In spite of several key provisions already in effect and new provisions becoming effective this month, public opinion data shows that very few Californians understand the law or how it will affect them and their families. In response, The California Endowment and its partners are undertaking the largest public education effort in the state to educate Californians about the benefits of the law. Targeted groups for the initial phase of the education effort include Latinos, the business community and young adults under the age of 26.

“This new landmark law will provide Californians more options and real benefits. We want to help people understand these new opportunities and take full advantage of them,” said Dr. Robert Ross, President and CEO of The California Endowment. “Successful implementation of the new Affordable Care Act is critical for all Californians and our state’s bottom line. When it is fully implemented, the Affordable Care Act will bring in more than $120 billion federal dollars that will be invested in the health and well-being of Californians and their communities.”

This broad effort will include:

Paid media through Latino media outlets;

Online and social media outreach, targeted largely to the under-26 audience;

Local events in or near The Endowment’s 14 Building Healthy Communities (BHC) sites to educate Californians about the provision of the Affordable Care Act.

Dr. Ross, joined by Lt. Governor Abel Maldonado at The California Endowment’s Center for Healthy Communities in Los Angeles, helped announce the statewide education effort and unveiled a 60-second television spot.

“In order to be productive, people need to be healthy. In order to be healthy, people need to know about their health care benefits and use them,” Lt. Governor Maldonado said. “I commend The California Endowment and their partner organizations throughout the state for launching this important effort to educate every Californian about their health care opportunities.”

California Endowment Senior Vice President Daniel Zingale said this education effort is the first phase of a larger multi-year effort to educate every Californian about their access to health care.

“The California Endowment’s mission is to expand access to affordable, quality health care for underserved individuals and communities, and to promote fundamental improvements in the health status of all Californians,” remarked Zingale. “Making Californians aware of the new law’s benefits is critical to the success of our mission – especially in the 14 Building Healthy Communities locations where too often, people go without basic health care.”

The California Endowment will also provide educational materials about the Affordable Care Act law. This includes a timeline of when specific provisions of the law become effective.

Anisha Mudaliar.

CARLSBAD–Anisha Mudaliar, a senior at Pacific Ridge School in Carlsbad, has been named the first Distinguished Young Woman for the State of California, following three days of competition among 39 other women in Bakersfield, Calif. Previously known as the Junior Miss competition, Anisha joins only two other San Diego women since 1958 to win the top honors at the state level. In June 2011, Anisha will travel to Mobile, Ala., to compete in the Distinguished Young Women of America program.

Distinguished Young Women are recognized for scholastic achievement, community involvement, creativity and the quest for excellence in every facet of life. All of the young women competed in five categories: interview, scholastic, talent, self-expression and fitness. In addition to winning the overall title and $19,250 in scholarships, Anisha also won first place in the scholastic, talent and self-expression competitions.  

While maintaining a 4.82 GPA, Anisha has been recognized for her academic achievements in recent years, including:

• National Finalist, Young Epidemiology Scholars (YES) Competition (2010)
• STEM (Science, Technology, Engineering, Mathematics) Grant (2010)
• First Place, Medicine & Health Sciences Category, Greater San Diego Science & Engineering Fair (2010)
• Kaiser Permanente Award, Greater San Diego Science & Engineering Fair (2010)
• Second Place, Animal Sciences Category, Greater San Diego Science & Engineering Fair (2010)
• Ethical Responsibility Award, Pacific Ridge School (2010)
• San Diego Oceans Foundation Award, Greater San Diego Science & Engineering Fair (2009)
• Best Delegate, Outstanding Delegate, and Best Research Award Winner, Model UN Conferences (Stanford University, UCSD, University of Washington, respectively) (2009)
• Founder’s Award, Pacific Ridge School (2009)
• Intel Research Grant (2008)
• Caroline D. Bradley Scholarship (2006-Present)

Active in the community as well, Anisha  spent three weeks building a classroom in Kenya (2009) and two weeks constructing a water system in Ecuador (2008) as part of the Free the Children service learning group at Pacific Ridge School.  In 2009, after founding the Otesha service learning chapter at Pacific Ridge School, Anisha led the fundraising of $9,000 to construct a schoolhouse in Kenya and the fundraising of another $6,000 to build a Children’s Resource Center in India. A few years prior, Anisha founded the House of India Project in Balboa Park and remains one of its four young cultural ambassadors. She has assisted in establishing the economic rehabilitation program for the Thirumani Leprosy Community and spent over a month teaching English at an orphanage in India.

