| Wednesday,
April 14, 2010 Canada's Health Care
Brian H. wrote: "...Can't have "2-tier" services,
you see, the theory being that all the doctors and services will migrate
to the private carriage trade. That even includes no running the existing
MRI machines outside official 9-5 hours, so they sit idle most of the
time, with 6-month waiting lists."
It's worse than that sets out. The MRI's (and we have
waaay less per capita than the US) are not used because the govt/hospitals
cannot fund the technicians for 24/7 service. The MRI's themselves are never
turned off: too long to re-boot!. So at night, they sit there, unused,
except of course, if your vet want's an MRI done on your dog. He can get in
there any night at midnight or so, at most hospitals with an MRI, and for
$300 (reported by the National Post as the 'going rate'), you get an MRI. Of
COURSE, the tech is not "credentialed" to do MRI's on HUMANS, so he won't do
your back, but gee, it's only a dog, so no-one is likely to get sued if
something goes wrong. So what's wrong with this picture?
meanwhile, my longtime GP retired a year ago, after
two years of attempting to sell his practice. No luck. Why *buy* a practice,
when you can just put up a shingle and a 'take-a-number' machine. New doc,
same location, over her head with applications. Luckily for me, she took on
old patients first so I now have a GP, who I have not yet met for my now
three-year delayed 'annual'. For which she will get I don't know, $100???
Geoff
Ouch. I have an appointment for my more or less
annual this afternoon. Made it yesterday. But that's Kaiser in
California.
==========
Subject: Flight plan closed after 44 years
Dr. Pournelle,
I thought you would find this worth posting.
http://www.omaha.com/article/20100409/NEWS01/704109784
"Their helicopter vanished into dense jungle on Dec.
28, 1965.
With no conclusive information about what happened,
their flight plan remained “open” for decades.
The crash site was officially located a few years ago
and finally excavated last year."
Matt Kirchner
Closure...
==============
It appears that there is more
to the Colchicine story than first appeared.
: Colchicine
Hi Jerry,
I am an academic Internist and Clinical Pharmacologist
with 28 years experience as a practicing physician and with a long-standing
research interest in adverse drug events. I have used colchicine many times
in my career but each time I have done so, it has been with trepidation. In
recent years, I have rarely used this drug due to concern about the quality
of the available products and the toxicity of the drug even when
administered properly. I thought I might share with you my perspective on
the FDA's recent approval of a new colchicine product and impending removal
of competing "grandfather" colchicine products.
The safety of the previously available colchicine
products was *not* well-established prior to the recent approval by the FDA
of a new product. In fact, there have been deaths related to improperly
compounded colchicine and deaths from properly compounded colchicine. In the
absence of FDA oversight, one manufacturer managed to formulate a colchicine
product with 10X the labeled dose. For many patients, that would be a fatal
dose. This was rather a big problem for the average patient, who would go to
his pharmacist with a prescription for colchicine in hand and be dispensed
something which might have the right dose of colchicine in it, might have
10X too much colchicine and might have no colchicine at all! (e.g., http://
www.portlandtribune.com/news/story.php?story_id=117762600839413400)
An abstract from the recent literature: Schlesinger N.
Reassessing the safety of intravenous and compounded injectable colchicine
in acute gout treatment. Expert Opin Drug Saf. 2007 Nov;6(6):625-9.Division
of Rheumatology, UMDNJ/Robert Wood Johnson Medical School, New Brunswick, NJ
08901-1977, USA. schlesna@umdnj.edu
<begin abstract/> "Colchicine has been used for over
2000 years. Intravenous (i.v.) colchicine has been used for the treatment
of acute gout since the 1950s. I.v. and oral colchicine were
'grandfathered' before the 1969 FDA Phase III trials for drug toxicity
became law. Data on toxic reactions are, therefore, based only on passive
surveillance. The risk of toxicity with i.v. use depends on the total dose
over a period of time, the presence of comorbid conditions and the size of
individual dose. Colchicine toxicity has been compared to arsenic
poisoning. Symptoms start 2-5 h after the toxic dose has been ingested and
not uncommonly lead to death. Injections of compounded colchicine have
been implicated in the deaths of several patients, several of which
received off-label i.v. colchicine for back pain. Given that colchicine
has the smallest benefit to toxicity ratio of the drugs that are used in
the management of acute gout and the fact that acute gout is not life-
threatening, one could make a strong case for eliminating the use of i.v.
colchicine the treatment of acute gout."</end abstract>
The availability of an FDA-approved colchicine product
is a genuine improvement over the past situation. There were numerous hoops
that required jumps in order to get this product approved. Hoop jumping is
expensive. At least some of these hoops also have merit: it is nice to have
a drug that is manufactured according to GMP, that has been shown to be safe
and effective in clinical trials, and that is properly labeled. The company
likely got some period of exclusivity (probably about 3 years) after which
generic competitors will come into the market. The price of colchicine will
then drop to a low value due to competition. This seems quite reasonable to
me.
Of course, one might imagine an alternate universe
where the safety of medications was assured via free market mechanisms.
However, that is not the system we currently have. The conservative approach
is to limit regulatory actions by the FDA to those where the public health
is endangered. That is what happened here. There are thousands of unapproved
pharmaceutical products on the market. Generally, the FDA does not act to
remove these drugs from the market unless there is a threat to the public
health. If we decide as a society to "reform" the FDA to better comply with
libertarian principles, that reform ought to be done in a thoughtful,
prudent, conservative manner. I would certainly support some cautious
movement in a libertarian direction. But the FDA acted appropriately here.
My 2¢…
-Steve
I questioned that and got
Jerry-
There seems to be a general ignorance of what happened
here. If one accepts the idea that the government should create monopolies
by establishing protection for intellectual property, then what happened
here is very reasonable. There is a libertarian position that patents,
copyrights, and market exclusivity should not be allowed. That would be an
interesting experiment, although I am not at all sure the results would be
good or bad or neutral.
It is important to consider the IP issues separately.
The FDA granted three years of exclusivity for colcrys for gout and 7 years
of exclusivity for familial mediterranean fever. This limits marketing by
competitors between year 3 and year 7 but competitors will be able to enter
the market with a package label indication for acute gout during this time.
See, for example,
http://www.mdconsult.com/das/
news/body/195089773-2/mnfp/0/216043/1.html?
nid=216043&date=all&general=true&mine=true
The longer patent (2016) that USPTO granted was
actually for a *novel* combination of colchicine and a macrolide antibiotic.
Colchicine is metabolized by the liver enzyme CYP3A4. The metabolic
clearance of colchicine is thus slowed by coadministration of a macrolide as
macrolides inhibit CYP3A4. This is actually a clever approach for decreasing
total dose and thereby increasing safety. See
http://www.drugpatentwatch.com/ultimate/
preview/patent/index.php?query=7601758
The AGREE study results show that the lower 0.3 mg
dose of colchicine is as effective as the old higher dose. This strongly
implies greater safety, as the toxicity risk increases with dose.
http://www.prnewswire.com/news-releases/
colcrysr-colchicine-usp-shows-superior-safety
-with-comparable-efficacy-compared-to-high-dose
-colchicine-in-treatment-of-early-acute-
gout-flares-89610352.html
-Steve
Now I believe in copyrights, and I have no
objection to a patent on new formulations of this stuff, but that isn't
what happened as far as I can see. The FDA commissioned one company to
invest in a study -- I have not been able to determine if that was done by
competitive bids or just how the study was let -- and rather than pay for
the study, the FDA issued a monopoly not on the new formulation, which
would have been fine, but on the whole kit and kaboodle folk remedy and
all. That's presumably because the new product wouldn't compete if priced
at $5 bucks a pill as opposed to a dime; lots of people including doctors
would decided that if grandma was happy enough with the dime stuff (more
likely grandpa, of course) then I will be. To hell with five bucks a pop
to big pharma.
Now we are at the edge of the real question:
provided you know the truth, whose final decision is it? Yours, a
doctor's, or the FDA's? I tend to think the Nanny State is already
too big. I can live with the FDA requiring label warnings, but no on
granting monopolies to generics and folk remedies.
The real question is, who decides what is
"dangerous" and "not properly prepared" and thus must be forbidden from
sales? How much authority do we give the federal government? I see nothing
in the Constitution that gives them any at all but we have over a century
of precedents; that doesn't mean that we automatically expand the Federal
authority. We know the FDA grows by the Iron Law. Not only to all such
organizations grow that way, but this one certainly has stuck its nose
into things. I used to have to smuggle SAMe into the US from Italy because
the FDA forbade its sale in the US. I could tell other such stories. I
start with the presumption that Nanny wants more control. I see no reason
to believe that this is anything else.
The proper remedy to a folk remedy being
dangerous is free speech. Publicity. If the folk product is inferior to a
better crafted one, get that word out: but forbidding something because it
isn't approved is a dangerous practice. I seem to recall going through all
this in the 1970's when a Glendale Dentist tried to tell people that
aspirin would be useful in preventing heart attacks. Then there was SAMe.
And the Folic Acid disaster in which the FDA caused a bunch of retarded
children. Nanny knows best except when she doesn't.
I have no quarrel with granting monopolies over
something one has developed. I remain unconvinced at the value of letting
the FDA take over folk remedies.
============
UK vs US Health Care
Dear Dr. Pournelle,
Harry Erwin made the argument that the UK health care
system is “better” and based that on the life expectancy statistics. This is
flawed as life expectancy statistics do not draw a direct correlation
between money spent on health care and level of service. I would suspect
that the higher number of murders is pulling the US statistic down, rather
than any supposed benefit from preventative measures. According to the CIA
Factbook he links to, there are 35 countries that have “better” health care
systems, including Canada at #7 with a life expectancy of 81.23.
