It happened again! Another government agency—this time the USA Food and Drug Administration (FDA)—has made another major contribution to bad information design.

This time it comes in the form of ‘New Prescription Drug Information Format to Improve Patient Safety’

http://www.fda.gov/bbs/topics/news/2005/NEW01272.html

Superficially, this is a good initiative:
“Providing healthcare professionals and patients with clear and concise information about prescriptions will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare,” said HHS Secretary Mike Leavitt. “By improving the package insert to make it more useful for healthcare providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients.”

I would not fault the laudable and wholly worthwhile intentions. Avoiding death and harm is a good idea. This is, after all, why pharmaceutical companies are required to spend millions on testing the effectiveness of new medicines, and the likely side effects or interactions with other medicines. It’s only when they have done all these things to the satisfaction of agencies like the FDA that they are allowed to market the medicine. In other words they have to provide EVIDENCE that the medicine does what they say it does.

But then we come to the information that goes with the medicine.

The FDA is fully aware that medicines are information dependent products. Without information medicine is unusable and dangerous. But where is the EVIDENCE that the information is ‘clear and concise’, or that the FDA is ‘making it easier for [healthcare providers] to explain the benefits and risks of medications for their patients’? Why is it that the stringent requirements for EVIDENCE in support of the medicine itself don’t apply to the information on which it is dependent?

Reading through the ‘Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products’, its clear that the FDA has consulted widely. So they have partially scoped the problem, but they provide us with no definitive description of what it is that people should be able to do with the information—the information design equivalent of the specific action of the medicine. They provide no EVIDENCE on the performance of the existing labeling—what people can do with the existing labels. They provide no description of the writing and design process they have gone through to arrive at their prescribed content or format. And finally, they provide no EVIDENCE to support their claim that the new content and format will indeed be an improvement. If they have no EVIDENCE from before, how can they make the claim that there is an improvement?

BTW, the FDA is far from alone in making these contributions to bad design, but it’s still unacceptable.

If I was getting financial advice, I would (I think) like it to be ‘clear, concise and effective’. And that is exactly what the Australian Securities and Investment Commission (ASIC)—the Australian Government’s regulator of business and finance—introduced as its policy in 2004. So far so good, or so it seems…

The problems begin firstly for the writers of financial advice when they ask: how do I know what I have written is clear, concise and effective? Moreover, as this is a legal requirement, what legal principle or test do I apply to what I have written to make sure that it is clear, concise and effective? And in the worst case, suppose someone takes me to court claiming that my advice is not clear, concise and effective, what would be my defence, and how would the court decide?

For consumers, the problems are just as obvious, and no less difficult. Suppose as a customer you are given a document that you are told is ’clear, concise and effective’, and you cannot find what you are looking for, make sense of what you find, or use it to make a decision. Who’s at fault? Many consumers will say silently to themselves: “I must be stupid, and that makes it my fault!” If added to this ’clear, concise and effective’ document is a ‘Crystal Mark’ (as in the UK) or an ‘Award for Clarity’ (as in Canada), you can virtually guarantee that the document is beyond criticism, like the emperor’s clothes. (In my view such ‘Marks’ and ‘Awards are a pernicious evil and I hope never come to Australia. At the very least they are questionable under the ‘misleading or deceptive conduct’ provisions of legislation that is there to protect consumers. But more importantly, they inhibit legitimate complaint and criticism. If a document is clear to consumers, why do you need a certificate on every copy of the document to say so?. Who is assuring whom, and more significantly, who is promoting whom? In the guise of ‘empowering’ consumers, they in fact disempower everyone.)

These are some of the issues which this type of regulation gives rise to. I say ‘type of regulation’ because this is just one of the possible ways in which regulators can try to control business in the public interest. It’s what I call a ‘content-based’ approach to regulation; it controls business by requiring the mandatory inclusion of some or all of the content of a document, label, etc. As long as the mandatory content is present on a document, the document is legal.

In many jurisdictions, a rigid content-based approach is common. The resultant documents are usually incomprehensible to most customers. But the regulators can claim that they have discharged their duty to protect the public interest by controlling industry. And the industry, parts of which have no interest in clear communication with its customers, simply complies. On the question of clear communication with the public, both partake in a complicity of silence but claim to have discharged their public obligation.

ASIC’s approach is content-based but it seeks to control the quality of the content of documents rather than rigidly prescribing the content. It is potentially better. Note that I say potentially better, not actually better. It will only be better if the questions such an approach raises are addressed.

This may be happening. The demand for quality has resulted in a highly productive dialogue between the financial services industry and the regulator, out of which is emerging a body of practice that in many respects has the capacity to develop something far more useful than the requirement to be ‘clear, concise and effective’: what I have called a ‘performance-based’ approach to regulation, where the emphasis is on the tasks people can perform with the documents.

But there is a long way to go.

Last year, ASIC produced an example of what it claims was an example of a ‘clear, concise and effective’ Statement of Advice (SOA) for use by financial advisors. How do we know that this example is ‘clear concise and effective’ and for whom? Well, we don’t. ASIC claims it is, but offers us no evidence in support of its claim.

This is the next step—providing credible evidence in support of such claims. To do this requires a very different approach to regulation and, for that matter, self regulation by the industry. It requires what I have called a ‘performance-based’ approach to regulating information provided by industry to consumers. Instead of focusing on the content of the documents, the focus should be on how well consumers can use the documents. And that requires industry and regulator to agree on what it is people should be able to do with the documents, before they create examples, and then provide evidence to show that the examples can indeed be used by consumers to do these things. I’m encouraged to see that the Financial Planning Association in Australia (http://www.fpa.asn.au) is rising to this challenge through their guidelines for their members: Guide to the development of effective Statements of Advice.

I hope that many follow their lead.

So ‘Clear concise and effective’ was a good beginning, but it will never, in itself, be either clear, concise, or effective enough to regulate financial information.

This space—this blog—has been set up for months, and was there in an earlier form as my director’s notes, but somehow never got going. Travelling, settling into our new home in Melbourne, cooking, carpentry, and gardening (not to mention the day job) all seemed to get in the way. Then there is my old friend, procrastination, always ready to help me out. But in the end, here I am.

The problem is, where to begin? I have a long list of things that I think may interest you, my reader. But there is no way of choosing—not without a conversation—and this is not a conversation. As the title suggests, it’s a soap box. So I shall go where my gut and keyboard takes me… You are of course free to heckle.

Position, position, position! Isn’t this what real estate agents say about the three most important attributes of a desirable property? Well, in a different way—using the word position in a slightly different context—I’ve come to the view that position, position, position, are the most important attributes of communication between people. When I have conversations I speak and listen from particular positions. Others taking part in the conversation do so too. In fact, I’ve argued in one of my books that there is an inexorable logic—a logic of positions—that governs what we can and cannot do in conversation. Well, enough of theory for the moment. I must watch myself and not get carried away up my own spiral of abstraction—something I’m fond of accusing others of doing.

Here is a specific issue of position: the relationship between people and a health system. One of the repeated mantras among today’s health professional is:

“We must involve patients in the decision-making about their health.”

I came across it again, just a few days ago.

“The National Patient Safety Agency (NPSA) today previewed to the NHS a new campaign to empower patients to take a more active role in managing their health.”

http://www.npsa.nhs.uk/display?contentId=4795

Good stuff? Progress? Enlightened? No, not really. At the heart of this well-meaning mantra is a misunderstanding.

Here is how I manage my health. I spend a lot of my eating, drinking and occasional exercising with one eye on whether or not I am doing these things ‘healthily’. If I feel unwell, I go and lie down. If I am in pain, I take a pill. If my throat hurts or irritates, I have chamomile tea with honey, lemon, and scotch. If I feel anxious and worried, I go for a long walk. Only when none of these work, or I am struck by some catastrophic failure of my body, do I ask for help from the ‘health system’. I don’t know what the proportions are, but at a rough guess I manage my health for 99% of my time and ask for help from the ‘system’ 1% of the time. So how come I’m being asked to take a ‘more active role in managing my health’. Is 99% not enough?

Either somebody in the system wants to take less responsibility for the little I ask them to do, or they have a profound misunderstanding about the relationship between me and them. I suspect the former, but I’ll assume the latter. When I do visit a doctor or hospital it is because I have decided to involve them in managing my health. I usually do so only at the point when my own management has failed. I need help.

The idea that I need to be more involved is absurd. All this talk of ‘empowerment’ misses the point. Having overcome my reluctance to ask anyone for help, put to one side my fear of additional pain, ignored my instinct that tells me hospitals are dangerous places, and prepared myself to deal with arrogant and uncommunicative doctors, I ask for help.

It would be refreshing and reassuring at that moment and throughout my stay if someone told me what they were going to do, why, what the risks were, and what the outcome might be; it might also be helpful for me to know what it might feel like to me and what I need to do, etc: in other words good communication between me and the people I have asked for help.

Instead of this, the representative of the health system is quoted as saying:
“Safer healthcare is everyone’s responsibility. By providing practical information about safety issues and good health behaviour, the NPSA hopes to encourage patients and the public to get more involved in their own healthcare – to ask questions, discuss concerns and share their experiences with us. Informed patients are an important part of a safer patient journey.”

In other words, I should take over 99.5% of my health management, and the system may do me less harm in the 0.5% it manages, as I travel along my ‘patient journey’.

It’s time to go to 99.9% management of my health!