ICAN's Patient Advocacy Representative to the FDA: Raymond McGlamery
Raymond McGlamery is a member of ICAN's National Board of Advisors and is a chronic lymphocytic leukemia patient with experience in cancer clinical trials. Given his involvement and passion about advocacy and expediting clinical trials pipeline for patients with blood cancers (and for patients with solid tumors), ICAN took great pride in nominating Raymond to be an official patient representative at the Food and Drug Administration (FDA). Raymond's posting at the FDA will revolve around drug approval issues or other areas of interest to the FDA's outreach efforts toward cancer patients. Please join us in welcoming the addition of Raymond's blog about his experiences with the FDA and the important work this public agency does in the drug approvals arena.
As time goes by, some things change while many remain the same. It’s hard for me to believe it has been so long since I wrote a piece for ICAN, and frankly it’s a little embarrassing, as they have given me the privilege and the space to expound. There have been many things to discuss over all of this time, but let me begin by reintroducing and outing myself at the same time.
My previous pieces were written under a pseudonym but I can now introduce myself to you with my real name, Raymond McGlamery. I am a cancer survivor, and I was very proud to have been nominated by ICAN three years ago to be a patient representative at the Food and Drug Administration (FDA). Since its founding ICAN has worked with the FDA’s Office of Special Health Initiatives (OSHI) now known as the Office of Health and Constituent Affairs (OHCA) on patient access issues and was very excited to learn about the FDA Patient Representative Program was seeking additional patient rep applicants. The ICAN board and I were thrilled to get the great news that I had been chosen to be a Patient Rep and that I would receive intensive training at the FDA campus before being asked to serve on an FDA drug approval advisory committee.
When ICAN asked me to write up my experiences as a patient rep, I was afraid if I used my real name it could work against me if I were to be looking for a job, or it could be used against me in a number of other ways. I have since decided to put away my fears and talk openly about my experiences. I know in my heart of hearts that this is absolutely the right thing to do. I have an amazing story about many wonderful people who have helped me get where I am and have supported me in any number of ways. And while this piece is not supposed to be so much about me as it is my experience with the Patient Rep program and the FDA, it is all so tightly intertwined, it would be hard to separate them out.
Being a Patient Rep is sometimes a frustrating piece of business, primarily because I have a great desire to be more involved. Since my last piece I have been served on only two committees for drug approval, one for the Cardiovascular and Renal Drugs Advisory Committee, and one for the Office of Hematology and Oncology Drugs Committee. These were very different proceedings, with one common factor; these were very low profile drugs that didn’t get much notice. That doesn’t lessen the importance for the patient community, but the proceedings are fairly low key compared to the high profile breast cancer drug meetings that garner huge media attention and grassroots activism before, during, and after those meetings take place.
There are millions of patients, hundreds of thousands of drugs, hundreds of rare conditions and everyone wanting to do what is best in protecting the patient population from greater harm from a drug than from a disease. The conversations are very detailed, specific and challenging, and often there is no easy answer. If you only believe what you see in the media, these processes are flawed at best, but in truth, everyone works very hard to get it right. When they do get it right, there is very little fanfare over time, but when something goes wrong, it is headline news.
Of course the other elephant in the room is cost. The government and private payers are not too keen on paying hundreds of thousands of dollars for a drug that may give a patient a minimal extension of survival time. As the drug companies are struggling with how to spend their considerable resources on developing new drug therapies, the ROI equation is a tough one to answer. In spite of that, we do have dedicated scientists and clinicians who are constantly striving for new ways to fight rare, deadly diseases, and new drugs evolve from these processes. Every step in every process from development through clinical trials to approval screams “RISK!”, yet there are scores of people who are trying their hardest, doing their best, and hoping against hope to get it right, sometimes regardless of the size of the patient population for a given disease.
One meeting that I attended as an FDA Patient Rep was to evaluate the proposed additional use of an injectable drug which is used in perioperative settings and for the treatment of patients in shock. The equation here is quite a bit simpler; the drug is already used regularly, the manufacturer just wanted to get approval to use it in a new way. There are mountains of evidence that the risks with this drug are very low, so this meeting felt more like a session for ‘talking it out’, just to make sure all the bases were being covered. If there were any situations where the FDA might be able to fast-track any of their processes, drugs that fall into this category might find another path to approval that did not involve such a formal process. The potential for problems seems very low, but, of course, if one patient died from the drug and the process was seen as ‘not thorough enough’ the FDA would get excoriated in the press and a drug company could be demonized at least and bankrupted at worst.
Both of the meetings I attended and participated in resulted in approvals for the drugs being evaluated, which I see as a good thing. The process worked as it is supposed to; evidence was given, pros and cons were presented, much discussion and erudition were on display and the vote was taken. In the end, I see this as a ‘win’ for the patient community.
There will be more to come from me in the weeks and months ahead, likely in more bite-sized pieces. As I travel my own path of experience with CLL, I will also relate how this all ties together for me, and for us as patients, and hope that, if you’re reading this, you might come away with a little more optimism and information than you had before.
I wish you all good health.
My First ODAC (Oncologic Drug Advisory Committee)
While being a patient representative for the FDA is very rewarding, it can also be somewhat maddening. The runway to any real participation is long, and the waiting can be a tad frustrating; not because there is any expectation that you should be participating quickly, but because you want to. Read more...
Sometimes, things are just as easy as they seem; sometimes the book is exactly what the cover makes it out to be. Generally, when this is the case, you don’t really discover this until after you’ve read the book and given it some thought and maybe even read the study guide. This has definitely been the case with me and my early experiences with the FDA as a patient representative. Read more...
On Friday September 2, 2005 at 5:00 pm PST, I received a diagnosis of Chronic Lymphocytic Leukemia. I was 45 years old with no genetic disposition for this disease and had less than 1% chance of ever being diagnosed with it. I had also just had a son and was afraid for his future as a CLL patient as I struggled with the myriad of emotions that come with a cancer diagnosis. I was otherwise healthy, happy and looking forward to a long life with a personal goal of living to see 100 years of age. Read more...