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Friday, February 13, 2015

The FDA's Role in Falsified Research

Almost two and a half years ago I wrote: "US Scientific Medical Studies: a 1 in 20 Accuracy Rate?"

Another post from 2011, linked in the article above, about how falsified studies are now the norm is available at "Falsified Medical Studies the Norm".

The bottom line is that most medical research, and yes, this could include research on ecigarettes and vaping, is falsified in some way.

One would hope, that in the case of things like medications, the FDA would be stepping in and weed out the problematic and false studies.

Unfortunately, according to this Slate article, it would not seem to be the case: "That misconduct [ by commercial companies ] 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."

The Slate article is the result of this JAMA Internal Medicine article.

So if I, a big medical company, falsifies my research on a new drug the FDA helps me out by hiding this fact from everyone. 

Lies are told.

Records and research lost, falsified or hidden.

People die.

According to the linked JAMA article: "... 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."

Now what this means is that when a study is invalidated by the FDA the FDA does not typically notify scientific journals

So articles or news stories written about the research are presented as true when, in fact, the FDA may have determined that they are invalid or outright false in any number of ways.

An article made public, therefore, may have zero scientific credibility, even with the FDA, but it won't tell anyone this.

Including you the consumer or potential consumer.

One wonders if the articles on the dangers of vaping and formaldehyde suffer from the same fate?

Are these articles reliable?

In the case of vaping and formaldehyde probably not (see this, google any number of other letters and notes on the relative problems with the original research).

Now the original JAMA article does not talk about vaping specifically and I did not check thoroughly through all the studies they examined to find out if they did but here are some interesting take-aways:

1) The FDA is a government agency.  Much of the type of information discussed here (from 483s notifications, e.g., FDA "warning letters", see this) are available though probably redacted.

Vaping should be trolling through this looking for tips and slips related to any vaping or ecig research that's on going at big tobacco and big pharma.

2) The existence of the JAMA research itself should be used to call into question the FDA's motives on "safety."

Anyone happy to let known-to-be-false research be published should be called on the carpet.

3) All vaping research must be reproducible.  If its not (though not that anyone in authority at a large government agency would care) then we are just as guilty and evil as "big pharma" and "big government."

From what I have see much of what's done in the "pro vaping" area looks reasonable - though without full disclosure no one can really tell.

1 comment:

  1. Questioning Authority might be better for our health than playing submissive to the dominance of this Overlord of discretionary BS!