Here’s a letter I received in our daily WhatsApp chat group. It reads:
“Tell us Prof Dr JB Lim how is it that Ivermectin is still not being approved for use by FDA, WHO and by almost all countries in this world for Covid treatment
I came to know that you are a Special Medical and Science Adviser to a local drug company, and you will be the most qualified person to tell us
We always enjoy reading your well versed answers, and perhaps we can await your highly learned and esteemed answer to this dilemma since there are 'evidences' voiced by doctors that Ivermectin is effective”
Prof NC Tan
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Here’s my brief reply to Prof Dr Tan
“Thank you Prof Tan for your question
The answer is very lengthy as many controversial questions has to be discussed and these have been hotly argued by other experts too
For instance, some of them argue that Ivermectin can only inhibit the SARS-CoV-2 virus duplication in vitro, namely in lab studies, but not in vivo in human subjects in a clinical setting.
Then there is this dose problem that has not being worked out because ivermectin has never been used officially for the treatment of Covid patients.
Furthermore, most people recovered on their own without Ivermectin, oxygen or any other support system
In fact out of 20,000 new cases each day in this country or elsewhere, only less than 300 died, and that's just 1.5 % mortality
The rest recovered on their own uneventfully
So drugs like Ivermectin may not have any role at all in their recovery even if given
The best is our own immune system that plays the major role in almost all recoveries
We shall try to avoid all these debates among experts themselves”
Instead, I shall try to answer your question as briefly as possible in the eyes of FDA
Because of its length I have decided to post my opinion in my blog for others
outside this chat group to read as well, here:
Regards, and thank you once again for your enquiry and interest
Jb lim
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Thank you for your question Professor Tan requesting my opinion. It is very lengthy for me to explain in detail, let alone explain the numerous flaws and controversies in the study design and statistical treatment of the so-called data found in isolated studies here and there.
I have read many of their papers, but I am not satisfied by their findings especially the way the methodology these studies were conducted.
But we shall not go into them as they are very technical for lay readers to understand. There were also many statistical flaws in sampling. None was well-designed.
But we shall try to be as brief as possible, described in as simple a language as necessary so that this understanding is not lost in transition Firstly, in order for any drug, whether new or old to be used for another purpose (repurposed) other than already approved for specific treatment previously, a new application needs to be submitted once again to FDA for New Drug Application (NDA).
For such a repurpose application (such as ivermectin for Covid), the medical establishment or any organization must first submit thousands of pages to the FDA for review and approval.
That type of research or data can cost a person or any drug manufacturer tens of billions of US dollars. Who wants to do this? This is only the first step for an official request for ivermectin or any drug to be used for Covid. This applies to any drug whether old or new that they intend to use for any other treatment other than what it was originally approved and intended.
The NDA demands all animal and human data, plus side effects, dosing, and effectiveness to be submitted to them. Other information, such as pharmacokinetics (how the drug is absorbed, moves, distributed, and retained through the body), and specifics of manufacturing process are also to be revealed such as the purity of the drug for human use, and not in some crude form as an anti-parasitic agent meant for veterinary applications.
At the moment nobody knows the safe and effective dosage of ivermectin for humans. Reports came in of some taking only only one tablet to ‘cure’ Covid, others landing up with acute poisoning swallowing 15 tablets in one sitting until the Ministry of Health Malaysia has reported this to the National Poison Centre to classify ivermectin as a poison.
Once any health authorities submit their tens of hundreds of thousands of research data to the FDA team the FDA will take at least 60 days to review the NDA and determine if it will be filed for further review. Firstly, any person, manufacturer, clinician, whosoever, wants to have a drug approved for a new use, they must submit all these data all over again, and they can be in these stages:
1. Discovery that ivermectin is effective for Covid from casual observation.
2. Preclinical Research using cell-line studies, animal assays, toxicological, and teratogenic studies, dosage for humans…etc. etc.
3. Clinical Research. This can be in at least two phases - initial clinical trials involving just a few dozens to a few hundred patients. If the drug seems promising, the study will be extended to tens of millions of people world-wide from all participating countries with very strict clinical and statistical protocols to be observed. 3.
4. FDA Review will then review all these studies once again and that can cost tens of billions of US dollars, and this 10 to 15 years to study, and not just in one year in 2012.
5. FDA Post-Market Safety Monitoring (Pharmacovigilance)
A drug for repurpose must undergo Priority Review, and the FDA takes action on a new drug application within six months, compared to 10 months under standard review. These drugs receive higher priority because they can significantly improve the treatment such as for emergency use for Covid, its diagnosis, or prevention of serious conditions.
FDA Advisory Board:
Next comes a group of independent physicians and other clinicians, who are then finally called in to give their opinion to the FDA Advisory Board. These medical experts discuss with the NDA and FDA reviewers the drug use for a new treatment such as the use of ivermectin for Covid.
The FDA often follows the advice of the Board, but is not obligated to do so. This advisory team includes physicians, research scientists pharmacists, chemists, pharmacologists, statisticians, and even patient representatives.
