четверг, 30 июня 2011 г.
Right To 'Preserve One's Health' At Stake In Supreme Court Case Concerning Federal Abortion Ban, Opinion Piece Says
"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
среда, 29 июня 2011 г.
Kansas Abortion Opponents Petition For Grand Jury Investigation Of Abortion Provider Tiller
State Attorney General Paul Morrison (D) in June filed charges alleging that Tiller, who owns Women's Health Care Services in Wichita, Kan., had financial ties to physician Ann Kristin Neuhaus, from whom he received a second opinion before performing 19 late-term abortions in 2003.
A 1998 Kansas law says that before an abortion of a fetus of 21 weeks' gestation or more, two physicians must determine if continuation of a pregnancy will lead to death or "substantial and irreversible" harm to a "major bodily function." Consulting physicians cannot have legal or financial ties to abortion providers. Tiller's attorneys have entered a not guilty plea to the alleged misdemeanors and filed a motion to dismiss the charges. If convicted, Tiller could face up to one year in jail and a $2,500 fine for each of the 19 misdemeanor charges (Kaiser Daily Women's Health Policy Report, 8/7).
Grand Jury Petition
According to the AP/Eagle, petitioners want the grand jury to examine late-term abortions that Tiller performed during the past five years and the reasons cited for the abortions. The group said it does not want the Sedgwick County Office of the District Attorney or Morrison's office associated with the investigation because neither could conduct an unbiased investigation. According to the group, Morrison was not thorough enough in his examination of Tiller's case.
"We waited nine years for those in law enforcement to do their jobs," David Gittrich, state development director for Kansans for Life, said. Tiller's attorneys did not have immediate comment on the petition, according to a receptionist at the law office of Tiller attorney Lee Thompson. "I can assure you the attorney general will enforce the law regardless of his personal view," Ashley Anstaett, spokesperson for Morrison, said, adding, "He does not and will not let politics influence this or any other case." Georgia Cole, spokesperson for Sedgwick County District Attorney Nola Foulston (D), said, "We are confident they will do as the law allows."
According to the AP/Eagle, the number of signatures submitted by Kansans for Life is nearly three times the number needed to convene a grand jury (Hegeman, AP/Wichita Eagle, 9/6).
Morrison Allowed To Intervene in Planned Parenthood, Kline Case
In related news, the Kansas Supreme Court on Wednesday ruled that Morrison could intervene in the legal dispute between Planned Parenthood of Kansas and Mid-Missouri's Overland Park clinic Comprehensive Health and former state Attorney General Phill Kline (R), the Kansas City Star reports (Klepper, Kansas City Star, 9/5).
Kline in 2004 subpoenaed the records of 90 women and girls who in 2003 underwent late-term abortions at Comprehensive Health or Women's Health Care Services in Wichita, which is owned by Tiller, saying there is probable cause that each record contains evidence of a felony. The state Supreme Court in February 2006 ruled that Kline could seek access to the records but that he must return to Shawnee County, Kan., District Court Judge Richard Anderson and present his reasons for seeking the subpoenas. Anderson turned over the records to Kline's office in November 2006 after removing information that would identify individuals.
Morrison -- who defeated Kline in the November 2006 election -- in May in a letter to PPKM attorney Pedro Irigonegaray wrote that he has ended the investigation of Comprehensive Health. Morrison added that the attorney general's office "found no evidence of any criminal wrongdoing" by the clinic. Morrison in the letter also said that Kline forwarded copies of the medical records from PPKM patients to the Johnson County, Kan., district attorney's office on Jan. 5 -- three days before he left the state attorney general's office. Kline, who replaced Morrison as Johnson County district attorney, retains copies of the records, according to Morrison's letter (Kaiser Daily Women's Health Policy Report, 7/23). PPKM is seeking the return of the records used by Kline in the investigation.
According to the Star, Morrison also is suing Anderson in a separate lawsuit. Records in that case also are sealed. Kline said that if Morrison is attempting to force Anderson to return the records, it would be "unprecedented, bizarre and contrary to the responsibilities of a prosecutor." Anstaett declined to comment on the details of either lawsuit. She said that because of the court seal, Morrison's office could not review the Planned Parenthood lawsuit without getting permission to intervene (Kansas City Star, 9/5).
вторник, 28 июня 2011 г.
Six-Week Course Of Antiretroviral Nevirapine Did Not Clearly Reduce Risk Of HIV Among Breastfed Infants, Study Finds
In an effort to prevent MTCT, researchers have "stumbled into their own terrible dilemma," the Times reports. A single dose of nevirapine can prevent MTCT, but a single dose is not always effective. In addition, nevirapine can have side effects, and some infants develop liver failure, rashes or low white blood cell counts. Resistance to nevirapine also develops quickly, meaning that an infant who receives nevirapine and still contracts HIV will be unable to combination therapies that contain it or any related drug (McNeil, New York Times, 7/29).
For the study, researchers administered nevirapine to infants in Ethiopia, India and Uganda whose mothers were HIV-positive (Britt, Bloomberg, 7/25). The infants were randomly assigned to receive a single dose of the drug, while the other half received a six-week course (Bollinger et al., Lancet, 7/26). The study found that infants who took daily doses of nevirapine for six weeks reduced their risk of MTCT by 15% (Bloomberg, 7/25). "Although a six-week regimen of daily nevirapine might be associated with a reduction in the risk of HIV transmission at six weeks of age, the lack of a significant reduction in the primary endpoint -- risk of HIV transmission at six months -- suggests that a longer course of daily infant nevirapine to prevent HIV transmission via breastmilk might be more effective where access to affordable and safe replacement feeding is not yet available and where the risks of replacement feeding are high," the researchers wrote (Lancet, 7/26).
However, three members of the research team led by Mrudula Phadke of the Maharshtra University of Health Sciences in Nashik, India, in a letter to the journal wrote that it is "wrong that a drug that has not shown significant benefit and which has serious toxic side effects in 38.4% of babies should be tried for longer." The study's design of six months was based on the 10 to 14 days that it takes nevirapine to build up in infants' blood, the three researchers wrote in the letter, adding that the finding that incidence was lower after six weeks "does not reflect the effect of six weeks of treatment at all." Instead of using nevirapine, HIV/AIDS experts should focus on methods to make infant formula more available and acceptable to HIV-positive mothers in developing countries, the researchers added.
The disagreement among the study's authors is unusual, Lancet editors Pia Pini and Sabine Kleinert wrote in an accompanying commentary. They added that NIH, which funded the study, said there was no "breach of research integrity." They added, "In our opinion, publication of these important data, with complete disclosure, is the best course of action." Jeffrey Stringer and Benjamin Chi from the University of Alabama-Birmingham wrote in an accompanying commentary that "[e]xtended infant prophylaxis with nevirapine is simple enough to be implemented almost anywhere. It represents a long-awaited, if partial, solution to a mother's impossible choice. We should not delay" (Bloomberg, 7/25).
The study is available online. The letter also is available online.
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.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Nevada Mother-To-Child HIV Prevention Program Faces Funding Cuts
According to the AP/Appeal, when the Nevada Care Program began providing MTCT prevention services in 2006, Clark County had four reported HIV cases among infants. However, since the program launched, the county has reported no new cases, although 40 infants have been born to HIV-positive women. Echezona Ezeanolue, director of the Nevada Care Program, said eliminating the program is "a life and death decision that will have consequences far greater than the state has obviously considered." He said, "These children, who would otherwise have a 98% chance to be born without the HIV virus, will more likely be born with the virus." According to Ezeanolue, the budget cuts will not affect the availability of antiretroviral drugs, but they will prevent the program from having office space or medical assistants.
