Improving how we evaluate the toxicity of approved drugs
Adverse Drug Reaction Reporting Systems
Drug-Related Side Effects and Adverse Reactions
This historical analysis leads to several suggestions for improving the information about medications after they are marketed and improving the dissemination of this information to all who need to know it. Voluntary case reporting is useful for detecting unexpected unusual events that might be due to antecedent drugs. It also detects diseases caused by new drugs when experience has shown that these diseases can be caused by drugs. Hepatic necrosis and blood dyscrasias are examples of the success of disease registries. Thus disease registries, as well as case reporting of unexpected and unusual events, should be encouraged. The analysis of recent MedWatch drug alerts shows that more alerts were from clinical trial data than from case reporting. We have information about publication bias caused by not publishing studies that fail to show efficacy. We do not know the extent to which studies that show hazard have been kept from public view. All clinical trial results should be published without excessive delay. IRBs have the power to make this a requirement for approval of a clinical trial protocol. The organizations representing the institutions in which clinical trials are done, such as the Association of American Medical Colleges, the American Hospital Association, and free-standing clinical research organizations, should initiate this requirement among their members now. The FDA should be enabled to require publication of every clinical trial submitted to it. Finally, at this time, one can expect few additional resources from the federal government for adverse reaction studies or publicly funded clinical trials. Moreover, the drug companies' goals are to discover, develop, and successfully market new drugs. One cannot identify why any manufacturer would have an interest in funding studies intended to decrease its market for a drug or studies of multisource generic products. The financial benefits of funding studies of marketed drugs to learn the most cost-effective treatments when good alternatives exist go to the health insurers paying for medical care. They also yield financial benefit when new adverse effects are identified, so the patients they insure have less drug-induced illness. It is the health insurance industry, both private and public, that has the resources and the financial interest to counter the excessive advertising and promotion of some drug manufacturers and to fund the studies currently needed but not done. A strong FDA is necessary but not sufficient to ensure that we are doing the best we can with the medicines we have. More is needed to achieve this goal. This historical analysis has identified some activities that could be implemented without new legislation. These are to add selective disease registries to voluntary case reporting programs, require prompt publication of all clinical trials, and develop an additional independent institution by the health insurance industry to evaluate marketed drugs and to publicize the results of the evaluations. These activities do not require new legislation. They require that all of us interested in better health care accept the responsibility to take the initiative to improve our system. © 2006 American Society for Clinical Pharmacology and Therapeutics.
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