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.

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