Direct-to-Consumer (DTC) advertising: misnamed, misunderstood, and underappreciated
Maligned by doctors and often parodied, appropriately regulated direct-to-consumer drug advertising is a net positive for American patients and can even help reduce drug costs.
Peter Kolchinsky, Ph.D.
This is the ninth in a series of articles that aim to define the biopharmaceutical industry’s social contract with America, to examine practices that deviate from that contract, and to propose refinements to healthcare policy to ensure that our continued investment in scientific progress ultimately yields affordable, effective therapeutics for future generations.
Article 1: America’s Social Contract with the Biopharmaceutical Industry
Article 2: What happens when a drug won’t go generic?
Article 3: Protecting Off-Patent Sole-source Drugs from Price-Jacking
Article 4: Why wait for Generics? In praise of me-too drugs
Article 5: False Heroes — How PBMs Add Insult to the Injury of Insurance Cost-Sharing
Op-Ed: Let’s Throw a Patent-Burning Party
Article 6: The favors they do us: Charging less in other countries makes drugs more affordable in America
Article 7: Hard Negotiating Tactics: Compulsory Licensing and Willingness to Deny
Article 8: Unintended Consequences of “Fairness”: Critically examining the idea of the US referencing EU prices
Article 9: Direct-to-Consumer (DTC) Advertising: misnamed, misunderstood, and underappreciated
Article 10: The strange and special case of epinephrine
Please see Important Disclosures for Readers at the end.
Sometime in the next few months, television viewers in the United States will stop seeing what is probably a familiar commercial¹. A middle-aged man, sitting at a picnic table by the beach, massages his foot and grimaces, lamenting the “shooting, burning pins and needles” of diabetic nerve pain that are wracking “feet that made waves in high school.” Cut to the bare feet of a surfer, of a dad kicking a ball, then the boot-clad feet of a carpenter … raising a barn? “So I talked to my doctor, and he prescribed Lyrica,” says the man.
That drug treats various forms of neuropathic pain and is soon going off patent. When Lyrica’s exclusivity expires, several low-cost generics will quickly enter the market. The price of branded Lyrica will also drop, to compete with those generics. The drugmaker Pfizer will lose the Lyrica’s billions in annual sales. Not that you should feel badly for Pfizer. They have made tens of billions of dollars on Lyrica since the drug first hit the US market in 2004, and will continue to market a longer-acting version of the drug for a few more years.
In fact, I think we should celebrate. But this patent-burning celebration, the fulfillment of the biopharmaceutical industry’s social contract with America, also means Pfizer is no longer incented to market Lyrica and raise awareness of those shooting, burning pins-and-needles. No more budget for 60-second Lyrica TV spots (of which 27 seconds comprise descriptions of adverse events, warnings, and contraindications), or four-page glossy ads in Time magazine. The direct-to-consumer (DTC) advertising campaign for Lyrica will be over.
Once FDA approves a drug in the US, its manufacturer typically promotes it to physicians and, unlike in almost every other country in the world, can advertise directly to “consumers.” I use quotes because patients aren’t exactly consumers, shopping to satisfy a material want. They are patients who count on their physicians to prescribe to them what they need for problems they feel powerless to solve otherwise.
There are going to be plenty of people who will be happy to see those Lyrica commercials disappear. Some critics would argue that all DTC advertising should go. The American Medical Association called for a ban on DTC ads in 2015², on the basis that they drive demand for expensive drugs when lower-cost alternatives are available, and that the cost of the ads contribute to “escalating drug prices.” Others argue that DTC ads can boost off-label use of some treatments³.
There is some merit to anti-DTC arguments. DTC advertising does result in over-diagnosis and over-treatment, for example. But these arguments can’t be viewed in a vacuum. Without DTC advertising, patients are indeed under-diagnosed and under-treated, for a few reasons. Some people could be embarrassed to discuss their conditions; depression, fibromyalgia (which many physicians dismissed as illegitimate for many years⁴), intimacy issues, or irritable bowel syndrome, for example. Some may not even know that what they are experiencing is caused by a treatable disorder they can and should discuss with their physicians. Still others may have doctors who don’t themselves realize that a treatment for a patient’s condition even exists. They could have learned about the latest advances by reading the medical literature — the clinical trial results of just about every approved drug are published before the drug becomes commercially available. But many physicians don’t have time to read all they should.⁵ Some institutions and physicians even refuse to see sales reps trying to inform doctors of the availability of a brand-new drug.⁶
When a company invents a new product and brings it to market, the dissemination to physicians and patients of knowledge about the product and how it can be used is part of the product itself. Branded drug prices fund this campaign and incentivize the company to do it effectively. For example, that so many people know about anaphylaxis and the utility of epinephrine is thanks to Mylan’s well-funded, highly effective marketing of the EpiPen, which makes the world safer for families grappling with allergies, like mine. Marketing campaigns for statins made it common knowledge that they are a first-line treatment for high cholesterol. Now that they are generic, we don’t hear about statins anymore, though they remain widely used. Therefore, marketing, including DTC advertising, is a component of the Biotech Social Contract; once a drug goes generic, the marketing stops, but hopefully society will have by then incorporated that drug into standard-of-care.
