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Dendreon Corp. Message Board

  • beach_broke_mountain beach_broke_mountain Jul 9, 2009 12:21 AM Flag

    GOD BLESS DR.SCHER!!!!

    That man has saved millions of lives.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • awesome.

    • SCHER can walk on water

    • This doctor scher has saved millions of lives while gold tries to peddle snake oil.

    • Yeah for DR SCHER@@@!!!

    • bump-

    • great man

    • good guys like Scher will always win.

    • UNANAMOUS DENIAL.....


      .........................








      Dendreon Disclosure May Endanger Provenge Study
      Matthew Herper,


      Has Dendreon, a money-losing drug developer, imperiled the main study of its experimental prostate cancer treatment Provenge?

      On Oct. 6, Dendreon put out a press release that sent its shares up 33% in a day. Provenge appeared to cut patients' death rates by 20% compared with a placebo treatment, the company said. The release also contained statistical details that made good results seem likely when final results are released in April.

      But four top statisticians now say Dendreon may have compromised the integrity of the trial by putting out the release. They say it was unorthodox for Dendreon to even know such a detailed result, much less to publicize it. The danger: The company, patients or doctors might have changed what they were doing once they knew how the study was going. If the final outcome is only marginally statistically significant, it might be tossed, putting Dendreon and its drug back at square one.

      "I'm shocked. It's unblinding, despite what the press release says," says Donald Berry, chairman of biostatistics at M.D. Anderson Cancer Center.

      Janet Wittes of the Statistics Collaborative, a company that works with drug makers, also says she was also "shocked" by Dendreon's actions. "When we as a company are serving as the reporting statisticians for a trial and a company asks for this sort of information, we refuse to release it."

      Normally, only a secretive committee of hand-selected scientists would be privy to the analysis unless it showed Provenge was either so effective or so dangerous that the study needed to be stopped immediately. For Dendreon to get and publicize the results appears to violate section 6.3 of Food and Drug Administration guidance issued in March 2006.



      Dendreon's future is riding on Provenge. The company has only one other drug in clinical trials and, as of its last quarterly report, it had just $102 million in cash; the company posted a $70 million annual loss for the year. If the main study of Provenge does not succeed, it may be difficult for Dendreon to mount another big clinical trial to prove the drug works.

      In May 2007, the FDA told Dendreon it would need more data to get Provenge approved. That put the focus on a 500-person study called IMPACT, which was already underway and aimed to show that Provenge reduced the risk of death compared with a sham treatment in men whose prostate cancer had spread to their bones or lymph nodes.

      Dendreon had always planned to have the independent data safety monitoring board (DSMB) for the trial take a look at the data before the study ended. In March 2008, Dendreon announced that it was reducing the statistical power of that analysis in order to shorten the IMPACT trial by one year. At the time, the company said it had OK'd its strategy with regulators via a Special Protocol Assessment (SPA), in which the FDA agrees the study will answer its outstanding questions.

      If the interim analysis for IMPACT had shown an unambiguous result, that would have been enough to get Provenge approved, but it didn't meet that high hurdle.

      What was unexpected was that the DSMB gave the full data to Dendreon and released it to the world. When asked if this could potentially compromise the trial, Thomas Fleming, a statistician at the University of Washington, said that it could.



      Fleming says that the existence of the SPA does not change his opinion. The statisticians are left scratching their heads at the data release.

      "I have no idea what their rationale would have been," says Susan Ellenberg, a statistician at the University of Pennsylvania. "I can't rule out the possibility that they did have a reason I'd be comfortable with, but I can't think what it might be."

    • wwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwww








      Has Dendreon, a money-losing drug developer, imperiled the main study of its experimental prostate cancer treatment Provenge?

      On Oct. 6, Dendreon put out a press release that sent its shares up 33% in a day. Provenge appeared to cut patients' death rates by 20% compared with a placebo treatment, the company said. The release also contained statistical details that made good results seem likely when final results are released in April.

      But four top statisticians now say Dendreon may have compromised the integrity of the trial by putting out the release. They say it was unorthodox for Dendreon to even know such a detailed result, much less to publicize it. The danger: The company, patients or doctors might have changed what they were doing once they knew how the study was going. If the final outcome is only marginally statistically significant, it might be tossed, putting Dendreon and its drug back at square one.

      "I'm shocked. It's unblinding, despite what the press release says," says Donald Berry, chairman of biostatistics at M.D. Anderson Cancer Center.

      Janet Wittes of the Statistics Collaborative, a company that works with drug makers, also says she was also "shocked" by Dendreon's actions. "When we as a company are serving as the reporting statisticians for a trial and a company asks for this sort of information, we refuse to release it."

      Normally, only a secretive committee of hand-selected scientists would be privy to the analysis unless it showed Provenge was either so effective or so dangerous that the study needed to be stopped immediately. For Dendreon to get and publicize the results appears to violate section 6.3 of Food and Drug Administration guidance issued in March 2006.

    • ........

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