Re: FDA to take "unprecedented" action Re: pain meds
- From: Hawaiian Wayne <birdie998@xxxxxxxxxxx>
- Date: Sun, 6 Dec 2009 18:35:23 -0800 (PST)
On Dec 5, 7:41 pm, "oldgoat" <oldgoatm...@xxxxxxxxx> wrote:
Hey Folks,
More of the usual scare talk about special certifications to prescribe
certain classes of meds. They talk such a great game, expressing concern
about patient access, what a load of crap. I can just see doctors being
"instructed" by the DEA in the proper use (or non-use) of these medications.
They're going to drive any doctors even remotely close to retirement to do
so when they're already looking at a huge physician shortage. It's already
hard to find a decent Primary Care doc, much less one willing to deal with
chronic pain issues. Good thing the government takes forever to do anything.
We haven't heard the last of this one--og
Drugmakers, FDA move to curb painkiller abuse
WASHINGTON - Pharmaceutical executives laid out plans Friday to prevent the
misuse of prescription painkillers, under pressure from regulators trying to
stop hundreds of fatal overdoses each year.
But Food and Drug Administration officials said industry's proposals were
short on specifics and that more work is needed before any measures are put
in place.
Johnson & Johnson, King Pharmaceuticals and other drugmakers proposed using
patient medication guides, letters to doctors and additional physician
training to curb inappropriate use and prescribing of painkillers.
The FDA sent letters to 16 companies in February ordering them to design
so-called risk management plans for their drugs. The drugmakers are
presenting their joint proposal to the agency after several months of
discussion.
The companies at Friday's meeting produce 24 opioid drugs - including
morphine, oxycodone and methadone - which are often abused for their
euphoric effect.
The FDA has required risk management plans for individual drugs before, but
never for an entire class of drugs.
Industry consultant Sidney Schnoll said the requirement is "unprecedented in
the history of pharmaceutical medicine and in the history of the FDA." Risk
management plans can include: safety labeling, educational campaigns and
even certification requirements for physicians.
Schnoll and others warned that mandatory certification standards could cause
some physicians to stop prescribing the medications altogether, limiting
access to patients.
"The bottom line here is that the 'risk management plans' should not impede
important medication from reaching appropriate patients," said Schnoll, a
paid consultant for the companies with Pinney Associates.
In place of mandatory certification, the drug industry said the federal Drug
Enforcement Administration could offer voluntary training to prescribers.
However, executives acknowledged that congressional action would be needed
to allow the DEA to provide such training. Currently, the agency's mission
is to enforce laws governing highly addictive medications.
FDA leaders expressed concern that a key component of the companies' plan
relies on congressional action.
"Congress can act very quickly sometimes and very slowly other times," said
Dr. John Jenkins, FDA's director of new drugs. "And sometimes they don't act
at all."
Other FDA officials said they wanted to hear more specifics from the
drugmakers.
No matter what form they take, the final risk management plans won't be in
place anytime soon. FDA officials said they want to hold another public
meeting in the spring to gather more input before finalizing the
requirements.
The products targeted by the FDA, which come in both pill and patch forms,
generally feature extended-release formulas designed to give long-lasting
effects. But that potency carries serious risks when patients abuse them as
stimulants.
The FDA has issued a number of warnings on prescription pain relievers in
recent years but with little success. A federal survey conducted in 2007
found 5.2 million people in the U.S. reported using prescription pain drugs
inappropriately.
Companies attending the meeting include makers of generic pills as well as
brand-name products, like Johnson & Johnson's Duragesic patch, King
Pharmaceuticals' extended-releases Avinza and Embeda pills, and Purdue
Pharma's extended-release OxyContin.
There are other problems with opioids besides deliberate abuse.
The FDA has documented many cases of physicians prescribing the potent
painkillers for patients with migraine headaches, an unapproved use. The FDA
said patients also sometimes chew extended-release pills that are designed
to be swallowed, causing an overdose of the drug.
Aloha All!
