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  • Richard Garr

Awareness of Right to Treatment Programs

“You can do anything you decide to do. You can act to change and control your life. . . .”

Amelia Earhart

We’re rolling out our platform of Right to Try treatment programs at Access Hope CRO. However, there are some limitations on how and when we can disseminate information about them to patients, their caregivers, and doctors. I thought it might be helpful to explain how the process works, and why we have set it up the way we have.

Right to Try (RTT) is a new federal law meant to expand the population of patients with access to drugs in FDA-approved clinical trials, outside of those trials. The new law defines eligible patients and eligible drugs, and then allows licensed physicians to treat properly-informed and consented patients with these treatments, outside of the traditional FDA clinical trial process. To make this at all workable, RTT exempts everyone involved in the process from a myriad FDA rules and regulations. However, some regulations remain. The most meaningful of these is that you still may not promote an unapproved drug.

There is a long history of dispute in the industry about what constitutes “promotion,” as opposed to factual education; but that is a fight for another day. For now, we are taking the position that we can only give out information about any of our programs after we have received informed consent from patients acknowledging that we are providing information on potential treatment programs only. This informed consent also may involve transmission of patient health information, which is protected under privacy laws. This is why we do not list our ongoing programs on the web site. This is why you must opt in to our data base before we can offer program information. This is also why we do not take information over the phone, but only communicate through our HIPPA-compliant data base. Our privacy policy is clearly described on the web site, devoid of small-print legalese. Please read it before opting in to the database.

The number and type of programs that we run will change constantly as we add new ones. Once you’ve opted in to the AHCRO database, we can tell you if there is a program for you now. We can also contact you if there’s a match in the future. You don’t need to do anything more. But we can’t do any of this if you are not in our data base.

Amelia Earhart also said, “the most difficult thing is the decision to act, the rest is mere tenacity.”



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