"Curly Surmudgeon" wrote in message
. ..
On Tue, 16 Sep 2008 17:33:16 -0400, Ed Huntress wrote:

snip

Yes, now I would. I just went through six sessions of laser eye surgery
for PDR. I don't want to do it again. I'll pay for the best control I can
get.

Physicians Desk Reference? Dunno "PDR." Most diabetics would opt for
injections when the pump is out of pocket, except for those in extreme
distress.

Sorry, you seemed to know about diabetes so I used the abbreviation for
proliferative diabetic retinopathy.

As for opting for injections, that's fine if you're lucky enough to have A1c
readings of less than 7.0. Some people's systems just won't allow it, even
if they do multiple blood-glucose tests and inject ten times a day. I test 5
times a day and inject 6 or more separate doses, but my A1c runs around 7.2.
The newest pumps should get someone like me down to something under 6.8.

7.0 will carry you if you have good genes and haven't been diabetic for more
than 10 or 15 years. I have the right genes, but it's 35 years for me. Until
the eye problem I was the only Type 1 (juvenile) diabetic I knew with more
than 30 years on the clock who had no major problems. Now I have one, but,
thanks to advanced medical technology (laser surgery) I may not have the
problem again. Maybe.


Note, I've designed medical instrumentation. One product is not too
dissimilar to your insulin pump, it took a blood sample from a drip line
and tested for lactate acid giving real time results. I am very
familiar with the industry.

Well, maybe I should interview you for an article I've had in the can for
a year. It's about medical-device manufacturing and meeting the FDA and
customer requirements. I have eight interviews done, but I'm losing
energy
for it.

Use my email in the header.

Thanks. I've put this message into the file in case I revive that article. I
have around 50 hours invested in it so I do want to finish it.

snip

True but the root cause is that health care insurance is unavailable at
rational cost. Kaiser for my wife and I would be $1600/month in the USA
and is about $25 in Argentina.

So, Argentina has subsidized or government-run insurance. I'm all for it.

Kinda, sorta both. Immigrants can buy into the state system but each
municipality has an open clinic where the costs are very cheap. A
front/side chest x-ray cost about $13, dental extraction of molar with
abscess cost a friend $6.70, etc. I've bought into private health care
at a local hospital chain. Ambulance service is free, I used it two
nights running when semi-conscious and unable to drive. Heh, I had
_chicken_pox_ at my age... Never knew it could be life threatening...

Being in the seond or third economic tier can produce some wonderful
benefits for a country. For example, you don't have to invent or develop
much of anything. You just use the same stuff that was developed in the
leading countries.

You'll find that the companies selling that stuff can be very compliant to
your political needs. They'll set up an entirely separate accounting system
for dealing with you, one that doesn't have to account for any upfront
costs, because those are all paid for in the leading country. Since your
market is basically a gift to those companies, providing unanticipated sales
on otherwise idle production capacity, they'll be happy to treat you as a
source of marginal sales, and all that their books will show as expense
against their selling price in your country is the marginal manufacturing
costs and shipping. Something that costs $100 in the leading country, where
they're amortizing all of the upfront costs, might cost $2 in your country.
And it will appear on their books as a profitable sale -- because it's a
marginal sale.

Accounting can be a very creative thing. d8-) The problem with being a
second- or third-tier country in those circumstances is that your economy
basically don't exist outside of the orbit of the leading countries. It
creates quite a web of dependencies over which you have no control. But it
sure saves a hell of a lot of money.


There's always a ready market for new drugs and new medical
technology.

True, and sometimes the costs are justified. But recognize that a
full 60% of new drugs are governmentally subsidized through university
research then turned over to pharmaceuticals for manufacture and
distribution with but a bare tithe to the university while Abbott et.
al. gains usuary profits on our own tax dollar.

sigh I'm well aware of how that works. My last job in a medical
communication agency involved a drug on which Sanofi-Aventis had paid
something like $135 million in development costs, and $110 million in
pre-approval marketing costs (which was paying my salary). Then the FDA
decided not to approve the drug. So my company laid half of us off.
d8-)

The basic research on that drug was not from a university, however. I
know that a lot of the basic research is done in universities. What you
may not know is that the testing that the pharma companies have to go
through after some basic-science lab makes a discovery often costs ten
times more than the basic research.

I'm familiar with the problem. The FDA should be an advisory, not
regulatory, agency. All the special interest groups like, encourage,
support, and fund that evil.

I completely disagree about having the FDA become an advisory agency,

We disagree then. I see the FDA as a self-serving bureaucracy controlled
by special interests. I do not like the idea of a governmental agency
telling me what medicines or treatments I can, and can't, have.

The thing is, Curly, that you have no experience of buying or using drugs in
an environment that isn't dictated by the FDA and similar agencies in other
highly developed countries. So you're speculating about how it would work
out.

Those lower-tier economies have an office that sounds like FDA, but it's
usually an empty shell full of rubber stamps, giving supposed approval to
drugs and procedures that have gone through the approval process of the FDA
or the British, French, or German equivalents. And the drugs they sell
over-the-counter are mostly ones that have been vetted, for prescription
sale or otherwise, by the leading countries.

