Crisis within the ‘Complex’ as COVID-19 Clinical Trials Leads to Mostly Waste of Time, Energy & Money

Jul 7, 2020 | Clinical Trials, COVID-19, News, The Complex

Crisis within the ‘Complex’ as COVID-19 Clinical Trials Leads to Mostly Waste of Time, Energy & Money

As the COVID-19 pandemic spread around the world most clinical research programs were put on pause while industry, government and academic sponsors pivoted in a frenzy to research centering on the novel coronavirus. With 1,200 clinical trials commencing almost literally overnight it turns out enormous amounts of time, money and human capital were wasted according to a recent Stat critical review. Because the studies are too small or rushed in some way leading to flawed assumptions, most of them won’t produce anything near clear results.

First a Word on ‘The Complex’

TrialSite News has identified an intertwined set of research institutions—spanning public, academic and private sector—groups consisting of good, well-intentioned and of course brilliant people, prominent influencers and an associated ecosystem of powerful financiers, advisors and regulators as part of a natural but in some ways devolving industry sector that may in fact, be driven more by cold economic expediency than “the people’s” health care and wellbeing, pandemic or not.  

From the apparent politicization of certain drugs to a complete lack of intellectual curiosity to what could be possible economical and pragmatic approaches (for at least some parts of the world) to treat the novel coronavirus, mounting evidence leads some educated people to believe bias, nepotism and a form of “crony capitalism” now grips the pharmaceutical, academic and government entities that shape the world of new drug development.

That true innovation is about finding the fastest and most economical path to health care, not the most exotic, advanced and expensive approach, is lost on many including at least some factions in regulators and the nation’s research agency. Because although they are in fact brilliant and wonderful people, they are part of a system that shapes, molds and prescribes how they must view the world.

Only a health care movement, one propelled by a spirited, bi-partisan non-ideological and informed health care consumer or advocate en masse—can counter such a truly powerful, rapidly devolving, twisted market distortion. But remember, without our health we have nothing.

A Waste of Time, Energy & Money

In an important piece by pharma industry journalist heavy Matthew Herper and Erin Riglin, Martin Landray, professor of medicine at Oxford University (and investigator on the RECOVERY study), was quoted in the recent sobering Stat account that “It’s a huge amount of wasted effort and wasted energy when actually a bit of coordination and collaboration could go a long way to answer a few questions.” That 39% of the trials involving less than 100 patients that is just one of the findings derived from the alliance of Stat and Applied XL, a computational journalism venture. The two sought to analyze COVID-19 data from Clinicaltrials.gov to find that 237,000 of the 685,000 of the patient participants enrolled in studies were of hydroxychloroquine and chloroquine, controversial drugs that were meant to be administered early if successful.

Ivermectin & Favipiravir Shunned by “the Complex”

Stat, in a perhaps evidencing bias in the clinical research “complex” mentioned above emphasized that “Since patents willing to enter studies are one of the scarcest resources in medicine, this means that other potential treatments, such as Ivermectin and favipiravir, were not studied.” And given TrialSite News is at least one of a number of groups closely monitoring clinical research in the age of COVID-19, some evidence of bias and favoritism certainly manifest in unfolding research endeavors. The recent Stat piece touches on this.

Some Success

The article summarizes that COVID-19 researchers did produce some wins, such as the identification of dexamethasone as a possible inexpensive and available treatment for those patients with severe to critical COVID-19 put on ventilators. Not included were the publicly funded, expensive failures such as the IL-6 inhibitors where companies rushed to repurpose expensive biological drugs in the hopes of monetizing the situation. But they were not planned well acting more in a reactionary way. A CEO of a prominent company is even on the record that there is a low probability of success when you try everything in the kitchen sink. Well then why do it in the first place? Well, if tax payer money helps cover the costs, there is an opportunity to roll the dice.

Source: STAT News

1 Comment

  1. John Liposky

    The FDA has a system that can be used to survey anecdotal evidence It’s called Real World Evidence, RWE, so that more people can get off label treatments to see what works best. This should get more patient with quicker recovery and fewer deaths.

Pin It on Pinterest