A public Health Approach to Innovation

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7.4: Cross cutting issues: Women

Priority Medicines for Europe and the World

"A Public Health Approach to Innovation"

Background Paper

Pharmaceuticals and Women

By M.J.C. Willemen; F.F.T. Ververs, Pharm D; and Prof. H.G.M. Leufkens
7 October 2004

Table of Contents

Summary 4

Reproduction control 4

Female subfertility 4

Pregnancy and lactation, including birth defects 5

Hormone replacement therapy (HRT) 5

General 5

Introduction 6

Size and nature of disease burden 6

Absence of a uniform classification system concerning safety (drug use in pregnancy and lactation) 7

Reproduction control 7

Subfertility 8

Pregnancy and lactation, including birth defects 8

Post-reproduction hormones 9

What are the current or likely future factors that impact disease burden? 10

Reproduction control 10

Subfertility 11

Pregnancy and lactation, including birth defects 11

Prenatal testing 11

Post-reproduction hormones 12

What is the control strategy? 12

General 12

Improving participation in clinical trials 12

Specific 13

Reproduction control 13

Subfertility 13

Pregnancy and lactation, including birth defects 13

Prevention of birth defects 14

Post-reproduction hormones 14

Why does the disease burden persist? 14

General problems 14

Lack of knowledge 14

Specific problems 15

Reproduction control 15

Subfertility 15

Pregnancy and lactation, including birth defects 16

Post-reproduction hormones 16

What can be learnt from past/current research into pharmaceutical interventions for these conditions? 16

Stimulating research in women 16

Post-marketing research in pregnant women 17

What is the current "pipeline" of products that are to be used for this particular condition? 17

General 17

Research in women 17

Specific issues 17

Hormone therapies 17

Pregnancy and lactation, including birth defects 18

What are the opportunities for research into new pharmaceutical interventions including delivery methods? 18

What are the gaps between current research and potential research issues which could make a difference, are affordable and could be carried out in a) 5 years or b) in the longer term? For which of these gaps are there opportunities for pharmaceutical research? 19

Research in women 19

Dosing 19

Conclusion 19

References 20


The thalidomide-crisis in the early 1960s made the world aware of the difficulties of drug use in women.1 Since then, women’s health is at the top of virtually every health care policy agenda. Paradoxically, there are still various gaps in know­ledge and research related to female drug treatment.
Four issues (reproduction control, female subfertility, pregnancy and lactation (including birth defects and teratogenicity) and post-reproduction hormones) are discussed in this paper.

Reproduction control

Since the introduction in the 1960s, the use of pharmaceutical contraceptives has increased enormously. Due to different reasons, the use varies widely between different countries.2 Although, the discussions about the safety are still ongoing. In the beginning, high doses of estrogens were of major concern. In the 1980s, the differential risks of progestogens, as part of low dose OCs have been the subject of an ongoing series of controversies, scientific inquiry and societal debate.3
Opportunities for research concerning contraceptives lay in the field of looking for new targets for intervention,4 new classes of chemical compounds (compounds which have estrogenic effects such as synthetic steroids like tibolone),5 and new drug delivery systems (e.g. the vaginal ring, injections).6, 7 As compliance is a major factor for effective contraception, the development of long acting or controlled release formulations should be encouraged. Current societal developments ask for more emphasis on equal responsibility and burden between women and men, including strengthening the search for pills for men.

Female subfertility

Female subfertility can be caused by different disorders. With the increasing age of women having children, the rates of female infertility increase due to a decrease in the oocyte/follicle pool. Also ovulation disorders (25%), tubal disorders (20%) and endometriosis (5-10%) cause infertility. Although the knowledge of subfertility has increased in the previous years, in about 30% of the cases the cause of the subfertility is unknown.8, 9
In vitro fertilisation (IVF) is for many couples the last opportunity to have children. The success rate of IVF is only about 25% per cycle and the technique is associated with side effects, increased risks for complications, and multiple births.10 Multiple births are associated with an increased morbidity and mortality (e.g. prematurity, low birth-weight, neurological handicaps). The hormones used by IVF are another concern. The effects of these hormones are not completely clear yet. The long term effects (e.g. puberal development, future fertility of the child) are still unknown. To obtain sufficient information of the effects of the hormones on both the mother and the child, long-term follow up is needed. 11, 12

Pregnancy and lactation, including birth defects

Research in pregnant and lactating women is very controversial, especially since the thalidomide disaster in the early 1960s.1 Although many women need to use medication during their pregnancy or lactation, there is a lack of knowledge of the safety of many drugs.
The wide variation in prevalence of teratogenic effects imply the need for large data banks which include information on different issues (e.g. drug exposure, illness of the mother before/during pregnancy, epidemiology of congenital abnormalities) from large numbers of women and their children, during a long period of time, are needed. 13
To prevent neural tube defects, the preconceptional use of folic acid is strongly recommended. Unless various public awareness campaigns, less than 50% of the women uses folic acid before conception.14 Accordingly, the enrichment of food with adequate amounts of folic acid might be considered.
Because of the risks, pharmaceutical industry is far from eager to financially support studies which involve pregnant women and tend to advise negatively in using their drug during lactation. Recently, both FDA and EMEA developed guidelines to improve the post-marketing research in pregnant women.15, 16 It is expected that these guidelines will work out good, but only the future will tell us.

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