Medicine Lessons and articles

Rapid HIV tests have been found to be highly effective in preventing mother-to-child HIV transmission in clinical trials in India, according to a study published online Tuesday in PLoS Medicine, the Times of India reports (Sinha, Times of India, 5/7). For the study, the researchers used OraSure Technologies‘ OraQuick Advance Rapid HIV 1/2 Antibody Test (Derfel, Montreal Gazette, 5/6).

The OraQuick test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the test result is negative and the person is HIV-negative, and two appear if the result is positive and the person is HIV-positive. Positive results require a follow-up test with a medical professional for confirmation (Kaiser Daily HIV/AIDS Report, 4/1). According to the Gazette, although standard blood tests are available in India, they are not always accessible. In addition, it can take up to two hours to receive results from standard blood tests, and laboratory technicians are not on call during the evening to administer the tests — meaning that most women give birth without being tested for HIV (Montreal Gazette, 5/6).

For the study, Nitika Pant Pai of the division of infectious diseases at McGill University’s Health Center and colleagues administered both an oral HIV test and a traditional blood test to 1,222 pregnant women during a nine-month period in the labor ward of the Mahatma Gandhi Institute of Medical Sciences in India. The results from both tests corresponded in 100% of cases, the researchers found (ANI/DailyIndia.com, 5/6). Of the participants, about 82% had never taken an HIV test, according to the study. The tests found that 11 women were HIV-positive. These women were given antiretroviral drugs to prevent MTCT. According to the study, 10 of these infants survived and tested negative for HIV.

According to the World Health Organization, there were 420,000 new HIV cases among children reported last year in India, most of which occurred through MTCT (Montreal Gazette, 5/6). “Most Indian women do not receive prenatal care and therefore do not get tested for HIV during pregnancy,” Pai said, adding, “Testing in the labor ward is the last chance to prevent” MTCT (ANI/DailyIndia.com, 5/6). In addition, “Indian patients often refuse blood collection in fear” of being ostracized, but “saliva collection poses no problem,” according to Pai (Times of India, 5/7). Pai suggested that the OraQuick test should become a standard procedure in India, as well as in South Africa and China (Montreal Gazette, 5/6).


The study is available online.

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.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
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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.

© 2008 The Advisory Board Company. All rights reserved.

Women suffering with postpartum depression may in future be able to receive psychotherapy from a specially trained nurse over the phone, eliminating barriers to treatment such as distance, time or the availability of a psychologist or psychiatrist.

Professor Cindy-Lee Dennis, Canada Research Chair in Perinatal Community Health at U of T’s Lawrence S. Bloomberg Faculty of Nursing is the lead investigator in the postpartum depression interpersonal psychotherapy trial, which is evaluating an innovative way to deliver treatment for postpartum depression, particularly to women in rural or remote areas where they may not have access to a psychologist or psychiatrist, let alone one who specializes in postpartum depression.

“This is pushing the boundaries of the role of nurses,” said Dennis.

In this research study, nurses are highly trained by psychiatrists to provide interpersonal psychotherapy, a brief and highly structured manual-based therapy that addresses interpersonal issues in depression such as family conflicts or role transitions. It has been shown to be an effective treatment for general depression and it is typically provided face-to-face by a psychiatrist or psychologist.

To improve access to care, it is being offered over the telephone in approximately 12 weekly sessions lasting 50 to 60 minutes.

Two hundred and forty clinically depressed women across 24 health regions in Ontario, Manitoba, Saskatchewan, Alberta and B.C. will participate in the trial.

This study, funded with more than $900,000 from the Canadian Institutes of Health Research, will determine if the telephone therapy given by nurses is an effective way to treat postpartum depression.

Source: Lucianna Ciccocioppo

University of Toronto

BiPar Sciences, Inc.
announced the expansion of Phase 2 clinical trial programs for its lead
product, BSI-201, in ovarian cancer. This is the third major clinical trial
of BSI-201 that BiPar has launched in the past 6 months, expanding on
on going trials in breast and brain cancer.

The company is evaluating BSI-201, the first poly ADP-ribose polymerase
(PARP) inhibitor in its DNA repair portfolio, as a monotherapy for patients
whose ovarian cancer is linked to a hereditary genetic defect. Clinicians
at Memorial Sloan-Kettering Cancer Center will enroll patients who have a
mutation in their BRCA1 or BRCA2 genes.

