van Schalkwyk and Turner1 offer a three-point critique of our paper in the Journal of Clinical Hypertension.2 We empirically demonstrated how increases in access limits of all pharmaceutical sales representatives to physicians decreased the amount and speed of their clinical prescription responses to both positive (first-in-class drug) and negative new medical information (black-box warning) relative to physicians in more open-access offices. We unequivocally challenge their critique for lacking theoretical, empirical, and legal merit.
First, van Schalkwyk and Turner have simply mischaracterized our paper. Detailing is not the subject of our paper, but rather what happens when the market for accessing complex medical information is distorted. Our model analyzed not the effect of the amount of detailing done by one product or the other, but the effects of limited access imposed on all sales representatives’ detailing to physicians. Our study uniquely demonstrated on an unprecedented scale using robust empirical techniques how physician-level prescription clinical decisions were affected in the absence of critical medical information provided by pharmaceutical sales representatives. van Schalkwyk and Turner chose to deny our empirical evidence and instead hold onto an ideological position lacking merit. Physicians need the latest information to make the most accurate clinical decisions. The consequences of lacking the latest information to better inform a correct diagnosis and proper treatment option can have serious consequences to patients. van Schalkwyk and Turner wish us to believe that promoting greater physician ignorance by restraining the flow of Food and Drug Administration (FDA)–approved medical information produces better clinical decisions. Seminal empirical work in health economics referenced in our paper challenge this position.3,4
Second, van Schalkwyk and Turner have minimized the availability of numerous unbiased medical information channels available to physicians. Pharmaceutical detailing is just one of many channels physicians use to acquire medical information. Physicians use many digital channels to access product and disease-specific Web sites and are engaged in physician discussion groups. Physicians read academic medical journals and FDA announcements, attend medical conferences and local physician society meetings, engage colleagues and key medical opinion leaders on treatment paradigms, and leverage experiences from their own clinical practice. Our empirical model design described and indirectly captured many of these effects. This explains why we found that the influence of increasing access limits had its largest effect for the first-in-class product launch case (sitagliptin), where sales representatives have novel information for physicians. Access limits played a much smaller role in the negative medical event cases (simvastatin/ezetimibe and rosiglitazone), where physicians tend to get this information from other sources. We explained why access limits mattered less to specialists vs primary care physicians (PCPs). PCPs track information for a much larger number of products, therefore keeping current is more difficult. So unlike van Schalkwyk and Turner, we correctly assumed and empirically verified physicians as sophisticated and discriminating consumers of multi-sourced medical information. Moreover, we challenge the notion that academic detailers, especially those supported by state governments here in the United States, are free from advancing their own agendas at the potential expense of patients. States are not disinterested parties to drug selection given the rising budget costs of Medicaid. State Medicaid plans encourage cost-only–driven generic utilization through bioequivalent and therapeutic interchange. States often erect pharmacy drug product selection laws making it easier for pharmacists to dispense generic drugs to control drug spending. This raises the question of whether these cost-only–driven policies promoting generic utilization through therapeutic interchange and substitution (substitution across drugs with different indications) serve the best interests of all patients. A strong policy statement from the American College of Cardiology Foundation Clinical Quality Committee has warned about the dangers of this drug policy.5 Further, medical information provided by pharmaceutical sales representatives are tightly regulated by the FDA. All messages and printed materials must be on-label and supported by FDA-approved clinical data. The argument that such information is “biased” simply because sales representatives are out to generate more physician prescriptions flies against the entire monitoring and enforcement regulatory structure. This argument is part of the “conflict-of-interest” narrative that has produced an explosion of policies limiting medical and industry connections that Lesko and colleagues6 argued do not promote public health and reduce medical innovation. Greene7 provides an instructive historical review on how the current system of pharmaceutical detailing evolved as a joint venture between physicians and industry. Greene7 noted that the opt-out AMA Prescribing Data Restriction Program (PDRP), in existence since May 2006, allowing physicians to shield their prescribing data from pharmaceutical sales representatives, had barely received more than 1% support. Recent data suggest that this estimate is in the 4% to 5% range using about 31,000 physicians who signed up for PDRP.8 It is hard to believe that this program would receive so little support if physicians felt that pharmaceutical sales representatives provided such biased information as van Schalkwyk and Turner suggest.
Finally, the remedy by van Schalkwyk and Turner that the further limiting of pharmaceutical detailing is required, thus suppressing commercial speech, lacks legal merit. The US Supreme Court in Sorrell v. IMS Health ruled 6–3 in 2011 that restricting the flow of physician prescriber level data to pharmaceutical companies in order to limit detailing rests on faulty assumptions that do not promote public health:
Vermont’s law also rests on the illegitimate premise that physicians are not making what the State considers to be the optimal prescription decisions for their patients. The law is based on derogatory assumptions about doctors and the counterintuitive notion that doctors will make better decisions about patient health if they are deprived of FDA-regulated speech about FDA-approved drugs. The First Amendment prevents a State from impeding the flow of truthful and non-misleading information based on such paternalistic assumptions.9
Promoting public health is best achieved by encouraging greater competition of medical information through supporting free speech from all FDA-regulated sources, and not arbitrarily suppressing certain forms of speech simply because it does not conform to one’s ideological views. Our empirical study, while not analyzing patient health outcomes, provides initial affirming evidence to the words of the Court’s majority opinion that suppressing commercial speech is not in the best interests of physicians and patients.