Top : 2007 : 2007_02_16

Roche seeks OK for child dose of Tamiflu

Fri, 16 Feb 2007 13:12:58 GMT

BASEL, Switzerland - Swiss drug maker Roche Holding AG said Friday it is seeking approval for smaller child-sized capsules of Tamiflu, the medicine many governments have been stockpiling as an initial defense against a pandemic that might result from the bird flu virus.
Roche said it has already asked the European Medicines Agency, which regulates the use of drugs in Europe, to approve two smaller capsules — 30 mg and 45 mg — and planned a similar filing soon with the Food and Drug Administration in the United States.

The World Health Organization recommends Tamiflu as the treatment of choice for patients with the deadly H5N1 strain of bird flu. If patients are given Tamiflu within two days of symptom onset, doctors believe it can substantially improve their survival chances. Most bird flu cases have occurred in children and young adults.

"Roche has been granted an accelerated review and is optimistic that EMEA will complete their evaluation by midyear," said a company statement.

The new capsules would be in addition to the already approved 75 mg dosages and will be easier to use than the liquid already available for children, it said. The capsules also will have a longer shelf life than the liquid.

Although the lower dosage capsules have been developed mainly for use in children, they also will be useful for the elderly or other adults who have difficulty swallowing the standard capsule, the company said.

Oseltamivir is being stockpiled by governments in case the H5N1 strain of the bird flu virus mutates into a version that is easily transmitted among humans, setting off a pandemic. The medicine would be a first line of defense until a specific vaccine could be developed to target the pandemic strain.

Roche says the drug is designed to be effective against various kinds of influenza and that it works by blocking the action of the neuraminidase protein on the surface of the virus. Most flu drugs work by inhibiting neuraminidase, which prevents the virus from spreading in the body.

Worldwide, flu kills 250,000-500,000 people every year.

"Children younger than 2 years old are as likely as those over age 65 to be hospitalized because of influenza," Roche said. "It is estimated that children are three times more likely to get sick with the flu on average: one in 10 adults is affected by influenza annually, compared with one in three children."


Texas lawmakers seek HPV brochure

Fri, 16 Feb 2007 01:34:58 GMT
By LIZ AUSTIN PETERSON, Associated Press Writer
AUSTIN, Texas - As lawmakers prepare to debate an override of the governor's order that schoolgirls be inoculated against the virus that causes cervical cancer, a group of legislators wants the state to produce a brochure about the vaccine.
"We want families to know the facts," said state Rep. Dennis Bonnen, a Republican. "No one here is against a family studying the facts for themselves and deciding this is the right thing to do. ... What we don't want to do is tell them that we know better than them."

Bonnen is co-sponsoring a bill that would direct the state to produce and distribute informational materials about vaccines against the human papillomavirus, or HPV. The brochure would be distributed at doctor's offices, health clinics and hospitals.

The bill will be discussed Monday at a hearing also to feature debate about a measure aimed at overriding Perry's Feb. 2 order, which requires girls entering the sixth grade as of September 2008 to be vaccinated. Opponents say the order intrudes into families' lives and contradicts Texas' abstinence-only sex education policies.

Perry said Thursday that he is open to changes to his order but would not say whether he would veto a measure eliminating the vaccine requirement.

"I'm not rigid," he said. "If the Legislature has some restrictions that they want to put on this, I'm highly respectful of this process."

New Jersey-based Merck & Co.'s Gardasil vaccine is the only HPV vaccine on the market. It protects girls and women against the strains of HPV that cause most cases of cervical cancer and genital warts.


Heart disease more common in W.Va. Ky.

Fri, 16 Feb 2007 03:41:09 GMT
By MIKE STOBBE, AP Medical Writer
ATLANTA - West Virginia and Kentucky — states known for high levels of obesity, diabetes and smoking — have the highest proportion of people with heart disease in the nation, U.S. health officials said Thursday.
The findings, from the first study ever to look at heart disease prevalence state by state, showed that states in the Southeast and Southwest were heart disease leaders. Colorado and the District of Columbia had the lowest percentages.

The results line up well with previous, state-specific reports about heart disease death rates, obesity and other risk factors, said Wayne Rosamond, an epidemiology professor at the University of North Carolina who chairs a statistics committee for the http://www.cdc.gov/mmwr/

FDA approves laser to treat baldness

Fri, 16 Feb 2007 01:30:41 GMT

WASHINGTON - Drawing this special comb over a balding pate could restore some real hair — according to a Florida company. The Food and Drug Administration has cleared for sale a handheld laser device to promote hair growth.
Called the Hairmax Lasercomb, it increases the numbers of thick hairs on the scalp, according to 26-week clinical trials conducted by its manufacturer, Lexington International LLC.

As the device's name suggests, it combines a low-level laser with a comb. When drawn through the hair, the laser strikes the scalp to promote hair growth, according to the company.

The device, sold on the Web for $545, is the only drug-free product meant for home use in combatting hair loss that's won the endorsement of the FDA, the company said.


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