No Red Flags-- Ellenberg, Dir of Epidemiology, FDA CBER

[Guest guest]

Newark NJ Star Ledger 12/19/00:

" FDA plans meeting to review safety of Lyme vaccine "

http://www.nj.com/business/ledger/index.ssf?/business/ledger/11cceff.htm

12/19/00

BY ED SILVERMAN

STAR-LEDGER STAFF

After more than a year of controversy, the Food and Drug

Administration will hold a special meeting next month to

review the safety of the Lyme disease vaccine, which some

doctors and consumers believe causes a severe arthritic

side effect.

The Jan. 31 session will be the first such hearing since

Lymerix was approved two years ago by regulators amid a

growing clamor for a treatment for Lyme disease, which

claims up to 16,000 new victims each year nationwide.

The meeting also comes after FDA investigators recently

expanded their routine review of Lymerix side effect reports

to include any side effect that simply mentions arthritis or

similar maladies.

An FDA spokeswoman declined to comment on the

specifics of the meeting or any possible outcomes, while a

spokeswoman for Kline Beecham, the British drug

maker that is about to merge with Glaxo Wellcome plc,

maintained Lymerix is safe.

" We're not seeing any unexpected adverse events coming

through, " said Carmel Hogan, the Kline

spokeswoman. " But we see this very much as an

opportunity to put our data out in the public domain. "

The controversy hinges on theories that a protein contained

in the vaccine may produce an untreatable form of severe

arthritis in people with a particular gene, known as

HLA-DR4. About 30 percent of the population is believed to

have this gene.

So far, more than 440,000 people have been vaccinated

with Lymerix. Several dozen people since have claimed

they developed severe arthritis-like symptoms and,

subsequently, some tested positive for the HLA-DR4 gene.

Through July, the FDA tabulated 774 adverse events,

including 77 reports that specifically mentioned some form

of arthritis. For its part, Kline, which is seeking

regulatory approval to market a children's version, is

conducting a follow-up safety study.

" But here you have healthy, young people getting the

vaccine and then getting sick, " said Charlene DeMarco, a

physician and an emerging-diseases specialist in Egg

Harbor. " It's impossible that the vaccine didn't have

anything to do with those reactions. "

DeMarco and others want a moratorium, especially since

Lymerix packaging information doesn't mention

hypothetical genetic links -- information that was given

patients in clinical trials run by Yale University just weeks

before the FDA approved the vaccine.

" This meeting is a case of better late that never, " said

Sheller, a Philadelphia attorney who has filed

numerous lawsuits on behalf people who claim they were

harmed by Lymerix. " But people need to know about

adverse events not mentioned on the label. "

In a recent interview, Ellenberg, director of

biostatistics and epidemiology at the FDA, said: " We're

not seeing a red flag . . . So far, there's nothing that tells

us we have evidence these (side effect) cases are caused

by the vaccine. "

Ed Silverman covers the drug industry and can be reached

at Ellenberg, FDA's CBER Director of Epidemiology