Martin J Walker: HRT Licensed to Kill and Maim
Chapter 1The Personal and Political
Women of the Menopausal Helpline
Chapter 2Changing Ros
Chapter 3Adverse Circumstances
Chapter 4Limited but Spectacular Victories
Chapter 5A Vanishing History
and Disposable Science I
Chapter 6A Vanishing History
and Disposable Science II
Chapter 7A Vanishing History
and Disposable Science III
Chapter 8A Vanishing History
and Disposable Science IV
Chapter 9The Woman Who Slipped through the Net
Chapter 10Coming off, Getting On and Coping
Chapter 11The Profit, the Whole Profit and Nothing but the Profit
Eugenics and the idea of designer people are still very much at the heart of life science. Equally, the struggle to overcome imperfections in the human body and personality has always been widely perceived as a reputable part of medicine. Whether for good or ill, it remains one of the principal objectives of modern science to re-create, with amendments, the human form. Although progress in these areas is always portrayed as being of consequence to medicine and primarily devoted to the prevention or curing of illness, almost all this science is actually motivated by a search for the holy grail, a process of replicating a human person, all the functions of which can be controlled.
- The proponents of HRT have never proved that there is an oestrogen deficiency, nor have they explained the mechanism by which the therapy of choice effected its miracles. They have taken the improper course of defining a disease from its therapy - Germaine Greer (3)
- Everybody knows that the boat is leaking - Leonard Cohen (4)
For over half a century, drug companies have accumulated great profits by pumping life-changing and life-threatening quantities of hormones into women, who have rarely had any knowledge of just how deeply and insidiously these mainly synthetic substances can affect their physiology, their biology or their consciousness.
While mechanistic medical scientists have proved sceptical about the use of vitamin supplementation, pointing to the fact that all aspects of the process, from consumption to absorption to excretion, have to be considered, allopathic physicians and drug company scientists have rarely voiced similar concerns in relation to hormone supplementation. Thousands of women have died, while others have spent years in illness and misery, after becoming, in the words of the author Barbara Seaman, subjects in ‘the greatest experiment ever performed on women’. (5)
Since the British licensing system came into effect, there have been around 160 hormone replacement products, in a variety of presentations, floated on the British market. Of these, 85 are currently authorised, and the remainder have been withdrawn by their makers for commercial reasons. None of the products has been withdrawn by the licensing authorities for any reason.
Some of these preparations have been manufactured from the urine of pregnant mares, while others have used entirely synthetic hormones. Most of the preparations prescribed to women for effects of the menopause are based upon oestrogen, the main hormone of the female reproductive system, the production of which declines as a woman reaches the change of life.
In questionnaires returned by women who contacted the Menopausal Helpline (6) in the late 1990s, 25 different preparations are reported. These are marketed in the form of pills, implants, creams or patches. Oestrogens and progestogens (steroid hormones with progesterone-like activity) are also present in the contraceptive ‘Pill’, and oestrogen is present in the breast-cancer drug Tamoxifen and some other anti-cancer medications.
Despite the fact that producing companies have, over the years, added to the marketable value of hormone replacement therapies by suggesting – in defiance of findings to the absolute contrary – that they act against heart attack, breast cancer, Alzheimer’s disease, stroke and deep-vein thrombosis, in both Britain and North American brands of HRT are licensed for a relatively narrow band of conditions. First, they are approved for what the US Food and Drug Administration (FDA) entitles ‘moderate to severe vasomotor symptoms of the menopause’, and for conditions related to either hysterectomy or oophorectomy (removal of the womb or ovaries), including, in both cases, vaginal or urethral atrophy and primary ovarian failure. Secondly, until recently, HRT was prescribed for osteoporosis, either in actuality or as a prophylactic.
