The Provenge Vaccine, A Hedge Fund Manager And The SEC

In a curious postscript to the long-running saga that has been the Provenge vaccine, the US Securities and Exchange Commission has levied a $25,000 fine on a former hedge fund analyst, who caused a stir by writing a medical study that questioned the benefit of the medicine and, subsequently, claimed she received threatening remarks on investor message boards. The agency had charged Marie Huber, who co-authored a paper last year in the Journal of the National Cancer Institute, with making misleading statements about her activities and violating the Securities Act for her role in disseminating the study. The SEC cease-and-desist order also notes that Huber had also traded Dendreon options, but suffered “significant trading losses.” Provenge, you may recall, generated considerable controversy for several years. Before the Dendreon vaccine was approved, the prostate cancer treatment was the subject of an unusual FDA review in which members of an agency advisory committee wrote FDA officials to urge that Provenge not be approved. They later claimed to have received threats while attending a cancer meeting five years ago (back story). Later, patients and investors regularly protested at FDA offices and filed a lawsuit against the agency over the review process and alleged conflicts of interest involving committee members before approval was given in 2011 (see here). Even after Provenge became available, though, the vaccine continued to generate debate over the extent to which p...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs