A Consumer Representative to the FDA on Advocacy

Diane Aronson is a Special Government Employee, serving as Consumer and Patient Representatives for the Food and Drug Administration (FDA). Working through its Center for Drug Evaluation and Research (CDER), Diane has served on many of its Advisory Committees and has been a standing member of the Arthritis Advisory Committee. She is Past Executive Director of RESOLVE, the National Infertility Association, Past-President of the International Federation of Infertility Patient Associations and the Road Back Foundation, an on-line service that provides education, medical articles and peer-support about the use of antibiotics for the treatment of rheumatic diseases.  Diane has also served as a Consumer Representative for the Centers for Disease Control and Information (CDC) and the National Institutes of Health (NIH).

LG: How did you become a health consumer advocate?

DA: I noticed at a young age that I can be compelled to speak up for others when needed and that this ability can lead to making a difference.  My style is to listen carefully and provide support and information, especially where issues of safety or risk are concerned.  The path to my health consumer advocacy work started as a result of my own medical issues with arthritis, cancer, and infertility. My rheumatoid arthritis wasn’t diagnosed for years after symptoms started in my late teens.  The pain and fatigue were discounted by my physician who told me that I looked fine despite some irregular lab results and took no further action to explore what caused the symptoms.  What activated me included the consequences of this approach and a desire to help others who struggle to find successful medical treatment. This perspective encouraged me to volunteer to share my experiences and later, led to paid consumer advocacy work and to my current position with the FDA.  Despite past complex and challenging health issues, I am grateful to be healthy and very active.

LG: How did you start working at the FDA?

DA: I learned that the FDA was seeking a Consumer Representative for their Arthritis Advisory Committee and so I applied.  They are often looking for individuals who can provide a consumer perspective to their advisory deliberations as well as an interest in and ability to assess medical data. The application process is about six months long as it includes a review for any potential conflicts of interest.

LG: Tell me about what you do at the FDA.

DA: I am asked to serve on Advisory Committees to review drugs that may need an additional review of outside experts.  Committee Panels most often include physicians, researchers, statisticians, patients, consumers and non-voting industry representatives.  For each meeting, panel members are sent information from the company-sponsor as well as the FDA about the drug to be reviewed.  A list of questions is also sent to panel members who are encouraged at the meetings to ask questions and, at the end, to vote on and provide opinion about the drug under review.  For me, the position requires the combination of the advocate in me, an interest in science and biology, my past medical experiences, the desire to represent a broad constituency of health care consumers and a general interest to review details and solve problems. It is very gratifying through my research and study before meetings, and especially as a layperson, to be able to contribute a perspective that may not be considered but may be helpful to the discussion. At one panel meeting and due to my research preparation, I found myself advocating for members of the military who might be prescribed a potent drug that was being reviewed.  I found that one of the active ingredients was counter indicated with SSIs. Since many in the military are reported to be treated for depression with SSIs, I advocated for a consideration of this interaction on the label should the drug be approved by the FDA.  I am hopeful that this kind of a consumer perspective can make a contribution to the deliberations when I raise concerns such as this.

LG: Can you tell me another instance?

DA: I served on committee for a cancer drug which had a regimen of 3 years and included some serious side effects.  There was an alternative existing drug with similar side effects, effectiveness and result but with a short-term treatment.  I raised a concern that the long-term treatment would be arduous on patients with only a very slight percentage of improvement in the death rate.  Although we are asked at panel meetings to review safety and efficacy, I believe that quality of life issues are also an important perspective.

LG: What role does empathy play in your advocacy work?

DA: I leverage my own experiences and understanding of being challenged by a health concern, my broader experience in representing consumers and my desire to improve the quality of people’s lives when they are suffering physically and emotionally from health concerns. In the case of the cancer drug, it was clear to me that no one should suffer longer than necessary from side effects and with little improvement in the primary outcome of death survival.

LG: What achievements are you proudest of?

DA: I have served as a mentor for new Consumer and Patient Representatives and enjoy passing on tips to help with the initial orientation process.   I am extremely grateful to have had the past work advocacy opportunities to author countless editorials, articles, book chapters, etc. and to give many speeches nationally and internationally at consumer and medical associations, run conferences and workshops and work on legislation about consumer health care issues.

