Brown University School of Public Health Dean Misinforms the World in NY Times Opinion

In an opinion published in the New York Times on November 24, Dr Ashish Jha argues against the early treatment of COVID-19. He misinforms the world about what early treatment is and also misrepresents what the three other witnesses said at the November 19 hearing convened by US Senator Ron Johnson. This piece rebuts Jha’s arguments and emphasizes how critical the generalization of early outpatient treatment is to help resolve the COVID-19 crisis.

This is an independent apolitical opinion piece by Jean-Pierre Kiekens, a policy analyst who is editor of COVEXIT.com, Oxford graduate, former university lecturer in Brussels, and now living in Canada.

For Dr Jha, who has admitted to never have treated a single COVID-19 patient, people who get COVID-19 just need to stay home, do nothing, seek no treatment whatsoever, and wait …

Imagine it’s you. You may be lucky and get over it. But over 250,000 American citizens did not overcome by themselves the early stage of the disease. Their immune system was unable to curb the replication of the virus. And many died afterwards in hospital, which was unable to help them once a more advanced stage of the disease was reached.

With Dr Jha’s ill-conceived approach, you don’t do anything when the disease progresses, until you can’t breath any longer, which is already a significantly advanced stage of the disease. 

This late treatment approach to COVID-19 is contrary to what responsible medicine is. If you get cancer, you need to get early detection and early treatment. If you get a stroke or more generally cardiovascular disease, you need to get early detection and early treatment. Examples where early treatment is even more urgent include bacterial pneumonia and acute staphylococcal skin infections.

Imagine this. There is a fire in your house. Are you waiting in the hope that the fire will extinguish itself without any intervention? Or are you intervening immediately, for example with a fire extinguisher, or even  a bucket of water? Of course, you need to call the fire department, but you are going to do what you can to extinguish that fire.

Now, regarding COVID-19, even in case an infection is detected early through testing, Jha’s position is that you should not receive any form of early treatment until when you get to the hospital. There, the data show that the odds of severe complications with long term effects, or of dying, are considerably increased.

To this date, there has been progress with hospital level treatment, but hospital level mortality remains very high, at around 25%. A key rationale for early treatment is to avoid hospitalization altogether and therefore to avoid facing such poor odds of survival.

The benefits of early treatment for society are considerable, as it reduces the pressure on the health system by leading to fewer hospitalizations and ICU transfers. Today, everything points at mounting pressure on hospitals and ICUs, with the increasing risk of triage, at least in some institutions.

Early treatment also potentially saves huge amounts of money. Some COVID-19 patients are known to have cost over US$1 million to treat, while they could have been treated for a few hundred dollars, would they have taken early treatment.

There has been much hope placed in hospital level treatment. Some progress has been made in the quality of treatment, for example through the work of the East Virginia Medical group under the leadership of Professor Paul Marik, but the level of mortality from COVID-19 in hospitals remains unacceptably high.

It’s important to note the regrettable widespread use in US hospitals of the remdesivir drug, known for its toxicity to kidneys and the liver, yet touted since April by NIH, with slim evidence, for becoming the standard of care in the US for COVID-19. 

In October, the World Health Organization released results of the large-scale SOLIDARITY clinical trials, concluding against its use for COVID-19. To this day, the drug remains however authorized and recommended by FDA and NIH in the US, despite its ineffectiveness and well-documented toxicity.

At the very beginning of the pandemic in the US, in February / March, the position of Dr Jha was largely correct. There was still little understanding of the COVID-19 disease and how to treat it.

But today, there is considerable knowledge about how to treat COVID-19. It is known that there is a viral replication phase at the beginning (when people are asked to stay home) followed by an acute inflammation phase characterized by a cytokine storm, followed by a third phase with the development of micro thrombosis, when the disease becomes particularly lethal.

Of these three phases of the disease, the initial viral replication phase is now known to be the easiest to treat. It’s common sense. You treat early to avoid a more severe form of the disease, avoid hospitalization and ultimately reduce mortality. This is the rationale for outpatient home-based treatment for COVID-19.

Curbing the replication of the virus at the early stage is the most effective way to treat COVID-19, as it will help avoid the disease to progress to the next phases, which require hospitalization, and for which the odds of avoiding long term symptoms and of surviving are much lower.

