US Supreme Court to rule on medical-device liability

The US position on state sovereignty can create messy situations. Recent government administrations have taken oppposite sides of this thorny one (Clinton's for, Bush's against)--does federal approval of medical devices shield manufacturers from product liability lawsuits in state courts. So far, according to this AP story, most federal appeals courts have said, yes, indeed, if your FDA-approved device fails during my operation, I can sue you anyway in state court.

Given the maze of legislative entanglements device manufacturers face anyway--federal regs in the US and, heck, there's even a Journal of Medical Device Regulations--a decisive ruling here will be welcome. It's always a delicate balance between getting new technology out to the public and making sure safety and effectiveness are kept in balance.

If you've got some time to kill, here's the US government's stuff on the topic of medical device safety.

Big news about the genome

Genes aren't the discrete little self-contained dots of biological information they were thought to be, says a worldwide study of human DNA. Scientists all over the world have for three years been digging deeper into the genome, and BIG stuff is afoot in the bioscience field.

This report in the Washington Post says results of this study label previous conclusions about human genetic material as simplistic. "DNA letters revealed to great fanfare by the $3 billion Human Genome Project in 2003 was but a skeletal version of the human construction manual."

The new efforts reveal that all kinds of molecular code previously thought to be "junk" isn't extraneous at all but is instead actively interacting in the form of ordering, splicing, and silencing mechanisms. They think, now, that a predisposition to disease may not be in the genes themselves but in the stuff in between.

Good. This study comes just in time to derail the looming ghoulish specter of humans using genetic engineering to justify killing off people when their individual genes look broken. So now we know it's not that simple.

But wait a minute... Later in the story we read this:

"The expectation was that many of the most active DNA sequences in humans
would be prevalent in other mammals, too, because evolution tends to save and
reuse what works best. But more than half were not found in other creatures,
which suggests they may not be that important in people, either..."

Huh? Because other creatures don't have this material means it's useless? Isn't this whole study about how we completely overlooked massive amounts of information in our 2003 "definitive" map of the 3 billion pieces of code in the genome?

Instead of concluding that what we don't understand means nothing, we need to find the same humility that quantum physicists come to when they admit that they can find nothing but air between the smallest non-observable particles they've discovered and no explanation for the "miraculous" automatic mirror actions of pairs that are huge distances apart.

Like a tiny baby in a crib, we can see the mattress, the bars, the walls and floor of the room we inhabit, and we can glimpse the hall through the doorway. Until we get beyond that space, though, we tend to believe that all we see is all there is. But once we see other doorways, we rightly begin to imagine the world of possibilities beyond.

Alzheimer's inquiry--with inflammation "moderation is the key"

Boy, we're basically just stumbling around--albeit in an educated manner--when we're researching the cures to illness. This study, conducted an an engineered mouse with an engineered molecule finds that brain inflammation may not be such a bad guy after all in Alzheimer's patients.

Finding high levels of such markers in Alzheimer's patients who died, led scientists to believe inflammation played a major role in causing or worsening the condition. Now, by manipulating in this engineered mouse the signaling molecule (IL-1 beta) that promotes inflammation, the researchers found increasing this signal (and thus inflammation) they dramatically reduced the number of amyloid plaques that are the hallmark of the disease. This mouse who was engineered to develop Alzheimer's, had 50% fewer plaques than the controls.

So, even though this is a tiny experiment and it's only on a mouse, it's leading us down that moderation path that we see with so many other substances in the human body. Just like nitric oxide, that wonderful stuff that performs miracles in our blood vessels gets toxic if there's too much of it, inflammation may need to be balanced as well. Is that like when our muscles become inflamed from too much work or working out in order to a) tell us to stop, and b) make us rest so we'll heal.