It sounds as though you made your appointment with
your dermatologist directly. That would be impossible in Canada, and I would
suspect in the UK, as well. One must request such an appointment from your
General Practitioner, who receives a $54 referral fee from the government.
There have been stories of GP who can make upwards of 15 referrals per hour.
Stay well,
Bill Grigg
At Kaiser you need a referral for your first
appointment with a specialist, but after that he's not involved any
longer. I've been seeing the dermatologist for barnacles -- well,
precancerous conditions taken care of with a can of liquid air -- for some
years. Same with the cancer chap and the heart specialist. One reason I
like the Kaiser system. Incidentally they claim that no one will lose
Kaiser membership as a result of the health care bill. I rejoice at that.
==
"Better" Part 2
I agree with you that expected survival at birth is a
rather blunt tool for differentiating health care systems, but what about
maternal mortality, which is twice as high in the USA as in Albania or the
UK? Waiting times are a poor measure, too--if you remember your queueing
theory, they're non-linear in the system load, so that they typically double
as you go from 90 to 95% load. My recent experience with a non-critical (low
priority) eye condition is that I had to wait a week to see my primary
physician and 24 days to see a specialist, but that was acceptable. There
are also issues with treatment facilities and the availability of
treatments--UK doctors differentiate between hard and soft results in the
medical literature and tend to ignore the latter. However the dramatic
difference in the level of expenditure is important. The median household
income in the UK is about 78% of the same figure for the USA <http://en.wikipedia.org/wiki/Median_household_income>,
but the mean medical expenditure per person in the UK is about 40% of the
level in the USA with very comparable outcomes. The UK doesn't have
copayments (except for dentistry), so that mechanism to discourage moral
hazard is weaker here, yet expenditure levels are much lower than in the
USA. Given our experience here that most of the increase in the NHS budget
over the last 13 years of Labour Government has benefited the medical
practitioners rather than the medical consumers, I suspect there's a *lot*
of air in the American system.
You have seen me complain about problems in UK health
system, but they're in the skin. The problems in the US system are in the
bones.
-- Harry Erwin, PhD, Senior Lecturer of Computing,
University of Sunderland. Computational neuroethologist: http://crowan-scat.sunderland.ac.uk/~harryerw/mediawiki/index.php
Well the stories of facilities I have heard are
anecdotal but I believe my sources, who tell me they shopped in stores for
mops and cleaning equipment and scrubbed floors and walls around their
father's are in the ward, the rest of the place being unsanitary: this in
a standard hospital, not a long term care facility, the ward being for
recovery from surgery. I have also read the same stories in published
accounts. I have never been in an English hospital. I do think the stories
about waiting times must have some foundation.
As to the terrible problems in the US systems, my
experiences have been good and that's true of most of the people I know.
Until I turned 65 I paid $350 a month for my Kaiser dues -- I paid it all,
since I am self-employed -- and that covered me, my wife, and the kids
until they left, forget whether 18 or 21. I suppose that was expensive but
it wasn't excessively so, and in those times it covered essentially
everything. I suppose there was a nominal copayment. Today's visit cost $5
for my checkup interview and another $15 for a chest x-ray. Enough to keep
me from going out daily for a chat, but hardly crippling.
I keep hearing how awful the US system is, but my
experiences don't match those stories, most of which seem fairly unusual.
==============
LEO Price
Just checked out the price of LEO for Space-X's
vehicles
4905.491 dollars a pound
<http://www.spacex.com/falcon1.php>
Far better than NASA's cost of 15000 dollars a pound
in 1988 dollars. The maximum payload of 1010 KG's. And the latest version of
their ship promisses cheaper flights.
And I just did the numbers on their next vehicle
The Falcon 9
http://www.spacex.com/falcon9.php
1632.80 dollars per pound!
David March
Hurrah
==
Astounding Mars video from JPL
Jerry,
I still recall my excitement, and then crushing
disappointment, as a 10 year old when Mariner 4 returned the first flyby
pictures of Mars in 1965, and we saw that it was "As dead as the moon."
We've been some decades correcting that misperception,
but now we see that it is a very interesting world with LOTS of water ice.
This short video from JPL is well worth the viewing. Note especially that if
Viking had dug down 6 more INCHES, we would have known of subsurface water
ice on Mars 35 years ago.
Would this have changed space policy? Probably not; it
came at least six years after we had already decided to dismantle the
infrastructure that could have taken us to Mars in just a few years, and
other events determined the course of space policy.
I was at the Udvar-Hazy branch of the Air and Space
museum last week (also well worth it for anyone who reads these pages), and
saw one of those magnificent F-1 engines from the Saturn V. Oh, what might
have been...
Anyway, this is a nice video on MRO science results:
http://marsprogram.jpl.nasa.gov/
mro/videos/mro/movies/200909
24a/mro20090924-480cc.mov
Chuck
TOP
CURRENT
VIEW Wednesday
|
