Sunday, January 19, 2025 3:34:16 PM
Since you requested a rebuttal to you paper comments....
Quality of the Paper: Peer review is more than an initial quality check. It is a validation by people experienced in the field who examine the paper, it analysis, and its conclusions. The ultimate arbiter of the "claim's universal validity" is an almost meaningless phrase, but let's assume that it has some meaning. The "ultimate arbiter" will be time and the overall the continued advancements of the field.
Role of the 58 Authors: Of course all 58 authors did not contribute equally to the paper. That intuitively obvious. Each author contributed his or hers area of expertise. What is important is that the 58 people put their signature and reputation on that paper. That means they agree with the paper and its conclusions. The is a lot of expertise in different areas agreeing with the paper.
Regulatory Approval:No one suggested that the EMA and FDA base their decisions solely on the authorship or reputation of those listed. You are creating a straw man argument. The RA do consider peer reviewed papers in their regulatory decisions as one of the many factors that they consider. The FDA has said that it likes to see peer reviewed papers on a drug that is applying for approval.
Limitations of the Paper: Of course the paper acknowledges the "key" limitations. That is a standard part of a scientific paper. Every paper has limitations. Journal papers are necessarily limited in size and can not go into the depth that NDA or EMA filing would. Again that is an obvious statement. That is why the Journal paper 12 pages and EMA and NDA filings are in the many tens of thousands of pages.
On Constructive Discussion: Your final line gets it right. "In summary, the presence of expert authors on a paper enhances its credibility but does not make it immune to scrutiny. Engaging with the reasoning behind skepticism instead of dismissing it outright helps cultivate a more informed and respectful discussion."
The problem is there has been not nearly as much skeptical reasoning as there has been cynical negativity.
Quality of the Paper: Peer review is more than an initial quality check. It is a validation by people experienced in the field who examine the paper, it analysis, and its conclusions. The ultimate arbiter of the "claim's universal validity" is an almost meaningless phrase, but let's assume that it has some meaning. The "ultimate arbiter" will be time and the overall the continued advancements of the field.
Role of the 58 Authors: Of course all 58 authors did not contribute equally to the paper. That intuitively obvious. Each author contributed his or hers area of expertise. What is important is that the 58 people put their signature and reputation on that paper. That means they agree with the paper and its conclusions. The is a lot of expertise in different areas agreeing with the paper.
Regulatory Approval:No one suggested that the EMA and FDA base their decisions solely on the authorship or reputation of those listed. You are creating a straw man argument. The RA do consider peer reviewed papers in their regulatory decisions as one of the many factors that they consider. The FDA has said that it likes to see peer reviewed papers on a drug that is applying for approval.
Limitations of the Paper: Of course the paper acknowledges the "key" limitations. That is a standard part of a scientific paper. Every paper has limitations. Journal papers are necessarily limited in size and can not go into the depth that NDA or EMA filing would. Again that is an obvious statement. That is why the Journal paper 12 pages and EMA and NDA filings are in the many tens of thousands of pages.
On Constructive Discussion: Your final line gets it right. "In summary, the presence of expert authors on a paper enhances its credibility but does not make it immune to scrutiny. Engaging with the reasoning behind skepticism instead of dismissing it outright helps cultivate a more informed and respectful discussion."
The problem is there has been not nearly as much skeptical reasoning as there has been cynical negativity.
Nunc est Bibendum
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