In 2009, the FDA ordered the drug company Bayer to run corrective advertising for its oral contraceptive Yaz. The FDA charged that the television commercials were misleading about what conditions besides pregnancy prevention Yaz could help. Bayer agreed to the settlement and started running the new commercials. However, the company¶s lack of corporate responsibility, its history of running misleading advertising, and the legal repercussions from women who were injured taking the pill for conditions it could not control will make it difficult for Yaz, and its sister drugs Yasmin and Ocella, to regain its position in the birth control market. Yaz commercials falsely claimed to cure ³pimples or facial acne´ and ³get rid of PMS symptoms´ (³Yaz Birth Control,´ 2010). ³Reguators say the ads overstated the drug¶s ability to improve women¶s moods and clear up acne, while playing down its potential health risks´ (Singer, 2009). The Food and Drug Administration approved the drug as effective for ³moderate to severe´ acne (³Yaz: Popular Birth Control,´ 2010). However, it was not approved to completely treat acne, unlike what the advertising claimed (Bremner, 2009). The drug also claimed to help users lose weight (Bremner, 2009). However, the lost weight was just water weight, and the drug did that by potassium retention, which can cause heart problems (Bremner, 2009). The FDA, which sent warning letters to Bayer about the ³Balloons´ and ³We¶re Not Gonna Take It´ ads (Myers, 2008), said the ads were misleading because they ³encourage use of YAZ in circumstances other than those in which the drug has been approved,´ ³over-promise the benefits´ and ³minimize the risks associated with Yaz´ (Zoll, 2009). Yaz advertising made more false claims and insinuations, such as suggesting that the pill could help control pre-menstrual syndrome (³Premenstrual Syndrome,´ 2008). The FDA approved Yaz to counter the effects of PMDD, or premenstrual dysphoric disorder (Bremner, 2009). PMDD is not the same as PMS On the Yaz Web site, Bayer said that ³YAZ is the ONLY


birth control proven to treat premenstrual dysphoric disorder´ (³PMS or PMDD´), and defines it as ³a condition with emotional and physical premenstrual symptoms severe enough to impact your life´ (³Go Beyond Birth Control´). PMDD differs from PMS in that it ³occurs when premenstrual symptoms are severe enough to impact your life,´ while PMS is ³a less serious cluster of symptoms occurring before your period´ (³PMS or PMDD´). PMDD symptoms include bloating, change in appetite, headaches, muscle aches, anxiety and irritability (³Go Beyond Birth Control´), all of which are listed as PMS symptoms by the Mayo Clinic (³Premenstrual Syndrome,´ 2008). The clinic also recognizes PMDD as similar to PMS, seconding Bayer¶s definition of PMDD as similar to PMS except for the ³severity of its symptoms and its impact on relationships and daily activities´ (³Premenstrual Dysphoric Disorder,´ 2008). The clinic also notes that ³the cause of PMDD isn¶t clear´ (³Premenstrual Dysphoric Disorder,´ 2008). There can be a lot of confusion over whether a woman has PMS or PMDD, especially because the symptoms for both are similar. In fact, even though PMDD is more severe and more rare than PMS, many women have ³physical pain and emotional distress´ that is ³severe enough to affect their daily routines and activities,´ but is still classified as PMS rather than PMDD (³Premenstrual Syndrome,´ 2008). Only up to 10 percent of women suffer from PMDD (³Premenstrual Dysphoric Disorder,´ 2008), while ³at least 85 percent of menstruating women have at least one PMS symptom as part of their monthly cycle´ (³Premenstrual Syndrome,´ 2007). This confusion plays a large part in why the television ads suggesting that Yaz could control PMS were misleading. The ads, playing empowering songs like ³We¶re Not Going to Take It´ and ³Goodbye to You,´ showed women kicking away balloons that had symptoms such


