Big Money, Politics & Fed Gov Redirects & Captivates Mass Attention: Obscuring Pragmatic Off-Label Studies Targeting COVID-19

Aug 24, 2020 | COLCORONA Trial, COVID-19, News, Off-Label, Operation Warp Speed, Popular Posts, Survey

Big Money, Politics & Fed Gov Redirects & Captivates Mass Attention Obscuring Pragmatic Off-Label Studies Targeting COVID-19

COVID-19 therapeutic clinical trials involving off-label, generics and those sponsored by small biotech generally continue to experience delays due to lack of awareness during the political season, consolidation of federal research power during the pandemic as well as testing notification delays. For those sponsors that aren’t part of the U.S. government’s federally-driven “Operation Warp Speed,” such as the Montreal Heart Institute’s COLCORONA trial, this dynamic spells real trouble as a recent Harris Polling survey shows that 60% of Americans have never heard or read little to nothing about available clinical trials for newly diagnosed COVID-19 patients involving generic medications or drugs that are already approved for other uses. Mass media, social networks, and other information sources direct the masses to the sensationalism of political squabbles or the high-profile, big ticket vaccine studies or monoclonal antibody treatments. Other less known studies sponsored by small biotech or other generic or off-label studies are left in the corners of obscurity. The loser: the American people.

Lack of Media Access Terminal for Studies

Studies such as the COLCORONA trial are a case in point. While 77 percent of Americans know about the usage of hydroxychloroquine thanks in part to either President Donald Trump or his detractors, next to none know about the COLCORONA trial, testing available treatments that could offer immediate results, reports Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, and COLCORONA principal investigator.  

Dr. Tardif reminded audiences that while hydroxychloroquine overall has led to disappointing results, the public is oblivious to that fact that at least three smaller studies actually revealed some promise with colchicine. He concludes, “Each of those studies concluded we need quality, robust clinical trials like COLCORONA to definitively change clinical practice for colchicine usage.”

The Study

TrialSite showcased this international clinical trial investigating the efficacy of the common drug used for gout as a potential therapy to reduce the severity of illness, complications and hospitalizations associated with COVID-19.

Trial sites are distributed across the United States in the tri-state area (NY, NJ, CT), all the way to California (Bakersfield, San Francisco and Los Angeles), Florida (Miami and Jacksonville), Texas (Houston and Dallas), Arizona (Phoenix and Yuma) and Rochester, Minnesota.

TrialSite reported that the COLCORONA study was actually a form of decentralized study, making it easier for patients to participate. Its actually an at-home, contact-less clinical trial approved by the appropriate health authorities and designed to have minimal burden on patients. It’s actually one of the few current studies of COVID-19 infection in which non-hospitalized individuals can participate.

What is Colchicine?

Colchicine is a generic, orally administered anti-inflammatory medication currently indicated for the management of pericarditis, gout and familial Mediterranean fever. It is not a non-steroidal anti-inflammatory medicine. This drug was recently studied in the COLCOT study (published in the New England Journal of Medicine), which showed that the drug significantly reduces the risk of ischemic cardiovascular events. Colchicine has also been studied for treatment of COVID-19 in the GRECCO-19 study (with the results published in the Journal of American Medicine Association), which showed statistically significant improvement in resumption of normal activities or time to clinical deterioration.

Gov. & Big Pharma Vs. Off-Label Generics? Not a Chance

But in the United States, the federal government has centralized research to consolidate and drive efficiencies for purposes of trial site networks and importantly, patient recruitment. For example, the National Institute of Allergy and Infectious Diseases (NIAID) consolidated several infectious disease-focused investigator and trial site networks into the COVID-19 Protection Network

Now there is one central website, for example, marketed across the nation. Alongside peer groups, such as ACTIV, that vet and decide which studies will receive federal funding, the independent study focusing on the economical and pragmatic off-label approaches are pretty much dead on arrival—they just don’t stand a chance in a society that doesn’t include a large, dynamic and educated critical thinking population. 

Rather what gets the attention:

·         First & foremost vaccine trials (Moderna, etc.)

·         Eli Lilly and Regeneron advanced monoclonal antibody studies

Lead Research/Investigator COLOCRONA Study

Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, and COLCORONA principal investigator

Call to Action: Interested in learning more about this study? Contact 1-877-536-6837.

Source: PR Newswire


  1. Paul Elkins

    Very well said Trial Site News! It’s criminal that the NIH is spending massive amounts of taxpayers’ dollars on funding Big Pharma trials while neglecting the already approved promising drugs ripe for repurposing! Big Pharma is already incentivized to fund a good portion of their product trials since they stand to make billions in profits. Much of the taxpayers’ dollars should be directed at already approved and promising repurposed drugs to benefit the public’s health in the shortest turnaround time. These drugs are generic and therefore offer no incentive to Big Pharma. While the NIH is sponsoring the repurposed drug RCTs the FDA should issue EUAs on any promising repurposed drug that already has an excellent safety profile. The NIH/FDA and Big Pharma’s cross pollination is costing way too many lives. This shouldn’t be busy as usual!

    • ML

      Well said, Mr. Elkins. I 100% concur! And I’ll go a step further- the fact that we are not using EARLY therapeutics known from real-world experiences to be helping people, is criminally negligent. We absolutely must treat people in the viremic phase of this disease and not allow them to descend into the dangerous pulmonary phase and the highly inflammatory immune dysregulation phase of this terrible disease. Once body systems are irreparably damaged, we have less tools to salvage these people. Early therapeutics are the absolute key to corralling Covid-19. The fact that the USA has been wholesale against this tactic takes the mask off of this so-called “exceptional nation” and shows it for what it actually is- rapacious, corrupt, and frankly, wicked.

  2. Sabuktagin

    It appears that we are in the hands of profiteers! Life of people aren’t stakes, remedy is there in hands, people of developing countries getting the benefits from cheaply available medicines. The doctors prescribing without federal or state control resulting ver less number of people dying
    May God Save Our America from complex health system.

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