“We believe BSI-201 holds great promise as a targeted therapy in this
difficult-to-treat type of ovarian cancer,” said Carol Aghajanian, M.D.,
co- principal investigator and chief of the gynecologic medical oncology
service at Memorial Sloan-Kettering Cancer Center. “BRCA-negative patients
are at higher risk of breast and ovarian cancer because BRCA plays a key
role in repairing DNA errors that lead to tumor formation.”

Ovarian cancer strikes more than 21,000 women a year in the United
States and is one of the most common causes of cancer death in women,
killing more than 15,000 annually in the United States. Patients with the
hereditable BRCA- negative form of the disease account for about 15 percent
of the patient population. Women with defective BRCA genes are also at
considerably higher risk of breast cancer.

“We have identified a number of important types of cancer where PARP
plays a crucial role in tumor growth, and we believe that BRCA-negative
ovarian cancer represents another excellent target for BSI-201,” said Barry
Sherman, M.D., BiPar’s Executive Vice President of Development. “We will
soon have patients enrolled in four separate Phase 2 trials of BSI-201,
reflecting the breadth of tumor types that could be sensitive to the drug.”

The company is currently conducting a Phase 2 trial of BSI-201 in
triple- negative breast cancer and is collaborating with the New Approaches
to Brain Tumor Therapy (NABTT) consortium, a National Cancer
Institute-funded research group, to test BSI-201 in glioblastoma multiforme
(GBM), the most common brain cancer in adults. An additional trial in
uterine cancer is expected to begin enrollment in the coming weeks. The
company also plans to present data from its Phase 1 trials of BSI-201 in
solid tumors at the American Society of Clinical Oncology Annual Meeting
that begins later this month in Chicago.

About BiPar Sciences

BiPar Sciences is a drug development company with a therapeutic focus
on exploring novel mechanisms of action in oncology. The lead development
program is based on DNA repair, specifically with poly ADP-ribose
polymerase (PARP) inhibitors. The lead product within that program is
BSI-201, a platform drug with the potential to be a superior new treatment
across a range of tumor types, both as monotherapy and in combination with
chemotherapy. The company is currently testing BSI-201 in a range of Phase
2 trials in breast, brain and ovarian cancer.

BiPar Sciences, Inc.
http://www.biparsciences.com

The International Academy of Compounding Pharmacists joined hundreds of thousands of women and doctors in applauding the introduction
of H. Con. Res. 342, a bipartisan resolution stating that “the Food and Drug
Administration’s (FDA) new policy restricting women’s access to medications containing
estriol does not serve the public interest” and calling on the FDA to “reverse its policy.”

Reps. Mike Ross (D-Ark.), Jo Ann Emerson (R-Mo.), Sam Farr (D-Calif.), Tammy
Baldwin (D-Wisc.), Michael Burgess (R-Texas), John Carter (R-Texas) and Gabrielle
Giffords (D-Ariz.) introduced the resolution in the House of Representatives.

“We commend all of the sponsors for standing up for women and introducing H. Con.
Res. 342,” said L.D. King. “Women with menopause suffer enough. Fortunately, this
resolution aims to provide them with some relief.”

For decades, doctors have prescribed compounded hormones containing estriol to women
suffering from the painful symptoms of menopause. IACP estimates that hundreds of
thousands of women are prescribed these drugs today. FDA’s policy would force these
women to discontinue the hormone treatments that their doctors have determined is
appropriate for them.

Wyeth petitioned the FDA in October 2005 to prohibit compounding pharmacists from
preparing hormones that contain estriol on the grounds that doing so posed a “serious
threat to public health.” At the same time, though, Wyeth was marketing drugs
containing estriol as “an ideal therapy” across Europe.

Wyeth’s petition generated more than 70,000 responses, the overwhelming majority of
which from women and doctors opposed to Wyeth’s request. Unfortunately, FDA
fulfilled Wyeth’s request earlier this year when it announced that it would “halt” the
compounding of compounded hormones containing estriol.

“FDA ignored the comments of tens of thousands of women and instead listened to
Wyeth,” continued Mr. King. “Removing this drug from the market robs patients of a
long-standing, vital and legal menopause treatment alternative to Wyeth’s products.
FDA’s policy is an unwelcome intrusion of federal bureaucrats into thousands of doctors’
offices.”

