GlaxoSmithKline Announces Swiss Approval Of Tyverb®, A New Oral Treatment For Advanced Breast Cancer

GlaxoSmithKline announced today an important milestone for advanced breast cancer patients across Europe with approval of the first oral ErbB1 and ErbB2 dual inhibitor, Tyverb® (lapatinib). Lapatinib, in combination with capecitabine, received approval from Switzerland's regulatory authority,Swissmedic,for the treatment of patients with advanced ormetastatic breast cancer whose tumours overexpress ErbB2 (HER-2) and who have relapsed after, or not responded to, trastuzumab therapy.


Lapatinib is a small molecule that is administered orally and works by getting inside the cancer cell and inhibiting two receptor proteins the tyrosine kinase components of ErbB1 and ErbB2 receptors, which are responsible for tumour growth. This innovative mechanism of action is a new way to treat breast cancer and is different from current targeted therapies for ErbB2 positive disease.


This approval was based on a pivotal Phase III trial (EGF100151) in women with advanced ormetastatic ErbB2 positive breast cancer whose disease had progressed following treatment with trastuzumab and other cancer therapies. The data showed that the median time to progression was 27.1 weeks on the combination of lapatinib and capecitabine versus 18.6 weeks on capecitabine alone (hazard ratio 0.57 (CI 0.43, 0.77) p=0.0001). The response rate was 23.7% versus 13.9% (p=0.017).[1]


The most common adverse events during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea and vomiting) or skin toxicities (hand and foot syndrome and rash). The majority of adverse events and laboratory abnormalities were mild to moderate in severity and were not significantly higher than those seen with capecitabine monotherapy.


"This is an extremely significant and exciting breakthrough for patients and physicians across Switzerland. Lapatinib offers patients an effective, well-tolerated treatment and as an oral therapy offers added convenience for patients. Lapatinib is now available in Switzerland and subject to regulatory approval we remain ontrack to launch lapatinib in the rest of Europe during the second half of 2007" said Paolo Paoletti, SVP and Global Head of the Oncology Medicine Development Centre at GSK. "The approval of lapatinib demonstrates our R&D organisation's strong commitment to the discovery and development of novel cancer treatments. We are dedicated to the further study and development of lapatinib in a variety of settings including early breast cancer as well as in other types of cancer."


Brain Metastases as Relapse Site


Brain metastases develop in one third of women with ErbB2 (HER-2) positive metastatic breast cancer, and is an area of significant unmet medical need. Once the disease advances to this site, overall prognosis is poor with the average one-year survival estimated at about 20 percent.[2]
In the Phase III trial on which the Swiss approval is based, preliminary results suggest that lapatinib may play a role in decreasing the development of brain metastases as site of first relapse. CNS relapse were lower in the lapatinib plus capecitabine arm versus the capecitabine alone arm.i Additional studies are ongoing in an effort to confirm this preliminary finding.















Future for Lapatinib - Ongoing Clinical Trials


Further studies are ongoing and are investigating the use of lapatinib either alone or in combination with other therapies for the treatment of breast cancer in women that are ErbB2 positive, including first-line in previously untreated metastatic breast cancer, as well as an adjuvant therapy for primary or early breast cancer. Trials are also ongoing in a range of other solid tumours that overexpress ErbB1 and/or ErbB2, including head & neck and renal cell cancer.[3],,[4]


GSK in Oncology


GSK Oncology is dedicated to producing innovations in cancer that will make profound differences in the lives of patients. Through GSK's revolutionary "bench to bedside" approach, we are transforming the way treatments are discovered and developed, resulting in one of the most robust pipelines in the oncology sector. Our worldwide research in oncology includes partnerships with more than 160 cancer centres. GSK is closing in on cancer from all sides with a new generation of patient focused cancer treatments in prevention, supportive care, chemotherapy and targeted therapies.


About GlaxoSmithKline


GlaxoSmithKline one of the world's leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For company information, visit GlaxoSmithKline at gsk.


Tyverb® and Tykerb® are registered trade marks of the GlaxoSmithKline group of companies.


Tykerb® (lapatinib) is available in the United States and has received regulatory approval in Bahrain, Kuwait, and conditional approval in UAE.


Lapatinib has not received regulatory approval in the European Union. A registration dossier has been filed with the European Medicines Agency. Tyverb® is the proposed trade mark for lapatinib in the European Union, subject to regulatory approval.


Registration dossiers for lapatinib (under the trade mark Tykerb®) have been filed in Australia, Canada, New Zealand and a number of countries in Asia, Latin Americaand the Middle East.


