January 14

FDA Weakens Rules on Testing New Drugs_LA Times

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
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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