Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
I would be wary of testosterone patches for women for what ever reason
- Aasa H. Reidak (26 November 2004)
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Breast cancer risk with unopposed testosterone
- Ray M. Schilling, M.D. (26 November 2004)
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My Personal Testimony - The Efficacy Of Topically Applied Low Dose Testosterone As An Essential Part Of HRT For Menopausal Women
- Marcia L Sudlow (5 December 2004)
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Testosterone HRT is dangerous
- Ellen C G Grant (6 December 2004)
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Dangers of testosterone treatment
- Finn Edler von Eyben (8 December 2004)
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Testosterone Therapy for women, another perspective.
- NIcholas J O'Hara Smith (11 December 2004)
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The Other Side: Failure in Fair Balance Reporting
- Stanley E Althof, Lorraine Dennerstein, Anita Clayton, Irwin Goldstein, Lesley Marson, Alan Altman, Edgardo Becher, Lori Brotto, Sheryl Kingsberg, Annamaria Giraldi, Patricia Schreiner-Engel, Ridwan Shabsigh, Yoram Vardi, Kim Wallen (1 January 2005)
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Aasa H. Reidak, Elementary teacher Toronto, Ontario M5B 2H9
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I am not a doctor but common sense is telling me that adhering testosterone patches to females of our species is not a good idea, whatever the sexual promises may have been. Dr. Boyd Haley spoke of children who had been diagnosed with autism, not too long ago, whose mothers had had an overabundance of testosterone in their amniotic fluid. It seems to me that a lot more research has to happen in this area before any pharmaceutical company can deem it all right to promote testosterone patches for women of child-bearing age. Aasa Competing interests: None declared |
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Ray M. Schilling, M.D., Medical Advisor workers' Compensation of B.C./ Kelowna/Canada
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I noticed that the testosterone patch is being promoted for a lack of female sex drive. I am concerned about unopposed testosterone as we just recently learnt that unopposed estrogen in menopausal women can cause serious health problems like breast cancer, heart attacks and strokes. There is a 1997 publication (Am J Epidemiol. 1997 Jun 1;145(11):1030-8.) that showed a 2.7-fold risk of breast cancer development in the highest testosterone level group of postmenopausal women. Nature has a peculiar way of giving us the right amount of hormone mixes in both males and females. Why not address the real issues and use nature's ways to solve the problem. If the person is overweight or obese, the sex hormone binding globulin likely is interfering with the free testosterone level. Insulin resistance and the metablic syndrome are likely also interfering with normal hormone function. Instead of introducing more hormones into this precariously balanced hormone system it makes more sense to increase exercise and fitness, decrease excessive calorie intake and weight by balancing food intake(less fat, less refined carbohydrates and the proper amount of protein). This will re-establish a normal hormone balance on its own and in many cases allow the sex drive to reappear on its own(more free testosterone available again). I would like to see thorough trials that test the effects and side-effects and that report the results in an unbiased evidence-based manner (reporting absolute risks rather than relative risks)prior to the release of the patch. Ray Schilling, M.D., Kelowna/BC/Canada Competing interests: No competeing interests, but author of www.nethealthbook.com/ and www.askdrray.com/ |
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Marcia L Sudlow, researcher 1870 Scottsville Rd Danby, VT 05739
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With all due respect it seems clear that the FDA's reluctance to approve the Intrinsa patch is an effort to diffuse the backlash caused by the vioxx scandal, and it is strangely coincidental that a female health product has been chosen to take the fall. If this patch dispensed a viagra-like remedy for men it would have been approved yesterday, but since this patch is designed for women apparently it is acceptable to deny approval tomorrow. I can tell you first-hand that the benefits of topically administered low dose testosterone are nothing short of dramatic. I have been on a low dose testosterone gel for two years, together with non-oral formulations of estrogen and progesterone, with excellent results. This androgen-inclusive topical hormone replacement therapy (HRT) has reversed vaginal dryness and atrophy, restored sexual desire and vanquished the backaches and migraines. I've had two normal pap smears and two normal mammograms while on non-oral low dose estrogen, progesterone & and testosterone. I am 54 years old and I expect that this regimen will be the cornerstone to my future well-being. I can testify that it has improved the quality of my life 180%. For the previous decade I followed the gynecological community's "recommended HRT protocol" of oral estrogen and progesterone, and during those 10 years my libido crashed and hit rock bottom and my physical wellbeing plummeted. Taking hormones by mouth is ineffective since most of the drugs do not survive the digestion process. They must therefore be consumed in 3 or 4 times the amount needed, which increases any health risk by that