On April 3rd, 2022, the principal investigator of the TOGETHER trial, Edward Mills, was responding to some questions. Medical researchers weren’t happy with a growing list of issues in the trial’s published data. Those problems haven’t gone away, but that’s a story for another day. For now, I want to look closely at what Mills said when responding to the problems.
“I don’t understand the psychology of the ivermectin advocates. They fail to see the positive in this study and just focus on it not being overwhelmingly positive. I actually think it is quite positive.”
I will presume that Mills doesn’t understand why the ‘ivermectin advocates’ are angry about his study. Allow me to illuminate the issue: the conclusion of his paper said ”treatment with ivermectin did not result in a lower incidence of medical admission to a hospital”
In that same email exchange I quoted above, where Mills was privately talking with with annoyed researchers, Mills said the Ivermectin trial showed “a 17% reduction in hospitalizations that would be significant if more patients were added”.
So where it mattered - in the paper - Mills said Ivermectin didn’t reduce hospitalisations. That generated headlines all around the world. In private, Mills admitted “there was a 17% reduction in hospitalizations”
“Ivermectin did not result in a lower incidence of medical admission to a hospital”, Edward Mills in TOGETHER paper, March 30th 2022.
“There was a 17% reduction in hospitalizations that would be significant if more patients were added”, Edward Mills in private, April 3rd 2022
Lets just run with this a little further. Edward Mills shared preliminary findings from the paper before it was published. In the discussion, Frank Harrell, a Professor of Biostatistics, said “When you have a confidence interval that goes all the way down to a 30% reduction in relative risk, the question of whether the trial was stopped too early in light of the political ramifications of needing to demonstrate that the efficacy is really unimpressive, it really could be raised as a logical question…. ”
“Any reaction to that?” asked the host.
“I totally agree with Frank,” Mills said.
Moments prior to agreeing that ‘political ramifications’ may have influenced when the trial was stopped, Mills pondered what might have happened if they’d instead allowed more patients to be randomized to the trial. He hinted that statistical significant results for Ivermectin could have been found. Other arms of the TOGETHER trial over ran with 9% more patients added than planned - it was perfectly possible to add more to Ivermectin if the data was looking promising. The clip of the bizarre exchange is below, starting at 29 minutes.
Of course, the issue doesn’t end there. Not only did Mills hold a private view on the data totally at odds with the conclusion he oversaw, he even took part in a press campaign to editorialise the paper in definitively negative way.
Two weeks before the paper was published, a press line was released to the media via the Wall Street Journal. The headline, as you can see, is definitive and totally at odds with his private understanding of the data. As part of the press strategy, Mills offered up a quote, “There was no indication that ivermectin is clinically useful”.
“Ivermectin Didn’t Reduce Covid-19 Hospitalizations”, Headline in Wall Street Journal as part of a press campaign, March 18th 2022.
“There was no indication that ivermectin is clinically useful”, Edward Mills quote, as part of press campaign, March 18th 2022
“There was a 17% reduction in hospitalizations that would be significant if more patients were added”, Edward Mills in private, April 3rd 2022
Peter Hotez, dean of the National School of Tropical Medicine, was also part of the same press strategy. The study, he said, “should really help put to rest ivermectin and not give any credibility to the use of it for Covid-19”. His assessment was objectively wrong, but its exactly what you’d want inside a press campaign designed to discredit Ivermectin.
Mills was even paraphrased using the ‘people are clearing themselves of worms’ line which had already proved itself as a very effective ‘line’ in the popular press. “Ivermectin could improve outcomes in Covid-19 patients who are fighting off certain parasitic diseases at the same time,” Mills was paraphrased as saying, “but based on his team’s findings… the drug doesn’t seem to have any effect on Covid-19 itself.” A tired trope already rolled out in 2021 was resurrected once more to give Ivermectin another kick to the ribs. Mills was happy to oblige.
Need I go on?
Press Relations agencies like to ‘space out the messaging’ to keep their target message in the newscycle for longer periods of time. It creates more impact if the messaging is sustained. As such, in a separate press ‘engagement’, the New York Times were courted with quotes from David Boulaware - another author from the botched study.
The exclusive dropped on the same day the paper was published: March 30th. It had an almost identical headline to the WSJ article published weeks before, “Ivermectin Does Not Reduce Risk of Covid Hospitalisation”. Notice a pattern?
The messaging is no co-incidence. Typically, a PR agency has everything prepared for the journalist; the quotes, the interviews, the pictures, the data, and a hard ‘nudge’ on the editorial line. Journalists are engaged weeks prior to ‘launch’, and they usually have their article ready to go. In exchange for ‘the exclusive’, journalists agree to publishing on the date the PR agency requests. After ‘the period of exclusivity’ is over, the PR agency offer up ‘sloppy seconds’ all the way down the news pipeline.
