Mary Jennings-Smith spent more than three decades working at a California community college. Her career would have gone longer too, had metastatic breast cancer not gotten in the way. She recalls crying at the last graduation ceremony she attended in 2009.
The diagnosis led Jennings-Smith on a winding road of treatment, marked by chemotherapy, infusions and potent enzyme inhibitors. But it was her volunteer work with a patient support organization that connected her to producers creating direct-to-consumer (DTC) advertising for Eli Lilly's drug Verzenio (abemaciclib).
The Belmont, California native took part in a commercial for the treatment, and was one of hundreds of patients the big pharma says it consulted before launching the 90-second TV spot in April.
It's the latest example of a relatively recent phenomena in pharmaceutical marketing: using DTC campaigns for cancer medicines. The practice has drawn particular concern given the severity and complexity of the diseases they aim to treat, as well as the high price tags most treatments carry. Getting the campaigns right is tricky, to say the least, and some argue the industry hasn't achieved that yet.
The U.S. is one of two countries that allow DTC advertising. Though its roots go back to print ads in the early 1980s, revised standards helped usher in the first DTC commercial, for Schering-Plough's Claritin, in 1996. Spending on TV spots has exploded ever since, and with it, controversy. Critics say — and studies have confirmed — the ads promote use of costly, but not necessarily the most effective, drugs. Generics rarely get advertised.
As the debate rages on, cancer drugmakers appear poised to keep pumping massive amounts of money into the practice.
Investment in DTC advertising for prescription cancer medications more than tripled from $163 million in 2015 to $505 million in 2017, data from media intelligence firm Kantar Media shows.
"Metastatic breast cancer is relentless, but I'm relentless too," says a woman at the opening of the Verzenio commercial. White text then relays the benefits of treatment: 55.4% of MBC patients in clinical studies who took Lilly's drug plus an aromatase inhibitor experienced shrinking tumors, compared to 40.2% who received just the inhibitor.
But there are drawbacks too.
A narrator mentions diarrhea is common with treatment, and may be severe. Verzenio can lower white blood cell counts too, which may lead to life-threatening infections. What's more, the drug isn't approved for at least 30% of the MBC population.
Studies are also trying to determine the overall survival benefit, noted in small type in the ad.
Pharmaceutical marketers call the requirement to weigh benefits with risks fair balance.
Federal rules mandate that drugmakers spell out the most common and dangerous side effects listed on the product's label. In the Verzenio commercial, these come later on, after the moving introduction. Though data suggests the FDA has adopted a more lenient stance toward promotional activities in recent years, the agency still can punish a drugmaker for not sticking to a product's label when marketing it.
"You do a lot of rigorous testing about messaging, and you figure out what's the got-to-haves to tell the product story to get the point across. And sometimes you don't have room to tell all the product story because you have to tell the fair balance," said Howard Courtemanche, president of the global healthcare practice at Young & Rubicam (Y&R), a marketing firm.
Whether it's possible to convey the experiences of a cancer patient along with the nuances of a drug, especially within the confines of a two-minute or less TV spot, remains up for debate.
Last year, as part of its "Living Longer Is Possible" campaign for Keytruda (pembrolizumab), Merck & Co. released a commercial about the immunotherapy's effects on non-small cell lung cancer. It stated "in a clinical study, Keytruda offered patients a longer life than chemotherapy."
While that's true — treatment with Keytruda reduced the risk of dying by 40% versus chemotherapy — what the ad doesn't mention is that more than half of patients given Merck's drug didn't respond.
Though they represent real clinical advances over standard treatments, immunotherapies like Keytruda and Bristol-Myers Squibb's Opdivo (nivolumab) don't offer health benefits to a good portion of patients taking them. That's a reality that may get lost behind taglines like "Living Longer is Possible," a point made by those critical of of DTC ads.
"Patients ought to get a little more data as to, out of 100 people, how often it works," said Lowell Schnipper, clinical director at Beth Israel Deaconess Medical Center and professor of medicine at Harvard University, speaking about cancer immunotherapies.
"Indeed there have been great successes with these drugs in a modest number of patients, but it's very important for people to understand that there's an equal number who have just side effects, or minimal benefit and the side effects," he said.
Total DTC advertising spend for cancer medications has steadily increased since 2015Data provided by Kantar Media
Including every detail of a treatment's label in a campaign isn't feasible, though. Even if it was, it wouldn't be particularly compelling for consumers. To discern what information gets priority, cancer drugmakers say they have turned to a vital resource: the patients themselves.
