Fw: Concerns Grow Over Reactions to Lyme Shots

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> http://www.nytimes.com/2000/11/21/science/21LYME.html

>

> NY Times, Science section November 21, 2000

>

> Concerns Grow Over Reactions to Lyme Shots By HOLCOMB B. NOBLE

>

> Federal health authorities are investigating whether some people who

> received the vaccine against Lyme disease later developed severe cases of

> arthritis and even Lyme disease itself as a result.

>

> The Food and Drug Administration has received reports of such problems,

> mainly from doctors and researchers in the Northeast. The vaccine, made by

> Kline Beecham Biologicals, a subsidiary of the British pharmaceutical

> giant Kline Beecham, was approved by the drug agency two years ago,

> and about 440,000 Americans have received it. Kline Beecham defends

> it as safe. ...

>

> Dr. Orenstein likened the new investigations to those begun in the fall of

> 1998 after the licensing of the rotavirus vaccine against childhood

> gastroenteritis. Within six months, doctors reported 15 cases of

> intestinal blockages among vaccinated infants; though the number of cases

> was small, the rate was so much higher than normal that the drug and

> disease-control agencies declared a moratorium on the vaccine's use while

> the investigation continued. In October 1999, 98 cases cases had been

> reported and the manufacturer, American Home Products of Madison, N.J.,

> withdrew the vaccine from the market, Dr. Orenstein said.

>

> Some doctors say the drug agency should never have approved the Lyme

> vaccine or should have responded more quickly to adverse reports. Dr.

> Gaito, a New Jersey rheumatologist and president of the

> International Lyme and Associated Disorders Society, said she had told the

> agency that 21 patients developed severe arthritis soon after being given

> the vaccine by other doctors.

>

> Dr. Gaito, who does not give the vaccine, said she believed that the

> vaccine caused arthritis and Lyme disease itself but that the problems

> were not always linked to it because the vaccine took effect only after

> three immunization shots given over the course of a year. " The F.D.A. had

> just better withdraw this vaccine now, " Dr. Gaito said.

>

> Dr. Charlene C. Demarco of Egg Harbor, N.J., an internist and family

> doctor, said 50 of her patients had developed autoimmune arthritis after

> receiving Lyme vaccine from other doctors and 30 others appeared to have

> flare-ups of previous Lyme infections.

>

> Dr. Demarco said the agency had not moved quickly enough after initial

> reports of adverse effects.

>

> Dr. Ellenberg conceded that the drug agency had at times acted too

> slowly. " We wish that some of these cases had been brought to our

> attention sooner, " she said. " They should have been given a higher

> priority. " She said " we have made that clear " to the unit that takes in

> the reports and records the medical data.

>

>