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There are several treatment options that are being used in countries all over the world, and for which there are many studies showing effectiveness. These treatment options are all involving several approved generic and cheap drugs, with very well established safety profiles.

An example of treatment was developed by Professor Thomas Borody from Australia, renowned internationally for his work in developing therapies for diseases such as peptic ulcer and Crohn disease, which have saved hundreds of thousands of lives and saved billions to health authorities all over the world.

Professor Thomas Borody is an expert in repurposing existing drugs. This is exactly what he did for COVID-19. He recommends a tri-therapy involving two generic drugs – Ivermectin (an anti-parasitic) and Doxycycline (an anti-biotic) – in combination with one over the counter supplement – zinc sulfate. The treatment has of course to be taken under medical supervision.

Additional drugs are sometimes needed for the early treatment of the disease, such as aspirin, prednisone, heparin, colchicine, and others. Also oxygen may be needed, which can also be taken as a home treatment, with proper monitoring of oxygen levels in the blood through an oximeter, and of course, again, with proper medical supervision.

These treatment options are encapsulated in an algorithm framework developed by a team of US and Italian medical doctors led by Dr Peter McCullough. This early treatment algorithm was peer reviewed and published in the American Journal of Medicine on August 6.

We are not talking about snake oil here. We are talking here about therapies developed by some of the top level medical doctors in the world. We are talking about treatment protocols that are readily operational because relying on approved drugs with well established safety profiles. We are talking about the art and science of medicine at its best.

The father of early treatment for COVID-19 in the US is without doubt Dr Zev Zelenko who, eager to save his community from a major outbreak of COVID-19, developed a tri-therapy, also relying on an anti-biotic, an anti-parasitic and the important supplement zinc.

The pioneer work of Dr Zev Zelenko was studied by two German researchers – Dr Roland Derwand and Professor Martin Scholz and their academic article was peer reviewed and is forthcoming in the International Journal of Antimicrobial Agents. The study is important as it demonstrates how early treatment reduces the need for hospitalization, so it’s important to look at it in some detail.

While Dr Zev Zelenko and his team have treated over 2000 patients so far, the study covers only 141 patients, for which confirmatory COVID-19 testing was made, during the period between 18 March 2020 and 14 May 2020. Those patients were high risk patients, as Dr Zev Zelenko had risk stratified his patients (using criteria such age, diabetes and obesity).

From a methodological perspective, this is a retrospective case series research, and not a placebo randomized controlled clinical trial. Dr Zev Zelenko’s goal was to treat his patients as best as he could, according to his hippocratic oath, and not denying treatment to half of his patients, using placebos, something that is unacceptable for a disease known to be particularly deadly. 

The therapeutic outcomes achieved for those patients were compared to those for 377 patients from a medical practice in the vicinity, where no such early treatment was used. 

What are the results? For Dr Zelenko’s patients, the lethality rate with treatment was 0.71% while it was 5 times higher, at 3.5%, without treatment, in the medical practice from the vicinity. The only death in Dr Zelenko’s cohort was a patient with a history of cancer who took only one daily dose of the triple therapy before hospital admission.

Regarding the proportion of patients requiring hospitalization, it was 2.8% among Dr Zelenko’s patients having received the treatment, while it was also 5 times higher, reaching 15.4%, for patients not having received early treatment at the nearby medical practice. The latter result was found to be highly statistically significant, even with such a small cohort of treated patients.

This study of Dr Zev Zelenko’s therapeutic results confirms that early treatment for COVID-19 makes abundant sense, by considerably reducing the need for hospitalization and ultimately mortality.

There are other medical practices that have used early treatment with great success. One example is Dr Brian Tyson, from El Centro California. In an October 1 interview with covexit.com, but also in interviews with other media, he confirmed he treated early some 1900 COVID-19 positive patients, with just one requiring hospitalization, and zero death.

What to make from this data from Dr Brian Tyson? As of October 1, case fatality rate in the US was 2.9%, i.e. there were in average 2.9 deaths for 100 confirmed cases. For 1900 patients, it would have been normal that at least 55 deaths to occur in this group of patients.

