Archive for January, 2008
Swiss change safe sex message on HIV (AP)
The proposal astonished AIDS researchers in Europe and North America who have long argued that safe sex with a condom is the single most effective way of preventing the spread of the disease — apart from abstinence.
“Not only is (the Swiss proposal) dangerous, it’s misleading and it is not considering the implications of the biological facts involved with HIV transmission,” said Jay Levy, director of the Laboratory for Tumor and AIDS Virus Research at the University of California in San Francisco.
The Swiss National AIDS Commission said patients who can satisfy strict conditions, including successful antiretroviral treatment to suppress the virus and who do not have any other sexually transmitted diseases, do not pose a danger to others. The proposal was published this week in the Bulletin of Swiss Medicine.
The Swiss scientists took as their starting point a 1999 study by the U.S. Centers for Disease Control and Prevention, which showed that transmission depends strongly on the viral load in the blood.
The other studies had also found that patients on regular AIDS treatment did not pass on the virus, and that HIV could not be detected in their genital fluids.
“Let’s be clear, the decision has to remain with the HIV-negative partner,” said Pietro Vernazza, head of infectious diseases at the cantonal hospital of St. Gallen in Switzerland and an author of the report.
The studies cited by the Swiss commission did not themselves definitively conclude whether people with HIV and on antiretroviral treatment could safely have unprotected sex without passing on the virus.
The World Health Organization said Switzerland would be the first country in the world to try this approach.
“There is still some concern that you can never guarantee that somebody will not be infectious, and the evidence I have to say is not conclusive,” said Charlie Gilks, director of AIDS treatment and prevention at WHO.
“We are not going to be changing in any way our very clear recommendations that people on treatment continue to practice safer sex, including protected sex with a condom, in any relationship,” he added.
In any case, of the 2 million people worldwide now receiving HIV treatment, only a very small number receive medical care comparable to that in Switzerland, Gilks said.
1 commentNew York Times Publishes Several Women’s Health-Related Articles
The New York Times on Tuesday in its health section published several articles related to women’s health. Summaries appear below.
- “New Insights Into Genital Pain in Women”: As many as one in six women experience vulvodynia — a condition characterized by intense pain when pressure is applied to the vulva — at some point during their lives, according to an NIH-funded study recently conducted by Bernard Harlow of Harvard University, the Times reports. According to recent research led by William Ledger, professor emeritus of obstetrics and gynecology at Weill Cornell Medical College, the condition likely is caused by two genetic factors. In one, women produce an inadequate amount of a substance that blocks inflammation of the vulva. In another, a genetic abnormality causes unstable production of a substance that responds to yeast or bacteria, placing women at increased risk of chronic infections. Ledger said there is solid evidence that many women who experience vulvodynia have excess nerve endings in the vulva. The condition is difficult to treat but has been treated with estrogen, steroids, surgery and pain medications, the Times reports (Brody, New York Times, 1/29).
- “Maladies: Hormone Levels and Chronic Fatigue”: Women with chronic fatigue syndrome have lower amounts of the hormone cortisol when they wake up, according to a study recently published online in the Journal of Clinical Endocrinology and Metabolism, the Times reports. Cortisol helps people deal with stress and might play a role in the condition. The study measured cortisol levels in saliva samples taken from 700 male and female volunteers immediately after waking up, 30 minutes after waking up and one hour after waking up. Some of the participants had the condition and some did not. The lower cortisol levels were not found in men, according to the study. William Reeves, a study author from CDC, said the study could “help to explain the higher prevalence” of the condition in women (Nagourney, New York Times, 1/29). An abstract of the study is available online.
- “Questioning the Allure of Putting Cells in the Bank”: Several companies recently have launched services that collect and store stem cells from sources beyond umbilical cord blood — including menstrual fluid, adult blood, fat removed by liposuction, children’s teeth after they fall out and excess embryos at fertility clinics — the Times reports. Although the new services have a “potentially broader appeal” beyond people who are delivering infants, some experts have said it is not clear how useful the costly services will be in future medical treatments, according to the Times. Collection and storage of menstrual fluid is the latest service. Oldsmar, Fla.-based company Cryo-Cell in November 2007 began a service called C’elle in which women use a silicone menstrual cup that is similar to a tampon to collect two samples from the same menstrual period. One sample is used for disease testing and another is used to extract stem cells. The service costs $499 for collection and processing and an additional $99 annual storage fee. The company has not published research verifying its claim that menstrual stem cells can be used for future treatments, but the company is having outside experts review the stem cells it extracts (Pollack [1], New York Times, 1/29).
- “Menstruation as a Source of Stem Cells? Maybe Not”: Some experts have theorized that menstrual stem cells could be endometrial stem cells that are extracted each month during menstruation, but other experts say it is unlikely the body sheds a large number of stem cells during menstruation, the Times reports. Hugh Taylor, chief of reproductive endocrinology at Yale University, said the healthiest stem cells are from regeneration of the uterine lining during menstruation. Menstrual fluid cells are dying, Taylor said, adding, “I think it’s premature to start telling everyone to go in and save their menses. … A woman can come in and have [an] endometrial biopsy all the time and get those cells in a fresh, pure form” (Pollack [2], New York Times, 1/29).
© 2007 The Advisory Board Company. All rights reserved.
Integration Of Family Planning, Reproductive Health, Antiretroviral Services Could Reduce HIV/AIDS Cases In Africa, Experts Say
Integrating family planning, reproductive health and antiretroviral drug services could reduce the number of new HIV cases in Africa, experts said recently at the fifth African Population Conference in Arusha, Tanzania, the New Vision/AllAfrica.com reports. Researchers, demographers, policymakers and others attending the conference said that offering a combination of related services at a single health center also could reduce costs and stigma, as well as increase accessibility to services and provide additional health benefits.
“Integration of services into one-stop health care centers makes systems more supportive, especially for people living with HIV/AIDS,” William Stone of the department of obstetrics and gynecology at the University of Aga Khan in Nairobi, Kenya, said. He said that most developing countries with high HIV/AIDS burdens focus on prevention of mother-to-child transmission programs but added that “it should be a whole package of preventing infections, unwanted pregnancies, postabortion care, PMTCT, treatment and care.” Stone discussed the findings of two pilot projects in Ghana and Uganda. One study found that 39,000 HIV-positive births were prevented through PMTCT while 71,000 were prevented by family planning programs. “When you avoid unintended pregnancies, you avert more infections,” he said.
According to Elly Mugumya, executive director of Reproductive Health Uganda, integration of services is long overdue. “Given that HIV is a sexuality issue and interlinked, we should have considered integration right from the beginning of our fight against the scourge,” Mugumya said. “Let’s not wait to give [antiretrovirals] and build orphanages. This can only be possible through integration” of family planning, reproductive health and HIV/AIDS treatment, Mugumya added.
