Zeneca’s DTC Advertising of Nolvadex Essay

Custom Student Mr. Teacher ENG 1001-04 13 July 2017

Zeneca’s DTC Advertising of Nolvadex

Zeneca is largest pharmaceutical and agricultural/industrial chemical company in United States. In 1999 breast cancer was the most frequent diseases were found in American women, about 175,000 cases of breast cancer were diagnosed and about 43,500 women were died due to the breast cancer. 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 Administration (FDA) for the use of Nolvadex, Zeneca had decided to start direct to consumer advertisement campaign for Nolvadex.

Findings In finding report will find over all performance of Zeneca’s 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 activist’s protests. 1. 1-Uncertainties from medical o Lack 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 skin 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 benefit

They give assurance that women can both learn and control their risk, when, in fact, the risk model that is being promoted by Zeneca has been rightfully criticized by biostatisticians. The drug that Zeneca is promoting is one 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 too 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 wait for more data regarding Nolvadex and comparing trial of Nolvadex with Eli Lilly’s Evista which some believed that safer then Zeneca’s Nolvadex. 1. 2-Uncertainties from regulatory o According to Food and Drug Administration (FDA) there were some problem 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 treatment

FDA was disagreed with Zeneca’s ads. because they were lack of brief summary regarding the risk and other information about Nolvadex. They wanted to disclose 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 ever the word Nolvadex comes in video

FDA’s Division of Drug Marketing, Advertising and Communication (DDMAC) reviewed the information material in advertising campaign and determine that they are false 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 Model Risk Assessment Tool in the print advertisement or brochure which damage the importance of an accurate risk assessment and side effects.

Due 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-Zeneca’s decisions on DTC campaign When Zeneca decided to do the DTC campaign for Nolvadex, they had done some research before advertising campaign but this research only focusing on women’s thinking about breast cancer. They did not involve patients, physician, advocacy group and activist groups in ad campaign.

Another draw back came from The Food and Drug Administration’s regulation and guide lines which were keep changing during the development of direct to consumer advertising campaign. FDA’s guide lines were influencing the Zeneca’s decisions on advertisement campaign. They were trying to follow FDA’s regulations but other side they had ignored physicians and activist groups during the development of DTC advertisement campaign and later Zeneca’s campaign was concern 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 drug’s benefit and risk it would affect the advertisement effectiveness. That’s why they decided not do the branded advertisement. Zeneca’s unbranded advertisement was less concern by regulatory in terms of disclosing drug’s 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 developing DTC campaign. They had followed the rules and regulations of FDA but failed to take physicians, patients and activist groups in confidence.

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