The lead author of a paper that argued that the prostate cancer immunotherapy Provenge endangered lives of cancer patients has entered a settlement agreement with the Securities and Exchange Commission. The agreement states that Marie Huber, an analyst at a hedge fund, had prepared and anonymously circulated a paper about Provenge (sipuleucel-T) at a time when her put options in Dendreon Inc., the drug’s sponsor, were about to expire. Huber subsequently expanded her arguments as the lead author of a 2012 paper in JNCI. Disclosure that accompanied that paper stated that Huber holds no position in the company, but stops short of disclosing that she had shorted the stock 18 months earlier. JNCI requires disclosure of relevant conflicts for a period of 36 months prior to submission. In the agreement with SEC dated Nov. 27, Huber admitted no guilt, but agreed to pay a $25,000 fine and accepted a six-month suspension from participating in securities trading activities. Her associate, Jess Jones, who played a supporting role in distribution of the document, also signed the agreement with SEC and was subjected to the same penalties. More than anything, the story of Provenge, an autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castration resistant prostate cancer, points to fluidity of the boundaries between the investment community, academia and advocacy groups. Since March 29, 2007, the day the Provenge application was first considered by the FDA Cellular, Tissue and Gene Therapies Advisory Committee, these interests—in both the pro-Provenge and anti-Provenge camps—clashed ferociously (The Cancer Letter, April 13, 2007; April 27, 2007; May 4, 2007). During the drug’s colorful history, the most unseemly behavior came from the pro-Provenge forces, a loose conglomeration of self-described patients and investors. Many of these individuals—derided as “Dendreonites” and “Provengeans” by people who didn’t share their zeal—congregated on the Investor Village forum, whipping themselves into frenzy of enthusiasm for Provenge and vitriol toward skeptics. At one point, death threats were made against doctors and scientists who advised FDA to delay approval until data from a randomized trial became available. Money was collected on Investor Village to sue FDA, and unsuccessful efforts were made to seize computers from The Cancer Letter as part of discovery in that suit. An Ohio judge ultimately fined the plaintiff for using invalid subpoenas and engaging in behavior that was meant to harass this publication (The Cancer Letter, Dec. 9, 2010). Dendreon wasn’t involved in these activities and was at times their target. |
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FDA has initiated the approval of leucovorin calcium tablets, rushing them to market as part of a push from the Trump administration to identify potential treatments for autism spectrum disorder.
