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83-457: In its entirety, the WHI enrolled more than 160,000 postmenopausal women aged 50–79 years (at time of study enrollment) over 15 years, making it one of the largest U.S. prevention studies of its kind, with a budget of $ 625 million. A 2014 analysis calculated a net economic return on investment of $ 37.1 billion for the estrogen-plus-progestin arm of the study's hormone trial alone, providing a strong case for

166-537: A hysterectomy were treated with unopposed estrogen, specifically conjugated estrogens (Premarin, manufactured by Wyeth ), at a dosage of 0.625 mg/day ("E-alone," n = 5310; placebo, n = 5429). Women with an intact uterus were treated by a combined estrogen plus progestin regimen ("E+P," n = 8506; placebo, n = 8102), specifically the aforementioned estrogen regimen with the addition of 2.5 mg/day of medroxyprogesterone acetate (MPA; Prempro, also manufactured by Wyeth). The addition of progestin has been linked to

249-621: A School of Public Health, re-christening the College of Medicine into a College of Medicine and Public Health. Her efforts led to the medical school's designation as a National Center of Excellence in Women's Health. A new department of orthopaedics was created along with a planned development of a Musculoskeletal Institute. The James Cancer Center expanded its efforts in basic research with recruitment of Dr. Clara Bloomfield, an oncologist and leukemia researcher, and her husband Dr. Albert de la Chappelle ,

332-866: A cardiologist and researcher, who was recruited from Johns Hopkins, helped create the Heart and Lung Institute. Healy served on numerous medical advisory committees and boards over her career. They included committees of the National Academy of Sciences ' Institute of Medicine, of which she was a member, and the national Academy of Engineering ; the Department of Energy , NASA , and the National Institutes of Health. She participated briefly on an advisory board of The Advancement of Sound Science Coalition (an organization later shown to have been funded by Philip Morris ), and served on numerous advisory groups and boards of

415-473: A comparative observational assessment to the CT interventions. Participants underwent an initial baseline screening, including the collection of physical measurements, blood specimens, an inventory of medications and supplements, and completion of questionnaires pertaining to medical history, family history, reproductive history, lifestyle and behavioral factors, and quality of life. In addition, more specific information

498-542: A consequence, the HT study pills were stopped in July 2002, with an average follow-up period of 5.2 years. The unopposed estrogen trial was halted in February 2004, after an average follow-up period of 6.8 years, on the basis that unopposed estrogen did not appear to affect the risk of heart disease, the primary outcome, which was in contrast to the findings of previous observational studies. On

581-594: A decrease in breast cancer rates in postmenopausal women, attributed to the decline in use of HT. In 2014, an analysis was conducted to determine the economic impact of the estrogen-plus-progestin trial findings, which calculated the net economic return on investment to be $ 37.1 billion, owing to a combination of averted health-related expenditures and increased number of quality-adjusted life years (QALYs). The United States Preventive Services Task Force , though initially endorsing hormone replacement, in their most recent published recommendation in 2017 discouraged its use for

664-457: A high degree of adherence on the basis of both food-intake questionnaires and clinical laboratory findings. The WHT did not proceed with its full-scale trial, as it was not awarded further funding from the NIH on the basis of the potential inability of the study to test the hypothesis in a larger cohort of women. In 1990, however, interest in the impact of diet on cancer and cardiovascular disease in women

747-481: A large NIH-funded research program in hypertension, and was the lead investigator for the Cleveland Clinic's participation in a major clinical research study comparing angioplasty with coronary artery bypass surgery. She headed the NIH advisory board for another multi-center clinical study that showed that statins could slow the course of atherosclerosis in coronary artery bypass grafts. During this time she initiated

830-581: A life." Her tenure at the Red Cross was unsteady. In the spring of 2001, the FDA issued a record fine to the Red Cross for mishandling CMV infected blood products. The American Red Cross was criticized in the news media, notably by Fox News Channel host Bill O'Reilly, New York State Attorney General Eliot Spitzer , and some in Congress for misleading donors by soliciting and receiving donations worth $ 564 million after

913-409: A marked reduction in the risk for the development of endometrial cancer in women receiving estrogen treatment who have not undergone a hysterectomy. In addition to the global exclusion criteria, women were ineligible for the HT component if safety was a concern. Such concerns included a breast cancer diagnosis at any time in the past, other cancers (excluding non-melanoma skin cancer) diagnosed within

