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How to Be More Truthful

Pharmaceutical ExecutivePharmaceutical Executive-06-01-2011
Volume 0
Issue 0

Suggestions for testing new ways of addressing difficult issues of risk

Establish a trusted arbiter, or a panel of arbiters, of relative risk issues who could address such questions as:

  • How does the risk of treating diabetes stack up against the risk of not treating it?

  • How does the risk of a very effective treatment with serious problems stack up against a not-so-effective treatment with annoying problems that might stop you from taking it?

  • How does any of this look next to the risk of a diet dominated by Big Macs? Even if your lawyers would let you do this (which they won't), people wouldn't believe you.

And who might these arbiters be? What about a group of nurses, patients, and providers funded, in part, by industry?

This well might work if a reputable third party selected the trusted arbiter or assembled the panel of arbiters and the companies set clear, transparent rules for how data would be presented to the arbiter(s). There is, of course, no way of comparing the heart attack risk from eating five hamburgers a week with the risk from a new medicine, but the different risks could be explained by using some variant of the traffic light system used in Europe for food labelling.

Or it could start in an area that confuses everybody—osteoarthritis, for example. Do we really think self-medicating periodic back pain with high-dose aspirin is safer than someone using up their stockpile of Vioxx? (OK, the probability of that question actually being on the table is nil, but it is the kind of question that should be considered). There is, of course, also no one answer: a Cox 2 inhibitor is probably an acceptable risk for someone with a low preexisting risk of cardiovascular events but may be much more problematic for the Big Mac eater.

Who Do We Trust?

Establish new, standardized ways of allowing a panel of experts to talk about risk.

This would include a variety of scenarios in language that ordinary people can understand. Today, many patients will ask their doctor: if you had a brother/sister with my symptoms and my risks, what would you advise him/her to do? So, let a trusted third party (or a panel) pick the experts and give them a set of scenarios about just these kind of situations. Patients can then see how they relate to each scenario (accepting that none will be a perfect fit). Pharma could submit profiles and data, but, again, the framework would need to be transparent This may sound impossible, but FDA advisory committees, despite all their problems, haven't yet been swamped by politicking, lobbying and corruption.

Mark Chataway is co-owner at Hyderus/Baird's communication Mangement Consultants. He can be reached at mark.chtaway@bairdscmc.com

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