Nick Auden (Save Locky's Dad) update

I know some of you remember me sharing the petition for Nick Auden to try and gain compassionate use of either Merck's or BMS's anti-pd1 drug.  While waiting to try and get this drug, he started TIL treatment at MD Anderson.  I learned this weekend that Nick passed away on Friday.  Please keep his wife Amy and their 3 young children in your thoughts and prayers.


Nick reached out to me in January of this year.  We were both trying to get in to the anti-pd1 trial about the same time.  I remember his first note talking about keeping in touch and comparing notes as we went thru this drug.  He had tried a number of other treatments already (IL2, Ipi, Zelboraf, etc).  We had somewhat similar stories - tumors in abdomen, small intestine.  I would start Merck's phase 1 trial Jan 21st.  Nick never got to start.  The first time he was disqualified due to brain mets.  The 2nd time, they determined brain mets were stable and would allow him in, but then a bowel obstruction prevented him from ever getting started.  He was again disqualified from starting the trial.

In the last 3 years of dealing with Melanoma I've seen so much progress... yet we still have so far to go!  I understand why drug companies don't want to open up the drug to everyone (or allow compassionate use when still in phase 1 trials) but for someone like Nick who had run out of options - you're willing to try anything!  He never got the chance.

Erin
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(Some definitions of compassionate use, etc)

Compassionate Drug Use

What is compassionate drug use?

Medical professionals use the term “compassionate use” to refer to the treatment of a seriously ill patient using a new, unapproved drug when no other treatments are available.
Drugs that are being tested but have not yet been approved by the US Food and Drug Administration (FDA) are calledinvestigational drugs. These drugs are generally available only to people who are taking part in a clinical trial (a research study that is testing the drug). Being able to use one of these drugs when you are not in a clinical trial has many names, but is most commonly referred to as compassionate use.

Is compassionate drug use legal?

Compassionate drug use is legal, but it’s tightly restricted to people who meet certain conditions. The FDA first approved investigational drugs to be used in this way for critically ill patients in 1987. For people who aren’t in clinical trials, there are 2 ways a drug company can allow use of their unapproved drug: through expanded access programs (EAPs) or through single patient access.

Expanded access

A company sponsoring a drug in the late stages of drug development, such as Phase III clinical trials, can offer expanded access programs for patients who are not able to enroll in a clinical trial. (See Clinical Trials: What You Need to Know to learn more about the phases of clinical trials.)
The FDA generally approves these EAPs if the drug has shown that it works at least somewhat to treat cancer in the clinical trials that are being done. This can allow a lot of people access to the unapproved drug, as long as they meet the requirements of the EAP.

Single patient access

Patients who don’t qualify for either clinical trials or an expanded access program (if one exists) may be able to get the unapproved new drug by applying for single patient access.
In this case, the patient’s doctor must first ask the drug company if the drug can be used for the patient and see if the drug company will supply it. If the company agrees, the patient’s doctor works with the drug company to ask the FDA to approve the drug for use by this one patient.
The FDA requires the doctor to send information about the patient, why the request is being made, the proposed treatment plan, and a signed informed consent from the patient (see our document Informed Consent for more on this). The length of time it takes to get single patient access varies. But if it’s an emergency, the FDA can complete the paperwork in 24 hours.

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