Henry Kakande of ACQUIRE Project, a USAID-funded pilot program in Uganda, said that a “one-stop health care center would address” HIV/AIDS-related stigma and discrimination, as well as the lack of awareness about the disease. Providers also would be “empowered to handle such clients as they come because they are not comfortable opening up to different people and this undermines our efforts” to fight the disease and improve child and maternal health, he said.
According to the 2006 State of Uganda Population report, integration would increase efficiency and convenience for patients, as well as opportunities to promote reproductive health and HIV/AIDS awareness. However, the report found that shortages of health care workers might hinder the benefits of integration because demand could overload staff and diminish the quality of care. “Weak logistics systems are another issue, and each aspect requires strong supervision and referrals for management plus follow-up,” the report said (Nabusoba/Emasu, New Vision/AllAfrica.com, 1/28).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Finding That Oral Contraceptive Use Reduces Ovarian Cancer ‘Worth Celebrating,’ Opinion Piece Says
The recent finding that the risk of developing ovarian cancer declines the longer a woman takes oral contraceptives is “worth celebrating, partly because health claims about the pill are often much harder to parse,” Slate columnist Amanda Schaffer writes in an opinion piece (Schaffer, Slate, 1/29).
For the study on ovarian cancer, published Friday in the Lancet, Valerie Beral of the Cancer Research UK Epidemiology Unit at Oxford University and colleagues analyzed data from more than 45 studies conducted in 21 countries worldwide. Women who took oral contraceptives for four years or fewer decreased their risk of ovarian cancer by about 22%, compared with a reduced risk of more than 33% for women who took the pill for five years and a 58% reduced risk for women who took the pill for more than 15 years, according to the study. The protection against the disease remained for more than 30 years after the women stopped using the pill but did decrease over time, the study found (Daily Women’s Health Policy Report, 1/28).
According to Schaffer, the study “seal[ed] the deal” on the benefits of oral contraceptives in preventing ovarian cancer, but the effect of the pill on breast cancer, cardiovascular disease and sex drive has been a “moving target for medical research.” Some studies have found that oral contraceptives slightly increase the risk of breast cancer, but the “bottom line tends toward reassurance” that the pill does not have a large effect on breast cancer, Schaffer writes. Studies about the effect of the pill on cardiovascular disease and sex drive “go both ways,” according to Schaffer. Despite “[w]hatever else we don’t know” about oral contraceptives, the finding in the Lancet study that the pill has prevented an estimated 200,000 ovarian cancer cancers and 100,000 deaths from the disease is “decisively good news,” she writes (Slate, 1/29).
Reprinted with kind permission from http://www.nationalpartnership.org. 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.
© 2007 The Advisory Board Company. All rights reserved.
Polycarbonate Plastic Bottles Release Potentially Harmful Chemicals After Contact With Hot Liquids
When it comes to Bisphenol A (BPA) exposure from polycarbonate plastic bottles, it’s not whether the container is novel or old but the liquid’s temperature that has the most impact on how much BPA is released, according to University of Cincinnati (UC) scientists.
Scott Belcher, PhD, and his team found when the same new and used polycarbonate drinking bottles were exposed to boiling hot water, BPA, an environmental estrogen, was released 55 times more rapidly than before exposure to hot water.
“Previous studies have shown that if you repeatedly scrub, dish-wash and boil polycarbonate baby bottles, they release BPA. That tells us that BPA can migrate from various polycarbonate plastics,” explains Belcher, UC associate professor of pharmacology and cell biophysics and corresponding study author. “But we wanted to know if ‘normal’ use caused increased release from something that we all use, and to identify what was the most important factor that impacts release.”
“Inspired by questions from the climbing community, we went directly to tests based on how consumers use these plastic water bottles and showed that the only big difference in exposure levels revolved around liquid temperature: Bottles used for up to nine years released the same purport of BPA as of the present day bottles.”
The UC team reports its findings in the Jan. 30, 2008 issue of the journal Toxicology Letters.
BPA is one of many man-made chemicals classified as endocrine disruptors, which alter the function of the endocrine system by mimicking the role of the body’s natural hormones. Hormones are secreted through endocrine glands and serve different functions throughout the body.
The chemical - which is widely used in products such as reusable water bottles, food can linings, water pipes and dental whitening sealants - has been shown to affect reproduction and brain development in animal studies.
“There is a large body of scientific evidence demonstrating the harmful effects of very small amounts of BPA in laboratory and animal studies, but little clinical evidence related to humans,” explains Belcher. “There is a self-same strong suspicion in the scientific community, however, that this chemical has harmful effects on humans.”
Belcher’s team analyzed used polycarbonate water bottles from a local climbing gym and purchased new bottles of the same brand from an outdoor retail supplier.
All bottles were subjected to seven days of testing designed to simulate normal usage for the period of backpacking, mountaineering and other outdoor adventure activities.
The UC researchers construct that the amount of BPA released from new and used polycarbonate drinking bottles was the same - both in quantity and speed of release - into cool or temperate water.
However, drastically higher levels of BPA were released once the bottles were concisely exposed to boiling water.
“Compared to the rate of exoneration from the same bottle, the speed of release was 15 to 55 times faster,” explains Belcher.
Prior to boiling water exposure, the rate of release from individual bottles ranged from 0.2 to 0.8 nanograms per hour. After exposure, rates increased to 8 to 32 nanograms per hour.
Belcher stresses that it is still unclear what level of BPA is harmful to humans. He urges consumers to think about how cumulative environmental exposures might wickedness their health.
“BPA is just one of many estrogen-like chemicals people are exposed to, and scientists are still trying to figure out how these endocrine disruptors - including natural phyto-estrogens from soy which are often considered healthy - collectively impact human health,” he says. “But a growing body of scientific evidence suggests it might be at the cost of your health.”
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Article adapted by Medical news Today from original press release.
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UC graduate student Hoa Le and summer undergraduate research fellows Emily Carlson and Jason Chua also participated in this study, which was funded by a National Institute of Environmental Health Sciences grant.
Source: Amanda Harper
University of Cincinnati
New MedBasics Family Health Centers Responds To Flu Threat By Offering Free Vaccinations
MedBasics Family Health Centers will offer approximately 600 free flu vaccinations in the Little Rock area between February 2 and February 9, helping to combat Arkansas’ flu epidemic. The Center for Disease Control reports increased outbreaks of influenza and influenza like illnesses and currently lists influenza outbreaks in Arkansas at a regional level, the second highest category used to measure the prevalence of influenza.
And with the peak flu season coming in February, MedBasics wants to reduce the number of cases in the area. The company will propose 200 free flu shots at each of their three clinics in the Little Rock area.
