Fortyfour percent of workingclass women want to have fewer children or delay pregnancy because of the economic recession, according to a study by the Guttmacher Institute, the Washington Posts “Daily Dose” reports. A nationally representative sample of 947 women ages 18 to 34 at risk of getting pregnant and living in households with incomes less than $75,000 was surveyed in July and August. Of women who reported a desire to reduce or delay childbearing because of the economic recession, 31% said they want to get pregnant later, 28% want fewer children than previously planned and 7% no longer want any additional children (Stein, “Daily Dose,” Washington Post, 9/23).

Laura Lindberg, a senior research associate at Guttmacher, said, “The recession has impacted much more than peoples wallets,” adding, “Women, especially those that are facing financial difficulties, want to avoid unintended pregnancy more than ever, and many of them are having difficulties affording their contraception to do this” (Reinberg, HealthDay/U.S. News & World Report, 9/23).

Fiftytwo percent of respondents said they are financially worse off now than in 2008, and nearly three in four said they worry more about money. Fiftyseven percent of women with children reported worrying more about taking care of their children, and 64% agreed with the statement, “With the economy the way it is, I cant afford to have a baby right now.”

The study also found that 29% of women agreed with the statement, “With the economy the way it is, I am more careful than I used to be about using contraception every time I have sex” (”Daily Dose,” Washington Post, 9/23). According to HealthDay/U.S. News, some women are switching from daily, oral contraception to longer lasting methods, such as intrauterine devices and injectable contraceptives. Fortysix percent of the women who said they did not want more children also said they are “thinking more about sterilization,” the study found (HealthDay/ U.S. News & World Report, 9/23).

At the same time, financial strains are making it more difficult for some women to use effective contraception consistently, the “Daily Dose” reports. The study found that nearly one in four women reported having to delay gynecological or birth control visits in the past year to save money. Twentythree percent of the women said that they are having more difficulty paying for birth control than in the past, and 8% said they sometimes do not use any birth control as a way to save money. In addition, 18% of women using the birth control pills reported inconsistent use as a way to save money.

Sharon Camp, president and CEO of Guttmacher, said the economic downturn is “putting many women and their partners between a rock and a hard place,” adding, “They want to avoid an unplanned pregnancy more than ever, but for many of them the ability to afford the birth control they need is getting harder than ever.” Camp said, “These are women who might not have health insurance or may have lost their health insurance, and so might be most stressed” (”Daily Dose,” Washington Post, 9/23).

Cecile Richards, president of the Planned Parenthood Federation of America, said the study “confirms what we are hearing at Planned Parenthood health centers across the country.” Richards added that 17.5 million women currently are in need of publicly funded family planning services.

Men appear to have similar concerns about childbearing during the recession, according HealthDay/U.S. News & World Report. In early 2009, doctors reported an increase in the number of vasectomies performed since the start of the economic downturn. Doctors said the rise could come from a decreased desire to have children because of financial concerns, as well as fears of losing a job and health insurance.

According to Lindberg, the attitude and behavioral changes reported in the study could continue long after the recession is officially over. “National economic indicators may take a long time to translate into families homes and bedrooms,” she said (HealthDay/U.S. News & World Report, 9/23).

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

© 2009 The Advisory Board Company. All rights reserved.

When they think of attention deficit hyperactivity disorder, most people think of squirming kids unable to sit still. ADHD, as it is more generally known, is one of the most common disorders of childhood. But symptoms of ADHD often linger into adulthood.

Approximately 2 to 4 percent of college students report significant symptoms of ADHD such as difficulty with attention, impulse control, and restlessness.

Although there is a great deal of information about childhood and adult ADHD and treatments, theres scarce information about the effectiveness of medication on college students with ADHD.

That is all about to change. Researchers at the University of Rhode Island and Lehigh University are about to launch a study to test the effectiveness of the stimulant medication, Vyvanse™, on college students with ADHD. It is the first such study for this population.

