Bring Back The Lyme Vaccine

PHILADELPHIA — IN August 2005 my son Alec, then 39 years old, collapsed into unconsciousness while walking his dog in the suburbs of Philadelphia. By the time he arrived at the hospital, his heart rate had slowed to 30 beats per minute. Fortunately, an experienced physician recognized that Alec was having a cardiac complication of Lyme infection. Installation of a pacemaker and an infusion of antibiotics saved his life.

Each year there are more than 30,000 cases of Lyme disease reported to the Centers for Disease Control and Prevention. But last month, the C.D.C. announced that the real number of annual infections was closer to 300,000.

Alec had one of the most serious consequences of a Lyme infection, but the microbe can also lead to neurological illnesses like meningitis and encephalitis and, more commonly, fatigue, arthritis and rashes. But the symptoms can be hard to spot. Indeed, days before he became gravely ill, Alec consulted a physician because of a rash, but because it did not appear in a bull’s-eye shape, Lyme disease was not suspected. (It is a common misconception that the Lyme disease rash always appears this way.)

The ticks that carry Lyme disease — which are prevalent in the Northeast United States, the Upper Midwest and Northern California, as well as in Central Europe and Scandinavia — can be hard to spot, too. Both nymph and adult ticks can transmit the bacteria, but the tiny nymphs — which emerge in the springtime — are hard to see with the naked eye until they mature in the fall.

In other words, it’s easy to be bitten and not realize it. If you are infected, it’s easy for a doctor to miss the symptoms. Shouldn’t there be a vaccine for such a prevalent and dangerous disease?

In fact, we used to have one, and are perfectly capable of producing another, if the public demand is high and we avoid the mistakes of the past.

In 1998 SmithKline Beecham (now GlaxoSmithKline) developed a vaccine that was about 80 percent effective for at least a year after three doses. But the Advisory Committee on Immunization Practices, which counsels the C.D.C. on vaccine use, was lukewarm about the real benefits and necessity of it. The committee made a weak recommendation to “consider” vaccination for high-risk persons, overlooking the fact that plenty of casual gardeners and hikers were being infected. Instead, the committee emphasized the use of protective clothing and insect repellents, despite little evidence that those measures prevent tick bites and even less evidence that people will constantly use them.

Nevertheless, the vaccine was put on the market and physicians had to decide what to do with the ambiguous recommendations. Then the manufacturer made a strategic error of its own, deciding to directly advertise the vaccination to the public, despite the fact that by and large people rely on their doctors’ recommendations to decide whether to receive a vaccine. In addition, the manufacturer put the vaccine on the market before it had been tested in children, so it could be prescribed only to adults.

But the biggest blow to the marketing campaign came from a group of volunteers who had been involved in the vaccine’s prelicensure studies and who reported developing arthritic symptoms after the vaccination. Although the rate of arthritis in the vaccinated volunteers was the same as the rate in the control group, some Lyme disease activists concluded that the vaccine caused, rather than prevented, Lyme disease. In 1999, a class-action suit was brought against the manufacturer. Retrospective studies have shown no connection between the vaccination and arthritis, but at the time, sales of the vaccine dropped precipitously, and in 2002 the manufacturer withdrew it from the market.

Of course, Lyme disease did not go away. The tick that carries the Lyme bacteria is spreading to new areas. And though early antibiotic treatment can kill the Lyme bacteria, the diagnosis is frequently missed at the beginning of the disease, as in my son’s case. We need to prevent people from getting Lyme disease in the first place.

The experience of Glaxo has unfortunately frightened other companies away from pursuing this needed vaccine. I am a consultant to most of the major vaccine manufacturers (though I have no financial interest in the development of a Lyme vaccine) and I have long been arguing for a return to this area.

Despite the manufacturers’ reluctance, scientific studies have continued and experimental vaccines against Lyme infection are available for further development. If manufacturers think there is a market for them, they will work to obtain a license from the Food and Drug Administration, but first they must be convinced that the fiasco of the first vaccine will not be repeated. Physicians and patients should write to the C.D.C. to remind them of high public demand. It is likely that a new vaccine would now be recommended for all those who work or play outdoors in the areas where Lyme-bearing ticks are common — a large part of the population of the United States.

Until then, Americans can vaccinate their dogs against Lyme disease, but have no such option for themselves.

Stanley A. Plotkin is a professor of pediatrics at the University of Pennsylvania.

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