To address the funding shortfall, David Gremse, head of the School of Medicine's pediatric program, recently sent a letter to Rep. Shelley Berkley (D-Nev.) asking for assistance in securing funding to continue the Nevada Care Program. According to Gremse, eliminating funding for the program does not make financial sense. He wrote that by preventing MTCT for 40 infants, the program saved the state $12,124,000 over two years, based on the cost of providing health care for HIV-positive children. According to the AP/Appeal, Berkley has said that she is "hopeful that the financial resources will be found to keep this important program in place" (Harasim, AP/Nevada Appeal, 4/11).
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.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
FIGO's New Classification Of Causes Of Abnormal Uterine Benefits Patients
"There has been general inconsistency in the nomenclature used to describe abnormal uterine bleeding in reproductive aged women, and there is a plethora of potential causes-several of which may coexist in a given individual," commented Malcolm G. Munro, MD, FRCS(c), FACOG, Professor of Obstetrics and Gynecology at the David Geffen School of Medicine, UCLA and Director of Gynecologic Services, Kaiser Permanente, Los Angeles Medical Center, Los Angeles, California. "It seems clear that the development of consistent and universally accepted nomenclature is a step toward rectifying this unsatisfactory circumstance. Another requirement is the development of a classification system for the causes of AUB, which can be used by clinicians, investigators, and even patients themselves to facilitate communication, clinical care, and research."
Beginning with workshops in 2005, contributors from more than 17 countries on 6 continents developed the PALM-COEIN (pronounced "pahm-koin") classification system for causes of AUB in the reproductive years. The basic system comprises 9 categories: The first 4 are defined by visually objective structural criteria (PALM: polyp; adenomyosis; leiomyoma; and malignancy and hyperplasia); a second 4 that are unrelated to structural anomalies (COEI: coagulopathy; ovulatory dysfunction; endometrial; and iatrogenic), and a final category reserved for entities that are not yet classified (N). A draft system was developed and revised, distributed for comments, and then discussed at a face-to-face meeting held in association with the 2009 FIGO World Congress in Cape Town, South Africa.
The process was systematically designed to create a practical system that could be used by clinicians in most countries worldwide to classify patients with AUB readily and consistently. Drs. Munro, Critchley and Fraser note that it is "recognized that the system will require periodic modification and occasional substantial revision depending on advances in knowledge and technology, and increasing availability of investigative options across geographic regions. Consequently, we recommend a scheduled systematic review of the system on a regular basis by a permanent committee of an international organization such as FIGO, which has already endorsed the establishment of a suitable ongoing Working Group on Menstrual Disorders."
FIGO Chief Executive Hamid Rushwan said: "There is no existing classification of the causes of these common gynecologic symptoms that allows good communication between practicing clinicians and researchers, and which encourages focus on the optimal approaches to modern management. Therefore, FIGO is pleased to have a role in facilitating the use of this ground-breaking new classification worldwide."
The article is "FIGO classification system (PALM-COEIN) for causes of abnormal uterine bleeding in nongravid women of reproductive age" by Malcolm G. Munro, Hilary O.D. Critchley, Michael S. Broder, and Ian S. Fraser; for the FIGO Working Group on Menstrual Disorders (doi: 10.1016/j.ijgo.2010.11.011). The editorial is "The FIGO classification of causes of abnormal uterine bleeding" by Malcolm G. Munro, Hilary O.D. Critchley, and Ian S. Fraser (doi: 10.1016/j.ijgo.2011.01.001). Both appear in the International Journal of Gynecology & Obstetrics, Volume 113, Issue 1, April 2011, published by Elsevier.
Source:
International Federation of Gynecology and Obstetrics (FIGO)
Elsevier
Independence Blue Cross Delivers Important Reminder To Women During Cervical Cancer Awareness Month
the United States are diagnosed with cervical cancer and 3,700 women die
unnecessarily from this disease(1). In recognition of Cervical Cancer
Awareness month, Independence Blue Cross will make more than 100,000 member
outreach calls reminding women that early detection and prevention of
cancer can help save lives.
During this educational campaign, Independence Blue Cross will remind
women ages 21-49 to receive their cervical cancer screening. In addition,
women will be encouraged to discuss the Human Papillomavirus (HPV) vaccine,
which is recommended for girls ages 11-12 and females ages 13-26, with
their health care providers. HPV is one of the most common sexually
transmitted infections in the United States and most cases of cervical
cancer are associated with previous HPV infection.
Independence Blue Cross is providing this important reminder to members
because research shows that receiving the three-shot HPV vaccine and
recommended cervical cancer Pap test screening can decrease the chance of
developing cervical cancer(2). However, it is important to note that even
if a woman has had the HPV vaccine, she will continue to require regular
cervical cancer screening by the Pap test and the HPV test when
recommended(2).
"Our goal is to help keep our members healthy today, tomorrow, and well
into the future," Says Dr. Esther Nash, senior medical director of
Population Health and Wellness at Independence Blue Cross. "Prevention is a
key. Providing important reminders about health screenings and
vaccinations, wellness education, and increasing members' awareness of
consumer tools and resources available to them are just some of the ways
we're helping to keep our members feeling great in '08 and beyond."
About Independence Blue Cross
Independence Blue Cross is a leading health insurer in southeastern
Pennsylvania. Nationwide, Independence Blue Cross and its affiliates
provide coverage to nearly 3.4 million people. For 70 years, Independence
Blue Cross has offered high-quality health care coverage tailored to meet
the changing needs of members, employers, and health care professionals.
Independence Blue Cross's HMO and PPO health care plans have consistently
received the highest ratings from the National Committee for Quality
Assurance.
Independence Blue Cross is an independent licensee of the Blue Cross
and Blue Shield Association. More information about Independence Blue Cross
is available at ibx.
References
1. American Cancer Society, 2007
2. National Cervical Cancer Coalition
Independence Blue Cross
ibx
New HHS Grant Will Allow Pennsylvania HIV, STI Education Program Targeting Hispanic Women To Continue
The partnership's executive director, Cheryl Guthier, said that it focuses on the city of Reading because of its large Hispanic population, adding that the program plans to expand to Muhlenberg Township, which also has a large Hispanic population. The Eagle reports that the program's classes help alleviate the stigma that can prevent open discussion about HIV/AIDS and substance abuse. The partnership has offered the program for about eight years, the Eagle reports. The recent grant is the third from HHS' Center for Substance Abuse and Prevention. Guthier said because the grant is for five years, there is "more time to do services in the community, more time to evaluate whether or not it's effective." She added, "It will enable us to reach more people" (Negley, Reading Eagle, 3/10).
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.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Moffitt Cancer Center Partners With Saks Fifth Avenue For KEY TO THE CURE
A Kickoff Party will get the weekend started. On Wednesday, Oct. 17, from 5:30 p.m. to 9 p.m., Saks Fifth Avenue will be open to more than 500 guests for a private VIP reception chaired by Susan Taulbee and Susan Thompson. The honorary chairs are Don and Erika Wallace of Lazydays RV. Guests once again will be dazzled by a fashion show featuring women who have survived cancer and who will have Tampa Bay Buccaneers as their escorts. Fleming's Prime Steakhouse and Wine Bar will provide the food, and Barefoot Wines will bring the wine to this evening of entertainment, auctions and shopping. Saks Fifth Avenue will close its store during the party. Tickets are $100 per person, $250 for event supporters and $600 per patron, which includes two tickets to the Patron Party and the Kickoff Party.
Also, Tampa Saks Fifth Avenue and Moffitt will again feature the Sponsor a Survivor program. Individuals and businesses are invited to make a $750 donation to honor a woman who has survived some type of women's reproductive cancer: breast, ovarian, uterine or cervical. Honorees will receive a day of pampering at The Salon & Spa at Saks Fifth Avenue. The sponsor and the survivor will receive two tickets to the Kickoff Party and the Patron Party.
KEY TO THE CURE, in partnership with EIF, takes place each fall in Saks Fifth Avenue stores nationwide to benefit organizations involved with the treatment and research of women's reproductive cancers. Actress Renee Zellweger has been named EIF's 2007 ambassador for this event. Zellweger will appear in national public service announcements and in major fashion and lifestyle magazines wearing the limited edition T-shirt designed by Juicy Couture. Mercedes-Benz will continue its national partnership.
