Essays
The Bitter Pill of Name-Brand Drugs by moti gorin
I
magine a drug—let’s call it Curebitt—that is safe, cheap, and very effective: take a pill once a day and you will be healthier. The only drawback of Curebitt is that it has an extremely bitter taste. The taste is so unpleasant, in fact, that a significant proportion of patients cannot bring themselves to ingest the pill regularly. If they are not able to adhere to the treatment regimen, though, they are not receiving the full clinical benefit of the drug. Should physicians still prescribe Curebitt? Yes: That some patients are so averse to taking the drug is unfortunate, but since many patients can overcome the bitterness to receive the benefit, it is ethically appropriate for physicians to continue prescribing Curebitt. Now suppose that after some time, another drug, Curesweet, hits the market. This drug is clinically equivalent to Curebitt and costs the same, but it is much more palatable, so that adherence rates for Curesweet are significantly higher than for Curebitt. Consequently, more patients receive a benefit when Curesweet is prescribed than when Curebitt is. Also, the probability that any given patient’s health will improve is higher when she is prescribed Curesweet. Should physicians continue prescribing Curebitt, now that Curesweet is available? No: Prescribing the bitter pill puts patients at a greater risk of nonadherence and ultimately results in reduced clinical benefit for a significant proportion of patients, whereas prescribing Curesweet benefits more patients and increases the probability that any given patient’s health will improve. The Curebitt versus Curesweet scenario draws our attention to how a physician can fail her patients by prescribing drugs with lower adherence rates when equivalent drugs with higher adherence rates are available. Of course this case is fictional, and so perhaps it is not obvious what, if anything, it tells us about the real world. In fact, it tells us a lot. We know that adherence rates vary with out-of-pocket costs.1 Name-brand drugs carry higher out-of-pocket costs Moti Gorin, “The Bitter Pill of Name-Brand Drugs,” Hastings Center Report 45, no. 4 (2015): 11-12. DOI: 10.1002/hast.468
July-August 2015
than their generic counterparts, rendering very plausible the claim that adherence rates for name-brand drugs are lower than for generics. Not surprisingly, research supports this proposition.2 What this means is that when name-brand drugs are prescribed rather than their generic counterparts, fewer patients receive health benefits. Indeed, when clinicians prescribe name-brand drugs, an unnecessary risk— namely, the increased risk of nonadherence and its clinical ramifications—is imposed on patients. Prescribing a namebrand drug when a clinically equivalent generic is available is analogous to prescribing Curebitt when Curesweet is available. If prescribing Curebitt is unethical, then so is prescribing the name-brand drug. To criticize this argument, either one can deny that it is ethically impermissible to prescribe Curebitt when Curesweet is available, or one can argue that I have missed some important difference between the imaginary case and the real-life cases. The first approach is rather unattractive, for it requires countenancing the claim that clinicians do nothing wrong if they prescribe medication that a significant proportion of patients will not take even though a clinically equivalent medication is available that the patients will take. Essentially withholding beneficial treatment from patients in the absence of a compelling justification amounts to a failure on the part of the physician to abide by her professional duty to provide the best treatment. The second approach requires claiming that the cases are not analogous in some relevant way. Clearly, the cases are not identical in every feature, but it is hard to see how the differences matter. With respect to their ethically relevant features, the analogy holds: both bitterness and costliness are predictably aversive, and the aversion in both cases predictably leads to worse health outcomes. The bitter-pill thought experiment illuminates a largely overlooked ethical aspect of the prescribing behavior of physicians, one grounded directly in patient health and physicians’ professional obligation to help protect and promote it. The most common argument in support of policies that H AS TI N GS C EN TE R RE P O RT
11
When clinicians prescribe name-brand drugs, an unnecessary risk— the increased risk of nonadherence and its clinical ramifications—is imposed on patients. shift prescription drug use away from name-brand drugs and toward generics focuses on financial costs: health care costs are exceedingly high, and generics can save many billions of dollars every year for insurers, employers, Medicare and Medicaid, and individual patients.3 As compelling as this macroeconomic argument is, debates about how to allocate massive sums of money distributed across a complex system of health care delivery may not change the prescribing behavior of physicians, who treat patients one at a time. Every physician knows that whatever prescribing choices she makes for the patient now sitting in front of her, the financial effect on a system in which trillions of dollars change hands will be negligible. Moreover, even clinicians who are conscientiously concerned about health care costs and who are motivated to do their part, however small, to reduce spending may nonetheless be overwhelmed by industry-shaped biases.4 Arguments that appeal to the financial harm visited on patients by unnecessarily high out-of-pocket expenses may fare better, since those arguments focus attention at the level of individual patients, yet even these direct appeals to a patient’s overall well-being may fail to gain traction with those who believe physicians should concentrate narrowly on clinical considerations alone.5 The argument by analogy set out above remains neutral on the more general and controversial question concerning the proper scope of physician concern. It bypasses the arguably incidental problem of suffocating health care costs and shows that doctors have ethically compelling reasons, grounded in their clinical responsibilities to their patients, to stop prescribing name-brand drugs when generic counterparts are available. This conclusion leads to a related question about whether payers should cover the costs of name-brand drugs. Putting aside considerations of direct costs, payers have good reason to favor generics strongly. That policy will ensure the best health outcomes for the population of patients they cover. There is an important caveat here: some patients may be so firmly committed to using name-brand drugs that prescribing generic equivalents would serve only to discourage them
