The Customer is Sometimes Right: Direct-to-consumer Ads in Rheumatology

Direct-to-consumer advertisements in health care occasionally provide patients with helpful information that sends them into the clinic with appropriate questions for their doctor. These questions, then, occasionally spark frank conversations that occasionally translate into shared decision-making to produce positive outcomes.

However, when treatment decisions are a matter of life or death, as is often the case in the rheumatologic diseases, and patients enter the clinic with misinformation gleaned from a direct-to-consumer ad, it begs the question of whether “occasionally” is good enough.

There is no question, however, that direct-to-consumer (DTC) advertising has become a significant part of the health care system in the United States. According to MediaRadar’s annual review of TV spending, pharma spent $6.6 billion on TV advertising in 2018. Perhaps that bears repeating: $6.6 billion, for television commercials alone.

Steven Woloshin, MD, MS, of the Dartmouth Institute for Health Policy and Clinical Practice, put the figure in the ballpark of $30 billion when print and online ads for both professional and DTC marketing are factored into the equation. “That is equivalent to the GDP of many small countries,” he said.

As more biologics, biosimilars and gene-based treatments hit the market, patients with rheumatologic and autoimmune diseases are sure to be bombarded with a media blitz in 2019 and beyond. Clinicians should be prepared for an onslaught of questions, if they are not already. The questions are likely to be appropriate ... occasionally.

It is important to understand that not all of the ads that consumers see are unhelpful. There are benefits to DTC advertising beyond the aforementioned doctor-patient conversations, and understanding those benefits may prove useful in shaping the future of DTC advertising.

That said, many experts, like Louis Tharp, co-founder and executive director of the Global Healthy Living Foundation, are understandably cynical. “The main advantage of DTC advertising is for pharma,” he told Healio Rheumatology. “They are making huge sums of money off of this. If that were not the case, they would not do it.”

With the kind of money involved, regulation is a natural consequence. Pharma and the FDA have been engaged in a regulatory dance for decades, culminating, most recently, in a Trump Administration proposal to require pharmaceutical companies to include the list price of the medications in all TV advertisements. Some experts, like Tharp, believe this is a “gimmick,” at best, and that it is unlikely to come to pass.

Woloshin believes that this may be an attempt to provide a simple answer to a complicated problem like drug pricing. “The criticism of the Trump plan is that, for most people with insurance or Medicare, they will not see the list price anyway,” he said in an interview. “The price that people pay is a function of insurance coverage, rebates, coupons and other factors, and not the actual list price. As proposed, the price they see on the commercial will be irrelevant to many.”

This is just one of the drawbacks of DTC advertising that needs to be explored. But despite these drawbacks, for better or for worse, DTC advertising in medicine is not going away. The challenge for clinicians, researchers and advocates in the rheumatology space is to make sure that advertising is not just “occasionally” helpful to patients, but often, or always.

Opening the Floodgates

To understand how DTC advertising became the multibillion-dollar industry it is today, it is important to trace back to regulatory decisions made in its earliest iterations. A critical turning point came in 1985, when the FDA lifted a temporary moratorium to allow DTC ads in print media.

With that move, there was blood in the water. Through the early 1990s, an emboldened pharmaceutical industry pressured the FDA to allow television commercials.

In 1997, the FDA turned the corner, and allowed for TV advertising with a draft guidance that was an attempt to translate print regulations to the screen. Authors of the guidance placed parameters on DTC TV ads, which they knew could be a lucrative and powerful tool for pharma if left unchecked. However, some experts believe the draft guidance had the opposite of the desired effect.

“The 1997 draft guidance by the FDA likely opened the market to the kind of ubiquitous broadcast advertising we see now,” Joseph Flood, MD, a rheumatologist at Columbus Arthritis Center and clinical professor of internal medicine at The Ohio State University College of Medicine, told Healio Rheumatology.

