Tom Regan, PeTA, and AR Lying by Omission

By:  Jonathan Ball 

Saint Tom (Regan) has a terrific ally and statistician in (Former TPA Loon O’ The Month Award Winner) Derek Nash, doesn't he?
 
 Digging a little to uncover the depth of Derek's clumsy, inept lying has revealed that Saint Tom, and all "ARAs" who rely on the GAO's 1990 report on the FDA's drugs testing procedures, are lying by omission FOUR - count 'em, 4 - times.
 
 Here is Saint Tom's citation of the GAO's 1990 report, in his book co-authored with Carl Cohen:
 
Professor Cohen surely must know that many drugs that have cleared animal tests are later found to be toxic for humans.  A 1990 report issued by the General Accounting Office found that approximately 50 percent of the FDA-approved drugs investigated    either had to be taken off the market or relabeled because of their toxic effects on the people who were using them.
 
 Big Lie #1:
 The first instance of "AR" lying is the most well known:  they omit to say that the withdrawn/relabeled drugs were tested on humans in addition to being tested on animals.  If the later determination of unsafety of a drug is said to invalidate animal testing, it
necessarily must be seen as invalidating the human testing phases (plural), as well.
 
  Big Lie #2:
 The second big lie concerns the absolute number of drugs that are withdrawn or relabeled, choosing to focus misleading attention on the percentage that this
 represents of all drugs that are investigated for adverse drug experience (ADE).  50% sounds like an alarmingly high number...until you obtain information from the FDA itself that reveals that from 1981 through 2000, 543 new molecular entities were approved for
 marketing, and only 14, or 2.6%, were withdrawn for safety reasons.
 
 By omitting to mention the absolute number of drugs investigated and then withdrawn or relabeled, "ARAs" are again lying.  In fact, as the FBR page reveals, quoting Neal Barnard of PCRM, only 198 drugs were investigated in the 10 year period (1976-1985) covered by the GAO report, and only 102 of those were withdrawn/relabeled.
 
 Lie #2 is somewhat a lie of commission:  Saint Tom the Untruthful begins his passage by saying that "Professor Cohen surely must know that many drugs that have cleared animal tests are later found to be toxic for humans."  There are two lies of commission here: first, in saying that "many" drugs later have problems; second, in saying that they are later found to be "toxic".  In fact, Saint Tom doesn't know that they were found to be "toxic" at all; and since only half of the drugs investigated are withdrawn or relabeled, and
 most of those are relabeled, his claim that the drugs are found to be "toxic" appears to be a lie.
 
 Big Lie #3:
 Saint Tom, and his trusty statistician Derek, and other "AR" liars basing their lies on the GAO report next lie by omitting to say that of all the drugs that are withdrawn or relabeled, the overwhelming majority are relabeled and remain available for use.  The relabeling might be something as relatively innocuous as "don't use this drug if you are already taking drug 'X'."  But drug 'X' might not even have been on the market, or even conceived, when the relabeled drug was tested earlier.
 
 Big Lie #4:
 Finally (or maybe not), Saint Tom and other "AR" liars omit to tell the listener or reader that
    

The recommendations made by GAO at the end of its report had to do with better ways to use information from clinical trials, not the animal tests that precede them.

http://www.fbresearch.org/scapegt.html
 
Four colossal "AR" lies of omission, all contained in ONE miscitation of the GAO report.
 
Predictably, PeTA repeats the same tiresome, false claims based on the 1990 GAO study, with a novel and intentionally misleading twist of their own.

Drug Testing: Pain, Not Gain

More than 205,000 new drugs are marketed worldwide every year (1), most after undergoing the most archaic and unreliable testing methods still in use:  animal studies. The current system of drug testing places consumers in a dangerous predicament.     According to the General Accounting Office, more than half of the prescription drugs approved by the Food and Drug Administration (FDA) between 1976 and 1985 caused serious side effects that later caused the drugs to be either relabeled or removed from the market. Drugs approved for children were twice as likely to have serious post-approval risks as other medications.(2)


 http://www.peta-online.org/mc/facts/fsae11.html


 Their source for the 205,000 figure is something called "Naked Empress: Or the Great Medical Fraud", by someone named Hans Ruesch.  In a side note, this figure, along with the standard sleazy misrepresentation of the GAO's study, turns up all over the Internet.  But Ruesch's book was published in 1982, while the GAO report was published in 1990.  The appearance of this number as part of a deliberately false interpretation of the GAO
 report is the classic example of what I mean when I refer to dishonest activists simply copying one another's pages as their "sources".

But the obvious problem with the 205,000 figure is that it is intended deliberately to overstate the magnitude of the falsely claimed "failure" of testing on animals.  In fact, the U.S. FDA, and all other national drug certification agencies, approve molecular compounds, not branded products.  And according to the FDA's own pages, the number of compounds approved over a 20-year interval was only 543:

During the period 1981 to 2000, we approved 543 new molecular entities. Fourteen of these, or 2.6 percent, were withdrawn for safety reasons after joint FDA-manufacturer review. The record of withdrawal of drugs approved in recent years is similar to previous periods when we were criticized for taking too long to review drug applications.  Nonetheless, the increased number of drugs and the large number of patients taking multiple drugs have created the potential for more drug safety problems.


http://www.fda.gov/cder/reports/RTN2000/RTN2000-3.HTM - DrugRecallsandWithdraw

 For the rest, PeTA is just doing the garden variety "AR" lying by omission, first failing to point out that any withdrawn or relabeled drug also passed at least three phases of testing on humans before being approved by the FDA, and also omitting to point out that the overwhelming majority of the drugs that had problems were relabeled and remained available for prescription to humans.

 There's another point I'm curious about.  In the U.S., the FDA also exercises approval authority over veterinary drugs.  I would be very interested to know if any of the drugs referred to in the 1990 GAO study were veterinary drugs.