Citizens’ Petition for Redress of Grievances

The undersigned private person hereby petitions lawful authority for redress of misfeasance, nonfeasance and malfeasance in the health policies and operations of government programs, releasing this statement to the Lead Petitioners, seeking redress as follows.

It has been stated, by leading longevity researchers, as follows:

• It is widely known that the leading causes of death among the citizens of advanced nations relate to what has been considered normal aging. In those who do not die from a degenerative illness or other cause, the aging process itself results in termination of life in 100% of humans. (No one has ever survived aging.)
• Experimental therapies exist today that may delay or reverse certain normal aging processes.
• Volunteer study participants and various organizations would like to initiate experimental interventions with fully informed patient consent and Institutional Review Board (IRB)approval but opt-out of FDA’s clinical trial approval process that increases research costs while delaying implementation of a plethora of  experimental interventions.
• Study participants will be fully informed that these regenerative medicine experimental or non-medical nutritional studies have not been reviewed by the FDA for safety, and therefore may pose significant health risks.
• Any publication of the findings from these clinical trials will clearly state that the design, execution, analyses, and all other aspects of these IRB-approved, Informed Consent-granted clinical trials have not been reviewed by, nor approved by the FDA for safety or efficacy.
• Some trials will deal with one or more repurposed drugs that are already FDA approved, or with experimental compounds that have not been extensively studied in humans.

The undersigned joins the Lead Petitioners in any formal petition to FDA for exercise of its regulatory oversight discretion for informed consent study participants and organizations conducting clinical research that design and carry out truthful, non-misleading clinical trials to attempt to delay and/or reverse the most common reason for American disabilities and deaths, i.e., aging.

The undersigned gives permission for this statement to be conveyed by Lead Petitioners to involved government and private agencies and stakeholders.