Smallpox vaccination program in trouble

In February, I wrote a three-part article on the smallpox vaccination program, which appeared on these pages. The essentials of the article revolved around the unknown risk of a terrorist smallpox attack, the known risk of complications, the unsolved questions of compensation – both short-term and long-term – for morbidity and mortality.

I had been struck by an early comment by the director of the Centers for Disease Control that, “the program will not be delayed because of concerns for compensation.” This struck me as unenlightened and suggested big problems for the implementation of the program.

Since then the program has been modified due to lack of volunteers stepping forward to be vaccinated, safety issues, monetary concerns – individual questions regarding compensation and questions by state health organizations regarding funding and the adequacy of personnel to implement the program – and a general overall attitude of many parties that the threat of a smallpox attack has lessened.

A major factor for the modification of the program is the deaths of at least three recipients due to heart disease. It had been known that the vaccine could cause an inflammation of the heart and this was thought to be operative in these deaths as well as in at least 10 military personnel who suffered from myocarditis. As late as March, one serviceman continued to have cardiac impairment.

Despite the fact that Congress passed compensation legislation, the details of the implementation of that issue remains hazy.

The CDC, which is the major force behind the vaccination program, has left up to the state health departments the implementation and much of the administration of the program, thus creating funding and personnel problems. The health departments have the final word on implementation. Maine has adopted a go slowly approach but only last week a number of volunteers were vaccinated in Portland.

From the beginning of the program the CDC has been advised by an independent group known as the Institute of Medicine, whose panel on smallpox is composed of leading experts from a wide field. On May 27, the panel suggested a “pause” in the program citing much of the above as reasons for their decision. In addition to concerns about the real, known complications, the institute pointed out that not all of the vaccinated individuals had had proper followup and monitoring for complication, so it goes without saying the true incidence of complications has not yet been determined.

One news story notes that David Bloom, the reporter who died in Iraq of a pulmonary embolus, received not only an anthrax vaccination but also a smallpox vaccination. It seems far-fetched that his death could be attributed in any way to these vaccinations yet if he had been monitored and recorded as a complication, the timing of his death fell within the monitored time frame.

It seems to me that the Institute of Medicine has offered the most logical and scientifically sound approach. Perhaps it comes a bit late, but nevertheless is the right one.

To say the program is in trouble (and may have created trouble) seems obvious.

William Gallagher, M.D. is a Bangor dermatologist. He is a member of the American Academy of Dermatology.