Dogs Get Lyme Disease Too

One year after it debuted in an advertising blitz, a SmithKline Beecham vaccine designed to protect against Lyme disease is under attack, accused of making some people sick. Four residents of Pennsylvania and New Jersey filed suit yesterday in Philadelphia, alleging they have suffered severe health problems, including an incurable illness that mimics Lyme disease, as a result of taking the vaccine called Lymerix.

The suits allege that SmithKline violated state negligence and consumer laws by not warning of potential dangers. And they complain that Yale University may have had a conflict of interest in testing the vaccine because it stood to earn royalty payments from Lymerix sales.

“I would have been better off just knowing the symptoms of Lyme disease in dogs,” said Jonathan Taylor, of Unionville in Chester County, who says he has suffered severe joint pain since he took the vaccine last spring.

Taylor was among those who filed suit against SmithKline in Common Pleas Court in Philadelphia, where SmithKline's U.S. pharmaceutical business has its headquarters.

Several suits seeking medical monitoring for Lymerix recipients have been filed, including one in Chester County. But the suits filed against SmithKline yesterday are believed to be the first Lymerix personal-injury cases initiated in the country.

SmithKline introduced Lymerix last spring as the first vaccine approved by the Food and Drug Administration to protect against Lyme disease. SmithKline has distributed 1 million doses of the medication.

Lyme disease is transmitted mainly by deer ticks and creates symptoms that include fatigue, headaches and joint pain. Named after the Connecticut town where it was discovered in the 1970s, Lyme disease can be treated with antibiotics, but it can create serious medical problems, including paralysis.

The suits come at a time when SmithKline is again heavily promoting Lymerix at the beginning of the outdoor season on the East Coast, where Lyme disease is most common.

SmithKline insists that the vaccine, which was studied in 11,000 patients during clinical trials before winning FDA approval in 2005, is safe. SmithKline spokeswoman Carmel Hogan said she had not seen yesterday's suits, but was aware of allegations that the vaccine caused health problems in some people. “We will defend this vigorously,” she said. “We urge people to look to the science. This is not about opinion or hypotheses.”

The FDA has received 500 reports of patients who may have had a problem related to the vaccine, including three deaths. Of those, 45 were considered serious incidents involving hospitalization or disability.

FDA spokeswoman Lenore Gelb cautioned that the reports do not indicate a confirmed link to the vaccine. One of the three deaths, she said, was a suicide. She refused to say whether 500 incidents was significant for this kind of drug.

“We have been monitoring this closely, and we have not seen any red flags,” Gelb said.

The vaccine was controversial when it was launched with a reported $18 million barrage of consumer advertising last spring.

Lyme Disease