as ³muscle aches,´ ³irritability´ and ³bloating´ written on them (Bremner, 2009). These are symptoms of PMDD and PMS, but the distinction was not made. This lack of information made it seem like the birth control would help control PMS, which it was not authorized to do. However, birth control, among other medications, can help PMDD. ³Oral contraceptives stop ovulation and stabilize hormone fluctuations, which reduces mood swings´ (³Premenstrual Dysphoric Disorder,´ 2008). Yaz can help with PMDD (Carver, 2010), and was approved by the FDA to do so (³Yaz Gallbladder Disease,´ 2010); the claims on Yaz¶s Web site that it can treat the PMDD are correct (³Go Beyond Birth Control´). However, it is not meant to improve regular PMS, nor is Yaz approved for PMS treatment (³Yaz Birth Control,´ 2010). The FDA issued Bayer a warning letter in October 2008 (Myers, 2008). Since then, the FDA and 27 state attorneys general have ordered Bayer to run corrective advertising (Singer, 2009). The drug company complied, and in February 2010, it ³agreed to spend $20 million on the campaign and for the next six years to submit all Yaz ads for federal screening´ (Singer, 2009). However, as part of the settlement, Bayer has not admitted that it ³engaged in deceptive advertising or committed any wrongdoing (Singer, 2009). Other drug companies have had advertising scandals as well. In 2009, the drug company Pfizer pleaded guilty to a criminal charge for ³misbranding [its drug] Bextra with the intent to defraud or mislead´ (Adams, 2009). Mike Adams, the editor of NatutralNews.com, summarized the Department of Justice documents by saying, ³Essentially, Pfizer asked the FDA to approve Bextra for a variety of diseases and conditions, and when the FDA refused those approvals, Pfizer decided to go ahead and market the drugs for those diseases and conditions anyway (Offlabel marketing)´ (Adams, 2009). Pfizer is also in trouble for ³illegally promoting´ three other


drugs: Geodon, Zyvox and Lyrica (Adams, 2009). Pfizer is paying over $2 billion in fines, and the ³multi-billion dollar settlement is the largest in the history of the DOJ´ (Adams, 2009). Pfizer and its rival Merck were also involved in a scandal with their drugs Celebrex and Vioxx, respectively. Critics said there was ³lax drug safety regulation coupled with overadvertising that caused consumers to take pricey drugs they didn¶t need´ (Herper, 2007). Both companies underplayed the heart risks associated with the drugs. The FDA refused to let Vioxx return to the market after its recall (Herper, 2007). Mike Rea, the managing director of IdeaPharma, a pharmaceutical drug marketing firm, said, ³From a pharmaceutical marketing perspective it was beautiful. ³This was a market waiting for a brand. The audience was sold something they didn¶t need but definitely really wanted´ (Colyer, 2010). Rea said the companies, though they talked about some of the side effects, underplayed others (Colyer, 2010). In fact, Yasmin, Yaz¶s sister drug, was also involved in an advertising issue. In 2003, when the drug was owned by Berlex Labratories, the FDA sent a letter warning against the pill¶s marketing (Singer, 2009). It contended that Berlex¶s ads were ³implying the pills were superior to other oral contraceptives and for minimizing risks specific to the drug´ (Singer, 2009). These were not the only scandals that have rocked the pharmaceutical world. In 2007, the FDA ordered Novartis to pull its Zelnorm advertising (Herper, 2007). Novartis also got in trouble in 1996, and the FTC ordered the company to run advertising on Doan¶s, the first corrective advertising campaign it had ordered in 25 years (Mazis, 2001). Pfizer¶s Lipitor commercials featuring Dr. Robert Jarvik came under fire in 2008 by a congressional committee for showing the scientist in a misleading manner (³Lipitor Commercials,´ 2008). Yaz is definitely not the first drug to be in trouble because of its advertising methods since the FDA allowed direct-to-consumer advertising in 1985 (Sheehan, 2004). Often, scandals involve


