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Exposing that murderous ole FDA
July 2016
by Jeffrey Bouley  |  Email the author
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If ever a headline to one of my editorials needed a “sarcasm font style” (and seriously, why have we not created one yet?), this would be it. We’ll get back to the FDA and its bloodthirsty reign of terror shortly.
 
I see a lot of stuff in my inbox intended to be earnest and sincere that can amuse me in that eye-rolling way or amuse me with outright laughter—either because the given email or letter so clearly doesn’t belong in DDNews (like promotion of dating events in Cleveland or the latest new dystopian sci-fi e-book from a random unknown person) or because it’s so tangential. For the latter, I can already see in my email inbox today “Article: Food Options That Can Heal The Brain” and “Hopewell Successful with Young Adults with Mental Illness; Prepares Them to Thrive When They Return Home”...and—delete without reading!
 
But then there’s the stuff that should, theoretically, be potentially useful for my coverage of pharma, biotech and diagnostics but isn’t—groan-worthy rather than amusing. Half to two-thirds of the emails I get from Public Citizen fall into that category. Seriously, do they ever have anything truly nice (or even neutral) to say about the FDA, the NIH or any other governmental health/life-sciences agency?
 
And then in early July came the email on behalf of the Alliance for Natural Health USA touting its new FDA Death Meter website.
 
I’m not providing the link; I’m probably giving them too much publicity even mentioning them to begin with, but I can’t help myself. Your favorite search engine can help you if you’re morbidly curious to check it out.
 
But seriously...Death Meter?
 
Surely, I thought, this is just something to grab attention for some group like Public Citizen that is over-earnest and overly critical but ultimately well-meaning and residing in reality—or at least in a nearby suburb of it.
 
And the news release I got seemed at first to be free of major histrionics, saying things like:
 
“Today the Alliance for Natural Health USA (ANH-USA) released a new online tool that analyzes the damage being done to the American public through the mismanagement, harmful policies, and negligence of the US Food and Drug Administration (FDA).
 
“Drawing on data feeds from a variety of governmental sources, users are able to look at the actual numbers of serious adverse events like hospitalizations and deaths from FDA-approved drugs, vaccines, and medical devices. Because the government openly acknowledges that adverse events are grossly underreported, the FDA DeathMeter allows users to apply different underreporting adjustments to the numbers. This will give the American public a more complete understanding of how extensively the FDA has been hijacked by the pharmaceutical and medical industries.”
 
OK, “hijacked” gets a little histrionic, but still...
 
So I went to the website, where the meter says there have been more than 750,000 deaths  from FDA-approved drugs, vaccines, and medical devices since 2005—as reported by the FDA itself. OK, still with you. When you consider misuse of drugs, unavoidable adverse events for some, etc. I don’t see that as particularly shocking.
 
But then they say, “the real number of deaths is between 5-100x more than what the FDA is required to report,” then offering the “real” numbers that account for “underreporting.” The day I checked the site they came out to 3,753,861 for the 5x modifier, 15,015,442 for the 20x modifier and 75,077,211 for the 100x. Yes, they are actually saying it’s reasonable to lay as many as 15 million to 75 million deaths since 2005 at the FDA’s feet. Congratulations, FDA, apparently you’re worse than Hitler or Stalin (or at least as bad as either of them).
 
And how did we get the ridiculous claim that FDA might possibly be underreporting deaths from their approved drugs and devices by a factor of as much as 100?
 
Because in 1993, Dr. David Aaron Kessler, FDA Commissioner from 1990 to 1997, told the Journal of the American Medical Association that only 1 percent of serious adverse events are reported and because an analysis by Wald and Shojania found that only 1.5 percent of all adverse events result in an incident report.
 
That’s right folks, the Death Meter folks conflated “adverse event” with “death” even though adverse effects is just the fancy terms for “side effects.” This might actually be more ridiculous than the notion that President Obama was going to form “death panels” as part of healthcare coverage reform that would deny necessary healthcare to most of our grandmas.
 
People who do not understand numbers or definitions of healthcare/public health terms should not be allowed near statistics, and this is coming from a journalism major—we’re not known for our mathematical prowess, generally speaking.
 
But even I can see the total lack of logic at work here, and it makes me feel so much more love for Public Citizen now. And, given the fact I think there are plenty of flaws at FDA and have said so before, I’m going to say something uncharacteristic: “I’m sorry FDA; do you need a hug?”

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