LG: What direction do you see the FDA moving in?

DA: I am truly in awe at the number of issues that the FDA considers regarding drugs that have already been approved and by ones that are in the pipeline as well as the huge number of medical devices for which they have oversight.  Since the passage of legislation (FDAAA), the FDA has been working on enhancing transparency and involving more consumers and patients in their various activities. The social media is now very important as an educational resource.  Recently, it has reported on a number of drugs that had been approved by the FDA but now have serious side effects reported which weren’t able to be considered at the time of approval.  Examples are a recent one for diabetes and drugs used for osteoporosis.  FDA leaders want consumers to more readily report side effects to them via the MedWatch area of its Web site set up for safety information and adverse event reporting.   In addition, they hold frequent meetings and Webinars on a variety of topics for patients and consumers and a number of these presentations are available through http://www.fda.gov.

LG: How do your advocacy skills work with family and friends?

DA: Most of my family and friends probably don’t realize the level of involvement I have had as a lay health consumer advocate but some do turn to me and ask for a perspective that they can add to their research and deliberations with their physician.  I might suggest resources and strategies but above all provide a listening ear to their concerns and overall experience. I speak up about health care perspectives but realize that in the end everyone has to make their own choice about their personal health care decisions.

LG: What are your recommendations to people who have health conditions?

DA: Read everything; talk to others.  Do the research.  Seek out credible internet Websites and verify information with published medical articles. Consider joining a support group.  Make informed decisions using evidence-based information not just an anecdotal experience about which you have heard.  Seek medical professionals who will work in partnership with you and respect your decisions about treatment.

LG: Should everyone who experiences health problems become “activated” and help others in some way?

DA: Advocacy is a passion.  You have to have a strong desire to take the time required to make someone’s experience easier and more hopeful.  And, you need to come from a position of knowledge so your research and perspective are critical.  In addition, you might feel activated towards advocacy at various points in your life and not at others, depending on your current experience.  The hope is that education, peer-support and advocacy on behalf of others can contribute to enhancing the health care system to benefit a broad group of individuals impacted by debilitating diseases.

Stories that Enhance Health Website Design: If It Helped Them It Might Help Me Too

Stories can enhance health websites because they resonate with health information seekers, who find support and encouragement from the experiences of others like them. Two excellent examples are Weight Watchers’ Success Stories and Livestrong.org’s Survivorship Stories. Both sites include extensive libraries of well-written stories about people’s experiences losing weight and surviving cancer, respectively.

Because of the effectiveness of stories in health websites like these, I challenge my Online Consumer Health students to consider how the inclusion of stories can enhance the websites they design in class. In one assignment, they first review the purpose, length, transparency of authorship, writing style, and perceived accuracy of stories on health websites. Then they either write or reuse stories from other websites for their own sites.

In my constant search for examples to use in class, I came across the stories in RediscoverYourGo. I contacted the developer to learn about the planning and design of the website, particularly how the decision was made to use stories.

“I can do anything I want, now. I would say I’m ‘back to normal,’ but I didn’t know ‘normal’ for years. I would say I gained back 15 years or so. It’s really, really good.”

I spoke with Simon Lee, CEO of Lee-Stafford on February 8, 2010. RediscoverYourGo was developed for a medical device company, Smith & Nephew, that manufactures parts for hip and knee implants. On the home page, “stories” is one of 4 tabs on the left and 3 links to stories are featured on the lower right next to “Learn from real patients who have rediscovered what it means to live pain free.” The “stories” tab leads to a list of the replacement products headed by, “Real people who have rediscovered their go.” Each replacement product has story snippets from people who have had surgery to implant that product (example to the left). The story snippets are brief, first-person quotes and they include the name (generally the first name and last initial but in some cases the full name), city, and product, illustrated by a photograph. Rather than use a headshot, many show active poses and look like they were taken informally, not by a professional photographer (in contrast to the posed “after” pictures on Weight Watchers). There is some duplication, with some people appearing in more than one category, presumably because the person has used multiple products. The first person quotes were extracted from a letter or interview with, as Simon said, “100% real patients.”