same percentage. Taking only two of the 3 sex hormones is also bad medicine. Androgens, estrogens and progesterones act in concert in both men and women. Replenishing just one or two of these hormones is guaranteed to cause imbalance. (Especially since estrogen replacement in menopausal women suppresses whatever small amount of testosterone she was formerly producing.) Research indicates that adding androgens may well remove the small health risk that the flawed WHI study uncovered and that the media has blown out of all proportion. The hype coming from the press on the subject of Hormone Replacement Therapy in menopausal women has been nothing short of irresponsible. A few years ago, they blew the risks uncovered by the flawed Women's Health Initiative (WHI) HRT study out of all proportion, causing thousands of women to stop their therapy... with adverse effects. Now the press is insinuating (or should I say fictionalizing) a risk of heart attack inherent in testosterone therapy in women. Their evidence - the flawed WHI study result. The WHI study did not have anything to do with testosterone therapy!!!! The test subjects were NOT given testosterone in any form. The press might as well be citing dangers uncovered in a study about aspirin or antidepressants as evidence of "risk" associated with this testosterone patch! The slight risk of heart attack in one half of the WHI test subjects (those taking estrogen and progesterone) is believed to have been due to coronary risk factors that developed before the start of the trial. All the test subjects were in their 60s. In order to provide protection against heart disease, HRT must be begun at the onset of menopause. The cancer risk factor of progesterone was greatly increased by the fact it was given orally instead of topically, as as such had to be administered in an excessive amount. The biggest irony is that recent evidence suggests that if testosterone had also been given to the women along with progesterone and estrogen, the risk factors could likely have been reversed. (Source 1: "Testosterone May Counter HRT's Cancer Effects" Dr. Carolyn A. Bondy, National Institutes of Health in Bethesda, Maryland Dr. Robert A. Jones, Memorial Medical Center in North Adelaide, South Australia Published: Menopause, September/October 2004 Source 2: Studies demonstrate that low testosterone increases risk of heart disease Published: Diabetes Care, June 6, 2003. Michiaki Fukui, MD, department of endocrinology and hematology, Osaka General Hospital of West Japan Railway Co., Osaka, Japan. Karen Herbst, MD, PhD, assistant professor of medicine, Division of Endocrinology, Metabolism and Molecular Medicine, Charles R. Drew University of Medicine and Science, Los Angeles.) The media in this country is apparently on a mission to disseminate untruthful information about everything from health factors to politics, and I'm frankly sick of it! I don't watch US network television news at all anymore - I watch CBC out of Canada - they were the ones who ran a documentary about the benefits of testosterone supplementation for women a couple years ago which is where I first heard of it. The truth is, limited research has been done on testosterone in women, and more needs to be done. (IMO the research community should be held accountable for WHY that research has NOT been done.) However the findings to the limited research have been promising and point to health BENEFITS (not risks) for women. Now it seems some "consumer advocate groups" (probably motivated by sensationalized media reports) are lobbying against product approval. I don't know who these "consumer advocates" believe they are lobbying for, but I can tell you they do not speak for THIS consumer. Please do not jump on the media hype bandwagon and deny millions of menopausal women access to this breakthrough improvement. APPROVE the Intrinsa (Procter & Gamble Co.) testosterone female patch! Competing interests: None declared |
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Ellen C G Grant, physician and medical gynaecologist 20 Coombe Ridings, Kingston-upon-Thames, KT2 7JU, UK
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A 54 year-old woman who has taken HRT for being “menopausal” for the last 12 years is expecting to take a cocktail of testosterone, oestrogen and progesterone for the rest of her life. No one has a menopause that lasts for decades but taking hormones causes addiction and withdrawal symptoms when the hormones are stopped.1 A quick search of Pub Med under “testosterone and cancer” comes up with over 8000 references. This researcher is brave but misinformed. She confuses her need to suppress HRT withdrawal symptoms with the life saving benefits of not taking hormones at all. The Million Women Study found HRT current use doubled the risk of breast cancer and mortality, in a short-term follow-up, was increased by 22%.2 Although the risk increased with length of use, it was also significantly increased with very short use of less than one year. There were significant increased risks of breast cancer with transdermal or implanted HRT. The real increases are likely to be much greater as many never users of HRT already had higher risks from past use of contraceptive hormones.3,4 Removal of ovaries, and therefore endogenous hormone production, has been the main-stay of premenopausal breast cancer treatment for nearly 200 years. The world’s main randomised controlled double-blind HRT studies have been stopped early because of the unacceptable increases in cancers, thrombosis, strokes, heart attacks and even dementia, with no improvement in the quality of life. At last the nonsense