Greetings from Chicago, where I host a breast cancer education event this week. I just got back from Washington, D.C., where I testified before an FDA advisory hearing of the Oncologic Drug Advisory Committee. I am still reeling from what happened there and wanted to share it with you because it says a lot about where we are with drug development and cancer drug approvals.

Here goes:

First, let me explain who was at this meeting. The FDA calls on advisory committees of physicians, biostatisticians, consumer advocates and patients to answer key questions about drugs, medical devices, diagnostic tests, etc. that have applied for FDA approval.

This week, the advisory committee on cancer drugs met in Silver Spring, Md. outside Washington, D.C. The morning session was about a proposed CLL drug, Genasense. It's a little like a debate and a little like a legal proceeding. The FDA gives its opening remarks ? in this case putting Genasense in a negative light right from the start ? and then the sponsor (in this case a fairly early stage biotech company with hundreds of millions of dollars at risk), presents its data on how its proposed new drug can make a difference. Then there's a lot of discussion.

The company in discussion was Genta, which had already been bashed by the FDA once before when data didn't look promising enough for Genasense in malignant melanoma. Now the company was making its case in CLL, my condition, and I was there to make a plea for having more drugs in our doctors' tool kits. Alongside me were other patients who had received Genasense (I had not) and felt they were alive today because of it.

The hearing took all morning. A dream team of CLL specialists were there including: M. D. Anderson doctors Michael Keating and Susan O'Brien, Bruce Chesson from Georgetown, and Kanti Rai (the grandfather of CLL care) from Long Island Jewish. Dr. John Reed, another hematologist superstar, was also there as were others I know less well. They feel Genasense works as a chemosensitizing agent, in some people who are failing, help them do better with Fludara (fludarabine) and Cytoxan (cyclosphosphamide) than if those drugs were used alone. The data showed a 10 percent benefit. More simply put, one in 10 patients who received it had real improvement and often a very significant remission. For the FDA, this was not significant because they saw too many others who didn't get much benefit and thought the expense wasn't worth it ? if who could or couldn't receive the drug wasn't able to be pre-determined. Most of the panel agreed and voted 7 to 3 against the drug. It was effectively a nail in the coffin for Genasense and maybe for Genta as a company too ? although I am not an investment type, so take that comment with a big grain of salt.

Here's the shame of it all. There are real people who would be dead who received Genasense and are alive today and doing well. The CLL specialists are begging for a new drug to help people who aren't responding well to Fludarabine used alone or with other "on the market" drugs. The experts like Susan O'Brien believe Genasense is worthwhile and that a first-in-class chemosensitizing agent is important.

The panel followed the FDA lead and said, "No dice". They were not impressed. But for me as an observer it seemed there was a big disconnection. That's because only two of the docs on the panel were hematologists who actually treated CLL patients. One of them voted for the drug as did the CLL patient and the oncology nurse who was the consumer representative on the panel. But the panel was stacked with solid tumor docs and a biostatistician. The solid tumor docs did not "get" the heterogeneity of CLL and the unmet need Genasense can fill. The biostatistician, I believe, didn't get that even saving a few lives in cancer is worth it. For him (and the FDA), it was all about approving drugs for the "broad CLL population." Genasense doesn't do that. But isn't that understandable when CLL is increasingly seen as different from one patient to the next?

I asked an FDA official why the panel couldn't have more hematologists on it when a drug like this comes up. "Not practical," she said. "We have trouble getting to docs we have now." "And besides," she continued, "we bring in consultants who are experts to advise us." I heard some of the CLL experts disputing that.

And who loses? Sure Genta loses - so do their investors. But we patients lose too. Here's another case of people who could be at death's door being denied a drug that may give more time and better health back to some of them. Don't we deserve to have it available?

And there's another bad influence here too. This year the National Cancer Institute has cut back its funding of cancer research. So who will make up the difference in our "war on cancer?" Maybe some groups like the Leukemia & Lymphoma Society or the American Cancer Society or Susan G. Komen. But really, we need drug companies and their investors to take a financial risk. Will they if the FDA is so conservative and the process is set up so panelists may lack relevant experience to give the applicant the fairest shake?

Look, I am no scientist, and I know the FDA gets criticized all the time when a drug is approved that later has to be pulled off the market. And all the panelists are outstanding experts in their fields. But was this panel expert in CLL? And was the FDA taking too hard a stance when lives are on the line and patients and specialists are desperately seeking more treatment options?

Okay, so, Andrew, what are you going to do about it? First, I am going to volunteer to be a consumer advocate on FDA advisory panels and second I am going to try to meet with my U.S. Senators to apprise them of my concerns about the approval process. And third I am going to ? right now ? solicit your comments. C'mon, please sound off on what you think, and I'll tell the FDA to take a look. Otherwise, we patients are just numbers to them.

Am I being unfair? You can tell I am grumpy from the experience. But I'd do it again in a flash with the hope we can get new, effective drugs approved, and that more people can live longer and live well in spite of life threatening conditions. And I will continue to pray for a cure, of course.

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.