In reality, however, the prescription net for the treatment is far wider. Many women accept the prescription of HRT simply because their doctors think that they may be reaching menopause and might want to stay ‘young at heart’, or because those doctors guess at the possibility of their patient developing osteoporosis. Other women seek out HRT and doctors who will prescribe it, because they are determined to stay attractive and sexually active for longer than they imagine they might do ‘naturally’. To a lesser extent, in North America, oestrogen products are prescribed for breast and prostate cancers, even though, as detailed below, as early as the 1950s, oestrogen was identified with increased risk of breast cancer.
Throughout the 1990s, in North America, there were six preparations available that were licensed for both ‘symptoms of the menopause’ and osteoporosis. These products were – and are – manufactured by a range of pharmaceutical companies, including Wyeth (formerly Wyeth-Ayerst), Lilly, Solvay, Schering and SmithKline Beecham. In Britain, the implant, Riselle, which is currently prescribed to around 15,000 women, is produced by Organon. Wyeth Pharmaceuticals has led the market in HRT products since the 1940s and, up until the critical findings of a number of studies in the late 1990s, they controlled around 70 per cent of the market.
Both oestrogen and progestogen, when taken as supplements, can cause recognised adverse reactions, which are noted on the packaging or the patient information leaflets given out with treatments, on the data sheets and in compendiums of drugs data. It is now apparently accepted by all the pharmaceutical companies that oestrogens taken over long periods can trigger endometrial cancer, breast cancer and gall bladder disease, heart attacks, strokes, deep-vein thrombosis and pancreatitis. Lower-level imbalances can cause, among many things, breast tenderness, hair loss, fluid retention, weight gain, the sensation of burning skin and irregular bleeding. Progestogen can cause breast tenderness, distension, oedema, abdominal cramps and pre-menstrual-like syndrome, as well as anxiety, irritability, depression and drowsiness. (7)
* * *
Although it had occurred to physicians as early as the 18th century that they could tinker with body chemistry in both males and females, with a view to putting off ageing or aiding sexual potency, it was not until after the Second World War that doctors argued that it was actually in the interest of women to maintain artificially high levels of hormones during or after the menopause. (8)
Oestrogen was first isolated in the 1930s, and was chemically synthesised at the end of that decade. In the 1940s, Wyeth Pharmaceuticals produced what it described as a ‘natural’ oestrogen replacement called Premarin, extracted from (pre)gnant (ma)res’ u(rine). (9)
After the Second World War, especially in North America, other companies began to produce synthetic oestrogen replacement therapy (ERT). Doctors were quick to prescribe ERT to address a perceived connection between cancer and low oestrogen levels. By the late Fifties, synthetic ERT was being prescribed to women as an aid to easy and successful pregnancy, and to help with ‘women’s problems’, on the flimsiest and most flawed of medical evidence.
During the 1960s, sensing a billion-dollar market, pharmaceutical companies developed the argument that the menopause – the time when women cease to be child bearers – was a medical condition. They promoted the attitude that the end of the women’s reproductive cycle actually heralded an end to their experience of sexuality, accompanied by a continuing state of ill health. Oestrogen replacement could, they suggested, change both these circumstances, relieving the adverse effects of menopause and returning women to their younger sexual selves, by topping up hormone levels that declined naturally at menopause or as a result of the surgical removal of the ovaries.
The role of oestrogen in the creation of cancer and other serious conditions has been known for many years. In the 1952 Merck Index, which lists trade-name drugs and all their chemical formulations, the medical use of oestradiol (one of the oestrogens) is shown as a replacement therapy in oestrogen deficiency. However, the book specifically cautions against the use of this therapy by any patient who has a history of breast or genital cancer. Despite this caveat, hormone replacement therapy became one of the first drugs sold in great quantity in a public market created by the pharmaceutical industry.
As with many drug-marketing operations, hormone replacement therapy did appear, on occasion, to have beneficial uses. In those cases of women who had had their ovaries removed at an early age, and who had, therefore, suffered an early menopause, there appeared to be a genuine, if cosmetic, case for artificially introducing hormones. Cosmetic, because the introduction of hormones could never return their bodies to their natural state and because, as soon as they stopped taking the ‘medication’, the menopausal state was destined to return.
