards Raoult right after he reported the effectiveness of HCQ...

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That's sort of what I expected. There have not been any serious consequences for Didier Raoult, only complaints from a bunch of gamma ankle biters

On the contrary, he has demonstrated scientific fraud, unethical experimentation on children, science denialism and many other problems and even crimes, he has never refuted successfully the evidence and just repeats everything is false as if that were enough, it is obviously not.

He is under investigation inside and outside science, but those are not things that resolve immediately, specially against people with exaggerated invalid influences as he has. It may surprise you no single accuser have any real importance, the huge amount of evidence collected about his misdeeds is the one that simply cannot be silenced.

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