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Health Highlights: June 23, 2006

Human Bird-Flu Transmission Confirmed in Indonesian Cluster FDA Approves Generic Version of Zocor U.S. Outpatient Medical Care Tops 1 Billion Visits Flu Vaccine Makers Project Stable Supply Merck Halts New Parkinson's Drug Trials

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Human Bird-Flu Transmission Confirmed in Indonesian Cluster

The first case of human-to-human transmission of the bird flu virus has been confirmed in laboratory tests of samples taken from a 10-year-old Indonesian boy who died last month from the H5N1 avian influenza strain, a World Health Organization official said Friday.

Genetic sequencing of a virus sample taken from the boy showed a minute change that was also found in a sample taken from his father, who also later died, said Dick Thompson, a spokesman for the United Nations health agency in Geneva, Switzerland. Human-to-human transmission had been suspected as the cause of the infection in seven members of a family of eight from the island of Sumatra.

"We have seen a genetic change that confirms in a laboratory that the virus has moved from one human to another," Thompson told Bloomberg News. The change in the virus "doesn't seem to have any significance in terms of the pathology of the disease or how easily it's transmitted,' he said.

The Sumatran cluster attracted international attention because it represented the largest reported instance of bird-flu spread among people and the first evidence of a three-person chain of infection.

A 37-year-old woman suspected of being the first family member to die was buried before samples were taken. She reportedly mixed fowl manure with soil with her bare hands to fertilize her garden.

The woman's 10-year-old nephew, an 18-month-old niece, two teenage sons and a 29-year-old sister became sick between May 2 and May 4, and later died after having close contact with the woman during her illness, Bloomberg said. A 25-year-old brother was also infected but survived.

The New York Times reported that the first five family members to fall ill had identical strains of H5N1, but the virus had mutated slightly in the sixth victim, the 10-year-old boy, who passed it to his father. That mutation allowed the lab to confirm the route of transmission.

World health officials said there was no evidence that the mutated virus is any better adapted to human infection than before. In fact, the WHO has been following 54 neighbors and family members who lived near the family for a month, and none has contracted the virus, the newspaper said.

At least 130 of the 228 people known to be infected with bird flu since 2003 have died, according to the WHO. World health officials are tracking the spread of the virus in the event it becomes more adept at infecting people.

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FDA Approves Generic Version of Zocor

The U.S. Food and Drug Administration Friday approved the first generic version of Zocor, Merck & Co.'s popular cholesterol-lowering statin drug whose patent protection expires at midnight.

The FDA decision capped a difficult week for Merck, since Zocor generated $3.1 billion in sales in the United States and $4.4 billion worldwide last year for the firm. But Zocor's patent expiration also could mean fewer profits at drug maker Pfizer Inc., whose rival cholesterol drug, Lipitor, is the world's most popular medicine, with global sales last year of $12 billion. Lipitor's patent runs until 2011.

Stains drugs accounted for $16 billion in U.S. sales in 2005. Simvastatin (Zocor) is recommended for use with a diet restricted in saturated fat to treat high cholesterol and to reduce triglycerides and other fatty substances in the blood , the FDA said.

"Simvastatin is a widely used cholesterol lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease," Gary J. Buehler, director of FDA's Office of Generic Drugs, said in a prepared statement.

Zocor has sold for about $3 a daily pill. As a result of the patent expiration, simvastatin's cost could drop 30 percent or more in the next few days, and by as much as 90 percent next year, to about 30 cents a pill, according to The New York Times.

In addition to approving simvastatin, the FDA approved three other generics this week:

  • Finasteride tablets, 1 mg (Propecia), for the treatment of mild to moderate male pattern hair loss in men between 18 and 41 years of age.
  • Finasteride tablets, 5 mg, (Proscar), for the treatment of benign prostatic hypertrophy (BPH) in men with an enlarged prostate to improve symptoms by reducing the size of the prostate.
  • Lamotrigine tablets (chewable), 5 mg and 25 mg (Lamictal), as therapy for treating patients with seizures due to epilepsy. .

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U.S. Outpatient Medical Care Tops 1 Billion Visits

Ambulatory care visits to doctors' offices, emergency rooms and hospital outpatient departments grew to more than 1 billion instances, and have increased at three times the rate of population growth over the past decade, according to new reports from the U.S. Centers for Disease Control and Prevention.

A CDC analysis of visits to ambulatory health-care settings in 2004 also found that with the increase in traffic, the amount of time a patient waited before seeing a physician in the emergency department went up from 38 minutes in 1997 to 47 minutes in 2004.

Infants under 12 months had the highest rate of visits to primary-care offices, hospital outpatient and emergency departments, when compared to other age groups, the CDC report found.

No change was reported in the average time a patient spent face-to-face with a doctor in an office visit -- just 16 minutes, the CDC reported.

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Flu Vaccine Makers Project Stable Supply

Flu vaccine makers said Thursday that U.S. supplies for the coming season will reach a record 100 million doses and may even create a surplus -- a far different scenario than two years ago, when contamination at a Liverpool, England, factory resulted in shortages and long lines.

Fearing a possible flu pandemic, public-health officials want to build demand for the shots to keep the nation's vaccine infrastructure strong. The fear is that if not enough people get the shots, manufacturers won't want to keep producing that much vaccine, the Associated Press reported.

Flu vaccine is made fresh each year to match virus types expected in the coming season. Unused vaccine must be thrown out, but new supplies are difficult to build up since it takes about nine months to make a new batch.

About 86 million doses of flu vaccine were produced for the United States last year, and 81 million were distributed.

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Merck Halts New Parkinson's Drug Trials

German drug maker Merck KGaA is dropping development of an experimental medicine for Parkinson's disease after Phase III clinical trials did not confirm results from previous studies.

The compound, called Sarizotan, was intended to treat advanced Parkinson's patients suffering from dyskinesia, the involuntary, jerky movements often associated with the disease.

The company said in a statement Friday that the trials "did not confirm Phase II results or results from preclinical studies."

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