It normally takes between 12 to 18 years, and sometimes even as long as 20 years for any drug to be approved by FDA for use for any specific treatment such as ivermectin for Covid. It is not as easy as that.
FDA and WHO have their teams of highly qualified medical and scientific experts to advise them, and they care two hoots what any individual doctor or a private GP has to say by publicizing his personal views and uploading them social media video.
For sure FDA will not listen even if thousands of doctors demand the drug can be used for a disease no matter how convincing individual and isolated studies published here and there.
This doctor in the video sent to me is only a private GP who tells only his own grandmother story like a fairy tales using social media video to convince other patients or even to other specialist doctors.
He even has the audacity to complain and advised the Director of a government hospital how his Covid-infected relative needed to be treated by giving ivermectin along with other medication.
This behaviour is very unbecoming of a doctor trying to interfere with the treatment given to a patient being treated in a government or a private hospital. What right has he? This is highly unethical and unprofessional code of conduct for a doctor.
If there is any suggestion for a new treatment, the researchers worth their salt will tell the academic and medical world by publishing their studies and findings in proper referral scientific journals and not use video through social media to publicize, let alone interfere with treatment given by other doctors in a hospital who need to follow standard treatment protocols.
Yet almost all the studies done on ivermectin and covid management were rejected by FDA and WHO due to flaws in their study design and sampling.
Read here for the details the criteria how drugs have to undergo lengthy and very strict investigation protocols before any drug can be approved for any use.
https://www.medicinenet.com/script/main/art.asp?articlekey=9877
It is not as easy as that for sure, just because tens of hundreds of doctors gather to demand it. Neither FDA, WHO or Drug Control Bureau in any country will give way to anybody no matter how loudly they shout and demand in public, through circulating social media, through whatsapp, or using their personal videos uploaded for public viewing.
Publicizing their opinion in social media, in whatsapp, in video in Google is NOT the way medical or clinical research are being conducted ethically, professionally and scientifically. It is not meant for any doctor to decide which drug is effective and safe. They need to get approval from higher authorities for safety reasons no matter how urgent its need, especially for drugs that has never been thoroughly studied for a repurpose.
Neither FDA, WHO or any drug control authorities in any country in the world will give way to individual opinions of any doctor or even if thousands of them believe in them and demand collectively its use.
Only individual patients and the public will listen to their doctors and believe in him or her, but definitely not the Ministry of Health of any country. Most countries listen and follow the advice of WHO and FDA as both these two organizations have hundreds of far better and more qualified experts to advise them even though almost every country has their own drug control and regulatory bodies. FDA in the US are the experts on usage of drugs, not anyone else, and WHO on all health matters for the entire world to follow.
Neither can any Big Pharma control the FDA, WHO or any drug control authority in any country as some believe. In fact the reverse is true. The Big Pharm are under the absolute and total control of FDA and WHO screens them all and gives consent only to a list of essential drugs.
FDA can reject licence for any drug to be used, and even when already approved, they can still withdraw its use at any time if they find serious adverse reactions during the post-marketing pharmaco-vigilance although the drug manufacturers have already spent US $ 20 billion over 15 years developing the drug for any previous use or for repurpose for Covid.
A lot of people do not understand how extremely strict these drug approval and control authorities are. They just cannot allow ivermectin to be used rampantly by just anybody including by doctors or pharmacists or by the public just because everybody shouts loudly in public videos demanding ivermectin be used for managing Covid.
That maybe only their personal view and experience, not the scientific community, let alone the entire world.
Then we also have no idea what happens when the SARS-CoV-2 virus mutates under threat of a drug and becomes a much more resilient variant that shall evolve to become resistant to all drugs. What we are afraid is, if we challlenge any organism with drugs, agents, chemicals, or probably even vaccines, it will mutate into hardier strains and variants as part of their genetic programme to become more resistant to a hostile environment whether within or outside our body.
It is just a recognized biological law of adaptation for their existence and survival obseverable in all living creatures including 'non-living' viruses. This sort of adaptive scernarios has already been in placed for 4 billion years since life first arrived on Earth.
We can clearly see this in lots of bacteria already resistant to several generations of antibiotics, including antiparasitic drugs like chloroquine used against malarial parasites.
This may also be an outcome if we use ivermectin and antiparasitic drug rampantly just as we do with antibiotics against pathogenic bacteria to give rise to superbugs like methicillin-resistant Staphylococcus aureus (MRSA) that causes stap nosocomial infections in hospitals.
This is part of Nature being observed in the evolution of all life in the past 4 thousand million years of adaptation and evolution, and I think clinicians should also learn evolutionary medicine, not just clinical medicine in order for them to understand the nature of disease better
How this virus is going to evolve into more aggrressive pathogenic variants because we want to challenge its existence and survival we need also to consider, and it is highly unprofessional and unscientific for any drug to be used rampantly especially coming from clinicians and other health professionals who ought to be more careful, professional and scientific.
I hope I have briefly answered and explained, and thank you for your question
L im ju boo
Monday, September 6, 2021
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