The
article asked a wonderful set of questions. I decided I'd stick my neck out and give my initial thoughts (
italicized) on these questions and even throw in a few comments designed to "stimulate" the conversation. So don't believe everything I say. (Like I needed to tell you that.)
- The policy that requires pre-market approval of new pharmaceuticals and medical devices may prevent harm, and it also may suppress would-have-been benefits (by suppressing drug development, causing delays, or increasing costs). This may be particularly true for less common conditions.
- Consider now only the second policy effect, suppression of would-have-been benefits. Which of the following statements best describes your view of the public discourse about this effect? The Orphan Drug Act addressed rare, but not common, conditions. Many people may turn to alternative, relatively untested, therapies because they don't have good FDA-approved options.
- Which best describes your attitude toward the U.S. government policy that requires pre-market approval of new pharmaceuticals and devices? Greater access to information and shared expertise will continue to shape my opinion.
- Do you think there is a sound market-failure rationale for the policy that requires premarket approval?
- Given that you believe there is no sound market failure rationale for the policy that requires pre-market approval, please explain why you do not oppose the policy. Much better access to information
- Do you believe that consumers or patients systematically err when coping with uncertainties related to health and treatment? Most definitely.
- In what ways does consumer or patient erring manifest itself? Sham treatments remain a big business.
- Do you believe that doctors systematically err when selecting and prescribing therapies? If you include value (i.e., cost per successful therapy), then this occurs frequently.
- In what ways does doctor erring manifest itself? In addition to costs we still see a lot of prescriptions for drugs that simply don't work or have much better alternatives.
- Say the policy that requires pre-market approval was eliminated and, in its place, a policy was implemented allowing new pharmaceuticals/devices and initially classifying them as requiring a doctor’s prescription (pending a review process to consider dropping the prescription requirement). Do you think such a liberalized system would be superior to the current system? I don't think that individual physicians have the time to track down and evaluate whether a new drug offers a better alternative to existing therapies.
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