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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 “pimples or facial acne” and “get rid of PMS

symptoms” (“Yaz Birth Control,” 2010). “Reguators 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 “moderate

to severe” acne (“Yaz: 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 “Balloons” and “We’re Not

Gonna Take It” ads (Myers, 2008), said the ads were misleading because they “encourage use of

YAZ in circumstances other than those in which the drug has been approved,” “over-promise the

benefits” and “minimize 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 (“Premenstrual 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 “YAZ is the ONLY

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birth control proven to treat premenstrual dysphoric disorder” (“PMS or PMDD”), and defines it

as “a condition with emotional and physical premenstrual symptoms severe enough to impact

your life” (“Go Beyond Birth Control”). PMDD differs from PMS in that it “occurs when

premenstrual symptoms are severe enough to impact your life,” while PMS is “a less serious

cluster of symptoms occurring before your period” (“PMS or PMDD”). PMDD symptoms

include bloating, change in appetite, headaches, muscle aches, anxiety and irritability (“Go

Beyond Birth Control”), all of which are listed as PMS symptoms by the Mayo Clinic

(“Premenstrual Syndrome,” 2008). The clinic also recognizes PMDD as similar to PMS,

seconding Bayer’s definition of PMDD as similar to PMS except for the “severity of its

symptoms and its impact on relationships and daily activities” (“Premenstrual Dysphoric

Disorder,” 2008). The clinic also notes that “the cause of PMDD isn’t clear” (“Premenstrual

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 “physical pain and emotional distress” that is “severe enough

to affect their daily routines and activities,” but is still classified as PMS rather than PMDD

(“Premenstrual Syndrome,” 2008). Only up to 10 percent of women suffer from PMDD

(“Premenstrual Dysphoric Disorder,” 2008), while “at least 85 percent of menstruating women

have at least one PMS symptom as part of their monthly cycle” (“Premenstrual 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 “We’re Not Going to

Take It” and “Goodbye to You,” showed women kicking away balloons that had symptoms such

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as “muscle aches,” “irritability” and “bloating” 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. “Oral contraceptives stop

ovulation and stabilize hormone fluctuations, which reduces mood swings” (“Premenstrual

Dysphoric Disorder,” 2008). Yaz can help with PMDD (Carver, 2010), and was approved by the

FDA to do so (“Yaz Gallbladder Disease,” 2010); the claims on Yaz’s Web site that it can treat

the PMDD are correct (“Go Beyond Birth Control”). However, it is not meant to improve regular

PMS, nor is Yaz approved for PMS treatment (“Yaz 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 “agreed 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 “engaged 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 “misbranding [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, “Essentially, 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 (Off-

label marketing)” (Adams, 2009). Pfizer is also in trouble for “illegally promoting” three other

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drugs: Geodon, Zyvox and Lyrica (Adams, 2009). Pfizer is paying over $2 billion in fines, and

the “multi-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 “lax drug safety regulation coupled with over-

advertising 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, “From a pharmaceutical marketing

perspective it was beautiful. “This 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 “implying 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 (“Lipitor 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

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consumers not receiving information about health risks. The FDA’s DDMAC division “has

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

(“FDA 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 (“FDA 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 (“FDA 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 (“Federal Trade Commission,” 2007).

The FTC said that Bayer was making unsubstantiated claims, which violated a 1991 Commission

order that “all 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 “unsubstantiated claims about

rivals to its Ascencia diabetes blood glucose monitor” (Edwards, 2009).

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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 one-

time 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 “synthetic form of progestin” (“Yaz Birth Control Recall,”

2010), are also the subject of new lawsuits (“Yaz Injuries,” 2010). The injury lawsuits “all allege

serious injuries and in some severe cases death” caused by the drugs (“Yaz Injuries,” 2010).

Because of the high number of suits being filed across the country, lawyers are beginning to call

this the “newest mass tort” (“Yaz 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, “Even with the new ads, the warnings are still grossly

inadequate” (“Yaz Injuries,” 2010). Zoll’s law firm is one among many offering services for

those injured by the drug after the advertising “minimized the risks” of the pill (Zoll, 2009), and

ended up killing 50 people and severely injuring others (“Yaz and Yasmin,” 2010). Many

women were deceived by it and have even had severe health issues because of it (“Yaz Injuries,”

2010). The lawsuits are pouring in (“Yaz Injuries,” 2010), and with each new suit, along with

evidence of the harm the oral contraceptive pill caused, Bayer’s standing decreases.

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One problem the drug company is facing is its own success: Yaz was “the most popular

birth control pill in the United States” (Singer, 2009). In fact, Yasmin is Bayer’s “best-selling

pharmaceutical product group” (Edwards, 2009). Bayer saw an overall decline in sales

throughout 2009, with a 20.9 percent decrease (“Yaz, Yasmin, Ocella,” 2009). It has also had

losses overseas because of the “global crisis” (“Yaz, 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 (“New Safety Label,” 2010). “In 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” (“New Safety Label,” 2010). This shows

consumers that Yaz is taking the crisis seriously and is doing what it can to prevent further

misunderstandings.

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Bayer’s threats to any continued success of Yaz, besides the scandal, are its competition

from other oral contraceptives. Seasonique, currently produced by Teva (“Bayer reports,” 2010),

is marketed as a birth control that decreases women’s menstrual periods from 12 to four a year

(“Seasonique,” 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 “unclear” 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, “The 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

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camera as she says, “You 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. “New 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 “unusual” for the

FDA to require any sort of corrective advertising (Singer, 2009). According to the New York

Times,

‘They 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. “These 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. “He referred to

the corrective $20 million ad campaign for Yaz as ‘chump change’ and ‘just the cost of doing

business’” (Singer, 2009). Nor does he feel that the ads will have a long-term effect. “I don’t

think [misleading advertising] is likely to stop unless there are more significant consequences”

(Singer, 2009).

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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 (“Going 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 (“Going 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 (“Going Beyond Birth Control”). Bayer’s press release indicates that the

updated labels were also mandated by the FDA. The statement begins by saying, “In full

agreement with the U.S. Food and Drug Administration . . .” (“Going 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. (“Going 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, “At 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” (“Going Beyond Birth Control”).

Bayer does not ask customers to take many actions regarding the product. The

company included the standard “talk to your doctor about Yaz” (Unquid, 2009) that is

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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, “You are encouraged to report negative side effects of

prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-

1088” (Yaz). The only other major call to action is directed toward women who are

interested in taking the pill. “Women who would like to learn more about YAZ should

call the toll-free number 1-888-84-BAYER or visit www.yaz-us.com” (“Going

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.

“CSR is a citizenship function for ‘mutually 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

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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 (“Bayer 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

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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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from http://www.toledolaw.com/yasmin4.php.