Lisa Weyandt, an associate professor of psychology at URI and one of the nations leading researchers on ADHD in college students, was awarded a grant from Shire Development Inc. to support the study. Shire, the manufacturer of Vyvanse™, is a global specialty biopharmaceuticals company that focuses on attention deficit and hyperactivity disorder, human genetic therapies, and gastrointestinal diseases.

As principal investigator on the grant, Weyandt has subcontracted the study with her coinvestigator ADHD expert George DuPaul, professor of school psychology who chairs the Department of Education and Human Services at Lehigh. DuPauls research interests include the assessment and treatment of college students with significant ADHD symptoms. DuPaul earned his graduate degrees from URI.

“College students with ADHD are at a greater risk for academic and psychological difficulties. They are also in a unique developmental context at this stage of their lives, when they are expected to live and act independently,” says DuPaul.

“Many colleges and universities offer resources to help students with ADHD from a functional standpoint. However, we are the first to look at the impact of medication to treat the symptoms of ADHD.”

The study will begin this fall. Twentyfive students from URI and Lehigh University will be recruited for the fiveweek study through disability support services offices and advertisements.

Each student will be evaluated during a baseline level (no meds, no placebo), a placebo condition, and during three different levels of medication. The study, designed as a placebo controlled double blind, ensures that neither the student nor the data collector know the level of the drug, if any, the student is taking. Students will receive a $300 honorarium if they complete the study.

The grant will fund the salaries of two graduate students at each institution.

“The study will measure changes in attention and executive functions and social/psychological functioning, as well as perceived changes among the students,” said Weyandt. “Feedback from the students professors will also be sought.”

Study results will be announced in fall of 2010.

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Jan Wenzel

The Dallas Morning News reports on the lure of the medical imaging business, which is many say is a “growth industry,” including the idea that a “second or thirdhand MRI machine” can be purchased by a physician practice or freestanding imaging center for a few hundred thousand dollars but yield millions in new revenue. A report by Americas Health Insurance Plans says as many as half the scans are unnecessary, and a McKinsey Global Institute study found the extra machines produce around $26.4 billion in additional costs each year. In addition, they expose patients to avoidable radiation (McNeill, 9/22).

Separately, drug maker Eli Lilly recently disclosed payments to 3,400 doctors around the country who promoted the companys products to other doctors in their communities, the Orlando Sentinel reports. The payments to the socalled “Lilly faculty” totaled more than $22 million in the first quarter of this year, and were disclosed as part of a settlement with the federal government. An Institute of Medicine panel said the speaking payments lead to increased drug sales and should be halted. A Harvard medical school professor and panelist said the speeches also drive up health costs by encouraging doctors to choose more expensive, brandname drugs (LaMendola and Quintero, 9/23).

This information was reprinted from kaiserhealthnews.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Health Policy Report, search the archives and sign up for email delivery at kaiserhealthnews.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

Cancer predisposition resulting from the presence of a specific gene variant shows a strong gender bias, researchers at the University of Cincinnati (UC) have demonstrated.

In addition, the research indicates that the risk for development of cancer in individuals harboring the gene variant can be further increased as a result of environmental exposure.

Peter Stambrook, PhD, a professor in the department of molecular genetics, biochemistry and microbiology, and colleagues report their findings this week in Proceedings of the National Academy of Sciences (PNAS). Coauthors include researchers from Wright State University and the Laboratory for Health Protection Research, National Institute of Public Health and the Environment, the Netherlands.

Stambrook says the gene CHEK2 is part of a DNA damage response pathway that can have an impact on whether or not cancers develop. A CHEK2 variant, CHEK2*1100delC, is associated with increased risk of cancer.

“Women who carry this particular gene variant are predisposed to developing breast or ovarian cancer,” says Stambrook, “while men have a higher risk of developing prostate cancer.”

Stambrooks team has produced a mouse model in which the CHEK2 gene was replaced by the variant and found that the overwhelming majority of mice that developed cancer were female about 80 percent, as opposed to slightly more than 15 percent for males. This contrasts sharply with the incidence of cancer in wildtype mice (those with the normal CHEK2 gene), in which male and female mice developed cancer to about the same extent but at a much lower frequency.

Stambrook says his team will be exploring possible reasons behind the difference, looking at hormonal involvement and possible interactions between the gene variant and estrogen receptors or estrogen itself.

By using a known carcinogen, dimethyl benzanthracene, the researchers also determined that mice that harbor the variant are more susceptible to an environmental challenge than those that dont. The compound was administered orally to female mice.

“When they delivered the compound, the lifespan of the mice was reduced significantly they developed breast cancer as well as other types of cancers,” Stambrook says. “In addition, the mice that harbored this variant were more susceptible in other words, they developed tumors more quickly than wildtype mice.”

Stambrook says that by learning more about the signaling pathway of the CHEK2 gene, researchers can explore ways to “rescue” it and identify potential therapeutic targets.

“Its an interesting gene,” says Stambrook, “and there are a lot of interesting directions that this finding will take us.”

The work was supported in part by grants from the National Institutes of Health and UCs Center for Environmental Genetics.

Keith Herrell Keith Herrell

An article published Online First and in a future edition of The Lancet reports that hormone replacement therapy (HRT) using oestrogen and progestin increases the risk of death from lung cancer. This finding should be included into riskbenefit consideration for women considering HRT. It is especially essential for women at high risk of lung cancer. The article is the work of Professor Rowan Chlebowski, of the Los Angeles Biomedical Research Institute at HarbourUCLA Medical Center, Torrance, CA, USA, and colleagues.

Data from the Womens Health Initiative (WHI) trial was studied. This large trial, of HRT (oestrogen plus progestin) in postmenopausal women, was stopped prematurely when health risks were found to outweigh benefits. Followup after an average of 5.6 years showed that participants assigned to HRT had higher risks of cardiovascular disease, coronary heart disease, stroke, venous thromboembolism, and breast cancer, and lower risks of fractures and colorectal cancers than did women assigned to placebo. Between study groups, allcause mortality did not fluctuate. In addition, results from further followup of an additional 2.4 years (totalling 8 years of monitoring) suggested that the combined hormone therapy might increase mortality from lung cancer. In order to corroborate this association, the authors evaluated the number of lung cancers diagnosed in the trial over the whole followup period.

The WHI study involved 16,608 postmenopausal women aged 50 to 79 years with an intact uterus. It was a randomised controlled trial that took place in 40 centres in the USA. A group of 8,506 women received a oncedaily tablet of 0.625 mg conjugated equine oestrogen plus 2.5 mg medroxyprogesterone acetate. The other group of 8,102 women received matching placebo. After the 8 years total followup the researchers found that more women died from lung cancer in the combined hormone therapy group than in the placebo group (73 compared to 40 deaths). In other words, women in the HRT group were 71 percent more likely to die. This was mostly as a result of a higher number of deaths from nonsmallcell lung cancer (NSCLC) in the combined therapy group (62 compared to 31 deaths). Women in the HRT group were 87 percent more likely to die particularly of NSCLC. In addition, women in the HRT group were 28 percent more likely to be diagnosed with lung cancer than those given placebo, although this finding was not statistically significant. Between groups, incidence and mortality rates of smallcell lung cancer were comparable.

Dr. Rowan T. Chlebowski, MD, PhD, Los Angeles Biomedical Research Institute (LA BioMed) chief of oncology and author of the study comments”Postmenopausal women, especially current smokers or longterm past smokers, should carefully consider these new lung cancer findings before initiating or continuing combined estrogen plus progestin use.”

The authors write in conclusion “Treatment with oestrogen plus progestin in postmenopausal women…increased the number of deaths from lung cancer, in particular deaths from nonsmallcell lung cancer. These findings should be incorporated into riskbenefit discussions with women considering combined hormone therapy, especially those with a high risk of lung cancer…such as current smokers or longterm past smokers.”

