Colchicine had been a Godsend drug to millions of gout sufferers worldwide - until the FDA stepped in and restricted its use. Colchicine, derived from the flowering autumn crocus plant, has been used since 1500 BC to treat joint swelling with exceptional pain-relieving properties. Unfortunately, like many effective compounds, this medication was captured by regulators, and the public paid the price.
Before 2007, colchicine was widely, safely, and appropriately prescribed to some two million US patients each year at the cost of just 9 cents per pill. However, the FDA gained jurisdiction over all prescribed drugs in 1962 - ostensibly with the sole purpose of protecting the public. Some medications that were in widespread use before 1962, like colchicine, escaped this FDA approval. Therefore, in 2007, the FDA sought to remedy this problem by forcing a study to prove that colchicine truly worked and was safe to use. Never mind the real-world evidence accumulated by the practicing experts, the in-the-trenches physicians.
So, Takeda Pharmaceuticals undertook this task, and tested the known drug colchicine in 184 patients, and guess what the study revealed? It answered the question that had already been answered. As expected, colchicine proved effective in gout, and it was effective in Familial Mediterranean Fever. In 2009, the FDA officially placed its rubber stamp of approval on the oral colchicine product, now known by the shiny new name of Colcrys. Unfortunately, with the title came a price, and the cost of Colcrys was 5 dollars per pill - which was a 50 fold markup over the generic version.
Suddenly most patients could no longer afford their colchicine. Many were forced to take less expensive, less effective, and more dangerous drugs instead. Dr. E. William Sinclair, president of the American College of Rheumatology (ACR), brought legal action against the FDA requesting that an affordable generic version be made available. After a legal battle, the court sided with the ACR. However, today the price of colchicine remains measured in terms of dollars, not cents.
Other physician groups spoke in outrage. Dr. Aaron Kesselheim of Harvard Medical School was particularly vocal,
"The way this case was handled has led to a potentially useful drug, colchicine, being prescribed to fewer patients, while there have been substantial cost increases for those who do use it and no evidence of a reduction in unsafe co-prescriptions."
Closely related to this are the now proposed "forced studies" by opponents of Ivermectin. WHO scientist and evidence-synthesis researcher Dr. Tess Lawrie's peer-reviewed work is ranked in the top 5% of such scientists worldwide. She recently published the most comprehensive and authoritative meta-analysis on Ivermectin, analyzing some 24 randomized controlled trials involving 3406 patients. She concluded,
"The findings indicate with moderate certainty that Ivermectin treatment in COVID-19 provides a significant survival benefit.”
Dr. Lawrie commented about its overwhelming evidence of safety,
"Ivermectin is not a new and experimental drug with an unknown safety profile. It is a WHO “Essential Medicine” already used in several different indications, in colossal cumulative volumes."
Safety concerns were disingenuously claimed by the WHO, the FDA, and even Merck. The WHO backed by the Gates Foundation, and Merck, who recently received 1.2 billion dollars for their new drug Molnupiravir (a competitor to Ivermectin), all expressed "safety concerns" with Ivermectin, and all three suffered massive financial conflicts of interest. Merck in particular, could not have been more aware of the contrary evidence from its own Mectizan Donation Program proving the drug to be exceedingly safe in billions of Mectizan doses since 1987.
Dr. John Campbell called them out, "It is almost…as if they are saying that a drug known to be safe in one disease is somehow dangerous for another." See the 16:50 mark.
Dr. Campbell went on to explain that the basic science of pharmacokinetics disproves this statement. He reiterated that if a drug has been deemed safe, as Ivermectin has, it cannot become unsafe.”
Notwithstanding this, Dr. Lawrie stated the obvious in proposing its immediate use in the pandemic,
"Given the evidence of efficacy, safety, low cost, and current death rates, Ivermectin is likely to have an impact on health and economic outcomes of the pandemic across many countries. Ivermectin is likely to be an equitable, acceptable, and feasible global intervention against COVID-19. Health professionals should strongly consider its use, in both treatment and prophylaxis."
Dr. Lawrie addressed the recent call for another study by Oxford,
"By calling for more trials on Ivermectin in the current health emergency, our scientific advisers appear to have suspended their common sense. Let’s not suspend ours. Ivermectin is the key to restoring health and economies. We have nothing to lose by using safe old Ivermectin to save lives in this dire situation. The worst thing that can happen is that the global population is de-wormed. The best is that the health of people and nations is restored. Better safe than sorry."
Dr. Tess Lawrie has decades of experience in performing the technique of meta-analysis. The meta-analysis represents a pooling of multiple randomized controlled trials and deriving an overall signal. The meta-analysis ranks as the top form of medical evidence, and it even outranks the revered randomized controlled trial (RCT) that we have heard so much about. If the randomized controlled trial is the captain, then the meta-analysis is the admiral.
