The Debate Over Hydroxychloroquine
President Trump’s surprise announcement on Monday, May 18, that he is taking hydroxychloroquine as a preventative against COVID-19 prompted Fox News host Neil Cavuto to quickly warn,
“If you are in a risky population here, and you are taking this as a preventative treatment to ward off the virus or in a worst-case scenario you are dealing with the virus and you are in this vulnerable population, it will kill you. I cannot stress enough: This will kill you.”
Cavuto added,
“A VA study showed that among a population in a hospital receiving this treatment, those with vulnerable conditions – respiratory conditions, heart ailments – they died.”
He also mentioned that other studies have similarly found that hydroxychloroquine is ineffective at treating COVID-19.
Right after Cavuto went off the air, Fox News host Greg Gutfeld of “The Five” encouraged viewers to take the drug:
“If it’s available to you and you can take it, you do it,” Gutfeld said. “That’s a prudent way of looking at it.”
(Business Insider, May 18, 2020, https://www.businessinsider.com/fox-news-neil-cavuto-shocked-trump-hyroxychloroquine-announcement-video-2020-5)
That evening, the president tweeted,
“@FoxNews is no longer the same. We miss the great Roger Ailes. You have more anti-Trump people, by far, than ever before. Looking for a new outlet!”
(Donald J. Trump, Twitter, May 18, 2020, https://twitter.com/realDonaldTrump/status/1262563582086184970)
The most important takeaway for investors is to keep an eye on what policies, treatments, and preventions transcend the political fray and result in a steady decline in coronavirus cases, allowing economies to continue their gradual restarts. A major risk via a second wave of contagion could threaten the already-weakened business environment so a false-start on any policy, treatment, or prevention can result in a move in markets.
Regarding the VA study, Trump remarked that it involved “people that aren’t big Trump fans.” He added, “It was a very unscientific report, by the way.”
(Fox News, May 18, 2020, https://www.youtube.com/embed/cGTfW2gb2SI, minutes 31:45, 32:50)
Fox News host Laura Ingraham, who for several months has been touting hydroxychloroquine, has laid out the case against the VA study, focusing on the fact that it involved only patients who were in the advanced stages of COVID-19 infection, had already been intubated, and subsequently died. She quotes the eminent but controversial French virologist Dr. Didier Raoult, who has stated in response to the VA study, “This is unreasonable [treatment] at the time of the cytokine storm, as it is unlikely that hydroxychloroquine alone would be able to control patients at this stage of the disease.”
(Fox News, April 22, 2020, https://www.youtube.com/embed/RexUJeWmzSE, minute 4:10)
Thus Cavuto failed to draw an important distinction: You may die if you have a serious case of COVID-19, are intubated, and take hydroxychloroquine; but it might not be the hydroxychloroquine that kills you. Correlation, as we know in our financial market and economic business, is not causation.
Dr. Raoult is interesting. A May 12 profile in the New York Times Magazine had this to say about him:
“Raoult, who founded and directs the research hospital known as the Institut Hospitalo-Universitaire Méditerranée Infection, or IHU, has made a great career assailing orthodoxy, in both word and practice. ‘There’s nothing I like more than blowing up a theory that’s been so nicely established,’ he once said. He has a reputation for bluster but also for a certain creativity. He looks where no one else cares to, with methods no one else is using, and finds things. … He detests consensus and comity; he believes that science, and life, ought to be a fight.
“It is in this spirit that, over the objections of his peers, and no doubt because of them, too, he has promoted a combination of hydroxychloroquine, an antimalarial drug, and azithromycin, a common antibiotic, as a remedy for Covid-19. He has taken to declaring, ‘We know how to cure the disease.’”
(“He Was a Science Star. Then He Promoted a Questionable Cure for Covid-19.” New York Times Magazine, May 12, 2020, https://www.nytimes.com/2020/05/12/magazine/didier-raoult-hydroxychloroquine.html)
In a groundswell of hopeful enthusiasm, Dr. Raoult’s treatment has been authorized for testing or use in many countries around the world, including the US, France, Italy, China, and India.
