The Speculist

Over at Tech Central Station James Miller is arguing for "pharmaceutical freedom" for the elderly.

Let's give pharmaceutical freedom to our elderly. Elderly Americans should be legally permitted to use any drug their doctor approves of, even if the drug has not been approved by the Food and Drug Administration.

Miller points out that it takes 12-15 years on average for a drug to be approved. Sick people are stalled to death by this system.

But I think there is a real danger that Miller's suggestion could turn elderly patients into guinea pigs. The key to avoiding that possibility is oversight. A doctor might be tempted to push a treatment on a patient who lacks the capacity to understand or consent. Third party review - perhaps from a federal magistrate - could guard against that.

The patient's eligibility for this program should not depend on age. An elderly patient could be in robust health, while a younger patient could be within days of dying without a miracle. Why risk the good health of an older person or deny a fighting chance to a younger person on the basis of age?

Unconventional, experimental treatment is exactly like a "Hail Mary pass" in football - a play "made in desperation with only a very small chance of success." It would be the job of the magistrate to decide if "Hail Mary" medical treatment is rational under the circumstances. The magistrate's "decision tree" could look something like this:

1. Is it the opinion of the treating doctor that with conventional FDA-approved care that it probable that the patient will be dead within six months?

2. Has the patient sought a second opinion? Is it the opinion of this second doctor that with conventional FDA-approved care that it probable that the patient will be dead within six months?

3. Are the treating doctor and the second doctor in agreement on the proposed non-FDA approved treatment?

4. What additional danger, if any, does this treatment present?

5. What is the likelihood that the experimental treatment will improve the patient's health?

6. Does the patient have the capacity to understand the nature of the risk involved?

7. Has the patient been given the information he or she needs to make an informed decision?

8. Did the patient actually consent to the treatment?

This program would be more politically viable than an age-based program. This looks less like using the elderly for experimentation (something the AARP would doubtless be against) and more like giving the desperately ill a fighting chance (something the AARP might support).