In a supplementary note, Dr Apar Kishor Ganti, University of Nebraska Medical Center, Omaha, NE, USA, remarks “Because the optimum safe duration of hormonereplacement therapy in terms of lungcancer survival is unclear, such therapy should probably be avoided in women at a high risk of developing lung cancer, especially those with a history of smoking. These results, along with the findings showing no protection against coronary heart disease, seriously question whether hormonereplacement therapy has any role in medicine today. It is difficult to presume that the benefits of routine use of such therapy for menopausal symptoms outweigh the increased risks of mortality, especially in the absence of improvement in the quality of life.”

“Oestrogen plus progestin and lung cancer in postmenopausal women (Womens Health Initiative trial) a posthoc analysis of a randomised controlled trial”
Rowan T Chlebowski, Ann G Schwartz, Heather Wakelee, Garnet L Anderson, Marcia L Stefanick, JoAnn E Manson, Rebecca J Rodabough, Jason W Chien, Jean WactawskiWende, Margery Gass, Jane Morley Kotchen, Karen C Johnson, Mary Jo OSullivan, Judith K Ockene, Chu Chen, F Allan Hubbell, for the Womens Health Initiative Investigators
DOI 10.1016/S01406736(09)615269
The Lancet

Nicola Rossi, Director of Communications, BT Health, has been appointed Director of Communications for the National Pharmacy Association. Nicola will be taking up her new role in December 2009.

Nicola has spent the last three years managing communications for BTs NHS contracts and in that time she has worked with her team to build a comprehensive proactive communications programme as well as ensuring that external interest in BTs work in health is handled professionally. Immediately prior to that, she set up BTs first analyst relations programme, independently benchmarked as one of the best in the Europe. She has been working in communications management roles for BT for more than 20 years.

Nicola said “Community pharmacy is extremely popular with the general public. With its ubiquitous membership the NPA has a legitimate voice on a whole range of healthcare issues. My job will be to ensure that voice is heard, on behalf of community pharmacy, helping it to play a strategic role in policy making and service delivery.”

John Turk, Chief Executive of the National Pharmacy Association said “We have made this appointment to strengthen our representation with our most influential stakeholders. I am delighted that Nicola is joining us. She has a very strong track record working with strategic audiences and I look forward to working with her.”

Source

More than 200 million women worldwide want contraceptives, but currently have no access to them. Addressing this unmet need, and the 76 million unintended pregnancies globally each year, would slow population growth. This in turn would reduce demographic pressure on the environment. Those issues are discussed in the lead editorial in this week´s edition of The Lancet.

The editorial says “Countries in the developing world least responsible for the growing emissions are likely to experience the heaviest impact of climate change, with women bearing the greatest toll. In tandem with other factors, rapid population growth in these regions increases the scale of vulnerability to the consequences of climate change, for example, food and water scarcity, environmental degradation, and human displacement.”

The editorial mentions the recent International Conference on Population and Development (ICPD) meeting in Berlin and observes “Many of the NGOs still seem to be working in silos, avoiding the multisectoral engagement required to change societal attitudes.” It qualifies of disappointing the remaining tensions between various groups in these communities, but continues to remark “However, the discussions on how the sexual and reproductive health community are grappling with the emergent environmental crises that now shadow the landscape of womens health drew much attention at the Berlin meeting.”

A study of the first 40 National Adaptation Programmes of Action (NAPAs) is soon to be published by the WHO. It is submitted by the least developed countries to the UN Framework Convention on Climate Change. The study shows that 37 of these countries made the association between population growth and climate change. However, only six of them identified family planning as an element of their adaptation strategy. This is because family planning falls under the responsibility of the Ministries of Health rather than Environment, who are responsible for the NAPA documents. Also, only 7 percent of the 448 projects across the 40 NAPAs were in the health sector.

According to the editorial, the health response is not part of the current approaches to combat climate change. There is reference to a case study in Ethiopia, where people were trained in sustainable land management practices.At the same time the availability of family planning was increased. The programme resulted in a direct improvement to the environment with better agricultural practices. This outcome will be sustained in the longterm and will not be deteriorated by a rapidly increasing population.

