Wiki states that George Vithoulkas has been described as “the maestro of classical homeopathy” and is “widely considered to be the greatest living homeopathic theorist”. Others call him a “contemporary master of homeopathy” or credit him with the revival of the credibility of homeopathy.
A few days ago, THE MAESTRO has given an interview about the coronavirus which, I believe, is too hilarious to miss:
Q. What is your opinion of coronavirus, what homeopathy can do ?
A. Unless we have selected the real symptoms of the different stages of this influenza from the clinicians who are dealing at this moment with the infected cases, we cannot do anything substantial.
We should know the symptomatology of the beginning stages -before the pneumonia- and propose remedies for this stage in order to reduce the victims of going to the second stage. Also we should know the symptomatology of the later stage of pneumonia or diarrhea to propose different remedies for this advanced stage.
But the symptomatology has to be taken by an experienced homeopath in order to be reliable.
I think the best would be to establish contact with the clinicians in order to give us a fist hand information.
To give at random remedies as a prophylaxis and to make people think that they are protected it is irresponsible.
Q. What do you think about those homeopaths who advertise that are treating cancer cases using homeopathic remedies while at the same time the patients are treated with allopathic drugs?
Advertising that cancer cases can be cured by homeopathy in spite of the fact patients are treated with conventional drugs is an unethical act that should be avoided at all costs by any honest homeopath.
The reasons are simple.
A. The homeopathic remedy will act if it is prescribed according to the symptoms of the case. But in such a situation where the patient is under chemotherapy, the symptoms are suppressed by the allopathic drugs. Therefore the prescriptions at best are not prescribed according to the law of similars but are given in an arbitrary way, therefore instead of the similimum, several remedies are prescribed at random. Actually in this way, the case becomes more and more confused and the organism is more and more disorganised.
B. The homeopathic remedy acts on the energy level -on the vital force- inciting the organism to increase its response (initial aggravation) so the two treatments are antagonistic, the one suppresses the defense mechanism, the other strengthens it.
C. Out of such a confusion within the organism, no one can say what actually has happened in such a patient.
Of course each doctor is free to apply any treatment that according to his understanding will benefit the patient, but to claim publicly that homeopathy can cure cancer under such conditions is totally immoral.
Obviously patients will flock around such physicians in the beginning and can make them rich but in the end the disappointments will be for both parties, the doctors and the patients but mostly on the part of doctors.
Q. Perhaps because of the guilt for all the lies and false hopes?
Homeopathy is an amazing therapeutic system, that can make doctors and patients extremely happy but has limits and the doctors should not transgress these boundaries for material gain.
It is a great pity that homeopathy will be reduced to a routine massive therapy with meagre results by those who are advertising polypharmacy with such mongrel practices like the ones with prearranged therapeutic protocols or mixopathy.
If such practices prevail, finally the real classical homeopathy, that can have such amazing results, if it is learned and practiced correctly, will die out amidst an aggressive and competitive society.
So, essentially the great Vithoulkas seems to be saying that treating even the most serious diseases with homeopathy is fine, as long as homeopaths use no treatments other than homeopathy and as long as they do exactly what Vithoulkas proclaims or – even better – Vithoulkas does it himself.
I know, this is very similar to what Hahnemann, the creator of this cult, stated about 200 years ago … but it is nevertheless totally bonkers.
Did you read what he said?
Vithoulkas said, “Of course each doctor is free to apply any treatment that according to his understanding will benefit the patient, but to claim publicly that homeopathy can cure cancer under such conditions is totally immoral.”
He is definitely Not saying “.. that treating even the most serious diseases with homeopathy is fine, as long as homeopaths use no treatments other than homeopathy and as long as they do exactly what Vithoulkas proclaims.”
He is saying you cant mix in other treatments, CALL it homeopathy, and then claim that homeopathy is curing cancer. Pretty reasonable and pretty clear to anyone who speaks English.
If you find this “hilarious”, you have a pretty low bar for humor.
thank you for quoting one of the most ‘bonkers’ statement:
“Of course each doctor is free to apply any treatment that according to his understanding will benefit the patient…”
Doctors are obliged to apply those treatments that are supported by sound evidence.
HOW COME HOMEOPATHS DON’T KNOW THIS?
As I have said before, contact Dr Farokh Master, or better yet sit in on his clinic. He successfully treats cancer (and just about everything else) with homeopathy. He has sound evidence that it works; his own clinical experience. Conventional Medicine does not have a very good track record with cancer. Cure rates except for certain types of cancers have stayed pretty much stable (poor) despite the billions spent.
“Doctors are obliged to apply those treatments that are supported by sound evidence.”
I doubt that’s true. Can you back that up?
Good medical practice describes what it means to be a good doctor.
It says that as a good doctor you will:
make the care of your patient your first concern
be competent and keep your professional knowledge and skills up to date
take prompt action if you think patient safety is being compromised
establish and maintain good partnerships with your patients and colleagues
maintain trust in you and the profession by being open, honest and acting with integrity.
