Trying to understand what I learned in my conversation with the ACTIV-6 patient, I looked at who is actually responsible for the ACTIV trials. It turns out that ACTIV is a “Public-Private” partnership, with several pharmaceutical companies having representatives on its executive committee:
It's profoundly disheartening to see your work, and imagine what the governments/med establishment could've done with their limitless pool of financial resources and talent, had they just had the teensiest bit of will to do so.
I mean that in the most complementary way possible :))
I note that both FDA representatives on the board of the so-called ACTIV public-private partnership (Janet Woodcock; Peter Marks) have taken actions suggestive of being more concerned with the interests of the pharmaceutical industry than the public interest. Woodcock in particular exhibits this behavior on multiple occasions. Example - she took actions to suppress availability of hcq. https://twitter.com/april_harding/status/1500234042028998660
(The link takes you to an excerpt from the book by Peter Navarro).
And, we know from the emails obtained by Judicial Watch, that (Interim FDA Commissioner) Woodcock was exerting pressure (via Marks) on Maryanne Gruber and her team to approve the vaccine boosters. https://twitter.com/april_harding/status/1585059645546442752
And, by the way, the fact that they had reps from research-based pharma companies on a steering board for their so-called public private partnership is nuts. These companies are all interested in the trial results. No one concerned with the public interest would involve them in steering the trial design, management and implementation. The fact that NIH got away with doing something so misconceived - suggests the organization's oversight is profoundly broken.
Nov 2, 2022·edited Nov 2, 2022Liked by Alexandros Marinos
I guess you're aware D. Boulware was already involved in a trial which concluded HCQ did not work as a post-exposure prophylactic treatment; and re-analysing the raw data led several searchers to claim the results of the trial actually proved HCQ was effective.
I feel so much better knowing that BARDA was involved. "Together with our industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats." I guess Ivermectin is one countermeasure BARDA did not want, but they are proud of their 64 FDA Approvals:
Lt. General N. B. Forrest, considered the only tactical genius to emerge from the Civil War, when asked to explain his success replied, "I got there first with the most men." His formal military training was nil, which he expressed as, "I never rubbed my back up against a college."
Corporal Boulware has made a career of "trials" that go against Forrest's principle and all medical common sense. Even his choice of Fedex to deliver the drug/placebo is suspect. My experience is that Fedex is much less reliable than UPS regarding on-time deliveries.
That Boulware's email to Kory did not disclose that he was seeking consultation regarding a proposed trial is more than disingenuous; it seems like a set-up to smear FLCCC. Unfortunately, the open-hearted Dr. Kory replied somewhat less circumspectly than would have been optimal. Nevertheless, it is likely that FLCCC could win a libel suit against Boulware, especially given the pattern of phony trials that you have uncovered.
It seems without fail the big RCTs continually apply Ivermectin on an empty stomach (a recommendation based out of the parasite/worms treatment usage). You'd think that anyone with a brain would realize that 2.5x bioavailability would be a significant difference to consider... Great work again.
Also: many of the flaws you perfectly describe only suggest that the *intentions* of the trial team were not to do the best they could.
But I think these flaws hardly affect the *results* of the trial, which can be explained by one single limitation: the patients involved in the trial were at very low risk of getting severe Covid (mostly because they were young.)
The fact the placebo group had zero death (and about 1% of all cause hospitalizations — or maybe even 0.3%, according to which figures in the study we rely on, those in eFigure1A or those in Table 2) made it impossible for any treatment to do better.
Even a miraculously efficient treatment against the risks of getting severe Covid or dying — even if it had been correctly administered, with correct dosing and timing — would have failed in front of a placebo group that hardly had any trouble with Covid!
Then, when the team acknowledged they couldn't work with so few events to analyze, and decided to change their "primary outcome", they again made a strange choice. The replacement primary outcome they selected was "time to recovery". Which roughly led to study whether the low-dose late-ish given IVM could reduce the time it takes for low-risk patients to stop coughing... Is that really what the world needed to know about IVM?
(Btw, the very same limitation eventually gave the opportunity to the team to study the same outcome — reduction in the timing of disappearance of the last symptom — for all the repurposed drugs in the ACTIV-6 trial : fluticasone and fluvoxamine gave the same kind of results.)
Table 1 of the main paper lists the IQR (middle half) of "Days between symptom onset and receipt of drug" as 5-8 for the 817 ivermectin patients. But the caption of eFigure 3 in the supplement says:
> The ‘mITT population’ reflects a modified intent-to-treat analysis of participants randomized who received study medicine within 7 days.
This seems like a contradiction because the mITT ivermectin population is also 817. Were patients who received the drug after more than 7 days excluded or not?
Thanks once again for your important contributions to public health. Maybe we have to highlight , like you did the doctors who are treating covid, long covid, the vaccine injured and their protocols. Medicine , is not about one medication, often combinations , also supporting in a holistic way the immune system. Doctors with a high success rate interest me more than RCTs. This type of evidence unfortunately is being pushed aside, together with patient - doctor relationshp and collaboration , especially when it comes to off-label use of medication, these FDA authorized meds being now banned in many countries.
Sending your truth bombs to my psychosis-riddled family & "friends" and hoping for that Jenga moment when the MSM propaganda & vax lies come tumbling down!
