Health Highlights: Dec. 14, 2003

Flu Vaccine Effectiveness Was Questioned by FDA Panel Pa. H.S. Students May Be Secondary Hepatitis A Victims Study Finds Women With Breast Cancer Don't Get Enough Chemo FDA Approves European Wrinkle Smoother

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

Flu Vaccine Effectiveness Was Questioned by FDA Panel

Members of an advisory panel that backed this year's flu vaccine expressed doubts about its potential effectiveness before recommending it for Food and Drug Administration approval, CNN reports.

Some said they were concerned the vaccine would not provide as much protection against the Fujian strain of flu that was thought most likely to dominate this year's flu season, according to a transcript of the group's deliberations.

The Fujian strain, which emerged in the Far East, is now responsible for 75 percent of U.S. flu cases, the Centers for Disease Control and Prevention said.

But drug makers could not culture the Fujian strain in a way to meet FDA standards, forcing the advisory committee to make this year's flu vaccine the same as it was last year.

The committee's decision in March has come under a microscope now because the flu is reaching near epidemic proportions in the United States, amid widespread vaccine shortages.

The number of states hit hardest by the flu has doubled to 24 over the past week and now includes most of the western half of the country, according to the Associated Press. Nationwide, at least 20 children have died in what could become the worst flu season in years.

A batch of 100,000 flu shots for adults was expected to be ready for distribution in the United States starting Saturday. But an additional 150,000 shots for children are not due to arrive until January because of delays in packaging and other administrative problems, U.S. Health and Human Services Secretary Tommy Thompson said.

Thompson said flu shots are in short supply in the United States, because producers last year had an surplus and had to dump 12 million extra doses. This year, they were not prepared to meet demand.

"We are doing everything we can," Thompson said. "But (the government) cannot manufacture vaccines."

Meanwhile, the manufacturers of tests used to determine if a patient has the flu say the current outbreak has strained their ability to meet demand from hospitals, medical laboratories and doctors' offices.

Jack Kraeutler, president of test kit distributor based Meridian Bioscience Inc., said the company is running about a week behind in filling orders. And Baltimore-based BD Diagnostics Systems, which also manufactures the kits, said it already has received as many orders as the company got last year for the entire flu season.


Pa. H.S. Students May Be Secondary Hepatitis A Victims

A group of Pennsylvania high school students who have tested positive for hepatitis A may be the first people to have contracted the virus from victims of last month's outbreak at a Mexican restaurant.

State health officials said they will know Monday or Tuesday whether the latest cases, involving an unspecified number of high school students in Hookstown, are the first secondary cases tied to the largest known hepatitis A outbreak, which was confirmed at a Chi-Chi's restaurant about 25 miles northwest of Pittsburgh.

Health officials have confirmed 640 people -- including three who died -- got the virus from eating or working at the restaurant, but have yet to confirm any secondary cases in which those infected spread the disease to others, the Associated Press reports.

The high school where some students tested positive for hepatitis A in the past week is about 10 miles from the restaurant.

The South Side Area School District has sent a letter to parents informing them that some students have hepatitis A. The district also enacted some temporary health guidelines, including requiring that all food brought to schools be sealed and store-bought.


Study Finds Women With Breast Cancer Don't Get Enough Chemo

New research on 20,000 women with early breast cancer has found that more than half did not receive the recommended schedule of chemotherapy, which may have put them at risk for worsening of the disease or recurrences that could have been avoided.

Writing in the Dec. 15 Journal of Clinical Oncology, Dr. Gary H. Lyman, an oncologist at the University of Rochester, and his co-authors describe their findings as alarming, particularly in light of growing evidence that the odds of curing breast cancer are highest when patients complete a full course of chemotherapy within a certain period of time. "Women who get less have a significantly higher risk," Lyman said.

The study analyzed the medical records of about 20,000 women who were treated by 1,243 doctors in private practices around the United States, according to The New York Times. When the researchers compared the treatment that the women actually received with the standard regimens, they found that more than half received less than 85 percent of the recommended dose intensity. Previous studies had found that such reductions could increase the risk of recurrence and death.

It is not known whether the women in the study suffered as a result of reduced treatments; that kind of follow-up was not part of the plan, the Times says.

A researcher who was not part of the study, Dr. Larry Norton, head of medical oncology at Memorial Sloan-Kettering Cancer Center in New York, said he was surprised and disturbed by the widespread failure to stick to a treatment schedule.

"This should remotivate both doctors and patients to be sure both dose rate and level are adequate," Norton told the newspaper.


FDA Approves European Wrinkle Smoother

A new wrinkle smoother has won approval from the U.S. Food and Drug Administration.

The treatment, an injectable gel called Restylane, has long been used in Europe and is the third injectable wrinkle treatment to win FDA approval, the Associated Press reports.

The other two are Botox and Collegen. Botox temporarily paralyzes muscles beneath the skin to smooth frown lines between the eyes. Collagen is used to fill other wrinkles, including those Restylane can treat. Both wrinkle fillers last about six months.

Restylane is made with hyaluronic acid, a substance normally found in the skin that helps keep it plump.

In studies, 138 patients had wrinkles on one side of the nose injected with Restylane and the other side with collagen. Both sides appeared comparable. Most of the patients studied were Caucasian.

Restylane manufacturer Q-Med AB of Sweden has agreed to do more research on whether the treatment will cause any pigment alternations if used by non-Caucasians, although FDA said widespread use in other countries hasn't raised concern.

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