How do we spur development of new antibiotics?

At my hospital (Harbor-UCLA Medical Center) Dr. John Edwards, an infectious disease specialist, spoke at our grand rounds this morning.

He gave a rather chilling review of a problem many people aren't aware of. There is much more of a profit to be made on drugs people will be taking for a lifetime (anti-inflammatories, antihypertensive meds, anti-cholesterol meds, etc.) Because of this, there is very little incentive for drug companies to develop new antibiotics which will only be taken for a short time.

Given the extraordinary cost of bringing a drug to market, there are very few new antibiotics in the pipeline at this time. Unfortunately, the microbes are developing multi-drug resistance very rapidly and in time, will evolve to a state where they're resistant to just about anything now available.

Without new classes of antibiotics being developed to treat these evolving organisms, we could be facing a biologic disaster of literally biblical proportions.

Some ideas proposed to resolve this problem:

• Establishment of a governmental body to determine drug classes with major public health implications who's development should be somehow encouraged.
• Give drug companies financial incentives to pursue "less profitable" drug classes (eg. tax cuts on expenses directed at antibiotic development).
• Cut some of the "red tape" currently in place to streamline the FDA approval process for such drugs.
• Enhance intellectual property protections for such drugs (eg. extend patent protections, or give companies "vouchers" to extend patent protections to other drugs that the company produces in return for developing novel antibiotics.
• Granting companies the ability to recover patent time lost during the development process.
• Granting some sort of liability protections for drugs deemed of unique public health importance.

Personally, I would be in favor of some of the above proposals as long as they didn't interfere with patient safety and only conferred financial advantages to drug companies. Granting tax incentives and extending patent protections fall into that category.

I don't think that I'd be in favor "streamlining" the approval process or limiting liability for certain drug classes at this point. To me, that can only encourage a lack of conscientiousness and would not promote patient safety.

One general question I have for the drug companies is this. Why aren't antibiotics profitable? In a free market, wouldn't it be reasonable for drug companies to recoup their development costs by simply charging more for those medications? If a course of antibiotics was as expensive as a brief course of some chemotherapeutic agents ($1,000+++) wouldn't the market pay it if there was no other option? Isn't this the essense of supply and demand?

One would think that providers would then conform to established guidelines suggesting when antibiotics are actually indicated. They would then be expected to prescribe the standard first line regimens when indicated reserving these new "big guns" for specific situations.

At any rate, a good review of these issues was presented in this Infectious Diseases Society of America (IDSA) white paper called Bad Bugs, No Drugs.