Healthwise

Tuesday, November 12, 2002

The 70-year-old Camp Deer Creek in Indianola touts itself as the oldest operating summer day camp in the Pittsburgh area. It's hugely popular despite its rustic setting, offering hundreds of youngsters days of horseback riding, creek wading and other fun.

Virginia Linn

Like other older establishments, however, it's been slow to update certain things, such as the medical form that pediatricians fill out to provide information on the health status of each camper. It still asks for documentation for three vaccines: polio, tetanus and smallpox.

The smallpox vaccine, mind you, was last available here in 1972 -- 30 years ago. There hadn't been a documented case on U.S. soil since 1949, and none in the world since 1977. But, I've obviously underestimated the vision of the Deer Creek owners. They apparently knew all along that the smallpox vaccine would be back.

Its inclusion on the form shows just how standard the smallpox inoculation was years ago for all children. Little regard was given to the risks of the vaccine when the disease was killing 30 percent of the folks infected.

But I'll have to think long and hard before I'll let my children even close to the vaccine's bifurcated needle now.

Federal health officials are seeking public comment on whether they should test the smallpox vaccine in toddlers and preschoolers for effectiveness and safety. Under a proposed study, 40 healthy children, ages 2 to 5, would be enrolled at Children's Hospital Medical Center in Cincinnati and Harbor-UCLA Medical Center in Los Angeles. But the study raises a host of thorny ethical issues because these children aren't old enough to give informed consent about their participation.

The smallpox vaccine contains the live vaccinia virus. It doesn't contain the smallpox virus and cannot give you smallpox, but it can cause severe skin rashes or encephalitis (a potentially deadly disorder that causes swelling of the brain). The Centers for Disease Control and Prevention estimates it may kill 1 or 2 people of every million vaccinated; in the past between 14 and 52 people out of every 1 million vaccinated experienced life-threatening reactions.

Even Dr. Paul Offit, chief of infectious diseases at Children's Hospital of Philadelphia, who has crusaded on the safety of the measles-mumps-rubella vaccine against skeptics who fear a link to autism, doesn't hold the same enthusiasm for the smallpox vaccine.

"There is no vaccine with comparable risks," he recently told the Wall Street Journal. "I would never give that vaccine to my children because right now there is no disease out there."

Nonetheless, Dr. David Greenberg, head of the Center for Vaccine Research at Children's Hospital of Pittsburgh, said there are good reasons to have the vaccine tested in children at this time.

Even though there are years of data to show how the vaccine affected children in the past, no one knows how the vaccine called Dryvax will work since it has been frozen for 30 years. A diluted version will be tested to see if it will provide immunity.

Adverse reactions, for the most part, are minor, Greenberg said, but there can be redness, scabbing, swelling and drainage at the inoculation site. Children who touch the infected area can spread the virus to others, or if the virus spreads to the eye, it could cause blindness. Health-care workers and parents need to be educated on the best way to provide care to the injection site.

This is particularly important in today's society, he said. "When these vaccines were used years ago, we didn't have as many people in the community with immune deficiencies. There weren't the cancer chemotherapy patients, HIV was not an issue. Even though an adult or child entering into a research study is perfectly healthy, you have to sure he or she has no contact with someone who isn't."

Because a threat of a bioterrorism attack using smallpox "is greater than zero," he said, it's best to have the vaccine tested under very strict controls and monitoring in a federal study with parents' informed decisions, rather than throwing it out to the masses without testing if an outbreak occurs.

"I think it is the right thing to do so physicians and health-care workers have a better idea of what to expect," he said of the study. "We do need to be prepared."

With 500,000 health workers first in line to get the vaccine, the government is talking about creating a compensation fund to address problems with the smallpox vaccine much like one created in 1988 for childhood immunizations to address the side effects caused by an earlier version of the pertussis vaccine.

Earlier testing of the vaccine to prevent whooping cough led to development of a much safer one. Greenberg said he hopes the same improvements can be made through testing of the smallpox vaccine.

It's rare that the Food and Drug Administration seeks public input on research, and the agency should be commended for eliciting such comments. Here's your opportunity to weigh in. Comments will be taken through Dec. 2.

You can e-mail comments to FDA Web site at www.fda.gov/dockets/ecomments. Or you can respond by letter to Dockets Management Branch, Food and Drug Administration, 5630 Fishers Lane Room 1061, Rockville, MD 20852. You must have write Docket No. 02N-0466 on the envelope.

Your Health editor Virginia Linn writes about consumer issues. You can reach her at health@post-gazette.com