today's Interviews - 12/09/09
J Prat - Endometrial Cancer (play)
P Koninkx - Deep and intestinal Endometriosis(play)
M Brincat - The role of gynaecologists in elderly women(play)
J Dequesne - New horizons in gynecological surgery (play)
The Editorial
David Sturdee
MENOPAUSE 2009
Any doctor who may have only the slightest interest in or knowledge of the menopause will nevertheless be well aware that managing the menopause has changed dramatically over the last few years, and especially since 2002 and the first reports from the Women’s Health Initiative (WHI) study(1).
The sensationalist presentation of these reports made several assumptions that have terrified women and their doctors, such that many are now being denied the benefits of an improved quality of life that has been available for at least the previous two generations with the use of hormone replacement therapy (HRT). What makes the current situation so frustrating is that the WHI investigators are now realising that they overcalled and misinterpreted the initial data, so that many of their statements that caused so much sensation and turned many doctors off from ever prescribing HRT again, are now being revised. For example, the mean age of women entering the WHI study was 63 years, so they were 68 years old when the combined arm of the study was stopped, but the conclusions were that the results would apply to women of any age. Subsequent analyses have however clearly demonstrated that this is not true and in respect of coronary heart disease(CHD) for women aged 50-59 years HRT does not increase the risk in healthy women and may even decrease the risk in this age group(2). Furthermore, estrogen-alone therapy in the age group 50-59 years was associated with significantly less coronary artery calcification (equivalent to a smaller plaque burden)3, which is consistent with findings of a lower coronary intervention score in women of this age. [It is also of interest that no other current treatment for heart disease has been shown to have this beneficial effect.] Following these reports the chief investigator, Dr Jacques Rossouw did actually admit that…”I understand some people are going to say we’ve reversed course”, which is what they have done, but with none of the publicity that they attracted for their initial damning statements, and then....”What’s important about the analysis is that it shows there may be some credence to the notion that there’s a ‘window of opportunity’ when hormone use is reasonably safe for younger women”(3). Thus admitting that their initial analysis and denial of any relevance of the age at which HRT is started was wrong.
Whereas the first reports received banner headlines on the front pages of the major newspapers, these retractions have met with minimal publicity because only bad and sensational news sells newspapers and such good news, even though it is of major importance to millions of women and their doctors worldwide, is not interesting enough! Similarly the risk of breast cancer has been exaggerated with the use of alarming relative risk figures, whereas if put in to absolute terms, which women can more easily understand, there may be an extra 8 cases of breast cancer per year for every 10,000 women using combined HRT for more than five years. This compares favourably with many of the other risk factors for breast cancer that receive much less publicity such as having the first baby after the age of 30years, drinking alcohol or using a statin(4). When any of us with a special interest in the menopause and HRT try to redress this imbalance, we are accused by some epidemiologists of being selective in the use of data to support our views. Yes, of course we are selective by using only what is considered to be the best grade A evidence. Regrettably our Regulatory Authorities who have such a strong influence on clinical prescribing are heavily influenced by epidemiologists and statisticians, many of whom have never seen a patient in the flesh but just see subjects in hundreds and thousands or even a million women on a computer screen. Clinicians who deal with individual women and their problems are left to try and put the scaremongering in to appropriate perspective, and provide reassurance that for the vast majority of women going through the menopause and who are experiencing a reduced quality of life, HRT can make a tremendous difference and the risks for healthy women are minimal.
Another unfortunate implication of the misrepresentation of the WHI studies is that what has been bad publicity for HRT over the last few years has been an opportunity for manufacturers of alternative therapies and dietary supplements to promote their non-HRT options with hard-hitting advertising and unsubstantiated claims of efficacy. Without the need for proper clinical research, information on mode of action, randomised controlled trial data showing superior effects on menopausal symptoms to a placebo, or evidence of safety, they are able to persuade many women to spend large sums of money on useless and possibly even harmful ‘treatments’. In addition, a further lobby is promoting bio-identical hormones as the safe alternative to HRT, again with unsubstantiated claims that the unsuspecting lay woman can not be expected to appreciate. Thus menopausal women have been done a great disservice over the last few years, and countless numbers are suffering and possibly some even dying unnecessarily. They are being denied relief of their hot flushes, night sweats and disturbed sleep, poor memory and concentration, vaginal dryness and dyspareunia, loss of libido and for some the prevention of osteoporosis and delaying of coronary atheroma formation. Hopefully the persistence of the misperceptions about HRT and the menopause will eventually be corrected and the merits and disadvantages of HRT put in to an appropriate perspective, but it takes so much longer to undo a wrong than to damn a right.
David Sturdee, MD, FRCOG
President International Menopause Society
References
- Rossouw JE, Anderson GL, Prentice R et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women. JAMA 2002; 288: 321-33.
- Rossouw JE, Prentice RL, Manson JE et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA 2007; 297: 1465-77.