Saks Fifth Avenue initiated its shopping weekend in 1999. Since then, the company has donated more than $20 million to women's cancer research and treatment organizations throughout the United States. Locally, the Tampa and Sarasota communities have demonstrated their dedication to ending cancer by donating more than $600,000 to research efforts at Moffitt.
About H. Lee Moffitt Cancer Center & Research Institute
Located in Tampa, Florida on the University of South Florida campus, H. Lee Moffitt Cancer Center & Research Institute is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer and ear, nose and throat. Moffitt's sole mission is to contribute to the prevention and cure of cancer.
moffitt
Kaiser Daily Women's Health Policy Report Highlights Issues Related To 2006 Election
The following highlights election-related news on women's health issues.
Missouri: The Missouri Coalition for Lifesaving Cures -- which is supporting a measure that would amend the state constitution to ensure that stem cell research permitted under federal law is protected in the state and would prohibit human cloning -- has raised $28.7 million for its campaign, $28 million of which has come from one source. Opponents of the initiative have likely raised less than $2 million, the St. Louis Post-Dispatch reports (Franck, St. Louis Post-Dispatch, 10/16). The proposal, titled the Missouri Stem Cell Research and Cures Initiative, would allow stem cell research that involves somatic cell nuclear transfer, which some consider a type of human cloning. Somatic cell nuclear transfer is conducted by inserting the genetic material from a patient's cell -- usually from a skin cell -- into an unfertilized egg from another person. The patient's genetic material incorporates into the egg and causes it to develop into an embryo that is a genetic match to the skin cell patient (Kaiser Daily Women's Health Policy Report, 6/8). The $28 million donation to MCLC came from Jim and Virginia Stowers, founders of American Century Investments. According to the Post-Dispatch, the couple declined an interview request, but their attorney David Welte said, "They are cancer survivors who are able to fund research that benefits the whole of Missouri." Jaci Winship of the Missourians Against Human Cloning, which is opposing the measure, said opponents likely will raise between $3 million and $5 million by election day (St. Louis Post-Dispatch, 10/16).
Missouri: The state embryonic stem cell ballot initiative -- which was "a defining issue" in the U.S. Senate race between incumbent Sen. Jim Talent (R) and state Auditor Claire McCaskill (D) earlier this year -- recently has become "almost too hot to touch" in a race that "appears to be a dead heat," the New York Times reports (Saulny, New York Times, 10/15). McCaskill, who supports the measure, has said it would "enabl[e] Missouri doctors and researchers to be at the forefront of lifesaving research." Talent has said, "I personally cannot support the initiative because I've always been opposed to human cloning, and this measure would make cloning human life at the earliest stage a constitutional right" (Kaiser Daily Women's Health Policy Report, 5/3). McCaskill after a recent debate in Clayton, Mo., said the initiative is not included in her typical campaign speech but added, "It's not that I'm ignoring it, but the stem cell issue usually comes up in the context of question and answer." Talent said he has "urged everyone" to decide "on their own" how to vote on the measure (New York Times, 10/15).
South Dakota: U.S. House candidate Bruce Whalen (R), who opposes abortion rights, during a televised debate on South Dakota Public Broadcasting on Tuesday criticized incumbent Rep. Stephanie Herseth (D) for opposing a state law (HB 1215) banning abortion in the state except to save a woman's life, the Associated Press reports (Kafka, Associated Press, 10/18). The South Dakota Campaign for Healthy Families -- a coalition of opponents of the ban -- successfully blocked the July 1 enactment of the law by gathering enough signatures to put the issue on the November ballot (Kaiser Daily Women's Health Policy Report, 10/13). Whalen -- who also criticized Herseth for taking contributions from Planned Parenthood Federation of America and NARAL Pro-Choice America -- said he would vote to sustain the law. Herseth said she has spoken against the ban because it does not allow exceptions for rape and incest, adding, "Mr. Whalen would want the government to make the decision for women and their families that face dire circumstances. I believe the individual is in the best position to make that very personal and private decision." Libertarian Party candidate Larry Rudebusch said both sides in the abortion-rights debate should be working to try and find effective means of reducing the number of abortions (Associated Press, 10/18).
South Dakota: Campaigns supporting and opposing the state abortion ban say that "behind-the-scenes" work to get their voters to the polls next month will determine the outcome of the ballot referendum, the AP/Yankton Daily Press reports. Jan Nicolay, head of the Campaign for Healthy Families, said abortion-rights opponents have the advantage of having a long-standing organization of supporters, while "[w]e have to identify our voters because we didn't have that base to start with." The Campaign for Healthy Families will continue its door-to-door campaign to encourage voters to reject the ban, Nicolay said. Leslee Unruh -- head of VoteYesforLife, which supports the law -- said the group's supporters will display more than 30,000 signs before the election and encourage physicians and others to advocate for voters to approve the law. "Our people are well trained and organized," Unruh said, adding, "They've waited a long time for a day like this to come, where they come together and work to do something." According to the AP/Daily Press, both sides plan to continue to run television advertisements (Brokaw, AP/Yankton Daily Press, 10/17).
NPR's "Talk of the Nation" on Wednesday included a discussion of issues on state ballots, including stem cell research in Missouri and the abortion ban in South Dakota. Guests on the program included:
Kareem Crayton, assistant professor of law and politics at the University of Southern California Gould School of Law;
Bill Richardson, chair of the political science department at the University of South Dakota; and
Steve Kraske, host of KCUR's "Up to Date" and political correspondent for the Kansas City Star (Conan, "Talk of the Nation," NPR, 10/18).
The complete segment is available online in RealPlayer.
"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.
Do Testosterone Patches Help Women With Under-active Pituitary Glands?
Loss of ovarian and/or adrenal function can cause many women to experience hypopituitarism or under-active pituitary glands, and therefore low levels of testosterone, which is responsible for producing estrogen. This lack of testosterone can be blamed for loss of sex drive, loss of muscle tone and decrease of cognitive sharpness.
Researchers, led by Karen K. Miller, M.D., wanted to determine whether using physiological testosterone replacement in the form of dermal patches would improve (1) bone density, (2) body composition and (3) neuro-behavioral function in these women with low testosterone levels resulting from hypopituitarism.
Fifty-one women of reproductive age with low testosterone levels from hypopituitarism participated in this 12-month study by wearing a testosterone-administering patch that delivered 300 mcg daily or a placebo. Researchers analyzed bone density, fat-free mass and fat mass, as well as thigh muscle and abdominal area. Mood, sexual function, quality of life and cognitive function were assessed by questionnaire.
Results demonstrated an encouraging effect, with few side effects, and may prove to be useful in the clinical setting for women with low testosterone levels resulting from under-active pituitary glands.
Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones, and the clinical practice of endocrinology. Endocrinologists are specially trained doctors who diagnose, treat and conduct basic and clinical research on complex hormonal disorders such as diabetes, thyroid disease, osteoporosis, obesity, hypertension, cholesterol and reproductive disorders. Today, The Endocrine Society's membership consists of over 13,000 scientists, physicians, educators, nurses and students, in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society, and the field of endocrinology, visit the Society's web site at endo-society/
Contact: Tadu Yimam
The Endocrine Society & The Hormone Foundation
Tension Free Vaginal Tape Underneath Bladder Base: Does It Prevent Cystocele Recurrence?
Consequently, I began placing them after completion of the anterior colporraphy technique - not as originally intended, underneath the mid-urethra, but instead underneath the bladder base. Of course, the passage of the needles was carried out before starting with the colporraphy sutures. Then, the anterior colporraphy in typical manner ensued, and afterwards the previously placed vaginal tape was fixed with Vicryl sutures underneath the bladder base. Initially I used both TVT and TOT tapes, but in a further series of cases, I used only TOT tapes in order to establish a more homogeneous study.