Then why exactly is Oxford University touting their upcoming RCT when the world already has heard the answer from the meta-analysis performed by the best of the best, Dr. Tess Lawrie?
Perhaps it is because Oxford, who famously backs the Astra Zeneca vaccine, has a financial conflict of interest.
If Ivermectin were approved, the Emergency Use Authorization for the experimental Astra Zeneca Vaccine would likely be voided.
The Gates Foundation has taken a particular interest in "testing" Ivermectin. In addition to the Gates' support of the Oxford Ivermectin Study, they are funding the TOGETHER Trial at none-other than McMaster University, the same one that botched the WHO Ivermectin review, and advised against the use of Ivermectin - all by using academic sleight of hand - by eliminating the favorable studies, and over-weighting the one neutral study. And by calling a precise result imprecise.
Dr. Lawrie had this to say in her meta-analysis about the way the McMaster magicians made Ivermectin disappear, about the way they downgraded precision of a precise number by two levels without explanation,
"The recently updated WHO therapeutics guidelines included seven trials and 1419 people in the analysis of mortality. Reporting a risk reduction of 81% (odds ratio 0.19, 95% CI 0.09–0.36), the effect estimate favoring Ivermectin was downgraded by two levels for imprecision, although the justification for this is unclear as the reported CI is precise (64%–91%)."
The TIRC, the infamous Tobacco Industry Research Council, funded studies of tobacco that found results consistent with their interests. This resulted in more death and disease from cigarette smoking for five decades while the powerful tobacco lobby funded contrived studies.
We now see Oxford and McMaster trying hard to keep the EUA for vaccines alive amidst growing concerns of vaccine toxicity and variant escape. Will society stand by and allow Oxford and McMaster to subvert the overwhelming evidence already published in favor of Ivermectin?
Dr. Tess Lawrie was clear in her IICC speech when she wisely stated,
"Those who design the trials and control the data also control the outcome. So this system of industry-led trials needs to be put to an end. Data from ongoing and future trials of novel COVID treatments must be independently controlled and analyzed. Anything less than full transparency cannot be trusted." See the 2:57 mark.
Similarly, Yale's Dr. Harvey Risch, distinguished epidemiologist and Associate Editor of the Journal of the National Cancer Institute, has found alarming evidence of similar trials that were designed to fail in the case of Hydroxychloroquine (HCQ).
In a presentation delivered on June 24, 2021, Dr. Risch discussed how the conflicts of interest drove tainted data and designed-to-fail studies. He explained,
“Randomized controlled trials are totally easy to subvert – in full public view. All you have to do is design them for unrealistic magnitudes of benefit, stop them early, use subjective outcomes or change outcomes in the middle of a trial or don’t validate the participants or their outcomes, ignore the medication shipping delays, use easily recognizable placebos so people can tell the difference, give inadequate or toxic doses, draw conclusions from part of the results and ignore inconvenient results, generalize the conclusions much wider than as applying to the actual subject, etc.” See the 18:25 mark.
"Just to set the stage, I point out that both Boulware and Mitja had active pharma conflicts of interest at the time they published these studies, but neither author disclosed those conflicts in the materials with the published papers. The conflicts were discovered from the documents found on the internet." See the 24:10 mark.
What Dr. Boulware failed to disclose in his 2020 HCQ publications was his speaker research support from Gilead that he revealed in a 2019 conference, the ASTMH Annual Meeting on Tropical Medicine, given at National Harbor, Maryland.
Dr. Mitja also failed to disclose ties with Gilead. Gilead is significant as it manufactures Remdesivir, a direct competitor to HCQ.
Dr. Risch went on to review nine studies from across the world associated with a 4-fold [75%] reduction in mortality [RR of .25 (0.19 - 0.34)] with HCQ used in early outpatient treatment in COVID-19. Dr. Risch summarized that the HCQ studies involved some 40,000 patients, and the magnitude of early outpatient treatment mortality reduction appeared even greater than with Ivermectin. See the 43:05 mark.
These positive studies never made it to the mainstream media, unlike the subverted studies that demonized HCQ. The result of the deceptive studies was that the word of HCQ's effectiveness never got out, and hundreds of thousands of lives were lost.
Former Harvard Professor and NIH scientist Dr. George Fareed has treated outpatients with a cocktail including HCQ since the beginning of the pandemic and has received praise and appreciation from thousands whose lives he has saved. Most notably, Dr. Fareed and his dynamic young associate, Dr. Brian Tyson, would not be silenced, despite the adverse publicity on the drug. Their story, “The Miracle of the Imperial Valley,” has been published as a model for other physicians to follow:
They have refined their cocktail with the addition of Ivermectin and Fluvoxamine, and various nutraceuticals. Dr. Fareed and Dr. Tyson together have now saved the lives of some 6,000 COVID-19 patients. There has been only one recorded death in a patient who presented late and did not receive the entire treatment course. There were only five hospitalizations.
