NYT FDA: "Genetic Pre-screening"

[Mort Zuckerman]

To: zerh...@od.nih.gov, Spin...@yahoogroups.com,
kshe...@calea.org, fit...@gmail.com, patrick.f...@usdoj.gov,
model...@sbcglobal.net, jdr...@nejm.org, let...@courant.com,
Jgerb...@cdc.gov, len...@courant.com, michae...@po.state.ct.us,
con...@po.state.ct.us, executiv...@nytimes.com, managing-
edi...@nytimes.com, news...@nytimes.com, the-...@nytimes.com,
biz...@nytimes.com, for...@nytimes.com, me...@nytimes.com,
nati...@nytimes.com, dv...@cdc.gov, brigidc...@optonline.net,
tr...@hotmail.com, ubi...@courant.com, ma...@concentric.net,
camp...@courant.com, jhorn...@fff.org, thomas...@usdoj.gov,
thoma...@po.state.ct.us, kur...@washpost.com,
georg...@washpost.com, hor...@courant.com,
commissi...@po.state.ct.us, cohen...@aol.com,
FalN...@aol.com, brans...@comcast.net, vts...@comcast.net,
o...@po.state.ct.us, da...@davila-dilzer.com,
scott....@po.state.ct.us, govern...@po.state.ct.us,
attorney...@po.state.ct.us, randall...@usdoj.gov
Cc: fra...@ucia.gov, dr-ahma...@president.ir,
eugener...@washpost.com, hor...@courant.com,
bmi...@newstimes.com, tr...@hotmail.com, rast...@aol.com,
billc...@gmail.com, thomas...@usdoj.gov, amcg...@rms-law.com,
rjmu...@aol.com, paulcrai...@yahoo.com,
sidney_b...@yahoo.com, criminal...@usdoj.gov,
karla.d...@usdoj.gov, christophe...@usdoj.gov

Subject: NYT FDA: "Genetic Pre-screening"

Date: Jul 24, 2008 10:35 AM

We learned from the LYMErix vaccine fiasco that all people should be
pre-screened
for all
vaccines. The pre-screening will tell us which are the pre-autistic
children.

This is a huge breakthrough. They finally admit that Steere's LYMErix
Disease
(hypersensitivity to OspA) is not the only kind of Lyme:
http://www.actionlyme.org/CRYMEDISEASE_CHP3_B.htm

This lays the groundwork for all the individual lawsuits against Yale
by all the
people who were harmed by the Steere/Yale diagnostic standard. And we
say YALE,
because of what Robert Schoen did as re 1) the adverse events to
LYMErix and the
2) unreadable Western Blots upon vaccination with OspA:
http://www.actionlyme.org/DICKSON_FDA_SUBMISSION_FULL.htm

And of course all the perjury against myself and others by Yale staff,
namely James
Phillips:
http://www.actionlyme.org/PHILLIPS_JE_PERVERT.htm

Phillips was clearly given the RICO data stolen off of AG Blumenthal's
desk
and he said it meant I was "like Ted Kascynksi," in court, under oath:
http://www.actionlyme.org/BLUMENTHALS_MAIL_STOLEN_BY_JESSICA_GAUVIN.htm

This is big.

Kathleen M. Dickson
http://www.actionlyme.org

http://www.nytimes.com/2008/07/24/business/24gene.html?pagewanted=print

The New York Times
Printer Friendly Format Sponsored By

July 24, 2008
F.D.A. Urges Genetic Test Before Giving AIDS Drug
By ANDREW POLLACK

Seeking to prevent life-threatening side effects, the Food and Drug
Administration
is urging doctors to use a genetic test to screen patients before
prescribing a
drug widely used for H.I.V. infection and AIDS.

In an advisory it is expected to issue Thursday, the agency says that
patients with
a particular variation in an immune system gene should not be given
the drug abacavir
because they are at a far higher risk of a severe allergic reaction to
the drug.

Abacavir, developed by GlaxoSmithKline, is sold under the name Ziagen.
It is also
a component of two combination pills — Trizivir and Epzicom.

The recommendation for the test is part of a movement toward so-called
personalized
medicine, in which genetic or other tests are used to determine which
drugs are
best for a patient and which should be avoided.

The labels of several other drugs, like the blood thinner warfarin and
the cancer
drug irinotecan, also recommend tests aimed at avoiding side effects
or helping
to adjust the dose.

F.D.A. officials said they believed that the genetic test, which is
already available
from some laboratories, would be quickly adopted for screening
patients before prescribing
abacavir. In part that is because the test recommendation will be
included in a
black box warning, the strongest kind, on the drug’s label.

A small percentage of abacavir users suffer so-called hypersensitivity
reactions,
either when they start the drug or when they resume using it after
some interval.
Symptoms can include fever, rash, nausea and breathing difficulties.

The association between the variant in the immune system gene and risk
of the reactions
was first reported several years ago. But F.D.A. officials said a
randomized clinical
trial had since definitively proved the value of the genetic
prescreening.

The study, published in The New England Journal of Medicine in
February, found that
prescreening reduced the incidence of suspected hypersensitivity
reactions to 3.4
percent, from 7.8 percent. Based on that data it was estimated that 61
percent of
people with the genetic variant — called HLA-B*5701 — would suffer a
hypersensitivity
reaction, in contrast to only 4 percent without the variant, according
to new information
on the drug’s label.

Drug companies often are reluctant to back tests that exclude patients
from getting
their drug. But GlaxoSmithKline sponsored and helped conduct the study
published
in February.

Because only about 5 percent of people have the genetic variant,
excluding them
from using abacavir does not shrink the market much. But it may
reassure doctors
that they can safely prescribe the drug for a vast majority of
patients who do not
have the variant.

The label for abacavir is also being changed to mention a study that
found a correlation
between taking the drug and elevated incidence of heart attacks. But
the label also
mentions that Glaxo then did its own review, pooling the results of
numerous clinical
trials, and found no elevated risk of heart attack.

The new label says that “in totality” the data are “inconclusive” on
whether there
is an elevated risk of heart attack, but that doctors should be
cautious nonetheless.

Home