https://www.bharian.com.my/berita/nasional/...in-secara-label

Langkah tepat guna Ivermectin secara 'off label'

KUALA LUMPUR: Kebenaran menggunakan Ivermectin secara 'off label' bagi merawat pesakit COVID-19 ketika ini disifatkan sebagai langkah tepat dalam menentukan keberkesanan dan kesan sampingannya.

Penggunaan secara 'off label' merujuk kepada penggunaan ubat di luar tertera dalam label dan belum atau di luar persetujuan badan atau lembaga bertanggungjawab.

Timbalan Pengarah Pusat Kajian, Inovasi dan Pembangunan (IRDI) Universiti Perubatan Antarabangsa (IMU), Prof Dr Azizi Ayob, berkata Kementerian Kesihatan (KKM) harus diberi ruang membuat penyelidikan dan melengkapkan kajian klinikal supaya maklumat keberkesanan dan keselamatan ubat berkenaan dapat dikenal pasti.

"Indikasi sebenar ubat ini ialah sebagai anti-helmint (ubat cacing parasit) termasuklah onchocerciasis, strongyloidiasis dan helminthoases.

"Justeru, mana-mana dakwaan atau indikasi baharu perlu diuji semula secara kajian klinikal dengan mengambil kira kenapa ia perlu diuji berdasarkan penemuan baharu praklinikal.

"Saya tidak menghalang penggunaan Ivermectin namun secara 'off label' buat sementara.

"Pada masa sama, KKM terus menjalankan kajian sehingga mendapat data lebih sempurna untuk menyokong cadangan penggunaan ubat ini," katanya ketika dihubungi BH, hari ini.

Dr Azizi yang juga Timbalan Presiden Ikatan Pengamal Perubatan dan Kesihatan Muslim Malaysia (I-Medik) berkata, setakat ini tiada indikasi praklinikal bahawa Ivermectin boleh menggantikan fungsi vaksin COVID-19 kerana sifat mekanisme tindakan Ivermectin adalah berbeza.

"Sebagai pakar farmakologi, saya percaya kajian klinikal rawak boleh merungkai potensi tindakan mekanisme baharu bagi Ivermectin seperti yang ditemui dalam kajian makmal," katanya.

Semalam, Ketua Pengarah Kesihatan, Tan Sri Dr Noor Hisham Abdullah, dilaporkan berkata, KKM tidak menolak kemungkinan meluluskan penggunaan Ivermectin bagi merawat pesakit COVID-19 jika ada bukti kukuh menjelaskan keberkesanan dan kesan sampingannya.

Ketika ini, katanya, penggunaan Ivermectin hanya dibenarkan secara 'off label' sehingga kajian menyeluruh dijalankan.

Ivermectin adalah sejenis ubat antiparasit diluluskan Pentadbiran Makanan dan Ubat-Ubatan (FDA) yang digunakan secara meluas bagi rawatan beberapa penyakit tropika terabai, termasuk onchocerciasis, strongyloidiasis dan helminthiases.

IMMEDIATE U-TURN!

https://www.thestar.com.my/news/true-or-not...-treat-covid-19

PETALING JAYA: The Health Ministry has denied a viral message claiming that they are allowing off-label usage of the anti-parasitic drug Ivermectin to treat Covid-19.

"The off-label use of Ivermectin to treat Covid-19 is only for clinical trials – not on the request of patients in hospital," it said in a Facebook post on Saturday (July 10).

The post claimed that the Ministry was allowing the use of Ivermectin for those who ask for it.

Ivermectin has been in use for decades to treat head lice and river blindness in humans and heartworm in animals.

In regards to Covid-19 treatment, laboratory experiments by researchers at the Monash University in Australia found that Ivermectin in vitro had an inhibitory action on SARS-CoV-2, reducing the load of viral RNA by 5,000 times in 48 hours.

On June 5, the Ministry and the Institute for Clinical Research started clinical trials to study the use and efficacy of Ivermectin for high-risk Covid-19 patients at 12 hospitals.

Health director-general Tan Sri Dr Noor Hisham Abdullah said evidence was inconclusive to recommend routine use of Ivermectin for Covid-19 patients.

Dr Noor Hisham said the United States Food and Drug Administration (FDA) had not approved Ivermectin for treatment of Covid-19 in humans and that the World Health Organisation only recommended it in a clinical trial setting.

