Can Transparency=Trust? - Pharmaceutical Technology

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Can Transparency=Trust?
Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting.


Pharmaceutical Technology


Managing the trade-off

We need to manage this trade-off by creating a balanced environment for the appropriate interpretation of these and other data. Scientific inquiry involves posing and testing hypotheses, not big "truths," but reliable, repeatable observations subject to further refinement and challenge. The reliability of the observation is a function of the process from which it was derived, not its inherent plausibility or political attractiveness. Clinical research has a long tradition of excellence.

Clinical research is founded upon placebo-controlled, double blinded trials. Generally, this means that patients are divided into groups—one gets the placebo, the other the active drug. Neither the patient nor the doctor knows who is getting what. Often, studies are triple blinded, meaning the sponsor (usually a drug company) is also blinded and does not see the results until the trial is complete. These types of studies are quite effective at managing bias in interpreting results.

Let's contrast this process with "data" provided by Kevin Trudeau on his infomercials promoting his book, Natural Cures They Don't Want You to Know About. Trudeau asserts that most drugs don't work, and actually cause harm. He exhorts listeners to purchase his book based on a series of anecdotes, including one story about a woman who was cured of cancer by taking an over-the-counter supplement. On a website promoting his book, the reader is told you can "cure yourself of virtually every disease."

I suppose you could laugh about this ridiculous man—but his books sell and his "data" seem more credible than the data derived from clinical trials. We have an obligation to try and differentiate between dangerous, self-serving demagoguery and thoughtful, rigorous, expensive, and yes, sometimes self-serving research.

Trust

We need to rebuild trust in our industry. Our first priority is, appropriately, to address those practices that diminish our credibility with stakeholders and to dramatically increase the transparency of what we do. If our friends can see how we really behave, they can better support us. If our critics can appreciate who we are and what we do, perhaps they can focus their criticisms more productively. There is no more powerful way to demonstrate integrity than allowing the world to see, in excruciating detail, exactly how we manage our business, ensure patient safety, and bring new medicines to patients in need.

John Swen is vice-president of science policies and public affairs at Pfizer Inc, 50 Pequot Ave., MS 6025–C5139, New London, CT 06320,


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