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996-556: A medical student program in alliance with Ohio State University that served as a precursor to the founding of the Cleveland Clinic Lerner College of Medicine in 2004. Healy was recruited away from Ohio State to become president and CEO of the American Red Cross in late 1999, succeeding Elizabeth Dole . From the outset, she strove to unite the various services and volunteers under the banner "Together we can save

1079-426: A reduced risk of hip and other fractures, as well as breast and colorectal cancer. Women participating in this intervention were randomly assigned to receive a regimen of 1000 mg calcium in combination with 400 International Units (IU) of vitamin D (n = 18176) or a placebo (n = 18106), and were followed for an average of 7 years, with monitoring for bone density, fractures, and pathologically confirmed cancers as

1162-842: A reduction of lung cancer risk for multivitamins. The Women's Health Initiative Strong and Healthy Study (WHISH) , started in 2015 and expected to last four years, seeks to examine the impact of physical activity in older women on certain outcomes such as heart disease and metrics including maintaining an independent lifestyle. The study has enrolled nearly 50,000 participants as of October 2016, whose assigned interventions will include varying physical activity routines, which are monitored by mail and via phone, using an interactive voice response (IVR) system. Public health investigators and biostatisticians can apply to use WHI study data in conjunction with their investigations. As of June 2013, nearly 450 Ancillary Studies have been proposed. Newly generated data from these Ancillary Studies must be submitted to

1245-464: A regimen of trainings, group meetings, and consultations which encouraged low-fat eating habits, targeted to 20% of daily caloric intake, along with increasing the consumption of fruits, vegetables, and grains. Those assigned to the control group were not asked to adopt any specific dietary changes. The mean follow-up for the DM intervention was 8.1 years. At study years 1 and 6, the dietary fat intake levels for

1328-563: A stronger correlation between physical activity and cardiovascular disease and total mortality. The COcoa Supplement and Multivitamin Outcomes Study (COSMOS) at Brigham and Women's Hospital and the Fred Hutchinson Cancer Research Center (Seattle, WA) was a four-year clinical trial with more than 21,000 women and men, recruited from across the U.S. The study was supported by Mars and Pfizer . The objective of

1411-454: A variety of hypotheses, as well as generate new hypotheses with respect to disease etiology in women. The WHI OS has and continues to yield many findings and new hypotheses, a small sampling of which are highlighted below: The WHI study has received three extensions; these extensions are referred to as "Extension Study 1" (2005-2010), "Extension Study 2" (2010-2015), and the recently undertaken "Extension Study 3" (2015-2020). Participants from

1494-513: A wide array of medical topics from women's health to marijuana , coronary artery disease to cancer , tattoos to male circumcision , and medical preparedness to health reform. Healy became the focus of controversy when she questioned the 2004 finding of the Institute of Medicine that the evidence refuting a link between childhood vaccinations and autism was conclusive. In a nationally televised CBS interview with Sharyl Attkisson , she alleged that

1577-399: A world-famous geneticist: Together, they expanded the college's programs in cancer research and tumor genetics. Cardiovascular research and practice grew with the recruitment of Dr. Robert Michler of Columbia University , who helped to revitalize the thoracic surgery and heart transplantation programs and developed one of the earliest robotic heart surgery programs. Dr. Pascal Goldschmidt ,

1660-577: Is not a trigger or cause of autism, and for her vigorous insistence that adequate science be done to resolve the issue. The scientific consensus was and is that no association has been found between vaccines and autism. In 1985 Healy left Washington and moved to Cleveland where she became chair of the Cleveland Clinic Lerner Research Institute and also practiced cardiology. In addition to building major new programs in molecular biology, neuroscience, and cancer biology, she headed

1743-616: The North American Menopause Society , the American College of Obstetricians and Gynecologists (ACOG), and the Endocrine Society all continue to recommend it as the most effective therapy for short-term treatment of menopausal symptoms in newly-menopausal women who are under the age of 60 year or within 10 years of entering menopause. The dietary modification (DM) trial was conducted with the purpose of identifying

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1826-426: The 50-79 age range, and sought to be as inclusive as practical. The wide nature of the age range balanced the need to observe the effects of hormone therapy on younger women, while also attempting to capture physical and cognitive outcomes in older populations. In addition, a 20% minority enrollment rate was set for all components, to accurately represent the proportion of minorities within the study demographic (17% at

