It is not up.to the Food and Drug Administration to carry out clinical trials. That is up to the person or company which wants its drug to be approved.
Fabunan has yet to seek approval for Fabunan Antiviral Injection.
Curiously, the social media campaign appears to.be using a social media infrastructure connected to the present Philippines administration. The profiles of those promoting it are overwhelmingly pro-administration, with hashtags such as #FAI and #protectthepresident appearing in promotional posts.
Evidence of troll-farm involvement is the promotion of FAI on a website called Attracttour. A whois check shows that the site conceals its ownership behind a Panama company called Whoisguard. Prima facie evidence of troll farming.
Real medicines of therapeutic value have been through a rigorous process off research and trials to prove that they work. A potential drug may be patented before research begins, so a patent does not mean the drug is effective.
Dependency on the notorious troll farms of the Philippines reduces the credibility of the Fabunan claims.
It is up.to those making a medical claim to satisfy the regulatory authorities that the claim is justified and that the medicine is as effective and as safe as possible. This is done by presenting clinical trials data for peer review.
Let’s look at the typical process:
First, there will be in vitro, ‘in glass’ studies to see how the drug affects, say, the virus it is targetted at and its effect on human cells.
Next come animal trials. These help identify safety issues as well as effectiveness. Again, these studies will be submitted to reputable journals, submitted to experts in the field and published if recommended.
From there the proposed medicines are tested on healthy humans, and these studies will again be published.
Finally, the medicines will undergo clinical trials on people suffering the target disease. Once more these will be published.
There is another route that is used: Through correspondence in a noted medical journal. A search of medical journal databases show that no such correspondence is recorded involving Fabunan, nor have any clinical trials been published.
Personal testimony by itself is meaningless. An important part of the trials is to compare results between patients who have been given the actual drug and those who have been given something that looks the same but has none of the active ingredient called a placebo. If there is no difference then the drug is .is deemed ineffective.
This placebo effect can be very strong. In a University of Nottingham study comparing painkillers to placebos some 80 per cent of those taking the placebo reported a painkilling effect.
Even people who have undergone ‘placebo surgery‘ where no actual surgical procedure was carried out have reported benefits from something that did not actually happen.
Very relevant to FAI, since it claims to be effective against the Common Cold, is a 2011 study which demonstrated that patients taking medicines which they believed contained an active ingredient showed benefits.
So, patient testimony is worthless unless trials take account of the Placebo Effect.
All of these studies will.be presented to regulatory bodies for approval. It provides evidence that the medicine works and how safe it is.
No such trials have been published for FAI. Without them, it cannot be approved.
A fact missing from the social media campaign is that no application for approval of Fabunan Antiviral Injection has ever been made to the FDA. On 8 April 2020 the FDA made the following statement in a warning about using non-approved medicines:
“Manufacturers and vendors of unlicensed products such as PRODEX B and the Fabunan Antiviral Injections have been informed regarding the process and requirements to register their products with the FDA Center for Drug Regulation and Research (CDRR). No applications for product registration have been filed to date. Untinl such products are proven safe and effective for use in the treatment of COVID-19 they cannot be dispensed to the public nor can therapeutic claims be made.*.
On 28 April Department of Health officials warned that FDA approval had still not been given, no registration applied for and that used of the drug for Coviid-19 was illegal.
The requirements for registration are here.