J Clin Hypertens (Greenwich). 2012; 14:435–446. ©2012 Wiley Periodicals, Inc. The authors explored to what extent important medical decisions by practitioners can be influenced by pharmaceutical representatives and, in particular, whether restricting such access could delay appropriate changes in clinical practice. Medical practices were divided into four categories based on the degree of sales representative access to clinicians: very low, low, medium, and high from a database compiled by ZS Associates called AccessMonitor (Evanston, IL) used extensively by many pharmaceutical companies. Clinical decisions of 58,647 to 72,114 physicians were statistically analyzed using prescription data from IMS Health (Danbury, CT) in three critical areas: an innovative drug for type 2 diabetes (sitagliptin), an older diabetes drug with a new Food and Drug Administration–required black box warning for cardiovascular safety (rosiglitazone), and a combination lipid therapy that had reported negative outcomes in a clinical trial (simvastatin+ezetimbe). For the uptake of the new diabetes agent, the authors found that physicians with very low access to representatives had the lowest adoption of this new therapy and took 1.4 and 4.6 times longer to adopt than physicians in the low‐ and medium‐access restriction categories, respectively. In responding to the black box warning for rosiglitazone, the authors found that physicians with very low access were 4.0 times slower to reduce their use of this treatment than those with low access. Likewise, there was significantly less response in terms of changing prescribing to the negative news with the lipid therapy for physicians in more access‐restricted offices. Overall, cardiologists were the most responsive to information changes relative to primary care physicians. These findings emphasize that limiting access to pharmaceutical representatives can have the unintended effect of reducing appropriate responses to negative information about drugs just as much as responses to positive information about innovative drugs.

Objectives  This paper analyses generic‐to‐branded drug switch‐back patterns in the statin class. Methods  Utilizing LifeLink™ Anonymized Patient Level Data (APLD) from IMS Health, 17.3 million unique treated patients over a 2‐year period from July 2006 to June 2008 were analysed. Switch‐backs to branded drugs were analysed for patients who started on a branded drug and were switched to a generic statin, or for patients who started therapy on a generic drug. Key findings  A total of 538 000 patients, or 3.1% of the total number of treated patients, engaged in switch‐backs, of which 69 000 and 469 000 patients are bioequivalent and therapeutic switch‐backs, respectively. Excluding 9.7 million patients never on generic drugs, 7.1% of the remaining 7.6 million patients engaged in switch‐backs. Switch‐back patterns increased with greater patient health risk such as increasing age and co‐morbidities. Higher patient doses of simvastatin increased switch‐back rates, from about 10% at the 5 and 10 mg doses to 16% at the 80 mg dose. Among switch‐back patients, 37% had high cardiovascular risk based on the number of co‐morbidities. Switch‐backs increased with physician specialty status. Conclusions  Managed care controls play a significant role in encouraging initial brand‐to‐generic substitution which in turn results in switch‐back patterns for some classes of patients. Future research considerations and policy implications are discussed. The results suggest that while generic drugs seem to be as good as branded drugs most of the time, this may not always be true. Thus, a universal policy approach mandating generic utilization for all patients, particularly when driven on purely cost grounds, is not appropriate.

Pharmaceutical companies have traditionally relied on product-specific in-person calls to physicians (detailing) to market their drugs. However, US pharmaceutical sales representative access to physicians is decreasing, resulting in important changes in marketing strategy, sales force optimization and operations, and other processes. Despite these changes, no studies have examined the determinants of pharmaceutical sales representative access limits to physicians. We analyzed effects from prescription volume, managed care control, group practice size, urban location, and physician-level attributes for three product cases involving type 2 diabetes and dyslipidemia covering 58,647 to 72,114 US physicians using an ordered multinomial logistic regression model. A database available to and used by US pharmaceutical companies was utilized that measures sales representative physician-level access limits. Results revealed physicians with moderate managed care control had greater access limits than physicians with high or low managed care control, as did physicians with higher prescription volume, in smaller practices, and fewer years since graduation. Access limits also significantly varied by specific urban location. The results fit a time allocation model explaining how physicians and sales representatives allocate their time, and suggest effects from physician adoption of newer digital channels for medical information and changing norms at medical schools toward industry representatives. Commercial implications of restrictive access limits for companies are discussed as well as future extensions of this research.

offer a three-point critique of our paper in the Journal of Clinical Hypertension. 2We 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 physician...

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