SwiftJustice88 | 13 points
Ivermectin Added to the Australian COVID Treatment Protocol1. There are many great comments here. To many of them I can provide responses, but before I do, I need to receive responses to one or more of these emails:
1.1. https://gumshoenews.com/2020/10/02/urgent-make-ivermectin-available-and-lets-get-back-to-normal/
1.2. https://gumshoenews.com/2020/09/21/letter-to-ass-prof-senanayake-regarding-efficacy-of-ivermectin-and-the-double-blind-event-at-toronto-nursing-home/
1.3. 06/10/2020: 2×emails re the in vitro hi (IVHi) dose quote out of Monash Uni (which TLA, myself & others despise). The emails were to two individuals associated with Monash Uni ie Dr Kylie M. Wagstaff (kylie.wagstaff@monash.edu) & Associate Professor Steven Tong (steven.tong@mh.org.au) requesting that they explain or resolve the following conflictions & advise me accordingly:
Conflictions exist between the following two publications:
Pub1. "The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro." https://doi.org/10.1016/j.antiviral.2020.104787 Volume 178 dated June 2020. Author: Dr Kylie M. Wagstaff. [Monash Uni (Doherty Inst)]
Pub2. https://www1.racgp.org.au/newsgp/clinical/insufficient-evidence-to-currently-support-ivermec RACGP - Insufficient evidence to support ivermectin as COVID-19 treatment dated 15/08/2020. (RACGP: Royal Australian College of General Practitioners) Pub2 provides quotes by Associate Professor Steven Tong.
In Pub1, Dr Wagstaff suggests very positive expectations for the ability of Ivermectin in combatting the COVID-19 virus while in Pub2, Associate Professor Steven Tong suggests quite the opposite. This negative attitude is somewhat reflected in the title of Pub2: "Insufficient evidence to support ivermectin as COVID-19 treatment."
2. I have received no response whatsoever from any of them, not even a "Thanks for your enquiry (or suggestions, etc), but get f***ed!" I have my doubts that I will receive any returns, but I remain slightly optimistic because I intend to initiate some follow up action.
3. Very soon, I will send emails to each Email Addressee (EA) suggesting that the lack of a response from each of them could provide evidence to implicate each EA in a deliberate attempt to restrict access by Oz patients to IVERMECTIN, thereby increasing the chance of death or actually causing the death of the following patients: Aaaa Bbbbb, Cccc Dddd, etc. This charge could result in each EA becoming a defendant in one or more of a number of Class Actions that are currently being prepared.
4. I have already assailed @GregHuntMP (Federal Minister for Health) via NUMEROUS Tweets from my account <@RhodusRod, but again, not one damn reply, even after I've attempted to seduce one with the phrase: PLZ SHOW RESPECT: ANSWER THIS TWEET!
5. I have a very minor association with the paradoxical & illusive Prof Borody, which has allowed me to talk to him for a few minutes during just one phone call. This only happened after a couple of emails & a number of phone calls by me to his work place (offices or clinic) in Sydney. During that brief phone call, he provided very few facts then suddenly said he had to go but promised to call me back, which he never did. He also has provided me with no personal ph nos of his, hence my suggestion that he's "illusive". TLA's Comment of: "Borody is aggressively vague" is VERY ASTUTE!
6. It has also been suggested that Borody's vagueness is a deliberate effort to control his financial interests in his so-called Ivermectin Triple Therapy (ITT). After all, every one of the 3 components of the ITT is available individually, either on prescription (Ivermectin & Doxycycline) from potentially any doctor, or across-the-counter (Zinc). I believe the only way he can control any doctor from using "his" supposed invention is to control knowledge of the dosage.
7. I can easily guess what the dosage is. It's been revealed indirectly by a number of anecdotal documents by free-minded doctors, generally in USA & S.America, who have been very successful (often 100% successful) in treating infected patients with off-label Ivermectin etc. Doseage is:
7.1. IVERMECTIN: One Standard Single Dose (SSD) (my terminology) IMMEDIATELY after COVID-19 infection is confirmed or reasonably suspected if no testing facility is available. If symptoms persist after 7 days or are not totally eradicated: One more SSD. In the extremely unlikely event symptoms are not totally eradicated after 14 days, consider seeking medical advice &/or possibly try a double Standard Single Dose provided there has been no adverse reaction from previous SSDs. Ivermectin has been tested to 10x that dosege without any toxic or extreme side-effects.