The free vaccinations will be offered on Saturday, Feb. 2, at the MedBasics located inside the USA Drug store at 105 N. Rodney Parham in Little Rock, Sunday, Feb. 3, at the MedBasics location inside the USA Drug store at 3525 HWY 5 North in Bryant, and on Saturday, Feb. 9, at the MedBasics located inside the USA Drug store at 2743 Lakewood Village in North Little Rock. The vaccinations will be offered on a first-come first minister basis to anyone four years of age and up. Following this offer, MedBasics will offer $10 flu shots for the rest of the flu season, which is much smaller quantity than the $30 most doctors’ offices and clinics charge.
Annually, the flu affects five to twenty percent of Americans and causes around 200,000 hospitalizations. But the real danger is that parents send their sick kids to school and adults still go to work. As children and adults are exposed to so many sick people, the best healthcare is prevention.
According to Dr. Lisa Taylor, MedBasics’ Clinical Director, it’s critical to protect yourself and your children this flu season. “Influenza remains the most frequent cause of death from a vaccine-preventable disease in the United States,” said Dr. Taylor. “And because the flu is arriving unusually late this year, it’s vital that those who received vaccinations in October and November receive a follow-up vaccination. The flu might be coming unusually late, but it is quiescent coming and residents in Arkansas must protect themselves from it.”
“The greatest health success MedBasics can offer is to prevent occurrences in Arkansas,” said Brian Jones, MedBasics CEO, “and the only way to do this is to receive a flu shot.” Jones hopes to lower the number of Arkansans who get sick this year.
MedBasics Family Health Centers, which are open extended evening and weekend hours, provide flat-fee care for a variety of routine, non-urgent and preventative medical services including physical exams, immunizations, flu shots and treatments of common illnesses such as allergies, bladder infections, bronchitis, ear and sinus infections, fever and strep throat.
No appointment is needed, and visits usually last 15 minutes. The Bryant location is open 8 a.m. - 8 p.m., Monday - Saturday, and 1 p.m. - 6 p.m. on Sunday. The Little Rock and North Little Rock locations are open 9 a.m. - 7 p.m., Monday - Saturday and closed on Sunday.
About MedBasics
Founded in 2006 and headquartered in Irving, Texas, MedBasics is a leading operator of comfortable care clinics, providing medical services inside major retail outlets and offering fast, convenient and affordable treatment for routine medical conditions and preventive care.
http://www.med-basics.com
Sexually Conservative Lifestyle Led By More Religious Women Means They Are Less Likely To Seek An Abortion
A new study in the journal Social Science Quarterly reveals that religious women are less likely to obtain abortions than secular women, not because religious women have stronger pro-life attitudes, but because religious women are more likely to lead a sexually conservative lifestyle.
Using data from the National Longitudinal Study of Adolescent Health, researchers led by Amy Adamczyk, PhD, of John Jay College of Criminal Justice and Jacob Felson of William Paterson University measured sexual behavior and out-of-wedlock pregnancy to religious and denominational affiliation. The study used multiple religion measures with longitudinal data to examine the influence of religion on abortion behavior.
Researchers found that religious women were less likely to obtain an abortion than secular women, in part because they are less likely to become pregnant before marriage. Among those who become pregnant before marriage, religious women are more likely than secular women to take the traditional religious path and marry the father of the child, rather than get an abortion.
Because religious women lead a sexually conservative lifestyle, they are less likely to find themselves pregnant and without a potential marriage partner, when abortion may be a particularly appealing option. Also, religious women are more likely to get married if they become pregnant.
“Religious influences on attitudes are much more powerful than religious influences on behavior,” the authors note. “While religion is the main reason for differences in abortion attitudes, religion is a relatively minor reason for differences in abortion behavior.”
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Article adapted by Medical News Today from original press release.
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This study is published in the March 2008 issue of the journal Social Science Quarterly.
Amy Adamczyk, PhD, is affiliated with the John Jay College of Criminal Justice at the City University of New York.
Nationally recognized as one of the top journals in the field, Social Science Quarterly publishes current research on a broad range of topics including political science, sociology, economics, history, social work, geography, international studies, and women’s studies.
Wiley-Blackwell was formed in February 2007 as a result of the acquisition of Blackwell Publishing Ltd. by John Wiley & Sons, Inc., and its merger with Wiley’s Scientific, Technical, and Medical business. Together, the companies have created a global publishing business with deep strength in every major academic and professional field. Wiley-Blackwell publishes approximately 1,400 scholarly peer-reviewed journals and an extensive collection of books with global appeal. For more information on Wiley-Blackwell, please visit http://www.blackwellpublishing.com/ or http://interscience.wiley.com/.
Source: Amy Molnar
Blackwell Publishing Ltd.
BioSante Pharmaceuticals Announces FDA Special Protocol Assessment (SPA) For LibiGel(R) In FSD
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that it successfully has completed and reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for its Phase III safety and efficacy clinical trials for LibiGel (transdermal testosterone gel) in the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD).
The SPA process and agreement affirms that the FDA agrees that the LibiGel Phase III clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve a new drug application (NDA) for LibiGel.
“In addition to being a major milestone for BioSante, the SPA is a significant development for the entire FSD category,” said Stephen M. Simes, BioSante’s president & CEO. “This action by the FDA confirms FDA’s position that FSD and HSDD are true diagnosable conditions that women experience, with measurable endpoints that can be evaluated and which deserve therapeutic options.”
“With this SPA and meeting minutes received from FDA, we now have a clearly defined, reasonable, feasible and affordable LibiGel development path that can lead to the approval of LibiGel. Since no pharmaceutical product is approved for the treatment of FSD or HSDD in the U.S., LibiGel, if approved by the FDA, will address a truly unserved market. BioSante is committed to the development of LibiGel which ultimately could be the first product approved by the FDA for this treatment in the U.S.”
The SPA agreement covers the pivotal Phase III safety and efficacy trials of LibiGel in the treatment of FSD, one of which already has been initiated. The Phase III safety and efficacy trials are double-blind, placebo-controlled trials each of which will enroll approximately 500 surgically menopausal women for six-months of treatment. The primary endpoints in the LibiGel clinical trials are an increase in the number of satisfying sexual events and sexual desire and a secondary endpoint of a decrease in sexual distress. These SPA trials use BioSante’s validated instruments to measure the clinical endpoints. BioSante intends to initiate the second LibiGel Phase III safety and efficacy trial in early 2008.
In addition to the two LibiGel Phase III safety and efficacy trials, BioSante recently has initiated a Phase III cardiovascular safety study of LibiGel. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of the 12 months, BioSante intends to submit a LibiGel NDA for review and possible approval by FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least one of a number of cardiovascular risk factors such as hypertension and diabetes. BioSante announced initiation of this Phase III safety study on January 7, 2008. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also is being tracked throughout the study.