consumers not receiving information about health risks. The FDA¶s DDMAC division ³has voiced concerns that marketers overemphasize drug efficacy while downplaying the major statement´ (Sheehan, 2004). Yaz is just one of many drugs that has gotten into trouble for its advertising. Bayer does not have a good track record with deceptive advertising, including claiming medicines do things that they do not. In 2008, the FDA sent a warning letter to the company for marketing two products, Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage), the FDA had not approved (³FDA Issues Warning,´ 2008). Not only had the two drugs not been reviewed, they were also claiming that they reduce the risk of heart disease, and Bayer Women¶s claimed to help with osteoporosis (³FDA Issues Warning,´ 2008). Neither of those claims had been reviewed or approved for those issues, and without approval, they were not supposed to be sold over the counter (³FDA Issues Warning,´ 2008). In 2007, Bayer ran up against the FTC with its ads for One-A-Day weight Smart, which claimed to increase metabolism and prevent weight gain (³Federal Trade Commission,´ 2007). The FTC said that Bayer was making unsubstantiated claims, which violated a 1991 Commission order that ³all claims about the benefits of One-A-Day brand products to be substantiated by competent and reliable scientific evidence´ (Federal Trade Commission,´ 2007). It was forced to pay a $3.2 million penalty (Federal Trade Commission,´ 2007). The National Advertising Division has also caught Bayer making false claims several times. The NAD said that Bayer¶s All-Day Energy multivitamin does not actually last all day, Bayer was lying about Aleve being the No. 1 medicine among orthopedic surgeons, and it was making ³unsubstantiated claims about rivals to its Ascencia diabetes blood glucose monitor´ (Edwards, 2009).


Bayer has several factors working against it in the crisis. One such factor is its bad track record with false advertising and unsubstantiated claims. Because the company has a history of smudging the facts about its products, and has been fined for past false claims, it does not have a leg to stand on. In fact, it did not even admit guilt to running deceptive advertising (Singer, 2009). This will make it harder for Bayer to give a sincere and believable apology. The company cannot claim that it has a history of being careful with its drug advertising and that this is a onetime error that it will quickly correct. Bayer¶s track record of advertising issues could lead to further mistrust among the general public, and hurt Yaz¶s chances of regaining its standing among oral contraceptives. Another problem for the company is that Yaz and Yasmin, another fourth-generation birth control with drospirenone, a ³synthetic form of progestin´ (³Yaz Birth Control Recall,´ 2010), are also the subject of new lawsuits (³Yaz Injuries,´ 2010). The injury lawsuits ³all allege serious injuries and in some severe cases death´ caused by the drugs (³Yaz Injuries,´ 2010). Because of the high number of suits being filed across the country, lawyers are beginning to call this the ³newest mass tort´ (³Yaz Injuries´ 2010). Even though Bayer is running corrective advertising, many attorneys expect the number of lawsuits to rise. According to David Zoll of Zoll, Kranz & Borgess in Toledo, Ohio, ³Even with the new ads, the warnings are still grossly inadequate´ (³Yaz Injuries,´ 2010). Zoll¶s law firm is one among many offering services for those injured by the drug after the advertising ³minimized the risks´ of the pill (Zoll, 2009), and ended up killing 50 people and severely injuring others (³Yaz and Yasmin,´ 2010). Many women were deceived by it and have even had severe health issues because of it (³Yaz Injuries,´ 2010). The lawsuits are pouring in (³Yaz Injuries,´ 2010), and with each new suit, along with evidence of the harm the oral contraceptive pill caused, Bayer¶s standing decreases.


One problem the drug company is facing is its own success: Yaz was ³the most popular birth control pill in the United States´ (Singer, 2009). In fact, Yasmin is Bayer¶s ³best-selling pharmaceutical product group´ (Edwards, 2009). Bayer saw an overall decline in sales throughout 2009, with a 20.9 percent decrease (³Yaz, Yasmin, Ocella,´ 2009). It has also had losses overseas because of the ³global crisis´ (³Yaz, Yasmin, Ocella,´ 2009). In light of both the advertising issues and the lawsuits about the drug¶s safety, Yaz will have a hard time regaining its position in the market. In fact, in all likelihood it will never again be in the top position. Yaz¶s success can also help the company. Though the pill had a marked decrease in consumer consumption, not everyone has stopped taking it. Bayer¶s biggest-selling drug is still Yaz, despite the over 1,100 lawsuits the company is facing from women who claim the drug causes blood clots (Edwards, 2009). The internet is full of positive comments about Yaz and Yasmin (Cornforth, 2003). Though some comments are from a couple years ago, the fact that they¶re still very visible in internet searches means that women might, after seeing the positive reviews from other women, be inclined to try it. Bayer¶s showing of corporate social responsibility is another thing in Yaz¶s favor. The company is cooperating with the FDA and running corrective advertising as ordered. In addition, it is being careful about adding warning labels to the product. On April 9, 2010, Bayer announced that it was adding warning about potential blood clots to the Yaz and Yasmin packaging (³New Safety Label,´ 2010). ³In cooperation with the Food and Drug Administration, the company said it added new labeling stating that the risks of blood clots with Yaz and Yasmin are similar to those with other oral contraceptives´ (³New Safety Label,´ 2010). This shows consumers that Yaz is taking the crisis seriously and is doing what it can to prevent further misunderstandings.


