A Georgia law (HB 388) that took effect on Wednesday allows state residents to “adopt” embryos created for fertility treatments, the Atlanta JournalConstitution reports (Gould Sheinin, Atlanta JournalConstitution, 7/1). According to the AP/Cedartown Standard, the bill aims to prevent embryo donors from later asserting legal rights to children born from adopted embryos (Bluestein, AP/Cedartown Standard, 6/30). The bills authors did not address whether an embryo is a person, and the legislation does not give embryos rights (Atlanta JournalConstitution, 7/1). However, religious conservatives have backed the law as an alternative use for surplus embryos originally created for fertility treatments. Opponents say the law ultimately could be used to restrict abortion rights (AP/Cedartown Standard, 6/30).

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.

Sepracor Inc. (Nasdaq SEPR) announced that it has completed the analysis and validation of the preliminary results of a Phase II, 514patient study evaluating the efficacy and safety of SEP225289 for the treatment of Major Depressive Disorder, including patients with melancholic and atypical features. Sepracor determined that SEP225289 did not meet the primary efficacy endpoint, which was a reduction in symptoms of depression following eight weeks of treatment, as assessed using the clinicianrated, 17item HAMD scale (Hamilton Depression Rating Scale, a standard scale used to assess depression in clinical trials and consisting of a list of symptoms commonly associated with depression). The positive control in the study (venlafaxine extendedrelease) did achieve separation from placebo that was statistically significant on the primary endpoint.

In this study, the measured serum concentrations of SEP225289 were found to be below expected levels of exposure for both doses studied and were well below exposure profiles observed in several Phase I studies. Further, the adverse event profile demonstrated by SEP225289 was inconsistent with prior clinical experience and was similar to the side effect profile observed when patients were administered placebo. As such, preliminary data are inconclusive pending further investigation of the dose exposure relationship of SEP225289.

“While we are clearly disappointed with the findings from the analysis of the preliminary study results, we are in the process of further analysis of the dose response and secondary endpoints to determine how or if we will take this novel mechanistic approach forward,” said Mark H.N. Corrigan, M.D., Executive Vice President, Research and Development at Sepracor.

SEP225289 is a member of a relatively new class of pharmacologic agents referred to as triple reuptake inhibitors based on their activities at the serotonin, norepinephrine and dopamine transporters. The pharmacological profile of SEP225289 is distinct from all other currently approved antidepressant agents due to its significant affinity for the dopamine transporter as well as its high potency reuptake inhibition at the serotonin and norepinephrine transporters.

In 2008 and early 2009, Sepracor completed two pediatric studies of LUNESTA® brand eszopiclone in response to a Written Request from the United States Food and Drug Administration (FDA) in connection with its efforts to obtain a pediatric exclusivity extension for LUNESTA. In April 2009, Sepracor initiated two additional pediatric studies in accordance with the FDAs Written Request. The FDA has notified us that these two studies have been put on clinical hold due to its concerns regarding nonclinical data that could be relevant to the administration of eszopiclone in children. The clinical hold does not relate to any findings observed in the pediatric clinical studies nor does it impact any ongoing eszopiclone clinical trials in adults. In addition, this action does not impact the availability or prescribing information for LUNESTA in the treatment of adults with insomnia. LUNESTA has been proven to be safe and well tolerated in the treatment of adults and elderly patients with insomnia. Sepracor intends to work with the FDA to address the potential resolution of FDAs concerns regarding the nonclinical data with respect to human pediatric subjects.

“We are focusing our nearterm research and development efforts on STEDESA™, which is a potential new adjunctive treatment for partialonset epilepsy currently under review at the FDA, and OMNARIS® HFA Nasal Aerosol for the treatment of allergic rhinitis, which is on target to enter its second largescale Phase III clinical study in the fall of 2009,” said Adrian Adams, President and Chief Executive Officer of Sepracor. “We will provide an update on the ongoing analysis of the SEP225289 data and the LUNESTA pediatric studies during our second quarter 2009 conference call that will be held later in July. In addition, we will provide a general review of progress with our pharmaceutical product pipeline.”

Source

Teva Pharmaceutical Industries Ltd. (Nasdaq TEVA) announced that the U.S. Food and Drug Administration has granted approval for the Companys Abbreviated New Drug Application (ANDA) to market a generic version of Ortho McNeil Janssens oral contraceptive, Ortho TriCyclen® Lo. Shipment of this product, for which Tevas trade name is TriLo Sprintec, has commenced.

As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180day period of marketing exclusivity.

