Illinois Pharmacists, Walgreen Reach Settlement On EC Distribution Rule

Illinois pharmacists who object to dispensing emergency contraception on moral grounds would be allowed to let another person on staff fill the prescription under a settlement filed last week between Deerfield, Ill.-based Walgreen and the state, the AP/Yahoo! News reports. According to the settlement, trained technicians or store owners would be able to contact a pharmacist at another location and then follow his or her directions for dispensing EC, which can prevent pregnancy if taken within 72 hours of sexual intercourse (Wills, AP/Yahoo! News, 10/11).

The Washington, D.C.-based American Center for Law and Justice in January 2006 filed a state lawsuit against Walgreen on behalf of four Illinois pharmacists who were suspended without pay in November 2005 for declining to dispense EC based on moral or religious beliefs. The lawsuit -- which was filed in Madison County, Ill., Circuit Court -- says the company violated the Illinois Health Care Right of Conscience Act, which allows health care providers to refuse to perform procedures that conflict with their moral or religious beliefs.

Under an Illinois rule -- which was proposed by Gov. Rod Blagojevich (D) and approved in August 2005 by the Illinois Joint Committee on Administrative Rules -- state pharmacies are required to dispense EC if they stock any FDA-approved contraceptive or risk losing their licenses. If any prescribed contraceptive is out of stock, pharmacies must provide an alternative, order the drug, make arrangements for another local pharmacy to fill the order or return the prescription to the customer. The rule allows pharmacies to opt not to sell any contraceptives (Kaiser Daily Women's Health Policy Report, 1/13).

Reaction
Francis Manion, an attorney for the pharmacists who filed the lawsuit, said the settlement is between Walgreen and the state, adding that his clients generally support it and will not continue with the litigation. "We think it's fair for us as well as our pharmacists," Walgreen spokesperson Tiffani Bruce said, adding that the deal "allows us to continue to care for patients." Attorneys said the settlement does not include any exchange of money.

"It seems to be a thoughtful settlement," Pam Sutherland, president of Illinois Planned Parenthood, said Wednesday, adding that the settlement gives pharmacists "an out, and it still makes sure the woman gets her prescription." The settlement must be reviewed by a legislative panel before it can take effect because it requires a change in state rules (AP/Yahoo! News, 10/11).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Low-Income Women Less Likely To Receive Mammograms, CDC Report Finds, USA

Women without a high school diploma or with an annual household income lower than $15,000 are less likely to receive mammograms than women with more education and a higher income, according to a CDC report published on Thursday in the Morbidity and Mortality Weekly Report, the South Florida Sun-Sentinel reports. The report, which focused on 35 metropolitan areas nationwide, examined 2000 census data and records from a national health survey conducted by telephone in 2002. According to the report, 78.5% of women ages 40 and older said that they had received a mammogram within the previous two years. Among those women, 68.4% with an annual household income of less than $15,000 underwent mammograms, compared with 82.5% with an annual household income of more than $50,000, the report found. The report said that more research is required to determine the reasons for the disparity, although the difference might result from factors such as access to health care, cost, availability of public transportation or availability of public heath clinics (McVicar, South Florida Sun-Sentinel, 10/7). The complete report is available online.


"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Preventive Surgeries Linked To Lower Risk Of Breast And Ovarian Cancer

Women with the inherited mutations of the BRCA1 or BRCA2 genes who had preventive (prophylactic) breast removal (mastectomy) or the removal of the fallopian tubes and ovaries (salpingo-oophorectomy) were found to have a significantly lower risk of developing ovarian and breast cancers, says a study published in JAMA (Journal of the American Medical Association), September 1st issue.


The authors wrote that females who carry the inherited mutations of the BRCA1 or BRCA2 genes have a considerably higher chance of developing breast or ovarian cancer - there is a 56% lifetime risk of breast cancer and 84% lifetime risk of ovarian cancer.


