Moving the Needle on Clinical Trial Recruitment

Poor Communication is Among the Obstacles to Research
The passing of Senator Ted Kennedy has come to dramatize many things, like the importance of representing all stata of society and the need for new voices of compromise in the Congress. And, the necessity of further advancements in cancer therapeutics.

Senator Kennedy died of glioblastoma, one of those cancers that goes tragically hand-in-hand with “death sentence.” He had the best care available but, obviously, it wasn’t nearly good enough. There have been advancements, of course. Survival for this particular form of cancer has improved from about four months to about 15 since President Nixon’s famous 1971 declaration of a “war” on cancer.

The change has been incremental. A big obstacle to the discovery of truly breakthrough medicines has been the maddeningly complex nature of the disease. There is hope, however, that our ever-increasing understanding the molecular biology of tumors will lead to new interventions.

But that brings us to another big obstacle. When new, experimental therapeutics are available, they must be tested in clinical trials to ensure that they meet agreed upon standards of safety and effectiveness in people. The problem is that there is a chronic shortage of patient volunteers. Currently, there are more than 6,500 cancer clinical trials available (most trying to fine-tune cocktails of existing drugs) yet only three percent of adult patients agree to participate. In a recent article in The New York Times (“Lack of Study Volunteers Hobbles Cancer Fight”), Gina Kolata reported that “more than one trial in five sponsored by the National Cancer Institute failed to enroll a single subject, and only half reached the minimum needed for a meaningful result.”

The article cited a number of reasons for this low participation rate, among them: oncologists not wanting to refer patients away from their practices, reimbursement headaches, record-keeping and staff requirements and patients wanting to avoid any additional hassles.

Then, there’s fear. Even with Institutional Review Boards checking the ethics of study protocols and crafting of extensive Informed Consent documents, patients worry about being guinea pigs. They worry about getting a placebo instead of the active agent, even though the vast majority of studies only use the current standard of care and the investigational product. For some, tragedies of the past are proof of what can go wrong. The Tuskegee study (looking at the long-term effects of untreated syphilis in African-American men) and the Atomic Energy Commission study (that gave pregnant women radioactive iron but were told it was a “vitamin cocktail”) continued into the 1970s. That’s recent history for some of us.

Another barrier to patient recruitment is just a plain lack of information – most patients (and many physicians) are unaware of the existence of clinical trials that might be appropriate for them. It has been reported that 85 percent patients and 31 percent of physicians lack sufficient information about available studies. For those who were aware of trials, the top reason for refusing to participate was concern over their privacy and confidentiality (according to the Institute of Medicine).

Professional and patient advocacy organizations, the National Institutes of Health, hospitals and biopharmaceutical companies all promote clinical trials in some form or another, and try to communicate privacy safeguards. Now, Pfizer is taking a new step to address these impediments to research progress. They announced a partnership with Private Access to allow patients to “be more quickly and precisely matched to appropriate clinical trials while simultaneously protecting their confidential personal health information.” This on-line platform is planned for introduction late this year.

This could be an important, innovative step but perhaps a small one. A Harris Interactive survey in 2007 showed that the public’s confidence that their health records will be kept confidential is already fairly high. Seventy percent of respondents agreed that they are “generally satisfied with how their personal health information is handled with regards to privacy protections and security.”

So, where are the gaps? What else can be done to help convince patients to participate in clinical trials?

1. Clearly, we must keep communicating and educating – keep pushing the rock up the hill. The word must continue to get out with information targeted to the audience.

2. The process must be made as simple as possible – simple to understand for the patients and simple to administer for the study coordinators. And, some of the trials and their reporting requirements must be simplified. Not slackened – simplified. I have consulted on a number of patient recruitment projects and, after reviewing the protocol, and surveying the investigators, study nurses and the study population, have told the sponsors on a number of occasions that their study is just too complicated, just too onerous. First, sharpen the objectives and focus on what is truly important. Then, find ways to cut down on the number of office visits, the number of needle sticks, whatever.

3. The “what’s in it for me” question must also be addressed for all the parties involved. What would it take to get more physicians to refer their patients? What changes to reimbursement need to be made? What can be said to patients and their families so that they better understand their contribution, and feel more connected to the study and its outcome? What new incentives can be created to ensure that investigators don’t just sign on to the protocol but actively recruit study volunteers?

We can’t expect to achieve all that we want by attempting to address just one piece of the patient recruitment puzzle. We need to look at these issues – including privacy – together to really move the needle.

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TV News is Taking Viewer Opinion to the Extreme

This article also appears in odwyerpr.com.

Sloppy Journalism Can Distort Public Sentiment
I have spoken out about the decline of journalism a number of times. Staff and budgets are shrinking, and the ability of the public to receive well researched news and information is suffering. How are news organizations coping?

One way has been to update and elevate the “man-on-the-street” interview. Used typically to gather some quick reactions from “average” citizens, television news has been devoting an increasing amount of air time to these spots at the expense of real reporting.

With an Internet connection, anyone can become an information source. And anyone can call him or herself a journalist. Some have heralded the arrival of the “citizen journalist” and the gigabytes of “consumer-generated content” as a way to fill the void. I am not one of them. As I’ve said before, citizen journalism is not journalism.

But that opinion doesn’t seem to be shared by television news. They are all eager to receive your emails, YouTube videos, “tweets” and Facebook postings in reaction to the issues of the day. In return, you will get your message posted and maybe even shown or read on the air.

I acknowledge that news and entertainment was converging before this big downturn in the business of journalism, and that this a clever way to engage the audience. Reaching out and obtaining feedback is smart. All businesses need to connect to their stakeholders. But you wouldn’t find a business pulling random customers off the street and putting them on the factory floor or on the phones.

Beyond this being a cheap and easy way to fill some time during a 24-hour day, there’s a more insidious element. Who chooses which comments to air? How are respondents vetted, if at all? Is a balance of opinion sought and, if so, how is it defned? Do the aired responses in any way reflect actual national, regional or local opinion? Does anyone understand how easily bias can be introduced to the news?

My fear is that expediency and a tilt toward showcasing intentionally provocative responses gives a warped portrayal of public opinion. More than just cutting corners or differentiating their broadcasts, this sloppy journalism can give the appearance of an actual poll. I’m all for sharing comments, and exchanging views and information but a more rigorous approach toward 21st century man-on-the-street interviews must be taken to ensure interesting but accurate reporting.

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Homework for America

Read First, Debate Healthcare Reform Second
Healthcare reform has been discussed since Teddy Roosevelt’s time. We’ve made improvements throughout the years, of course. But they’ve always come with a struggle. The issues and arguments we hear today – excessive cost, loss of choice, the proper role of government – are not new. So, should the Democrats be surprised that some angry people are showing up at their Town Hall meetings?

Probably not. The trend had already been set. Unfortunately, though, we’ve seen an escalation in anger and a decrease in civility at public events over the years. What promised to be a vigorous negotiation over the latest round of healthcare reform proposals has turned into some ugly confrontations. True, America is all about standing up for ones beliefs and having the freedom to do so in public. What we have seen, however, is not a respectful give and take. There’s not nearly enough discourse and debate, and there’s entirely too much ranting and raving. The bottom line is that there’s precious little communicating going on.

Indeed, debate is about putting forth a proposition and allowing a rebuttal. Instead, healthcare reform is being hijacked by a loud minority of citizens who have no actual interest in participating in a productive conversation. For them, it’s not a question of finding a solution, thrashing out a compromise on problematic provisions, or discussing to what extent the government should play a role. It’s about no government. Rather than becoming a rallying point for a common good, healthcare reform has become yet another “wedge issue” like abortion, school prayer or creationism. It’s another example of the polarization of America , the land of the disappearing middle ground, where threats and intimidation can displace rational thought. Agreeing to disagree is becoming less of an option.

When challenged, when asked to stop the heckling, the healthcare reform protesters exclaim “This is America. It’s my Constitutional right!” And, they’re right… to a point. It’s not alright to inhibit the speech of others. We should want debate. We should want to exchange views. We should want the facts. We should want to communicate.

Invoking the Constitution is interesting, though. I’m wondering just how many Americans have actually read it. The protesters should remember that some of its first words are to “form a more perfect union” and to “promote the general welfare.”

So here’s the homework assignment America: read the Constitution. Know what you’re talking about when you use it to defend your rights. And, while you’re at it, read a few good biographies of the “founding fathers.” See for yourselves what their intentions were in creating our United States.

