Glob Health Action. 2014; 7: 10.3402/gha.v7.25484.
Published online 2014 Dec 9. doi: 10.3402/gha.v7.25484
PMCID: PMC4262757
This article has been cited by other articles in PMC.
Abstract
This
thesis is part of the studies of gender bias in health which together
with the paradigm of evidence-based medicine shares the empirical
assumption that there are inaccuracies in medical practice, in addition
to a lack of rigour and transparency. It worked with the distinction
between the concepts of sex and gender and between the concepts of
sex-related differences and gender inequalities, in terms of applying a
gender perspective in the study design and the subsequent analysis. This
PhD review presents the research process conducted in Spain, which can
provide an example for future research. Study I described a review of 58
clinical trials (CTs) of etoricoxib to assess its compliance with the
Recommendations of Evaluation of Gender Differences in the Clinical
Evaluation of Drugs. In Study II, key informants from professions
related to different areas in drug development and pharmacovigilance
held a working meeting to reach a consensus document on recommendations
for the study and evaluation of gender differences in CTs in Spain. In
Study III, the websites of the eight best-selling hormone replacement
therapy drugs in Spain on Google first page of results were analysed. In
Study IV, a logistic regression analysis was performed to compare
analgesic prescription by sex in regions with a higher or lower Gender
Development Index (GDI) than the Spanish average. Gender biases
identified in this thesis limited the legitimacy of medicine, which is
not based on the best possible evidence. The results also demonstrate
the existence of inequalities between men and women that are not due
merely to biological differences, but are gender inequalities stemming
from the social differences that exist between both sexes.
Keywords: clinical trials, gender bias, hormone replacement therapy, marketing, prescription, analgesia, gender development
This
thesis is part of the studies of gender bias in health which together
with the paradigm of evidence-based medicine shares the empirical
assumption that there are inaccuracies in medical practice, in addition
to a lack of rigour and transparency. This research was conducted in
Spain, a country where inter-regional differences persist, showing a
north–south pattern in gender development, pro-northern regions (1),
even in recent years have reduced inequalities in development between
women and men. In recent years in this country, there have been
significant legislative changes in relation to equality between men and
women in research.
The Organic Law 3/2007 of 22 March on effective equality between women and men (2)
states that wherever possible, the data contained in records, surveys,
statistics, and other medical information systems should be
disaggregated by sex to facilitate a gender analysis. Point 3 of Article
27 states that through the health services and the competent bodies in
each case and in accordance with the principle of equal opportunities,
the public authorities will implement the following actions: Promotion
of scientific research into differences between women and men related to
health care, particularly as regards diagnostic and therapeutic
accessibility and strategies, whether in clinical trials (CTs) or health
care provision.
In the same vein, the Law 14/2011 of 1 June, on Science, Technology and Innovation (3),
established the perspective of gender as a cross-sectional category in
scientific and technological research which should be applied throughout
all aspects of the process in order to guarantee effective equality
between men and women.
Gender bias
Making
the presence of gender bias visible allows us to fill the gaps in
knowledge about the health of women and men and to understand their
health needs and risks, that is, to improve health care and
interventions.
The Journal of the American Medical Women's Association
defined gender bias in clinical practice in the 90s as ‘differences in
the treatment of women and men with the same diagnosis, which may be
positive, negative or neutral to the health of these’. The principal
consequence is discrimination against one sex with respect to the other
in the health services (4).
The main problem with this definition is that it ascribes exclusive
responsibility to health professionals. However, health professionals
diagnose and treat according to the training received and the
information available to them. Therefore, the real source of gender bias
in clinical practice may be due to errors in research resulting from a
lack of gender awareness. Then, and in line with the ideas of feminist
empiricism, a more comprehensive definition of gender bias would be a
systematic error related to a lack of gender awareness, leading to the
mistaken view of men and women as similar (or different) in exposure to
risks or in the natural history of a disease (symptoms and signs of
onset and course, response to treatment and prognosis) (5, 6), and where the main consequence of gender bias in research and health care is the lack of valid results (6).
Thus,
gender bias in health care is largely a result of gender bias in the
generation of knowledge. However, we should also consider that marketing
has become one of the most important filters of medical knowledge.
