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Fear factor doomed Lymerix

When safety protests failed, angry patients targeted sales

Sunday, March 03, 2002

BY ED SILVERMANs
Star-Ledger Staff

For the past three years, Pat Smith has been the ultimate squeaky wheel.

As head of the Lyme Disease Association, a consumer advocacy group based in Jackson, Smith was one of the earliest critics of Lymerix, the vaccine discontinued this week by GlaxoSmithKline Plc.

Her tactics were both old-fashioned and high-tech. Members of Congress were lobbied. Lawsuits were filed. Internet chat rooms were used to share experiences. And the media was courted to generate negative publicity for the vaccine.

Even so, three years of screaming that Lymerix caused severe side effects didn't convince the Food and Drug Administration. And when Glaxo yanked Lymerix, the drug maker cited only declining sales. Safety, the company said, wasn't an issue.

And that is what makes the Lymerix saga unusual.

Safety has almost always been cited when other medicines were recalled. Now, questions are being raised about whether patients should take matters into their own hands and make so much noise that continued marketing is pointless.

"We needed somebody to protect the little guy, but that didn't happen here," said Smith, who complained the FDA repeatedly delayed meeting with her group to review concerns that Lymerix caused severe arthritic side effects.

"It took a lot of intense political pressure from patient groups to reach this point. I don't think the FDA really wanted to examine the issue."

Patient advocates aren't the only ones who believe this. Some doctors agree.

"Something wasn't right with this vaccine, but people had to take things into their own hands," said Andrea Gaito, a Basking Ridge rheumatologist. "From now on, patients may have to do investigations of their own and get more opinions if they suspect a problem."

VACCINE HAS SUPPORTERS

Others, though, contend the debate over Lymerix was misguided.

And as a result, a medicine that may have been helpful for many people was forced off the market because a small but highly vocal group was effective in scaring others.

An FDA spokeswoman, Lenore Gelb, noted clinical-trial data supported continued use. Originally compiled by SmithKline, a big drug maker since bought by Glaxo, the data did not indicate Lymerix was likely to cause severe arthritic side effects.

She also noted the agency early last year convened a special advisory panel meeting to review safety concerns. And as part of the proceedings, more than two dozen patients were allowed to testify about side effects allegedly caused by Lymerix.

"We're not issuing any (public statement) because the withdrawal had nothing to do with safety concerns," Gelb said. "What the company did was its own decision. All we're doing is what we were already doing -- analyzing and collecting adverse events."

Recently, the Centers for Disease Control and Prevention scrutinized 905 adverse events, or reported side effects, but found no unusual pattern to suggest Lymerix caused severe arthritis. To some doctors, this indicated a need for more scrutiny, not a withdrawal.

"I think the public lost a useful product," said Paul Offit, chief of infectious diseases at Children's Hospital in Philadelphia and a member of the CDC's advisory panel on immunization practices. "On some level, it was death of a vaccine from fear."

In discussing the removal, a Glaxo spokeswoman earlier this week said "insufficient demand" was to blame. She declined to provide sales figures other than to say sales during the vaccine's first year on the market -- 1999 -- were $40 million.

In addition to removing Lymerix, Glaxo also has ended plans to seek FDA approval to market a pediatric version of the vaccine. And further research into Lyme disease has been put on a shelf, at least for now.

TROUBLED HISTORY

From the start, Lymerix raised questions.

The vaccine was only 80 percent effective, but it was a one-of-a-kind product. As a result, Lymerix was hailed as a breakthrough in combating a notorious bacteria that claims up to 16,000 victims each year.

Given the ongoing controversy over detecting and treating Lyme disease, SmithKline was confident Lymerix would become a big seller. At the time it became available three years ago, the company went so far as to label the product as "growth driver."

But side-effect reports began to trickle in. Patients swapped experiences on the Internet. Questions were raised about the vaccine's underlying science. Lawsuits were filed against the manufacturer. At that point, national news stories followed.

The controversy turned on the science.

A protein called OspA, which was used to make Lymerix, may also produce an untreatable form of severe arthritis in people with a particular gene. The catch: up to 30 percent of the population has the gene.

The issue was discussed at an FDA panel meeting prior to the vaccine's approval. But since clinical-trial data didn't suggest a safety issue, the panel members reluctantly recommended the agency endorse Lymerix.

Given that some 350 lawsuits were subsequently filed, consumer advocates were emboldened to demand further investigation. One group claimed to have found evidence that side effects weren't recorded properly in the company's clinical trials.

Glaxo, meanwhile, was laboring to conduct a follow-up study to examine safety issues. But at last year's FDA meeting, the company was chastised for not moving fast enough. Some experts later said the adverse publicity made it difficult to enroll patients.

In the absence of any further action, Smith's group and others, such as the Lyme Disease Foundation, which is based in Hartford, Conn., became even more aggressive. They contacted members of Congress to demand investigations.

By this past winter, though, the future for Lymerix looked dim. Stung by the controversy, Glaxo quietly removed any mention of the vaccine from its Web site months earlier. And ongoing news accounts seemed to discourage others from being vaccinated.

"It's all very complicated. I believe it was effective, but whether it caused these problems is unclear," said Arthur Weinstein, head of rheumatology at Washington Hospital Center. "In the end, though, I do believe the public outcry played a role in its removal."

Ed Silverman can be reached at esilverman@starledger.com or (973) 392-1542.

Copyright 2002 The Star-Ledger. Used by NJ.com with permission.

ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE.  THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.