1909-490: The 9/11 attacks, after it was discovered that the majority of the received funds were put aside for the organization's long-term use rather than going to support victims and volunteers. The Red Cross was forced to change its policy. Healy also advocated withholding dues from the International Federation of Red Cross and Red Crescent Societies for not allowing Israel's Red Cross society (Magen David Adom) to join

1992-696: The American Federation of Clinical Research, the American College of Cardiology, and the American Heart Association , an organization she later led as its volunteer president, and served on advisory committees to the National Heart, Lung and Blood Institute. The nonprofit Age of Autism named her 2008 Person of the Year for her publicly stated opinion that it had not been shown that vaccination

2075-501: The American Heart Association and the American College of Cardiology, where she was an outspoken critic of smoking and its effects on the cardiovascular system. Over her career Healy served as a medical commentator and consultant for CBS , PBS and MSNBC , and made numerous appearances on CNN , C-SPAN and Fox News Channel . Healy authored a column, "On Health", for U.S. News & World Report beginning in 2003 on

2158-539: The American Heart Association from 1988 to 1989, she sought to convince both the public and medical community that heart disease is also a woman's disease, "not a man's disease in disguise." Appointed president of the American Red Cross in 1999, Healy worked to improve the safety and availability of the American blood supply while overseeing the development of a Weapons of Mass Destruction response program. In 2001 she led

2241-455: The CT, a partial factorial study design was utilized for the investigation of three overlapping interventions (dietary modification, hormone therapy, and calcium/vitamin D supplementation), as this would provide considerable cost efficiencies. Willing study-eligible women were asked to join either the hormone therapy (HT trial), the dietary modification (DM) trial, or both. After one year, willing and eligible CT participants were also asked to join

2324-722: The Extension Study 2 participants (n = 7875), aged 63–99 and meeting other eligibility criteria, were consented into the Long Life Study (LLS), the purpose of which was to establish new baselines from which new studies in disease and aging can work. In-person visits were conducted to assess and collect physical and functional measurements, as well as blood to replenish the WHI biospecimen repository and determine current CBC parameters for these participants. The LLS completed its in-person visits and blood collections in May 2013. A large subset of

2407-516: The LLS participants (n ≈ 7400) were further enrolled in the Objective Physical Activity and Cardiovascular Health in Women (OPACH) study, the purpose of which was to assess physical activity in women capable of ambulation. These women were asked to maintain a week-long sleep log, wear an accelerometer for a week, and keep track of falls on a month basis for one year. The goal was to establish

2490-495: The NIH. Given the complexity of the WHI study, both in terms of the number of interventions and outcomes studied, as well as the number and geographic distribution of participants and clinical centers, careful orchestration was required. To this end, the WHI maintained a carefully designed organizational structure, along with governance- and science-specific committees and communications channels for staff and investigators to resolve study-related questions and exchange information. As

2573-587: The President's Council of Advisers on Science and Technology during the administration of Presidents George H. W. Bush and George W. Bush . Healy was director of the Research Institute at the Cleveland Clinic Foundation when President George H. W. Bush tapped her in 1991 to become director of the NIH, its first woman head. She took on many initiatives during her two years at the helm, including

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2656-475: The WHI clinical trial's role in preventing patient harm due to HRT administration, noting also the risks inherent to smaller observational studies, which previously had yielded misleading, potentially harmful recommendations to medical practitioners. It is important to note that this evidence primarily concerns longer-term HRT use for prevention of chronic disease in older women. The USPSTF did not evaluate HRT's use for alleviation of symptoms of menopause , whereas

2739-517: The WHI results were published. In the 1980s, it had become apparent that past biomedical research had focused disproportionately on white men, often neglecting prevention and treatment studies of diseases that are either unique to or more common in women and minorities. In 1985, the Public Health Service Task Force on Women's Health Issues issued recommendations that biomedical and behavioral research should be expanded to provide for

2822-410: The WHI study findings, the HT findings could be argued to have yielded the farthest-reaching societal and economic impacts, and received substantial media attention. Large reductions in HT prescriptions ensued, resulting in a substantial loss of revenue in sales of this class of drugs, with a presumably commensurate savings to patients and insurers. More importantly, in subsequent years, studies have shown

2905-624: The WHI, which in turn provides a richer data resource for subsequent studies. Bernadine Healy Bernadine Patricia Healy (August 4, 1944 – August 6, 2011) was an American cardiologist and the first female director of the National Institutes of Health (NIH). During her career, Healy held leadership positions at the Johns Hopkins University , the Cleveland Clinic , Ohio State University , and Harvard University . She

