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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 ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn