Category > FDA

National Cancer Institute a “rudderless ship”

jacquie strax » 06 August 2009 » In Cancer, Cancer research, FDA, NCI, Prostate Cancer, Public Health » No Comments

James Watson, the scientist who was one of the discoverers of the double-helical structure of DNA, says in an op-ed today that the National Cancer Institute (NCI) is “a largely rudderless ship in dire need of a bold captain.” Aside from that, Watson is optimistic:

Continue reading...

Tags:

Kurt Donsbach Arrested on Health Fraud Charges

jacquie strax » 19 April 2009 » In Cancer, Complementary + Alt Med, FDA, Legal, Prostate Cancer » No Comments

Kurt Donsbach, 73, who markets supplements including some for conditions of the prostate, was arrested April 8 during his internet radio show “Let’s Talk Health” on a warrant charging him with 11 felonies including treating patients without a license, misbranding drugs for sale, grand theft, unlawfully dispensing drugs as a cure for cancer and falsely representing a cure for cancer. Bail was set at $1,500,000.

A San Diego news site reports: “District Attorney Bonnie Dumanis said that Kurt Walter Donsbach, 73, “preyed on vulnerable patients who were looking for medical help.”

Arraigned April 13, Donsbach plead not guilty in San Diego’s downtown Superior Court. Bail was lowered to $250,00.

Continue reading...

Generic Casodex: Tentative US Approval

Steve » 08 January 2009 » In Casodex, FDA, Prostate Cancer » No Comments

On December 24, 2008 the US Food & Drug Administration granted tentative approval to Accord Healthcare’s bicalutamide.

Accord is a subsidiary of Intas Pharmaceuticals, Ltd., an Indian company. Accord’s function is licensing and marketing.

Continue reading...

Provenge and Meta-Analysis — Compare Avandia

admin » 07 July 2007 » In Chemotherapy, Clinical trials, FDA, Prostate Cancer, Provenge » No Comments

In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.

Continue reading...

Tags: , ,