2988-664: The White House Office of Science and Technology Policy. She served as chairman of the White House Cabinet Group on Biotechnology, executive secretary of the White House Science Council's Panel on the Health of Universities, and a member of several advisory groups on developing government-wide guidelines for research in human subjects and for the humane treatment of animals in research. She subsequently served on

3071-490: The age of 50 bear much of the disease burden. It had been generally accepted that postmenopausal estrogen deficiency may play a role in these morbidities, and that dietary, behavioral, and drug interventions may forestall their development. However, these findings were identified on the basis of epidemiologic observational studies alone. Such interventions would require testing through clinical trials before they, along with their full range of risks and benefits, could be used as

3154-639: The basis for setting public health policy and creating prevention guidelines. However, concerns existed about the feasibility of such a complex clinical trial among participants in this demographic of older women, particularly with respect to sufficient recruitment and adherence to the dietary and hormone-treatment regimens. In 1987, the NIH funded the Postmenopausal Estrogen/Progestin Intervention (PEPI). The trial followed 875 women who underwent treatment with estrogen, estrogen and progestin, or placebo, and — even quite early in

3237-409: The calcium/vitamin D trial (CaD). Recruitment goals for the HT, DM, and CaD components of the CT were 27,500, 48,000, and 45,000, respectively, each obtained on the basis of calculations of statistical power with regard to the outcomes of interest for each component. Participants who either did not qualify for or declined to participate in the CT were, if eligible and willing to consent, enrolled in

3320-436: The concern over the relationship between HT and elevated breast cancer risk, breast cancer was selected as the primary adverse outcome. Additional outcomes monitored included stroke , pulmonary embolism (PE), endometrial cancer , colorectal cancer , hip fracture , and death due to other causes. Two regimens were selected, in addition to a placebo group. Women assigned to the intervention group who had previously undergone

3403-652: The continued use of this variety of large, publicly funded population study. In the years following the WHI, studies have shown a decrease in breast cancer rates in postmenopausal women, attributed to the decline in use of hormone replacement therapy. However, initial interpretation and communication about the studies' findings have been criticized for failing to clarify that the studies were weighted toward women already 60 or older (average age 63). This meant that women in their 50s, who tend to be healthier and have more menopausal symptoms, were underrepresented. Systemic hormone therapy has decreased dramatically among U.S. women since

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3486-438: The coordination of the 40 study clinics that would eventually recruit women nationwide, as well as ensuring their consistent adherence to the study design and guidelines. In 1991, working groups were formed to determine the study plan for both the clinical trials (CT) and the observational study (OS). These groups included experts from diverse arenas of medicine, public health, and clinical trial design from both within and outside

3569-516: The development of a major intramural laboratory for human genomics; recruited a world-renowned team to head the Human Genome Project , including former NIH director Dr. Francis Collins ; elevated nursing research to an independent NIH institute; and established a policy whereby the NIH would fund only those clinical trials that included both men and women when the condition being studied affects both sexes. According to Francis Collins, Healy

3652-426: The effects of a low-fat eating pattern; the primary outcome measures were the incidence of invasive breast and colorectal cancers, fatal and nonfatal coronary heart disease (CHD), stroke, and overall cardiovascular disease (CVD), calculated as a composite of CHD and stroke. Women in the trial were randomly assigned to the dietary intervention group (40%; n = 19541) or the control group (60%; n = 29294). In addition to

3735-418: The first phase of the WHI study were consented and enrolled, with the intention of collecting additional longitudinal data from subjects involved in all of the original study components. The primary outcomes were the same, although greater emphasis was placed on the investigation of cardiovascular disease and aging. Extension Study 1 enrolled 115,403 of the original WHI participants, or 77% of those eligible from

3818-501: The first study phase. Extension Study 2 was able to enroll 93,540 participants, or 87% of those eligible from Extension Study 1. Preliminary estimates for Extension Study 3 participation, as of September 30, 2015, estimate that 36,115 of the Clinical Trial participants and 45,271 Observational Study participants remain active in the WHI study, for a total of 81,386 or 87% of those previously enrolled in Extension Study 2. A subsample of

