| I'll be the first to say the folks at the
| |
| | I've asked the LLS to tell me and to tell
|
| FDA have a hard job. It is their
| |
| | us as patients how our voices can help.
|
| responsibility to protect the public
| |
| | Are there congressional representatives
|
| safety and certainly not subject those of
| |
| | and senators we should talk to? Would the
|
| us who are ill to drugs that offer false
| |
| | leadership of the FDA listen to us?
|
| hope or tremendous risk. And when it
| |
| | Because of my business endeavors, there
|
| comes to considering new drugs for
| |
| | are a few things you should know.
|
| approval, I know how much they want to
| |
| | HealthTalk has, in the past, produced
|
| get it right the first time. The last
| |
| | programs on CLL treatment that were
|
| thing they need is to have to pull a drug
| |
| | sponsored by unrestricted grants from
|
| off the market after people have been
| |
| | Genta, the developer of Genasense. While
|
| hurt causing damage to the FDA's
| |
| | there are no current or planned programs,
|
| credibility to Congress.
| |
| | you should know that the possibility of
|
| I get all that, and what follows is not
| |
| | future programs exists. In addition, I
|
| written disrespectfully. But my glimpse
| |
| | now run a company called Patient Power
|
| the other day in Washington, D.C. into
| |
| | that received an unrestricted grant from
|
| the process of considering new cancer
| |
| | Genta to facilitate the travel of three
|
| drugs left me feeling the FDA was
| |
| | people (myself, a CLL patient's family
|
| operating too conservatively when it
| |
| | member, and another CLL patient) to the
|
| comes to potentially lifesaving or
| |
| | public hearing last week. Both at
|
| life-extending drugs.
| |
| | HealthTalk and at Patient Power, Genta
|
| It was also clear to me their advisors
| |
| | has neither prompted nor had any control
|
| (or at least a majority of them) were not
| |
| | or influence over what we say or write.
|
| as knowledgeable as we patients would
| |
| | Speaking personally, as a CLL patient, I
|
| expect. They seemed unfamiliar with the
| |
| | have nothing to gain with Genasense being
|
| new science being considered as well as
| |
| | approved. Right now, I need no medicine.
|
| the needs of the community that would
| |
| | Certainly, there are other patients who
|
| benefit. That was the case when the new
| |
| | do need it. But putting that aside for a
|
| drug application on Genasense for CLL
| |
| | minute, what about the next cancer drug
|
| seemed doomed by the Oncologic Drug
| |
| | hearing? Will the panel clearly
|
| Advisory Committee and the cancer
| |
| | understand the issues and have expertise
|
| leadership of the FDA.
| |
| | in the relevant cancer area, and will the
|
| My immediate reaction was that an
| |
| | FDA cancer drug leadership understand? If
|
| injustice had been done. And the faces of
| |
| | they don't, will the treatment you need
|
| several of the nation's leukemia super
| |
| | someday (or perhaps a senator or
|
| specialists confirmed that, as the
| |
| | congressional rep may need) not be
|
| hearing ended. So what to do? Was this
| |
| | available because of the cold water being
|
| just a loss for people like me with CLL,
| |
| | thrown on drug development now? I am
|
| or is there a bigger concern that could
| |
| | worried.
|
| make it hard for anything but
| |
| | One other thing: I very much appreciated
|
| breakthrough cancer drugs to be approved?
| |
| | having the opportunity to testify at the
|
| Are congressional concerns on drug safety
| |
| | recent FDA committee hearing. They
|
| putting so much pressure on the FDA that
| |
| | listened respectfully, and it was a very
|
| the bar is being set too high?
| |
| | open hearing. But there was a part of the
|
| Am I all wet?
| |
| | process that seemed improperly behind
|
| I called the VP of legislative affairs
| |
| | closed doors. As the hearing ended, I
|
| with the Leukemia & Lymphoma Society
| |
| | questioned an FDA official about who they
|
| (LLS) to find out. The answer was no, not
| |
| | drew on for CLL expertise. She said they
|
| at all. According to George Dahlman,
| |
| | had phone conversations with CLL
|
| while they don't endorse any particular
| |
| | consultants but that they were under
|
| drug application, they generally feel the
| |
| | confidentiality agreements and prohibited
|
| FDA drug advisory committees and the FDA
| |
| | from revealing who they were or how the
|
| itself do not have enough expertise when
| |
| | FDA was advised. She said I'd need
|
| it comes to reviewing proposed cancer
| |
| | approval from the drug applicant company
|
| treatments that could offer incremental
| |
| | to get more information. I checked with
|
| treatment benefit. And they worry drug
| |
| | the company, and they said I have their
|
| companies will not push ahead with new
| |
| | permission.
|
| drugs with the government taking such a
| |
| | So now I'll go back to the FDA to learn
|
| conservative, and maybe uninformed,
| |
| | more about the process and share it with
|
| approach. Drug development experts I've
| |
| | you. I am just trying to learn if the
|
| talked to (scientists who care about
| |
| | process is broken and our hope for new
|
| saving lives) are now increasingly
| |
| | medicines is at-risk. Stay tuned and let
|
| discouraged. I am, as a patient and a
| |
| | me know what you think.
|
| patient advocate, discouraged too.
| |
| |
|