I must say it is appealing to use these tapes in this manner, as they are able to serve as a second-line option to vaginal meshes. The follow-up data are encouraging since thus far no dyspareunia in any of the patients has been noted.
This usage could evolve to become a solution for younger patients, however, longer follow up is required, and of course a wider ranging study.
Theoharis Tantanasis, MD as part of Beyond the Abstract on UroToday
UroToday - the only urology website with original content global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:
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Copyright © 2008 - UroToday
Rite Aid Pharmacists Have A Heart For Those Who Want To Stay Heart Healthy
Working with Billy Blanks, Tae Bo creator, actor, author and humanitarian, the Rite Aid drugstore chain is offering exclusive heart-healthy tips and information. The information includes a set of Amped Moves developed by Billy Blanks himself just for Rite Aid customers. Performing these cardio exercises is the perfect way for customers of any fitness level, age and ability, to take a positive step on the road to better health. Customers can visit any Rite Aid store nationwide to pick up the free materials, and start leading healthier lives.
The free comprehensive Rite Aid Heart Guide provides information on detection and prevention of heart disease. It also offers helpful advice on heart risks, the signs of a heart attack, and helpful products to aide heart health, among other things. "Rite Aid pharmacists and associates are committed to providing the everyday products and services to help valued customers lead healthier lives," said John Learish, Rite Aid's senior executive vice president of marketing. "Couple our Heart Guide with the Billy Blanks Amped Moves workout, and customers will be on their way to battling heart disease."
Customers can also receive a Billy Blanks cookbook with heart smart recipes if they purchase $30 worth of select items.
Rite Aid is also giving customers the chance to purchase a "Red Dress" for $1 at any location nationwide. All proceeds from the "Red Dress" sales will benefit the Go Red for Women movement of the American Heart Association.
Rite Aid customers aren't the only ones encouraged to take part in the heart healthy campaign - Rite Aid associates are getting in on the action, too. On Friday, February 1, associates across the country will wear red to participate in the AHA's National Go Red for Women Day.
Rite Aid's focus on heart health is part of its yearlong commitment to patient health and wellness. Each year Rite Aid offers free information, answers and guidance on health and wellness topics including allergy awareness, skin care, pain management, diabetes and heart health.
Rite Aid Corporation is one of the nation's leading drugstore chains with more than 5,000 stores in 31 states and the District of Columbia. Information about Rite Aid, including corporate background and press releases, is available through the company's website at riteaid/.
Since 2004, Go Red for Women has captured the energy, passion and intelligence of women to work collectively to wipe out heart disease - the No. 1 killer of women. We want millions of women across America to take heart disease personally. Using the platform "Love Your Heart," Go Red for Women engages women and the men who love them to embrace the cause. Healthcare providers, celebrities and politicians also elevate the cause and spread the word about women and heart disease.
GoRedForWomen
Hair Test Can Help Detect Anorexia Nervosa And Bulimia
You can read about this in the journal Rapid Communications in Mass Spectrometry.
The new test analyzes carbon and nitrogen content in your hair. The nutritional health of a person can be determined because the body records eating habits in the hair. As your hair grows, new proteins are added to the base of each strand. What you eat influences the proteins. You could say that your hair is your nutritional chemical diary.
Lead researcher, Kent Hatch, said "By taking some hairs from an individual and analyzing it for carbon and nitrogen, we can tell with 80 percent accuracy whether someone has anorexia or bulimia. The test provides an objective way of discerning whether they have an eating disorder."
The scientists wanted to see whether the test could differentiate between people who have an eating disorder and those who don't. They found that it was so effective they needed no more than five strands of hair per person.
Kent Hatch said the test could eventually help monitor a patient's progress. He added that further studies are needed before the test can be effectively used by healthcare professionals.
"An objective means of diagnosing anorexia nervosa and bulimia nervosa using 15N/14N and 13C/12C ratios in hair"
Kent A. Hatch, Morgan A. Crawford, Amanda W. Kunz, Steven R. Thomsen, Dennis L. Eggett , Stephen T. Nelson , Beverly L. Roeder
Rapid Communications in Mass Spectrometry
DOI 10.1002/rcm.2740 - Volume 20, Issue 22 , Pages 3367 - 3373
Click here to see abstract online
The Scent Of A Woman: Men's Testosterone Responses To Olfactory Ovulation Cues
Smells are known to be critical to animal mating habits: Animal studies have shown that male testosterone levels are influenced by odor signals emitted by females, particularly when they are ovulating (that is, when they are the most fertile). Psychological scientists Saul L. Miller and Jon K. Maner from Florida State University wanted to see if a similar response occurs in humans. In two studies, women wore tee shirts for 3 nights during various phases of their menstrual cycles. Male volunteers smelled one of the tee shirts that had been worn by a female participant. In addition, some of the male volunteers smelled control tee shirts that had not been worn by anyone. Saliva samples for testosterone analysis were collected before and after the men smelled the shirts.
Results revealed that men who smelled tee shirts of ovulating women subsequently had higher levels of testosterone than men who smelled tee shirts worn by non-ovulating women or men who smelled the control shirts. In addition, after smelling the shirts, the men rated the odors on pleasantness and rated the shirts worn by ovulating women as the most pleasant smelling.
The authors note that "the present research is the first to provide direct evidence that olfactory cues to female ovulation influence biological responses in men." In other words, this study suggests that testosterone levels may be responsive to smells indicating when a woman is fertile. The authors conclude that this biological response may promote mating-related behavior by males.
Source: Barbara Isanski
Association for Psychological Science
Weekly Progesterone Derivative Injections Could Have Prevented 10,000 Premature Births in 2002, Study Says
Previous Study
According to an NIH-funded study published in the New England Journal of Medicine in June 2003, Dr. Paul Meis of Wake Forest University and colleagues conducted a double-blind, placebo-controlled study at 19 clinical centers across the nation involving pregnant women at 16 to 20 weeks of gestation, each of whom had a documented history of spontaneous early delivery. Researchers assigned 310 women to receive weekly injections of 250 mg of 17P and 153 women to receive weekly injections of an inert oil placebo. All participants received injections until delivery or up to 36 weeks gestation. Researchers found that 36% of the women who received progesterone injections delivered before 37 weeks gestation, compared with 55% of women who received the placebo. In addition, progesterone appeared to be "even more effective" during the earlier weeks of pregnancy, with only 11% of women who received progesterone delivering before 32 weeks, compared with 20% of women in the placebo group (Kaiser Daily Reproductive Health Report, 6/12/03). A November 2003 opinion issued by the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice calls for additional research on the 17P's role in preventing premature birth and reminds doctors to restrict the use of 17P to pregnant women with a history of spontanteous premature birth at less than 37 weeks of gestation (ACOG release, 10/31/03). According to the March of Dimes, more than 470,000 infants are born prematurely each year, and the rate of premature births in the United States has risen 29% since 1981 (March of Dimes release, 1/31).
"Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily Reproductive Health Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/repro. The Kaiser Daily Reproductive Health 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.
How Obama Can Effect Health Care Reform
is highly optimistic regarding President-elect Obama's ability to
influence real change in health care policy - one of the United
States' most divisive political issues.
"Health system
strengthening must be a top priority for the new administration if 46
million uninsured US residents are to have access to health care," say
the writers of the editorial. "Obama's plans to offer a range of
payment
choices, his commitment to ensure that all children have health
insurance, and the requirement that insurance companies cover
pre-existing conditions are positive steps towards an inclusive health
system. In addition, Medicaid and Medicare must be rebuilt, reinforced,
and fully supported."
They add that, "It was encouraging to hear UK Prime
Minister Gordon Brown say at last week's international conference on
the Social Determinants of Health in London that Barack Obama is
committed to tackling domestic and global inequality."
According to the editorial, Obama's plan for global health
must consider climate change, two ongoing wars, and trade relations.
The writers propose six steps with which Obama can effect meaningful
change:
"Health equity and human
security should be a stated objective of foreign policy."
