Many people were downloading slides from our website these last few days with clinical data about a drug called Genasense. It has not been approved by the FDA and I am among patients with chronic lymphocytic leukemia who think the FDA and its advisors have not given the sponsoring company, Genta, a fair shake

Genta, a small biotech company, has filed an appeal. It’s like walking into the lion’s den again. Very gutsy. And I applaud them for taking this step.

From my investigation, the FDA has some powerbrokers within it – government bureaucrats who may not get paid a lot of money but can fairly easily affect the fortunes of major pharmaceutical companies and, most importantly, the health of patients now and in the future.

A lot has been said about the FDA approving drugs too easily and harming the public health because of it. And a recurring story is how the FDA needs to be even more vigilant – like with the latest pet food scare. The FDA oversees pet food too.

But there’s another side to this: what if “under the radar” of FDA protecting the public safety, there are “czars” within the FDA who keep lifesaving or life extending drugs off the market, not based on a fair analysis of clinical trial data, but mostly because of their own biases?

It’s tough to fight City Hall but that is what Genta is attempting. I don’t know whether to be optimistic or not. But I do know Genta, CLL patients, and the public deserve a better, fairer process. Hopefully, a fair review of the appeal by a senior FDA official can make things right. We’ll know in 30-60 days.