News (Updated June 4, 2006)
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GENEVA (Reuters) - Female circumcision, performed on as many as 3 million girls each year, complicates childbirth later in life and causes higher mortality among their babies, the World Health Organization (WHO) said on Friday.
In a new report, the United Nations agency said women who had undergone the practice, also known as female genital mutilation, were up to 70 percent more vulnerable to potentially fatal hemorrhage after delivery than those who had not.
Its study, involving some 28,000 women at obstetric centers in six African countries where the practice is common, said babies born to circumcised women were as much as 55 percent more likely to die during or immediately after childbirth.
"We have, for the first time, evidence that deliveries among women who have been subject to female genital mutilation are significantly more likely to be complicated and dangerous," said Joy Phumaphi, WHO assistant director-general for family and community health.
Up to 20 out of every 1,000 babies born in Africa die as a direct result of their mothers' circumcision, the WHO said.
About 100 million women worldwide are estimated to have undergone genital mutilation, which can involve cutting away the clitoris and external genitalia and stitching the vaginal opening in order to reduce women's sexual appetite.
The WHO said relatively inelastic scar tissue formed around the wounds could cause obstruction and prolonged labor "which increases the risk of caesarean section, heavy bleeding, distress in the infant and stillbirth."
The degree of complications increased according to the extent and severity of the procedure.
While predominant in 28 African countries, including Sudan, Chad, Sierra Leone and Djibouti, female circumcision also takes place in some areas of the Middle East and Asia and among immigrant communities in Europe and North America.
Girls generally undergo the rite before the age of 10, often without anesthesia and in unsanitary conditions where they are exposed to dangerous infections including HIV.
Phumaphi said the WHO strongly opposed having doctors perform female genital mutilations to ensure they took place in a clean or safe setting.
Recommending that health professionals be involved in female circumcision would be endorsing an unacceptable practice, she said. "That is the worst possible thing we can do. It is worse than turning a blind eye."
Many African nations have legislated against female genital mutilation but few are enforcing the rules, Berhane Ras-Work of the Inter-African Committee for Traditional Practices said.
Citing Senegal and Burkina Faso as exceptions, she said most countries in Africa were doing little to stop the widely decried practice meant to ensure girls stay chaste before marriage and remain loyal to their husbands.
In some areas, female circumcision is also seen as a means to initiate girls into womanhood or improve hygiene. While some consider the rite a requirement under the Muslim faith, the WHO denied this, saying the practice predated Islam.
By Anne HardingMon May 29, 3:07 PM ET
Programs intended to help individuals infected with HIV, the virus that causes AIDS, to reduce their sexual risk work best if they include training on skills like how to use a condom, as well as motivational training designed to boost social support or otherwise improve overall quality of life, a review of studies suggests.
But Dr. Blair T. Johnson of the Center for Health/HIV Intervention and Prevention at the University of Connecticut in Storrs and colleagues found that interventions including skills and motivational components have actually not been tested in HIV-positive men who have sex with men. "We don't really know how good prevention could be with them," Johnson told Reuters Health.
Motivational components might include information that would help an HIV-positive person feel optimistic about the future, Johnson explained. Basically, this approach is intended to give a person a sense that it's worth it to "keep their guard up and act safe," he added.
Johnson and his team reviewed 15 studies including a total of 3,234 participants, all of which tested the effectiveness of a particular approach to reducing sexual risk behavior among HIV-infected individuals. To date, they note in their report in the Journal of the Acquired Immune Deficiency Syndromes, evidence for such programs' effectiveness has been "mixed."
On average, the researchers found, the interventions increased participants' condom use by 16 percent, but had no effect on their number of sexual partners. The programs' effectiveness varied widely. Those that included a motivational component and skills training along with information on risk increased condom use by 32 percent, compared to just 5 percent for interventions that provided information only.
Younger people also showed more of a response to the interventions. Twenty-year-olds were 53 percent more likely to use condoms, on average, after participating, compared to an 11 percent increase in condom use among 40-year-olds.
