Three U.S. congressmen have come to the aid of Dendreon Corp., asking a House committee to investigate potential conflicts of interest involved in an approvable letter the FDA sent to the company last May for its Provenge drug for prostate cancer.

The letter - signed jointly by Congressmen Mike Michaud (D-Maine), Dan Burton (R-Ind.) and Tim Ryan (D-Ohio) - alleges that "there is reason to believe that serious ethics rules were violated by two FDA advisory panel members and that these violations played a role in the subsequent FDA decision to not approve Provenge at this time."

Last March, the FDA's immunotherapy expert advisory panel voted unanimously that Provenge is safe and voted 13-4 that it was effective, meeting the statutory requirements for immediate licensure of Provenge, while the company continued the ongoing study. But in a May approvable letter, the FDA overruled the panel and ordered additional clinical trials, likely delaying the approval process until 2010. (See BioWorld Today, May 10, 2007.)

Since then, noted the congressmen, "cancer activists have raised questions about two of the negative voters, academic medical oncologists Maha Hussain and Howard Scher. Dr. Howard Scher is lead investigator for a competing cancer drug made by Novacea [Inc., of South San Francisco] and is listed as an adviser to a large venture capital firm that is also a major investor in Novacea. We believe the FDA should not be appointing scientists leading the testing of a rival drug for another firm onto an advisory committee evaluating Provenge nor should the FDA appoint an adviser to a large investor in such a competitive firm as a panel member. It is important that Congress examines possible ethical violations of these panel Members considering the viability of potentially important life-saving drugs."

Early last month, Novacea and partner Schering-Plough Corp., of Kenilworth, N.J., halted a Phase III study of its prostate cancer treatment, Asentar, in combination with docetaxel chemotherapy due to a higher rate of deaths in the Asentar arm, despite promising survival data over placebo. (See BioWorld Today, Nov. 6, 2007.)

The letter, to the House Energy and Commerce Committee, said the FDA "has repeatedly failed to take substantive action to effectively restore confidence in the agency." It noted that a January 2007 report to Congress said the agency granted conflict waivers to 24 percent of the 928 members of its 47 advisory committees that met from Nov. 10, 2005 through Jan. 4, 2007.

"Top-notch scientists without such substantial conflicts are available to the FDA now and are willing to serve, as noted in a recent letter to Senators [Ted] Kennedy and [Christopher] Dodd by a number of prominent physicians, including two former editors of the New England Journal of Medicine," the letter stated.

Shares of Dendreon (NASDAQ:DNDN), which gained more than $1 on the news Thursday, rose another 35 cents Friday to close at $7.33.

U.S., China Getting Together On Biofuels

Two U.S. cabinet departments - agriculture and energy - have signed a memorandum of understanding (MOU) with China's National Development and Reform Commission on the joint development of biofuels.

The MOU notes that, as the two largest energy consumers in the world, the U.S. and China both have incentives to reduce their dependence on foreign oil. The agreement "specifically encourages cooperation in biomass and feedstock production and sustainability; conversion technology and engineering; bio-based product development and utilization standards; and rural and agricultural development strategies," according to a joint statement from the two countries.

This follows President Bush's announcement earlier this year of a Twenty in Ten Plan, which seeks to reduce U.S. gasoline consumption by 20 percent in 10 years through increased production of renewable and alternative fuels and increased transportation efficiency.

The MOU follows two bilateral agreements signed in September between The Department of Energy and China's NDRC. The first MOU signed by DOE and China's Ministry of Science and Technology aims to promote large-scale deployment of next-generation efficiency vehicle technologies in the U.S. and China, specifically electric, hybrid-electric, fuel cell, and alternative fuel technologies. The second agreement aims to increase cooperation and energy efficiency in China's industrial sector, which accounts for 70 percent of the country's total energy demand. The DOE will conduct on-site plant audits of the production process and plant energy systems for up to 12 facilities from "The Top 1000" energy enterprises in China.

FDA recommends gene testing carbamazepine

The road to individualized medicine continues, and FDA continues to play a role in that effort. The agency announced that product labels for the antidepressant carbamazepine will henceforth recommend that any patient of Asian ancestry obtain a gene test to check for susceptibility to a rare but often deadly skin reaction.

According to the FDA, the prescribing information for carbamazepine "already includes a warning that for all patients . . . regardless of ethnicity, rare but severe and sometimes life-threatening skin reactions can occur." However, those of Asian ancestry apparently are at greater risk for potential reactions, which include two syndromes that occur as a result of toxicity to keratinocytes: toxic epidermal necrolysis (TEN), which is deadly in as many as 30 percent to 40 percent of cases, and Stevens-Johnson syndrome, the more severe form of TEN, which may spread to the lining of the bronchial tubes.

The FDA announcement stated that epidemiologists believe that "the risk of these reactions is estimated to be about one to six per 10,000" in countries with mainly white populations, but see the risk as being about 10 times higher "in some Asian countries." The FDA estimates that about 5 percent of Americans would have to be tested for this ethnic indication.

Carbamazepine also is used to treat epilepsy, bipolar disorder and neuropathic pain and is sold as Carbatrol, Equetro and Tegretol. An immune system gene, HLA-B 1502, is thought to be the culprit in this reaction and according to the FDA, that gene is "found almost exclusively in people with Asian ancestry."