7.1.1. One Standard Single Dose (SSD) is 1×3mg Ivermectin Tablet per 15-to-20kg Patient Body Wt eg for patient weighing say 70kg, dosage is 4x Tablets.
7.1.1.1. 15-to-20kg Patient Body Wt = 33-to-44lbs (1kg = 2.2lbs)
7.2. DOXYCYCLINE: As per standard Doxycycline prescription format ie normally 1x Tablet/Capsule once or twice a day, on every day until the prescribed number of Tablets/Capsules have all been consumed.
7.3. ZINC: As per instructions on the bottle, normally one or two Tablets/Capsules per day.
7.4. NOTE: frequency of Tablet/Capsule consumption is generally the same for Doxycycline & Zinc ie once or twice DAILY which is totally different from the Ivermectin ie WEEKLY.
8. That's it for today's lesson! I'll post another Comment when I've worked through all the Comments here &/or when more relevant info comes to hand. Cheers.
[-] TrumpLyftAlles | 4 points
Ivermectin was added to a long list of things not recommended outside of trials, so I'm not sure this is a positive development. It's like the FDA coming out against ivermectin for covid-19 a week after the April 3 publication of Monash 48 hours, with the intention of heading off a lunge toward treating covid-19 patients with the drug. My guess: this is a response to the controversy raised by Borody, which has resulted in ivermectin being used in some nursing homes. AFAIK there are no details available about that, e.g. how many nursing homes, any indications of success/failure.
Calcifediol (a form of vitamin D) is also on the list.
Edit: Borody is aggressively vague. From this 2020-10-17 article:
The professor – famous for his development of the triple-therapy cure for peptic ulcers in 1987 – said: “a number” of Victorian aged care facilities had this week signed up to start using the therapy, which was Federal Drug Agency and World Health Organisation approved.
"A number". Grrr. 1 is a number, though I supposed a larger number is implied. Why can't Borody give an actual number?
I googled: "Federal Drug Agency" doesn't exist. Presumably the writer is referring to the FDA - the US Food and Drug Administration. The FDA has approved ivermectin for a couple parasites, not covid-19. Same with WHO, AFAIK. I think someone would have noticed if WHO endorsed ivermectin for covid-19.
Trial site news is interviewing Professor Borody on the 28th October in relation to his use of the triple combination Ivermectin, Zinc, Doxycycline. I assume he will talk about the use of it in nursing homes in Melbourne Australia but as of today we have 0 cases of Covid and yesterday had 2 cases of Covid in Melbourne, Victoria so we will await his results.
[-] TrumpLyftAlles | 3 points
That's wonderful news, that cases are so low! :)
TSN solicited questions for Professor Borody on twitter. I suggested asking whether he intends to patent his combo drug, when will it hit the US market and what will it cost. I also asked TSN to ask him about whether the nursing home treatments are going to produce a research result. And has Borody written anything about his treatment. I don't know if they'll ask him any of that. Thanks for the heads up about the interview!
[-] saitchouette | 4 points
Based on that WHYY article by Nina Feldman (Link), it looks as if the fact that ivermectin is cheap and generic has been a factor in holding back RCTs in developed countries. Pharmaceutical companies don't stand to profit from expensive RCTs. To do so, is not economically sound (although it may be ethical). Are pharmaceutical companies governed by rational choice theory to a greater extent than by altruism, or the other way around?
If it were practicable to patent a combo drug of the three, would the (lack of) profitability situation be what it is? It would make economic sense for pharmaceutical companies to have RCTs (if they could turn a profit from patenting a combo). In which case, wouldn't RCTs have been completed by now?
