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Date: 21-May-2000 at 02:32 PM EDT
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Document Title: Article "Ticked Off" Sunday Star-Ledger 5/21/00

Don't know how to scan this newspaper article in today's Sunday Star-Ledger in as text, so will retype it here. It appears on page in the Busines Section, Section 3. The headline is "Ticked Off" and there's a small picture of SmithKline's Lymerix (stet) vaccine. The subhead reads,

"The much-hearalded vaccine against Lyme disease is now said to cause crippling side effects"

(Story is by Edward R. Silverman of the Star-Ledger staff)..

Jenny Marra wakes each morning with aching bones. The joints in her arma and legs are so stiff that her husband and (stet) often helps her out of bed. She can't do routine chores, such as shopping and cooking. And playing with her 10-year-old son is now a rarity.

These severe pains began only last year, shortly after Marra, 41, was given the new vaccine for Lyme disease. Her doctor believes it was the Lymerix vaccine that actually caused the kind of arthritic symptoms it is supposed to prevent.

"There've been times when I can't take a step, like I'm paralyzed," said Marra, a registered nurse who lives in Ocean Townehip. "I would've been better off getting Lyme. At least that can be treated. This can't. It's scary, and I don't know what the future holds."

Marra isn't alone. Dozens of people are claining they've been harmed by the vaccine, which became available last year and is made by SmithKline Beecham Plc. The big drug maker, based in Philadelphia, denies the vaccine is responsible for such side effects.

It wasn't supposed to be this way. Then Lymerix arrived, it was greeted with fanfare by countless doctors and patients in New Jersey, where there were 1,722 reported cases of Lyme disease last year, and other states where tick bites are a fact of life.

Although the vaccine is only 80 percent
Vaccine - (page 4, continued from page 1)

A groundswell of anger (sub-head)


effective, insurers quickly agreed to pay the $70 for each of three needed doses. For the first time, there appeared to be a salve to combat a notorious bacteria that claims up to 16,000 new victims each year nationwide.

Instead, the vaccine has spawned several lawsuits. Negative publicity and a groundswell of concern in the medical community have followed, matched only by a rising number of complaints and questions posted on Internet sites where Lyme is discussed.

And rather than becoming a smash for SmithKline, which not long ago touted the vaccine as a "driver of growth," Lymerix sales last year were a diappointing $40 million. That was less than a third of what Wall Street forecast originally.

"Clearly, these developments are not positive for the product," said Thomas Deschamps, an analyst at Mehta Partners, who follows the pharmaceutical industry. "The vaccine, so far, is not making the impact we expected."

Anemic sales and a need for booster shots, which isn't mentioned on the Lymerix product label, even prompted rival Aventis SA to shelve an identical vaccine in favor of developing an advanced version. A spokesman denied this reflected fears over side effects.

The controversy is also raising questions about the oversight of the Food and Drug Administration, which has been widely criticized for its handling of several recently approved medicines that were subsequently withdrawn.

Some doctors are angry the FDA approved Lymerix in the first place, given theories that a protein called OspA may produce an untreatable form of severe arthritis in people with a particular gene. (A similar-acting synthetic version of OspA is at the heart of the vaccine.)

Hotly contested theory

As it turns out, up to 30 percent of the population is believed to have this gene, known as HLA-DR4. Although this doesn't appear on the vaccine's warning label, doctors say the connection suggests a large number of people may be at risk of developing a problem.

"How else do they explain all the people who have these problems?" asked Charlene DeMarco, an infectious-diseases specialist in Egg Harbor who is Marra's physician and also a consultant to a law firm that recently filed a class-action lawsuit over the vaccine.

They have all these articles written prior to, and after, the FDA approval linking DR4 to OspA," she says. "But they're really not giving doctors the information they need. And there's no way the average doctor is going to pick up on it."

One of the studies to which DeMarco referred was conducted last year by a University of Wisconsin researcher, who found the OspA protein can cause severe arthritis in handlers. Animal studies are usually considered a harbinger of reactions in humans.

Not surprisingly, this theory is hotly contested. SmithKline maintains its clinical trials, which tested about 11,000 patients, indicated no association between the vaccine and any form of arthritis.

"A lot of these allegations that are out there may not be based in scientific fact," said Dennis Parenti, the drug maker's group director of adult vaccines. "It's not appropriate for me to speculate" on reports of side effects. "But we think the issues have already been addressed."

Lymerix works by stimulating the immune system to product antibodies to the OspA protein found on the outer surfactt of a bacterial spirochete known as B. burgdorferi, which is carried by ticks and causes Lyme disease.

The vaccine has only been approved for people between 15 and 70 years old, although SmithKline is seeking FDA approval to market the vaccine to children and a decision is expected later this year.

No red flags

So far, about 1 million doses of Lymerix have been administered nationwide. That translates into approximately 300,000 people who have been vaccinated, since each person must be given the vaccine three times over the course of a year.