A special homework assignment is given to all of the politicians and political pundits out there. Read the healthcare reform proposals for yourselves before you talk about the potential pluses and minuses. This is for the public good as well as your own (unless you want to be embarrassed by a poor grasp of the facts). For example, over the past few weeks there have been repeated warnings about government “death panels” that will decide who lives and who dies. On former Senator Fred Thompson’s radio show, former New York Lieutenant Governor Elizabeth McCaughey said, “Congress would make it mandatory – absolutely require – that every five years, people in Medicare have a required counseling session that will tell them how to end their life sooner, how to decline nutrition, how to decline being hydrated, how to go into hospice care.” Politifact.com awarded her its “pants on fire” rating for its complete lack of truth. And former Speaker of the House Newt Gingrich was corrected twice by “This Week” host George Stephanopoulis this past Sunday. Mr. Gingrich waved him off and implied that something along those lines were buried somewhere in the 1000+ page proposal. (Again, it’s not.)

I’m hopeful the situation will improve. I saw a good sign at the President’s Town Hall in New Hampshire on Tuesday. The huge crowd was well behaved. Views were expressed, questions were asked and responses were returned. Why the difference? Perhaps people were more deferential toward the President than they were toward members of Congress. Perhaps it was the heavy presence of Secret Service agents. Or, perhaps it was because the attendees were a true cross section of America. Unlike the Town Hall meetings held by members of Congress, people were admitted to the Presidential Town Hall by a lottery – they were randomly selected. Thus, it was impossible to stack the deck with partisans and troublemakers. Whatever the reason(s), let’s continue to communicate knowledgeably, passionately and respectfully.

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Observations on the Social Media Landscape

This article also appears in odwyerpr.com

Web 2.0 is Like Being at Square 2.0
We can see some of the benefits of new media every day. Companies, associations and organizations are reaching out to engage, educate and sell to their publics. Information is finding new ways to bore through the firewalls of intolerant regimes. The lonely and the shut-ins have virtual life lines to the outside world. People are reconnecting, catching up and sharing news.

I’ve had some good experiences with new media, reaching "influencers" and gaining news placements. On the personal side, it’s been nice to reconnect with old friends and colleagues. Not long ago, I received a LinkedIn invitation from a friend who was in Cub Scout Pack 92 with me back in the fourth grade. Twitter is a different story, though. I'm still churning through sites in the hope that they can give me at least a 10 percent chance of reading something of actual interest.

That aside, it’s exciting to see new ideas and experimentation taking place. Yet, with the deluge of offers I receive for webinars, courses and books, you would think the self-proclaimed gurus have Web 2.0 all figured out. Every time I turn around, my e-mail in box fills with “must attend” events like Social Media Crash Course, New Media Boot Camp, Social Media and New Media Boot Camp, New Media PR Master Class, Writing for Social Media, Social Media Best Practices, Social Media PR Power Guide, Social Media for Disaster Response and Recovery, and Social Media Strategies. (Note to gurus: it is not a strategy – it’s a tactic.)

While there are people who have better technical skills and know more than others about these media, we’re a long way from fully grasping its potential and its potential consequences. Along the evolutionary continuum of social media, we’ve just left knuckle walking to stand upright. Like the Neanderthals, we’re bound to see lots of offshoots that dead end into oblivion.

Oblivion is where many in and around the media business say newspapers (and books and magazines) are headed. They may be right… eventually. I do read a lot of material electronically but I don’t want to give up the ability to turn the page of my hard copy. (I take some comfort knowing that the crystal ball keepers who manage the Star Trek franchise have, on several occasions, made books the perfect gift in the 23rd and 24th centuries.) Indeed, when it comes to media consumption (according to Ketchum’s Media Myths & Realities Survey, 2008), social networking sites, blogs, videocasts and podcasts combined don’t come close to local newspapers (or network or local or cable TV news).

As social and electronic media gain ground, however, it seems to be pushing other forms of communication to the rear. A growing number of people -- practically everyone I know in generations Y and Z -- will use Facebook, AIM or send a text message before they’d ever make a telephone call. This leads me to question the actual use of the term “social” in social media. Certainly, it’s safer to write a message than to use one’s voice. Words can be chosen and rewritten before sending. Direct confrontation is avoided. But this is the opposite of social interaction. It’s remote, it’s disembodied. From the Random House dictionary (the 10 pounder on my bookshelf), social “pertains to, devoted to, or characterized by friendly companionship or relations.” Merriam-Webster (on-line) defines social as “marked by or passed in pleasant companionship with one's friends or associates.”

Like friends, music and art, a mix of the old and the new can make the picture complete.

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A Message to Reach the Stars

Communicating Our Way to Space
Forty years ago today. I can remember that evening so clearly, sitting at the edge of my parent's bed to get the best view of the TV as Neil Armstrong descended the ladder of the Lunar Excursion Module. Then, with Walter Cronkite's narration, we all witnessed the triumph of the first step on the moon. No VCRs or DVRs, kids. My father put his Bolex camera on a tripod and took 16mm movies of the television tube.

I'm sorry that Cronkite won't see this or any other anniversary of the moon landing. The legendary/iconic/most trusted/uncle-to-all news man will be missed. For other fans of the space program, when it comes to walking on the surface of other worlds, all we'll have is anniversaries for a while.

For the surviving septa and octogenarians who were part of those groundbreaking Mercury, Gemini and Apollo missions, this is another milestone to lament the long absence of people breaking away from earth orbit. There have been some tremendous milestones in space, of course -- weather and communications satellites, the International Space Station, space telescopes and other astronomical instruments, deep space probes, the Martian rovers. But robotic tracks on Mars are no substitute for human footprints.

What first put us into space, however, was far from these lofty visions. It was the Cold War and the strategic "missile gap" with the USSR. In an opinion piece in Saturday's The New York Times (One Giant Leap to Nowhere), Tom Wolfe wrote that we were successful in winning the space race because we had a clear purpose, a clear rallying cry, a clear message.

He may have a point. We've gone from regaining a military advantage and saving the "American way of life" to... what exactly? We've heard a number messages from NASA, its contractors, space enthusiasts and Congress, including: we need to ensure our global competitiveness, we must continue to map and explore the heavens, some science can be conducted only outside of our atmosphere, it's a moral imperative for the U.S to lead in space, it will sustain thousands of skilled jobs, it will spawn new businesses and products, we need new inspiration to drive us forward and revive our spirit.

Wolfe said that "What NASA needs is the power of the Word" and a "philosopher" to help articulate the rationale for an ongoing commitment to space. The one and only, he said, was Werner von Braun but "NASA couldn’t present as its spokesman and great philosopher a former high-ranking member of the Nazi Wehrmacht with a heavy German accent." The message von Braun wanted to convey was that we need to find a way to get off the planet -- all of us. He knew that, in its death throws (a few billion years from now), our star will expand and envelope Earth. We would have to get away one day, and not just to potentially habitable Mars. We would have to leave the solar system.

The survival of humanity. This is clearly the most important message one could ever hear but also the least urgent. Maybe in the year 100,002,009 Congress will start appropriating some funds with a few hundred million years to spare! Of course, we might want to act faster. Von Braun, as far as I know, didn't mention the possibility of nuclear war, a collision with an asteroid or comet, or the impact of unchecked climate change.

We need more than messages, of course. Any communicator knows that a message requires proof points -- evidence to support the statement. They must have relevance and be compelling, and instill support if not positive action. They must be coherent, and in a language the public and other stakeholders can understand. And, they must have immediacy. The question of why now must be answered.

Whatever the message and whoever the spokesperson, I hope we get back on a trajectory to the stars.

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What's in a Name?

A Story of Discrimination

The Senate hearings for Associate Justice-designate Sonia Sotomayor have been full of talk about discrimination -- her "wise Latina" comment and the case involving white New Haven firefighters, for example. It reminded me about a piece I wrote on gender discrimination several years back but never published. I'm sharing it with you now:

I can remember when, a few years ago, an acquaintance heard that my wife and I were expecting a baby girl. It was information I was delighted to have circulated but I learned quickly that he didn’t see the news in the same light. “You must be disappointed,” he said. I felt a viceral jolt with those four words. I couldn’t believe what just came out of his mouth and into my ears. So, I asked him to repeat it. He attempted to clarify by saying, “You know, with this one you’ll have four daughters. Are you OK with it?”

Yes, my wife and I have four kids -- one shy of an all female basketball team. (No, we don't plan to fill the Center position.) Each of my children have their own unique gifts but share savvy, humor and compassion. I get comments all the time about their beauty and good manners. Unfortunately, people also feel quite uninhibited in sharing and spreading their prejudice.

Whether on a city street or a suburban sidewalk, in an airplane, at a mall, in a museum or while eating at a restaurant, people have felt free to approach me and my children (yes, with the kids surrounding me) and ask, “Are you still trying for the boy?” or “Did you get someone upstairs angry at you? Ha, ha!” Someone at an elementary school event asked, “Do you feel less of a man, not having a son to pass things down to?” Even some not-to-be-named relatives wondered out loud "How can you handle all of those girls?”