DTC pharmaceutical ads only prompt a discussion, hopefully with an informed physician with good judgment who can explain a patient’s options, since every treatment comes with trade-offs including financial costs and side effects. And whereas doctors can’t prescribe a drug they don’t know about to patients who don’t report having a problem, they certainly can and should say “no” when they think that the advertised drug is inappropriate for the patient asking for it.
Doctors should embrace their authority
Good physicians know that they can’t help patients who don’t know to seek treatment or who are reluctant to report embarrassing symptoms¹⁰. Such physicians not only won’t shy away from a conversation with an engaged patient, they would welcome more such conversations (that many physicians are overworked and have little time is no excuse to keep patients in the dark). Some patients will come in overly confident in their own self-diagnosis with ideas of what they need, regardless of whether that self-diagnosis was helped along by a DTC ad, but they are powerless to get any prescription medication without a physician’s consent.
Some physicians complain that DTC is about maximizing profits without regard for how physicians are burdened with having to talk a patient out of taking a drug that isn’t right for them. Or, as some physicians put it, DTC “results in poor practice if the doctor capitulates and prescribes an inappropriate agent.”¹¹ Some physicians might prefer that patients not put pressure on them with questions, keeping the interaction as simple as the relationship between a veterinarian and a sheep.
An informed physician should always know when to say “no” and have the fortitude to say “no” to an insistent patient. No, you don’t need that drug. No, there’s an alternative that’s cheaper and probably safer, as we understand it better. No, let’s try to treat this without drugs first. No, I’d rather order a test that confirms you have that condition before prescribing this. The law actually assumes that a doctor is a learned intermediary, protecting even the most insistent patient from harm because no amount of pestering or biased information can force the physician to write a prescription against her own better training and judgment. Critics would rather keep patients in the dark, instead of calling for physicians to do their jobs better. Insurance companies similarly shift the blame for over-utilization to patients when they impose onerous cost sharing schemes, deputizing them into second guessing their doctors’ recommendations, instead of working with physicians directly to make sure they prescribe the right drugs.
On the whole, doctors are not at the mercy of their patients. But for various reasons some doctors cave to patients’ demands. Those doctors should be held accountable, even if we can understand their human fallibility, stressed as many are by the demands on their time. Let’s better equip physicians with the judgment and strength to say “no.” Issuing timely, updated medical treatment guidelines soon after new drugs launch, perhaps. Or giving doctors more time to educate patients about their conditions and their treatment options. Doctors can’t treat patients that, not realizing they even have a problem, just never show up to their office.
Given that physicians report that one of their greatest challenges is getting patients to stick with therapy (an estimated 50% of patients do not take their medications as prescribed)¹², it’s also worth noting that drug advertisements help in that regard, reminding those patients already prescribed a medication to take it as directed by their physician.¹³
Enforcement of DTC regulation by FDA and media works
Let’s not forget that DTC ads are policed by the FDA. Inflated efficacy claims and inadequate risk disclosure are punished, as they should be.
The FDA’s stance on DTC advertising took on its current form in 1997, with an easement that allowed television and radio ads to mention a drug’s important risks but otherwise direct patients to other sources for additional information (rather than requiring that those commercials numbingly rattle off all the detail included in a print ad). Per those regulations, all pharmaceutical DTC ads that make medical claims (1) cannot be false or misleading, (2) must present a balance of risks and benefits, (3) must state facts that are material to the advertised uses, and (4) must include every risk from the product’s approved labeling (if in print) or several sources where a patient might find information about all the risks.¹⁴ That’s a lot of information — approaching what a physician would learn if they read the scientific literature — and often just as dry because it’s restricted to scientifically proven medical claims.
