Background

The pharmaceutical industry is in the business of developing, manufacturing and selling drugs, vaccines, and devices. Although basic research has become more important in recent years, it is not the primary aim of industry. However, increasingly and usually dictated by opportunity, industry is investing in a highly targeted fashion in some aspects of basic research, but the development of a product is always to the fore.

This thrust, however, need not exclude the gathering ofbasic data, which may prove invaluable to the research process. Regrettably, these data were frequently inaccessible, in some instances owing to the needs of confidentiality, product protection, or even legal concerns, but by far the greatest reason is that such data are regarded as a by-product, almost 'waste data', for they are not part of the mainstream of product development. Such data are recorded but rarely utilized, frequently residing in notebooks, case records, mainframe databanks, statistical reports, or data tabulations in the back of appendices of regulatory submissions.

So it is with gender data: it is collected, analyzed and tabulated by each study and by each drug, but data on drugs of the same class and between each government agency handling multiple applications are virtually inaccessible. Mining this data requires more creative solutions than 'regulations'. This is now happening.

It has been estimated that the cost of developing a new medicine is now $350-550 million (Arlington, 2000). This estimate mostly comprises costs in development, but includes the loss of other revenue if the development money had instead been invested cumulatively. These costs are passed directly on to the consumer.

Drug costs have risen slowly compared to other health costs, when adjusted for inflation. When compared to other health costs, in 1965 the drug/ device cost was less than a dime per health dollar and in 1999 is less than a nickel (Health Care Financing Administration • • •). Drug cost is, and must remain, one of the most affordable aspects of treatment. A large component of drug development cost is caused by regulatory needs to test for drug safety and efficacy, both for the USA and foreign agencies. Clearly, the cost of any additional regulation imposed on top of the current burden will also be directly reflected in the eventual cost to the consumer.

Women comprise 51% of the population of most nations; in Western countries, 54% of women are of child-bearing potential (15-49 years). Women account for 57% of physician visits (National Disease and Therapeutic Index •••) (FDA, 1986). In the age group 20-39 years, women were found to be the biggest users of anti-infectives, especially ampicillin and amoxicillin; antidepressants are prescribed twice as often to women as to men (Stewart, 1998); and of some concern was that tetracycline, a known teratogen, was the eighth most prescribed drug in this group most likely to bear children (FDA, 1986).

As major users, it might be postulated that women, including those of child-bearing age, should be the group on which Phase I and Phase II dosing (early efficacy and safety) should be based. Why is this not so? Critics of the industry, and indeed of the wider research process, claim that it is entrenched discrimination by males, which is disguised as 'concern and gallantry'. Critics also point out that both medicine and research are dominated by males, who place research into women's diseases on the back burner of their male priorities and only see data, even on women, from a man's point of view. They point to a report by Coale (1991) on the 'missing 100 million women' in Asia and the Indian subcontinent, whom are speculated not to exist becaues of abortion and medical and nutritional neglect. They also point to the misuse of science (ultrasound or amniocentesis) for sex determination.

While these are extreme examples of societal attitudes, it is true that women have been excluded from many large, well-published studies, such as the Physicians' Health Study of aspirin in cardiovascular disease (Hennekens, 1989). It is also true that many early studies of drugs in Phases I and II were conducted in healthy white males 18-40 years old and the results then extrapolated to women in Phase III studies, primarily aimed at expanded efficacy and safety. Only recently, Paul Williams (1996) confirmed that exercise raised HDL cholesterol in women, many years later than reported in men. It is, however, in most cases, grossly naive to attribute this to deliberate 'male discrimination' to exclude research on women.

It is also frequently mentioned that fear of embryonic malformation, whether or not drug-related, and subsequent litigation is the major determining factor for exclusion of females from therapeutic and basic research projects. This overly simple explanation covers up other difficulties, such as methodology, lack of relevant baseline information, and biochemical variables, both hormonal and gender-related. It also ignores the use of information derived from other groups of women, those of no child-bearing potential, sterile or post-menopausal, the elderly, or children just entering puberty, where the risk of fetal exposure is nonexistent or minimal.

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