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FDA approves first rapid, take-home HIV test

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Some HIV/AIDS experts and survivors insist for the first-time tester, the clinic is the best place

By Chris Levister

Americans will soon be able to test themselves in the privacy of their own homes for the virus that causes AIDS, now that the Food and Drug Administration has approved the first rapid, over-the-counter HIV test. The OraQuick test detects the presence of HIV antibodies using a mouth swab and returns a result in 20 to 40 minutes.

Government officials estimate that about 240,000 people, or one-fifth of the roughly 1.2 million people carrying HIV in the U.S., don't know they are infected. Testing is a chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

FDA officials said the test is designed for people who might not otherwise get tested. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate," said Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research. Orasure plans to start selling the test in October, both online and through retailers like Walgreens, CVS and Walmart.

It hasn't set a price yet but expects the consumer version to cost less than $60 but more than the one marketed to health professionals, which costs about $17.50. CEO Doug Michels said the price increase will help pay for a toll-free call center to provide counseling and medical referrals to test users.

The company's marketing efforts will focus on populations at greatest risk of being infected with HIV, including gay and bisexual men, African Americans and Hispanics. Over 46 percent of Americans who have been diagnosed with HIV since 1981 have been African American. And although AIDS diagnoses and deaths have declined substantially in the United States since the mid-1990s with the advent of highly active antiretroviral therapy (HAART), African Americans have continued to be diagnosed with HIV/AIDS in numbers disproportionate to their percentage of the population.

The FDA stressed in its approval announcement that the test is not 100 percent accurate in identifying people with the virus. A trial conducted by test maker Orasure showed OraQuick detected HIV in those carrying the virus only 92 percent of the time, though it was 99.9 percent accurate in ruling out HIV in patients not carrying the virus. That means the test could miss one in 12 HIV-infected people who use it but would incorrectly identify only one patient as having HIV for every 5,000 HIV-negative people tested, the FDA said.

People who test negative should get re-tested after three months, because it can take several weeks for detectable antibodies to HIV to appear, according to Dr. Jonathan Mermin, director of the Centers for Disease Control and Prevention's HIV unit. The FDA has approved several other HIV test kits designed for home use, but they usually require a blood sample that must be sent to a laboratory for development.

HIV awareness groups hailed the approval as an important step in expanding testing for the virus. "This test will allow anyone to empower themselves to know their HIV status when, how and with whom they want to," said Tom Donohue, founding director of Who's Positive. But some HIV/AIDS experts and survivors say OraSure could lead to more people knowing their status but fear those who learn they have the virus won’t get counseling, care. Carla Bailey is a mother of six who has been battling full blown AIDS since 1992. When she first tested positive all sorts of things went through her head. “Well, first, it was an extreme sense of denial, that I wasn't infected, that there was a serious mistake because I had no symptoms. I guess my first rational thoughts were ‘oh my God my whole world is crashing’,” said Bailey. “I was in a state of shock. I couldn’t even bring myself to tell my family – I lapsed into a state of severe depression for three years.

Initially, we lost everything - house, cars, all of it. I lost my job, I couldn't work. It was quite literally a living hell,” she said. “I was having trouble with medications, I was lucky to have my older sister, who is a health care professional and she walked me through a lot of this stuff, even the crying in the middle of the night.

A diagnosis of HIV is not the kind of news you want to learn at home in your bathroom with no available counseling care.” Bailey says despite her concerns, the hope is in-home testing could lead to more people knowing their HIV status and, in turn, earlier intervention. “I strongly encourage people to get tested – that said, one size does not fit everyone. If you choose not to go to a clinic, have a family member or close friend at your side when you do the first home test.”

Bailey says she fears a dangerous disconnect if people get a positive diagnosis and don’t follow up with a confirming blood test. On the other hand she said a negative result could lead to a false sense of security. “It’s a slippery slope.”

Decorated Serviceman and Deacon Willie Evans Remembered

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Evans was born January 15, 1925 in Brenham, Texas to Melinda Winston and Willie Evans, Sr. He was the youngest of three children. At the young age of 18, he decided to enlist in the armed forces. Evans proudly served his country with the U.S. Navy. He served in several wars including World War, II, the Korean Conflict and the Vietnam Conflict to which he received many awards and commendations for his bravery. He achieved a stellar 28-year naval career.

In 1966, Evans was extended the Armed Forces Community Award in 1984 and 1985, acknowledged for outstanding and valuable service to the San Diego Consistory. As an E-9 Master Chief in the military, he received many honors, awards, commendations and salutations but the most memorable and monumental of all was surrendering his life to Jesus Christ uniting with the Pilgrim Progressive Baptist Church of San Diego under the pastorate of the late Rev. Marvin Hines. He was not only a highly decorated serviceman, but a tender loving father as well. While still in the military, Evans executed a most noble gesture by taking leave from the Navy and journeying back to Texas to retrieve his one and half year old daughter La Trecee to bring her back to San Diego and raise her as a single father. By her testimony, it was only because of the fact that Evans was such a nurturing, involved, disciplining and supportive single parent that she has become who she is today. There never came a day that he did not tell her that he loved her and that he would always be there for her.

