Journal of Postgraduate Medicine Medknow Publications and Staff Society of Seth GS Medical College and KEM Hospital, Mumbai, India ISSN: 0022-3859 EISSN: 0972-2823 Vol. 57, Num. 3, 2011, pp. 256-257

Journal of Postgraduate Medicine, Vol. 57, No. 3, July-September, 2011, pp. 256-257

Letter

Reporting of outcomes in drug promotional materials distributed by pharmaceutical companies

C Jaykaran¹, D Saxena², P Yadav¹, ND Kantharia¹

¹ Department of Pharmacology, Government Medical College, Surat, Gujarat, India
² Department of Community Medicine, Government Medical College, Surat, Gujarat, India
Correspondence Address: C Jaykaran, Department of Pharmacology, Government Medical College, Surat, Gujarat, India, drjaykaran@yahoo.co.in

Code Number: jp11071

PMID: 21941074
DOI: 10.4103/0022-3859.85226

Sir,

Pharmaceutical promotional materials/drug advertisements distributed to doctors in hospitals is considered as an important method of spreading the information related to existing and new drugs. Many studies revealed that quality of information given in these drug advertisements is poor. One of the major areas of deficiency is reporting of patient outcomes. ^[1],[2] Changes in outcomes because of drugs can be reported by various methods such as relative risk reduction (RRR), absolute risk reduction (ARR), and number needed to treat (NNT). Various studies showed that the way of presentation of change in outcomes influence the physician decision regarding the drug prescription. Inclination toward the use of drug is more when the outcomes are given as RRR and it is less when the outcome is given as NNT. ^[3] Some studies are done in western countries to see reporting of these parameters in drug advertisements/drug promotional materials, but no such study was done for drug promotional materials distributed by pharmaceutical companies in India. As method of reporting these outcomes influences the prescribing of clinicians it is important to survey how outcomes are actually reported in these drug promotional materials . Hence, this study is done with the aim of appraising various drug promotional materials distributed by pharmaceutical companies for reporting of methods of patient outcomes.

This study was done between Oct to Dec 2010. After taking permission from Institutional Ethics Committee, all drug promotional materials distributed by medical representatives of pharmaceutical companies at various out patient departments (OPDs) of New Civil Hospital and Govt. Medical College, Surat were collected. Drug promotional materials related to medical and surgical instruments were excluded from the study. Each drug promotional material was appraised by the first author (J. K) for reporting of RRR, ARR, and NNT. Relative risk reduction shows that how much risk is reduced in the experimental group (drug) as compared to control group (comparator drug or placebo). Suppose 40% of control group subjects died and 20% of experimental group subjects died then relative risk reduction will be 50%. Absolute risk reduction denotes absolute difference in the outcome between control and experimental group in the above example ARR will be 20%, that is, (40 to 20%). Number needed to treat calculates the number of patients that would need to be treated to prevent one bad outcome (death in this example) and it can be calculated by the formula 1/ARR. So in this case NNT is 5 (1/0.20). It was also seen that whether on the basis of given data RRR, ARR, or NNT can be calculated. All these advertisements were rechecked by the second author (D. S.) (K=0.84) and discrepancies were resolved by consensus.

Three hundred and forty-seven drug promotional materials of 256 different products were analyzed for reporting of change in clinical outcomes. Out of 347 promotional material 38 (10.9%, 95% CI 8% to 14.6%) drug promotional materials reported change in clinical outcomes. Relative risk reduction was exclusively reported in 14 (36%) drug promotional materials. In 6 (15.7%) promotional materials though only relative risk was reported but ARR and NNT could be calculated by given data in graph or in text. In rest 18 (47%) drug promotional materials nothing out of RRR, ARR, and NNT was reported exclusively but all three parameters could be calculated by given data in graph/table/text. In none of the promotional materials ARR or NNT was reported exclusively.

This study shows that clinical outcomes are not reported frequently in drug promotional materials distributed by pharmaceutical companies and this finding is supported from other studies done with the similar objectives. ^[4] Relative risk reduction is reported frequently but a knowledgeable clinician can calculate ARR and NNT from given data. There may be various reasons for reporting the results as RRR one of the important reasons is that in the case of RRR even the small difference can be shown more impressive in the form of percentage reduction or increase. Clinicians should be trained regarding the critical appraisal of drug promotional materials distributed by pharmaceutical companies as well as drug advertisements published in medical journals so that they can take the decision based on evidence while prescribing drugs to his patients. Pharmaceutical companies should report quantitative data in there drug promotional materials so that the confusion and error created because of qualitative data can be decreased.

References

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