That’s not to say that companies don’t sometimes misrepresent their products, claiming more efficacy than has been proven, adding positive spin or omitting an important side-effect. Critics are right to argue that DTC ads can be misleading, but that’s what the regulators are there to police and punish.¹⁵ If those punishments aren’t enough of a deterrent, perhaps they should be stiffened. Pharmaceutical companies used to only promote FDA-approved drugs directly to physicians. When DTC advertising first emerged in the 1980s, it prompted an outcry from physicians and watchdog groups that triggered an FDA moratorium on DTC ads. Indeed, drug marketing materials were once commonly too creative with the facts or played on the fears of the worried well, but today the rules are enforced pretty carefully. The FDA has studied¹⁶ the benefit-risk of DTC advertising repeatedly over the years and found that, when done in accordance with regulations, it confers a net benefit by making patients better informed and equipped to advocate for their care.
Still, the negative connotation of DTC ads hasn’t quite worn off and is often parodied. “There doesn’t have to be anything wrong with you to take Preniva,” explains the celebrity pitchwoman in a Saturday Night Live sketch¹⁷. “You just have to be scared.” The juxtaposition of the ads’ typically happy imagery with an actor’s voice casually listing various potential side effects makes them a somewhat obvious target for mockery¹⁸. Besides the watchfulness of the FDA, the willingness of the media to point out industry’s DTC transgressions, both real and exaggerated for comedic effect, helps keep DTC ads in check.
The cost and hidden savings of DTC drug ads
But the main arguments critics like the AMA deploy against DTC ads allege that the industry charges higher prices for drugs to pay for this advertising. DTC spending amounted to $6.1B in 2017¹⁹, which is not even 2% of total branded US drug revenues. So if DTC spending were purely a cost passed onto patients, then eliminating it is not a meaningful source of overall savings. However, DTC advertising most likely lowers the cost of a drug on a per patient basis. Here’s why.
A pharmaceutical company invests in a drug’s development believing that it will generate a future return that is based on the price of the drug, the number of patients with the relevant disease, and the fraction of those patients that will be diagnosed and actually prescribed that drug (i.e. the penetration of the drug into its target market). DTC advertisements increase the number of patients diagnosed with a given disorder as well the number of diagnosed patients who are then treated with the advertised drug, usually more than offsetting the cost of DTC itself²⁰. (If this weren’t true, pharmaceutical companies wouldn’t spend money on DTC year after year.)
This means that the cost of generating a return on investment is spread across more patients taking the drug. If not for DTC, the penetration assumption would be lower and the company would have to charge a higher price so that it could generate a meaningful return from the drug’s use by fewer patients. DTC can lower costs indirectly, as well. Advertisements for branded statins drove more patients to seek treatment for high cholesterol and yet many were actually treated with cheaper, non-advertised generic statins.²¹ That savings is in addition to costs avoided because more patients achieved medically recommended goals, preventing heart attacks and strokes associated with high cholesterol.
“I want Paxil”
A study published in 2005 elegantly demonstrated the power of patients asking for treatment based on DTC.²² Actors were trained to pose as patients with different types of mood disorders. Some reported symptoms consistent with major depression that, based on medical guidelines, merited treatment with an anti-depressant. Others reported symptoms consistent with an “adjustment disorder” that doesn’t merit prescribing a drug. Some actors in each group requested that the doctor prescribe a specific branded drug, Paxil; some asked for treatment in general; and some did not request treatment, leaving the physician to take the initiative.
Those who should have received but didn’t request treatment were treated in accordance with standard of care only 56% of the time (which doesn’t necessarily mean that they got anti-depressants; some were referred for counseling). Those who did ask for treatment, either generally or Paxil specifically, were treated in accordance with standard of care 90% of the time. In other words, patients who asked for proper care were more likely to get proper care. Meanwhile only a minority of the major depression group who requested Paxil by name were actually prescribed Paxil (27%). Another 26% got a different drug, including generics, and many others were referred for counseling. Therefore, even when a patient asks for a drug he saw in an advertisement, a doctor can make her own decision about proper treatment.
Equally importantly, those actors in the adjustment disorder group that did not ask for treatment were offered a drug only 10% of the time (which means that 90% of physicians acted appropriately). But they got a script for an anti-depressant 39% of the time when they asked for treatment in general and 55% of the time if they asked for Paxil specifically. Yes, those doctors were over-treating. They failed to say “no.”
