Biotech Values

[DewDiligence]

Re: The Abigail Alliance

>I think a lot of what the AA advocates gets blown out of proportion by negative spin.<

Spin this: the Abigail Alliance wants Genasense approved immediately. The following is from #msg-19383332 (emphasis mine):

>>
Consider the FDA's handling of Genasense, a new drug for melanoma and chronic lymphocytic leukemia (CLL), two often terminal forms of cancer. The drug is being developed by Genta, a small, innovative company with only one approved drug and limited financial resources. Despite compelling evidence that Genasense is making progress in fighting both diseases, the FDA appears determined to kill the drug.

In the case of the melanoma application, instead of reviewing the clinical-trial data in accordance with usual methods (which showed positive results), the FDA chose a nonstandard statistical approach aimed at discrediting the results.

…Now, Genta has found a serious mathematical error in the FDA's analysis, rendering its results meaningless. Genta is filing a complaint under the Federal Data Quality Act to correct the record. But in the meantime, the drug remains unapproved and melanoma patients continue to wait.

…the Director of the FDA's cancer division, Dr. Richard Pazdur, again convened a public meeting of his advisory committee. After an agency presentation designed to elicit a negative outcome, the panel voted 7 to 3 against approval, triggering an immediate reaction of surprise and dismay among many CLL experts.

…A shocked Genta quickly requested a meeting with the FDA to seek clarity on the agency's position, and to present additional information from patient follow-up... Making these arguments were two cancer-medicine professors at M.D. Anderson Cancer Center, the recused ODAC member and an immediate past president of the American Society of Hematology -- all experts in CLL.

The FDA's inane answer to the CLL experts was that the long-lasting disappearance of disease in patients taking Genasense was a "theoretical construct" and not grounds for approval.

…The experts were unanimous in advising that Genasense should be approved, but the FDA was unmoved... Less than 48 hours later, the FDA rejected Genasense.

...The FDA's handling of Genasense lays bare the all too common, aggressive incompetence of the FDA's cancer-drug division and should lead to an immediate examination of its policies and leadership, followed by swift corrective action.
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The last paragraph, especially, marks the Abigail Alliance as a dangerous and radical group, in my opinion.