Fw: LYME VACCINE LINKED TO AUTOIMMUNE ARTHRITIS

[Guest guest]

Whew...there's that HLA gene again...

Patty

From: ilena rose <ilena@...>

Sent: Monday, January 22, 2001 6:51 PM

Subject: LYME VACCINE LINKED TO AUTOIMMUNE ARTHRITIS

> LYME VACCINE LINKED TO AUTOIMMUNE ARTHRITIS

> By Otto in the January 200l issue of PHARMACY TODAY

>

> Kline Beechan To Defend Vaccine In Class Action Suit

>

> Concerns are growing that Kline Beecham's Lyme vaccine (LYMErix) may

> cause irreversible autoimmune arthritis in some patients. About 15% of the

> nearly 400 LYMErix adverse events reported to FDA in 1999 involved

> rheumatologic

> symptoms ranging from muscle pain and acing joints to severe arthritis.

>

> The reports suggest that a concern raised in preapproval hearings-the

> possib-

> ility that the vaccine could trigger degenerative autoimmune disease-may

not

> have been unfounded. Although patients who received the vaccine during

> trials

> were no more likely than others to develop long-term rheumatologic or

> neurologic disorders, vaccine recipients were significantly more likely to

> report arthralgia and myalgia within 30 days of administration.

>

> Kline Beecham stands by the safety of its vaccine, currently the only

> one on the market for Lyme disease. " We are aware that this debate is out

> there about this theoretical risk, " the company told PHARMACY TODAY. " But

we

> are not seeing any unusual, unexpected patterns, " she said, noting that

the

> rates of rheumatologic disease among LYMErix patients are similar to those

> in the general population. The vaccine is about 80% effective in

preventing

> Lyme

> disease and has been administered to 440,000 patients since its approval

in

> 1998.

>

> DEEP QUESTIONS ABOUT SURFACE ANTIGENS

>

> The concerns about arthritis hinge on human leukocyte antigen DR4

(HLA-DR4),

> a surface protein found on white blood cells in about 10% to 30% of the

pop-

> ulation. It is easily detected by a blood test, but the test costs $300.

>

> A class action lawsuit has been filed against Kline by scores of

> patients who developed severe arthritis after getting the vaccine. The

suit

> alleges that LYMErix triggers degenerative autoimmune disease in

> HLA-DR4-positive patients and that Kline knew of the association

before

> its vaccine was approved but failed to warn doctors.

>

> The spokesperson denies the charge. " We looked at it in our clinical

trials,

> specifically at this idea that people who tested positive for the HLA-DR4

> were more likely to develop arthritis than anyone else, and found no

> evidence

> of it " , she said. The company plans a vigorous defense of its product.

>

> But a handful of rheumatologists are already refusing to give the vaccine

to

> their patients, among them Andra Gaito, MD, president of the International

> Lyme and Associated Diseases Society. Gaito has treated 22 patients who

deve

> loped severe, crippling rheumatologic disorders following vaccination. A

> colleague of hers at Yale has treated 40 such patients.

>

> " The rheumatology community was suspicious of this vaccine to begin with, "

> Gaito said. " Before it was ever approved, there were reports published of

> autoimmune reactions in rats, mice, and other lab animals. It doesn't seem

> limited to DR4 positive patients. There is such a clear-cut problem here

> that

> this (product) needs to come off the market. "

>

> In response to such concerns, FDA recently said it would investigate all

> cases of vaccine-associated arthritis, a step that indicates heightened

> concern. The agency usually only investigates life-threatening vaccine

> complications.

>

> PREAPPROVAL TESTIMONY

>

> LYMErix was generally recommended as safe and effective for adults when

appr

> oved in 1998, but FDA panelists in preapproval hearings were concerned

> that it could trigger autoimmune reactions in HLA-DRA4-positive patients.

>

> Two HLA-DR4-positive study patients, did, in fact, develop joint pain that

> lasted for months after being immunized. FDA wondered if these cases

> pointed to a potential problem and if the clinical trials had been

powerful

> enough to

> detect one if it existed.

>

> " I am not sure that we have the answer to your question, " a Kline

> researcher told the panelists, but the agency was assured that if the

> vaccine

> " induces joint symptoms, it must be a rare phenomenon, much rarer than the

> (HLA=-DR4 trait) itself. " The idea of testing patients for the trait was

> mentioned, but dismissed as " very difficult. " Concern about HLA-DR4 status

> was deemed more academic than practical, the company researcher argued.

>

> " The concern is more than academic if this vaccine were to be delivered to

> millions of people, " a FDA panelist shot back. " We don't know for a fact

> that

> the vaccine elicited either one of these episodes of arthritis and

> paresthesias, but I think we are all worried about that. I am left with

> uncertainties about whether these two cases are in fact a signal of

> something

> that we would have seen if we had been able to follow (patients) longer.

>

>