I must have read my petition a hundred times prior to posting it but realized I needed to clarify that the word treatment should not be used in any (Phase I-III, not FDA approved) research informed consents. Phase I (safety) going from the rats to the humans, Phase II safety and efficacy, Phase III safety, efficacy, how does it compare to the standard treatment. I am disheartened by the number of prestigious American Universities/Hospital systems that are recruiting into these trials with misleading language on consents and/or advertising. Some of their websites are referring to Phase I-III drug trials as treatment, as safe, maybe even superior to the standard. I have obtained the consent of hundreds of research participants and have overseen many drug trials. We are not suppose to be using this language as it is against our Code of Federal Regulations and Ethical Guidelines, but people are too afraid to speak out for fear of retaliation. 

I have talked to families who have had their lives ruined because they were misled into participating in a drug trial due to thinking it was a treatment option. One woman showed me a picture of her loved one and said he was a man of great dignity, and the drug trial took that from him as he was never able to care for himself again following his participation. She said we even had plans to go to dinner the night of the drug trial as the informed consent stated treatment throughout it and did not explain the highly experimental nature of a Phase I trial. 

Dr. Sharpless has returned to the National Cancer Institute, and Dr. Stephen Hahn is now the FDA Commissioner. I have directly petitioned him as well as Alex Azar II, Secretary of Health and Human Services, Dr. Jerry Menicoff, Director Office for Human Research Protections (OHRP), Dr. Stephen Rosenfeld, Secretary's Advisory Committee on Human Research Protections (SACHRP).

Thank you all so much for your support. Please forward my petition to others.  Melanie