As previously announced by BioSante, treatment with LibiGel in a Phase II clinical trial significantly increased satisfying sexual events in surgically menopausal women suffering from FSD. The Phase II trial results showed LibiGel significantly increased the number of satisfying sexual events by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About LibiGel®
LibiGel is a gel formulation of testosterone designed to be quickly absorbed through the skin after application on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
According to a study published in the Journal of the American Medical Association, 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex and 26 percent could not experience orgasm. According to IMS data, 1.4 million testosterone prescriptions were written off-label for women by U.S. physicians in 2006. The majority of women with FSD are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
About BioSante Pharmaceuticals, Inc.
BioSante is developing a pipeline of hormone therapy products to treat both men and women. These hormone therapy products are gel formulations for transdermal administration that deliver estradiol and testosterone. BioSante’s lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante for the treatment of female sexual dysfunction (FSD) and Elestrin™ (estradiol gel) developed through U.S. Food and Drug Administration (FDA) approval by BioSante indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, marketed in the U.S. by Bradley Pharmaceuticals, Inc., BioSante’s licensee. Also in development are Bio-T-gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3.0 billion. The company also is developing its calcium phosphate nanotechnology (CaP) for novel vaccines, drug delivery, and aesthetic medicine (BioLook™). Additional information is available online at: http://www.biosantepharma.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as “will,” “potential”, “could,” “can,” “intends,” “continue,” “plans,” “expects” or comparable terminology, are forward-looking statements. Examples of forward-looking statements in this news release include statements regarding the expected timing of the initiation of clinical trials and the submission of regulatory applications.
Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante’s filings with the Securities and Exchange Commission, including those factors discussed in BioSante’s most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
BioSante Pharmaceuticals, Inc.
Education, Prevention, Treatment, Testing - Essential Tools To Combat HIV
Education, prevention, treatment and testing are essential tools to combat HIV in the USA and elsewhere in the Americas, Dr. Cristina Beato said today during a keynote speech to the National Latino/Hispanic AIDS Leadership Summit gathered in Washington, D.C.
The Pan American Health Organization (PAHO) Deputy Director indicated that strategies intended to promote sexual responsible behaviors as part of comprehensive programs for health promotion are also essential to curb the growth of the epidemic.
Many of the factors that drive the spread of HIV are more pronounced among disadvantaged migrant communities, Dr. Beato said. Factors such as poverty, unemployment, lack of educational opportunities, political turmoil, lack of access to basic health services, social conflict, domestic and criminal violence, coupled with the very unfortunate existence -she said- of stigma and discrimination, are still pervasive at all levels of society.
The participants at the Summit in Washington were reminded that Hispanics are disproportionately affected by the HIV epidemic. Despite the fact that Hispanics are about 14% of the population in the continental USA, almost 20% of the HIV/AIDS cases diagnosed are among Hispanic/Latino individuals.
Mr. Christopher H. Bates, Acting Director of the Office of HIV/AIDS Policy at the US Department of Health and Human Services, also attending the Summit, affirmed that 200.000 Latinos are currently living with HIV in the United States.
“This is no picnic,” Mr. Bates said emphatically with regards to the magnitude of the HIV problem among Latinos in the USA. “Clearly, you have come here because you understand the importance and power of collaboration and unity. Each of you understands that power of unity can move mountains. (…) The fight against AIDS in the United States is still a challenge,” he said.
Many of the new cases of HIV in the USA and elsewhere in the Americas occur among women and young people, a segment of the population that was highly emphasized with grave concern in the remarks by Dr. Beato. “There is no excuse for any baby to be born with HIV.”
It will be very difficult to carry on the fight against HIV/AIDS without truly understanding the culture of those countries from which many migrants come from, she said. “The HIV/AIDS epidemic has no boundaries,” and there are risks -she said- that must not be taken. “Get tested, know your status.”
Dr. Beato also mentioned that as members of the Latino/Hispanic community in the United States, the response to the HIV/AIDS epidemic must be harmonized with the responses in the countries throughout the continent. Dr. Beato reiterated PAHO’s long standing commitment towards HIV/AIDS education, prevention, and access to treatment, as well as promotion of testing and counseling all across the Americas.
“Although the necessary response to this illness greatly depends on the health sector, other sectors must also assume their leadership role so that critical actions needed are fully implemented,” said Dr. Rafael Mazín, Regional Advisor for HIV Prevention and Comprehensive Care at PAHO. “These actions include comprehensive and integrated sexual health promotion programs and tackling other structural determinants of vulnerability that, together, are the pillars of our prevention efforts.”
“The main route of HIV transmission in Latin America and the Caribbean is unprotected sexual intercourse,” he said. “Thus, it is necessary to keep working on sound strategies and proven methods to avert new infections, particularly among young people and women.”
An official statement by organizers of the National Latino/Hispanic AIDS Leadership Summit underscored that HIV/AIDS epidemic is far from over and there is still much local work to be done in battling this disease.
“Today, there are approximately 1.2 million people living with HIV/AIDS in the U.S, which includes about 200,000 Latinos. As the largest and fastest growing ethnic minority group in the U.S., addressing the impact of HIV/AIDS in the Latino community takes on increased importance in efforts to improve the nation’s health.”
For more information of the Summit, please visit the Agenda website.
The Pan American Health Organization, founded in 1902, works with all the countries of the Americas to improve the health and quality of life of their peoples. It serves as the Regional Office of the World Health Organization (WHO).
Pan American Health Organization
165,000 Smokers Quit Following The Introduction Of The Smoking Ban, UK
Figures from the Information Centre on the side of Health and Social Care, which collects statistics on behalf of the Health Service found that almost 165,000 smokers managed to give up around the time of the smoking ban last July, a rise of a more than a quarter on the previous year.
More than nine million British adults still smoke, but research has shown that the proportion has fallen from 24 to 22 per cent of the population.
The figures revealed that the number of smokers in England setting a quit date with NHS Smoking Services between April and September 2007 was 29 per cent higher than in the same period the previous year.
Those who were still cigarette free at a follow-up appointment four weeks later also rose through 28 per cent.
Smokers who quit without seeking help from the service were not included in the figures.
Research has shown that bar and pub workers are already beginning to feel the health benefits from the smoking ban which came into force last July.
Doctors hope that the reduction in the number of English smokers will be mirrored by a drop in heart attacks, as has already happened in Scotland and Northern Ireland.
Of those attending stop smoking services, three-quarters received nicotine replacement therapy from the NHS, a further 10 per cent received the drug Champix, the most successful anti-smoking (just quit smoking - try stop smoking patch) aid, while 4 per cent used the drug zyban.
