Still looking for the link to FDA document talking about the example. I stand by my criticism of the statement made. There are good drugs and devices with years of experience that fail or are very slow to get to market because the bar is set inordinately high. The delay in getting the Bryan disk is typical (see: http://www.medscape.com/viewarticle/489858_4 ). This was in clinical use in 2002 in Australia and Europe, submitted to the FDA soon after, clinical trials in 2002, reviewed in 2007 (http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4305b1-09.pdf) and approved in 2009. If that seems to be expeditious, then we simply disagree in perspective.
No, actually they hold up plenty of good drugs for the stupidest of reasons. One example, the FDA pulled the one product that prevented post-op nerve scarring after back surgery. This is the number one cause of failure after surgery. Why did they pull approval? Because the safety manuals were written in Dutch. And the product was being produced in...? Yes, dear, the Netherlands. Company could not comply fast enough, the product was never allowed back in the states.
So quite the opposite. As is characteristic of many TD stories there is much more to this one than meets the eye. And honestly, it takes a fairly comprehensive understanding of medicine and medical practice to be able to sort through the fog and shape-shifting...
So try this thought experiment; substitute "automobile" for "firearm". Bet the conclusions would be the same for death and injury. Does that mean your doctor should record whether you drive a corvette or a prius?
The zinger lies in the fact that the professional medical organizations have no business in political advocacy. AAP has been at this for years and it's no less unseemly now than it was then. My doctor has no business telling me not to buy a gun.
As a doc involved in trauma and head injury I see that an overwhelming majority of patients who come in hurt are drunk. Like 80+%. So is it the car, the motorcycle, the stairways, the gun, the fist? Or the booze? Should I advocate to my patients not to drink at all?
We can drill this one down all day. Red meat...colon cancer. Smoking...cancer, hi BP, MI, etc. The thing about this is a values decision.
First off, the AAP (the professional organization for pediatricians) has long held what many would consider very disturbing views on gun ownership. For instance from their website healthychildren.org comes this little zinger:
The best way to keep your children safe from injury or death from guns is to NEVER have a gun in the home.
Do not purchase a gun, especially a handgun
This is hardly the worst from them, just what I could source easily. There has been the suggestion that firearms ownership is tantamount to child abuse.
This current bill stems from the Obamacare legislation, wherein the government can mandate physicians to document unhealthy behaviours, i.e gun ownership, listening to talk radio...oh sorry..tinfoil hat mode off...The concern for gun owners is the potential for abuse that this whole unhealthy behaviours questioning mixed with a government controlled health insurance can allow. Particularly when much of the implementation is extra-judicial (yeah - intended word).
It is interesting that this whole bill stems from an incident where a pediatrician fired a patient after asking there were guns in the house. So in the end, maybe all politics is local.
My guess is that they will simply put them away until the current crop of funereal imbiciles die, and trot them out again. It's the nice thing about belonging to a religious order with 800 or so years of history behind it.
Time to google patients? Not likely. Hell, I have hardly enough time to spend doing a good job evaluating, deciding, and informing, let alone snooping on my patiens.
Tempest in a teacup. Maybe the authors of the JMEdEthics article really need to get out and talk to docs who spend their days working for a living. The LATimes article is a joke, as far as I can see. Is there a "silly season" for health writers, or is it post Obamacare mania?
I was booted by my ISP 3 times for 'illegal activities' like bit-torrent sharing a copy of some movie, too much email, and some other nonsensical thing. All of which was traced to 'my' cable modem. Sure enough, after the third time I made them swap out my modem because I was sure it was being spoofed. (Had to explain 'spoofed' to the help desk personnel.) Voila! No more random cut-off from the ISP. Any legal standing for me? Any pre-settlement letter that I can send to Midco? Doubt it. Golden rule, or Shark rule rather. Whoever has the sharks makes the rules.