Re: Scientists worry over spread of new superbug
Quote:
Where common day every day bacteria can kill you. Welcome to 1800s.
Yep! Just your lovely FDA at work for ya! Keepin' you safe from harmful, nasty drugs!
This "debate" has been going on for 10 years! 10 years???????
Arsenal Of Antibiotics Not Being Restocked
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The FDA
is now proposing that antibiotics used to treat non-lethal infections which often resolve on their own, such as sinusitis, ear infections and bronchitis, be tested under different methods: superiority trials or placebo-based trials.But
showing one antibiotic is superior to another is hard because many antibiotics work so well, Spellberg said.
Cox of the FDA said clinical trials that show an experimental drug is significantly better than a current drug would provide clear evidence that the experimental drug works. He also acknowledged
it may be difficult to show that an experimental antibacterial drug is better than a current drug.Placebo trials, in which the drug is tested against a look-alike but useless pill or injection, are also unrealistic, according to some experts.
It’s nearly impossible to persuade patients with a painful sinus infection to enroll in a study with a 50 percent chance of getting a sugar pill and not a drug, they said.
Dr. David Shlaes, who worked in pharmaceutical antibiotic development for decades and is now a consultant to the industry, said
it is absurd to be, in effect, questioning if antibiotics work.http://pharmalive.com/News/index.cfm?articleid=722254