March 22, 2020 JV

A New Hope?

President Trump is often criticised for saying things that are not totally aligned with that of the scientific consensus.  In a March 20 press briefing, Dr. Tony Fauci (director of the US National Institute of Allergy and Infectious Diseases (NIAID)) was asked about the effects of an established anti-malaria drug Hydroxychloroquine (HCQ) as a treatment for COVID-19.  Dr Fauci was dismissive of the early results (from a team of French epidemiologists) saying the results were “anecdotal; not done in a clinical trial.”  Later in the same press briefing, President Trump went on to say

“I’m more of a fan of that (Hydroxychloroquine) than anybody… We’ll see what happens… It may work and it may not work.”

CNN immediately wrote an article entitled “Trump peddles unsubstantiated hope in dark times” likely based on a reporter’s question

“is it possible that your impulse to put a positive spin on things may be giving Americans a false sense of hope?”

Trump went on to say “I feel good about it… That’s all it is, just a feeling … and you’re going to see soon enough.”  Trump was accused of a meltdown over the interchange where he labelled the question as “bad reporting.”

President Trump admitted that his enthusiasm for the drug was based largely on gut instinct, after an open disagreement with the nation’s top infectious disease expert.  “I think we disagree a little bit,” Trump added. He ended the exchange with a typical Trumpian quip:

“I’ve been right a lot, you know.”

HCQ, long used to treat malaria and diseases including rheumatoid arthritis and lupus, has shown limited efficacy at treating coronavirus, and has not yet been fully tested either as a treatment or preventive medicine in a large, formal trial. Trump, nonetheless, said the White House had ordered millions of doses — perhaps a reference to Bayer’s recent announcement that it would donate three million tablets of the drug to the American government.

What was it that caused Trump to go out on a limb for this antique anti-malarial?  After all, extending false hope at this time would be crushing.  Could he know something that Fauci doesn’t?  Is he losing it (as the media claims), or does he have sharper instincts than the experts?  Is there something to this French study that demands further attention? 


The term anecdotal means “not necessarily true or reliable, because based on personal accounts rather than facts or research.”  Was Dr. Fauci’s label of the French study warranted?  I decided to do some further investigation on the topic.  The French study[1] conducted by a team of epidemiologists, produced a paper, noting that:

“Twenty cases were treated in this study and 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.  A graph of the study results is provided here:

Percentage of patients with PCR-positive nasopharyngeal samples from inclusion to day6 post-inclusion in COVID-19 patients treated with hydroxychloroquine only, in COVID-19 patients treated with hydroxychloroquine and azithomycin combination, and in COVID-19 control patients.

Conclusion:  Despite its small sample size our survey shows that hydroxychloroquine treatment is significantly associated with viral load reduction/disappearance in COVID-19 patients and its effect is reinforced by azithromycin.”

I listened to several Youtube videos and did some further reading, discovering that the anti-malarial has already been used to treat COVID-19 both within the US and across the globe.  Not one of the experts (other than Fauci) questioned about the French study results was negative.  In fact, all of those I watched or read were buoyed by what they’d seen and look forward to further clinical trials, especially in relation to the combination of HCQ and Azithromycin.  I’m not sure why Dr. Fauci was dismissive of this.  I’m assuming he’s a stickler for epidemiology process and prefers large study numbers.  However, with COVID-19 infections and fatalities on the rise and a vaccine 12 months away, is there not a good case for relaxing some treatment rules, especially for the critically ill?  After all, this is the ultimate Risk vs Reward question and there’s not much time left for many.

Dr. William Grace (Lennox Hill Oncologist) appeared on a March 20 episode of the Ingraham Angle.

Laura Ingraham: “So, how beneficial is Hydroxychloroquine?  My next guest says doctors are already using this treatment in the United States successfully.  Joining me now is Dr. William Grace, Oncologist with Lenox Hill Hospital in New York City.  Dr. Grace, great to see you tonight.  How big a deal would approving Chloroquine for the Coronavirus be?”  Dr. Grace:

“Well … everybody is using it now off-label.  We have a surge of Coronavirus-19 patients throughout the Metropolitan area of New York and the problem is these patients are coming in quite sick.

And when they get to a very difficult respiratory status, the doctors are using Hydroxychloroquine with or without a drug called Zithromax or Azithromycin, and that’s showing tremendous activity.  And we have not had a death in our Hospital.  We have probably close to 100 patients, and not had any deaths.”

Here is an excerpt from a statement made by New Jersey State Senator Joe Pennacchio on this topic:

“March 21, 2020 – President Trump has shown true leadership in his approach to allow an “off label” approach in the use of drugs for the treatment of COVID-19.  In particular, Hydroxychloroquine, which has a seventy-year record of being safe and effective in the treatment of malaria… 

Dr. William Grace, a top oncologist at Lenox Hill Hospital concurs with the findings, saying the positive therapeutic results of [the French] findings would be 1 in 10,000 of it happening by chance…

I understand and respect Dr. Fauci’s work in the public health field but also remind the public that most of science as we know it today begins with anecdotal and theoretical ideas.  What is important here is that HCQ has a long and safe history.  Dr. Fauci’s call for a large double-blind placebo study to evaluate the efficacy of HCQ in the treatment of COVID-19 is correct but not at the expense of dismissing HCQ efficacy as anecdotal.  Concurrent with Dr. Fauci’s “study” should be a gathering and sharing of all patient information worldwide when they have been treated with HCQ as a therapeutic.

Federal and State agencies should prepare themselves for real time evaluation of HCQ and have in place a protocol for its manufacturing and distribution.  President Trump has taken advice from a host of doctors, epidemiologists, scientists and public health officials.  Dr. Fauci and others may choose to dampen and disagree with the President’s approach while other advisors seemingly have not.

