ABC News- Controversy

NEW YORK, May 17 - Edward James Schneider, an avid gardener, only wanted to help his fellow hobbyists.

In the spring of 1995, Schneider, 60, of Poughkeepsie, N.Y., agreed to participate in the city's Health Department testing of a vaccine against Lyme disease, an illness that commonly afflicts people who spend a lot of time outside in wooded areas. His doctor said the vaccine carried little or no risk.

But six weeks after he received his second shot of LYMErix, licensed by Yale University and produced by drug giant SmithKline Beecham, headquartered in Philadelphia, Pa., Schneider lay paralyzed on his bedroom floor, desperately in need of help himself.

"I would just like to know what the heck I have because I have always been very healthy," says Schneider, who experienced, "fever and an intense, hellish pain," that day and for six weeks after. He continues to suffer from arthritis, numbness and widespread tingling.

Schneider is one of more than 70 plaintiffs in Karen Cassidy et al. vs. SmithKline Beecham, a Pennsylvania class action suit alleging SmithKline Beecham failed to warn doctors and the public that nearly a third of the general population is genetically predisposed to a non-treatable degenerative disease - known as autoimmune arthritis - triggered by the vaccine.

While the drugmaker and the Food and Drug Administration allege the vaccine does not present enough adverse effects to "raise a red flag," evidence to the contrary is mounting.

Difficult to Diagnose

Lyme disease, an inflammatory infection caused by B. Burgdorferi bacteria that live in deer ticks, was recognized and named in 1975 in Lyme, Conn. Since then, the disease has appeared in 47 states. It usually occurs in the summer and early fall after bacteria from deer ticks, which bite humans, enter the skin and spread through the blood to organs and other skin sites, causing inflammation, fatigue, chills and fever.

Lyme disease is often difficult to diagnose because its symptoms are similar to those of arthritis, influenza and mononucleosis. According to the Centers for Disease Control more than 139,000 cases of the disease have been reported since the agency began monitoring it in 1992.

LYMErix is the first Lyme disease vaccine approved by the FDA. Since its launch in January, 1999, SmithKline Beecham says more than 1 million doses of LYMErix have been distributed to health departments, hospitals, doctors and clinics, though the company has no record of how many of those doses have been administered or how many people have actually been vaccinated.

The key ingredient in LYMErix is a genetically engineered protein from the surface of the bacteria B. Burgdorferi that helps stimulate an immune response against the bacteria. The protein, called OspA, stimulates antibodies that disable B. burgdorferi bacteria's ability to infect people.

Protein Triggers Genetic Marker

Originally hailed as protection from the debilitating Lyme disease, some doctors are now saying LYMErix may do more harm than good in some people because of the OspA protein.

According to a report from Quest Diagnostics, a major lab in Horsham, Pa., about 30 percent of the general population is a genetic type called HLA-DR4+. Dr. Christine DeMarco, a member of the New Jersey Governor's Council on Lyme Disease, says OspA triggers autoimmune arthritis in individuals with this genetic marker.

"SmithKline has made no effort to make doctors aware of this," DeMarco says. Because of the prohibitive cost of testing for HLA-DR4+ - about $300.00 - she claims the drug company does not tell physicians of the preventable risk patients take when choosing to be vaccinated.

According to DeMarco, patients who live in Lyme areas now know what to do to prevent the disease, such as wearing protective clothing and checking for ticks. "Even at late stages, though, Lyme can be treated, while autoimmune arthritis cannot."

"Several people have become disabled and will continue to degenerate," says Steven Sheller of Philadelphia,, the lawyer in the class action suit against SmithKline Beecham. "These are outdoor people, healthy people. So we are taking people amongst our healthiest population and putting them at risk."

Drugmaker Denies Claims

While the drug maker says it cannot comment on specific cases, SmithKline spokeswoman Carmel Hogan did remark: "A pivotal efficacy trial for LYMErix was conducted and the data was presented to a data safety board. The board found no evidence of an association between LYMErix and autoimmune arthritis. In addition, we as a company are not aware of any other human data that established a causal connection between LYMErix and autoimmune arthritis."

FDA spokeswoman Lenore Gelb agreed, saying, "We have been monitoring adverse events and we don't see any red flags." To date 274 cases of adverse effects have been reported to the FDA. But, according to Dr. DeMarco, many cases - like Schneider's - may go unreported because doctors do not make the connection between the vaccine and patients' symptoms.

The Health Commissioner for Duchess County, N.Y., Dr. Michael Caldwell also says the allegations against the vaccine are unfounded. Caldwell is also a practicing physician in an area where Lyme disease is prevalent.

"My feeling is that if that hypothesis [HLA-DR4+] was true we would have found evidence of it. As a public health preventive measure, I feel comfortable with it [the vaccine]," said Caldwell, who was also one of the principal investigators of the original Lyme disease vaccine study and subsequent follow-ups.

Health Department Policies

Claire Pospisil, a New York State Health Department spokeswoman, says her department currently recommends the vaccine for people who are between 15 and 70 years of age who have high risk of acquiring Lyme disease.

Kristine Smith, another New York State Department spokeswoman, says department officials were aware of the "theoretical concerns surrounding OspA and the development of treatment-resistant arthritis...[and] considered these very issues before proceeding with our vaccination program for those employees considered to be at high risk for Lyme disease."

The New Jersey Health Department agrees with the CDC recommendation that the vaccine is a viable option for those living in Lyme-prone areas.

For the moment, Cassidy vs. SmithKline Beecham is on hold while the company answers the complaint and looks at data Sheller has compiled. Meanwhile, Sheller says two or three new people a day call each day to inquire about joining the suit.

As summer heats up and more and more people head for the woods, LYMErix vaccinations may be popular. For those thinking about getting the vaccine, Pospisil advises you consider your lifestyle. "If you are not a landscaper it may not be worth it."

Patient For a Lifetime

A hospice nurse from Ocean, N.J., Jenny Marra, 41, has experience with doctors. But the past year has been different.

In May 1999, Marra received her first dose of the SmithKline Beecham Lyme disease vaccine LYMErix. She immediately experienced severe flu symptoms, but was told her reaction was common. After her second injection, her elbows began to ache. The pain spread down her arms and throughout her body, until by November she could barely clasp a carton of milk, she said.

Diagnosed with chronic fatigue, depression and fibromyalgia, doctors eventually suggested the inflamed joints, aching muscles and accompanying pain Marra was experiencing might just be job stress - or her imagination. But Marra, who says she loves her job, knew that could not be true.

Serendipitously, in November she ran across a small magazine blurb about the Pennsylvania lawsuit Cassidy et al. v. SmithKline Beecham. Her symptoms matched the plaintiffs' allegations, so she researched the vaccine and discovered a network of vaccinees experiencing the same pain.

Since then, she has been diagnosed with autoimmune arthritis, an untreatable, disabling form of arthritis. Marra, like 30 percent of the general population, is of a genetic type called HLA-DR4+. Some experts say a key ingredient in LYMErix triggers autoimmune arthritis in such individuals.

Now, as Marra - who cut down her work hours and changed her lifestyle - looks ahead at a lifetime of being a patient, she says she will fight the drugmaker until the public is educated about LYMErix and the alleged avoidable risks involved in taking it.

"I want funding for research. They have to tell people," Marra says. "As a nurse, I have always been a patient advocate and I won't back down now."