A Mix of Relief & Concern

A mix of relief and concern as Lyme vaccine discontinued



Hyannis physician Tratt said he feels " naked " now that the nation's only

Lyme disease vaccine has been pulled from the market.

Lynne Lane at her West Barnstable home. She says she suffered serious health

problems while taking part in Lyme vaccine trials

(Staff photo by STEVE HEASLIP)

Citing falling sales, pharmaceutical giant GlaxoKline said this week it

was discontinuing LYMErix vaccine. " It wasn't perfect, but I was hopeful we

could offer a tremendous service, " said Tratt, who conducted one of the 10

clinical trials for the vaccine from 1995-98. More than 300 people took part

in the trial.Nantucket doctor Lepore, who also conducted a trial,

said he's seen a decrease in the number of patients diagnosed with Lyme

disease since the vaccine was approved in 1998, although he did not have

statistics to support this. He said the loss of the vaccine leaves doctors

with one less weapon to fight Lyme disease.

"We're back to telling people to tuck in their pants, " he said.Nantucket has the highest

incidence of Lyme disease in the nation, with between 100 and 150 new cases reported every

year. About 30 to 40 new cases are reported on Cape Cod annually, although

the actual number in both places is thought to be much higher.While Tratt and

Lepore bemoaned the loss of the vaccine, the news was embraced by Lyme

disease-patient advocates on Cape Cod, many of whom claimed the vaccine was

flawed and caused arthritic and Lyme diseaselike symptoms in many of those

who were inoculated. " I wrote a living will, " said Lynn Lane, 45, of West

Barnstable, who claims her health deteriorated drastically after she took

part in Tratt's trial. " I was sure I was dying. " She was among a group of 17

people who testified about their problems with the vaccine at a federal Food

and Drug Administration committee hearing last year. She said she will soon

join more than 400 others who have filed legal claims against


In a recent article in the medical journal, Vaccine,

researchers from the FDA and Centers for Disease Control and Prevention

detailed the adverse reactions to LYMErix. The article states that 1.5

million doses of LYMErix were given between December 1998 and August 2000.

During that time, 950 problems, were reported.The most common problems were

muscle and joint pain, muscle weakness, headaches, rashes and fever. Four

people died within one day to seven months after receiving the vaccine,

although the deaths were not definitively linked to LYMErix.

Transmitted by ticks Lyme disease is an infection transmitted by a bite from the common deer tick.

It is caused by a spirochete called Borrelia burgdorferi that lives first in

the bloodstream. It is one of the few bacteria that can cross into body

tissues. If it manages to cross from the blood through the protective

capillary walls into the brain, it can cause neurological damage.Early

symptoms include sometimes, but not always, a bull's-eye rash around the

bite, flulike symptoms, fatigue, and aches and pain in the joints.

Coughlin, president of Cape Cod Lyme Disease Awareness, who contracted Lyme

disease in 1992, called the halt in production of the vaccine " well overdue. "

"It really wasn't the vaccine we were looking for, " he said. " We had concerns

about it from the beginning. " But Tratt and Lepore said claims the vaccine

caused health problems were never proved. Lepore said since the vaccine did

not contain live Lyme spirochetes, it is impossible to get Lyme disease from

it.Tratt said the vaccine was 70 percent effective in preventing the

disease. " The vaccine was considered to be safe and effective by the FDA and

all of the scientific panels that looked at it, " he said.For high risk

people, like landscapers who spend many hours outdoors, the vaccine was a

good tool, he said. " We live in the epicenter of Lyme disease in the world, "

Tratt said. Lyme disease is seen mainly in Eastern states from land to


Concerns raised over vaccine

LYMErix, a manufactured vaccine that does not contain live Lyme spirochetes,

is designed to stimulate production of antibodies so the body will kill the

infection at the bite site. