Controversy over defunct Lyme vaccine continues

The LYMErix vaccine was pulled from the market more than a decade ago, but disputes still simmer. Here are three views of its demise.

Stephen A. Sheller of Sheller P.C., Philadelphia:

Dr. Stanley Plotkin is correct in saying that the world needs a Lyme disease vaccine, but an Inquirer article (Oct. 27) misled readers about why a past Lyme vaccine was taken off the market.

The story characterizes the demise of [Glaxo SmithKline's] LYMErix vaccine as the result of "negative media coverage, poor marketing, and tepid endorsement by federal officials." It also states that while the drugmaker paid legal fees to several law firms, including my own, the claimants received no restitution. That is far from the whole story. I know because I litigated the case, and hundreds of victims later got significant compensation.

LYMErix failed because it fell far short of providing universal immunity from Lyme disease. It was rushed to market without adequate testing, and caused hundreds of serious injuries. We initiated litigation with the sole goal of removing a dangerous product from the market, or, to insure that its label reflected its side effects. We achieved this in 2002 when LYMErix was voluntarily withdrawn.

The fees we received from that were far less than the $1 million implied by the story. The court-approved fees were paid to a New York law firm, not mine, and divided among several firms. But the lawsuit also let LYMErix victims pursue their individual claims without limitation. We later got substantial recoveries for many terribly injured clients.

When the story states there is "no indication" of any long-term adverse reactions, that is wrong. Many LYMErix users developed debilitating neurological symptoms, such as chronic arthritis, Bell's palsy and CIDP, a devastating immune condition. Baxter has begun trials in Europe for its new bioengineered Lyme vaccine. This type of science can be applied too early, causing devastating problems.

Dr. Stanley Plotkin, emeritus professor of pediatrics, Univ. of Pennsylvania:

Plotkin, creator of the rubella vaccine, was medical science director for Pasteur-Merieux-Connaught, now Sanofi Pasteur, whose Lyme disease vaccine was never sold.

LYMErix's maker took it off the market because of poor sales, due to weak guidance to doctors and misinformation spread among the public.

Two firms had made Lyme vaccines based on the same protein. Before licensure, they were tested in 20,000 people, including 10,000 control subjects who received harmless substances and whose clinical reactions were compared with the vaccinees. Aside from transitory mild symptoms, there were no differences between vaccinees and controls.

Of course, as the tests were done in adults, some later became ill, but there was no difference between those vaccinated and those not. Later, retrospective analyses were made by FDA and CDC after 1.4 million doses had been given. Those analyses, also published, concluded that severe or autoimmune reactions were no more common in vaccinees than in any group of adults. Also, people genetically susceptible to developing arthritis after Lyme infection were not more likely to develop arthritis after vaccination. Other studies, including one by the discoverer of Lyme disease, also found that autoimmune disease and arthritis were not caused by the vaccine.

Since the vaccine was pulled, hundreds of thousands of people have suffered Lyme disease. I hope the development of a new Lyme vaccine will not be impeded by legal attack.

GSK spokeswoman Anna Padula:

GSK voluntarily discontinued LYMErix based on commercial considerations. We stand behind the science of the product and believe the allegations made were without scientific basis.