........................The results from the WHIMS estrogen plus progestin trial showed that the combination hormone therapy does not protect women from normal cognitive decline when compared with the placebo.  Women taking the hormone combination performed slightly worse on the yearly test, though the differences were small and would probably not be noticeable to anyone.  Concerning the risk of developing dementia, women taking estrogen plus progestin were actually at higher risk than women taking placebo.  That is, women taking estrogen plus progestin were twice as likely to develop dementia over the course of the study.  While this difference is important and clearly indicates that estrogen plus progestin increases the risk of developing dementia in postmenopausal women, the actual number of cases of dementia was small.  Overall, 61 women were found to have probable dementia.  Forty of these women were taking estrogen plus progestin and 21 were taking the placebo pill.  This translates into 23 more cases of dementia per year for every 10,000 women 65 and older taking the combination hormone therapy.  With regard to the less severe cognitive decline, women in the estrogen plus progestin group developed mild cognitive impairment at the same rate as women in the placebo group (estrogen plus progestin=56 cases per 10,000 women every year; placebo=55 cases per 10,000 women every year), indicating that this hormone combination does not protect postmenopausal women from milder cognitive decline.......

...These results apply only to women 65 and older who take estrogen plus progestin.  They do not apply to women who are taking estrogen alone.

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Estrogen plus progestin increases the risk of ischemic stroke in generally healthy postmenopausal women.  Excess risk for all strokes attributed to estrogen plus progestin appeared to be present in all subgroups of women examined

FDA NEWS
FOR IMMEDIATE RELEASE PO3-01 January 8, 2003
Media Inquiries: 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Approves New Labels for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women Following Review of Women's Health Initiative Data
 

The Food and Drug Administration (FDA) today is advising women and health care professionals about important new safety changes to labeling of all estrogen and estrogen with progestin products for use by postmenopausal women.  These changes reflect FDA's analysis of data from the Women's Health Initiative study (WHI), a landmark study sponsored by the National Institutes of Health that raised concern about risks of using these products.

FDA's labeling revisions are part of a series of actions to provide risk management information to women and advice to health care providers who prescribe these estrogen and estrogen with progestin-containing drug products for postmenopausal women.  FDA will also be issuing updated guidances for manufacturers of estrogen and estrogen with progestin products regarding labeling of those products and development of new products for use in postmenopausal women.  FDA's new labeling changes include a new boxed warning that reflects new risk information and changes to the approved indications to emphasize individualized decisions that appropriately balance the benefits and the potential risks of these products.
 

July 9, 2002http://www.nhlbi.nih.gov/new/press/02-07-09.htm

Specific study findings for the estrogen plus progestin group compared to placebo include:

A 41 percent increase in strokes 
A 29 percent increase in heart attacks 
A doubling of rates of venous thromboembolism (blood clots) 
A 22 percent increase in total cardiovascular disease 
A 26 percent increase in breast cancer 
A 37 percent reduction in cases of colorectal cancer 
A one-third reduction in hip fracture rates 
A 24 percent reduction in total fractures 
No difference in total mortality (of all causes) 

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In reviewing the data for the 10th interim analyses on May 31, 2002, the DSMB found that the adverse effects in cardiovascular diseases persisted, although these results were still within the monitoring boundaries.  However, the design-specified weighted log-rank test statistic for breast cancer (z = -3.19) crossed the designated boundary (z = -2.32) and the global index was supportive of a finding of overall harm (z = -1.62). Updated analyses including 2 months of additional data, available by the time of the meeting, did not appreciably change the overall results.  On the basis of these data, the DSMB concluded that the evidence for breast cancer harm, along with evidence for some increase in CHD, stroke, and PE, outweighed the evidence of benefit for fractures and possible benefit for colon cancer over the average 5.2-year follow-up period.  Therefore, the DSMB recommended early stopping of the estrogen plus progestin component of the trial.  Because the balance of risks and benefits in the unopposed-estrogen component remains uncertain, the DSMB recommended continuation of that component of the WHI.  Individual trial participants have been informed.