"The
DHHS Director of Global Health Affairs, Bill Steiger - who has badly
hurt
America's reputation in global health - should be replaced with a more
experienced and appropriate politician."
"Mark Dybul, the head of
PEPFAR - the President's Emergency Plan for AIDS Relief, undoubtedly
the
biggest triumph of the Bush administration despite its
controversies - will likely be swiftly replaced. Strong leadership from
a
respected international expert, such as Jim Kim, could help to negate
PEPFAR's dogmatic and damaging policies - for example, its preference
for
abstinence-until-marriage programmes."
"Just as George W Bush
reinstated the global gag rule - a law that forces recipients
of federal
funding to agree that they will not perform or promote abortion as a
method of family planning - in his first day in office, Obama could
reverse this decision as soon as he is inaugurated and so improve
women's access to sexual and reproductive health in a single stroke."
"A public commitment to agree to spend the internationally
agreed
target of 0.7% of gross national income on aid by 2015 would set a good
example to the international community."
"As a signal that the USA
is committed to human rights, Obama could bring the USA in line with
most other UN member states by ratifying the UN Convention on the
Rights of the Child and the International Covenant on Economic, Social
and Cultural Rights."
The writers also hope that Obama will not be as antagonistic towards
the UN system as the Bush administration was.
"The choice of
the next UN Ambassador is
pivotal to improving these relationships, in health as well as in other
domains," concludes the editorial. "An increase in support - including
financial support - for WHO
would be a sign that the USA wishes to re-engage with the global health
community. President-elect Obama is a reminder about what is great
about the USA and that, indeed, 'change can happen'. The fruits of that
change will be judged by tangible improvements to the welfare and
health of Americans - and those affected by American foreign policy."
Obama and health: change can happen
The Lancet (2008). 372[9651]:
p. 1708.
Click Here to
View Journal Website
: Peter M Crosta
Stand Up To Cancer Funds Joint Effort By M. D. Anderson, Harvard, Memorial-Sloan-Kettering
The grant is one of five that bring top researchers from different institutions together to speed new cancer treatments to patients. Stand Up to Cancer, a program of the Entertainment Industry Foundation, is a novel charitable initiative that raised most of its funds during a telecast last September that aired simultaneously on ABC, NBC and CBS.
"The pathway involved here is the most common abnormally activated pathway in all of cancer," said Gordon Mills, M.D., Ph.D., professor and chair of M. D. Anderson's Department of Systems Biology and a co-leader on the project with two other scientists. "What we learn in women's cancers will apply to many other types."
Genetic aberrations in the network, known as the PI3K pathway, are found in half of all breast cancer patients, 60 percent of all cases of endometrial cancer and 20 percent of ovarian cancer patients. Other cancers that include a mutationally activated PI3K pathway include melanoma, colon and prostate cancers, brain tumors, and leukemia.
A variety of drugs under development target different aspects of the complex pathway, which Mills describes as a "target-rich environment."
"Our major goal is to determine which patients are most likely to benefit from these drugs, so that we get the right therapy to the right patient the first time," he said. "By the end of three years we are expected to have changed the way in which we manage patients. That's a very large challenge."
Dream Team collaborators with Mills are project leader Lewis C. Cantley, Ph.D., chief, division of signal transduction, Cancer Center at Beth Israel Deaconess Medical Center and professor of systems biology at Harvard Medical School, and co-leader Charles Sawyers, M.D., director, Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center in New York. The Dream Team also includes research groups at Vanderbilt-Ingram Cancer Center, Vall d'Hebron Oncology Research Institute in Barcelona, and Herbert Irving Comprehensive Cancer Center at Columbia University.
The PI3K network normally promotes cell survival, growth and protein synthesis. When it is abnormally activated by genetic aberrations, it contributes to tumor progression, connects to other cancer-causing pathways and causes resistance to treatment.
The team will use its combined cell line studies, animal model research and data from drugs that have completed phase I clinical trials to identify potential biomarkers - specific genetic mutations in patients' tumors, for example - that will indicate whether a drug will work for specific groups of patients.
Clinical trials of the targeted drugs also will test the validity of candidate biomarkers. Mills, who also directs the Kleberg Center for Molecular Markers at M. D. Anderson, expects the first phase II clinical trial, for endometrial cancer, to open in about six months.
Mills leads the team's tumor cell line and screening core, which will analyze every tumor sample to detect cancer-related genetic mutations, study the effect of genetic aberrations on the PI3K pathway and on PI3K inhibitors used in clinical trials, and identify drug combinations to block the pathway and biomarkers related to those drugs.
Combinations will likely be needed both to stifle the PI3K pathway and to inhibit a second interacting pathway, the MAPK/RAS network. Early cell line and animal model evidence suggest both pathways must be blocked to effectively treat the three cancers.
Also on the Dream Team from M. D. Anderson are Donald Berry, Ph.D., head of the Division of Quantitative Biology; Cheryl Lyn Walker, Ph.D., professor in the Department of Carcinogenesis and the co-director of M. D. Anderson's Gynecology Specialized Program in Research Excellence; and Russell Broaddus, M.D., Ph.D. associate professor in the Department of Pathology.
Clinical trials will be based at M. D. Anderson. The endometrial trials will be led by Karen Lu, M.D., and Robert Coleman, M.D., both professors, with Bryan Hennessy, M.D., assistant professor, all of the Department of Gynecologic Medical Oncology. Funda Meric-Bernstam, M.D., associate professor in the Department of Surgical Oncology, will be coordinator of clinical trials as well as leader of the breast cancer trials, working with Ana Gonzalez-Angullo, M.D., associate professor of breast medical oncology.
Stand Up to Cancer received 237 Dream Team applications and awarded a total of $73.6 million to the five teams announced at a news briefing in New York.
Source:
Scott Merville
University of Texas M. D. Anderson Cancer Center
Mandatory HPV Vaccination 'Presents Ethical Concerns,' Likely 'Counterproductive,' JAMA Editorial Says
Merck's HPV vaccine Gardasil and GlaxoSmithKline's HPV vaccine Cervarix in clinical trials have been shown to be 100% effective in preventing infection with HPV strains 16 and 18, which together cause about 70% of cervical cancer cases. FDA in July 2006 approved Gardasil for sale and marketing to girls and women ages nine to 26, and CDC's Advisory Committee on Immunization Practices later that month voted unanimously to recommend that girls ages 11 and 12 receive the vaccine. GSK last month announced that it has filed for FDA approval of Cervarix (Kaiser Daily Women's Health Policy Report, 4/23).
According to DeAngelis and Gostin, the effort to make the vaccine mandatory "contributes to long-standing parental concerns about the safety of school-based vaccinations" and has the "unintended consequence of heightening parental and public apprehensions about childhood vaccinations." Mandatory HPV legislation has "undermined public confidence and created a backlash among parents," the authors write, adding, "Public health authorities, pediatricians and infectious disease specialists, rather than political bodies, should drive mandatory vaccination decisions and policies."
Another concern surrounding mandatory HPV vaccination is how vaccine recipients "would be compensated if they incurred serious adverse effects" from a vaccine the state required. According to the authors, the vaccine is "supported by limited efficacy and safety data" and "still need[s] to be evaluated among a large population, and particularly among younger girls." DeAngelis and Gostin write that the HPV vaccine "is not immediately necessary to prevent harm to others," concluding that in the absence of such an "immediate risk of serious harm, it is preferable to adopt voluntary measures, making state compulsion a last resort" (JAMA, 5/2).
"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.
View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil.
Abortion Chemical May Prevent Breast And Ovarian Cancer
Mifepristone blocks the action of progesterone during the first three months of pregnancy, effectively leading to the death of the embryo/foetus. Progesterone is also nourishment for some types of cancer, without which they cannot grow. At a lower dose, Mifepristone can also be an emergency contraceptive.
You can read about this latest study in the journal Science.