Selecting a snippet leads to a longer story in the third person about the person’s experience with pain, learning about and contacting the surgeon, undergoing the surgery, recovering, and developing a post-surgery active lifestyle. The header includes more about the person, including occupation, a larger version of the snippet photograph, and a picture of the replacement product. Many of the stories identify the storyteller’s age, and the photographs indicate age as well. Stories are more likely to resonate with someone who identifies with the storyteller, which, in this case, might be because of replacement product, age, or recreational activity. Weight Watchers facilitates this by sorting stories by gender, age, or total weight loss and inviting a viewer to “Read about someone like you”.

The use of stories is “a toe in the water” to create an online community for patients with Smith & Nephew products. What lay behind the use of stories, Simon told me, was the desire to create a “patient ambassador network” to capitalize on patient stories. Often patients with debilitating pain became advocates for the surgeon who “fixed” their problem: they wrote letters thanking the doctors who performed their replacement surgery for giving them their life back and were eager to discuss their outcomes with others.

Simon believes the more open use of social media or forums was not possible because of concerns about monitoring, disclosures and privacy, a concern shared by all the major orthopaedic and spine device companies. Highlighting patient experiences on a website seemed the best alternative.

The overall website design goal was to modernize the brand and create more youthful and non-surgical-looking site as befitting one of the big growth areas: patients 45+. Previously, the primary target audience was 65+. The focus on the new demographic is because a growing number of younger people are seeking partial replacements. The potential exists that they will then become loyal customers to the brand and their surgeon. Simon believes that healthcare is local and that decisions to choose care are “based on who can treat me and where can I be treated.” Furthermore he believes that “educated patients are happy patients and happy patients are advocates for the doctor who ‘healed’ them.”

Health Stories: Asking the Doctor a Question Armed with the Answer

When I told Avi, an editor in Dallas, about my health research, he responded, “It’s coincidental that I had an Internet health moment this week.” Avi had switched to a generic SSRI anti-depressant from a name-brand and was feeling poorly.

The Web sites Avi used were the FDA, a mental-health news clearinghouse/portal, and, a respected online forum for patients using anti-depressants. He went on to say that this “online research showed a high probability that the nasty symptoms I’ve experienced the last couple of weeks are due to my switching from a name-brand drug to a generic version.”

Avi continued, “With the Web information in hand, I talked to my doc and the pharmacist, went back to my old med, and, today, I’m feeling much, much better. Did I need the Web for this? Not necessarily; a phone call to my doc may have done the same thing. What the Web did was immediately confirm the strong probability between the generic med and my symptoms, which allowed me to start the chain of events necessary to fix the problem.”
 
I asked Avi why he turned to the Web first. He said, “It’s a convenient, fast filter/information source, and I trust my Web-research skills. Moreover, I didn’t stop after doing my surfing; it was just a first pass at the information available before I called my doc, to whom I didn’t say, ‘Hey, all these blokes out on the Web are going through hell with this generic, get me off of this stuff!’ Rather, I first had a discussion with my pharmacist to find out if she had had similar feedback from her patients on the same drug. Then, with information from three serious, medically respected Web sites and my pharmacist’s comments in hand, I called my doc and simply asked him if there could be a causal link between my switch to the generic and my symptoms. If he had said no, I would have cited the evidence I had in hand that appeared to suggest a link. But, he didn’t, so I didn’t have to go beyond the initial question.”

Avi concluded, “So, there’s my story. Not very dramatic.” But it exemplifies both the empowered healthcare consumer who trusted his information literacy skills, and also the lack of disclosure about the use of the Internet that so frequently occurs between patients and doctors. (A.G., private correspondence, 8/5/08 and 8/6/08).

Seven Habits of Highly Connected People by Stephen Downes, Guest Contributor

Stephen Downes was kind enough to allow me to publish this here. I was especially interested in it because FranklinCovey was one of my clients when I worked at EDS. Watch for a version of this to appear in eLearn Magazine later this month!

With apologies – and all due credit – to Stephen Covey.

1. Be Reactive

There’s a lot of talk about user-generated content on the web. That’s great. But if publishing your own stuff comes at the expense of reading, and commenting on, other people’s stuff, that’s not so great.

