Access to Medication and Drug Company Sales Practices: Setting Priorities for Critique and Advocacy

On April 16, federal prosecutors announced Bayer's agreement to pay the government $257 million in a Medicaid fraud settlement. Afraid of losing business with insurance giant Kaiser Permanente, for five years Bayer had sold the antibiotic Cipro to Kaiser at prices below those Bayer charged to Medicaid. Because a federal "best price" law requires manufacturers to sell to Medicaid at the lowest price available, Bayer hid the transactions by relabeling the drugs with Kaiser's name and a new drug identification number. The scheme was only revealed when a whistle-blower released documents to the government. He noted that when Bayer executives at a 1999 ethics seminar were told to report any violations to the head of US operations, "the room had erupted in laughter." (Petersen 2003)

Should we be worried about doughnuts and pens? It might seem facile to respond with such a staggering example of what one could call "de maximus" pharmaceutical maneuverings. But the very issue raised by Dana Katz, Arthur L. Caplan, and Jon F. Merz (2003) is one of degree. Small gifts might be worrisome, though causal effects have not been documented. But the reason they might be worrisome, as the authors note, is that they might distort physician decision making. This is a problem because physician responsibility to the patient requires that the patient receive the safest and most effective medication to prevent or treat her condition. The underlying goal we wish to preserve, then, is patient access to appropriate medication, which is perfectly valid. But bioethicists who are concerned about this access should keep the bigger picture of barriers to medication in mind—and within this picture de minimis gifts deserve relatively minimal attention.

Many barriers to medication are due to nonexistent or inadequate healthcare coverage. People with no coverage have inconsistent access to proper diagnoses, treatment, and prescriptions. Many people with some health coverage lack coverage for prescription drugs. Among this group are one-third of Medicare beneficiaries (Medicare Rights Center 2003). Even Medicare beneficiaries who have some coverage through a supplemental Medigap or a retirement plan often face high deductibles and copayments and stringent caps on coverage. For people enrolled in Medicaid, drug coverage exists but is far from unlimited. States have varying restrictive Medicaid formularies, and members can face copayments or caps on the number of concurrent prescriptions covered (Kaiser Commission on Meidcaid and the Uninsured 2002). Finally, even people with private health insurance coverage can face high deductibles, copayments for prescription drugs, or formularies that constrain their prescription options. Such systemic problems might not be attributable to the pharmaceutical industry, but they form a context of barriers to medication access that should greatly concern bioethicists.

Within this context, drug companies engage in numerous practices to promote their products, driven not by patient interests but by profit. The most egregious examples involve blatant schemes to avoid compliance with the law. For example, Bayer's history of relabeling medications to avoid the "best price" law allowed the company both to keep Kaiser's business and to avoid paying rebates to Medicaid. Drug companies also often reward pharmacy benefit managers—the companies that negotiate drug benefits for most health insurance companies—if sales of their own drugs make up a certain percentage of drugs prescribed in a certain category. Some companies have also offered direct payments to pharmacy benefit managers in order to be included on their formularies (Pear 2003). And direct-to-consumer advertising raises drug costs considerably while focusing marketing on a lay population ill-equipped to skeptically interpret medical information.

If physicians were somehow always free to connect their patients with the optimal drugs for their conditions, small gift-giving might stand out as a significant distortion of the system. As things stand now, far too many people lack the medications they need because of woefully inadequate coverage and blatantly...