Treating Covid-19 patients with Ivermectin: An interview with Safiyya S. Shabazz, M.D.

https://new.finalcall.com/2021/07/14/treati...-s-shabazz-m-d/

Dr. Safiyya S. Shabazz is the owner and Medical Director of Fountain Medical Associates in Philadelphia. In May, 2020, during an online group chat for physicians, she learned that the anti-parasitic drug ivermectin was demonstrating effectiveness in treating Covid-19. She began using it at times in her treatment of patients.

Initially, Dr. Shabazz noted, since most people recovered from the disease and illness on their own, she wasn’t sure the ivermectin was actually making a difference. However, since it was safe and had the potential to keep her patients off ventilators, she continued to use it. In an interview on July 7, Dr. Shabazz shared her experience with ivermectin over the past year.

Charlene Muhammad (CM): What have you experienced, to date, using Ivermectin in your practice?

Dr. Safiyya Shabazz (SS): I would offer it to patients and let them know that at the time just a single dose was recommended and I thought the medication was safe. It may or may not work. Otherwise, I just had the vitamins that I would offer people. I experienced amongst my patients no problems or side effects. It’s true that most people will recover (from the virus), but it was sporadic at times.

Starting in October, 2020, in my area, we started to experience this surge of cases that really took us through the end of February, 2021. During that period of time, I treated, along with nurse practitioner Valeria Muhammad, a couple of hundred (200) patients with ivermectin, and the experience was positive. No one complained of side effects. Most of my patients recovered without the lingering symptoms that you hear about. And since the beginning of the pandemic, even with just the vitamins, none of my patients passed away.

We had a couple of hospitalizations. But overall, my experience has been very positive with the medication (ivermectin). I’ve had patients who were very thankful because they may have had several people in their household who had the infection but I was only caring for one of the people in the home; they felt badly that their relatives were not being treated and were not recovering as quickly. So, my personal experience has been positive, with the medication.

I’ve started to receive calls from all over the state of Pennsylvania, really mostly Caucasian people, who saw my name on a list of people who are willing to prescribe the medication, and they call from all over for it. I’ve used it less frequently for prevention. I think that it is an option, an alternative. I feel more confident that it can make a difference in treating people who actually have Covid or for after they’ve been exposed to prevent them from catching the infections. But yes. I’ve used it and I feel positively about it.

Dr. Shabazz next spoke to the overt suppression of ivermectin that she has encountered

SS: … there are many doctors who refuse to prescribe it. It is prescription only. … I have never in my life experienced pharmacies refusing to fill medications. There are pharmacists who refuse to fill it. We were contacted by CVS Pharmacy and told that they had a corporate mandate that they will not fill the prescription, which I thought was outlandish considering there is no safety concern that I’m aware of.

They fill (prescriptions for) narcotics every day that kill people. They know they kill people, and they’ll fill those all day long, but they refuse to fill the ivermectin. And the reason I was given is, it does not work, which has never been a reason why a medication was refused. I’ve never had a pharmacy refuse to fill a medication that I’ve prescribed before. I’ve had pharmacies call back to make sure that I got the dosage right so I don’t harm someone, but I have never had a pharmacy refuse any medication.

It doesn’t matter what I was prescribing, oxycodone, morphine, whatever, they’ll fill it. But they have outright refused at many of the larger pharmacies, which I believe is a direct result of one, politicization, but also, I suspect there are financial interests in not building the evidence that would make it clear that this very inexpensive, readily available, safe medication should be part of the arsenal that is offered to people.

Like I said, every intervention is like a layer of swiss cheese. It’s not completely foolproof, but if you can layer up several different interventions, together, then I believe you can make a difference, and it should be offered as part of the toolbox of options. My patients have done well. Very few of them have the long-haul syndrome so I’m going to continue doing it, unless I am unable to, which hopefully it doesn’t come to that.

CM: Thank you. Are any of your colleagues using it as well, and having the same results?

SS: I work basically alone in that I have a private practice and my nurse practitioner, Valeria Muhammad. But because there’s still a non-recommendation from the NIH (National Institutes of Health) or CDC (Centers for Disease Control) regarding it not being effective and shouldn’t be used, I think that many people are more algorithm-based or they may say evidence-based, but there is evidence that it works.

I don’t know if the type of evidence that people are saying they would want to see (large randomized controlled trials) before they use it will ever be generated. It’s a very inexpensive medication, and the focus really has been more on newer, likely much more expensive options, and I think that that is a big part of the pushback against its use. The risk is very low with using it. Even if it was marginally effective, I don’t know why you would discourage people from using it unless there is a safety concern, and I’m not aware of any safety concerns.