The only direct comparison you can make is to the US before there was an
FDA. It was much harder to get a centralized, reliable count in those days
of how many people were winding up dead from taking the drugs then
available. But the number was substantial. We can tell now, in a lot of
cases, because those drugs have since been run through large clinical trials
in which the results have been measured.


for
the same reason we got the FDA in the first place. Those greedy corporate
types you're complaining about wouldn't mind killing many more people if
they could get away with it. Testing on humans first is the way to make
more money.

That is not what I propose. Let the FDA provide online, honest, data on
drugs and let the buyer comment and beware.

You're proposing a system by which smart people save a few bucks, and
not-so-smart people make minor mistakes and drop dead. I don't really like
the sound of it.


Note that I've actually been through the FDA approval process. Not
responsible but as an independent contractor responsible for adhering
to the requirements on glucose monitors, inhalation dispensers and
patient monitoring systems.

I should point out here that testing a medical device is NOTHING like
testing a drug. It's much simpler, and it's done with much smaller cohorts,
so it's vastly cheaper. You don't see $50 million studies for devices, as
you often do for drugs.


Generics, Canadian, and other sources are often 90% cheaper.

Of course. Generics just ride on the research, testing, post-marketing
studies and marketing that was done for the original drug. All they
have to recover is manufacturing costs and quality-control reporting.
In Canada, they have price controls and just refuse to allow the drug
companies to amortize research and development. The Canadians, and the
French, and the Brits, and everyone else knows that they can collect
those costs in the US.

How long do you think a pharmaceutical should have a monopoly? Is 17
years not enough?

It depends on how you structure it. Some kind of regulated, extended and
mandatory licensing would reduce prices and keep up enough income to
fund big trials. And it's the big clinical trials that cost most of the
money in pharma. Patented medicines are too expensive, but generics are
too cheap.

Precisely why I want to change the FDA to an advisory agency. Today it
costs roughly half a billion dollars to bring a drug to market, that is
irrational and runs the prices up so that the general tax fund must
subsidize use.

But what's the basis on which the FDA would "advise"? The last drug I worked
on as an employee (rimonabant) was being sold in France, Germany, the UK,
and parts of South America before three long-term studies ordered by the FDA
turned up the problems with it. The Europeans got egg on their faces -- and
some dead citizens -- because they didn't require the long-term studies. Now
they're pulling back and black-boxing those drugs. But they never would have
known the problems without those huge studies, which cost something like
$100 million in total to run.

Who pays for that if the FDA doesn't impose it as a requirement for
approval? You're talking about going back to the dark ages of the drug
business, when people died from taking drugs and no one knew the drug was
involved in the deaths. Hell, no one even knew that the people who died had
been taking the drugs.

snip

You are one of the lucky, many cannot get insurance because they are
under employed, unemployed, homeless.

Yeah, we know. I'm very lucky. The year before last I paid insurance out
of my pocket for six months, and it cost me almost $7,000.

How would you change that inequity?

Universal health care, with a single-payer system and optional supplemental
insurance. Take the European and Canadian systems, analyze the good and the
bad in each, and design a better one based on those experiences.

You'll have to re-engineer a lot of the health care business to do it. Tort
reform, reducing redundancies in testing facilities, etc. Very
socialist-sounding. Very politically incorrect. But the only way to reduce
costs and provide health care for everyone at the same time.

The danger with it is not so much a case of limiting coverage (that will
happen no matter what system you use, including our present free-for-all
system), but rather limiting innovation. That part will require very careful
work.

Since the US is the last country of any substance without universal health
care, this is where most of the innovation happens. The Europeans and others
are tuned to our drum; they adjust their systems so they don't look too bad
in the innovation department, given our example. It's hard to say how that
would work if there was no free-for-all system like the US against which to
compare oneself. It is a concern, if every major country has a controlled
system. It's easy to become complacent if there is nothing against which to
compare your results.

I don't expect a universal system to work really well. I just expect it to
produce a better result than we have now, in terms of health statistics.
There is no way that it will produce as much innovation. You pay your money
and take your choice. My choice is universal coverage.


This transitions into the quality of care issue too. Another factor
we've not discussed is the costs caused by AMA monopoly of providers.
Midwives and alternative treatments have essentially been banned to
create a monopoly. Then there is the FDA making many drugs
prescription only. In fact some years ago the FDA stated that they
would have made many current over the counter drugs a prescription item
if they had it to do over. They are now trying to rectify that by
regulating vitamins, minerals and even tobacco.

We Americans have an aversion to reading about dead people who took
drugs they were told were OK.

**** happens. Life is not guaranteed safe. The government is only
permitted to regulate fraud and crime, not what we ingest.

I think the law disagrees with you on that. g Your ideas concerning pharma
are ideological, abstract, and unreal based on what we know about drugs,
Curly. You're laying out a prescription for ignorance and death. No one
would know what drugs are causing what side effects and adverse outcomes;
all you'd have is a collection of rumors, marketing claims, and guesswork.

We've gone beyond that and hardly anyone who knows the issues would want to
go back. Your reactionary approach would result in a meaner and riskier
health care system for everyone. It would be cheap, but it would leave a lot
of bodies and maimed lives in its wake.

--
Ed Huntress