The researchers, after carrying out studies on mice, believe that RU-486 may be beneficial for women who have a genetic propensity to developing cancer. Over 50% of women who carry a faulty BRCA1 gene will have either breast or ovarian cancer by their 70th birthday.
In this study, the scientists examined mice which had been genetically engineered to lack the BRCA1 gene. They discovered that the mammary glands of these mice built up more progesterone receptors. Progesterone receptors are molecules that allow progesterone to become effective. The progesterone attaches itself to these receptors and encourages cells to grow abnormally. All the mice had tumours by the time they were eight months' old.
However, half the genetically engineered mice had been treated with mifepristone - and none of these mice went on to develop tumors.
The trouble is, say the scientists, that mifepristone has an effect on other receptors as well. Meaning, mifepristone has some unpleasant side effects. They plan further research which might eventually target just the progesterone blocking action. This could lead to treatment which would prevent breast and ovarian cancers among women who carry the faulty BRAC1 gene.
"Prevention of Brca1-Mediated Mammary Tumorigenesis in Mice by a Progesterone Antagonist"
Aleksandra Jovanovic Poole, Ying Li, Yoon Kim, Suh-Chin J. Lin, Wen-Hwa Lee, Eva Y.-H. P. Lee
Science 1 December 2006 Vol. 314. no. 5804, pp. 1467 - 1470
DOI: 10.1126/science.1130471
Click here to see the abstract online
Palatin Technologies, Inc. Reports Positive Data From An At Home Study Of Pre And Postmenopausal Women With Female Sexual Arousal Disorder
(Amex: PTN) announced positive results from an at home Phase 2 trial
evaluating bremelanotide for the treatment of female sexual arousal
disorder (FSAD). The objective of this exploratory study was to identify
potential efficacy endpoints for future studies and to evaluate the safety
of intranasal (IN) bremelanotide, relative to placebo and under the
conditions of home use, for the treatment of FSAD in pre and
postmenopausal women.
"We are pleased with the overall data from this exploratory trial. The
efficacy response was consistent and robust across all domains,
particularly desire and arousal. We look forward to discussing the
program's further development with the FDA, including future dose-ranging
studies to improve the drug's benefit/risk profile," stated Dr. Trevor
Hallam, Executive Vice President of Research & Development for Palatin.
Study Highlights
The trial was double-blinded, placebo-controlled and enrolled 76
premenopausal and 87 postmenopausal women who were followed for one month
to determine their baseline level of sexual dysfunction. The patients were
then randomized to receive IN doses of either placebo or 10 mg of
bremelanotide. Changes in their level of sexual function were assessed over
a two month period using the Female Sexual Encounter Profile (FSEP), the
Female Sexual Function Index (FSFI) and the Female Sexual Distress Score
(FSDS). The first dose was given in the clinic. Prespecified changes in
blood pressure, as well as emesis, led to mandatory discontinuation. All
endpoints were exploratory without preset statistical goals.
Postmenopausal Patient Efficacy Results
In the Intention to Treat Population, the bremelanotide treated
postmenopausal women showed statistically significant improvements,
compared to baseline and placebo, in desire and arousal success rates, and
overall satisfaction at one and two months. In these patients, the FSFI
domains of arousal, desire and orgasm were statistically significantly
improved compared to placebo at one month. The arousal and orgasm domains
were statistically significantly improved compared to placebo at one and
two months.
Premenopausal Patient Efficacy Results
In the Intention-to-Treat Population, the bremelanotide treated
premenopausal women showed statistically significant improvements, compared
to baseline, in desire and arousal success rates, and overall satisfaction
at one and two months. However, while there was a consistent trend to
greater improvement in these measures in bremelanotide patients compared to
placebo treated patients, the differences were not statistically
significant between bremelanotide and placebo treated patients because the
placebo responses were themselves statistically significantly improved
compared to baseline.
Pre and Postmenopausal Safety Results
Adverse events where the incidence was higher than the incidence
associated with placebo primarily included nausea, emesis, flushing, blood
pressure increase, headache and nasal symptoms. There were no serious
adverse events related to bremelanotide. The most common cause for
mandatory discontinuation was protocol-specified blood pressure increase
criteria.
Preliminary Conclusions
Based on these data, Palatin is encouraged about the use of
bremelanotide for FSAD and believes that future studies in patients with
FSAD are warranted. Future dose-ranging studies at 10 mg and lower will be
necessary to improve the drug's benefit/risk ratio. Palatin plans to engage
the FDA in discussions regarding future development later this calendar
year.
Dr. Eileen Palace, The Center for Sexual Health, Metairie, LA, stated,
"With no approved medical therapies to treat patients with FSAD, I believe
the results of the clinical trials with bremelanotide warrant further
development." Dr. Palace is an investigator who enrolled patients in the
study and a member of the Bremelanotide Scientific Advisory Board.
Palatin's executive management will present additional detail of the
results of this study at future scientific meetings.
About Female Sexual Dysfunction (FSD)
FSD includes four disorders, hypoactive sexual desire disorder, female
sexual arousal disorder, dyspareunia and anorgasmia. To establish a
diagnosis of FSD, these syndromes must be associated with personal
distress, as determined by the affected woman. A February 10, 1999 study
published in the Journal of the American Medical Association, titled,
"Sexual Dysfunction in the United States: Prevalence and Predictors,"
states that approximately 43 percent of the postmenopausal female
population suffers from some form of FSD.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on
discovering and developing targeted, receptor-specific small molecule and
peptide therapeutics. The Company's internal research and development
capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling
product development. Palatin's strategy is to develop products and then
form marketing collaborations with industry leaders in order to maximize
their commercial potential. The Company currently has collaborations with
AstraZeneca and the Mallinckrodt division of Covidien. For additional
information regarding Palatin, please visit the Company's website at
palatin.
Forward-looking Statements
Statements about the Company's future expectations, including
statements about its development programs, the significance of the results
of clinical trials, the conduct of future clinical trials, proposed
indications for its product candidates, pre-clinical activities, marketing
collaborations, and all other statements in this document other than
historical facts, are "forward- looking statements" within the meaning of
Section 27A of the Securities Act of 1933, Section 21E of the Securities
Exchange Act of 1934 and as that term, is defined in the Private Securities
Litigation Reform Act of 1995. The Company intends that such
forward-looking statements shall be subject to the safe harbors created
thereby. Palatin's actual results may differ materially from those
discussed in the forward-looking statements for various reasons, including,
but not limited to the Company's ability to fund development of its
technology, ability to establish and successfully complete clinical trials
and pre-clinical studies and the results of those trials and studies,
dependence on its partners for certain development activities, need for
regulatory approvals and commercial acceptance of its products, ability to
recommence marketing and gain commercial acceptance of NeutroSpec(R),
ability to protect its intellectual property, and other factors discussed
in the Company's annual report and Form 10-K for the year ended June 30,
3007 and other periodic filings with the Securities and Exchange
Commission. The Company is not responsible for updating for events that
occur after the date of this press release.
Palatin Technologies, Inc.
palatin
Research Examines Use Of Antiretroviral Pills, Gels For Possible 'Pre-Exposure Prophylaxis' For HIV
Since antiretrovirals first became available in 1996, experts have debated how early, how long and how often the drugs should be used. For people who already have HIV, "[i]t's now clear that interrupting treatment is not a good idea and that starting it early in the course of infection may have real benefits, even though it means a lifetime of daily pill taking," according to the Post. If the new research is successful, it could mean that the drugs "are on the threshold of a new life as tools to prevent infection in individuals and brake the epidemic in populations as a whole," the Post reports. It is already known that administering antiretrovirals to newborns immediately after birth and during breastfeeding greatly reduces the chance of mother-to-child transmission. "We know that prevention works in babies. It shouldn't be any different in adults," John Mellors, a researcher at the University of Pittsburgh and chair of the conference, said (Brown, Washington Post, 2/21).