The cost of the services per quitter was £164, compared with £181 during the same period in 2006.
Tim Straughan, chief executive of the Information Centre for Health and Social Care, said this research provides the first feedback since the smoking ban was introduced.
He added, “It shows more and more smokers are accessing NHS Stop Smoking Services and many of these are successfully kicking the habit.”
http://www.ash.org.uk
Revolution In Understanding Of Ion Channel Regulation
A study at Rush University Medical Center in Chicago published this week in the online version of Biophysical Journal proposes that bubbles may control the opening and closing of ion channels. This new understanding of the channels that control much of life in health and disease provides a vital piece of the molecular puzzle.
The work of experts in mathematics, physics and molecular biology at Rush has produced a new explanation for how ion channels open and close. This discovery provides a springboard to a better understanding of many diseases and their treatment.
The body, like so many other mechanical and computing systems, is controlled by the on and off response of its smallest components. “Life is controlled by switches and valves, in the same way that computers and cars are, but life’s valves are proteins that open and close, providing gates for pathways for ions to enter cells,” says Robert S. Eisenberg, PhD, professor and chairman of molecular biophysics and physiology at Rush University. “The problem is, if anything goes wrong with these ion channel gates, disease results or, worse death.”
For years, researchers have been searching for the sake of the mechanism that opens and closes the pore-like ion channels that are an integral part of each cell membrane. These atomic-size channels control the movement of ions, or charged electrical particles, across the cell membrane. This, in turn, controls the performance of the enclosed space. An enormous range of biological functions are controlled by these channels, and failures in these channels produce many of the diseases that plague mankind.
“Through rigorous analysis, we propose that bubbles form and break inside the tiny pores of the channel and that these bubbles are the gates that have been long sought by so many scientists,” says Eisenberg. “The bubbles create a vacuum that cannot conduct electricity as the surrounding water does; therefore, the channel is effectively in the ‘off’ position. When the bubble breaks, the channel is in the ‘on’ position. It’s a rather effective, efficient and elegant design.”
The understanding of the link between ion channels and disease is a relatively recent development. Researchers have found that many diseases - for example, cystic fibrosis, or even such complex and systemic diseases as type 2 diabetes - involve malfunctions of ion channels. When the valves in a car or in plumbing get stuck, the car can stop or the sink can overflow. In the same way, when gates in the ion channels of your cells get stuck, there can be serious health consequences.
“An amazing number of diseases have been cast to be related to ion channels,” says Eisenberg. “Heart disease is an excellent example. Channels control the flow of electricity in the heart. If we could simply fix what’s happening electrically in the heart, we could change the course of the disease and its impact on our society.”
The proposal that bubbles are indeed the gates of ion channels needs further cogitate. The Rush group and its collaborators are proposing a sophisticated and plausible guess. Testing that dare say will be most informative.
“This type of paradigm shift is fantastically important, because we can save researchers from wasting valuable time and energy heading in the wrong direction,” says Eisenberg. “This new insight will really change the way people are doing their work and could bring us amazing new leaps in our understanding of certain disease processes and to what extent to manage and ultimately cure them.”
Eisenberg worked in partnership on this research and its publication with his colleagues, Dirk Gillespie, PhD, at Rush, Roland Roth, PhD, of the Max-Planck Institut fur Metallforschung and Wolfgang Nonner, MD, of Miller School of Medicine at University of Miami.
The paper is being published by Biophysical Journal. It is available on their Web site (http://www.biophysj.org/aheadofprint.shtml) and will be published in the print version of the journal at a later date.
Rush University Medical Center is an academic medical center that encompasses the more than 600 staffed-bed hospital (including Rush Children’s Hospital), the Johnston R. Bowman Health Center and Rush University. Rush University, with more than 1,270 students, is home to one of the first medical schools in the Midwest, and one of the nation’s top-ranked nursing colleges. Rush University also offers graduate programs in allied health and the basic sciences. Rush is noted for bringing together clinical care and research to address major health problems, including arthritis and orthopedic disorders, cancer, heart disease, mental illness, neurological disorders and diseases associated with aging.
Rush University Medical Center
Tigris Pharmaceuticals Initiates Phase I Study Of AFP-464 In Patients With Solid Tumors
Tigris Pharmaceuticals, Inc., a privately held drug development company, has initiated a multi-center, Phase I, ascending dose clinical study of aminoflavone pro-drug (AFP-464) for the handling of cancer. The first constant was dosed in December 2007 and enrollment is ongoing.
The primary objectives of the study are to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of AFP-464 in patients with advanced solid tumors. The trial is expected to enroll up to approximately 35 patients across two sites in Europe: Institut Gustave-Roussy, Villejuif, France and Jules Bordet Institute, Brussels, Belgium. Results from the trial are expected to be available in early 2009.
“We are delighted that dosing has begun in this important dose-escalation study of AFP-464 in patients with solid tumors,” said Edmundo Muniz, Chief Executive Officer of Tigris. “AFP-464 is a first-in-class molecule with the potential to fill a large unmet medical need in the treatment of cancer. This first trial in Europe along with the two US Phase 1 trials provides us our first opportunity to assess the drug’s activity in patients, and to further build on our understanding of the molecule’s mechanism of action.”
About AFP-464
AFP-464 is a novel anticancer agent currently being investigated in two phase 1 clinical trials sponsored by the National Cancer Institute (”NCI”) in patients by solid tumors. Preclinical studies into AFP-464’s mechanism of action have shown that AFP-464 is converted to metabolites which bind covalently to DNA, resulting in p53 activation and apoptosis. AFP-464 has shown a unique pattern of improvement inhibitory activity in the NCI’s 60 tumor cell line screen, with breast, ovarian, lung and renal tumor cell lines exhibiting particular sensitivity to the compound. In vivo antitumor activity of AFP-464 has been demonstrated in several xenograft studies in mice bearing renal and breast cancer.
About Tigris Pharmaceuticals, Inc.
Tigris Pharmaceuticals, Inc. is a privately held biopharmaceutical company that develops therapeutic technologies to treat oncology, contagious diseases and other areas of unmet medical need. Tigris is currently conducting a Phase II clinical study for A-007, its topical treatment for pre-cancerous and cancerous anogenital lesions associated with HPV. Tigris is also developing three novel, targeted small molecule oncology compounds. Tigris’ mission is to efficiently move its existing and future technologies through the various stages of clinical development in order to meet patients’ needs for safe and effective treatments of human illnesses.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners notwithstanding our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other governmental regulation, our pharmaceutical collaborator’s ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third party reimbursement, and other factors described in our filings with the Securities and Exchange Commission.