Anisha is also an experienced tabla drums player and has had 10 years of training in Bharathanatyam Dance, a 5,000-year-old Indian classical dance form.

The Distinguished Young Women program is a unique opportunity for young women to showcase their achievements, participate in a six-week mentorship program, and learn the true meaning of Be Your Best Self,” said Larry Frum, a volunteer with the San Diego County chapter of the Distinguished Young Women. “We are proud that Anisha Mudaliar is the State of California’s Distinguished Young Woman this year, as she has not only excelled in her academics and community service work, but also in her character and humility. We congratulate Anisha for this well-deserved recognition and look forward to watching her compete for the national title next year.”

The Distinguished Young Women Scholarship Program (formerly America’s Junior Miss) spans the country, with more than 5,000 of the nation’s brightest and most talented young women participating at the local, state and national levels each year. It is the oldest and largest national scholarship program of its type for high school females. Distinguished Young Women inspires high school females to develop their full, individual potential through a fun, transformative experience that culminates in a celebratory showcase of their accomplishments.  The program encourages continued education by providing college scholarships, develops self-confidence and the ability to interview effectively; encourages and showcases excellence in academic achievement, physical fitness, on-stage performance skills, and the ability to think and communicate clearly; and creates opportunities to beneficially inspire the lives of others. Headquartered in Mobile, Ala., Distinguished Young Women has provided life-changing experiences for more than 700,000 young women and more than $92 million in cash and college-granted scholarships, with previous participants and winners that include Diane Sawyer, Dr. Kiersten Richkenbach, Deborah Norville, Kim Bassinger, Debra Messing, Dr. Linda Rutledge and Judge Kay Kingsley. The program is supported by the more than 17,000 volunteers across the nation, and sponsors which include Regions Bank and Carlsbad-based Jazzercise, Inc.

For more information about the Distinguished Young Women program, visit http://www.distinguishedyw.org. For more information about Pacific Ridge School, visit http://www.pacificridge.org.

According to California Walnut Board member Jack Mariani, “This has been an excellent growing year – a nice wet winter and trees were strong and healthy. This estimated record crop along with the shortest carry-ins on record and vigorous consumer demand will help grow the industry.”

Consumers continue to demonstrate a strong preference for walnuts. Due to the strength of clinical research supporting benefits in cardiovascular health, the U.S. Food and Drug Administration approved a qualified health claim for walnuts in 2004.(1) In addition, walnuts are the only nut that contain a significant amount (2.5 grams per ounce) of alpha-linolenic acid (ALA) the plant based omega-3 essential fatty acid required by the human body.(2) Nielsen reported in 2009 that omega-3 foods bucked the recession and recorded a 42% growth last year.

“Today’s consumers prefer walnuts because they know it is a high-quality food that tastes great and is packed with nutrition. That makes walnuts a good value, and a solid investment in health,” explained Dennis A. Balint, Executive Director of the California Walnut Board.

California walnuts account for 99% of the commercial U.S. supply and three-fourths of world trade.

Latest celebrtiy news.

The main focus of the Family Health and Wellness Fair will be planned fitness activities with children and parents, healthy eating, and community information booths. There will be a special dedication ceremony for the completed Kennedy Park “Tot Lot” at 10:30 a.m. during the fair.

The fair will offer classes for children and adults of all ages such as hip hop and other outdoor activities and healthy foods and recipes. Community agencies will be onsite to offer helpful information towards healthier living.

For information regarding the Family Health/Wellness Fair, call Wendy at (619) 588-3265.

New fitness area at Jess Martin Park.

JULIAN–Local residents have a new way to work off calories gained from eating the town’s famous apple pie: with new fitness equipment and recreation areas at Jess Martin Park. County Supervisor Dianne Jacob, the County of San Diego Department of Parks and Recreation and the community of Julian officially opened an array of healthy new amenities at Jess Martin Park.

The improvements include a nine-station fitness area, community exercise path, a permanent restroom building, shade structure, picnic tables, barbeque grills, rock retaining walls, and footbridges.

“The County hopes moms, dads and kids will be excited about the variety of healthy fun now available at Jess Martin Park,” said Supervisor Jacob who worked closely with the Department of Parks and Recreation to help fund the improvements. “These exciting new additions are an example of how the County listens to communities and works with communities to make good things happen,” Jacob said during the ribbon cutting ceremony.