Years ago, as a younger father not wanting to offend anyone, I laughed off the insults by chuckling an inoffensive reply about how lucky I was to have such a wonderful family. Over the years, though, my standard retort got less tolerant and more admonishing. “I wouldn’t have it any other way.” “What century are you living in?" "We’ve taught our daughters that they can learn, do and accomplish anything.” “I can tell you honestly that I never hoped for a boy… just a healthy human!”

I can't answer why strangers feel compelled to offer up their misguided attempts at conversation and social commentary, but there’s a larger issue here. People don’t think about how their words can hurt children – and not just the girls. There’s a clear message being sent to the boys, too. These are exactly the kind of ignorant, damaging messages that support an environment of ongoing discrimination and bias. On a different scale, societal or religious indifference to – or acceptance of – unequal gender valuation has translated into female infanticide and genital mutilation.

When I read that an Egyptian father stabbed his seven children, murdering four, because he had no sons, my heart sank and my blood boiled. Where do we start? How do we get people to gain some insight and change behavior? In the schools? When one of my daughters was asked to draw a scientist, she was the only one in the class who thought to draw a female. In the entertainment media? Not with reality shows and shock jocks objectifying women. At the doctor’s office? When another daughter -- about eight years old at the time -- was being examined by a pediatrician, he said to her that “your daddy told me he wanted four boys instead.” She responded confidently, "No he didn't." We never went back.

For any chance at breaking the cycle, the best first course, I believe, is to start at home. Home needs to be a safe harbor. It must be a place where our children can expect best behaviors from us. We need to be more active commentators about discrimination, and strategize with our kids on how to advocate for themselves and others.

Home for one person, though, was where he received a badge of discrimination to wear for the rest of his life. I met a man while on a business trip who would most certainly have another name if prevailing attitudes were different. He introduced himself as Bingo. I thought he was making a joke until he said it was truly his legal name. He told me that his father desperately wanted a son and after five daughters… Bingo! His wish had come true.

Perhaps one day I’ll meet a woman named Bingo.

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Keeping Them Guessing

A Sometimes Risky Strategy

Politicians aren't products (exactly) but how would a marketing person dissect the surprise resignation of Governor Sarah Palin? Some take her at her word and others are convinced of hidden agendas. Why this sharp divide?

Some insights might be gained by examining the success factors that allow Apple to use mystery to drive interest and anticipation. Under the leadership of Steve Jobs, they have been brought back from the edge of oblivion to become the hallmark of that intersection between tech innovation and design. Feeding the cachet of the Apple brand has been their clever use of silence and, sometimes, misdirection. (Not so clever was the decision to keep Jobs' liver transplant a secret. True, they probably avoided some potential shareholder panic but disclosure would have been the appropriate path.)

How does Apple pull this off? How can they keep their plans quiet without infuriating their customers, the news media or investors? Sure, there have been glitches but mostly:

They deliver. Their products have been deemed to be worth much more than any of angst or frustration caused by the purposeful stealthiness. And, once a breakthrough device is delivered, they follow through with incremental improvements and extensions.

It's become a sport. With a successful track record and an established method of rolling out "must have" products, they've created something of a game -- a bit of cat-and-mouse. Their publics fill cyberspace with speculation and discussion in attempts to figure out the products' specifications and when they will be delivered.

Their appeal is broad. Frequently representing the leading edge, there is wide interest in Apple's exploits. Sure, there are people who don't care or refuse to get caught up in the Apple aura. But a key to the success of their strategy is that there are few who are engaged in any active dislike of the company or its products.

As for Sarah Palin, the now soon-to-be ex-Governor of Alaska did not directly address her plans during her press conference the other week. In follow up interviews, she repeated that she can be more effective as a private citizen. Also, fighting ethics complaints and the media have taken a financial toll on the state and her family and, because she already decided not to seek re-election, leaving now would be in everyone's best interest.

So, was this about spending more time with and shielding her family, digging out of a financial hole with book deals and speaking engagements, gaining a national platform by becoming a conservative TV commentator, gearing up for a Presidential run in 2012, all of the above or something completely different? While most of us were left to wonder, Republican political consultant Mary Matalin was convinced that Gov. Palin's move was "brilliant." Not so sure were other key Republican figures. Former Arkansas Gov. Mike Huckabee said her mid-term move "simply doesn't make sense" and Karl Rove, former President George W. Bush's counselor, said it was a "risky strategy" if she had any designs on elected office.

Michael Carey took a harder line in his commentary in the Anchorage Daily News: "We are left to guess. The only thing we can be absolutely sure of is this: Palin did not tell the truth when she said she is leaving for the good of Alaskans. She is leaving for her own good."

In response to all of the criticism, Gov. Palin said, "You know why they're confused? I guess they cannot take something nowadays at face value."

So, why isn't she getting the benefit of the doubt? Why is she in a defensive posture and repeating the words "I'm not a quitter, I'm a fighter" over and over? Why is the web overflowing with references to her "epic fail"?

I submit that we can use Apple's success as a guide to help us judge if "keeping them guessing" was a wise strategy:

Has she delivered? She made a stunning entrance onto the national scene with her selection as John McCain's running mate but, it was a bit like a Super Bowl ad with no marketing campaign to follow. While she can take credit for some accomplishments as Governor, there is some consensus that perhaps the most important work in Alaska is left unfinished.

Has Palin speculation become a sport? The Governor has, indeed, generated discussion around the world. However, the substance and tone are not entirely sporting -- not with polls asking whether or not she should run for President or "disappear."

Does she have broad appeal? Most political pundits agree that her support lies only at one end of the political spectrum. This polarization may ensure that an active set of detractors will always be second-guessing her intentions. And, questions will remain about the ethics of asking Alaskans to elect her Governor and then leave in a relative rush just a year and a half later.

The bottom line is that Apple can keep us guessing. They have cultivated their publics and grew from one success to the next. For Sarah Palin, one never knows but, without the time to fully bank political capital or build her reputation and public trust, she may have made one guess too many.

A Culture of Complaining

This article also appears in odwyerpr.com.

The Message in Misery

We have all engaged in complaining about something at some time. A bad meal. A crazy boss. A broken gadget. An outrageous bill.

Then, there's competitive complaining. In "Misery Poker: It's One Game Worth Losing," Elizabeth Bernstein wrote recently in The Wall Street Journal that "stressed to the max and desperate for everyone to know it, many of us are trying to trump each other with our carping." She went on to note that "instead of sharing our misery, we seem to be using it as a competitive weapon. ...there are those who use stress as a measure of success."

Perhaps we're seeing complaints in a new light or at a new level with this recession but I've seen this "out-martyring" routine many times before. I remember one notable example that I overheard during a bus ride in Chicago in the late 90s -- one guy said proudly that he had a heart attack at 45, the other guy scoffed and said that's when he had his second heart attack. He had his first at 42.

As a communicator, though, I'm looking for some deeper meaning in our complaints. After all, complaining is a form of communication and, like any exchange, we need to know our audience. Here's my attempt at categorizing complainers:

• Attention Seekers. This may be the largest category of complainers -- those who may have some unfulfilled emotional need for attention. If there's an unmet need, it might be worth exploring what caused the void, why it may not be getting filled and what it might take to make a permanent (or at least a long-lived) repair.
• Terminally Annoying. My sense is that there are some people that are just hard-wired to whine. They have to gain some insight, recognize the behavior and devise some tactics to overcome the impulse. Otherwise, we have to cope with it or tune it out.
• Clinically Complicated. Some complainers would be better categorized as patients with neuroses. Guiding them toward some medical or psychological intervention might be indicated.
• Pressure Cookers. It can be a scary situation to witness a usually even-keeled person erupting into a complaining rant. It's unexpected, it's out of character. These complainers lack a relief valve that can episodically vent some steam. They need to understand that providing feedback in a timely manner will not diminish their likability and will, in fact, create better relationships.
• Crowd Followers. Due to a lack of confidence or an eagerness to fit in and be accepted, some people will take the lead of others and join in on the complaining. They need to think more about which crowd they want to be aligned.
• Signal Senders. In my experience, there is an under-appreciated group that may be making actual attempts to communicate an issue or send an alert but the message is interpreted as a complaint. Rather than brushing it off, it may be worth investigating their motivation or intent.

Sure, complaining can alienate. It can brand us as disloyal. It can lead to stress and, some say, even shorten your life. (According to my mother, however, this was not the case for her mother-in-law. Decades ago when I told my mother that I hoped grandma wouldn't die, she said, "Don't worry. She has so much more complaining to do that she'll probably live forever.") We could and should be reading more into the whines, moans and carping we hear each day but, as Freud might have said, sometimes a complaint is just a complaint.

Between blog posts, I invite you to follow me on Twitter @pauloestreicher.