- Manson JE, Allison MA, Rossouw JE et al. Estrogen therapy and coronary-artery calcification. N Engl J Med 2007; 356: 2591-602.
- Hodis HN, Mack WJ. Postmenopausal hormone therapy in clinical practice. Menopause 2007; 14: 1-14.
Further reading:
Consensus statement from a Workshop on Aging, menopause, cardiovascular disease and HRT organized by Prof Andrea Genazzani and Dr Tommaso Simoncini for the International Menopause Society and with the participation of the task Force on gender of the European Society of Cardiology in February 2009 to be found on the website of IMS: www.imsociety.org and in press in Climacteric 2009; 12: 368-77.
The Editorial
Doctor Eric Sedbon
Dear Colleagues, Fellow Practitioners:
I first want to thank our Italian hosts for inviting me and to congratulate Italy for two world records: 1) Young people in Italy stay at home with their parents longer than anywhere else in the world living at home with your parents IS the most powerful form of contraception!!! 2) Italy also holds the record for the greatest percentage of children born to parents over the age of 40!!
Times change, society changes, technology changes and we , practitioners of assisted reproductive technology (A.R.T.), must face up to new situations and new demands, sometimes atypical demands, and stretch ourselves to the outer limits of tolerance. As an introduction to my talk today, I would like to tell you a little story that happened to me:
A young woman of 38 came to see me recently with her ultrasound showing a proper follicle developing in her left ovary. She asked me, "Doctor, as I have irregular menstruations and according to the ultrasound I had done yesterday, when is my ovulation day?" I looked at the picture and the size of the follicle and I asked "is your husband available?" She answered "But Doctor, I'm not married!""Do you have a companion?", she said, "I don't even have a boyfriend!" "How are you going to manage", I asked.She said, "very easily, I've found a website where men accept to help women like me, there's a long waiting list and it's finally my turn!"
I said: "Aren't you afraid of getting a sexually-transmitted disease?"She said: "But Doctor, there is no sexual intercourse, only a little catheter."I asked: "is it very expensive?" She said: "But Doctor, it's free !!!!!
Then I asked: "But why IS this man prepared to do this?". She answered: "with the approval of his wife (who cannot have children) he still wants to procreate; they want to help people like me and I'm pleased because I don't want the process to be anonymous, I want my child to know who the father IS, to avoid possible future psychological problems."
The gains that women in this twenty-first century (21st) have acquired, including contraception, emancipation, and parity, allow them to have a child when they want and by the method they choose.
Supply and demand have evolved, and the limits of what is acceptable have shifted.
Practitioners must now adapt themselves to uneasy positions, that vacillate between their duty towards their patients and those vis-a-vis society and its laws.
In France, women represent 45% of the actively-employed population and 80% are between the ages of 25 and 49. This figure of 80% is growing --it was only 57% in 1991.
Incidentally, womens' salaries compared to mens' have yet to achieve parity --they are 25% lower!
Women deliberately delay maternity in favour of professional careers. In certain countries such as Poland, women are delaying maternity by as much as 10 years
People in modern industrialized societies live AT a fast pace: Internet, Facebook, cyber sexuality, cellphones, Blackberries, iphones, etc.
Competition at schools and universities, the race for diplomas, and difficulties in the labour market change relationships between men and women.
These factors have important repercussions with respect to womens' sexuality, fertility, and psychological equilibrium, all of which have major impact as well on mens' behaviour.
What is the definition of "a couple" in the year 2009?
Should "the couple" be defined homosexual or heterosexual, married or in free union, and should these relationships be for a lifetime or limited duration?
In the last several decades in France and most other industrialized nations, there has been a drop in the number of marriages, with a corresponding increase in the number of divorces. This has had two consequences: a rise in the number of single people and an increase in newly-formed couples from the previously divorced.
Statistics show that there are about 15 million single people in France, a figure that has doubled in the past 40 years. The figures range from an estimated 18% of the overall population in Europe, with a high of 28% singles in Sweden to a low of 15% in Belgium and The Netherlands.
The consequences of new lifestyles in terms of reproduction are: age delay of the first child, a decrease in the overall birthrate, and an increase in those seeking assisted reproductive technology (A.R.T.).
The average age of a man's first sexual relation in Europe is at 17 1/2, and that of a woman's, 18 1/2.
The average age of mothers in France and in most European countries for the first child has been increasing since 1920, reaching 30 years of age today ,compare that to developing countries where it could be 10 to 15 years lower!
Five centuries ago, Francois 1iere, King of France, married Claude de France in 1514 --she died at 25 years of age after having given birth to 7 children. She gave birth to the first child at the age of 15, exactly half the age of today's average!
Paralleling this phenomenon, there has been a steady dimunition in the number of children born per couple over the last several decades in France and other industrialized countries; that number is approximately 2 children per couple, below the limit for population renewal.
