DTC Report 2016: Gut Check

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Last November, when many of the world's most engaged physicians convened at an interim meeting of the American Medical Association, they expected little of major consequence to transpire. Within the various reference committees, there would be talk about reimbursement-related concerns and possibly a push for a plan to spur vaccination rates. But for the most part, few delegates anticipated that anything coming out of the meeting would register on the mainstream radar much less rise to the level of policy smack-down.

And then, on November 17, the AMA issued a statement calling for a ban on direct-to-consumer advertising of prescription drugs and medical devices. Any number of physicians had expressed misgivings about DTC advertising in recent years and about the conveyance of risk information within such ads as well as their galvanizing effect on patients. But what made the pronouncement stunning was that the AMA explicitly linked DTC advertising to inflated drug costs, a link that AMA had never before formally made — indeed, one that almost nobody else had attempted to make.

“Physicians cited concerns that a growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives,” the statement read. Within it, AMA board chair-elect Dr. Patrice A. Harris was quoted as saying, “Today's vote in support of an advertising ban reflects concerns among physicians about the negative impact of commercially driven promotions and the role that marketing costs play in fueling escalating drug prices. Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when those drugs may not be appropriate.”

Reaction from pharma marketers came fast and furious, and one can guess on which side of the issue they landed.

“My initial reaction, to be quite honest, was, ‘What is this, North Korea?' There are bad actors, but a blanket ban is beyond silly. It's like, ‘You've got an ulcer on your foot, so let's cut off the leg at the knee,'” states Mike Luby, founder, president, and CEO of the BioPharma Alliance.

John Kamp, executive director of the Coalition for Healthcare Communication, remembers thinking, “Here we go again,” as does CMI/Compas SVP, media, Adam Scott Roberts: “What? They're picking on DTC? Really?”

American Association of Advertising Agencies SVP, government relations, Peter Kosmala recalls being “somewhat alarmed” upon learning of the AMA's statement; Decision Resources Group principal analyst Matt Arnold remembers it as “kind of a ‘howl' from the physician.”

More telling, however, was that an important party to the proceedings seemed to be on board with the AMA's proposal, and in a way they hadn't been during previous sessions in which changes to the organization's DTC stance were floated.

See also: A ranking of 2015's DTC Ads

“I can't actually remember a time that the AMA formally made an announcement around how the industry should be inter­acting with patients in that arena. I was surprised and pleased,” says Dr. Joseph S. Ross, an assistant professor of general internal medicine at the Yale University School of Medicine.

Dr. Jing Luo, a research fellow at Brigham and Women's Hospital, says, while he's not an AMA member, “I haven't seen too much in the scientific literature that links DTC advertising with higher [drug] prices, but my gestalt as an individual is that DTC is relevant to manufacturers' bottom lines.”

Nobody expects movement on the DTC front anytime soon. The current political climate in Washington might charitably be described as “less than cordial,” meaning that drafting a law that can satisfy all parties and pass constitutional muster is a near impossibility in the short term. But in the more distant future, might we look back on the AMA's disavowal of DTC as the first volley in a process that ultimately ended or scaled back pharma and device advertising in the U.S.? Or, to put it more succinctly: Could doctors undo DTC?

THE AFTERMATH

In the immediate wake of the AMA's issuance of its statement last November, pretty much everyone had something to say about it. Marketers weren't shy about voicing their opinions. Patient groups joined the fray. The New York Times jumped in with an editorial, “Turn the Volume Down on Drug Ads,” which was curiously free of opinion beyond its headline and failed to mention DTC's 21% spending jump last year to $5.2 billion. Since then, however, the silence has been deafening.

Asked in February to comment on the response to its policy shift, the AMA turned down an interview request, referring MM&M to its November statement. It did add that “a strategy to advance the new AMA policy in support of a ban on consumer ads for prescription drugs and devices is under development at the AMA.”

To those who disagree with the AMA's position, that lack of subsequent public lobbying is a statement in itself. “When somebody stakes a position out, they'll continually emphasize it. Maybe there's some hesitation to engage further,” Kosmala speculates, before adding, “or maybe they have a particular quarrel with you personally.”

See also: 2015 DTC spending: All the data in one place

Or it may just be, as the AMA said, that it's moving forward deliberately and will reveal its next steps in due course.

PhRMA, too, responded to an interview request with a statement, which read in part: “Beyond increasing patient awareness of disease (including undiagnosed con­ditions) and available treatments, DTC advertising has been found to increase awareness of the benefits and risks of new medicines and encourage appropriate use of medicines. In addition, DTC advertising encourages patients to visit their healthcare providers' offices for important conversations about health that might otherwise not take place.”

To summarize these two prominent organizational viewpoints in the absence of further information, then, one might craft something along the lines of “AMA: DTC bad” and “PhRMA: DTC good.” So to get a better idea as to how we got to where we now stand in the DTC debate — and, hopefully, better understand the thinking behind the AMA's policy shift — it's worth taking a look back at the buildup to the House of Delegates vote. And who better to serve as our after-the-fact tour guide than Peter Rheinstein?

THE DELEGATE

It is somewhat of an understatement to describe Rheinstein as an accomplished professional. A physician and an attorney, Rheinstein spent 25 years at the FDA, counting among his accomplishments a role in the development of rules governing Rx drug promotion. He's currently president of Severn Health Solutions and chairs both the USAN Council (which assigns names to generic drugs) and the American Board of Legal Medicine (which certifies attorney-physicians who profess to have advanced knowledge of medical law). Most relevant to this particular discussion, Rheinstein has been an AMA delegate for nearly 14 years, representing the Academy of Physicians in Clinical Research. During that time he was chief teller of the AMA's House of Delegates and chairman of its Reference Committee on Public Health.

