E-drug: Reply from Dr Attaran to Dr Srinivas (cont'd)
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Dr. Srinivas' argument is consistent with what is currently being
reported in the literature--see references below.
For newly marketed drugs, limited information is available for
generalizing relatively small clinical trials to the broader populations,
especially with respect to questions on safety for which average trials
are not specifically designed to assess.
Many hurried prescribers are under-informed and readily influenced
by marketing and/or the patient who may also be hurried and readily
influenced by marketing--in developed countries as well as
developing. Reporting and publication bias are known to exist, and, in
the absence of substantial training in epidemiology and the design of
clinical trials, healthcare professionals may find it challenging to
define the limitations of data on which marketing approval is based.
For instance, the generalizability of data to certain patient populations
may not be warranted, or the data may have a small p-value but have
very wide confidence intervals. This is where confusion can and does
occur (it has for me).
Sarah Sellers, PharmD
Johns Hopkins School of Public Health
USA
e-mail: ssellers@jhsph.edu
Some recent literature--
Villanueva P, Peiro S,Librero J, Pereiro I. Accuracy of pharmaceutical
advertisements in medical journals. Lancet 2003 Jan
4;361(9351):27-32.
Monaghan MS, Galt KA, Turner PD et al. Student understanding of
the relationship between the health profession and the
pharmaceutical industry. Tech Learn Med 2003 winter;15(1):14-20.
Stokamer CL. Pharmaceutical gift giving: analysis of an ethical
dilemma. J Nurs Adm 2003 Jan; 33(1):48-51.
Mukamal KJ, Markson LJ, Flier SR, Calabrese D. Restocking the
sample closet: results of a trial to alter medication prescribing. J Am
Board of Fam Pract 2002 Jul-Aug; 15(4):285-9.
Boltri JM, Gordon ER, Vogel RL. Effect of antihypertensive samples
on physician prescribing patterns. Fam Med 2002 Nov-Dec;
34(10):729-31.
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