In the US, the Food and Drug Administration issued an Emergency Use Authorization on March 30 that allowed the use of these drugs in COVID-19 patients who were not enrolled in clinical trials. Science magazine reported that a number of former agency leaders and President Obama disagreed with the move on the grounds that it “undermines FDA’s scientific authority because it appeared to be a response not to scientific evidence, but to fervent advocacy of the drugs by Trump and other political figures.” (“Former FDA leaders decry emergency authorization of malaria drugs for coronavirus,” Science, April 7, 2020, https://www.sciencemag.org/news/2020/04/former-fda-leaders-decry-emergency-authorization-malaria-drugs-coronavirus)
On March 16, Dr. Raoult released the results of a small clinical involving 36 patients, 20 of whom received hydroxychloroquine (six also took azithromycin), with 16 serving as controls. (This is the study that was touted by President Trump.) The Raoult team reported that the 20 who were treated “showed a significant reduction of the viral carriage at D6-post inclusion compared to controls, and much lower average carrying duration than reported of untreated patients in the literature. Azithromycin added to hydroxychloroquine was significantly more efficient for virus elimination.” (“Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” ScienceDirect, March 20, 2020, https://www.sciencedirect.com/science/article/pii/S0924857920300996?via%3Dihub)
However, on April 3, the International Society of Antimicrobial Chemotherapy (ISAC), co-publisher of the International Journal of Antimicrobial Agents, in which Raoult’s paper appeared, issued a statement which said that Raoult’s study “does not meet the Society’s expected standard, especially relating to the lack of better explanations of the inclusion criteria and the triage of patients to ensure patient safety.” Nevertheless, the ISAC defended the peer review process the study had already gone through. (“Journal Publisher Concerned over Hydroxychloroquine Study,” The Scientist, April 9, 2020, https://www.the-scientist.com/news-opinion/journal-publisher-concerned-over-hydroxychloroquine-study-67405)
Also, on April 9, Dr. Raoult released the abstract of a study his group conducted in which 1061 COVID-19 patients were treated for at least three days with the hydroxychloroquine-azithromycin combination, with a reported cure rate of 91.7% and “no cardiac toxicity.” (PDF file: https://www.mediterranee-infection.com/wp-content/uploads/2020/04/Abstract_Raoult_EarlyTrtCovid19_09042020_vD1v.pdf)
Derek Lowe, author of “In the Pipeline,” an editorially independent blog from the publishers of Science Translational Medicine, takes Raoult to task for the lack of any sort of control group in that study. (Raoult has objected to giving people the false hope that they are being treated.) But Lowe concedes that a large multinational collaboration involving researchers from Germany, Japan, Netherlands, Spain, the UK, and the US, which examined outcomes for patients taking hydroxychloroquine alone (310,350 users) or in combination with either azithromycin or amoxicillin (351,956 users), concluded that short-term (30-day) hydroxychloroquine treatment is safe. It should be noted that none of these patients had COVID-19. (“The Latest Hydroxychloroquine Data, As of April 11,” Science Translational Medicine, April 11, 2020, https://blogs.sciencemag.org/pipeline/archives/2020/04/11/the-latest-hydroxychloroquine-data-as-of-april-11)
However, trouble developed with the azithromycin combination. The authors of the study state,
“Worryingly, significant risks are identified for combination users of HCQ+AZM even in the short-term as proposed for COVID19 management, with a 15–20% increased risk of angina/chest pain and heart failure, and a two-fold risk of cardiovascular mortality in the first month of treatment.” (“Safety of hydroxychloroquine, alone and in combination with azithromycin, in light of rapid wide-spread use for COVID-19: a multinational, network cohort and self-controlled case series study,” medRxiv preprint, April 10, 2020, https://www.medrxiv.org/content/10.1101/2020.04.08.20054551v1.full.pdf)
In contrast to this robust and salutary conclusion regarding treatment with hydroxychloroquine alone, a study of 96,000 hospitalized coronavirus patients on six continents found that the 9,237 who received hydroxychloroquine had a significantly higher risk of death compared with those who did not and were also more likely to develop a type of irregular heart arrhythmia that can lead to sudden cardiac death. Derek Lowe analyzes this study and lays out the numbers on the increased death risk here: “Hydroxychloroquine: Enough Already?” Science Translational Medicine, May 22, 2020, https://blogs.sciencemag.org/pipeline/archives/2020/05/22/hydroxychloroquine-enough-already.