CM: Thank you.

https://spectator.com.au/2021/07/hunt-goes-...ith-ivermectin/

‘The whole aim of practical politics is to keep the populace alarmed (and hence clamorous to be led to safety) by menacing it with an endless series of hobgoblins, all of them imaginary’, observed H.L. Mencken.

The latest hobgoblin to be wheeled out in Australia’s endless Covid horror movie is a wheezy young waif in a hospital bed. The ad, authorised by the federal government, is the latest instalment in the relentless campaign of Project Fear to terrorise people into huddling in their homes until they can be vaccinated.

If the ad was subject to the rules governing commercial businesses, the government might be prosecuted for misleading consumers. A study from Oxford University has shown that severe Covid in young people is largely explained by obesity and Covid deaths are overwhelmingly in the elderly. The only people to die since the NSW lockdown began are a man in his 70s and a woman in her 90s.

That hasn’t daunted NSW’s chief health officer Kerry Chant who made a point of saying, very slowly, that at least one teen and a couple of people in their 20s and 30s were in intensive care while being cagey about disclosing any co-morbidities.

Ramping up the fear factor Premier Gladys Berejiklian warned people not to browse in supermarket aisles or go shopping for inessential items such as shoes but has so far failed to demonstrate how irrelevant they are by turning up to a press conference unshod.

Yet for epidemiologist Tony Blakely it wasn’t enough. He said there were only three options; to let the virus rip, resulting in thousands of deaths and health services overwhelmed, the current ‘soft’ lockdown which he said would drag on for months, or a hard lockdown enforced by the military and a shutdown of all lingerie shops. Presumably, those resisting arrest in aisle six or discovered with a newly purchased pair of pumps and panties could be shot on sight.

Overlooked by almost everyone is the possibility that the pandemic could end with an effective treatment. If there were an outbreak of plague (which still exists in parts of the US and Africa) would the Australian government lock down the country because there’s no vaccine? Let’s hope not since there’s a perfectly effective antibiotic to treat the Black Death. When HIV emerged in the 1980s, there was no vaccine to prevent it. There still isn’t. Yet Aids-related deaths have been reduced by over 60 per cent, thanks largely to effective treatment.

The first essential element in responding to any pandemic is not a vaccine, which does nothing for people already infected, it is treatment. Indeed, an effective treatment reduces the circulation of a virus reducing the chances of mutations and makes a mass vaccination program safer and more effective.

It is to Australia’s credit that one of the most effective treatments was identified at Monash University along with the Doherty Institute which showed that ivermectin kills the Sars-CoV-2 virus within 48 hours. Yet to our national shame, the researchers have been starved of resources and the discovery ignored.

Not so in Indonesia where an enterprising philanthropist, Haryoseno, leapt into action and made ivermectin available to the masses for free or at low cost. As a result, Indonesia has had an extremely low Covid mortality rate. That is until the Ministry of Health decided, in line with the WHO’s recommendation, that ivermectin would only be used in a clinical trial. Haryoseno has been threatened with a fine and a ten-year jail sentence and the supply of ivermectin has dried up. Result? Deaths per million have increased five-fold since withdrawal of ivermectin on 12 June.

In Australia, one of the few doctors brave enough to use the drug to treat patients and save lives, Dr Mark Hobart, was reported to the Australian Health Practitioner Regulation Agency (AHPRA). Thankfully, AHPRA advised that there had been no infringement. Indeed, federal Health Minister Greg Hunt wrote to one of the doctors in Australia who prescribes ivermectin confirming that he was aware that some physicians are prescribing ivermectin off-label for Covid and that they were quite within their rights as the practice of prescribing registered medicines outside of their approved indications is not regulated or controlled by the Therapeutic Goods Administration (TGA), it is at the discretion of the prescribing physician. Yet the silence persists. Ivermectin is the drug that dare not speak its name.

Some doctors prescribing ivermectin are members of the Covid Medical Network. They can be contacted via their website and provide prescriptions for prophylaxis and treatment anywhere in the country (covidmedicalnetwork.com). Many follow the protocol established by world-renowned researcher Dr Thomas Borody who, largely at his own expense, has run a trial of an ivermectin triple therapy which has shown a reduction in mortality of 86 per cent in patients who were seriously ill with Covid. The only patients who died in the study – which has been published on preprint server medRxiv – were those that declined treatment.

