UPDATES

New medicines for children

According to a new survey from the Pharmaceutical Research and Manufacturers of America, 217 new medications and vaccines for children are currently under development, 25 have been approved by the Food and Drug Administration (FDA) in the past year, and clinical trials will begin soon on another 52 candidates. FDA approvals went to a conjugate pneumococcal vaccine, a once-a-day therapy for AIDS, a remedy for juvenile rheumatoid arthritis, two new asthma meds, and one for children with partial onset epileptic seizures. Drugs currently in clinical trials or awaiting FDA action include many that are already approved for adults (asthma remedies such as zafirlukast, ventolin, and fluticasone, for example) but are now in trials specifically for pediatric use. The graph (below) summarizes the complete list of pediatric drugs under development.

Under the FDA Modernization Act, after December of this year pharmaceutical manufacturers must submit data on pediatric trials for all new drug applications. For drugs already on the market, the FDA can require children's studies in certain circumstances, as in cases in which pediatric labeling could avoid significant risk to children. Drugs whose patents have expired are not covered by the rule.

On the little screen

The electronic worlds of computers and television offer clinicians and parents an ever-expanding universe of information and support. Some recent entries include:

Between the Lions, a new public television daily program focusing on improving the literacy skills of young children. It uses a balance of whole language and phonics approaches to the teaching of reading. Children who have outgrown Sesame Street are just right for the new series. Interactive teaching materials that reinforce the televised broadcasts can be found on the Public Broadcasting System Web site www.pbs.org. Also on the Web are:

www.freedomfromfear.org, information on where to refer families for screening evaluations for social anxiety disorders.

www.centerwatch.com, a listing of more than 41,000 industry-and government-sponsored clinical trials, with information on enrollment criteria and details on how to contact the researchers conducting the trial. Centerwatch is a part of the PDR.net supersite.

www.cali.com/nccanch/services/statutes.htm#Series, a state-by-state listing of relevant civil and criminal statutes on child abuse. Legal and medical information available on this site includes how each state defines child abuse and neglect and what the rules are on mandatory reporting.

Get the lead out

Current recommendations for blood lead testing of children use 10 µg/dL as the cutoff point. The assumption is that children with blood lead levels lower than that are safe from the deleterious effects of lead. But a new study by Bruce P. Lanphear, MD, of the Children's Hospital Medical Center in Cincinnati, challenges that assumption. Dr. Lanphear and his colleagues, using data from the National Health and Nutrition Examination Survey III on 4,853 children between the ages of 6 and 16, found adverse cognitive effects in reading, math, visual construction skills, and short-term memory in children with lead levels as low as 2.5 µg/dL.

According to Dr. Lanphear, this means that more than 12.8 million US children and adolescents who were born between 1972 and 1988 are adversely affected by their exposure to lead in their environments.

AAP recommends conjugate pneumococcus vaccine

The American Academy of Pediatrics has added the new seven valent, conjugate pneumococcal vaccine (Prevnar) to the list of recommended immunizations for children. The new vaccine is recommended for all children 23 months of age and younger, to be given concurrently with other recommended vaccines at 2, 4, 6, and 12 to 15 months of age. The AAP also recommends the vaccine for children 24 to 59 months of age who are at especially high risk of invasive pneumococcal infection. This group includes children with sickle cell disease, human immunodeficiency virus infection, and those who are immunocompromised.

EYE ON WASHINGTON

Pediatricians waiting for some significant health-care legislation to emerge from this session of Congress should probably stop holding their breaths. Bills to reform managed care, protect patient privacy, and help the elderly cope with the high costs of prescription drugs have yet to reach the consensus stage that could produce legislation. Perhaps these issues have too much potential as weapons in the upcoming presidential campaign to look for resolution now. Which is not to say that health news isn't being made in the nation's capital this spring. Some examples:

The FDA is getting ready to simplify drug labels, in the hope that physicians will read and heed the major risks before they prescribe. According to Janet Woodcock, MD, the FDA's drug chief, "Our interest is the clinician who has 30 seconds to make that prescribing decision; clinicians need something right in front of them."