The editorial says in closing “With less than three months to go, the UN Copenhagen conference on climate change provides an opportunity to draw attention to the centrality of women. The sexual and reproductive health and rights community should challenge the global architecture of climate change, and its technology focus, and shift the discussion to a more humanbased, rightsbased adaptation approach. Such a strategy would better serve the range of issues pivotal to improving the health of women worldwide.”

“Sexual and reproductive health and climate change”
The Lancet

On September 18, six leading sexual health and HIV organisations are launching SHout loud (Sexual Health out loud) shoutloud.org.uk , a website which enables the general public, community groups and campaigners to have their say about sexual health, contraception and HIV services in England.

The new site, launching during sexual health week, is a joint initiative by the African HIV Policy Network (AHPN), Brook, fpa, the Medical Foundation for AIDS and Sexual Health (MedFASH), NAT (National AIDS Trust) and Terrence Higgins Trust. Visitors type in their postcode to receive local data about sexual health, find out if sexual health is a priority in their area and can use the site to take action by contacting key decisionmakers.

Everyone who is interested in sexual health will be encouraged to get involved from young people, to those living with or affected by HIV to anyone who feels its an issue worth shouting about.

Teenage pregnancy rates are high across particular areas in England, one in 12 young people has chlamydia and more people are living with HIV than ever before. Individuals and community groups will be encouraged to get in touch with their MP, Primary Care Trust (PCT) and local authority to demonstrate that these issues matter to them and to try and ensure that sexual health, HIV and contraception services get the attention and funding they deserve.

Sophie Robinson, SHout loud project officer said “Some people are embarrassed to talk about sexual health, which often means that they dont express their views about local services to help them improve. The SHout loud website gives people the opportunity to show that sexual health issues really matter to them and to campaign for support and investment. If you care about the subject, sign up now and get your voice heard.”

Getting local people engaged in campaigning on local healthcare priorities is essential, especially during a recession when resources are limited.

Individuals and community groups can join the site to get information and ideas on how to get involved. To sign up visit shoutloud.org.uk

Notes

The African HIV Policy Network (AHPN) is an alliance of various African communitybased organisations and their members who collaboratively work for fair policies for people living with or affected by HIV/AIDS in the UK, providing various services such as training, support, research and information. AHPN is the only organisation within the UK whose work is dedicated to policy, advocacy and representation at national level, its main focus being HIV and the Sexual Health of Africans in the UK.

Brook helps young people to make informed, active choices about their personal and sexual relationships so they can enjoy their sexuality without harm. Brook is the UKs leading provider of sexual health services and advice for all young people under 25 and provides free and confidential sexual health information, contraception, pregnancy testing, advice and counselling, testing and treatment for sexually transmitted infections and outreach and education work, reaching around 210,000 young people every year. Brook has 45 years of experience working with young people and currently has a network of services in England, Scotland, Northern Ireland and Jersey.

fpa is one of the UKs leading sexual health charities. Its mission is to help establish a society in which everyone has positive, informed and nonjudgmental attitudes to sex and relationships; where everyone can make informed choice about sex and reproduction so that they can enjoy sexual health free from prejudice and harm. fpa provides a range of information, education and support services and runs public awareness and high profile media campaigns on all aspects of sexual health. For more information go to fpa.org.uk

The Medical Foundation for AIDS & Sexual Health (MedFASH) is a charity dedicated to the pursuit of excellence in the healthcare of people affected by HIV, sexually transmitted infections and related conditions. It develops and disseminates information and practical guidance for health professionals and policymakers, fosters communication and collaboration within and beyond the healthcare sector, and builds links between practice and policy.

NAT (National AIDS Trust) is the UKs leading charity dedicated to transforming societys response to HIV. We provide fresh thinking, expert advice and practical resources. We campaign for change. Shaping attitudes. Challenging injustice. Changing lives. nat.org.uk

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APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQAPCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Deferoxamine Mesylate for Injection, USP, in two dosage strengths. Deferoxamine Mesylate is therapeutically equivalent to the referencelisted drug Desferal®, which is marketed by the innovator Novartis.

