BY Dr. Dharshana Kasthurirathna  In November 2021, an article was published in the British Medical Journal by the investigative journalist Paul D. Thacker. It was regarding some damning revelations by a whistleblower researcher who took part in the Pfizer Covid-19 vaccine Phase Three trials. The article was titled “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial” (https://www.bmj.com/content/375/bmj.n2635).  Even though this should have been a hot topic in both the global and domestic, mainstream, digital and print media, as it is regarding one of the most impactful contemporary medical products, the Pfizer Covid-19 vaccine, surprisingly (or perhaps unsurprisingly) it received virtually zero coverage.  The article gives interesting insights on a less talked about aspect of the vaccine and in general, drug trials, but it received little or no attention from the media. It is quite surprising (or perhaps not so surprising) considering that this article revealed some troubling aspects of a critical Phase III trial of arguably one of the most impactful medical products that modern medicine has produced in the last couple of years, messenger ribonucleic acid (mRNA) Covid-19 vaccines. Pfizer’s mRNA vaccine was the first to receive emergency approval from the Food and Drug Administration (FDA) in the US and it is the most widely administered Covid-19 vaccine according to Statistica.com, with the Pfizer vaccine being accounted for 61% of all those Covid-19 vaccinations.  In Sri Lanka, it is being used as the default “booster shot” as well as the default vaccine for children above 12 years. Thus, the above revelation is indeed very pertinent in the Sri Lankan context as well.  The article discloses some internal workings of the covert world of vaccine/drug trials. One of the key aspects is that global pharmaceutical giants tend to “outsource” their trials to third party research firms, perhaps to cut costs and also efficiently manage the trials during a short span of time.  The article specifically points the finger to a research company called the “Ventavia Research Group” who conducted the Texas, US-based trial on behalf of Pfizer.   Brook Jackson, who was one of the medical researchers in the capacity of a regional director, involved with the trials, has exposed that the following malpractices and errors were observed in the Phase Three trials conducted by this company. Some of the allegations involves falsified data, un-blinded patients, employed inadequately trained vaccinators, the lack of timely follow up of patients who experienced adverse events, protocol deviations not being reported, vaccines not being stored at proper temperatures, mislabelled laboratory specimens, and the targeting of Ventavia staff for reporting these types of problems. When Jackson informed the FDA about the matter, she had received a note thanking her, yet apparently no further action has been taken.  In Pfizer’s briefing document submitted to a FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its Covid-19 vaccine, the company made no mention of the problems at the Ventavia site. The following day, the FDA issued the authorisation of the vaccine. According to the article, in August 2021, after the full approval of the Pfizer vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation.  So these observations beg the question whether regulatory bodies such as the FDA, which US citizens as well as the people of the world are supposed to trust are complicit in what may amount to nothing less than scientific fraud. Perhaps it is not surprising given that nine out of the last 10 FDA Commissioners – representing nearly four decades of Agency leadership – have gone on to work for pharmaceutical companies. Former FDA Commissioner Scott Gottlieb joined Pfizer’s Board of Directors as the newest addition to this trend.  Aside from this apparent revolving door between the pharmaceutical companies and the so-called “regulator bodies”, the article brings forth a more fundamental issue regarding the vaccine, or more generally, the drug approval process in the US.  Given that subcontracting of medical research is a competitive industry, the research firms that may compete to win the contracts from pharmaceutical giants like Pfizer to conduct their trials may be pressed to “please” their clients (in this case Pfizer), in order to continue to win such contracts. No company likes to lose their client base, so the research firms like Ventavia may willingly or unwillingly be forced to play with the methodology of the experiments or even play with the raw data to produce more favourable outcomes, particularly when dealing with groundbreaking and billion dollar worth products like Covid-19 vaccines on behalf of their clients.  In short, scientific integrity and correctness may suffer when the company carrying out the research may have a direct financial benefit from the product being deemed to be effective and safe. It is the very definition of a conflict of interest.  In actuality, this may be nothing new or nothing specific to Covid-19 vaccines or even vaccines in general. This may be an inherent issue in all pharmaceutical trials that are conducted to get approvals from the regulators. The regulatory bodies such as the FDA do not conduct clinical trials. Rather, they depend on the raw and aggregated data and methodological details submitted by the pharmaceutical companies to decide whether to approve a drug or not. The issue here is that the regulatory body has to “trust” the company in that they are telling the truth. That they have actually carried out the experiment the way they claim to be (for instance, if they claim they did a double blind trial, that they really did a double blind trial and not an unblinded one, which is one of the allegations against Ventavia). It begs a more fundamental philosophical question that even in science, which is supposed to be objective and devoid of personal biases, whether we can completely give up the notion of “trust”. The issue is, the regulators are choosing to trust scientists and researchers who are employed in and report to companies that have a direct interest in getting the drugs or vaccines approved, so that it could very easily be misplaced trust.  What can countries like Sri Lanka do in the wake of all this? Of course, we have little or no influence on how the FDA operates, how Pfizer conducts their trials, etc. But at least we can do a small scale trial before an experimentally approved product is administered indiscriminately to the general public, including all children? Sure, the sample size may be lower leading to statistical bias, yet statistical bias may be easier to live with compared to a more glaring financial bias.  (The writer is a senior lecturer in computer science and software engineering)  ………………………  The views and opinions expressed in this article are those of the author, and do not necessarily reflect those of this publication.