Finally, the President’s comments and leadership have to be judged in the totality of this country’s experience with this pestilence.  As such, he should be applauded for his guidance, leadership and for above all offering the American people hope.”

I’d like to finish this article with some additional data of interest and one final thought on HCQ.  Africa is one of the last continents on earth to contract COVID-19.  With relatively poor hygiene and a weak medical system, it could be hit very hard by the new virus.  Africa was hit hard by Ebola.  It has also carried a disproportionately high share of the global malaria burden for many decades. In 2018, the region was home to 93% of malaria cases and 94% of the worldwide total of 405,000 malaria deaths.  Perhaps the already high use of HCQ throughout Africa may hold them in good stead, as both a preventive and treatment option.  Time will tell.  Africa could do with a break.

[1] Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label non‐randomized clinical trial. International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949

Post Script:  BREAKING NEWS (added 24/03/2020)

I’d like to refer you to some video footage from this Youtube clip:–E

At the 11:15 mark, the presenter commences her interview with Dr. Mehmet Oz.  He, in turn (at 13:30 mark) interviews the French professor of epidemiology, Dr. Didier Raoult regarding his findings from the HCQ study.  At the 16:15 mark we see a clip from MSNBC where Dr. Redlener discusses his concerns with patient safety (as a formal, large-scale clinical trial has not yet been completed).  Then Dr. Oz explains why a formal clinical trial of HCQ should occur in parallel with off-label treatment of the drug.  Finally, at the 19:20 mark, a COVID-19 infected US patient shares his story of the use of HCQ.

President Trump’s story has caused a rush on HCQ in Australia with pharmacists told to manage stocks.  It should only be dispensed by doctors to COVID-19 patients with severe symptoms (at this stage).  It’s prophylactic effects are as yet, unproven.

PPS   BREAKING NEWS (added 28/03/2020).

The world-leading French epidemiologist, Professor Didier Raoult has just released a new study using 80 patients.  Here is an excerpt from the latest study (just released):

“In 80 in-patients receiving a combination of hydroxychloroquine and azithromycin, the team found a clinical improvement in all but one 86 year-old patient who died, and one 74-year old patient still in intensive care unit. The team also found that, by administering hydroxychloroquine combined with azithromycin, they were able to observe an improvement in all cases, except in one patient who arrived with an advanced form, who was over the age of 86, and in whom the evolution was irreversible,” according to a new paper published today in IHU Méditerranée Infection.

“For all other patients in the cohort of 80 people, the combination of hydroxychloroquine and azithromycin resulted in a clinical improvement that appeared significant when compared to the natural evolution in patients with a definite outcome, as described in the literature.  In a cohort of 191 Chinese inpatients, of whom 95% received antibiotics and 21% received an association of lopinavir and ritonavir, the median duration of fever was 12 days and that of cough 19 days in survivors, with a 28% case-fatality rate,” the team said.

The team went on to say: “Thus, in addition to its direct therapeutic role, this association can play a role in controlling the disease epidemic by limiting the duration of virus shedding, which can last for several weeks in the absence of specific treatment.  In our Institute, which contains 75 individual rooms for treating highly contagious patients, we currently have a turnover rate of 1/3 which allows us to receive a large number of these contagious patients with early discharge.  Chloroquine and hydroxychloroquine are extremely well-known drugs which have already been prescribed to billions of people.”

In conclusion, we confirm the efficacy of hydroxychloroquine associated with azithromycin in the treatment of COVID-19 and its potential effectiveness in the early impairment of contagiousness.  Given the urgent therapeutic need to manage this disease with effective and safe drugs and given the negligible cost of both hydroxychloroquine and azithromycin, we believe that other teams should urgently evaluate this therapeutic strategy both to avoid the spread of the disease and to treat patients before severe irreversible respiratory complications take hold,” the team concluded.

PPPS   BREAKING NEWS (added 30/03/2020).

Two separate stories broke recently regarding this story.  They are included here:

NIH failed to test coronavirus drugs, studied drunk monkeys, soap operas, and tailgating instead

The US NIH knew about the efficacy of hydroxychloroquine and azithromycin in the treatment of coronavirusus as early as 2003.  However, they wasted taxpayer money on ridiculous studies instead.

After President Trump’s hunch about these drugs “I feel good about it… That’s all it is, just a feeling … and you’re going to see soon enough,” the US FDA gave emergency approval to use anti-malaria drugs to fight coronavirus.

I think President Trump is going to redefine the concept of  “a bull in a China shop.”  Bureaucracies are laid bare, red tape is slashed and valuable drugs are made available to those in need.

PPPPS   BREAKING NEWS (added 7/04/2020).

In a Hannity program, Dr Oz spoke about a 1,000 patient Case Series (non-randomised study) completed by Professor Didier Raoult that is yet to be released.  1,000 were provided with a combination of HCQ and Azithromycin.  Of these, 7 died, 20 were intubated.  The remainder were cured with results similar to those from the earlier 20 person study.  This is not anecdotal evidence.  It is way beyond that.  Every doctor would love a randomised, double-blinded clinical trial of the above combination.  However, as people are dying from COVID-19, Professor Raoult believes that a randomised trial of HCQ and Azithromycin is simply unethical.  A global survey of doctors shows that these drugs are the most popular combo prescribed for the treatment of COVID-19.

On 30 March, the US FDA approved use of HCQ and Azithromycin for COVID-19.  Early application of these should see reduced time in hospital with COVID-19 symptoms and fewer intubations, reducing the demand on respirators.

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