[https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice]
What you posted doesn’t say a doctor is obliged to apply treatments that are supported by sound evidence. What you posted says that a doctor is obliged to apply any treatment that according to his understanding will benefit the patient.
“be competent and keep your professional knowledge and skills up to date” = treat according to best available evidence in my book
“Best available evidence” is one tool amongst many. Make the care of your patient your first concern.
From the GMC source provided by Edzard:
“provide effective treatments based on the best available evidence”
[https://www.gmc-uk.org/ethical-guidance/ethical-guidance-for-doctors/good-medical-practice]
Pete,
Yup, that’s item #16. Item #4 is “You must use your judgement in applying the principles to the various situations you will face as a doctor, whether or not you hold a licence to practise, whatever field of medicine you work in, and whether or not you routinely see patients. You must be prepared to explain and justify your decisions and actions.”
So doctors who prescribe antidepressants despite the lack of evidence are immoral?
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2412901/
So Mr Vithoulkas thinks “… the best would be to establish contact with the clinicians in order to give us a first hand information. …”
I should hope that any clinicians worth their salt are too busy right now either trying to contain a further spread of COVID-19 – or too busy trying to come up with an adequate response, preferable in the shape of a vaccine – to even consider talking to esoteric quacks like Mr Vithoulkas.
I can’t believe we are still having to debunk the claims of people with no idea of how scientific evidence is obtained, and who don’t have any kind of medical background.
“I can’t believe we are still having to debunk the claims of people with no idea of how scientific evidence is obtained, and who don’t have any kind of medical background.”
Homeopathy was used during the Spanish flu of 1918-1920 in America.
A report was published based upon information collated by a homeopath doctor.
https://www.ecampnd.com/homeopathy/A_Chorus_of_Fifty_in_Harmony.pdf
Do we expect the Covid 19 to mutate into an aggressive killer like the Spanish flu virus and then test effectiveness of homeopathy ?
https://edzardernst.com/2017/02/homeopaths-love-it-the-epidemiological-evidence-suggesting-that-homeopathy-works/
https://edzardernst.com/2017/02/homeopaths-love-it-the-epidemiological-evidence-suggesting-that-homeopathy-works/
If the virus mutates and in the second wave (similar to the Spanish Flu ) start killing masses, you suggest a control group of infected patients be created for treatment with placebo, were positive results to be available with a medicine?
And during this trial, who is held responsible for the deaths of the patients in the control group?
did I really suggest that?
or are you perhaps just a little deluded?
Is that not what you implied?
What would be the trial protocol for an epidemic like the Spanish flu? Or for that matter, Covid 19?
no
You know a lot about trials based upon reviews that you carried out in the past.
What would you propose for a control group that meets trial requirements and still remains safe in a killer epidemic?
Covid 19 flu is no good if South Korea data is anything to go by!
https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6
“You know a lot about trials based upon reviews that you carried out in the past”
Yes, but not only from that; I also conducted ~40 clinical trials myself.
When it comes to a new vaccine, however, I would leave this to those who have experience with such trials.
In any case – and that was the gist of my post – I would not draw firm or even tentative conclusions on evidently dodgy epidemiological data!!!
“When it comes to a new vaccine, however, I would leave this to those who have experience with such trials.”
I am keen to find method used to form control group that meets trial requirements and still remains safe in an epidemic? Testing a vaccine may not be possible if not done during epidemic?
Have you evaluated any such trial. Please provide a link.
I Krishna,
The mortality rate from the Spanish flu has been estimated to be 2 – 3%. Although we don’t have enough data yet to be very certain of the mortality rate from Covid-19, best estimates are that it is 1 – 2%, so not that dissimilar.
Covd-19 is highly infectious, again like the flu, though the ease of global travel compared to 1918 greatly facilitates its spread.
It is estimated that about a quarter of the world’s population contracted Spanish flu. One epidemiologist was quoted in New Scientist two weeks ago as predicting that Covid-19 would ultimately infect about 60% before winding down in about 18 months’ time as herd immunity from survivors reduced the transmission rate, at which point it will become endemic. Their estimate was that it would cause 100 million deaths (Spanish Flu probably caused a bit less than that).
One difference is that Spanish flu predominantly killed young adults and children, whereas it is the elderly who are most at risk from Covid-19.
So what further mutations do you think are required before it becomes problematic?
“The mortality rate from the Spanish flu has been estimated to be 2 – 3%. Although we don’t have enough data yet to be very certain of the mortality rate from Covid-19, best estimates are that it is 1 – 2%, so not that dissimilar.”
The figure about Spanish flu is incorrect. “It is estimated that about 500 million people or one-third of the world’s population became infected with this virus. The number of deaths was estimated to be at least 50 million worldwide with about 675,000 occurring in the United States.”
https://www.cdc.gov/flu/pandemic-resources/1918-pandemic-h1n1.html
This figure puts the death rate at 10% at minimum or maybe higher.