See also: Larry Dobrow on the worst DTC ads of 2015

In Rheinstein's telling, the DTC recommendation sort of snuck up on everyone at the interim meeting. As opposed to most of the resolutions discussed at the meeting, the DTC resolution was not included in the handbook circulated to attendees ahead of time. Most delegates, then, likely didn't have the chance to discuss it prior to the meeting with the societies or organizations they represent.

“There are always a couple of hundred resolutions, so I suspect a lot of people didn't notice it,” Rheinstein says. “Normally as a delegate you read everything ahead of time and you discuss everything with the board of your organization and you formulate a posi­tion, then you might testify on the floor in accord with that. But this was last minute.”

Plus, Rheinstein continues, the DTC policy adopted at the interim meeting went further than many attendees suspected it might. “With the caveat that I wasn't there myself, somehow in the reference committee it morphed from ‘Let's study the issue of DTC advertising' into a recommendation that it be banned and that all existing AMA policy on DTC be rescinded,” he says. “I've been in the House of Delegates for 14 years with the organization I currently represent and for another 11 or 12 years before that as a liaison for the FDA. I was there when we crafted all the current policy that the AMA has in regard to DTC. So I was really taken aback — here you had a reference committee report that proposed just throwing all of that out.”

Which isn't to say that Rheinstein is a flag-waving DTC zealot. He acknowledges a “background buzz” among physicians about patients who demand a certain brand after seeing it advertised on TV and empathizes with those among his peers who feel they spend an inordinate amount of time explaining to DTC-driven patients why a certain product or treatment course is the one that makes best medical sense. He also, on some level, understands the DTC advertising/drug pricing link suggested by the new AMA policy: “This is me putting myself in the minds of the people making the argument, but you hear, ‘Gee, advertising costs a lot of money, so maybe that's what's responsible for these prices being so high. If we can get rid of DTC, maybe that would generate savings that would be passed on to patients and perhaps make more money available for other parts of the healthcare system.'”

Rheinstein doesn't buy it. “As a society, we generally think it's a good thing to get information out to people,” he explains. “And the courts, in a long line of cases protecting the freedom of commercial speech, have basically said that any restriction on advertising needs to be narrowly drawn to fit whatever the problem is.” He also notes a kind of paradox in the AMA's stance: “In another reference committee [at the interim meeting], delegates were talking about how to increase rates of vaccination — and of course, one of the ways you do that is to promote vaccines, which are prescription drugs. That probably means advertising to consumers, doesn't it?”

THE PATH FORWARD


It's hard to find anyone, even those who believe DTC advertising is a pox on the modern healthcare ecosystem, who believes a blanket ban will at some point be enacted. That's not to say that doctors' grievances aren't legitimate or that not every single drug and device ad has ceased to walk the thin line between “acceptable” and “kinda sketchy, dude.” But clearly it will take more than an AMA policy shift to effect even a small degree of change to the DTC regulations.

“It's probably more a question for a First Amendment lawyer than a doctor like me, to be honest,” Yale's Ross says, “because DTC has been classified as protected speech. So you'd need an explicitly written act prohibiting it, which — even if it gets through Congress — would almost certainly be challenged in court.” In the interim, he doesn't expect the industry to self-regulate: “Perhaps if the pharma and medical device companies who are behind these ads see that physicians aren't supportive, they'll voluntarily cut back. But that's very, very unlikely.”

See also: Politics led to DTC uproar, but curbs unlikely in current climate

The anti-DTC argument likely to have the least impact is the one that suggests such pitches unduly influence or burden physicians. Similarly, the argument that physicians' egos are taking a beating now that they're no longer the Deciders With A Capital D they once were — not explicitly made by any physician MM&M has met, spoken to, or been treated by, it should be noted — doesn't hold much water.

“Nobody's walking into a doctor's office and getting drugs for diseases they don't have,” CMI/Compas' Roberts says. “To paint that picture is a disservice to consumer intelligence.”

And Luby agrees: “I feel for today's physicians, but there are very few situations where doctors get guns pointed at their heads to prescribe drugs.”

Another issue left unaddressed by the AMA in its statement — potential consumer reaction to a DTC ban, which would deprive patients, caregivers, and others of a source of information many have come to appreciate — could also prove problematic.

“It's a crowd-pleaser to rant about pharma ads because sometimes they're mildly annoying,” Decision Resources' Arnold says. “But if you took [DTC] away from consumers, there would be incredible outrage. You can't put that genie back in the bottle. Consumer empowerment is here to stay.”

What the AMA policy shift does more than anything else, then, is inject the anti-DTC movement with a degree of momentum it had lacked and a popular cause around which to rally. In February Rep. Rosa DeLauro introduced the Responsibility in Drug Advertising Act, which would limit DTC advertising of new products for three years after a product's approval. HHS could shorten the waiting period to two years in instances where DTC ads “would have an affirmative value to public health”; it would also be able to extend the period beyond three years if a drug is found to have “significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, the scientific literature, any clinical or observational studies, or any other appropriate resource.”

In March Sen. Al Franken took his own swing at DTC by introducing a bill that would end a prized tax deduction for pharma marketers — the one that allows them to write off spending on DTC drug ads.

Kamp says that he “doesn't see the stamp” of the AMA's policy change on the DeLauro bill and that he doubts it will become law in anything approaching its current form. At the same time, he notes that “the ideas in it are not outrageous. We think they're wrongheaded, but they could get through.”

And so it goes for those who believe DTC adver­tising is flawed but generally good and effective: Cover one flank and find yourself under siege from another. The battle rages on. 

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