Annual sales of Ortho TriCyclen® Lo were approximately $400 million in the United States for the twelve months that ended March 31, 2009 based on IMS sales data.

Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.

PROLOR Biotech, Inc. (OTC Bulletin Board PBTH), formerly Modigene Inc., announced that the U. S. Patent and Trademark Office (PTO) has issued two new patents for the companys longacting CTPenhanced human growth hormone (hGHCTP) and human erythropoietin (EPOCTP). The patents cover the composition of PROLORs proprietary pharmaceutical compounds as well as certain associated methods. PROLORs CTP technology is based on a short amino acid sequence, the Carboxyl Terminal Peptide that occurs naturally in humans. When attached to a therapeutic protein, CTP extends the time that the protein is active in the body.

“These two new patents covering CTPenhanced human growth hormone and erythropoietin represent another significant layer of protection within our CTPbased intellectual property portfolio,” said Shai Novik, president of PROLOR. “We have also filed several other patent applications for additional CTPenhanced longacting therapeutic proteins and peptides that are currently pending. We are confident that our growing CTP patent estate will provide excellent protection for both our compounds under development and for our innovative and versatile platform technology, and we believe it will serve as an important value driver for PROLOR in the future.”

The potential utility of the CTP technology has been demonstrated by ScheringPlough, which is developing the technology for fertility applications only. Data from its Phase III ENGAGE trial demonstrated that women receiving a single injection of the fertility drug FSHCTP achieved the same pregnancy rates as women receiving seven consecutive daily injections of commercial FSH. This 1,509 patient trial, which was the largest doubleblind fertility trial ever conducted, formed the basis for a Marketing Authorization Application by ScheringPlough that is under review by the European Medicines Agency.

PROLOR is using the same CTP technology to extend the duration of action of other therapeutic proteins. CTP was discovered at Washington University in St. Louis, which has exclusively licensed rights for the use of CTP with all therapeutic proteins to PROLOR, with the exception of four endocrine hormones licensed to ScheringPlough. PROLOR plans to initiate human clinical trials with hGHCTP, its longeracting version of human growth hormone, later this year.

ABOUT PROLOR BIOTECH

PROLOR Biotech, Inc. is a biopharmaceutical company applying its patented CTP technology to develop longeracting, proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins and PROLOR is currently developing longacting versions of human growth hormone, interferon beta and erythropoietin, which are in late preclinical development, as well as GLP1.

Safe Harbor Statement This press release contains forwardlooking statements, including statements regarding the results of current studies and preclinical experiments and the effectiveness of PROLORs longacting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forwardlooking statements involve risks and uncertainties that may affect PROLORs business and prospects, including the risks that PROLOR may not succeed in developing any commercial products based upon its longacting protein technology, including any longacting versions of human growth hormone, erythropoietin, interferon beta or GLP1; that the longacting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from the OCS is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forwardlooking statements. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLORs filings with the Securities and Exchange Commission.

Source PROLOR Biotech, Inc

Perhaps the only thing harder than sticking to a weight loss plan is starting a new one after yet another failed diet attempt. Physicians Sharon Herring and Stephanie Ward recognize such “diet fatigue” in their patients and their own families. Now, theyre offering a “fresh start” to the dietweary.

Temples “Fresh Start to a Healthy Weight,” is designed to promote healthy behaviors such as physical activity and better food choices and prevent and treat adult obesity through oneonone counseling. An extension of the General Internal Medicine Practices at Temple, the program opens in July.

“We know that when patients engage with providers who are solely focused on weight loss issues, they lose weight so thats what we plan to do,” said Sharon Herring, MD, MPH, Assistant Professor of Medicine and Public Health at Temple Universitys Center for Obesity Research and Education.

Herring and Ward are committed to getting to know each patients clinical status and concerns and will create an individualized care plan through a combination of

Behavior modification focusing on caloric restriction and physical activityCognitive therapy identifying and modifying distorted thinking about food, activity, and body image Weight loss medications as an adjunct to participant efforts.

Ward, a practicing general internist at Temple University Hospital, predominantly serves minorities of lower socioeconomic status, a population disproportionately affected by obesity. Study after study confirms that weight related diseases, like diabetes and hypertension, can be prevented or delayed with aggressive weight management, even if the weight loss is modest.

“You dont have to be a size zero to start seeing the benefits of losing weight,” said Ward, Assistant Professor of Medicine and Public Health at the School of Medicine. “You may have diabetes or arthritis, but if you lose weight, you may be able to reduce the effects of those diseases. Even losing just five to ten percent of body weight improves your health and quality of life.”