Demonstrating the complete lack of urgency with which it treats repurposed drugs, the TGA last updated its advice on ivermectin on 1 June. It claims that there is currently insufficient evidence to support its safe and effective use. Yet since 1 June results of 15 new trials and meta-analyses of ivermectin have been published almost all showing steep declines in mortality. The question that the TGA has to answer is how is it possible to approve an experimental gene therapy vaccine with plummeting efficacy, significant short-term safety signals and unknown longterm side effects and yet not recommend a drug with an outstanding safety profile, which is supported by Nobel laureates and multiple randomised controlled trials?

On Wednesday, when Premier Berejiklian decided to lock down Greater Sydney for another two weeks only 24 people who had tested positive were in the community. In order to bring that to zero the lockdown is estimated to cost about $16 billion. Sydney’s new Northern Beaches hospital only cost about $2 billion. Covid has cost the Australian economy $311 billion or in our new Covid currency 156 hospitals.

It probably not a coincidence that it is NSW Treasurer Dominic Perrottet and federal Treasurer Josh Frydenberg who have suggested we to learn to live with the virus. Yet we don’t have to sacrifice lives or bankrupt the country. We only have to use an Australian treatment that will one day be recognised as the greatest medical discovery since penicillin.

https://worldivermectinday.org/events/world...aysian-chapter/

https://worldivermectinday.org/

https://malaysia.news.yahoo.com/harapan-hea...-072000968.html

Harapan health experts warn against pushing ivermectin before clinical trial results

Three Pakatan Harapan health experts have warned that the approval of any Covid-19 treatment, especially ivermectin, has to be based on science and data.

Former health minister Dzulkefly Ahmad, former deputy health minister Dr Lee Boon Chye and Bandar Kuching MP Dr Kelvin Yii also cited a recent study published yesterday by Cochrane, which showed strong evidence that ivermectin should not be used for the treatment and prevention of Covid-19, except in the context of clinical studies.

This comes after a number of MPs from the same coalition including R Sivarasa, Khalid Samad and Mohamad Sabu pressured Health Minister Dr Adham Baba over whether the government would look into ivermectin as a possible treatment option for Covid-19 patients.

Sivarasa even called on the Healthy Ministry to approve the off-label use of ivermectin for medical doctors to treat patients, instead of allowing its off-label use in clinical trials only.

Dzulkefly, Lee and Yii said that any such treatment must also go through specific clinical trials conducted under the principle of “evidence-based medicine”.

“This includes the approval of ivermectin for the treatment of Covid-19 which should be based on data collected through randomised clinical trials conducted by the Health Ministry and around the world,” added the trio.

They also cited a systematic review published in the British Journal of Medicine that stated that all data up to March 1 had found evidence on the benefits of ivermectin was of “very low certainty” due to the lack of methodology and small sample size of the studies involved.

“We must examine the data that has been released, including the results of clinical trials by the Health Ministry which are expected to be completed in September,” said the three MPs who called on Malaysians to be confident in approved Covid-19 vaccines which have reduced infection and mortality rates in Labuan recently.

Unproven claims

In May, the Health Ministry had announced plans to carry out randomised clinical trials to see if ivermectin can be used to treat Covid-19, following unproven claims regarding its use as a preventive drug for the disease.

Ivermectin is an anti-parasitic drug mostly used in veterinary medicine, especially in treating worm infestations.

Yesterday, the Malaysian Pharmacists Society (MPS) and the Malaysian Medical Association (MMA) called for an end to the illegal sales of ivermectin.

The groups expressed concern that many Malaysians are illegally sourcing the drugs after hearing of its supposed efficacy against Covid-19.

Ivermectin has not been registered for the prevention or treatment of Covid-19, and can only be used in clinical trials that are now taking place in 12 hospitals in Malaysia.

Anyone caught selling the anti-parasitic drug as treatment and prevention of Covid-19 can be fined between RM25,000 and RM50,000.

The clinical trial results are expected to be ready in September.

It will involve 500 high-risk Covid-19 patients who are still in the initial phases of infection, to see if fewer patients would progress to severe disease or die compared to those who only received standard hospital care.

Previous studies on ivermectin were inconclusive and yield mixed results.

Merck's patent on ivermectin expired in 1996.

https://www.scielosp.org/article/bwho/2004.v82n8/562-562/

Whatever you are researching right now I have done it ages ago. So please do not ask me to Google it.

