Cel-Sci claims treatment with Multikine led to a statistically significant reduction in cholesterol, but what was their drug compared to for that conclusion to be reached? None of the phase II studies of Multikine conducted by Cel-Sci included a control arm -- meaning all the patients received Multikine. How then, can these studies demonstrate a statistically significant reduction in cholesterol? Cel-Sci doesn't say.
Perhaps Cel-Sci split the Multikine-treated patients into two groups -- those taking statin drugs for high cholesterol and those who were not. Again, Cel-Sci doesn't explain. Of course, it doesn't really matter because we run full circle back to the data-mining problem -- the studies weren't originally designed to split patients into statin and non-statin users.
If the cholesterol-lowering finding from this meta-analysis of Multikine studies is reality challenged, why would Cel-Sci bother with it? The answer goes back to what I warned up top -- positive results derived from post-hoc data mining are usually a smokescreen seeking to cover up other problems.
In Cel-Sci's case that means problems with the ongoing phase III study of Multikine, which is taking forever to get off the ground. The number of press releases issued by Cel-Sci announcing the start of the phase III trial appears to exceed the number of patients actually enrolled. Cel-Sci's problems run deeper still because lackluster Multikine data from the phase II studies gives the drug little chance of succeeding in the phase III study.Yet Cel-Sci's needs to keep hope alive, lest gullible retail shareholders lose interest and the disbursement of management's annual paychecks become threatened. Desperate companies like Apricus and Cel-Sci use data dredging as a necessary survival tool. Smart investors recognize the danger signs and steer clear. Post script: As I was putting this column together, I saw news that Transdel Pharmaceuticals (TDLP) filed for bankruptcy this week and sold off its remaining assets. Transdel was also a data-mining offender. Fair warning. More companies guilty of data-mining: Osiris Therapeutics (OSIR), Agenus (AGEN) (formerly Antigenics), Introgen Therapeutics (defunct, another bankruptcy), and Cell Therapeutics (CTIC), which famously re-analyzed a failed lung cancer trial claiming its drug Opaxio (formerly Xyotax) only worked for women.
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