Observations From the Consumer Genetics Conference

The First and Certainly Not the Last Meeting

I was able to catch the last day of the three-day Consumer Genetics Conference in Boston last week. Part scientific exchange, pep-rally, and company show-and-tell, it attracted about 500 attendees. Jumping to the end, the meeting was concluded with, "See you all next year," though Linda Avey, co-founder of 23andMe, thinks we'll see big changes in the Conference down the road. She likened genomics to the early days of the Internet. "There were conferences just on the Internet," she said. "Now, you wouldn't think of such a thing -- it's ingrained in everything."

So, the future prospect of some sort of Conference occurring next year was assured. I'm not sure the same can be said of this emerging industry. Sure, enormous advancements in genomics technology have been made. Cash has been poured into a variety of companies, though unevenly distributed to be sure. A variety of consumer and medical applications are beginning to take hold. Yet, from what I observed, the overarching question that speaker after speaker sought to address was, "Is consumer genomics ready for prime time?"

Here are some of the challenges I noted:

The Science. There are still worlds to conquer in order to achieve the accuracy, speed and cost required to achieve business success. Then, there are the issues of standardization: how much information is sufficient to associate a genetic variation with a medical issue or outcome, and how do we account for multi-genic contributions to a drug response or disease process?

Investment. In this economic environment, some companies are having a difficult time hurdling over the bar set by venture capitalists for business and financial modeling. Making the leaps from research to development to marketing can be harder and longer than ever.

Medical Education. Genomics needs medical champions yet there is practically no training available for healthcare providers. Interestingly, the Life Technologies Foundation announced that it is teaming with the New York Academy of Sciences to offer genomics training to medical students. We'll have to track this, given the hardening line taken against industry support for medical education.

Public Education. This, too, is a substantial obstacle. What to expect, what to do with genetic information, what the probabilities really mean? "People don't like probabilities," said Talya Miron-Shatz from the Center for Health and Wellbeing at Princeton University. "They like binary - yes/no - information" but that's not what they'll be receiving.

Proving Value. As a corollary to the above points, what does value look like? How can we measure outcomes? Who will pay for genomic tests?

Healthcare Delivery. An important issue, though not addressed specifically, is how to extend the benefits of genomics to all. Carol Isaacson Barash, Principal at Genetics, Ethics & Policy Consulting, Inc. remarked to me that, "were it not for the public's gift [of resources to the NIH], our knowledge would not exist. Given the global interconnectedness of data and economies, ensuring global benefit is, in my view, an urgent need."

But maybe we don't need genomics at all. That's what James Heywood, Chairman of Patients Like Me, envisions -- a "Twitter for medicine" where participants share their health information to "achieve personalized medicine based on phenotype."

It seemed clear, however, that there is enough "there there" to be optimistic. Genomics has and will continue to make an important mark on health and medicine. Mark Stevenson, President and COO of Life Technologies, predicted that genomics will be "a standard tool in the doctor's office in 8-10 years. He sees a model similar to i-Tunes -- a decoupling. The location of diagnosis and the location of treatment will not be dictated by the hospital or the physician but by the consumer.

Stay tuned!

A Chink in Oprah's Armor

Is She Putting Your Health At Risk?

The list of Oprah Winfrey's accomplishments is long. The value of what she brings to her viewers and readers, and to communities worldwide is enormous. Yet, as Newsweek tells it in their June 8 cover story, "Crazy Talk: Oprah, Wacky Cures & You," there is danger in her embrace of alternative therapies -- danger to the public health and danger to her reputation.

The article discusses several cases where both lay and professional health "experts" have dispensed potentially dangerous advice, including the use of Tarot cards to diagnose illnesses, refusal of vaccinations, and self-medicating with hormones, herbal supplements and mega-doses of vitamins. Moreover, Oprah herself has spoken positively about a number of these "treatments" and "cures," providing an endorsement of gigantic proportions.

In response to the article and the condemnation of mainstream medicine, Oprah released a statement saying, "For 23 years, my show has presented thousands of topics that reflect the human experience, including doctors' advice and personal health stories that have prompted conversations between our audience members and healthcare providers. I trust viewers, and know that they are smart and discerning enough to seek out medical opinions to determine what may be best for them."

Let's break this down:

1. Doctors' advice. Yes, Oprah has welcomed quite a few esteemed medical experts who have clearly and accurately described a wide variety of medical conditions and potential interventions. Some physicians and their advice are more equal than others, however. There is a cadre of highly credentialed individuals who have repudiated peer-reviewed data in favor of so-called natural remedies. Dr. R.W. Donnell, the physician blogger, calls them “quackademics.” The article highlighted Christaine Northrup, M.D. who said that, "in many women, thyroid dysfunction develops because of an energy blockage in the throat region, the result of a lifetime of 'swallowing' words one is aching to say." She also said women should consider iodine supplements (which, in reality, will make hypothyroidism worse). Oprah calls Northrup's book, The Wisdom of Menopause, her "Bible."

2. Personal health stories. We all know that information conveyed in a personal, emotional way connects with audiences better than just some dry facts. The flip side of this is that many times the information is less fact than it is anecdote or wishful thinking. Suzanne Somers, for example, speaks to Oprah's audience of her own quest to look younger and double her lifespan with a regimen of non-FDA approved bioidentical hormones and 60 other supplements, which she ingests, applies and injects. Though a personal story, Somers wants to be viewed as an expert. "I have spent thousands of hours on this. I've written 18 books. I know my stuff," she told Newsweek. Oprah said "every woman should read" Somers' books.

3. Trusting viewers. In my view, the word "trust" is just not applicable here. The issue is whether or not her viewers are a) exposed to other sources of information and b) able to differentiate real science from junk science. This is not an issue of smarts, either. The point is that, while there are plenty of intelligent Americans, the vast majority have low health literacy. In a survey of more than 19,000 adults (age 16 and up) conducted a few years ago by the National Center for Education Statistics, only 11% where found to be "proficient" in their health literacy. The majority, 53%, where in the "intermediate range," while 22% had "basic" and 14% "below basic" health literacy. Without proficiency, it is exceedingly difficult to integrate, synthesize and analyze the sometimes complex information that one is expected to tackle.

Is this Oprah's "jump the shark" moment? Her ratings are down as is readership in her magazine, O. But I hope the answer is no. Rather than defend the past and continue on this course, Oprah should seize the opportunity to do better in the future. Please Oprah, ensure that all sides of the medical argument are heard. Leverage your reach and good intentions by being a champion of health and science literacy.

Hospitals Pushing the Envelope with Social Media

This article also appeared in odwyerpr.com.

The Line Between Marketing and Education Begins to Shift

The usually conservative hospital sector has started to embrace social media. Whether it's increasing competition, the need to keep patients coming through the door, reputation management or recruiting, hospitals are turning to these new web-based tools for assistance in increasing numbers. Ed Bennett, the director of Web Strategy at the University of Maryland Medical System, keeps tabs on this: there are 128 hospitals that have YouTube channels, 87 with Facebook pages, 140 have Twitter accounts and 23 have blogs. It's notable but still a minority. There are over 5,000 hospitals in the US.

In the StarTribune (Minneapolis-St. Paul), Chen May Yee spotlighted how "Mayo Turns to Social Media to Reach Out to Potential Patients." Lee Aase, manager of Syndication and Social Media, has helped to give the famous medical center an even greater public platform. Indeed, it was reported that he has developed so much expertise that he "travels the country to speak at conferences and runs his own virtual Social Media University, Global (SMUG), a web site with courses such as Blogging 101." The newspaper called him "a rock star in that space where social media and health care marketing overlap."

Two good examples of appropriate and valuable uses of the technology include Innovis Health in Fargo, which used Twitter to help people find the safest route to the hospital during the recent floods in North Dakota, and the University of California at San Francisco, which used YouTube to reach out to potential patients for a clinical trial that had difficulty enrolling volunteers.

But I see another side to this coin. In "Webcast Your Brain Surgery? Hospitals See Marketing Tool," Pam Belluck of The New York Times reported on a surgeon who was tweeting during the removal of a kidney tumor. He said, "Gosh, this is big" and "Could I have picked a harder case for this?" The hospital's web services manager said, "some bleeding needed to be controlled," but "we just tweeted right through it." Maybe there is some educational value in this but my first reaction was "please stop tweeting and give your full attention to the patient!"

Methodist University Hospital in Memphis transmits live webcasts for some surgeries. After seeing an advertisement for an upcoming craniotomy, a man called to volunteer and was accepted to be a patient. He said that if the doctor "was operating live on the web, he must be pretty darn good." What the hospital told the Times, however, was that a back-up video is always at the ready. "If something unforeseen happens and you need to cut away from the surgery, you can fall back on your previous surgery." OK, you want to spare your audience (and the family) from potential tragedy but there is something bait-and-switch-ish about this.

As we've seen, some of the most venerable names in patient care are joining other industry sectors in engaging the public. But does that make it right? Should hospitals behave like consumer goods companies?