Madelaine A. Feldman, MD, president of the Coalition of State Rheumatology Organizations and clinical assistant professor of medicine at Tulane University School of Medicine, explained further. “Prior to 1997, there was much more information required on TV ads about the efficacy and safety of medication,” she said. “The final guidance allowed the drug manufacturer to list toll free numbers and websites on the ad, directing the public to the full information, to take the place of having to put all of the side effect information in the TV ad itself. This allowed the commercials to be shorter, thus more affordable, vastly increasing the amount of DTC advertising since then.”

The numbers bear that out. In a study published in JAMA, Schwartz and Woloshin investigated medical marketing between 1997 and 2016 and reported almost nothing but increases, across the board. “Spending on medical marketing of drugs, disease awareness campaigns, health services and laboratory testing increased from $17.7 to $29.9 billion,” they wrote. “The most rapid increase was in DTC advertising, which increased from $2.1 billion (11.9%) of total spending in 1997 to $9.6 billion (32.0%) of total spending in 2016.”

With these staggering figures in mind, Woloshin spoke directly to the impact this had — and continues to have — in rheumatology. “The study includes a graphic showing growth of ads by category over the study period,” he said. “Arthritis is in the top five.”

A Closer Look at the ‘Brief Summary’

Another important component of the 1997 guidance that continues to resonate today is the so-called “brief summary” of risk. This is the listing of possible side effects and adverse events that comes at the tail end of a TV ad. The document outlined three types of advertisements — “help-seeking,” “reminder” and “product claim” ads — and whether, and how, the brief summary should be presented.

Help-seeking ads simply offer information on a disease state without mentioning a drug or product and encourage patients to talk to their doctor. As no product is mentioned, nor are any claims made about efficacy, the brief summary is not required.

Most health care professionals see these commercials as providing the best of what DTC advertising has to offer, with the fewest side effects, so to speak. They provide awareness to patients, including those with rare or complicated diseases, and lead to those fruitful doctor-patient conversations that happen occasionally.

“Looking at the rheumatology field now, with so many biologics coming out, and biosimilars, gene therapies and beyond, it is going to require that patients know what is going on,” Tharp said. “Through help-seeking DTC ads, patients may learn that there are new drugs for their condition, and how those drugs work.”

But Woloshin offered the obvious counter to this argument. “There are probably better ways to educate doctors and patients, from a source that does not have such a strong vested interest,” he said.

The other two types of ads are less benign than help-seeking ads, and the FDA chose to regulate them accordingly. Reminder ads include the product name and may offer information about dosing, form or price. These spots do not offer specific indications or make claims about the efficacy or potential curative impact of the treatment, so, again, no brief summary is required. However, if a drug contains a boxed warning about serious risks, the FDA does not allow DTC ads for it.

Product claim ads mention the name of the product, along with its indication and efficacy and/or safety claims. In these cases, the brief summary is required.

In theory, the listing of adverse events should be a positive component of drug advertising, but there is one key drawback, according to Tharp. “Injection site reactions and melanoma are not the same thing,” he said. “They are presented equally, when, in reality, they are not equal at all.”

Patients may hear “cancer” on television and assume — or, worse, fear — that that is what will happen if they take that particular drug. “But listing all of these events does not relate to the frequency or a patient’s personal probability of experiencing a side effect,” Tharp said.

Among his own patients, Flood experienced similar problems when broaching the topic of biologics. “My patients can become uneasy when I mention a biological product because they have heard all the potential adverse reactions in the ads,” he said. “The FDA requires that these be included, but they can frighten people.”

Tharp offered a solution to this problem. “We can now predict side effects on an individual basis by looking at the patient history, family history, their disease state, how long they have had it — all of these factors,” he said. “We should be looking into ways to incorporate this information into ads as well.”

Woloshin suggested that a fact box clearly explaining the drug’s efficacy and safety information might be another solution. He conducted a study with Schwartz and colleagues in which 231 participants from two cohorts completed surveys pertaining to the efficacy and safety of proton pump inhibitors and histamine-2 blockers in preventing heartburn.

One group received advertisements with the brief summary, while the other group received ads with the brief summary replaced by a drug facts box. In one cohort, 70% of patients who received the drug facts box and 8% of those who received the brief summary correctly identified the safer and more efficacious drug. In the other cohort, that difference was 80% vs. 38% in favor of those who received the drug facts box.

