No compassion in compassionate use

CTALK - Cito Beltran (The Philippine Star) - April 12, 2021 - 12:00am

In our collective battle against COVID-19 and its minions or variants there is now a great divide. On one side are the men and women from all professions and expertise who seek any and all remedies, possibilities and solutions to save lives, cure those infected and prevent further destruction and infections from taking place. They are the ones that have pushed for many new techniques, doing away with certain treatments for certain patients, improving handling, using different kinds of medicines for “Off Label” use such as Hydroxychloroquine, Ivermectin, Remdesivir, Leronlimab and others.

On the dark side of the divide are the government “experts” and authorities who seek safety, protection and to wash their hands the same way Pontius Pilate did. These people on the dark side are those who have memorized and recite a phrase in order to justify their inaction or their seeming indifference or unwillingness to just listen, read or consider possibilities:

“The clinical practice guidelines of the Philippines and the DOH drafted by experts on COVID-19 state that: There is insufficient evidence to recommend the use of – in the treatment of patients with COVID-19.”

Add to this the official statement of the Food and Drug Administration or FDA that they are willing to immediately issue a “Compassionate Use Permit” for such products or medicines provided that a licensed physician makes the request under the condition that the physician undertakes responsibility for any and all outcomes related to the use of the medicine. Further, the medicine must have undergone scientific study related to its use for COVID-19 treatments.

This is the height of HYPOCRISY and BUREAUCRATIC BS! Can someone from the DOH or any one in the world certify, authenticate and validate that there is, or there are, true COVID-19 experts in our midst? The disease is anywhere from 14 months to 18 months old in terms of human history. We may have true experts in virology, genome sequencing and contagion, but even the leading MDs in the US and Europe have said in so many interviews that COVID-19 is still a puzzle and a global challenge.

There are certainly no “experts” on COVID-19, especially not in the DOH. Even Dr. Francisco Duque, has deferred time and again to the WHO, which from time to time has had to recalibrate its position or opinion on several matters such as the source of the virus, the use of face masks, democratic and humane distribution of vaccines. They pick and choose what to say or do as they go because there is no proven handbook or history of managing COVID-19.

Time and again the naysayers in the DOH, IATF and FDA have pointed out that there are no long-term or wide-ranging clinical studies regarding the medicines now being pushed for consideration by other physicians desperate to save people’s lives. First of all, it is the same situation for almost all the vaccines currently in the pipeline. Most of the vaccines are either lacking in the required stages of testing, lacking in scientific data and papers for review, are manifesting never before seen adverse effects and yet in its desperation the Republic of the Philippines, through the FDA, has issued EUAs or Emergency Use Authorizations and has allowed the vaccination of all our frontliners. Did anybody consider that if something seriously went wrong we would have wiped out our health sector using vaccines that have been tested only in less than a handful of countries?

It seems to me that when it is convenient or necessary for the government, DOH or FDA, they can wave their hand in approval but when smaller groups are calling for government to CONSIDER or STUDY a possible solution, the people in the dark side immediately fash mobs and beat down the idea and the proponents.

Here is another thing to consider, if the DOH and FDA claim to have experts studying the data on alternative drugs, may we know who and how exactly are these experts doing the study and for how long do they conduct research in order to authoritatively declare that what they say is gospel truth and uncontestable? It would take months to go through the scientific studies just to read them, then validate or corroborate. It would take half a year to years to duplicate or conduct confirmatory laboratory/clinical/patient-based studies.

As far as I can remember, most of the medicines proposed for consideration were only brought to public attention within the last six months. So if some paid consultant simply read through a 20-page summary or read the accompanying leaflet for a medicine, sorry that is reading the instructions, not research.

As for the Compassionate Use Authority of the FDA, there is not an ounce of compassion in it, when in order to get the FDA permission, a doctor or physician has to expose him or her self to being sued by anybody and run the risk of being stripped of their license to practice medicine just because a dying or critically ill patient was administered a medicine on “Off Label Use” as a last choice.

The logic and intent of the Compassionate Use Authority is to save a life or remedy a critical situation; the assumption is that it is a desperate move and if the family of the patient has been informed and agreed to it, perhaps even signed a waiver, then no doctor should be required or forced to sign such undertaking or responsibility. It is bad enough to lose a patient, such an undertaking of responsibility is an insult to the medical profession that is rooted in saving lives at all cost.

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E-mail: utalk2ctalk@gmail.com

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