I don't know Professor Thomas Borody. Nor do I have a medical/science/pharma background. However, based on his triple therapy for peptic ulcers, I'm inclined to believe that he believes that existing drugs can be repurposed for certain conditions with a reconciliation of safety and efficacy. He appears to believe that not every stone has been left unturned in pharmacology (for certain conditions, at least). He applies existing knowledge and science in different ways to lots of other doctors. He may or may not seek fame. But I can't find any suggestion that he's making this effort with ivermectin in order to get rich(er).
[-] TrumpLyftAlles | 2 points
it looks as if the fact that ivermectin is cheap and generic has been a factor in holding back RCTs in developed countries.
Absolutely. Of the 68 registered trials, only 3 are in the US. Most are in places like Bangladesh and India where ivermectin's low price (50 cents per treatment in India) is important.
If it were practicable to patent a combo drug of the three, would the (lack of) profitability situation be what it is?
You're right, nothing stops Merck (the inventor of ivermectin, which gave away a billion doses in 2019) from patenting a combo drug like Borody is proposing. I can't tell you why they're not interested.
But I can't find any suggestion that he's making this effort with ivermectin in order to get rich(er).
There are signs that make me suspicious.
First, he's being cagey about what his formulation is. His ClinicalTrials registration doesn't specify doses, e.g how much ivermectin, which is really unusual. To get the formula in Australia, docs have to call a particular pharmacy and ask. Most scientists just tell anyone interested what their protocol is. I infer that he's seeking to keep his formula patentable.
Second, Borody oversells ivermectin. "100% cure". "We can all be back to normal by Christmas." To me, he sounds like someone selling a product.
Third, he's working with a business, not a university or hospital, in his US ivermectin trial.
Fourth, he has 150 patents.
Hence my curiosity and my suggestion to TrialsSiteNews that they ask! :)
I suspect that if the FDA is ever going to approve ivermectin for covid-19, it will be because of Borody's trial. I hope the trial is successful. If Borody makes some money, who cares? I have no objection in principle, if BorodyMectin(tm) isn't priced ridiculously high. (I made up that name.)
[-] saitchouette | 3 points
First, he's being cagey about what his formulation is. His ClinicalTrials registration doesn't specify doses, e.g how much ivermectin, which is really unusual.
Oh that's probably because it's only allowed off-label in Australia. Neither our federal government nor our health professionals want patients attempting to self-administer a drug (especially one that's off-label).
If a person gets COVID here, they can approach their GP and ask about this "triple therapy". Whereupon, the GP would look into it. If the GP thinks it's worth it, then the GP can send an email to the address cited by Borody and obtain the dosing protocol.
At that point, the GP can prescribe the "triple therapy" with the caveat that it's not clinically-proven, although it's believed to be safe, and with the okay of the patient.
Checks and balances. Australia is, generally, a very regulated country.
No problems. Yes I asked Trial Site news when it would be on and they told me around October 28th. In the Trial Site youtube video titled "Cure Seekers Dr. Sabine Hazan Episode 1. The Beginning. Ivermectin" Dr. Hazan states that they are going to call the combination Ziverdox so I assume this will be patented.
[-] TrumpLyftAlles | 2 points
Wow, you are all over this! Excellent. Keep us posted1
[-] saitchouette | 2 points
Good find. Dr Sabine Hazan is collaborating with Professor Thomas Borody, is she not?
Supposing they were to patent "Ziverdox". That has no implication on the legal status of ivermectin, doxycycline or zinc as individual ingredients. Could doctors simply prescribe them individually without needing to prescribe "Ziverdox"?
I don't know enough about IP law to answer that. Maybe somebody on here does.
Yes Dr Sabine Hazan is collaborating with Professor Thomas Borody. I'm pretty sure if they were to patent it in a blister pack as he says they are going to do that it wouldn't have any implications on the individual ingredients. Drs in Australia can prescribe them individually off label for Covid 19 now but a lot still aren't doing it. That's all I know. I don't know enough about IP law either. Someone might be able to help us out.
[-] saitchouette | 2 points
I'm pretty sure if they were to patent it in a blister pack as he says they are going to do that it wouldn't have any implications on the individual ingredients.