In all other cases apart from hysterectomy and oophorectomy, however, the marketing of hormone replacement therapy was widely based upon the apparent desires of male physicians to experiment on women, and, ultimately, to control their reproductive and ageing processes.
From the 1940s to the 1960s, millions of women, particularly in North America, were prescribed diethylstilbestrol (DES), one of the first synthesised oestrogens, formulated in 1938. Although it was originally prescribed to prevent miscarriage and premature birth, before long it was being touted as a ‘miracle cure’ for any female reproductive problem. In North America, it was handed out to women with no known risk of miscarriage in the misguided belief that it would produce bigger, healthier and stronger babies. DES was thought to be effective against acne and prostate cancer, it was given as a morning-after contraceptive, and was even used to inhibit the growth of adolescent girls who feared being too tall.
In the 1960s, however, it became apparent that the use of oestrogen replacement therapy by menopausal women increased their chance of endometrial cancer (the endometrium is the lining membrane of the womb). One study found that in women who had used the treatment for seven years or more, there was a fourteenfold increase in the incidence of this disease. (10) Research in the 1990s would further show that women who had taken DES had a 35 per cent increased risk of breast cancer. It has been suggested that approximately 60,000 North American women will die of this cancer as a consequence of having taken the drug.
DES mothers, duped and well meaning, also bequeathed to their children a dangerous inheritance. In 1971, the New England Journal of Medicine documented a rare form of vaginal cancer in adolescent daughters of women who had taken DES when pregnant. Thousands of ‘DES sons’ and ‘DES daughters’ were born with malformations of the genitals. Studies from the 1930s and 1940s, which had revealed that DES caused cancer in laboratory rats, were ignored by industry and regulators alike. The most ardent proponents of vivisection can apparently take or leave the findings that it throws up if it suits them. (11)
As a bitter irony, it was found that, far from promoting bonny, bouncing, full-term babies, DES actually increased the risk of miscarriage. After a series of costly court cases, it was taken off the market, but the concerns continue. Researchers are now watching DES grandchildren to see if disease and abnormalities pass on to the third generation.
Medical researchers should have learned something from the DES tragedy, yet the desire to manipulate women’s hormones continues unabated, even as the evidence stacks up of very serious health risks connected with HRT in successive formulations.
Following the finding of links between excessive oestrogen and both endometrial cancer and hyperplasia (a pre-cancerous abnormal overgrowth of the endometrium, causing irregular and excessive bleeding), the drug companies introduced a conjugated treatment in which progestogens were taken together with the oestrogen. There was also a drive by some doctors and some pharmaceutical companies to get women to have their uteruses removed so that they could continue taking ‘safe’ oestrogen. (1 2)
In 1977, McDonald, Annegers and O’Fallon et al, reported the growing incidence of endometrial cancer in relation to exogenous oestrogen. Their paper cited long-term therapy with oestrogens for menopausal symptoms as the usual history in such cases. (13)
Throughout the 1980s and 1990s, a series of studies showed that synthetic human hormones, introduced into women’s bodies as contraceptives or as hormone replacement therapies, even as anti-cancer drugs, had the capability to produce not just cancer, but thrombosis and cardiovascular problems. (14)
A British study published in the British Journal of Obstetrics and Gynaecology in 1987, which followed 4,544 women for an average of five-and-a-half years, showed that breast cancer risk was one-and-a-half times greater in HRT users, while the risk of endometrial cancer nearly trebled. (15)
A Swedish study published two years later, in 1989, which followed 23,000 women over time, found that HRT doubled a woman’s chances of getting breast cancer.
In 1995, the New England Journal of Medicine reported a study involving 121,700 women, which found that those taking HRT for more than five years during menopause increased their chances of developing breast cancer by 30 to 40 per cent. In women between the ages of 60 and 64, there was a 70 per cent increase in risk after five years.
