An Investigation by Zoll, Kranz and Borgess
In 2003, the United States Food and Drug Administration (“FDA”) the FDA sent a warning letter to Berlex Laboratories* faulting its ads for Yasmin, (the precursor to YAZ and Ocella), for implying the pills were superior to other oral contraceptives and for downplaying its risks.
Specifically, the FDA advised that 60-second TV ad entitled “Goodbye Kiss” was “misleading because it implies clinical superiority claims to other combination oral contraceptives and minimizes the important risk information that distinguishes Yasmin from other combination oral contraceptives. As a result, the TV ad raises significant public health and safety concerns.”
In that letter, the FDA specifically examined the different kind of hormone, called drsp or drospirenone (pronounced dros-peer-eh-known), used it the drug, stating as follows:
“Yasmin contains the estrogen ethinyl estradiol and the progestin drospirenone. Drospirenone has antimineralocorticoid properties, which means that it can work against the body’s normal mechanism for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients, resulting in potentially serious heart and health problems.***Consequently, Yasmin can exacerbate serious heart and health problems, in addition to the potential problems common to all COCs. Women taking Yasmin must be concerned about drug interactions that will increase potassium, in addition to the drug interactions common to all COCs. Therefore, these women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over COCs without drospirenone.
Misleading Efficacy and Safety Presentations
Prescription drug ads are false or misleading if they contain a drug comparison that represents or suggests that a prescription drug is more effective or safer than another drug when it has not been demonstrated to be safer or more effective by substantial evidence or substantial clinical experience(21 CFR 202.1(e)(6)(ii)). The TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone. The unifying theme of the ad, typified by the tagline “Ask about Yasmin, and the difference a little chemistry can make” (emphasis added) suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body. This “chemistry” difference is presented as a product benefit. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone as communicated in the Warnings/Bolded Warning, and Precautions/Drug Interactions sections of the PI.
Specifically, the following claims in the TV ad address Yasmin’s efficacy: “You don’t settle when it comes to the guy…so why settle when it comes to the pill? <b> The Yasmin birth control pill uses a different kind of hormone. One that may work with your body chemistry.</b> Yasmin is over 99% effective at preventing pregnancy. So when you’re looking for the right pill, ask your doctor about the difference a little chemistry can make.” (emphasis added) These claims are misleading because they suggest that Yasmin’s “different kind of hormone” offers unique “chemistry” benefits and that this difference contributes to the high rate of drug efficacy. Moreover, these claims are misleading because they imply superiority to other COCs (and thus do not offer the same product benefits as Yasmin Tablets) when such has not been demonstrated by substantial evidence or substantial clinical experience. Finally, these claims are misleading because they misrepresent Yasmin’s mechanism of action by stating that Yasmin “uses a different kind of hormone. One that may work with your body chemistry.” However, COCs, including Yasmin, prevent ovulation by working against the usual body chemistry of a woman of childbearing potential by suppressing endogenous gonadotropins and, thereby, inhibiting ovulation and altering other changes associated with the menstrual cycle.
In addition, the statement “Yasmin contains a different progestin, which may increase potassium” is misleading because the “may increase potassium” disclosure fails to communicate that the potential to increase potassium is a risk. Furthermore, consumers may interpret the statement as a product benefit claim rather than a risk disclosure due to the overall positive message that Yasmin’s “chemistry” is a product benefit. The ad conveys this positive message to consumers, notwithstanding the disclosure that “You should not take Yasmin if you have kidney, liver, or adrenal disease,” because the “different kind of hormone” and “chemistry’” messages are never clearly identified as potentially leading to increased potassium levels or that increased serum potassium can be dangerous.***
Thus, by failing to add the necessary context to clarify that increased blood potassium is a safety risk rather than a clinical benefit, the ad misleadingly represents or suggests that Yasmin is safer than has been demonstrated by substantial evidence or substantial clinical experience. In summary, the TV ad not only misleads consumers about the efficacy of Yasmin, the ad also minimizes important context about the health risks of the drug.” (Emphasis in original.)
(Click here review this FDA Yaz warning letter (Part 1) in its entirety (Part 2).
Unfortunately, after the drug company, Bayer purchased Berlex Laboratories and developed a more recent version of Yasmin, called YAZ, in 2006, the deceptive and misleading advertising continued.
In October of 2008, the FDA took action against drug manufacturers for again using deceptive advertising related to YAZ. Specifically, the FDA advised in an October 3, 2008 Yaz warning letter that two 60-second direct-to-consumer (DTC) broadcast TV Ads entitled “Not Gonna Take it” and “Balloons” for YAZ were misleading because they (1) “encourage use of YAZ in circumstances other than those in which the drug has been approved,” (2) “over-promise the benefits,” and (3) “minimize the risks associated with YAZ.”
With respect to Bayer’s encouragement of use of YAZ in circumstances other than those for which the drug had been approved, the letter states as follows:
Premenstrual Dysphoric Disorder (PMDD)
***
The TV Ads entirely omit the material limitation from the PI of the drug’s PMDD indication i.e., that “YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS)” and fail to convey that the drug is only indicated for women who experience the symptoms presented to such a degree that they have PMDD, rather than PMS. As a result of the failure to convey these material facts, and the failure to explain what PMDD is, in contrast to PMS, the TV ads misleading suggest that YAZ is approved to treat women with any severity of the symptoms presented, regardless of whether their symptoms are actually severe enough to constitute PMDD.