Advertising in marketing campaigns can help to strengthen erroneously
the perception that certain diseases are more frequent in one sex than
another through greater representation of one of the two sexes. In
addition, concern has been consistently expressed that pharmaceutical
marketing contributes to the medicalisation of women's life processes (7).
A
specific strategy has been employed for the research on which all the
articles are based, namely, to identify gender bias. To this end, a
working definition was used which was adapted to each context studied
and from which the categories and variables to be analysed were
selected. Focusing on therapeutic strategies, this PhD review comprises
three interconnected contexts, including knowledge production, knowledge
diffusion, and health care (Fig. 1).
Interconnection between knowledge production, knowledge diffusion and health care.
Gender bias in knowledge production
The
erroneous assumption that men and women are the same is evidenced by
the exclusive inclusion of men in CTs, with subsequent extrapolation of
the results to women (5).
The arguments in favour of the systematic exclusion of women from CTs
have been based on foetal risk during pregnancy, hormonal interactions
due to the menstrual cycle or the concomitant use of exogenous hormones
[hormonal contraceptives and hormonal replacement therapy (HRT)],
difficulties in recruiting, and higher dropout rates (8, 9). However, these reasons are precisely why women's participation in CTs is necessary.
Feminist
empiricism postulates that sexism and androcentrism both constitute
social biases which could be corrected through strict adherence to valid
methodological standards in scientific research when testing hypotheses
and interpreting data; in other words, within the context of the
rationale. Feminism is proposed as a correction factor for already
established theories. One of the strengths attributed to feminist
empiricism is that it observes valid methodological standards in
science, since it believes that the problem is bad science. The
exclusion of women from CTs is an example of the poor application of the
scientific method as a result of the androcentric nature of science.
Under the false premise that men and women are the same, medications
have traditionally been tested on men and the knowledge obtained about
efficacy and effectiveness has been extrapolated to women.
Following the scandals related to the teratogenic effects of thalidomide and diethylstilboestrol (10), in 1977 the Food and Drug Administration (FDA) issued the ‘General Considerations for Clinical Evaluation of Drugs’ (11).
This document recommended that women of childbearing age should not be
included in the early phases of CTs, until sufficient data on drug
toxicity had been obtained. In practice, this resulted in the exclusion
of women from CTs (Fig. 2).
Summary of turning points in the regulation of women's participation in CTs.
In the 1980s, the National Institutes of Health (NIH) began to promote women's inclusion in CTs (12); nevertheless, in 1992 the US General Accounting Office (GAO) voiced concern about the under-representation of women in CTs (13).
In response, FDA published its ‘Guideline for the study and evaluation
of gender differences in the clinical evaluation of drugs’, which argued
that it was necessary to include women in CTs and also that the results
should be stratified by sex and drug interactions with both endogenous
and exogenous hormones being studied (14).
Similarly, the NHI Revitalization Act was approved, making it a
requirement that women be included in all NIH-funded CTs, or in the
event that they are not then reasons for this be given (15).
The
case in Europe is different. In 2005 and 2009, the European Medicines
Agency (EMA) published ‘Gender considerations in the conduct of clinical
trials’ (16),
which stated that the publication of a specific guideline was not
necessary. This statement was based on a review of the agency’s own data
(about which little information is available) and using debatable
arguments (17).
Since
1993, when the FDA lifted its ban on the inclusion of women in the
early stages of CTs through the publication of its guidelines (14) and the NIH changed its policy (15)
regarding the funding of clinical research, numerous studies have been
published in scientific journals concerning the participation of women
in CTs.
An editorial published in 1993 in the European Journal of Public Health
highlighted the importance of re-examining results once they have been
published, since if stratified by sex, the conclusions may be different
for men and women (18).
Therefore, literature reviews constitute an essential tool in gender
studies. As part of this study, a literature review was conducted from a
gender perspective on the CTs of a symptomatic drug with a questionable
benefit–risk profile.
With the
objective of contributing to the transfer of knowledge in order to
support the incorporation of a gender perspective into the clinical
research agenda in Spain, and more specifically into CTs, one aim of
this PhD study was to develop a consensus document on the inclusion of
women in CTs and the sex-stratified analysis of findings, in
collaboration with a group of key informants in different areas of
pharmacology and clinical research.
