Bloody mess

On a blood kick, must have something to do with that weird bat that bit me.

Anyway, interesting article on medical ethics involving new critical care techniques. At issue, some folks think they have new ways to save lives, the FDA says it needs testing, which raises the question, "How do you get permission to test a new product or method on someone who is unconscious?" Toughie. The plan now, is since you can't, don't (there's a plan, but I don't see it really working. So in the end, consent is forced). Personally, I don't like it. First let me say that I understand that there was a truly exhaustive review process.

Before starting the research at each site, researchers complete a "community consultation" process. Local organizers try to notify the public about the study and gauge the reaction through public meetings, telephone surveys, Internet postings and advertisements, and through reports in local news media. Anyone who objects can get a special bracelet to alert medical workers that they refuse to participate.

The project proceeds only after also being vetted by a set of local independent reviewers known as an institutional review board. Another group of independent advisers known as a data safety monitoring board will periodically review the study for any signs of problems.

Again, I'm not a fan, but I doubt I'll get one of those cool bracelets. But if there were lots of tests and the bracelets were all different colors, I could relive my high school days. Anyway, this process seems like its taking the long way round. Rather than canvas a city like Dallas, and expecting to get anything close to market awareness and real consent without spending months and millions, why not find high risk groups and target them. Emergency personnel, NASCAR drivers, and military folks are all much smaller groups with much higher need. You can reach them all fast, and still get the tests done. Doing the presentation in Iraq, getting consent (or handing out bracelets), and starting the tests is a much faster and cheaper prospect than doing the same in Seattle. Also, you can bet there will be lawsuits the first time someone who received one of the tested procedures/medicines or a placebo dies. It would be hard to prove they saw any of the advertising and had a real chance to "opt out."

The current plan is troublesome in many ways. All of the issues are alleviated by finding smaller, higher risk groups to test.

Plus, I'm interested to see what our resident hemopussy thinks of all this.