American College of Pediatricians: Another Blow to Children's Rights

GAINESVILLE, Fla., April 8 (Pharmablog)- The following was released today by the American College of Pediatricians:

Children's rights have suffered a severe blow in the last week. Iowa and Vermont became the third and fourth states to redefine marriage and in so doing has jeopardized every child's right to be nurtured by a mother and a father. Of particular concern, the Iowa Supreme Court defended its decision with the brazen statement that, "The traditional notion that children need a mother and a father to be raised into healthy, well-adjusted adults is based more on stereotype than anything else." This is categorically false. Over three decades of social science research confirms and reconfirms that men and women parent differently, and that children thrive best across all areas of development when reared by their biologic mother and father in a low-conflict marriage.

During the last two decades, medical research has even confirmed the existence of genetically-determined gender differences in brain anatomy, neural pathways, cognitive processing, and hormone physiology. These account for differences in how men and women relate to people and the world around them, which in turn explains why parenting differences between the genders are not mere social constructs. Mothers and fathers are not interchangeable and neither is dispensable. Two women cannot compensate for the absence of a father, and two men cannot fill the unique role of a mother. In addition, social science research clearly demonstrates that the further society deviates from the model of the fundamental mother/father family unit, the more children and society suffer.

The American College of Pediatricians asks, in hope and challenge, when will legislatures and the courts place the real needs of children ahead of or at least on an equal plane with the wants of adults?

FDA Approves Label Change for Non-Invasive Fibroid Treatment

TIRAT CARMEL, Israel, April 7 (Pharmablog)- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate(R) 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.

"In allowing doctors to destroy the entire fibroid, we believe the FDA has demonstrated further confidence in the safety and efficacy of the non-invasive ExAblate system," said Haywood L. Brown, MD, Chair of Obstetrics and Gynecology/Maternal-Fetal Medicine at Duke Medicine in Durham, North Carolina.

The FDA label change was based on a growing body of evidence supporting the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology demonstrating that patients experience longer and improved symptom reduction as a greater volume of the fibroid is destroyed.

"We're extremely pleased that the FDA approved this important label change and believe this underscores the safety of our system, the only non-invasive treatment for uterine fibroids available today," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "We remain committed to continuously expanding our treatment indications and applications through research. An ongoing research study is evaluating the potential of treating fibroids with the ExAblate system to enhance fertility when other potential causes of women's infertility have been ruled out. The study will compare birth rates of women who underwent ExAblate treatment to those who had a surgical myomectomy."

"Evidence supports removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage," Dr. Brown added. This trial tests the premise in women who have not been eligible for minimally invasive treatment.

The Fertility Enhancement study is being conducted at the Mayo Clinic in Rochester, Minnesota; Duke University in Durham, North Carolina; Willowbend Health and Wellness in Plano, Texas; and Focused Ultrasound Northwest in Renton, Washington. For more information on the study please visit http://www.clinicaltrials.gov/

To date, InSightec has reported 54 pregnancies, 22 deliveries with 11 ongoing pregnancies with women who previously underwent the ExAblate procedure.

Core Essence Receives FDA Approval for SECURUS(TM), an Innovative Knotless Suture Anchor System

YARDLEY, Pa., April 8 (Pharmablog)- Core Essence Orthopaedics, Inc., a medical device company focused on soft tissue and skeletal repair of the extremities, today announced that it has received 510(k) regulatory approval from the Food and Drug Administration (FDA) for SECURUS(TM), a novel knotless suture anchor system used in minimally invasive, arthroscopic surgery. SECURUS provides increased flexibility, simplicity, and ease for surgeons seeking to employ minimally invasive techniques in the surgical treatment of rotator cuff repair.

"SECURUS is a game-changing product in the area of rotator cuff repair," said Shawn Huxel, co-founder and Chief Executive Officer of Core Essence. "In the U.S., rotator cuff repair represents a $600 million device market opportunity, a market that continues to increase as the population ages. And yet today, only a small fraction of shoulder tendon repairs are performed using the less invasive arthroscopic surgical approach - the approach preferred by most patients - because surgeons have been dissatisfied with the tools available for these less invasive procedures."

SECURUS is specifically designed to give surgeons the motivation to make the transition to minimally invasive surgery at the precise time when the demand for arthroscopic surgery is more significant than ever. The 510(k) regulatory approval means Core Essence will be on track to ramp up distribution over the course of 2009.

