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FDA hiding science fraud?

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From IO8: The FDA Is Hiding Scientific Fraud, And You Should Be Pissed

Okay, somewhat crudely put. But anyway:

When the FDA encounters instances of scientific misconduct, it buries the evidence. A recent investigation sheds light on the extent of the problem.

The U.S. Food and Drug Administration – the agency tasked with protecting public health via regulation of everything from food safety to prescription drugs – occasionally encounters serious instances of misconduct in biomedical research. According to an investigation published in the latest issue of the Journal of the American Medical Association, these cases include

…falsification or submission of false information… problems with adverse events reporting… protocol violations… inadequate or inaccurate recordkeeping… failure to protect the safety of patients and/or issues with oversight or informed consent… [among other violations]

Study author Charles Seife, an acclaimed science writer and professor of journalism at NYU, writes that “the FDA has no systematic method of communicating these findings to the scientific community, leaving open the possibility that research misconduct detected by a government agency goes unremarked in the peer-reviewed literature.”

Here’s Seife’s piece at Slate:

We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. More.

Article at JAMA (Public access) From the Abstract:

Conclusions and Relevance When the FDA finds significant departures from good clinical practice, those findings are seldom reflected in the peer-reviewed literature, even when there is evidence of data fabrication or other forms of research misconduct.

Primary documents here.

Overall, the comments seen so far at IO8 seem overly focused on what “deniers” will think. But one commenter makes quite a sensible point:

The trouble is, to suggest that “these guys lied and the people paid to oversee their work covered it up, so we can’t necessarily trust any of them” is an entirely rational conclusion to reach.

Yes.

Like they say, fool me once, shame on you, fool me twice, shame on me. Fool me thrice, and I am co-dependent with a phoney.

But what if I’m just not the co-dependent type?

There are times when it pays to be a denier.

See also: It’s hard to believe anyone is still writing this kind of garbage about peer review

A friend draws our attention to a paper on “unfounded authority” in science

and

If peer review is working, why all the retractions?

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Hat tip: Stephanie West Allen at Brains on Purpose

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