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NEW YORK (Reuters) - Drugmaker Wyeth on Wednesday said it channged 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. 

Media Response

First, here are extracts from a USA Today article published a month after the announcement summing up the widespread denial of the results.

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."

"I'm getting letters saying 'How dare you publish this without also publishing a rebuttal?'  " says Catherine DeAngelis, editor of the Journal of the American Medical Association, which posted the study on the Web on July 9 and published it July 17.  "What rebuttal?"
-

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......Moreover, the unexpected findings of the WHI investigation, that this major primary prevention trial was stopped early because the risks of combination estrogen-plus-progestin therapy outweighed the benefits for postmenopausal women, have implications for millions of women taking hormone therapy.  Thus, it was virtually inevitable that the study results would generate intense interest among clinicians and widespread attention from the news media and the public.

Accordingly, coordinated release and communication of the peer-reviewed study findings were essential to help ensure accurate and timely communication to physicians and patients and to provide appropriate caveats about the study results to help avoid a sense of panic.  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......

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The arrogance of preventive medicine 
David L. Sackett   CMAJ 2002;167 363-364 
First paragraph:

Preventive medicine displays all 3 elements of arrogance. First, it is aggressively assertive, pursuing symptomless individuals and telling them what they must do to remain healthy. Occasionally invoking the force of law (immunizations, seat belts), it prescribes and proscribes for both individual patients and the general citizenry of every age and stage. Second, preventive medicine is presumptuous, confident that the interventions it espouses will, on average, do more good than harm to those who accept and adhere to them. Finally, preventive medicine is overbearing, attacking those who question the value of its recommendations. 

.......The results of the WHI may be viewed as "unwelcome news" by some, but for vast numbers of physicians and their patients, the information simplifies what has been a confusing past decade.  We should not use HRT for its purported preventive effects, because it causes more harm than good.  Instead, women, with the support of their physicians, should focus on adopting preventive strategies that are clearly proven to be helpful.  The WHI also confirms the importance of well-designed, large randomized trials as the only reliable method to evaluate most common interventions......

........The lessons learned so far from the WHI are important for both men and women.  The norms and values of the society in which an individual and their physician reside often influence patient care.  On the basis of a belief that hormones are associated with youth and health, hormone replacement therapy for women was believed to be good.  In a similar fashion, we are now witnessing the discovery of andropause and the initiation of androgen therapy for men with the belief that it will lead to better overall health.  The WHI has clearly demonstrated that it is imperative that trials assessing the overall risk and benefit of primary prevention interventions for both men and women be conducted before such therapies are broadly instituted.  We must ensure that we understand the values and paradigms that drive our hypotheses and we must be willing to fund the research necessary to validate the effectiveness of our interventions.  The WHI demonstrates the potential for doing harm ... we cannot continue to do so.

HRT with combined estrogen–progestin causes net harm when used for an average of 5.2 years.  Although event rates are low, reductions in the risk of fracture and colorectal cancer are outweighed by increases in the risk of cardiovascular disease and breast cancer.  HRT remains an effective treatment for moderate or severe postmenopausal symptoms; however, the results of this trial support a recommendation to limit its use to as short a period as possible.

Reflections on the WHI Findings: Avoiding a Pill Scare and Taking Sensible Steps Forward
Paul D. Blumenthal, MD, MPH Posted 07/18/2002

........................an ERT/hormone replacement therapy (HRT) pill scare is likely to mean that women with menopausal symptoms who could be helped through this life phase by low-dose, relatively short-term hormone therapy, which has not been implicated as being risky or dangerous, will be shifted away from the most effective means of treatment toward less effective modalities

The first thing is to put the whole issue into perspective. The term hormone replacement therapy is a misnomer. Menopausal women are hormone deficient but not hormone depleted. How much endogenous estradiol an individual menopausal woman produces will determine whether or not she needs hormonal therapy for quality-of-life purposes. Her risk factors for osteoporosis, cardiovascular disease, and cognitive dysfunction will determine whether she will need additional therapy (and possibly hormone therapy) for those indications.

