New medicines for children; On the little screen; Get the lead out; AAP recommends conjugate pneumococcus vaccine



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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.


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."

The National Institute of Environmental Health Sciences has released the 9th edition of its Report on Carcinogens, a compendium that identifies substances and exposures that are known or "reasonably anticipated" to cause cancer. The new edition includes 218 such entries, 14 of which are new this year, and removes two older entries—saccharin and ethyl acrylate—from the list. Among the substances and exposures added as known human carcinogens or upgraded to that category are environmental tobacco smoke; smokeless tobacco; tobacco smoking itself, in addition to component substances already listed; consumption of alcoholic beverages; ultraviolet radiation, whether from exposure to sun, sunlamps, or tanning beds; and tamoxifen, because of the risk of uterine cancer. Questions regarding the report can be addressed toliaison@starbase.niehs.nih.gov.

The Consumer Products Safety Commission announced the recall of some Bounce 'n Play Activity Domes (suffocation hazards) and 3-in-1 Cradle Swings (the handles may fall off), both manufactured by Fisher-Price. At the same time, K-mart announced the recall of a line of Little Ones children's lamps made in appealing shapes like airplanes, alphabet letters, and bats; short circuits have caused some of these lamps to catch fire.

The Department of Agriculture, in its annual report Expenditures on Children by Families, notes that the cost of raising a middle-class child through the age of 17 is about $160,140. According to the Agriculture Department, parents are spending 33% of that total sum to house the child, 18% to feed him or her, 14% for transportation, 10% for education and child care, 7% for clothing, 7% for health care, and 11% for "other." And all that comes before the child is old enough for college.

The Department of Health and Human Services and the Department of Agriculture released new dietary guidelines intended to get Americans to slim down, exercise more, and reduce their consumption of saturated fat and cholesterol, salt, and sugar. For his pains, Secretary of Agriculture Dan Glickman got flack from nutritionists for softening the wording of the guidelines' warning about consuming too much sugar and a tofu pie in the face for—as the pie thrower from People for the Ethical Treatment of Animals (PETA) put it—"promoting meat."

The Centers for Disease Control and Prevention published data from the 1999 Youth Risk Behavior Survey, and the picture that emerges is mixed. In some respects, adolescent behavior became less risky in the 1990s. When the 1999 data are compared with survey results throughout the decade, more teens report wearing seat belts and helmets and using condoms, while fewer have ridden with a drunk driver, carried a weapon, seriously considered suicide, or had four or more sexual partners. On the down side, teens are smoking more, doing more binge drinking, using more marijuana and cocaine, and are more are involved in buying drugs on school property.


October 7, Long Term Health Implications of Hemolytic Uremic Syndrome, Seattle, WA. For information, call STOP (Safe Tables Our Priority), the sponsoring organization, at 800-350-STOP

October 13, Society for Pediatric Anesthesia, San Francisco, CA. To register, call Bob Specht at 804-282-9780

October 19­20, Youth and the Promise of a New Millennium; International Conference on Adolescent Health, London, UK. For information, call the Youth Support Conference Secretariat at 020-8325-8162

October 26­29, Society for Ear, Nose, and Throat Advances in Children, Chicago, IL. To register, call Dave Parsons at 864-281-9440

October 26­28, Children and Adults with Attention Deficit Disorders, Chicago, IL. To register, call Sharon Graham at 954-587-3700

October 27­28, Feeding Conference, Philadelphia, PA. For information, call Glorene D. Ford at 215-590-5263

October 28­November 1, American Academy of Pediatrics Annual Meeting, Chicago, IL. To register, call Melissa Singleton at 800-433-9016

October 31­November 3, Annual Meeting of the International Society for Pediatric and Adolescent Diabetes, Los Angeles, CA. To register, call Patricia Gaines at 770-751-7332

November 16­18, National Perinatal Association Annual Meeting, Charlotte, NC. To register, call Sheila Surkin at 813-971-1008.

Judith Asch-Goodkin
Contributing Editor


Julia McMillan. Updates. Contemporary Pediatrics 2000;7:13.

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