Terminal Patient Access & Quality Care

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members of the United States House and Senate

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Members of the United States House and Senate,

In recognizing

an estimated 80\% of clinical trials in the United States are delayed because of inefficient enrollment
an anemic 3\% to 5\% of all adult cancer patients are estimated to ever participate in clinical trials
approximately 8 years pass from the time a cancer therapy enters clinical trial to the time it receives FDA approval for sale to the public, on top of the six years of research already spent before it enters clinical study
many terminal patients continue living today unaware of their option to utilize experimental therapies outside of a clinical trial (I.e, through Expanded Access programs)
only 11 open Expanded Access programs for cancer exist while approximately 6,700 open clinical trials for cancer exist (about 2/100ths of ONE PERCENT of therapies in clinical trial for cancer are also available for Expanded Access)
Most illnesses and infections can be better combated if done so through drug cocktails rather than through attacking these ailments one mechanism of action at a time
Many therapies that are proven to be safe and effective on their particular molecular target are not approved for use because they fail to meet the statistical marks for primary endpoints like survival rate; even though, they yield statistically significant marks on their particular molecular target
Patients with seriously compromising illnesses and infections can be most effectively treated if the molecular, genetic, or most basal characteristics of their ailments are known.

We petition that you spend your valuable time to solve these problems and accomplish the following goals, recognizing them as most important to us:

1. To increase and improve terminal and seriously ill patients' access to experimental therapies, and their knowledge of this access.
2. To improve enrollment efficiency in clinical trials.
3. To increase the utilization of personalized diagnosis (at the molecular, genetic, or most basal layer possible) and treatment off of that diagnosis, most especially in the event of seriously compromising ailments.
4. To stimulate the amount of drug cocktails investigated for various diseases and ailments.
5. To revisit the FDA rules regarding drug approval to ensure they are in the best interest of patients, that interest being to have the most effective and safe medical care possible.

We urge you to take immediate action to solve these issues, and we strongly request that a detailed proposal to solve these issues is written, completed, and set for implementation within the remainder of the year. Inaction is not an option. We will follow up on your progress. Thank you.

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Linda S. Walden
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