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PHARMA: More from James Gardner on the DTC hearings

Here’s more from James Gardner of One to One Interactive  on the FDA Hearings on DTC Advertising.

Welcome back for the second of two postings I’ll be making about the FDA’s public hearings on direct-to-consumer (DTC) promotion of regulated medical products. Today I have some observations about the presentation by Pat Kelly, President of Pfizer’s US Pharmaceutical’s group and a few other speakers. I’ll also share my own presentation and invite comments about its point of view.

Patrick Kelly, President Pfizer US Pharmaceuticals

Pat_kellyPat Kelly made a spirited, if formulaic, defense of DTC pharmaceutical promotion. I give him credit for making the effort to spend the morning at the hearings and can only speculate about what was more important for Kelly’s peers at Novartis, Astra Zeneca, and elsewhere. Shame on them for not making this a priority! Touching briefly on the free speech implications of restricting advertising, Kelly focused more on the very real public health problem of undiagnosed and untreated condition sufferers. It’s a powerful argument, but one where Pfizer and others may have undercut themselves of late with their overzealous use of promotional, not educational, messaging. Viagra’s NASCAR sponsorship is, after all, hard to defend from an educational perspective!

With the key message of “We can do better:, Kelly definitely scored points when he pointed out Pfizer’s voluntary compliance with the PhRMA guidelines and, more recently, its stated intention to exceed them in many cases. They’ve apparently earmarked a media budget equivalent to a “major brand” for condition-oriented health education initiatives. They’ll also be strictly limiting some of their DTC promotional efforts in the first 6 month after a drug’s launch and avoiding so-called “reminder ads”. Details were skimpy so it will be interesting to see how they bring these promises to life.

Importantly, the FDA’s line of questioning to Kelly focused on the theme of better communicating risk-related information to consumers. The FDA apparently feels that the overly effective communication of product benefits (real and implied) has come at the expense of the communication of corresponding risks.

It’s a fair perspective to hold, I’d say, so I was surprised to see Kelly wobble on his answers. Concerns about the communication of safety information in the context of a 30 or 60 second television commercial are not new. So, at last, some hard questions are being asked about the content, format, and literacy level of package inserts, safety warnings, and the like. I would expect to see these all reinvented through this process with an aim to making them more effective communication tools. Amongst many changes, look for a simpler literacy level (perhaps as low as grade 6), the removal of extraneous information (“less may be more”, commented one of the FDA panelists), and guidelines about font and font size.

(Even the visual layout of ads was called into question later in the day. The subject of debate: Can an image of a smiling and somewhat youngish-looking woman kneeling to tie her grandson’s shoelace somehow be construed as over-promising the effectiveness of a drug like Vioxx? How does that change if she’s not kneeling? How about not smiling? Can subjective impressions like this even be measured, let alone regulated?)

Kelly was promptly mobbed after his presentation. Most of the questions to him focused on his reaction to Astra Zeneca’s announcement that they’ll be advocating for a mandatory process of FDA/DDMAC pre-approval of all DTC promotional materials. Knowing that the FDA is woefully understaffed for this type of effort, it’s a “can’t lose” offer on Astra Zeneca’s part! However, it’ll play well in the popular press so my sense is that it was a smart move on their part. Kelly was non-committal on Pfizer’s response.

Abby Metha, Gallup and Robinson

Metha presented some interesting research about the effectiveness of DTC print advertising with and without celebrities. The use (and potential abuse) of celebrities is a known FDA concern so her research was quite well received.

The bottom line, at least as far as I could tell, is that celebrities can be effective as a “magnet” to draw initial attention to an ad, but they’re not necessarily effective at communicating critical messages. Specific to the FDA’s concerns, they’re also not necessarily more at creating an expectation of increased efficacy. The research was fascinating so I’d hope that Metha will post if for further discussion and review.

Michele Spence, PhD, manager, pharmacy outcomes at Kaiser Permanente

Spence shared a sobering study about the impact of DTC promotion on Kaiser Permanente’s efforts to control the cost of COX-2 inhibitors (e.g. Vioxx, Celebrex, Bextra).   

According to her press release:

“In 2001, researchers from Kaiser Permanente and UCLA surveyed 3,000 Kaiser Permanente patients. The patients were first asked if they had seen ads for the COX-2 inhibitor drugs, Celebrex or Vioxx. Patients who had seen the ads were then asked whether they had asked their physicians about the drugs. Prescription data was then analyzed to see if the patients actually were prescribed the COX-2 inhibitor drugs, whether the prescription was consistent with clinical protocols which called for reserving COX-2 inhibitors for patients at increased risk of gastrointestinal bleeding. This is the primary group thought to obtain benefit of the drugs compared to older non-steroidal anti-inflammatory drugs (NSAIDS). Results of the analysis show patients not at increased risk of gastrointestinal bleeding who saw the ads and asked their physician about the advertised drugs were 4 times more likely to be prescribed a COX-2 inhibitor than similar patients who did not see the ads.”

Importantly, as one of the FDA panelists pointed out, the increased likelihood of COX-2 inhibitors being prescribed may or may not represent an actual clinical problem since wedon’t know the factors that were part of the physician’s decision-making process. Spence  acknowledged that point and stressed that her conclusions focused more on the cost containment challenges faced by third-party payors.On the bright side, Spence’s research also showed a small benefit associated with DTC promotion of COX-2 inhibitor products. By causing an overall increase in the likelihood of COX-2 inhibitors being prescribed, DTC promotion also increased its usage amongst appropriate patients, i.e. those actually at increased risk of GI bleeding. If you or a loved one were in that admittedly smaller population of patients who benefited from DTC advertising, you might have a different perspective.

There’s more information about her research here:

Lisa Van Syckel, DrugAwareness.org

Van Syckel shocked the room into silence with a devastatingly emotional set of video clips related to anti-depressant medications and their now widely-known link to teen suicides. She related a tragic story about the alleged role that antidepressants played in her daughter’s repeated suicide attempts and called for the FDA to take action before more are hurt. Gripping testimony!

For those wanting to learn more, start at Van Syckel’s website:My own presentation to the panel focused on the role that the Internet does – and should – play in direct-to-consumer pharmaceutical marketing. Specifically, I shared some data about its usage by American health information seekers, presented a few best practice examples of its usage as an education and compliance tool, and called for the FDA to consider the channel’s unique qualities before imposing blanket cross-channel rules. If you’re curious, please download it here. Feedback would be welcome either here or to me directly.

Thanks again to Matthew for the opportunity to share my observations about these important FDA hearings. I wasn’t able to participate on day 2 of the hearings but would strong suggest you follow John Mack’s weblog as he continues to follow the sessions and related fallout.

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