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From The Editor

FDA - FANCY FRAUD?
Jan 2005 Editorial

Barbara "BJ" Andrews BioMore televised announcements about the suffering of those who have relied on Celebrex, Vioxx and other COX2 inhibitor pain killers.  Stay with me here and if you won’t protect yourself, think about your dogs.  This is just the tip of the iceberg and we promise you more news on statin drugs and chronic heart failure.  But first you need some background.....

Networks are running clips provided by the drug companies.  Typical human interest sidebars; a clip of one elderly lady who is in pain and doesn’t know what to take, a woman with an existing cardiovascular problem who fearfully threw her Aleve away.  Both are suffering and mad at FDA for “not taking longer” to investigate such products.  No mention of how many have already suffered fatal heart attacks, ulcers, kidney or liver damage, etc.  No mention at all.  The clips are designed to prevent another “tobacco debacle”.  In fairness, it would be awful not to trust what our doctors prescribe.  In reality, the drug companies are currently the single largest income-producing category for television!

A good reporter looks at what is not said as much as we note what is said.  The reports say not a word about responsibility.  We're told it takes years and many millions of dollars to gain approval.  That is why new prescriptions cost so much.  Therefore we understand that the drug companies must recoup their extraordinary investment at our expense.  And for lucky Americans, insurance companies cover at least a part of the cost, right?  So we’re made to think it “all works out in the end.”

And it does.  The insurance companies raise their “premiums.”  The government raises taxes on that dwindling part of the population that makes enough money to pay taxes to support those who don’t.  Unlike Medicare, social programs do pay for prescriptions and many drug companies subsidize cost for indigent people.  The bestseller of the 80’s Life Extensions by Pearson and Shaw explains why.  Let’s just say we might be grateful that Medicare does not pay prescription costs for seniors.  President Bush reduced taxes but we continue to pay the drug companies who pay the (federal agency) FDA to approve their product.  By paying off, of course I mean legally.  You know, in the normal course of doing business.

What applies to you, applies to your dogs and they can't read so you have to do it for them.  If you haven't read about the Proheart recall and the problems with Rimadyl and Deramaxx, be sure to follow the links in the footnotes.*

First, clinical and laboratory tests are easily flawed.  More to the point, those designed to hasten FDA approval of a multi-billion dollar product, are often structured or conducted in such a way as to reach a pre-determined conclusion.  If anyone reading this needs any proof whatsoever that this happens, just pay attention to the epidemic of drug recalls.

Second, money not only talks, it is a symphony of security for an ever-increasing segment of society. Can it corrupt medicine?  Sure FDA is protecting us, albeit after the fact.  Chemically engineered products are being recalled because the drug companies are being sued because people are dying!  If the FDA scrutinized testing as we are led to believe, how did these drugs come to market? 

You know the answer.  Either FDA inadvertently slipped up and simply didn’t do its job or someone took bribes.  Either way, does that inspire confidence? 

 Now scale that down to veterinary prescriptions.  Expensive?  Yes.  Needed?  Sometimes.  Profitable all the way down the line?  Yes.  Harmful to your pets?  Sometimes.  In 1998 Rimadyl alone accounted for 39% of ALL adverse reactions reported to the FDA.  But listen, it still took until 2004 to settle a class-action lawsuit and force changes in the product.  How many “adverse reactions” were not reported?  How many vets advised owners that a potential cause was a product they dispensed?  What about ProHeart 6 Injectable Heartworm Preventative?  How many dogs were “injured” and how many complaints generated before FDA finally said “take it off the market”?  Why was it ON the market?  How did it get there?

 As if this were not of enough concern, let me leave you with this chilling thought.  If you are forced to trust pharmaceuticals because the natural supplements, homeopathic and herbal remedies that have survived centuries of “clinical trials” are also taken away, how will you treat yourself and your pets?  This is not sensationalism, there is a World Health Organization  agreement..... oh well, we will tell you about that later.  It could take effect as early as August 2005. 

 One of many examples: Reacting to the hysteria over ephedra, Richard J. Durbin (D-IL) brought forth Senate Bill 722, cosponsored by Hillary Clinton (D-NY), Dianne Feinstein (D-CA) and Charles Schumer (D-NY), which provides the FDA with the unprecedented power to remove nutritional supplements from the market.  The FDA is empowered to act on a single adverse reaction report and immediately take the product off the market while it is being investigated. 

Sounds like the FDA really means to protect us, right?  Quoting Dr. Julian Whittaker, world-renowned physician and outspoken television medical watchdog, “The bill also gives the FDA license to require supplement manufacturers to submit safety information that would cost hundreds of millions of dollars, patterned on regulations required for new drugs. This is absurd. New drugs need rigorous safety testing because they are compounds that have never been ingested by human beings. The ubiquitous use and long history of safety of nutritional supplements is apparently irrelevant to the sponsors of this bill.”

 The subject is complex and fraught with peril for those who dare to pursue it.  We don't solicit drug advertising.  I located a direct link on one of my research sites for those who want to contact their Senator regarding this bill: http://www.metagenics.com/company/t1initiative.asp

 It’s a war alright.  If you won’t fight for yourself, do it for your animals.  You are their voice and you are all they have.  Do not rely on the FDA to protect them.  It can’t even protect YOU. 

Drug war?  You betcha!  This is the real war on drugs.  The rest is just diversionary tactics.  This drug war just might be winnable with your votes and your voice.

Barbara J. Andrews

* as of 1/3/05, Proheart 6 has 6042 reactions and 599 deaths 'possibly' related to it that have been reported to the FDA. Rimadyl has 12,516 reactions and 2,349 deaths possibly related. Deramaxx has 2371 reactions and deaths jumped 75 to 515 possibly related.  For more information on adverse reactions, go to www.DogsAdverseReactions.com

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