Former FDA auditor offers honest appraisal of vax development process

Walking a Fine Line

“Follow the appropriate procedures and listen to the data,” was the key message in a presentation by former FDA auditor and sponsor consultant Pat Stone, who discussed clinical research audits, assessments, mediations and eventual drug confirmations in an online conversation with the Clinical Trials Guru. Stone, who is the author of Bubble Gum Badge an FDA His-story, explores the importance of the US Food and Drug Administration (FDA) in his book by providing a glimpse of what the FDA does well, what it needs to improve on and what clinical trials are trying to accomplish.

Stone describes himself as a patient safety advocate for effective medicine. “Auditors swear on the bible that they will uphold certain procedures, and I did this in 1998,” he said.

Currently, Stone is focused on developing clinical trial sponsors that grow into bigger organizations. Sponsor deficiencies, he said, can arise from a number of factors. These deficiencies can be a matter of quality systems when the CRO does all the work. It can be an interfacing problem when much of the work is virtual. Sponsors need to ensure oversight by understanding and managing all of the procedures in a clinical study and making sure that everyone knows that deviations are unacceptable.

Stone expressed concern that the current crop of COVID-19 vaccines did not have the benefit of the 9 or 10 years it normally takes to roll out a drug. As he explained, “The speed at which we’re approving drugs Is a little too fast for vaccines.  There could be too many adverse effects. Some are transitional, and some are lifelong. We needed more safety studies before giving the vaccines to the public.”

He added, “The FDA is trying to walk a fine line of politics and science. In some cases, diseases are very lethal. However, most age ranges will not die of COVID, so I’m not sure we needed a rollout this quickly. We wanted to keep the safety in mind, and now we’re seeing that the efficacy isn’t there. We need to be more cautious.”

Stone is disturbed that the US Food and Drug Administration (FDA) has told Pfizer that it does not have to release information on its clinical trials for 50 years. He believes that stripping away potential culpability is a problem.

“This vaccine is more like a gene therapy than a vaccine,” Stone said. “You use a human stem cell, and you change it to give it an mRNA mechanism. You only manufacture spike proteins. It’s not like a flue vaccine, because it doesn’t provide an immunity.”

Stone, who wonders why drugmakers did not manufacture a traditional vaccine, pointed out that because the coronavirus mutates, it is a moving target. The body, he explained, does not always respond to spike proteins and react to them with an immune response. As he said, “If an individual is vaccinated twice and catches COVID, the COVID virus is at higher levels. Gene therapies are cures. They are saving people.”

Stone believes that misinformation is being disseminated by news outlets. For instance, there were more COVID deaths in 2021 than in 2020, but it was not reported by the media.

Only a handful of sites are doing the COVID studies. After getting adverse events, the sites need to say so, he said. There have also been cases of manufacturing problems, such as having two kinds of vaccine in one vial. He questioned whether adverse effects at the site level were reported on time, within 24 hours, and whether proper data validation was done to match source data to line listings.

“We need more safety profiles,” Stone said. “The CDC stopped counting breakthrough cases – individuals who were double vaccinated but contracted COVID. You have to count when a product doesn’t work. You can’t hide the data, because you won’t know the true efficacy.”

Stone is very concerned that every study requires that no experimental treatment is done on the last day of the study, but all COVID product in the US was designated as being for experimental use at the outset of the approval process. He reasons that if a drug is safe and effective, it is not necessary to hide behind an immunity clause. “You can mandate whatever you want, but you have to make the manufacturers accountable,” he added.

Hospitals, according to Stone, are filled with COVID patients “who have been jabbed two or three times.” He speculated that the m RNA model may not be the best fit for treating COVID, although it may have appeared to be the best option in 2019. 

Stone is also convinced that the COVID pandemic did not emanate from a natural occurrence. It is rare for viruses to be transmitted from one species to another. He described the COVID pandemic as biological warfare, although he thinks it was probably accidental. “A viral vector lab, level 4, in a nation like China that is not ready to handle it is a Pandora’s Box,” he said. “We need to elevate medicine, to find better ways to fight viral vectors.”

According to Stone, the effectiveness of the current COVID vaccines is just over the numbers for the placebo. There are many breakthrough cases, especially with variants coming into play. Now that the flu season has arrived, there could be 200,000 deaths from COVID and flu combined.

“We have to keep civil discourse in America,” he said. “We have to look at the data and see what works. We also need better treatment studies. Some trends are good for research. Scientific minds and emerging sponsors are on the rise. We should be aiming for good and effective research that minimizes the need for mandates. Then we can get individuals back to work and enjoying life.”

He concluded, “The bottom line is that we have to listen to the actual data. We can’t skew it or shorten the process and expect the same results.”

Watch the full video here: