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I could not leave last week’s column on media inspired patient fear without another example. The excellent New York Times reporter Gina Kolata did a story on patients resisting drug treatment for osteoporosis out of side effect fears. The story in the June 1 New York Times said millions of people were forgoing osteoporosis drugs out of fear from exceedingly rare side effects.

Ms. Kolata highlights the problems doctors are having convincing patients who need drugs to start therapy. Use of these drugs has gone down by 50%. The incidence of broken thighbone side effects is 10-40 patients for every 100,000 and one in 100,000 for broken jawbones. This means millions of sufferers of osteoporosis are needlessly suffering fractures because they fear side effects.

Who is to blame? The media reports are partially to blame because they do not give the minuscule odds of a side effect compared to the effects of non-treatment. Lawyers are to blame fishing for patients who take these drugs and claim side effects. How many commercials do we see from lawyers listing a litany of drugs that may have caused side effects?

The FDA is to blame for requiring these extremely rare side effects be part of the ads. While every patient should know the risks, saying fatality in an ad without context is a disservice to patients. What we need is a reporting of the odds of a serious side effect, not vague terms like rare. Consumers will overstate the odds if they hear the word death in an ad. I doubt too many consumers would avoid a drug with a one in a 100,000 incidence. To consumers, words like rare could mean 1/100 not 1/100,000.

FDA needs to have a much better guidance on quantifying risk. Serious risks require clear quantitative odds of occurrence. Patients deserve it. The media should also be held to a high standard when doing their sensationalist stories on drug risk. As this article reports, scared patients make irrational risk/benefit decisions.

I was a strong supporter of the Novartis heart failure disease awareness ad. This was the one with the man in the room with water pouring in and filling up the room. It was criticized by some doctors for being alarmist. I never thought so myself, as heart failure is about as serious cause for alarm as there can be.

The disease ad was a precursor to a branded ad for Entresto, which I can’t stop thinking of as Ernesto. This ad is the polar opposite in tone to the disease education campaign. While the message of preventing heart failure is the same, the branded ad takes an uplifting approach.

The ad uses the song from Annie, “Tomorrow” which I guarantee you will sing for at least 24 hours after seeing it. It is a series of patient vignettes where the actors sing parts of the song. The message is that Entresto will help make more tomorrows possible. The commercial is beautifully simple and engaging.

I have to give Novartis and their agency, McCann, a lot of credit for a combination of disease and branded ads so different yet entirely complementary. The disease ad really stopped you in your tracks alerting viewers that heart failure is something to watch out for and act on. While deadly serious in tone, I think it was entirely appropriate. They could have used the same idea for the branded ad but they smartly chose to play up the positives. It is better to promise in the branded campaign hope about living longer than warning about early death.

What was necessary in the disease ad to get your attention was not the best approach in the branded ad. Instead showing a world of family and friends that you can enjoy longer if you treat with Entresto was a good approach. I am sure the doctors critical of the disease ad had the opposite reaction to the “Tomorrow” campaign.

I am not sure whether the criticisms from the medical community affected the branded strategy. Maybe that led to the decision to go more upbeat. In any event, whatever the reason, Entresto is a solid ad that is memorable and positive

I wanted to explain why after 16 years of developing conferences we decided to run one solely on tv and print this fall. It seems odd that the media with the most spending seems to get the least discussion on the agenda. Our DTC National offers a wide array of topics but most are in new media. I always ask people to submit speaking proposals on television and print but few are received. While drug marketers are anxious to learn the latest on new media, there is a lot that can be improved in the meat and potatoes category.

Most of our speakers are on digital, big data, patient relationships, point of care, and technology. While this may be the DTC future, the overwhelming media allocation remains in television and print. After 20 years maybe there is not much left to learn in mass media. I kind of doubt that.

We are seeing great new creative in mass media so clearly agencies and clients are learning how to constantly improve their ads. We are also learning so much more about patient receptivity to ads depending on day part, show type, and where the ad is in the show. We are seeing FDA doing many studies on elements of advertising from supers, cartoon images, how risk is narrated. We are getting new research that dissects effectiveness to new levels of detail.

We are also experiencing growth in mass media for drug categories that never would have used it a few years before. Cancer and rare diseases have decided that the ROI is positive using mass techniques. So there seems to be a renaissance in expanding use of mass media.

We also see print titles doing quite well. DTC ads dominate some magazines. I have always believed there is tremendous opportunity to improve the creative impact in print. Too many ads are still missing a dominant headline or visual, choosing dense copy and too many sub headlines. While FDA mandates make print more difficult, there is no reason any ad should not be visually arresting.

My guess is every media plan can be 10-20% more effective with some simple tweaks. Better creative, more pre-testing, more targeted media planning, and more robust evaluation are all possible and affordable. In 20 years of being involved in DTC I have seen many campaigns that I know are weak, yet somehow they made it on air. Mediocre ads get through for many reasons. It can be bad copy strategy, testing the wrong objectives, rushed creative, forgetting the competitive set, group think, overloading information, or many other factors. Sometimes there is so much testing that the marketers are overwhelmed and miss the need to simplify for consumers.

So in October we will do an entire conference that never mentions social media, mobile, relationship marketing, or personal fitness devices. Instead we will focus on making our tv and print ads better, spending more effectively, and doing better analysis. I am not pushing mass media over new media, just recognizing that if more than 80% of our budget is spent there, we might as well strive to do it better.

Treato, an online consumer insights company, released a survey on DTC 4/18. It was done with 529 Treato.com consumer users. The headline in their press release that said “Treato Finds DTC Pharma TV Advertisements Have Little Influence”. They cite a result that only 7% of respondents asked their doctor about an advertised drug this year compared to 21% last year.

When you do a survey and get some strange results like a decline from 21% to 7% you have to ask why. There is no reason that consumers would react so differently year to year. You have to question the methodology, the panel who responded, or some other factor. People would not find 2015 advertising so much less influential than 2014 advertising.

Treato did not analyze what TV ad influence means in terms of ROI for drug companies. Television ads payback, and the evidence is overwhelming. Whether the real consumer request number is 7%, 21% or anywhere in between, the drug makers look at the value of consumers who do request based on their ads. For many branded drugs 7% would be a great number.

The drug industry does not expect their ads to influence a majority or even a large minority of consumers. They know most consumers rely entirely on their doctor to tell them which drug to use. The drug makers hope a large enough segment of a potential user population see an ad and ask their doctor.

I remember the launch campaign for Lipitor had a marginal share boost. That marginal boost, however, was a great ROI on our investment. So Treato may be correct that TV has less influence than the DTC critics give it credit for having. Maybe Hillary will see that DTC is not the force for evil she contends in her speeches.

When you examine any blockbuster drug performance DTC has a marginal influence. Lipitor spent about 100-150 million on DTC in its peak days. It was doing over 5 billion in sales. So it probably generated 200-300 million in incremental sales from DTC. Maybe it had 4-6% influence. I think that percent would be a fair estimate for most billion dollar plus drugs doing television DTC.

Treato suggests that drug companies look for other ways to influence consumers. This statement misses the ROI truth. Drug marketers will use any medium that pays back. Television may not be seen by media pundits as innovative, but drug marketers are evaluated on ROI success, not how much they experiment. Television ROI is less than some other more targeted techniques like Point of Care. Drug companies do both to achieve their goals.

So Treato’s headline has some truth despite the odd decline they state from 21% to 7%. Their term “little influence” has very different meanings to drug company marketers and DTC observers. A little influence can generate a great ROI on premium priced drugs. For most brands’ mass media plan it is 1.5 to 3 to one. Pharma lobbyists should tout this survey to DTC critics showing there is no need to be concerned that consumers are being hypnotized by television into mass use of drugs.

The FDA is becoming very active in DTC research. By my count they have identified ten studies that are in process to be fielded. Their glacial pace of completing their studies is well known so I am not sure when these ten will be completed and published. I know the people doing the studies are well qualified professionals who are hampered by government procedures that slow down the process. They go through numerous mandated public comment periods and have to get budget approval from Office of Management and Budget bureaucrats. It is unfortunate that after 20 years of DTC, FDA is still doing basic research that should have been done 15 years ago.

FDA is doing some important studies and some that I question for their usefulness. On the positive side they are doing an important study on shortening the risk statement to focus on the major risks rather than the long litany of risks in many ads. They are also doing important work in the area of price discussion in DTC ads. FDA is also studying how to convey quantitative clinical information in understandable visuals. A fourth study which is important is how to measure the impact of superimposed text on the screen, as to size, contrast to background, and use on mobile devices.

FDA is also doing a major consumer attitude study on DTC, which was last done in 2002. This is long overdue and might be the most important of all their proposed studies. With all the criticism from payers, politicians, and physicians it is critical to get comprehensive consumer feedback.

There are a few studies I find less useful. One is measuring DTC television ads impact on the hard of hearing. One can assume that anyone who cannot hear well will have trouble with the audio and have less comprehension. This is one of those studies without a practical purpose. What are drug makers supposed to do differently? Are they supposed to have special ads for the hearing impaired?

Another study is one done with teens on ADHD drugs. Does it matter what teens take away from DTC ads? Their parents and physicians are the gatekeepers. Again what is a drug maker supposed to do when advertising ADHD drugs? Are they expected to make sure teens understand risk/benefit?

One thing FDA needs to do is better communicate the research results to the DTC community. Their findings should be announced and summarized in user friendly formats. It is ironic that an agency dedicated to improving consumer communication does a mediocre job of organizing and releasing their data. They need to have an easy to understand summary chart of each study with objectives, findings, conclusions, and next steps. No business person would accept the current way of communication and neither should FDA. Hopefully their web site will be better run and targeted to the people who actually are expected to act on their research.