TrialSite chronicled the efforts of Dr. Jackie Stone in Zimbabwe during the worst stages of the pandemic. Born in Zimbabwe, Dr. Stone has been fascinated by research since a young age, and her commitment to caring for people during the pandemic has been legendary. While her off-label ivermectin-based combination regimen was identified with the saving of many lives in this southern African country, the medical establishment isn’t too keen on thinking outside of the box, even during the worst pandemic in a century. Dr. Stone now faces a court trial with criminal charges for merely treating COVID-19 patients with an early outpatient treatment protocol based on a combination of off-label treatments that includes ivermectin. This, even though Dr. Stone treated many in the Zimbabwe government and military successfully. In fact, for a while, the Medicines Control Authority of Zimbabwe (MCAZ) authorized access on an emergency basis for research—which amounted to care in this low-and middle-income country. The regulatory agency did a turnaround with ivermectin due to the results in the clinic of Dr. Jackie Stone.
Articles about Dr. Stone and Zimbabwe can be found at TrialSite. A fighter to the end originally of English and Norwegian descent, curious, and tough, yet elegant and empathetic, she grew up in the bush in this part of Africa, as her father was involved with geology and mining. Dr. Stone’s ethos, integrity, and commitment to doing good should have led her to awards from groups such as the World Health Organization.
Together Trial Mainstream Media Interpretations Could Put Low-Cost Regimen at Risk in MICs
Stone recently got together remotely with TrialSite’s founder Daniel O’Connor to discuss her concern with the Together Trial. While mainstream media have pounced on the findings, at least a dozen physicians and scientists are findings various issues with the data.
Ed Mills, the principal investigator, did the right thing investing his time as well as raising money to study repurposed drugs. While the Together trial’s primary endpoint failed to show efficacy for ivermectin, even Mills went on the record in a private email declaring ivermectin proponents should be upbeat about some of the data generated in the study. But Mills’ data was taken by mainstream media and used as a weapon to attack the use of the drug worldwide. This isn’t Dr. Mills’ fault–again he took the time to investigate the drug as well as other important repurposed drugs.
But Stone’s concern centers on the needs of low and middle-income countries (LMICs) for low-cost, available regimens for early care. Stone told TrialSite, “in poor and up-and-coming countries we don’t always have the luxury of waiting around for gold standard evidence. Rather, in the case of the pandemic, we need to move fast, and we did, leading to the saving of many thousands of lives.”
She continued, “My concern now is that papers such as the New York Times or Wall Street Journal pounce on data, often misinterpreting quotes from the PI can lead to a cutting off of life-saving approaches in LMICs such as my country.”
“Dr. Stone’s commitment to LMICs cannot be denied based on a clear track record of success. With COVID-19 came politics around the use of off-label drugs such as ivermectin, and unfortunately, Dr. Stone is caught in the middle of a political battle, but she is one of the most resilient individuals I have ever come across,” reports TrialSite’s O’Connor.
What about Together?
Dozens of scientists and doctors now pour through data of the Together Trial. Recently, Dr. David Wiseman, affiliated with TrialSite, shared a dozen bullet points of concern associated with Together, including inputs from Dr. Flavio Cadegiani and others that TrialSite poses as questions.
Together Trial Questions: Ivermectin
#Question/Concern Issues for Discussion with Together Trial1.Did the ivermectin arm of Together run later than the placebo arm, a time when a more virulent strain was present in that part of Brazil?2.Why wouldn’t the protocol call for screening for ivermectin use—after all the drug was used in many parts of Brazil. Were those participating already using the drug? It would be hard to prove now.3.The critics fret about the lack of reported boosts in gastrointestinal side effects in the ivermectin arm leading to what they believe is a fundamental problem with the study—either A) placebo group was on ivermectin or B) those taking ivermectin were not administered real study drug4.Were these placebo pills produced to look identical to the study drug? As the drug is commonly used, this would have unblinded the study.5.Together used ivermectin alone yet the early care community uses the drug in combination with other economical safe drugs such as antibiotics, steroids, as well as nutraceuticals such as vitamin D, C, and zinc. The study of ivermectin alone doesn’t mean much to frontline doctors.6.Together started up to 8 days post symptom onset, but frontline ivermectin proponents declare the drug should be given immediately upon symptomatic infection. The P.1 variant also saw a faster progression to severe illness only compounding the problem.7.In the Together study, they used a dose of (0.4 mg per kilo per day) which many critics called inadequate for ill patents–was the study underdosed?8.Given ivermectin proponents suggest using the drug till symptoms are resolved, why did the Together protocol only call for use for 3 days?9.Why did the protocol call for administration of the drug on an empty stomach when proponents declare the drug works best when associated with consumption of fatty food?10.Why is so much basic data missing from the study results such as Recruitment Period, Recruitment Locations, Recruitment and allocation order per sit, Description of how the molecules and placebo were produced or compounded to look identical (otherwise loss of blinding); why is there missing age data for 98 patients? Other gaps in data or anomalies are present for those interested11.Some basic math shows that the numbers listed in the trial paper for the different arms and outcomes in the trial do not add up to the totals and percentages that they give – either a gross mathematical error or fraud. To see many of the strange mathematical discrepancies which invalidate the trial conclusions, go to investigative journalist Phil Harper’s article: Moreover Wiseman declares And the alteration of the death count in the trial data raises serious questions:
Seeking more information about Dr. Stone?
For all of those interested in Dr. Stone’s story check out the many articles published in TrialSite along with this important letter authored by Dr. Eleftherios Gkioulekas, Professor of Mathematics Undergraduate Program Coordinator at The University of Texas — Rio Grande Valley School of Mathematical and Statistical Sciences in Edinburg, Texas.