He was a dedicated husband as well. In 1979, he met the love of his life Ella Kenniebrew, but because both parties continuously stated they were not ready, they did not marry until 2001. When they finally married, Evans decided to make up for lost time by loving Ella with affection and aggression for the balance of his living days.

Evans took great pleasure in serving on the local, state, and national level. The Western Baptist State Convention, Pilgrim Progressive Baptist Church and the New Hope Missionary Baptist Church of San Bernardino, appreciated and recognized Evans as a convention laymen president on both the state and national levels, Bible instructor, deacon and state convention treasurer. Also, the Western Baptist State Convention Layman Mass Choir was organized under his presidency. Evans was also an active member of the AFM (Prince Hall) GA Thomas where he served as Master Mason.

Evans was an active and faithful member of New Hope Missionary Baptist Church in San Bernardino. He leaves to cherish his memory, his loving wife Ella Evans; daughter La Trecee Evans; stepson William Kenniebrew; stepdaughter Glenda Gilbert; grandson, Tas Jioan Brown of San Diego, one sister Ethel Hubbard of Pontiac, Michigan; two nieces and two nephews, and a host of family and friends.


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BVN Staff

Now's the time to speak out on San Bernardino’s budget and crime woes. Sixth Ward Councilman Rikke Van Johnson will host a Town Hall meeting Thursday, July 12 at Inghram Community Center, 2050 N. Mt. Vernon Avenue beginning at 6:00 p.m. Residents will get an update on the city’s budget and hear how dwindling revenues and uncertainty over the state’s finances will impact their neighborhoods.

The city began its fiscal year in June without a budget beyond July. To bridge the growing budget deficit, council members approved a one-month spending plan based on the past year's budget. That gives staff members enough time to work out a plan to provide needed services when projected revenues are lower than expenses, said Acting City Manager Andrea Travis-Miller. "The structural issues which have resulted in deficit spending have implications for the upcoming budget, and a long-term strategy to address the ongoing structural deficit is required," Travis-Miller said in a report to the City Council, which must approve any budget. The situation is further complicated by the expiration of labor agreements that had city workers giving up 10 percent of their salaries and by the abolition of redevelopment agencies statewide, eliminating a tool upon which the city had relied, she said. Johnson will also discuss public safety, new and on-going projects.

Police Chief Rob Handy will be on hand to update residents on efforts to stem the city recent rash of homicides.

Residents are encouraged to contribute their thoughts and ideas about the budget and public safety. For more information about the Town Hall meeting, contact the Council office at (909) 384-5378.

Health Care Ruling Puts Reform on Front Burner

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Chief Justice Roberts – praised and denounced

Chris Levister

When Wendell and Thomasena Andes of Redlands sprang from their bed at 6:45 a.m. Thursday, June 28 to hear the most anticipated Supreme Court ruling in years, they never suspected conservative-leaning Supreme Court Justice John Roberts would make their day. “We were all but certain the court would throw ‘Obamacare’ out,” said Thomasena, an unemployed chemist who says she was rejected by her insurance company after she developed complications from a pre-existing rare blood disease known as Fanconi anemia (FA) “We were praying the Roberts’ court would put politics aside for the good of all Americans,” said Wendell.

In a landmark ruling that will impact the November election and the lives of every American, the U.S. Supreme Court upheld the controversial health care law championed by President Barack Obama. Chief Justice John Roberts wrote the majority opinion in the 5-4 ruling. The decision was a victory for Obama but also will serve as a rallying issue for Republicans calling for repeal of the Affordable Care Act passed by Democrats in 2010. “When we heard the words ‘upheld’ – we danced around the room hugging each other, thanking God, the President and Chief Justice Roberts,” said Thomasena. Obama called the ruling “a victory for people all over this country whose lives will be more secure because of this law.”

“I'm as confident as ever that when we look back five years from now or 10 years from now, or 20 years from now, we will be better off because we had the courage to pass this law, and keep moving forward,” said Obama. Republican presidential candidate Mitt Romney, who previously pledged to issue waivers to states if the health care law was upheld, pledged last week that if elected, he would work to repeal the law.

“Obamacare' was bad policy yesterday. It is bad policy today. It will be bad policy tomorrow,” said Romney as congressional allies scheduled a symbolic repeal vote for July 11. At this urgent care clinic in Moreno Valley, reaction to the ruling ranged from arm waving victory to finger pointing outrage.

“It means we won’t have to beg for care,” said Caprice Adams as she kept an eye on her 8-year-old son Jamie who suffers from chronic asthma. “We can’t afford to buy health insurance,” said Caprice’s husband Wynford. “A routine doctor’s visit is too expensive,” said Caprice. “So we come here with our hand out.” Seated next to Wynford, Barry Fidler had harsh words for the ruling and its chief architect – Justice John Roberts.

