The FDA Evidently Colludes in Hiding Medical Industry Corruption in Clinical Trials — according to an Investigation by Charles Seife and His Students

10 February 2015

We do not have to look far to see why the American public does not trust government

Governance seems to have devolved into an occupation that prospers well-connected, Ivy-schooled types — while some (but not all) of the often uncontrollable bureaucracies that they pretend to supervise extort flesh from those who lack money and recourse.

The latest evidence to support this cynical view comes from science and medicine chronicler Charles Seife, writing in JAMA Internal Medicine:

Every year, the US Food and Drug Administration (FDA) inspects several hundred clinical sites performing biomedical research on human participants and occasionally finds evidence of substantial departures from good clinical practice and research misconduct.

However, 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.

Fifty-seven published clinical trials were identified for which an FDA inspection of a trial site had found significant evidence of 1 or more of the following problems:

falsification or submission of false information, 22 trials (39%);

problems with adverse events reporting, 14 trials (25%);

[scientific] protocol violations, 42 trials (74%);

inadequate or inaccurate recordkeeping, 35 trials (61%);

failure to protect the safety of patients and/or issues with oversight or informed consent, 30 trials (53%);

and

violations not otherwise categorized, 20 trials (35%).

Only 3 of the 78 publications (4%) that resulted from trials in which the FDA found significant violations mentioned the objectionable conditions or practices found during the inspection.

No corrections, retractions, expressions of concern, or other comments acknowledging the key issues identified by the inspection were subsequently published.

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.

© 2015 Charles Seife, Research Misconduct Identified by the US Food and Drug Administration: Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature, JAMA Internal Medicine, DOI:10.1001/jamainternmed.2014.7774 (online first, 09 February 2015) (at Abstract) (extracts)

FDA cover up practices are almost certainly intentional

Regulators often climb into bed with the institutions that they are supposed to oversee. As Charles Seife said in Slate:

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wild video.

It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reports. Forged retinal scans. Phony lab tests. Secretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

That misconduct happens isn’t shocking. What is:

When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary.

For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses.

The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market.

Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn't get forthright answers.

For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

Getting the goods on the FDA’s sniveling lackeys

Mr. Seife points to the prevalence of highly redacted FDA inspection documents — meaning that the agency has blacked out words, sentences and paragraphs. The agency thereby ensures that no one can see just how corrupt the industry it regulates is — nor how complicit the agency itself is in cooperating with the cover up:

If you manage to get your hands on these [inspection-related] 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.

I recommend that readers look at Seife’s persuasively reasoned and documented Slate article.

For more background on conundrums in medicine, see here.

The malevolent FDA’s behavior is just another example of American government’s burgeoning love affair with fascism

Properly defined:

Fascism is an ultra conservative political ideology combining a totalitarian state with big business. It is not necessarily racist . . . .

Most definitions of fascism, including Wikipedia’s, are too broadly amorphous to be historically and semantically useful. Fascism distinguishes itself from communism and nationalistic totalitarianism via government's focused connivance with business titans at the People's expense.

The United States, a nation in which wealth buys political power and influence, has become an increasingly fascist state.

The moral? — Fascism begins when business wealth captures government institutions and bends them to its will

When American leaders speak about expanding democracy’s sway throughout the world, they are peddling a myth that conceals a profitable anti-public intent.

It is not just the bomb, bullet and missile guys, who are unceremoniously unseating “We the People” from our allegedly democratic republic.

PeteFree.com

The FDA Evidently Colludes in Hiding Medical Industry Corruption in Clinical Trials — according to an Investigation by Charles Seife and His Students