NYT: FDA and "judges"- a dangerous confluence of stupidity

NYT: FDA and "judges"- a dangerous confluence of stupidity

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Subject: NYT: FDA and "judges"- a dangerous confluence of stupidity

Date: Apr 6, 2008 3:47 PM

Uh, no. The FDA disclaims their obligation to look at the data
BigPharma sends
them:
http :// www .actionlyme.org/FDA DISCLAIMS JOB RESPONSIBILITY.htm

FDA says no manufacturer is legally obligated to follow FDA's rules,
and that
was the FDA's answer to my question of why they did not look at Yale's
new
idea for the testing for Lyme (it came from a scientific fraud crime
committed by
Allen Steere in Europe, and was intended to falsely qualify LYMErix by
making Lyme
undetectable:
http :// www .actionlyme.org/CRYMEDISEASE CHP3.htm )
to see if it met their (FDA's) rules for a scientifically valid method
to detect
Lyme disease.

Here is the NYTimes story:

http :// www .nytimes,com /2008/04/06/washington/06patch.html?hp=&pagewanted=print

Judges are known to be stupid and incompetent to science, especially.
"Judge"
John C. Driscoll of the Corrupticourts made it clear to me that he
does not know
what evidence *is.* The same is true for Antonio Scalia, since he got
pissed when
asked to referee the global warming issue.

http :// www .actionlyme.org/070508.htm

We can hardly leave drugs to the FDA or creepy morons who are picked
by the likes
of Jodi Rell, John Rowland or the Bushies to be judges.

When the day comes that any "judge" can explain to us why DNA evidence
is admissible (accuracy, specificity, data strength), and include an
understanding
of statistics and probability, even a one that rises to the level of
understanding
in the Appendix of "THE BELL CURVE" (intended for stupid White
people),
then we can *begin* to consider the validity of the concept of
"judges"
determining that the FDA is competent to be assessing any data
BigPharma sends them.

LYMErix was a whopper, and the CT Attorney General is suing the Yale
Lyme cabal
over the validity of the testing for Lyme.
http :// www .actionlyme.org/BLUMENTHAL ANTITRUST.htm

Recall that Klempner ran an imaginary study using the Steere Cryme
method to detect
late, treated Lyme, when the Steere method was intended to detect LATE
Lyme arthritis
in a knee that ONLY occurs in EARLY Lyme.
http :// www .actionlyme.org/KLEMPNER.htm

Get it?

One can only have "Lyme Disease" if one has *LATE* Lyme arthritis in a
knee, only, and only if it happens in EARLY Lyme.

'Makes no sense, but thats the DHHS at the helm for ya.
That's what we're getting for megamillions in tax dollars.

TOTAL INCOMPETENCE and DELIBERATE DERELICTION OF DUTY, on top of
natural judgetardation.

Kathleen M. Dickson

=======================================
From:
"Bishop III, John" <john.bishop@fda.hhs.gov>

[Add to Address Book]
To:
"'kmdickson@comcast,net '" <kmdickson@comcast,net >
Subject:
RE: Criteria for method validation
Date:
Tuesday, October 03, 2006 1:25:20 PM

[View Source]



Note the introduction that indicates what this guidance was intended
for -
and that CBER is not listed on this particular guidance.

Note that both CBER and CDER have published similar guidance
(guidances are
not legal requirements such as rules/regulations - and that is a key
point).

I refer you to ICH guidance Q2B from 1997:
http :// www .fda.gov/cber/ich/ichguid.htm

John G Bishop III, PhD
Manufacturers Assistance and Technical Training Branch
Division of Manufacturers Assistance and Training
Office of Communication, Training, and Manufacturers Assistance
Center for Biologics Evaluation and Research/FDA
301-827-2000
800-835-4709
john.bishop@fda.hhs.gov
This communication is consistent with 21 CFR 10.85 (k) and constitutes
an
informal communication that represents my best judgment at this time
but
does not constitute an advisory opinion, does not necessarily
represent the
formal position of FDA, and does not bind or otherwise obligate or
commit
the agency to the views expressed.



-----Original Message-----
From: kmdickson@comcast,net [mailto:kmdickson@comcast,net ]
Sent: Tuesday, October 03, 2006 1:11 PM
To: Bishop III, John
Subject: Criteria for method validation

http :// www .fda.gov/CDER/GUIDANCE/4252fnl.htm


Specificity
Accuracy
Precision
Linearity in and out of matrix
Limit of Quantitation
Ruggedness


Kathleen