The biggest questions, in my view though, revolve around ethics and value:

1. Is the particular use or application ethical? While hospitals take great care in protecting patient confidentiality, more care needs to be applied to marketing and public relations. Sure, sharing information is great. But Jeffrey Kahn, a University of Minnesota bioethicist, pointed out in the Times article that, while there is "value in demystifying medical care," the ability to use new web technologies "creates an aura of sophistication and high-tech ability" that may not represent the "quality of care at the hospital."

2. Is the particular use or application creating any value? Just because social marketing tools are cheap to implement doesn't mean they should always be utilized. The "we have nothing to lose" argument does not apply. And, even though web conversations are occurring anyway doesn't mean you must always be an active participant. Clearly, the people behind the social media push are gaining notoriety but less clear is the pay-off for the hospitals they represent. For every patient that might be impressed, there may be others who are dismayed.

It's a fascinating time in the world of marketing and communications. Yet, while we create new tools and channels, we'll need to ensure they accomplish what we intend.

A Spokesperson Goes Off Track

Remember to Keep an Ear to the Rail

Brands have several options when it comes to gaining endorsements. Among them are experts, celebrities, and people with actual success stories. In the pharmaceutical industry, the last example would be happy, grateful patients. Patient spokespersons have proven effective in communicating key messages authentically.

But not always. In "A Celebrity Patient's Backing Turns Sour for Drug Company," by Shirley S. Wang in The Wall Street Journal, we learn about Andy Behrman and his relationship with Bristol-Myers Squibb. Mr. Behrman is a well-known figure; he chronicled his life with bipolar disorder in "Electroboy: A Memoir of Mania," published in 2002. Reports indicate that BMS paid him $400,000 in 2004 and 2005 to discuss the benefits of their blockbuster drug, Abilify(R). Mr. Behrman appeared in videos, at BMS events, and in various media interviews, sharing how Abilify was life-changing and had no side effects.

Now we hear from Mr. Behrman, whose non-disclosure agreement has lapsed, that what was reported wasn't true. He stated that he experienced side effects worse than any treatment he had tried and stopped taking Abilify within the first year.

Working with endorsers can be tricky, but BMS reportedly said that every collaboration, except for this one, has been positive. Indeed, the first celebrity campaign—for the arthritis drug Voltaren(R)—gave CIBA-Geigy (now part of Novartis) quite a pain in the late 1980s. Baseball legend Mickey Mantle, who wasn't taking Voltaren and didn't disclose the corporate relationship, went about as far off message as one can go by claiming the drug can cure hangovers!

The WSJ article provides insights on how to minimize the chances of being surprised and disappointed by a patient spokesperson. Here are some principles to consider:

• Don't talk in absolutes. When he switched to Abilify, Mr. Behrman said that all of his drug side effects "went away." This assertion was made repeatedly and never should have been sanctioned by BMS and its PR firm. While Abilify may have a better safety profile than some other atypical antipsychotics, it carries a long list of side effects and warnings on its label.

• Ensure authenticity. The BMS contract didn't require Mr. Behrman to take Abilify yet there he was talking up the benefits.

• Conduct due diligence. Mr. Behrman signed a waiver allowing his doctor to share his medical records but BMS never checked them.

• Communicate good news and bad. Although Mr. Behrman said he was in almost constant contact with BMS and its PR firm, the bad news that he was, in fact, experiencing some side effects and stopped taking the medication was either ignored and/or never brought to a higher level.

• Be prepared to jump the rails. It's hard to pull the plug on a program, an investment, but that's what we must do when things go dangerously off track.

Staying the course may damage BMS's reputation, and Mr. Behrman's reversal might raise questions about his motives. His website includes a link to The Daily News gossip column, Side Dish, from November 19, 2008, which stated that Brad Pitt and Matt Damon might be interested in his new book, Adventures in the Drug Trade: I Was a Big Pharma Pusher. So, is Andy Behrman an honest whistle-blower or a calculating opportunist? Has he been overtaken by his illness again? These are questions we might not ask if more thought, care, and scrutiny had gone into the communications planning and review process.

Good - Not Great - News on Pharma Reputation

Hold the Champagne for Now

You may have read of the recent Harris Interactive Reputation Study that showed that "the overall reputation of Corporate America has never been worse in the eyes of the general public." The bright spot in the report? Surprise! It's the pharmaceutical industry.

Pharmaceuticals posted their highest rating in five years -- up to 31% in 2008 from 26% in 2007. Is this the beginning of a turnaround? Is the public perceiving more value in the discoveries and treatments from this critical industry? Maybe, maybe not.

To place this in perspective, we can look at what else transpired in this time frame. With bank failures, AIG, home foreclosures, executive bonuses and Bernie Madoff, the financial services industry has fallen into the reputation cellar with the tobacco industry. Both share an 11% positive rating by the public. And, there's the auto industry. It suffered the largest decline (22%) in the survey's history. So, while there may indeed be some reason to cheer, the uptick for pharma may be a case of looking good by comparison. And, remember, 31% good means 69% not good.

I'll hold on to some hope, though. This increase in Harris' "Reputation Quotient" was observed during a time of high-profile drug withdrawals, the Presidential election (which included industry bashing from both sides) and the largest average price increase in five years. Something went right for the industry.

During this time, also, was a steep decline in DTC advertising -- a drop-off of 8% in 2008, which followed a 4% decline in 2007. Is less DTC advertising inversely proportional to pharma reputation? Or, is this pure coincidence? I wish I had some data to share -- this would be an interesting phenomenon to study.

What I can tell you is that I have a hunch that these facts do have an association. I've been saying for years that, while some efforts do a great job of informing and educating, DTC advertising can trivialize side effects, create false hope and interfere with an individual's calculus of risk/benefit. In addition, the pervasiveness of some ads has fueled the perception that increases in promotional spending come at the expense of research and development. Indeed, at the end of last year Roche CEO Bill Burns said, "DTC advertising has been the worst decision for the drug industry. When industry says we're spending all the money on R&D, but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility." And, more recently, concerns have been escalating over the appropriateness of some ads (e.g., ED spots during "family hour").

Here's a case where less really could mean more. Fewer shot-gun approaches to advertising and fewer goofy stunts in an attempt to start a discussion may lead us back to more effective communications that improve relationships with stakeholders and enhance industry reputation.

Swine Flu's Teachable Moment

An Opportunity for Public Health and Vaccine Manufacturers

It was disturbing to read about a growing public health threat in "Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases" in this week's New England Journal of Medicine (Omer et al.). The bottom line is that there is a critical need for new education and policy efforts to protect children (sometimes from their own parents) and the general public.

Here's an example of some of the bad news: In the case of measles, it's been estimated that more than two million cases occurred each year in the U.S. before a vaccine was available. In a triumph of science and medicine, the number of cases dropped to a mean of 62 per year between 2000 and 2007. In the first four months of 2008, however, 64 cases were reported with 63 of those occurring in children who were not vaccinated. Why?

• Past success. With a number of diseases nearly wiped out by vaccines, it seems as though our memories have been wiped out as well. As time marches on, many have forgotten the potential severity of vaccine-preventable diseases. Using the measles example, some cases can cause pneumonia, seizures, meningitis or even death.


• Alternative medicine and junk science. Of course, "western medicine" does not have all the answers. But it's been reported that parents of unvaccinated children "were more likely than parents of vaccinated children both to have providers who offered complementary or alternative health care and to obtain information from the Internet and groups opposed to aspects of immunization."


• Ease of opting out. Although the constitutionality of mandatory immunizations has been upheld, individual states have the ability to set the bar and allow exemptions based on personal or religious beliefs. In another unfortunate example, "the mean annual incidence of pertussis was almost twice as high in states with administrative procedures that made it easy to obtain exemptions as in states that made it more difficult." It was reported also that children with exemptions were 35 times more likely to contract measles.


• Denial. Compared to parents of vaccinated children, significantly more parents of unvaccinated children believed their kids had a low susceptibility to diseases (58% vs. 15%) and that the severity of disease was low (51% vs. 18%).


• Lack of trust. Again, compared to parents of vaccinated children, significantly more parents of unvaccinated children believed that vaccine efficacy and safety were low (58% vs. 17%, 60% vs. 15%).

Although the hearts of parents who withhold vaccinations from their children for non-medical reasons might be in the right place, their brains are not. In the "rugged individualism" that many Americans use to define themselves, there is a consequence of putting others in harm's way. Those who are unvaccinated put their communities at a higher risk of disease outbreak.

Now, there's a race to develop another vaccine -- this one against the swine (H1N1) flu. Although no one wants a new disease to contend with, there may be a silver lining -- a chance to reengage the public on the importance of immunizations. No doubt there will be an educational push when the vaccine is available. But at the same time, a campaign should be tied-in to reverse the dangerous growth of vaccination exemptions.