3901-602: The founding of the medical school in 1893, and at the same time honored Garrett, the Victorian socialite and philanthropist who made sure that Johns Hopkins School of Medicine opened its admissions to women (the medical school opened its doors in October 1893; and three of the eighteen original candidates for the M.D. degree were women) and ultimately admitted women and men precisely on the same terms. While at Johns Hopkins, Healy held several leadership positions in organizations such as

3984-416: The global exclusion criteria, component-specific exclusion criteria included prior breast cancer, colorectal cancer, other cancers excluding nonmelanoma skin cancer in the past 10 years, adherence or retention concerns (e.g., a substance abuse history or dementia), or a baseline diet that included a fat intake accounting for less than 32% of total energy intake. Participants in the intervention group underwent

4067-592: The government has avoided studying whether there are any susceptible population sub-groups in which vaccination may result in autism, because of a fear that, if such a link were found between vaccines and autism, people would stop vaccinating. Healy was married to cardiac surgeon Floyd D. Loop, a former CEO of the Cleveland Clinic , Ohio. She and her husband had one daughter, Marie McGrath Loop. She had another daughter, Bartlett Bulkley, from her previous marriage. Healy died on August 6, 2011, in Gates Mills, Ohio , ending

4150-532: The importance of education and she excelled at her studies. In 1962, she graduated top of her class at the Hunter College High School in Manhattan . With a full scholarship, she attended Vassar College , graduating summa cum laude in 1965 with a major in chemistry and a minor in philosophy. She was elected to Phi Beta Kappa . She then went on to Harvard Medical School , also on full scholarship, and

4233-424: The incidence of breast cancer. Finally, an increased risk of kidney stones was observed among those taking calcium plus vitamin D. The Observational study (OS) study recruited eligible postmenopausal women (n = 93676) who were either ineligible or unwilling to participate in the CT portion of the study, for the purpose of obtaining additional risk factor information, identifying risk-related biomarkers, and serving as

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4316-633: The inclusion diseases and conditions identified among women of all age groups. In 1986, the NIH issued recommendations that women be included in all research studies. To further promote the study of women, in 1990, the NIH created the Office of Research on Women's Health. In 1990, however, a report was published by the General Accounting Office (GAO), at the request of the Congressional Caucus on Women's Issues, which stated that this NIH policy

4399-474: The international body without adopting the cross or crescent as its symbol. The Red Cross Board of Directors hired her as a "change agent" but chafed at her steely managerial style and the board's "loss of control over day-to-day decision-making." The board forced her resignation in the wake of these disagreements and controversies. Healy departed the organization as president on December 31, 2001. President Ronald Reagan appointed Healy deputy director of

4482-563: The intervention group were 10.7% and 8.2% less than those of the control group, respectively. The results indicated that, despite some reduction in CVD risk factors (e.g., blood lipids and diastolic blood pressure), there was no significant reduction in the risk of CHD, stroke, or CVD, indicating that a more focused combination of diet and lifestyle interventions may be required to further improve CVD risk factors and reduce overall risk. In addition, no statistically significant reduction in breast cancer risk

4565-473: The loss of funding to other women's health-related studies, funding was requested and obtained directly from Congress in the form of a discrete line item, with a projected budget of $ 625 million over the life of the 15-year study. The NIH awarded the role of Clinical Coordinating Center (CCC) to the Fred Hutchinson Cancer Research Center (FHCRC), located in Seattle, Washington . The CCC's responsibilities included

4648-476: The measures of outcomes. Women in the CaD trial were already participating in the HT trial, the DM trial, or both. In addition to the global exclusion criteria, component-specific exclusion criteria hypercalcemia , renal calculi , corticosteroid use, and calcitriol use. Among the intervention cohort, a small but significant improvement in hip bone density was observed, although a significant reduction in hip fractures

4731-423: The observational study (OS), which had an enrollment goal of 100,000. The WHI study was composed of four study components, to include three overlapping clinical trial (CT) interventions and one observational study (OS). Component enrollment and the primary findings are summarized in the following two tables, respectively, with additional detail following subsequently: The design of the hormone therapy trial (HT)

4814-538: The organization's response to the September 11 attacks . In 1994, Healy was a Republican candidate to represent Ohio in the U.S. Senate . She ran in the GOP primary and came in second in a four-person race. Lt. Gov. Mike DeWine won and prevailed in the general election. Healy served as professor and dean of the College of Medicine from 1995 to 1999. During her tenure, the college expanded its public health programs to become

