Modern Methods of Clinical Investigation (1990) / Chapter Skim
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11. Attitudinal Factors That Influence the Utilization of Modern Evaluative Methods
11. Attitudinal Factors That Influence the Utilization of Modern Evaluative Methods
Pages 135-146
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From page 135... ...
We have not asked whether the regulatory process is sufficient for gathering data necessary for the optimization of medical practice or how attitudes of medicine are pervasive in affecting what methods of clinical evaluation are used or disregarded. I will argue that data generation sufficient for regulation of new chemical entities seems to be the major determinant of the methods of clinical evaluation used and who uses them.
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From page 136... ...
In fact, some would say that the passive behavior of the profession already has distorted the process and crippled it by asking more than legitimately can be expected from the agency based on the food and drug act. Because it may not understand them, the medical profession does not seem to have defended the minimal and legitimate regulatory requirements needed for marketing a drug.
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From page 137... ...
We should not be surprised that the vast majority of marketed drugs ultimately are used for unapproved purposes and in unapproved dosages, as IMS America told the Joint Commission on Prescription Drug Use. Because the FDA cannot regulate the optimal use of a drug, there are few incentives for it to search for post-marketed effects of drugs.
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From page 138... ...
The spokespersons for the medical profession have to begin thinking seriously about the information they want that will be sufficient for the best possible use of marketed drugs. They can start by appreciating the wisdom of the food and drug act and publicly protecting the performance of the agency in its most important legal functions.
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From page 139... ...
Observational studies can fill crucial gaps in our understanding of what drugs will do in practice settings, many of which are unavailable for intentional experimental study. DISINCENTIVES AND INCENTIVES TO THE GATHERING OF POST-MARKETING DATA If expectations of pre-marketing studies are legitimate, and if the FDA is truly restricted from interference with the practice of medicine, then the agency has a disincentive to find effects that better serve as modulators of appropriate use than as signals of unbalanced danger.
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From page 140... ...
Congressional hearings and the efforts of some public causes over newly found data on drugs can be framed in such a way as to be unfairly demoralizing to the agency. If new and more important efficacy is revealed of a marketed drug, the overseers can ask why it was not found sooner; when serious adverse effects that are not serious enough to be considered imminent public health hazards are revealed, the overseers condemn the regulators for releasing the drug in the first place.
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From page 141... ...
As he studied medically substantial adverse drug reactions of the last decade (incidence 1:500 - 1:10,000) , he demonstrated how quickly leads on unexpected events caused by newly marketed drugs are found and confirmed but how slowly medicine's habits change to accommodate the new information (7~.
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From page 142... ...
The ambivalence these countercurrent drives create probably is responsible for certain irrational behavior of the agency. Many in industry and some in academia complain that trivial, unnecessary, and time consuming pre-marketing expectations of drug testing frequently add inordinate delays to drug development.
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From page 143... ...
We should have known whether the adverse effects were valid and collected data that demonstrated expected efficacy and potential unanticipated efficacies in very important diseases. If we had been systematic in our data gathering, we would have known today whether Xomax, as opposed to other non-steroidal anti-inflammatory agents, truly could have reduced the incidence of myocardial infarction, pulmonary embolism, and stroke that was attributed to it only after the drug was withdrawn from the market (9~.
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From page 144... ...
of the regulatory process has to respect the intent of the food and drug act, the development of the FDA, and the functions and the effect of the process as it responds to the law. The scholar also would have to conclude that what may be adequate for regulatory purposes is inadequate for medical purposes and even for evolving regulatory purposes (self regulatory and/or governmental regulatory purposes)
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From page 145... ...
(Where would we be today if aspirin had been banned early in its use because it caused gastrointestinal bleedings; (2) understand the profession's role in monitoring events and interpreting generated signals; (3)
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