"Supreme Caveat: FDA Approval"
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Subject: "Supreme Caveat: FDA Approval"
Date: Mar 4, 2008 3:50 PM
No.
FDA disclaims their obligation to look at data:
http://www.actionlyme.org/FDA_DISCLAIMS_JOB_RESPONSIBILITY.htm
The FDA officially disclaim their obligation to look at the data
BigPharma sends
them. I had asked them why they did not look into the fact that the
current testing
schema for Lyme is scientifically invalid, according to FDA's own
rules for
the validation of a method. They referred me to their own, self-
disclaimer page.
This does not necessarily help with the Supreme Court because lawyers
and
judges are all hopelessly retarded. You can't explain anything
scientific to
them. They don't know that scientific facts trump opinion.
For example, if I say "all psychotropics are brain damaging" and that
"one is not supposed to treat a brain disease that causes a delirium
with a
delirium-causing psychotropic," and that the American Psychiatric
Association
agrees, and in fact, that is their "GUIDELINE," those statements of
fact
do not fly in a "court," since you can get any whore to perjure
themselves
and say "these facts do not apply" and "MDs can do whatever they
want."
http://www.actionlyme.org/PHILLIPS_AND_MARCUS_PERJURY.htm
You can't talk to any of them. Psychiatrists and lawyers have the
same type
of tardation where facts have no meaning. It's who you know, not what
you know.
Sorta like teenage girls.
I wish I could help by proving that the FDA disclaims their obligation
to actually
look at the data BigPharma sends them, but it won't help because of
this specific
kind of mental retardation among lawyers and "judges" that
approximates
the behavior of snotty teenage girls in the lockerroom.
Kathleen M. Dickson
==============================
http://www.commondreams.org/archive/2008/03/04/7469/
Published on Tuesday, March 4, 2008 by the St. Louis Post-Dispatch
Supreme Caveat: FDA Approval
Editorial
FDA approval is a ticket to market medical devices and drugs. It could
soon also
become a kind of "get-out-of-jail free" card for their makers, freeing
them from
liability for producing defective or unsafe products.
The U.S. Supreme Court ruled last week that consumers cannot sue the
makers of faulty
medical devices if those products have been approved by the Food and
Drug Administration.
In another case argued last week, the court seems poised to extend
similar protections
to the makers of unsafe drugs.
FDA approval protects consumers from faulty products, Justice Antonin
Scalia wrote
in the majority opinion, because the review that precedes it "is
focused on safety."
In theory, maybe. In reality:
- The FDA is inadequately funded and poorly equipped. Since 1994, it
has lost 1,311
employees. Adjusted for inflation, its budget is down by nearly $300
million during
that time.
- Separate reviews by the Institute of Medicine (part of the National
Academies
of Science), the Government Accountability Office and a scientific
advisory panel
established by the FDA have concluded that the agency is in urgent
need of reorganization
and a substantial budget increase. The advisory panel called for an
increase of
150 percent over five years.
- This week, FDA head Dr. Andrew von Eisenbach said his agency needs
more funding
than the almost 3 percent increase recommended in President George W.
Bush's budget.
"I think what we do requires substantially more dollars than what has
been invested
in the FDA so far," he told The Wall Street Journal.
- The agency is in the middle of yet another major drug recall - this
time involving
the anti-clotting drug heparin. Congress is investigating the failure
of FDA regulators
to inspect overseas plants that make key ingredients and finished
medicines sold
in this country.
- A separate congressional panel is studying potential financial
conflicts of interest
among doctors whose research led the FDA to approve a new artificial
spinal disk.
That investigation has raised questions about payments from drug and
device makers
to doctors who recommend their products.
- Last summer, the FDA was faulted for allowing poisonous pet food
into the country.
In recent years, some of the agency's own drug reviewers have raised
questions about
drugs it allowed on the market. Among them is Vioxx, the arthritis
medicine withdrawn
in 2004 after studies showed it increased the risk of heart attack and
stroke.
- In 2005, it was revealed that FDA officials waited four months to
warn patients
about potentially life-threatening problems with a medical device
called an implantable
defibrillator. The devices at issue in that case were made by
Medtronic, the same
company at the center of last week's Supreme Court ruling. So-called
pre-marketing
approval is based on tests involving relatively small numbers of
patients; unforeseen
risks often emerge when drugs and medical devices are in widespread
use. In other
cases, as with the faulty defibrillators, design shortcomings only
become apparent
later.
Before President George W. Bush took office, the FDA supported
allowing patients
to sue. In a 1997 filing, an agency lawyer wrote that "even the most
thorough regulation
of a product such as a critical medical device may fail to identify
problems."
Blocking lawsuits will prevent problems from coming to light, but it
won't prevent
them from occurring. Even though problems are supposed to be reported
to the FDA,
that doesn't always happen.
Congress can, and must, clarify the right of patients to seek damages
when injured
by faulty products. It also must increase significantly the FDA's
budget so it can
do the job we all expect of it. Until that happens, consumers should
take FDA approval
with a large grain of salt.
Copyright (c) 2008 St. Louis Post-Dispatch L.L.C.
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