"Curly Surmudgeon" wrote in message
. ..
On Wed, 17 Sep 2008 02:49:15 -0400, Ed Huntress wrote:


"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.

I'll keep my fingers crossed for you but do not extrapolate your extreme
medical condition to the general populace.

Thanks, and I don't extrapolate. Type I diabetics make up just a fraction of
1% of the population. I'm just a shining example d8-)

But considering that Type II (adult-onset) diabetics have similar
problems -- some of them worse, in fact, including the incidence of loss of
limbs -- and make up 23.1% of the US population over age 60 (and those are
just the ones that have been diagnosed), my situation is not really
"extreme." It's just that I got started earlier and serve as a kind of
weathervane for those who acquired the similar condition later in life. If
you're in your 50s or older, those 10-15 years of grace that 20-year-olds
enjoy may shrink to just a few years.


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.

All true. On the other hand you are talking about providing cutting edge
technology to the general population and that's not a reasonable
expectation. Regrettably it's a path that will bankrupt the health care
system. Life sometimes sucks and if you are very poor you may not be able
to afford a life saving proceedure, that's what charity is for. On the
other hand those costs are outrageous and we must bring them down to
earth.

Well, that's all true, too. The healthcare issue as many people see it is
that everyone should have the same cutting-edge technology available to
them. That's a majority position in the US (as in most of the world) now, as
unrealistic as it may be. It will be the guiding idea behind health care
reforms.

The practical outcome will be different. The question is how much different
it will be, because health care reform is coming, whether the conservative
ideologues want it or not. It's a tsunami that's racing across the seas from
all directions.


Your program further inflates costs to the majority for the few, mine
chops the hell out of those costs for the majority at the expense of a
few. I believe that my program is the more humane by far.

If you follow the polls, you realize that yours is definitely a minority
position, and the trend is against you. It will lose, politically. It's just
a question of how soon it will come to a vote and move.

What will happen is that universal health care will be sold in a package
with efforts to cut medical costs. Some efforts will be successful. Others
will not. It will extend the delay to the crisis point for a while, maybe
for many years. And then we'll decide what we want and can have, once again.


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.

To the contrary, remember, I've lived in Argentina for about 3 years now
where I can buy just about any drug without a prescription and those that
do are drugs that I'm not interested in.

No, because Argentina's health care system, as I explained above, exists in
the shadow of the FDA and the European (and Japanese) equivalents of our
system. I don't know Argentina in particular but most countries are in that
situation. Argentina's health care system can only function because it's
parasitic on the systems of the major players, in terms of what drugs are
available, how they've been vetted, and what experience from those more
regulated countries tells the Argentinians about what works and what
doesn't.

They don't operate in a vacuum. A friend of mine who was the Carter-Wallace
rep for Africa, and who also repped throughout the Caribbean, explained it
in fine detail to me over a period of years. What I learned from working for
Big Pharma confirms the same thing. They're all riding on information that
comes from the drug development, testing, approval process, and
record-keeping of the major western countries. They make their own
decisions, but they don't have any significant amount of their own
information on which to base them. They can get all the information they
need from us, for free.

You can go online and collect the PIs (prescribing information) forms from
the FDA for 1,000 drugs in a couple of days; put a team of physicians and
other specialists together to review them; and develop a drug policy and
approvals for a medium-sized country in less than a month. And that's the
skeleton of how they actually do it.


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.

And it's wonderful. I needn't visit a doctor for simple drugs, I can
self-medicate, I can refill my one long term medication without being
molested by a self-interested bureaucracy. I can get immunizations and
injections at the pharmacy too. This is one major reason I live here, I
hate the "Big Brother" attitude.

It's only possible because there is a Big Brother who provides them with all
the information, for free. Then they make their own decisions, based on
their politics, their sense of responsibility to their people, their legal
structure, and their tolerance for a few unfortunate deaths resulting from
people who are medically ignorant making life-and-death medical decisions.
In the case of many countries, their willingness to institute a system of
controls -- that is, their willingness to pay for such a system -- enters as
a big factor.


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.

That's an excellent foundation to convert the FDA upon too. That work
will not be lost, its the basis for evolving healthcare.

It won't be lost, but it's only available for drugs that are already
available. New ones need new studies and analysis.


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.

"A few bucks"????? We're talking thousands and tens of thousands of
dollars per person! Do not extrapolate your health condition to the
population at large. Not-smart people do not "drop dead" they don't
medicate usually and if a few do "drop-dead" then that's life. Or death.