“Globally, about 3.4% of reported COVID-19 cases have died. By comparison, seasonal flu generally kills far fewer than 1% of those infected.”
https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19—3-march-2020
Also these would be preliminary figures. Using data from South Korea (35 dead and 41 recovered) and Italy (107 dead and 276 recovered) as the final picture would be known much later, the outcome is more severe. (https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6 16.00 GMT)
China data as always, is suspect and should be disregarded.
The link you provided, insists for control group to be treated by placebo but a condition, as exists now, is not assumed in the trial protocol.
With present data, there is no way a patient would accept to participate in trial if he/she understood data implication. And therefore there is no chance of a vaccine to be ever accepted for such epidemics.
I stand corrected with regard to the death rate from Spanish flu, which as you point out was much higher than we generally see from seasonal flu.
You can’t use those figures in that way. The outbreaks in Italy and South Korea are comparatively recent, the number of cases in both countries are growing exponentially and rapidly (I’m sorry I haven’t taken the trouble to work out the doubling time but I think it is of the order of 2 – 3 days in Italy and a bit longer in South Korea) and in both countries the vast majority of cases are still current and we don’t know what their outcome is going to be.
One interesting comparison is that there are (so far) about a third as many dead in South Korea as in Italy with double the number of cases, which suggests to me that South Korea are either better at detecting cases or more open about reporting them.
We can’t disregard Chinese data since they comprise 90% of all cases, and they have a two-month head start on the rest of the world with regard to information on the natural history of this infection. In any case it seems that China are being much more open than usual about Covid-19. For instance they shared the DNA of the virus with the rest of the world as soon as they sequenced it, enabling virologists in other countries to start studying it straight away, and also to confirm that its genome is a lot more stable than, for instance, influenza.
Of course China cares a lot more about controlling what its own population thinks than about the rest of the world, but they do seem to have realised the importance of sharing data here. It might be unsafe to take it as completely accurate, of course, but it would be reckless to ignore it.
“We can’t disregard Chinese data since they comprise 90% of all cases, and they have a two-month head start on the rest of the world with regard to information on the natural history of this infection.”
If data from South Korea is correct, Chinese data is fudged. There is no doubt about it.
Check North Korea. Not one case reported. They are 2 steps ahead of China in allowing information to go out exactly as they please.
Considering the case can go either way, recovered vs dead is the correct assessment of severity. This started as <2% (of infected) dead based upon data reported by Chinese and has now almost doubled to 3.4%. With more open countries reporting infections, the possibility of severity, is of it going either way!
"The link you provided, insists for control group to be treated by placebo but a condition, as exists now, is not assumed in the trial protocol.
With present data, there is no way a patient would accept to participate in trial if he/she understood data implication. And therefore there is no chance of a vaccine to be ever accepted for such epidemics."
This is still open. Any comment?
Dr Ernst?
No.
1. If the caseload were steady we could use that. However, the numbers are currently rising rapidly and the vast majority of cases are “active”, i.e. the outcome is yet to occur and therefore unknown. For this reason, if the time from diagnosis to death is shorter than the time from diagnosis to recovery then comparing the ratio of recovered to dead will give an artificially inflated number.
2. We don’t know what proportion of people infected remain asymptomatic, and so they don’t figure in the statistics at all at the moment, and will not until mass screening is implemented. Disregarding them will also give an estimate of the death rate which is too high. At present we can only estimated the death rate for people who have been diagnosed and recorded.
We don’t have any data from North Korea so it is irrelevant whether we should choose to use it. We do, however, have a lot of data from China, and even if it is not wholly accurate, nevertheless it still represents important information. We also have poor data from Iran, and the data from Italy certainly seems a lot less accurate than that from other European countries. Epidemiologists have to work with the information that they have in front of them, and by and large they know how to use it.
“We do, however, have a lot of data from China, and even if it is not wholly accurate, nevertheless it still represents important information.”
Inaccurate data is as good as no data.
My earlier message remains unanswered.
“The link you provided, insists for control group to be treated by placebo but a condition, as exists now, is not assumed in the trial protocol.
With present data, there is no way a patient would accept to participate in trial if he/she understood data implication. And therefore there is no chance of using a control group and a vaccine to be ever accepted for such epidemics.”
This is still open. What is the suggested approach?
Dr Ernst?
I Krishna,
You appear not to have understood my post, nor the WHO recommendations for vaccine trial design. Perhaps you should take your queries up with them, not with me.
In most clinical trials of a new treatment, it is tested against the best existing treatment. Placebos are used so that subjects do not know which treatment they are getting (e.g. drug A plus placebo version of B vs. drug B plus placebo version of A). Where there is no existing treatment, then the candidate drug (or whatever) is tested against an inactive placebo. For something like a vaccine, there might be a dummy injection, or more likely no placebo will be used but the controls will simply not be vaccinated.