The Department of Parks and Recreation partnered with residents to design park improvements that reflect the needs and history of the community of Julian. The improvements incorporate the architectural elements outlined on the Julian Historic District Design Guidelines.

“The addition of the fitness and recreation areas gives the public the opportunity to enjoy the outdoors, work out for free and stay healthy,” said Renee Hilton, Assistant Director of Parks and Recreation.

The park improvements were paid for with county funds, federal grants and local parkland funds. For additional information on the County’s Department of Parks and Recreation visit www.sdparks.org

Governor Schwarzenegger discusses California’s budget at a news conference.

Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a biological product.  After the FDA approves the product as safe and effective for a specified use, any promotion by the manufacturer for other uses – known as “off-label” uses – renders the product misbranded.

Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, and Sally Quillian Yates, U.S. Attorney for the Northern District of Georgia, today announced the filing of a criminal information against Allergan for promoting Botox® for headache, pain, spasticity and juvenile cerebral palsy – none of which were approved by the FDA.  According to the criminal information, Allergan made it a top corporate priority to maximize sales of Botox® for such off-label uses.

In 1989, the FDA approved Botox®, a prescription biological product containing botulinum toxin type A, a purified neurotoxin, to treat strabismus (crossed eyes) and blepharospasm (involuntary eyelid muscle contraction).  In 2000 and 2004, approval was given to treat cervical dystonia (involuntary neck muscle contraction) and primary axillary hyperhidrosis (excessive underarm sweating), respectively.  In 2010, approval was given to treat adult upper-limb spasticity.

The criminal information alleges that Allergan exploited its on-label cervical dystonia (CD) indication to grow off-label pain and headache (HA) sales.  In 2003, Allergan developed the “CD/HA Initiative” as a “rescue strategy” in the event of negative results from its clinical trials to ensure continued expansion into the pain and headache markets.  As part of this initiative, Allergan claimed that cervical dystonia was “underdiagnosed” and that doctors could diagnose cervical dystonia based on headache and pain symptoms, even when the doctor “doesn’t see any cervical dystonia.”

Allergan’s off-label marketing tactics also included calling on doctors who typically treat patients with off-label conditions.  In 2003, Allergan doubled the size of its reimbursement team to assist doctors in obtaining payment for off-label Botox® injections.  Allergan held workshops to teach doctors and their office staffs how to bill for off-label uses, conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®, and operated the Botox® Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses.  Allergan also lobbied government health care programs to expand coverage for off-label uses, directed physician workshops and dinners focused on off-label uses, paid doctors to attend “advisory boards” promoting off-label uses, and created a purportedly independent online neurotoxin education organization to stimulate increased use of Botox® for off-label indications.

“The Food, Drug and Cosmetic Act protects the public from drugs and biologic products that are not proven to be safe and effective.  When drug companies make unsubstantiated and misleading statements about their products, they undermine the Act’s protection of public health,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.  “We will continue to pursue drug companies that violate the Act for their own financial gain.”

“The FDA had approved therapeutic uses of Botox for only four rare conditions, yet Allergan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by FDA,” said Sally Yates, U.S. Attorney for the Northern District of Georgia.  “Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective.  The FDA approval process ensures that pharmaceutical companies market their medications for uses that are proven to be safe and effective, and this case demonstrates that companies that fail to comply with these rules face criminal prosecution and stiff penalties.”

Allergan has agreed to plead guilty to a criminal misdemeanor for misbranding Botox® in violation of the FDCA.  Under the plea agreement, the company will pay a criminal fine of $375 million, which includes forfeiting assets of $25 million.  Allergan’s guilty plea and sentence is not final until accepted by the U.S. District Court.

“The FDA exists to assure that drugs marketed to the American people are safe and effective” said Dr. Margaret Hamburg, Commissioner, Food and Drug Administration. “The ‘off-label’ promotion of drugs threatens public health and the role of the FDA, which has served our country well and has protected Americans from unsafe and ineffective drugs.”

As part of the civil settlement, Allergan has agreed to pay an additional $225 million to the federal government and the states to resolve claims that its unlawful marketing practices caused false claims to be submitted to government health care programs such as Medicare, Medicaid, TRICARE, and to the Federal Employees Health Benefit Program, the Department of Veterans’ Affairs, and the Department of Labor’s Office of Workers’ Compensation Programs.   The civil settlement addresses allegations that from 2001 through at least 2008, Allergan promoted Botox for off-label indications that were not medically accepted and therefore not covered by federal health care programs, made unsubstantiated and misleading statements about the safety and efficacy of Botox® for off-label indications, instructed doctors to miscode Botox® claims for uncovered indications using inappropriate diagnosis codes to ensure payment by government health care programs, and provided inducements to doctors to inject more Botox®.   The federal share of the civil settlement amount is $210,250,000, and Allergan will pay up to $14,750,000 to states that opt to participate in the agreement.

