PATIENT’S RIGHTS TO EXPERIMENTAL DRUGS Raymond Rupert MD, MBA, Rupert Case Management Inc.

Posted on in General

Critically ill patients and their doctors who have tried everything eventually run out of options. In order to increase their options some US states have passed new “Right To Try” laws.

Patients such as Larry Kutt, age 65, of Lyon Colorado who has advanced blood cancer (multiple myeloma) has run out of options.

Now under the “Right To Try” legislation, he can ask for and receive drugs that do not yet have federal approval.

The “Right To Try” legislation could give him access to several new compounds that are in clinical trials.

The federal agency already has a process in place for helping very ill persons to receive unapproved treatments.

This is known as the “compassionate use” program. This is the standard way for very ill patients to seek permission to use unapproved therapies.

Patient advocacy groups are objecting to the long and rigorous 3 stage process required for drugs to receive formal approval.

The advocacy groups want very ill patients to have access to drugs that have passed at least the first stage of testing.

Larry Kutt has petitioned companies for 3 therapies:  SAR650984,  Elotuzumab and Daratumumab.

reference: New York Times, Sunday Jan 11, 2015.