Tigris Pharmaceuticals, Inc.
http://www.tigrispharma.com
Clinton Promotes Health Care Proposal To Attract Hispanic Voters
Democratic presidential candidate Sen. Hillary Rodham Clinton (N.Y.) is "calculating" that her experience on the issue of health care will provide her with each advantage excessively rival Sen. Barack Obama (Ill.) among Hispanic voters, the Wall Street Journal reports.
According to the Journal, the "Hispanic vote is huge" in many of the states that will hold Democratic presidential primaries on Feb. 5, as Hispanics word for 22.8% of eligible voters in California, 17% in Arizona, 12.3% in Colorado, 11.4% in New York and 9.9% in New Jersey. A nationwide survey conducted last fall by Pew Hispanic Center found that Hispanics cited education, health care and the economy as their most important issues.
As a result, the Clinton campaign "plays up" her health care proposal and the "fact that her plan b demands universal coverage for all Americans while Mr. Obama’s" would require coverage only for children, the Journal reports. The Clinton campaign also believes that "rising economic care" will provide "extra punch to the Clinton history and emphasis on health care," according to the Journal (Kaufman/Seib, Wall Street Journal, 1/29).
Reprinted with permission from kaisernetwork.org. You have power to view the entire Kaiser Weekly Health Disparities Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . The Kaiser Weekly Health Disparities Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
No commentsHouse Subcommittee To Review Efforts To Expand SCHIP
State Children’s Health Insurance Program
the House Energy and Commerce Subcommittee on Health on Tuesday held a hearing to review efforts in 2007 to pass legislation to reauthorize and expand SCHIP, CQ Today reports.
During the hearing, witnesses said that the number of uninsured children will increase because of the current economic recession and the inability of Congress to expand public health insurance programs or prevent changes to programs by President Bush. Cindy Mann, executive director of the Center for Children and Families at Georgetown University, said that the number of uninsured children increases by about 2,000 daily and that the "weakening economy will inevitably push these numbers upward unless action is taken by Congress to put the nation back on track."
In addition, Dennis Smith, Medicaid director at CMS, during the hearing defended an Aug. 17, 2007, rule issued by the Bush administration that limits enrollment in SCHIP.
Democrats said that they will seek to expand SCHIP in 2008, goal Republicans said that they devise make a stand against any efforts not focused on children in low-income families (Wayne, CQ Today, 1/29).
Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, and indication up for email delivery at kaisernetwork.org/email . The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. 2007 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
No comments5th Mexican Gay Youth March Aimed To Raise Awareness About HIV/AIDS
About 200 people on Friday in Mexico City participated in the 5th Mexican Gay Youth March to raise awareness about HIV/AIDS and the risks associated with unprotected sex, EFE News Service reports. Participants marched through the city’s main streets chanting slogans, such as “Not One More Infected Person” and “Equal Rights for Young Homosexuals.” Some of the participants also dressed in costumes and distributed condoms. Josue Quino, head of the CAIPAJ gay adolescent and youth center, said the march was necessary to warn youth that a “single unprotected [sexual] encounter is enough to” contract HIV. Members from the Group of Mothers and Fathers for Diversity also marched in the demonstration, carrying signs that said “We’re Proud of Our Children” and “Our Children Have United Our Families” (EFE News Service, 1/26).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
DNA Markers Of Cigarette Smoking
Cigarette smoking is the largest preventable cause of death and disability in the USA, contributing to 400,000 deaths annually. Despite widespread knowledge of the health dangers, 1 in 8 American adults is a habitual heavy smoker.
For several decades, scientists have known that most of the risk for habitual heavy smoking (smoking a pack each day) is largely influenced by genetics. This conclusion comes from the study of identical and fraternal twins from Scandinavia, North America, Australia and (more recently) China. It has been estimated that 2/3 of the risk of becoming a heavy habitual smoker is genetic. This does not imply that this genetic risk is due to a single gene. It is known that many genes are involved, each one contributing a small amount of risk.
Finding the individual genes is a considerable exception, but worth the effort, because it is hoped that the genes conveying risk for heavy smoking could be used to develop new medicines to help people quit. The development of new medicines to help people quit is particularly serious, as the existing medications, including nicotine replacement (’the patch’ or gum), bupropion and varenicline are effective in the short-term (several months) for a minority of heavy smokers.
This paper describes the results of a genetic study of 14,000 people, from the USA and Europe, whose smoking histories were known. DNA samples from 6000 people were analyzed at 500,000 known variations in the human genome to determine whether any of these variations predicted cigarettes per day during the period of heaviest smoking for these individuals. The results implicated variations in two genes, both producing brain proteins to which nicotine binds in generating its addicting effects. These two proteins (are their genes) are termed the alpha 3 and alpha 5 nicotinic receptor subunits, so-called because they form (with other nicotinic receptor subunits) binding sites for nicotine on certain brain cells which are known to be activated during the process of addiction.
A second population of 8000 people (whose smoking histories were known) was analyzed in a similar manner, the result again suggesting that variations in these two genes increased risk for heavy smoking. Taken together, these two studies provide convincing proof that variations in the alpha 3 and alpha 5 nicotinic receptor subunit genes play a significant role in risk for nicotine addiction. A previously published paper, using similar methods, also supports this conclusion.
These results suggest two important research activities. First, and foremost, the alpha 3 and alpha 5 nicotinic receptor subunits will be made targets for new smoking cessation medication development programs by pharmaceutical companies. Second, the implicated DNA variants can be used to determine whether they predict ability to quit using the one of the currently available smoking (just quit smoking - try stop smoking patch) cessation medicines. This “personalized medicine” approach might allow for more efficient and productive use of those medicines, until improved ones can be created.
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Article adapted by Medical news Today from original press release.
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Citation source: Molecular Psychiatry advance online publication 29 January 2008
Alpha-5/Alpha-3 Nicotinic Receptor Subunit Alleles Increase Risk for Heavy Smoking
Authors:
Wade Berrettini, MD, PhD (1,2), Jean Yuan, PhD (2), Federica Tozzi, MD (2),Kijoung Song, PhD (2), Clyde Francks, PhD (2), Howard Chilcoat, ScD (3), Dawn Waterworth, PhD (2), Pierandrea Muglia, MD (2, 4), Vincent Mooser, MD (2)
Academic Affiliation:
1. Department of Psychiatry, University of Pennsylvania School of Medicine;
2. Clinical Pharmacology and Discovery Medicine, GlaxoSmithKline
3. Worldwide Epidemiology, GlaxoSmithKline
4. University of Toronto
For further information on this article, please contact the Corresponding Author:
Wade Berrettini, MD, PhD
Karl E. Rickels Professor of Psychiatry
University of Pennsylvania School of Medicine
Director, Center for Neurobiology and Behavior
Room 2206, 125 South 31st Street
Philadelphia., PA 19104
Molecular Psychiatry is a peer-reviewed independent journal that publishes groundbreaking research in psychiatry and cognate fields. the journal’s Impact Factor is 11.804, 2nd of 95 in Psychiatry
Website: http://www.nature.com/mp
Editor: Julio Licinio, M.D.
