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The problem isn't that there's conflict between safety and efficacy or between getting a useful medicine to market and protecting the public from a dangerous one. The problem is that the conflict isn't well structured. That needs to change.
As i look through this issue of Pharm Exec, I realize that there is an unintended theme running through it: Over and over our authors look at the kinds of structured conflicts that keep the industry functioning (and that threaten it when they get out of balance.
Our profile of the generic giant Teva (on) is a good example. Here is a company that thrives by attacking the patents of innovator companies, creating products based on other people's R&D, and pricing in a way that drains profits away. But at the same time, the generics industry plays a healthy role in pushing research-based companies to innovate, controlling healthcare costs, and creating a context in which companies can command premium prices for truly innovative drugs. The relationship between innovator companies and generics companies may be difficult, but it serves the public interest—and arguably the long-term interest of pharma. But the conflict between the two sides is in constant need of adjustment as each side jockeys for advantage. It's urgent that neither side gain a permanent, overwhelming advantage.
Structured conflict doesn't just happen between companies and industry segments. It also takes place within companies. And a good example of how a company can encourage and focus this sort of conflict can be found in our article on Wyeth's new approach to R&D, on. Much of the program has to do with new concepts and techniques—adaptive trials, collapsing research phases together, and so forth—but to make the concepts work, the company has restructured R&D in ways that enhance debate on key issues.
For instance, drug candidates used to be managed by teams that handled a single drug. That meant that the people closest to the project were invested in its success; they had no incentive to encourage full-fledged competition for resources between their product and others in the pipeline. Today, teams manage the portfolio of an entire clinical area. The competition between drugs is no longer an obstruction for them; it's their central concern.
Wyeth's new approach builds in debate—and conflict—at almost every level. There's the potential for wrangling, but Wyeth has reconfigured its governance structure to provide venues to resolve the inevitable conflicts. Debate is no longer an adverse event, as it so often can be—it's the point.
A third example shows a system in trouble. We examine the recent survey of FDA scientists conducted by the Union of Concerned Scientists, which has a long-term concern with preserving the independence of scientific opinion in public affairs. The results of the survey are worrisome; far too many of the scientists feel unsupported by management and exposed to outside pressure. If that pressure distorts scientific data, it is a bad thing. The public and the industry need the validation of science.
But it's important not to overread the data. The problem is not that there is conflict—between safety and efficacy, between getting a useful medicine to market and protecting the public from a dangerous one. If there is a problem it is that the conflict isn't well structured. We need to get past the idea that unhappy scientists or agency whistleblowers automatically mean that something is wrong at FDA. We have ample evidence that well-managed conflict is a good thing. It's time to extend that insight into the regulatory world. What we need is not less conflict, but better conflict.