MELIHAT kepada perkembangan semasa penularan penyakit COVID-19 di negara ini, situasinya amat membimbangkan. Hampir dua minggu peningkatan jangkitan mencecah belasan ribu pesakit berbanding sebelum ini. Meskipun kadar kebolehjangkitan Covid-19 Ro/Rt untuk seluruh negara adalah 1.07, namun kadar kebolehjangkitan di beberapa buah negeri masih menunjukkan perkembangan yang menakutkan.

Ini menunjukkan kes sporadik semakin meningkat di dalam jangkitan komuniti tidak kira sama ada berada di bandar mahupun di luar bandar. Dalam kemelut wabak COVID-19 yang semakin meruncing ini, timbul pula ura-ura daripada sebahagian pakar yang mengesyorkan penggunaan ubat Ivermectin. Pada awalnya, Kementerian Kesihatan Malaysia (KKM) dilihat tidak memberikan sebarang respon terhadap cadangan tersebut.

Dalam bahasa mudahnya, KKM tidak mengambil cadangan tersebut sebagai prosedur rawatan COVID-19. Tindakan tersebut sedikit sebanyak menimbulkan pelbagai spekulasi dan persoalan terhadap pihak berwajib. Hal ini kerana, semakin banyak kajian yang menunjukkan keberkesanan Ivermectin dalam merawat pesakit COVID-19.

Malah, dari segi keselamatan Ivermectin terhadap manusia, dilaporkan ianya boleh disifatkan sebagai ubat dalam kategori selamat. Menurut Prof. Mustafa Ali Mohd yang merupakan pakar Farmakologi dan Taksikologi, beliau mempersoalkan tentang tindakan kerajaan tidak memberikan sebarang rawatan kepada pesakit COVID-19 semasa tempoh kuarantin di pusat-pusat kuarantin. Sedangkan, terdapat 50 lebih negara mencatatkan kesan positif dalam ujian klinikal dalam penggunaan Ivermectin.

Menurut beliau, Ivermectin adalah berkesan kepada pesakit di tahap awal bagi mengelakkan golongan ini menjadi lebih kritikal iaitu tahap ke-4 dan ke-5. Dari segi logiknya, pandangan beliau dalam isu ini perlu dipertimbangkan. Hal ini kerana, pihak KKM perlu bersedia dengan sebarang kemungkinan. Dalam erti kata lain, selain meneruskan usaha pemberian vaksin, pihak kerajaan juga perlu menyediakan alternatif kepada masyarakat dalam mengekang penularan virus khususnya melibatkan kematian akibat wabak ini.

Mana tidaknya, program vaksinasasi negara memakan masa yang panjang. Keutamaan diberikan kepada golongan tertentu. Sedangkan kehidupan masyarakat perlu diteruskan seperti sedia kala. Ini bermakna, ada pihak yang terpaksa menempuh kehidupan dalam keadaan tidak mempunyai protection daripada vaksin akibat belum tiba giliran.Di samping itu, apa yang lebih membimbangkan adalah tentang keberkesanan vaksin COVID-19.

Sedia maklum bahawa, vaksin COVID-19 dibenarkan penggunaannya atas tiket authorised for emergency use. Ini bermaksud, kajian yang sempurna masih belum dapat dihasilkan. Buktinya, sehingga kini keberkesanan vaksin yang disuntik ke dalam masyarakat di negara ini berhadapan dengan pelbagai penemuan baharu. Pertama tentang keberkesanannya untuk melawan mutasi virus baharu iaitu varian Delta. Kedua, penemuan tentang bilangan dos yang diperlukan untuk mewujudkan imuniti bagi melawan COVID-19.

Malah, lebih membingungkan ialah jangka hayat keberkesanan vaksin ini. Umpamanya, terdapat pandangan yang menyatakan bahawa vaksin pfizer perlu disuntik 6 bulan sekali atau setiap tahun sekali. Penemuan-penemuan baharu tentang vaksin COVID-19 ini akhirnya menimbulkan satu persoalan lebih besar iaitu adakah suntikan vaksin benar-benar menjadi solusi keluar dari kemelut wabak COVID-19?

Sungguhpun begitu, perlu ditegaskan bahawa masyarakat perlu mengambil langkah proaktif untuk mendapatkan suntikan seperti yang disarankan. Bukan sebaliknya, mengambil langkah tidak wajar seperti memboikot atau bertindak seperti golongan anti-vaksin. Hal ini kerana, apapun status vaksin COVID-19, ianya telah melalui ujian klinikal yang panjang. Malah, pemantauan yang rapi disediakan oleh pihak kerajaan bagi meneliti sebarang bentuk kesan sampingan yang memudaratkan kepada penerima.