Hey OG. This, for whatever it's worth, is kinda old news. Did this
only just run in some newspaper somewhere? If I may be so bold, may I
ask which one? The way I had heard about this was approximately 6
months ago through my FDA Alerts that I have set up. I have found this
to be quite the informative little bugger at times for info on all
things pain related. If anyone wants the proper links for the site,
just let me know. I am still very curious as to which newspaper or
news source is the "creeping charlie". So please let me know, OK? Not
that I can do anything about it other than never use them for real
"current events".
Unfortunately, I didn't really think all that much of it at the time
(and still don't), so I didn't save that particular 'alert' or
anything related to it. However, I do remember (believe it or not!)
that most doctors, pharmacists and medical professionals were willing
to go along with making the patient guideline insert have a more bold
and stern warning on it (kind of like the big and bold one they now
have for anti-depressants warning patients about the risk of suicidal
tendencies and thoughts) along with pharmacists instructing those that
use pain meds on how to use them and all that. Also, as you said OG,
believe it or not, doctors were even willing to go along with
instructing their patients (which would mean spending more time with
them, which comes as a bit of a shock unless they also were going to
charge extra for their time-heh...)
Of course the article you have here mentions DEA having instructions
for doctors. I agree with you, I can't see doctors doing this with the
personalities most of them have. You all know how they are (my
apologies to any doctors who see this); With their "god-like"
personalities and their "don't you tell me how to diagnose and treat
ANYTHING" attitudes. In a way, I can understand how doctors feel
(outside those with that "god-like" personality). After all, here they
have gone through many years of schooling and in some cases, a decades
worth! I know I'd be quite stand offish if, after all that, an
organization approached me to instruct me on how to 'better handle how
I was just trained to do".
Anyway, I just wanted to let you all know that this really isn't all
that new and has been 'out there' for some time. If I am correct about
this, then that could be a "good thing" because your post here is the
only other time I've heard anything about this new so-called 'idea'
from the Feds.
Just a side note that is kind of related to this; I have seen some
rather angry blogs from doctors of late expressing how they don't
appreciate how the government treats them as if they aren't real
people like the rest of us "grunts" out there in the work force (or
when we WERE in the work force). I never really thought of it before
until I read some of these guys blogs. Seems that the government is
treating those in the medical profession like a commodity rather than
plain human beings who just happen to do a specialty for a living such
as a plumber or electrician (or accountant for that matter). I mean,
really, how many of us would like it if we were told how to actually
do certain parts of our careers after we have been specifically
trained for it? Yes, yes, I know...they are dealing with human beings,
so maybe that's the only reason the government should have some sort
of "say" about how they do specific areas of their jobs. What do you
all think?
My 3 cents is I don't think the government really should enter the
realm of the medical profession UNLESS, for some weird reason, doctors
are blatantly doing something that is killing off people and they
simply refuse to address the issue. That's about the only time that I
could see it happening. With all this talk of "health care reform",
the doctors are paying very close attention to what's going on and, if
you start to notice, they ARE being treated as a non-human commodity
rather than a person/human being. I guess I'd be pissed if anyone or
anything called and treated me as that.
Tough call on some of these issues regarding this. I'm going to start
another thread concerning all this health care talk because it is
slowly but steadily making its way up the chain of government and we
may be stuck with something that some of us don't really want for
health care. I know for myself, as long as I have been on my wife's
health insurance coverage through her employer, my coverage couldn't
be any better even if I was a wealthy person and got it myself since
what she has is the absolute best a person can get in the state of
Hawaii. There is NO WAY I could have had anything close to what I've
had for medical treatment and especially the crucial pain medications
I take. I've been lucky to have been able to afford top notch pain
meds that really do the job for me (most of the time, anyway). I'm
scared shitless if I can no longer afford what I have because I KNOW
there is nothing out there other than what I take that works well
enough. But it has cost from $6,000 to $10,000 a MONTH for JUST my
main pain meds. If I added the rest of the 7-8 meds, well, what
difference do they make? If I can't afford to get my pain meds
anymore, what's the sense in bothering with the rest? I have been to
the point of 'no return' with my thinking that if something should
happen where I can't get them and I have to live at a pain level I am
not comfortable with (no higher than a 5, maybe a 6) I'm "outta here".
Sorry. That's just the way it is and it can't be changed.
On that note...
Aloha For Now,
Hawaiian Wayne
.
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