The first thing any connected person should be is receptive. Whether on a discussion forum, mailing list, or in a blogging community or gaming site, it is important to spend some time listening and getting the lay of the land.

Then, your forays into creating content should be as reactions to other people’s points of view. This will ensure, first of all, that they read your comment, and second, that your post is relevant to the discussion at hand.

Posting, after all, isn’t about airing your own views. It’s about connecting, and the best way to connect is to clearly draw the link between their content, and yours.

2. Go With The Flow

We all know those people in our online community who are out to Prove Something, to Get Things Done, or to Market Themselves.

These are people we tend to avoid. Because no matter what the topic of discussion, they’ll weigh in with their pet project, peeve or talking point.

When connecting online, it is more important to find the places you can add value rather than to pursue a particular goal or objective. The web is a fast-changing medium, and you need to adapt to fit the needs of the moment, rather than to be driving it forward along a specific agenda.

This doesn’t mean you shouldn’t have any goals or principles for yourself. You should; that’s what will inform your participation. It’s just a reminder that your goals are not the same as other people’s goals, and therefore that your online participation needs to respect that fact.

3. Connection Comes First

People talk about not having time for email, of not having time for blogs. Sometimes they even talk about working without an internet connection.

It’s good to take a break and go out camping, or to the club, or whatever. But the idea of replacing your online connecting with busy-work is mistaken.

In almost all fields, connecting with others online is the work. The papers you write, the memos your read and toss – all these have to do with connecting with people. Even if you work with your hands, making cabinets or rebuilding engines, all your contacts with customers and suppliers are about connecting with people.

If you don’t have enough time for reading email, writing blog posts, or posting discussion lists, ask yourself what other activities you are doing that are cutting in to your time. These are the things that are often less efficient uses of your time.

If you are spending time in meetings, spending time traveling or commuting to work, spending time reading books and magazines, spending time telephoning people (or worse, on hold, or playing phone tag) then you are wasting time that you could be spending connecting to people online.

If you make connecting a priority, you can take that walk in the forest of vacation in Cadiz without feeling you are not caught up.

4. Share

We’re all heard the advice to “think win-win”. Forget that advice. If you follow that advice, you will always be looking at things and saying, “what’s in it for me?” That’s exactly the wrong attitude to have in a connected world.

The way to function in a connected world is to share without thinking about what you will get in return. It is to share without worrying about so-called “free-riders” or people taking advantage of your work.

In a connected world, you want to be needed and wanted. This will, over time, cause resources to be sent to you, not as a reward for some piece of work, but because people will want to send you stuff to help you to be even more valuable to them.

When you share, people are more willing to share with you. In a networked world, this gives you access to more than you could ever produce or buy by yourself. By sharing, you increase your own capacity, which increases your marketability.

5. RTFM

RTFM stands for ‘Read The Fine Manual’ (or some variant thereof) and is one of the primary rules of conduct on the internet.

What it means, basically, is that people should make the effort to learn for themselves before seeking instruction from others.

Almost everything a person could need to know has been recorded somewhere online (by people who are sharing their knowledge freely). Taking the time and effort to look at this work is not merely respectful, it demonstrates a certain degree of competence and self-reliance.

For example, if your software fails to install, instead of calling customer service or posting a note on a bulletin board, copy the error message into the Google search field and look for answers. Almost every software error has been encountered (and documented) by someone before you.

Finally, when you do ask for help, you can state what you’ve read and tried, and why it didn’t work. This saves people from giving you advice you don’t need, and helps them focus on what’s unique about your problem.

6. Cooperate

Offline people collaborate. They join teams, share goals, and work together. Everybody works in the same place, thy use the same tools, and have the same underlying vision of the project or organization.

Online, people cooperate. They network. Each has his or her own goals and objectives, but what joins the whole is a web of protocols and communications. People contribute their own parts, created (as they say in open source programming) to ‘satisfy their own itch’.

This is probably the consequence of distance. Online, it is not possible to enforce your will or (beyond a limited extend) to get your way by shouting and intimidation. This means that online communications are much more voluntary than offline communications. And successful online connectors recognize this.