“Most of the population does not understand the concept of risk,” Flood said. “Understanding is needed to put the claims for benefit and the potential for adverse reaction in perspective.”

Drawbacks to Pitching Lifestyle over Information

Clearly explaining the risks and benefits of a medication, and the problems that can arise from that challenge, is only one disadvantage many experts see with DTC advertising. “Bypassing providers and going directly to the consumer can increase the pressure on providers to potentially utilize advertised therapies,” Stanley Cohen, MD, a clinical professor in the department of internal medicine at the University of Texas Southwestern Medical School, told Healio Rheumatology.

A related concern is that certain patients may be inappropriately treated or are not candidates for these therapies, Cohen added. “Also, these are all very expensive therapies and can lead to significant increases in health care expenditures that may not be warranted,” he said.

Further drawbacks pertain to the vast divide between the realities of treating a chronic condition and what happens in TV ads. “Seeing an ad with a woman running on the beach in high heels sets patients up for disappointment,” Tharp said. “If a patient then takes the drug and does not experience the life-changing results represented in the commercial, they blame themselves. It is difficult to explain to them that there are many reasons why medications fail.”

The disappointment can run even deeper. Patients may also learn that they are not candidates for the drug in the first place, it is not covered by their insurance, or they have to fail on another drug before they can be treated with the one in the advertisement. There is one critical problem with this, according to Cohen. “Patients frequently do not want to hear ‘no’ as an answer,” he said.

As these disappointments mount, further comorbidity can occur. “Being denied treatment with the drug, or failing on it, can feed into the depression and anxiety that often accompany chronic rheumatologic diseases,” Tharp said.

He added a final component to the disappointments that can come from DTC advertising. “There is also the nocebo effect,” Tharp said. “Patients see an ad for a drug, and whatever they are taking suddenly becomes less effective.”

A Strong Case for DTC Ads

With so many drawbacks, it is hard to imagine that there are any benefits to DTC advertising. But it is not without its merits, particularly in the rheumatology field. “Direct-to-consumer advertising has been helpful in establishing the rheumatologist as the expert in the diseases we treat with the drugs they advertise,” Flood said.

Early advertisements in the rheumatology space failed to use the name of the specialty — the “R” word, as Flood said it was called — but now most ads do. This helps inform patients, to a point. “Most of my patients will ask my opinion about what they may have heard or read,” Flood said. “They trust my judgement about the choice of medication in our collaboration about their treatment.”

Beyond relationship building, Tharp acknowledged another key advantage. “If a drug comes out for a chronic condition that consumers have stopped consulting their doctors about, they may never know that there is a new drug unless they see an ad,” he said.

Feldman viewed the issue through a different lens. “DTC advertising may be helpful emotionally for patients who feel isolated and alone with certain conditions,” she said.

For the most part, the advantages to DTC advertising have not changed since the 1990s. For that reason, Tharp is most concerned with doing a better job of making advertising work for patients, and he offered concrete steps to get there. “We need to have a 1:1 ratio of branded vs. unbranded advertising,” he said. “There needs to be disease education from sources that do not stand to profit from that education, and we need to make available information about what patients can do to get healthy and stay healthy.”

Advertising Under Fire

Ongoing discussion of the advantages and disadvantages of DTC advertising did not slow increases in the number of ads through the 2000s — but opposition mounted. In 2015, the AMA voted to prohibit DTC advertising. The following year, former Sen. Al Franken, D-Minn., introduced the Protecting Americans from Drug Marketing Act, which proposed eliminating tax incentives for pharma companies that use DTC advertising. In the House, Rep. Rosa DeLauro, D-Conn., introduced a bill calling for a 3-year moratorium on ads for newly approved drugs. Neither of these pieces of legislation were passed.

Then, in May 2019, the executive branch stepped in. HHS Secretary Alex Azar announced a rule requiring the list price to be displayed in ads for any prescription with a price tag of $35 or more for 30 days of treatment.