APP will package Deferoxamine Mesylate in single dose vials of 500 mg, 10 mL and 2 gram, 30 mL. APPs Deferoxamine Mesylate is APrated, barcoded and latexfree. According to IMS data, 2008 sales of this product in the United States were approximately $11.8 million1.

Deferoxamine Mesylate is an iron chelating agent that is used for iron poisoning as well as chronic iron overload due to transfusiondependent anemias. In the case of acute iron poisoning, Deferoxamine Mesylate is most effective when given early in the treatment of iron poisoning. Longterm treatment with Deferoxamine Mesylate has been shown to slow the accumulation of excess iron in the liver and can slow or eliminate the progression of a serious form of liver damage called liver fibrosis.

APP plans to launch Deferoxamine Mesylate in the fourth quarter of 2009, which will further expand the companys critical care product line.

About APP Pharmaceuticals, Inc.

APP Pharmaceuticals, Inc. is a fullyintegrated pharmaceutical company that develops, manufactures and markets injectable pharmaceutical products with a primary focus on the oncology, antiinfective, anesthetic/analgesic and critical care markets. The company offers one of the most comprehensive product portfolios used in hospitals, longterm care facilities, alternate care sites and clinics within North America and manufactures a comprehensive range of dosage formulations. Fresenius Kabi Pharmaceuticals Holding, Inc., a wholly owned subsidiary of Fresenius Kabi AG, acquired APP Pharmaceuticals, Inc. on September 10, 2008. For more information about APP Pharmaceuticals, Inc., please visit the companys Web site at APPpharma.com.

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Ipsen (ParisIPN), announced preliminary results from a Phase II openlabel clinical trial (MS316 study) that evaluates the coadministration of recombinant human growth hormone (rhGH) and recombinant human insulinlike growth factor1 (rhIGF1) in two separate daily injections as a potential treatment for children with otherwise unexplained short stature associated with low IGF1 levels. Ipsen also announced results from a longterm study of rhIGF1 (study 1419) in patients with severe primary insulinlike growth factor deficiency (sPIGFD) that demonstrated that longterm twicedaily therapy with rhIGF1 improved the adult and near adult heights of extremely short patients with sPIGFD. The data from these two studies were presented along with posters on rhIGF1 (Increlex®, mecasermin [rDNA origin] injection) at the 8th Joint Meeting of the Lawson Wilkins Pediatric Endocrine Society / European Society for Pediatric Endocrinology (LWPES/ESPE) in New York, NY.

These studies were performed under INDs (investigational new drug application protocols) and the coadministration of rhGH and rhIGF1 is not an approved administration regimen for Increlex®. At this point in time, Increlex® is marketed in the U.S. and other countries throughout the world for the treatment of growth failure in children with severe Primary IGFD using twicedaily injections.

“The structuring of its US platform in 2008 enabled Ipsen to build a fully fledged commercial presence in the US but also to gain access to a promising pipeline. The Group intends to capitalize on its unique growth disorders and endocrinology franchise. The interim data presented at the LWPES/ ESPE meeting validate ongoing investigations and we look forward to continuing our research progress with our partners on this effort,” said JeanLuc Bélingard, Chairman and Chief Executive Officer, Ipsen. “Ipsen Group remains fully committed to furthering its endocrinology research and product development in support to its fastest growing franchise in this highlyspecialized therapeutic area.”

