Zeno Group Blog

It has become more than clear that the controversy with screening will not cease. This week, the U.S. Preventative Services Task Force added fuel to the controversy by advising against regular mammography screening for women 40-49 years of age, provide mammograms only every other year for women between 50 and 74, and stop all breast cancer screening in women over 74. Soon after that statement was issued many including Komen, American Cancer Society and the American College of Radiology, issued statements against this new recommendation.

As I wonder why this controversy is heating up now, I wonder if it is all due to the renewed emphasis on cost-cutting measures and getting our country’s health care budget under control? Or is it that we are finally realizing that we need more research to understand why even though we have early screening guidelines for many types of cancer we are still losing many of our loved ones unnecessarily? I think that many of us can agree that we need new and improved tests to detect cancer at an earlier stage and there are many in the works but not approved yet. But until we improve on what we have are issuing conflicting guidelines by prominent health organizations really going to save lives and improve care or just create more stress that leads to even more disease in this country?  I believe the argument for delaying testing by many is that there is no proof that testing in younger patients has saved lives. But I wonder if I wait until 50 to get a mammogram, and then at that point I am told that I have cancer and its advanced, how I will feel about having waited? I personally would rather endure the yearly mammogram than have the uncertainty and regret later. This is of course a personal decision with perhaps no right or wrong answer but I am certain of one issue: creating confusion in the minds of Americans will not lead to better outcomes.

“It’s important and we will do it.” Thus spoke Thomas Abrams, head of the FDA’s DDMAC, at the end of the hearing on the promotion of FDA-regulated products through digital and social media. My head is still spinning from the speed and number of presentations packed into two eight-hour sessions.

Below, I go through the themes that stood out for me today. But my biggest takeaway from the past two days is simple: listening. It’s what the FDA decided to do by holding these hearings – and as much as everyone wanted more feedback from the panel, aren’t they doing what we always recommend? Before you engage, listen. Conduct the research, put your ear to the ground, get a better sense of the issues and then develop a plan to engage.

It’s what many of the speakers decided to do before the hearings. They listened by fielding new research, identifying information they already had on hand that would be of use to the FDA, and sharing their presentations for feedback and collaboration. It’s what interested parties did by tweeting and retweeting up a storm with the hashtag #fdasm well in advance of the hearing and through the hearing itself, creating a unique record of reactions and insights.

While I wish the hearing provided more of the patient perspective, I think there is a strong possibility that they are using this time to listen, as well, and I hope they take advantage of the FDA public docket being open through February to submit comments.

All in all, it reminds me quite a bit of Zeno Group’s namesake, Zeno of Citium: “We have two ears and one mouth, so we should listen more than we say.” And unfortunately, we have been operating in an environment where many companies have been afraid to do the essential work of listening due to uncertainty of their role and responsibility to engage. Hopefully this hearing is the first step in removing that barrier.

As promised, a few themes from the day (from a PR perspective):

• Transparency. The FDA was encouraged to develop a clear definition of sponsorship. Many presenters focused on the need for companies to be transparent when it comes to sponsorship, and ensure that consumers and HCPs clearly understand what is sponsored content and what is not.

• Responsibility. Adverse event reporting, and the level of responsibility companies have to report events found online, is such an important topic that the entire morning session was devoted to the issue. There were frequent references to an environment of paralysis with companies not knowing the level of their responsibility for adverse event reporting and off-label discussions online.

• Privacy. In developing guidance, speakers stressed the need to balance the importance of allowing companies to engage in conversation and correct erroneous information, with the importance of respecting patient anonymity and the doctor-patient relationship online.

• Clarity. The FDA was encouraged to provide clarity around the following questions by various speakers:
  • How should “sponsorship” should be defined?
  • To what extent should companies be required to track down all details about a potential adverse event report when key information such as a person’s name is missing?
  • Does AE reporting as it currently stands serve the needs of patients?
  • Should FDA’s MedWatch change its name and overall user experience to be more accessible to consumers?
  • Shouldn’t the FDA distinguish between types of digital media, with unique guidelines for forums, blogs, etc.?
  • Shouldn’t the FDA make a distinction on guidelines based on audience – consumers or healthcare providers?

Consumers now expect companies to be listening, accessible and responsive to them through social media channels. Healthcare professionals expect the same. Companies outside of the health space have set a new standard for customer service and, frankly, have raised the bar across industries. But we must acknowledge that there are ways in which the health space is unique, and respect the complexity of what the FDA must tackle in the coming months.

