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1. Medtronic pays surgeon * much* more than the “more than $20,000” reporting requirement. I just heard Art Caplan wax on about how even the little pens and mugs influence doctors. Imagine how much cold, hard cash could influence—or even if (for the sake of argument) it truly doesn’t influence, what about the appearance of impropriety?
2. Researchers probe how the mind determines crime and punishment, how brain scans could be used in court as evidence (or not!). Apparently, technicians have a large degree of control over what the scan image looks like, through use of color choices, etc.—and such choices could influence a jury’s reaction to the image. Interesting stuff. After 2.5 years of law school, I’m sure images of my brain would be kinda scary to see.
3. DTC genetic tests for heart disease and cancer risk launched by DecodeMe. But . . .the clinical utility remains in question. How should one act on knowledge of “increased risk,” as opposed to a certain outcome? Panic would be one possibility, unfortunately.
BIOTECH AND THE LAW:
1. New company stock suit filed against Boston Scientific.
BIOTECH IN CLINICAL MEDICINE:
1. Heart failure gene more common in South Asia.
2. Genetic testing not cost-effective in guiding initial dosing of warfarin.
1. Disabling an enzyme allows lab mice to eat voraciously, yet remain slinky and svelte. Where do I sign up?
2. Epigenetics may account for some inherited traits and diseases—DNA may not be the only carrier of genetic information! A-ha! A whole new DTC market of the future.
COMMERCIAL BIOTECH APPLICATIONS:
1. UK panel of chemists and engineers touts genetically modified foods to head off global food crisis. They shrug off mere “socio-political fear of new technology.”
2. This year’s International Consumer Electronics Show features home monitoring devices and the like for “growing old at home.” I guess they know their demographics!
3. Experts and lawmakers starting to worry about the extensive outsourcing of drug manufacturing. Concerns range from potential quality issues to supply issues (imagine if a key country decided to withhold a critical ingredient, for example).
1. J&J eyeing potential buyouts, despite revenue declines (see story below). Other smaller fish could be weak and on the cheap.
2. Boston Scientific wins one-year Veteran’s Affairs contract for a full line of pacemakers and defibrillators. Sweet deal. Someone posted a comment on the story about defects in those devices. Hmmm . . .
3. J&J revenue see first decline in 76 years.
LEGISLATIVE AND POLICY DEVELOPMENTS:
1. Chairman of JPMorgan calls for universal health care coverage at annual health care conference. Policy proclamations from an unexpected source.
2. In honor of Inauguration Week, a selection of articles and views on health reform.
3. Congress wants to restrict drug access to save costs, by examining “cost effectiveness” of various treatments. But is Congress the right body to make these detailed, item by item determinations? What, me worry?
4. Congress considers nanotech safety high priority—bill introduced to address environmental, health, and safety risks potentially posed. It’s the little things that mean so much.
1. Court invalidates two patents for King Pharma’s best-selling drug, a muscle relaxant called Skelaxin. (What a great name for a muscle relaxant! You can just picture it!)
2. The “patent cliff” is coming—more than 100 pharma patents are set to expire at the end of this year alone.
REGULATORY MATTERS/FDA ACTIVITY:
1. Nanotech squeezing into yet another arena—dietary supplements—creating yet more regulatory gaps for the FDA.
2. Japan moves closer to allowing cloned food—says it’s as safe to eat as conventionally bred livestock. They say they’re just as healthy. Did anyone ever figure out what put Dolly the Sheep into an early grave?
3. FDA says topical anesthetics could cause serious adverse reactions. When I received this email from FDLI, the subject line was cut off so that it said only “FDA says topical anesthetics could cause.” Hmmm, numbness? Seriously, apparently there are some OTC preparations that can cause some significant problems if used in certain ways.
4. HHS opens FDA offices in India. Spread the joy.
1. Study says women are less able to suppress hunger than men. I quote: “There is something going on in the female. The signal is so much different.” I just can’t make this stuff up, folks.
A MESSAGE FROM YOUR EDITOR:
New administration, new policies. Your Editor is certain there will be much news on the Biotech front as a result! Stay tuned.
As always, let me know if you have other suggestions, submissions or comments. You know where to find me.
CONTRIBUTOR CREDITS FOR THIS ISSUE:
Thanks to Linda Glenn and Hugh Wellons for their contributions this week!
Lisa M. von Biela is the author of Bio Blurb (ABA, 2008). That weekly blurb is a member benefit of the Biotechnology Law Committee. Join the Committee today for free to receive your weekly issue. Lisa is a J.D. Candidat,e 2009 at the University of Minnesota Law School. She can be reached at firstname.lastname@example.org.