We note that the list of symptoms displayed in the TV Ads are accompanied by the text “YAZ treats PMDD” along with a SUPER reading “PMDD is a mood disorder related to the menstrual cycle.” However, these disclosures do not suffice to communicate the material fact that YAZ is not approved for treatment of PMS or to overcome the implication created by the totality of the visuals and images in the ads that YAZ is appropriate for any woman who experiences the symptoms presented. We also note that the voiceover states that “YAZ is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life.” However, this claim also fails to communicate that YAZ is not approved for treatment of PMS, and fails to distinguish between PMS and PMDD.
The totality of the visual and audio presentations in both TV ads suggest that YAZ is approved to treat women with any severity of the symptoms presented, including women with PMS, when this is not the case. Thus, the TV Ads misleadingly broaden the indication of the drug.
Acne
In addition, the TV Ads suggest that YAZ is approved for acne of all severities when this is not the case. Specifically, in “Not Gonna Take it,” the word “ACNE” appears in large print in the middle of the screen along with the audio claim “It can also help keep your skin clear,” which is accompanied by a close-up visual of a woman with completely clear skin. Similarly, in “Balloons,” the “ACNE” balloon is prominently displayed on the screen, as it floats by a smiling woman with obviously clear skin, along with the audio claim that YAZ “… also helps keep skin clear.” These presentations fail to adequately convey that, as noted in the PI, “YAZ is indicated for the treatment of moderate acne vulgaris…” (emphasis added). While the TV Ads do include a SUPER which refers to “improvement in … moderate acne” in small, unbolded print, this does not mitigate the misleading impression created by the prominent audio and visual claims in the TV Ads that YAZ is indicated for acne of all severities.
With respect to Bayer’s “over-promise of benefits” related to YAZ, the letter states as follows:
PMDD
“Balloons”
The TV Ad is misleading because it suggests that YAZ is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The totality of the audio and visual claims and presentations misleadingly suggests that treatment with YAZ will allow women to say “good-bye” to their symptoms completely. For example, the TV Ad’s theme song “Good-Bye to you” plays in the background as energetic, euphoric: playful women release balloons into the air displaying certain symptoms (e.g., irritability, moodiness, feeling anxious, bloating, fatigue, muscle aches, headaches, increased appetite, and acne). The balloons then float up and away from the women misleadingly suggesting that these women are saying, “goodbye” to their symptoms and are now symptom-free, when such an elimination of symptoms has not been demonstrated by substantial evidence or substantial clinical experience. According to the PI, in the primary clinical trial that served as the basis for approval of YAZ in the PMDD population, “… the average decrease (improvement) from baseline was 37.5 points in women taking YAZ, compared to 30.0 points in women taking placebo” (added emphasis). These results do not support the implication that YAZ will result in a complete cessation of PMDD symptoms.
Acne
“Not Gonna Take It” & “Balloons”
The TV Ads include close-up images of women with completely clear, acne-free skin. In the TV Ad “Not Gonna Take It,” there is an image of a woman with the word “ACNE” prominently displayed on the screen before the word “ACNE” fades away from view. The woman turns her face to the side showing viewers that she has no visible signs of acne on her face, in conjunction with the audio claim “It can also help keep your skin clear.” In “Balloons,” a woman with obviously clear skin smiles and acknowledges the “ACNE” balloon as it floats away from the center of the screen and disappears into the sky, in conjunction with, the background song “Good-bye to you” and the audio claim that YAZ “… also helps keep skin clear.” The overwhelming impression conveyed by the TV Ads is that treatment with YAZ results in clear, acne-free skin for those women suffering from acne when this has not been demonstrated by substantial evidence or substantial clinical experience. As illustrated by Table III in the PI, the percentage of subjects assessed by the Investigator’s Static Global Assessment (ISGA) with a ‘clear’ or ‘almost clear’ rating at day 15 of cycle 6 was 15% and 21% for subjects receiving YAZ versus 4% and 9% of placebo subjects in Studies 1 and 2, respectively. Furthermore, the mean percent reduction of total lesions at day 15 of cycle 6 was 42% and 46% for subjects receiving YAZ versus 25% and 31 % of placebo subjects in these results are significant, they do not demonstrate that Y Al results in clear, acne-free skin for a typical woman; rather, these results studies 1 and 2, respectively. Although demonstrate that it reduces the amount of acne lesions more than placebo but does not result in completely clear skin for these women. Thus, the TV Ads misleadingly overstate the efficacy of the drug.
Finally, with respect to Bayer’s minimization of risks associated with YAZ, the letter states as follows:
Minimization of Risk
“Not Gonna Take It” & “Balloons”
The audio communication of serious risk disclosures during the “major statement” is minimized by distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information. In “Not Gonna Take It”, the fast-paced visuals depict various women looking at pictures, trying on clothes, chatting at a cafe, stretching/exercising in a park, and walking down the street while the audio component describes the major risks associated with YAZ. Similarly, in “Balloons,” the background music plays as fast-paced visuals depict various women running in a park, sitting on a scenic waterfront, smiling, walking out of a coffee shop, driving and singing, walking out on a balcony, using an elevator, walking through the street to join friends, in addition, to a pigeon on a building ledge and balloons being released and floating away. These complex presentations distract from and make it difficult for viewers to process and comprehend the important risks being conveyed. This is particularly troubling as some of the risks being conveyed are serious, even life-threatening. The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that YAZ is safer than has been demonstrated by substantial evidence or substantial clinical experience.
(Click here to review this 2008 Yaz Warning letter in its entirety)
If you or someone you love has suffered a serious injury while on Yaz, Yasmin or Ocella, please call us immediately for a consultation. There is charge to discuss this matter and the call is toll free: 1-888-841-9623.
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*Part 1 of letter. Click here for 2003 FDA warning letter to Berlex Laboratories, Part 2.