Gender bias in knowledge dissemination
The
feminist standpoint states that the dominant position of men in social
life results in partial knowledge, whereas the subjugated position of
women opens the possibility of a more complete knowledge (selection of
research problems, definition of a problem, research priorities); in
other words, within the context of discovery. So recognition of health
problems specific to women has been slow, as is the case of HRT (Fig. 3). Towards the end of the 1930s, a debate arose about the relationship between oestrogen and breast cancer (19, 20), and during the 1950s, concern was voiced about its use during menopause (21). Nonetheless, HRT became a commercial success (22, 23). Following publication in the New England Journal of Medicine of the relationship between endometrial cancer and oestrogen (24, 25),
combined HRT (oestrogen and progesterone) was released. Perhaps the
most important event in the history of HRT was the publication of the
results of the Women's Health Initiative (WHI) after the drug had been
withdrawn due to the unacceptably high incidence of cancer and adverse
cardiovascular effects in women taking HRT (26).
Publication of the WHI results led to a sharp drop in sales in
Anglo-Saxon countries. However, the Spanish Medicines Agency of
Medicines and Health Products (SAMHP) waited until 2004 before
restricting the indications for HRT (27), reaffirming these restrictions in 2008 (28).
In fact, the biological, clinical, and epidemiological evidence
highlighting the risks and refuting the alleged benefits associated with
HRT has been a source of debate among pharmaceutical companies,
epidemiologists, regulatory agencies, and feminist groups (29).
The question posed by Nancy Krieger was ‘Why, for four decades, since
the mid-1960s, were millions of women prescribed powerful
pharmacological agents already shown, three decades earlier, to be
carcinogenic?’ (29).
Summary of the history of HRT use and its relationship with adverse effects.
Despite
the risks associated with HRT use, pharmaceutical marketing has
presented the menopause, a natural part of women's life cycle, as
pathological, creating the feeling of real illness among the population
and ensuring that HRT is recommended and prescribed (30).
The interests of certain medical specialities reluctant to stop
prescribing hormonal drugs, particularly to women, together with those
of the pharmaceutical industry and the media, which play such an
important role in disseminating information to promote sales without
considering the evident side effects (31),
explain the importance of conducting research from a gender perspective
which focuses on communication and advertising of hormonal drugs in
Spain for commercial purposes. As Muir Gray aptly pointed out, it is a
right and obligation of public health bodies to ensure that information
is not misleading (32).
In this respect, the European Union has voiced the need to review the
rigour, integrity, and consistency of health information, including
information available online (33), which has rapidly become the medium used by physicians and patients to access information on drugs (34) since it facilitates patient involvement by providing easily accessible information on health topics (35). For this reason, this PhD study also includes an analysis of the information about HRT drugs available online.
Gender bias in health care
Historically, women's health has usually been seen almost exclusively in terms of reproductive health (36, 37).
As a result of biological essentialism, knowledge about women's health
is limited and does not take into account the ways in which the social
reality of gender is manifested in women. Betty Friedan described how
women's dissatisfaction was related to the fact that their opportunities
were exclusively restricted to being a homemaker, wife, and mother (38).
The emotional distress of women is medicalised by erroneous symptomatic
treatment strategies which ignore the causes. Thus, it has been
reported that women are more likely to be prescribed anti-anxiety drugs,
sleeping pills, and medication for mental health problems than men (39).
This may reflect a greater tendency among health professionals to
attribute what are actually physical symptoms with atypical presentation
to psychological factors when treating women, or a greater tendency to
prescribe drugs for women than men when treating low-level depressive
symptoms (40).
Although
it has generally been observed that diagnosis and/or treatment are
determined individually, they are nevertheless the result of a complex
pattern of causes, including social determinants (41).
When women enter the health care system, they may experience different
treatment or diagnosis according to their status, social power, and
socioeconomic status (42).
In addition, it has been shown that women experience problems related
to equality and quality of health care as regards access to specialists,
one consequence of which is the increased prescription of symptomatic
treatments (6, 43).
The
discipline of epidemiology has shown no interest in investigating the
reasons behind the contexts in which relationships between risk factors
and disease arise (36).
Due to the lack of information on the social determinants of health
problems, the risks to women's health are often decontextualised and
depoliticised (36).