Lowe concludes:
“There was no evidence whatsoever of any benefit with any of these treatment regimes. There was significant evidence of harm. Here’s how it works: when something is real, you continue to see a real signal as you collect more and better data. When something is not real, it disappears. Tell me again why anyone should be advocating such treatments.”
And here is the Lancet study cited by Lowe: “Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis,” The Lancet, May 22, 2020, https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31180-6/fulltext.
Citing this Lancet study, WHO Director-General Tedros Adhanom Ghebreyesus announced on May 26 that WHO is temporarily suspending a trial of hydroxychloroquine in treating COVID-19, over concerns about the drug's potential danger. WHO chief scientist Dr. Soumya Swaminathan said WHO will take another week or two to gather more data.
“We want to use hydroxychloroquine if it is safe, if it reduces mortality, reduces the length of hospitalization, without increasing the adverse events,” Swaminathan added.
(“WHO temporarily halts trial of hydroxychloroquine over safety concerns,” NBC News, May 25, 2020, https://www.nbcnews.com/news/world/who-temporarily-halts-trial-hydroxychloroquine-over-safety-concerns-n1214341)
Bottom line: Hydroxychloroquine for the treatment of COVID-19 needs continued high-quality research – and is getting it. According to New York Times Magazine, one in every five registered drug trials in the world is now testing hydroxychloroquine.
The NIH announced on May 14 that it was launching a clinical trial involving approximately 2,000 adults to evaluate whether the hydroxychloroquine together with the antibiotic azithromycin can prevent hospitalization and death from COVID-19. NIAID director Dr. Anthony Fauci stated, “Although there is anecdotal evidence that hydroxychloroquine and azithromycin may benefit people with COVID-19, we need solid data from a large randomized, controlled clinical trial to determine whether this experimental treatment is safe and can improve clinical outcomes.”
Dear Readers: I have personally interviewed several frontline physicians who are watching the use of HCQ+AZM. In two cases, they are watching use in trials. Every single doctor says the AZM combination raises risk. So the Cavuto warning on Fox News is being independently verified. Readers are encouraged to ask their own medical advisors.
HCQ by itself is controversial for COVID-19 but appropriate for malaria. I have traveled to places with high malaria risk and have taken malaria vaccine and carried treatment with me when needed.
I’ve also personally spoken with lupus victims who use HCQ and heard directly from one of them about its importance and about the fear of shortages created by Trump’s endorsement. Every one of them now sees the president’s behavior as a direct threat to their lives and families. (See “Why Hoarding of Hydroxychloroquine Needs to Stop,” “Shots,” NPR, March 23, 2020, https://www.npr.org/sections/health-shots/2020/03/23/820228658/why-hoarding-of-hydroxychloroquine-needs-to-stop)
We have also seen Brazilian president Jair Bolsonaro endorsing chloroquine use as cases and deaths spike higher in his country. (“Brazil expands approval of chloroquine to treat COVID-19. ” Yahoo, May 21, 2020, https://sports.yahoo.com/brazil-expands-approval-chloroquine-treat-051957756.html)
When a politician plays doctor, he had better be right or he may have deaths on his record. Trump and Bolsonaro may have put themselves at risk with that position.
A personal note. Over the years I’ve met Neil Cavuto several times and been interviewed by him on his show. He is a hard-working and exacting journalist. He overcomes a difficult personal disability every day so he can achieve the highest standards of professional action.
The issue of hydroxychloroquine use has become personal for thousands of Americans and millions of people worldwide. Medical trials may, repeat may, reveal increasingly reliable HCQ information. Meanwhile, Cavuto gets my vote. He has opted for truth and not the fake news spread by some of his Fox colleagues.
David R. Kotok
Chairman of the Board & Chief Investment Officer
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