claims of observational studies, which bore no relation to my own and others research results in the 1960s and 1970s, have been exposed. It is absurd that hormones, too dangerous to use in controlled trials, are still being widely and unnecessarily promoted for both men and women. The idea that daily applications of three sex hormones can replicate the complicated fluctuations during ovulatory cycles is risible. Healthy women living well into their 90s have spent most of their lives without extra sex hormone stimulation. Having to cope with hormone changes premenstrually, in the post partum and at the menopause is biologically stressful and a healthy menopause is a welcome relief. Health at any age depends on having a normal nutritional status. Normal range zinc, copper, magnesium and superoxide dismutase activities are crucially important and taking steroid sex hormones is the quickest way to cause mineral imbalances and deficiencies.3 It is true that warning symptoms may be suppressed by hormone dose manipulations by underlying biochemical changes inevitably occur if the doses have any effect at all. Progesterone dominant combined HRT taken over 10 years caused the researcher’s well being to plummet, leaving her with vaginal dryness and atrophy, loss of libido, migraine and backaches. Withdrawal symptoms caused by stopping hormones can be much more severe and long-lasting than the occasional adverse reactions to foods and chemicals at a normal menopause around age 52. Premature menopauses are endemic because over 90% of women in “developed” countries have taken sex hormones as contraceptives, up to half have hysterectomies, many smoke, drink alcohol, and nutritional deficiencies wide-spread. The answer is not to take yet more hormones, applied in different ways or in different doses, but to research the real “facts of life”. Testosterone and progesterone are even more immunosuppressive than oestrogen, and the result is increases in hormone-dependent cancers and other cancers, vascular and mental diseases and immune disorders. Triple hormone use has a synergistic effect on cancers and vascular diseases and progestogens with androgenic activity caused the most abnormal vascular development in my studies of over 60 formulations.5 1 White M, Grant ECG. Addiction to oestrogen and progesterone. J Nutr Environ Med 1998; 8 :117-120. 2 Million Women Study Collaborators. Breast cancer and hormone- replacement therapy in the Million Women Study. Lancet 2003:362: 419-427. 3 Grant ECG. Increases in breast cancer incidence http://bmj.com/cgi/eletters/328/7445/921#55298, 1 Apr 2004 4 Grant ECG. Re: Rapid Responses; Authors' reply. http://bmj.com/cgi/eletters/328/7445/921#55843, 6 Apr 2004 5 Grant ECG. The pill, hormone replacement therapy, vascular and mood over-reactivity, and mineral imbalance .J Nutr Environ Med 1998; 8:105- 116. Competing interests: None declared |
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Finn Edler von Eyben, physician Center of tobacco control research
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Reading many reviews on testosterone treatment, it seems as if long- term effects of testosterone treatment are laerrgely unknown. Men live six years shorter than women, and we know that estrogen treatment of postmennopausal women did not provide coronary protection and increased life span. We know that men have an android distribution of fat compared with women. This fat distribution may conytribute to many of the aspects of the metabolic syndrome. Women with polycystic ovary syndrome have increased testosterone and increased intraabdominaal fat. We saw previously impaired male health from using estrogens as protection for coronary heart disease. Wide use of androgens for men and women might give a similarly impaired health. Any approval by authorities should await well -documented research on the long-term effects by researchers fully independent of pharmaceutical interests. Competing interests: None declared |
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NIcholas J O'Hara Smith, Network Manager and Lay Advocate Hayes and Sunbury, Middx TW16 7TW
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Seventeen years ago, I lost both testicles because of Cancer. Since then, I have had no choice but to use Testosterone therapy in order to maintain some semblance of good health. Things have improved latterly. I now help Hypogonadal people sort out their health problems. Therapies, and the science behind them, has changed radically since 1988. The importance of Testosterone balance in the overall endocrine function is becoming more apparent, as research scientists begin to understand and publish in increasing numbers. The American Association of Clinical Endocrinologists make much of this in their 2002 Hypogonadism guidelines at http://www.aace.com/clin/guidelines/hypogonadism.pdf. It is a fact that most men suffering from Testosterone Deficiency can be aided better, by treating other factors such as changes in lifestyle, SHBG, Insulin Deficiency and Pituitary malfunction. However, for a man with Testicular malfunction, there is no choice. Without Testosterone replacement, his endocrine system's balance will be affected and late-onset ill health will result. For women who have had to endure Ovarian malfunction, the story is the same. The major source of Testosterone supply for the body is no longer capable of producing. Tinkering to get SHBG low, when Testosterone is already low, might expose them to ill health, as it does for males. Similarly no amount of excercise will restore production and visceral fat will continue to be a problem, as Testosterone is