In 1996 came the first reports that HRT obscured breast cancer findings in mammography tests for women by making breast tissue denser. A study looking at 9,000 postmenopausal US women with breast cancer found that those on HRT were 71 per cent more likely to have a false negative result.
Not only was hormone therapy predisposing them to cancer, but it was increasing their risk of death by militating against early detection.
In October of that year, newspapers reported on three studies from Britain and North America, published in The Lancet, which revealed an increase of between two and four times in the risk of deep-vein thrombosis in women taking HRT. (16)
In 1997, Beresford, Weiss and Voigt et al reported in The Lancet on the risk of endometrial cancer in relation to use of oestrogen combined with cyclic progestogen therapy in postmenopausal women. (17)
In 1997, another paper published in The Lancet showed, yet again, increased cases of breast cancer. In 1998, the Journal of the American Medical Association (18) reported the results of the Heart and Estrogen/Progesterone Replacement Study (HERS), involving 2,763 postmenopausal women with a mean age of 66.7 years, with a history of coronary disease. The study showed conclusively that HRT conferred no overall benefit to people with heart conditions: those on HRT and a control group on a placebo had the same incidence outcome. In the first year of HRT use, however, there was a higher, but non-significant, incidence of heart attack.
Despite this accumulating scientific evidence of increasing health problems for women, and considerable areas of ignorance about introducing synthetic and ‘other animal’ hormones into the human body, between 1960 and the year 2000, the drug companies developed and expanded a fabulous, mythical identity for HRT. With next to no supporting evidence, the manufacturers, particularly Wyeth, argued that HRT not only smoothed the passage through the menopause, but was also a defence against osteoporosis, stroke, Alzheimer’s disease, (19) coronary heart disease and deep-vein thrombosis. The companies never went as far as suggesting that the treatment was a cure for dying, but they came as near as damn to it.
Despite the fact that hormone replacement was not licensed for anything other than menopausal difficulties, and despite the fact that it was contraindicated in a wide range of cases, HRT was prescribed ‘at the drop of a hat’, particularly to ‘cure’ osteoporosis. In December 2000, a US Government scientific advisory panel recommended that synthetic oestrogen used in HRT be added to the list of cancer-causing agents.
In July 2002, new findings from a major North American study, which compared a placebo group with women taking Prempro, a combination of oestrogen and synthetic progestogen, confirmed the findings that those using the therapy stood a greater chance of developing breast cancer, with a greater probability that the tumours would not be picked up in the early stages by mammograms. The increased breast cancer risk for the HRT group treatment was assessed to be 26 per cent, and there was also a higher incidence of strokes and blood clots among users.
The study, which followed 16,608 women aged 50 to 79, who had not undergone a hysterectomy, began in 1997 and, by 1999, the alarm bells should already have been ringing, when an independent data and safety monitoring board (DSMB) employed on it observed small but consistent cardiovascular adverse effects. However, none of these results crossed the clinical boundaries set by the study, so it was not discontinued. In the years 2000 and 2001, participants were belatedly given information about increases in heart attacks, stroke, pulmonary embolisms and deep-vein thrombosis. Still, the study continued, because even then no clinical boundaries had been crossed. Not until May 2002, did the study find that adverse events of breast cancer crossed the designated boundary, and on the basis of these data, the oestrogen-plus-progestogen component of the trial was stopped.
By the time it was wound up, this strand of the study had recorded in the HRT group a 41 per cent increase in strokes, 29 per cent increase in heart attacks, 100 per cent increase in blood clots, 22 per cent increase in total cardiovascular disease, and a 26 per cent increase in breast cancer. Claude Lenfant, Director of the NHLBI, said: ‘The cardiovascular and cancer risks of oestrogen plus progestogen outweigh any benefits – and a 26 per cent increase in breast cancer risk is too high a price to pay, even if there were a heart benefit.’