You clearly think this is unethical. However:
1. The candidate vaccine may not work (this often turns out to be the case in vaccine trials)
2. The candidate vaccine may actually be harmful (this is also often the case – what if it triggers the same immune reaction which is responsible for death from multiple organ failure in actual Covid-19 infections?)
3. Without a control group the trial will not yield useful information, resulting in potentially avoidable harm to a lot of people in the future.
You seem to believe that a vaccine trial is there to prove that the vaccine works. That is not what clinical trials are for. The point of any vaccine trial is to find out whether the vaccine works and whether it is safe. You can’t pre-empt the results by assuming that they are going to be favourable.
You also seem to believe that it would be difficult to recruit to a placebo-based trial of a Covid-19 vaccine. From my experience in clinical research I doubt that would be the case. People are very often willing to enter trials in the knowledge that they are unlikely to benefit personally, even when the trial involves a considerable amount of trouble and unpleasantness on their part. Knowing that they could be helping somebody else can be a strong motivating factor.
Data are often inaccurate or incomplete. There are statistical tools for dealing with this. Regardless it is always a good idea to make an assessment of the reliability of a source of information before you use it.
I don’t know what your background is, so it is difficult to know on what level to engage with you. Are you a layman, or do you have training and experience in epidemiology, statistical methods and clinical trial design?
“Where there is no existing treatment, then the candidate drug (or whatever) is tested against an inactive placebo. For something like a vaccine, there might be a dummy injection, or more likely no placebo will be used but the controls will simply not be vaccinated.”
This seems unethical because if left untreated, in a situation like Spanish Flu, the patient has high probability of dying. A vaccine is a possible way out (if not successful, does not change the odds). If placebo trial is done, this small possibility is compromised?
You clearly think this is unethical. However:
1. The candidate vaccine may not work (this often turns out to be the case in vaccine trials):
Makes no change in the outcome!
2. The candidate vaccine may actually be harmful (this is also often the case – what if it triggers the same immune reaction which is responsible for death from multiple organ failure in actual Covid-19 infections?) :
This is a tricky situation. Does past experience not help? Doctors know pneumonia as the main outcome for deaths in flu? Will the vaccine kill faster than the Spanish flu virus?
3. Without a control group the trial will not yield useful information, resulting in potentially avoidable harm to a lot of people in the future:
Considering in epidemics most patients follow the same trajectory of infection, illness and outcome, the data over large numbers would automatically provides control group, especially those who could not be provided with the vaccine? (treated vs untreated?)
” That is not what clinical trials are for. The point of any vaccine trial is to find out whether the vaccine works and whether it is safe.”
I agree. But in a epidemic, like Spanish flu with 10%-20% expected to die in a short span of time, if safety is the first concern, then what is the effect on safety of control group? Not providing these patients with a small window of possible safety would not be unethical?
“From my experience in clinical research I doubt that would be the case. People are very often willing to enter trials in the knowledge that they are unlikely to benefit personally, even when the trial involves a considerable amount of trouble and unpleasantness on their part.”
Does that include informing them of the possibility of death? And to realize that even if the vaccine is successful, it may not work against the next flu?
“Data are often inaccurate or incomplete. There are statistical tools for dealing with this.”
Not in our system. Data is sacrosanct. If adjustments are to be made, data is not required in the first place. We come across numerous studies, where small modification in data, in the name of “statistical tool” changes the complete picture.
I Krishna,
You really do seem to have trouble understanding some fundamental concepts.
Once again, you are pre-empting the result of the trial. Even with Spanish Flu, given a 10 – 20% mortality rate the odds are between 5:1 and 9:1 that the patient does not die. However, vaccines are not given to patients who have been diagnosed with the disease, they are given to an at-risk population, not all of whom would contract it. So the outcome for an unvaccinated individual is that they are quite unlikely to die from the disease.
If the vaccine is inactive it makes no change to the outcome (unless a misplaced belief in it leads to unsafe behaviour). If, however, it is harmful then it does change the outcome, and not favourably.
In the case of Covid-19, the approaches that are being used in developing vaccines are completely new.
We won’t know the answer to that without proper trials. What about the current controversy (detailed in this week’s British Medical Journal) about how a recent malaria vaccine trial was conducted, particujlarly with regard to informed consent, after data suggested that the vaccine increased the all-cause mortality in one test population? Bear in mind that malaria has been estimated to have killed one half of all people who have ever lived.
As of now there have been 106,017 recorded cases of coronavirus and we are still unclear regarding the trajectory of infection, illness and outcome. It is also quite clear that individual patients follow a different trajectory, some being asymptomatic, some suffering a mild illness, some becoming critically ill, some dying of respiratory failure and some dying of multi-system failure, and the epidemiology suggests that not all infected individuals shed the virus at the same rate.
