Emergency Use Authorization and Ivermectin
When the subject of ivermectin for treating COVID comes up, the naysayers come out of the woodwork insisting that research does not support the use of ivermectin for treatment of COVID. Anything to the contrary is billed as misinformation. What I haven't seen in all the controversy surrounding the use of ivermectin is a reference to the Emergency Use Authorization (EUA) law, a law which would have prevented the distribution of vaccines without safety signal data. The absence of alternative treatments is critical to establishing EUA. It was imperative for the pharmacy companies to insist that ivermectin was not an alternative treatment for COVID for them to bypass the EUA law and move forward with producing and selling their vaccines without the usual research protocols.
There is plenty of evidence that ivermectin is effective against COVID, but this fact needed to be suppressed so Big Pharma could distribute their vaccines without first looking for enough safety signals. The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. An illness or another medicine taken by the patient could also be the cause. The assessment of safety signals with a control arm establishes whether or not there is a causal relationship between the medicine and the reported adverse events. The evaluation of safety signals is part of routine pharmacological vigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine's benefits and risks.
Please note that having a control arm is not part of looking for safety signals. The important word is assessment. A control arm would be necessary to determine a causal relationship between the adverse event, the medication, and a vaccination. It’s not as though we have no history of using safety signals to improve medication and vaccine outcomes.
The polio vaccine was revised in the late 50s and early 60s because of safety signals, which were eventually proven to be cause-and-effect.
The smallpox vaccination was eventually discontinued because the safety signals were validated, indicating that more people died from the vaccination then from the smallpox disease itself. There are people who say that the smallpox vaccine eradicated smallpox and that might be true, but when it was discovered that people died because of the smallpox vaccine, the smallpox vaccine was discontinued.
The original Diphtheria, Pertussis and Tetanus (DPT) vaccine was re-designed because of safety signals, indicating that many children became seriously ill. The more serious injuries included encephalitis and permanent neurologic injury. The DPT lawsuits were the cause of the 1986 law signed by President Reagan, limiting liability or granting complete immunity from prosecution to vaccine manufacturers. The DPT vaccine was reformulated to DTaP for children and Tdap as a booster for older people. The size of the bacteria load for diptheria and tetenus was decreased, and the pertussis component was made attenuated or weakened. With these changes, the new DTaP has proven to be as effective and much safer. So it is possible to learn from mistakes and to make a better and safer vaccine.
The main reason that as a physician I am skeptical of the COVID vaccine when it bypassed the EUA restrictions can be traced back to my memory of the swine flu vax under President Carter. This was a similar situation. Drug companies were hurrying to manufacturer vaccine and didn’t completely understand its risks or its benefits. But because safety signals weren't used, we discovered that a lot of people were having trouble with Guillain-Barré, as we have discovered with the new COVID vax.
Problems with the COVID vax are many. Because it is called a vaccine, many people do not realize it is not a vaccine like the ones we are familiar with such as tetanus vaccinations. This is the first "vaccine" to contain messenger RNA. This makes this shot's gene therapy unlike any previous vaccinations. Problems include:
1. DNA contamination is over the acceptable limit and varies from batch to batch.
2. mRNA has a short life. To overcome this problem, the mRNA needed to be wrapped in a lipid nanoparticle. While the nanoparticle protects the RNA, it is very soluble and therefore doesn't stay put in the arm as previous vaccines did. Instead, once the mRNA is delivered into your body, it can travel anywhere. It seems to have an affinity for ovaries, testicles, and heart muscle.
3. The COVID vaccine does not have what is known as a stop codon. Stop codons are extremely necessary to define the limits and character of a gene sequence. Without stop codons, we don't know how long a gene sequence will continue to change, so we don't know how long these sequences will become or what the sequence will mean for health and life.
I was invited to testify before the North Dakota House of Representatives healthcare committee in support of North Dakota House Bill HB1519 to collect safety signals for vaccine incidents and adverse reactions. In my testimony I spoke about how Big Pharma, by insisting that ivermectin was ineffective against COVID, could bypass the EUA laws and produce and sell their vaccines without any attention paid to safety signals.
Ivermectin is indeed effective in the treatment of COVID, but in order to avoid having to first test their vaccines for safety signals, Big Pharma had to deny there was an existing treatment for COVID and hence bypass the EUA laws.
First, a bit of history about ivermectin. Ivermectin has been around a long time and is very inexpensive. Ivermectin has been available for animals since the early 80s and for use in humans since the late 80s. Note, ivermectin is used in the treatment of human disease. It has a long history of established safety and efficacy. In addition to its use in parasitic infections, it has a widely documented history of activity against RNA and DNA viruses such as dengue, Zika, yellow fever, and others. It has also been well known to reduce the viral load of COVID infections and has been studied as chemo agents for use against cancer.
There is and has been enough evidence to support the safe and effective use of Ivermectin. But there has been much pushback to try to pretend that there was no existing treatment for COVID and that ivermectin was horse medicine. The Food and Drug Administration (FDA) actually tweeted in August of 2021:
“You are not a horse. You are not a cow. Serious y’all. Stop it."
Critical to establishing EUA (Emergency Use Authorization) without first performing signal testing is the absence of alternatives. Ivermectin is an alternative medication available to treat COVID, so use of it with COVID had to be labelled misinformation.
“For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition."
The evaluation of safety signals is part of routine pharmacological vigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine's benefits and risks.
Having a control arm is not part of looking for safety signals. The important word is assessment, which is a process by which the control arm would be necessary to determine a causal relationship between the adverse event, and the medication and a vaccination as in this case.
It’s not as though we have no history of using safety signals to improve medication and vaccine outcomes.
Many are now aware that physicians or scientists who raised concerns about the vaccines were targeted with all kinds of inaccurate allegations. Dr Pierre Kory, Dr. Scott Jenson, and many others were denigrated,. Many lost their medical licenses or were punished in other ways just for thinking.
The Center for Research on Multinational Corporations in the Netherlands has produced an extensive report on the 90 billion dollars in profits Big Pharma made from vaccines in 2021 and 2022, profits generated at the expense of tax payers.
'Without mandatory rules here, little will change. Corporate giants will continue to receive unconditional public funding and negotiate perverse deals. Public funding has to serve the public interest, which means affordable and safe medicines that are accessible to all, not super-profits for Big Pharma.”
Esther de Haan, Senior Researcher at SOMO
When I testified before the North Dakota House committee on HB1519, supporting the bill's establishing safety signals for North Dakota, those testifying against the bill kept repeating "correlation does not equal causation" and "we don't want to encourage vaccination hesitancy." That in no way means we shouldn't look for safety signals which do not require a control arm. We usually have looked for safety signals in the past. Looking for safety signals has served us well in finding and repairing problems with previous vaccinations. That's the bottom line.