US judge slams pharma regulator for rubbishing drug ivermectin

The US FDA has been rebuked by a top US court for telling Americans in 2021 that they were not ‘cows or horses’, so they should not take ivermectin.

Ivermectin is a generic anti-parasitic medication. Picture: The Pulse

The world’s most powerful drug regulator has been humiliated after a US federal court ruled it was out of bounds in telling Americans they were not a “horse” so should not take the drug ivermectin – an anti-parasitic medication whose inventors won the Nobel Prize for medicine in 2015 – to treat Covid-19.

The US federal appeals court in Louisiana on Friday (Saturday AEST) ruled the Food and Drug Administration erred in a tweet that went viral in August 2021, saying “You are not a horse. You are not a cow. Seriously, y’all. Stop it”, in response to reports, later debunked, that Americans were overdosing by taking the drug as an alternative to Covid vaccines.

“FDA is not a physician. It has authority to inform, announce, and apprise – but not to endorse, denounce, or advise,” judge Don Willett wrote for the appeals court. “The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to,” the judge concluded, referring to three doctors who had sued the FDA for, in effect, stymieing their ability to prescribe ivermectin to their patients.

Mary Bowden, one of the plaintiffs, claimed her ability to prescribe ivermectin for patients had been undermined by the FDA’s social media posts, which caused some pharmacies to withhold the drug, in addition to reputational damage caused.

“I’ve treated over 6000 Covid patients now and found ivermectin not only effective but also extremely safe,” she told The Australian in an interview.

Throughout the pandemic an aggressive war emerged between some doctors and pharmaceutical regulators over the utility of two off-patent drugs, ivermectin and hydroxychloroquine, which some observational studies had shown to be effective if prescribed early in the onset of Covid-19 symptoms.

In January the US federal court blocked California from enforcing a new state law that would have punished doctors for giving advice contrary to the government public health and pharmaceutical regulators.

“There are a number of significant public health risks associated with taking ivermectin in an attempt to prevent Covid-19 infection rather than getting vaccinated,” Australia’s Therapeutic Goods Administration said in September 2021, as it banned Australian doctors from prescribing the drug.

Dr Bowden suspected institutional resistance to ivermectin for Covid-19, in the US and other developed nations including Australia, stemmed from a desire to encourage take-up of next-generation vaccine technology.

“If they had a safe, effective treatment, that would be an obstacle to getting the vaccine out, which really is too big to fail, just too much money and ego involved,” she said.

It has been reported that US law prevented the granting of Emergency Use Authorisation for then new Covid-19 vaccines, which have generated more than $US110bn in revenue for the three US pharmaceutical giants if existing prophylactic treatments were already available.

Robert Clancy, a retired University of Newcastle professor of immunology, told The Australian it was “nonsense to say ivermectin didn’t work”. “It was panned because it would have stopped the FDA and TGA from legally allowing the Covid-19 vaccines,” he posited.

In 2021, America’s top podcaster, Joe Rogan, and CNN butted heads over the drug after the latter accused Rogan, who said he had taken the drug via a prescription from his doctor, had consumed “horse dewormer”.

The TGA in May reversed its 2021 ban on prescribing ivermectin for Covid-19, claiming “sufficient evidence the safety risks to individuals and public health” was “low”.

However, the TGA does not endorse off-label prescribing of ivermectin for the treatment or prevention of COVID-19.

Asked if drugs such as ivermectin were more effective than the Covid-19 vaccines, Dr Bowden said “hands down, the medications”. “That’s what prompted my scepticism to begin with: I was seeing a lot of patients coming in who had been vaccinated, and they were just as sick if not sicker than the patients that were not vaccinated.”