No vaccine is risk-free and not every mind can be changed. Still, the CDC (with their reach and clout), vaccine manufacturers (who can gain sales and reputation) and health care providers (who are a trusted source and carry influence on family health care decisions) should join forces to develop a new dialogue with the public. And let's sustain the discussion, let's put the science and evidence in perspective, and let's build some trust.

A Report Card on Report Cards

Why They Don't Always Measure Up

The run-up to the Obama administration's 100th day in office was truly a spectacle. It seemed that every media outlet had a countdown clock to April 29th and massed panels of experts to give the still new President a grade. The Report Card phenomenon has grown wildly in recent years. On the political side, a Google search of "President Obama Report Card" yielded 23,900,000 hits whereas "President Bush Report Card" produced 10,800,000. A crude yardstick, sure, but what makes this even more lopsided is that it took about three percent of the time (100 days vs. eight years) to double the number of hits.

We love to grade and that's fine by me. Measuring success is crucial -- in politics, business, health and medicine, sports, everywhere. There are some problems, however, and we need to ask a few important questions in order to place any grade in perspective:

• Who is grading? We need to consider the source, and determine their qualifications and potential biases. The "experts" gave the President every grade from A to F.


• What are the conditions? An honest appraisal of the environment is necessary in order to compensate for those issues and conditions that are beyond the control of the person being graded.


• How are grades being assessed? The scale must be the same, applied and then evaluated in an identical manner to all in the sample population -- all of the politicians, restaurants, doctors, etc.


• What are we measuring and how much weight should be assigned? The issues or subjects to be graded and for how much they count should be determined in advance. A post hoc analysis isn't fair or valid. In school, classes have levels and we multiply the grade by the number of credits. For news media consumption, this would get complicated. But some discussion of how outcomes are weighed should be attempted. Does reversing the ban on Federally-funded stem cell research count more, less or the same as closing the Guantanamo prison camp, filling Cabinet posts or passing the economic stimulus bill?


• When is it time to grade? Like defining the measurement scales and methods of analysis, the grading timeline should be predetermined. We've seized upon the 100 day mark but, in Washington time, that's practically light speed -- probably not the best time to hand out a report card. Many pundits ended up giving the President an "incomplete" because so many initiatives were in progress (though it would have been more accurate to say, "it's just too early but here's what the trend looks like.").

In days leading to April 29th, the President's staff repeated the message that 100 days is just a number, it's arbitrary. But what did we see on that Wednesday night? The President took the prime time stage to grade himself. Rather than dismiss the inevitable, he saw an opportunity and leveraged the milestone. The President used his position to choose the parameters, select the subjects and weigh the outcomes. If nothing else, and no matter where you are along the political spectrum, that should get a high mark for public relations.

The Secrecy Bucket is Full of Holes

Get Used to It

The following was published in PRWeek:

The FDA has been under fire for years. Approvals are too slow. No, approvals are too fast. Inspections are not rigorous enough and enforcement is too weak. No, FDA is over-reaching. There's too much interaction with industry. No, there's not enough. This push and pull has been played out in Congress, in the industries that FDA regulates (or hopes to regulate), in advocacy organizations and in the news media.

How do we know so much about some of these sharp divisions and controversies? It's because there have been loads of information leaking out of the FDA -- internal disputes, data allegedly ignored and stories of staffers being pressured to make various decisions. To plug the holes, Acting Commissioner Frank Torti sent an internal memo last month reminding staff about the types of information that must remain proprietary. Want to guess what happened next? Yup, the memo was leaked (and criticized by those who believe such a memo inhibits transparency).

Dr. Torti sent a farewell memo the other week to FDA staff which -- no big surprise -- was leaked, too. (He is returning to Wake Forest University to make room for incoming Commissioner Margaret Hamburg.) Despite the roiling atmosphere, he had some interesting perspectives and high praise to share with the agency: "The FDA is now defined by others. You must speak up and take the FDA back. It's yours, not theirs. You do more good day in and day out than most others, inside or outside of government." He added that, "what's written about the FDA is always from the outside, and I wish there was a way we could communicate what we've done, sometimes under very difficult circumstances."

I see three key points. First, the FDA has, indeed, lost control of its message. Regaining its public relations footing is possible but the agency is in a tough spot: dealing with hugely complex issues that can defy the sound bite, being overseen by elected officials eager to score political points, walking a tightrope trying to balance on the safety and efficacy of new drugs and devices, the list goes on. And when they tried to get some PR help late last year, it backfired. They were taken to task for awarding a no-bid contract.

Second, while transparency is crucial (as I have written here in the past) it cannot be used as a blunt instrument. There really are secrets that must be kept, at least for some period of time. Premature release of information can create a panic among patients in the case of drugs and devices, or among the entire public in the case of food. Or, there may be patent issues or patient information that demand confidentiality.

Third, we need to examine just how much secrecy we should expect these days. Our interest in inclusion means more people are exposed to secrets. More people means more mouths. And with people involved in social issues in addition to work, they often feel forced to choose sides. I can remember working for Roche and getting a call from an HIV/AIDS activist asking me to confirm some data that the company had sent down to the FDA just hours earlier.

The push toward more secret sharing is bound to accelerate. We have a generation growing up on Facebook, MySpace and Twitter, and all the other generations are aching to catch up. The amount of personal information people are willing to share is stunning. Clearly, the need to unleash our inner narcissist has overpowered our interest in keeping information private. A secret isn't what it used to be.

When an Ethics Company Does Wrong

Lessons From Coast IRB

Some of you know that I've been teaching Research Process & Methodology one night a week this semester at NYU's M.S. program in Public Relations and Corporate Communications. One of the concepts we discuss is confidence - what it means to have confidence in results, how to achieve it, how to measure it, how to determine the amount you actually need. The first thing we started out with, however, was ethics. Indeed, all of the students must pass a test given by NYU's University Committee on Activities Involving Human Subjects - the school's Institutional Review Board (IRB).

Special treatment on the subject of ethics in public relations? Yes, we're serious about this. The fact that some think it oxymoronic is, in fact, a crisis in confidence. With less than solid ethics, we risk creating a false or negative impression of ourselves, our business and our clients.

Ethics and confidence. Everyone knows that they exist in proportional units - the more the ethical behavior, the higher the confidence we have in the message, product, person, whatever. It's all part of the corporate reputation equation. Yet, each day we find new ways to rip ethics and confidence apart.

This is where we come back to the IRB. If there's ever a place where ethics and confidence should be at their most high, it's with research involving human beings. Unfortunately, such was not the case with Coast IRB of Colorado Springs. Federal investigators from the Government Accountability Office (GAO) concocted a fictitious clinical trial for a made-up medical device and attempted to get several IRBs to approve the study. Coast was the one that got out its rubber stamp.

Coast's press release last month said the Company had uncovered a "Congressional 'Sting' Operation." And, in testimony last week to Congress, Coast's CEO, Dan Dueber, complained of "extensive fraud" by the government. But the tune has changed. Now on their web site, Dueber says, "Coast IRB is cooperating fully with the Food and Drug Administration," and that efforts are underway to change "everything" and revamp "every aspect of the company."

Fortunately, no one was harmed although this episode called into question the hundreds of other studies Coast had approved. Those studies are continuing though Coast is banned from approving any new studies or adding patient volunteers to existing studies until the company can be brought into compliance.

Some of the key points I see are:

• Follow through on your promise. Coast IRB says its mission is "to protect the rights and welfare of subjects in clinical trials by providing and ethical and thorough review in a timely and efficient manner." Mr. Dueber, please review.

• Take responsibility. The Company's first reaction was to shift the blame - to the GAO, no less. If you're a company built on ethics, stick to the code.

• We need ongoing monitoring and reporting. Ethical codes stand only as long as there is a commitment to the enforcement of those standards.

• What's best for your audience, your customer, is what's best for you. James Grunig put it succinctly in his Symmetrical Communication model: the organization must consider the public interest to be at least as important as its own.

• Attempt to reassure and apologize. I did not observe any effort to address the hundreds of investigators and thousands of patients participating in Coast-approved trials. Try showing some empathy.

Disclosure - Keep It Coming

Try to Avoid Taking Two Steps Forward and One Step Back

Slowly but surely, pharmaceutical companies are stepping up. Unfortunately, at times (too many times) it's been painful to watch the industry progress toward a more open and transparent orientation.

On the good news side, Pfizer announced that it is the first pharmaceutical company to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). This helps to ensure the ethical treatment of clinical trial volunteers no matter where the research is conducted. The accreditation process is rigorous and took 15 months.