Compounded hormones containing estriol are lawfully prescribed, prepared and
dispensed in all 50 states and their use is accepted by the United States Pharmacopeia and
the Pharmacy Compounding Accreditation Board. The FDA has acknowledged that it is
unaware of any adverse events associated with the use of these drugs. Estriol is a
component of a multiple sclerosis treatment undergoing Phase II clinical trials; in
compounded form it is prescribed by doctors to treat both multiple sclerosis and
symptoms of menopause.

Since FDA announced its estriol policy in January, the agency has since attempted to
allay the concerns of thousands of women by stating that doctors may prescribe
compounded hormones containing estriol if they complete an Investigational New Drug
Application (IND). Unfortunately, this process is unworkable.

“FDA is trying to fit a square peg in a round hole,” concluded Mr. King. “FDA is setting
doctors up to fail, leaving them in the same position are they are in now - unable to treat
women with the medication of their choice.”

Pharmacy compounding is a long-standing, state-regulated and medically vital practice.
Millions of Americans have unique health needs that off-the-shelf prescription
medications cannot meet. For them, customized, compounded medications - prescribed
or ordered by licensed physicians or veterinarians and mixed safely by trained, licensed
compounding pharmacists - are the only way to better health.

About IACP

The International Academy of Compounding Pharmacists (IACP) is a non-profit
association founded in 1991 to protect and promote the art and skill of the compounding
pharmacy profession. We represent more than 2,000 pharmacists, physicians, technicians
and patients who are committed to the safe practice of pharmacy compounding. We are
committed to ensuring the rights of physicians to prescribe, of pharmacists to prepare and
of patients to take customized medications that meet their unique, individual needs.

International Academy of Compounding Pharmacists

Providing appropriate treatment methods to HIV-positive women during pregnancy can prevent nearly all risk of mother-to-child transmission of the virus, according to a study published online Wednesday in the journal AIDS, the PA/Google.com reports (Kirby, PA/Google.com, 5/6).

For the study, Claire Townsend, research fellow at the University College London Institute of Child Health, and colleagues analyzed 5,151 pregnancies among HIV-positive women in the United Kingdom and Ireland between 2000 and 2006. The study found that the rate of MTCT decreased to 1.2% from 20% in the mid-1990s.

According to the researchers, the primary reason for the decline was the increase in prenatal HIV testing following the implementation of routine screening policies in the countries, BBC News reports. Routine screening increased diagnosis rates before delivery from about 70% in 2000 to about 95% in 2005, data showed (BBC News, 5/6). Routine screening policies were introduced in Ireland in 1999 and between 2000 and 2003 in the United Kingdom, the PA/Google.com reports.

Expanded access to antiretroviral treatment for HIV-positive pregnant women also was a factor, researchers said. The HIV transmission rate for women taking antiretroviral therapy for a minimum of two weeks prior to delivery was 0.8%, according to the study (PA/Google.com, 5/6). The rate was found regardless of the type of antiretrovirals the women received or whether they had vaginal births or cesarean sections, the study found.

It was the first time such low rates of MTCT have been found at a population level, researchers said (BBC News, 5/6). Townsend said, “Continuing to improve the offer and uptake of antenatal HIV testing could have a significant impact on further reducing MTCT, since most perinatally acquired infection is now in infants whose mothers are among the approximately 5% of infected women who remain undiagnosed at delivery” (PA/Google.com, 5/6). She also said, “This emphasizes the importance of achieving and maintaining a high uptake of antenatal HIV testing on a national scale.”

Lisa Power of the Terrence Higgins Trust said, “With the right treatment and relevant support, the vast majority of women living with HIV can have healthy uninfected children,” adding, “This is why testing for HIV in pregnancy is so important and why treatment for pregnant women living with HIV in the [United Kingdom] should always be free, whatever their immigration status” (BBC News, 5/6).


The study is available online.

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.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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.

© 2008 The Advisory Board Company. All rights reserved.