In December 2002, the US National Institute of Environmental Health Sciences labelled steroidal oestrogen a ‘known carcinogen’. In August 2003, one strand of the British ‘Million Women’ study was called off because results published in The Lancet showed that HRT caused breast cancer. Professor Valerie Beral, Director of the Cancer UK Epidemiology Unit, said, ‘We estimate that over the past decade, use of HRT by UK women aged between 50 and 64 has resulted in an extra 20,000 breast cancers, oestrogen-progestogen combination therapy accounting for 15,000 of these.’ (20) A North American research paper estimated that cases of breast cancer in the US caused by HRT, could be as high as 120,000. (21)
In February 2004, two Swedish HRT trials were stopped. One published in The Lancet found an increased risk of the recurrence of breast cancer in women who had previously recovered from the disease and who were taking HRT for ‘acute menopausal symptoms’.
In March 2004, a second strand of the Women’s Health Initiative (WHI) study, which had been looking at the effect of oestrogen replacement in relation to heart disease, was also called off. The study had found that the use of oestrogen supplementation increased the risk of strokes, while showing no signs of averting heart attacks, as its manufacturers and prescribing physicians were still obdurately claiming that it could. (The incidence of coronary heart disease in women increases after the menopause, so, runs the simplistic argument, HRT must have a cardio-protective effect.)
One thing that could be seen with certainty following the publications of these critical studies was that, in the main, doctors loyal to pharmaceutical companies used science to defend themselves only when it suited them. When science threatened the financial base of the pharmaceutical industry, they suddenly ceased to believe, and put everything down to personal choice.
Over the period that the critical studies were published, all the research scientists, Department of Health officials, FDA staff, drug companies’ representatives and general practitioners played the ‘risk game’. They washed their hands of responsibility and suggested that it was patients who determined what happened, who ‘made up their own minds’, once they had been told all the facts by their physician.
Some medical experts did make plain statements about the catastrophe that science had begun to structure. In Germany, Professor Bruno Muller-Oerlinghausen, chairman of the German Commission on the Safety of Medicines, compared HRT to thalidomide, saying that it had been a ‘national and international tragedy’. (22)
By March 2004, the month that the adverse findings of the WHI were made known, even World Health Organisation (WHO) officials were making clear statements, distancing themselves from the treatment. On March 5 at a conference in Sydney, Australia, the co-ordinator of the WHO said that hormone replacement therapy was ‘not good for women’. Alexandre Kalache said that science sometimes makes big mistakes and it had done so with HRT. Professor Jay Olshansky, a Public Health Professor at the University of Illinois, said, ‘Scientists now suggest that in most cases HRT should not be used. It’s harmful for some and of no use to others.’
Despite it having been dispensed in Britain since the 1970s, little information about the minor or the major dangers of HRT was picked up over the past 30 years by the regulatory agencies. Had doctors, governments and regulators been paying attention over three decades, they would have seen that hormone replacement therapy was producing serious adverse reactions in many women.
Perhaps Department of Health officials did know about the adverse reactions women had been suffering, and perhaps they too had been playing the risk game. After all, as buyers and monopoly suppliers of huge quantities of drugs for distribution throughout the health service, their contracts and other business dealings with drug companies, involving millions of pounds, might have been, on balance, more important than the quality of life of a ‘small’ number of women.
By the end of the first quarter of 2004, it was clear that the tide was beginning to turn, and that HRT would eventually be seen as a scientific and medical mistake. For the moment, the drug companies, the regulatory agencies, and, in Britain, the government, tried to slip away as quietly as possible from the scene of the crime.
But even at this late stage, the experts and the organisations supported by the drug companies, were trying to find a small patch of safe ground on which to fight their last rearguard action. This patch turned out to be osteoporosis.
In October 2004, the Women’s Health Initiative published its final results. On HRT, the study concluded that women who had taken the combination hormone therapy had doubled the risk of developing blood clots (venous thrombosis). (23) The study found that conjugated equine oestrogen (from pregnant mares’ urine) increased rates of venous thrombosis.
