When should the physician question information disseminated by the pharmaceutical industry?

Abstract

When should the physician question information disseminated by the pharmaceutical industry?T he act of prescribing any drug involves at least three interested parties: the drug manufacturer; the individual prescribing the drug; and the patient. In a simplistic way, all three participants in this process share a common interest in ameliorating or resolving the problem that caused the patient to seek medicaI attention. Other interests, not all of which will be common to each of these three participants, may be present consciously or unconsciously.To obtain a licence for its commercialization, every drug must satisfy a series of norms that vary from country to country. These norms generally require documentation of the minimum and acceptable risk of serious or frequent side effects of the drug, as well as requiring it to be effective and efficacious within its proposed target population.With the constant advance of technology, and the recognition that resources allotted to health care are finite and proportionally more and more scarce,. there has been a recent-tendency to require that a new drug be as, or more, efficient than those already available and commercialized. Some countries, such as Canada and Australia, already require that a new drug be shown to be economically superior to its competitors.However rigorous that these norms regulating the approval of pharmaceutics may be, they are not even close to being sufficient to guarantee complete safety to each of the parties involved. The act of prescribing is extremely complex and involves the use of information which may particularize each clinicaI case. For a drug to be evaluated, it is necessary to have a minimum of information available to back up any analysis: it is necessary to have valid, scientific evidence.Generating the evidence which permits the evaluation of the effecti veness, efficacy, and efficiency of the drug is also complexo At least three interested parties also . participate in this process: the drug manufacturer, the researcher, and the patient. In this, the principal common interest is to contribute to the advance of science~while providing patients "and health professionals alike with berter means to reestablish the physical, social and mental well-being of the patient. In this process too, other interests, common to all three participants or not, may also be present consciously or unconsciously.In the generation of this new knowledge, the three parties make investments and incur risks. The patient, being submitted to clinicaI research, however ethical and informed, is not exempt from risks.The researcher, serving his objective of promoting the advance of science, has the responsibility, along with the medicaI and non-medicaI community, to plan, execute, and anaIyze th~proposed research in the best possibIe way. The researcher's investment and risk is directly linked to the repercussions of each investigation, and to the effects of its results on his professionaI career.Besides the concerns cited above, the pharmaceuticaI industry has an in...