Zeno Group Blog

Our client today announced results for a very exciting medical prospect on the horizon for women’s health — the ability to definitively diagnose ovarian cancer, the deadliest of gynecological cancers, with a blood test. All of us women at some point in our lives worry and wonder, if we or someone close to us might have ovarian cancer. It’s a disease that is often asymptomatic; most women don’t know they have it until it’s in advanced stages, when the five year survival rate is just 23 percent. Imagine if along with her PAP smear, a woman could go to their OBGYN for her checkup, be tested for ovarian cancer and find it early when the survival rate is 94 percent. The future holds great hope for the diagnosis and treatment of cancer and this is just one example of what is on the horizon.

I have now returned to Washington, after a fabulous vacation in Montenegro. The trip has given me new perspective on several things. Mostly that we in the West take many things for granted. I had thought that before I left, but now I know that for sure.

Firstly, in the West when we say we lack resources we are generally talking money. In Montenegro they are talking both volunteers and budget. They have trouble getting volunteers for two reasons: because they have a law that requires them to have contracts with “volunteers” and because volunteers are seen as weird and unusual. I thought to myself the very idea of having a contract with volunteers is counter to the concept of “volunteering.” And because few volunteer due to the cultural legacy of socialism and the state taking care of everything, those who do volunteer are seen as unusual. We in the U.S. have a culture of volunteerism that we teach at the youngest of ages. It seems normal but we should know that it is not the norm in the entire world.

Secondly, in the world of health, we have many celebrities and role models willing to step up and discuss their illnesses and diseases. In Montenegro I was told that people do not discuss their illnesses, sometimes even with their own family. They stay close to home until they are well and do not discuss their issues with anyone, let alone go to a support group. We are lucky that more and more, role models and celebrities are willing to discuss their illnesses and give of their time to educate others. In addition, we have a support group for almost every disease that exists. For example, many breast cancer patients will walk around proudly with a bald head and have a choice of support groups to attend. In Montenegro you generally would not see bald heads out in the street and no support groups exist. To me it is very sad that people who are sick, who need support the most, have very few people to turn to due to stigma of illness.

Thirdly, while we sometimes get frustrated with our government and wish the outcomes of projects were different, we generally know the rules of engagement with the government. There are laws that exist for comment periods after a proposed rule as well as clear timeframes are established for feedback from the government. In Montenegro, hard working NGOs can submit comments to the government on an issue and may never hear back or have their comments acknowledged. That seems very frustrating. We think it is normal to have all these rules set up to promote public engagement and prevent abuse by government, it is not. Transparency in the U.S. is generally the norm, not the exception.

But mostly what I had taken for granted, is that in the U.S. generally if you work hard, you can be successful regardless of your family or connections. They of course help but I know I control my own life path, not my heritage and family name. It never occurred to me that because I was born to a certain family that my prospects were limited. My parents gave me self confidence and an education, and then I set on my way to build my life. In Montenegro an education and confidence does not appear to be enough.

I left Montenegro feeling hopeful that they will fully embrace democracy, with all the good and the bad it brings. I have to remind myself it has taken many, many years for our government and society to evolve and I have no doubt that Montenegro will, it’s just a matter of time! The importance of time should not be taken for granted!

Today was another great day in Montenegro. I spent the whole day with healthcare groups including the Ministry of Heath and major NGOs. For the most part they deal with the same issues as we do in healthcare except our alcoholism problems are much greater as they do not consider it the forbidden proof. What is also different is that here sick are stigmatized and people do not discuss their sicknesses including breast and prostate cancers. Also, here they do not understand why people stigmatize those in the U.S. who have lung cancer. Here smoking is the norm and very accepted. I was asked today if there is really science studies that prove there is a link between smoking and lung cancer. After that question I realized some things are very different!

As the health care debate continues, women’s issues are taking center stage. Now, more than ever, women are key stakeholders and must remain engaged.

This week Sen. Barbara A. Mikulski (D., Md.) offered an amendment that would require insurers to cover more screening and preventive care for women, with no co-payments. According to a Dec. 1 New York Times article, “Senators Pitch to Women and Elderly on Health Bill,” Mikulsi said, “Women often forgo those critical preventive screenings because they simply cannot afford it, or their insurance company won’t pay for it unless it is mandated by state law.”

But not so fast, according to the article, Sen. Kay Bailey Hutchison (R., TX) criticized Mikulski’s proposal which would develop comprehensive guidelines recommending preventive care and screenings for women, saying it would “allow yet another government agency to interfere in the relationship between a woman and her doctor.”

The New York Times Economix blog’s November 30th post, “Sex, Abortions and Health Insurance,” by New York Times blogger and University of Massachusetts economics professor, Nancy Folbre, noted that the Stupak-Pitts amendment in proposed House legislation that would prohibit companies from offering policies covering abortions in subsidized health insurance exchanges.

