It Is Too Early For Fauci to Proclaim Remdesivir As a Standard of Care.
Yesterday, in a striking departure from academic medical decorum, Dr. Anthony Fauci proclaimed Gilead’s anti-viral drug, Remdesivir, THE new “standard of care” (SOC) for treatment of SARS-CoV-2 infections.
To be clear, it is a cause for celebration that Remdesivir is reducing the length of hospital stay for COVID-19 patients by a few days. Hopefully, it’ll also salvage those who get critically ill and end up in ICUs — though I suspect that’s going to be a more complex issue.
Notwithstanding, my main criticism is Dr. Fauci’s proclamation the Remdesivir is now “THE standard of care” for treatment of COVID-19 disease.
To put this in perspective, in the practice of medicine, especially for treatment of common illnesses (which COVID-19 disease now is) SOCs are established in one of two ways: 1) through expert society consensus or, 2) using randomized controlled clinical trials (RCT) that demonstrate treatment efficacy. Typically, the latter approach is the preferable one, which most consider the gold-standard in an “evidence-based” approach to the practice of medicine — because it is scientific and it is more likely to eliminate the professional or expert biases that could contaminate consensus-based standardization.
Of course, despite our best hope that standardization is always a good thing, as with most things, the creation of SOCs is a two-edged sword!
The upside of establishing SOCs in medicine, or in any profession, is that standards maximize overall societal benefit and minimize errors. SOCs in contemporary medicine do so in two ways: 1) SOCs ensure patient access by justifying provider reimbursement in our contemporary payor scheme and 2) SOCs eliminate the overt application of unproven treatments with questionable safety or efficacy, by exposing a non-standard practice to liability — afterall the majority of practitioners practice SOCs on the majority of patients.
The downside of establishing SOCs in medicine can, equally, maximize harm and stifle innovation on a systemic level. Because once a SOC is established for a disease, most patients and providers are locked into the box defined by that standard. SOCs are susceptible to the following dangerous pitfalls: 1) Consensus-based SOCs risk incorporating a particular group’s professional prejudices or ignorance — usually at cost to a specific subsets of patients whose risks are either “assumed benign” or are not carefully calibrated by the experts’ consensus, 2) SOCs developed based on randomized control trials (RCT), because of their gold-standard status in evidence-based medicine, can put significant financial and political barriers to efficient development, testing and adoption of potentially safer and more effective treatments. Therefore, any particular consensus-based SOC could be “negligent”, if it is based on incorrect or unjustified assumptions underlying the expert consensus that gave birth to them. And, any particular RCT-based SOC could powerfully stifle innovation and eliminate potentially more beneficial treatments if it fails to compare all/most feasible and cogent treatment options. This is particularly true when RCT standardized therapies are financially lucrative by virtue of high volume. SOCs, by definition, create service lines and service lines make money! But if the lucrative service line box is either based on incorrect assumptions or has not been compared comprehensively to the array of available treatment options, it can do harm and stifle progress.
With the above background about SOCs in medicine, let’s go back to Dr. Fauci’s proclamation about Remdesivir being “THE Standard of Care” for treatment of COVID-19 disease from the oval office yesterday, April 29, 2020.
To reiterate the unprecedented nature of what happened: in the span of approximately 6 weeks, ONE single trademarked, non-generic drug from ONE multinational corporation, was unilaterally proclaimed from the oval office to be THE new SOC for the treatment of a pandemic virus we’ve known for only a few months.
Fauci’s proclamation about this drug from the Oval office, a political office, was shocking to me. Strikingly, the Fauci proclamation of THE new SOC comes before ANY objective third-party scientific peer review has taken place - and before ANY comprehensive evaluation of the other scientifically cogent drugs, that MUST be evaluated carefully, has taken place.
Again, I want to be clear: Remdesivir’s capacity to save a few hospital days for each patient is not to be discounted — it is a hopeful sign and a testament to our medical establishment’s power to work quickly. Of course, the full picture, especially with respect to salvaging those patients who become critically ill on death’s door, is likely going to be a lot more complex.
Here, for the reader’s consideration, are the dangerous pitfalls in Fauci’s exuberant proclamation about Gilead’s Remdesivir:
- The oval office was used in an unprecedented way as an advertising platform for ONE company, Gilead’s, ONE trademarked drug, Remdesivir! Last I checked, the White House is not a Madison Avenue advertising firm in the business of establishing monopolies, which is essentially what the Fauci proclamation has done for Gilead and its investors.
- At the time of the Fauci oval office proclamation, The Remdesivir study had not yet been peer-reviewed by a group of objective third party scientists outside of those with a vested interest in the drug’s success — both the clinicians doing the study and the administration officials, whose president wants things to go back to “normal” as quickly as possible. Though Fauci himself is a man of integrity, the trouble is that one man’s integrity, alone, does not guarantee that bias or irrational exuberance are eliminated as possibilities.
- By prematurely proclaiming that every other drug that is used to combat a NEW four month-old viral disease must now be compared to Remdesivir, Fauci has dominantly stifled innovation and progress in the treatment of COVID-19 disease, which we do not even fully understand as a disease yet. First, because faced with the possibility of death, most patients and their loved ones will likely choose the “known SOC” in favor of any other “unknown experimental”. And, second, because the majority of financial resources and incentives are now going to be preferentially funneled into delivery of the one standard instead of searching for the most effective one. This kind of market dominance would be ok, of course, if an already exhaustive search and evaluation process for an effective drug had already taken place. Simply put, Fauci’s proclamation about Remdesivir has now dangerously stifled discovery in the case of a brand new disease we do not fully understand — perhaps even more so than Trump’s own non-expert touting of Hydroxychloroquine did, several weeks ago.
I want to be clear, if Remdesivir is able to successfully reduce the length of hospital stay for COVID-19 patients, that is a hopeful achievement. But Facui’s nearly political proclamation that this drug is now THE standard of care in treatment of COVID-19 disease, only a few weeks old in the US, is a dangerous and unprecedented error in public health judgement.
I think that Fauci’s premature public proclamation about Gilead’s Remedesivir, alongside the presidents marketing of Hydroxychloroquine, will go down in history as a dramatic misuse of government power in clinical medicine. Because, Fauci has used the rhetoric of “evidence-based medicine” to prematurely create a new “standard of care” and establish a stifling monopoly — in the midst of a deadly pandemic with millions of lives on the line, when creating rigid practice patterns might cost us the whole of America.
