Miracle Cure For Covid-19 or Fabunan Fable? Part 1

No such report has been published by the Jakarta Post

Update: 6 December 2020: A press release issued by Universitas Gadjah Mada of Indonesia implicitly  developconfirms that social media reports of Fabunan Antiviral Injection already being deployed in Indonesia and already approved for clinical trials are false. The Indonesian university announce an MoU under which it will collaborate with a ‘philanthropic’ company, PT Filipinas Antiviral Indonesia, FAI, to develop ‘antiviral products. No approvals have been given for clinical trials and the deal appears to be a promise of funding by FAI for research. No mention is made of any Fabunan products. FAI is headed by Mariano Marcos, who has made a number of social media videos claiming that Fabunan Antiviral Injection is already being used indonesia. The press release is here.

Update 17 August 2020: Fabunan promoters have been pasting a photoshopped picture of the Front page of the Jakarta Post, Indonesia, to make it appear that the newspaper front-paged Fabunan FAI. The Jakarta Post has no such report.

Update 1 August 2020: Indonesia’s Health Ministry, through the Indonesian Embassy, says that Fabunan has received no approvals for any activity in the country. This explains the absence of Fabunan’s FAI from the country’s database of clinical trials. The Ministry was responding to fact-checking organisation Vera Files.

Update 26 July 2020: FAI promoters now claim that Indonesian authorities have approved a patent for 20 years, following a supposed deal with a government-owned pharmaceutical company. Neither is required to show that FAI works. There is, again, no independent confirmation of these claims. They assume that social media campaigns will force governments to overlook the total lack of clinical evidence to support the alleged benefits of FAI. Requirements for pharmaceuticals approval are here.

Update 22 July 2020: FAI promoters claim that FAI is responsible for recoveries in Indonesia but provide no evidence. Indonesia has just reported its second highest death toll. They also claim it is being sold by an Indonesian state pharmaceutical company to Ab u Dhabi. Again, no independent evidence for this claim.

Update 13 July 2020: The promised trials are a no-show. FAI promoters now say next week. Despite a legal requirement in Indonesia for all clinical trials to be registered, there is no registration for these alleged trials. Promoters now saw that there will be no publication of double-blind, placebo-controlled studies in any peer-reviewed medical journal of note, the minimum requirement for validation and that it will rely entirely on social media marketing.

Update 8 July 2020: Fabunan promoters on social media claim that clinical trial results will be released on Saturday, 11 July 2020.
Update 6 July 2020: Social media posts claim that clinical trial results will be announced this week. However, no such clinical trial;s have been registered with the Indonesian Clinical Trial Registry, indeed, no clinical trials involving Covid-19 are being undertaken.

Update 3 July 2020: A promotional video for Fabunan Antiviral Injection has been banned from Youtube for breaching community standards.  The video claimed that a production deal for FAI was signed in Jakarta. There is no independent confirmation of any such deal, nor of the claimed clinical trials, supposedly involving 20 hospitals in Indonesia.

Update 21 June 2020: It is widely claimed on social media that Fabunan invented and patented Dexamethosone. This is false. It was invented in 1957 by Philip Showalter Hench and approved for medical use in 1961. When one claims that every viral disease that hits the headlines is cured by your brand of jollop, with no scientific evidence to back of any of those claims, you don’t get to claim you discovered a cure.

Update 20 June 2020: FAI promoters claim that the results of human trials will be announced in Indonesia at a press conference in Jakarta. No record of any such trials is recorded in any database. Nothing has been said about double-blind, placebo controlled , peer-reviewed trial publication.  Dubious claims continue to circulate on social media alone.

Update 17 June: Oxford University has announced successful trials using dexamethasone, an ingredient in FAI, in hospitalised patients suffering severe respiratory distress. There was no benefit in those not suffering respiratory distress, so it has no curative or preventative action as proposed by the Fabunans. It therefore indicates that FAI is ineffective.

Update: 13 June 2020: One of the promoters of FAI has indocated that any clinical trials in Indonesia will not be submitted for peer-review in a recognised medical journal and the results will only be announced by press release in the Indonesian press. If so, it will indicate that the trial results are less than reliable and will be rejected by the medical community.

Update 21 September 2020: Despite claims made on social media there is still no evidence that FAI has been approved, or undergoing clinical trial, or being legally used anywhere.

: 8 June 2020. Social media posts claim that the Indonesian health authorities had agreed to conduct clinical trials on Fabunan Antiviral Injection. The claims appear only from know promoters of FAI. Despite the importance of such a move, if true, it remains unconfirmed by medical news and information outlets, the WHO database of ongoing Covid-19 measures, Indonesian media, Philippine media or any reliable source. Given the track record of misinformation by FAI promoters (Such as claims that the Philippine FDA had approved FAI), we catalogue the claim as dubious.Clinical trials must be registered, yet no such trial can be found on clinical trial databases such as  centerwatch.com or clinicaltrials.gov.Update: 31 May. Malacanang corrects false information regarding FAI.

