Invisible women
1993/01/01 Elhuyar Zientzia Iturria: Elhuyar aldizkaria
The pharmaceutical industry does not properly carry out its work to analyze the possible incidence of drugs that want to market in women. This is what a report presented to the Congress of the United States says. According to this report, the procedures provided by the organization “Food and Drug Administration” (FDA) to market drugs in this country are not adequately met for women, and even the organization itself has not properly controlled the procedure in these cases.
The report analyzes the case of 53 new drugs approved between 1988 and 1991. The report notes that in one of three tests carried out with women, the figure of 250 established by the FDA has not been reached. This number is the minimum established to detect different reactions by sexes.
In 8 of the 13 drugs for cardiovascular diseases, there was not enough trial in women, even though those that cause the highest female mortality were those diseases, and in one case the proportion of women among the subjects of the test corresponded with the proportion of women among the patients who owed medicine.
Among these 52 drugs, only in 12 cases has interaction with oral contraceptives or female hormones been studied.
The report recommends that companies responsible for the clinical analysis of drugs and the FDA ensure that the characteristics of the people used in the tests are as close as possible to the characteristics of the population segment that uses it. Among these characteristics, sex is not at all negligible, since it is shown that on many occasions drugs can have a different influence between men and women.
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