I received this thought-provoking article from a friend. - Dominie

FDA Weakens Rules on Testing New Drugs - LA Times

Promoting Openness, Full Disclosure, and Accountability

FYI - 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


From 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

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

"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

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

"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

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

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