References:


[1] Tyverb® Prescribing Information. GSK data on file.


[2] Weil R. et al. Breast Cancer Metastasis to the Central Nervous System. American Journal of Pathology. 2005;167:913-920.


[3] El-Hariry, I., Harrington K. et al. A phase I, open label study (EGF100262) of lapatinib plus chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Oral presentation, 1st International Meeting on Innovative Approaches in Head & Neck Oncology, Barcelona, Spain. 22nd - 24th February 2007.


[4] Ravaud A, Gardner, R. Hawkins H et al. Efficacy of lapatinib in patients with high Tumour EGFR expression: Results of a phase III trial in advanced renal cell carcinoma (RCC).Journal of Clinical Oncology, 2006 ASCO Annual Meeting ProceedingsPartI.Vol 24, No. 18S (June 20 Supplement) 2006:



View drug information on Tykerb.

Nepalese Maternal Mortality Rate Among Highest Worldwide, IFRC Report Says

Nearly 6,000 women and 30,000 infants in Nepal die annually because of unsafe childbirth and neonatal practices, according to an International Federation of Red Cross and Red Crescent Societies report released on Monday in Kathmandu, Nepal, Reuters reports. The group's "World Disasters Report 2006" found that Nepal is "the deadliest place in the world to give birth, outside Afghanistan and a clutch of countries in sub-Saharan Africa." According to the report, there are 1,300 doctors, 90,000 undertrained health workers, 87 hospitals and fewer than 1,000 health centers for Nepal's 26 million people. The report also found that many of the country's 4,000 villages have no health center and that 90% of infants are delivered in homes without the help of trained nurses. In addition, nearly 40% of people in Nepal have incomes of less than $1 per day and many cannot afford to pay medical bills. According to the report authors, Nepali women are not permitted to discuss pregnancy with anyone but their husbands or seek medical attention without the assistance of another person. Mothers and infants also are regarded as "unclean" and are often forced to stay in unsanitary rooms or cowsheds for the first 11 days after delivery. Jonathan Walter, the report's editor, said, "This kind of discrimination greatly hampers [a woman and child's] chance of survival." The government in 2002 legalized abortion to help protect women from untrained health workers and has begun efforts to educate people about safe childbirth, Reuters reports (Sharma, Reuters, 12/18).

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

TAXUS WOMAN Study Reports Positive Clinical Outcomes For The TAXUS Drug-Eluting In Women

Boston Scientific Corporation (NYSE: BSX) announced results from the TAXUS WOMAN study, a gender specific analysis of the TAXUS II, IV, V and VI trials assessing the efficacy data of the TAXUS™ paclitaxel-eluting coronary stent in women undergoing coronary revascularization. The study found paclitaxel-eluting stents to have similar clinical outcomes in women and men, despite the higher risk profile in women patients. Results of the analysis of the TAXUS WOMAN study were released at the annual European Society of Cardiology Congress in Vienna, Austria.


"This study of data from the TAXUS trials offers encouraging news for women with coronary artery disease," said Ghada Mikhail, M.D., Consultant Cardiologist, St Mary's Hospital Trust, London, UK. "Previous trials and registries have demonstrated a less favorable clinical outcome in women compared to men when undergoing coronary revascularization with bare-metal stents. That difference has been previously explained by the smaller vessels and higher risk profile seen in women. These data show, however, that the TAXUS paclitaxel-eluting coronary stent works equally well in women, maintaining its anti-restenotic efficacy advantages and positive safety profile relative to bare-metal stents."


"Heart disease is the number one cause of death among women in the United States, and more women than men die from cardiovascular disease each year," said Hank Kucheman, Senior Vice President and Group President, Interventional Cardiology. "The findings of the TAXUS WOMAN study show the clear and sustained benefit of the TAXUS stent in women with heart disease."


The TAXUS II, IV, V and VI trials evaluated the performance of the TAXUS paclitaxel-eluting stent (PES) compared to a bare-metal stent (BMS) control in patients with coronary artery disease. The TAXUS WOMAN study analysed pooled results of the women enrolled in these TAXUS trials and compared them with the corresponding endpoints in men.