The WHI findings provide definitive evidence that the use of the Prempro formulation of combination HRT increases breast cancer as well as cardiovascular disease events. Although the absolute risk of an adverse outcome for an individual woman is very small, the ramifications of the findings are significant. Most importantly, they are a call for clinicians and their menopausal and postmenopausal patients to reevaluate, on an individualized basis, why combination HRT has been prescribed and whether it makes sense for the particular patient, based on symptoms and risk factors, to continue therapy or consider alternatives.

If we truly believe that good data direct good practice, then there is no question that these long-anticipated studies direct us to modify our practices to reflect them. Many practitioners have been doing so since the original HERS study was reported, and many patients have been doing so when the symptoms from the HRT they were taking outweighed the immediate benefit they were noting. The primary indications for HRT have not changed: the relief of vasomotor symptoms and vulvovaginal atrophy. Beyond these relatively short-term perimenopausal and early postmenopausal concerns, CEE/MPA appears to have more risks than benefits for most women. This redirection in thinking for many of us, and many of our patients, will require us to assume even greater roles as providers of health information as well as providers of traditional healthcare. 

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WASHINGTON — In a rare move, the government has halted a major study of hormone therapy three years earlier than planned because of a slightly increased risk of invasive breast cancer, researchers said Tuesday.

The new findings, to appear today in The Journal of the American Medical Association, shoot down the deeply engrained belief that estrogen reduces older women's risks of chronic diseases. (Women who have not had a hysterectomy also take progestin to protect the uterine lining from estrogen's cancer-causing effect.)

Last week, JAMA published research from the Heart and Estrogen/progestin Replacement Study (HERS) that showed no benefit for women with heart disease after nearly seven years of treatment.

In response, the leading organizations of obstetrician/gynecologists noted that the HERS findings might not apply to healthy postmenopausal women. Only the Women's Health Initiative, the groups said, could answer that.

http://www.medicalpost.com/article5.html july 11

"The real story here is that, upon hearing about the termination of this trial, scared women are going to make quick decisions with potentially bad consequences," Dr. Wulf Utian, reproductive endocrinologist at the Cleveland Clinic in Cleveland, Ohio, told the Medical Post. 
   "This morning, when the local paper broke the story, frightened women started calling the clinic at a rate of eight to 10 per hour asking what they should do," Dr. Utian said. "The fact is that we don't know if they really have anything substantial to fear from this dual hormone therapy. The researchers got caught by their own overly strict guidelines for risk evaluations. What we could have learned from a few more years of this study is lost." 

Shares of Wyeth Pharmaceuticals, of Collegeville, Pa., fell more than 22% to a two-year low. The company manufactures Prempro, an estrogen-progestin pill, used by millions of women for symptoms of menopause. 
   "While the study provides important information, it did not evaluate the benefits of combination (hormone replacement therapy) in the treatment of menopausal symptoms," the company said in a statement. "As stated in the NIH news release, for women taking combination (hormone replacement therapy) for the short-term treatment of symptoms, the benefits are likely to outweigh the risks." 

You'd think she'd be happy.  After more than 15 years of challenging the dogma that all women need hormone replacement to prevent heart disease and bone breaks after menopause, Maryann Napoli has been vindicated.  <snip> "I just wish there had been more caution about giving women this drug combination in the first place," she says, looking up at the shoes passing by the window of her tiny, donated office space in a West Village basement.  Instead, "they turned a stage of life into a disease for which you're supposed to take drugs every day for the rest of your life," she says.  "It was a pharmaceutical industry's dream come true."

For many women, though, the treatment of menopause has been a nightmare.  Greed and misogyny dovetailed in a massive marketing campaign for products that turned out to be both dangerous and unnecessary....................<more>

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Law firms across the country are rushing to capitalize on the just-released findings of a government study that links a top-selling brand of postmenopausal hormones with increased risks of health problems.
<snip>
Wyeth spokeswoman Natalie de Vane describes the lawsuits as baseless.  ''We don't believe there is any legal or factual basis for the claims filed against Wyeth related to Prempro'' and the government study, de Vane says.

