The brouhaha over the Food and Drug Administration's delay of the potential approval of the prostate cancer drug Provenge from the small biotechnology company Dendreon , is now entering the prestigious and credible sphere of peer-reviewed scientific journals.
"Nature Biotechnology" is weighing in on the Dendreon-Provenge controversy in a somewhat strongly-worded editorial headlined, "The regulator disapproves," which is being published in the January issue of the magazine. The sub-headline says, "Pressure is mounting on the US (FDA) to explain its decision to ignore an advisory committee's positive recommendation for the cancer vaccine Provenge."
The body of the editorial goes on to give the backstory familiar to "Pharma's Market" blogreaders, so I won't go into that. But the piece, which refers to the FDA's decision as a "flip-flop", directs criticism at both Dendreon and the FDA. First, it says, "Dendreon shot itself in the foot by setting an over-optimistic efficacy expectation....," in the clinical trial it had done to try to win approval of Provenge.
But then it goes on to say, "...Dendreon's underpowered trials do show real efficacious value, despite clear deficiencies in trial design and execution." Provenge was shown in a re-analysis of that relatively small study to extend some men's lives by four-and-a-half months.
"And when the sole therapy available to end-stage prostate cancer patients is Taxotere--which extends survival by only two-and-a-half months and is so toxic it kills 300 patients itself every year--it's easy to understand why patients feel the (Provenge) data were strong enough," the editorial states. Dendreon is in the middle of a larger clinical trial designed specifically to see if Provenge extends lives.
In the last couple of paragraphs, the editorial takes a couple of shots at regulators:
"FDA appears to have neglected its role in guidance because of a knee-jerk defensive response to accusations of process impropriety. At the very least, FDA should now explain its decision. Those developing other cancer vaccines would welcome the clarity. And prostate cancer patients, denied access to a potentially life-preserving therapy, deserve an answer. Anything less and confidence in the agency's competence to regulate similar experimental cancer therapies could be seriously compromised."
The FDA has maintained that it makes its decisions based solely on scientific data.
Three Congressmen recently sent a letter requesting the House Energy & Commerce Committee hold a hearing about Provenge. This morning, a spokesperson for the committee told me that Chairman John Dingell (D-MI) will be back in town next week along with all of the subcommittee chairs and that they will meet around mid- to late-week to begin to hammer out the agenda for this year.
When that meeting's over, I should be able to find outif there will be a hearing/investigation into the Provenge matter and, if so, when it might take place.
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