off-label prescriptions

Candobetter Editor: We have been reluctant to get into any COVID-19 treatment controversies, because we figure it is hard enough dealing with a pandemic, without the additional stress of wondering about unproven treatments. Recent framing of Ivermectin as dangerous horse-medicine, however, is unfair and misleading. Ivermectin has been long been used to treat humans as well as other animals. This treatment might be controversial, but it should not be that controversial. We would make the case that, since people will take Ivermectin, whether or not it is prescribed by a doctor, it would be better for it to be prescribed and supervised by a doctor, to avoid the risk of major overdose and serious consequences. (Details on adverse consequences can be found in Dr Hansen's video: /node/6172.) The article below is based on a statement from the COVID-19 Antiviral Advisory Group, which references a major meta-analysis of Ivermectin as treatment and prophylaxis for COVID-19. A contrary analysis by can be found at https://www.cochrane.org/news/ivermectin-preventing-and-treating-covid-19. That study finds no proof as yet for or against. Another analysis by US lung specialist in emergency medicine can be found here: /node/6172.

Ivermectin for COVID-19: real-time meta-analysis of 63 studies - https://ivmmeta.com/. The COVID-19 Antiviral Advisory Group which advises more than 200 Australian doctors on early antiviral treatments for COVID-19 has called on the Therapeutic Goods Administration (TGA) to immediately reverse its decision that was announced late on Friday, which effectively prevents doctors from prescribing an effective triple therapy medication off-label for COVID-19 because it includes ivermectin. The Antiviral Advisory Groups says, "This represents an unprecedented attack on the sanctity of the doctor-patient relationship and interferes with normal clinical practice."

The Group quotes Professor Robert Clancy:

“September 10, 2021, was a black day, the day a group of faceless bureaucrats known as the “Advisory Committee for Medicines Scheduling”, through its effector arm, the Therapeutic Goods Administration (TGA), compromised medical practice and the health of their fellow Australians. The TGA used its regulatory muscle to prevent doctors at the COVID-19 pandemic’s coalface from prescribing ivermectin (IVM), the one therapy available that is safe, cheap and which reduces mortality in the order of 60 per cent. This poorly conceived action threatens the high standards of medical practice we have achieved in Australia, and the credibility of the administrative structure within which medicine operates.” (Professor Robert Clancy in Quadrant Magazine - 14 September, 2021. Emeritus Professor of Pathology at the University of Newcastle Medical School. Member of the Australian Academy of Science’s COVID-19 Expert Database. https://quadrant.org.au/opinion/public-health/2021/09/a-sad-and-shameful-day-for-australian-medicine/

The Advisory Group states that the TGA has seriously compromised Australian doctors’ ability to practice medicine and treat patients by banning the use of TGA approved ivermectin as an off-label prescription. It says that the TGA in its statement said it aimed to ‘protect public health’ but instead has damaged public health by increasing mortality.

The Advisory Group states that off-label prescriptions comprise more than 25% of prescriptions in Australia. This allows doctors to customise their treatment of care to patients for a vast range of chronic and life-threatening conditions.

"People are being sent home with a positive COVID-19 test and told to call a doctor or an ambulance if their condition deteriorates. Without the off-label ivermectin triple therapy as an treatment more people will die at home or end up in Emergency and ICU."

In their press release, they give the example of Patient Katia Dandan, who they say was severely ill with Covid and is now 100% healed, saying:

“I am alive today because of the courage of a doctor who was willing to prescribe ivermectin triple protocol. I do not want the people of Australia to be deprived of a medication that works. I do not want people to be allowed to die because TGA has some other agenda for banning this drug. It is a criminal act to ban a medication that saves lives.”

[Candobetter Editor comment: Patient testimony is not valid scientific argument.]

The COVID-19 Antiviral Advisory Group states,

"This is an unprecedented attack on the medical profession and the Australian people who trust us for their health. The TGA should not be telling doctors how to treat patients and practice medicine without proper and open consultation."

As a group we have given more than 450 patients Ivermectin Triple Therapy prescriptions which are saving lives and keeping people out of the emergency hospital system. On top of this, there have been hundreds of preventative prescriptions of this protocol to protect frontline health workers from infection. These treatments are extremely safe and effective and all patients we have treated have been healed within a matter of days.

The Group sees this is an unprecedented move by the TGA to interfere with the doctor-patient relationship without proper and open consultation. It says,

"The TGA is effectively stopping us from practicing medicine. Indeed, Federal Health Minister Greg Hunt recently 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”.

The Doctors in the COVID-19 Antiviral Advisory Group call for the TGA to:

· Immediately remove the Sept 10 Amendment in the next 48 hours because people will die.

· Provide complete transparency around the data and reasoning that has informed the TGA’s ban.

· Immediately provide Ivermectin Triple Therapy access to the 14,000 Australians in NSW currently in quarantine (and other States as needed), with a working party of frontline doctors overseeing distribution, management, and data collection processes.

The Group's press release concludes:

This TGA draconian overreach will drive patients out of doctors’ offices where they get safe, trusted medical advice and prescriptions, to self-treat using veterinary products. Ivermectin has proven to be safe and effective with 33 countries using it currently as part of COVID-19 therapy.

This Nobel Prize award-winning medicine was discovered 30 years ago. It has been safely prescribed more than 3.2 billion times to humans and has saved millions of lives. Ivermectin alone or in combinations has been used for long-term treatment of parasites which only require low doses. Slightly higher doses have been used safely for the aggressive Delta strain but using doses within published safe range. No increase in adverse side effects have been seen. Ivermectin toxicity is not a known condition.

“Ivermectin is generally very well tolerated, with no indication of associated CNS toxicity for doses up to 10 times the highest FDA-approved dose of 200 μg/kg.” See study in American College of Clinical Pharmacology published in the Journal of Clinical Pharmacology.

The Group concludes its statement:

Do we want to see more patients die in their homes and further stress our hospital system because they have been denied treatments by the TGA otherwise available overseas? To ban a TGA approved therapy when there are limited at home treatment alternatives for people diagnosed with COVID-19 will mean that patients will die.”

The claim that Australia has low supply of ivermectin is quite incorrect as there is an adequate supply for all in Australia through compounding chemists.

The Triple Therapy includes human prescription only Ivermectin, combined with prescription only Doxycycline and over the counter zinc. All doctors confirm that this is an early, safe and effective treatment for Covid but shouldn’t replace the need for patients to discuss vaccination with their doctors."

Short film interviewing Dr Tess Lawrie, leading UK researcher on Ivermectin early treatment protocols: https://www.youtube.com/watch?v=j2EEDJuQNrI