I looked into it. Apparently, it would have no implication. According to this article in IP Watchdog written by Philip Stevens and Jack Ellis (7 July, 2017)
"Patents awarded to combination drugs represent a new patent for a new product. That new patent does nothing to extend the patent term of the individual drugs that form the combination. Generic manufacturers are therefore not blocked from manufacturing the separate component medicines, so long as they are off-patent. "
Drs in Australia can prescribe them individually off label for Covid 19 now but a lot still aren't doing it.
I'm based in Melbourne :) .Yeah, I wonder how many have been prescribing it.
I used to work with the Director of Anaesthetics at Monash Hospital in Melbourne Dr Mani Shashikant. He has recently been in India informing the Doctors over there that he had been using the Ivermectin triple combo with a lot of success. He is advocating it. He is a very clever man and was always a pleasure to work with.
[-] saitchouette | 2 points
I've read about his advocating it in India. Lovely anecdote. He sounds like a good person. Are you still involved in health (in Melbourne)?
I used to work as an Anaesthetic/Recovery Room nurse but have recently retired. I am obviously still very interested in anything medical and have been following this Covid very closely since January. It sounds like you have too. It is morbidly fascinating but I hope we get some real answers soon. Very hard and exceedingly frustrating to cut through the bureacracy.
[-] saitchouette | 1 points
I know what you mean. It's very fascinating (even to me with a non-healthcare background). I can imagine for those people such as you, who've worked in healthcare, the bureaucracy and lack of RCTs must be very frustrating indeed.
Mum used to be a nurse. In my wider family, there are a few specialists and a couple of GPs (none treating COVID patients, at present, to my knowledge). I've discussed ivermectin as a potential therapeutic to just one of them. Not to the other others.
The family member to whom I spoke, who's a very experienced physician cited the need for RCTs (I agree there).
Then I sent the WHYY article by Nina Feldman. That article suggested that some physicians Stateside believe in the correlation of ivermectin and successful treatment of COVID (while acknowledging that there can't be evidence of causation without RCTs). When I sent this article to that person in my family, they were quite sceptical and fairly conservative, despite not really being conservative at all outside of medicine.
I really don't know. I wish Norman Swan had had Thomas Borody on the Coronacast podcast (from the ABC). If he wants to take a sceptical approach and cross-examine Borody about how ivermectin, doxycycline and zinc could possibly work, so be it. But that's an important conversation. Norman Swan can challenge Borody, and Borody marshall his scientific arguments. Win win.
Yes wouldn't it be great to have Norman Swan interview him. Yes the medical fraternity aren't interested without RCTs which is understandable. There are about 30 RCTs going on worldwide at the moment with Ivermectin. This is obviously always best practice but this is a pandemic and none of us have ever lived through an emergency such as this. What is happening is small pockets of Drs see their patients suffering and dying and try anything that might work at their request for compassionate reasons and start seeing some results and then start to use it in other patients and feel like they are seeing even better results. The alternative is to tell their patients to go home on Paracetemol and when you get really sick come into hospital. By then it is getting late into the disease and the damage has already been done in a lot of people. They managed to do really fast very good quality clinical trials on Remdesivir (which they now think doesn't really work) and Dexamethasone but this Ivermectin combo a lot of the 1st world countries are ignoring. Countries like Egypt, India, Bangladesh and Argentina have started to use it so we shall see. I think with this disease though you need to treat it early on which is where we are doing it wrong but we didn't know that to begin with. Any anti viral needs to be used early on in a disease if it's going to work. Later on in the disease the horse has already bolted. It's the same with the flu. The anti viral Tamiflu has to be used early or it doesn't work. Anyway only time will tell and not to use a drug that could work and we know it is safe because it has been used since the 1980s is bordering on immoral in a Pandemic especially in Australia where Ivermectin is now actually allowed to be used off label for Covid. That is just my opinion. Anyway stay safe and hopefully we will have some answers sooner rather than later.
[-] saitchouette | 2 points
Excellent post. I couldn't agree more. You've describe the situation and its ethical complications very well.
Anyway stay safe and hopefully we will have some answers sooner rather than later.
The same to you :)
[-] saitchouette | 3 points
"A number". Grrr. 1 is a number, though I supposed a larger number is implied. Why can't Borody give an actual number?
