FDA weighs overcounter cholesterol drug
Sat, 19 Jan 2008 09:18:49 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it's sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.
Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.
A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be "a reasonably safe and effective" option — if consumers used it as directed.
But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly — 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded FDA's lead medical reviewer.
Moreover, about 30 percent of people who already were diagnosed with heart disease, diabetes or had had a stroke wanted to purchase over-the-counter Mevacor, people who need a doctor's care, the FDA documents say.
The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.
Merck argues that most people made the right decision on whether they should buy OTC Mevacor even if they missed some answers.
On Thursday, Merck will present its case to the FDA's independent scientific advisers, hoping they will recommend that Mevacor become the first in the family of cholesterol-lowering "statin" drugs to be sold in this country without a prescription. Twice before, FDA has said no.
FDA approves HIV drug etravirine
Sat, 19 Jan 2008 06:27:20 GMTWASHINGTON - Tablets of the drug etravirine were approved Friday by the Food and Drug Administration for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals.
Sold under the trade name Intelence, etravirine is a non-nucleoside reverse transcriptase inhibitor, or NNRTI, that helps to block an enzyme that the human immunodeficiency virus needs to multiply, the FDA said. It was approved for use in combination with other anti-HIV medications.
Etravirine can reduce the amount of HIV in the blood and increase white blood cells that help fight off other infections, the FDA said. It also may reduce the risk of death or infections that can occur with a weakened immune system.
The government gave etravirine a priority review, a status granted to medications aimed at treating serious or life-threatening conditions. Tibotec Pharmaceuticals Ltd., a unit of Johnson & Johnson, said last July that it had requested etravirine be placed on a fast track for review.
"This is another significant new product for many HIV-infected patients who are NNRTI-resistant and whose infections are not responding to currently available medications," said Dr. Debra B. Birnkrant, director of the FDA's Division of Antiviral Products.
The drug is distributed by Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., a Johnson & Johnson company based in Bridgewater, N.J.
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On the Net:
Food and Drug Administration: http://www.fda.gov
Tibotec: http://www.tibotec.com/
US abortions at lowest rate since 1974
Sat, 19 Jan 2008 11:56:24 GMTBy DAVID CRARY, AP National Writer
NEW YORK - The number of abortions in the United States fell to 1.2 million in 2005, down 25 percent from the all-time high of 1.6 million in 1990 and dropping the abortion rate to its lowest level since 1974, according to report issued Thursday.
The Guttmacher Institute, which surveyed abortion providers nationwide, said there likely were several reasons for the decline, including more effective use of contraceptives, lower levels of unintended pregnancy and greater difficulty obtaining abortions in some parts of the country.
The institute's president, Sharon Camp, noted that despite the drop, more than one in five pregnancies ended in abortion in 2005.
"Our policymakers at the state and federal levels need to understand that behind virtually every abortion is an unintended pregnancy, so we must redouble our efforts towards prevention, through better access to contraception," Camp said.
The Guttmacher Institute supports abortion rights, yet both sides in the debate on the issue consider its abortion surveys the most comprehensive in the United States because they encompass California, the most populous state. California state agencies do not collect abortion data to contribute to federal surveys.
According to the Guttmacher data, the number of abortions declined by 8 percent between 2000 and 2005, from 1.31 million to 1.21 million — the lowest total since the 1.18 million abortions tallied in 1976.
The 2005 abortion rate of 19.4 per 1,000 women aged 15 to 44 was the lowest since 1974, when it was 19.3.
Abortion rates were highest in Washington, D.C., New York, New Jersey, Delaware, Florida, Maryland and California. Rates were lowest in largely rural states: Wyoming, Kentucky, Mississippi, South Dakota, Idaho and Utah.
However, the report noted that the rates reflected the state in which the abortion occurred, thus including nonresident women who crossed state lines to get an abortion.
By region, the Northeast had the highest abortion rate, followed by the West, the South and the Midwest.
One pronounced trend in recent years is an increase in early medication abortion — notably through use of the RU-486 abortion pill. These types of procedures accounted for 13 percent of all abortions in 2005, more than double the level in 2001.