Mengenai Ivermectin, kerajaan disaran untuk mengambil langkah proaktif bagi mengkaji lanjut segala dakwaan yang timbul bagi menentukan keberkesanan Ivermectin.Tidak dinafikan usaha yang telah dilakukan oleh KKM melalui ujian awal Ivermectin terhadap 500 pesakit COVID-19. Namun begitu, usaha yang lebih proaktif harap dapat diambil oleh pihak ini dalam menentukan status Ivermectin. Ini sebagai langkah menyediakan alternatif kepada golongan yang masih belum menerima suntikan vaksin mahupun menampung kekurangan vaksin COVID-19.

Malahan juga, mereka yang menerima suntikan tidak bermakna terhindar dari sebarang jangkitan wabak ini. Bermaksud, sekiranya kerajaan bertindak proaktif dalam mengenal pasti kedudukan sebenar Ivermectin dalam rawatan COVID-19, maka sudah pasti ia boleh digunakan sebagai ikhtiar rawatan jika didapati ubat ini benar-benar berkesan.

Dalam konteks semasa, mungkin tidak keterlaluan sekiranya dibenarkan penggunaan Ivermectin dalam kalangan masyarakat dengan pemantauan ketat oleh pihak KKM melalui kerjasama agensi kerajaan yang lain. Dalam hal ini, teknologi seperti block chain boleh dimanfaatkan bagi mengawal penjualan dan pembelian ubat ini. Sebenarnya, langkah menghalang penjualan terus ubat ini dari pasaran yang sah seperti Farmasi dan Klinik dilihat lebih mengundang bahaya.

Pihak berwajib perlu sedar, keadaan masyarakat sedang kritikal dengan jangkitan wabak COVID-19 dalam kalangan keluarga. Dalam keadaan ini, sudah tentu mereka sanggup melakukan apa sahaja bagi memastikan kesembuhan anggota keluarga. Ini bermakna, jika masyarakat mempercayai dakwaan Ivermectin memberi kesembuhan, maka usaha mendapatkan bekalannya akan diteruskan walaupun melalui pasaran gelap yang mungkin berhadapan dengan isu pemalsuan ubat. Oleh kerana itu, mungkinkah tiba masanya KKM membenarkan kegunaan ubat ini dalam keadaan authorised for emergency use dengan pemantau yang rapi.

Dr. Norhidayah Pauzi
Pensyarah Kanan, Jabatan Fiqh dan Usul, Akademi Pengajian Islam, Universiti Malaya Kuala Lumpur &

Dr. Muhammad Safwan Harun
Pensyarah Kanan, Jabatan Fiqh dan Usul, Akademi Pengajian Islam, Universiti Malaya Kuala Lumpur

Artikel ini merupakan sebahagian daripada dapatan projek penyelidikan di bawah geran “Isu Etika Dalam Percubaan Klinikal Dari Perspektif Hukum Islam Untuk Menangani Penyakit Berjangkit” (GPF072B-2020).

https://malaysiagazette.com/2021/08/07/rele...sakit-covid-19/

PETALING JAYA: The Consumers Association of Penang (CAP) has voiced its support for the Malaysian Alliance for Effective Covid Control (MAECC)’s call for allowing Ivermectin use under the emergency use authorisation (EUA) together with the current vaccination programme.

The government must respond positively to the call as it is to save lives, CAP president Mohideen Abdul Kader said today.

“If adopted, Malaysia would be among the 32 countries worldwide to use this drug in successful Covid-19 preventative and treatment programmes. Moreover, Ivermectin is a low risk, low cost and an established medicine that is readily available. It had been in use for decades, albeit for different indications,” he said in a statement.

“Former director of the National Poison Center at Universiti Sains Malaysia Tan Sri Dzulkifli Abdul Razak pointed out that proponents of Ivermectin use argues that it represents an important ‘alternative’ treatment for Covid-19.

“He added that ‘poorer’ countries are mostly left out in the global Covid-19 vaccine rollout as the process is dominated by what is termed as vaccine ‘nationalism’ and ‘apartheid’. This causes continued disparities in vaccine access worldwide.”