To cooperate, it is necessary to know the protocols. These are not rules – anybody can break them. But they establish the basis for communication. Protocols exist in all facets of online communications, from the technologies that connect software (like TCP/IP and HTML) to the ways people talk with each other (like netiquette and emoticons).

7. Be Yourself

What makes online communication work is the realization that, at the other end of that lifeless terminal, is a living and breathing human being.

The only way to enable people to understand you is to allow them to sympathize with you, to get to know you, to feel empathy for you. Comprehension has as much to do with feeling as it does with cognition.

People who use online communications ‘only for business’ – or worse, feel that other people shouldn’t be posting cat photos or playing Scrabble on Facebook – are employing only a small part of the communications capacity of the internet.

Learning and communicating are not merely acts of sending content over a wire. They are about engaging in (what Wittgenstein called) a ‘Way of Life’. Having a cat is as important for a physicist as having an advanced research lab. These common everyday things form the mental structure on which we hang the highly theoretical structure.

The idea behind ‘being yourself’ is not that you have some sort of offline life (though you may). Rather, it’s a recognition that your online life encompasses the many different facets of your life, and that it is important that these facets all be represented and work together.

The Disconnect Between Patients and Doctors

In yesterday’s talk, Patient, Heal Thyself: How to Succeed with Online Consumer Health Sites, I started off by asking if I should lose 10 lbs. on the Atkins diet or by joining Weight Watchers. Melanie Zibit answered that I would lose the weight more slowly with Weight Watchers but would be more likely to keep it off. Most people agreed that this was good advice (the wisdom of crowds). I then asked if knowing anything about the weight loss experience or medical credentials of the advice-giver would have an impact, which people agreed with. Using sites like Amazon.com, a book-purchasing decision can be made based on the wisdom of crowds (ranking and ratings), expert opinions (from professional reviewers or well-known people in the field), or other readers (whose reviews are themselves rated). But a poor book choice has few ramifications, while health decisions can have severe consequences.

Many people get weight loss or any other type of health advice from strangers or friends, often knowing little about their experience or credentials; from books or magazines (every celebrity seems to have a weight loss secret or problem, based on a perusal at the supermarket check-out); from ads in magazines or television; or even from spam (I get frequent offer for weight loss drugs without a doctor’s prescription). People also learn about weight loss online – 49% of U.S. internet users search for diet or nutrition advice and 80% search for health advice. A search for “weight loss” returned 75,000,000 results, with “diet” and “fat” getting even more, and “weight” returning 1/2 billion results! Weight loss is certainly a common concern, but searches on other health topics also yield millions of results.

The results range from the Mayo Clinic to herbal remedies “As Seen on Oprah”. Most health seekers gather “health advice online without consistently examining the quality indicators of the information they find“. Information and health literacy impact the search results people select and the sites they use. Poor information literacy skills impact people’s ability to discern the quality of information. Poor health literacy skills – the lack of understanding about health coupled with the emotional burden of health concerns – make it far too easy for people to desire and seek magical cures or easy solutions. There are few reliable indications of quality; the only “Good Housekeeping Seal of Approval” in health is HONcode.

Sites vary in their usefulness, accuracy, branding, presence of advertising, and amount of interactivity, to name a few attributes. The most heavily used sites are WebMD.com and RevolutionHealth.com, both covering all diseases and conditions. Other sites are more specialized, such as Leroy Sievers’ heavily commented cancer blog at NPR.org, the very focused discussions on the Road Back Foundation bulletin board, and the well-segmented and very active community message boards at Weightwatchers.com. There are millions more examples, well-designed and dreadful, heavily used and ghost towns, frequently updated and unchanged in 10 years.

With consumer-directed care, patients are being asked to play a greater role in their health care. Providers are putting considerable effort into Electronic Health Records, Pay-for-Performance – countless initiatives to improve quality, reduce errors, and cut costs. But when a someone lies in bed at night worrying about their own health or that of a loved ones, EHR privacy is unlikely to be what is on their mind. Turning to the internet is easy with the constant availability – no need for an appointment or co-pay.

