S Kannan1, S Gowri2, V Tyagi1, S Kohli1, R Jain1, P Kapil1, A Bhardwaj3. 1. Department of Pharmacology, Subharti Medical College and Hospital, Meerut, India. 2. Department of Prosthodontics, Subharti Dental College, Meerut, India. 3. Department of Dermatology, Subharti Medical College and Hospital, Meerut, India.
Abstract
BACKGROUND: Direct to physician advertisements and direct to consumer advertisement (DTCA) is a well-known marketing strategy of pharmaceutical companies. Studies from the West and also from the Indian sub-continent revealed several lacunae in such advertisements. OBJECTIVES: The present study was carried out to understand the international and national scenario regarding the lacunae in drug advertisements and the opinion of both physicians and patients regarding DTCA. METHODS: The present study was conducted after obtaining approval from the institutional ethics committee. Warning letters (WLs) issued to pharmaceutical companies by United States Food and Drug Administration (USFDA) and Therapeutic Goods Administration (TGA) due to discrepancies in the advertisements were analyzed for reasons that were grouped into one of the following categories: overstatement of efficacy; unapproved indication; lack of adequate directions to use; omission of adverse effects; misleading claims; advertisement made for an unapproved drug (investigational new product). Drug advertisements in Current Index of Medical Specialties (CIMS) April-July 2014 issue was also analyzed for lacunae depending on categories as mentioned above. Physicians and patients in a tertiary care medical college and hospital were administered a validated questionnaire exploring their views about crucial aspects of DTCA. Descriptive statistics was used for each of the categories. RESULTS: A total of 93 WLs issued by USFDA and 36 by TGA were assessed. Majority of the WLs by USFDA were issued for omission of adverse effects (61/93, 65.6%) followed by misleading claims (54/93, 58.1%). Similarly, WLs by TGA were also mainly issued for the presence of misleading claims (35/36, 97.2%) followed by overstatement of efficacy (26/36, 72.2%) and CIMS evaluation had revealed that 78/92 (84.8%) advertisements omitted adverse effects, 20/92 (21.7%) had misleading claims, 9/92 (9.8%) had unapproved indications and 7/92 (7.6%) overstated the efficacy. With regard to the opinion regarding DTCA, 69.9% physicians had a patient discussing DTCA that was clinically inappropriate. One hundred (64.5%) out of 155 physicians opined that DTCA encourage patients to attend physicians regarding preventive healthcare. On the contrary, 82/155 (52.9%) physicians felt that DTCA would damage the same. Similarly, 69 out of the total 100 patients felt that drug advertisements aid them to have better discussions with their treating physicians. Surprisingly, a large majority (91/100) were of the opinion that only safe drugs are allowed to be advertised. CONCLUSION: To conclude, from the findings of this study both the physicians and patients should be cautious and not overzealous while dealing with drug advertisements or promotional literature. More stringent scrutiny and issue of WLs or blacklisting of indulging pharmaceutical companies are mandatory by the regulatory agency to contain the same.
BACKGROUND: Direct to physician advertisements and direct to consumer advertisement (DTCA) is a well-known marketing strategy of pharmaceutical companies. Studies from the West and also from the Indian sub-continent revealed several lacunae in such advertisements. OBJECTIVES: The present study was carried out to understand the international and national scenario regarding the lacunae in drug advertisements and the opinion of both physicians and patients regarding DTCA. METHODS: The present study was conducted after obtaining approval from the institutional ethics committee. Warning letters (WLs) issued to pharmaceutical companies by United States Food and Drug Administration (USFDA) and Therapeutic Goods Administration (TGA) due to discrepancies in the advertisements were analyzed for reasons that were grouped into one of the following categories: overstatement of efficacy; unapproved indication; lack of adequate directions to use; omission of adverse effects; misleading claims; advertisement made for an unapproved drug (investigational new product). Drug advertisements in Current Index of Medical Specialties (CIMS) April-July 2014 issue was also analyzed for lacunae depending on categories as mentioned above. Physicians and patients in a tertiary care medical college and hospital were administered a validated questionnaire exploring their views about crucial aspects of DTCA. Descriptive statistics was used for each of the categories. RESULTS: A total of 93 WLs issued by USFDA and 36 by TGA were assessed. Majority of the WLs by USFDA were issued for omission of adverse effects (61/93, 65.6%) followed by misleading claims (54/93, 58.1%). Similarly, WLs by TGA were also mainly issued for the presence of misleading claims (35/36, 97.2%) followed by overstatement of efficacy (26/36, 72.2%) and CIMS evaluation had revealed that 78/92 (84.8%) advertisements omitted adverse effects, 20/92 (21.7%) had misleading claims, 9/92 (9.8%) had unapproved indications and 7/92 (7.6%) overstated the efficacy. With regard to the opinion regarding DTCA, 69.9% physicians had a patient discussing DTCA that was clinically inappropriate. One hundred (64.5%) out of 155 physicians opined that DTCA encourage patients to attend physicians regarding preventive healthcare. On the contrary, 82/155 (52.9%) physicians felt that DTCA would damage the same. Similarly, 69 out of the total 100 patients felt that drug advertisements aid them to have better discussions with their treating physicians. Surprisingly, a large majority (91/100) were of the opinion that only safe drugs are allowed to be advertised. CONCLUSION: To conclude, from the findings of this study both the physicians and patients should be cautious and not overzealous while dealing with drug advertisements or promotional literature. More stringent scrutiny and issue of WLs or blacklisting of indulging pharmaceutical companies are mandatory by the regulatory agency to contain the same.