Linda, as usual you provide a thoughtful analysis of an important issue.  My
comment is derived from experience in my role as patient representative at FDA
for PD and my experience initiating a program for the PDF that I call the
pipeline project (AKA Parkinson-FDA-Industry initiative, see
www.parkinsonscare.org/RxDEv.html).

Given the NIH research agenda and the momentum building in genomics and
understanding of the disease process at the cellular level, cures could be found
in the next 5 years, but there's a catch.  Tacked on to the discovery is 5 to 10
years development of the treatment in animal models and evaluation and proof of
safety and effectiveness for humans by FDA. While getting new treatments through
the pipeline was always important, currently a new generation of
neuro-protective compounds, which promise  to slow the progression while we wait
for the cure, is now reaching clinical phases of evaluation by FDA.

When advocates in Washington met 2 years ago with Dr. Harold Varmus, Director of
NIH, he said, "you should be lobbying industry." He was right. Working from the
knowledge produced by science (NIH's primary mission), industry has the role of
developing, manufacturing and distributing the treatments. As patients with a
chronic degenerative condition, our interests are almost totally aligned with
industry in the desire for safe, effective, and timely new treatments.  While
the FDA is only concerned with the first two,  thanks to patent law and
intellectual property, pharmaceutical companies are highly motivated by big
profits to get improved treatments to market fast.  Working with FDA we need to
try to find ways to accelerate the process (using fast-tracking and accelerated
review provisions of FDA law and working to speed recruitment and process of
clinical research ) without sacrificing a reasonable assessment from the patient
perspective of  risk - benefit tradeoff of safety and effectiveness. Only when
it comes to price do our interests diverge from industry.  The questions are how
much profit is needed to provide incentive to industry? who pays? and are price
controls the answer?

Who pays for prescription drugs and how much is the central question. The issue
is a concern for the individual depending on which insurance group if any he/she
falls into. This question can also  be addressed on a macro level of relative
payment by different countries as well as the total cost to consumers versus
profits to producers.

Individuals with PD of course need very good insurance coverage for
medications.  Medicare does not cover prescription drugs except for the minority
of seniors who have signed up for managed care plans.  For non-medicare as well
as medicare, the coverage for medications seems to be going in the wrong
direction as health plans raise copays and put caps on coverage so the sickest
people who are lucky enough to have effective treatments (that's us) pay the
most.  With no government intervention requiring minimum coverage the health
plans are motivated to limit coverage in order to attract the healthier people
with low premiums.  Although it is a form of tax, I think it would be fair for
the society to set a standard minimum coverage including catastrophic coverage
after a certain level of out of pocket costs to protect people with very high
costs from dire choices of food or medicine. Ironically medicare recipients had
such catastrophic coverage in the 80's but in what I believe were terribly
misguided protests over paying the few hundred $ in premiums, the senior lobby
pressured the congress to rescind this coverage.

The Innovation Imperative. Bolstered by the engine of basic science largely
funded by NIH and the system of patent protections and insurance coverage for
health care provides powerful economic incentive for taking huge risks of
developing new treatments.  We who benefit from this development especially
don't want to throw out the baby (innovation) with the bath water (the high cost
of drugs). Among developed countries, whether the US should pay far more than
Europe and Canada is another issue as is the obligation toward lesser developed
countries. Whether drug companies should receive excess profits from high
monopoly prices is also questionable.

My view is that market forces and the free exchange of information and products
is the most efficient and effective, although not perfect, method to set prices.
So if Canada and Europe enjoy lower prices, loosening restrictions on mail order
or other ways to import prescription drugs will give consumers in the US more
leverage in transactions to squeeze excess profits from industry.
Unfortunately, just last year an effort to do this was turned back by the
Secretary of HHS, citing lower manufacturing standards and inability to control
the quality of the product produced overseas.  It appears that we have our work
cut out for us politically to  level prices across countries by loosening
restrictions on buying from outside the US.

Price controls are not the answer in my view. I do not think price controls have
ever worked effectively in a market economy because of the distortions they
cause in economic activity, When it comes to who pays and how much, I think
forming buyer cooperatives, large groups of consumers, by state or multi state
will also give consumers in the US more leverage in transactions to squeeze
excess profits from industry.

An example of an attempt to implement these ideas is DC Prescription Drug Task
Force Formed by the Insurance Commissioner in DC, this task force is taking a
three step approach to address the issue of lack of coverage and the high and
increasing cost of medicine.  The task force is considering joining a buying
cooperative, the New England Consortium. In addition a consumer counseling
service is contemplated to help people with high drug costs understand the
complex of choices available from patient assistant programs of drug companies
and charities.  The third component is a subsidy for catastrophic coverage.  One
source of revenue contemplated is the income from the 8 figure proceeds from the
conversion to for-profit status of a large tax exempt health plan.

Perry Cohen
Washington, DC
www.parkinsonscare.org

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