Less Screening Urged for Some for Cervix Cancer 
By DENISE GRADY

The American Cancer Society has issued new guidelines for cervical cancer screening that will allow some women to skip Pap tests entirely or have them less often.

The new guidelines, published in the November-December issue of the cancer society's journal CA, were developed to help reduce the number of women who are screened needlessly and get falsely positive or ambiguous results that lead to costly, unneeded and nerve-racking invasive procedures. About 50 million women a year in the United States have Pap tests.

"Close to three million women get abnormal results every year," Dr. Saslow said, "and only 13,000 have cancer."

WASHINGTON (Reuters Health) - A new US government report has for the first time identified estrogen-containing drugs and ultraviolet light as cancer-causing agents, federal agencies announced Wednesday. <snip> Steroidal estrogens were added to the list for the first time because of research data linking the compounds to an increased risk of cancer of the endometrium, or lining of the uterus.  They have also been associated with a rise in breast cancer risk.

http://jama.ama-assn.org/issues/v288n22/ffull/jlt1211-1.html
Risks of Postmenopausal Hormone Replacement 

The Medical Research Council (MRC) announced on Wednesday 23 October that a research study examining the risks and benefits of the long-term use of hormone replacement therapy (HRT) is to be stopped for scientific and practical reasons.

The MRC stressed that there were no safety concerns for the 5700 women involved in the study known as WISDOM (Women’s International Study of Long Duration Oestrogen after Menopause).<snip>

The IIC reviewed the findings from the WHI trial, the progress to date of WISDOM and other evidence and made a recommendation that the WISDOM study should stop.  In the light of the new evidence and the slow recruitment to date, WISDOM was considered unlikely to provide substantial evidence to influence clinical practice in the next ten years. <snip>

http://www.nytimes.com/2002/10/07/opinion/07LOVE.html
Detecting Breast Cancer Before It Starts 
By SUSAN M.  LOVE (who is author of ‘‘Dr.  Susan Love’s Breast Book’’ and an adjunct professor of surgery at U.C.L.A. Medical School)

.....................Even so, what's the harm of continuing to promote self-exams and mammography?  The harm is that they give us a false sense that we have a good way to find cancers and thus cure them and that very sense may keep us from redirecting resources to finding a better approach

.......................It's time to move beyond the debates about the utility of breast self-examination and mammography and increase the resources and energy devoted to finding something that will truly give us early detection.

Journal of the National Cancer Institute, Vol.  94, No.  19, 1419, 
October 2, 2002 
© 2002 Oxford University Press

Extracts from Press Release 
Study Finds No Evidence That Teaching Breast Self-Examination Saves Lives
Linda Wang, Assistant News Editor, Katherine Arnold, News Editor

Teaching women breast self-examination (BSE) does not appear to decrease the number of deaths from breast cancer, according to a study in the October 2 issue of the Journal of the National Cancer Institute.  However, intensive teaching of BSE was found to increase the rate of benign breast biopsies, potentially adding to health care costs without benefits.

Evidence from non-randomized observational studies had not been consistent.  Given such evidence, the U.S. Preventive Health Services Task Force currently does not recommend for or against the teaching of BSE.

related material

Based on the available evidence, the whole question of mammographic screening under age 50 should be disposed of. In terms of women age 50 to 59, we need to consider the best- and worst-case scenario. At best, screening decreases the relative risk of breast cancer specific mortality by 25%. If we assume this to be true, we need to screen 1,000 women for 10 years to save one life. But those who set screening policy say we can't tell the women that because they may not come for screening. I say so be it. I resent the way the screening program insults the intelligence of women.

NEW YORK (Reuters) - Drugmaker Wyeth on Wednesday said it changged the prescribing recommendations for women taking its hormone replacement therapy products in response to recent studies that raised safety concerns about the medicines and sparked a nationwide debate. 

Labels for the company's Premarin, Prempro and Premphase will now recommend that women remain on the therapies for the shortest duration possible, taking into account the individual patient's treatment goals. The drugs should also not be taken to prevent heart disease, and other treatments should be considered to prevent osteoporosis, a common use of hormone replacement therapy, according to the new labels. 

