Zenecas DTC Advertising of Nolvadex Essay Example for Free

Zenecas DTC Advertising of Nolvadex EssayZeneca is largest pharmaceutical and agricultural/industrial chemical company in United States. In 1999 pectus crab louse was the most frequent diseases were found in American women, intimately 175,000 cases of boob pubic louse were diagnosed and about 43,500 women were died due to the breast crabby person. According to the breast cancer prevention trial (BCPT), 45% reduction in breast cancer cases came through the use of Nolvadex. In November 1998 due to the new indications from the Food and Drug governing (FDA) for the use of Nolvadex, Zeneca had decided to start direct to consumer advertizing pass for Nolvadex. Findings In finding report will find over all performance of Zenecas advertisement campaign. This report will also look at the ethical issues which were raised in the case study, issues which were raised by activist groups and recommendations for managing the activists protests. 1. 1-Uncertainties from medical o wish of sufficient data form breast cancer preventing trial physicians were worried about the side effects of Nolvadex, because the women who have high risk of breast cancer who might die if they do not take drug but for healthy women Nolvadex were not suitable from their point of view.According to physicians past experiences, Nolvadex lowered the breast cancer risk in women age 35 or more but increase the risk of other diseases in healthy women like endometrial cancer and other minor side effects like blood clots in the legs and lungs, hot flashes flushing, irregular menstrual periods, dizziness, headaches, fatigue, loss of appetite, vomiting and irritation of scrape around the vagina. o Same studies like breast cancer preventing trial came from British and Italian studies which failed to show that tamoxifne was associated with a cancer risk reduction do goodThey give assurance that women can both learn and control their risk, when, in fact, the risk model that is being promoted by Zenec a has been rightfully criticized by biostatisticians. The drug that Zeneca is promoting is atomic number 53 whose short tern benefits in healthy women are in question, and whose long term risks among healthy women are still unknown. o Some doctors were argued that side effect was in any case serious to prescribe for women who did not have breast cancer. They were asking to add more advisability of using the drug to lower the risk of breast cancer.These physicians wanted to face for more data regarding Nolvadex and comparing trial of Nolvadex with Eli Lillys Evista which some believed that safer then Zenecas Nolvadex. 1. 2-Uncertainties from regulatory o According to Food and Drug Administration (FDA) there were some difficulty with exact language that contained in the new labelling e. g. Zeneca wanted to use word Prevention for describing the Nolvadex but FDA was not agree because labelling was lack of enough data on what happened to the women in the study after five years of tr eatmentFDA was disagreed with Zenecas ads. because they were lack of brief summary regarding the risk and other discipline about Nolvadex. They wanted to conk out those information in advertising campaign o Zeneca had made the video for unbranded advertisement which was included full information of breast cancer and about Nolvadex but FDA had argued that video was heavily branded and lack of fair balance between benefits and risks of Nolvadex o Zeneca was required to include a four-part disclaimer (including side effects) when incessantly the word Nolvadex comes in videoFDAs Division of Drug Marketing, Advertising and Communication (DDMAC) reviewed the information material in advertising campaign and determine that they are inconclusive or misleading and lacking fair balance and they are full of product and in violation of the Act for the above reasons o Zeneca was failed to discuss the Gail molding Risk Assessment Tool in the print advertisement or brochure which damage the im portance of an accurate risk assessment and side effects. receivable to lack of mortality data FDA approved the Nolvadex for women at high risk of breast cancer but did not approved it for use as a breast cancer prevention agent and they refer Nolvadex as a risk reduction therapy 1. 3-Zenecas decisions on DTC campaign When Zeneca decided to do the DTC campaign for Nolvadex, they had make some research before advertising campaign but this research only focusing on womens thinking about breast cancer. They did not bring patients, physician, protagonism group and activist groups in ad campaign.Another draw back came from The Food and Drug Administrations regulation and guide lines which were keep changing during the suppuration of direct to consumer advertising campaign. FDAs guide lines were influencing the Zenecas decisions on advertisement campaign. They were trying to follow FDAs regulations but other side they had ignored physicians and activist groups during the development of DTC advertisement campaign and later Zenecas campaign was touch on by these independent groups.They had tried to make branded ad but due to the regulatory it was required full information regarding drug. They were feared that if they disclosed the information regarding drugs benefit and risk it would affect the advertisement effectiveness. Thats why they decided not do the branded advertisement. Zenecas unbranded advertisement was less concern by regulatory in terms of disclosing drugs information but more concern by activist groups because of incomplete information.Also assumptions in advertisement were not appropriately taken into consideration e. g. women care their body shape more then health or you can only get breast cancer if you have family history which were concerned by regulatory and activist groups. In brief Zeneca had taken inappropriate decision regarding DTC advertisement campaign. They did not involved patients, physicians, distributors and advocacy groups before d eveloping DTC campaign. They had followed the rules and regulations of FDA but failed to take physicians, patients and activist groups in confidence.