4897-400: The other hand, there were indications for an increased risk of stroke. Unopposed estrogen did reduce the risk for osteoporotic fractures and, unlike the estrogen/progestin treatment, showed a decrease in breast cancer risk. As a consequence of the findings, which indicated that the incurred risks of HT outweigh the identified benefits, the study authors recommended that HT not be prescribed for

4980-466: The prevention of chronic diseases such as osteoporosis or cardiovascular disease . When they first evaluated the impact of HRT in 1996, the USPSTF assigned a "B" grade to hormone replacement therapy for use in primary prevention of chronic conditions in postmenopausal women, basing their results on observational studies and short-term trials. A score of "B" carries an official message of, "The USPSTF recommends

5063-435: The previous 10 years, or low hematocrit or platelet counts. The HT component had originally been designed to include a follow-up period of nine years. However, interim monitoring of the combined estrogen/progestin treatment group indicated an increased risk of breast cancer, coronary heart disease, stroke, and pulmonary embolism, which outweighed the evidence indicating a benefit in preventing colorectal cancer and fractures. As

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5146-443: The purpose of chronic disease prevention in postmenopausal women. The hypothesized and observed risks of specific clinical outcomes are summarized in the following table. Of particular interest are the contrasts between several of the hypothesized risks and the observed attributable risks , which are instructive in demonstrating the distinct differences between the HT trial findings and those of previous observational studies. Of all

5229-488: The rank of professor of medicine. For eight years she headed the coronary care unit at the Johns Hopkins Hospital. At the medical school, she served as assistant dean for post-doctoral programs and faculty development. During that time she organized a nationally covered Mary Elizabeth Garrett symposium on women in medicine which examined the opportunities and hurdles faced by women physicians roughly 90 years after

5312-414: The service has no net benefit or that the harms outweigh the benefits," and discourages health providers from offering the service or treatment. In 2017, the USPSTF again evaluated the use of HRT, and again assessed a "D" score. The publication of this most recent recommendation against the use of HRT for the treatment of chronic postmenopausal symptoms was accompanied by several companion editorials, lauding

5395-489: The service. There is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial." In light of subsequent results from the Heart and Estrogen/progestin Replacement Study (HERS) and the WHI trials, the USPSTF downgraded the scoring to a "D," which corresponds to a message of, "The USPSTF recommends against the service. There is moderate or high certainty that

5478-472: The study launched concurrently with the early stages of modern Internet connectivity, the study centers had to be supplied with computing and networking equipment to connect to the WHI network; WHI-hosted e-mail facilitated the efficient exchange of information among staff and scientists, as well as the transfer of study-related data. The launch of the study was undertaken in two stages. At first, 16 "vanguard" study centers entered active operation, to evaluate

5561-470: The study protocol and procedures. Once this initial portion of the study was underway, the remaining 24 study centers entered the study around a year later, each assigned to one of the "vanguard" study centers for purposes of mentorship. Study centers were subdivided into four regions, each under the supervision of a regional center, to further facilitate communication and information exchange among study centers. The WHI study recruited postmenopausal women in

5644-404: The study recruitment for a least three years after enrollment. Global exclusion criteria included medical conditions that would be predictive of a survival of less than three years, possessing characteristics or conditions that may diminish study adherence (e.g., substance abuse, mental illness, or cognitive impairment), or concurrent enrollment in another randomized controlled clinical trial. For

5727-410: The study was to investigate whether either cocoa flavanols (600 mg/day) or a common multivitamin affects the risk of developing heart disease, stroke, and cancer. First results showed no effect on the pre-registered primary endpoints (incidences of heart disease and cancer), but they did show an effect on secondary endpoints with a reduction in heart disease mortality for cocoa flavanols and

5810-538: The study — demonstrated both successful recruitment and participant retention/adherence in a hormone therapy (HT) setting. Many of the operational procedures from PEPI, including the study drug dosing, were retained in the larger WHI-HT clinical trial. In 1984, the NIH provided funding for a feasibility study pertaining to diet adherence, conducted by the Women's Health Trial (WHT). The WHT, which commenced in 1986 and involved 303 women randomized into dietary intervention and control groups, yielded results demonstrating

5893-446: The time of the 1990 U.S. Census). To achieve this, 10 of the 40 WHI clinical centers were designated as minority recruitment centers, with enhanced minority recruitment goals. Eligibility and exclusion criteria also were defined, both study-wide and component-specific. Global inclusion criteria included postmenopausal women, between 50 and 79 years of age, who were willing and able to provide written consent, and who planned to reside in