"A lot of the creative does leverage sort of real stories and real people as a way to try to connect to potential patients and others," said Hensley Evans, principal at marketing agency ZS Associates, in an interview.
In crafting the Verzenio campaign, Lilly knew it needed to convey the medicine's value and side effects, but talked to many women with MBC to better understand how to approach the subject.
The thinking was "we put that story in front of them, and they will tell us how we should present that to them," Amy Meadows, a senior advisor for consumer marketing at Eli Lilly's U.S. oncology business, told BioPharma Dive.
For Jennings-Smith, most of the cancer drug commercials she'd seen weren't relatable.
"I didn't like the way they did the story line, it looked so phony," she said. "That was one of the reasons I also jumped at doing this for Lilly, because they kept telling me 'we want your input because we want these to look real.'"
The payoff, risks
Incorporating patient perspectives also reinforces a common defense of DTC advertising, that the end goal is to educate consumers about diseases and available treatment options.
There's some evidence to back up that claim.
A 2002 survey conducted by the Food and Drug Administration found 43% of responders said ads prompted them to search for more information about a drug or their health. A much more recent survey from industry trade group PhRMA determined 35% of responders talked to their doctor about a new medical condition or illness after exposure to a prescription medicine ad.
"People want to know the scientific community is prioritizing them," Meadows said. "When we approach oncology and the oncology portfolio, we want people to know about the options that exist for them and ... talk to their oncologist and care teams to see what's right for them."
But there is ample evidence that suggests the ads are potentially harmful.
Some research has found including disease information in a DTC prescription drug ad can instill the idea that the drug treats symptoms for which it's not indicated.
The patient experience can also get warped. A commercial for Bristol-Myers Squibb's Opdivo (nivolumab) received criticism from an article published in JAMA Oncology and co-authored by Schnipper for featuring uplifting music, a sunset, and people with cancer enjoying a baseball game and playing with their grandchildren. And yet, "No one is filmed being infused, and no one seems to be experiencing significant toxic effects," the article points out.
With cancer DTC campaigns, "you could argue that this is quite an exaggerated presentation, with a singular focus that isn't necessarily real — and occasionally can lead to practice changes in the short run that only have to be revisited in the longer run because of unanticipated or unknown or unappreciated [consequences]." Schnipper said.
Still, the investments have kept flowing, often amid eyebrow-raising product sales.
Big pharmas are pouring millions of dollars into cancer DTC marketingData provided by Kantar Media
In 2017, Keytruda brought in $3.81 billion for Merck; Opdivo $4.95 billion for Bristol-Myers; Ibrance (palbociclib) $3.1 billion for Pfizer. Y&R's Courtemanche, who used to work on Opdivo ads, explained that DTC ads drove sales of the immunotherapy, in turn helping to lift Bristol-Myers' stock when earnings came around, which then offset the cost of making the campaign.
Additionally, the high list prices set for many cancer treatments mean it takes a relatively modest number of patient sign-ups for drugmakers to start turning profits.
"Our funding of the DTC campaign is based on a belief that it is important to invest in efforts that provide support and education to patients and help these patients understand there is a potential option that may be appropriate for them," Bristol-Myers said in an emailed statement to BioPharma Dive.
A more crowded future
Opdivo and Keytruda, it turns out, are frequently cited as catalysts for the recent uptick in cancer drug DTC advertising.
The rivalry between Bristol-Myers and Merck while they sped their immuno-oncology drugs to market created a sort of arms race, in which television proved to be an invaluable tool, according to Courtemanche. "A benefit of advertising on television first was to own the class of drug and the breakthrough in the minds of investors, of opinion leaders, of scientists — and frankly to get there first, to be the first person on the moon," he said.
Pharma marketers admit not every drug has such a compelling narrative. Yet with the cancer therapeutic field growing increasingly crowded, companies may turn to DTC campaigns even if their products lack the characteristics that traditionally make something a good fit for DTC advertising, such as a novel mechanism of action or the potential to lock down more indications in the future.
"There are all sorts of organizations that are coming into the oncology space that is not their heritage," said Evans of ZS Associates. "For some of those organizations, DTC may be aimed not only to consumers but also to healthcare professionals and investors to sort of establish leadership in a category as they're expanding and building their pipeline."