Gels Hold Promise for Women
The development of an antiretroviral gel that could prevent HIV transmission would be particularly beneficial to women. Women in Africa account for most new HIV cases and are often infected by their husbands, Reuters reports.
In a study presented at the conference, the drug maraviroc, sold by Pfizer under the brand name Selzentry, protected female monkeys from sexual transmission for about four hours after application. Weill Cornell Medical College's John Moore, who participated in the study, said that a vaginal ring with a time-release formula might work better for long-term protection. Selzentry is part of a new class of drugs called CCR5 entry inhibitors, which are designed to stop HIV from entering human cells. CCR5 inhibitors are not yet widely used for treatment in Africa, which means there is a lower risk that patients will develop resistance, Moore said.
Laura Guay of the Elizabeth Glaser Pediatric AIDS Foundation said her group supports the development of microbicides to protect women and, in turn, their children. "The hope is by putting antiretrovirals into the microbicide you can prevent the virus from either entering or replicating," she said (Fox, Reuters, 2/20).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
View drug information on Selzentry.
Wrongful-Death Lawsuit Filed Against Ortho Evra Manufacturer Ortho-McNeil
"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.
Elbit Imaging Announces InSightec's First Non-Invasive Technology For Treatment Of Uterine Fibroids Awarded MHLW Approval In Japan
ExAblate is currently the only noninvasive treatment for uterine fibroids approved for use in Japan.
InSightec Ltd. estimates that approximately 25% of Japanese women will develop symptomatic uterine fibroids, primarily during childbearing years. These benign tumors can significantly impair functionality and degrade quality of life, resulting in significant work absences.
Using the ExAblate system, the physician uses the Magnetic Resonance Imaging (MRI) to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. An additional benefit of using InSightec's ExAblate system is that during the procedure to destroy the targeted tissue, patients require only limited conscious sedation as opposed to full sedation.
The ExAblate system received the CE Mark for uterine fibroids in October 2002 and US Food and Drug Administration (FDA) approval in 2004. Over 5,500 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery.
GE Healthcare is the approval holder and distributor of ExAblate in Japan.
Dr. Kobi Vortman, President and Chief Executive Officer of InSightec, said: "The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition. ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE."
Dudi Machluf, Chief Executive Officer (Co-CEO) of Elbit Imaging, said: "InSightec's technology is the first non-invasive treatment for uterine fibroids approved for use by Japan's Ministry of Health, Labor and Welfare (MHLW), an accomplishment which speaks for itself. In receiving this approval, InSightec made significant progress towards increasing its activity in Japan and receiving reimbursement. We expect that InSightec will leverage the great potential capitalized in this in this market."
About InSightec
InSightec Ltd. is a privately held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas.
About Elbit Imaging Ltd.
The Activities of Elbit Imaging Ltd. are divided into the following principal fields: (i) Shopping and Entertainment Centers - Initiation, construction, operation, management and sale of shopping and entertainment centers and other mixed-use real property projects, predominantly in the retail sector, located in Central and Eastern Europe and in India; (ii) Hotels - Hotel ownership, operation, management and sale, primarily in major European cities; (iii) Image Guided Treatment - Investments in the research and development, production and marketing of magnetic resonance imaging guided focused ultrasound treatment equipment; (vi) Residential Projects - Initiation, construction and sale of residential projects and other mixed-use real projects, predominantly residential, located in Eastern Europe and in India; and (v) Other Activities - (a) The distribution and marketing of fashion apparel and accessories in Israel; (b) venture capital investments; and (c) investments in hospitals, and farm and dairy plants in India, which are in preliminary stages.
Any forward-looking statements in our releases include statements regarding the intent, belief or current expectations of Elbit Imaging Ltd. and our management about our business, financial condition, results of operations, and its relationship with its employees and the condition of our properties. Words such as "believe," "expect," "intend," "estimate" and similar expressions are intended to identify forward-looking statements but are not the exclusive means of identifying such statements. Actual results may differ materially from those projected, expressed or implied in the forward-looking statements as a result of various factors including, without limitation, the factors set forth in our filings with the Securities and Exchange Commission including, without limitation, Item 3.D of our annual report on Form 20-F for the fiscal year ended December 31, 2008, under the caption "Risk Factors." Any forward-looking statements contained in our releases speak only as of the date of such release, and we caution existing and prospective investors not to place undue reliance on such statements. Such forward-looking statements do not purport to be predictions of future events or circumstances, and therefore, there can be no assurance that any forward-looking statement contained our releases will prove to be accurate. We undertake no obligation to update or revise any forward-looking statements. All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth in our filings with the Securities and Exchange Commission including, without limitation, Item 3.D of our annual report on Form 20-F for the fiscal year ended December 31, 2008, under the caption "Risk Factors."
Source: Elbit Imaging Ltd
New York Times Examines 'Unusual' FDA Order Requiring Corrections To Yaz Ad Campaign
Yaz is the best-selling oral contraceptive in the U.S., with sales of about $616 million in 2008, according to health care information company IMS Health. FDA approved the drug in 2006 as an oral contraceptive that also treats premenstrual dysphoric disorder, a mood-related psychological problem, and in 2007 expanded the indications to include moderate acne. However, the drug also carries an increased risk of serious heart or other health problems related to the ingredient drospirenone, a progestin that can cause excess potassium production in some patients. FDA in October 2008 sent a warning letter to Bayer stating that two Yaz commercials overstated the drug's benefits and downplayed its risks. The agency said the ads gave consumers the impression that the drug could be used to treat acne and general mood problems, which were not included in its approval. Nada Stotland, a professor of psychiatry at Rush University Medical Center, said the 2008 ads were "basically speaking to a majority of menstruating women," rather than the minority of women with the psychological disorder the drug is approved to treat.
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2009 The Advisory Board Company. All rights reserved.
National Institutes Of Health To Map Genomic Changes Of Lung, Brain And Ovarian Cancers
"The selection of the first three cancer types to be studied by TCGA signals the scientific start of this initiative. Thanks to the tools and technologies developed by the Human Genome Project, scientists can collaborate to determine whether it will be possible to develop a useful atlas of the changes in the human genetic blueprint associated with all types of cancer," said NIH Director Elias A. Zerhouni, M.D.
It is estimated that 174,470 new cases of lung cancer will be diagnosed in the United States in 2006. Lung cancer is the major cause of cancer-related mortality in both men and women, with an estimated 162,460 deaths expected to occur in 2006. Brain tumors account for nearly 90 percent of all primary central nervous system tumors. It is estimated that 18,820 new cases of brain cancer will be diagnosed in the United States this year, and 12,820 patients will die from the disease. Glioblastomas, also called glioblastoma multiforme or grade IV astrocytoma, are often fatal, malignant brain tumors that grow and spread very aggressively, and are the most frequently occurring type of brain cancer. An estimated 20,180 new cases of ovarian cancer and an estimated 15,310 deaths from the disease are expected in the United States in 2006. Often detected late, ovarian cancer causes more deaths than any other cancer of the female reproductive system.
NCI and NHGRI launched TCGA in December 2005 as a collaborative three-year pilot project to test the feasibility of using large-scale genome analysis technologies to determine all of the important genomic changes involved in cancer. When fully operational, TCGA will consist of four integrated components: a Biospecimen Core Resource (BCR); Cancer Genome Characterization Centers; Genome Sequencing Centers; and a Principal Bioinformatics Resource.
Today, the two institutes also announced the biorepositories that will provide biospecimens of the first three cancer types to be studied as part of the TCGA Pilot Project. The source of the lung cancer biospecimens will be the Lung Cancer Tissue Bank of the Cancer and Leukemia Group B (CALGB) clinical trials group, which is housed at the Brigham and Women's Hospital in Boston, Mass. The source of the brain tumor (glioblastoma) biospecimens will be MD Anderson Cancer Center in Houston, Texas. The ovarian cancer biospecimens will be provided by the Gynecologic Oncology Group tissue bank at the Children's Hospital of the Ohio State University in Columbus, Ohio.