5976-542: Was also president of both the American Red Cross and the American Heart Association . She was health editor and columnist for U.S. News & World Report and a well-known commentator in the news media on health issues. Healey was born on August 4, 1944, in New York City to Violet McGrath and Michael Healy, the second of their four daughters. She was raised in Long Island City , Queens . Her parents stressed

6059-429: Was approached with the hypothesis that estrogen therapy would result in a decrease in coronary heart disease and osteoporosis-related fractures. As such, the primary outcome of interest was coronary heart disease, as this is a major cause of morbidity and mortality among women, particularly those over age 65, and because, at the time, no clinical trial had been undertaken to prove the cardioprotective effects of HT. Due to

6142-543: Was collected with regard to the participant's geographic residence history, passive (i.e., "second-hand") smoking exposure in childhood and adulthood, early life exposures, details of physical activity, weight and weight-cycling history, and occupational exposures. In addition to the baseline data collected, OS participants received annual questionnaire mailings to update selected exposures and outcomes, and were expected to make an additional clinic visit, to include an additional blood collection, about three years post-enrollment. It

6225-405: Was conceived and designed by Healy and remains the largest randomized clinical trial in history to involve only women, studying the effects of specific prevention strategies on major causes of death and disability in women after menopause. Soon after the beginning of the WHI studies, Healy died of brain tumors resulting from glioblastoma . She never saw the result of her initiative. As president of

6308-415: Was identified, although the results approached significance and indicated that longer-term follow-up may yield a more definitive comparison. The trial also did not identify a reduction in colorectal cancer risk attributable to a low-fat dietary pattern. The calcium/vitamin D (CaD) trial component was designed to test the hypothesis that women taking a combination of calcium and vitamin D will experience

6391-401: Was not being adequately applied to research grant applications. As a consequence, beginning in 1991, NIH strengthened the policy to require, rather than recommend, the inclusion of women in clinical research (when appropriate) in order to obtain funding. It was these changes in societal attitudes and policy toward women's health research, in addition to the demonstration that such a large study

6474-410: Was not observed. However, subgroup analysis revealed a possible benefit to older women in terms of a reduced risk of hip fractures, attributable to calcium plus vitamin D supplementation. It was also found that the intervention did not have an effect on the incidence of colorectal cancer, possibly owing to the long latency associated with colorectal cancers. Calcium plus vitamin D was not found to affect

6557-427: Was not only feasible, but could be done economically, that gave rise to the WHI. Among postmenopausal women, cardiovascular disease, cancer, and osteoporosis are the leading causes of morbidity and mortality, as well as impaired quality of life. Among women in all age groups, cancer and cardiovascular disease are the leading causes of mortality. As the incidence of these diseases increases according to age, women over

6640-484: Was one of only ten women out of 120 students in her class. After graduating cum laude from Harvard Medical School in 1970, she completed her internship and residency in internal medicine and cardiology fellowship at the Johns Hopkins School of Medicine and Johns Hopkins Hospital . After finishing her post-doctoral training, she became the first woman to join its full-time faculty in cardiology and rose quickly to

6723-465: Was planned that participants would be followed for an average of 9 years. The major outcomes of interest for the OS were coronary heart disease, stroke, breast cancer, colorectal cancer, osteoporotic fractures, diabetes , and total mortality. Given the size and diversity of the cohort, taken together with the data and specimen collection being undertaken, it was expected that this cohort could yield insights into

6806-543: Was renewed, and a joint National Cancer Institute (NCI)-National Heart, Lung, and Blood Institute (NHLBI) workshop concluded that a full-scale dietary trial, with a focus on these two diseases, was warranted. On April 19, 1991, Dr. Bernadine Healy , newly appointed as the first female director of the NIH, announced her plan for the Women's Health Initiative (WHI). Planning for the WHI CT/OS study began that year. In order to promote cross-institutional collaboration, and to prevent

6889-549: Was responsible for pressuring James Watson to retire as director of the Human Genome Project due to Watson's publicized belief that identified DNA gene sequences should be openly available for use to prevent disease instead of allowing DNA sequences to be patented, an idea which Watson characterized as crazy and insane, and an idea which Healy preferred. In 1991, she started the Women's Health Initiative studies. The WHI study

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