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SYDNEY, Australia - 

Australia issued an urgent warning Thursday against long-term hormone replacement therapy, following U.S. findings that its risks outweigh its benefits.The Australian Medical Association said 600,000 women are on some form of hormone treatment and that the government's warning was premature. "It will unnecessarily, in our view, panic more women," said the association's federal vice president Trevor Mudge.

The [Australian] media, medical and political reaction to this report has been nothing short of extraordinary. Radio, television and newspapers have devoted an amazing amount of space to the subject. Even the Prime Minister paused his European perambulations to urge women back home not to panic. I can't remember when society has ever been so concerned about a women's health issue. 
<snip>
.....yet a close reading of the study (available at the Journal of the American Medical Association's Web site, jama.com) shows a more complicated, and far less worrisome, picture.

It is a shame the report did not address the question of how the women with breast cancer were responding to treatment. For women grappling with whether to discontinue HRT such information would have been useful. Breast cancer is a terrible affliction, one that kills almost 2600 Australian women every year, but many more are able to be successfully treated. 

At the weekend, Professor John Eisman, of the Garvan Institute, condemned as "criminal" that the trial was stopped. "The answer could be that those women who used HRT and developed breast cancer actually overall had a better outcome," he was quoted as saying. "But we'll never know that now ..."
<snip>
I know a lot of women who take HRT - myself included - but I don't know a single one who is taking it in order to prevent heart or other diseases. Some women take it to keep their bones strong (which is effective, according to the study), some take it so they can still enjoy sex (some husbands insist on it) and some take it to keep their skin supple. The trouble is that many women who initially take it for menopause relief find the fringe benefits so alluring they want to stay on it - perhaps forever.

By age 50 we might, as Colette put it, have the faces we deserve but many women would prefer to stop the aging process right there rather than watch their skin sag, their hair thin and all the other bits deteriorate as our bodies stop producing oestrogen. 

Once the choice was to risk pregnancy or take the pill. Now it's risk cancer with a little pill that allows us to get on with our lives. It's a devil of a choice - but we women should be the ones to make it for ourselves.

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Forget the facelift. Get the hysterectomy.

You think I'm kidding? Read on.

Two years ago in this space I wrote, "What's a girl to do? To HRT or not to HRT, that is the question?"

This week, the question was answered definitively when a major, government-funded U.S. study showed that HRT significantly increases risk of breast cancer, heart disease and stroke. 

At least, when I read the embargoed study on Monday, I thought the question was answered definitively. And about time, too. Millions of women have been taking a drug that had never been tested in a large-scale, long-term randomized controlled clinical trial — the gold standard for evidence-based medicine.

But now I'm not so sure the case has been made. And not because the study is inconclusive or questionable. It isn't.

The problem is that there are two enormously powerful motivations to downplay or obfuscate the results and both are at work now: vanity and greed.
<snip>
Billions of dollars of marketing have helped to reposition HRT not as a drug to control symptoms, not even as a drug to prevent disease in healthy women (a questionable proposition itself) but as a lifestyle drug promising better skin, better attitude and better sex. This hasn't been articulated in so many words; the preferred phrase is "quality of life."

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Today on Commentary, she says the promotion of hormone replacement therapy is a disgrace within the medical system.