As with feminist empiricism, this critique suggests that there is an
error in the application of scientific method, since important
structural factors that affect men and women differently are not
addressed.
Inequality between men and women has not
traditionally been considered as a determinant of health care. It was
Kawachi who published one of the first studies to indicate the
importance of gender inequality as a social determinant of health,
demonstrating the association between women's social status and
morbidity in both sexes according to geographical region in the same
country (44).
A relationship has also been shown between women's empowerment and
indicators of community health: women's empowerment and their
participation in political, economic, and social life are associated
with lower mortality are associated with child health and with lower
mortality rates in men and women (45).
Consistent
with a higher prevalence of pain, epidemiological studies have reported
a greater use of analgesics among women than men. However, although
logically, pain should be the main reason for prescribing analgesia, the
literature indicates that pain alone does not explain higher rates of
prescription to women, since given the same intensity of pain women are
more likely than men to be prescribed analgesia (46). As Malterud has stated, doctors interpret symptoms differently according to whether they occur in a man or a woman (47).
Thus, the prescription of analgesia depends less on the discomfort
expressed by those experiencing it than on the perception that health
professionals have of the patient in question (46, 48).
Given
that individual factors do not explain the greater prescription of
analgesia to women than men, and that contextual factors in health
differences between men and women have not traditionally been studied,
the present doctoral thesis includes an analysis of the influence of
context, in this case gender development, in the prescription of
analgesia in Spain.
The thesis worked
with the distinction between the concepts of sex and gender and between
the concepts of sex-related differences and gender inequalities, both in
terms of applying a gender perspective in the study design and in the
subsequent analysis. Below, we presented the research process which can
be an example to future researches.
Research process
Gender bias in knowledge production: Study I (49) and Study II (50)
As part of this study, a literature review was
conducted from a gender perspective on the CTs of a symptomatic drug
with a questionable benefit–risk profile, namely, the anti-inflammatory,
etoricoxib (Arcoxia, Merck Sharp & Dome) (51). This drug is mainly used by women, and the summary of product characteristics warns of interactions with female hormones (52).
The 58 CTs reviewed were published between 2000 and 2007 to assess
compliance of these CTs with the recommendations of the FDA guideline (14) and the Sex, Gender and Pain Special Interest Group Consensus Working Report (53). The protocol designed ad-hoc included these variables:
- Sex differences (stratified data in order to enable gender analysis of the results, efficacy, adverse effects, dose–response, blood concentration–response and discussion of the results by sex).
- Women-specific issues (pregnancy as an exclusion criterion, use of contraceptive methods, use of hormonal contraceptives, use of HRT, menstrual cycle and status).
To
develop a consensus document on the inclusion of women in CTs and the
sex-stratified analysis of findings, this study had the collaboration of
a group of key informants in different areas of pharmacology and
clinical research (Ethics Committees for Clinical Research,
Universities, Health Service CT inspection, pharmacovigilance, CT
research and development companies, the SAMHP and the EMA, providing
added transfer value to the research). First, key informants were
provided with the relevant literature on women's inclusion in CTs,
evaluation of gender differences, and sex-stratified analyses of CTs of a
new drug (3–8, 15, 16),
and they responded individually to an open-ended questionnaire about
the challenges of conducting CTs to determine gender differences in
pharmacokinetics, the problems arising from the failure to consider
these differences in trials, and the establishment of priorities
according to the feasibility of systematically incorporating the ‘gender
difference’ factor in each phase of the development of a new drug. Once
the information given in the responses had been processed, a working
meeting was held with key informants and participants; then a debate was
held in order to reach consensus on the suitability of developing
recommendations for studying and evaluating gender differences in CTs in
Spain, the content of such recommendations, and the steps to take in
order to improve information on gender differences and implement gender
analyses in the process of developing a new drug.
Gender bias in knowledge diffusion: Study III (54)
A
search was carried out on the Internet (January 2009) using the eight
best-selling HRT drugs in Spain (information obtained from the Spanish
Ministry of Health and Consumer Affairs General). The brand name of each
drug was entered into Google's search engine. The websites appearing on
the first page of results and the corresponding companies were analysed
using the European Code of Good Practice as the reference point:
- Restriction of the information to a specialised public.
- Obligatory inclusion of the drug's summary of product characteristics.
- Conformity of the indications with the patient information leaflet.
