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.