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Who is the FDA trying to protect

I'll be the first to say the folks at the FDA have a hard job. It is their responsibility to protect the public safety and certainly not subject those of us who are ill to drugs that offer false hope or tremendous risk. And when it comes to considering new drugs for approval, I know how much they want to get it right the first time. The last thing they need is to have to pull a drug off the market after people have been hurt causing damage to the FDA's credibility to Congress.

I get all that, and what follows is not written disrespectfully. But my glimpse the other day in Washington, D.C. into the process of considering new cancer drugs left me feeling the FDA was operating too conservatively when it comes to potentially lifesaving or life-extending drugs.

It was also clear to me their advisors (or at least a majority of them) were not as knowledgeable as we patients would expect. They seemed unfamiliar with the new science being considered as well as the needs of the community that would benefit. That was the case when the new drug application on Genasense for CLL seemed doomed by the Oncologic Drug Advisory Committee and the cancer leadership of the FDA.

My immediate reaction was that an injustice had been done. And the faces of several of the nation's leukemia super specialists confirmed that, as the hearing ended. So what to do? Was this just a loss for people like me with CLL, or is there a bigger concern that could make it hard for anything but breakthrough cancer drugs to be approved? Are congressional concerns on drug safety putting so much pressure on the FDA that the bar is being set too high?

Am I all wet?

I called the VP of legislative affairs with the Leukemia & Lymphoma Society (LLS) to find out. The answer was no, not at all. According to George Dahlman, while they don't endorse any particular drug application, they generally feel the FDA drug advisory committees and the FDA itself do not have enough expertise when it comes to reviewing proposed cancer treatments that could offer incremental treatment benefit. And they worry drug companies will not push ahead with new drugs with the government taking such a conservative, and maybe uninformed, approach. Drug development experts I've talked to (scientists who care about saving lives) are now increasingly discouraged. I am, as a patient and a patient advocate, discouraged too.

I've asked the LLS to tell me and to tell us as patients how our voices can help. Are there congressional representatives and senators we should talk to? Would the leadership of the FDA listen to us?

Because of my business endeavors, there are a few things you should know. HealthTalk has, in the past, produced programs on CLL treatment that were sponsored by unrestricted grants from Genta, the developer of Genasense. While there are no current or planned programs, you should know that the possibility of future programs exists. In addition, I now run a company called Patient Power that received an unrestricted grant from Genta to facilitate the travel of three people (myself, a CLL patient's family member, and another CLL patient) to the public hearing last week. Both at HealthTalk and at Patient Power, Genta has neither prompted nor had any control or influence over what we say or write.

Speaking personally, as a CLL patient, I have nothing to gain with Genasense being approved. Right now, I need no medicine. Certainly, there are other patients who do need it. But putting that aside for a minute, what about the next cancer drug hearing? Will the panel clearly understand the issues and have expertise in the relevant cancer area, and will the FDA cancer drug leadership understand? If they don't, will the treatment you need someday (or perhaps a senator or congressional rep may need) not be available because of the cold water being thrown on drug development now? I am worried.

One other thing: I very much appreciated having the opportunity to testify at the recent FDA committee hearing. They listened respectfully, and it was a very open hearing. But there was a part of the process that seemed improperly behind closed doors. As the hearing ended, I questioned an FDA official about who they drew on for CLL expertise. She said they had phone conversations with CLL consultants but that they were under confidentiality agreements and prohibited from revealing who they were or how the FDA was advised. She said I'd need approval from the drug applicant company to get more information. I checked with the company, and they said I have their permission.

So now I'll go back to the FDA to learn more about the process and share it with you. I am just trying to learn if the process is broken and our hope for new medicines is at-risk. Stay tuned and let me know what you think.

Andrew Schorr

Andrew is a CLL survivor and the founder of HealthTalk

Andrews Blog can be found at http://blog.healthtalk.com/andrewschorr/

For more information, articles and programs about chronic lymphocytic leukemia or other forms of cancer please visit http://healthtalk.com/cancer/

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