I can't answer for sure. My best guess is that Australian domestic politics, diplomacy, principles of scientific rigour and the Australian federal government not wanting to give false hope are factors here (after Donald Trump endorsed hydroxychloroquine without evidence).
I'm not sure if you're familiar with the political set-up in Australia. We have a conservative "Liberal" federal government (N.B. the British-Australian understanding of "liberal" is not the same as the US understanding of "liberal"). My state is Victoria, which has had the most COVID cases. Victoria has a leftish "Labor" government.
The Australian federal government is open to the idea of ivermectin. However, the word is that the Victorian state government isn't keen on investigating.
Health is, primarily, a state competence (as opposed to a federal competence). But there has been very little COVID in Australia, outside of the state of Victoria.
So the only place where investigation can be done (into ivermectin, doxycycline + zinc in a clinical setting) has to be done in an Australian state whose government doesn't appear to be backing its use.
My guess is that the "tread carefully" approach is in play here. But we can only speculate.
[-] TrumpLyftAlles | 3 points
Thanks for all that. I know/knew nothing about the political setup.
So any and all investigation that can be done, into ivermectin, doxycycline + zinc in a clinical setting, has to be done in the only Australian state doesn't appear to be backing its use.
Bummer. The universe conspires against ivermectin. Kidding.
[-] saitchouette | 2 points
Ivermectin was added to a long list of things not recommended outside of trials, so I'm not sure this is a positive development. It's like the FDA coming out against ivermectin for covid-19 a week after the April 3 publication of Monash 48 hours, with the intention of heading off a lunge toward treating covid-19 patients with the drug. My guess: this is a response to the controversy raised by Borody, which has resulted in ivermectin being used in some nursing homes. AFAIK there are no details available about that, e.g. how many nursing homes, any indications of success/failure.
Perhaps but I'm not quite sure the outlook is that negative. Here's the Australian Government's official advice. As of now, they say
"There is currently not enough evidence to show that ivermectin, doxycycline or zinc (together or separately), is safe or effective to prevent or treat COVID-19. Research into the potential of ivermectin as a treatment option, is underway in Australia and overseas. "
In Australia, the equivalent of the FDA is the TGA. The TGA approves of these drugs for other conditions. As such, in Australia, "off-label" prescription is possible for ivermectin, doxycycline and zinc for COVID-19 patient.
In another thread, somebody posted a link to Professor' Thomas Borody's radio interview (in Australia). That interview gave me to understand that some sort of government announcement would be made around about now with specifics on their trials. Haven't heard anything yet, though.
[-] TrumpLyftAlles | 1 points
There is currently not enough evidence to show that ivermectin, doxycycline or zinc
Right: That's Borody's so-called triple therapy -- so-called because his trial has 5 components, those plus vitamins C an D, IIRC.
I don't know what the legal environment is like in Australia. US MDs can prescribe ivermectin off-label because it is FDA approved for other purposes. However, off-label use of any drug makes the doctor vulnerable to some degree to lawsuits. My medically-conservative MD refused to prescribe it for me.
Thanks for keeping an ear out for news about Prof Borody. I hope that the eventual nursing home data is credible. I wince at the thought that people in nursing homes are dying needlessly every day because they're not using ivermectin. Unfortunately, that has to be proven before it will be adopted in the US. Good for Borody for helping make it happen in Australia.
[-] saitchouette | 3 points
The legal situation is essentially similar here. Possibly, the US more litigious than Australia. However doctors fear lawsuits in Australia and are often quite conservative.
[-] Ok-Film-9049 | 3 points
If the numbers are that low I can imagine the government don't want lots of people taking it prophylacticly, until proven. Clearly it would be a far bigger issue in a country where there is pressure on hospitals because of rising cases e.g. most of Europe
[-] saitchouette | 2 points
I gather one of the possible side-effects is diarrhoea. In which case, it wouldn't be terribly fun to have it prophylacticly, even if it's perfect safe (and potentially great for COVID patients).
[-] propargyl | 6 points | Oct 17 2020 03:47:39
I like it. As Australian doctors are both very conservative and informed by data, this is a big deal.
permalink