DRUG TESTING ON HUMANS
I received this thought-provoking article
from a friend. - Dominie
FDA Weakens Rules on
Testing New Drugs - LA Times
ALLIANCE FOR HUMAN RESEARCH
PROTECTION (AHRP)
Promoting Openness, Full Disclosure, and
Accountability
www.ahrp.orgFYI - The FDA has embarked on another ill-conceived road in an effort
to
bail out the pharmaceutical industry who are experiencing a dry well
in
their drug development hopper.
Having put all their marbles into
immediate profit-producing
drugs--many of which turned out to be lethal, the
industry has
persuaded the FDA to cut corners in the name of
"efficiency."
The target is speeding the
testing of unknown, potentially toxic
products in humans (Phase I trials)
without adequate pre-human tests.
The
unintended, but predictable ill effects will most certainly to be
borne by
the human test subjects.
What will the consent forms disclose about the risks
involved?
Contact: Vera Hassner
Sharav
212-595-8974
veracare@ahrp.org
http://www.latimes.com/news/science/la-011206fda_lat,0,5408373.storyFrom the Los Angeles Times
FDA Issues Rules on Testing New
Drugs
By Ricardo Alonso-Zaldivar
Times Staff Writer
1:29 PM PST,
January 12, 2006
WASHINGTON - Trying to increase the number of new drugs
that make it
to market, the Food and Drug Administration issued guidelines
today
allowing investigators to test minute doses of experimental drugs
on
people, to see if the results are promising enough to
warrant
full-scale clinical testing.
The FDA action was welcomed by
scientific researchers and the
industry, but some agency critics said they
were concerned that it
could increase hazards for volunteers, or facilitate
the approval of
drugs before their risks are fully understood.
Of
thousands of compounds that researchers test for potential
therapeutic
effects, only a tiny handful ever make it to the
pharmacy
shelf.
Pharmaceutical research and development spending
increased about 250%
in the last decade, approaching $39 billion last year.
But the number
of new drugs submitted for FDA approval went down during that
period.
Last year, the agency approved only 20 new drugs, compared with 36
in
2004.
"Drug development is very,
very high risk and the failure rate is
still too high," said Dr.
Raymond Woosley, president of the C-Path
Institute, a nonprofit organization
based at the University of
Arizona, which aims to speed the development of
new drugs without
compromising safety. "This is an important step toward
getting greater
efficiency and more modern science into the drug development
process."
The new FDA guidelines would enable researchers to test a
"micro-dose"
of an experimental drug on a small number of human volunteers to
see
how the body reacts.
Such testing would replace some, though not
all, of the early
experiments now carried out on animals. The results are
expected to be
more accurate than animal testing alone in predicting which
compounds
should go to full-scale clinical trials with larger numbers of
human
volunteers.
Full clinical trials are used to establish whether a
drug is safe,
what its appropriate dosage is, and whether it is effective
against a
placebo. The FDA's action today did not affect the full-scale
tests.
Critics of the FDA and the industry saw a potential danger in the
new
guidelines.
"Last time they speeded up the process of drug
approval, it led to the
approval of lethal drugs," said Vera Sharav of the
Alliance for Human
Research Protection in New York. "Now they are trying to
fiddle around
with the [earliest phase of] trials? Those, by definition, are
the
highest risk."
The FDA already has a system for accelerated
approval of drugs that
show promise in the course of clinical trials, said
Dr. Sidney Wolfe
of the Public Citizen advocacy group. He questioned whether
the agency
has a strong enough scientific argument for also speeding the
early
stages of drug research.
"This
is allowing the companies to get away with far less stringent
animal
studies," Wolfe said. "It appears to weaken protections for
human
subjects."
Acting FDA Commissioner Dr. Andrew von Eschenbach
said the agency has
laid down rules to protect people who volunteer for such
experiments,
and to make sure they are fully informed of potential risks.
Some of
the volunteers are expected to be patients dealing with advanced
forms
of cancer and other serious illnesses.
Nine out of 10 experimental drugs fail in human studies,
Eschenbach
noted. Drugs "behave differently in people than in animals," he
said.
The FDA is "trying to remove some of the hurdles from the
earliest
phases of drug testing and development so researchers can more
rapidly
establish whether a new compound has benefits for people,"
Eschenbach
added.
The doses used in the new early human testing would
be so small that
they should not cause any ill effects or benefits, said
Woosley.
But researchers would still be able to determine how the
experimental
drug behaved in the body. In the case of a cancer drug, for
example,
they could learn through a biopsy whether it went to the tumor
site.
"A micro-dose is about one-hundredth of the dose that would have
any
chance of doing anything," said Woosley. "With modern
analytical
techniques, you can find out if it went to the place where you
want it
to do its work.
"You can learn how long it stays in the body,
without ever having to
give a potentially effective or toxic dose. You are
just much more
intelligent about the drug when you decide whether to go to
clinical
trials."
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