Tuesday, March 08, 2005

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.

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3 Comments:

Blogger Henry Stern, LUTCF said...

There's another issue at play here as regards profitability: insurance carriers and formulies.

To a great extent, those who PAY for the meds drive the COST of the meds, and therefore their profitability. So the question needs to be addressed thru that lens, as well.

I feel like I've just participated in a drive-by commenting; I don't have the time to give this the explication it deserves. I'll try to stop by again later to flesh this out.

Sorry!

March 09, 2005 11:55 AM  
Blogger chargemaster said...

I had post to Medicine Man's quesion about profitability of antibiotics but for some reason it didn't post. I'll try a run at it again later.

hgstern

I think another wrinkle to your comment of "those who pay for meds drives the cost of the meds" is that Medicare now has a rule for competitive acquisition of outpatient drugs and biologicals. this rule states (for Medicare providers) that "Beginning January 1, 2006, physicians will generally be given a choice between obtaining these drugs from vendors selected through a competitive bidding process or directly purchasing these drugs and being paid under the average sales price system." What Medicare is doing is saying that they will take data from around the country of average sales prices and use an average of those averages to purchase drugs and also to base their reimbursement to hopsitals and physicians.

Here is the link.
http://www.cms.hhs.gov/providerupdate/regs/cms1325p.pdf

This is specifically for part B, but there is a program for part A as well.

As a general rule, what Medicare does, most large insurers will follow. Which in turn drives down profits.

March 09, 2005 1:07 PM  
Blogger OBloodyHell said...

If I may offer a trivial observation, part of this is also to be found in the doctor-patient relationship.

I am quite intelligent. In my younger days, I certainly was guilty of the common behavior of incomplete dosing. At no point did any doctor actually discuss with my why I should take every one of them, I was just given them and told to take them.

When you make the reasons for a behavior clear to a patient, then they can make properly informed choices about compliance. No, this does not mean that they all will, but it does increase the chances of it at little cost to the doctor or patient.

This isn't always practical, but when doctors take on that air of a boss, then the natural human tendency for individualism kicks in, and there is a tendency to resist any instruction for which the reasons seem insufficient.

May 31, 2005 10:19 PM  

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