Givepatientsafightingchance.com

This page is simply a page called What if....................... What if we proposed legislation or a State proposition as follows. What would it look like? How could it be worded to get the most amount of support and still have its intended result? Thus these are pages in progress.  Pages to think through such that every thing and the consequences are well thought out. Right now, the language is raw, needs lots of work and refining, and there may be parts of the language that could be counter productive. It will need the support of the Medical Associations, Research Universities, the Pharmasuetical Industry, and the Research community. There are many out there that can help and if you are in agreement with the message of this web site, please e-mail us your ideas. Or better, join the effort. Italized writing in blue is written to help understand intent of language only. Lastly, This "What if" page is idealistic and it is definitly written from a Pateint Focused perspective geared towards efficiency and saving our lives. Doctors, FDA, and research interests would have to be on board as well. If all the forces, whoever they are, could iron out these issues, many lives could possibly be saved and technology can procede faster than it ever has. No matter how skeptic you are, try to see the possibilities of "What if. " Most importantly how could this page be improved to meet its goals.

Proposed California (or any other state) State Proposition Give Patients a Fighting Chance Legislation to give terminal patients a fighting Chance.

 The Give Patients A

Fighting Chance Act.

Possible Terms between the Patient and the research Doctor team.

Passage of this State Proposition or State legislation will allow patients with terminal disease the option to try untested Drugs or treatments under the following conditions and guidelines.

1) The Patient has the documented opinion of three Doctors including two who are specialists in the specific disease of the Patient. All three Doctors agree that said patient, with in resonable assumption, has less than 3-6 months to live.

2)  Agreement that Said patient has exhausted most all (with in reason)FDA accepted modes of treatment for Pt's disease with no realistic hope of success other than the possibility of developing research.

3) It is the Research physician's opinion that the Patient doesn't qualify for any Clinical Trial that would offer realistic hope or that conditions exsist such that the Patient will not be able to get into a Clinical Trial. 

4)The Patient has gone through two separate sessions of informed consent at least three days apart, both of which are video taped. During informed consent all of the following will be explained in explicite detail. The procedure, the new drug and its history to date,  why the research Doctor feels that the Treatment offers the best possible hope, result of no treatment(in these scanarios it will always be death), the low probability of miraculous success in these similar treatments, and What the patient can expect through out the treatment process.It should be observable to anyone watching the video that the Patient understands the high risk involved, the low probability of success, is coherent, and capable of such a decision.

5)Patient and Pt's Family and any other associates to Pt, by law have to hold Research Doctors and Institutions harmless for any and all results negative or positive.

 State Proposition Give Patients a Fighting Chance Legislation to give terminal patients a fighting chance

The Give Patients A

Fighting Chance Act

Possible Terms between the FDA,Or Government, and Research institutions

Passage of this State Proposition, or State Legislation will allow Research institutions and Research Oriented University Hospitals to treat terminal Patients with any possible Treatment that offers any hope per the following conditions.

A) FDA (Or the State of California) with help of the Specialist Health Societies to authorize certain top research institutions for specific diseases. Institutions to be chosen based on current research being done, top producers of new technology, and geographical considerations. These institutions will be called Give Patients A Fighting Chance Act Authorized Institutions. (GPAFCA authorized Institutions) For example, for the disease of CLL, the top institutions in California would definitely  be UC San Diego,  and Stanford, and possibly one or two others. Nation wide it would be MD Anderson in Houston, Baylor in houston, Ohio State,  The Mayo Clinic, Maryland, and another 15 or so.

B) FDA (Or the State of California) to establish an internet based data bank that GPAFCA research institutions must use in reporting results of all Give Patients a Fighting Chance Act procedures, dosage stratagies,  treatments, and treatment results. In effect then, Patients would no longer be required to get FDA approval each and everytime. The FDA or State agency would have the right to come in and check and make sure that rules are followed. How public, and when exsposing the data base to all eyes  would depend on the best interests of researchers and regulatory agencies. Certainly dosage stratagies, and specific protocols should be used to learn for the next attempt. Keeping track of indiviual results insures efficeincy for the next time. Keeping private for a certain length of time could insure that enough patients try a protocol such that true data can be extracted.

C)Research Universities will gain approval from FDA or California State to be a practicing "Give Patients a Fighting Chance Act Facility" which will allow them free reighn to try new treatments assuming all other numbered criteria is met with each Patient.

D) FDA and or State of California understand that all researchers working under Give Patients a Fighting Chance  Act(GPAFCA) will be held harmless for any result. 

E) All Treatments or therapies used on terminal Patients must have had at least one round of successful testing. Whether in animal study or petri dish study, the therapy to be used has shown success that resulted in the publishing of those results in a Scientifically Sound Medical Journal. In esence this addition will lower the bar substantially over what is currently being done. This is key to helping researchers lower costs and to actually saving lives by getting terminal patients into medicine that normally would take another 5-10 years before being seen in a human being. those patients who don't like the idea of being a "guinea pig" simply won't be interested. But those who are younger and still desire to serve and live will probably at least try.

F) All participating Institutions agree to provide meticulous testing and recording of Patient's clinical revelent information consistent with that Patient's disease and based on the latest learned of that specific disease. Institution agrees to document before, during, and after results and happenings to FDA (Or California Data Base) data base with in and agreed upon time frame of happenings. Any application of treatment that results in immediate catastrophic result must be reported to FDA ( Or California Data Base) data base with in 24 hours.

G) Despite sharing as much information as possible, companies developing research will still be assured of patent rights to developing technologies.

This is a tough one but essential since a pharmacuetical company or research team is often putting up the dollars to make drug developement happen. Certainly this portion would turn into a large legal document. When we make development of life saving technologies cheaper and thus more profitable for pharmacuetical companies, we will simply see more life saving technologies being developed.  Thus, the ecomomics of drug develpoement should be set up to encourage drug developement, not discourage it.