Zeneca's DTC Advertising of Nolvadex

Zeneca’s DTC Advertising of Nolvadex

Q1- What uncertainties (medical and regulatory) did Zeneca face when they decided to advertise Nolvadex direct to consumers? Did the company decisions appropriately take these into consideration when designing the ad. campaign?

Q2- What ethical and social ramifications were relevant in developing the ad. Campaign? Were these issues adequately addressed?

Q3- Were the Nolvadex ads. irresponsible as the breast cancer activists claimed?

Q4- How should Zeneca have managed the protests of the breast cancer activists?

Executive Summary

This report is prepared about Zeneca direct to consumer advertising campaign for Nolvadex. During the development of this campaign they had to face uncertainties from regulatory and medical point of view. Firstly this report has highlighted these issues in regulatory and medical point of view and also looked at company’s decisions when designing the advertising campaign. Secondly it has analysed some issues regarding ethical and social point of view which were raised during the development of advertising campaign and how did company address?

Thirdly report has analysed protest from activist groups as they claimed irresponsible campaign and at the end it has come with possible and suitable recommendations for managing the protest of the breast cancer activists.

Table of contents

Introduction-------------------------------------------------------4

Findings------------------------------------------------------------4

Uncertainties from medical--------------------------------------4

Uncertainties from regulatory-----------------------------------5

Zeneca’s decision on DTC campaign------------------------------7

Ethical and social ramifications and Zeneca’s response for these issues-------------------------------------------------------8

Irresponsible advertisement from activists’ point of view-----9

Conclusion---------------------------------------------------------10

Recommendations for managing the activists’ protests--------10

Bibliography------------------------------------------------------12

Zeneca’s Direct-To-Consumer Advertising of Nolvadex®

Introduction

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

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, ...

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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.

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.

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

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

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

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

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.

2-Ethical and social ramifications and Zeneca’s response for these issues

As it mentioned above regarding Zeneca’s decisions on DTC advertising campaign were not appropriate which raised some ethical social questions. In Zeneca, they did not educate health care professionals even they did not involved physicians and advocacy group in developing DTC campaign. As it mentioned earlier they had done some research before developing advertisement campaign. Although this research had presented more specific idea about the disease, its detection and treatment but they did not mention the drug information to consumer.

Zeneca did not want to disclose the full information regarding drugs benefits and risk in the advertisement campaign because if they disclose the information regarding drug’s side effects then women would be fear to use Nolvadex and company would not get desire results from advertisement. Nolvadex had some side effects which were rear from company’s point of view and the chances for these side effects were expected to occur less than one present. But they did not mention the side effects in advertisement and they were taking all the decisions which were in their own favour that’s why Zeneca’s behaviour in advertisement campaign was totally unethical.

Company had decided to use unbranded advertisement due to regulatory concerns with free toll number where patients could get information about breast cancer, drug and they can also order some materials like video and brochures with full information of breast cancer and drug benefits and risk. But message in unbranded advertisement was mislead by women and more concern by activist groups.

Zeneca had used incorrect and unethical assumptions about breast cancer in television advertisements, for instance “you can only get breast cancer if you have a family history or that the risk of breast cancer decreased with age” and “women were more interested in their body shape than their health”. These assumptions were criticized by FDA and some activist groups, which were corrected for the viewing audience. Zeneca was failed to address above issues adequately and physicians were not eager to prescribe for healthy women.

3-Irresponsible advertisement from activists’ point of view

Zeneca’s advertisement is totally irresponsible and dangerous for several reasons. For instance in advertisement they did not properly mention what they are talking about and did not mention information regarding breast cancer and drug related information like drug benefits its usage and its risk which could frighten and mislead women into thinking that their risk was too high, causing them to get therapy which they did not need and could get serious side effects. Also they did not take any responsibility regarding drug’s risks and no proper steps for protecting the confidentiality of patient information. They were taking all the steps in advertisement which were acceptable by regulatory but they were not looking the noise in whole communication process.

They were irresponsible in making false assumptions and they were misleading because some women who saw the ad, they thought they would get information regarding their diet and exercise. They had also highlighted breast cancer risk without presenting the actual risk statistic in print advertisement campaign. If they involved physicians, advocacy and activist groups in advertising campaign then it would had been increased the effectiveness of the drug and its advertisement and would had strong support. Also if they disclose the information regarding drug in more appropriate way then it could increase the physicians and patients trust towards drugs and they could develop successful DTC advertisement campaign.

Conclusion

Although Zeneca had used different marketing strategies and communications tools but they could have done their advertisement campaign in more appropriate way. Due to the irresponsible advertising campaign they had to face lot of uncertainties from medical and regulatory point of view. Also they were failed to address the ethical issues which were raised in advertising campaign that’s why activist groups were against the Zeneca’s DTC advertising campaign.

Recommendations for managing the activists’ protests

There are some recommendations for Zeneca which could help to manage the protests of the breast cancer activists.

First of all they should build up strong public relation through educating health care professionals about drug and involved physicians, patients, distributors and activist groups or in other words direct marketing to business to business and business to consumer before developing DTC advertisement campaign

It could be done through events, seminars and also through direct marketing to physicians and distributors about Nolvadex, so Zeneca will have more chance to clear any doubts about their drug and explain more information in front of physicians and activists groups. Because physicians are the people who recommend the drug and if they are satisfied with drug then it will be helpful for getting desired result form advertisement

They should also use the web sites to communicate to patients the benefits and risks of Nolvadex and breast cancer so women will not mislead with advertisement

They had done some research on focusing group to understand how women felt about breast cancer but the should do more research on physicians, women and activists groups about their views for Nolvadex and its advertisement before developing DTC campaign

They should protect the confidentiality of patient information because DTC enables drug companies to collect the name of patients and it also encourages them to seek from pharmacies or other sources, the name of patients taking their drug or a competitor’s drug

They should avoid unbranded advertisement which could mislead the message to women. Zeneca should use branded advertisement with fair balance of drug benefits and risk and also they should take some responsibility for potential drug’s risks. Because if they mention the brief summary about drug then women will get right message, physicians and patients will trust on Nolvadex

They should avoid any noise in whole communication process like incomplete information or incorrect assumptions which could be concern by activist groups

They should be consistence and try not to make any incorrect assumptions which can be concern by regulatory and activist groups. They should use accurate communications of drug indications. To meet this standard, a commercial must mention the limitation on indications. They should make sure that commercial will provide equally prominent and equally communicative language for benefits and risks.

Bibliography