.....Salim Yusuf and Sonia Anand describe the importance of this large, well-designed and carefully conducted study [WHI] and comment on the implications for the future health of women.  In a related commentary, Anna Day highlights the importance of randomized controlled trials in preventive medicine, with particular attention to women's health.  In another commentary, David Sackett weighs heavily into the often "traditional" assumptions that underlie preventive medicine.

.....As part of the effort, federal officials want to explore whether hormone therapies and their producers have encouraged women to believe menopause is a condition to be treated, rather than an inevitable and natural set of changes to be managed...... 

.....Reflecting the FDA's discomfort with the way that hormone treatments have been widely presented as an antidote to menopause, the agency has told Wyeth to remove all references to "hormone replacement therapy" from its Prempro label.  The "replacement" model, officials said, has never been accepted by the agency.....,

 Because of differences in estrogenic potency and product composition, the extent that the new findings about risks are generalizable to other combination estrogen/progrestin products is not known.  The long-term risks of lower doses of Prempro were not evaluated in the WHI trial.

The Department of Health and Human Services will host public sessions on this issue in the fall.  More information on this will follow.  Consideration will be given to the extent to which the WHI results might be extrapolated to other combination estrogen/progestin products and doses, an assessment of known benefits for approved indications in the light of these new data, and the WHI's implications for future clinical trials of hormonal therapy.

.....  Unfortunately, an embargo break with unauthorized early release of information about the WHI study resulted in significant disruption in the plans for orderly communication of these results and had far-reaching implications.  Because of the widespread concern this embargo break generated, an explanation of the events that occurred and the ramifications of the embargo violation is warranted......

http://www.usatoday.com/news/health/2002-08-07-hormone-replacement_x.htm
Disbelief is HRT study side effect
By Rita Rubin, USA TODAY

......."People openly just wanted it to come out differently, and they're having a hard time facing it," says one of the researchers, obstetrician/gynecologist Susan Johnson of the University of Iowa. <snip> "If this were a new drug that no one had ever heard of ... and you came up with exactly these same results, it would just be abandoned," says Johnson.  "But what we have here, instead, is a drug that's been around for 50 years that people have very deeply ingrained beliefs about."

After two major studies link hormone replacement therapy to serious health risks like heart disease and breast cancer, millions of menopausal women are reconsidering their options.  Many of them are turning to the Internet for answers.  NPR's Joanne Silbern

More media response to WHI

If one filters out the frequent references to thyroid extract which seems to have been viewed as a cureall for the climacteric - much as estrogen later became -  this describes symptoms and situations which are very familiar to anyone knowledgeable about perimenopause. Of prime interest is the fact that they are attributed to both sexes, rather than being at worst the fault of the female, at best hers alone to suffer. The recommendations for dealing with them may be over sixty years old but they are still well worth considering - even the thyroid testing.

more history

Since the HERS results were published, many physicians have clutched at every hint that HRT might have benefit in preventing disease, death, and long-term disability in postmenopausal women.  More evidence brings more pessimism about the preventive benefits of HRT and ERT.  What then remains?
<major snip>
Pessimism about HRT and ERT does not mean pessimism about disease prevention in postmenopausal women.  Randomized trials that included women provide strong support for the use of [see article]

http://jama.ama-assn.org/issues/v288n1/abs/joc20521.html 
Cardiovascular Disease Outcomes During 6.8 Years of Hormone Therapy Heart and Estrogen/Progestin Replacement Study Follow-up (HERS II)
Conclusions 

Lower rates of CHD events among women in the hormone group in the final years of HERS did not persist during additional years of follow-up.  After 6.8 years, hormone therapy did not reduce risk of cardiovascular events in women with CHD.  Postmenopausal hormone therapy should not be used to reduce risk for CHD events in women with CHD.

http://jama.ama-assn.org/issues/v288n1/abs/joc20522.html
Cardiovascular Disease Outcomes During 6.8 Years of Hormone Therapy:Heart and Estrogen/Progestin Replacement Study Follow-up (HERS II)
Conclusions 

Treatment for 6.8 years with estrogen plus progestin in older women with coronary disease increased the rates of venous thromboembolism and biliary tract surgery.  Trends in other disease outcomes were not favorable and should be assessed in larger trials and in broader populations.