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Actually, the number of deaths without treatment would probably have been much higher, in part because Dr Tyson’s patients were not only confirmed COVID-19 positive but also symptomatic, which is far from always being the case, especially with the now widespread testing.

Out of 1900 patients confirmed COVID-19 positive with symptoms, Dr Tyson had zero death and just one short hospitalization. While no formal academic study has yet been done on his data, one thing is sure. It’s totally impossible, statistically speaking, for such outcome to have resulted by mere luck, from chance. Dr Brian Tyson and his team in California got it right, from the very beginning in March, similarly as Dr Zelenko got it right since March in New York State.

Dr Tyson’s experience was not only covered in our in depth interview with him on October 1 but also in our October 27 webinar on outpatient treatment with Dr Peter McCullough. What is highlighted in the webinar is the importance of a quality package of care, with careful evaluation of the patients, assessment for complications, risk stratification, administration of drugs, and follow up of the patients – all actions that were taken by Dr Tyson and his team.

All this information, and of course the academic publications of Dr Peter McCullough, Professor Risch, and the many other studies published about early treatment, including that of Dr Zev Zelenko’s experience in New York State, was public prior to the Senate committee hearing, and was accessible to Dr Jha and his assistants.

But even prior to the hearing, Dr Jha had decided, via his tweets, to make it a debate about the extremely politicized drug hydroxychloroquine, which is used, among a range of other drugs, not all the time, and never alone, because it only works well in combination with other drugs, and as part of a package of care professionally provided by a medical doctor.

Even after the testimonies of the three distinguished witnesses who presented the case for early treatment, Jha decided to double down and to get this opinion piece published in the NY Times, completely ignoring what was presented at the hearing and not showing any curiosity about the already widely used protocols for early treatment – even if he recognized at the hearing that early treatment would be very important would it work.

In his opinion piece, Jha disrespectfully uses terms such as “snake-oil salesmen” to describe the three other distinguished medical doctors who testified at the hearing. This his totally misplaced and he should be happy not to get a diffamation lawsuit because of such statement.  Like in any profession, medical doctors often disagree, but there are lines not to be crossed.

Jha pretends these three doctors are just part of a “group of people essentially arguing that the coronavirus was no problem” while none of those doctors has ever claimed that, quite the contrary. As a matter of fact, Dr McCullough sounded the alarm during the hearing about an imminent crisis, affirming that “we are weeks away of mass panic and mass mortality” if no action is taken to vigorously implement early treatment for COVID-19 in the country.

Jha also claims that the other witnesses dismiss science, while those have authored many more published and peer-reviewed articles than him about COVID-19, especially about how to treat it with early therapies.

Jha’s lack of understanding of the early treatment of COVID-19 is made abundantly clear by the articles he quotes in the NY Times opinion piece. For example, he refers to the RECOVERY clinical trial in the UK, where hydroxychloroquine was administered late, in hospital, not in combination with zinc and an antibiotic, and in probably excessive dosage. 

The topic of the Senate hearing was early, outpatient, treatment, yet Jha thereby referred to a study about patients in the later cytokine storm or micro-thrombosis phase of the disease, where treatment protocols are completely different.

Another study quoted by Jha, about “post-exposure prophylaxis” has also very little relevance, as it was a mono-therapy study, without neither zinc nor an antibiotic, and without even any real diagnosis or testing for most study participants. 

This post-exposure study was so poorly conducted statistically that an independent researcher, reworking the stats, found some statistically significant effectiveness for hydroxychloroquine – the exact contrary conclusion published in the article!

None of the studies quoted by Jha in the NY Times proves that early treatment is ineffective or unsafe. At the same time, Jha ignores studies such as the one discussed above about the experience of Dr Zelenko, demonstrating very clearly how early treatment is so crucially important to deal with the current crisis.

Jha is misleading everyone when he writes, in his opinion piece, that Dr McCullough, Professor Risch and Dr Fareed consider that coronavirus is no problem.

These thee distinguished medical doctors are actually mostly on his side, when he argues “that the pandemic is hard, that we have few easy solutions, and that we have to work constantly to protect lives through public health measures while we await widespread vaccinations.”

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What these three distinguished doctors mostly argue is that one should add early outpatient treatment to the tools already used for fighting the epidemic. Early treatment constitutes a missing tool in the pandemic response, that is complementary to measures to avoid contagion, hospital treatment and immunization with vaccines.

