OPINION
New Zealand Doctors Speaking Out with Science
Once again, a corrupt public body meant to serve the people, rather than industry and its own pockets, has had to back down. While it has not admitted fault, the US Food and Drug Administration (FDA) has reached a settlement with three frontline doctors whose foremost interest is successful patient outcomes.
The three doctors who brought a case against the FDA for interfering in the doctor-patient relationship, and for overstepping its authority are celebrating a victory. Dr. Mary Talley Bowden, one of the doctors, said in a statement. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”
The doctors at NZDSOS have also been pointing out ‘the government in the consultation room’ and advocating for doctors to be able to be doctors and have informed discussions with their patients, so they can make their own personal decisions.
In 2021, the FDA discouraged use of ivermectin to the extent of engaging in a propaganda campaign, most famously this tweet on 21 August 2021, linked to this consumer update expressing concern about “a growing interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans.“
As well as their social media campaign, the FDA sent a letter to the Federation of State Medical Boards and the American Board of Pharmacy in December 2021 to claim that use of ivermectin in prevention or treatment of Covid “may pose risks to patient health or lead to delays in getting effective treatment of COVID-19.“.
This apparent attempt to regulate its use directly contradicts the legal right of physicians to use any FDA-approved (Medsafe-approved in NZ) drug for “off-label prescribing”, meaning to treat conditions which the drug was not officially approved for. Because many drugs have multiple mechanisms of action, off-label prescribing is used in around one third of all treatment prescriptions.
It seems the reason for the suppression of the use of ivermectin was to pave the way for the vaccines. An Emergency Use Authorisation (EUA) for the injections was not possible in the US if an effective treatment was available.
In New Zealand, the Royal New Zealand College of General Practitioners, issued a similar warning to its members on 3 Sept 2021.
“Off-label use of Ivermectin for treatment of COVID-19 is strongly not recommended.”
Medsafe issued an Alert on 6 Sept 2021 which included the comment:
“Ivermectin is NOT APPROVED to prevent or treat COVID-19, which means that Medsafe has not assessed the safety and efficacy for this use. Inappropriate use of ivermectin can be dangerous.”
The Pharmacy Council NZ issued a notice in Oct 2021 with advice to pharmacists referencing the Medsafe statement and the RNZCGP. This encouraged pharmacists to report (dob in) doctors who were prescribing this safe medication.
“Current evidence does not support the efficacy of ivermectin for the prevention or treatment of COVID-19. Ivermectin, particularly when used at high doses, has the potential to cause adverse effects including: severe nausea, vomiting, and neurological effects such as dizziness, seizures and coma.”
“If a pharmacist has concerns regarding the competence or conduct of a prescriber, they may make a notification to the registrar of the relevant responsible authority.”
Represented by legal counsel with a history of litigating against federal and regulatory agencies for wrongdoing, the three frontline physicians – Dr Robert Apter, Dr Mary Talley Bowden and Dr Paul Marik filed a lawsuit against the FDA. The legal argument revolved around the FDA practising medicine by recommending against ivermectin for COVID-19 when they had not collected evidence to determine whether ivermectin was safe and effective for this purpose.
The doctors also alleged that the FDA was exceeding its authority by attempting to set medical standards which impacted the rights of clinicians to prescribe off-label. The role of the FDA is to assess safety and efficacy of medicines and approve them if appropriate. It is not the FDA’s role to regulate their use once approved. Read the amicus curiae here, and a summary by Dr Pierre Kory, here.
When the lawsuit was initially filed, the FDA successfully moved to have the case dismissed by arguing that it cannot be sued because it has “sovereign immunity.”??? Legal counsel for the doctors immediately appealed using the argument of ultra vires, which describes an official acting outside their authority. The Appeals Court judge ruled that the case could proceed and the FDA finally settled out of court with the plaintiffs (doctors). The FDA now must remove all posted or published advice recommending against the use of ivermectin for Covid-19.
Dr Kory is of the opinion that the FDA closed on settlement rather than pursuing the legal case, because the entire PR campaign against ivermectin was devised and executed by a PR firm working for Pfizer, Moderna and the CDC, and that legal discovery would have caused reputational damage to individuals involved.
Dr Marik said at the FLCCC press briefing after settlement, that “We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”
An interesting perspective on the story is that weaponised narratives such as the propaganda against ivermectin, leading to public harm whilst benefiting those in positions of power, establish “narrative scaffolds”. Once false information has solidified a narrative scaffold into place, the truth may be revealed but public opinion is already formed around the scaffold and may never be revised.
Meanwhile NZDSOS and, we trust, our supporters, will continue to work at showing New Zealanders that the ivermectin story is a part of the bigger picture of public-private partnerships between captured regulators such as Medsafe, and the pharmaceutical industry who fund a staggering proportion of the budget of regulators.
Watch: Ashley Bloomfield and Dr. Ian Town: Ivermectin Bad, Remdesivir Good
Dr Scott Jensen from Minnesota, USA responded to the FDA settlement ruling in this video. Thanks to Coronavirus Plushie for the below excellent montage illustrating the establishment of a weaponised narrative scaffold. We look forward to the day that fraudulent narrators, including Dr Ian Town, Dr Ashley Bloomfield and Sarah Fitt, are held accountable for the harm their actions have caused to New Zealanders.