The MS316 study is an ongoing Phase II, randomized, openlabel, activetreatment controlled trial evaluating the efficacy and safety of the coadministration of rhGH and rhIGF1 therapy versus rhGH alone in 106 children with short stature associated with low levels of IGF1. All participants received morning injections of either rhGH alone (45 μg/kg oncedaily) or coadministered with rhIGF1 (45 μg/kg rhGH and 50, 100 or 150 μg/kg rhIGF1 also once daily as two injections). Subjects had a baseline mean height standard deviation score (SDS) of 2.5. Thirtysix of the children enrolled in the study have completed one year of treatment. Firstyear height velocities were 9.2 cm for the patients receiving rhGH alone and 10.4, 10.7, and 12.1cm for the three rhGH/rhIGF1 groups. At the end of one year, changes in mean height SDS were 0.72 for the patients receiving rhGH alone and 0.88, 0.91, and 1.11 for the three rhGH/rhIGF1 groups. Among all patients, the most common adverse events (> 15%) were headache, upper respiratory infection, injection site reactions and fever. Other noteworthy but less frequent adverse events included vomiting, hypoglycemia and gynecomastia. In addition, 2 transient cases of papilledema (probable intracranial hypertension) occurred with coadministration. In both cases, treatment was discontinued and restarted without recurrence.

“The preliminary results for the MS316 study of a coadministration treatment of recombinant IGF1 and recombinant growth hormone in children with short stature associated with low IGF1 are encouraging,” said L. Kurt Midyett, MD, Medical Director, Childrens Mercy Hospital and Clinics, Kansas City, Missouri. “While there is a compelling scientific rationale for coadministration therapy, this remains a research endeavor at this point and I look forward to seeing the completed data compiled and analyzed for this potential coadministration treatment option.”

Ipsen also announced data on 16 patients with severe Primary IGFD treated with Increlex® until adult or nearadult height. These patients were part of the original registration trial for Increlex® (study 1419), which continues to collect longterm followup data on treatment until they reached adult height. The analysis was done with 9 male and 7 female patients. Patients received a mean dose of 112 μg/kg Increlex® twicedaily for a mean of 9.9 years. Five patients also received GnRHanalog. The mean estimated gain in height up to the time of nearadult height in patients taking Increlex® was 13.2 cm (range 0.4 to 23.4) and the mean estimated gain in adult height was conservatively estimated as 10.5 cm (range 2.9 to 22.3). While longterm Increlex® therapy improved adult height for extremely short patients with severe Primary IGFD, most patients did not experience enough catchup growth to bring their heights into the normal adult range. The most common side effects associated with Increlex® include dizziness, headache, nausea and vomiting.

“The data supporting the efficacy and safety of recombinant human IGFI (rhIGFI) (Increlex®) continue to grow, and these results demonstrate that children with severe Primary IGFI deficiency can improve their adult/near adult height with longterm IGFI therapy,” said Philippe F. Backeljauw, MD, Professor of Pediatrics, Cincinnati Childrens Hospital Medical Center. “These results provide increased confidence to treat patients with severe Primary IGFD with rhIGFI (Increlex®).”

Other Ipsen poster presentations included safety and efficacy data of Increlex® based on the IGFD Registry database, which now has over 700 patients enrolled since May 2006, and data on an 86week, openlabel trial of pharmacokinetic (PK)based oncedaily (QD) dosing of rhIGF1 in 45 treatmentnaïve prepubertal children with short stature associated with low IGF1 levels.

About Increlex® (mecasermin (rDNA origin) injection)

The active ingredient of Increlex® is recombinant human insulinlike growth factor1 (IGF1). IGF1 is the direct mediator of many of growth hormones (GH) effects on statural growth, and must be present for normal growth of bones and cartilage in children. Without adequate IGF1, children may not achieve normal height.

Increlex® has been marketed in the United States since early 2006 and in Europe since late 2007 for the treatment of growth failure in children with severe Primary IGFD. Severe Primary IGFD is defined by height at least three standard deviations below the mean and IGF1 levels at least three standard deviations below the mean for age and sex, and presence of normal or elevated GH level in the US, and IGF1 levels below the 2.5% percentile for age and sex, and GH sufficiency throughout Europe. In children with this disorder, low IGF1 levels may be due to growthhormone resistance or insensitivity associated with mutations in GH receptors, postGH receptor signaling pathways, or to defects in the IGF1 gene.

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