Restrictions urged for Lyme vaccine

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Restrictions urged for Lyme vaccine

Patients complain of severe arthritis-like pain

ASSOCIATED PRESS

BETHESDA, Md., Jan. 31 - About a dozen people who believe they were severely

sickened by the Lyme disease vaccine pleaded with government scientists

Wednesday to restrict vaccine sales or at least to insist that doctors

disclose all possible side effects.

VACCINE SAFETY experts found no proof that the Lymerix vaccine is

dangerous - the rare cases of arthritis and other symptoms could be

coincidence. But they called the accusations troubling and demanded that

Americans be better informed before being inoculated.

The Food and Drug Administration has opened an unusually intense

investigation of the Lymerix complaints. Wednesday, the agency's scientific

advisers expressed frustration that vaccine manufacturer GlaxoKline has

had two years to answer lingering safety questions, but still hasn't.

There must be " some way to at least inform people of these concerns,

albeit not proven, " FDA adviser Dr. Pamela of the Chicago Department of

Public Health said.

Patients and their relatives said doctors hid possible side effects

before administering the vaccine, then often dismissed symptoms when they

appeared. One woman in the vaccine's original study charged that researchers

refused to record her symptoms, which would be a violation of federal

research rules if it occurred.

'COULDN'T PEEL A BANANA'

" Everything that's part of your day-to-day functioning is taken away

from you, " said Biegel of Blue Point, N.Y., describing her husband's

intense pain after vaccination.

" How many of you have had it? How many of you people would give it to

your loved ones? " Burk of Bethlehem, Pa., asked panelists. She said

her husband " couldn't get out of bed, ... couldn't walk, couldn't peel a

banana " after being vaccinated.

Lyme disease, spread by deer ticks in the Northeast and certain other

parts of the country, causes fatigue, fevers and joint pain that can persist

for weeks. Some patients develop severe arthritis. If untreated with

antibiotics, it also can severely damage the heart and nervous system.

Lyme sufferers begged the FDA to approve Lymerix, the world's first

Lyme vaccine, in 1998. It requires two shots given about a month apart and a

third a year later to get about 80 percent protection from Lyme disease.

The FDA has received 1,048 reports of Lymerix recipients suffering

possible side effects. GlaxoKline, which insists the vaccine is safe,

has distributed 1.4 million doses to doctors but can't say how many people

have been inoculated.

MINOR TO SEVERE COMPLAINTS

Many reports are of minor complaints or are not believed to have been

caused by the vaccine, but the FDA is studying 133 reports of severe

arthritis-like symptoms. That's because of a theory that the vaccine might

set off an autoimmune reaction where the body attacks its own tissues,

particularly in people who carry a certain gene called HLA-4.

In one safety study, 5,000 people got Lymerix and another 5,000 got

dummy shots. Two percent of people developed arthritis-like symptoms in each

group, regardless of gene status, said FDA's Dr. Ellenberg.

The FDA is investigating whether the vaccine might cause rare but

serious side effects. Ellenberg cautioned, however, that because it's 80

percent protective, " a lot of people are out there walking around healthy

because of this vaccine. "

To ensure the first study didn't miss a small but real risk,

GlaxoKline promised to study 25,000 more people after sales began.

Also, because some possible side effects mimic Lyme disease itself,

questions arose about whether it's safe to vaccinate someone with active

Lyme disease.

Yet so far, the company's study contains just 3,600 people, far too

few to answer the lingering questions, FDA's advisers complained.

While one FDA adviser suggested a moratorium on vaccinations until

safety questions are settled, the panel ultimately said no convincing

evidence exists either that the vaccine causes serious problems. Conversely,

it said, the status is too unclear to dismiss the complaints.

They urged FDA and GlaxoKline to hurry new safety studies and

demanded the government act to ensure patients are told about possible risks

before inoculation. Among those steps, they urged that the Centers for

Disease Control and Prevention aggressively distribute a patient-friendly

safety fact sheet about Lymerix.

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