Bayer¶s threats to any continued success of Yaz, besides the scandal, are its competition from other oral contraceptives. Seasonique, currently produced by Teva (³Bayer reports,´ 2010), is marketed as a birth control that decreases women¶s menstrual periods from 12 to four a year (³Seasonique,´ 2010). If fewer women are willing to take Yaz ± and Yasmin and Ocella, its sister pills ± then Seasonique¶s market share, as well as that of other oral contraceptives, could rise and eclipse Yaz. Though Bayer is attempting to keep Yaz on the market and comply with the FDA rather than remove the pill, its status has been damaged. The company is facing over 1,100 lawsuits over the drug (Edwards, 2009), and the internet is flooded with sites offering legal services to anyone wishing to sue Bayer. Because it is a popular oral contraceptive and because many women have reported good experiences, it is unlikely that the pill will disappear entirely from the market. However, Yaz¶s downfall is very public, especially with the repeated reminders of what happened flashing across the screen in the form of corrective advertisement. Every time the woman in the new commercial talks about Yaz¶s previously ³unclear´ messages (Singer, 2009), people will be reminded of the previous deceptive advertising and Yaz¶s ongoing struggle to remain afloat. Though the drug will likely remain on the market for the foreseeable future, it will probably not retain its position as the best-selling oral contraceptive (Singer, 2009). Advertising is a major component of the of Bayer¶s response to the crisis. The FDA ordered the drug company to spend $20 million on a corrective advertising campaign, as well as submit all Yaz advertising for review for the next six years. The advertising is intended to more clearly define what Yaz is approved for, and the risks associated with it. According to the New York Times, a Bayer spokesperson said, ³The ad for Yaz was revised to more clearly state the indications for Yaz´ (Singer, 2009). The new ads show an actress looking directly into the


camera as she says, ³You may have seen some Yaz commercials recently that were not clear. The F.D.A. wants us to correct a few points in those ads´ (Singer, 2009). The ad goes on to address the differences between PMDD and regular PMS, and also that Yaz is approved to treat serious, not moderate, acne (Unquid, 2009). The advertisement is a major part of the brand¶s communications strategy, but Bayer cannot be applauded for choosing the advertisement as a way of warning current and potential consumers. As the commercial states, the FDA ordered Bayer to run the ad, and spend a required amount of money on the campaign. The company also began running magazine ads about the product. ³New print ads, in national magazines like Lucky and Elle, give detailed information about Yaz, but do not indicate they are meant to correct earlier television ads´ (Singer, 2009). Though other companies, as noted above, have faced advertising controversy, the FDA does not always come down on them like it did on Bayer and Yaz. In fact, it is ³unusual´ for the FDA to require any sort of corrective advertising (Singer, 2009). According to the New York Times, µThey rarely require these corrective campaigns,¶ said Judy Norsigian, the executive director of Our Bodies Ourselves, a health education and women¶s advocacy group in Cambridge, Mass. But she said the popularity of the Yaz brand and the misleading ads had demanded a rare punishment. ³These ads should never have been out there,´ Ms. Norsigian said (Singer, 2009). Many approve of the FDA¶s ruling, including Professor of pharmacy administration Bruce L. Lambert. However, Lambert believes the ads won¶t really hurt Bayer. ³He referred to the corrective $20 million ad campaign for Yaz as µchump change¶ and µjust the cost of doing business¶´ (Singer, 2009). Nor does he feel that the ads will have a long-term effect. ³I don¶t think [misleading advertising] is likely to stop unless there are more significant consequences´ (Singer, 2009).