Data over large numbers does not control for confounding factors and therefore is not a substitute for a control group. This is a very basic concept in trial design.
Do you really suppose that if a vaccine became available, factors preventing a group from having access to the vaccine (population demographics, poverty, poor education, nutritional status, co-morbidity, lack of health care infrastructure, war…) might not have any other effect on their outcome? Or indeed on how accurately outcomes are recorded?
And providing them with an untested and potentially dangerous intervention which could make the situation worse is ethical?
Yes, it does. That is called obtaining informed consent.
Also covered by informed consent.
I have no idea what you are talking about. I suspect neither do you.
I am finding it increasingly wearisome replying to your rather naive assertions. Rather than continuing to try to explain to you concepts which you seem persistently unable to grasp, even though they are not particularly advanced, I would suggest that you get hold of a textbook on medical statistics, and also a copy of the Declaration of Helsinki. When you have read them both, perhaps we can have a more productive discussion.
By Doctors, I think the Great George V means homeopaths.
His statement “each doctor is free to apply any treatment that according to his understanding will benefit the patient” means that for him there is no standard of care in homeopathy.
Edzard Ernst
“When it comes to a new vaccine, however, I would leave this to those who have experience with such trials.”
17. Bracho et. al. Application of 200C potency of bacteria for Leptospirosis epidemic control in Cuba 2007-8 (2010)
Conducted by the Finlay Institute, a vaccines producer in Cuba gave 2.308562 million (70% of the target population above the age of 1 year) people in Cuba given two doses (1 dose=5 drops) of 200C potency of a nosode prepared from Leptospirosis bacteria, each (7-9 days apart), for protection against Leptospirosis (fever+jaundice+ inflammation in kidney+enlargement of spleen) with 84% decrease in disease incidence and only 10 reported cases. Dramatic decrease in morbidity within two weeks and zero morbidity of hospitalised patients, non-treated (8.8 millions) area saw an increase in number of cases from 309 cases in 2007 to 376 in 2008 representing a 21% increase. The cost of homeopathic immunization =1/15th of conventional vaccine.
It seems that the researchers involved in this trial were experts in vaccine development and had been involved with conventional vaccine development at Finlay Institute in Cuba. The Finlay institute is recognized by WHO for vaccine development and production.
There was a follow up study that confirmed the out come.
19. Reevaluation of the Effectiveness of Homoeoprophylaxis Against Leptospirosis in Cuba in 2007-8, Journal of Evidence-based Complementary & Alternative Medicine (2014)
The results support the previous conclusions that homoeoprophylaxis can be used to effectively immunize people against targeted infectious diseases such as leptospirosis.
“Today we know that this was not necessarily due to the effects of homeopathy per se, but might have been a false impression caused by bias and confounding.”
Which of the stated reason, in your message fits in to, to be used for negating this study.
https://edzardernst.com/2017/02/homeopaths-love-it-the-epidemiological-evidence-suggesting-that-homeopathy-works/
I’m not at all clear what point you are trying to make, other than that you don’t understand maths very well.
but that’s an important point; well-done Krishna!
Edzard Ernst
This was consequent to your comment ““When it comes to a new vaccine, however, I would leave this to those who have experience with such trials.”
You included this study in the many, for which your comment was: “Whenever I read articles of this nature, I get a little embarrassed. It seems obvious to me that the authors of such reviews have done some ‘research’ and believe strongly in the correctness in what they write. It embarrasses me to see how such people, full of good will, can be so naïve, ignorant and wrong. They clearly fail to understand several crucial issues. To me. this seems like someone such as me lecturing others about car mechanics, quantum physics or kite flying. I have no idea about these subjects, and therefore it would be idiotic to lecture others about them. But homeopaths tend to be different! And this is when my embarrassment quickly turns into anger: articles like the above spread nonsense and misguide people about important issues. THEY ARE DANGEROUS! There is little room for embarrassment and plenty of room for criticism.”
Then you listed out some basic reasons why the study was not valid.
I looked at this study and it seems to meet the requirement for trial done during epidemic.
What was your reason for negating this study?
Dr Julian Money-Kyrle
The earlier message was not addressed to you. It was for requiring information from Dr Ernst.
I will address your maths shortly.
I can’t wait!
But while you’re doing your sums, can you say how the model in the Leptospirosis trial that the homeopathy was compared to was validated and who in the intervention region were vaccinated with the vax-SPIRAL prophylactic?
During cross check, I found a message on the BMJ that seemed to be directed at you (?). Is that you?
“Alan Henness, who calls himself a ‘challenger of misleading health claims,’ continues to make vague assertions and accusations without having any grasp of the basic facts.
His previous attempts to delegitimize the Cuban homeopathic leptospirosis trial having been defused by David Eyles, he falls back on this last attempt:
“Presumably then, if homeoprophylaxis for Leptospirosis was so successful and saved so many lives, the Cuban health authorities will have been boldly rolling it out all over Cuba for the last five years?”