I’m not saying that’s what happened with Carl Zimmer at the New York Times, or Sarah Toy at the Wall Street Journal, I’m saying that such a scenario is typical.
To anyone with a grasp of press relations, the quotes selected for the New York Times are shamelessly naked in their ambition to achieve a certain editorial line. “There’s really no sign of any benefit” Boulaware was quoted as saying, “Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin towards other therapies.”
The PR agency behind this have an absolutely crystal clear objective: editorialise the study to ‘steer the majority of doctors away from ivermectin’. Both Mills and Boulaware were happy to use false statements such as “there’s really no sign of any benefit” to achieve that objective. In private, amongst peers, Mills conceded the study showed something very different to the press campaign he and Boulaware were a part of.
It leaves some questions for Mills and Boulaware which deserve an answer. Are you happy with the press line you took? Given your study insight that ivermectin reduced hospitalisation, will you seek to have the WSJ and NYTimes correct their headlines that say the exact opposite? Which people from the study’s many stakeholders arranged for the press campaign to characterise the findings in this way? Was it an external press relations agency? Who funded that press strategy? Are you comfortable with your work being misrepresented in this manner?
These press campaigns have a direct impact on doctors using Ivermectin for their patients; a practice supported by the trial’s data but not its aggressive press line. Doctors can now expect to be bullied and shamed for using a drug they believe, and the data shows, can save lives. The responsibility for this kind of bullying, and the lack of uptake amongst other doctors, lies with the people who led a deliberately misleading press campaign to achieve a political objective.
Phil, thanks for covering this. A couple of weeks ago I watched the video (and read the news coverage) and noticed the same points you covered in your post. I was planning on trying to pass it on to somebody (perhaps Jimmy Dore, who just dropped a video discussing this TOGETHER trial a few days ago. A while back, he ripped into Andrew Hill for his hypocrisy. I'd love it if he ripped into Ed Mills as well!).
Here's the link to Ed Mills discussing the TOGETHER trial (Grand Rounds Rethinking Clinical Trials 03-18-2022), and my rough notes with time stamps (includes some other points not covered in your post). Mills was a bit disingenuous when discussing funding & why the study was stopped early:
https://rethinkingclinicaltrials.org/news/grand-rounds-march-18-early-treatment-of-covid-19-the-together-adaptive-platform-trial-edward-mills-phd-frcp-craig-rayner-pharmd/
From Ed Mills Presentation:
??:?? Discussed theory used to set low IVM dosage. Acknowledges that more effective with meals, but gave fasting so matches label? [Why not use higher does & duration practitioner's were using for Gamma?]
28:36 Wondered what would have happened if had kept randomizing? Changed things? I don't know. Waiting for other trials.
29:31 If more randomized; hospitalization changed to significant? Entirely possible.
29:45 IVM not a safety concern
30:44 Cannot rule out small treatment effect. Answer not yet conclusive. Subgroup within trial possibly antiparasitic [see other March '22 JAMA paper] which responsible for effect.
From Q & A:
32:50 “No significant effect. Doesn't mean anything. Low confidence interval, Stopped too early? “ : I totally agree.
I don't call shots when to stop trial [really?] The DSMV decides [later hes says they make recommendation to the steering committee that Mills is on!] ]
Funding issue; 32 year old [billionaire!] was funding, limited resources [? With Billionaire?]. We were being abused by community, I lost interest because of attacks receiving.
35:50 Lessons. $4M, little money. $500B NIH trials ACTIV. Maybe IVM had 10% effect, no better than Fluvoxamine 30%. How much genuine interest in using repurposed drugs? Didn't get picked up by [IDSA,NIH,CDC/WHO] guidelines, why is that?
38:20 “Dosing? Want to take best shot using a high dose with a 1-arm treatment. Avoids the 'wasn't enough' question.”: Mills doesn't answer question.
45:40 DSMV parameters for stopping?: Rules in plan published. They followed the plan [really?] provided to them. Public pressure. If not for pressure, would have discontinued IVM. They can do what they like in making recommendations to the steering committee [of which Mills was a member; this committee makes the decision?].
56:54 Political. Zealots, opposite too, making fun. Nobody was right about that. How come back together?
Thank you, Phil. You are generous in ascribing the title of “Journalists” to those “engaged weeks prior to ‘launch’“. Complicit shills doing the bidding of their pimps. Can remember the Pentagon Papers and the Watergate Scandal. Apparently many professing independent journalism have found the bottom of the slippery slope and morphed into corporate media.