Why no Antibiotic development?

Here’s a hint on why the R and D on antibiotics is drying up–FDA can claim some credit for the problem.

R and D for antibiotics requires trials and trials, and the FDA created a higher threshold for phase 3 studies.

That’s a consideration.

2 responses to “Why no Antibiotic development?

  1. Gotta disagree a bit here, and to also state “I just don’t get it”. True, the FDA rules (for better or worse) make testing and bringing a drug to market in the US horrendously expensive. But… as we tend to easily forget, the US is but a small segment of the world.
    Why don’t we see Indian drug companies, for example (and there’s a _huge_ industry there) coming out with new products? Same for Europe, Red China, Russia, and even Cuba.
    There are (to make up a number) thousands of garbage products outside the US that shouldn’t even be thrown out in our garbage. But when we get to the category of “accepted in France (or Brazil, Switzerland, etc.), probably ok, but blocked by the FDA” we’re talking about barely a handful. If that.
    (There are also lots of specialized orphan products, so to speak, that “a lab out there” may be custom making, but that’s a different issue).

  2. I was tangentially in the pharmaceutical industry during summers in high school (president of the company created summer jobs for so-inclined high-school children of employees in the research labs (very savvy long-term recruitment strategy)); my Dad was upper-level management in the company.

    Research scientists don’t just get a blank check to do what interests them. They get managed, with goals, timelines and all the rest. Clearly the goal was to produce drugs that require lifetime use.

    Antibiotics were initially on the menu, with (literally) dirt samples being sent in from all over the world, and screened for organisms with antibiotic activity.

    The emphasis though, was on developing drugs to treat chronic ailments that might require lifetime administration of medication.

    The trend was for new antibiotics to be moved to the bottom of the development list since they would only be used for a week or two then discontinued.

    I believe this was the beginning of the pharmaceutical industry’s migration from short-duration life-saving drugs to lifetime-duration drugs for chronic illness (forget whether the endpoints were surrogate (cholesterol, blood pressure, palliative (asthma for instance) or popular (ED for instance) – they were all designed to be chronically administered). This leaves antibiotics out in the cold. Who doesn’t acknowledge that bacteria become resistant to antibiotics? Nevertheless, I saw pharmaceutical sales reps convincing nurses that “this is the only antibiotic you will ever need to give.”

    I guess you reap what you sow, and I can’t think of a better example.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s