The Food and Drug Administration plays an important role in the world of medicine, specifically in drug approvals with credibility being like a vital organ. The FDA is constantly being challenged by advocacy groups, doctors, patients and caregivers demanding answers. One of these groups is CareToLive, a non-profit organization that came into existence as a patient advocacy group. They filed suit against the FDA over the lack of the approval of Provenge, a cancer vaccine manufactured by Dendreon to help fight prostate cancer.
CareToLive spokesman Mike Kearney discusses recent controversy over disapproval of Provenge. He also comments on how terminally ill patients access immunotherapies. Prostate cancer patients, Ted Girgus and Eduardo Garcia, share their stories in hopes of helping all of us understand why they both desperately seek FDA approval of Provenge. Ultimately, the goal is to rebuild the immune system to fight cancer; the current method of treatment is chemotherapy, which kills bad cells but also the good cells.
Andrew leads the discussion with an emphasis on obstacles that delay approval for drugs that seem to help patients substantially, but contrary to that might be getting approved too easily.
A critical point is the suggested evidence from previous clinical trials that Provenge works, which is why CareToLive is fighting the FDA for approval of this drug. CareToLive is made up of a myriad of people, patients, their families, doctors, lawyers, scientists, investors, and people who care to fight cancer. The underlying goal of this program is to give hope to patients and assist in getting safe and effective immunotherapy to patients who have no other options.
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Mike Kearney , Ted Girgus and Eduardo Garcia
This is Andrew Schorr, and we are live on Patient Power, and we've had some technical problems, but we have a very important show to talk about, and that is if you are facing a life-threatening condition, should the FDA stand in the way of you having access to drugs that are very promising but where they're requesting more data to consider approval? In other words, maybe there is data that shows it's very convincing, but there is some obstacle at the FDA even though many doctors and scientists say it has great validity. Should people who are worried about a terminal condition, should they have access to these drugs in the meantime?
Well, there is a lawsuit about just that, and so that's what we're going to talk about today. I'm just going to share a little bit of my own personal experience, and that is about a year ago, I was asked to testify at an FDA Oncology Drug Advisory Committee hearing. So, I went to Maryland, and it was related to a drug for the condition I have, and that is chronic lymphocytic leukemia. And the idea was it was a drug that might be helpful for people where other drugs have failed, and that drug is called Genasense, and years it has been in research for another condition, multiple myeloma, and then in CLL. Well, there were couple of problems I noticed just attending the hearing. One was that the leading experts in CLL for the most part were not part of the advisory panel that the FDA had put together. That was the first thing. The second thing was is that the doctors who were on the panel, many of them were experts in other kinds of cancers, particularly solid tumor cancers. So, what happened was, was that I felt the vote, which was largely against approval of the drug, was kind of a stacked deck with no knowledgeable people about the disease on the panel, and the FDA I think also was very vigorous in not giving it a fair hearing, and that they almost made a summation to the jury at the very beginning before the data was presented. So, it kind of bugged me. Well, it turns out that this is not just related to this drug, which unfortunately now it looks like it won't go forward, it is not clear yet, but there are other drugs that are even more promising. There is one in prostate cancer; a cancer vaccine called Provenge, and so even though there was a vote in this case by the advisory committee by the doctors who fortunately were familiar with it that it was safe and that it was effective, the FDA wants more data.
Well, what does that mean for men with advanced prostate cancer where the hope is that this drug could work for them where maybe others are failing, and that's really what our program is about today. We're going to meet somebody who has started an organization called Care to Live. Mike, how do you pronounce your last name? Is it Kearney? Is that right?
"Carney." And where are you Mike?
I'm in New Jersey.
Okay. So tell me, did I sum this up right? You've formed your organization. You've had cancer touch your family more than once, and you kind of feel there is an injustice going on with the FDA where they're keeping Americans at their sickest time, some of us, from drugs that could lengthen or save our lives?