In fact, this is precisely what has been done, with remarkable effect: leptospirosis is now nearly eradicated – so much so that the homeopathic prophylaxis is no longer routinely needed.”
https://www.bmj.com/content/345/bmj.e6184/rr/616928
It seems, you have expressed interest in this study in the past also. Are you still lacking information? There was a follow up study (19) :https://journals.sagepub.com/doi/full/10.1177/2156587214525402
that provides further information. Did you see it?
Did you check with Dr Gustavo Bracho or the question is just rhetorical in nature?
LOL!
I had a conversation with Bracho some years ago – he wasn’t able to answer my questions but maybe you know the answers to ones I asked you? I’m all ears…
So it is the same person.
You seem to ask a lot of questions. Time you answer some questions, and in a specific manner? For example:
” … had a conversation with Bracho some years ago – he wasn’t able to answer my questions.”
This is misrepresenting facts. The correct and specific version would have been: “I had a conversation with Bracho some years ago : I did not understand/ was not satisfied, with his answers.”
There was no one better than Dr Bracho to answer your questions as it was a trial done under his leadership. He put his education, years of experience in vaccine research & development into the project. What is your experience in vaccine research and development to be able to say “he wasn’t able to answer my questions” ?
Dr Edzard states ” When it comes to a new vaccine, however, I would leave this to those who have experience with such trials.” Dr Edzard shared the list of studies performed by him. Your list of studies on vaccines? Are you really a specialist or “you did not understand explanation offered by Dr Bracho”?
I would believe, Dr Bracho would report to people senior and important enough to realize that , if this was a manipulated study, reputation of the institute they worked for, would be tarnished with commercial implications. Still they went ahead with publication? Also, if the Institute had WHO accreditation, would WHO allow the Dr to risk the lives of millions of Cuban nationals? Did WHO withdraw the accreditation of the institute after the results were published? What was the cross check made by you?
I believe you did not read the study in detail. The circumstances in which it was done and the outcome.
Trial design is important, but more important is the justification of the reason for gaps and reading the results after adjusting for the reasons.
Do you see doctors today, in the middle of Covid 19 pandemic, handling the patients in the standard way?
““Du said that doctors should not hesitate to escalate measures for patients facing respiratory distress, as organ failure can set in quickly after. That means doctors should intervene aggressively with invasive ventilation measures — inserting a tube into a patient’s throat or cutting the throat open to create an airway — when low blood oxygen levels can’t be improved by less invasive measures.”
And off course use of traditional medicines and drug cocktails.
Maybe you could answer some questions for a change: and please be specific.
1. The vaccine Vax-Spiral was introduced in 1998. Good control was seen until 2007 when the authorities ran short of vaccine. The effect of lack of vaccine use can be seen in 2007. How many doses were required to create herd immunity in 2,112,257 residents and how many were actually used? You can link some document that explains this? Results we saw.
2. “The reduction in the number of confirmed cases in IR occurred within 2 weeks but was sustained for the next 57 weeks. This sharp decrease of incidence does not suggest an expected effect of vaccination or chemoprophylaxis considering the time needed to induce a protective immune response by vaccines and the short temporal protection of antibiotics.”
That is from the report. What was the variable you are able to see that does not support this comment and the basis of this.
3. What happened subsequent to 2008? Why did the cases drop altogether and there was seen no requirement of yearly use of Vax-Spiral as earlier?
In today’s time, with COVID 19 wrecking havoc in Italy, for a vaccine trial, any researcher in his right mind will look for a control group? (Infected 31506. Dead 2503) Was not the situation in Cuba similar in 2007?
Please be specific in your answers.
If you can’t answer the questions I asked you, please just say so.
“If you can’t answer the questions I asked you, please just say so.”
This question you would have directed at Dr Bracho also? He could not answer it/ you did not understand.
Now you want me to answer the same question and would you understand the answer would be the new question:
To start with : what is your education/ experience that allows you to understand the subject of vaccines and studies? Not every one is conversant as Dr Edzard puts it.
What makes you confident that the study by Dr Bracho was manipulated at worst and misleading at best, as you imply!
This is about you and should be easy to answer. I would not want you to say “I could not answer”. If you would have looked closely, I have already answered the question. The answer was clearly available in the report.
I will share my education and experience and of my associates for this case.
if you ever wanted to get SOMETHING right, you could start by my name maybe.
“if you ever wanted to get SOMETHING right, you could start by my name maybe.”
This was addressed to “Alan Henness on Wednesday 18 March 2020 at 12:29 for his question!
If you can’t answer the questions I asked you, please just say so.
I believed he was making answer on your behalf: he jumped in earlier also for a message I posted for Dr Julian Money-Kyrle who intervened for a message that was meant for you.
