The pandemic has shined a light on the fact that the national and international health authorities aren’t always correct in their guidance to the public. During the course of this pandemic, more scrutiny has been placed on the public health agencies and regulatory bodies’ performance during these challenging times. In a time when the world needed clear guidance based and reasonable evaluation of quickly changing evidence, these agencies grossly under-performed such as:
1. The WHO stating there was no airborne transmission, only to be proven wrong by hundreds of scientists.
2. The WHO, NIH, and EMA strongly advising against the use of systemic steroid treatment only to be proven wrong by the RECOVERY trial.
3. The NIH/FDA approving Remdesivir for Covid-19 treatment only to be proven wrong by multiple large RCTs such as the WHO’s SOLIDARITY trial.
These failures and many more have left the public searching for credible sources of information. Unfortunately, this void has been filled by a wide variety of voices, with some dispensing harmful information and others providing clear analysis of the ever-evolving knowledge of Covid-19. The challenge for the average layperson is to determining if a source is credible. Enter the self-proclaimed “fact checkers.”
The goal of fact-checking is to provide unbiased assessments of various media sources so a reader can evaluate the validity of a particular source, article, or assertion. In the best of circumstances, fact checking is a challenge since there are many opposing viewpoints on any topic. However, with science in general, knowledge is based upon a consensus of opinion of accumulated evidence. For the scientific community to come to a consensus on a particular fact takes many years and voluminous data. Even then, there are many times consensus is never achieved.
As TrialSite has documented, early treatment therapeutics have shown promise in many RCTs, OCTs, and case series during the pandemic. We’re on the record that too little investment was placed behind well-designed RCTs to determine which of these promising repurposed therapeutics were efficacious against Covid-19. Instead, regulatory bodies and medical science agencies placed all the emphasis on novel therapeutics and vaccine development.
Therefore, the public has been left with the choice of following the official health guidelines, which have been proven wrong time and time again, or turn to credible sources who review imperfect data and make risk-balanced recommendations to the public, such as the FLCCC, BiRD, and many others. Recently, the AIIMS and ICMR in India have added their voice in support of early treatment.
This brings us to the recent developments in India. It’s well known that India experienced a massive surge in cases starting in late March 2021 with a 7-day new daily case average peaking on May 8th (see data below from Worldometers.info):
In response to this massive surge in new cases and deaths, the AIIMS issued new treatment guidelines for Covid-19 on April 22nd, 2021.
These treatment guidelines included the optional use of the following early treatment therapeutics: Ivermectin, Hydroxychloroquine, and inhaled Budesonide. It’s impossible not to notice a strong temporal association between the updated guidelines and the following dramatic reduction in new cases. While this correlation does not prove causation, it adds to the growing body of evidence for the use of early treatment therapeutics. This association has not gone unnoticed and many are proclaiming that this association combined with the excellent safety profile and promising data from multiple meta-analyses justifies broad adoption of early treatment therapeutics globally.
This has led to self-appointed “fact checkers” to refute the association and issue their verdict:
There is no evidence that new guidance on the use of ivermectin and hydroxychloroquine led to a reduction in COVID-19 cases in India. In fact, hydroxychloroquine was reported to be in widespread use well prior to the country’s second-wave outbreak.
Experts told AAP FactCheck the treatments had not been shown to be effective in combating the coronavirus. India’s reduction in cases also coincides with other public-health measures, such as the vaccine rollout and statewide lockdowns.
False – Content that has no basis in fact.
So who is the AAP and is their Fact Checking based on credible evidence? First, the AAP is the Australian Associated Press. According to their website, “Australian Associated Press is the beating heart of Australian news. AAP is Australia’s only independent national newswire and has been delivering accurate, reliable and fast news content to the media industry, government and corporate sector for 85 years. We keep Australia informed.” Their newswire service is offered through various products to influence the agenda every day. One of those products is their FactCheck service. They tout that their FactCheck service is IFCN accredited. What is the process to become IFCN-accredited and does it ensure an entity is qualified to be FactCheckers? The IFCN accreditation process is outlined on their website in the following three steps:
Step 1: Application – Submit an application online and pay $200
Step 2: Assessment – External assessors will evaluate the applicant at $350/each. A vote of 4 assessors is required for approval.
Step 3: Verification – If the applicant fails to meet certain criteria, they can pay $200 fee to be reassessed after making edits.
Once approved, signatories can put a badge on their site indicating they are IFCN approved. Every year, the signatory needs to re-apply to renew their verification (Step 3 above).
Does this process ensure that IFCN-approved FactCheckers are actually qualified to pass judgment on all topics? Does this process ensure that each article the signatory writes is accurate and not misleading? Who will fact check the fact checkers when questions arise?
As before, TrialSite will step into this void and provide an unbiased viewpoint on the topic and allow our readers to make their own informed decisions.
The AAP factcheck article makes the following questionable statements in their analysis:
1. “While India’s COVID-19 cases have declined from their peak in early May, there is no evidence a “regime” of the drugs hydroxychloroquine and ivermectin are responsible for the fall.” This statement is clearly false. By definitio,n there is evidence of an association between the change in guidelines and the following rapid reduction in new cases and deaths. The question is not if there is any evidence. The question regards the quality of the evidence. TrialSite would agree that taken alone, the epidemiological data showing an association of the new guidelines and the drop in new cases and deaths is not strong evidence. However, it is additional data that aligns with the multiple meta-analyses, RCTs, OCTs, and case series that should be considered as a comprehensive body of evidence.