Even when the full truth is out about the number of premature deaths caused by different forms of HRT, questions will remain to be answered. These questions go to the very heart of the relationship between pharmaceutical companies and physicians, the prescription of pharmaceutical medicines in a socialised health care system, and the nature of science and its links with medicine.
When the results of the aborted British ‘Million Women’ study were published in 2003, the chief of breast cancer medicine at Memorial Sloan-Kettering Cancer Center in New York, Dr Clifford Hudis, made a simple statement, which raised what must be considered the important question about HRT, science, medicine and health: ‘The whole health benefit story for hormones has really unravelled.’
Hudis also put the adverse reaction of breast cancer into context, posing the question: ‘This will give women something to think about. Do you want to take an intervention like oestrogen plus progestin that will reduce hot flashes (flushes) 90 per cent, probably, at the cost of having a 1 in 25 chance of having this abnormal mammogram, which might be more significant? I think a lot of women with modest symptoms will now say, “wait a minute.”’
Despite the fact that hormone replacement therapy in various forms has killed, maimed and made thousands of women ill over the past half century, the latest revelations about the treatment have seemingly raised no issues regarding the criminality of the companies concerned. It seems that quite different standards are used in judging the criminality of drug companies from those used in judging, say, toy companies which produce a product which is a danger to children.
What is more, once the scientific dust had settled and many women had voted against HRT with their feet, the official view appeared to be that Wyeth, the drug company most significantly involved, had lost half its market and that this, in itself, was sufficient punishment. (24) Even more disturbing, the future ‘rump’ market for HRT now appears to be secure because, as Victoria Kusiak, Wyeth vice-president, said in February 2004, the average user of HRT is now a 51-year-old woman who takes the hormones for less than two years. On hearing this, well informed women might have wondered why it had taken half a century and mounting deaths to return to the protocols laid down for the original prescription of oestrogen replacement therapy.
Even better-informed people, including physicians, should also be asking: ‘What is the point of prescribing HRT to ameliorate the symptoms of the menopause, if when women stop taking it their menopause begins all over again, even more severely?’ And, ‘How can we continue to use HRT as a prophylactic against osteoporosis when its use over long periods has consistently been shown to introduce high risks to women?’
Despite apparent acceptance of the serious adverse effects of HRT, the drug companies, depending on the short memory span of the media, began almost immediately to rebuild their markets. By 2006 there were a growing number of studies which began to advocate extensive use of HRT.
* * *
Now in her early sixties, Maggie Tuttle was born in the English Midlands. She had an interesting younger life as a popular singer and social campaigner. In 1979, when she was 37, after losing a baby and suffering irregular periods, she was prescribed hormone replacement therapy by her general practitioner. From the first time she took HRT, although her periods stabilised, Maggie felt unwell, with a confusion of different feelings and physical symptoms.
For 15 years, Maggie attended a large number of doctors, who all told her that her newly experienced symptoms were due not to HRT but to a variety of new illnesses. Sure in her own mind that her symptoms were actually adverse reactions to HRT, and that she was the victim of iatrogenic illness – illness created by professional physicians – Maggie changed her prescriptions many times and experimented with various alternative treatments. Nothing, however, stopped the terrible pains in her back and shoulders, hot and cold fevers, sweating or the extreme fatigue that had descended on her. Perhaps worst of all were the times when she literally lost her mind, suffering bouts of unconsciousness while going about her everyday life.
In 1995, after a period on a new prescription, which led to her hair falling out, Maggie did the only thing that she had so far failed to do: she stopped taking HRT. Stopping was not easy and, fearing the consequences, she put an advertisement in a local newspaper, asking if anyone had any advice, either about HRT or alternatives to it. Three months after she stopped taking hormones, most of Maggie’s symptoms had gone and her hair had begun to grow back.