Yesterday H. Con. Res. 342 was introduced by Rep. Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) opposing the Food and Drug Administration’s (FDA) decision to restrict Estriol (a form of Estrogen), a compounded hormone preparation used by women to alleviate the symptoms of menopause. The action was taken after the FDA sent letters to seven pharmacies in January asking them to cease and desist with the use of estriol. At this time, there is insufficient evidence substantiating the need for restriction. In response Bruce Roberts, RPh, executive vice president and CEO of the National Community Pharmacists Association (NCPA), issued the following statement:

“Estriol helps women manage the menopause process and has been proven safe and effective. FDA’s decision is not predicated on evidence, therefore questioning their interference in the states’ jurisdiction over drug compounding. The National Community Pharmacists Association commends Representatives Mike Ross and Jo Ann Emerson for their ‘Sense of Congress’ resolution urging the FDA to reconsider their restrictions on the use of Estriol.”

NOTE: Representatives Tammy Baldwin (D-Wis.), Michael Burgess (R-Texas), John Carter (R-Texas), Sam Farr (D-Calif.), and Gabrielle Giffords (D-Ariz.) were also instrumental in bringing this much needed language to the House floor.

The National Community Pharmacists Association, founded in 1898, represents the nation’s community pharmacists, including the owners of more than 23,000 pharmacies. The nation’s independent pharmacies, independent pharmacy franchises, and independent chains dispense nearly half of the nation’s retail prescription medicines.

National Community Pharmacists Association

GE Healthcare is featuring its innovative technologies that can enable earlier detection, more accurate diagnoses of health conditions, and personalized treatment plans for women who are pregnant or affected by cancer, heart disease, osteoporosis, uterine fibroids and other conditions. Through May 7 at the 56th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) in New Orleans, GE Healthcare is showcasing its commitment to the development of devices and services for clinicians and patients in women’s health care.

GE Ultrasound: Extraordinary vision

With our focus on reproductive medicine, obstetrics, labor & delivery, maternal fetal medicine and gynecology, GE continues to develop a broad selection of ultrasound and IT solutions. Whether clinicians need 2D or 3D/4D ultrasound, full-size consoles or new generation compact systems, GE offers innovative tools for the smallest private office to the largest hospital networks. GE’s advanced ultrasound technology gives clinicians extraordinary imaging capabilities that help them make clinical decisions earlier and with enhanced confidence. Clinical workflow advances on the Voluson systems include automation tools for the acquisition of images used to diagnose fetal heart defects, called Sonography based Volume Computer Aided Diagnosis (SonoVCAD), and another tool for follicular assessment called Sonography based Automated Volume Count (SonoAVC). Advanced imaging capabilities on both the LOGIQ 9 and LOGIQ i systems deliver high-frequency imaging and penetration needed to detect and characterize breast lesions. Viewpoint, a data management solution, makes ultrasound workflow quicker and easier by combining reporting and image capabilities.

Maternal-Fetal Monitoring

New enhancements to GE’s leading maternal-fetal monitor series provide more comprehensive perinatal monitoring of mothers and fetuses as they progress through the birthing process. GE is showcasing a new model — the Corometrics 250cx Series Maternal/Fetal Monitor. The enhanced model features the optional Exergen TAT-5000 Maternal TemporalScannerTM that allows clinicians to obtain maternal temperature using a non-invasive infrared technology that detects heat through the skin surface via an external scanner and the optional Extend-A-ViewTM 15-inch Color Remote Display that provides clinicians access to the same maternal and fetal vital parameters as seen on the bedside monitor. These new options, combined with our standard advanced parameters such as Smart BPTM that delays automated non-invasive blood pressure (NIBP) measurement during contractions, and DINAMAP® SuperSTATTM NIBP technology that decreases the amount of time required to take the blood pressure of a laboring mother, allow medical facilities to deliver a high-touch experience for every patient from prenatal evaluations to postpartum assessments and every stage in between - including celebrating the birth with a choice of three songs.

Bone Mineral Densitometry: Osteoporosis

When undetected, the bone loss that accompanies osteoporosis, “the silent disease,” can have a permanent impact on the overall health of a patient. One in three women, and one in five men over 50 will experience osteoporotic fractures.1,2,3 In women over 45 years of age, osteoporosis accounts for more days spent in hospital than many other diseases, including diabetes, myocardial infarction and breast cancer.4

The good news is that GE Lunar technology can help clinicians prevent and detect osteoporosis. GE Lunar has a broad range of efficient, comprehensive bone mineral density (BMD) and portable bone ultrasonometer solutions that can help clinicians differentiate their practice, helping more patients detect bone loss earlier.

