Thursday, April 30, 2009

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.

Thursday, April 23, 2009

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.

Wednesday, April 15, 2009

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.

Tuesday, April 7, 2009

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.

Wednesday, April 1, 2009

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.