Looking behind the FDA curtain

Thank you for all the comments to my blog postings about the FDA and its process for reviewing Genasense. It’s still up to the FDA to approve it or not. It is an uphill battle as the advisory committee voted 7-3 against approval. The earlier blog posting and the very expert comments from so many CLL’ers will provide you with a all the background if you are new to the discussion.As you know, the FDA has told me they had CLL specialists who consulted with them. I asked who and was told it was confidential and that the sponsor of the drug up for approval, Genta, would have to request the FDA take me behind the scenes. Genta has done that, and I have been told from the FDA that I will be hearing from Dr. Pazdur’s office. He’s their head man in the analysis of new oncology drugs. I will let you know what I find out. My goal is to probe whether or not this drug is getting a fair shake both from what we saw publicly at the Oncologic Drug Advisory Committee Hearing in Washington, D.C. and what the FDA does back at the office down the street? Beyond that, I am trying to understand if the process is well set up (particularly the picking of advisory committee members), for future drug applications across all diseases.For our HealthTalk readers with other serious conditions beyond CLL, this does have significance for you. As we look increasingly at “personalized” medicines, might the FDA deny your doctor the chance to use a new drug because the effectiveness data was marginal across the whole population, even though it could be significant in a slice of the disease group? The problem, of course, is knowing which people might get the benefit. That is the problem today as diagnostics and typing lag. But when we are talking about cancer (where such a drug could be lifesaving or life-extending), if the proposed drug has relatively low side effects, shouldn’t it be given a chance for doctors to learn how to use it best - and in addition encourage the diagnostics to catch up? In CLL, that is certainly happening with Campath (alemtuzumab) and Rituxan (rituximab), neither of which have a low toxicity.As I have written before, I am worried smaller biotechs and Wall Street backers will be very discouraged, and that will mean fewer innovative drugs in the pipeline for you, me and our loved ones.Obviously, I cannot fight this battle alone. My plan is to have further dialogue with the FDA and, with you, to lobby our U.S. senators to look into this issue. I recognize they are already looking at protecting the public safety and not approving drugs that could threaten lives once they get on the market. But where should the bar be set and how does it apply to already life threatening conditions?This comes at an interesting time when some senators are threatening a “hold” on the approval of Dr. von Eschenbach, a cancer physician from M. D. Anderson as FDA Commissioner. Maybe this can become part of the discussion?If you’d like to write to the FDA, e-mail:ombuds@oc.fda.gov or visit their Web site.Again, for our friends with autoimmune conditions and other cancers, this is your fight too. I hope you will join me.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. Both at HealthTalk and at Patient Power, Genta has neither prompted nor had any control or influence over what we say or write.