MR-guided Focused Ultrasound: Uterine Fibroid Treatment

GE will also showcase the only non-invasive surgical treatment available for uterine fibroids in the United States. GE and InSightec, a company that develops non-invasive therapy systems, developed the world’s first magnetic resonance (MR) image guided focused ultrasound system. MRgFUS technology combines MR - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. InSightec’s ExAblate 2000 system, approved by the Food and Drug Administration (FDA) in October 2004, works exclusively in combination with GE’s Signa MR system to non-invasively treat symptomatic uterine fibroids.

Clinical Education: Fetal Heart Monitoring

The new Electronic Fetal Heart Monitoring Interpretation and Management Education Program can help enhance communication among healthcare providers by promoting standardization of fetal heart monitoring (FHR) definitions and interpretation. Developed by nationally recognized fetal monitoring experts Frank Miller, M.D., FACOG and David Miller, M.D., FACOG, this Web-based, interactive education program reinforces the standardized National Institute of Child Health and Human Development (NICHD) definitions of FHR patterns.

Integrated IT Solutions

In perinatal, technology is crucial for delivering insight to the point of care. GE will showcase its latest release of Centricity Perinatal (CPN) 6.8, a clinician software package that combines the company’s long-time expertise in labor & delivery with enhancements to its neonatal intensive care unit (NICU) capability. As the percentage of babies arriving in NICU continues to rise, CPN 6.8 helps to foster their development with enhanced NICU-specific capabilities, including: Mother-Baby Link, which automatically populates the infant’s record with relevant maternal and delivery information; NICU Chalkboards, a quick, dynamically updated unit overview for a simple, yet comprehensive view that can be customized for a variety of purposes; and Advanced Reporting, which generates data that facilitates benchmarking specific to a particular care initiative to enhance unit performance. The solution also completes Perinatal Continuum of Care by making prenatal data from GE Healthcare’s Centricity Electronic Medical Record (EMR) located in many private practice environments, available in Centricity Perinatal at the hospital, and closes the loop by sending a delivery summary back to Centricity EMR in the office.

References:

1. Melton LJ, 3rd, Atkinson EJ, O’Connor MK, et al. (1998) Bone density and fracture risk in men. J Bone Miner Res 13:1915.
2. Melton LJ, 3rd, Chrischilles EA, Cooper C, et al. (1992) Perspective. How many women have osteoporosis? J Bone Miner Res 7:1005.
3. Kanis JA, Johnell O, Oden A, et al. (2000) Long-term risk of osteoporotic fracture in Malmo. Osteoporos Int 11:669.
4. Kanis JA, Delmas P, Burckhardt P, et al. (1997) Guidelines for diagnosis and management of osteoporosis. The European Foundation for Osteoporosis and Bone Disease. Osteoporos Int 7:390.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest.

GE Healthcare’s broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.

GE Healthcare

When reauthorizing the President’s Emergency Plan for AIDS Relief, Congress should address the “cultural tragedy” that married women in Africa are at an increased risk of HIV, a Kansas City Star editorial says. According to the Star, women and young girls make up more than 60% of those living with HIV in Africa and as many as 75% of HIV-positive young people in sub-Saharan Africa. It adds that these figures in part are “due to women’s lack of rights, including the inability to request that their husbands use condoms, or even their ability to refuse sex.”

According to the editorial, the most effective way to reach women is during routine prenatal visits, when health professionals are more likely to discuss HIV/AIDS with women before they contract the virus or at least during the early stages of the disease. Therefore, PEPFAR funding should be made available in “family health clinics, where women can access HIV testing and treatment services early as they see doctors for their pregnancies,” the editorial says. However, some PEPFAR funds are “being held hostage by unsubstantiated fears that the money would support doctors who perform abortions,” the editorial says, adding that the “truth is that abortion is illegal” throughout most of the continent. “Integrating HIV prevention and treatment with women’s other health care would save hundreds of thousands of lives,” the editorial says, adding, “Current restrictions segregate HIV/AIDS assistance, in separate clinics. As a result, many women are not seen until they have AIDS, when it is too late for medicines to help” (Kansas City Star, 5/4).

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.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.