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Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature.

barbc56

Senior Member
Messages
3,657
This was quite eye opening.

Research Misconduct Identified by the US Food and Drug Administration

The findings presented in this study should give us pause. This investigation has found numerous studies for which the FDA determined there was significant evidence of fraudulent or otherwise problematic data. Such issues raise questions about the integrity of a clinical trial, and mention of these problems is missing from the relevant peer-reviewed literature. The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds. The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.

The FDA has legal as well as ethical responsibilities regarding the scientific misconduct it finds during its inspections. When the agency withholds the identity of a clinical trial affected by scientific misconduct, it does so because it considers the identity to be confidential commercial information, which it feels bound to protect.184 However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health. Such allegations are relevant to include in the peer-reviewed literature on which physicians and other medical researchers rely to help them choose treatments that they offer to patients and other research participants.

To better serve the public health, the FDA should make unredacted information about its findings of research misconduct more readily available. The agency should make sure that any substantial evidence of misconduct is available to editors and readers of the scientific literature. One possible mechanism for this would be to use the national clinical trials database: any OAI inspection affecting a trial site should be promptly noted at http://www.clinicaltrials.gov. The FDA should also create a website or a publicly available database that lists all OAI-rated inspections of clinical sites and provides links to copies of the relevant, unredacted, inspection-related documents

http://archinte.jamanetwork.com/article.aspx?articleid=2109855#Conclusions
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barbc56

Senior Member
Messages
3,657
An important point here.

We frequently point out flaws in the practice of science as a way to inform interpretation of the scientific literature, and to suggest specific improvements to make the practice of science more reliable and transparent. Others, however, point to the same flaws as a way of dismissing the findings of science in general, or at least anything with which they disagree.

Findings such as these can be used as a way of improving the institutions of science, or as a way of tearing it down. I prefer the former.

http://www.sciencebasedmedicine.org/reporting-research-misconduct/
 

barbc56

Senior Member
Messages
3,657
@Snowdrop

I don't think it's a matter of conflict of interest or malfeasance per se, but more of a glitch in a system that needs to be fixed.

Nonetheless, an interesting point. Can you elaborate?

Barb
 

Snowdrop

Rebel without a biscuit
Messages
2,933
I was thinking of :

However, failing to notify the medical or scientific communities about allegations of serious research misconduct in clinical trials is incompatible with the FDA’s mission to protect the public health.

In the second paragraph of the first post. I have this week read of another science researcher who allegedly falsified data. It seems to be a growing problem (although this was not a clinical trial). So I guess I was being a bit general in my post that there should be an oversight agency that has the mandate to expose misconduct. It seems that there are conflicts with the FDA as I read this comment.
 

barbc56

Senior Member
Messages
3,657
The FDA’S reply:

[UPDATE: An FDA spokesman later sends a note to say the agency is "committed to increasing the transparency of compliance and enforcement activities with the goal of enhancing the public’s understanding of the FDA’s decisions, promoting the accountability of the FDA, and fostering an understanding among regulated industry about the need for consistently safe and high-quality products.

"Regarding redaction of warning letters, the majority of information that is redacted from warning letters about clinical trials pertains to either the protocol or patient identifiers. The FDA redacts protocol information from warning letters because the information pertains to a pending application, not because it may reveal investigator misconduct. Information on pending applications is exempt from public disclosure based on several federal statutes and regulations, such as the Freedom of Information Act"

Not sure what to make of this.

Barb
 

barbc56

Senior Member
Messages
3,657
@Snowdrop

This says it better than I can.

To put the problem into perspective, in 2013 FDA inspections uncovered misconduct in 2% of their investigations. Further, the FDA takes steps to correct the problems they uncover, such as excluding tainted data or even entire studies. The problem here is one of transparency, especially in the peer-reviewed literature. I don’t know if it is fair to say that the FDA buries its findings of misconduct, rather than they simply have no systematic method of reporting their findings
.

http://www.sciencebasedmedicine.org/reporting-research-misconduct/