Mohideen pointed out that the success stories of Ivermectin use to treat Covid-19 cases are impressive despite the fact that the World Health Organisation (WHO) doesn’t recommend its use for Covid-19 treatment.

In April 2020, India had the world’s highest daily infection record of 360,960 cases and a month of mass distribution of Ivermectin in the most affected states and cities, the infection rate plunged to below 7,000 daily cases, he said.

“Given the slow progress in vaccinating people and the delay in the results of the Ivermectin trial which only started in June 2021, we cannot wait any longer to be confronted by another Wave of highly infectious variants. Our healthcare system is already buckling under the pressure of daily number of positive cases,” Mohideen added.

“After more than a year of Movement Control Orders (MCO), the country is suffering economically and people having poor mental health. Within the first five months of 2021 there were 468 suicides. The situation is likely to deteriorate if the government continues to drag its feet in managing the pandemic effectively. Experience of countries using Ivermectin to deal with the Covid-19 pandemic gives hope of restoring normalcy here in Malaysia.”

https://www.thesundaily.my/home/govt-urged-...combo-EE8125789

cool down.

Whither Ivermectin

DESPITE some bad impression the Ivermectin, a Nobel prize-winning drug with a wide margin of safety and decades of safety data, has received recently due to overdose cases, to form an educated opinion on it we must look at the whole spectrum of information comprising only scientific facts and hard empirical evidence.

This is especially important when the drug may have a potential to provide a safety bridge to full vaccination (but not vaccine substitution in any measure) without devastating the economy and keep our back, even in the presence of variants, should the current vaccines start failing us.
First, we clarify that the following discussion is all about human-grade Ivermectin, while the animal-grade version is not for humans and its effects are largely unknown.

And even human-grade Ivermectin is strictly not for self-medication until proper guidance from the health authorities.

Furthermore, this discussion is not to provide ground to either proponents or opponents of Ivermectin but to invite both sides to relook into this issue in a more detailed and balanced way backed by science.

After all, we are not out of the wood yet with this pandemic, while the science behind Ivermectin may have a valuable piece of knowledge to face current and possible future pandemics.

SARS-CoV-2 is not the first virus to draw scientists' close attention to this drug.

Near five decades of scientific literature documents Ivermectin's potent virostatic effects on a broad range of RNA and DNA viruses such as Zika, dengue, yellow fever, West Nile, Human immunodeficiency virus type 1 and many others.

The recent research significantly expands understanding of the link between this humble de-wormer and various viral infections, including SARS-CoV-2.
Ivermectin, primarily discovered for its deworming function, acts on parasites' neural and muscle cells by hyperpolarising them, interrupting proper functioning and causing paralysis and death for parasites.

Though the drug is safe for humans in therapeutic doses (FDA approved) of 150 – 200 μg per kg of body weight and even higher doses as documented in the literature in various protocol regimes.

However, if Ivermectin crosses the blood-brain barrier, it may cause brain damage.

In other words, it is not to be consumed by those with a compromised blood-brain barrier—for example, meningitis patients, children below two years old or below 15 kg weight, and pregnant or breastfeeding women due to danger for the child.

Furthermore, people with impaired liver or kidney function should also be cautious with Ivermectin. However, many people might be unaware of their liver or kidney malfunction, which underscores once again that Ivermectin is strictly not for self-medication.

But research discovers that Ivermectin's beneficial functions do not stop at paralysing worms and here science gets exciting.

Although Ivermectin does not kill the virus directly, its several mechanisms inhibit viral replication and could be best described as having a virostatic effect.

First, Ivermectin is found to inhibit SARS-CoV-2 ability (and primary target) to suppress the host's cellular defensive mechanisms.

As a result, the cell can recognise the viral intrusion and ramp up not only its own defence but inform the neighbouring cells to ramp up their defences as well.

Furthermore, Ivermectin exhibits relatively high binding efficacy to SARS-CoV-2 RNA-dependent RNA polymerase (RdRp)—the essential protein for viral replication inside the host's cells.

By blocking RdRp, Ivermectin halts the replication of SARS-CoV-2 viral RNA, rendering newly formed viral copies hollow and useless.

Additionally, in silico examinations of molecular docking capabilities revealed that Ivermectin efficiently binds to the SARS-CoV-2 S-protein as well as to the human cell receptors ACE-2.

While being sandwiched between these two structures, Ivermectin can prevent viral entry into human cells.