Of the 3,445 patients enrolled in the TAXUS trials between June 2001 and March 2004, 955 (27.7%) were women. Of these women, 480 received PES and 475 received BMS. Of the 2,490 men enrolled, 1,238 received PES and 1,252 received BMS. As compared to men, women were older (mean age 65.4?±10.9 years versus 61.0?±10.4 years), had smaller body surface area (1.80?±0.19m2 versus 2.05?±0.20m2), had more diabetes (30.4% versus 21.0%), had more hypertension (78.0% versus 65.1%), had smaller vessels (pre-procedure reference vessel diameter 2.63?±0.46mm versus 2.78?±0.52mm), and had more history of coronary artery disease (62.2% versus 54.7%) (p for all

Advocacy Group Launches Ads Urging Massachusetts Gov. Patrick To Accept Federal Abstinence-Only Sex Education Grant

The National Abstinence Education Association on Wednesday launched an advertising campaign calling on Massachusetts Gov. Deval Patrick (D) to accept a $700,000 federal grant for abstinence-only sex education classes, the Boston Herald reports (Fargen, Boston Herald, 9/6). Patrick in July vetoed a provision in a state budget measure that would have accepted the federal grant.

According to the Sexuality Information and Education Council of the United States, eight other states have rejected the funding, which requires that sex education curricula promote abstinence until marriage, and 12 additional states are considering not applying for the grant. In rejecting the funding, Patrick's administration cited a study commissioned by Congress and released in June that found students who participate in abstinence-only programs are as likely to have sex as students who do not participate in the programs.

Dorchester, Mass.-based Healthy Futures -- which teaches abstinence education to 7,000 middle school students annually -- has said it will lose about $500,000, or about 50% of its annual budget, without the federal grant. Rep. Brad Jones (R) in July said he will call on the Republican leadership in the Legislature to attempt to override Patrick's veto. However, Patrick could still decide not to apply for the grant if his veto is overridden (Kaiser Daily Women's Health Policy Report, 7/19).

According to the AP/Boston Globe, NAEA has spent $75,000 for the media campaign, which will issue ads in newspapers and on the radio. One of the ads says, "Deval Patrick Doesn't Want 11-Year-Olds Taught To Say 'No' to Sex." The group also has launched a Web site urging Patrick to accept the funds.

Patrick spokesperson Kyle Sullivan called the ad "a complete and utter distortion of the facts" (AP/Boston Globe, 9/6). JudyAnn Bigby, secretary of health and human services, said the Patrick administration will not change its mind, adding that although abstinence is part of comprehensive sex education, restrictions on the federal grant "require that we teach things that are either unfounded in fact or are very biased in terms of the values."

Valerie Huber, director of NAEA, said that Patrick's veto is "taking away the freedom of choice for Massachusetts schools to select abstinence education." She added that Massachusetts is the first state targeted in NAEA's ad campaign but that more could come (Boston Herald, 9/6).

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

Healthcare Watchdog Renews Call For Robust Safety Checks In Maternity Units As Investigation Describes Deaths Of 10 Women, UK

The Healthcare Commission will today (Wednesday) publish an investigation report into the deaths of ten women who gave birth at Northwick Park Hospital, West London.


The findings have prompted the inspectorate to renew its call for NHS trusts to check that they have robust systems for monitoring the safety of maternity units.


The report describes what happened to each of the ten women, all of whom died during pregnancy or within 42 days of giving birth between April 2002 and April 2005. This number of deaths was significantly higher than the national average for maternity.


In April last year, the Commission stepped in and recommended that the Government place North West London Hospitals NHS Trust under special measures, calling in an external team to safeguard women at Northwick Park Hospital's maternity unit.


This report, which aimed to identify if there were common factors between the deaths, paints a stark picture of what can happen when a maternity unit has inadequate systems to protect the women it cares for.


The Commission criticises the quality of care given by the Trust in nine out of the ten cases.


Common factors include:


-- insufficient input from a consultant or a senior midwife (in five cases), with difficult decisions often left to junior staff.

-- failure in a number of cases to recognise and respond quickly where a woman's condition changed unexpectedly

-- inadequate resources to deal with high-risk cases: too few consultant obstetricians and midwives; not enough dedicated theatre staff; a reliance on agency and locum staff without adequate managerial or professional support; and a lack of a dedicated high dependency unit

-- a working culture that led to poor working practices and resulted in poor quality of care

-- failure to learn lessons on the unit - the Trust took action following the deaths but the working environment was such that mistakes were repeated

-- failure by the Trust's board to appreciate the seriousness of the situation - the board was aware of the high number of deaths, and should have acted sooner to rectify problems.


The Commission does not criticise all aspects of the hospital's care. Anaesthetic staff and the haematology department, which provided blood for the patients, were praised for responding well under difficult circumstances.