Important update: 27 May: The Fabunan Medical Clinic has closed.

Update, 24 May, 2020: The Philippine FDA has issued a cease-and-desist order, DoH is ‘working up a case’ against Dr Willie Fabunan. Here for more information.

New information is emerging on the Fabunan claims which are now being verified. Updates will be made as these are checked.

Corrections of factual errors are welcome in the comments section, which is moderated.

Right now, things are little different from the 1918 Spanish flu pandemic which killed up.to 18 million people, according to some estimates. Many of the rumoured ‘cures’ have re-emerged in the Covid-19 crisis. You’ll find some familiar claims in this recording.

Now, as then, fake news and fake cures have appeare throughout social media, presenting serious hazards, as the International Consortium of Investigative Journalist reports.

In the US alone, thousands of fake products have been seized which claim to protect or cure Covid-19

The case of the Fabunan patented jollop raises a number of red-flags suggesting that a patented mixture of painkiller and a steroid for treating Covid-19, Fabunan Antiviral Injection, is, prehaps less than is claimed for it. It is not encouraging that development was led by an accupuncturist, Willie Fabunan.

Indeed, the signboard of the Fabunan Clinic dies not inspire confidence, suggesting, as it does, that it can ‘sterlize’ HIV/AIDS and Dengue, diseases with no known cure. These are among the ‘red flags’ that indicate a problem in accepting the claims.

In the Philippines, it is widely assumed that a US product has more credibility than a Filipino product and a US connection is often leveraged for marketing purposes.

The most important words missing from the signboard are ‘US Approved’

The 2007 patent for FAI applies to a range of drug mixtures made of anaesthetics and corticosteroids, and injection programmes, generally three injections. Each injection costs about 20USD, so a full course costs a not-inconsiderable sum, for most Filipinos, of 60USD.

A red-flag is that the patent claims it is effective against the common cold, influenza, measles, chickenpox, SARS, and HIV.. it has not been approved for use against such infections.

In 15 years no scientific evidence has been presented to support these claims. Indeed, a 2011PhD thesis by a biochemist, Najoua Elbourakadi at the University of North Carolina at Greensboro, dismisses FAI as ineffective against HIV.It is claimed that the components of FAI metabolised into an antiviral substance called DEAE. The researcher determined that the yield of DEAE was too small to have any effect. Dexamethasone was used alone in vitro experiments which had theoretical promise. No further experiments have been conducted.A recent trial by Oxford University found that, while effective in Covid-19 patients with. severe respiratory distress, Dexamethosone had no benefits for patients without respiratory distress and provides a list of worrying side-effects

This image appeared in Facebook posts. Dr Fabunan presented no papers at the conference and there is, ss yet, no record of Fil-Am Tech making a formal presentation. We are awaiting confirmation from the conference organiser.

In communications with me Doctor Ted Herbosa, Associate Professor at the University of the Philippines recalls that in the 1960s rural doctors would use a mixture of steroid and paracetamol as a ‘cure’. The steroids would make the patient feel good and give an energy boost. In the 1970s the practice of doctors making up their own medicines was banned and physicians were required to use only registered drugs.Although the ingredients of FAI are separately registered for otherr medical conditions, neither is registered for use against Covid-19,The Fabunan Medical Clinic biodata for Dr Fabunan deserves attention. It makes reference to the National Inventors Hall of Fame in Ohio but he is not among that organisation’s inductees. Much of the data appears to consist of Who’s Who publications of the kind that charge for inclusion, or purchasing copies. No medical or scientific organisations are mentioned, nor any relevant publications.

The ingredients of the so-called FAI, as given in its patent, raise concerns. It has no antiviral component but it does have a powerful anaesthetic, Procaine, and a corticosteroid called dexamethasone sodium phosphate.

In fact, recent correspondence in the eminent medical journal The Lancet, warns against the use of corticosteroids in the treatment of Covid-19, “Overall, we call for caution in the use of corticosteroids for COVID-19 and do not recommend this as a routine treatment.”

A further red-flag is that no mention is made of side-effects, although its constituents, whiich are off-the shelf drugs, certainly do.

Having seen a number of calls on social media, especially Facebook and Youtube for the Food and Drug Administration of the Philippines to approve or use a medication, allegedly an anti-viral, patented by Dr Ruben Fabulan of San Marcellino, Zambales.
While the gentleman has a number of patents getting a patent does not indicate that the medicine is effective in any way.
Youtube videos exist, but these are not evidential with regard to efficacy or safety.
Searches of medical research databases show no published peer-reviewed clinical trials in any journals, something one would expect to find in the biography of a self-styled ‘drug designer’.

Until Dr Fabulan has published his research in appropriate medical journals of recognised authority it is unlikely that the DoH or BFAD will take the claim seriously and, indeed, would be foolhardy to do so.

To understand the indicators that FAI is, at best, misguided, at worst a scam, let’s look to how real medicines are developed and their safety and effectiveness ensured.

Part Two

Part Three

Part Four