The challenge is getting patients to change their behavior and feel satisfied with less. While exercise is important, Herring and Ward say diet and calories trump that when it comes to weight loss. Many of their patients know the calorierich foods they eat or sodas they drink arent good for them, but they admit they enjoy the taste. It will be up to both physicians to teach them how to make healthy food just as delicious and opt for the produce aisle at the grocery store instead of the drivethru lane at a fast food restaurant.

“We may even take patients to the market to look at food labels, increase their awareness of whats in processed foods and how to shop for truly healthy foods,” said Herring.

Both physicians agree that oneonone interventions are missing during primary care visits, just as behavior change to address obesity is absent from medical school curriculum. They hope this program will change that by eventually offering fourth year medical students a chance to earn elective rotation credits, while facilitating training about obesity prevention and management for all residents.

“We empathize with the struggle and while we may not have all the answers, we will help our patients to come up with solutions that work ” say both Herring and Ward.

“Fresh Start to a Healthy Weight” opens July 6, 2009 in the ground floor of Jones Hall, 1316 W. Ontario Street (in the Internal Medicine Faculty Practice).

The European Medicines Agency (EMEA) has today announced their recommendation to withdraw the marketing authorisations for dextropropoxyphenecontaining medicines (including coproxamol) across the European Union (EU). This recommendation was made after the Committee on Medicinal Products for Human Use (CHMP) concluded that the risks, particularly of potentially fatal overdose, were greater than the medicines benefits. The EMEAs recommendation has been forwarded to the European Commission (EC) for a decision which will be legally binding across the EU. In the UK, the only medicine affected by the EMEAs announcement is coproxamol.

The MHRA announced its decision to withdraw coproxamol in 2005. Since then the vast majority of patients have managed to find an acceptable alternative, after consultation with their health care professional.

Coproxamol is a combination of a weak opioid (a weak painkiller), dextropropoxyphene (DXP), with a relatively low dose of paracetamol. There is no robust evidence that coproxamol offers any advantage over other widely used painkillers, paracetamol or ibuprofen, at normal doses. Coproxamol is extremely dangerous in overdose as only a small overdose can be fatal, and death can occur very rapidly before medical attention can be sought.

The MHRA does recognise that there is a small group of patients who have found it very difficult to change from coproxamol, when alternatives appear not to be effective or suitable. We have worked with the manufacturer to ensure some unlicensed product remains available. As with any unlicensed medicine there is a provision for the supply of unlicensed coproxamol, on the responsibility of the prescriber, who can judge the risks and benefits in consultation with the patient.

A key part of the National Suicide Prevention Strategy is to reduce ready access to methods of suicide. Coproxamol has been a significant cause of death from overdose, and its withdrawal has saved the lives of around 300 400 people per annum in the United Kingdom from selfpoisoning, of which around a fifth were accidental.

The International Diabetes Federations 20th World Diabetes Congress will be held at the Palais des Congrès de Montréal in Montreal, Canada from October 18 22, 2009. The Congress will bring together over 15,000 delegates from over 160 countries to share the latest developments in clinical research, release new data on the state of the diabetes pandemic, and lobby for political change to tackle diabetes care worldwide.

Media Registration

As always with the World Diabetes Congress, registration of journalists is complimentary but can only be made after you have filled in our media accreditation form and we have received a copy of your press ID or recommendation letter from the EditorinChief. Journalists are kindly requested to register online here.

Media guidelines are available for download in English, French and Spanish Click here

About the World Diabetes Congress

We would like you to find out more about the World Diabetes Congress by reading our backgrounder online and available for PDF download in French and Spanish here.

Programme

The World Diabetes Congress has an exciting programme in store for you. It will feature debates, meettheexperts sessions, openforum sessions, speakers corner sessions, symposia, teaching lectures, workshops, and oral and poster presentations incorporated into six streams association development, clinical research, education, foundation science, healthcare and epidemiology and living with diabetes. Check out the Programme at a glance Click here.

Source

The American Diabetes Association, the nations leading health organization in the fight to stop diabetes, is pleased to announce that the National Employment Lawyers Association has honored Gary Branham, who successfully fought discrimination based on diabetes, as one of three “Workplace Heroes & Heroines.” The award honors those who have made a difference in the evolution of employee rights, and advancing equality and justice in the American workplace during the past twenty years. (For more information on this award, see nela.org.)

Branham was recognized for prevailing in his landmark legal battle against the IRS, which had denied him a promotion from his position as a revenue officer to a special agent explicitly because of his diabetes. The agency had assumed that Branham, who takes insulin to control his diabetes, would be unable to safely perform the duties of the position; IRSs decision failed to take into account clear medical evidence to the contrary, including the fact that Branham had maintained excellent control of his blood glucose for years.