The response to her newspaper advertisement, however, did not allow her to put her experiences behind her. Within weeks of the ad appearing, she was besieged by mail, phone calls, even personal callers, all wanting to report to her either their adverse reactions to hormone replacement therapy or the death or serious illness of a relative, which they were sure had been caused by the therapy.
In late 1995, as a response to these communications, Maggie set up the Menopausal Helpline (MHL) from her flat atop Muswell Hill in North London. From that point onwards, for the next five years, she gave her life to the cause. She read and researched the subject and became increasingly angry about the effects of the therapy reported to her. She pitted herself fearlessly against the drug companies, the medical establishment and their various agents.
Initially, the media appeared to aid Maggie in her campaign and she gave a number of newspaper interviews and appeared on television. In one of those rare examples of an academic who is not afraid to back a popularist, anecdotally-based campaign, Klim McPherson, Professor of Public Health and Epidemiology at the London School of Hygiene, in an article in The Sunday Telegraph, was happy to give the following comment in support of the Menopausal Helpline: ‘It’s a common notion amongst enthusiastic gynaecologists that the menopause is God’s mistake and that their job is to correct it. They like doing hysterectomies and they like HRT. They genuinely believe they are doing women a good turn. But the downside has not been talked about.’
Over the next five years, however, the going got rougher. The MHL was carefully pushed out of the limelight and ‘more balanced’ media reporting replaced Maggie’s sometimes raucous and, it was said, ‘anecdotal’ voice.
When Maggie wound up the Menopausal Helpline in 2003, despite having helped thousands of women, despite television and radio interviews and continuing exposure in newspapers and magazines, and despite escalating scientific reports of the detrimental consequences of HRT, she felt bitter because the voice of ‘the women’ she had represented had still not been properly heard.
Maggie Tuttle was used to campaigning, and over the five years of the existence of the MHL, she managed to present a good public record of the damage that HRT was doing to women. However, even in an ‘open’ society with a liberal media, especially in the field of medicine, it is difficult to push a patients’ campaign to the fore.
The public discourse around health has become highly specialised and dependent almost entirely upon a professed ‘objective’ knowledge of biology and science. The representation of vested interests, such as that of the drug companies, infiltrates every aspect of public information, despite almost always being anecdotal, well spun and often untruthful. The world of professional medicine and the machinery of its exploitation are perhaps the most secret and the most corrupted by power and profit outside the industries of oil, chemicals and politics.
Maggie Tuttle’s battle to publicise the adverse effects of HRT turned very quickly into one that highlighted all the principal characteristics of the conflict between the medical state and the individual, between the pharmaceutical corporation and the ‘consumer’, disabled as a consumer by medical professionals, and between the laity and the unholy alliance of professional physicians and science.
This book, although primarily about hormone replacement therapy, is not only about this therapy. It pursues social and political arguments intended to add to the debate about the power of the State and corporations, and the powerlessness of the consumer in the field of medicine.
Besides asking how it could be possible for a therapy that adversely affects a large number of women to retain its place in contemporary medicine, the book also asks how patients can defend themselves against the growing iatrogenic assault mounted by the drug companies and allopathic medicine.
3 Greer G. The Change: Women, ageing and the menopause. London: Hamish Hamilton; 1991.
4 ‘Everybody knows’, written by Leonard Cohen and Sharon Robinson, sung by Leonard Cohen.
5 Seaman B. The Greatest Experiment Ever Performed On Women: Exploding the estrogen myth. New York: Hyperion; 2003.
6 See Chapter 3, Adverse Circumstances.
7 Most of these adverse reactions are noted with supporting studies in Effectiveness and costs of osteoporosis screening and hormone replacement therapy. Vol. II: Evidence On Benefits, Risks, and Costs. Washington, DC: OTA; 1995. Other, later studies support those which are not found in this publication. And the data sheet which accompanies HRT has a long list of recognised adverse reactions, although nothing is said about their frequency.
