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Letting the public inside the drug development process may increase their faith in what we do.
Trust is a powerful determinant of personal and economic well-being. It is built through long experience and concerted effort—but remarkably fragile and easily destroyed. There may be no better example of the importance of trust than the complex relationship between pharmaceutical firms, government, doctors, payors, and patients. Patients seeking treatment are vulnerable—they must be able to trust their doctors to prescribe properly, the government to regulate well, the payors to provide access to appropriate therapies, and pharmaceutical firms to hold themselves to the highest professional and ethical standards in assessing and reporting on the safety and efficacy of medicines.
Over the past several years, there has been a multitude of media and lawsuits challenging the trustworthiness of this system—and no participant in the system has been spared. But the pharmaceutical industry has come under the most scrutiny and has, I believe, suffered the biggest loss of public trust. The consequences of this are profoundly disturbing and could potentially undermine industry's ability to continue to invent, develop, manufacture, and distribute new medicines.
These critics come in all shapes and sizes. The majority are honorable, intelligent, and well intentioned observers. Their points of view are based on life experience, political views, and direct experience with one or more elements of the system. My own views are formed in exactly the same way. I came to Pfizer (New York) after spending several years at a biotech firm. I was attracted to Pfizer because I believed the company had the resources to actually deliver new medicines to patients —something we were unable to do at a small biotech company.
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The drug development process—and the people who manage it—at Pfizer were a revelation to me. The size, technical complexity, and sheer difficulty of drug development done at scale still amazes me.
Industry, critics, doctors, and regulators agree that the ideal world would be one in which industry produces a constant stream of highly innovative medicines that are perfectly safe and accessible to all. Most of us recognize the reality that we (society) must constantly trade off one against the other. Critics challenge our values in making these trade-offs. Although I believe in the fundamental value and integrity of the system that produces miraculous drugs such as "Sutent," "Chantix," and "Maraviroc," I think we, as an industry, need to do a better job of allowing people to see into the discovery and development process so they can understand for themselves the quality and integrity that underlies our own confidence in the system.
What does transparency look like?
The leadership at Pfizer (and many other companies) recognizes that consumers need to know more about what we do and has dramatically increased its transparency. Take a look:
2002: Pfizer discloses all political contributions and begins posting clinical trials online at www.clinicaltrials.gov
2004: Pfizer begins posting clinical study results online at www.clinicalstudyresults.org
2006: Pfizer begins posting on its website all compounds in its research and development pipeline
2007: Pfizer begins posting on its website all FDA postmarketing commitments
2008: Pfizer begins posting on its website contributions of $500 or greater to US patient, scientific, and medical organizations.
Benefits and risks
Increased transparency provides patients with information about clinical trials that they might be interested in participating in, researchers with information about what work is being done and where, doctors with up-to-date information on the status of particular drugs, and regulators the ability to compare development programs across therapeutic areas and companies. As an ongoing record, it provides accountability and a comprehensive record of what research has been done —whether successful or not.
Of course, while the benefits of disclosure are real, there are risks as well. Will patients really be able to interpret results? Will physicians? Will plaintiffs' attorneys use these new data to file frivolous lawsuits, needlessly driving up development costs?
As more information becomes available, researchers of differing quality will attempt to analyze it and will publish these analyses. Many of these papers will be high quality efforts by seasoned experts. Some will not. But the public's and media's capacity to distinguish between the two is limited. And there is the rub. By exposing the underlying processes to public scrutiny, we hope to build confidence and trust—but if this information is used improperly, we could further undermine public confidence in this work.
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.
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, firstname.lastname@example.org