The civil settlement resolves three lawsuits filed in federal court in the Northern District of Georgia under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.  As part of today’s resolution, the whistleblowers – Dr. Amy Lang, Charles Rushin, Cher Beilfuss, Kathleen O’Conner-Masse, and Edward Hallivis – will receive $37.8 million from the federal share of the settlement amount.    

Allergan has also executed a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG).  The 5-year CIA requires, among other things, that the board of directors (or a committee of the board) annually review the company’s compliance program and pass a resolution that it has implemented an effective compliance program; that certain senior executives annually certify that their departments or functional areas are compliant with federal health care program requirements; that Allergan send doctors a letter notifying them about the settlement; and that the company post on its website information about payments to doctors, such as honoraria, travel, or lodging.  Allergan is subject to exclusion from federal health care programs, including Medicare and Medicaid, for a material breach of the CIA and subject to monetary penalties for less significant breaches.

“Fraudulent marketing of drugs through off-label promotion or kickbacks to prescribers undermines the protections afforded by the drug approval process and medical decision-making.  This conduct will not be tolerated,” said Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services.  “As a result of this settlement, OIG will oversee a Corporate Integrity Agreement with Allergan that increases the transparency of Allergan’s interactions with physicians and helps to ensure the company’s future compliance and accountability.”

“This was a complex investigation that required much in terms of investigative resources in order to conduct the many interviews and document reviews needed to get us where we are today,” said Brian D. Lamkin, Special Agent in Charge, FBI Atlanta.  “The FBI, through its vast experience investigating health care fraud, is not only able to provide such resources, but is also able to recognize which circumstances need those resources the most.  The off-label marketing tactics employed by Allergen was one of those aforementioned circumstances.”

Allergan markets Botox® for its approved cosmetic use under the trade name Botox® Cosmetic.  Botox® Cosmetic has its own FDA-approved label and drug code.  The resolution announced today does not address Botox® Cosmetic.

The criminal case is being prosecuted by the Civil Division’s Office of Consumer Litigation and the U.S. Attorney’s Office for the Northern District of Georgia.  The civil settlement was reached by the Civil Division’s Commercial Litigation Branch and the U.S. Attorney’s Office.  The HHS Office of Counsel to the Inspector General, the Center for Medicare and Medicaid Services, FDA’s Office of Chief Counsel, and the National Association of Medicaid Fraud Control Units provided assistance.

Mordechai Orian, an Israeli national; Pranee Tubchumpol, Shane Germann and Sam Wongsesanit of Global Horizons Manpower Inc., located in Los Angeles; and Thai labor recruiters Ratawan Chunharutai and Podjanee Sinchai were charged in engaging in a conspiracy to commit forced labor and document servitude. The charges arise from the defendants’ alleged scheme to coerce the labor and services of approximately 400 Thai nationals brought by the defendants to the United States from Thailand from May 2004 through September 2005 to work on farms across the country under the U.S. federal agricultural guest worker program. Orian, Tubchumpol and Chunharutai are also charged with three substantive counts of compelling the labor of three Thai guest workers.

If convicted, Orian and Tubchumpol each face maximum sentences of 70 years in prison, Chunharutai faces a maximum sentence of 65 years in prison, Germann and Wongsesanit each face a maximum sentence of 10 years in prison, and Sinchai, who was recently charged in Thailand with multiple counts of recruitment fraud, faces a maximum sentence of five years in prison if convicted in the United States.

Fire personnel will provide property owners with information regarding overgrown vegetation throughout the City and the Fire Department’s plan to reduce fire hazards. A new inspection program for identifying fire hazards on property and how owners will be notified of these hazards will also be addressed. The proposed weed abatement inspection program will be administered by a fire safety contractor, with the Fire Marshal providing program oversight.

The fire safety contractor has been invited to attend the workshop to answer any resident questions. Fire Marshal Robert Scott, will conduct the workshop and will be available to answer any resident questions.

This workshop will be held September 9 from 6:30 p.m. to 8:00 p.m. at theCity Hall Annex Building, 235 11th Street in Del Mar.