News (Updated February 2, 2003)

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From The Morning Call -- February 1, 2003

Bush touts AIDS test produced by Bethlehem firm



Of The Morning Call

President George W. Bush is applauded by Health and Human Services Secretary Tommy Thompson prior to a Mother-and-Child HIV Prevention Initiative event, January 31, 2003 in Washington. Bush cleared the way for providing wide access to new AIDS tests that can deliver results in minutes, and promised a big increase in domestic funding for AIDS prevention. Photo by Mike Theiler/Reuters
President George W. Bush is applauded by Health and Human Services Secretary Tommy Thompson prior to a Mother-and-Child HIV Prevention Initiative event, January 31, 2003 in Washington. Bush cleared the way for providing wide access to new AIDS tests that can deliver results in minutes, and promised a big increase in domestic funding for AIDS prevention. Photo by Mike Theiler/Reuters
- Jan 31 2:26 PM ET
 

President Bush on Friday widened his multibillion-dollar AIDS agenda and said a Bethlehem company's quick HIV test will be key to fighting the disease in the United States.

Bush highlighted the test made by OraSure Technologies in a White House speech to health care professionals, African diplomats and members of AIDS support and research groups.

He also made a surprise announcement that OraSure had been granted permission to sell the test to about 100,000 sites across the country, including physicians' offices and HIV counseling centers. The Food and Drug Administration in November had approved the test for sale to only 38,000 government-approved labs.

''We must…move quickly to increase the number of people who are tested for HIV,'' Bush said. ''How can you treat if you don't test? How can you help if you don't know? And so the Food and Drug Administration recently has approved a new HIV test, which can provide results in less than 30 minutes, with a 99.6 percent accuracy.

''So today I've got an announcement to make, and it's this: that the Department of Health and Human Services … has waived regulations so that the test will soon be more readily available to doctors and public health facilities throughout the country.''

OraSure's test, called OraQuick, is the first rapid HIV test to receive such widespread clearance.

Without the waiver, OraQuick ''would be limited to use in laboratory settings where many high-risk people do not go for testing,'' Health and Human Services Secretary Tommy Thompson said in a news release Friday.

News of the decision was hailed by public health officials, who waited years for a rapid test and believe OraQuick's speed will help save lives.

Most people who get an AIDS test now wait a week or more for results. At least 8,000 people a year who test positive never return to a clinic to get the news. So they don't start life-extending treatments and don't get counseling on how to avoid transmitting the virus to others.

''It is a big deal,'' said Daniel C. Montoya, director of government affairs for AIDS Project Los Angeles. ''This would allow us, out on the street, to do counseling along with delivery of results.''

The waiver should mean stronger sales for OraSure, which employs about 130 people in Bethlehem and 200 workers total. The company will probably have to add manufacturing workers in Bethlehem.

''It's huge for us,'' OraSure Chief Executive Michael Gausling said. ''We all did a lot of high fives.''

OraSure stock soared after Bush's announcement, and shares closed up almost 27 percent to $7.85 on the Nasdaq stock exchange. The stock has more than doubled since September.

The company submitted its waiver application to the FDA on Thursday. Many analysts were startled by the approval one day later. They didn't expect a decision for five months or more. ''By FDA standards, it's warp speed,'' Gausling said.

As part of its application, OraSure had to show that someone with a seventh-grade education could follow the product's instructions, Gausling said.

OraQuick is about as easy to use as a home pregnancy kit, health officials say. To use the pocket-size OraQuick test, a health worker pricks a person's finger, mixes a spot of blood into a vial of developing solution and drops in the stick-like testing device.

One reddish line on the dipstick means no HIV. Two reddish lines mean the person is probably infected and needs another test to be sure.

The fight against AIDS has become a major new policy priority for Bush. In his State of the Union address Tuesday, he called for a sharp increase in U.S. funds dedicated to the global battle against AIDS — to $15 billion over the next five years.

Bush plans to focus international efforts on 14 African and Caribbean nations with high HIV infection rates. There are 30 million HIV infected people in Africa, including 3 million children under age 15. Of those, only 1 percent receive drug treatment.

On Friday, Bush addressed AIDS in the United States. He said he will ask Congress for a 7 percent increase in the amount of money the nation spends to fight AIDS. He's seeking $16 billion for the prevention and treatment of AIDS domestically. Included are a $93 million increase for AIDS research and an extra $100 million for a program that pays for AIDS drugs for people lacking health coverage.

The Centers for Disease Control and Prevention in Atlanta estimates that 850,000 to 950,000 Americans are infected with HIV, including 24,000 people in Pennsylvania and more than 800 in the Lehigh Valley. About a quarter of those infected don't know it.

