Did the U.S. FDA Improperly Expedite Remdesivir’s Approval? The Public Citizen Demand Letter to FDA, Plus a TrialSite Perspective

Did the U.S. FDA Improperly Expedite Remdesivir’s Approval The Public Citizen Demand Letter to FDA Plus a TrialSite Perspective

Last month, the nonprofit group Public Citizen sent a letter to the U.S. Food and Drug Administration (FDA) to revisit the regulatory approval of Gilead’s antiviral drug remdesivir for the COVID-19 indication. Openly questioning the validity of the authorization coupled with a requested evaluation to determine if the status should be rescinded, they suggest that the FDA violated their own policies involving its public advisory committee in the effort to approve the controversial drug. Already, the World Health Organization (WHO) via the Solidarity trial has declared that the drug isn’t effective for treating COVID-19. TrialSite summarizes the intent of the letter and provides a perspective on how both the FDA and the National Institute of Allergy and Infectious Diseases (NIAID) may have some culpability.

On the Record

In a letter addressed directly to both Acting Commissioner of the FDA Janet Woodcock, MD, as well as Patrizia Cavazzoni, MD, Director of the Center for Drug Evaluation and Research for the FDA, Michael Abrams, MPH, PhD, a health researcher with the nonprofit organization, declared last month, “The FDA’s previous failure to convene its own public advisory committee to consider whether to approve remdesivir was inexcusable.” The representative continued, “This failure was particularly troubling given that the agency was aware of evidence from a major clinical trial that raised substantial doubts about whether the drug provides clinically meaningful benefit.”

What’s the Request?

First, Janet Woodcock, acting Commissioner of the FDA, as well as Dr. Cavazzoni  “convene a public meeting of the FDA’s Antimicrobial Drugs Advisory Committee to review the agency’s October 2020 decision to fully approve remdesivir.”

While the investigational product was authorized for emergency use thanks to Dr. Anthony Fauci and the National Institute for Allergy and Infectious Diseases (NIAID) flexibility to actually change a study endpoint at the very last weeks of the study, Public Citizen contends that sufficient data was available as to dissuade the FDA from proceeding with an approval.

What’s the Basis?

For example, Public Citizen’s point of view centers on the fact that two of the five studies under FDA review revealed that the antiviral drug reduced the duration of hospitalization only for a subset of patients infected with SARS-CoV-2, the virus behind COVID-19. And of course, as TrialSite showcased in “No Knock out Drug…” no studies actually evidenced a reduction in COVID-19 death rates. Again, the WHO study, the largest of all studies, revealed no benefit.

The TrialSite Point of View

TrialSite seeks greater research transparency and accessibility to ultimately advance biomedical research. Three important elements are necessary for greater research participation, including 1) awareness, 2) trust, and 3) engagement. The TrialSite platform supports and facilitates all three of these critically important elements.

Not only is TrialSite independent and not beholden to any particular agenda but also the media platform seeks an objective, unbiased perspective. During the rush to authorize remdesivir, American society and beyond faced tremendous pressure to find treatments that could help contribute to a reduction in death rate and hospitalization. The brand new disease had all concerned quite frightened and under the previous POTUS administration, definite pressures were underway to make good things happen.

Hence, although TrialSite went on the record with critical views of NIAID’s arbitrary modification of the study endpoints, it’s an activity that more than likely was deemed necessary as some treatments were needed, even if they were only partially effective in a period of unprecedented crisis.

Of course what must be investigated is the NIH (including NIAID) as well as FDA’s participation, if any, in stifling generic competition during the pandemic. An example has been the continued avoidance of evidence associated with ivermectin studies as an example. That Dr. Antony Fauci on the one hand is open-minded and progressive when coming to flexibility in interpretation, even openly changing critical endpoints at the end of the study while on the other hand taking on an aggressive, hostile stance to ivermectin data evidence indicates a particular position that must be investigated.

In regards to remdesivir, TrialSite accumulated dozens of examples of real-world cases where the use of remdesivir appeared to contribute to helping patients fighting COVID-19.  In fact, there are a few scenarios where the drug appeared to save lives. Does this mean that the drug is scientifically effective? No, of course not. But the drug does appear to have helped at least some COVID-19 patients.

As far as the $3 billion or so the company was able to make in association with the sales of the drug during the first nine months of the crisis, it was actually made possible potentially thanks to a concept called “regulatory capture”: that is, the apex research agency and the Gold Standard regulatory body in the United States are not fully objective and independent, but rather are part of an integrated ecosystem that involves deep industry ties. This doesn’t mean they are corrupt per se but rather of a particular state of mind and their associated actions so align between industry and regulators/government that in fact, they appear to act in unison.

TrialSite posits that Gilead can’t be blamed as they are not at the root cause of this problem. In fact, TrialSite has acknowledged that when it came to maneuvering and positioning drug development under pandemic conditions, this company’s teams were nothing short of brilliant. The leadership of Gilead must produce returns; otherwise, they’re out. That’s the way the system works.

So, blaming the company really doesn’t look at the true root cause of the erosive rot in the research and regulatory system. The fact that regulators and apex research officials failed to even consider generic alternatives during the height of the crisis is not only outrageous but merits a serious investigation into gross negligence if not more severe liability. Why? Well, if it turns out that other low-cost approaches are in fact even just partially effective and safe based on risk and benefit analyses, then many thousands if not hundreds of thousands of deaths could have possibly been avoided in America alone.  

Responses

  1. “The leadership of Gilead must produce returns; otherwise, they’re out. That’s the way the system works.”

    I wholeheartedly disagree with TrialSite’s assertion. DISHONESTY IS REPUGNANT EVEN IF THE EXECUTION IS BRILLIANT AND PROFIT MOTIVATED. TSN’s failure to call it so is disturbing.