The authors added:


Women who are mutation carriers have cancer risk-management options that include risk-reducing salpingo-oophorectomy, risk-reducing mastectomy, annual cancer screening, and chemoprevention.


Susan M. Domchek, M.D., of the University of Pennsylvania School of Medicine, Philadelphia, and team carried out a study involving 2,482 women who had the BRCA 1 and BRCA 2 mutations to find out what their cancer risk reduction was following a prophylactic salpingo-oophorectomy and mastectomy, incorporating mutation type (BRCA1 vs. BRCA2), and cancer history (prior history of breast cancer vs. none). The women's gene mutations were determined between 1974 and 2008.


The study was performed at 22 clinical and research genetics centers in North America and Europe. The participants were monitored through to the end of 2009.


Breast Cancer Risk: The investigators found that:

None of the women with the mutated genes who had a prophylactic mastectomy developed cancer during the 3-year follow-up period.
7% of the women with the mutated genes who did not have a prophylactic mastectomy developed cancer during the 3-year follow-up period.

Ovarian Cancer Risk: The investigators found that:

Risk-reducing salpingo-oophorectomy was associated with a decreased risk of ovarian cancer, with no ovarian cancer events seen during the 6 years of prospective follow-up in BRCA2 mutation carriers without prior breast cancer who underwent the procedure.
Three percent of women without salpingo-oophorectomy over a similar follow-up period were diagnosed with ovarian cancer.

The researchers found no cases of ovarian cancer among women with the BRCA 1 mutation after salpingo-oophorectomy, which was also linked to a lower risk of breast cancer in BRCA1 and BRCA2 mutation carriers without prior diagnosis of breast cancer.


The authors wrote:


Compared with women who did not undergo risk-reducing salpingo-oophorectomy, undergoing salpingo-oophorectomy was associated with lower all-cause mortality (10 percent vs. 3 percent), breast cancer-specific mortality (6 percent vs. 2 percent), and ovarian cancer-specific mortality (3 percent vs. 0.4 percent).





"Association of Risk-Reducing Surgery in BRCA1 or BRCA2 Mutation Carriers With Cancer Risk and Mortality"

Susan M. Domchek, MD; Tara M. Friebel, MPH; Christian F. Singer, MD, MPH; D. Gareth Evans, MD; Henry T. Lynch, MD; Claudine Isaacs, MD; Judy E. Garber, MD, MPH; Susan L. Neuhausen, PhD; Ellen Matloff, MS; Rosalind Eeles, PhD; Gabriella Pichert, MD; Laura Van t'veer, PhD; Nadine Tung, MD; Jeffrey N. Weitzel, MD; Fergus J. Couch, PhD; Wendy S. Rubinstein, MD, PhD; Patricia A. Ganz, MD; Mary B. Daly, MD, PhD; Olufunmilayo I. Olopade, MD; Gail Tomlinson, MD, PhD; Joellen Schildkraut, PhD; Joanne L. Blum, MD, PhD; Timothy R. Rebbeck, PhD

JAMA. 2010;304(9):967-975. doi:10.1001/jama.2010.1237

Missouri's Constitutional Amendment Protecting Stem Cell Research Encounters 'Political, Financial Roadblocks,' New York Times Reports

A constitutional amendment approved by Missouri voters in November 2006 that was expected to expand and protect human embryonic stem cell research in the state has "run into political and financial roadblocks, putting the future of the research in doubt," the New York Times reports. According to the Times, the debate over the amendment has become a "fight over what constitutes 'cloning.'"

Supporters of the amendment say that it bans human cloning, which is defined in the amendment as an act that could result in a pregnancy and the creation of a human fetus inside a woman's uterus. Opponents say that cloning is the replication of cells, regardless of implantation in the uterus. Some state lawmakers who oppose the amendment said they will continue to fight it by introducing new bills that would ban some types of stem cell research.