Huh? Over 125,000 people die in the US each year from drug reactions and
mistakes alone. Misprescribing leads to some of the reactions; lack of
clinical-study information about drug interactions leads to most of them.
That's not "a few" who are dropping dead.

As for the "tens of thousands of dollars per person," the average
pharmaceutical bill in the US is $850/person. The way to cut that is with
some reforms in health care and the way the pharma industry is regulated,
not in deep-sixing the FDA, because it's the FDA that keeps that 125,000
deaths from being a much larger number. We pop a hell of a lot of pills, and
a lot of them are deadly if they're used ignorantly.


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.

I think I mentioned elsewhere that a new drug requires roughly a half
billion dollars to become FDA certified. That is intolerable.

Half of that number is marketing. Cut the marketing, not the clinical
studies or drug regulations. I don't care how much the marketing people get
anymore. g


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.

There you go, publish those data, update as more data becomes available.
Caveat emptor.

That's precisely what they do. It's all available to the public, once it's
submitted for FDA approval. I read around 360 studies related to the
marketing for one drug, alone. Regarding "caveat emptor," how many do you
have time to read? They run around 8 or 10 pages each, on the average, and
they're not very entertaining.

I've read thousands of clinical studies but I'll do the emptoring, and let
the FDA do my caveating, thank you. d8-)


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.

Statistical review can pull that data from the noise. People died in the
example you offered even with testing.

Many die even with the testing we have now. Many more would die without it.

Not only test subjects but
subjects who were denied the new medications but might have been helped.
That's life. And death. **** happens, no one life is worth the cost of FDA
regulations.

FDA fast-tracks cancer drugs and many other critical drugs now. You might
want to make the track faster. I think it's about right.


It can be argued that limiting drugs as the FDA does costs lives too.

I've read the arguments. The data is available. You'll find it with a good
search on PubMed.


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.

Mandated health insurance, right? What about those who do not want
mandate health care?

Screw 'em. As it is, they're winding up in the ER and taxpayers are footing
the bill. This isn't Zimbabwe or the Sudan so we aren't going to just let
them die, so ram health care coverage down their throats, for the same
reason we don't let people drive without liability insurance.

What you propose violates my freedom and monopolizes
the health care industry.

Yup. When your "freedom" becomes my tax bill, because you can't or won't
cover your own ass, you've just forfeited some of your freedom, IMO. Or you
can move out. That's your freedom.

It is also a license to steal and further
empowers the FDA monopoly.

What's your gripe with the FDA? I can see bitching about Big Pharma, or
hospitals, or doctors, but the FDA does a pretty good job, IMO. What is it
you think they do?

Redirecting the FDA to an advisory agency would
immediately chop off at least half the cost of health.

Baloney. It would just speed up the casket business.

Remove the AMA
monopoly and another quarter might be saved.

Great. We'll let anybody put out a shingle. I told my wife, after studying
endocrinology for some of my work, that maybe I should go into the business
and start prescribing hormones. It would be a great experiment and fun, too.
d8-)

Cutting health care costs by
75% would be easy and making care available to those who now cannot afford
your care would save more lives than are now being lost.

Hey, you aren't in the market for a Bridge to Nowhere by any chance, are
you?


What we now have are a number of state protected monopolies which prevent
competitive forces to rein in health care costs. I cannot/will not vote
for that.

Significant competitive forces don't exist in health care; never did, and
never will. You don't shop around when you're having a heart attack.


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

You realize that I have a very low opinion of laws which violate my
liberty, don't you? We have no obligation to obey anti-constitutional
laws.

shrug The Founding Fathers didn't anticipate CT scans and open-heart
surgery. They were lucky to get leeches.


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.

That is an unsupportable assertion and one that I disagree with deeply.

Well, fine. Spend four or five years studying and writing about
pharmaceuticals and health insurance, and we'll have another talk.

When market forces are unleashed we also need to revamp fraud laws to keep
the manufacturers honest but all major diseases have drug treatment now so
the number of new drugs coming onto the market is smaller. And hideously
more costly given the current FDA regulations. We cannot permit an
industry to blackmail us for health care.

You tell 'em.


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.

Nope, all the current drug treatment programs would continue, no risk
involved. Only new drugs coming onto the market might risk, advise the
patient rather than burden the health care of every other individual on
earth. This is where the FDA would come in, monitor the use of new drugs
and provide statistical analysis of the effects for advising other users
in the future.

That's what they do now. Then they regulate the ones that would kill us off
the market. That's about it.

--
Ed Huntress