SECURUS is an innovative implantable platform system that locks down sutures in arthroscopic tendon repair surgeries, particularly high volume shoulder procedures focusing on rotator cuff repair. The product is available in 5.5mm and 7.0mm diameters to address varying degrees of bone quality, as well as rescue potential. In addition, the SECURUS system presents a number of distinct advantages to alternatives currently available on the market, including: consistent, reproducible bone and suture retention strength, tactile tensioning of sutures (allowing the surgeon to 'feel' the tension in the soft tissue prior to locking the anchor), and a readily revisable implant system. Unlike most current knotless anchors, SECURUS can be adjusted intraoperatively and even removed and replaced.

Dr. Andrew Rokito, Chief of the Division of Shoulder and Elbow Surgery at the New York University Hospital for Joint Diseases and a member of Core Essence's Scientific Advisory Board, explained, "I was extremely intrigued when I first learned about SECURUS. Because of its unique, intuitive, tactile feel, SECURUS is ideal for surgeons who currently prefer to perform open surgeries due to a lack of effective surgical tools designed for arthroscopic use. I am convinced SECURUS will encourage surgeons to perform more rotator cuff procedures arthroscopically due to its simple and elegant features."

In addition to SECURUS, Core Essence has recently launched novel orthopedic product platforms including Seg-Way(TM), a synchronized endoscopic guide system for carpel tunnel syndrome; reNOVO(TM), a suture anchor system, and reVERTO(TM), a shape memory staple system indicated for arthrodesis and skeletal fixation procedures.

Parkinson's Disease Medication Triggers Destructive Behaviors

ROCHESTER, Minn., April 8 (Pharmablog)- A new study conducted at Mayo Clinic reports that one in six patients receiving therapeutic doses of certain drugs for Parkinson's disease develops new-onset, potentially destructive behaviors, notably compulsive gambling or hypersexuality.

VIDEO ALERT: Additional audio and video resources including excerpts from an interview with Dr. J. Michael Bostwick describing the research, are available on the Mayo Clinic News Blog.

The study extends findings from two Mayo case series published in 2005 that reported a connection between dopamine agonist medications and compulsive gambling or hypersexuality.

Dopamine agonists are a class of drugs that include pramipexole and ropinirole. They are commonly used to treat Parkinson's disease, but low doses also are used for restless legs syndrome. They uniquely stimulate brain limbic circuits, which are thought to be fundamental substrates for emotional, reward and hedonistic behaviors.

"The 2005 case series alerted us that something bad was happening to some unfortunate people. This study was done to assess the likelihood that this effect would happen to the average Parkinson's patient treated with these agents," says J. Michael Bostwick, M.D., Mayo Clinic psychiatrist who spearheaded the new study. It is published in the April issue of Mayo Clinic Proceedings.

The researchers analyzed the medical records of patients with Parkinson's disease residing in counties surrounding Rochester, Minn., who received their primary neurological care at Mayo Clinic in Rochester between 2004 and 2006. This group included 267 patients. Of those, 66 were taking dopamine agonists for their Parkinson's disease. Of those 66, 38 were taking the drugs in therapeutic doses (doses expected to be at least minimally beneficial).

The findings were definitive. Seven patients experiencing new-onset compulsive gambling or hypersexuality were taking dopamine agonists in therapeutic doses. None of the other Parkinson's disease patients developed compulsive gambling habits or hypersexuality, including the 28 patients on subtherapeutic dopamine agonist doses or the other 201 patients not taking dopamine agonists. None of the 178 patients treated only with the standard drug for Parkinson's disease, carbidopa/levodopa, developed these behaviors.

"It is crucial for clinicians prescribing dopamine agonists to apprise patients as well as their spouses or partners about this potential side effect. The onset can be insidious and overlooked until life-altering problems develop," says J. Eric Ahlskog, M.D., Ph.D., Mayo Clinic neurologist who co-authored and treated many of the patients in the 2005 study. "It also is worth noting that the affected patients were all taking therapeutic doses. Very low doses, such as those used to treat restless legs syndrome, carry much less risk."

"For some patients, a reduction in the dose of the dopamine agonist may prove to be sufficient treatment," says Dr. Ahlskog, "although total elimination of the offending drug is often necessary."

A peer-review journal, Mayo Clinic Proceedings publishes original articles and reviews dealing with clinical and laboratory medicine, clinical research, basic science research and clinical epidemiology. Mayo Clinic Proceedings is published monthly by Mayo Foundation for Medical Education and Research as part of its commitment to the medical education of physicians. The journal has been published for more than 80 years and has a circulation of 130,000 nationally and internationally. Articles are available online at www.mayoclinicproceedings.com.