Finally, given the associations of emotional symptoms with high estradiol levels, it is not surprising that cycling perimenopausal women whose estrogen levels are at least intermittently extremely high would experience unwanted emotional symptoms.

Hormone Replacement Therapy Falls Out of Favor With Expert Committee

[Introduction only]

Bethesda, Md Falling in line with the evidence-based medicine trend, an international team of women's health experts is discouraging the use of hormone replacement therapy (HRT) for many postmenopausal conditions. Coronary heart disease, fractures, depression, urinary incontinenceall cited in the past as prime reasons to initiate HRTare losing favor as valid indications for it, as evidence from high-quality clinical trials accumulates.

For years, it was a medical truism that the earlier cancer could be detected, the better.  Most cancers would inevitably worsen if left untreated, the theory went.  Spontaneous remissions were so rare as to be almost unheard of.

But last week, those assumptions were shattered, at least in the case of a childhood cancer.  A screening test that looked as if it would save children from terrible deaths from a cancer of the nervous system utterly failed to fulfill its promise.

Now the story of that screening and questions about tests for adult cancers like mammography and a blood test for prostate cancer are ushering in a broader debate about cancer screening in general ..........

Benefits of screening mammography

Some research has doubted the benefit of screening mammography.  But new data now show that there may be a modest benefit for women aged 55 years or over........ they found a significant 21% reduction in breast cancer mortality for women given screening mammography.  But the benefit was less apparent in women aged 50-54 years.......

Raloxifene and Cardiovascular Events in Osteoporotic Postmenopausal Women
Four-Year Results From the MORE (Multiple Outcomes of Raloxifene Evaluation) Randomized Trial
Elizabeth Barrett-Connor, MD; Deborah Grady, MD; Andreas Sashegyi, PhD; Pamela W. Anderson, MD; David A.  Cox, PhD; Krzysztof Hoszowski, MD; Pentti Rautaharju, MD; Kristine D.  Harper, MD; for the MORE Investigators

Extract from
Discussion

In summary, there was no evidence that raloxifene caused an early increase in risk of CV events, either overall or among postmenopausal women at high risk for or with CHD.  Raloxifene therapy for 4 years did not significantly affect the overall risk of CV events in the total MORE cohort but did significantly reduce the risk of CV events among women at high risk for and among those with established CHD.  Before raloxifene is used for prevention of CV events, these findings must be confirmed by an adequately powered, randomized trial with CV events as predefined outcomes.

Unusually, early press releases on the study tended to be conservative and usually included reference to the study authors' cautions on interpretation, and though headlines focussed on the positive results they did incude the word "may" or "might". For example:

http://story.news.yahoo.com/news?tmpl=story&u=/nm/20020219/hl_nm/evista_heart_1
Raloxifene May Protect Hearts of High-Risk Women (Reuters)

http://story.news.yahoo.com/news?tmpl=story&u=/ap/20020219/ap_on_he_me/osteoporosis_drug_heart_2
Study: Drug May Lower Heart Risks (Associated Press)

related material

more history
soapbox archives

Objective: 

To determine whether the association between HRT and risk of breast cancer varies by HRT formulation and differs across histologic cancer types.

CHICAGO (Reuters) - 

The suspected breast cancer risk associated with post-menopausal hormone replacement therapy may involve a type of tumor that can be hard to detect, researchers reported on Tuesday............If there really is an increased risk for lobular breast cancer, it added, that "could have implications for screening, because lobular carcinomas are relatively more difficult to palpate (feel) and more difficult to diagnose by mammography......

http://www.usatoday.com/news/healthscience/health/women/2002-02-06-hormone-therapy.htm
Hormone therapy can lower energy levels
By Rita Rubin, USA TODAY

Postmenopausal women who aren't having hot flashes may feel worse physically if they start taking hormones, says a study out Wednesday.

