When Congress granted the FDA authority over prescription drug labeling and advertising in the 1960s, the organization was instructed to ensure ads were not false or misleading. They had to present a fair balance of risk and benefits, include facts material to the drug’s advertised use and include a summary that notes every risk in the drug’s labeling information. The first direct-to-consumer advertisement (DTCA) appeared in 1981, but the practice was not ubiquitous until the late 1990s. That was when the FDA eased regulations on required risk information, stipulating that ads need only include “major risks” and let consumers know where they can access additional information.^1,2

DTCA has its share of both proponents and critics. Advocates, for instance, believe the ads can strengthen relationships between patients and health-care providers.³ Detractors, meanwhile, have claimed DTCA has resulted in an increase of inappropriate prescribing and has the potential to strain the patient-physician relationship.^4,5 For example, drug ads can diminish a patient’s trust in their provider’s clinical decisions. When physicians deny a prescription, patients become unhappy and switch providers.¹

We interviewed physicians on their experiences with DTCA, how it affects patient interactions and whether it is helpful, or not, for practices.

DTCA — THE GOOD

A conversation starter

While ophthalmologists do not bump up against the DTCA issue as often as primary care physicians, they still receive their fair share of specific drug or product requests. Clearly, the companies do it because it works — at least from their perspective, says Uday Devgan, MD, a clinical professor of ophthalmology at Jules Stein Eye Institute, UCLA, and in private practice at Devgan Eye Surgery, in Los Angeles. His city had its own larger-than-life experience with DTCA. “Shortly after Xiidra [Shire] was approved, a 10-story billboard appeared on Sunset Boulevard,” says Dr. Devgan. “It was literally an entire side of a building featuring Jennifer Aniston talking about dry eye disease.”

Giant celebrities aside, an ad may motivate a patient to make an appointment with a doctor and start the conversation, and that is a good thing, he says. “My role as the doctor is to direct that discussion and guide the choice of therapy for a patient’s individual disease.” Patients regularly come to him having seen advertising for specific IOLs, Dr. Devgan notes. “But certain pre-existing conditions may disqualify them from being a candidate for the option they think they want. I need to steer them toward the implant that is the best fit for them and their visual needs,” he says. “The doctor’s recommendation is always the most important part of the equation.”

Of course, there are the patients who take a bit more to be dissuaded from receiving an advertised treatment, says Laura Periman, MD director of dry eye services and clinical research at Evergreen Eye Center in Seattle.

“Often, very frustrated patients will have done a lot of research, so I need to be able to redirect them toward what is best for them and their condition,” she says. “This is particularly true when it comes to dry eye, which is such a busy, noisy, messy, difficult-to-get-our-head-around disease state.” Maneuvering patients with compassion, care and teamwork helps her avoid tension that could otherwise arise when patients think they know exactly what treatment they need, she adds.

Patient education

DTCA is a “positive initial brush stroke in terms of patient education,” Dr. Periman says.

For Dr. Periman, having a teacher’s attitude and perspective is an important aspect of successful physician-patient relationships. “Patients come in all the time asking for specific medications and procedures, and I like it. It helps with my education efforts and discussion,” she says. “I might reply, ‘I’m so glad you read about that! Let’s do a thorough evaluation and figure out if that really is the best initial option for you.’”

As an educator, Dr. Periman says she favors anything that will help create a common vocabulary for discussion with patients. She warns, however, that certain online patient forums, support groups and blogs are overrun with misinformation. “Patients coming from that perspective are more challenging, and they are often angry — they still need our help,” she says.

She would welcome more general disease state education. “But, at the end of the day, sometimes what DTCA does is provide patients with a sense of hope that there’s something new that may help them.” There is a gap, she warns, between when an approved drug is advertised to patients and when they can access a therapy.

The most important question is, will insurance cover it? “In these situations when the drug is not paid for, sadly, the doctor is in the position of withholding care from patients,” she says.

DTCA — THE BAD

The question of insurance

For Darrell White, MD, founder of Skyvision Centers of Ohio, insurance coverage is a concern. “DTCA has an overall negative effect on the provision of health care. We are in an era where the goal is to practice medicine in a way that offers value, ie, the greatest effect at lowest net cost.” Advertising specific brands to patients who may not even have coverage for them does not help that, he says. When there is a choice of more than one branded medication, the prescription that gets fulfilled is the one that’s covered by insurance.

“Nothing else matters,” Dr. White says. “All that matters is that it’s going to be covered, because these are expensive branded medications.” Further, he continues, physicians can waste time explaining to patients why an advertised treatment is not right for them.

DTCA can be a public disservice

Every dollar that is spent on DTCA marketing, Dr. White believes, is a dollar that is being inappropriately spent. “These are dollars the pharmaceutical and the medical device companies should be putting into R&D or into lowering the cost of their therapies,” he says.

“Overprescribing branded medications that are not significant improvements over those available as generic is a large cost driver to the health-care system,” continues Dr. White. For him, there is a fine line between disease state awareness and DTC marketing. “The former is a public good for which groups, such as pharmaceutical and medical device companies, medical institutions and nonprofit organizations, should be lauded,” he says.

There are patients for whom the advertisement is a jumping-off point for more research, but, “that’s the equivalent of the unicorn patient,” he quips. “It’s money that shouldn’t be spent, and I believe it’s a source of confusion and a potential source of conflict in the office between a well-meaning patient and a well-meaning physician.”

CONCLUSION

Supporters of DTCA point to increased awareness that has in turn helped spur meaningful conversations between patients and physicians.⁵ These ads, however, often understate the risks of a medication and overstate the benefits from the patient’s perspective.⁶ Patients have become more aware of certain disease states and treatments, but, as a result, some doctor visits may be more time consuming.

Ophthalmologists, like all physicians, will be called on to navigate patient’s preconceived ideas about their condition and what medicine is right for them. With DTCA seemingly deeply entrenched in the U.S. health-care system, doctors may be best advised to use it as a teaching opportunity. OM

Disclosures: Dr. Devgan is a consultant to and member of the speakers’ bureau for Alcon and has an ownership interest in CataractCoach.com , IOLcalc.com , LensGen and Specialty Surgical.
Dr. Periman is a speaker for Allergan, Bio-Tissue, Lumenis and Topcon and is a consultant for Allergan, Eyedetec, ScienceBased Health, Shire, Sun, TearLab and Visant.
Dr. White is a consultant to Allergan, Eyevance, Kala, Ocular Science, Omeros, Rendia, Shire, Sun and TearLab; a speaker for Allergan, Omeros, Shire and Sun; has an ownership interest in Eyevance and Ocular Science.

REFERENCES

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4. Kessler DA, Levy DA. Direct-to-consumer is it too late to manage the risks? Ann Fam Med. 2007;5:4-5. doi: 10.1370/afm.655. http://www.annfammed.org/content/5/1/4.full.pdf+html?sid=b42de835-d50c-434f-b793-8cde7502e33e . Accessed Dec. 2, 2018.
5. Kravitz RL, Epstein RM, Feldman MD. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA. 2005;293:1995-2002.
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