J. Michael Cook to Retire from Lilly Board of Directors

INDIANAPOLIS, April 8 (Pharmablog) - The board of directors of Eli Lilly and Company (NYSE: LLY) today announced that J. Michael Cook will retire from the Lilly board effective April 20, 2009. Mr. Cook, the retired chairman and chief executive officer of Deloitte & Touche LLP, has been a director on the Lilly board since 2005. Mr. Cook has been a member of the board's compensation committee and finance committee, and has served as chair of the board's audit committee since 2006.

The board also announced that it has appointed Michael Eskew to replace Mr. Cook as chair of the audit committee. Mr. Eskew has been a member of the Lilly board since 2008 and has served on both the audit committee and compensation committee.

"I am extremely grateful for the contributions that Mike Cook has made to the Lilly board and the expert advice he has provided," commented John Lechleiter, Ph.D., Lilly chairman and chief executive officer. "As chair of the audit committee, Mike has helped shape the company's accounting policies and ensured full compliance with financial reporting requirements. We wish Mike well and thank him for his service to the Lilly board and our shareholders."

Mr. Cook is an emeritus member of the Advisory Council of the Public Company Accounting Oversight Board and is a trustee of The Scripps Research Institute. He serves on the boards of Comcast Corporation and International Flavors & Fragrances Inc. He chairs the audit committee for Comcast and chairs the compensation committee for International Flavors & Fragrances. He is chairman of the Accountability Advisory Council to the Comptroller General of the United States.

Michael L. Eskew is the retired chairman and chief executive officer of United Parcel Service, Inc., a position he held from January 2002 until December 2007. He continues to serve on the UPS board of directors. Mr. Eskew also serves as the chairman of the board of trustees of The Annie E. Casey Foundation, which is the country's largest foundation dedicated to disadvantaged youth. Mr. Eskew also serves on the boards of directors of the 3M Corporation and IBM Corporation. He is a member of 3M's audit committee and is the chairman of IBM's audit committee.

Sinobiopharma, Inc. Appoints New Director of Marketing

NANTONG, China, April 8 /(Pharmablog)- Sinobiopharma Pharmaceutical Group (OTC Bulletin Board: SNBP) is pleased to announce the appointment of Ms. Yan Tan as Director of Marketing.

Ms. Tan joins Sinobiopharma from Organon Pharmaceutical Co., Ltd., Netherlands. She served as a China-based Unit Marketing Director for Organon, which was recently sold to Schering-Plough. Prior to Organon, Ms. Tan held senior marketing management roles at China National Medicines Corporation Ltd.

"We are delighted to welcome Ms. Tan to our team," said Lequn Huang, Chairman and CEO of Sinobiopharma. "Ms. Tan's valuable experience in marketing and sales from global healthcare and consumer businesses will bring additional marketing expertise to the company's sales and marketing strategy. I am confident that she will help us grow our business both domestically and internationally with specific initial focus on increasing sales to hospitals and pharmacies across China."

New England Journal of Medicine Opinion Column Suggests Ineffective Shortcuts to Solve Obesity Challenge

WASHINGTON, April 8 (Pharmablog)- In response to an opinion column published today in the New England Journal of Medicine, Susan Neely, president and CEO for the American Beverage Association (ABA), issued the following statement:

"We agree that obesity is a serious and complex problem. It defies both science and common sense, however, to think singling out one product as a unique contributor to obesity will make a dent in the problem. An NIH-funded study published recently in the New England Journal of Medicine found that all calories count, regardless of the source -- reaffirming the science that balancing calories consumed from all foods and beverages with the calories burned through physical activity is what matters. And common sense is underscored by the fact that obesity rates were rising in America even though soft drink sales were declining for much of this decade.

Taxing these products won't make an ounce of difference in reducing obesity. But these taxes will inflict serious pain to hard-working families, who face higher costs at the store and the risk of losing their job all in the middle of a devastating recession.

Our industry directly supports more than 220,000 good-paying jobs with health benefits in communities large and small across the country and indirectly supports more than 700,000 additional jobs in communities.

Quite simply, the American public just doesn't buy these hapless tax schemes. Consumers see them as a pure money grab that will go to pay for budget deficits created by excessive government spending.

We witnessed this in Maine, where voters rose up to overturn a tax hike on soft drinks imposed by their governor and Legislature last fall, and in New York, where Gov. David Paterson withdrew his proposed tax hike on soda due to intense public opposition.

If we really want to tackle the obesity challenge, we need to work to educate the public - including parents, educators, health professionals and policymakers - about how to maintain a healthy weight. And we can do that by providing them with facts, not fiction."

The American Beverage Association is the trade association representing the broad spectrum of companies that manufacture and distribute non-alcoholic beverages in the United States.

SOURCE American Beverage Association