Respecting the right of terminally ill patients to have access to innovative drugs in development would seem to be a matter of compassion in an otherwise hopeless situation.
Yet, the Food and Drug Administration has a problem allowing anyone to live without its permission. And since the U.S. Supreme Court has ruled that patients have no right to use drugs not yet approved by the FDA, the only hope is a legislative remedy or medical treatment outside the United States.
Believe it or not, the FDA does not allow your own stem cells to be removed from your body, cultured and processed, and used for your own therapy. The FDA says your stem cells are chemicals, which it must regulate. Thus many terminally ill patients are forced to leave the country–at least those who can afford to–if they need to seek treatment with their own stem cells.
The idea that the FDA must test and approve a therapy that is, by definition, unique to each recipient is absurd. Even a massive bureaucracy like the FDA is incapable of such an impossible task. It is also the death knell for innovative, personalized medicine based on each individual’s genetic profile. Purposeless and omnipotent control is the only objective the FDA can hope to achieve.
Some of these patients, however, along with those who support them, continue to fight for their lives against the FDA. As Frank Burroughs, founder of the Abigail Alliance, pointed out: “Every drug for cancer and other serious life- threatening illnesses that the Abigail Alliance has pushed for earlier access to in our thirteen-year history is now approved by the FDA! There is not one drug that we pushed for earlier access to that did not make it through the clinical trial process. Many lives could have been saved or extended if there had been earlier access to these drugs!”
The Abigail Alliance gets its name from the daughter of Mr. Burroughs. Abigail passed away at age 21 after being denied access to one of those drugs.
The fight goes on as the Abigail Alliance seeks to push the Patient Choice Act through Congress. This legislation would allow compassionate access for terminally ill patients to drugs that have passed Phase I safety review by the FDA. The Abigail Alliance also presses for FDA regulatory science catch-up with the rapidly expanding knowledge of disease biology.
Other organizations are making equally courageous efforts in specialized areas.
Two of these are Patients for Stem Cells and ALS- Treat Us Now.
According to Patients for Stem Cells, “Accelerated access programs are needed in the U.S., similar to what Europe and Japan are already adopting. Starting with difficult diseases for which there are few medical options, like ALS, Parkinson’s, Alzheimer’s, and Multiple Sclerosis.”
ALS- Treat Us Now seeks “to assure compassionate access for ALS patients to treatments that have passed the FDA’s Phase I safety standards AND have demonstrated in Phase II trials the ability to slow the progression of or cure ALS.”
Imagine the anguish of observing the progression of your neurodegenerative disease when safe drugs have been developed and proven to slow that progression.
The fact that the FDA needs a little more time to conduct Phase III trials and finish the paperwork would be of little comfort. This is another area that clearly requires Congress to act.
We must no longer allow American citizens to die of government bureaucracy.
For more information on the Abigail Alliance, visit www.abigail-alliance.org.
For more information on Patients for Stem Cells, visit www.patientsforstemcells.org.
For more information on ALS- Treat Us Now, visit https://www.facebook.com/pages/ALS-Treat-Us-Now/220968231317148.
Richard E. Ralston
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