It’s time to update your crisis communications plan.  Before the holidays.

In case you missed Andy Greenberg’s recent interview with WikiLeak’s Julian Assange in Forbes, Assange says he is turning his sights on corporate America.  High on his list? Pharmaceutical companies. Assange says he has unpublished, damaging documents and he refers to the companies in the plural.

I love how Greenberg describes Assange as “the prophet of the coming age of involuntary transparency.” Love it or hate it, involuntary transparency pre-dates WikiLeaks (although it wasn’t so easy), giving you a resource. This is a good time to study how other companies have handled such leaks in the past.  Note who put their customers first and how they did it.  Note who is still trying to pull their feet out of their collective mouths.  Think about how you would handle it differently. Better.

How much is reputation worth?

By Sally Church

There has been quite a lot of noise in the media recently over the results of meta analyses of various clinical trials following the FDA committee meeting on Avandia in diabetes.

In modern medicine large scale studies are often limited in that they are designed to prove that a drug is generally or broadly safe and effective in order to gain approval in a wider population. We must remember that patients in the trials tend to be more motivated and have a better performance status than those in the general population, so extrapolating data from one to the other is fraught with difficulties.

One of the challenges is that sometimes a relatively rare (<5%) but fatal side effect may not show up in a short term trial, but will eventually emerge with more chronic use in a broader population. Of course, a relationship between two variables does not imply causation, therein lies the rub – how do we differentiate between spurious correlations and a real effect?

Unless health authorities are going to change the regulatory landscape to insist on expensive 5 or 10 year follow-up in larger epidemiology studies, this problem is going to recur time and time again. The current compromise solution is insistence on more stringent REMS in post marketing surveillance studies, although this is somewhat flawed by having industry monitor their own studies and not all companies are reliable at performing such an important task.

Meta analysis can have good effects though.  For example, we have seen that retrospective analysis of clinical trials in lung cancer with EGFR inhibitors helped determine which patients responded and why.  This led the EU and Japanese authorities to modify approval of the relevant drugs (Iressa and Tarceva) for EGFR mutation positive disease, thus allowing patients most likely to respond to receive appropriate therapy, while sparing those unlikely to do from systemic side effects and therefore receive a more appropriate treatment that might work.

In this respect, oncology is probably ahead of other therapy areas, since retrospective and prospective meta analyses have both been shown to be helpful, matching the underlying biology to treatment of the disease.

Sally Church is the author of the Pharma Strategy Blog and co-founder of Icarus Consultants.

Because those of you working in pharma and biotech are, understandably, sensitive to what may look like a ‘negativity rehash;” I want to say for the record that my intent is positive: to examine this topic in a public forum so that those of us who care (and know about RS Snapshot, so they can participate – please forward this to the best minds you know!) can find ways to constructively change the situation. Knee-jerk mistrust of the healthcare industry helps no one, patients least of all.  I’m not the only one who feels a sense of urgency about this.  Building trust doesn’t happen overnight and there is no time to waste.

Please let me know: What topics you would like to see covered in this series?