Or something like that, as explained to Pharmaceutical Executive by Jamie Reidy. I would have bought his book Hard Sell and read it, but of course I’m just too lazy,

Brandweek’s Jim Edwards has a very sensible opinion piece (i.e. one I agree with) suggesting that big Pharma needs to start treating consumers like adults and tell them about the risks as well as the benefits of their products. I’ve always said that it’s in the the best long term interest of pharma companies and patients that the best understanding about their products is out there clearly.  And it’s apparent from  some of the research discussed by James Gardner on TCHB and over on John Mack’s Pharma Marketing Blog last week that the way risks are described in current product advertising has been glossed over using some quite clever psychological techniques.

But the overall concept that all drugs have effects, mostly good effects on bad conditions, but some bad for some people, needs to be reintroduced, so that patients and doctors can make up their own minds. Otherwise I think the end result will be a nanny-state hamstringing the pharma companies even more, to the chagrin of my libertarian friends. Whether big Pharma will adopt this pose remains open to question, even if the signs have been slightly more encouraging in the last few months.

Here’s more from ********@*****************ve.com“>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 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.

Those of you following along at home know that big Pharma is trying to get ahead of a suddenly hostile Congress (including Bill Frist turning on them) on the subject of DTC advertising. This week they’re holding hearings on direct-to-consumer promotion of regulated medical products. Joining us from Washington DC as a guest blogger, ********@*****************ve.com“>James Gardner of One to One Interactive shares his observations on today’s hearings. James is an authority on Internet marketing and how the channel should most effectively be used by pharmaceutical and device marketers. As well as sharing his observations, he’ll also be addressing the panel and advocating for the interactive channel to be regulated differently than traditional TV, radio, and print. His agency’s past and current clients include GlaxoSmithKline, Pfizer, Roche, Boston Scientific, Schering/Berlex, and Digene.

Hello, welcome, and a big “thank you” to Matthew for allowing me to share my observations from today’s FDA hearings on direct-to-consumer (DTC) promotion of regulated pharmaceuticals and medical devices. I’m in Washington for the day to address the hearings with a point-of-view on the internet’s role in DTC promotion, but I’m excited to also provide some color commentary.

As some of you surely know, the FDA announced its intention in mid-September to hold a series of public meetings on a range of issues related to DTC marketing. The FDA’s goal, quite clearly, is to develop a new regulatory paradigm for pharmaceutical and device marketers. While the FDA has been down this path before, the political and business environment today seems more conducive than ever to having real change actually happen. In that sense, these hearings could be an important regulatory milestone.

My personal expectation, shared by many (but not all), is that we’ll see several things emerge from this process:

• Blanket restrictions on several currently popular promotional tactics

• Significantly clearer guidelines articulated about still-permissible tactics, and

• Much stiffer consequences for those failing to comply with the letter and spirit of the new rules.

I don’t see an outright ban on DTC promotions happening, although some will certainly advocate for that approach. Indeed, with the DTC promotion envelope continually and aggressively being pushed by adventurous marketers, one could plausibly argue that wholesale change is both inevitable and desirable.

That said, I think cooler heads will prevail and the FDA will choose a path of lesser resistance by instead adopting many of the voluntary guidelines articulated this summer by PhRMA, the industry’s trade group. Most of their proposals were quite sensible and all would serve as a good starting point for the FDA to regain control of the DTC promotion agenda, if nothing else. A pragmatist always, I see some positive change as being better than no change at all.

For those of you new to the world of FDA hearings, here’s what you’re missing:

There’s a large podium across the front where the first group of FDA panel members are sitting. Below them, on the audience’s left, are additional panel members. Also below them, but to the audience’s right, sit the 3-4 speakers in each “wave” awaiting their turn to address the group. Speakers use a podium on the audience’s right, projecting slides on two very large television screens. If you look closely, you’ll also see that we’re using the National Transportation and Safety Board’s auditorium – hence, their “shield” on the wall behind the podium.

Speakers have 12 minutes to make their case. When their time ends, the moderator thanks them graciously for participating and helps field questions from his colleagues and, time permitting, the audience. Questions from the FDA panel to speakers are obviously allowed, but questions to the panel in return are generally frowned upon.

Kudos to the FDA — it’s all quite well organized. We’re keeping to the agenda and making good progress.

Tomorrow: Thoughts and reactions to Patrick Kelly from Pfizer and speakers from the ASHP, AARP, and other organizations. I’ll also post my presentation with the hope of stimulating some discussion!

Derek Lowe has an intelligent post on the Pargluva mess, which is essential reading if you care about the FDA and big pharma and transparency — and you should.

Today I’m off to San Diego to hear David Brailer et al at the AHIMA conference, so expect some more about that later on this channel.

Meanwhile, the pro-PhRMA academics at Tufts have a new study which suggests that rushing drugs through the FDA process is neither better nor worse than slowing them down.  Note these are the same guys who keep coming up with the BS numbers of $800 million plus, plus, plus on how much a new drug costs, a stat that has been well fisked by the anti-big Pharma forces on many web sites. However, take a look at their new study and consider whether it’s the speed of approvals that’s the problem, or whether it’s that the FDA cannot be trusted to be open with the public about all the data it knows about a particular drug.

Then consider again whether any of the top brass at the FDA can be trusted, given all the recent shenanigans about Plan B, and Crawford’s recent rush to get out of town — allegedly ahead of an indictment — and the latest news that he won’t help an investigation about whom he was carrying the bag for when he stopped Plan B’s OTC approval. (Hint: it might be some people who have other problems on their minds right now.)