The focus on HIV testing could mean big business for OraSure, which lost money in 2001 and in the first nine months of 2002.

''We're confident that the OraQuick line is going to grow significantly, and that will have material impact in 2003 and beyond,'' said Aaron Lindberg, an analyst with William Smith Special Opportunities Research in Denver.

''I think the stock is going to move higher. Our prediction is for OraSure to turn profitable at the end of 2003 and remain so thereafter.''

OraSure's waiver for wider use comes less than three months after the FDA initially approved the test. ''This is a great opportunity for us in terms of the credibility of who's announcing it,'' Gausling said. ''The first FDA approval was Tommy Thompson, and now the waiver is President Bush. It doesn't get any better than that.''

OraSure expects at least $4 million in OraQuick sales this year as part of a distribution agreement with Abbott Laboratories. And Gausling said OraQuick could eventually generate annual sales between $8 million and $10 million.

Lindberg thinks sales could be much higher. He said OraSure could eventually reap between $200 million and $600 million in sales over five years as a result of the government's new international and domestic AIDS efforts.

Depending on how quickly demand for the OraQuick devices takes off, one of OraSure's biggest challenges could be making the test kits fast enough. OraQuick is made at the company's Eaton Avenue plant in Bethlehem, which Gausling said is capable of producing 100,000 tests a month.

OraSure is running one shift at the plant, but might soon have to add a second.

''We had the staff in place to make the initial product,'' Gausling said. ''We are at the place now of starting to add manufacturing people, and this may accelerate that.''

Now that the whole blood version of OraQuick has cleared all regulatory hurdles, OraSure can focus on securing FDA permission to begin clinical trials of the saliva-based version of OraQuick. That test, which works exactly like the blood version now on the market, is the world's only saliva-based rapid HIV test.

However, OraSure is still perfecting that product. The company said it could be a year or more before the saliva-based test hits the market. OraSure currently sells a lab-based oral HIV test.

The availability of a saliva-based HIV test would be another breakthrough because it would eliminate the need to handle blood, which can potentially infect medical workers who are exposed to it.

Morning Call reporter Gregory Karp and The Associated Press contributed to this story.

 

Botswana Aims to Bring Safe Sex Closer to Home

Thu Jan 30, 2:01 PM ET

GABORONE (Reuters) - Botswana plans to triple its distribution of condoms in a bid to curb the spread of AIDS  in the country, which has one of the world's highest HIV-infection rates, the health minister said on Thursday.

The aim of a new government drive is to hand out enough condoms so that most of the African country's 1.7 million people will not have to go more than a kilometer to get hold of one.

"We will treble the annual distribution of condoms and have them available within one kilometer (0.6 mile) of 85 percent of the population," Health Minister Joy Phumaphi said at the launch of the new program.

More than one third of people aged 15 to 49 have HIV in Botswana, which lies at the heart of a band of southern Africa struggling with the world's highest rates of HIV, the virus that causes AIDS.

As well as giving away condoms to reduce sexual transmission of HIV--Botswana has handed out 21 million of them over the last decade--the government plans to sell 14 million over the next four years at cost price.

 

Rights group says sexual abuse fueling spread of HIV in Zambian girls

Mon Jan 27,10:06 PM ET

JOHANNESBURG, South Africa - Widespread sexual abuse in Zambia is fueling the spread of HIV among girls and young women in the southern African nation, Human Rights Watch said in a report Tuesday.

An estimated 21.5 percent of adult Zambians are infected with HIV, the virus that causes AIDS. About 120,000 Zambian children are infected with the virus.

The Human Rights Watch report describes children sexually abused by trusted family members or by respected community leaders.

Girls are raped on long walks to school or sexually abused by teachers once they get there, the report said, describing some girls orphaned by HIV forced to sleep with older "sugar daddies" to survive. Others turn to outright prostitution, the group said.

"It is no accident that HIV prevalence is five times higher among girls than boys," said Janet Fleischman, director of the U.S.-based group's Africa division. "Young girls are preyed upon by older men — including those who dare to call themselves guardians or caretakers of these girls — and the government fails to protect them."

The report said police are often insensitive and ineffective in enforcing sexual abuse laws in Zambia, which deters many girls and women from reporting their abuse.

The group demanded that the government increase training for police and court officials about sexual abuse and rigorously prosecute those guilty of such abuse.

The report also asked for enhanced victim support networks and new laws to protect HIV-infected children from discrimination.