Sharon Batt:

Here's the headline that should have appeared in newspapers last week: hormone replacement therapy is the Enron of women's health.  Recent stock market scandals shook the world because, as George W. Bush intoned, "the market can't work without trust".  Well, medicine can't work without trust either.  The Women's Health Initiative held hormone replacement therapy to the light with a rigorous clinical trial.  The results exposed medicine's corrupt underbelly.  For more than three decades now, doctors have been telling their mid-life female patients their bodies are deficient after menopause, when our hormone levels take a dive.  Medicine's answer: replace the missing hormones with a drug.  The father of this theory was Dr. Robert Wilson.  His 1966 book, Feminine Forever, played masterfully on women's fears of losing their sexual allure.  Feminine Forever became a bestseller.  So did the drug the book promoted.  Years later, the public learned that drug's manufacturer secretly financed Wilson's book, and bankrolled the foundation that paid him to pitch his misogynist message.     (more at URL above)

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Hormone replacement therapy 
Findings of women's health initiative trial need not alarm users

...............................Survival of the human species over two million years implies that female sex hormones by themselves are not dangerous to health. If harm is established, we must therefore examine the types of substitutes that we use and their means of delivery.

..............................Hormone replacement therapy regimens using different oestrogens and progestogens, and different routes of administration, may be similar in their effects on the breast, bowel, and skeleton. But the metabolic effects of different regimens are clearly different, and this is most likely to have an impact on their cardiovascular effects. Indeed, the women's health initiative trial also has an oestrogen-alone arm for women with hysterectomies, which has not been stopped. We need to see these findings to know whether the medroxyprogesterone acetate is causing the harm. It is most unhelpful that this point about different oestrogens and progestogens was not appreciated by the recent recommendations of the Committee for Safety of Medicines and the Medicines Control Agency,7 which were inappropriate with respect to cardiovascular disease. Particularly for coronary heart disease, the dose (and possibly type) of oestrogen and the type of progestogen may be crucial. Similar studies using different types of hormone replacement therapy than the one used in this trial must be carried out. 

................................Women who are currently taking continuous combined oestrogen-progestogen should not panic, as it is most unlikely to have caused considerable harm

.................................There is no right or wrong hormone replacement therapy to use in the short term, but in the light of the findings of this trial the use of hormone replacement therapy regimens containing conjugated oestrogens 0.625 mg together with medroxyprogesterone acetate (at any dose) should be avoided in the long term. The findings of this trial may not apply to lower doses of conjugated equine oestrogens, given with or without other progestogens. The long term effects of alternative hormone replacement therapy preparations have not yet been tested in large randomised trials, and this must become a research priority.

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Women were frightened into using HRT; now the news that it carries health risks is frightening them out of using it.  Instead of spreading terror, doctors and the media should leave women to assess the dangers themselves..
<major snip>
Not a lot is known about the acceptors of HRT, but the limited data suggest that women have recourse to HRT not because they wish to reduce their risk of osteoporosis, heart disease and stroke, but because they are seeking relief from the symptoms of menopause, in particular hot flushes and sleeplessness, and their concomitants, exhaustion and depression.  In a recent study only 17 per cent of a group of 400 women aged between 40 and 65 were currently using HRT, while 11 per cent were past users, who had given it up because of side-effects, low effectiveness or risk associated with long-term use.  For 40 years gynaecologists have been complaining about poor compliance among HRT acceptors, and it would seem that women’s scepticism dies hard.  Indeed, in the recent American trial, one of a galaxy set up under the Women’s Health Initiative, more women than expected stopped taking the medication; by the sixth year fully two fifths had defected.  As the researchers ruefully noted, if all the women had stayed on the medication for the duration of the trial, the adverse outcome would have been even more pronounced.

 
NPR Special Report: 
Hormone Replacement Therapy (Real Audio file)

After two major studies link hormone replacement therapy to serious health risks like heart disease and breast cancer, millions of menopausal women -- and their doctors -- are reconsidering their options.  MMillions of those women are now reconsidering their use of hormone replacement pills.  And doctors around the country are trying to figure out what to tell them.  NPR's Joe Palca reports for Morning Edition.  (4:29)

» Expanded coverage » The links provided for information on menopause include this site 

Hormone Replacement Therapy (Real Audio file)

Commentator David Kessler describes the postive and negative effects of Hormone Replacement Therapy.  (3:08) See NPR's expanded coverage.

