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“Can I have that drug I saw on TV?”

Justice, cost-effectiveness, and the ethics of prescribing

Mark A. Graber, MD

The author is Professor of Emergency and Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, and a member of the JAAPA editorial advisory board. He has indicated no relationships to disclose relating to the content of this article.

I know. Nobody wants to read another diatribe against drug companies. That is so passé, so 2005. So how about a tirade against you instead? You, my fellow clinicians, are costing me money. Not only are you costing me money, but because of you, my neighbor no longer has health insurance. Stay with me for a minute, and see if you agree with this statement: The principle of justice requires that we prescribe generic drugs even if there may be some marginal benefit to brand name drugs. If you agree, go back to sleep. I’ll wake you up at the end.

Ethical principles

First, some background. Along with beneficence (doing good) and nonmaleficence (not doing harm), autonomy and justice form the ethical cornerstones of Western medicine. Autonomy is what protects patients from us; it allows them to make their own health care choices, even if their decisions are not ones we would agree with. True autonomy requires access to appropriate information (the “informed” part of “informed consent”); we do our best to keep our patients informed about what their options are and to give them as many choices as possible. Justice is the principle that states that everyone in a similar situation should be treated similarly. For example, if I can get hip surgery, someone who doesn’t have health insurance should be able to get hip surgery just as expeditiously. Justice also applies to the distribution of resources in society. If we agree that a minimum level of health care is a right, then justice requires that all individuals in society have access to this minimum level of care.

However—and this is the part they didn’t tell you about in school—applying the principle of autonomy may violate the principles of nonmaleficence and justice.

Prescribing, the myth of informed consent, and maleficence

All of us want the best treatment for ourselves and our families. Patients are no different; they often ask for what they believe is the best drug. Usually this is something that a family member or friend is taking, or it’s something they have seen advertised on TV or in Reader’s Digest. This makes sense; patients have no reason to know the names of generic and unadvertised drugs, any more than we have reason to know the inner workings of the space shuttle.

Nor do patients know the relative effectiveness of different drugs. In fact, many patients have an unrealistic view of advertised medications. For example, many patients believe that in order for a drug to be advertised on television, it has to be completely safe.¹Because they are making decisions based on faulty information, our patients are laboring under an illusion of autonomy and informed consent. By extension, so are we. Autonomy and informed consent cannot exist when choices are made on the basis of biased or incorrect information.

One outcome of this “uninformed consent” is increased patient harm—maleficence. Many newer drugs have potentially dangerous side effects that do not become apparent until they are in wide distribution.² A quick look at the headlines is all it takes to validate this claim: Vioxx, Bextra, Baycol, Natrecor, SSRIs, salmeterol (Advair, Serevent), and drugs for attention-deficit/hyperactivity disorder have been pulled from the market—or have been given, or are in line for, a black box warning. This is far from an isolated problem: 20% of drugs are either withdrawn from the market or given a black box warning within 25 years of being released.³

We frequently acquiesce to patient requests for brand name drugs even when we believe the drug requested is suboptimal. In our valiant (and appropriate) attempt to maintain patient autonomy, we become complicit in the web of expensive, suboptimal, and potentially harmful treatment. None of us would purposely harm a patient. Yet we persist in giving antibiotics for viral infections in response to patient pressure (number needed to treat: infinite, because there is no benefit; number needed to harm: finite, since some patients will have adverse effects). We also continue to prescribe new drugs (think Vioxx, Celebrex, or Bextra) when older drugs—ibuprofen, for example—are just as safe (or likely safer) and less expensive. Not only is this bad medicine, it is also bad ethics. We may be guilty of maleficence and allowing “uninformed consent” if we prescribe a drug before all of the adverse consequences are known.

In addition to the direct effects on patients, our drug choices have economic impacts. “Cost-effective medicine” has undergone a transition from being a buzzword to being an imperative. This is recognized by the pharmaceutical industry and is why practitioners are presented with so many “cost-effectiveness” analyses. There is a problem here, though. Have you ever noticed how the most expensive drug always turns out to be the cheapest?

This happens for two reasons. First, it is very difficult to do a methodologically sound cost-effectiveness analysis. Even Australia, which has a program to subsidize only cost-effective medications, has a difficult time deciding what is cost-effective.⁴ Second, the outcome is biased by the assumptions made in the study (length of stay, for example, or missed days of work). If these assumptions are changed, the outcome of the analysis changes. As it turns out, most cost-effectiveness analyses have major methodologic flaws and are biased toward the more expensive product.^5,6 For these reasons, industry-sponsored cost-effectiveness analyses should be regarded as advertising and nothing more.

Economics, prescribing, and justice

So who cares if a prescription drug costs more as long as the patient has prescription drug coverage and a fixed co-pay? We all should. When we prescribe expensive brand name medications, health care costs go up. As a result, health insurance premiums go up for all of us. In effect, we are subsidizing your patient’s prescription. This increased economic burden results in more patients going without insurance and adequate health care, which is a clear violation of the principle of justice.

You can rightly argue that the money saved by prescribing a generic drug will not be used to provide care for the poor and uninsured. Instead, it will probably reward the stockholders of the insurance company. But if we reduce health care costs, more of us will be able to afford health insurance, and more of us will have access to adequate health care. So even if there is a marginal benefit to an individual patient by prescribing a brand name drug, this may not justify the overall adverse impact on society. My neighbor no longer has health insurance because of your prescription. Think about this next time you reach for a prescription pad.

So am I a Luddite* who never uses a new or expensive drug? No. There are real benefits to some new drugs. For example, many of the newer antiseizure medications offer significant benefits over phenytoin, carbamazepine, and phenobarbital. But far more new drugs are either “me-too” drugs for which an effective generic alternative exists or are no better than what came before (think Xopenex, Nexium, and prescription NSAIDs). We should think twice about prescribing that unnecessary antibiotic or expensive new NSAID. That prescription may have real, adverse consequences on patients’ lives and the access of many to affordable health care.

JAAPA welcomes commentary about issues of significant concern to the PA profession. Authors should e-mail manuscripts to jaapa@aapa.org.

REFERENCES

1. Bell RA, Kravitz RL, Wilkes MS. Direct-to-consumer prescription drug advertising and the public. J Gen Intern Med. 1999;14:651-657.

2. Wood AJJ. The safety of new medicines. The importance of asking the right questions [editorial]. JAMA. 1999;28(18):1753-1754.

3. Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002;287(17):2215-2220.

4. Marley J. Cost-effectiveness: the need to know. Australian Prescriber. 1996;19:58-59. Available at: http://www.australianprescriber.com/magazine/19/3/58/9/. Accessed June 21, 2006.

5. Donaldson C, Currie G, Mitton C. Cost effectiveness analysis in health care: contraindications. BMJ. 2002;325:891-894.

6. McGregor M. Cost-utility analysis: use QALYs only with great caution [commentary]. Can Med Assoc J. 2003;168(4):433-434.