12 HASTI N G S C E N T E R R E P ORT
from taking their medication, an outcome that would be no better than reduced adherence due to bitterness or higher cost. Similarly, there are other attributes of drugs that may affect adherence, such as the ease or difficulty of taking a dose (for example, pill versus injection) or the complexity of the dosing routine (once a week versus daily, for instance). The point is that cost, too, is a clinical consideration insofar as it affects adherence. The ethically appropriate and pragmatic solution to brand-name adamancy is to minimize its negative effects by charging higher copays to obtain such medications. In any case, the rare cases of brand-name adamancy should not distract us from the far more common problem of nonadherence due to out-of-pocket costs borne by patients who are prescribed name-brand drugs when they would have been happy with, and more adherent to, an equivalent generic drug regimen. Prescribing and paying for name-brand drugs when equivalent generics are available is a bitter pill we have good reason to refuse. Acknowledgment
I would like to thank Chris Feudtner and Steven Joffe for their feedback on earlier drafts of this essay. 1. D. P. Goldman, G. F. Joyce, and Y. Zheng, “Prescription Drug Cost Sharing: Associations with Medication and Medical Utilization and Spending and Health,” Journal of the American Medical Association 298 (2007): 61-69; M. E. Chernew et al., “Impact of Decreasing Copayments on Medication Adherence within a Disease Management Environment,” Health Affairs 27, no. 1 (2008): 103-12. 2. W. H. Shrank et al., “The Implications of Choice: Prescribing Generic or Preferred Pharmaceuticals Improves Medication Adherence for Chronic Conditions,” Archives of Internal Medicine 166, no. 3 (2006): 332-37. 3. United States Government Accountability Office, “Drug Pricing: Research on Savings from Generic Drug Use,” 2012, http://www.gao. gov/assets/590/588064.pdf. 4. E. G. Campbell et al., “Physician Acquiescence to Patient Demands for Brand-Name Drugs: Results of a National Survey of Physicians,” JAMA Internal Medicine 173, no. 3 (2013): 237-39. 5. Alicia Hall, “Financial Side Effects: Why Patients Should Be Informed of Cost,” Hastings Center Report 44, no. 3 (2014): 41-47.
July-August 2015
The Bitter Pill of Name-Brand Drugs by moti gorin
I
magine a drug—let’s call it Curebitt—that is safe, cheap, and very effective: take a pill once a day and you will be healthier. The only drawback of Curebitt is that it has an extremely bitter taste. The taste is so unpleasant, in fact, that a significant proportion of patients cannot bring themselves to ingest the pill regularly. If they are not able to adhere to the treatment regimen, though, they are not receiving the full clinical benefit of the drug. Should physicians still prescribe Curebitt? Yes: That some patients are so averse to taking the drug is unfortunate, but since many patients can overcome the bitterness to receive the benefit, it is ethically appropriate for physicians to continue prescribing Curebitt. Now suppose that after some time, another drug, Curesweet, hits the market. This drug is clinically equivalent to Curebitt and costs the same, but it is much more palatable, so that adherence rates for Curesweet are significantly higher than for Curebitt. Consequently, more patients receive a benefit when Curesweet is prescribed than when Curebitt is. Also, the probability that any given patient’s health will improve is higher when she is prescribed Curesweet. Should physicians continue prescribing Curebitt, now that Curesweet is available? No: Prescribing the bitter pill puts patients at a greater risk of nonadherence and ultimately results in reduced clinical benefit for a significant proportion of patients, whereas prescribing Curesweet benefits more patients and increases the probability that any given patient’s health will improve. The Curebitt versus Curesweet scenario draws our attention to how a physician can fail her patients by prescribing drugs with lower adherence rates when equivalent drugs with higher adherence rates are available. Of course this case is fictional, and so perhaps it is not obvious what, if anything, it tells us about the real world. In fact, it tells us a lot. We know that adherence rates vary with out-of-pocket costs.1 Name-brand drugs carry higher out-of-pocket costs Moti Gorin, “The Bitter Pill of Name-Brand Drugs,” Hastings Center Report 45, no. 4 (2015): 11-12. DOI: 10.1002/hast.468
July-August 2015
