What is going on today with medical journalism in the United States, Europe, and elsewhere? Why is there suppression of important medical information? Why do social media punish and purge perfectly legitimate journalistic entries, just because they mention a repurposed drug in clinical trials applicable to COVID-19? Why does Francis Collins MD, PhD, in a recent 60 Minutes interview minimize the potential of finding existing reusable drugs, likening it to a “needle in a haystack,” when he been privy to so much activity around the world involving drugs like ivermectin, favipiravir, and even colchicine, as well as fluvoxamine here in America? Veronica Hackethal, MD, MSc, writes for MedPage and she commented recently in Drug Repurposing for COVID-19: What Went Wrong? But TrialSite asks, “when was it ever right?” Real-world initiatives to repurpose drugs don’t work much at all unless there are economic incentives for drug producers. That thesis has been handled well by scholars such as Robin Feldman calling out challenges with the drug development incentive system. Dr. Hackethal probably knows this well. But the impressive author contributes, unknowingly, to a broader misinformation imperative as she completely fails to even mention major drug repurposing initiatives around the world. While the author touches on the ACTIV-6 initiative, she completely omits ivermectin’s role in the study, and she doesn’t dare mention that the anti-parasite drug has been approved for at least emergency or compassionate use for COVID-19 in a number of countries, ranging from Macedonia and Slovakia, to parts of Brazil and South America, to Bangladesh and India. Fluvoxamine has demonstrated positive data yet no mention there either. Ditto for Favipiravir, although MedPage Today mentions one study about the antiviral drug approved in Japan for influenza, they fail to mention its in a handful of studies with prominent academic medical centers not to mention under review by Health Canada for market authorization against COVID-19. And for that matter, favipiravir has been authorized at least under emergency use in dozens of countries led by Russia, with use in China as well. Not reported on in the U.S. media is the fact that China has completely managed this pandemic—there has been no major spikes since the initial onset of the pandemic. MedPage Today isn’t the problem. It’s most of the U.S. and European media that won’t raise these topics and that’s concerning. Well intentioned, high quality media like MedPage Today in the aggregate end up suppressing what in all reality could be one of the biggest healthcare shames in modern times: the failure to adequately explore, study, and use repurposed drugs for COVID-19 on an accelerated timeline.
With impressive credentials, Dr. Hackethal was an excellent choice to author the piece. With an interest in “investigative reporting,” she rightly shares that repurposing proponents believe that this approach represents an important alternative to de novo drug development, as in the latter case, 90% of these drugs fail along the way. They also involve a decade or more of effort and can run a tab of over $3 billion for those that clear the market.
But the MedPage Today writer shares that according to a 2020 report by Roots Analysis, repurposing can accelerate drug development while costing a far less $300 million, still quite a lot. She nicely summarizes some of the repurposing initiatives in the United States that focused on identifying early-stage targets. As TrialSite has reported since the start of the pandemic, repurposing efforts from UCSF to Sanford Prebys to a Scripps and Calibr effort generated a number of seriously intriguing targets for COVID-19. Why weren’t these targets generated seriously considered? Why was the NIH’s ACTIV trials so overwhelmingly focused on both vaccines and novel therapeutics? Hackethal does share information about the RECOVERY trial (Oxford identifies dexamethasone) and also briefly points to the NIH’s Orchid trial, which didn’t fare well for HCQ.
ACTIV-6 is no Hollywood ending for the goal of repurposing, although Hackethal suggests that the re-purposing proponents are now “heard” thanks to the launch of this study. TrialSite commended the ACTIV-6 announcement but noted it’s far too late. In the process, reform in the NIH is needed.
While many point to “Pharma” as the core problem, that’s not the case—industry isn’t the root cause of the problem. They are simply responding to the market realities and system incentives. They must adhere to the laws of the market system as it’s been designed, including stringent return on investment demands.
Hackethal connects with interviewees that understand the need for reform in the publicly funded research institutions, given what we have witnessed with not only the pandemic deaths and the fight to get any kind of care, such as the legal cases of Ralph Lorigo: a fundamental political reckoning must build for addressing this problem. One that respects and honors pharmaceutical companies and the private sector but also a movement that respects constitutional liberties, the people’s choice, and the move to a more fair and rational system—not one compromised by crony scientific capitalism.
Why lack of Repurposing?
The MedPage Today writer interviewed various experts such as Rena Conti, PhD, associate research director of the Institute for Health System Innovation and Policy at Questrom School of Business at Boston University, who suggested the lack of the focus on repurposed drugs was an anomaly, declaring in the face of past infectious disease crises, the U.S. has “always pursued an all-in approach by investing in preventives as well as therapies.” But based on insight from the previous head of NIH’s NCATS, repurposing never really worked well in the first place.
Is there a Sea Change?
Dr. Hackethal suggests a “sea change” could be occurring, citing evidence from the ACTIV-6 announcement to Appili Therapeutics’ sponsoring of favipiravir in both Canada and the United States, noting their phase 3 PRESECO trial investigating oral favipiravir.