Please start stating “SOMTHING right:” like qualification of Mr Alan to state that Dr Bracho could not answer his questions, for a vaccine study.
Your statement: “Yes, but not only from that; I also conducted ~40 clinical trials myself. When it comes to a new vaccine, however, I would leave this to those who have experience with such trials.”
After conducting many trials and studies, you would insist that vaccine trials be left to those have experience with such trials.
Mr Alan’s experience in vaccine trials or studies and the reason for writing off Dr Bracho who meets your requirement of experience and hopefully education for such trials.
I KRISHNA said:
As I said, “If you can’t answer the questions I asked you, please just say so.”
Or do you still have another excuse up your sleeve?
Dr Edzard/Alan (who is who?)
“As I said, “If you can’t answer the questions I asked you, please just say so.”
Can not one of you, be clear to make an answer about the education and experience of Mr Alan to read and ask questions on vaccine studies from an expert and then write him off “he could not answer” ? Or the purpose is to misrepresent & misinform readers on this site?
you want me to answer this?
are you quite alright?
@I KRISHNA
As Carl Sagan said in The Demon-Haunted World: Science as a Candle in the Dark, there is no such thing as a dumb question.
But there are dumb answers. We’re yet to have the opportunity to judge yours.
Alan Henness on Saturday 21 March 2020 at 14:39
“As Carl Sagan said in The Demon-Haunted World: Science as a Candle in the Dark, there is no such thing as a dumb question.”
I agree. You show that you know a lot, by making such quotes. I am not impressed. This is one of the very old, very often used, red herring. Your own qualification and experience to evaluate a study on vaccine is not forthcoming. Because it will simply show your lack of understanding and experience of a specialist subject and make a mockery of your comments.
“But there are dumb answers. We’re yet to have the opportunity to judge yours.”
I am aware. Dr Bracho, was another dumb person (from the relativity point – dumb and expert are interchangeable) and still managed to bring down cases of Leptoporosis in Cuba.
On 26 November 2012, Christopher M Johnson wrote in BMJ:
“Alan Henness, who calls himself a ‘challenger of misleading health claims,’ continues to make vague assertions and accusations without having any grasp of the basic facts.”
He was right. You have not learned one bit. Time seems not to be in your favor. You are now missing details about yourself!
Edzard on Saturday 21 March 2020 at 14:33
“you want me to answer this?”
Not really. No answer, many times, is also an answer. Complicity, does not necessarily, have to be expressed always.
“are you quite alright?”
Yes, thank you. And you? Feeling the heat of COVID 19 yet?
The epicenter of medical world, USA, has 25500 cases with over 300 dead. And UK over 5000 cases and over 230 dead. With experts like you!
Oh dear, I KRISHNA.
You will remember to let us know when you have the answers to the questions I asked, won’t you?
“So the need is to save the 10%-20% of the infected. Should this medicine be tried on all infected or a trial group is still required?”
This % value is one good way to misrepresent. 10% of UK’s population would mean a lot to Dr Ernst considering he lives there but 5% of China’s population is bigger than 100% population of UK. Is this question still valid?
“If the vaccine is inactive it makes no change to the outcome (unless a misplaced belief in it leads to unsafe behavior). If, however, it is harmful, then it does change the outcome, and not favorably.”
If the vaccine is inactive and the chance of harm missing, it can be used without control group. Please check trial no. 17 in:
https://edzardernst.com/2017/02/homeopaths-love-it-the-epidemiological-evidence-suggesting-that-homeopathy-works/
This trial fell in “safe vaccine” category.
“We won’t know the answer to that without proper trials. What about the current controversy (detailed in this week’s British Medical Journal) about how a recent malaria vaccine trial was conducted, particularly with regard to informed consent, after data suggested that the vaccine increased the all-cause mortality in one test population? Bear in mind that malaria has been estimated to have killed one half of all people who have ever lived.”
Until now, for the past 100 years, the method used to control malaria, was to eliminate the cause and as expected, all attempts failed, as they were destined to! This change, making the human body immune to the disease/develop ability to neutralize the pathogen, is the sensible way. This may take time to fructify, as most good ideas do.
For flu, it is known that virus mutates over short time period, generally is benign in nature and this has been the reason why there is not much work done on vaccine. Also vaccine, when developed, are mostly ineffective, as the virus mutates by the next season.
“Without a control group the trial will not yield useful information, resulting in potentially avoidable harm to a lot of people in the future:”
Very surprising. Doctors are using Antiviral drugs from HIV, Chinese herbal remedies…. With what reason: the fear of losing patients. With an epidemic that kills swiftly, what “potentially avoidable harm are you talking about”? Numerous treatments in the past have been undertaken in the same circumstances. There is no background to the protocol of chemotherapy, radiation, surgery (not necessarily in the same sequence) for most cancers. No one follows control group trials? Or do they? What is the evidence basis of this protocol?