An FDA spokeswoman said, "We've not seen any red flage" from side-effect reports submitted to the agency. While the FDA could take steps, the agency doesn't plan to ask SmithKline to add information about the DR4 gene to the Lymerix product label.

Privately, though, one FDA official conceded that there are concerns about the reactions. The agency is watching the progress of a four-year follow-up study SmithKline is conducting in the Northeast among about 25,000 people.

The FDA was aware of concerns over the OspA protein and the DR4 gene before the vaccine was approved. The link was discussed at the May 1998 meeting of an FDA advisory panel, which reviewed the clinical trials conducted by SmithKline to demonstrate the vaccine's safety.

"I might comment that this is fairly rare for a vaccine to be voted on with so much ambivalence by everyone with a stack of provisos," Patricia Ferrieri, a University of Minnesota medical professor who chaired the meeting, said at the time.

Still, the FDA approved Lymerix on the strength of the clinical-trial data, which found very few cases of severe side effects. About 1 percent of those vaccinated and 1 percent of those in the placebo group developed any type of arthritic response.

"I was aware of the linkages" between the portein and DR4, said Kathryn Edwards, a pediatrics professor at Vanderbilt University who was a member of the FDA's 1998 panel. "But there was no data at that time to suggest to us the vaccine shouldn't be licensed."

Since then, however, a few patients in clinical trials have filed lawsuits cliaming they developed a severe arthritic reaction. One suit was filed against SmithKline and three were filed against Pasteur Connaught, now part of Aventis, which was working on an identical vaccine.

The debate grew even murkier when the physician who headed SmtihKline's clinical trials, Tufts University professor and well-known Lyme researcher Allen Steere published a scientific paper in 1998 in which he noted the linkage was worth watching.

At the time, the findings suggested the OspA protein might provoke an autoimmune response in some people who receive the vaccine. Steere told Science, a respected journal, that "this is an issue of concern. .. Ongoing surveillance will be improtant."

After he didn't respond to telephone and e-mail messages, Steere was reached at home last week and, while saying he forwarded interview requests to SmtihKline, attempted to clarify his position about any problem with the vaccine.

"I'm not on both sides of the fence. We have no evidence that in vaccinated subjects the gene leads to difficulty, he
said. "But we recognized the limitation of a study to pick up a rare side effect. It remains a theoretical consideration."

Other factors"

Some doctors aren't so sure DR4 is the only culprit. For instance, Zelma Johnson, a minister who lives in Green Brook, last year developed severe arthritic symptoms after being given the vaccine but has since tested negative for the DR4 gene.

"I do a lot of gardening. I was worried about Lyme and took this in good faith," said Johnson, who saw the vaccine touted on television. SmithKline mounted an $18 million ad campaign last year, according to Competitive Media Reporting, which tracks ad spending.

"Now, I'm being told there's no cure, and I'm experiencing this slow progression in the deterioration of my joints," she said. "I'm taking all sorts of medication to fight this. Right now, I'm doing well. But I don't know what's going to happend to me in five years."

One thing Johnson has in common with Jenny Marra, is that neither woman had a history of arthritis or prior exposure to Lyme disease. As far as some doctors are concerned, this makes Johnson's side effects all the more baffling.

"There are a lot of unanswered questions. Are these reactions a rare event? Are they impossible to prove? Did the vaccine trigger something in the body? Did it activate or reactivate sometrhing in people who had Lyme?" said Sam Donta, a professor of infectious diseases and director of the Lyme center at the Boston University Medical Center.

"Like any drug, sometimes when you put it on the market, you're finding more things than you did in your trial," he said. "But I don't think (SmithKline) was looking for the link to DR4. I'm not ready to blow off the vaccine at this point, but I need to learn mnore about this product. I don't think all the risks are known."

Attorneys say the doubts and confusion should require SmithKline to alter its warning label to include information about the DR4 gene, as well as the need for everyone to be tested for Lyme disease prior to vaccination, even though a definitive test is lacking.

"It's not as if these people fell out of the sky with these reactions," said Stephen Sheller, a Philadelphia attorney whose firm has filed class-action lawsuits against SmithKline in Pennsylvania and, more recently, in Superior Court of New Jersey in New Brunswick.

For now, the answers will be pursued in laboratories and courtrooms. Meanwhile, Marra is coping with still more disturbing news. Her husband, Frank, 47, was also vaccinated last year and is experiencing arthritic pains. And he's just been told he has the DR4 gene.

"Had I known there was a 30 percent chance of this happening, you better believe I wouldn't have done this, and neither would he," she said. "Now, our lives are day by day. Just taking a walk hurts. And there's nothing I can do."
________ (end of article)

Note underneath

"Ed Silverman covers the drug industry and can be reached at (973) 877-1542 or esilverman@starledger.com"

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