In 1943, 1,105 District residents came down with whooping cough; 37 died. Since then, the whooping cough vaccine, required by law before children can enter school in the District, Maryland, Virginia and most other states, has virtually eliminated the disease.
In 1984, says Dr. Martin Levy, administrator of preventive health services in the District, there were no reported cases.
But with some children suffering serious side effects or even dying after a whooping cough vaccination, many parents have nagging doubts about whether the prevention is worse than the disease.
Whooping cough, or pertussis, is the P in the DPT vaccine. Children generally get the three-pronged vaccine, which also protects against diphtheria and tetanus, at 2, 4, 6 and 18 months, with a final booster between the ages of 4 and 6 years.
The vaccine used today is essentially the same as the one introduced in the mid-1940s. Because it contains the whole bacterium, weakened by heat or chemicals so it won't grow in the body, it can cause some of the same neurological problems associated with a whooping cough infection itself. Ideal vaccines contain only components of the bacterium or virus, which lessens the chances of side effects.
The American Academy of Pediatrics estimates that a "serious, permanent neurological disorder" will follow one of every 310,000 DPT vaccinations. About 15 million doses are given in the United States each year. Because physicians are not required to report side effects of the vaccine, exact figures on side effects are not available.
The side effects identified by the Food and Drug Administration include swelling and pain at the injection site, fever and, less commonly, seizures. In rare cases there may be brain disease or death.
Dissatisfied Parents Together, a national group started by parents whose children became severely ill or died after a DPT shot, notes that the scientific literature reports episodes of diarrhea, rashes, abscesses, coughing, vomiting, unconsolable crying, shock-like collapse and sudden infant death syndrome (SIDS).
But the pediatrics academy has concluded that "pertussis the disease produces 10 times the rate of brain damage as pertussis the vaccine."
And if large numbers of children become unprotected, it could be a disaster.
In the mid-1970s, some adverse publicity about the vaccine sparked a drop in immunization rates in England. From 1977 to 1979, there was a whooping cough epidemic.
In that period, 102,500 cases of whooping cough, three time the normal number, were reported in the United Kingdom. More than 5,000 children had to be hospitalized, 50 were admitted into intensive care units, and 83 suffered convulsions.
Using data from that epidemic, the FDA estimates that the number of whooping cough cases would jump to 380,000 a year from the current 1,000 to 3,000 if the U.S. immunization rate dropped from 90 percent to the 30 to 40 percent range that was reached in the United Kingdom.
Those cases would result in 18,500 hospital admissions, 7,400 cases of pneumonia, 307 cases of convulsions, 184 cases of encephalopathy (brain swelling) and 104 deaths, the FDA estimates.
A new book, "DPT: A Shot in the Dark" by Harris L. Coulter and Barbara Loe Fisher (Harcourt, Brace, Jovanovich), criticizes predictions of an epidemic as overblown and says the vaccine's side effects are understated.
Fisher, one of the cofounders of Dissatisfied Parents Together, and Coulter write that the cyclical nature of whooping cough was responsible for at least some of the increase in the disease that showed up in some European countries following a drop in vaccine use in the 1970s. Increased reporting by physicians also helped to boost the total, they argue.
"Evidence from around the world indicates that whooping cough has become a milder disease in developed nations with good nutrition, medical care and sanitation," they write.
Fisher and Coulter also say that the vaccine was introduced "without a systematic study to evaluate its side effects," a study that has not yet been done to their satisfaction.
At the same time, however, Donna Middlehurst, a Chevy Chase lawyer who is one of the founders of Dissatisfied Parents Together and whose daughter died of seizures following her third DPT shot, says: "We are not unmindful about how dangerous the disease is. We're not advising parents not to get the shots."
What the group does advise is that parents make sure the person administering the shot takes a complete family history, including information about neurological disease and siblings' experience with the vaccine. The group also says the child should be healthy when the shot is given, and administration of the vaccine should be delayed for premature babies or babies with neurological problems. Following the shot, they recommend that parents watch their children carefully for three days.
Their advice differs little from that of the American Academy of Pediatrics, which suggests that children who have histories of convulsions or certain neurological conditions not be given the pertussis vaccine. The academy recommends that children who suffer severe neurologic reactions, persistent screaming, fever of 105 degrees or greater or an allergic reaction, or who go into a shock-like state, not receive further pertussis vaccinations. That advice is echoed by federal agencies.
These children can still be protected from diphtheria and tetanus with a DT shot.
Fisher and Coulter write that "more than one researcher has been impressed with the coincidence between the peak incidence of SIDS and the months in which most babies receive their first DPT shots."
However, a National Institutes of Health study comparing 380 SIDS victims with a group of 798 healthy babies of the same age found no relationship between SIDS and the DPT shot. The NIH results were presented at a 1982 conference on immunization sponsored by the Centers for Disease Control.
It's difficult to evaluate the side effects of a vaccination because there are no vaccine-free groups of children to compare the vaccinated group against. A condition that shows up after vaccination could be just an unrelated childhood illness.
The difficulty in eliminating the side effects, the threat of law suits and high insurance premiums forced two of the three drug companies that formerly sold the DPT vaccine to drop out of the market.
Lederle Laboratories, headquartered in Wayne, N.J., is currently the sole manufacturer of DPT. Late last year the company produced two batches of an ineffective vaccine and had to withdraw them from distribution. As a result of the bad lots and the lack of back-up production, there is now a DPT shortage.
To contend with the shortage, the CDC and the pediatric academy recommend that the last two shots of the series be postponed until more DPT is available. A Lederle spokesperson said the company is confident the shortage will be alleviated "by the fourth quarter of 1985."
In the meantime the District has relaxed its vaccination rules so that for the present, children need to have only three of the four shots to enter school.
Bills were introduced in the last Congress to provide compensation to vaccine-injured children, in the hope that it would provide enough legal and economic protection to lure drug companies back into DPT production.
Sen. Paula Hawkins (R-Fla.) is scheduled to introduce new legislation next week, and Rep. Henry Waxman (D-Cal.) is working on a similar bill.
The Hawkins bill is essentially a compromise between the American Academy of Pediatrics and Dissatisfied Parents Together that would establish a compensation procedure. Parents of injured children could sue on their own or present their case before a federal judge empowered to award compensation from a fund financed by a surcharge on the vaccine. The cost of this compensation fund already has been built into the price of the DPT vaccine, which has jumped from 11 cents a dose in 1982 to $2.80 a dose today.
The bill would also call for full disclosure of risks prior to vaccine administration, including the development of a vaccine reactions list. It also would require reporting of side effects to the government and endorse development of a new, safer vaccine. Other related bills also are being discussed.
Work on a new vaccine is already underway. The NIH is sponsoring clinical trials on vaccines now being used in Japan. The new vaccines consist of portions of the pertussis bacterium rather than the entire bacterium.
Until a safer vaccine is developed, not even DPT's critics recommend dropping the current vaccine. "People have to realize it's not that you can avoid the risk by doing nothing," says Levy. "If you do nothing, you go back to the old risk."