than their generic counterparts, rendering very plausible the claim that adherence rates for name-brand drugs are lower than for generics. Not surprisingly, research supports this proposition.2 What this means is that when name-brand drugs are prescribed rather than their generic counterparts, fewer patients receive health benefits. Indeed, when clinicians prescribe name-brand drugs, an unnecessary risk— namely, the increased risk of nonadherence and its clinical ramifications—is imposed on patients. Prescribing a namebrand drug when a clinically equivalent generic is available is analogous to prescribing Curebitt when Curesweet is available. If prescribing Curebitt is unethical, then so is prescribing the name-brand drug. To criticize this argument, either one can deny that it is ethically impermissible to prescribe Curebitt when Curesweet is available, or one can argue that I have missed some important difference between the imaginary case and the real-life cases. The first approach is rather unattractive, for it requires countenancing the claim that clinicians do nothing wrong if they prescribe medication that a significant proportion of patients will not take even though a clinically equivalent medication is available that the patients will take. Essentially withholding beneficial treatment from patients in the absence of a compelling justification amounts to a failure on the part of the physician to abide by her professional duty to provide the best treatment. The second approach requires claiming that the cases are not analogous in some relevant way. Clearly, the cases are not identical in every feature, but it is hard to see how the differences matter. With respect to their ethically relevant features, the analogy holds: both bitterness and costliness are predictably aversive, and the aversion in both cases predictably leads to worse health outcomes. The bitter-pill thought experiment illuminates a largely overlooked ethical aspect of the prescribing behavior of physicians, one grounded directly in patient health and physicians’ professional obligation to help protect and promote it. The most common argument in support of policies that H AS TI N GS C EN TE R RE P O RT
11
When clinicians prescribe name-brand drugs, an unnecessary risk— the increased risk of nonadherence and its clinical ramifications—is imposed on patients. shift prescription drug use away from name-brand drugs and toward generics focuses on financial costs: health care costs are exceedingly high, and generics can save many billions of dollars every year for insurers, employers, Medicare and Medicaid, and individual patients.3 As compelling as this macroeconomic argument is, debates about how to allocate massive sums of money distributed across a complex system of health care delivery may not change the prescribing behavior of physicians, who treat patients one at a time. Every physician knows that whatever prescribing choices she makes for the patient now sitting in front of her, the financial effect on a system in which trillions of dollars change hands will be negligible. Moreover, even clinicians who are conscientiously concerned about health care costs and who are motivated to do their part, however small, to reduce spending may nonetheless be overwhelmed by industry-shaped biases.4 Arguments that appeal to the financial harm visited on patients by unnecessarily high out-of-pocket expenses may fare better, since those arguments focus attention at the level of individual patients, yet even these direct appeals to a patient’s overall well-being may fail to gain traction with those who believe physicians should concentrate narrowly on clinical considerations alone.5 The argument by analogy set out above remains neutral on the more general and controversial question concerning the proper scope of physician concern. It bypasses the arguably incidental problem of suffocating health care costs and shows that doctors have ethically compelling reasons, grounded in their clinical responsibilities to their patients, to stop prescribing name-brand drugs when generic counterparts are available. This conclusion leads to a related question about whether payers should cover the costs of name-brand drugs. Putting aside considerations of direct costs, payers have good reason to favor generics strongly. That policy will ensure the best health outcomes for the population of patients they cover. There is an important caveat here: some patients may be so firmly committed to using name-brand drugs that prescribing generic equivalents would serve only to discourage them
12 HASTI N G S C E N T E R R E P ORT
from taking their medication, an outcome that would be no better than reduced adherence due to bitterness or higher cost. Similarly, there are other attributes of drugs that may affect adherence, such as the ease or difficulty of taking a dose (for example, pill versus injection) or the complexity of the dosing routine (once a week versus daily, for instance). The point is that cost, too, is a clinical consideration insofar as it affects adherence. The ethically appropriate and pragmatic solution to brand-name adamancy is to minimize its negative effects by charging higher copays to obtain such medications. In any case, the rare cases of brand-name adamancy should not distract us from the far more common problem of nonadherence due to out-of-pocket costs borne by patients who are prescribed name-brand drugs when they would have been happy with, and more adherent to, an equivalent generic drug regimen. Prescribing and paying for name-brand drugs when equivalent generics are available is a bitter pill we have good reason to refuse. Acknowledgment
I would like to thank Chris Feudtner and Steven Joffe for their feedback on earlier drafts of this essay. 1. D. P. Goldman, G. F. Joyce, and Y. Zheng, “Prescription Drug Cost Sharing: Associations with Medication and Medical Utilization and Spending and Health,” Journal of the American Medical Association 298 (2007): 61-69; M. E. Chernew et al., “Impact of Decreasing Copayments on Medication Adherence within a Disease Management Environment,” Health Affairs 27, no. 1 (2008): 103-12. 2. W. H. Shrank et al., “The Implications of Choice: Prescribing Generic or Preferred Pharmaceuticals Improves Medication Adherence for Chronic Conditions,” Archives of Internal Medicine 166, no. 3 (2006): 332-37. 3. United States Government Accountability Office, “Drug Pricing: Research on Savings from Generic Drug Use,” 2012, http://www.gao. gov/assets/590/588064.pdf. 4. E. G. Campbell et al., “Physician Acquiescence to Patient Demands for Brand-Name Drugs: Results of a National Survey of Physicians,” JAMA Internal Medicine 173, no. 3 (2013): 237-39. 5. Alicia Hall, “Financial Side Effects: Why Patients Should Be Informed of Cost,” Hastings Center Report 44, no. 3 (2014): 41-47.
July-August 2015
