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-------- Original Message --------
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<th align="right" nowrap="nowrap" valign="baseline">Subject: </th>
<td>QALY pharmacoeconomics</td>
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<th align="right" nowrap="nowrap" valign="baseline">Date: </th>
<td>Mon, 19 Dec 2005 00:21:26 -0600</td>
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<th align="right" nowrap="nowrap" valign="baseline">From: </th>
<td>Lifespan Pharma/Morris Johnson CTO <a class="moz-txt-link-rfc2396E" href="mailto:megao@sasktel.net"><megao@sasktel.net></a></td>
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<th align="right" nowrap="nowrap" valign="baseline">To: </th>
<td><a class="moz-txt-link-abbreviated" href="mailto:futuretag@yahoogroups.com">futuretag@yahoogroups.com</a>, Morris Johnson
<a class="moz-txt-link-rfc2396E" href="mailto:mfj.eav@gmail.com"><mfj.eav@gmail.com></a></td>
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<th align="right" nowrap="nowrap" valign="baseline">References: </th>
<td><a class="moz-txt-link-rfc2396E" href="mailto:B55E044559115F4B8C9EE62323C322B412DEE3A2@hickory.cmpcntr.tc.trincoll.edu"><B55E044559115F4B8C9EE62323C322B412DEE3A2@hickory.cmpcntr.tc.trincoll.edu></a></td>
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<pre>Hughes, James J. wrote:
> Interesting question, albeit not very coherently stated.
>
> Some observations:
>
> QALYs are a tool for assessing the social utility that can be generated
> by alternative investments of public monies. It can certainly be
> extended to include the social utility produced by both public
> expenditures and regulatory efforts, which are also an investment of
> sorts. However your posts seems to assume that public regulation is only
> to be judged in terms of how many benefits they deny the public access
> to. I'm willing to concede some of that, but I think there is a much
> stronger case on the other side: in general, food and drug regulations
> keep the public from wasting money on unproven, ineffective and
> dangerous drugs, "natural" and otherwise.
>
The idea behind QALY is to compare cost with efficacy.
The key would be to generate QALY from these less than perfect services
with the risk being that
they are QALY deficient. Low cost NHP's might compare favorably overall
when compared to high cost of
disease treatments they might forestall or compress into later life.
> For instance, millions of women took estrogen replacement therapy and
> then found out that it increased their risks of cancer and heart
> disease. In retrospect, it would have been nice to have required a large
> scale double-blind clinical trial of HRT before it was prescribed rather
> than after.
>
> As for "natural" therapies, a major study of milk thistle just found it
> ineffective in reducing liver disease, and St. Johns wort has been shown
> to be ineffective in treating depression.
>
At an NHP regulatory course I took I think I discovered one cause for this.
Their sample protocol was 2 caps echinacea with cisplatin as a trial to
extend teminal cancer survival times.
I said "whoa, if you want efficacy with herbals don't give 2 caps give
20. When I use NHP's I use teaspoons full not itsy bitsy
drug scale amounts." So negative results can be the result of poor
study dosage criteria for example.
> The reason that QALY calculations have not included "natural" treatments
> hitherto is because once we know, through clinical trials, what efficacy
> a treatment actually provides then its not "natural" anymore - its just
> medicine. As we've seen with Vioxx and many other drugs, however, even
> the process of clinical trsting is very problematic.
>
NHP's can do clinical trials just like regular pharma and still be
NHP's...in Canada anyway.
I'm sure some crude guesses can be generated for herbal NHP's without
formal trials.
Ginseng might be given some ball-park QALY compared with the pharma
quality clinical trialed "Cold FX" extract.
> Although the process and science of clinical trials can be much
> improved, if anything, public health and QALY maximization would be
> improved by more aggressive food and drug regulation, not less.
>
Getting all the data system-wide from all charts and records into an
accessible e-format and then
data mining it to find patterns would help things along. An impediment
is the confidentiality thing.
To me over-regulation of privacy is a problem.
> What keeps the FDA from acting in the public interest is the influence
> of the pharmaceutical and health supplements industries, pursuing their
> various forms of lobbying and influence, increasingly naked and
> unashamed under the Bush administration.
>
Politicians are as a group not med-tech insiders with enough life
experience to jump over their own
bureaucracy.
> So if your real concern is QALY maximization, let's start with policy
> questions such as:
>
> - what QALYs are being produced by investing in the administrative
> overhead of 1500 private insurance firms (and the administrative
> externaltiies they impose on hospitals and doctors' offices) versus
> investment in something like universal health insurance in the US?
>
Under a pure public medicare system there is the complaint often that
"union" dictated work protocols reduce the
flexibility of chains of command ability to maximixe individualization
of service delivery to give the same level of service per billed hour.
(system inefficiencies)
I would propose that total transactions over the totality of some
conditions over a lifetime
are higher because waiting list use allows conditions to become more
advanced and thus require more dramatic treatments.
If you are very ill (stroke) you get priority treatment, if you are
moderately ill (say need hip replacement) you wait your turn for months
at times. QALY rationing at work perhaps.
However there are bottlenecks in MRI and specialist consult access wait
times in the public system.
QALY breakdown.
How a mostly private system where a slice of every definable
transactional portion
is carved off as profit to the owners of each drug, service or facility
capital compares is one of my concerns.
Overall I believe the Canadian per capita health care costs are only 70%
of the mostly private USA system.
One would conclude from that that if the same amount of money was
expended by a pure public system that there would not
be wait lists and that total service would surpass the mostly private
system.
The average patient when entering for public system crisis treatment in
a system with rationing based waiting lists is generally sicker by the
time non-life threatening conditions are treated compared to under a
first come first served higher fee private system. QALY breakdown.
There is a slice of the mostly private system clientel who are rationed
by way of being un or under-insured
and not able to be listed on any wait list. So there is a sort of
invisible wait list that is never counted.
The libertarian view is "pay up or die". The pure public system is
"hurry up and wait".
The other side for public systems however is that early detection access
is faster at the start so people who might
not see a doctor do so without need to fit such a visit into their
budget or HMO plan coverage terms.(walk-in cataract surgery)
Public payors tend to cap the higher cost salaries much better than the
low end salaries.
QALY are the basis of disease criteria coverage rationing of highest
cost drugs.
It's hard to give the drug companies all the blame as they seem to
struggle just to keep shareholders happy.
I had a friend who had a heart lung transplant for polymyosistis in
California a couple of years back. He was on a waiting list up here.
When he asked for some cost sharing by medicare they said "If we knew
that you were going to get it someplace else
we would have put you through sooner, so we are not sharing in your
costs since you did not wait your turn. "
My friend said "I'd have died if I had waited so I had no choice."
QALY based public waits VS market driven waits.
It is stated that the more private system generates more technological
competition and I must give that some
importance. In Canada, Ray Kurzweil would not be booking into a clinic
one day a week to push the limits of technology
as well as getting unrestricted services on demand.
The system would dictate that since diabetes has an average course it is
not fair for one person to get so much service when
others are waiting for consults. The public system would not put
resources into individual life-extension over systemic
palliation.
This is the one major fault in the public system.
My business activities deal with the component of life extension from
NHP's and I see an uphill battle when dealing with both systems with the
public being the worse off as a result.
I don't want to play on the negative but think the QALY model has some
deficits in it's way of creating the numbers.
It needs improvement and better explanation to those who make
pharma/med-economic rationing decisions.
Especially in a monopoly public payor only system.
MFJ
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