[extropy-chat] QALY pharmacoeconomics

Mon Dec 19 14:58:55 UTC 2005

-------- Original Message --------
Subject: 	QALY pharmacoeconomics
Date: 	Mon, 19 Dec 2005 00:21:26 -0600
From: 	Lifespan Pharma/Morris Johnson CTO <megao at sasktel.net>
To: 	futuretag at yahoogroups.com, Morris Johnson <mfj.eav at gmail.com>
References: 
<B55E044559115F4B8C9EE62323C322B412DEE3A2 at hickory.cmpcntr.tc.trincoll.edu>

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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