“I realized that my dream of becoming a special agent may never materialize, and I knew I had to take the IRS on, hoping that my struggle would help others with diabetes fight discrimination and live their dreams,” said Branham.

With the assistance of the Association, Branham filed a lawsuit against the federal government challenging this unjust discrimination, but the court threw out Branhams case, finding that his diabetes was so wellmanaged that he did not have a disability, and therefore, was not protected against discrimination under federal law.

Undaunted, Branham decided to continue the fight for fairness for workers with diabetes turning to John Griffin, a prominent Texas attorney and member of the Associations Board of Directors (who himself has diabetes) to appeal the decision. Griffin successfully appealed to the U.S. Court of Appeals. Based on this decision, a trial was granted for Branham, and the jury issued a verdict finding that Branham is protected from discrimination and able to safely perform the special agent job. In addition, he was awarded compensation for six years of lost pay.

Ironically, by the time his case had reached conclusion, Branham had exceeded the maximum age for special agent eligibility. “I am not disappointed,” said Branham, “but truly encouraged now that this court and others have said that people with diabetes cannot be prevented from realizing their dreams based on stereotype or misinformation.”

“This is validation that people with diabetes can safely perform all types of jobs. Each person should be evaluated on a casebycase basis. President Obama did just that when he nominated Judge Sonia Sotomayor, who, like Branham, has type 1 diabetes, to the Supreme Court of the United States,” said Griffin.

Source

President Richard Nixon, who was in office when the Supreme Court issued its 1973 decision in Roe v. Wade, in secret recordings from January and February of that year discussed his views on abortion with an aide, the New York Times reports. The comments were among more than 150 hours of tape and 30,000 pages of documents made public Tuesday by the National Archives Nixon Presidential Library. The tapes were recorded by secret microphones in the White Houses Oval Office.

Nixon in the tapes expressed ambivalence over the decision, as well as concern that increased access to abortion leads to “permissiveness” and that “it breaks the family.” Nixon also said that he believed there was a need for abortion in some cases, including interracial pregnancies and rape. He said, “There are times when an abortion is necessary. I know that.” He added, “When you have a black and a white. Or a rape” (Savage, New York Times, 6/24).

Broadcast Coverage

NPRs “All Things Considered” on Tuesday reported on Nixons abortion comments and political reaction to Roe at the time of the decision (Totenberg, “All Things Considered,” NPR, 6/23).

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.

Research presented by Bernard Casey of the University of Warwicks Institute for Employment Research shows that workrelated stress today damages national output even more than the loss to national output due to strikes at the peak of industrial unrest in the 1970s.

At a presentation forming part of the University of Warwicks Social Science Festival Bernard Casey pointed out that at the peak of industrial unrest in the 1970s the UK lost around 12.9 million person days of output. But he also showed that loss of output due to workrelated stress today costs the economy around 13.5 million person days.

On top of 13.5m days lost by temporary absence, yet more days are lost by people leaving the labour force completely. The costs of such absence might be more than twice those associated with temporary absences. And the economic cost of presenteeism people going to work when ill when they should be at home might also be twice the costs of shortterm absenteeism,

Indeed, if shortterm absence, total withdrawals and presenteeism are added together, workrelated stress might cost as much as 1.25 per cent of national output.

That surprising large figure is still a conservative one. The estimates exclude the costs associated with the suffering endured by people who experience work as particularly stressful; these costs are far more difficult to quantify. They also exclude the costs of benefit payments to people temporarily or permanently off work.

Bernard Casey says

“The current recession is likely to intensify stress at work. Uncertainty, itself, breeds stress. Many organisations trying to survive by raising productivity will be putting their employees under increasing pressure.Moreover, fearing for their jobs, people who ought to be absent might choose, instead, to be “present”.”

Bernard Casey also said

“Recognition of the costs of workrelated stress is useful in determining the efficiency of treatments something in which NICE (the National Institute of Clinical Health and Excellence) has become much more interested in of late.Recognition should also help structure initiatives that follow up the Black review Working for a Healthier Tomorrow; these are supposed to pay special attention to mental health and work.

The current recession might be seen as making workrelated stress an issue of limited concern. As has been feared with respect to familyfriendly practices and policies to promote disadvantaged groups, in the current recession, policies to improve working conditions might be deemed luxuries that cannot be afforded.

Whatever ones perspective on the current recession may be, one thing is clear