"We think it's a false distinction to say that a clone exists only based on geography," Pam Fichter, president of Missouri Right to Life, said, adding that the group supports "ethical stem cell research, and we think cloning was misrepresented to voters. We know that a majority of Missourians oppose cloning." Donn Rubin -- chair of the Missouri Coalition for Lifesaving Cures, which led efforts to pass the amendment -- said that reproductive cloning was a major concern among voters. "What we protect is a very promising form of medical research that involves cells in a lab dish, not something that involves pregnancy," Rubin said.

Jaci Winship, executive director of Missourians Against Human Cloning, said the group is considering the possibility of a new initiative against the amendment, perhaps as soon as next year. Members of MRTL have been gathering signatures and contributions for the effort, the Times reports. According to Rubin, MCLC has continued raising money to prepare for another fight over the amendment.

Future of Research
According to the Times, although legislative efforts have failed so far, the "uncertainty" of the research's future in the state has made it difficult for facilities to attract stem cell specialists (Davey, New York Times, 8/10).

Many scientists who considered moving to Missouri to conduct stem cell research will not come to the state because of the uncertainty over whether the legislation will be overturned. The Stowers Institute for Medical Research in late July canceled plans to expand in Kansas City, Mo., because it was unable to recruit top stem cell researchers. The institute also transferred a large portion of its $2 million endowment to Delaware because the political climate in Missouri was too hostile (Kaiser Daily Women's Health Policy Report, 8/1).














Kevin Eggan, an assistant professor of molecular and cellular biology at Harvard University, said he strongly considered moving to Stowers but delayed his plans. "Everybody hoped that Missouri was going to be a good test case," Eggan said, adding, "It was exciting to us that stem cell research was being voted in a state which has very restrictive abortion laws. But it has turned out to be a big disappointment."

Sen. Chuck Graham (D) said, "For a bright shining moment in time, we were moving ahead as a state to protect research." He added, "But now the other side wants to walk away, not only from stem cell research, but all research. Their attitude now is, if there's a beaker or a Petri dish involved, we're not going to fund it." Rep. Jim Lembke (R), who opposes embryonic stem cell research and proposed legislation outlawing elements of the research, said, "As people are educated about this issue, they come around" (New York Times, 8/10).

"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

European Guidance For Osteoporosis Diagnosis And Management

The International Osteoporosis Foundation (IOF) has welcomed the recently published paper European guidance for the diagnosis and management of osteoporosis in postmenopausal women(1) from the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO).



This paper constitutes a roadmap for European countries to practically implement the new FRAX™ tool based on the WHO technical report, Assessment of osteoporosis at the primary health care level(2,3). The European guidance, published in Osteoporosis International, is a critical review of diagnostic methods, treatments and their monitoring options. It also shows case-finding strategies supported by health economic data.



IOF sees the ESCEO guidance as a positive move towards using the FRAX™ algorithm in daily practice. The WHO report and FRAX™ tool, released on February 21, 2008, help health practitioners to better understand the new paradigm for diagnosis and management of people at risk of developing fragility fractures.



In this regard, there will be a FRAX™ exhibition booth at the forthcoming ECCEO 8 Congress in Istanbul, Turkey, to be held at the Grand Cevahir Hotel & Convention Center. Participants will have the opportunity to have their 10-year fracture risk calculated, based on their geographic origin and individual risk factors. As a next step, the ESCEO paper can contribute with guidance on how to manage or monitor their condition, in the most rationale and cost-effective way.



Professor Jean-Yves Reginster, President of ESCEO, noted, "The ESCEO European guidance is convergent with the WHO report on how to assess and treat postmenopausal women with or at risk from osteoporosis. Moreover, cost-effectiveness analyses which illustrate scenarios based on a UK setting provide a starting point for health policy makers and health care providers to develop national guidelines on diagnosis and intervention thresholds."