Today was the first day of a two-day FDA hearing on the internet and social media, or as it is entered into the Federal Register, “Public Hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.” The last time the FDA addressed this topic was in 1996, and most everyone has welcomed the hearing as the first step in a process toward more specific guidance from the FDA.

After listening to 33 presentations, it became clear that there are areas where many stakeholders agree. A few that stood out to me:

• Patients are online. A growing number of Americans are already seeking health information and interaction online (data from the Pew Internet & American Life Project was cited by multiple speakers).
• Industry has a role. The conversation is already happening and industry should be a part of it, particularly because the industry is well suited to ensure patients have access to accurate product indication and safety information.
• Links should be embraced. The internet functions differently than other media, and links are the normal method of navigation – many presenters expressed support of a “one-click” rule for this reason.
• Content ownership and responsibility. Industry should be responsible for content they develop or control; however, while industry should monitor social media, there should not be an obligation to monitor and respond to user-developed content.

We’ll report back with another recap following tomorrow’s full day of speakers. And I’ll leave you with one of the examples used by Mary Ann Belliveau and Amy Cowan of Google when demonstrating how consumers search for health information: In September, 1.6 million people searched “breast cancer” through Google. (Wow!)

Since his arrival in Chicago three years ago, WLS-TV (ABC) anchor/reporter Ravi Baichwal has become one of the rising stars of Chicago’s broadcast news scene. During the week, Baichwal reports for the city’s top-rated news team and on weekends he co-anchors the 5 and 10 p.m. broadcasts. In 2008 he won the Emmy award for best anchor in the Chicago/Midwest region.

Last year I met Baichwal when WLS covered the arrival of Porter Airlines first flight from Toronto to Chicago Midway. Having previously worked in Toronto for Canada’s top national news outlet, CTV, Baichwal was perfectly suited to cover the new connection between the two Great Lakes cities. Ravi was kind enough to share some thoughts on the relationship between broadcast journalists and public relations practitioners in this edition of “Five Questions.”

Q: What goes into the daily decision making process at WLS in choosing which stories the team will cover?
A: The key questions we ask of ourselves focus on what’s of greatest importance to the most people. That’s why weather and crime are often in the lineup. Our job is to tell the stories of interesting people doing interesting things in the world we all share. Where we can find those stories, and where the impact or implications from those narratives hit home with wide swaths of people, that’s where we tend to direct resources. And we try to focus on events that are somehow out of the ordinary – where the video is exceptionally good, and the story in the visual medium is easy to tell. That’s why television news is especially suited to emotional, people-based stories rather than process stories. Our medium just conveys the message in the pictures that much more effectively than anything else.

Q: When PR people have a segment idea, what’s the best way to pitch that story to your news team?
A: Find individual reporters and build a relationship with them. Do this by offering stories that are arresting visually. Any pitch from a PR agency is going to engender suspicion in a newsroom. It has to; that’s just in the nature of our journalistic duty to be skeptical. That said, knowing that the PR person you are dealing with is an honest broker who understands how a TV story gets put together helps. We want to know that you know what deadlines are, how important it is to offer local experts and b-roll opportunities, and that if we can’t do it, you don’t take rejection personally.

Q:What separates “good pitches” from “bad pitches?” What types of things are you looking for in a pitch that will make it a story you’d cover?
A: A good pitch has to have good video that is at the core of the story’s appeal to broad spectrum of people. It is amazing how many interview “opportunities” I am offered for satellite interviews with people pitching products that I just don’t care about. The principal in the story has to be in Chicago otherwise I can tell you it is highly unlikely the story will be covered.

Q: When you’re on location shooting a segment, how can PR people best assist you and your team?
A: If you are working with a big company on a breaking story, making spokespeople available is number one. Having background statistics that are relevant and help us develop context is good, too. This is especially helpful on big public policy stories involving such subjects as health care and community development.

Q: What’s your most memorable story or experience as a broadcaster?
A: There are so many. The time when my son was born and I was anchoring Canada’s number one national broadcast for the first time and I went on air with no sleep for nearly 48 hours comes to mind. That was a special broadcast for a lot of reasons. Our lead story that night was word that a cult in Quebec had succeeded in cloning a human being. The story was subsequently debunked, but I am sure my son will get a laugh out of it in the years to come!