New Medicines In Development For Women
(continued)

A general weakness of the New Drugs in Development for Women report is that it fails to give a definition for the basis for the disease/condition categories selected for inclusion or for how women's health was defined other than to state that women's health is "not only broader but deeper" than reproductive-related functions. Categories included in the report are summarized below:

The "other" category included new medicines in development for women with obesity (2 drugs), shock (1 drug), sepsis/systemic infection (8 drugs), HIV infection (1 drug), and irritable bowel syndrome (3 drugs).

Critics of this report will likely point out that many of these "new medicines" are actually "me too" versions of existing drugs rather than novel compounds, breakthrough new drugs, or new chemical entities. While this is true, the criticism is misplaced and the need for second generation versions of original compounds is misunderstood. First of all, it is unrealistic to think that every new drug developed will be a breakthrough new chemical entity. Furthermore, to suggest that just because a new medicine is not a novel compound it does not have value is simply incorrect. For every minor modification of an existing compound, the side effect profile can vary. For some patients, an apparently inconsequential change in one molecule of a drug can make the difference between having nausea every day or precipitating a headache. For some patients, it may make the difference between being able to tolerate a medication and getting the desired effect, or not being able to take the medicine. For some of those patients, these little changes can ultimately mean the difference between life and death. From the medical perspective, every new medicine developed adds one more choice to our overall armament; it gives us one more choice to customizing care. From an economic perspective, every new medicine developed adds competitive pricing competition.