Treatment For Lyme Disease

Some doctors worried that patients would demand vaccine of Lyme disease even if they had a very low chance of getting the disease. Others feared that vaccinated people would gain a false sense of security and let their guard down against ticks. The vaccine, which requires three initial shots and boosters every other year, is 78 percent effective.

Taylor, 39, a self-employed computer consultant, received the vaccine last year while he was working as an independent contractor at SmithKline's King of Prussia research campus.

He said he saw signs in the building urging employees to be vaccinated through a special on-site program. He said he paid more than $100 for the first two shots because he was moving from Delaware to a wooded lot in Unionville, a community where there had been cases of Lyme disease.

“At that point, I thought it was going to be a real good idea. As a consultant, I cannot afford to be sick,” Taylor said.

Immediately after receiving the vaccine, Taylor said he suffered severe, flulike symptoms, that kept him out of work for weeks. He said he went to a doctor in Delaware, who suspected Lyme disease and treated him with antibiotics. His condition has improved, Taylor said, but he still has pain in his hands and knees that is sometimes so severe he cannot work.

A major allegation in the suits is that individuals of a certain genetic type, known as HLA-DR4+, are susceptible to developing an incurable form of arthritis if they are exposed to the protein that makes the vaccine work.

About 30 percent of the population, including Taylor, is HLA-DR4+, the suits claim. SmithKline said researchers at Yale University raised the possibility of this connection years ago.

Dr. Dennis Parenti, SmithKline's group director for adult vaccines, said several hundred patients who are HLA-DR4+ were tested in the first and second phases of the three-part clinical trial. No problems were reported, Parenti said.

Dr. Alan Kelsey, a physician in Whitehouse Station, N.J., was involved in the clinical trials and has administered Lymerix to 800 patients. He said he has noticed no problems with the vaccine.

“That's why this whole hullabaloo has amazed me,” Kelsey said. “I haven't seen anything that concerns me.”

The lawsuits against SmithKline also point to a potential conflict of interest with Yale University, where researchers first developed the vaccine and then sold the rights to SmithKline in return for royalty payments. Yale and SmithKline have refused to disclose the terms of the agreement.

The suits claim that Yale should not have been one of the testing sites. They also allege that another Yale-related entity stood to gain from approval of the vaccine because it markets a test that can tell the difference between an individual who has Lyme disease and one who has received Lymerix. People who have taken the vaccine test positive for Lyme disease with standard Lyme tests.

Tom Conroy, a spokesman for Yale, said the university has a comprehensive policy on conflicts of interest and disclosure to safeguard against bias.

Taylor said he finds it strange to be suing SmithKline because he has earned much of his living as a consultant for pharmaceutical companies.

“I don't know what's in it for me. I just wanted more information,” he said. “If there's any question about people's health and they're continuing to inject people, that's wrong.”

Lyme Disease