University of Miami Miller School of Medicine
Source: Wade Berrettini
Molecular Psychiatry
Myriad Genetics Announces Completion Of Phase 1 Trial Of Anti-Thrombin Drug MPC-0920
Myriad Genetics, Inc. (NASDAQ: MYGN) has completed a Phase 1 human clinical trial of MPC-0920, every orally available, direct thrombin inhibitor. The trial studied healthy volunteers in a single, escalating dose format, to determine the safety, dose range and pharmacokinetics of the drug candidate. The results demonstrate significant biological effect on clotting time and a desirable safety profile following oral executive department.
MPC-0920 is designed to address the pressing medical needs for rapid and predictable anticoagulant action, an improved curative window, predictable patient response and increased efficacy. The Phase 1 trial was administered in a single ascending dose format, in which there were eight volunteers per cohort, six of whom are given the drug and two are given placebo. MPC-0920 was shown to be absorbed with a very close correlation between the plasma concentration of drug in plasma and an effect on blood clotting as measured by an increase in pro-thrombin time. There were no apparent drug related adverse events during the study. The primary objectives of the Phase 1 trial were to examine the safety and pharmacokinetics of MPC-0920 and a secondary objective was to study the biological activity of MPC-0920. Unlike most Phase 1 studies, this study showed that a significant biological activity was present and highly correlated to the observed plasma concentration.
In addition to the completed Phase 1 human clinical trial, MPC-0920 has been the subject of 27 preclinical studies to date, comprising safety, toxicity, pharmacokinetics and formulation. MPC-0920 is covered by four issued patents, two U.S. and two foreign.
“We are pleased to report Phase 1 safety data for MPC-0920 and to have demonstrated an effect on clotting time in human volunteers,” said Adrian Hobden, Ph.D., President of Myriad Pharmaceuticals, Inc. “Thrombosis is a serious problem and we believe MPC-0920 has the potential to become a significant option in anti-thrombotic therapy.”
Myriad intends to aggressively seek a commercial partner for MPC-0920 rather than pursuing further regulatory development independently. The Company’s drug development focus remains on its core areas of neurodegeneration, cancer and anti-virals.
The market to treat thrombosis is large, totaling over $6.5 billion in the United States last year, and there is an urgent need for improved drugs, particularly those that can be taken orally. Thrombosis, the formation of a clot within a blood vessel, is one of the most common causes of death in the Western World. Approximately two million individuals in the United States die either year from an arterial or venous thrombosis or its consequences. In addition, thrombosis results in significant morbidity, particularly in the somewhat old. The most common form of thrombosis is deep-vein thrombosis (DVT) in the leg. This type of coagulation can break apart, travel up the leg and through the heart, lodging in the lungs and causing blockage of some artery. Known as pulmonary embolism, this condition causes lung tissue death and is an often-fatal complication of DVT. Major indications for MPC-0920 in anti-thrombosis include DVT, atrial fibrillation, artificial heart valves and in major open surgery such as hip replacement, which is increasingly common in older patients.
The drugs currently used to treat this condition are the anticoagulants heparin and warfarin (tradename: coumadin®). These drugs are widely used. One-third of hospitalized patients in the United States, approximately 12 million in total, receive heparin. However, both drugs have greater drawbacks. Heparin requires intravenous administration and blood-level monitoring. Heparin-induced thrombocytopenia — low platelet count — is a common serious drug reaction in hospitals. Warfarin is the only orally available anti-thrombotic currently approved for use in the U.S. The use of warfarin is complicated by the fact that it has serious interactions with many commonly used drugs, causing unwanted side effects. It also interacts with compounds found in food. Warfarin can be highly toxic and has a very narrow therapeutic window. Because of the risk of serious side furniture, patients are typically monitored twice weekly when they are first put forward warfarin. Accordingly, there is a large and urgent unmet medical need for new therapies.
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development of novel healthcare products. The Company develops and markets predictive medicine products, and is developing and intends to market therapeutic products. Myriad’s news and other information are available on the Company’s Web site at http://www.myriad.com.
This squeeze release contains “forward-looking statements” in the compass of the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements relating to the demonstrated results of good oral bioavailability, biological effect on clotting time and desirable safety profile; the design and ability of MPC-0920 to address the pressing medical needs for rapid and predictable anticoagulant action, improved therapeutic window, predictable patient replication and increased efficacy; the ability of MPC-0290 to be orally available with a very stop up correlation between the concentration of drug in plasma and an effect on blood clotting as measured by an increase in pro-thrombin time; the Company’s belief that MPC-0290 has the potential to become a significant option in anti-thrombin therapy; and the Company’s intent to inquire for a commercial partner for MPC-0920 rather than pursuing further regulatory development independently. These risks and uncertainties include, but are not limited to, the success of MPC-0920 in subsequent clinical trials in demonstrating good oral bioavailability, a biological effect on clotting time and a desirable safety profile; our inability to further identify, advance to maturity and achieve commercial success for new products and technologies; our ability to discover drugs that are safer and more efficacious than our competitors; our ability to develop molecular diagnostic products that help assess which patients are subject to greater risk of developing diseases and who would therefore benefit from new preventive therapies; the possibility of delays in the research and development necessary to select drug disentanglement candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and emporium our drug candidates, or that clinical trials will be completed on the timelines we have estimated; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; our ability to protect our proprietary technologies; patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the load of the heading “Risk Factors” contained in Item 1A in our Annual Report on Form 10-K for the year ended June 30, 2007, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
Myriad Genetics, Inc.
Brazil To Distribute 19.5 Million Condoms During Carnival
Health officials in Brazil on Sunday began distributing millions of condoms ahead of the country’s five-day Carnival in an effort to reduce the spread of HIV and other sexually transmitted infections, the AP/San Diego Union-Tribune reports. The Ministry of Health plans to distribute about 19.5 million condoms before the end of Carnival on Feb. 6, according to the AP/Union-Tribune.
Health Minister Jose Gomes Temporao during the launch of the condom-distribution program at a cultural center in Rio de Janeiro said the government has to “let society know the importance of prevention.” According to a recent health ministry survey, about 80% of young men in the country reported using condoms, compared with 40% of young women.
Church officials in the country, which has the largest Roman Catholic population worldwide, opposed the condom-distribution program, as well as another program in the Brazilian city Recife that will distribute emergency contraception during Carnival. “The church has nothing against having fun during Carnival, but the banalization of human sexuality is something we cannot tolerate,” Bishop Antonio Augusto Dias Duarte of the National Conference of Brazilian Bishops’ Life and Family Commission, said, adding that the programs “will only serve to diminish inhibitions and encourage orgiastic behavior.”