The ESCEO guidance is very timely, as across Europe, osteoporosis is a major public health problem with serious medical and economic impact. In 2000, throughout the region, there were an estimated 620,000 new hip fractures, 574,000 forearm fractures, 250,000 shoulder fractures, and 620,000 spinal fractures in men and women aged 50 years or over, accounting for 34.8% of such fractures worldwide(4). There are more than 2.7 million osteoporotic fractures in men and women in Europe at a direct cost of 36 billion euros(5). It is estimated that by 2050, direct costs related to hip fractures will increase to 76.7 billion euros(6).







Kanis JA, Burlet N, Cooper C, Delmas PD, Reginster, JY, Borgstr?¶m F, Rizzoli R, on behalf of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int 2008 Feb 12; [Epub ahead of print]
















Kanis JA on behalf of the World Health Organization Scientific Group (2008) Assessment of osteoporosis at the primary health care level. Technical Report. World Health Organization Collaborating Centre for Metabolic Bone Diseases. University of Sheffield, UK.



World Health Organization. Assessment of osteoporosis at the primary health care level. Summary Report of a WHO Scientific Group. WHO, Geneva. who.int/chp/topics/rheumatic/en/index.html



Johnell O, Kanis JA (2006) An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 17:1726-1733



Kanis JA, Johnell O, on behalf of the Committee of Scientific Advisors of the International Osteoporosis Foundation (2005) Requirements for DXA for the management of osteoporosis in Europe. Osteoporos Int 16:220-238



Kanis JA et al. Requirements for DXA for the management of Osteoporosis in Europe. Osteoporosis Int. 2005;16:229-38)



Osteoporosis, in which the bones become porous and break easily, is one of the world's most common and debilitating diseases. The result: pain, loss of movement, inability to perform daily chores, and in many cases, death. One out of three women over 50 will experience osteoporotic fractures, as will one out of five men (7,8,9).



Unfortunately, screening for people at risk is far from being a standard practice. Osteoporosis can, to a certain extent, be prevented, it can be easily diagnosed and effective treatments are available.



The International Osteoporosis Foundation (IOF) is the only worldwide organization dedicated to the fight against osteoporosis. It brings together scientists, physicians, patient societies and corporate partners.



Working with its 184 member societies in 89 locations, and other healthcare-related organizations around the world, IOF encourages awareness and prevention, early detection and improved treatment of osteoporosis.



Melton U, Chrischilles EA, Cooper C et al. How many women have osteoporosis" Journal of Bone Mineral Research, 1992; 7:1005-10



Kanis JA et al. Long-term risk of osteoporotic fracture in Malmo. Osteoporosis International, 2000; 11:669-674



Melton LJ, et al. Bone density and fracture risk in men. JBMR. 1998; 13:No 12:1915



For more information on osteoporosis and IOF please visit: iofbonehealth/



Source: janice blondeau


International Osteoporosis Foundation

Bionovo Completes Enrollment Of MF101 Phase 2 Trial To Evaluate A Safer, New Therapy For Menopausal Symptoms

Bionovo, Inc.
(OTC Bulletin Board: BNVI) provided an update on its Phase 2 clinical trial
of MF101, a novel, oral treatment for hot flashes and other symptoms of
menopause. The Company has fully enrolled its FDA-approved trial with 184
women volunteers. Dr. Deborah Grady at the University of California, San
Francisco is serving as the Principal Investigator and the multi-center
trial is being conducted at six clinical sites across the country. The
trial will evaluate the efficacy of MF101 on actual and perceived relief
from menopausal symptoms. The women enrolled in the trial are aged 40-60
and experiencing greater than 7 moderate-to-severe hot flashes each day.



MF101 is an estrogen receptor beta (ER-beta) selective drug developed
as an alternative to those products currently on the market that have been
shown to increase the risk for breast and uterine cancers. Bionovo
recognized the opportunity to commercialize a product that would be equally
effective, with an improved safety profile to hormone therapy, and began
the clinical development of MF101. The drug candidate has been evaluated by
an independent Data and Safety Monitoring Board and has passed through a
standard two-round examination for safety. The Phase 2 study is expected to
run for an additional four months with results anticipated in early April
2007.



