If A Drug Is Safe And Sometimes Works, Let COVID-19 Patients Take It

Italians can possibly get remdesivir by “compassionate use outside clinical trials” to treat serious COVID-19 emergencies.

COVID-19
Drug Addiction Clinic VitaWhen using on the Web, a hyperlink to https://www.vperemen.com/ is appreciated. / CC BY-SA

Italians can possibly get remdesivir to treat serious COVID-19 emergencies

Note to readers from Ron Trowbridge about his article to follow. Italians can possibly get remdesivir by “compassionate use outside clinical trials” to treat serious COVID-19 emergencies “in the lack of valid therapeutic alternatives.” Those ill should ask for it or at least inquire about it. It just might save your life.

In mid-March a Palo Alto, Cal., woman’s COVID-19 worsened to pneumonia while being treated at a Stanford University hospital. She had already suffered from asthma and diabetes. In a trial, doctors decided to give her the drug remdesivir, which has been well established as safe and used to treat ebola. It worked; she’s now home recovering wonderfully.

The outstanding question is: is it helpful for COVID-19? The answer is: yes, at least for some coronavirus victims. So why not let the drug be given to all COVID-19 patients rather than just in trials, as was the case for the Palo Alto woman’s trial? They have everything to gain and nothing to lose.  The drug sometimes cures pneumonia or possibly prevents it in the first place.

Governmental medical science, tragically, does not work this way. The Food and Drug Administration requires that, before a drug can be generally prescribed, it must clear three sets of clinical trials to prove that it’s safe and effective; that usually takes a year. COVID-19 patients usually have anywhere from a few days to a few weeks to live or die. Why can’t patients with the coronavirus take remdesivir to see if it helps? FDA approval for efficacy is largely pointless.

I learned of this sad FDA policy the hard way. I was on the board of the Abigail Alliance that sued the FDA when a terminal cancer patient was denied the right to experimental drugs even though the FDA had found them clinically safe and promising. Our argument was that if we have a constitutional right to defend ourselves against an attacker, why can’t we have that same right of self-defense when the attacker is cancer? I based this logic on my own wife’s experience: she had terminal lung cancer and was given an experimental drug that extended her life and eliminated her chronic pain.

Our case was heard in the D.C. Circuit Court of Appeals way back on August 7, 2007. We lost and would likely lose today because the FDA still mandates three clinical trials to prove drugs safe and effective. Dr. Anthony Fauci cites frequently the necessity of this three-clinical-trial process, referring to any other drug cure of the coronavirus as merely “anecdotal.”

Judge Judith Rogers supported our case and pointed out a cruel irony: in rejecting our appeal to extend cancer patients’ lives, said the judge, “the right to try to save one’s life is left out in the cold despite its textual anchor in the right to life.”

Chief Judge Douglas Ginsburg also supported our case. He argued: do we have a constitutional “right to eat meat” when the Constitution is silent on the matter? It is silent on drugs, which does not mean that we can’t take them. It is a right we are given by the Ninth Amendment: “The enumeration in the Constitution, of certain rights, shall not be construed to deny or disparage others retained by the people.”

It is tragic that a patient with COVID-19 and pneumonia or difficulty breathing cannot be given the remdesivir, which is safe and in some cases effective. It sent the Palo Alto woman home rather than to the morgue.

It should also be emphasized here that the FDA has just given emergency authorization for doctors to prescribe malaria drugs hydroxychloroquine and chloroquine for coronavirus.  Patients should inquire about these drugs.

Support our independent project!

Italics Magazine was born less than two years ago in Rome, from the idea of two friends who believed that Italy was lacking a complete, in-depth, across-the-board source of information in English. While some publications do a great job, writing about the latest news or focusing on specific areas of interest, we do believe that other kinds of quality insights are just as needed to better understand the complexity of a country that, very often, is only known abroad for the headlines that our politicians make, or for the classic touristic cliches. This is why Italics Magazine is quickly becoming a reference for foreign readers, professionals, expats and press interested in covering Italian issues thoroughly, appealing to diverse schools of thought. However, we started from scratch, and we are self-financing the project through (not too intrusive) ads, promotions, and donations, as we have decided not to opt for any paywall. This means that, while the effort is bigger, we can surely boast our independent and free editorial line. This is especially possible thanks to our readers, who we hope to keep inspiring with our articles. That’s why we kindly ask you to consider giving us your important contribution, which will help us make this project grow — and in the right direction. Thank you.