“I have heard that idea of the President’s bandied about, but I would be shocked if it actually came to pass,” Flood said, suggesting that the Pharmaceutical Research and Manufacturers of America (PhRMA) lobbying enterprise is strong enough to block it.

“I have come around to the idea that including list prices of drugs on TV ads might actually create some real competition to lower prices or perhaps force further transparency regarding price concessions,” Feldman said. “It would be nice to see which companies are really pricing their drugs lower.”

Feldman also believes that revealing the list price might make manufacturers think twice about “capricious” pricing increases. “Transparency in drug pricing needs to start somewhere,” she said.

Flood took this one step further. “People should know the actual cost of a drug, and while we are at it, why not also show the cost for the actual TV advertisement?” he said.

But for Woloshin, knowing the price is only a part of the equation. “Before you know how much a drug costs, you want to know how much it works, and whether it is harmful,” he said. “If one drug is cheaper than another but it does not work or comes with serious side effects, the lower price does not matter.”

An Uncertain Future

With so many unresolved issues surrounding TV advertising, regulating online DTC advertising seems almost insurmountable. “As far as internet, social media and other such modalities of DTC advertising go, the regulation is pretty murky right now,” Woloshin said. “Efforts to regulate it are constantly evolving.”

The impact of this on the clinic is difficult to estimate, but it is significant, according to Cohen. “The biggest difference in how we manage patients has been the internet and the fact the patient can go to many different sites to obtain information — true or false — about therapies,” he said. “This has a huge impact on the benefit risk discussion that we have with patients, because they come in with so many preconceived notions about the therapies.”

In short: Same problems, different media.

These numbers will continue to grow, according to Cohen. “As newer therapies are developed that target the critical components of the immune system, there will be a growth in the number of therapies available for our patients,” he said. “They will become increasingly expensive and will not make it to the marketplace unless they provide incremental benefit. Therefore, there will be more DTC marketing that will take place as pharmaceutical companies are well aware of how this influences utilization of these therapies.”

The biggest concern for Woloshin is that social media advertising is even more personal and direct than television advertising. “Advertisers are posting to people’s Facebook pages based on websites they have visited and information gleaned from their social media platforms,” he said. “How do you control that? It is going to be a tremendous challenge.”

For Flood, underlying structural concerns within the rheumatology community will make the obstacles particularly significant. “Immunology research is discovering new molecules at a rapid pace,” he said. “The manufacturers of all of these new products will want consumers to have them top of mind when they discuss treatment with their rheumatologist for a variety of diseases. But the rheumatology workforce is not sufficient to serve all the patients who will benefit from these drugs as advertised.”

This is unlikely to matter to pharma, according to Woloshin. “It is easy to predict the future of DTC advertising,” he said. “It is going to get bigger and bigger.” – by Rob Volansky

• References:
• Schwartz LM, Woloshin S. JAMA. 2019; doi: 10.1001/jama.2018.19320.
• Schwartz LM, et al. Ann Intern Med. 2009;doi:10.7326/0003-4819-150-8-200904210-00106.

• For more information:
• Stanley Cohen, MD, can be reached at 8144 Walnut Hill Ln., Suite 800, Dallas, TX 75231; email: arthdoc@aol.com.
• Madelaine A. Feldman, MD, can be reached at 2633 Napoleon Ave. #530, New Orleans, LA 70115; email: madelainefeldman@gmail.com.
• Joseph Flood, MD, can be reached at 1211 Dublin Rd., Columbus, OH 43215; email: jjflood@columbus.rr.com.
• Louis Tharp can be reached at 515 N. Midland Ave., Upper Nyack, NY 10960; email: ltharp@ghlf.org.
• Steven Woloshin, MD, MS, can be reached at 1 Medical Center Dr., Lebanon, NH, 03766; email: steven.woloshin@dartmouth.edu.

Disclosure: Cohen reports he is a clinical investigator and/or research consultant for Amgen, Biogen-IDEC, Bristol-Myers Squibb, Centocor, Genentech, Johnson & Johnson, Pfizer, Merck and Roche. Feldman reports an advisory board role with Merck. Flood, Tharp and Woloshin report no relevant financial disclosures.