Ad for Breast Cancer Drug Cited for False Promises

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Pharmaceutical company Novartis is in hot water with the FDA for making false and misleading representations about the efficacy of Kisqali in a TV ad.

A happy child runs up the steps of a house, where her grandmother, glowing with health and a smile, plays a card game with the child’s sister. Grandpa relaxes on the porch before coming down to join the game.

The family is happy and carefree.

“Postmenopausal women with HR-positive HER-2 negative metastatic breast cancer are living longer with Kisqali,” the voiceover begins as the happy family continues to play.

Pharmaceutical company Novartis is in hot water with the U.S. Food and Drug Administration (FDA) for making false and misleading representations about the efficacy of Kisqali, a drug prescribed to treat women with breast cancer, in an advertisement.

In particular, the FDA noted the advertisement’s use of the phrase, “Kisqali helps preserve quality of life, so you’re not just living, you’re living well.”

These claims of living longer are boosted with claims like “long live family time,” “long live dreams,” “long live you,” “long live hugs and kisses,” and “long live life.”

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“The claims that Kisqali ‘preserves quality of life’ and that patients taking the drug are ‘living well’ create a misleading impression that Kisquali has demonstrated a benefit on the patient reported outcoming measure of global quality of life,” Koung Lee and Rachael Conklin of the FDA’s Office of Prescription Drug Promotion wrote in a letter to Novartis.

Critical Information Competes Against Visuals for Viewer’s Attention

The FDA’s letter noted that, while the advertisement did include the required superimposed text explaining the medication’s side effects, the text vied for attention with messages of preservation of quality of life and living longer.

“The presentation of the [superimposed text] is undermined by multiple, competing presentational aspects that distract the viewer from material information about the benefits of Kisqali, and therefore, creates a misleading impression about the drug’s efficacy,” the authors wrote.

The ad’s visuals constantly change, from three women sitting by a lake to two adults and two children on a staircase. As visuals change, large text claiming that Kisqali “helps women live longer” and “preserves quality of life” appears on the screen in type many times larger than the text of the superimposed warning.

Additionally, the FDA noted that the superimposed warning contains so much information and is onscreen for such little time that a person would have to read at a rate of 576 words per minute to comprehend it; the average silent reading rate for adults in English is 238 words per minute.

“Overall, by presenting compelling and attention-grabbing visuals as well as information in other competing modalities during the presentation of the [superimposed text], which itself is presented in a manner that would not allow most viewers to read, process, and comprehend, the TV ad misleadingly undermines the communication of material information about the drug’s efficacy,” the letter stated.

Are Prescription Drug Ads FDA-Approved?

While the FDA oversees advertising for prescription drugs, it doesn’t require drug manufacturers to submit ads for approval before going to market.

“We see many ads at about the same time the public sees them,” the FDA writes in an FAQ section on its website.

Drug companies are encouraged to use precise language in their ads that the general public can understand. TV ads, like the Kisqali ad, must include a prominent statement covering the drug’s most significant risks, and the ad must be presented in a fair and balanced way.

Ads can violate the law in myriad ways, such as stating or implying the drug can treat a condition not approved by the FDA, making claims unsupported by adequate evidence, mispresenting data, overstating the drug’s benefits, or downplaying risk information.

The Kisqali ad made claims not supported by adequate evidence and downplayed risk information, failing to address that the overall survival rate for a woman taking the drug was only about 12 months longer than a study control group. It also failed, according to the letter, to address the serious nature of breast cancer.

The National Cancer Institute estimated there would be nearly 300,000 new breast cancer cases in 2023 in the United States, causing over 43,000 deaths. The National Breast Cancer Foundation estimates that 1 in 8 American women will be diagnosed with breast cancer in their lifetime.

Treatment options have come a long way in helping women with breast cancer. Options include surgery, radiation, hormone therapy, chemotherapy, and targeted therapy. Therapy is not without risk, however.

Kisqali, in particular, is associated with several risks, according to the FDA, with adverse reactions that include infections, nausea and vomiting, fatigue, back pain, hair loss, rash, constipation, headache, and reduced white blood cell and red blood cell counts.

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