Consumer health sites have a significant impact on the quality of life of their users who turn to them before – or instead of – seeking medical help. Many doctors don’t know what their patients are doing online, and many dread the patient who arrives at an appointment armed with search results. “There’s so much information (as well as misinformation) in medicine — and, yes, a lot of it can be Googled — that one major responsibility of an expert is to know what to ignore,” but patients often lack that expertise.

That is where the disconnect lies between patients and doctors: that the time spent online is invisible to or an annoyance to a doctor but is a lifeline for many patients. Doctors need to understand and learn from their patient’s information seeking behaviors. And there is a lot to learn since what patients communicate online is a very different lens on their concerns and needs than what a doctor hears during a consultation, which is a small snapshot of how the patient is feeling, provided in a location much less comfortable than the patient’s home. And doctors need to “prescribe” sites with reliable and useful information, and online health communities where peer support is available.

Technology is not the answer, even good design is not the answer – although both can help. So can better information and health literacy skills. The greatest impact will come from bridging the chasm between what patients are currently doing online and what takes place during the doctor-patient consultation.

Patient, Heal Thyself: How to Succeed with Online Consumer Health Sites

I spoke today at the Massachusetts Technology Leadership Council Healthcare Lunch & Learn Series on Patient, Heal Thyself: How to Succeed with Online Consumer Health Sites. My co-presenters were John Lester (also known as Pathfinder Linden) who left Second Life for Waltham and Amir Lewkowicz, co-founder and Vice President for Partnerships at Inspire. I will post my notes shortly but until then, here is the abstract:

With consumer-directed care, patients are being asked to play a greater role in their health care. Moreover, those with chronic diseases often get better counsel from other sufferers than they do from physicians. This talk will cover the most effective ways to design and evaluate online health communities.

Changes in the health care system and the pervasiveness of the Internet have led to an increased use of the Internet by health care consumers. 80% of people in the US who use the Internet are using it for health searches.

Health web sites and online health communities provide a means for patients and their families to learn about an illness and seek support. The importance of online consumer health is evidenced by the popularity of sites such as WebMD and RevolutionHealth. Consumer health sites have a significant impact on the quality of life of their users who turn to them before seeking medical help.

Health web sites and online health communities raise difficult design challenges. These challenges include wide variability of participant’s medical expertise, health literacy, and technology literacy. A major risk is the potential consequences when poor advice is taken or when professional treatment is not sought.

By participating in this interactive discussion you will learn:

1) How online communities benefit consumers and businesses
2) How the nature of the disease or illness impacts site design
3) How innovative Web 2.0 technologies can enhance participation
4) What is necessary to start and sustain successful sites

e-learning, Diet Coke, and the Super Bowl

The Super Bowl is all you hear about these days in Boston, where our sports teams are doing great (how ’bout those Red Sox!) I’m not a huge football fan, but I read reports of how Tom Brady practiced yesterday and his right ankle was not taped, swollen or discolored. And I stock up on Diet Coke at Super Bowl sales.

Technology is playing a greater role every year in sporting events. Social networking is being used by Nielsen to rate Super Bowl ads. “Nielsen Online also will provide real-time analysis of messages and opinions from 70 million blogs, message boards, online communities, video-sharing sites and sports enthusiast sites.” Their site, Hey! Nielsen, is “a way for you to influence the TV and movies you watch, the music you listen to, and more… all while making a name for yourself.” Clearly someone at Nielsen saw that Time Magazine’s Person of the Year for 2006 was You. I’d like to learn more about the technology they use for text analysis and drawing meaningful conclusions from these millions of messages.

But what does this have to do with e-learning? I kept hearing on the radio “blah blah University of Phoenix Stadium blah blah” before it hit me – the 2008 Super Bowl is being held at University of Phoenix Stadium! The University of Phoenix’ home page doesn’t mention this, but it can’t hurt enrollment. Does this mean e-learning has reached a tipping point?

My biggest take-away from all this has nothing to do with sports (although I might look for an online course to finally understand football). What I learned was linguistic. Today’s Boston Globe reported that “Plaxico Burress went Joe Namath on us Tuesday and got a lot of headlines.” Joe Namath? I’m going to use that 3 times in a sentence today.