But to be fair, physicians are driven to process patients quickly and often given little time to adequately stay on top of their fields. Their ignorance can be explained, but that doesn’t mean it should be excused. Nor should it be remedied by keeping patients ignorant of their options. Patients cannot afford to simply trust that they will be cared for by a system that is so bureaucratic that, despite healthcare professionals’ best intentions, appears to solve its bandwidth issues by pulling the wool over patients’ eyes, giving them the red-tape run-around, making them wait a long time to be seen, and making them hesitate to pursue care by burdening them with high deductibles and co-pays.
Better that patients be informed (by DTC advertising, by other patients, by message boards, by healthcare professionals, by their families), ask for treatments they suspect might help, and trust that physicians will be able to answer their questions (even if they have to do some hurried homework about a new drug). And better that physicians care enough about their patients and have the professional integrity to say “no” if a drug isn’t right.
Acknowledgements: I’m grateful to Chris Morrison for his invaluable and substantive thought-partnership and drafting/editing, to everyone who engaged with me in the constructive debates that led up to these articles, and to Erin Clutter and the RA Capital graphics team for creating artwork that so astutely captures the essence of each core concept.
Sources
¹ https://www.ispot.tv/ad/dfvu/lyrica-beach-day
³ http://www.who.int/bulletin/volumes/87/8/09-040809/en/
⁴ http://www.jrheum.org/content/36/4/671.long
⁵ https://www.medpagetoday.com/blogs/revolutionandrevelation/72029
⁸ https://en.wikipedia.org/wiki/Pseudobulbar_affect
⁹ https://www.nytimes.com/2017/05/12/business/media/pseudobulbar-affect-drug-advertising-sales.html
¹⁰ http://virtualmentor.ama-assn.org/2006/06/msoc1-0606.html
¹¹ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1115695/ ;
http://www.annfammed.org/content/5/2/101.full
¹² https://www.ncbi.nlm.nih.gov/pubmed/22964778
¹³ http://www.nber.org/papers/w21714.pdf
¹⁴ https://www.fda.gov/drugs/resourcesforyou/consumers/prescriptiondrugadvertising/ucm072077.htm
¹⁶ https://jamanetwork.com/journals/jama/fullarticle/1843445; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/
¹⁷ https://view.yahoo.com/show/saturday-night-live/clip/50056483/preniva
¹⁸ https://www.nbc.com/saturday-night-live/video/chantix/n13339; https://adage.com/article/the-media-guy/tbt-hilarious-snl-drug-commercial-parodies/301437/
²⁰ https://pdfs.semanticscholar.org/5bb3/6f34c96fb2748b69b948d12fea505ac45215.pdf
²¹ https://www.sciencedirect.com/science/article/pii/S0149291806003183 ; http://knowledge.wharton.upenn.edu/article/the-side-effects-of-prescription-drug-advertising/
²² Kravitz RL, Epstein RM, Feldman MD, et al. Influence of patients’ requests for direct-to-consumer advertised antidepressants: a randomized controlled trial. JAMA.2005;293:1995–2002
Peter Kolchinsky, Ph.D.
Peter Kolchinsky is a founder, Portfolio Manager, and Managing Director at RA Capital Management, LLC, a multi-stage investment manager dedicated to evidence-based investing in healthcare and life sciences. Peter is active in both public and private investments in companies developing drugs, medical devices, diagnostics, and research tools, and serves as a Board Member for various public and privately held companies, including Dicerna Pharmaceuticals, Inc. and Wave Life Sciences Ltd. Peter also leads the firm’s outreach and publishing efforts, which aim to make a positive social impact and spark collaboration among healthcare stakeholders, including patients, physicians, researchers, policy makers, and industry. He authored “The Entrepreneur’s Guide to a Biotech Startup”, written on the biotech social contract, and served on the Board of Global Science and Technology for the National Academy of Sciences. Peter holds a BS from Cornell University and a Ph.D. in Virology from Harvard University.
Important Disclosures for Readers
The contents of this publication are intended for informational and educational purposes. The views and opinions expressed are those of the author and are subject to change. They do not necessarily reflect the views or opinions of RA Capital Management® or any other person the author is affiliated with.
Nothing of the content should be construed as an offer to sell, a solicitation of an offer to buy, or a recommendation for any security or product. The author and/or RA Capital Management® may hold or trade securities of the companies named in this publication or that manufacture the drugs discussed.
Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this article are trade names, service marks, trademarks or registered trademarks of their respective owners.
The author’s opinions are based upon information he considers reliable, and there is no obligation to update or correct any information provided.
© 2018 Peter Kolchinsky, Ph.D.