Ivermectin also appears to have potent anti-inflammatory action. It is found to downregulate lipopolysaccharide-induced production of inflammatory cytokines in vitro and in vivo in mice, while SARS-CoV-2 triggers inflammation through a mechanism similar to that of lipopolysaccharides.

On top of all that, Ivermectin possibly reduces blood-vessel clotting observed in SARS-CoV-2 patients. The malaria parasite is well known to cause Red Blood Cells (RBC) clumping due to simultaneous binding with multiple RBCs via the CD147 receptor, which it uses to penetrate RBC.

The same CD147 receptor is identified as a key binding site, apart from ACE2, for SARS-CoV-2 S-protein and therefore possibly contributing to blood clotting by binding only.

This possibly explains reduced odds of severe disease outcomes among individuals with O blood group observed for malaria and SARS-CoV-2 alike due to lower CD147 density on RBCs of this blood type.

As mentioned above the Ivermectin molecule can bind with S-protein and therefore reduce blood clotting in SARS-CoV-2.

The figure below illustrates the concept.



The above scientific rationale made Ivermectin one of the most looked into potential repurposed drugs for COVID-19 management at all stages—from the prophylaxis to critical care.

The most recent, comprehensive and methodology-robust meta-analytical systematic reviews on efficacy and safety of Ivermectin therapy against COVID-19 which restricted the included studies to the highest level of evidence, that is, randomized clinical trials (RCTs) were published on June 6 2021 (based on 19 RCTs) and June 21 2021 (based on 24 RCTs).

To remind, meta-analysis is a systematic statistical method of summarising empirical findings from several similar studies with due consideration of any flaws in the evidence.

Both of the above mentioned meta-analytical studies came to similar conclusion that Ivermectin was associated with reduced risk of mortality and progression to severe disease in COVID-19 management.

The latter study also found that Ivermectin prophylaxis reduced COVID-19 infection by an average of 86% but graded this finding as low-certainty due to underlying study design limitations and fewer included trials.

There were too few adverse events reported which were not clearly associated with the use of Ivermectin and also minor and transitory in nature.

However, another recent meta-analytical review published on July 28 2021 in Cochrane Library—database highly regarded in the medical field, found no evidence of Ivermectin benefits in COVID-19 treatment.

One important variable that might explain these contradictory results between meta-analytical studies is dosage and protocol.

Indeed, majority of the studies included in Cochrane review, in contrast with to other reviews, used very low, close to therapeutic dose of Ivermectin.
Meanwhile it is already generally understood in the medical field that even if Ivermectin is to have beneficial effect in COVID-19 treatment outcome it can be achieved mostly at higher than therapeutic doses.

Therefore future research, whether RCTs or meta-analytical reviews should gear towards ascertaining the effect of Ivermectin dose.

In light of the above scientific rationale and empirical evidence, the fact that Malaysia's authorities at last initiated their own Ivermectin clinical trial (I-TECH study) is a highly positive development.

Although, it could have been done earlier.

However, the authorities should also consider immediate initiation of clinical trial for those in the very early stage of the disease (perhaps those in quarantine centres) and not only for critically ill as it is in the I-TECH study.

This is because the use of Ivermectin as an early treatment for those who have no immunity against COVID-19 (natural or vaccine-induced) has the greatest potential to effectively flatten the curve without economic collapse—form of a safety bridge to the time of full vaccination.

Furthermore, given the current public pressure for Ivermectin treatment and anecdotal evidence of its ongoing unauthorised use, volunteers recruitment can be expediated.

Should the study show positive results the strategy is clear—massive and quick testing and early Ivermectin treatment for those with no immunity against COVID-19.

This is similar to what Peru authorities have done in May 2020—one of the largest documented case studies on the population-wide use of Ivermectin for Covid-19 treatment with apparent success.

Importantly, note that most of the identified mechanisms of action on SARS-CoV-2 by Ivermectin are not impacted by the presence of SARS-CoV-2 variants.

Therefore, this drug has the potential to keep our back in case if current vaccines start losing their efficacy in the face of new variants.

Meanwhile, it is worrying that anecdotal evidence suggests ongoing unauthorised sale and re-sale of the Ivermectin in Malaysia and lives of Malaysians are in double jeopardy due to concern over the drug's authenticity and its use without proper medical guidance in terms of dosage, protocol or contraindications, and supervision.

Hopefully, health authorities can come up with some swift and definitive actions on all of the above.

https://www.astroawani.com/berita-malaysia/...ermectin-315932