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  • brandonuk03 brandonuk03 May 3, 2012 1:03 PM Flag

    May 10th is not a binary event

    Spartan, you have to have more knowledge of tumor pathology and studies of rat cancer to be able to discern the content in the 10K. The malignant tumors were only seen in the high dose group. There are plenty of approved medications that, if given in high enough doses, cause cancer in humans. Additionally, benign tumors are common to this species of rat, occuring at rates of approximately 30-35% without any sort of medication. In female humans, we see benign fibroadenomas in about 10% of the female population without medication. As you can see, while rats are mammals and we as humans are mammals, we are not exact and you cannot look at this data as absolute- it's our best educated guess scenario.

    I believe based on the studies, prolactin seems to be the implicated component. Anyone with a scientific background will tell you that there can be multiple studies done on the exact same concept that may yield different results. For example, it is about a 50/50 split whether Zinc and Vitamin C help with the common cold. There have been hundreds of studies on this, but we can not definitely say for sure it does or does not. Just as with the prolactin studies, we have more evidence for, than against. Also, if determining the cause of cancer is not an easy task at hand. I think what the FDA is looking for is data showing enough confidence that we won't see cancer in humans. If the FDA were really concerned with that data, they should not have allowed Phase 3 trials. Additionally, it was also found in Phase 3 trials, prolactin was not increased in humans at regular dosing of lorcaserin and hence no malignant or benign cancer seen. IMO the cancer issue stumbled about because of ignorance during the first ADCOM and lack of expertise present to discuss that topic.

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