- Inclusion of the registered company name and address.
- Inclusion of complete bibliographic references, including references to the original source.
Gender bias in health care: Study IV (55)
A
cross-sectional study of sex differences in analgesic prescription
according to the gender development of the regions studied was
performed. Analgesic prescription, pain, and demographic variables were
obtained from the Spanish Health Interview Survey in 2006. Gender
development was measured with the Gender Development Index (GDI). For
this study, we used a dichotomous classification of the 2005 GDI for the
different regions in Spain; below the national average in Spain or
above, based on previous work (1).
This classification showed a north–south pattern whereby gender
development in northern regions was above the national average whilst in
the south it was lower. A logistic regression analysis was conducted to
compare analgesic prescription by sex in regions with a GDI above or
below the Spanish average, adjusted for pain confirmed by a doctor, age,
and social class.
Results
Gender bias in knowledge production
In
etoricoxib CTs reviewed, 70% of the 49,835 subjects were women.
However, if we disaggregate data by phase of CTs, only 30% of the
participants were women. Nearly 85.7% of the trials did not stratify by
sex. With regard to efficacy, 90.6% did not perform an analysis by sex,
and this figure rose to 93.3% in the case of adverse effects. Little
information is available on the possible interactions of exogenous and
endogenous hormones with the drug. The authors interviewed by our e-mail
query indicate arguments related to insufficient sample size to detect
such differences. Another answer was that no sex analysis had been
carried out, but that subsequent studies on the need for analgesics
during the post-operative phase had detected sex differences.
According
to the answers from the experts, women should be included in the
development plan of any drug that they may potentially use and should be
included in CTs from the early stages of drug development.
Additionally, sex-disaggregated results should be given in CTs as
regards efficacy, adverse effects, dose response, and blood
concentration. Studies should be conducted on the possible interactions
of both endogenous and exogenous hormones with drugs. In accordance with
the Spanish Law on Equality, the experts considered that a consensus
document should be created that systematically supports compliance with
the necessary requirements throughout all stages of the development plan
of a new drug, including publication of results.
Gender bias in knowledge diffusion
In
the case of the best-selling HRT drugs in Spain, of the five
pharmaceutical company websites analysed, none gave bibliographical
references or included measures to ensure that the information was only
available to health professionals. Of the 27 non-corporate websites, 41%
did not give the company or registered name, 44% made no distinction
between patient and health professional information, and only 7% gave
bibliographical references. Among the indications given, 26% included
use for the prevention of osteoporosis and 19% included regulation of
the menstrual cycle, and even to enhance femininity. Two online
pharmacies were identified that sold HRT, available for purchase from
Spain. Their sites did not give the name or contact details of the
company or indicate that a medical prescription is required for HRT.
Gender bias in health care
Independent
of pain, age, and social class, women were more likely to be prescribed
analgesia than men OR=1.74 (1.59–1.91), as were residents of Autonomous
regions with lower GDIs compared to residents of regions with higher
GDIs: OR women=1.26 (1.12–1.42), OR men=1.30 (1.13–1.50). Women with
pain in Autonomous regions with a lower GDI were more likely to be
treated by a general practitioner rather than a specialist, OR=1.32
(1.04–1.67).
Discussion
Although there is a growing number of policies, at least in Spain (2),
aimed both at increasing women's presence in the population forming
part of a CT and encouraging analysis of the results by sex, women are
still under-represented in CTs. The first of the articles identified
gender bias in the context of rationale, based on the
under-representation of women in CTs of etoricoxib, particularly in the
initial phases. These initial phases are important for detecting
sex-related differences regarding pharmacokinetics and pharmacodynamics
and for providing the information that is used to design subsequent CT
phases. The other important finding was the virtual absence of any
analysis by sex of the results obtained in the etoricoxib CTs. The
under-representation of women in the design phase of CTs is probably the
reason behind the failure to analyse the results by sex or to consider
the interaction of women's hormonal changes with the drug. As suggested
by feminist empiricism, inadequate methodological design due to lack of
gender awareness in the context of clinical research has been a
determining factor in the emergence of concerns about the validity of
the knowledge produced about this drug (Table 1).