Folbre included comments from Wellesley economist Phillip Levine’s recent New York Times Op-Ed which labeled the controversy a “false alarm” stating that, “If health insurance reform passed, after all, the expansion of medical services to low-income women, including improved family planning services, would compensate for the risks of paying for abortions out-of-pocket.”

Folbre stated that she was “unconvinced” noting that “neither of the bills currently before either the House of Senate mandates coverage of contraceptive services, pelvic exams or counseling for sexually transmitted diseases.”

Regardless of where you stand, one thing we can all agree on is the importance of women’s health issues. It will be interesting to see how the debate plays out and how it ultimately affects women.

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!)

When you are fighting breast cancer, you get overdosed and overdone by many things. You are flooded by drugs and therapies and yes, the color pink. In doctor’s offices, infusion rooms and radiation centers, pink ribbons adorn everything from literature to nurse’s uniforms. During my treatment four years ago, I started to hate the color. Well-meaning friends sent me endless pink gifts all bedecked and often bejeweled with the ribbon. Pink T-shirts and bracelets, balloons and flowers, hats and scarves were lovingly sent. My bedroom began to resemble a little girl’s pink decorating scheme.

On my last day of chemo, I expected a pink balloon drop or shower of pink confetti. But none came. I realized that the celebration was not in the end of treatment, but in the start of a new chapter. Pink took on a new meaning at my first breast cancer walk. I was immersed in a sea of survivors and friends and family and yes, pink. Everywhere. On hats, banners, signs, balloons and the endless posters carried by survivors and friends. It was overwhelming and beautiful. Incredibly beautiful. So as we approach Breast Cancer Awareness Month, I say bring on the pink. I may not be wearing it myself, but I will be proudly walking with other survivors, doing my part to raise awareness, taking my medications and moving toward the incredibly wonderful pink light.

I’ve been working in digital media for a couple of years now, though I don’t pretend to be an expert in health care.  Social media marketing in health care is a whole different world than pure consumer categories, and with all the rules and regulations set forth by the FDA it’s no wonder why so many health care companies are hesitant to dip their toes in the murky waters.

A few weeks ago, I attended a Health Care Social Media Webinar, presented by WOMMA, and was intrigued by the discussion that took place.  The conversation centered on the pros and cons of engaging directly with patients online, as well as applying guidelines for health care and pharmaceutical companies to current social media marketing tactics (a topic that has been hotly debated for some time).  The bottom line is, at this point no one knows the rules yet, and it’s a scary place for some companies in the health care industry.  But for many, social media is becoming a reality however good or bad that may be, thus they must take the initial steps to understand it and eventually incorporate it into their overall business strategy.

Despite moderating and reporting adverse events, or sticking to the Fair Balance “one click” rule, social media presents some exciting opportunities for health care and pharmaceutical companies, as well as everyday consumers seeking health information.  Patients and anyone interested in health are more empowered than ever.  Web 1.0 fostered patient education through the presentation of new content, and now Web 2.0 allows the opportunity to engage directly with companies.  Hospitals and pharma companies have spent millions of dollars in years past trying to push their messages out to consumers, with mediocre results at best.  Today, social media allows them the opportunity to reach their core audience directly and have a conversation with them.

A 2008 report published by the California HealthCare Foundation maintained that Web 2.0 puts the power back into the hands of the consumer, but I don’t know if I completely agree with that statement.  In fact, I think it’s a nice balance of power between the two parties.  Consumers have always had the potential to be empowered; however, I think social media truly empowers the health care companies who are trying to reach and engage with people in a meaningful way.  From finding distinct groups of people to recruit for clinical trials to mining social networks for valuable customer feedback to discussing hot topics that affect health care companies as a whole, patients are finally willing to listen to what they have to say.  Social media allows all parties involved in health care, from doctors to pharma companies to patients, to engage in a meaningful, direct conversation; the next step for health care companies is learning to navigate the hurdles presented by FDA regulations in order to truly engage.

As we all digest the very sad news of the death of Senator Ted Kennedy, I feel there is some irony and injustice in his death. He was the champion of health care reform and led the charge for a long while for universal health. He knew the importance of good health care. The irony is despite the excellent health care he had access to from the Federal program and through his own family wealth, the current health care treatments could not save his life.

This is important to recognize as we grapple with health care reform. We must make sure that research dollars for new treatments are preserved and access to experimental drugs becomes a little easier. Yes it’s absolutely important for all Americans to have access to basic health care and current treatments, but let us all not forget that we must still keep working to find new therapies for all those illneses that do not have cures or for patients where the current treatments fail them. Only once we have these discoveries and treatments will we truly have universal health care.