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Insmed Incorporated Message Board

  • insm_truth_teller insm_truth_teller Apr 5, 2014 4:26 AM Flag

    How a control therapy achieved


    How a control therapy achieved a significant level of efficacy against an infection when it contained no antibiotic. The point is, that if anyone follows cffDOTorg for the last 3 years because they were invested here, they would have seen the parallel development of other significant treatments for lung infections which did not contain antibiotics. But this MB has always been myopic and narrow minded. I have not seen the data, but the sound byte plays out as, "I guess Arikace was not that significantly better than the placebo." The REASON was the placebo had an important component of efficacy. Read the patent info. The liposome mimics natural surfactant in the lung which is the substance that makes the lung expand, contract and eliminate secretions with such ease that the lungs function by involuntary reflexes (the person's brain does not actively send signals, breath in, breath out). This is speculation until the data is actually out.

    But the reason I brought this up is that I am aware of the same type of event happening in the early 1970s at Baxter. They were trying to get a drug approved, Chymopapain Discase and did an extensive clinical trial. They chose a placebo that actually had some ability to soften and liquify a displaced spinal disk. Chymopapain turned out to be 60% effective, but the placebo was 50% effective. Less than one standard deviation difference. The FDA determined it was a "coin flip" for efficacy. Dr. Lyman Smith sued to get the drug back, ran a trial with a true placebo and demonstrated efficacy with the active ingredient and on efficacy with the placebo. His firm marketed the product under the trade name Chymodactin. Look it up.

    Experience trumps speculation every time.

    This topic is deleted.
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