Pharmaceutical Industry Practice

In July 1991, a survey was completed by this author for the Pharmaceutical Manufacturers Association (PMA), Special Populations Committee on the current practice of the industry in handling gender and minority data (Edwards, 1991). Vice-Presidents of headquarters, clinical and regulatory affairs were contacted at 46 companies; 33 companies responded (nearly all the major companies). All 33 responding companies collect gender-related data on the participant patients in clinical studies. Over three-quarters of the companies reported that they deliberately recruit 'representative' numbers of women. It should be noted that the term 'representative' has not been defined by the FDA or by industry. However, only 10 companies (30%) frequently or usually collected data on menstrual cycle; 56% replied that the FDA at some time or other had requested the inclusion of women in trials. When women of child-bearing potential were included in protocol proposals, 21% of the respondents said that the FDA never disagreed, but 79% had experience of some FDA reviewers at one time or another excluding women of child-bearing potential. When excluded, this was usually in the Phase I and Phase II trials, 58% and 45%, respectively, correspondents reported.

While this survey was qualitative rather than quantitative, the results should not be dismissed lightly; because the survey was confidential, no respondents or their firms were exposed to open criticism. Because of their experience and senior positions, respondents had reviewed many different drugs and NDA applications. The survey replies were therefore likely to be reliable and provide a good approximation of the then-current industry gender practices and the frequency of clinically meaningful differences.

When gender differences in safety or efficacy were found to be clinically significant, most respondent companies (94%) opted to put the data in the product label, the Physicians' Desk

Reference and the product literature (72%), and to publish in the medical journals (69%). Presumably, the two companies that did not amend their labels acted thus because the products were only intended for one-gender use. By December 1999, there were 348 medicines in development for diseases only in women or where women are disproportionately affected (Holdin 2000). Not only has industry stepped up its research efforts, but many large firms have units devoted to women's health care.

Finally, correspondents were asked how frequently gender differences were found; 73% said 'occasionally', 3% said 'frequently' and the rest said 'never'. Of those who saw differences, only one-third found these differences to be clinically significant 5% of the time, while 17% of respondents said that significant differences occurred 10% of the time. This was more than expected, and provides further justification for gender testing.

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