Indication Bloat - The Next DTC Issue

What If There Were No DTC?

When I posed this question to members of the PHARMA-MKTING online discussion group it resulted in a flurry of feedback from members. I would like to reproduce some of that feedback here and focus on an alternative to DTC --– disease state awareness (DSA) advertising, which is getting more traction these days among pharmaceutical marketers. I will argue that replacing branded DTC with non-branded DSA may create a new problem -- what I call "indication bloat," or redefining a disease to increase the scope of the approved indication for a drug.

My comments are enclosed in brackets [].

Brian, a consultant from the UK, started the debate off by asking "“Is this really that important, in the big scheme of things?"

He went on to say:

"Sure, if you're one of the agencies promoting a big profit opportunity to the gullible masses of the American heartland, there are jobs & profits at stake.

"“As far as the DTC debate is concerned, I am firmly on the side of banning any kind of named brand advertising direct to the potentially sick and willingly misled. Sticking ads for prescription medications in, amongst and alongside ads for butter, breakfast cereal and pantyhose is fundamentally wrong. (And ethically and morally corrupt)."

Terry, a pharmaceutical marketer from the U.S., had this comeback and was the first to suggest a greater focus on disease state awareness advertising:

"“Many of us would not mourn the demise of DTC from a pecuniary perspective. I personally don't profit a whit from it. And the Vioxx case certainly is an example of creating plaintiffs, not profits.

"The right path is probably the one being pursued--a voluntary moratorium until enough time has passed for side effects to manifest and more emphasis on disease awareness as opposed to product ads."

[There seems to be a trend towards more emphasis on "disease awareness"” advertising -- or more euphemistically called "communications" -- as opposed to product ads by the pharmaceutical industry. BMS, for example, in its "Direct-to-Consumer Communications Code", pledged to "Develop disease state awareness advertising, as appropriate, for diseases that may be potentially treated by our newly launched medications in order to further educate consumers and healthcare professionals."

I think this is all well and good but I am also concerned that "“disease state awareness"” (DSA) ads may not be as politically correct as many people assume. One issue is who defines the “disease” and, by extension, how many people actually have the disease?

This issue was addressed in a recent Seattle Times article, "The hidden big business behind your doctor's diagnosis." I also have discussed this in relation to the erectile dysfunction (ED) market (see, for example, "“Pushing the Envelope is Bad for DTC"”). The drug industry has defined ED so liberally that they claim more than half of men over the age of 40 suffer from ED. "About 30 million men in the United States have difficulty getting or maintaining an erection," claims the disease information section of the Viagra website.

According to the National Institute of Diabetes and Digestive and Kidney Diseases, "...defining ED and estimating its incidence [is] difficult. Estimates range from 15 million to 30 million, depending on the definition used. According to the National Ambulatory Medical Care Survey (NAMCS), for every 1,000 men in the United States, 7.7 physician office visits were made for ED in 1985. By 1999, that rate had nearly tripled to 22.3."

Some might say that this increase in office visits is due to DTC, which made more men aware of the disease and encouraged them to seek treatment. Others might say that the DTC ads do not educate about the disease, but encourage men of all ages to seek ED drugs so that "If a playful moment turns into the right moment, you can be ready."” Hardly an appropriate disease awareness tagline, yet an example of what DSA ads might ultimately become if there were no DTC product ads!]

Abuzer, a consultant working for a pharma company, essentially agrees that it is the message rather than the medium:

"The ideal world, which we are far from but want to move towards, in my eyes is not the one without any DTC but the one where the best of DTC is sustained. It's about informing the patients not deceiving them, encouraging patient-doctor dialogue about that product rather than patients blind demand for it."

No DTC: Even Less Risk Information?
Sanjay, a longtime member of the group, worries that the risk information "“baby" contained in DTC ads would be thrown out with the "bath water" if DTC were banned:

"“Would a ban on DTC really lead to better and healthier lives for people? If the practices and controls over the execution of clinical studies and the dissemination of the results do not improve, then many of the same risks will still remain. Are there not examples of safety issues before DTC? Scale you might say, it is the scale! DTC spreads the usage of new drugs far and wide without enough validation of safety and efficacy/benefits. True. But is that all?

"“We should really examine how much different this 'launch momentum' will be without DTC. There are more reps, more products and more ways to reach physicians. And more wall street pressure on drug companies to meet the numbers. Taking DTC out of the launch equation may have some effect but not enough to really guarantee minimal exposure to safety issues."

Kathy, another consultant, defended DTC on the basis that it helps brings proper treatment to the undiagnosed:

"Sorry, Brian, but there is tons of data to show that DTC brings patients into the doc's office - people who would otherwise be undiagnosed and untreated. ... One of the biggest healthcare problems in this country is the undiagnosed, untreated and under-treated patients who consequently have poor outcomes and consume resources at a greater rate than those who are property diagnosed and treated."

[This presumes, of course, that once in the doc's office, these people will get a proper diagnosis and appropriate treatment. I'’ve already covered this topic somewhat: See "Blame the Doc, Not DTC!"”]

David, from an interactive agency that creates a lot of pharmaceutical web sites, suggested a thought experiment: "“Let's assume there is no DTC advertising. So, your only source of information about treatment options is the trusted word of your personal physician."

"But wait," said David. "Vitamins can advertise. Supplements can advertise. Nutraceuticals can advertise. And, these therapies look so professional and clinical on the Internet. One of my colleagues calls them 'Pretender Marketing.'’ And, funny enough, you can order them directly from these very pharma-looking web sites."”

David claims that physicians would know less about the effectiveness of these alternative treatments than they do about FDA-regulated drugs thanks to the pharmaceutical industry. "So, in this thought experiment the lack of DTC drives more people to be open to heavily marketing '‘therapies' not under the jurisdiction of the FDA. The cat is out of the bag. Pandora's box is open. The physician has lost exclusivity.

"Now I'm certainly not saying that this justifies DTC - I'm only illuminating another facet. I would be happy to discuss whether all these ads are duping the 'gullible masses' but at least we're talking about MEDICINE here and not quackery. At least physicians know how to decide about pharmaceuticals."

[Hmmm... see my remarks above about docs.]

Brian retorted:

"“In markets where DTC (on a brand named basis) is not permissible, companies are allowed in many cases to promote by therapeutic concern/area, and tell customers that if they have this or that problem, a solution can be discussed with their primary care physician. I have worked on a number of these myself, and would agree that information encouraging individuals to present with symptoms and signs that they may have chosen to ignore.

"“Not so much DTC as ITC (Indirectly to Customer)."

[What would DSA ads produced by the makers of ED treatments look like? First, as I mentioned above, there might be a tendency to overstate the frequency of the condition, especially among men under the age of 60. The DSAs would also have to be more sexually explicit and define what erectile dysfunction is. There are many definitions out there and I am sure marketers will tend to use the most liberal.

I see this kind of "“indication bloat"” as the next big issue that pharma marketers will have to defend. The problem is exacerbated by the fact that the FDA does not regulate DSA ads. Therefore, what's to stop "indication bloat" of the type that broadens the definition of a disease to include many more people than is actually justified by medical evidence and guidelines?]