The report said 57 percent of abortion providers now offer medication abortion services, compared with 33 percent in 2001.
"Currently, more than six in 10 abortions occur within the first eight weeks of pregnancy," said Rachel Jones, lead researcher for the survey. "Medication abortion, which provides women with an additional option early in pregnancy, clearly reinforces this very positive trend."
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On the Net:
http://www.guttmacher.org/
Experts call for rethinking AIDS money
Fri, 18 Jan 2008 17:38:01 GMTBy MARIA CHENG, AP Medical Writer
LONDON - In the two decades since AIDS began sweeping the globe, it has often been labeled as the biggest threat to international health.
But with revised numbers downsizing the pandemic — along with an admission that AIDS peaked in the late 1990s — some AIDS experts are now wondering if it might be wise to shift some of the billions of dollars of AIDS money to basic health problems like clean water, family planning or diarrhea.
"If we look at the data objectively, we are spending too much on AIDS," said Dr. Malcolm Potts, an AIDS expert at the University of California, Berkeley, who once worked with prostitutes on the front lines of the epidemic in Ghana.
Problems like malnutrition, pneumonia and malaria kill more children in Africa than AIDS.
"We are programmed to react quickly to small children with AIDS in distress," Potts said. "Unfortunately, we don't have that same reaction when looking at statistics that tell us what we should be spending on."
The world invests about $8 billion to $10 billion in AIDS every year, more than 100 times what it spends on water projects in developing countries. Yet more than 2 billion people do not have access to adequate sanitation, and about 1 billion lack clean water.
In a recent series in the journal Lancet, experts wrote that more than one-third of child deaths and 11 percent of the total disease burden worldwide are due to mothers and children not getting enough to eat — or not getting enough nutritional food.
"We have a system in public health where the loudest voice gets the most money," said Dr. Richard Horton, editor of Lancet. "AIDS has grossly distorted our limited budget."
But some AIDS experts argue that cutting back on fighting HIV would be dangerous.
"We cannot let the pendulum swing back to a time when we didn't spend a lot on AIDS," said Dr. Kevin De Cock, director of the AIDS department at the World Health Organization. "We now have millions of people on treatment and we can't just stop that."
Still, De Cock once worked on AIDS projects in Kenya, his office just above a large slum.
"It did feel a bit peculiar to be investing so much money into anti-retrovirals while the people there were dealing with huge problems like water and sanitation," De Cock said.
Part of the issue is advocacy, from celebrity ambassadors to red ribbons.
"No one is beating the drum for basic health problems," said Daniel Halperin, an AIDS expert at Harvard University's School of Public Health.
Aside from southern Africa, most of the continent has relatively low rates of HIV, and much higher rates of easily treatable diseases like diarrhea and respiratory illnesses. Yet much of the money from the West, especially from the United States, goes into AIDS.
Halperin recently wrote a commentary in The New York Times on the imbalance and said he was astounded by the response. Most were positive, he said, with many AIDS experts agreeing it was time to re-examine spending.
Most AIDS officials say the solution is to boost the budget for all of public health.
"Why does the public health budget have to be so limited?" asked Tom Coates, a professor of global AIDS research at the University of California, Los Angeles. "Let's not drag AIDS care and prevention down to the level of every other disease, but let's bring everything else up to the level of AIDS."
That may be wishful thinking.
"At the end of the day, there are limits to how big the public health pie can be," Halperin said.
Since the discovery of anti-retrovirals to fight HIV in the 1990s, AIDS has virtually become a chronic, treatable disease in the West. But the disease has not been conquered so easily in Africa. Not only are the AIDS drugs too expensive for most patients, but major problems in the health system need to be fixed first.
"It's hard to get Western donors to listen," said Dr. Richard Wamai, a Kenyan doctor at Harvard's School of Public Health.
Wamai said that some African health systems are so weak they cannot absorb the donations, and AIDS drugs are sometimes left in warehouses because governments cannot distribute them.
Still, "trying to redirect AIDS money will take a long time," Wamai said. "It's a bit like trying to stop an ocean liner."