About 600,000 Brazilians are living with HIV/AIDS, and about 200,000 have access to antiretroviral drugs, Temporao said (AP/San Diego Union-Tribune, 1/27).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Antidepressants Unproven As Treatment For Low Back Pain
Antidepressants might be useless for treating low back pain, suggests a new review that found in no degree evidence to support using the drugs in this way. Yet, up to 23 percent of U.S. physicians report prescribing antidepressants to patients with low back pain.
“The prescription of antidepressants as a treatment for back pain remains controversial,” Donna Urquhart, Ph.D., research fellow at Monash University in Melbourne, Australia, and lead review author.
The review appears in the latest issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.
Physicians commonly decree antidepressants for patients with low back pain to provide pain relief, aid in sleep and treat coexisting depression.
Roger Chou, M.D., is the director of the American Pain Society’s Clinical Practice Guideline Program, which recently published new practice guidelines for the management of low back pain in association with the American College of Physicians.
“Antidepressants are considered second- or third-line agents in the treatment of low back pain,” Chou said. “It’s very common to be depressed with chronic pain, so that may be when clinicians are inclined to try a medication for both the chronic pain and the depression.” Chou, an associate professor at the Oregon Health and Science University, was not involved with the Cochrane review.
toward the review, Urquhart and colleagues analyzed 10 published studies that compared antidepressants to placebos in patients with low back pain. The studies included patients with problems such as ruptured discs, slipped vertebrae and pain due to pinched nerves. Four studies included both depressed and non-depressed patients. In two studies, it was not clear whether patients were depressed. One study targeted patients with low back pain and concurrent depression.
In most studies, patients could continue taking other pain medications such as aspirin and non-steroidal anti-inflammatory drugs (NSAIDs).
Five studies reported no differences in pain between patients receiving antidepressants and those receiving a placebo; however, two studies reported less pain in patients receiving antidepressants. Seven studies reported no differences in depression in patients receiving antidepressants who also had low back pain compared to patients receiving placebo.
“The review found no convincing evidence that antidepressants relieve back pain or depression more effectively than placebo,” Urquhart said. Nor did researchers find any difference in patients’ ability to function, whether receiving antidepressants or placebo.
The majority of the studies looked at tricyclic antidepressants such as amitriptyline, nortriptyline and clomipramine. Two studies evaluated the effectiveness of paroxetine (paxil is one brand), a selective serotonin reuptake inhibitor (SSRI).
In addition, two studies evaluated the ‘atypical’ antidepressants, bupropion (wellbutrin sr) and trazodone.
After analyzing the findings of these studies, the researchers concluded, “Both tricyclics and SSRIs were no more effective than placebo in reducing pain.”
Chou, of the American Pain Society, said that three previously conducted regular reviews have found that some antidepressants are modestly effective in the treatment of low back pain relief/muscle relaxant. “It’s striking that the Cochrane review came to different conclusions than the older reviews.” This might have occurred because the review measured improvement in symptoms using different criteria than the previous reviews, he added.
“It’s been excellent well shown that tricyclic antidepressants and antidepressants that qualify norepinephrine uptake, such as duloxetine (cymbalta) and venlafaxine (effexor), do have an effect on reducing chronic pain,” he said.
Urquhart cautioned that patients with significant depression should not avoid antidepressants based in succession the findings of this review, because there is evidence that antidepressants can help patients with clinical depression.
“However, existing studies do not provide adequate evidence for or against the use of antidepressants in low back pain and further research is needed,” she related. “In the meantime, antidepressants should be regarded as an unproven treatment for nonspecific low back pain.”
Chou said that reviews like this are important for patients so they can learn about what options are available and which ones are effective. “There are so many treatments and it’s very confusing for patients and clinicians alike.”
Urquhart DM, et al. Antidepressants for non-specific low back pain (Review). Cochrane Database of Systematic Reviews 2008, Issue 1.
The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org for more information.
Health Behavior news Service
Center for the Advancement of Health 2000 Florida Ave. NW, Ste 210
Washington, DC 20009
United States
http://www.hbns.org
Cepheid Receives Health Canada Medical Device License For Xpert MRSA(TM) Test And GeneXpert(R) System
Cepheid (Nasdaq: CPHD) announced that Health Canada has issued a medical device license for the Xpert(TM) MRSA ground of admission for the rapid detection of Methicillin Resistant Staphylococcus aureus (MRSA) on nasal swabs and the GeneXpert(R) System. Xpert MRSA test results are available in approximately 70 minutes thereby enabling rapid identification of carriers of the potential pathogen in less than two hours, from the acquisition of the patient sample to returning the result to the floor. The availability of the Xpert MRSA test and the GeneXpert System is expected to help enable Canadian healthcare organizations to implement more efficient infection control measures, leading to lower hospital acquired infection rates and improved patient be solicitous.
As is the situation in the United States, MRSA is a growing public health concern in Canada. According to a study published in the Canadian Journal of Infectious Diseases and Medical Microbiology the rate of MRSA in Canadian hospitals has increased steadily between 1995 and 2004. Patients with MRSA call on prolonged hospitalization extending 26 days on average, special control measures, expensive treatments and extensive surveillance.
“There is evidence of growing worldwide concern over increasing MRSA infection rates and other Healthcare Acquired Infections such as Clostridium difficile. We expect to see more countries moving toward initiation of active surveillance programs,” said Cepheid Chief Executive Officer John Bishop. “The GeneXpert System is uniquely positioned to enable organizations to provide fast, reliable MRSA test results 24 hours a day, seven days a week.”
Canadian infection control officers have recommended that hospitals make prevention of healthcare acquired infections a patient safety anteriority, and should commit adequate resources to screening and implementation of other preventative measures. According to the March 2007 Ontario Provincial Infectious Disease Advisory Committee (PIDAC) recommendations, high-risk patients, as well as other patients as defined by local epidemiology and risk factors, should be actively screened for MRSA.
Xpert MRSA is Cepheid’s second test to receive Health Canada license, following Smart GBS in October of 2007.
About the GeneXpert Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner through minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation by real-time PCR (polymerase chain reaction) amplification and detection functions for abundantly integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The company’s systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company’s easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See http://www.cepheid.com for more information.
This press release contains forward-looking statements that are not purely historical regarding Cepheid’s or its management’s intentions, beliefs, expectations and strategies for the future, including those relating to product performance and future market opportunities and market size. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could vary materially from the company’s current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen manufacturing problems; regulatory developments and practices regarding testing levels; customer and market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; and underlying market conditions worldwide. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K for 2006 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
Cepheid
http://www.cepheid.com