............The women in the study had heart disease and their average age was 67, so the findings may not apply to healthy younger women who take hormones around the the time of menopause.  Nevertheless, researchers called the results surprising and said they cast doubt on the popular belief, encouraged by drug advertisements, that taking hormones after menopause can make most women feel more youthful, active and vibrant............

Although estrogen is approved to treat hot flashes and vaginal dryness and to prevent osteoporosis (bone-thinning), Chevy Chase gynecologist James Powers said the makers of hormone products commonly suggest in magazine advertisements that the drugs improve energy, mood and vitality.

"Even our own medical journals are laden with pictures of lovely, attractive women engaged in hard physical activity, as an example of how you can look and feel if you take their product," he said.

---

Unfortunately, many in the media have misrepresented the data, extrapolating the results of this study to all women, with inflammatory headlines such as, ``Treatment may not lessen effects of menopause'' and ``HRT benefits questioned.'' The published HERS data do nothing to resolve the issue of the effects on HRT on QOL of all women.

`We at NAMS are deeply disturbed that a paper with such highly questionable methodology would even have been published,'' commented Dr. Utian.  ``For the media to take that data and make a general statement that hormone replacement therapy does not improve the quality of life for all women is unconscionable.''

Extract from Lancet Volume 359, Number 9304 02 February 2002
Screening mammography: setting the record straight

Sir--Reviews of randomised screening trials done earlier than that undertaken by Ole Olsen and Peter Gøtzsche (Oct 20, p 1340)1 have supported the practice of screening for breast cancer with mammography, particularly for women older than 50 years;2,3 Olsen and Gøtzsche challenge this view.  Unfortunately, they provided one version of their review to The Cochrane Library4 and another (which is not an approved Cochrane review) to The Lancet.1 These two reviews, although similar, differ in some important features that may lead to confusion.

In his Oct 20 commentary,5 Richard Horton claims the Cochrane Breast Cancer Group (CBCG) attempted to unduly influence the text of Olsen and Gøtzsche's review in The Cochrane Library.  Since Olsen and Gøtzsche conclude that screening mammography is not justified, Horton implies that we tried to suppress this information, which is not the case.

Wednesday February 6, 4:08 pm Eastern Time Press Release SOURCE: Cancer Prevention Coalition
Extract from Mammography Is Dangerous Besides Ineffective, Warns Samuel S. Epstein, M.D. 

CHICAGO, Feb. 6 /PRNewswire/ -- The following was released by Samuel S. EEpstein, M.D., Chairman of the Cancer Prevention Coalition and Professor Emeritus of Environmental and Occupational Medicine, University of Illinois School of Public Health, Chicago:

Recent confirmation by Danish researchers of longstanding evidence on the ineffectiveness of screening mammography has been greeted by extensive nationwide headlines.  Entirely missing from this coverage, however, has been any reference to the [following] well-documented dangers of mammography.

---

Putting Mammograms to the Test 
By GINA KOLATA

In what is considered the gold standard of scientific evidence gathering, a randomized controlled clinical trial, some people are having the potentially lifesaving screening tests, and some are not.  An independent monitoring committee is standing by to see if the cancer death rate in one group exceeds that in the other.  At that point, the study will end.

But when it comes to mammograms, even Dr. Kramer gives up......

Dr. Kramer said: "I never like to say it's impossible.  But in the U.S. it would be very, very difficult" to do a new randomized mammography trial.

Health & Medicine 1/21/02
Hormones on trial Medical wisdom about menopause therapy is coming under question
BY AMANDA SPAKE

........like many of the 8 million to 16 million women over age 50 in the United States who are taking postmenopausal hormones, Chasin is having second thoughts.  Subsequent studies have made the issue of health benefits and risks a lot murkier than it originally appeared........