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atenelol, with what has been reported to be a lower CNS side-effect profile. The once-a-day ACE inhibitors appear to offer an advantage over the shorter acting agent in terms of patient compliance and effective antihypertensive therapy. In fact, the once-daily ACE inhibitors appear to be gaining in CHF therapy as well. Once again, the first agent of a class may not be the one with the greatest advantages or most frequent clinical use. A development program thus needs to define an agent so well that its attributes can be determined and used to gain approval and then permit the company to appropriately position the product to attract physician attention. Development plans need to go beyond the rudiments of the approval process. |
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A lack of information from the drug development process is a considerable liability. The selective publication of drug development information makes our knowledge very imperfect. The development program of a drug can be stopped and all we may know is the material from a single abstract. Recently, the development program of d-sotalol was stopped prematurely with the reporting of an adverse profile in the SWORD study. This has considerable impact in the antiarrhythmic drug development world because it suggests that pure type-III agents may not be nearly as safe as the mixed-function drugs such as sotalol, which has both type-III activity and beta-blocking activity. However, with so little information in the field for over a year now, the true ramifications cannot be discerned. This lack of early reporting limits the dissemination of information. So much information is lost due to the bias of both investigators and editors of journals against publishing negative or incomplete studies. However without the availability of this information, physicians may repeat the mistakes in development or other developers may retrace these same nonproductive paths in drug development because of a lack of effective information. This is why several years ago, I advocated the concept of a need for a repository of information on negative or adverse study outcomes that would provide sources from which those interested in drug development could learn of past mistakes and past failed ideas. Perhaps the on-line journal of clinical trials is well suited for this type of publication and would certainly enhance the rapidity of the information's availability. This information, I believe, would prove very valuable to those involved in drug development, those involved in designing clinical trials, and those involved in evaluating the efficacy of drugs in clinical testing. However, I am most unsure if we will ever be able to make use of the vast body of information that the pharmaceutical industry has accrued that will never see the light of day for publication. This sets back the field of clinical drug development and it sets back our understanding of pharmaceuticals. The process of publication, the disclosure of this information, would bring the drug development process and its literature closer to science than commercialism. This is a worthwhile goal to pursue. |
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