Johnson and his team hypothesize that older people may tend to be in longer-term partnerships, "a factor that is known to increase resistance to change."
Overall, the researchers found, interventions were not effective for men who have sex with men. But because none of the studies that included this population featured motivational and skills components, they add, it's not clear if these approaches would be helpful, and there's no evidence to show that men who have sex with men are as a rule less responsive to such efforts.
"Perhaps the most surprising finding of this work is that more than two decades into the epidemic, there have been so few intervention randomized controlled trials that focus on people living with HIV," the researchers note.
However, Johnson told Reuters Health, several such trials are underway. "I think this problem will be rectified very soon."
SOURCE: Journal of Acquired Immune Deficiency Syndromes, April 15, 2006.
Tue May 30, 2006 04:52 PM ET
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The group is also adding two more antiretroviral medicines to the scheme and has signed an eighth voluntary licence agreement, allowing South Africa's Sonke Pharmaceuticals to make generic copies of some of its drugs.
The moves are the latest in a series of price reductions introduced by Glaxo and other AIDS drugs manufacturers, who have been criticised in the past for not doing more to ensure access to life-saving treatments.
Glaxo has previously pledged to bring down prices as it achieves greater economies of scale, something that is now happening as shipments of HIV/AIDS medicines to Africa pick up.
About 1.3 million people in the developing world are currently on antiretrovirals but most of the estimated 40 million infected people around the world are still unaware of their status.
The new prices, which take effect from July 1, will see the price of a 60-tablet pack of Trizivir in poor countries fall 31 percent to $70 while Ziagen is reduced by 28 percent to $52.29.
Glaxo is differentiating packs of medicines destined for not-for-profit markets to prevent illegal diversion back to the company's profitable high-price markets.
Efavirenz is an anti-viral that is used with other AIDS combinations to help block the spread of HIV, the virus that causes AIDS.
Friday June 2, 4:01 pm ET
By Paul Elias, AP Biotechnology Writer
The popularity of the treatment, Truvada, is soaring because it has almost no side effects and requires patients to take only a single pill once a day. With close to two dozen AIDS drugs on the market, the company that once had Defense Secretary Donald Rumsfeld as its chairman is an industry leader. Its stock price has nearly doubled since Truvada was approved on Aug. 2, 2004.
But success on Wall Street hasn't insulated Gilead from complaints that it isn't doing enough to combat the disease where it hits hardest: in the Third World.
"For a company that prides itself on their access program, they have been irresponsible in getting the drug out," said David Bryden of the Global Aids Alliance, a Washington-based advocacy group that organized a small protest outside Gilead's annual shareholders meeting in May.
Truvada's chief asset is that it includes two drugs -- known generically as tenofovir and emtricitabine -- in a single pill.
That's a dramatic departure from a few years ago, when HIV-positive patients carried small alarm clocks to remind them to take their myriad pills at the right time. The onerous dosing regimen and often nasty side effects dissuaded many patients from taking their medication.
"Truvada is revolutionary because simplicity leads to better outcomes," said Gilead Chief Financial Officer John Milligan, a former Gilead scientist who has been with the company for 16 years.
Doctors now prescribe Truvada to 60 percent of all newly diagnosed HIV cases in the United States. The two drugs in Truvada will ring up close to $2 billion in sales this year individually or combined in the blue, teardrop shaped pill. That's about half the estimated global AIDS market of about $4 billion.
"The drug clearly dominates its class," said Sharon Seiler, an analyst at Punk, Ziegel who sent a note to her clients Tuesday advising them to buy the company's stock. "The company has a lot of credibility."
The Foster City company is expected to get an even bigger boost when the Food and Drug Administration approves a new, three-drug combination of Truvada and Bristol-Myers Squibb Co.'s popular Sustiva. Because all three drugs are already on the market, FDA approval is widely expected this year.
But the 1 million Americans estimated to be infected with HIV are a fraction of the 40 million people worldwide living with the AIDS virus. Nearly 25 million of those are in Africa south of the Sahara.
