According to a court order on April 6 as the World Health Organization (WHO), South African doctors will treat COVID-19 without fear of retaliation or waiting for approval from the South African Health Product Regulatory Authority (SAPHRA). You can now prescribe Ibermectin. ) The drug is recommended to be used only in trials.
A court order allowed human medicines containing ivermectin “as an active ingredient” to be registered by SAPHRA on March 16 and to combine or mix ivermectin with other registered medicines, “Article 14 of the Act (Article 14 of the Act). 4) Provisions. “
“Access in accordance with Article 14 (4) of the Act effectively means that physicians can prescribe ivermectin at their own discretion, and that no Article 21 application or report is required for compound ivermectin.” Barend Uys, Head of Research at the Afri Forum, said. a news release.. “The patient can then use this prescription to purchase Ibermectin from any pharmacy where the compounded Ibermectin is available.”
The AfriForum was one of four groups that filed proceedings against SAPHRA.
Prior to the ruling, doctors approved the use of Ibermectin through SAPHRA’s controlled and compassionate use program under Section 21 of the Pharmaceuticals and Related Substances Act, which allowed SAPHRA to sell unregistered medical products in the country. I had to apply.
However, filing the application did not guarantee approval from the healthcare regulator.
The court also ordered SAPHRA to report to the court every three months about the availability of Ibermectin and any changes made to its use.
WHO does not recommend the use of ivermectin
South Africa’s ruling, except in clinical practice, cites definitive data for a week after WHO advised not to use Ibermectin for COVID-19, a disease caused by the CCP (Chinese Communist Party) virus. Not passed.
“Current evidence of the use of Ibermectin to treat COVID-19 patients is inconclusive,” WHO said. Said In a press release. “Until more data are available, WHO recommends using this drug only in clinical trials.”
The WHO decided that the decision was a review of 16 randomized controlled trials by 2407 participants by a panel of experts assessing whether Ibermectin had any effect on hospitalization, viral clearance, mortality, and artificial respirators. Said that it is based on.
Dr. Pierre Collie, a member of the Frontline COVID-19 Critical Care (FLCCC) Alliance, said WHO’s remarks are not “science” based, but rather prejudiced.
“They don’t say that the vast majority of studies find really significant benefits. What they do is [say] The result is not a positive result, a result, a result, but all low quality or low certainty. ” Said With weekly updates of FLCCC. “We know that’s not true. There are some additional groups that have evaluated the quality, and we feel it’s actually moderate, including the WHO Principal Investigator.”
Cory also said that the WHO recommendation is one with a statement from the National Institutes of Health (NIH), the European Pharmaceutical Agency (EMA), and Merck that “manufactures where there is little or no scientific uncertainty.” I said that I am doing it.
WHO did not respond to a request for comment.
NIH initially stated that it would only recommend ivermectin for use in clinical trials, guidance After members of the FLCCC Alliance released data in January.
“The COVID-19 Treatment Guidelines Panel has insufficient data to recommend or oppose the use of ivermectin for the treatment of COVID-19,” said NIH.
In February, Merck, who held a patent until 1996 and advertised the safety of Ibermectin for many years, statement Against the use of Ibermectin for COVID-19 due to lack of safety and efficacy data.
“I don’t think the data available will support the safety and efficacy of ivermectin beyond the doses and populations shown in regulatory-approved prescribing information,” Merck said.
A month later, the pharmaceutical company Preliminary survey results Results of a Phase 2a trial of the experimental antiviral drug molnupiravir for early treatment of COVID-19 with ridgeback biotherapy. Oral drugs, like ivermectin, showed a more rapid reduction in infectious viruses. The Monupiravir Phase 2/3 trial will be completed in May.
Dr. Andrew Hill, Senior Visiting Fellow, Faculty of Pharmacology, University of Liverpool, led a meta-analytical study of Ibermectin funded by Unitide.This is part of the World Health Organization’s ACT Accelerator Initiative to Improve Access to COVID-19 Treatment. Diagnosed. Trial Site News..
In his meta-analysis study [pdf] Hill and his team found out of 18 trials in more than 2,200 patients that “improved survival by 75%, reduced time to clinical recovery, and controlled treatment with patients who received Ibermectin. We found that there were signs of a dose-dependent effect of virus clearance in patients who underwent.
“Despite the promising trends this existing database shows,” researchers say “additional, higher quality, larger clinical trials” are needed before “regulatory approval of ivermectin.” Stated.
Dr. Jean-Jacques Rajter, a respiratory practitioner who successfully treated patients with severe COVID-19 with Ibermectin early in the pandemic, confirmed the efficacy and safety of Ibermectin at a Senate hearing last December. He testified that it was difficult to fund and support randomized comparative trials. ..
“My team has multiple research protocols and is ready to do it in a short period of time,” says Rajter. Said.. “We have established relationships with international teams to complete such randomized controlled trials, but funding for such studies has been elusive at best.
According to Nobel laureate and co-developer of ivermectin Dr. Satoshi Omura, “A total of 91 trials in 27 countries” are being conducted, and COVID-19 is being conducted “80 for therapeutic purposes and 11 for preventive purposes”.
Ibermectin, the first inexpensive antiparasitic drug given to animals, was approved for human use in 1987 for the treatment of oncoselka disease or river blindness, a disease caused by insects transmitted by flies. .. Over 30 years, more than 3.7 billion Ibermectins have been distributed.
This drug is on the WHO List of Essential Medicines and has a high safety profile.
Evidence-based Medicine Consultancy Ltd. Dr. Tess Lawrie, director of the company, said: interview Approximately 4,600 adverse events and 16 deaths have been recorded in the Pharmacovigilance Database since Ibermectin was first administered to people on March 6.
According to the FDA, common side effects of ivermectin include nausea, diarrhea, dizziness, and skin rash.
According to Raleigh, remdesivir for hospitalized COVID-19 patients has had “more adverse events and 417 deaths” since it was approved by the Food and Drug Administration (FDA) last year. Side effects Remdesivir includes nausea, bleeding, and pain.
Ivermectin has several possible mechanisms of action in the treatment of COVID-19, with anti-inflammatory and anti-viral properties that “block viral proteins from entering the nucleus and prevent the virus from damaging the immune system.” I have. “It also has a mechanism of action that impairs the ability of the virus to replicate.”
Countries using Ibermectin
In the Philippines, the FDA has allowed one hospital to apply for the compassionate use of ivermectin, but the “distribution” of the drug remains “illegal,” the Philippine News Agency said. report.. Proponents of ivermectin are seeking approval for use in the treatment of COVID-19 due to the delayed deployment of the vaccine. Ivermectin is only available for domestic animals.
According to local news, officials in Belize, a Central American country, approved the use of Ibermectin to fight the CCP virus in December 2020. LoveFM..
Mexico City also began administering ivermectin to COVID-19 patients on December 29, 2020, after stating that the local government had considered more than 30 clinical studies using ivermectin as a treatment. By January 22, more than 50,000 people had been treated with this drug. El Financier report.
Slovakia became the first European Union country to approve ivermectin.Minister of Health of the country Approved Ivermectin as a preventative and therapeutic treatment for COVID-19 in January. Your doctor can prescribe it for the next 6 months.
According to the FDA, veterinary ivermectin is not recommended for human consumption because “animal drugs are often in high concentrations” and “may be very toxic to humans.”