A Lemon Law for Medications?

I always hear about expensive medications and what a racket that is for Big Pharma.  A recent exacerbation of asthma was an eye opener for me.  I have had to discard a lot of medications prescribed for me in the past because they either were not indicated (like an antibiotic for cellulitis when I really had gout) or medications that I thought were too risky (they shall remain nameless).

I posted some of my experiences with medications taken for asthma.  Over a two month period I took oral prednisone in addition to corticosteroid inhalers and beta agonist bronchodilators.  All of the medication was only moderately effective over a two month period and this necessitated switching between different preparations.  It also involved discarding some after only one or two doses due to intolerable side effects.  That trial and error came an a high cost.  Like most employees these days I have a high deductible health insurance plan.  That deductible is $3,000.  The final tab between the dates January 20, 2014 and February 25,  2014 was $3,000 out-of-pocket.   So I guess the good news is that I met my deductible for this year.

The drug costs are instructive. Some of the inhalers retail for $500 apiece. The out-of-pocket costs for a high deductible insurance plan varies from $50.65 to $251.03. The total out-of-pocket drug cost for one month of treatment for asthma was $1,284.92. The most important part was that about half of that cost was for medications that could not be tolerated or were ineffective and had to be discontinued ($565.72). This is a form of cost shifting that nobody ever talks about. I have over $500 worth of medication sitting on the shelf and ready to be discarded because it was ineffective or could not be tolerated. When I think about how many times I have prescribed a medication for a patient only to have the PBM fax me to say that they would only fill 90 days worth of the medication, I wonder about how many tens of thousands of these prescriptions are sitting out there unused.

What about really expensive medications? Some of those are about the equivalent in cost to a new car or several new cars. To give two examples of medications I recently learned about consider Olysio (simeprevir) and Sovaldi (sofosbuvir) new drugs for hepatitis C. Sofosbuvir costs $954.90 for a 400 mg tablet or a full course of therapy for $35,000 - $70,000. Simeprevir is $753.37 for a single 150 mg capsule. I have already read the cost-benefit analyses of theses medications and like most analyses of very expensive medications they seem justified. What happens when you take a very expensive agent like this and it is ineffective or you can't tolerate the side effects? Medicine may be the only area in American life where the customer underwrites the product cost no matter what. What other product works like that? Lemon laws protect car purchases. If you buy a new house, as part of that agreement you either sign an arbitration agreement or you are free to sue if something happens to that house. Most big ticket item retailers have return policies. With medications you are often left with an unused bottle staring at you from the medicine chest and reminding you of what it costs. It probably takes on a lot more importance now that the average employer plan leads to very high out-of-pocket costs.

I don't mean to imply that any of these products are ineffective.  My thoughts on what the FDA does in terms of drug approval are recorded here in this blog.  This all has to do with biological variability and balancing Type I versus Type II error.  Some of the medications I could not tolerate work exceedingly well for other people.  Some of the medications I take are toxic to others.  There are no medications that work well with minimal side effects across the entire population.

Is there a solution to this problem?  I think there is a very straightforward one.  Give the pharmacist the option of supplying a smaller portion of the prescription for the patient to test.  For example, a week of pills or an inhaler with a week of inhalations.  That would have saved me nearly $400 in unnecessary costs.  The environmental costs are also unknown.  There has only been recent interest in what happens to discarded pharmaceuticals when they enter our waste disposal systems and waterways.  That cost is currently unknown but needs to be considered.  This post also highlights the difference between biological products like prescriptions and non biological products like cars.  If a car is a lemon, that is independent of the biology of the owner.  Whether a prescription drug is a lemon or not is solely determined by biology.  

As the cost of health care is shifted back to the consumer, the financing needs to  be like any other expensive consumer good.  That would include some safeguard of value for the money.

George Dawson, MD, DFAPA