January 2024 Newsletter

I hope your 2024 has got off to a good start. I can’t complain about mine. My attitude to the new year is the same as my attitude towards air travel—it’s good if it’s uneventful :)))

This week a headline of the FDA scolding Novartis over its misleading TV ad for a breast cancer treatment caught my attention.

When I worked at Pfizer, I was on a team that was developing a Viagra backup. Needless to say, working on an erectile dysfunction drug had its funny moments. For example, the lead clinician on the very first Viagra trial explained to us very seriously about how he had to research the ‘best’ pornography to measure the primary endpoint in that trial :))))

But the one thing I learned, is that virtually all drugs have some side effects.

So imagine my surprise when, in the US, I came across direct-to-consumer (DTC) drug commercials.

The US is virtually the only country in the world that allows pharmaceutical companies to advertise directly to consumers.

We’ve all seen these ads, they’re ubiquitous—on TV, online, in magazines and newspapers, on billboards, on buses, on park benches. We are assaulted by ads with stock pictures and actors promoting treatments for psoriasis, heartburn, arthritis, depression, and even cancer.

Novartis’s ad for Kisqali is an interesting example of misleading DTC advertising.

Kisqali (Ribociclib) is a treatment used for hormone receptor positive, HER2-negative, advanced or metastatic breast cancer. It has to be used in combination with other therapies.

According to the FDA’s letter to Novartis , the “TV ad misleadingly undermines the communication of material information about the drug’s efficacy.” In summary, the letter states Novartis misleadingly claims that Kisqali preserves quality of life, which has not been shown in clinical trials. In fact, in many of the clinical trials, patients suffered deterioration of their global health scores. In addition, the FDA says the ad claims Kisqali prolongs patient lives using terms such as ‘living longer’, ‘long live’, ‘family time’, ‘long live dreams’, ‘long live view’, ‘long live hugs and kisses’ and ‘long live life’. These terms create a misleading impression about the drug’s efficacy.

The ad also caused Lilly, a Novartis competitor that markets a rival breast cancer drug, to report Novartis and its ad to the National Advertising Division (NAD) for making false claims about Kisqali being the only drug having survival benefit in this type of breast cancer.

Novartis has since pulled the ad.

The question I asked myself when I read this headline was, do DTC drugs ads work?

For the advertisers, which includes the pharmaceutical companies and the ad agencies, they certainly do. It’s a $10 billion, and growing, industry.

The advertisers often suggest the ads are a chance to educate people both about diseases, and available treatments. Another argument is the ads destigmatize certain conditions, such as mental illness or erectile dysfunction. And they also increase the detection of undiagnosed conditions if the DTC ad inspires a patient to consult a doctor.

Unfortunately, one of the biggest issues of many of these ads, as the Novartis ad demonstrates, is incomplete, often as relates to side effects, and worse, misleading, information.

In 2004, the FDA conducted a survey on patient and physician attitudes and behaviors associated with DTC promotion of prescription drugs.

The surveys were national, telephonic, and included ~2000 patients, and ~500 primary care physicians and specialists.

The findings from the patient studies revealed nearly universal awareness of DTC advertising in some form, with television being the most common vehicle of exposure. Grocery stores and pharmacies were significant as well.

DTC advertising prompted ~43% of respondents to look for more information, mainly from their doctors or pharmacist but also from reference books, friends, relatives, neighbors, and the Internet. Patients generally looked for side effects rather than benefits, 61% versus 10%. And some, ~ 4%, searched for cost.

Only 4% of patient said they visited their doctor because of a DTC advertisement.

The physician questionnaire on the other hand had slightly different findings.

85% of physicians said their patients often or all the time asked about prescription drugs.

~41% of physicians reported DTC exposure led to benefits, such as better discussions with patients, created awareness and education of treatments. However, 18% reported that the exposure led to problems which included extra time needed to correct patient misconceptions, requests for unnecessary drugs, and requests for DTC ad treatment over other effective treatments.

On the plus side 91% of physicians reported that the particular patient they recalled did not attempt to influence their treatment in a manner that would be harmful to the patient.

Primary care physicians reported more pressure to prescribe than specialists did, with 22% of primary care physicians feeling somewhat or very pressured to prescribe a drug compared with 13% of specialists.

At the end of the interview physicians were asked to give their general impressions of the influence of DTC advertising on their patients and practice, and responses were evenly divided with about a third each indicating that it had a positive effect, a negative effect, or no effect at all.

The FDA concluded, in 2004, that DTC advertising seems to increase awareness of conditions and treatments, and motivates patients to ask questions of their healthcare providers. However, it is also clear that DTC advertising has effects that can be troubling with sometimes excessive pressure to prescribe.

Both patients and doctors indicated that DTC advertisements overstated drug efficacy, and do not present a fair balance of benefit and risk information.

That FDA survey was in 2004.

Now, 20 years later, in 2024, we are facing a different issue regarding DTC advertising—social media influencers.