News (Updated October 11, 2009)

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US panel backs expanded use of Pfizer HIV drug

US health advisers favor expanded approval for Pfizer HIV drug as an initial treatment

ADELPHI, Maryland (AP) -- Federal health advisers said Thursday that Pfizer's HIV drug Selzentry should be approved for use by patients who have not already taken other drugs to combat the virus.

The Food and Drug Administration's panel of virus experts voted 10-4 in favor of the new use, despite some inconsistency in company studies of the drug. Selzentry is approved as a secondary option for HIV patients who are not responding to other antiviral drugs. New York-based Pfizer is asking the FDA to approve the drug as an initial treatment.

Pfizer's initial study comparing Selzentry with Bristol-Myers Squibb's Sustiva failed to meet the goal of showing it was at least as effective at suppressing HIV.

But when Pfizer reanalyzed the results using a different test to screen patients, the study met its goal.

FDA reviewers raised concerns about higher levels of viral activity in patients taking Selzentry compared with Sustiva. About 32 percent of patients did not adequately respond to Pfizer's drug, compared with 24 percent of patients taking the alternative.

A majority of panelists ultimately said the drug works and should be made available as an option for patients, though they expressed lingering concerns about the strength of its effect.

"It's clearly an active drug, it demonstrated effectiveness," said Dr. Russell Van Dyke, of the Tulane University School of Medicine. "But I'm worried it's not as potent as we might like."

Other panelists said they were not comfortable backing a product that could be inferior to drugs already on the market.

"There's a lot that's promising about this drug, but this trial doesn't convince me," said Dr. Barbara McGovern, of Tufts University Medical School .

Panelists said Pfizer should continue collecting data on the drug's effectiveness, particularly in minority populations.

While the FDA is not permitted to consider cost when deciding whether to approve a drug, several panelists commented on Selzentry's high price tag.

If approved, Selzentry would be the most expensive first-line HIV treatment on the U.S. market, according to the AIDS Healthcare Foundation, a nonprofit patient advocacy group. Selzentry's wholesale price per year is over $12,500, according to the group, compared with $4,800 for Bristol-Myers' Sustiva.

The FDA is not required to follow the advice of its panels, though it usually does.

Selzentry is part of a recently developed class of treatments that block HIV from entering white blood cells through a pathway present in some patients. While more than 1 million people in the U.S. are HIV positive, only a subset of that group respond to Pfizer's pill. The drug works by blocking the so-called CCR5 receptor.

HIV attacks the body's immune system, eventually causing AIDS.

Pfizer said the meeting "marks an important step in expanding available treatment options for patients with HIV infection."

Selzentry had sales of $46 million last year, according to Pfizer.

Report: 2 million babies and mothers die at birth

By CELEAN JACOBSON, Associated Press Writer Celean Jacobson, Associated Press Writer Tue Oct 6, 1:24 pm ET

JOHANNESBURG – More than 2 million babies and mothers die worldwide each year from childbirth complications, outnumbering child deaths from malaria and HIV/AIDS, according to a study released Tuesday.

The study, launched at the International Federation of Gynecology and Obstetrics world congress being held in Cape Town , also showed that such deaths could be easily avoided.

"The world will continue to miss the unheard cry of the 230 babies who die every hour from childbirth complications," unless there is better planning and implementation of policies, according to the study.

Some 1.02 million babies are stillborn and another 904,000 die soon after birth. By comparison, 820,000 children die from malaria and 208,000 die from HIV/AIDS worldwide.

About 42 percent of the world's 536,000 maternal deaths also occur during childbirth, according to the study. Deaths in Africa and South Asia account for three-quarters of the maternal and infant deaths.

The research was led by Save the Children, the Gates Foundation and Johns Hopkins University with investigators from a dozen countries. It was published in the October edition of the federation's journal.

"The huge numbers hide multiple personal stories of loss," said Joy Lawn, who runs Save the Children's Saving Newborn Lives campaign. "Each death is a tragedy to a family — actually a double tragedy since almost all these deaths could be prevented."

The report said that many of the deaths could be avoided with improvements in basic health care, and training for local health care workers to perform emergency Cesarean sections and other lifesaving techniques.

Lawn said she hoped that the study would be used by countries to ensure money was invested where it was needed.

Poverty is one of the main causes of these deaths. In wealthier countries most women give birth with a skilled attendant while in poor countries, few women do.

Most deaths also occur in remote rural areas where there are few doctors and nurses. Each year, 60 million of the world's 136 million births occur outside health facilities, and only one out of every five babies born in African hospitals are cared for by skilled staff.

Lawn told The Associated Press that researchers were taken aback by the shocking figures and the lack of attention given to these mothers and their babies.

"It is seen as women's business. Stillbirths don't count. Sometimes the deaths of women don't even count," she said.

However, she said that developments in Malawi show some signs of encouragement. The country, located in southern Africa , has only three pediatricians for about 12 million people. Yet, 60 percent of births took place in a clinic or hospital, she said, adding that the majority of Cesarean sections were performed not by doctors but by trained health workers.

"They knew they didn't have a lot of money or people and so had to be strategic," she said.

The authors of the research welcomed the $5.3 billion committed by world leaders to maternal and child care at last month's United Nations General Assembly.