8 Ernest Henry Starling introduced the term ‘hormone’ in his Croonian lectures to the Royal College of Physicians in June 1905. Previously, Claude Bernard (1813-78) and Charles Edouard Brown-Sequard (1817-94) had introduced the idea of internal secretions, but neither had thought of them as specific chemical messengers.
9 Many women using Premarin do not know that it is produced directly from pregnant mares’ urine. This is a particularly disgusting form of animal exploitation, depending as it does on getting mares pregnant before chaining them in stables to harvest their urine during that pregnancy. In 1995, the Today newspaper exposed the woeful state in which mares whose urine was used to make HRT were kept. The newspaper described conditions on Canadian farms as ‘factory farming at its worst’. Wyeth- Ayerst, manufacturers of Premarin and Prempak- C, commented that there existed codes of conduct for farms. At that time, Wyeth-Ayerst, a subsidiary of American Home Products, farmed pregnant mares’ urine from 485 farms, in Canada and North Dakota in the USA (Today, 16 January 1995).
10 Ziel HK, Finkle WD. Increased risk of endometrial carcinoma among users of conjugated estrogens. N Engl J Med, 1975; 293:1167-70.
11 See Hormone Experimentation and the Second World War for more of the DES story.
12 Robbins J. Reclaiming Our Health: Exploding the medical myth and embracing the source of true healing. Tiburon, CA: H J Kramer; 1996.
13 McDonald TW, Annegers JF, O'Fallon WM, Dockerty MB, Malkasian Jr GD, and Kurland LT. Exogenous estrogen and endometrial carcinoma: case-control and incidence study. Am J Obstet Gynecol 1977;127 (6): 572-80.
14 Anyone wanting to review these studies can begin by drawing on the six studies from the 1990s cited in Appendix VI, as well as those cited in the chapter.
15 Hunt K, Vessey M, McPherson K, Coleman M. Long-term surveillance of mortality and cancer incidence in women receiving hormone replacement therapy. Br J Obstet Gynaecol 1987;94:620-35.
16 The Lancet., October 1996.
17 Beresford SA, Weiss NS, Voigt LF, McKnight B. Risk of endometrial cancer in relation to use of oestrogen combined with cyclic progestagen therapy in postmenopausal women. The Lancet 1997;349:458-61.
18 Journal of the American Medical Association (1998; 280-605).
19 In November 1995, Californian research workers reported that the incidence of Alzheimer’s fell in relation to the amount of HRT taken. The announcement of the results, from a study conducted between 1981 and 1982 of deaths in a retirement village, immediately prompted British clinical researchers, who had paid no attention at all to previous studies which had claimed damaging effects of HRT, to do similar studies.
20 Beral V; Million Women Study Collaborators. Breast cancer and hormone-replacement therapy in the Million Women Study. The Lancet 2003;362:419-27.
21 Null G, Dean C, Feldman M, Rasio D, Smith D. Death by medicine. Life Extension Magazine, March 2004.
22 Thalidomide, a drug for depression developed in West Germany and licensed in the mid-Sixties, led to the birth of between eight and ten thousand cases of phocomelia: children born with deformed limbs or no limbs at all. This disaster precipitated Europe and US changes in drug monitoring and regulating systems. In Britain, the 1968 Medicines Act resulted in the setting up of the Medicines Control Agency and the four committees instigated to oversee the licensing of new drugs. A few years after the Act following a focused academic campaign, rules were put in place, which compelled members of these four committees to declare their interests in pharmaceutical companies and products.
23 Cushman M, Kuller LH, Prentice R, Rodabough RJ, Psaty BM, Stafford RS, Sidney S, Rosendaal FR; Women’s Health Initiative Investigators. Estrogen plus progestin and risk of venous thrombosis. JAMA, 2004;292:1573-80.
24 This is a standard free market answer to this kind of problem: The simplistic equation is that if a company product proves to be too great a risk to consumers, then they will cease to buy it and the producing company will make a loss. Unfortunately, this equation is based on conditions of perfect information, something which the drug companies have manifestly failed to provide over half a century.