What policymakers in Europe must ponder is that birthrates, for the first time on record, (particularly in southern and eastern Europe), have dropped in some cases below 1.3 --- the figure of 2.1 is widely considered to be the replacement rate,, whith means the average number of births per woman that will maintain a country's current population level. Setting aside eastern Europe, some of the lowest fertility rates in the world are to be found paradoxeically in the family-friendly countries of Italy, Spain and Greece, all currently hovering at around 1.3, according to Francesco Billari, of Bocconi University in Milano.
Other factors influencing fertility are: diet, tobacco smoking or other toxicities, coffee and alcohol consumption, pollution of the environment, and advanced age levels.
The percentage of infertile couples in industrialized nations has reached 20%, and incidentally, male sperm counts have been declining significantly over the past decades.
It's well known that female fertility is linked directly to age and that there's a significant drop at the age 37.
Male aging also has a negative impact on fertility.
When a couple voluntarily decides to seriously delay their first maternity, both parties should be aware of potential fertility failure.
The average age today of women having a first child is 30. The average age of seeking A.R.T. is now 34 1/2. And, the average age of loss of fertility is about 37. There is therefore a very short margin of medical manoevreability, and little has been done to educate the public properly about the problems linking aging and fertility.
On the scientific side, the evolution has been very rapid since the birth of Louise Brown in 1978 --more than 1.5 million IVF babies have been born in the world. There are four major biotechnological revolutions: freezing, ICSI, PGD, stemcells, as well as idealogical, social and ethical revolutions, two major world congresses, and more than one hundred meetings annually dealing with the subject of fertility.
The demand for A.R.T. is increasing every year: More than 50% of the demand is among couples over 35, and fifty percent of those couples are using ICSI.
In France, one couple out of every 7 is interested in exploring A.R.T., and that represents 175,000 consultations a year. A.R.T. is responsible for 2.5% of all children born annually in France.
I.V.F., however, is not the answer to age-related infertility. The success rate of this technique declines, as natural fertility declines after age 37.
A.R.T. in industrialized countries generates the necessity of appropriate legislation. France is now preparing a 3rd series of bio-ethical legislation following those passed in 1994 and 2004. These laws, in addition to others passed since 1789 ("Vive la France!!"), have changed the status of women in French society.
Scientific progress also generates big ethical questions such as: What is the status of THE embryo? To whom belong the reproductive cells? Is embryonic research ethical?
At the beginning of my talk I mentioned that scientific progress and the evolution of society are sources of new demand for A.R.T., and both appear to stretch the limits of tolerance. Must there be "a typically traditional couple"? Must such a couple be heterosexual or homosexual? In January of 2000, the Court of Human Rights sanctioned France for having refused a lesbian couple the right to adopt a child. Should demand for A.R.T. be acceptable for single women as well as for single men, and should surrogacy be permitted? There are further questions about the acceptability of such issues as embryo transfer post-mortems, choice of the sex of the child, and double donors (both egg and sperm).
Should there be an A.R.T. age limit for men and for women (and, if so, should those age limits be different?)
When one partner of a couple dies, what happens to frozen embryos and reproductive cells? What happens to couples who separate or divorce after having engaged in the A.R.T. process? Should there be a minimum of two years of living together, to protect the child being conceived?
Should donations of reproductive cells, or embryos, be controlled, prohibiting free choices in such areas as catalogue listings on the Internet and elsewhere? Should anonymity be preserved? Should there be a ban on "free-trade", for example foreign surrogates? Should post-menopausal women be prevented from using A.R.T. and at what age?
Should A.R.T. be acceptable within the same family, with the goal of preserving filiation?
Is gestation ethically correct by others within the same family or by a 3rd party? What are the risks of the commercialization of womens' bodies, that already has taken place in some countries, with a negative impact on human dignity?
Should a couple have A.R.T. when one of its partners has an incurable disease like HIV or cancer in a terminal phase, or other such grave incurable pathologies?
Should PGD, be less restrictive? Should the selection of embryos, choice of the sex, and conceiving additional children in the hope of saving siblings be regulated?
Should conservation of one's own reproductive cells or reproductive tissue be considered in order to delay maternity? Should the use of stemcells be regulated?
Should A.R.T. be admissable into the economic model resulting in an artificial boost of the number of pension fund subscribers? In both France and Sweden, 2.5% of children are born after A.R.T.
My dear colleagues, what is the reasonable level of society's tolerance and acceptability of these issues? Whatever we thought unreasonable yesterday is not necessarily unreasonable today. What is reasonable by law in one country is NOT in another, which can lead to "procreative tourism".
Fellow practitioners,Society changes. Laws change. The level of demand for A.R.T. is changing. The definition of coupledom has exploded beyond recognition. Values have been modified. Such is today's dynamic environment, and WE medical practitioners, must adapt!!!
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