FDA eases its guidelines for drug testing on humans

[question everything]

FDA eases its guidelines for drug testing on humans

Revisions aimed at speed, efficiency

By Michelle Fay Cortez
BLOOMBERG NEWS SERVICE

January 13, 2006

Drug makers may be able to home in on their most promising compounds more quickly under relaxed U.S. guidelines for human testing that apply more modern scientific techniques and ease manufacturing requirements.

The Food and Drug Administration guidelines, released yesterday, let companies make microscopic amounts of compounds and give them to fewer than a dozen people before animal studies are complete. Researchers would then use imaging tests to track the drugs' effects before undertaking larger and longer human studies.

The move is designed to overcome one of the most formidable hurdles in drug development: taking promising compounds from the laboratory to successful human trials. The FDA approved 20 new breakthrough drugs in 2005, the second-lowest number in more than a decade. While the revolution in human-genome research created insights into the biology underlying disease, the advances haven't been exploited to simplify and speed drug testing.

(snip)

Currently, 90 percent of experimental drugs that begin full-scale human trials ultimately fail, Health and Human Services Secretary Mike Leavitt said in a statement. The initiative was welcomed by the pharmaceutical industry... The new guidelines make it easier for researchers and companies to manufacture small amounts of experimental compounds. The rules bypass time-consuming requirements that govern mass production of drugs for sale to the public that also had been applied to the testing stages.

(snip)


Find this article at:
http://www.signonsandiego.com/uniontrib/20060113/news_1n13fda.html

[pinerow]

1. Well...that should be interesting...knowing how rigorous their

Quality Control is...

[firefox]

2. FDA approval means cannot sue for punitive damages

Didn't they make it a law in one of the budget bills last year that if the FDA approves a drug, that you cannot sue for punitive damages?

The FDA is the perfect example of the regulators of industry being taken over by industry they were meant to regulate.

Michael Moore announced his next movie would take on the medical care industry or aspects of it. Maybe he will answer the question for all America to see.

[fed-up]

3. Guinea pigs beware-they may not tell you of bad side effects (death) when

you volunteer to participate in one of their "studies". My sister volunteered for an MS drug study but dropped out later when it was publicized that a few of the volunteers died. It was later disclosed that they had withheld negative info from earlier trials.

There is a reason for the long wait and for drugs to be tested on animals first.

Think very carefully before you volunteer to become fodder for the money hungry pharmiceutical companies.

[kurth]

4. Speed and efficiency

Yeah. Why don't we just abolish that worthless agency and let the drug companies use TV viewers as their guinea pigs?

Oops. Aren't they doing that already?

[Selteri]

5. Yes, they've proven that the current set of guidelines works SO well

Vioxx comes right to mind.. then there are plenty of other examples.

NeutroSpec
Celebrex
Bextra
baycal
lipobay
Zyprexa
Prempro
accutane
Fen-Phen
Rezulin
Paxil
The list doesn't end there... these are ust the ones that have stood out in the news recently. Yes, let's make it faster, we're not killing enuogh AMERICANS! :sarcasm:

[WindRavenX]

7. what's wrong with paxil?

SO's on that...haven't heard of serious side affects.

[Selteri]

9. I could have sworn they put up some huge warning about Paxil

On the other hand, I wrote that list off of memory so it's hardly perfect.

[firefox]

6. But look at how they treat something already proven to work

Sativex is approved in Canada and of course we have thousands of years of experience with cannabis.

From http://www.cannabisnews.com/news/thread21478.shtml

FDA Okays Clinical Trial Of British Cannabis Spray

January 12, 2006 - Rockville, MD, USA

Rockville, MD: United States regulatory officials last week authorized the first-ever US clinical trial investigating the efficacy of Sativex, an oral spray consisting of natural cannabis extracts, for the treatment of cancer pain. Sativex is currently available by prescription in Canada and on a limited basis in Spain and Great Britain for patients suffering from neuropathic pain, Multiple Sclerosis (MS), and other conditions.

The FDA-approved trial is expected to begin later this year and will likely take 24 to 36 months to complete. Two hundred and fifty patients with advanced cancer will participate in the randomized, placebo-controlled study, which will evaluate the effect of Sativex in relieving patients' average daily pain, reducing their use of opioid medications, and improving their overall quality of life.

In a previous clinical trial of 177 cancer pain patients, volunteers administered Sativex demonstrated statistically significant improvements in comparison to placebo, with 40 percent of patients showing greater than 30 percent improvement in pain. Patients in the trial had previously been unresponsive to standard analgesic medicines (e.g., morphine).

Other clinical trials of Sativex have demonstrated the drug to alleviate numerous MS-associated symptoms compared to placebo, including pain, muscle spasms, and bladder incontinence.

[kurth]

8. Sad, ain't it?