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XVIII. The Scientific Advancement of Knowledge |
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A major fault in the drug development process is that it is aimed solely at commercial success. Often this goal is compatible with scientific knowledge advancement. But this is not invariably the case. Forcing a development program to yield results can, and often does, backfire. A limited approval and a smaller initial market is better than a failed program. Appropriate studies helping physicians place the drug in the existing therapy context is requisite in many European countries, but, sadly, this is not the case in the United States. A drug can often receive approval showing efficacy in a condition such as hypertension. What we need are agents that work in people who do not respond to the first-line drugs, and agents that work in people that do not respond even to second-line agents. We need to know how the agent fits in these more difficult-to-treat populations. We unfortunately often do not know how the agents work in combination. Thus the approval process often does not provide the information the clinicians need or the marketers could use to further drug sales. These studies are often undertaken as part of a Phase-IV program since they are needed to assist marketing. The antihypertensive field is an example where a new agent needs to be positioned to make a significant impact. The A-II antagonists are an example of an exciting new category of treatment. The pharmaceutical industry does not want the A-II antagonists they are developingthat they are pouring funds intoto be limited to those patients who cannot tolerate the cough one sees with ACE inhibitors that occurs in between 8 and 15% of patients. The pharmaceutical industry would like a far larger market, but without further studies and only the ones necessary for gaining approval, physicians will not be helped to place these agents in the antihypertensive armormentarium. In fact, the economic forces at work in medicine of the 90s and beyond further inhibit a new agent's use by blocking entry into formularies and prescription plans, except for the most revolutionary of products. |
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The FDA has in fact brought up the subject of the importance of novelty of a drug in development and that the novel agents should be given expeditious consideration in development and regulatory review. We hear of the time wasted in the development of me too products. This pharmaceutical elitism fails to take into account the previous experience in pharmaceutical drug development. Often the first agent in a series is not the best and most prescribed drug. A drug developed later may have a kinetic advantage or a better side-effect profile. Second-generation H2 blocker ranindine is favored over cimetidine by many because of fewer drug interactions or the more favorable side-effect profile reported with ranindine as compared to cimetidine. The first beta blocker, propranalol, has given way to the polar once-a-day beta blocker, |
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