responsible for lean body mass. Some women do not have Post Menopausal testosterone Deficiency, therefore should not receive a Testosterone patch. In order to maintain endocrine health, the lost Testosterone should be replaced with correct dosage. This should apply to women of any age. To ignore it consigns the patient to a miserable existence. Historically, therapies have been prone to overdose, thus causing both male and females to suffer adverse reaction. However, for men, this changed radically when tolerable daily preparations were introduced in the recent past. It appears Intrinsa's goal is to provide therapeutic daily Testosterone replacement for women who need it. Market analysis in the USA indicates 4 million women in need. By extrapolation, the UK may have 1 million women in need. Some are finding me on the Internet, only for me to inform them there is no suitable therapy available. Surely this hole in our health service needs filling if a closely dosed, monitored, daily therapy is available. There will be no large scale studies if patients continue to be told Testosterone is irrelevant to their health. Competing interests: None: However am the author of "The Testosterone Deficiency Centre" at www.androids.org.uk |
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Stanley E Althof, Professor of Psychology Case School of Medicine, Lorraine Dennerstein, Anita Clayton, Irwin Goldstein, Lesley Marson, Alan Altman, Edgardo Becher, Lori Brotto, Sheryl Kingsberg, Annamaria Giraldi, Patricia Schreiner-Engel, Ridwan Shabsigh, Yoram Vardi, Kim Wallen
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To the Editor: As officers of the International Society for the Study of Women’s Sexual Health (ISSWSH), we are responding to the biased, misleading, and unbalanced reporting in Ray Moynihan’s news release entitled, “Drug maker urges group to lobby FDA on testosterone for women” that appeared in the November 27th, 2004 issue of the BMJ. Mr. Moynihan insinuates that ISSWSH’s advocacy on behalf of Proctor and Gamble’s (P&G) drug under review by the Food and Drug Administration’s Advisory Panel could be secured because P&G gave financial support to the Society’s Annual Meeting and because “key office holders of the medical society have financial ties to P&G.” Mr. Moynihan also erroneously reports that the pharmaceutical company’s testosterone patch was “enthusiastically endorsed” in podium and poster presentations at ISSWSH’s Annual Meeting in Atlanta. Mr. Moynihan failed to provide the reader fair balance medical reporting. He did not carefully check his facts. He never asked about financial relationships between Board Members and P&G; he never took the time to report the official ISSWSH position response to the company’s request for support, and he did not accurately report on the podium presentations. The first fact is that the ISSWSH advocacy is NOT for sale. As a professional scientific organization ISSWSH strives to remain neutral and independent of advocacy for any pharmaceutical company’s products. The ISSWSH position has been and always will be to remain neutral in the area of endorsement of any commercial product in the field of women’s sexual health. For this specific request, no endorsement, letter or appearance was made to the FDA by ISSWSH or any ISSWSH representative in support of P&G’s testosterone patch. Unrestricted educational grants are commonly given by pharmaceutical companies to national/international professional meetings; they are unrestricted, meaning that the grantor can not influence the content of the scientific program. It is not a tacit agreement for future support of pharmaceutical company positions or ventures. Second, given that ISSWSH Board Members are key international opinion leaders, it is not surprising that some of them consult with pharmaceutical companies, including P&G. However, to boldly state that “key office holders have financial ties to P&G” is both inaccurate and malicious. Third, there were several presentations of results from P&G’s clinical trials based on empirical data derived from the clinical trials; they were not endorsements of the product. Indeed, members of the audience were pleased to hear about promising research but they also raised many of the same issues that were later discussed at the FDA Advisory Board Meeting concerning meaningful differences, safety concerns and problems with the FDA guidance on endpoints. Also, the diagnosis of HSDD is not ambiguous; it has been a diagnosis in the DSM for many years prior to any interest by industry in developing any commercial products. We are deeply troubled that news reporters like Ray Moynihan, who appear to have a self-serving agenda, who ignore or fail to check basic facts and who utilize peer reviewed medical journals, such as the BMJ, are able to report on scientific news without being subjected themselves to peer review or to a considered rebuttal by those involved. The ISSWSH Board: Stanley E. Althof, Ph.D. President, ISSWSH Lorraine Dennerstein, M.D.Past-President, ISSWSH Anita Clayton, M.D. Vice-President, ISSWSH Irwin Goldstein, M.D. Secretary, ISSWSH Lesley Marson, Ph.D. Treasurer, ISSWSH Alan Altman, M.D. Board Member, ISSWSH Edgardo Becher, M.D. Board Member, ISSWSH Lori Brotto, Ph.D. Board Member,ISSWSH Sheryl Kingsberg, Ph.D. Board Member, ISSWSH Annamaria Giraldi, M.D. Board Member, ISSWSH Patricia Schreiner-Engel,Ph.D. Board Member Ridwan Shabsigh, M.D Board Member, ISSWSH Yoram Vardi, Board Member, ISSWSH Kim Wallen Board Member, ISSWSH Board Member, ISSWSH Board Member, ISSWSH Competing interests: None declared |
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