It's profoundly disheartening to see your work, and imagine what the governments/med establishment could've done with their limitless pool of financial resources and talent, had they just had the teensiest bit of will to do so.
I mean that in the most complementary way possible :))
I note that both FDA representatives on the board of the so-called ACTIV public-private partnership (Janet Woodcock; Peter Marks) have taken actions suggestive of being more concerned with the interests of the pharmaceutical industry than the public interest. Woodcock in particular exhibits this behavior on multiple occasions. Example - she took actions to suppress availability of hcq. https://twitter.com/april_harding/status/1500234042028998660
(The link takes you to an excerpt from the book by Peter Navarro).
And, we know from the emails obtained by Judicial Watch, that (Interim FDA Commissioner) Woodcock was exerting pressure (via Marks) on Maryanne Gruber and her team to approve the vaccine boosters. https://twitter.com/april_harding/status/1585059645546442752
You've done it again.
Thank you for the work you do.
And, by the way, the fact that they had reps from research-based pharma companies on a steering board for their so-called public private partnership is nuts. These companies are all interested in the trial results. No one concerned with the public interest would involve them in steering the trial design, management and implementation. The fact that NIH got away with doing something so misconceived - suggests the organization's oversight is profoundly broken.
I guess you're aware D. Boulware was already involved in a trial which concluded HCQ did not work as a post-exposure prophylactic treatment; and re-analysing the raw data led several searchers to claim the results of the trial actually proved HCQ was effective.
All the links are here: https://c19hcq.org/boulwarepep.html
I feel so much better knowing that BARDA was involved. "Together with our industry partners, BARDA promotes the advanced development of medical countermeasures to protect Americans and respond to 21st century health security threats." I guess Ivermectin is one countermeasure BARDA did not want, but they are proud of their 64 FDA Approvals:
https://www.medicalcountermeasures.gov/barda/
=====
Excellent analysis of the study's shortcomings!
Lt. General N. B. Forrest, considered the only tactical genius to emerge from the Civil War, when asked to explain his success replied, "I got there first with the most men." His formal military training was nil, which he expressed as, "I never rubbed my back up against a college."
Corporal Boulware has made a career of "trials" that go against Forrest's principle and all medical common sense. Even his choice of Fedex to deliver the drug/placebo is suspect. My experience is that Fedex is much less reliable than UPS regarding on-time deliveries.
That Boulware's email to Kory did not disclose that he was seeking consultation regarding a proposed trial is more than disingenuous; it seems like a set-up to smear FLCCC. Unfortunately, the open-hearted Dr. Kory replied somewhat less circumspectly than would have been optimal. Nevertheless, it is likely that FLCCC could win a libel suit against Boulware, especially given the pattern of phony trials that you have uncovered.
Thank you for your supremely impressive work.
Thank you again for your amazing work. Incredible detail. I hope you’re paid a lot in your regular job, when your not being a journalist. 😁
It seems without fail the big RCTs continually apply Ivermectin on an empty stomach (a recommendation based out of the parasite/worms treatment usage). You'd think that anyone with a brain would realize that 2.5x bioavailability would be a significant difference to consider... Great work again.
Also: many of the flaws you perfectly describe only suggest that the *intentions* of the trial team were not to do the best they could.
But I think these flaws hardly affect the *results* of the trial, which can be explained by one single limitation: the patients involved in the trial were at very low risk of getting severe Covid (mostly because they were young.)
The fact the placebo group had zero death (and about 1% of all cause hospitalizations — or maybe even 0.3%, according to which figures in the study we rely on, those in eFigure1A or those in Table 2) made it impossible for any treatment to do better.
Even a miraculously efficient treatment against the risks of getting severe Covid or dying — even if it had been correctly administered, with correct dosing and timing — would have failed in front of a placebo group that hardly had any trouble with Covid!
Then, when the team acknowledged they couldn't work with so few events to analyze, and decided to change their "primary outcome", they again made a strange choice. The replacement primary outcome they selected was "time to recovery". Which roughly led to study whether the low-dose late-ish given IVM could reduce the time it takes for low-risk patients to stop coughing... Is that really what the world needed to know about IVM?
(Btw, the very same limitation eventually gave the opportunity to the team to study the same outcome — reduction in the timing of disappearance of the last symptom — for all the repurposed drugs in the ACTIV-6 trial : fluticasone and fluvoxamine gave the same kind of results.)
Table 1 of the main paper lists the IQR (middle half) of "Days between symptom onset and receipt of drug" as 5-8 for the 817 ivermectin patients. But the caption of eFigure 3 in the supplement says:
> The ‘mITT population’ reflects a modified intent-to-treat analysis of participants randomized who received study medicine within 7 days.
This seems like a contradiction because the mITT ivermectin population is also 817. Were patients who received the drug after more than 7 days excluded or not?
Thanks once again for your important contributions to public health. Maybe we have to highlight , like you did the doctors who are treating covid, long covid, the vaccine injured and their protocols. Medicine , is not about one medication, often combinations , also supporting in a holistic way the immune system. Doctors with a high success rate interest me more than RCTs. This type of evidence unfortunately is being pushed aside, together with patient - doctor relationshp and collaboration , especially when it comes to off-label use of medication, these FDA authorized meds being now banned in many countries.
Sending your truth bombs to my psychosis-riddled family & "friends" and hoping for that Jenga moment when the MSM propaganda & vax lies come tumbling down!