This is particularly relevant given that etoricoxib, with its
controversial risk–benefit profile, is widely prescribed to and taken by
women with musculoskeletal problems, which are common as we get older
and affect women more than men as the former have a longer life
expectancy. The study indicated that etoricoxib may pose the same
problems for women as other drugs in its class (COXIBs).
Summary of the methodological design of the doctoral thesis
One
of the main arguments put forward by pharmaceutical companies for not
conducting an analysis by sex or an analysis of hormonal interactions is
the cost involved in using a sufficient sample size to detect
differences. However, withdrawing a drug from the market due to the
higher presence of adverse effects in women, possibly related to lack of
information about this part of the population, is even more expensive (56).
Furthermore, economic cost is an argument which loses its impact when
one realises that companies spend more on marketing than on research and
development (57).
In opposition to the arguments used by pharmaceutical companies and
agencies such as the EMA, which do not consider the inclusion of women
in CTs or the study of sex-related differences to be relevant, we must
continue to insist on improving the findings of this ‘evidence-based’
medicine through the implementation in Europe of recommendations such as
those of the FDA, until the pharmaceutical companies and the EMA come
to accept the added value of incorporating sex–gender analyses in
clinical research, for their authority and their own interests,
including commercial interests.
As mentioned earlier,
one of the largest proportions of a pharmaceutical company's budget is
spent on developing marketing strategies to encourage the consumption of
drugs. For decades, the use of HRT has been widely debated in terms of
the risks associated with its consumption and the health benefits for
women. However, using the new information technologies and taking
advantage of the limited legislative control, companies recommend HRT to
prevent osteoporosis (where the increased risk of bone fractures is
described as a disease) and other indications which could entail
long-term consumption, ignoring the restrictions on HRT use approved by
the SAMHP. Furthermore, the information found on their websites is
confusing and does not adhere to existing regulations. On the websites
analysed, included were uses which had not been approved by the health
authorities and it was also easy to buy HRT. Such a situation is
extremely serious when considering that HRT is a potent drug with
thrombogenic and carcinogenic effects (26), and that patients increasingly turn to the Internet to find information about health and medication (34).
As
proposed by the feminist standpoint critique, in the case of HRT,
pharmaceutical marketing does not give sufficient weight to the risks
that may affect women's health. Thus, pharmaceutical marketing can be
detrimental to the health of women, by reinforcing gender stereotypes in
the social construction of disease and thereby contributing to the
generation of gender bias in health care (58–60).
It
is precisely for this reason that the study of health care, which forms
part of this study, has focused on the prescription of analgesia from a
gender perspective. Gender is one of the fundamental determinants of
health inequalities, according to the Spanish Commission on Social
Determinants of Health Inequalities (61).
This has been demonstrated by ample evidence indicating that compared
with men, women have unequal access to health resources, and even more
so to quality resources (6, 43, 62).
Thus, patterns of disease and treatment reflect the political and
economic characteristics of society and social inequalities (44, 45, 63, 64).
This study adds a contextual factor to the analysis of inequalities in
prescribing analgesia, showing that the political and economic
characteristics of society influence health and treatment of health
problems: being a woman and living in areas with a lower GDI constitute
two conditions that increase the likelihood of analgesia prescription,
and the latter condition also affects men. Furthermore, the results show
that women, especially those living in an area with a lower GDI,
receive symptomatic treatment of pain more often than men, which could
indicate that they do not receive adequate health care with regard to
the underlying cause of their symptoms. The scientific literature
indicates that women may encounter more obstacles to accessing
specialised services than men. The consequence is that the potential
conditions that may be causing pain are disregarded, reducing the
possibility of benefiting from the prescription of appropriate treatment
(43, 65).
Limitations and strengths
There
are some limitations related to the studies of this PhD thesis. In
first place, it is not possible to guarantee that all available clinical
information on etoricoxib has been reviewed; however, the review of the
58 CTs analysed provides new empirical evidence consistent with other
publications questioning the validity of the information for both sexes.
Consultation with the authors of the CTs analysed regarding their
reasons for not including an analysis of sex-related differences in the
CTs confirmed the relevance of performing these analyses since the
authors themselves were in favour.
The key informant
technique presents certain drawbacks, but one of the strengths of our
study is that it included professionals from different areas of
pharmacology and clinical research, even though pharmaceutical companies
did not participate.