Internet Information on Hormone Replacement Therapy (Real Audio file) 07-24-02 which includes input from two of alt.support.menopause's posters.

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

Hormone Replacement Therapy (Real Audio file) from Talk of the Nation, Friday, July 26, 2002 (48 minutes long but highly recommended)
The guests discussing HRT are Elizabeth Barrett-Connor, MD, Deborah Grady, MD, MPH, and Marcie Richardson, MD.

" Citing an increased risk for invasive breast cancer, researchers at the Women's Health Initiative recently halted a large clinical trial of the most commonly-used hormone combination by menopausal women.  In this hour, we'll look at the science of hormone replacement therapy--what do we really know about the risks and benefits of HRT?  "

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 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.

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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.  The hormone therapy issue is being actively debated within medical societies, too, with the American College of Obstetricians and Gynecologists, the North American Menopause Society and others forming task forces on hormone replacement in response to the WHI findings.

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, which approved Prempro for specific symptoms of menopause and to prevent osteoporosis, a reduction in bone mass.

"The impact of the WHI findings [is] very far-reaching, and that fact is not lost on the FDA," said Florence Houn, a director at the FDA's Center for Drug Evaluation and Research.  "As a public health agency, we need to step to the plate and reassess the risk-benefit conditions for labeling and risk management for patients."

New Hormone Program Information 
Since our last update to you, the Data and Safety Monitoring Board (DSMB) has finished another review of all the data from the beginning of the study up to February 28, 2001. The DSMB looked carefully at the safety of women in the study and the value of the study to all women across the nation. They unanimously said we should continue the study, because the overall balance between benefits and risks of hormone replacement therapy (HRT) is not clear.

Study findings as of February 28, 2001
In the spring of last year, we told you that there was "a small increase in the number of heart attacks, strokes, and blood clots in the lungs of women receiving active hormone replacement therapy compared to women taking inactive (placebo) pills. Fewer than l% of WHI women had any one of these problems, regardless of the type of study pills they were taking. Over time these differences between women on active and placebo pills seem to be getting smaller and may disappear." The DSMB has now reviewed the data through February 28, 2001 and has told us that the differences have not disappeared. The number of heart attacks, strokes, and blood clots remains higher in women taking active hormones. We do not know how this might change in future years.

The Balance Between Benefits and Risks
In trying to understand the overall balance of benefits and risks, the DSMB reviews data on many health conditions - including:

What We Are Doing to Understand These Risks
We have checked to see if the heart attacks, strokes. and blood clots in women on active hormones may be related to any individual risk factor (for example age or other health conditions like high blood pressure). So far, we have not found any particular group of women to be at higher risk. Now we are doing laboratory studies using stored blood samples from WHI women to see if we can identify women at risk. Whether or not these laboratory studies give us new information, the DSMB will continue to monitor the progress of the study and the effects of hormones on your health in future years.

The Health of Women in WHI
As a group, women who joined WHI were healthier than average. As a result the number of heart attacks, strokes, and blood clots in the WHI women is lower than in the general population of U.S. women. Each year in the study, less than one half of one percent of women have had a heart attack. The same is true of strokes and blood clots. Even so, more women taking active hormones than women taking placebos developed these conditions.

How You Can Help Maintain Your Health
To help prevent heart attacks or strokes a healthy lifestyle is important, including:

To help prevent blood clots, it is important to:

Female hormones are the number one selling prescription drugs in the U.S. - and the world. According to a recent survey by the American Heart Association 54% of women believe that hormones prevent heart attacks. However, we still do not know if taking hormones for many years prevents heart atacks and improves health. This study is even more inportant since we told you of the unexpected findings last year. The whole world is waiting for the final results of the WHO. Thank you for your contribution to this study.

Our commitment to you remains. We ask for your continued participation in this effort because we expect WHI to provide answers for women like you and for generations of women to come. As always, your participation is voluntary. We will continue to provide you with new information when it becomes available. And we will do our part to conduct this study according to the highest standards of medical research, so that the results will be as clear and useful as possible.