Transcript NATIONAL BIOETHICS COMMITTEE PHARMACOLOGICAL TRIALS ON …

ITALIAN BIOETHICS
COMMITTEE
PHARMACOLOGICAL TRIALS
ON WOMEN
28 November 2008
‘gender medicine’
• women have a “longer life expectancy” (in
comparison to men), but their life seems to
have “less health”
• medicine does not take into adequate
account sexual differences in prevention,
diagnosis and cure
• medicine tends to reflect predominantly a
male perspective, assimilating women to
men
‘gender pharmacology’
• there is an increase in the consumption of
medicines by women in comparison to
men
• the effects of drugs on women are less
studied or not adequately studied with
regard to female specificity
• women are more exposed to: less efficacy/
more serious side-effects in the use of the
drugs
NBC Opinion (2008)
- analysis of the data on clinical
experimentation on women
- analyses of the main reasons for this
shortcoming, the ethical problems arising
from it, the international and national rules
on the issue
- final recommendations
starting point
women appear to be “weak subjects”
- from a quantitative point of view (number
of enlisted women in comparison to the
number of men)
- from a qualitative point of view (analysis of
the data)
female pathologies
increase of studies carried out on women as
regards female pathologies
- fertilization, pregnancy, breast cancer, the
menopause (etc.)
- greater attention to phases II and III;
scarce attention to phase I and IV
male-female pathologies
the areas of disadvantage for women are
highlighted on pathologies that affect both
sexes
1) non-differentiation in enlistment: the
percentage of women recruited in the
experimentation is low
2) non-differentiation in data analysis: drug
dosage is generally measured on men and
women are considered a “variation” of the male
model
male-female pathologies
but there are a lot of physical differences
between men and women which
determine a considerable variation in the
pharmacokinetics and in the
pharmacodynamics
male-female pathologies
- women are generally included (if they are) in
phase III of the enlistment in the trails, but not in
phases I and II (important to establish drug
dosage, side-effects and safety)
- the lack of differentiated analysis and specific
studies on women, does not make it possible to
measure the real efficacy of the drugs on
women, but it could also have limited the
identification of a specifically female drug
male-female pathologies
- some of the illnesses considered
traditionally “male”, today tend to be more
frequent in women
due to the recent change in the conditions of
women’s health/illness within the context
of the general change in the female
condition (above all in western societies)
negative side effects
• women consume more drugs (take better
care of themselves, have better
awareness of their pathological condition)
• drugs have not been adequately tested on
them
• the result is inevitably a higher frequency
and seriousness of adverse reactions
reasons for women’s non
participation in clinical trials
a) social reasons: lack of time, low income,
lack of attention to the practical and
psychological needs of women
b) external environmental reasons: lifestyle
(exposure to substances that can interact
with the experimental drugs: diet/use of
natural remedies)
reasons for women’s non
participation in clinical trials
c) economic reasons: rise in costs for
pharmaceutical industry
d) biological reasons: the physiological
variations during childbearing and nonchildbearing age and the possible use of
contraceptives
reasons for women’s non
participation in clinical trials
e) possible pregnancy during childbearing age:
- the possibility that the trial of a new drug could
damage the foetus in case of pregnancy
- possible negative effects even after the end of
the trial, months later
the pharmaceutical industry generally imposes the
use of specific hormonal contraceptives as
condition for the participation in research that
can be considered “without risk” for the foetus
pharmacological experimentation
on women of childbearing age
1) some feel that the inclusion of women of
childbearing age in the trails is ethically
important
- the a priori exclusion is unjust, as women do not
have the same opportunities as men
- the possible damage to the foetus is considered
not a sufficient reason against experimentation
- the obligation to use oral contraceptives is
criticised as restrictive to women’s selfdetermination
pharmacological experimentation
on women of childbearing age
2) others maintain that exclusion of women of
childbearing age in the trails is ethically
important
- because of possible danger to the foetus
recognised as a subject having dignity
- the imposition of oral contraceptives is not
considered morally acceptable as detrimental to
freedom and responsibility
- woman’s explicit commitment to avoid
pregnancy is sufficient (including abstaining from
sexual intercourse)
pharmacological experimentation
on women of childbearing age
3) intermediate position:
- a personal informed consensus is
necessary (with an explicit commitment of
the woman to avoid pregnancy and to
undertake laboratory tests which can
ascertain the absence of pregnancy)
- the imposition of contraceptive use is not
ethically illicit, as does not modify personal
values and behaviours
NBC recommendations
1. promotion of women’s health against
“neutralistic” ideology of medicine;
promotion of fairness in pharmacological
trial (through identification and removal
of the causes of this unfairness)
2. improvement of analysis of the condition
of women’s health in the light of recent
changes in their psychological-social and
cultural condition
NBC recommendations
3. an increase of clinical trials on women, as
an important step towards an equality of
care in comparison to men
4. drug labels should indicate whether the
drug has been specifically tested on
women or not and should clarify any
element that could generate a different
response in men and women
NBC recommendations
5. improve the participation of women of childbearing age
in pharmacological trials, provided that an adequate
protection of the future child can be guaranteed
- necessity of clear statement of a conscious and
responsible commitment to avoid intercourse that could
lead to pregnancy
- request for the commitment to take contraceptives as a
safety measure can be included in the criteria to
participate in the study
- women’s husbands or partners must be involved in the
counselling
NBC recommendations
6. raise awareness in the local health authorities and
motivate the pharmaceutical industry to support sex
differentiated trials, even if not very lucrative
7. promote the participation of women in clinical trials,
giving adequate information (even through the media) on
the negative consequences of the lack of differentiated
trials
8. ensure a greater presence of women as experimenters
and as members of ethical committees in order to
achieve an active participation in women to the
elaboration of the procedures for the protocols
NBC recommendations
9. promote greater attention from ethical
committees to sexual difference in research
protocols
10. boost health training which focuses on the
female dimension within pharmacological trials,
as well as within research and cure
11. increase international cooperation, as well as
national and local, with the focus on the female
condition within clinical trials, involving health
authorities and the pharmaceutical industry