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Is Vanda Pharmaceuticals (VNDA) barking up the wrong tree?

The drug maker filed a lawsuit against the Food and Drug Administration for placing a partial clinical hold on a stomach medicine it’s testing and requiring a nine-month study in dogs in order to provide dosing in humans for more than 12 weeks.

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  • Vanda is taking a huge risk. It is not clear why. The best outcome for them seems to be a one-year delay in introducing their product. If they lose in court, which seems likely to me, the cost would be a year of litigation (with its attendant costs) plus a year or so to conduct the nine-month study. It is fairly routine for the FDA to require one-year tests in two species, so it is not clear why the FDA would be satisfied with a 9-month study in dogs. The cost of such a study must have been considered in the decision to take the product into the clinic. Atopic dermatitis is not life-threatening, so it is reasonable to set a high safety bar.

  • If anyone thinks that this has anything to go with the dogs, your crazy, its all about the cost, they just don’t want to pay.

  • I am so glad to hear Vanda is taking a stand on this issue. There are other options which must be considered and utilized. This is a cruel practice and needs to end. Please follow through!

  • I’m glad Vanda is pushing back against these cruel tests. Not only does experimenting on animals cause massive suffering, it’s delaying cures for human diseases. Nine out of ten experimental drugs fail in human trials, according to the FDA, because experiments on animals cannot accurately predict how drugs will affect humans. While animals and humans are alike in our ability to feel pain and suffer, responses to drugs and diseases can differ vastly between species.

    Meanwhile, the number of advanced non-animal testing methods continues to grow—we now have everything from “organ-on-a-chip” technology, to cell-based tests and tissue models, to sophisticated computer modeling and QSAR techniques, and more. These methods are humane far more accurate than tests on animals.

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