Let us acknowledge that Ivermectin reduces overall death by at least 62%, as Dr. Tess Lawrie has shown, and HCQ independently reduces it by 75%, as Dr. Risch has demonstrated. In that case, it is not surprising that the combination of the two drugs has reduced death by 99.98%, as the Fareed/Tyson series reveals.
Some might question these numbers, thinking that the Ivermectin data should produce greater efficacy because of the numerous impressive natural experiments in India, Mexico, and Zimbabwe, showing 90+ percent reductions in cases and deaths.
However, as Dr. Risch explains, we need to clarify precisely when these drugs are being used. We need to compare apples with apples. Dr. Risch confines his review to early outpatient treatment, while Dr. Lawrie looks at Ivermectin use across all phases, both inpatient and outpatient.
The reduction in death would be expected to be higher if the treatment review was confined to early in the outpatient phase rather than later in the hospital or the ICU. Ivermectin is proven to work well across all stages of the disease, including late in the cytokine storm, while HCQ works best early in the viral replication phase. In addition, many case reports have shown that a single dose of Ivermectin can liberate a patient from the ventilator, even in the latest, worst stages of the disease.
However, newer studies are in the pipeline showing that HCQ can be effective even in ventilated patients, including this preprint by Dr. Stephen Smith, where his data suggested a 2.9 fold greater likelihood of survival in ventilated patients receiving a combination of HCQ and Azithromycin.
In India, the use of Ivermectin has been awe-inspiring. Within weeks of ICMR and AIIMS instituting Ivermectin on April 20, 2021, Delhi and Uttar Pradesh cases were down 99%. Goa famously chose Ivermectin in all adults over 18, and their cases are down 95% [4195 to 215].
Goa’s deaths peaked at 75 and are now 5, down 93%. See the JHU CSSE database. However, just as publicly, the Indian State of Tamil Nadu rejected Ivermectin and vowed to use Remdesivir instead.
They paid the price with the highest number of daily COVID-19 cases in India and excess deaths that continue to this day.
As of June 26, 2021, there were 1258 deaths in India with a population of 1.36 billion. Tamil Nadu, with a population of 1/20 of India, saw 148 of these deaths, about 1/9 of India’s. This amounts to 80 excess deaths on June 26, 2021 [Predicted 1/20 of 1248 = 68. Actual = 148].
The question that emerges from Dr. Lawrie’s convincing meta-analysis and common sense when looking at Ivermectin’s massive benefit in those Indian States that used it is why any nation or state would want to repeat Tamil Nadu’s tragic error, and reject Ivermectin? Why would any area on earth wish to forego a treatment that works so well and is so safe?
Uttar Pradesh, a state with 200 million inhabitants, an area that uses Ivermectin, saw only 62 deaths. Uttar Pradesh, with 1/7 the population of India, did not experience 1/7 of the 1248 death toll, which would have been 178 lives [1/7 x 1248 = 178]. Instead, the Ivermectin saved at least 116 lives [Predicted deaths of 178 less actual deaths of 62 = 116 lives saved] just on June 26, 2021.
Ivermectin reduces death in COVID-19 by a substantial percentage and with virtually no risk and minimal cost. But, do we truly need more studies on Ivermectin while the Delta Variant rages on and vaccine resistance grows greater by the day? Do we need more studies on a drug that the world's very best evidence - the meta-analysis - has proven reduces death by 62 to 91% and is safer than most vitamins?
Why would we require a second-rate form of evidence, another RCT, when the gold-standard meta-analysis has already been published?
We are asked to suspend our common sense while more people die and while Oxford and McMaster, both funded by the Gates (Vaccine) Foundation, make us wait on the result of another contrived-to-fail and forced study.
Dr. Tess Lawrie has been aptly named “The Conscience of Medicine.” She has stood up against the WHO at great personal and professional cost to do what is right and moral and do what is in her patients' best interests. She has chosen to honor her Hippocratic Oath.
Like Dr. Roy Vagelos of Merck, Dr. Tess Lawrie considers herself a physician first and foremost. Both individuals placed the interests of patients above those of money.
Dr. Tess Lawrie closed her first annual International Ivermectin for COVID Conference with this passionate speech and these inspiring words to her fellow physicians,
“And never before has our role as doctors been more important, because never before have we become complicit in potentially causing so much harm. I ask all doctors here today to look into their hearts and remember their (Hippocratic) Oath so that we can move forward, united in the protection of those we serve, and with the greatest of courage.” See the 7:33 mark.