mmmm_frietjes | 12 points
How to convince my country's regulatory agency about Ivermectin?The medicine agency of my country recently published this:
BCFI received reports of use in outpatient practice of ivermectin per os in patients with COVID-19. Ivermectin is an antiparasitic agent used per os in, among others, scabies [ivermectin is not available in Belgium for oral administration, only as a cream]. The claim that ivermectin is effective per os in COVID-19 is not based on any clinical evidence. An antiviral effect was seen in vitro at concentrations much higher than the plasma concentrations found after using ivermectin per os for the treatment of certain parasitic diseases. In addition, an in vitro effect is at best hypothesis-generating, and does not allow any statement about a clinical effect. Use of ivermectin may be accompanied by serious undesirable effects (e.g., severe skin reactions, liver toxicity).1
I sent them an email:
This is not correct. There have already been several in vivo studies. The regions where it is already used also have significantly fewer deaths.
Meta studies: "Ivermectin is an effective treatment for COVID-19. The probability that an ineffective treatment generated results as positive as the 22 studies to date is estimated to be 1 in 4 million (p = 0.00000024). Early treatment is most successful, with an estimated reduction of 90% in the effect measured using a random effects meta-analysis, RR 0.10 [0.03-0.38]. https://ivmmeta.com/
"Search keywords- "COVID-19 (and synonyms) AND ivermectin"-generated 86 articles on PubMed, 48 on medRvix and 37 on clinicaltrials.gov at the time of writing. Twelve of these were listed as completed clinical trials and of these, 8 were included as investigators had released results. Positive mortality benefit, reduced time to clinical recovery, reduced incidence of disease progression and decreased duration of hospital admission were reported in patients across all stages of clinical severity". https://www.medrxiv.org/content/10.1101/2020.11.30.20236570v1
Another overview: https://c19ivermectin.com/
It can also help people who still suffer from symptoms after months: RESULTS: 33 adult patients with Persistent or Post-Acute Symptoms of COVID-19 were treated with Ivermectin. In 94% of the 33 patients, clinical improvement to some degree (partial or total) was observed after 2 doses of Ivermectin. Total improvement (without any symptoms) was observed in 87. 9% of the patients after the 2 daily doses of Ivermectin. In 12. 1% of patients whose symptoms had not been completely resolved after the first 2 doses, additional doses of Ivermectin treatment were administered according to the protocol, and total clinical resolution of symptoms was observed in 94% of cases. https://www.researchgate.net/publication/344318845_POST-ACUTE_OR_PROLONGED_COVID-19_IVERMECTIN_TREATMENT_FOR_PATIENTS_WITH_PERSISTENT_SYMPTOMS_OR_POST-ACUTE
They replied:
Regarding our articles on ivermectin and its contradiction with other sources, we can only reiterate that we base ourselves to the maximum on controlled randomized studies with clinical, hard endpoints if possible (which is of course possible in case of infections). About COVID-19, dozens of studies appear that do not meet these requirements.
Other studies can be very interesting as hypothesis-forming research but are mostly biased selection of who received which treatment, non-blinded evaluation, non-clinical endpoints... The study methodology also has its scientific rules. In order to prove causality (e.g. that a drug is better than spontaneous healing) randomised controlled research is decisive. This research must have been published in journals that have reviewed the methodology (peer-review). We only mention other studies if there really is no other way of research possible. See also https://www.bcfi.be/nl/articles/3399?folia=3392
The BCFI has the same approach in assessing hypertension studies, cancer drugs, antibiotics, vaccines, homeopathic medicines...
E.g. articles in medRxiv are pre-publications that have NOT (yet) gone through the peer-review process.
Everything Translated with www.DeepL.com/Translator (free version)
How should I reply? I'm not an expert so..
[-] Murky-Lengthiness | 5 points
There are already 10 successful RCT’s on the use if Ivermectin in the information you sent them, THEY DID NOT read them.
I always wonder why they do not chose to do studies themselves?
Okay, they think every study with a good result is fake, how about they do some research and do their own study based on ideas there?
If it could save thousands of lives, why not?
[-] sausageface123 | 4 points
Does it boil down to the old "there's no money in existing medicine"? Horrible, but likely the case
[-] lurker_lurks | 3 points
It may not work in your area, but for others, you could work with your local health authorities to start a deworming campaign. It worked for a state in Paraguay: https://twitter.com/lurker_lurks/status/1337936277463699456
I pulled this example from Dr Kory's testimony in a senate committee hearing oncl c-span (a clipped version was removed from youtube last week).
https://www.c-span.org/video/?507035-1/medical-response-covid-19
He goes into a powerpoint at the 1:54:00 mark.
What I am trying to do in the US is start a petition to organize the masses against this OUTRAGEOUS SCANDAL and FORCE the regulatory agencies though sheer numbers to allow it to be used for large scale observational trials.
Accomplishing this could save THOUSANDS upon THOUSANDS of lives. It is worth trying. https://www.change.org/nih-update-your-covid-guidelines
[-] blueheelercd | 1 points
SIGNED, DONATED, WILL FORWARD!
[-] sicklypersonforever | 1 points
signed
It's the same in every country. Nobody reads anything if it's not announced by some big pharma company or the WHO. We have to wait until the vaccines are sold or the US starts applying ivermectin. Then everyone will follow. It's funny how science is acting like a religious cult.
I expect a lot of the people involved have their hands tied by regulations and beurocratcy. That said, there is clearly no will from those who could make a difference on this. My guess is that there is far too much at stake for a wonder drug to turn everything on its head.
It's not as if we dont have recent precedents for changing the rules and emergency use. Rhemdesivir got a golden ticket by US authorities and then there are the vaccines of course.
We've seen this kind of thing numerous times throughout the pandemic, such as with the HCQ situation. Another example is vitamin d; the UK health secretary denied that it could make difference in front of parliament when questioned about it a few months back. This raised a few eyebrows so they made a u turn and are now distributing vit d to the vulnerable free of charge. But... they only get a daily dose of 400iu which will make no difference whatsoever. You'd need 100x that amount to have any real impact.
The way governments and related agencies are behaving is infuriating!
Its worthwhile to continue pushing for them to be proactive but i dont think there is any chance they'll make any significant policy changes. At least they wont be able to claim ignorance. Good on you for going out of your way to do this.
[-] [deleted] | 1 points
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[-] [deleted] | 1 points
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[-] dogrescuersometimes | 1 points
CORRECTION:
I-MASK+ is PROPHYLACTIC and ONSET TREATMENT
I-MATH+ is infection treatment.
I meant to say I-MASK+ throughout the info below
Pierre kory said that a number of studies were published after his testimony on sec 8.
The pharma do not want us to know about the cheap and effective treatments.
The people are traumatized which closes down their minds.
It's a worthy battle but it will be work.
Iver is horse paste so you can get it from a pet care store.
I made a list of the math plus protocols items hope it helps
https://shop.bestredlighttherapy.com/shop/math-protocol/
I live to the north of you, The Netherlands, same problem here. Maybe your country has one the world's highest mortality rates because of the bann on Ivermectin for oral use🤔. You can point out to them that authorities in Australia ARE treating people (elderly specifically) and health workers who tested positive on Covid-19 with an Ivermectin Triple Therapy Protocol from august 2020 on and their numbers are "somewhat" different from the Belgian ones!!!
[-] johnnight | 9 points | Dec 15 2020 15:18:26
Well, they have a rigid process that prevents them from relying on pre-publications. It would be noncontroversial, if we had time.
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