Risk: The Series

Back in the height of the debate over importation of drugs from Canada, one of the basic disagreements had to do with the supply chain. To supporters of importation, drugs were safe if they were properly manufactured and shipped to Canadian pharmacies. To FDA, the industry, and other opponents, that was a dangerously simplistic view. A great part of the value of a drug is the process that guarantees its integrity, guards against counterfeits, ensures proper handling, and delivers it to the patient with appropriate warnings, documentation, and oversight. With imported drugs, there's no process, thus no way to guarantee their safety and value. If the supply chain is damaged, the product is suspect.

Patrick Clinton

A similar issue is affecting another of pharma's products—the scientific knowledge that informs physicians' decisions and gives them a reason to prescribe. Without it, the information a physician hears about a drug is like medicine from Canada: It might be good, but there's no way to tell.

And that means pharma has to be concerned about the supply chain that brings information to the physician. Companies, of course, have had to adapt to new detailing guidelines (and new threats for those that failed to comply). But that is just the last stage of the chain, and today there is reason to worry about what happens earlier.

Medical journals, in particular, have been taking a hard look at their standards and practices and are concluding that they need to be more aggressive in rooting out conflicts of interest and promotion disguised as science. On page 54 of this issue, Senior Editor Joanna Breitstein interviews editors and publishers of top journals. They're facing tough questions: How can they tell the diffence between a legitimate author receiving legitimate assistance from a company and a corporate mouthpiece who has simply signed his name to a pharma-written article? What's the appropriate way to disclose all the work (and all the financial interests) that went into an article? What do peer reviewers need to do their job more effectively?

On paper, the information supply chain looks pretty robust, with lots of checks and balances. If a sponsor tries to impose improper conditions on a research site, the site has contract administrators to push back. Individual researchers, who live by their reputations, have strong motives to defend the quality of articles that bear their names. Journals have editors to fight for standards and the peer-review system to bring the knowledge of the research community to bear. It's the kind of system in which enlightened self-interest is supposed to lead to good outcomes.

At the moment, though, it feels like it's breaking down. Research sites are a little too willing to go along with sponsor demands. (A study in the May 26 New England Journal of Medicine surveys medical school contract administrators to see what they would agree to. While many set reasonable limits, others seem prepared to give away the store.) Researchers—at least some—are a little too willing to let companies ghostwrite their articles. There's a strong general suspicion that conflict of interest isn't always being revealed.

The finger of blame, as so often happens, is being pointed at pharma. That's not entirely fair, but it's not entirely unfair either. A system of checks and balances requires a balance of power. Pharma may have grown too rich and powerful for its own good in this particular setting.

That needs to be fixed, of course, and soon. It's no use arguing that your clinical research was valid as conducted, and that the problems of journals and others are no concern of the industry's. Remember Canada. If the supply chain is broken, the product is suspect. Information is one of your most important products. It's time to protect it.

Patrick Clinton is Pharmaceutical Executive's editor-in-chief and can be reached at pclinton@advanstar.com