Outpatient early treatment is a crucially important tool that has not been included so far in a significant scale in the US in the strategy to respond to the COVID-19 crisis. Other countries have included early treatment, such as Algeria, Bahrain, Turkey and Greece, to name just a few, but the US, and many other countries, haven’t. 

Countries that have included early treatment in their strategies have typically fared much better, for example in terms of mortality per million inhabitant, than the US, which has now one of the highest mortality in the world from COVID-19, along with countries such as Belgium, Peru, Spain, Italy, Argentina and the UK.

Implementing early outpatient treatment on a wide scale is not an easy task at all, and it will take considerable effort to make it widely accessible. 

Many medical doctors in the US are already prescribing early outpatient treatments, either publicly, or on the quiet, given the toxic politicization of the debate surrounding early therapies for COVID-19. Yet, most medical doctors don’t prescribe such treatment, because of a lack of information about it or fear of negative consequences for themselves.

What is actually required is to let medical doctors prescribe the best treatment possible for their patients, as early as possible, in the context of the sanctity of the doctor patient relationship. Early outpatient treatment for COVID-19 needs to become a most normal, non-controversial, act of medical practice, and the sooner the better.

Of course, it’s easier said than done, as many doctors fear prescribing such early therapies by fear of reprisal from medical boards or even lawsuits. In addition, in many states, there are restrictions to the dispensation of the required drugs, which would need to be lifted.

Senator Johnson emphasized at the hearing the importance of letting medical doctors to be doctors, to let them treat early and prescribe, without any hurdle and without a climate of fear.

Personally, as a potential future COVID-19 patient, early treatment makes huge sense to me. If I need to, I will consult with a medical doctor who has experience in treating the disease early. 

Although I live in a country, Canada, that has even stricter barriers to early treatment than the US, I will do my best to receive early treatment if a medical diagnosis indicates it’s needed.

I obviously have read a lot about early treatment over the past months, and I am convinced that, along with proper prophylaxis with supplements such as Vitamin D, Zinc and Quercetin, it’s the most effective means to avoid an acute form of the disease. 

One of the best up to date resources available about early treatment is the “Guide to Home-Based COVID Treatment” recently published by the American Association of Physicians and Surgeons, which everybody should read, to best prepare oneself to the possibility at some point of contracting the disease.

If I get COVID-19, I will not seek a consultation with Dr Jha, whom I hope will educate himself about early treatment, change his position and stop spreading misinformation globally.

Lives are more important than personal, political or whatever other agendas.

The worst thing that could happen to the US is for a Biden administration to refrain from implementing early outpatient treatment because of the ill-conceived advice from individuals like Jha who might be extremely influential in the coming months.


COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study, by Roland Derwand, Martin Scholz & Vladimir Zelenko

https://reader.elsevier.com/reader/sd/pii/S0924857920304258

Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection, by Peter A. McCullough, MD, MPH , Ronan J. Kelly, MD, Gaetano Ruocco, MD, Edgar Lerma, MD, James Tumlin, MD, Kevin R. Wheelan, MD, Nevin Katz, MD, Norman E. Lepor, MD, Kris Vijay, MD, Harvey Carter, MD, Bhupinder Singh, MD, Sean P. McCullough, BS, Brijesh K. Bhambi, MD, Alberto Palazzuoli, MD, PhD, Gaetano M. De Ferrari, MD, PhD, Gregory P. Milligan, MD, MPH, Taimur Safder, MD, MPH, Kristen M. Tecson, PhD, Dee Dee Wang, MD, John E. McKinnon, MD, William W. O’Neill, MD, Marcus Zervos, MD, Harvey A. Risch, MD, PhD

https://www.amjmed.com/article/S0002-9343(20)30673-2/fulltext

Outpatient Early Treatment Algorithm for COVID-19 – a Webinar with Dr Peter A. McCullough, with the participation of Dr Brian Tyson in the Q&As

Interview with Brian Tyson, MD, from California – a Pioneer of Outpatient Treatment for COVID-19

Professor Thomas Borody Interview 


Early Home Treatment for COVID-19 Explained. An interview about the Guide to Home-Based COVID Treatment

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