The 2007 BIO conference finished up last week in Boston. It was not our favorite conference, if only because of the unfocused nature of the agenda and the badly signed architectural failure (also called a convention center) in which the event took place.

Perhaps next year, in San Diego, will be better. Or at least have a few signs guiding visitors to their destinations correctly. Even the humans weren’t sure how to direct us. Which is typical of Boston but unwelcoming to visitors.

There were a few highlights. The FDA’s Matthew Eckel is director of Europe in the Office of International Programs at FDA. A lawyer, he described the efforts to share pre-approval and other data with the EMEA. “There has been a quiet revolution going on at FDA,” Eckel said. In 2006, there were 200 non-public information exchanges with the FDA’s European counterparts. This year, there have already been 800.

European Collaboration

The goal has been to collaborate closely with the Europeans. But existing U.S. law has made that complex. The agency has fashioned ongoing, broad agreements to honor key provisions in the laws that prevent the Europeans from additional disclosure of privileged information. Previously, such arrangements were hammered out on a case by case basis. “We are able to talk about things that are the most important,” Eckel says, “the things we have not approved.”

“We can finally do these things quicker, more reliably, more uniformly,” Eckel says. “We didn’t have any nonpublic information with the EMEA or European Community five years ago.”

Boger On Drug Safety

There was also a panel of biotechnology stalwarts. None of them used Powerpoint, for reasons that escaped us. We’ll be doing a separate article on the remarks of ex-FDA official Scott Gottlieb, who is now at the American Enterprise Institute.

Another highlight was Vertex founder, president and CEO Josh Boger. He spoke with calmness but frustration about the outdated nature of the drug approval process. He suggested that information technology could be part of a better drug safety surveillance system. “At some point in time, a revolution is a better solution than evolution,” Boger said. “We can have increased efficacy and increased safety. But we have to remodel the system. It won’t come through incremental improvement.”

A Goal But No Map

Boger suggested that routine, ongoing surveillance of all patients might be a clinically useful thing. Once such data were de-identified, they might prove valuable in detecting safety signals and drugs that were working well. “There is a lot of enthusiasm for that,” Boger says. “No one quite knows how to do that.”

Boger suggested that the present system could be improved upon: “We could bring drugs to the marketplace sooner knowing this monitoring system would pick up low-level signals. There are some of us who think that clinical trials are a bad place to pick up low-level signals.”

Political Gridlock

Boger’s comments are completely in line with what most in the industry believe. This correspondent shares Boger’s frustration with the antiquated design of the present system. No sensible observer could doubt that a properly funded, technologically modern FDA would hear drug safety signals earlier, and that such a system could reduce the cost of getting new drugs approved. 

But the industry today lacks the political capital to effect or even discuss such changes. The key is to do so in a transparent, above board manner. Yes, the industry may be able to get a few of the needed changes through regulation or legislation via the usual back-door political channels. Those channels have long been used by this industry and every other industry.

Over the long run, however, that approach will sow more discontent at lower levels of the FDA, and feed lingering scientific disputes between the FDA, industry and academia. As many of these disputes become quite public, it will be increasingly difficult to get business done and develop a 21st century system of finding and evaluating new drugs.

Elephants In The Room

Sadly, a sweeping and public discussion about society-wide drug risk and benefit is not yet possible in the U.S. That’s no fault of Boger or any particular company. In our view, such a discussion is needed to appropriately calibrate public notions of exactly how safe drugs can be. (The answer is: very safe, but not utterly safe.) Without that discussion, additional Vioxx fiascoes are in our collective future.

There are two impediments to a real discussion about drug safety.

One is growing scientific illiteracy in the U.S., where many citizens do not understand evolution or viruses, much less genomics and biostatistics. The other factor: stratospheric levels of mistrust of the industry.

Those two elephantine issues were not tackled at this year’s BIO. We doubt they will come up next year in San Diego. Perhaps we should let better-educated, more collaborative Europeans have the discussion and show us how to start it in the States.