If you haven't seen the TED talk by Tim Berners-Lee, you should. Follow the link right now if you haven't. It will only take 6 minutes, and I'll be waiting right here when you're done.
So now you've seen the talk, right? Good. We can take the following as axioms in today's technology and culture:
- There is a stronger push toward greater transparency, and resisting that push is futile.
- With technology, people will create their own open data. When they create their own open data, they will create their own analyses. And when they create their own analyses, they will create their own conclusions.
To see the first point, I direct you to the excellent Eye on FDA, a blog run by Mark Senak who is a communications professional who is very familiar with the workings of the FDA and pharmaceutical industry. Further evidence is the opening of data by the government, as evidenced by the creation of the Data.gov site in the US and corresponding sites in other countries. Even municipalities such as San Francisco are joining the movement. And, of course, the efforts of Berners-Lee is further evidence.
The second point is perhaps a little harder to see. However, realize that there are discussion forums where doctors discuss adverse events of drugs, without any intervention or oversight from the companies that create these products. This also gets discussed, in an informal way, on the CafePharma.com website, the wild, wild west of pharma rep discussion boards. With text analysis and web search tools, it is possible to analyze this data, too, much like the Google Flu trend tool.
The traditionally tight-lipped pharmaceutical and biotech industries, who rely on data for their livelihoods, have to adjust, far beyond what is presented in the prescribing information labels. So far, this movement hasn't been kind to pharma companies, as evidenced by the Avandia meta-analysis that essentially brought the drug down and created a multibillion dollar nightmare for GlaxoSmithKline which, by the way, was based on data that GSK had published through its efforts on being transparent with clinical trial data. At first, it sounded like Steve Nissen (the primary author of the meta-analysis) was simply trying to bring the company down. However, as more details emerged, it turned out that GSK was aware of the results of the meta-analysis before publication. GSK was caught with its pants down, in essence, not sure as a company how to function in this new environment of data.
Attacking an analysis on the basis of methodological questions doesn't seem to work, at least so far. For example, the analysis method that Nissen used in the Avandia meta-analysis wasn't quite correct, as it ignored studies where no cardiovascular events occurred. Nor did the fact that the oft-cited 43% increase in risk was a bit misleading as the cardiovascular event risk of Avandia was very small, and small risks tend to result in large relative risks.
Here, GSK was a leader in opening its data, and it got burned. However, this kind of openness will have to continue, as there is too much public good in having open data. One way or another, we will have to adjust to living in an open-data world.
Update: Bonus: Ask-Cato notes this issue from a different perspective
Update: Bonus: Ask-Cato notes this issue from a different perspective
