Meet Michael Waxman, a physician from Kansas City and participant in one of the largest hydroxychloroquine clinical trials in the United States. He also happens to have the honor of being the study’s “truest guinea pig” doing it “gladly and “without reservation.” The study, called HERO, is led by Duke Clinical Research Institute and takes place across 40 trial sites across the United States, including the University of Kansas Medical Center where Dr. Waxman was treated with the anti-malaria drug. Dr. Waxman is glad he has participated in this study, commenting as well that “You get to see (on the) front line how bad and awful the disease can be.” A true hero, Dr. Waxman chose to go that extra step to help the anti-COVID-19 cause. But as TrialSite and others have reported, controversy swirling around hydroxychloroquine has led to public confusion and intensive “politicizing,” making it difficult to study the drug’s potential prophylactic powers.
Sold under the trade name Plaquenil, few drugs have become as controversial as Hydroxychloroquine. The drug has been around since the 1950s, used to help treat lupus. But in an already politically charged era, President Donald Trump claimed the drug was a “game changer” treatment for COVID-19. This upbeat and energetic endorsement was based in part of the findings of French research. There was a run on the drug and those individuals with lupus and rheumatoid arthritis were left in a difficult place due to severe shortages of the drug back in early Spring.
The HERO Trial
The HERO trial, led by Duke’s Adrian Hernandez in collaboration with the Patient-Centered Outcomes Research Institute (PCORI), was covered by TrialSite as well. This interventional, double blind, placebo controlled study in approximately 2,000 health care workers at risk for exposure to COVID-19. The study started April 22, 2020 and is scheduled to run until September 20, 2020. The study has expanded to 34 trial site locations.
A “Four Letter Word” at University of Kansas
Given the political wars raging in Washington and across Main Street over the current president versus an alternative; over masks versus no masks; interpretation of science and the like has all led to hydroxychloroquine becoming “a four letter word.”
For example, the recent PennLive article introduces University of Kansas clinical research coordinator Maggie Messplay, who reports when discussing the study with prospective participants they will at some point agree to participate but “then they say ‘Wait, wait, wait. Is this a hydroxychloroquine trial?'”
Politicizing Hurts Study
According to a recent update by PennLive, recruitment to this critically important trial got essentially adversely impacted by the ongoing (what TrialSite called) politicizing of the drug. Although back in April the study team actually hoped to get 15,000 health care workers involved, those high ambitions were shot down due to the conflict around the drug. From initial comments from President Trump on the big potential of the drug, but qualifying that its just a “feeling” to media declarations that studies reveal the drug doesn’t benefit COVID-19 patents, serious clinical trials, such as HERO, are hurt in the process. Recently, pro-Hydroxychloroquine groups wore white lab coats and marched in front of the Supreme Court touting the drug as a “cure.” Twitter, Facebook and YouTube banned a video of the group as “it violated their misinformation policies.”
A case in point as to how the politicizing impacted the KU clinical trial participation goals. The trial site initially targeted 500 health care workers form the Kansas City metropolitan area to participate in the HERO study. To date, they have only been able to sign up 94 participants for the study. And this is actually more than many other sites, evidencing the fact that if there ever was some nefarious agenda to terminate hydroxychloroquine, it’s certainly working. Note, the KU researchers report none of the 94 participants have reported any adverse effects associated with the drug.
Overall, the HERO study, originally hoping for 15,000 now has 1,165 signed up, despite the U.S. representing the epicenter of the pandemic. Because of the shortages due to the ongoing potentially politically-inspired fear, uncertainty and doubt, study sites face tremendous pressure to recruit participants.
The PennLive article: “Conversations playing out in the media can create confusion, which is bad for public health, and could create unintended consequences, such as impacting recruitment for critical clinical research trials designed to help find answers about what works, what doesn’t.”
The Surgisphere Bomb
KU’s Maggie Messplay recalls The Lancet study published in May declaring hydroxychloroquine was not effective in treating COVID-19, as well as the drug could trigger heart issues and worse. Directly thereafter, the World Health Organization (WHO) temporarily halted its hydroxychloroquine studies. However, TrialSite, among many others, including over a hundred prominent scientists, found the whole underlying data suspicious. Thereafter, The Lancet retracted the study due to insufficient validation of the third-party data used for the Surgisphere study. Who was really behind Surgisphere? Why did The Lancet just blindly accept a study from a questionable firm with little experience, few employees and no real defensible track record?
After Surgisphere, Ms. Messplay commented, “It just took the wind out of our sales.” Thereafter, study recruitment goals would be very difficult to achieve. Hence, the team tried to reposition the study, that it was prevention study and not a drug for actually treating COVID-19. Moreover, in these studies participants aren’t sick but rather are healthy health care workers. KU Principal Investigator Mario Castro, who is also vice chair for clinical and translational research at University of Kansas School of Medicine commented, “It had a definite negative impact.” Dr. Castro emphasized that they have tried to turn the study around by emphasizing that again its not a treatment trial but rather testing to see if hydroxychloroquine has prophylaxis-like qualities.
A Political Ping-Pong
Dr. Todd Rice is a participating investigator in the HERO trial. The pulmonologist and associate professor of medicine at Vanderbilt University in Nashville reports its been “fascinating” in observing the ups and downs of this story. He was reported that in March, doctors were so desperate to find some drug to combat this novel coronavirus and hence, “You were a devil if you didn’t give every patient hydroxychloroquine.” How do things change? Fast forward a few months, and “Now, you’re a devil if you’re giving it to people.” But Dr. Rice suspects the pendulum, which has swung back and forth, may be settling in the middle range.
Protecting Health Care Workers
These frontline heroes around the word are the direct troops in this health war against COVID-19. Of the HERO registry, of the more than 12,000 individuals who have registered by May, forty-three percent were infected with COVID-19. It turns out in America that Black and Latino health care workers face twice as high a risk of infection, reports Duke. The whole goal of HERO was to help determine if hydroxychloroquine could potentially act as a prophylaxis. With many lives at stake, the politicizing directly threatened the heroes in the field, on the frontlines of the global pandemic.
Over Reporting, Under Researching
Back to Dr. Waxman participating in the HERO study at the KU trial site, he noted on the unfortunate circumstances associated with hydroxychloroquine commenting, “People have been reporting next to everything they’ve been seeing, they’ve been experiencing, and there’s been an utter lack of really great research that’s been reported.”
Duke researchers conclude, “Large, randomized controlled trials” represent the true path to the truth as to whether hydroxychloroquine can stop COVID-19 in those facing higher risk of infection. There is very little prophylaxis information about hydroxychloroquine, reports Dr. Castro, principal investigator with KU stating, “We are hoping now…that we’ll be able to answer this definitely with an adequate sample size.”