NCI and NHGRI also announced today that the International Genomics Consortium, part of the Translational Genomics Research Institute, of Phoenix, Ariz., was selected to establish and manage TCGA's BCR. The BCR will collect, store, process, and distribute biomolecules from cancerous and normal samples to the Cancer Genome Characterization Centers and Genome Sequencing Centers for genomic analysis.
TCGA's Cancer Genome Characterization Centers will analyze samples from the BCR to identify key genomic alterations, such as copy number changes and/or chromosomal rearrangements, some of which are known to contribute to cancer development and/or progression. Selected genes will be sequenced by the Genome Sequencing Centers using high-throughput methods to identify small genomic changes, such as single base mutations and small insertion/deletions. TCGA Cancer Genome Characterization Centers and the Genome Sequencing Centers will be selected in the coming months.
"Cancer is exceedingly complex, and includes more than 200 different diseases. The overall goal of TCGA is to delve more deeply into the genetic origins that lead to this complexity, in order to enable the discovery and development of a new generation of therapies, diagnostics, and preventive strategies for all cancers," noted Acting NCI Director John E. Niederhuber, M.D. "Results from the TCGA Pilot Project may provide the results we need to detect cancer early, in its most treatable stage, and provide new targets for the development of specific therapies."
"The Cancer Genome Atlas will use cutting-edge technologies and knowledge from the Human Genome Project and other genomic studies to assess the range of genomic changes that cause the uncontrolled cell growth that characterizes cancer," explained National Human Genome Research Institute Director Francis S. Collins, M.D., Ph.D. "TCGA will analyze hundreds of tumor specimens with multiple technologies, including the comparison of genome sequences from the cancers with the normal DNA sequence derived from the same patients, in order to identify changes that are specifically associated with cancer."
The three cancers selected for study by TCGA were identified in a process that began in the fall of 2005 with a Request for Information (RFI) from NCI and notification to NCI Cancer Centers. The goal of the RFI was to identify candidate biospecimen collections that employed the highest level of ethical, technical, biologic, pathologic, and bioinformatics standards in the development of their biorepository.
The collections that qualified were evaluated in a three-stage process. The primary criteria addressed minimal requirements for the quality and quantity of the samples and the associated clinical information. Secondary criteria were then applied to effectively rank those tumor collections that met the primary criteria. Site visits to the biorepositories were then conducted by NCI and NHGRI staff. Critical factors for TCGA, such as timing, logistics, and the need for re-consent of patients, were factored into selection of the biorepositories to be considered. Finally, the biorepositories that emerged from this tiered process were further reviewed by an expert panel that included representatives from the surgery, research, pathology, bioethics, and patient advocate communities. The primary, secondary, and additional criteria are described in detail at cancergenome.nih/media/qanda.asp
"The Cancer Genome Atlas Pilot Project is an important opportunity as we survey the potential future of cancer research. We must put aside our specific disease interests and channel our energy into the larger issues that can empower the cancer research enterprise to find new ways to improve outcomes for all cancer patients," said Doug Ulman, cancer survivor, chief mission officer of the Lance Armstrong Foundation, and chair of the NCI Director's Consumer Liaison Group. Success factors for the TCGA Pilot Project include completion of genomic analysis of the three initial cancer types; identification of specific alterations in genes associated with cancer; and differentiation of cancer subtypes based on genomic changes. In addition, the pilot project will establish a publicly available integrated database that scientists can use to generate new knowledge through research. TCGA data will be made available through public databases supported by NCI's cancer Biomedical Informatics GridTM (caBIGTM) and the National Library of Medicine's National Center for Biotechnology Information (NCBI). TCGA data will be provided in a manner that meets the highest standards for protection and respect of the research participants. "The Cancer Genome Atlas is a revolutionary project with the potential to provide cancer researchers the information needed to generate new hypotheses that can be tested in the laboratory and the clinic," said NCI Deputy Director Anna D. Barker, Ph.D. "Achieving the long-term goal of TCGA to identify all of the significant genomic changes in all cancers will benefit patients by enabling the discovery and development of the molecular biomarkers needed to develop targeted interventions to prevent and cure cancer."
Data from the TCGA Pilot Project will provide researchers and clinicians with an early glimpse of what promises to become an unprecedented, comprehensive "atlas" of molecular information describing the genomic changes in all types of cancer. TCGA will ultimately enable researchers throughout the world to analyze and employ the data to develop a new generation of targeted diagnostics, therapeutics, and preventives for all cancers, and pave the way for more personalized cancer medicine.
NCI and NHGRI are two of the 27 institutes and centers at NIH, an agency of the U.S. Department of Health and Human Services.
For more details about The Cancer Genome Atlas, please go to cancergenome.nih/.
More information about lung, brain and ovarian cancers can be found at cancer/cancertopics/types/lung, cancer/cancertopics/types/brain and cancer/cancertopics/types/ovarian, respectively.
For more information about cancer and the National Cancer Institute, please visit the NCI Web site at cancer/.
For more information about the National Human Genome Research Institute, please visit the NHGRI Web site at genome/.
Contact: Geoff Spencer
NIH/National Human Genome Research Institute
Medical Liability A Chronic Crisis - American Congress of Obstetricians and Gynecologists
"The American Congress of Obstetricians and Gynecologists (ACOG) has long endorsed measures to make health care safer for patients while also protecting access to the physicians who care for them. The President's proposal is an important step in the right direction toward fostering a reliable system of medical justice and enacting common sense reforms that protect patients, halt lawsuit abuse, and keep doctors in practice," said ACOG President Richard N. Waldman, MD.
"The medical liability situation for ob-gyns remains a chronic crisis and continues to deprive women of all ages-especially pregnant women-of experienced ob-gyns," said Albert L. Strunk, JD, MD, deputy executive vice president of ACOG. According to an ACOG survey , 90% of ob-gyns have been sued at least once during their professional careers. Currently, the average age at which physicians cease practicing obstetrics is 48, an age once considered the midpoint of an ob-gyn's career.
"Women's health care suffers as ob-gyns further decrease obstetric services, reduce gynecologic procedures, and are forced to practice defensive medicine," added Dr. Strunk. The ACOG survey also found:
- More than 63% of ob-gyns have changed their practice due to the risk or fear of liability claims or litigation.
- One in 12 obstetricians who have changed their practice has stopped delivering babies.
- 15% of ob-gyns have decreased gynecologic surgical procedures because of the risk or fear of being sued.
- Over half of all liability claims against ob-gyns were dropped or settled without payment on behalf of the ob-gyn.
ACOG is fully committed to the enactment of a national law patterned on The HEALTH Act (HR 5) and the Texas and California medical liability reforms. "While ACOG works to attain this goal, we support interim measures and alternatives that address the long delays, excessive costs, and the unpredictability and inequality of compensation in our current system. Successful alternatives could help guarantee that injured patients are compensated fairly and quickly while promoting quality of care and patient safety," said Dr. Waldman.
One alternative in particular which is highlighted in President Obama's budget is health care courts. These special courts would take injury claims out of the adversarial tort system, where facts are often poorly understood, and put them into the hands of experts whose goals are fairness and patient safety. "Health courts would allow for a bench or jury trial presided over by a specially trained judge to exclusively hear medical liability cases. A judge with specialized training would resolve disputes with greater reliability, consistency, and efficiency than would untrained judges or juries and could issue opinions that define standards of care or set legal precedent," noted Dr. Strunk. Other promising alternatives that can make a difference include early offer systems and expert witness qualification programs.
"Without reform of America's broken liability system, women will increasingly find that they cannot get the prenatal and obstetric care they need, and many pregnant women will not be able to find doctors to deliver their babies. Women will lose care that will help protect fertility, end pelvic pain, and detect and treat cancer early," said Dr. Waldman. "Women deserve better."
Source:
American Congress of Obstetricians and Gynecologists (ACOG)