On the bad news side, this is 2009. Reports of unethical clinical trials have been popping up for decades. Indeed, Pfizer said that "AAHRPP accreditation is another step in Pfizer's ongoing efforts to earn public trust for integrity in research." So, why has this taken so long and why is Pfizer the only pharmaceutical company to mark the milestone so far? The AAHRPP has been awarding accreditation to programs since 2003.

This reminds me of the years that it has taken for pharmaceutical companies to post information about their clinical trials in public databases. Even after it was reported that a number of pharmaceutical companies were cherry-picking data from selected clinical trials that favored their investigational products, there was intense resistance to disclosing the existence of the previously unknown studies. Only after exposure in the news media and threats from Congress did the industry acquiesce. And still there's a steady flow of news about critical information being withheld here and there from the FDA.

There's just too much kicking and screaming, and it's not only about the progression toward more openness. Think of the history of the Medicare drug benefit, or instituting reforms on gifts and promotions.

The industry is full of smart, driven and ethical people, and they are supported by a lot of smart, driven and ethical consultants. I'm sure that they all recognize that the best way to run a business and to manage an issue is to move the information -- good or bad -- out quickly. More often than not, it's the tone and timing of the message that matters more than the severity of the issue. In practice, though, it's a different story. Of course, there are legitimate secrets and there are sometimes limits on what can be said. Still, we see companies (and governments and all manner of institutions) undermining their reputations by dribbling out crucial information over long periods of time.

There are lots of issues out there. Many companies are good at taking stock of their situations, writing extensive Q&A documents, developing "what if" scenarios and building advocacy networks to support their positions. But a lot of companies stumble on the next step -- getting out ahead of the issues. They're coming, you can see them. So, step over them, step around them, confront them head on, whatever. Just don't get run over again.

The World's Shortest Diet Book

It's All There in Clear, Concise Messages

I went to my local bookstore the other day to look at the management and leadership books. It was a mission to do a little competitive intelligence, since I'm working on one myself. (Yes, I do think there's room for one more! And if you know of an agent or publisher willing to work with a first time book author let me know.) On the way to my target, though, some catchy titles in the aisle of diet and weight loss books caught my eye. I diverted over there and... yikes. What a mess. How could anyone make heads or tails out of all the claims and contradictions?

Could this be an opportunity to work on a second book? Could I retrieve some of my long ago training in nutritional biochemistry, and meld it with my career in communications and passion for health and science literacy?

There's a huge need to be sure. The National Institute of Diabetes and Digestive and Kidney Diseases reports that two-thirds of U.S. adults are overweight or obese and nearly one-third are obese. Attempting to meet this vast market are the hundreds of fat-burning, colon-cleansing miracle products seen in advertisements and infomercials, and the thousands of books that claim to be the solitary answer to such a vexing and pervasive problem. (Message to the FTC and FDA: please help protect a desperate public from these purveyors of junk science.)

So, I got serious for a moment but then realized that I couldn't put an entire book together. I couldn't even think of enough material to fill a page much less a chapter. Why? Because it would be the world's shortest book. In my view, it all boils down to four words:

Eat less. Exercise more.

As communicators, we're taught to make the messages few, simple and memorable. I think I aced that test with my book title and book in one.

OK. Maybe there's a little bit more. There are different body shapes, different rates of metabolism, different personality types as well as economic issues. Unfortunately, when trying to stretch a dollar, junk food can often fill the belly at a lower cost. There are some people who must have a thorough medical examination to search for underlying causes of weight gain, and others who need some intervention to help them get jump-started be it through counseling, pharmaceuticals or surgery.

But the formula is pretty simple, nevertheless. If you don't put enough gas in your car, it dies while you're driving. Put too much in when it doesn't need it, you have an overflowing, dangerous mess. The key, therefore, is balance.

Michael Phelps, the record-shattering swimmer, gives us balance in the extreme. Did you happen to see one of those "up close and personal" vignettes from the Beijing Olympics where he was eating one of his meals? It was like Nathan's hot dog eating contest came to Animal House. Anything and everything was going down his gut. Yet, he's won more medals than anyone in history and hangs in poster form in many a teenager's room. He balances the ingestion of 10,000 calories with 10,000 worth of exercise.

I know my message is simplistic and I know also that the execution is not always so easy. Our bodies and our lifestyles change with age. Keeping in balance gets harder. We all know that we should eat a nutritious, varied, well-balanced diet. So, if one key is balance the other is expectation. We need to take the long view and not hope for or plan on a rapid reduction in weight. The goals must be achievable and bite-sized. With this in mind, I should double the length of my diet book:

Eat a little less. Exercise a little more.

Out of This World PR

This article also appears in odwyerpr.com.

How a Comedian Outwitted Some Rocket Scientists

I have been fascinated by our space program for as long as I can remember. Indeed, one of my earliest memories was watching John Glenn lift off in Friendship 7 in 1962 and seeing my mother cry. She said she didn't know if he would make it back.

Yes, spaceflight is serious business. But Stephen Colbert, the outstanding political satirist of Comedy Central, knows how to send us over the moon at NASA's expense.

You may have heard that NASA launched an on-line contest to help name a new module (now referred to as Node 3) for the International Space Station (ISS). Hoping to follow the tradition of naming past modules with lofty, cosmic names (Node 1 was named Unity, Node 2 was named Harmony), NASA opened up voting with Earthwise, Legacy, Serenity and Venture. They also allowed write-in votes.

Here's where Mr. Colbert comes in. This man is the Donald Trump of comedy. He has already managed to get a new species of spider named after him (Aptostichus stephencolberti) and a flavor of Ben and Jerry's ice cream (Stephen Colbert's AmeriCone Dream). In 2006, he asked viewers of his show to submit his name to Hungary's Ministry of Transport for their on-line effort to name a new bridge over the Danube River. It was reported that Colbert won the first round of voting with over 17 million votes. I should note that the population of Hungary is about 9.9 million. The Ministry then changed the rules.

For the NASA contest, a total of 1,190,437 votes were cast. Colbert scored 230,539 votes, outscoring Serenity by more than 40,000 votes. So, what does NASA do? Well, according to Space.com, agency personnel are floating the idea of naming the Station's new toilet in the module "Colbert." This is proof that NASA should stick to space and aeronautics and not venture into comedy. A Colbert space toilet isn't funny - I think it's demeaning.

Although the rules of the contest state that "the results are not binding on NASA" and "NASA reserves the right to modify these Contest Rules at any time," what happened to fair and square? But being an optimist, I'm wondering if there's a win-win in this somewhere.

NASA has abbreviations and acronyms for everything, so why not now? Here's my idea: For Stephen T. Colbert, let's come up with something space-like using his initials. Node 3 could become the STC - Serenity Transorbital Compartment. Or something like that. NASA gets to use the Serenity name and Colbert gets his initials immortalized (at least until the ISS burns up in the atmosphere after its service life is over).

NASA could embrace this situation. Why not invite Colbert to tour the STC mock-up or to the actual launch at the Cape? Why not have him on a video link with the orbiting crew during the taping of his show? Sure, he'll make fun and get some laughs but these would be sure fire ways for the agency to make science more accessible and gain a huge audience.

So, I've done my part to help solve this planetary crisis. Now it's time for NASA to learn a few communication tips:

• Don't ask for something that you don't want to hear.
• Changing the rules makes one look like a sore loser.
• In the age of on-line vote stuffing, enforce the one person, one vote rule.
• Plan strategically, and think through the intended and unintended consequences of any action.
• Play to your strengths - science not satire.

Healthcare Journalism Needs a Recovery Plan

There’s More Evidence That the Profession is Suffering
I’ve spoken out before (Give Me an S, Give Me a C, Give Me an…, Personalized Promise, Heading in the Wrong Direction, NEJM Makes It Official) on the need for increased health and science literacy. This is crucial if we are to promote evidence-based decision making, increase productivity, enhance economic competitiveness and ensure the continuation of the democratic process. The Obama administration is sending the right signals but a survey of health care journalists conducted by the Kaiser Family Foundation and the Association of Health Care Journalists shows that the state of health and science media, like the economy, may not have turned the corner quite yet.

In response to the question of “what do you think is the biggest opportunity in the field of health care journalism?” the number one response was the “ability to educate and empower consumers.” Great. But overall they expressed concern about “staff cutbacks, less time for reporting, fewer resources for training, and more pressure to produce short, quick hit stories.” Almost all (94%) said bottom line pressure hurts the quality of health news. Sixty-five percent judged the quality of health coverage as fair or poor, and only one percent said it was excellent.

Even so, respondents had “a cautiously optimistic view of the direction in which health journalism is headed.” While 24% said journalism in general was heading in the right direction, the number jumped to 52% when asked specifically about health journalism. This didn’t give me much comfort, though. That still left 48% who thought health journalism was heading in the wrong direction.

It’s been noted that as the amount of health and science information has grown, the amount of time and space devoted to them has shrunk. This has created opportunities for non-journalists to jump in but I, for one, don’t want to see this gap filled by consumer-generated content alone.

