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Strategies & Market Trends : 2026 TeoTwawKi ... 2032 Darkest Interregnum -- Ignore unavailable to you. Want to Upgrade?

To: Metacomet who wrote (107681)	9/21/2014 1:22:49 PM
From: Elroy Jetson	Respond to of 220208

A.) When the FDA gives permission to something it allows risk of harm, which to some extent is by its nature unquantifiable. B.) When the FDA chooses not to allow something to happen, this frequently allows the continuation of quantifiable known harm to a large number of people in addition to some unquantifiable harm. In many cases this harm is clearly and overwhelmingly larger than the potential risks created by giving permission. Example: If the FDA is reviewing access to a cosmetic skin cream, approval should never be granted until you have a very high certainty that it is safe because the downside of not having access to a new beauty product is vanishingly small. If the FDA is reviewing a treatment for a rapidly fatal cancer or other disease, I think the balance of risk has to shift to avoiding the known harm of people dying untreated. Henry Waxman was wholly unable to distinguish why reviewing the risks of a beauty cream or a me-too statin or blood pressure medication should be different from approving the treatment for a disease without good treatment alternatives. Even his wife disagreed with him completely. He had no legitimate argument to make apart from protecting the status quo of the regulatory environment he'd helped create. At that time the FDA had no legal ability to take into account the risks and harm of non-approval. This issue was so compelling to so many people we were able to change the regulatory structure with Waxman fighting every step of the way. Because of his obstruction what got passed were immediate solutions, so this concept of balancing risks still needs to be addressed more comprehensively in the relevant laws.