US trio win Nobel Medicine Prize for research on ageing

Mon Oct 5, 8:13 AM

STOCKHOLM (AFP) - Australian-American researcher Elizabeth Blackburn and Carol Greider and Jack Szostak of the United States won the Nobel Medicine Prize on Monday for identifying a key switch in cellular ageing.

The trio were honoured for the discovery of how chromosomes are protected by telomeres and the role of an enzyme called telomerase in maintaining or stripping away this molecular shield.

"The award of the Nobel Prize recognises the discovery of a fundamental mechanism in the cell, a discovery that has stimulated the development of new therapeutic strategies," the Nobel jury said.

Blackburn and Greider are only the ninth and tenth women to win the Nobel Medicine Prize since 1901 -- out of a total 195 medicine laureates -- and this is the first time two women have shared the honour. Previous US winners of the same award.

But Nobel committee secretary Goeran Hansson said gender played no part in the decision.

"They're not being honoured because they are women. They are being honoured because they've made a fundamentally important discovery," he told Swedish news agency TT.

The three laureates told Swedish Radio they were overjoyed by the news.

Greider, born in 1961 and a molecular biology and genetics professor at Johns Hopkins University School of Medicine in Baltimore , was "just thrilled."

"I just think that the recognition for curiosity-driven basic science is very, very nice," she said, adding that she was up doing laundry in the US when the early morning call came from Sweden .

Blackburn, born in 1948, who teaches biology and physiology at the University of California in San Francisco , said she knew when they made their Christmas Day 1984 discovery that they were on to something big.

"I felt very excited ... and I thought this is very interesting, this is a very important result, and you don't often feel that about a result," she said.

Szostak, 56, a professor of genetics at Massachusetts General Hospital in Boston , said he planned to celebrate with "a big party at some point."

Telomeres are a minute yet vital factor in ageing. They are like a nubby, protective cap, fitting on the ends of the strands of DNA -- the chemical recipe for life -- that are packed into chromosomes.

Blackburn and Szostak discovered in 1982 that a unique DNA sequence in the telomeres protects the chromosomes from degradation when the cells divide. With Greider, Blackburn also identified telomerase, the enzyme that makes the telomere DNA.

If telomeres become worn, cells age.

But if telomerase levels are high, the telomere length is maintained, and cellular ageing is braked. A small number of rare but very destructive diseases, including a form of severe anaemia, are linked to defective telomerase, resulting in damaged cells.

Yet there is also a darker and more complex side to this picture.

Many experts initially speculated that ageing could be pinned to telomere shortening, but the process has emerged as something that encompasses different factors, as well as telomeres.

In addition, high telomerase also helps cancer, enabling its cells to replicate endlessly and achieve what scientists call "cellular immortality."

Finding ways of blocking this machinery through "telomerase inhibitors" is one of the most eagerly explored areas of cancer research.

The trio's work has "added a new dimension to our understanding of the cell, shed light on disease mechanisms, and stimulated the development of potential new therapies," the Nobel citation said.

The three won the 2006 Lasker Prize, one of the most prestigious US science awards, for the same work.

The Medicine Prize is the first award to be announced in this year's Nobel season. Recent winners of the Nobel Medicine Prize.

The Physics Prize is to be announced on Tuesday followed by the Chemistry Prize on Wednesday. The Literature Prize will be announced on Thursday and the Peace Prize on Friday.

The Economics Prize will wrap up the awards on October 12.

The laureates receive a gold medal, a diploma and 10 million Swedish kronor (1.42 million dollars, 980,000 euros) which can be split between up to three winners per prize. The prizes are awarded in Stockholm and Oslo on December 10.

Official site of the Nobel Medicine Prize

HIV outpaces provision of anti-AIDS drugs

Andy Coghlan, reporter

Despite huge efforts to provide all HIV-infected people in the world with antiretrovirals, HIV continues to prove a formidable foe. The problem is that the virus is spreading faster than access to the drugs. In 2007 there were 2.7 million new infections, bringing the number of people with HIV to 33 million. Two-thirds of them are in sub-Saharan Africa .

The good news is last year the number of HIV-positive people in poorer countries who are receiving antiretroviral therapy jumped by just over 1 million, from 33 per cent to 42 per cent.

But the figures, released yesterday jointly by the World Health Organization and the United Nations bodies UNAIDS and UNICEF, also reveal that because of lack of access to testing, less than 40 per cent of people who are infected know they are.

This is the key to tackling the epidemic: once people know they are carrying the virus, they can avoid passing it on to others through risky sex. Where treatment is available, they can also begin to take antiretroviral drugs, thereby reducing the levels of virus circulating in the blood almost to zero.

Starting the treatment too late reduces people's chances of survival, because by then the virus has the upper hand. "Late initiation of ART [antiretroviral therapy], often due to late diagnosis, remains the most significant threat to patient survival during the first year of treatment," says the report. Thankfully, testing is on the up, doubling in sub-Saharan Africa between 2007 and 2008.

There's still some way to go before everyone who needs treatment gets it, but there are other rays of hope, not least the first hints of a vaccine that works and the first trials of some novel gene therapies to tackle HIV.

There are also opportunities to use ART more effectively by giving it to everyone as soon as they're diagnosed. At present, people don't receive ART until their CD4 cells - the ones attacked by HIV - fall below a pre-specified level. Some researchers argue that if everyone testing positive received ART immediately, or even prophylactically, the virus would be run out of town far faster.

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