Gilead acknowledges a responsibility to make its drugs available to the developing world and has touted its Gilead Access Program in several press releases since it was unveiled nearly three years ago. In April 2003, Gilead said it would make tenofovir available in all of Africa plus dozens of other developing nations "at no profit."
But medical and AIDS advocacy groups say the access program is little more than an empty promise. In February, the international humanitarian group Doctors Without Borders issued a scathing report that concluded the company has failed to gain regulatory approval in nearly all the impoverished countries it promised to serve.
On the same day in New Delhi, activists protested Gilead's plans to patent tenofovir in India, which has the most AIDS cases of any country. Close to 6 million people are living with the AIDS virus in India. Tenofovir has been available generically in India since last year and activists fear the cheaper drugs will disappear if Gilead is granted a patent.
"We certainly believe in intellectual property around the world," Gilead chief executive John Martin said. "On principal we believe that our product should be patented."
What's more, Martin said, critics should give Gilead a chance to get its drugs approved by government regulators in each of the poor countries where it has promised access. Several countries having been reviewing the company's applications for two years, he said.
"We are one small company in a big world where billions of dollars are being put at the problem of AIDS," Martin said. "I am proud of what we have been able to accomplish and look forward to what we'll do in the future."
The federal guidebook for reducing the spread of AIDS highlights initiatives that are at least 7 years old, which some say hinders the nation's battle against the disease.
In 1999, the Centers for Disease Control and Prevention published summaries of 24 initiatives shown to reduce transmission of HIV, the virus that causes AIDS. Today, those strategies guide the actions of HIV prevention programs nationwide because they met the agency's guidelines for scientific evaluation.
Rep. Henry Waxman, D-Calif., says the CDC itself has found numerous other programs to be effective. In a letter sent Tuesday to CDC Director Julie Gerberding, he questioned why the guidance had not been updated to include those programs.
He suggested that politics might be a factor.
"It is perhaps not coincidental that the new prevention programs include interventions that some political constituencies oppose, such as condom instruction for high-risk populations," Waxman said.
Tom Skinner, spokesman for the CDC, said the agency was still digesting Waxman's letter, and he declined to respond to any specific points.
"All I can say is we've received the letter and look forward to responding to the concerns raised by Congressman Waxman," Skinner said.
Waxman is a frequent critic of the Bush administration's focus on abstinence education when it comes to preventing unwanted pregnancies or sexually transmitted diseases.
The CDC's document is called the "Compendium of HIV Prevention Interventions with Evidence of Effectiveness." It contains one-page summaries of studies involving four groups: drug users, heterosexual adults, youth and men who have sex with men.
Agencies that receive federal AIDS-prevention funding use the document as a tool to help them shape their prevention programs.
Among the programs backed by the 1999 guidance:
_Small group therapy sessions aimed at deterring heroin users from moving from inhaling the drug to injecting it.
_Therapy sessions aimed at female methadone patients who showed a significant increase in condom use with their partners compared with methadone patients who didn't attend the counseling.
_Intensive AIDS education in jail.
Some health analysts agreed with Waxman's assessment that an update of the guidebook is warranted.
"There is incredible pressure to make sure that we're using our scarce prevention resources well with interventions proven to be effective," said Julie Scofield, executive director of the National Alliance of State & Territorial AIDS Directors. "Relying on interventions from '99 in 2006 is really quite unacceptable."
She said that AIDS directors at state and local health departments are particularly looking for programs proven effective in reaching high-risk populations in the black and Hispanic community.
"There numbers are clearly increasing in the epidemic," Scofield said. We're very much concerned, and we don't have the right arsenal of interventions to use to try to reach those populations."
Annual HIV incidence peaked in the mid 1980s when more than 150,000 new infections were reported. Since the mid-to-late 1990s', the number of new infections has stabilized at about 40,000 a year, according to the Kaiser Family Foundation, which conducts health research.
Blacks made up 49 percent of new AIDS cases in 2003, whites, 28 percent; and Hispanics, 20 percent, the foundation said.