Macedonia Nears Approval of Ivermectin for COVID-19 as Word of the Drug Spreads in the Balkan Peninsula

Macedonia Nears Approval of Ivermectin for COVID-19 as Word of the Drug Spreads in the Balkan Peninsula

The southeastern European nation of Macedonia’s health authority plans on authorizing the use of Ivermectin for an at home treatment targeting COVID-19. The low cost, pervasive anti-parasitic medication, used by hundreds of millions annually in the tropics, has a well-known safety profile: mounting studies point to the drug’s ability to dramatically inhibit SARS-CoV-2, the virus behind the COVID-19 pandemic. Now Macedonian authorities, namely the Minister of Health, have prepared a positive opinion and plans on sending this to the MALMED Drug Agency (the drug regulatory for North Macedonia). Once that occurs, the drug can be legally exported to Macedonia specifically for use against COVID-19. This country recognizes the growing evidence that If used early on with mild to moderate cases, the drug can reduce the intensity of the illness associated with COVID-19. Apparently, they have been influenced by others in the Balkan Peninsula such as Greece and Bulgaria, where use of Ivermectin against the novel coronavirus is now common.

Actually called the Republic of North Macedonia, this Southeastern European nation gained independence in 1991. A landlocked country bordering Kosovo to the northwest to the northwest, Serbia to the north, Bulgaria to the east and Greece to the south, as well as Albania to the west, it now includes a total population of about 2.06 million.

A Grey Market Formed

As word as spread about “the people’s medicine” that is the term coined by Dr. Tarek Alam with the Bangladesh Medical College in Dhaka—a prominent researcher/physician studying the drug’s use in COVID-19 patients—more and more residents in this country were importing the drug from abroad (e.g. mail order pharmacy, etc. but mostly from Greece) as the pharmacies and hospitals had no supply.   Paying 1200 denars for four 3 milligram pills, this was higher than the €10 ($12.28) but Macedonians must pay shipping and other intermediary costs.

Current COVID-19 Treatment Guidelines

Ivermectin has been up to now precluded from Macedonian treatment guidelines as adopted by the expert collegium of the PHI University Clinic for Pulmonology and Allergology as well as the COVID-19 centers in the internal medicine unit, the Ministry of Health informed the local press known as Free Press.

Did the Patient’s Lead the Way?

Interestingly in a similar story to what TrialSite found in Peru (see our documentary), it would appear that although evidence for ivermectin safety and efficacy was in fact building, the local health regulatory, MALMED, the people and their physicians were a step ahead, creating a groundswell of demand as has been the case in other jurisdictions, such as Uttar Pradesh in India.

Although physicians have been ordering the drug for patients and patients were again even going to buy directly online via Greece, this wasn’t discussed openly. Perhaps that will change now that the drug will become formally authorized for COVID-19.

What Happened: Why is Ivermectin Now Getting Authorized?

Apparently, according to Ljirim Shabani, director of the Drug Agency, the Commission for Infectious Diseases was asked for its expert testimony on the safety and efficacy of Ivermectin as it relates to the novel coronavirus. The positive attributes were confirmed, hence leading to the drug’s approval.

Awaiting Final Decision

Now the country is awaiting final approval from the Commission for Infectious Disease, which plans on supporting the direct importation from company’s with the product abroad. Shabani reported that in addition to running vaccine trials, they are awaiting the final decision and expect that soon.

Ivermectin Support

Apparently, some of the county’s most respected authorities are pro Ivermectin. For example, Professor Nikola Panovski and former Minister of Health Dr. Dragan Danilovski are openly in favor of the drug. In fact, Dr. Danilovski just stated last month, “I would give Ivermectin. But the decisions are elsewhere. I will repeat, I consider Ivermectin superior to remdesivir.” He went on to compare costs, highlighting how expensive remdesivir actually was ($3,000 per patient and must be administered in the hospital) while Ivermectin can be taken right in the home; an economical drug that reduces the duration of the infection as well as mortality.

The Balkan Peninsula: The Ivermectin Baptism

Apparently, Greece has turned Macedonia into an Ivermectin market. The Greeks have discovered the drug and are actively using it to fight off COVID-19.  But so is Bulgaria, as hospitals have adopted the antiparasitic drug as part of local protocols, such as at Acibadem City Clinic, a hospital in Sofia. There Ivermectin is apparently the official COVID-19 treatment. TrialSite recently introduced the prominent Professor Ivo Petrov’s opinion the drug—which was very positive.

Although the major media in North America, and Europe for that matter, don’t report on these unfolding events, TrialSite does. There is a growing recognition among many physicians and researchers in North America that the National institutes of Health should publicly support Ivermectin-based research. Why not? There is sufficient data to justify research after dozens of studies show positive results. The U.S. government recently awarded AstraZeneca $486 million for yet another advanced, novel monoclonal antibody combination cocktail. The drug is being tested for both pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) and the price will undoubtedly be high and still require an injection and a significant healthcare expenditure. Why won’t the U.S. federal health authorities even consider an ivermectin study?

Responses

  1. that’s a really good question, when we are unsure of the answer being posed to the FDA, that is indicative of us not trusting the Institution…. things need to be analyzed, discussed, and improved

  2. People are suffering and dying and its all about the money. I can imagine a huge class action lawsuit in the future unless unless officials get on this now and it may be beyond too late already.

  3. Although some governments have started to test Stromectol (ivermectin) and might even have endorsed it, India has dropped it from its treatment protocol for COVID-19:
    https://www.indiatvnews.com/news/india/ivermectin-drug-not-included-centre-covid-19-management-protocol-659148

    Stromectol (ivermectin) has only a mediocre safety profile:
    https://en.wikipedia.org/wiki/Ivermectin#Contraindications

    Meanwhile, Alinia (nitazoxanide) has a very good safety profile like Avigan (favipiravir), Foistar (camostat), and artemisinin, all of which have shown moderately good efficacy against early COVID-19:
    https://en.wikipedia.org/wiki/Nitazoxanide#Clinical_trials
    https://pubmed.ncbi.nlm.nih.gov/33031085/
    https://pubmed.ncbi.nlm.nih.gov/32725286/
    https://www.medrxiv.org/content/10.1101/2020.10.21.20217208v1

    Foistar (camostat):
    https://www.medrxiv.org/content/10.1101/2020.12.10.20240689v1
    https://pbs.twimg.com/media/EURFxodXsAEIsIQ.jpg:large
    https://livedoor.blogimg.jp/toua2chdqn/imgs/4/6/4606c81f.jpg

    Artemisinin:
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605811/
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7572038/

    Meanwhile, Alzumab (itolizumab) has a very good safety profile like Actemra (tocilizumab) and both drugs have shown moderately good efficacy against mid-stage and end-stage COVID-19:
    https://www.medrxiv.org/content/10.1101/2020.12.01.20239574v1
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7688906/
    https://immunityageing.biomedcentral.com/articles/10.1186/s12979-020-00207-8
    https://immunityageing.biomedcentral.com/articles/10.1186/s12979-020-00207-8/figures/2

  4. TrialSite News has been wonderful in its monitoring the strange lack of curiosity from media and medicos regarding ivermectin. They have sniffed out every mention of ivermectin across the world since about March I think.

    In my view, in Australia, ivermectin should be given TGA approval for use at home without a prescription so that early or a pre-emptive dose can be taken.

    The dose rate seems to be set at about 8 mg for first dose for a 70 kg body.

    I have paid AUD$80 for my supply of 20 tablets and have been happy to have had them on hand but feel sorry for all those people kept in the dark by that strange but now explained elsewhere in other TrialSite news recently.