Due to the dynamic nature of the
Internet, the results for websites promoting HRT may vary when searching
on a different date to that when the original search was conducted
(January 2009). Thus, the review of information from the websites
retrieved on the first page of Google results does not include all the
information available on the Internet about each of the drugs analysed.
The Internet literature search on HRT drugs simulated the kind of search
any HRT user might carry out, since increasing number of patients now
seek information about diseases and drugs online.
Although
it has been shown that the Spanish National Health Survey is a valid
instrument which is widely used to describe patterns of drug
prescription, the questionnaire presented some limitations that affected
the study of analgesia prescription discussed in this thesis. However,
the application of a gender perspective in the analysis of analgesia
prescription patterns added a contextual factor that conditions the
treatment of pain, differentiating it from individual risk and therefore
offering a dual, more comprehensive vision of reality.
Conclusions
The
results extracted from the articles indicate gender bias in the
production of knowledge about drugs, in the dissemination and marketing
of these, and in therapeutic strategies in professional practice. The
gender biases identified included extrapolation to the general
population of information obtained from CTs which did not reflect the
proportion of women who would consume the medication and which did not
take possible hormonal interactions into account. These results indicate
unawareness from agencies involved in drug development. In Spain,
Spanish Agency for Medicines and Health Products should encourage
compliance with the Organic Law 3/2007 for effective equality between
women and men. Drug advertising could represent a serious public health
problem, as it is characterised by containing errors that reinforce
and/or increase the gender biases identified in CTs, though not
including information on risks to women and extending the therapeutic
indications for HRT, and this presents a serious public health problem.
Finally, the findings for professional practice revealed the existence
of gender bias in therapeutic strategies. Excessive levels of
symptomatic treatment were identified in terms of analgesic prescription
to women and in regions with a lower GDI. Gender bias may be one way in
which inequalities in analgesic treatment adversely affect the health
of women, through the medicalisation of women's discomfort.
This
limits the legitimacy of medicine, which is not based on the best
possible evidence. The results also demonstrate the existence of
inequalities between men and women, which are not due merely to
biological differences but are gender inequalities stemming from the
social differences that exist between both sexes. Gender based medicine
expects that the results of research strengthen the validity of
medicine.
What's next?
The
generation and dissemination of knowledge biased from a gender, the
perspective and its subsequent implementation, both in health practice
and health policy can continue to perpetuate inequalities in the health
of women and men. Therefore, it is necessary to delve into the factors
involved in social inequalities between men and women to provide answers
about the causes of health inequalities and, consequently, the key to
its disappearance. Gender analysis is to figure out how sex–gender
system impacts the health of women and men, thus generating health
inequalities.
This thesis worked with different
strategies depending on the context, defining working definitions of
gender bias, and applying the gender perspective in the design and
analysis of research, thus may serve as a benchmark for future research.
It
is crucially important to identify gender bias and understand how it
operates in medicine, as is socially harmful and expensive; there is a
growing demand for information from the gender feminist movements,
international conferences and forums, college programs in the area of
gender, and the requirements of international agencies sponsoring
projects. But a new perspective has emerged, it is called Gendered
Innovations, that harnesses the creative power of sex and gender
analysis to discover new things, by integrating methods of sex and
gender analysis into basic and applied research, Gendered innovations
produces excellence in medicine (66).
The knowledge generated by both perspectives, gender bias and gendered
innovations, can be a powerful tool that contributes to the gender-based
medicine.
Acknowledgement
I
would like to express my most sincere gratitude to Dr. Maria Teresa
Ruiz Cantero (cantero@ua.es) for sharing her knowledge and expertise
about health and gender and supervise this doctoral thesis. She has also
authored various articles.
Notes
This article has been commented on by Carlos Alvarez-Dardet Diaz. Read the commentary here.
Conflict of interest and funding
The
author declares no conflict of interest. This work was funded by Center
of Women's Studies at the University of Alicante (Spain), Observatory
of Women's Health (Spain), Women's Institute, Health Research Fund of
Carlos III Health Institute of the Spanish Ministry of Health and
Consumption, CIBER of Epidemiology and Public Health (CIBERESP, Spain)
and the Prometeo Project of the Secretariat for Higher Education,
Science, Technology and Innovation of the Republic of Ecuador.
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