Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Dear Editor:
As a physician who has both conducted and participated in research, I must maintain certification in ethics and research standards. As an undergrad at Yale forty years ago, we were compelled to participate in psychiatric research as part of our grade. That would now be recognized as coercion. Clinical trials are supposed to adhere to the strictest level of protocol, blinding and ethical methods. Without those measures, one cannot decipher meaningful outcomes. When the placebo group is unblinded and given treatment with the study agent - absolutely no meaningful conclusions can be drawn.
Since 1989, the research around mRNA vaccinations and treatments had not achieved longstanding approvals due to severe complications. Use of mRNA as delivery of treatment has been relegated to the likes of terminally ill patients. The Dengue-vaccine disaster in the Philippines is a clear example of what happens when you rush a vaccine to market. Pfizer's failure to adhere to clinical trial protocols (via a subcontractor or not), reveals that patients don't matter, only money does.
Furthermore, to completely ignore the basic tenets of virology and immunology as I was taught in medical school, is that your primary exposure to a pathogen is the permanent pattern by which your body responds in the future. Thomas Francis in 1960 coined the phrase "original antigenic sin". Natural infection induces all portions of the immune response, not just a single antigen - like a spike protein.
I, too, posted the BMJ article to Facebook and was cautioned that it was fraudulent information. I did it anyway. Thank you for publicizing Pfizer's failure to maintain proper standards of research.
Rapid Response:
Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Dear Editor:
As a physician who has both conducted and participated in research, I must maintain certification in ethics and research standards. As an undergrad at Yale forty years ago, we were compelled to participate in psychiatric research as part of our grade. That would now be recognized as coercion. Clinical trials are supposed to adhere to the strictest level of protocol, blinding and ethical methods. Without those measures, one cannot decipher meaningful outcomes. When the placebo group is unblinded and given treatment with the study agent - absolutely no meaningful conclusions can be drawn.
Since 1989, the research around mRNA vaccinations and treatments had not achieved longstanding approvals due to severe complications. Use of mRNA as delivery of treatment has been relegated to the likes of terminally ill patients. The Dengue-vaccine disaster in the Philippines is a clear example of what happens when you rush a vaccine to market. Pfizer's failure to adhere to clinical trial protocols (via a subcontractor or not), reveals that patients don't matter, only money does.
Furthermore, to completely ignore the basic tenets of virology and immunology as I was taught in medical school, is that your primary exposure to a pathogen is the permanent pattern by which your body responds in the future. Thomas Francis in 1960 coined the phrase "original antigenic sin". Natural infection induces all portions of the immune response, not just a single antigen - like a spike protein.
I, too, posted the BMJ article to Facebook and was cautioned that it was fraudulent information. I did it anyway. Thank you for publicizing Pfizer's failure to maintain proper standards of research.
Competing interests: No competing interests