In her writing ,we see that Collins backtracks from the strategies of the NIH/ACTIV at the start of the pandemic. Again, he leads the NIH and his excuse was “…an awful lot of scattershot efforts to try and first find effective treatments. It wasn’t as coordinated as it needed to be…I wish we had a stronger push for agents that you can take by mouth before you get in the hospital to prevent disease. It took a while after the hydroxychloroquine debacle to get that back on track.” What? There was tremendous evidence building up for ivermectin, as an example, which was completely ignored for months. TrialSite is an authority here as it was the only media platform consistently tracking and reporting on comprehensive sampling of repurposing research around the world. All the while, YouTube and Facebook have been working furiously to purge any evidence of any reality that didn’t fit into an agreed upon narrative for American consumption.
On September 12, 2020, TrialSite sent Dr. Collins directly an email pleading for support of the ivermectin research based on the results of Dr. Jean-Jacques Rajter’s CHEST study in Florida and other studies around the world. TrialSite interviewed many researchers from Bangladesh to Peru, Egypt and Israel, and the matter was urgent.
TrialSite is aware of many other prominent people communicating to NIH about such studies earlier on as well. Collins and the NIH had the information but purposely kept programs going, such as the convalescent plasma debacle, while ignoring the repurposing agenda.
To MedPage Today’s credit, their author understands something is terribly wrong, and takeaways from some of the interviews calls out for research reform. But on the need for low cost therapies for early onset COVID, they avoid, like the majority of media, the malodorous truth associated with peeling open the onion layers here. There has never been a rational repurposing strategy that’s worked involving the $40+ billion annual spend from the NIH, for example. It’s an abject failure that’s now only apparent after the disaster that is COVID-19.
What is the Reason?
TrialSite’s recently shared thoughts on the departure of NCATS director Christopher P. Austin, a big repurposing proponent, who stepped down recently even though the umbrella was announcing the ACTIV-6 program. Why? Well, we cannot say with certainty, but after speaking with others with knowledge of the situation as well as reading various reports and presentations, Austin makes it very clear—the NIH (government) has no good track record for repurposed drugs.
Why not? Well, Dr. Austin tells the world science is not the problem. Much like the 50+ ivermectin studies, including robust meta-analyses that MedPage Today completely ignores, the avoidance is as much political and technocratic defense and economic as it is for scientific reasons.
Ex-Director Austin implies in his talks that so many potential repurposed candidates would die on the proverbial vine. TrialSite highlights Mr. Austin’s true explanation, which is that the when compared to the massive spend accomplished during the first half year of the pandemic, NIH does next to nothing to support repurposed drug candidates for the people.
While in normal times, this isn’t that noticeable, its certainly abundantly apparent in pandemic times. While the NIH spends $41 billion per annum on research, Austin declares explicitly they don’t like to spend money on repurposed drugs at all.
The truth is validated by the facts. This is very evident during the pandemic as TrialSite meticulously chronicled—while what we estimated as over $15 billion being spent just on subsidizing research, the overwhelming majority of this funding went to just to a handful of pharmaceutical companies developing vaccines and novel therapeutics, primarily monoclonal antibodies. There is nothing wrong with this by itself, its that they should have been funding parallel research into repurposed drugs.
In a special about repurposed drugs, why would such a product completely omit one of the biggest repurposed drug topics around the world? There have been 50+ clinical trials, numerous countries that have accepted the repurposed drug for at least emergency or compassionate use scenarios (search TrialSite for articles), and even news that the NIH’s COVID-19 Treatments Guideline panel met with ivermectin repurposing proponents Front Line COVID-19 Critical Care Alliance (FLCCC) to learn more about their ivermectin meta-analysis. Notably, after that meeting, the apex research body changed their recommendation from opposed except for research to neutral.
Why wouldn’t Ms. Hackethal at least acknowledge such material events unless her organization is also adhering to some form of gag mandate so many others sheepishly follow?
We know this is the case as TrialSite has experienced censorship via the social media giants first hand with objective, factual reporting on research being classified as misinformation just because ivermectin is the study drug. Mary Beth Pfeiffer a fantastic journalist who has written stories for TrialSite and shared some of the pain and consequences associated with such censorship in The War on ‘Misinformation’ Claims Two Victims: Truth and the Right to Treatment while Jane Marke recently authored Silencing Mary Beth Pfeiffer and Suppressing Ivermectin. If TrialSite was dependent on social media or advertising, it would be DOA.
Well-established and respected publications like MedPage Today cannot have it both ways. If they want to provide objective medical journalism, they should provide objective, unbiased information from the relevant points of view. But in this latest piece, while they purport to provide a well-balanced, objective assessment of the situation by completely omitting profound repurposing advancements and movements associated with therapies such as ivermectin, they literally participate in what some consider one of the most egregious coverups in recent history.