Source: Trial Site News
Australia’s medicine and therapeutic regulatory, the Therapeutic Good Administration (TGA) recently took the gloves off with Ivermectin, the economical anti-parasitic drug associated with at least 63 completed clinical trials involving SARS-CoV-2, the virus behind COVID-19. Now TGA formally places a national prohibition on off-label prescribing of ivermectin to all general practitioners. A comparable move as to what TGA did with hydroxychloroquine in 2020. Clearly further evidence of tightening encroachment of the critically important doctor-patient treatment relationship allowing consent to medical treatment using off-label medications. Of course, this isn’t occurring in a vacuum—it’s part of an unfolding, integrated and what have the signs of a coordinated and orchestrated government action to stop any and all treatments other than those the government declares acceptable.
The new restrictions are based on the inputs of the Advisory Committee for Medicines Scheduling (ACMS), an advisory group that makes recommendations to the Secretary Department of Health. Since 2010 this executive branch function has sole decision making authority, superseding that power from the National Drugs and Poisons Schedule Committee (NDPSC).
The new restrictions materially impact what general practitioners and specialists can do with their patients. Now via national regulatory edict, general practitioners (GP) can only prescribe ivermectin for TGA—approved conditions or what is known as indications. In this case, that means scabies and certain parasitic conditions. This is the case even if the GP has consulted with specialists and believes the treatment is the most appropriate for the patient. A stunning move that in normal times would have physician associations’ attention.
While select specialists may be able to access the drug, the proclamation carves out the potential opportunity for infectious disease physicians, dermatologists, gastroenterologists, and hepatologists (liver disease specialists) to prescribe off label to the patient if they deem such decision appropriate for the particular patient, the rule will overnight dramatically reduce the number of prescriptions.
And even for the exemptions, new policies, procedures, and practices will encumber even these specialists in their ability to practice medicine. The costs associated with applying, registering and complying will deter most from such a pathway.
Overall Rationale for Decision
According to the TGA, this decision came about “because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19.”The regulator’s logic rests on the premise that ivermectin isn’t approved by Australia or any other “developed” countries and thus its “use is by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organization and the U.S. Food and Drug Administration (FDA).
What are the Declared Risks Supporting the Decision?
The regulatory body cites three (3) risk factors driving their decision, including 1) interruption of vaccination program 2) higher dosage (e.g., implied safety risk) and 3) dramatic increase in prescriptions—all three above of which represent a threat to public health.
In a refreshingly clear manner, TGA firstly indicates the use of ivermectin off-label threatens the mass vaccination program. For much of the pandemic, Australia kept cases out of the country with strict border controls and stern measures on mobility, including lockdowns and the like. However, with the highly transmissible delta, the government went into full throttle a vaccine-centric strategy similar to that in America. From this vantage, the risks of the pandemic nationwide are mitigated only first and foremost by universal vaccination.
With substantial vaccine hesitancy in the country, the Australian government took the vaccine-centric mandate into overdrive starting in the early summer. Since then, vaccination rates have rapidly climbed (as of Sep 9–53% at least one dose and 32.6% fully vaccinated) marked by notable events such as the inoculation of 20,000 high school kids at the nation’s largest stadium.
The way TGA views the world, if people believe they are protected from infection by taking another drug prescribed by their GP, then they may opt to avoid the jab. In their own words, “Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of COVID-19 infection throughout the community.”
While TGA cites concerns of social media and “other” sources influencing the public, the proclamation indicates that ivermectin doses used off-label for COVID-19 are higher than the current indication, thus implicating safety concerns. Based on this logic, Australia’s GPs are not equipped to know the difference hence are now banned from prescribing this drug off label. Yet, of course, specialists may apply for an exemption—but everything will be controlled and monitored much like controlled substances (e.g., opiates are managed).
Finally, with such huge demand comes what are declared to be local shortages of ivermectin for its current intended use. This could have an adverse impact on what they consider legitimate uses. When combining these three factors in the context of the overall rationale, TGA issued the rule.
Who Supplies the Country & For What Indication?
The only TGA-approved oral ivermectin product is Merck’s Stromectol Ivermectin 3mg tablet blister pack, indicated for the treatment of river blindness (onchocerciasis) threadworm of the intestines (intestinal strongyloidiasis) and scabies. Merck has been active in lobbying its interests here.
The TrialSite community is aware that Merck is in a frantic race to own the COVID-19 antiviral market, next to Pfizer and Roche via a partnership with Atea Pharmaceuticals. At stake is what TrialSite estimates is a large market, anywhere from a few billion per year to several billion worldwide, maybe more. That’s because over 90% of COVID-19 cases are mild-to-moderate, requiring isolation, bed rest and time. Any antiviral that compresses that time, reduces symptoms and importantly lowers the probability of disease progression makes a profound impact on the pandemic.
In addition to rumblings that Merck is cautioning national governments about ivermectin, TrialSite reported they have smartly inked deals in low-and middle-income countries (LMICs), including multiple production and distribution deals in India.
In fact, it is with one of those Indian licensors of the product that has led to a deal in Vietnam, as reported by TrialSite. Indian suppliers to that country shipped the investigational product to public health authorities that are using the experimental drug in a real-world setting: a pilot public health home care program in Ho Chi Minh City. An unorthodox situation—this isn’t a study but rather, an actual medical care setting via the public health agency for the largest city in the nation. This raises important ethical concerns, including conflict of interest and informed consent principles.
Now a regulatory electric fence exists between general practice doctors on the one hand, and on the other, what they can prescribe to their patients. Cross that line and the GP has violated a federal rule, risking civil penalties and a loss of a license. While a carve out an exemption for specialists exists undoubtedly more top-down national controls reinforce the overall effect on the power, or lack thereof, of physicians generally.
Some in Australia question the ethical practice of the ACMS and its determination of what medical care is available to the Australian public. As mentioned previously since 2010, the Secretary Department of Health is empowered with sole decision-making authority based on ACMS inputs.
What happens next? What about thousands of people in Australia that may have what were perfectly legal off-label prescriptions for ivermectin? Have these doctors now violated the regulatory rule? What happens to the patient—are they just cut off? What if the regimen is working well? Will legal challenges ensue?
Based on this national command, it appears unlikely that the government will take a flexible, negotiation friendly stance with health care professionals. Thus, a trend that appears present around the developed world—centralizing tendencies with national health, in this case here in Australia—indicates an erosion of private choice to access medical treatment.
TrialSite, dedicated to transparent, accessible, and open research worldwide, exists to chronicle, analyze, and publish unbiased, objective news and information. Ultimately health is the most important personal security and without correct information, individuals cannot make the most informed decisions.
Thus with no attachment to ivermectin, TrialSite simply tracked the various studies around the world that indicated positive results. Intrigued, we interviewed many dozens of physicians and scientists, part of the quest to better understand the unfolding situation. The TrialSite fact sheet provides what we believe is one of the more unbiased perspectives at least up until this writing.
TrialSite has reported the government health agencies in America, coupled with medical societies now circle the ivermectin proponent wagon and similar formal edicts may be coming soon.