Testimony of Courtney Alexander-Miller
FDA Advisory Committee Hearing
December 20, 2012
My name is Courtney Miller, and these are my sons Dan and Alex. My husband Bob has been disabled by CFS for all of our children’s lives.
13 years ago, Dr. Peterson enrolled Bob in the Ampligen study after years of suffering. That was the first time we moved to Reno to access Ampligen.
We are the lucky ones. Before Ampligen, Bob’s days were largely spent in bed. He was dizzy, weak, in pain, and had cognitive problems causing him to get lost.
On Ampligen, Bob could care for our twin boys. His pain diminished. My boys could play with their dad.
On Ampligen, his natural killer cell function rose from 2 to 36%. That’s so important because those cells fight cancer, which has struck most of his family. National Cancer Institute data show a higher incidence of lymphomas in CFS patients.
Bob went off the drug in 2003 and we moved to Virginia.
It crossed my mind that he might need treatment again. Maybe in 5 years – surely a medicine that works for lots of patients would be approved by then. It never crossed my mind that it would take 13 years to get here. It never crossed my mind that we would have to move back to Reno so Bob could go back on Ampligen.
By 2008, he was largely bedridden again. He couldn’t go to our boys’ ball games. It became clear that Bob needed Ampligen – first to me, then he admitted it. There was no alternative. No other clinical trials are approved by the FDA for CFS. And there was nowhere to get it except Reno, despite 20 years of safe use.
We didn’t want to move our boys. They loved their house and friends. We knew we had to stay together. So we sold our house, uproot our kids and move back to Reno. It broke our hearts to tell them.
We mark the length of this approval process by the age of our sons.
Ampligen is safe. It works brilliantly in subsets of patients. And, it is the first drug tested for a very complicated illness. It is incumbent on you to think about firsts. Radiation wasn’t perfect. Chemotherapy only works for some types of cancer. Tysabri, with real safety risk, has changed the course of Multiple Sclerosis. The FDA allows doctors and cancer or MS patients to decide if the reward outweighs the risk every day.
Chemotherapy has helped subgroup cancers: why do some respond and not others? AZT isn’t perfect, but led to drug cocktails.
Please understand that all CFS patients are not alike. All the recent science points to subsets of patients. So, when your statisticians say subgrouping Ampligen data is “hypothesis-driven”, it is actually illness-driven. The trial data is identifying subgroups.
FDA promotes a new law meant to fill exactly the kind of unmet need that we have. It comes at the same time President Obama became the first President to elevate CFS as a national health priority, after a promise he made to me.
FDA’s Commissioner writes that you are “permitting shorter, smaller, or fewer clinical studies” to “reduce the length of drug testing.” We need you to apply that spirit to this medication.
Until today, the first drug for CFS has been hostage to process for 20 years. There is great benefit to continuing to study Ampligen. But, restudying and reassigning it without approving it is doing patients harm.
My family is testament: It’s safe. It’s effective. It’s time to approve Ampligen and let patients and their doctors decide.