“As of now there have been 145,639 recorded cases of corona virus and we are still unclear regarding the trajectory of infection, illness and outcome. It is also quite clear that individual patients follow a different trajectory, some being asymptomatic, some suffering a mild illness, some becoming critically ill, some dying of respiratory failure and some dying of multi-system failure, and the epidemiology suggests that not all infected individuals shed the virus at the same rate.”
This is not correct. The action of COVID 19 is fairly well understood now. The infection reaches the lungs of the patient in 2 phases. It follows a clear trajectory and as expected, group symptoms also follow a pattern and it is understood as to who are at risk.
“Du said that doctors should not hesitate to escalate measures for patients facing respiratory distress, as organ failure can set in quickly after. That means doctors should intervene aggressively with invasive ventilation measures — inserting a tube into a patient’s throat or cutting the throat open to create an airway — when low blood oxygen levels can’t be improved by less invasive measures.”
https://www.bloomberg.com/news/articles/2020-03-09/top-virus-doctor-says-high-blood-pressure-is-major-death-risk
https://www.nationalgeographic.com/science/2020/02/here-is-what-coronavirus-does-to-the-body/
If co-morbidity exists, the infection can prove fatal. “The largest Chinese study with 44,672 confirmed cases of Covid-19 shows a high overall case fatality rate (CFR) of 2.3%. Important co-morbidities are hypertension (CFR 6.0%), diabetes (CFR 7.3%), cardiovascular disease (CFR 10.5%) and age >70 (CFR 10.2%).
“The question is, does there exist a connection between the use of these drugs and severe sequela of Covid-19? While the epidemiological association has not been investigated yet, several indicators underline the hypothesis of the link between ACE inhibitors and Covid-19”.
https://www.bmj.com/content/368/bmj.m810/rr-2
“Data over large numbers does not control for confounding factors and therefore is not a substitute for a control group. This is a very basic concept in trial design.”
This is against the statistics data philosophy. The bigger the sample size, better the outcome. Most RCT results get over turned as the sample size is increased. Drugs get recalled only after release and use by large set of population wherein the picture becomes clear.
“And providing them with an untested and potentially dangerous intervention which could make the situation worse is ethical?”
Safety, is your main reason for insisting on working with a small control group. When lives are at stake, doctors try ANYTHING. For COVID 19, doctors are using, Anti-viral drugs meant for HIV, new drug cocktails, Chinese traditional medicine…… If there is a potential for a medicine/vaccine, it would be tried, especially if it has no possibility of adverse effect.
“I have no idea what you are talking about. I suspect neither do you.”
I manage quality system for a company involved in outsourcing, component production and assembly, where product failure during use can be fatal. All failures can be traced back to, by passing process steps and adjusting data: minor changes in data to hide the fact.
One of my son is research associate, working on theoretical validation of non-linear outcomes, the other, data analyst, part of bio-informatics unit, provides software design for research studies, with focus on cancer studies. Both deal with medical world where data adjustment, in studies, seems to be in line with your comments and rue the fact, that the results leave a lot of gap in reliability and outcome compared to reality.
“I would suggest that you get hold of a textbook on medical statistics, and also a copy of the Declaration of Helsinki. When you have read them both, perhaps we can have a more productive discussion.”
I am aware of such groups in general, have been part of committees for reviewing and updating standard for component testing. While the purpose is to improve the quality of outcome and make it reflective of field outcomes, the discussions invariably center around why such improvement is difficult to follow/enforce and how can improvement suggestions be watered down and be made “workable” based upon consensus. The focus of disagreement is linked to what it would mean in terms of its effect on market share!
A failure leading to fatality in my operational area leads to severe penalties, as such, data for assessing quality cannot be “adjusted”. This is not true for the medical world?
Probably that is the reason why you are discussing “medical statistics”. How can statistics, as a mathematical tool, be different for 2 areas? Is it part of the compromise because all members on the committee are from the medical industry and adjust for industry limitations?
I would like to go through your reply in detail but unfortunately I don’t have the time just at the moment. However, almost all of what you are saying here is factually wrong.
You are thinking like an engineer. I have a lot of respect for engineers (they have, after all, designed almost everything in our lives) but their way of thinking tends to come unstuck when it is applied to biological systems, which are subject to so many random factors, and where no two individuals behave in the same way.
We do a lot more than building and designing things in life!
I consult for 2 hospitals today, in setting up Quality manual for their Operating procedures: regular and emergency. I have little understanding of activities of the medical ground realities.
That is very important in order to prevent avoidable adverse events, and I don’t doubt that you are doing a good job. Vaccine research, epidemiology and the design and analysis of clinical trials requires a completely different skill set, however.
“Vaccine research, epidemiology and the design and analysis of clinical trials requires a completely different skill set, however.”
This is the standard and the first response by people running organizations/functions before they would start implementing data based quality system.
Quality systems are general in nature and cover all development activities : including research projects, irrespective of its “requirements of special skills”.