"For too long women had to face the choice between quality of life and
their long-term health," said Isaac Cohen, President and CEO, Bionovo. "The
market for menopausal products is enormous and growing, and we believe
there is great opportunity for a product that offers both efficacy and
safety."



The Phase 2 trial is a double-blind, randomized, placebo-controlled
trial. Women volunteers were randomized to groups of 60 receiving 2 doses
of MF101 or placebo. The trial is being conducted at the following sites:
University of California, San Francisco, University of Pittsburgh,
University of Minnesota, University of Tennessee, University of Alabama and
the San Diego Medical Center for Clinical Research.



About MF101



MF101, an ER-beta selective agonist, is designed for the treatment of
vasomotor symptoms such as hot flashes and night sweats in postmenopausal
women. In animal studies, MF101 has been shown to prevent tumor formation
in the breast and uterus, suggesting that Bionovo's lead drug will not
increase the risk of either breast or uterine cancer. In Phase 1 clinical
testing of MF101, the drug was found to be safe, well tolerated and taken
with high compliance. A multi-center, Phase 2, double-blind,
placebo-controlled, randomized clinical trial of MF101 has completed full
enrollment of 180 patients.



About Bionovo, Inc.



Bionovo is a drug development company focusing on the discovery of
novel pharmaceutical agents for cancer and women's health. The company has
one drug in Phase 2 clinical testing to treat conditions associated with
menopause and a second drug, BZL101, for breast cancer that will enter
Phase 2 clinical testing later this year. The company is developing its
products in close collaboration with leading U.S. academic research
centers, including the University of California, San Francisco, University
of Colorado Health Sciences Center, University of California, Berkeley, and
the University of Texas, Southwestern. For further information please
visit: bionovo/.


Bionovo, Inc

bionovo/

How Predictable Are Urinary Tract Infections?

It is expected that women will experience urinary tract infections (UTIs) at least twice during their lifetime. If a test existed that could predict UTIs, health care providers and patients would benefit. In the February 2008 issue of Urologic Nursing, Deborah Kuklinski and Sumana Koduri explore using urine dipsticks, an in-office test, to predict UTI.


Kuklinski and Koduri say a urine dipstick positive for nitrites (produced by bacteria in a UTI) implies UTI, but the urine culture, which takes longer and is more expensive, is the gold standard for a positive diagnosis. If the urine dipstick could be used to diagnose a UTI, say the authors, treatment could begin immediately. They found that despite associating urine dipsticks and urine cultures positive for nitrites, 40%-50% of the UTIs would have been missed without the urine culture due to the sensitivity of the bacteria.


Although Kuklinski and Koduri couldn't conclude the urine dipstick accurately diagnosed UTI, their study indicates the urine culture is still important for diagnosis and treatment. They recommend practitioners continue to use the urine culture and offer patient education on UTI symptoms.


Predicting Urinary Tract Infections in a Urogynecology Population

Deborah Kuklinski, MS, RNC, WHNP; Sumana Koduri, MD

Urologic Nursing; February 2008

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The Society of Urologic Nurses and Associates is a national, non-profit professional membership association with over 3,000 members and annual revenues of $1.5 million. SUNA derives its income from membership dues (only $60), conference registration fees, exhibits, advertising, grants, and the sale of educational products.


SUNA publishes a professional, peer-reviewed bi-monthly journal (Urologic Nursing Journal) and a bi-monthly newsletter (Uro-Gram). SUNA establishes the scope and standards of urologic nursing practice and the scope and standards of advanced urologic nursing practice. SUNA provides scholarships, grants and awards to deserving nurses and other health care professionals.


SUNA supports and promotes the certification of urologic nurses and associates by providing educational preparation for the examinations offered which lead to certification in three areas.


SUNA provides a variety of opportunities for participation including local chapters, task forces and Special Interest Groups (SIGS) in five major subspecialty areas.


suna