“It’s a sucker punch. This law is gonna put a whole lot more people in the poor house,” he said. “Obama and Congress fed us a pack of lies now Roberts has caved in to the liberal rhetoric,” said Hicks, an unemployed building contractor. As the government writes the regulations and sets the policies that will bring the law to life, cheering and jeering Americans alike are asking, “what does it mean for our pocketbooks? The law requires nearly all U.S. citizens and legal residents to buy health insurance. Penalties would be phased in over three years starting in 2014, with steadily increasing amounts applied. For example, in 2014 it would be $95 or 0.5 percent of income, whichever is greater. By 2016, the penalty would be either $750 to $2,250 a year per family or 2 percent of household income, whichever is greater.

While the health care law will benefit all Americans, health experts say it will be especially helpful for African Americans who suffered the most under the nation’s ruptured health care system. Here are eight ways the health care law will help African Americans: 1. It will prohibit insurance companies from denying coverage to children with pre-existing conditions under all new plans. 2. It will prohibit insurance companies from dropping sick patients from their rolls. 3. It will give tax credits to small businesses for health insurance and allow small businesses to shop for plans that fit their needs. 4. It will prohibit insurance companies from placing annual and lifetime limits on coverage. 5. It will require insurance plans to cover screenings and vaccines without any deductibles or co-pays under any new insurance plans. 6. It will allow a child to remain on their parents’ insurance plan until the age of 26. 7. It will require insurance plans to cover prescription drugs for seniors or close the so-called donut hole, meaning that the elderly will no longer have to cover the cost for prescription drugs when their benefits run out. 8. It will expand funding for community health centers.

Amid the cheering in many quarters over the Supreme Court's decision, experts say a sobering fact remains: California's ailing healthcare system won't be easy to fix. Millions of Californians will still lack insurance even after a massive coverage expansion. Medical costs and premiums are expected to keep rising, at least in the short run. And many of those who do gain coverage could have a tough time finding a doctor to treat them.

The court ruling does provide enormous benefits to a state where 7 million residents are uninsured. Starting in 2014, California will receive as much as $15 billion a year to expand Medi-Cal coverage for the poor and to provide federal subsidies to people buying policies in a state-run exchange. About 4 million Californians are expected to gain coverage. California Insurance Commissioner Dave Jones said covering even a portion of the state's uninsured should sharply reduce the amount of uncompensated medical care that's driving up the price of health insurance.

On average, California families pay an extra $1,400 each in annual premiums to cover medical bills for the uninsured, according to the California Endowment.

Rodney King remembered as ‘symbol of forgiveness’

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Beating victim eulogized during public memorial service

Chris Levister Rodney King, whose beating by police in 1992 sparked one of the worst urban riots in US history, has been laid to rest in Los Angeles. The Reverend Al Sharpton who delivered the eulogy called King a "symbol of forgiveness” ahead of his funeral on Sunday at the Forest Lawn-Hollywood Hills cemetery, north of the city. "People should not be judged by the mistakes that they make, but by how they rise above them," Reverend Sharpton said.

"Rodney had risen above his mistakes; he never mocked anyone, not the police, not the justice system, not anyone."

One of King's daughters, 28-year-old Laura Dene King, called her father a "gentle giant". "I will remember his smile, his unconditional love ... He was a great father, a great friend, he loved everyone," she said.

"People will just have to smile when they think of him." Several donors helped defray the funeral costs including a reception that followed the service. Television producer Anthony Zulker, creator of the CSI series donated $10,000. “We lost a symbol, they lost a loved one,” he said in support of the King family. King was found unresponsive at the bottom of his swimming pool in Rialto, in the early hours of June 17, by his fiancee Cynthia Kelley. A preliminary investigation showed no signs of foul play, while a full autopsy and toxicology reports are still pending.

Video footage of King being beaten by four white police officers in 1991 sparked deadly riots in Los Angeles and prompted a national debate about police brutality and race relations. Police struck him more than 50 times with their wooden batons and used a stun gun following a high-speed car chase.

The officers went on trial for use of excessive force but were acquitted on April 29, 1992, triggering days of riots that left more than 50 people dead and caused around $1 billion in damage. As Los Angeles was ripped apart by crowds who looted businesses, torched buildings and attacked one another, King made a personal plea for peace. "People, I just want to say, you know, can we all get along? Can we get along?" he asked on the third day of rioting, going off script from the statement planned by his lawyers. Two of the officers were later convicted on federal charges of violating King's civil rights and were sentenced to prison.

At Saturday's funeral, the words "Can We All Just Get Along" could be seen embroidered on the open lid of his coffin during a pre-funeral service. Speaking ahead of the 20th anniversary of the riots this year, King said racism still has to be challenged.

He published a memoir, The Riot Within: My Journey From Rebellion to Redemption, to mark the anniversary.

"There's always going to be some type of racism. But it's up to us as individuals in this country to look back and see all the accomplishments that we have gotten to this far," he told CNN.

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