2. “Meanwhile, the drop in COVID-19 cases also coincides with the acceleration of the country’s vaccination program. According to Our World in Data, more than 140 million people had received at least one dose of a COVID-19 vaccine by mid-May. The figure represents around 10 percent of the population.” To insinuate that the drop in cases is due to the acceleration of the country’s vaccination program is extremely misleading. The average new daily cases started to drop on May 8th. At that time, the percent of fully vaccinated people in India was only 2.47%. This percentage falls far short of even the most optimistic herd immunity requirements. In addition, AAP chose to use the inflated statistic of a single dose, which is grossly misleading. It’s well documented that it takes time for immunity to develop after the jab. It’s generally accepted that there is no benefit to vaccination until at least 12 days after the first dose. Even then, protection continues to build over time and does not reach the numbers seen in the RCTs until 2 weeks after the final dose is administered.
3. “Both drugs have been frequently touted as possible COVID-19 treatments, however international health agencies (see here, here, here and here) have advised against their use citing a lack of evidence of their efficacy as well as potential side-effects.” This is accurate but misleading by the act of omission. They chose to not include the National Institutes of Health’s Guideline. The NIH Guidelines are followed closely by many countries around the globe. The NIH reviewed the evidence for Ivermectin early in 2021 and upgraded their guidance to neutral for Ivermectin in the treatment of Covid-19. This leaves the decision in the hands of the treating clinician and their patient.
4. “The health ministry’s clinical treatment guidelines, issued on 24 May, also said doctors should ‘consider’ giving either ivermectin or hydroxychloroquine to patients with mild cases of COVID-19.” This fact was used to support a false conclusion. The guidelines and the protocols being used in India are not as clear cut as they are in other counties. The AIIMS issued guidance for the use of Ivermectin, HCQ and Budesonide for early treatment on April 22nd 2021. Their guidelines are followed widely in India. This critical guideline change occurred over a month prior to the published guideline the AAP chose to cite as the beginning of the early treatments. This is false and irresponsible reporting. See here.
5. “However, the guidelines did not represent a major shift in the official advice except for the addition of ivermectin. India’s superseded guidelines, issued on July 3, 2020, also said hydroxychloroquine could be used for both mild and moderate cases.” This is false. The earlier guidelines only included HCQ. They did not include either Ivermectin or Budesonide. Is it possible that these two new therapeutics represent a significant change in efficacy of the early treatment regime? Maybe that is the question the AAP should be investigating.
6. “Professor Catherine Bennett, the chair of epidemiology at Deakin University, wrote in February that the evidence on hydroxychloroquine and ivermectin was lacking. When contacted by AAP FactCheck, she said her opinion remained the same:
“There has been no change re: evidence, except even more trial results published that indicate neither make a difference in moderating disease outcomes in those with COVID-19,” she said in an email.” This is false. There have been numerous RCTs published since February that support the use of Ivermectin in Covid-19. Here is just one example of a peer reviewed published double blind randomized placebo controlled trial of 100 patients.
The conclusion of this study: “Combination of ivermectin and azithromycin was more effective in making patients symptom free than azithromycin alone.” This is just yet another small RCT added to the large body of evidence in support of Ivermectin against Covid-19. To state that there has been no change in evidence to support Ivermectin since Feb, is clearly false. There are many additional examples to be found on TrialSite News and at the following website here.
7. “fact-checkers Health Feedback noted India’s reproduction rate (R rate) – a measure of the number of new COVID-19 infections generated by each case – was already falling prior to the health ministry’s new guidance.” This statement is false. As shown above, India’s guidelines were updated to include Ivermectin and Budesonide on April 22nd, which is over a month earlier than the AAP represents. This does represent a temporal association of the drop in daily new cases and the change in early treatment guidelines.
8. Finally, from AAP’s Verdict section: “Experts told AAP FactCheck the treatments had not been shown to be effective in combating the coronavirus. India’s reduction in cases also coincides with other public-health measures, such as the vaccine rollout and statewide lockdowns.” AAPs final verdict was “False – Content that has no basis in fact.”
While there is no doubt that multiple factors were in play during the massive surge in India, such as lockdowns, wider adoption of masking, and closer adherence to NPIs, it’s also clear that there was a change in early treatment guidelines that preceded the dramatic drop in average new daily cases and deaths. Epidemiological data will never prove causation. It’s too complex to be able to draw any firm causation relationships. However, epidemiological data does provide insights. It’s fair to look into what might have been different in similar populations that deployed different mitigation measures. One of those measures was the adoption of early treatments in some Indian states that showed a marked decline in cases while other states that didn’t adopt early treatments did not experience the same level of decline.
Seeing so many misleading statements in this AAP “fact check” piece begs the question: What are the motives behind this type of piece, where there is clear examples of erroneous and misleading statements? Here at TrialSite, we’ll continue to follow the evidence regardless of whether it’s the popular opinion at that moment in time. We’ve already seen too many times during this pandemic that misinformation one day turns out to be found credible once the “authorities” and “factcheckers” catch up to the data.