News in brief - Sept. 25, 2006

Ample flu vaccine expected - Dermatologists complain about risk management program for acne drug - Early obesity could be precursor - New artificial heart gains approval

Ample flu vaccine expected

More than 100 million doses of influenza vaccine are expected for the 2006-07 season, and the bulk of supplies will be distributed before the end of October, according to a Sept. 6 statement from the Centers for Disease Control and Prevention.

"If the manufacturers' estimates hold, more people than ever before will be able to protect themselves and their loved ones from influenza this year," said CDC Director Julie Gerberding, MD, MPH.

All four flu vaccine manufacturers have started shipping supplies. About 75 million doses are expected to be available before the end of October, and another 25 million are expected before the beginning of January.

Every physician or other administrator of vaccine should receive at least a partial order, but public health officials did express caution. Although an ample supply of vaccine is expected throughout the season, whether an individual physician has supplies is dependent on a number of variables.

"When and how much vaccine each health care provider or clinic receives depends on who they ordered from and when they ordered," said Lance Rodewald, MD, director of the CDC's Immunization Services Division. "There are many manufacturers and distributors, each of which has different distribution plans and schedules. We expect that some health care providers and clinics may get or have more influenza vaccine that others in the first months or so, but people will have plenty of opportunities to be vaccinated during October and November, as well as December or later."

Dermatologists complain about risk management program for acne drug

The system established to reduce the chance that a woman will become pregnant while taking isotretinoin is confusing, onerous and disruptive, according to an American Academy of Dermatology Assn. survey released this month to mark the six-month anniversary of the program.

According to the survey carried out by Doane Marketing Research, more than 90% of physicians who prescribe this drug have had at least some problems with the iPLEDGE program, which requires registration of everyone involved with dispensing and using this medication. More than 50% had problems getting help from iPLEDGE call center staff, and more than 35% said the system was confusing.

To make this system less of a burden, many survey respondents want the 30-day requirement between appointments scrapped and an allowance that prescriptions can be rewritten if a patient is unable to pick up their medications within a seven-day window. Nearly 13% want to see the program eliminated, and 10% would like to see male patients and women who are unable to have children exempt.

Isotretinoin is a known teratogen. The iPLEDGE system is the latest attempt to keep it available while reducing the risk of fetal exposure.

A Food and Drug Administration spokeswoman acknowledged that there have been problems with the system, particularly in the first month of operation, but that many had been addressed.

Early obesity could be precursor

Lending support to the idea that it's never too early to pay heed to healthy living, a new report by the National Institutes of Health and several academic research centers found that overweight toddlers and preschoolers are more likely to become overweight teens.

Researchers periodically collected height and weight measurements of more than 1,000 children ages 2 to 12. They found that children who were overweight at least once between ages 2 and 4½ were five times more likely to be overweight at age 12 compared with children who were not overweight in earlier childhood.

"These findings underscore the need to maintain a healthy weight beginning in early childhood," said Duane Alexander, MD, director of NIH's National Institute of Child Health and Human Development, which funded the study. "Contrary to popular belief, young children who are overweight or obese typically won't lose the extra weight simply as a result of getting older."

The analysis is in the September Pediatrics.

New artificial heart gains approval

The Food and Drug Administration approved on Sept. 5 the sale of the first totally implanted artificial heart that involves both pumping chambers. The device had been used experimentally in just 14 patients with advanced heart failure and, although all died, they did live longer than they would have without it.

The two-pound mechanical heart, which has an internal battery, takes over the pumping function of a diseased heart and allows a recipient to be free from all external connections for up to one hour. The system includes two external batteries that allow for two hours of free movement, and it also can be plugged into an electrical outlet for longer periods of recharging or during sleep.

The heart was approved under the Humanitarian Use Device provisions of the Food, Drug and Cosmetic Act. The provisions are intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States.