As for the type and placement of health and science stories, the trend of focusing on political or business angles will continue. And with the politicization of healthcare – be it Medicare, Medicaid, FDA, stem cells or pharmaceuticals – it was not surprising that the business/economics of health care, health care quality and performance, and health policy were all ranked higher than medical research and science as areas where more training was needed.

Healthcare journalists are hungry for ongoing opportunities to elevate their knowledge and skills yet 43% said training opportunities have declined. Twenty percent said opportunities increased. In a report to the Kaiser Family Foundation written by Gary Schwitzer of the University of Minnesota, a radio reporter said, “My biggest challenge is having enough background and training to cover health care. This is an incredibly complex and challenging beat. People are pitching stories left and right and if you don’t have a way to analyze their claims, you could be doing your listeners a big disservice.” To be sure, the proliferation of junk science continues to give me great concern.

This less than rosy picture comes to us despite the availability of some terrific training programs, workshops and “boot camps” underwritten by various foundations, government agencies and companies. I hope that even more can be done, and find ways to help journalists get the time and resources to attend. Indeed, 69% of the respondents reported that opportunities for travel declined in the past few years.

Maybe this will all turn around with time. I’m going to hope that we’ll see demand for health and science reporting increase as we continue to shake off some of the anti-intellectualism that has bogged us down. I’ll hope that we’ll see more public and private investment in training and continuing education. And I’ll hope that we’ll see some newsrooms staffing up as the economy recovers.

New Bedside Manners

Tell Me – Not the Internet – How You Feel
I haven’t conducted a formal survey but I’d be willing to pull some money out from under my mattress and bet that two of the most often-used words these days in the worlds of business and politics are transparency and accountability. There’s been little choice, if you think about it. The collision between out-of-control companies and politicians with public outrage and instant communication tools has sparked unprecedented demands for truth and openness.

The push to expand transparency and accountability has given rise to numerous rating sites on the internet – everything from food to teachers to virtually any product. This long list includes about 40 web sites where one can rate their healthcare provider.

In an AP story last week, “Docs seek gag orders to stop patients' reviews,” Lindsey Tanner reported how some physicians are coping with anonymous, negative patient commentaries on sites like RateMDs.com. Intrigued, I went to the web site and saw that over 185,000 “doctors” were rated, but this includes acupuncturists, chiropractors, podiatrists, psychologists and dentists. I clicked on the most reviewed doctors and found that the top four are ob/gyns and number five is a cosmetic/plastic surgeon. (Number six, I must note, is the fictitious Dr. Gregory House.)

It’s not a big surprise that women, the most influential healthcare decision makers in the family unit, are the most vocal. Randomly scrolling through, I found some posts to be reverential and others to be scathing. These comments are a one-way street, however. The doctor’s name is used but not the patient’s and, because of rules protecting patient confidentiality, there’s no way for the doctor to respond.

Here’s where a company called Medical Justice comes in. For a fee, they offer physicians a service that monitors the internet for patient comments and a contract (“mutual privacy agreements”) for their patients to sign where they “agree not to post about their doctor on the Web without the doctor's permission.” In addressing First Amendment rights, the site states that “Patients are free to discuss their care with other doctors, family, friends, licensing boards, attorneys, and any number of institutions. Mutual privacy agreements do not create a choice between healthcare and one's right to free speech (as some have erroneously claimed).”

So, on one hand we have sites that allow unfettered forums for blasting (or praising) health care providers. On the other hand, we have an effort to limit where patients can express their views. Here are a few thoughts:

Health care providers need to accept the reality of our information society. Telling someone they can’t do something is a sure-fire way to promote the opposite of what is intended.

Entering into a contractual arrangement with a patient over issues of speech may raise questions about the doctor’s motives, potentially damage the relationship and erect a barrier that decreases communication.

If women are using this medium most frequently, then some special attention needs to be paid to their concerns and communication preferences. There should be an office environment where concerns can be aired before they hit the internet. And, if face-to-face commentary is uncomfortable, perhaps an anonymous mail-in survey should be made available.

While both sides have legitimate positions, I think we require a third hand. What’s needed is a forum where patients can post justifiable comments, where those who read them can have some assurance that no axes are being grinded. Health care providers need assurance that inaccurate, reputation-killing commentary is kept off the web, where it’s so difficult to excise.

Patient advocates and organized medicine should collaborate on setting standards and policies – a code – for responsible, ethical rating sites. Both patients and their doctors need to get on the same side of the fence on this issue. When it comes to your health and wellness, I can’t think of an issue where it’s more important for all the parties to act as a team.

Knowledge Base

Perspectives on the State of Research Readiness in Public Relations
The following was published in the March 2009 issue of PRSA’s Tactics:

I recently finished teaching the Research Process & Methodology course at NYU’s master’s program in Public Relations and Corporate Communications. Serving as an adjunct professor is a great outlet for the coaching and mentoring that I’ve missed since becoming a communications and business development consultant in 2006. But this particular experience left me a bit unsettled. It drove home the fact that research remains a weak link in the development, execution and evaluation of PR programs.

Becoming Involved
I was invited by my friend and the academic director of the NYU program, John Doorley, to guest lecture within the program and later teach the Strategic Communication course. Then came a request to teach Research Process & Methodology.

Here, however, I had some reservations. Like Strategic Communication, RP&M was mandatory, but this was a subject that most students dreaded. We were to cover qualitative research, including interviews and focus groups, and quantitative methods such as sample selection, questionnaire design and data collection and analysis. The objections were along the lines of, “We’re the creative people, not number crunchers. We’re supposed to be intuitive — that’s why people hire us!”

Even though I had the feeling of being dropped behind enemy lines, I was energized by the opportunity to convey the need for more rigor in PR programming. Now, more than ever, it is necessary to identify competitive, political and social issues; understand key audiences, their preferences and perceptions; differentiate companies and products, and demonstrate the value of communications on business objectives and measure outcomes.

Clients crave creativity but they don’t want guesswork. To be effective, we need information to drive insight. If PR professionals want to be strategic, then research is required to help make the best possible predictions about the potential intended and unintended outcomes in PR programming.

Getting Down to Business
Most of the students’ anxiety was assuaged soon after starting the first class. Setting unambiguous expectations and goals were key. I made it clear that I did not intend to transform them into statisticians or programmers. Instead, they would become more informed users and evaluators of research. To reach this endpoint, and to keep the students engaged for the six hours per week that we met, we worked to strike a balance between theory and application — a mix of book learning with in-class exercises.

In one class, we reviewed and evaluated a variety of award-winning PR case studies including corporate rebranding, the launch of new products and national events. They were eye-opening — even for me. If these were chosen to represent the best work of the industry, the pinnacle of public relations, then we — the profession — had some work to do. Why did those objectives look like a bunch of tactics? What did “we achieved a high level of buzz,” mean? Was the result at all meaningful to the business? One hundred million impressions is a big number, but did the message reach the intended audience?

This analysis helped make the research process more real, more accessible. By the end of the course, the role of research in public relations was duly elevated in the minds of the students. They didn’t leave with a list of formulas memorized, but they did leave knowing how to ask good questions and take their place at the table of strategic PR planning.

Taking the Next Step
While feeling rewarded by the response of the students and the opportunity to connect with some terrific guest experts, I was left with some concerns. After I reviewed the final projects — detailed proposals for their Capstone papers — and posted the grades, I wondered about the state of research training in PR agencies. How do these firms really value research? What expectations do they have of the staff? How is research taught in other programs outside NYU?

I decided to send a three-question survey to the top 25 agencies. I inquired if they had an in-house training program, which courses they offered and if any were mandatory. Only eight of 25 surveys were returned — perhaps these were the firms that were most proud of their programs.

However, the results were still revealing. As one would hope and expect, 100 percent of the respondents offered a variety of courses and workshops. All of the agencies had programs in the traditional areas of public relations: writing skills, presentation skills and media relations. Some offered training in issues/risk/crisis management, advocacy/third-party relations, conflict resolution and digital media.

On the other hand, only three of eight said some or all classes were mandatory. I found this to be both surprising and disturbing. Competitiveness, differentiation and excellence are all based on learning.

When it came to metrics and numbers, the story did not improve. Only half of those responding reported that they offered training in research methods and/or measurement. Respondents at 50 percent of these agencies offered courses on budgeting and/or forecasting. I wasn’t hugely surprised by these answers, as I’ve known for a long time that numbers and words don’t mix for many PR practitioners.

But it’s time to push old habits aside. Indeed, these tough economic times reinforce the importance of numbers. “Good enough” is out. Precision is in. Of course, creativity and fresh ideas are essential. But we need balance: The same urgency that is placed on learning, thinking and executing the soft side of public relations must also be placed on the hard.