Beyond the corrective advertising, Bayer does not appear to have done much to stem the crisis. In fact, it appears to be relying solely on the advertising, and perhaps Yaz¶s standing and market share, to do the job. The Yaz Web site is careful to outline potential risks and define the difference between PMDD and PMS (³Going Beyond Birth Control´), since that has caused quite a bit of controversy. In fact, a link to information about PMDD is prominently displayed on the Yaz homepage (³Going Beyond Birth Control´). The other major component of the crisis management is that Bayer put out an announcement that it recently updated its labels about the risks of taking Yaz (³Going Beyond Birth Control´). Bayer¶s press release indicates that the updated labels were also mandated by the FDA. The statement begins by saying, ³In full agreement with the U.S. Food and Drug Administration . . .´ (³Going Beyond Birth Control´). Kemal Malik, MD, the chief medical officer at Bayer, said, The FDA¶s thoughtful and balanced analysis will provide helpful information for healthcare professionals to use when they are providing guidance and counsel to patients. In weighing the evidence on the relative risk of combination oral contraceptives, the FDA has underscored the importance of protocol methodology on the outcomes and findings of scientific studies and we appreciate the rigor they have applied to their analysis. (³Going Beyond Birth Control´) The press release also contains warning information about the drug, and urges those with health-related problems to contact the FDA. Malik said, ³At Bayer, our unwavering commitment to our customers¶ health and well-being is always our first priority and we will continue to provide information which will support health care providers and their patients in making informed decisions about appropriate treatment choices´ (³Going Beyond Birth Control´). Bayer does not ask customers to take many actions regarding the product. The company included the standard ³talk to your doctor about Yaz´ (Unquid, 2009) that is


in many drug commercials. The line seems to have two uses: to get women to consider getting on the pill, and to secure their lack of liability since they urge women to talk to doctors about the birth control before they start taking it. Another major call to action is that Bayer urges women who have Yaz-related health problems to contact the FDA. The press release said, ³You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA1088´ (Yaz). The only other major call to action is directed toward women who are interested in taking the pill. ³Women who would like to learn more about YAZ should call the toll-free number 1-888-84-BAYER or visit www.yaz-us.com´ (³Going Beyond Birth Control´). Two of the three major calls to action urge women to get information about Yaz so they can consider taking it and Bayer can gain more profits. Only one, urging women to contact the FDA if they have problems with the pill, is related to crisis management, and is quite possibly ordered by the FDA like the corrective advertising. Corporate social responsibility has become an important asset for companies. ³CSR is a citizenship function for µmutually beneficial exchange¶ between an organization and the public´ (Lee, 2010). Companies are responsible to the public for the content of their products and should act on that responsibility to deliver safe items to and be honest with consumers. Yaz has not been socially responsible. It distorted its message, in the form of advertising, to make consumers believe the product did one thing ± that is, that Yaz could control PMS ± when it could not control it and was not approved for it. Yaz was also not honest about the kind of acne it could help with; the messages made it seem


like anyone with acne could use the oral contraception to control it, when it fact they cannot. Yaz has since corrected the message, but only because it was ordered to by the FDA. The company did not take the step of realizing it was distributing a misleading message and fix it. The corrective advertising seems to have done little to fix the public opinion about the company. In fact, things for the company are not looking good; Bayer has reported that 1,100 lawsuits have been filed against the company because of the harm Yaz has caused women (³Bayer Reports,´ 2010). The advertising corrects previous misconceptions, but the rumors and facts about the detrimental effects the birth control has had on women seem to be given greater weight. Yaz has gotten a very negative reputation. This, coupled with the fact that the new advertising is ordered, not distributed by Bayer as an act of apology and an attempt to sincerely help women know the facts about the drug, mean that the advertising does not appear to strike a strong chord with women. The new advertising was truthful, since it was reviewed by the FDA (Singer, 2009), but it was a disciplinary action, not an attempt to respect customers. Yaz is not the first drug to get in trouble with the FDA or FTC, and it will probably not be the last. Bayer is running $20 million in corrective advertising, as ordered, because of the misconceptions presented in its previous ads. Yaz still has some things going for it, including its previous reputation, sales and market share. However, because of the multitude of lawsuits resulting from injuries and deaths caused by Yaz, it is unlikely that the company will completely recover from the crisis. The corrective advertising clears up misconceptions about what the birth control can


do, and the new warning labels and continued compliance with the FDA act in the company¶s favor, but the horror stories and offers of legal assistance to women injured by Yaz overpower the positive messages. In light of the constant stream of lawsuits and negative messages from non-company sources, Yaz, and its sister drugs Yasmin and Ocella, is probably not going to recover from this crisis, even with the help of advertising.


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