Medical device-makers get into the ad game, heating up ethics debate

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Screenshot of the Linx website. (www.linxforlife.com)

MINNEAPOLIS — Giant gray stomachs filled with toxic waste and flame-wielding archers have appeared in the skies above Twin Cities highways, courtesy of a medical device-maker called Torax Medical.

The billboards are intended to advertise a Torax medical device, the Linx, which treats painful acid reflux by using magnets to clamp down on the lower esophagus when drugs and natural bodily mechanisms can’t control stomach acid. Torax hopes the colorful billboards spur people with gastroesophageal reflux disease to visit an educational website, and then prod their doctors (and insurers) about the therapy.

“We’d like patients to be more educated with their disease,” Torax Chief Executive Todd Berg said, regarding the billboards and related online advertising. “No one should be afraid of an educated patient.”

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The billboards, however, are an unusual step in the medical device industry, which usually markets its products to doctors, not consumers. By putting up signs along the highway, the company joins a debate over whether such ads benefit patients, and whether they should even be allowed.

The nation’s largest and most influential physicians group, the American Medical Association, has called for an outright ban on direct-to-consumer ads for prescription drugs and implantable medical devices. If device companies start to advertise alongside the $4.5 billion in ads that drugmakers buy, disagreements about the role of advertising in building demand for health care are likely to grow.

Although such ads can have positive effects, the AMA’s governing body reasoned, they are outweighed by the risk of artificially inflating demand for new and expensive treatments that may not be appropriate for every patient with the advertised disease. Only the United States and New Zealand allow direct health care product advertising to patients.

“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,” future AMA Chairwoman Dr. Patrice A. Harris said in a November news release.

AMA officials declined an interview request to flesh out the specifics of the recent policy. It’s not yet clear how the 235,000-member trade group for medicine plans to implement the governing body’s recommendation.

Dr. David Thorson, a family practice doctor in the Twin Cities area and president of the Minnesota Medical Association, agrees that ads for health care products aimed at consumers can add complexity and extra time for discussion in the exam room.

That doesn’t mean turning back the clock on ads for devices and drugs is the right way to think about the problem, though.

“While I can understand the advantage of a ban, I don’t think that in a country that has free speech and the freedoms we have that a ban is an obtainable thing,” Thorson said. “Patients need to understand that these general advertisements are just that — they are general. They don’t necessarily meet the patient’s specific needs.”

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For Berg, the issue isn’t whether such direct-to-consumer ads will be banned. He notes the long tenure of the Minnesota Department of Health’s “Cover your butt!” billboard campaign to promote colonoscopies for colorectal cancer detection. Some of the billboards have advertised a specific medical group where a colonoscopy can be done.

Berg said Torax needs its ad campaign to compete with some of the most heavily advertised drug therapies on the market, including acid reflux pill Prilosec OTC.

The pill’s maker, Procter & Gamble, uses celebrity endorser Larry the Cable Guy and the slogan “You can’t beat zero heartburn” to promote the drug, alongside coupons and free-sample offers. One lighthearted Prilosec TV commercial features Larry grabbing a chicken leg off the grill while endorsing the drug.

Berg is critical of such ads, saying they present acid reflux as “a gimmick and a joke” while encouraging people to keep eating foods that can lead to long-term complications from acid reflux. Berg notes that widespread use of acid reflux drugs has not cut the national rates of esophageal cancer, which can form more readily after gastroesophageal reflux disease gives rise to a form of esophagus damage called Barrett’s esophagus.

The Torax ad campaign is intended to “give them the other side of the story,” Berg said.

“We take the responsibility of marketing products to a consumer very seriously. We want to do it in a responsible way. I think you are going to see a lot of companies engaging those patients directly, because you can’t rely on the health care system necessarily to do that. Especially if the only person talking to them are the pharmaceutical companies.”

A handful of medical device-makers have used TV ads, typically for orthopedic devices like hip replacement systems. They don’t typically use highway billboards. But Torax’s billboard is intended to drive traffic to its informational website, and use of the Internet to advertise devices is already common and becoming more so.

Medtronic and Boston Scientific Corp. both maintain websites about medical conditions for which their devices are therapeutic options.

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Medtronic maintains www.back.com to help educate about its back-pain therapies, for example. Boston Scientific has www.EDcure.org

“It seems that there has been a reawakening in this direct-to-patient opportunity, from the standpoint of patients seeking education,” said Eric Siebert, digital marketing vice president at Boston Scientific. “We know that digital channels are the port of call for deep information.”

EDcure.org includes analyses of various therapies for ED, including an analysis of the pros and cons of heavily advertised drugs like Viagra, Levitra and Cialis, made by pharma companies. The Boston Scientific site claims the Medicare out-of-pocket cost of its outpatient medical device implant is equal to the advertised price for 30 ED pills, which half of men give up or find stop working for them.

“Pros: Pills can help you achieve an erection quickly and may have an effect on sexual intimacy,” the Boston Scientific website says. “Cons: Some men cannot achieve a satisfactory erection with pills and other men will switch the type of pills to achieve a satisfactory outcome.”

The website advertised on the Torax billboards notes that in a study of 100 early Linx patients, four reported having daily difficulties swallowing after two years. The device had to be removed in three patients. The instructions for use on the titanium device say it is not safe when exposed to powerful magnetic fields from a 1.5 Tesla magnetic resonance imaging (MRI) scanner or larger.

None of that information is contained in the Torax billboards. And the Food and Drug Administration, which has the power to regulate ads for drugs and medical devices, doesn’t expect it to be there.

FDA spokeswoman Deborah Kotz said medical device-makers don’t have to get their broadcast and print ads preapproved before publication. Drugmakers do.

She noted drug ads are subject to more detailed regulations than device ads are, though both face similar rules on avoiding false or misleading information and only making claims that are “in line with FDA-approved or cleared intended uses.”

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The FDA regularly updates its rules on drug advertising, but no one is predicting the agency will soon announce the ban on direct-to-consumer ads that the AMA endorses. If anything, digital advertising of medical devices appears poised for growth.

“I think the movement of all of this is sort of driven by the greater empowerment of consumers to be advocates for their own health,” said Jeffrey Ross, Washington-based chief client officer with ad firm Wunderman Health. “They are going to do their research.”

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Advertising Health Products to Consumers

1969

The U.S. Food and Drug Administration finalizes rules for drug advertising to consumers, including a requirement to summarize every risk on the product’s label in the ads.

1981-83

Ads for Boots Pharmaceuticals’ pain drug Rufen and Merck’s vaccine Pneumovax trigger new regulatory interest in regulating drug ads.

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1985

New FDA rules reiterate the need to provide to provide pros and cons of drugs and list all possible side effects. This limits the ads to print media, where small type can be used.

1997

FDA unveils its “adequate provision” rules allowing advertisers to reference a toll-free phone number or website for more information. Total ad spending for drugs jumps fivefold in four years, surpassing $1.6 billion by 1999.

2006

Spending on consumer advertising of drugs peaks at $5.4 billion. Consumer ad spending by medical device companies like Medtronic and Abbott is said to be less than $200 million.

Nov. 2015

The American Medical Association calls for a ban on direct-to-consumer ads for drugs and implantable medical devices, saying the risks of such ads outweigh the benefits.

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–Sources: FDA, American Journal of Public Health, American Medical Association

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©2016 Star Tribune (Minneapolis)

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