The Trust remains under special measures, but the Commission says there have been significant improvements in the maternity services provided there. These have included the recruitment of three additional consultants and 20 more midwives.


The inspectorate also believes there is now better team working between consultants and the obstetric staff, and between the obstetric staff and midwives.


Marcia Fry, the Commission's Head of Operational Development, said: "This was a sad and tragic series of events. We hope this report at least gives some answers to the families involved.















"At the time of the deaths, the working practices at the Trust were unacceptable. However, under special measures the Trust has got its maternity services on the road to recovery. We will continue to work with them to ensure that they continue to progress and that everything possible is done to stop this happening again."


Mrs. Fry added: "We expect trusts across the country to read this report and learn the lessons. Most women in this country give birth safely. But there are risks and the NHS must ensure it does all it can to reduce them. There can be no excuse for failing to learn the lessons from tragedies of this kind."


This is the Commission's second report into Northwick Park Hospital's maternity services. The first, in July 2005, identified system failures including lack of leadership and weak risk management. This report outlines the impact on the ten women concerned.


Last year, Commission Chairman Sir Ian Kennedy called on NHS trusts to raise standards in their maternity services to those of the best. He drew on the similarities between Northwick Park and two other trusts where maternity services had been investigated.


Sir Ian said the overall root cause of poor performance is often weak managerial or clinical leadership which can leave problems unidentified or unresolved. He also highlighted:


-- weak risk management with poor incident reporting and complaints handling

-- poor working relationships and working in multi-disciplinary teams

-- inadequate training and supervision of clinical staff

-- poor environment with services isolated geographically or clinically
-- shortages of staff coupled with poor management of temporary employees.


The Commission is stepping up its assessments of maternity services, which will provide it with information on patient experience and clinical outcomes. It is planning a major survey of looking at women's experience of maternity care, as well as a national review of maternity units, which will include clinical indicators that enable NHS trusts to compare their performance.


-- Investigation into 10 maternal deaths at, or following delivery at, Northwick park Hospital, North West London Hospitals NHS Trust, between April 2002 and April 2005 (pdf 920kb)


-- More information about North West london Hospitals NHS Trust


About the Investigation


-- On 15 August 2006 the Commission conducted an unannounced visit at Northwick Park's maternity unit. The Commission looked at antenatal, post-natal and delivery services. The Commission was satisfied that progress has been made in these three areas and that there was improvement in working practices at the unit.


-- This second investigation was conducted between June 2005 and June 2006


-- Healthcare Commission staff worked with a team of clinical advisors with specialist knowledge of maternity services, anaesthetic services and the management of risk. Additional specialist advice was sought from a consultant haematologist, a consultant cardiologist and a consultant hepatobiliary liver transplant surgeon


-- The investigation team reviewed the clinical records of the ten women who died and the documentation from the trust's internal and external reviews of their deaths. This included previous statements made by staff, inquest transcripts and other external reports


-- The team also reviewed information from other trusts that were involved in events leading up to the deaths of the ten women. Interviews were conducted with 46 NHS staff (both past and present employees of the trust)


-- Each of the families of the ten women were invited to meet with the Commission's investigation team. Meetings were held with five of the families and one family responded in writing


-- The national average for maternal deaths as reported by CEMACH is one death per 8,775 maternities or 11.4 deaths per 100,000 maternities. The maternal death rate for Northwick Park maternity unit (in the period April 2002 to March 2004) was 74.2 deaths per 100,000 maternities


About the Healthcare Commission


---- The Healthcare Commission is the independent inspection body for both the NHS and the private and voluntary healthcare sectors. It exists to promote improvements in the quality of healthcare in England and Wales


---- The Healthcare Commission has a legal obligation under the Health and Social Care Act 2003 to report significant failings to the Secretary of State; this may also include recommendations for special measures. Special measures are designed to generate improvements where other methods have failed, or are considered likely to do so.


---- The Healthcare Commission has 15 commissioners and is chaired by Professor Sir Ian Kennedy who was chairman of the public inquiry into children's heart surgery at Bristol Royal Infirmary, published in 2001


---- Its roles in England include -


- assessment of performance of health service providers against Government standards

- investigation of serious failures in healthcare services

- independent review of complaints about the NHS which have not been resolved locally

- rating the performance of NHS hospitals and trusts

- publication of an annual report on healthcare performance


Further information on the Healthcare Commission is available on healthcarecommission

Separating Fact From Fiction: The Truth About Nutrition In Pregnancy

Pregnant women need to be especially
careful to eat healthfully and pregnancy is a great time to learn,
according to a leading nutrition expert.


