FDA Weakens Rules on Testing New Drugs_LA Times

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[sSRI-Research] FDA Weakens Rules on Testing New Drugs_LA Times

 

 

 

FDA Weakens Rules on Testing New Drugs_LA Times

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

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

212-595-8974

veracare

 

 

 

http://www.latimes.com/news/science/la-011206fda_lat,0,5408373.story

 

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

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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