 

Pakistan's religious right wants Americans fingerprinted, tested for HIV; Government rejects demands

Tue Jan 28, 8:44 AM ET

By KATHY GANNON, Associated Press Writer

ISLAMABAD, Pakistan - Reflecting growing outrage against America, Pakistan's religious right presented the government with a new list of demands Tuesday, calling for the fingerprinting of Americans, a boycott of U.S. products and compulsory AIDS testing of U.S. visitors.

A coalition of Islamic parties, which gained considerable political clout after last October's general elections, is threatening nationwide demonstrations to press the demands.

But a government spokesman said it had no plans to either fingerprint Americans or impose mandatory HIV testing.

"Such demands cannot be accepted," Interior Ministry spokesman Iftikar Ahmad said, without elaborating. He accused the religious right of trying to make trouble for President Gen. Pervez Musharraf and the pro-military government, a staunch ally of the United States in its war on terror.

"Religious leaders keep making such absurd demands. ... Such statements serve no cause except to create problems for the government," Ahmad said.

The demand for fingerprinting of Americans reflects Pakistanis' anger over new U.S. rules requiring citizens of Pakistan, other predominantly Muslim countries and North Korea to be fingerprinted and photographed by immigration agents while staying in the United States.

Pakistan has complained about the new rules.

A coalition of six radical Islamic parties known as the United Action Forum won unprecedented support in October 2002 elections on a strong anti-American platform. They came in third nationwide, and won control of two important Pakistani provinces bordering Afghanistan.

The coalition's parties sympathize with the Taliban and their hardline interpretation of Islam, and agree with the Taliban that it is against Islamic tenets to betray a fellow Muslim.

"We will protest throughout the country to rally support" for the demands, said Liaqat Baluch, a member of coalition party Jamaat-e-Islami.

Baluch said it also wants the government to expel American FBI agents and put an end to their involvement in searches and arrests of Pakistanis. FBI officials have apparently been involved in the arrest of at least two doctors in the eastern city of Lahore. The physicians were detained because of alleged links to al-Qaida. One doctor, Ahmad Javed Khawaja, a naturalized American, is still in custody.

"It is the integrity and sovereignty of Pakistan that is at stake here," said Ameer ul-Azeem, a spokesman for the religious coalition.

"Would the United States allow Pakistani security agency men to search homes in America? We also have Pakistanis who are wanted here and hiding in the United States, but our law enforcement agencies can't go there and arrest them," he said.

The religious right also wants Musharraf to close Pakistani bases to the U.S. military. Currently the United States occupies five bases in Pakistan where it provides logistic support to its 8,000 soldiers in Afghanistan.

Musharraf has vowed continued support for the American war on terror.

 

Thu Jan 30, 8:15 AM ET

MAPUTO, Mozambique - The government of Mozambique will begin providing a key AIDS drug to HIV-infected pregnant women to help prevent the spread of the virus to their babies during childbirth, the Mozambique news agency AIM reported Thursday.

The program to give women the drug nevirapine will start in hospitals in the central cities of Beira and Chimoio this year and will then expand to a hospital in Gaza province.

By giving one dose to the mother during labor and one to the infant soon after, health officials can halve the chances the baby will be born infected, studies have shown.

German pharmaceutical company Boehringer Ingelheim has offered nevirapine free to developing countries for use in preventing mother-to-child transmission of HIV.

Until now, however, Mozambique had not been properly equipped to administer the drug.

"We think this project should be extended to the entire country," local UNICEF official Michael Klaus told AIM.

An estimated 13 percent of Mozambicans are infected with HIV.

 

 

Fri Jan 31, 9:49 AM ET

TOKYO - A total of 5,121 people in Japan had tested positive for HIV through December, an increase of 139 from three months earlier, Japan's health authorities said Friday.

Most of the new cases, or 77, were transmitted via homosexual contact, said Makoto Iwakura, a spokesman for the Ministry of Health, Labor and Welfare. An additional 45 people contracted HIV, the virus that causes AIDS , through heterosexual contact.

There were no reported cases of transmission through infected needles in Japan, where drug use is relatively rare.

Also during the October-December period, 61 HIV-positive people developed full-blown AIDS, bringing Japan's total number of AIDS patients to 2,549, Iwakura said. Four other patients died from AIDS in the period, he added.

Critics say actual numbers of HIV-infected patients in Japan are likely much higher, because many people shy away from being tested for the disease to avoid facing discrimination.

The ministry's committee on AIDS surveillance began meeting every three months to compile statistics in 1984, when Japan's first AIDS patient was diagnosed.

 


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