Marion Nestle, Ph.D., M.P.H., a nationally-renowned nutritionist and
author, said women who are pregnant or thinking about getting pregnant
should use this time to learn the basics of good nutrition before, during
and after pregnancy. The basic principles of healthful diets apply even
more to pregnancy: eat enough (but not too much); stay active; eat plenty
of fruits, vegetables, and whole grains; don't eat too much junk food; and
enjoy!



Dr. Nestle spoke during a March of Dimes-sponsored National
Communications Advisory Council luncheon entitled "Mythbusters: Myths and
Misconceptions on Nutrition in Pregnancy." Dr. Nestle, who is the Paulette
Goddard Professor of Nutrition, Food Studies, and Public Health at the
Steinhardt School of Culture, Education, and Human Development at New York
University, said, "You have to be a savvy shopper about food just as you
would be with anything else you buy. If claims about a particular food or
product seem too good to be true, they undoubtedly are! Be a skeptic, do
some homework, ask questions. Rely on research, not opinion. And check any
major decision with your prenatal provider."



The March of Dimes says consumers have lots of questions about good
nutrition in pregnancy including: "Does salt have anything to do with
hypertension?"; "Is it okay to eat artificial sweeteners?"; and "Are herbal
supplements safe because they're 'natural'?"



Also speaking at the luncheon was Kim Saul, a vegetarian and the mother
of 3-year-old Quinn. "I knew a lot about eating well for my own health, but
when I got pregnant I learned some important food tips from my
obstetrician. I didn't need more protein, but did have to add calcium and
keep my iron levels up. I limited fish that might have high mercury
content. I also ate eggs, but made sure they were cooked thoroughly. I
didn't overdue anything. For me, moderation was and is the key."



The March of Dimes works to improve the health of babies by preventing
birth defects, premature birth and infant mortality.


March of Dimes

marchofdimes

Texas Lawmakers Divert Millions From Family Planning Clinics To Community Health Centers

Specialty clinics that provide family planning services in Texas have seen a significant decrease in state funding over the past four years because lawmakers have redirected millions of dollars to expand family planning at community health centers, the Dallas Morning News reports. The funding changes began in 2005, when lawmakers said they were shifting funding to community health centers because they offered more comprehensive health care to low-income patients. Advocates for the family planning clinics argue that the policy is an attempt by antiabortion-rights advocates to shut the clinics down. Although clinics that receive state funding are prohibited from offering abortion services, some conservative lawmakers believe that limiting the funding will hurt groups like Planned Parenthood, which offers abortion services at other locations, according to some family planning advocates. The Morning News reports that state lawmakers might return some of the funding to the specialty clinics during the current legislative session; however, the funding only would equal any money left unused by the community health centers.

The most significant funding change occurred in 2005, when almost 25% of the state's $45 million annual family planning budget was set aside for "federally qualified health centers" -- community health centers that offer services to uninsured and underserved people. Advocates for family planning clinics say that the number of patients receiving state-funded reproductive services declined by nearly 22%, from 326,000 patients in 2005 to 255,000 in the last fiscal year. They also note that the community health centers have an unused surplus of more than $11.5 million since 2005, which they say the family planning clinics could have used.

According to the Morning News, many public health experts believe that specialty clinics that have family planning services offer more efficient and effective reproductive care than community health centers. David Warner, a health care finance and policy expert at the University of Texas Lyndon B. Johnson School of Public Affairs, said the specialty clinics are "very targeted" and "don't have a lot of overhead," whereas the community clinics have "limited enrollment and can be a lot less accessible." He added, "Continuing to starve those clinics means that you're not going to be reaching the number of people you could be reaching with family planning services." Family planning clinics in Texas offer more than a dozen services ranging from birth control prescriptions to breast and cervical cancer screening and sexually transmitted infection testing. However, reproductive health advocates say many people often associate the clinics with abortion services, which gives antiabortion-rights lawmakers an incentive to shut down the clinics by withholding funding. Fran Hagerty, CEO of the Women's Health and Family Planning Association of Texas, said, "Some lawmakers believe if they can prevent Planned Parenthood from participating in the state's family planning program, then they've accomplished their goal."

Supporters of community health centers say that billing issues and other administrative problems have distorted their data on how many reproductive health patients they are treating. Many women receive care at the community centers for family planning services along with treatment of other health problems, so they often are not recorded as reproductive health patients, according to the centers (Ramshaw, Dallas Morning News, 5/22).


Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.


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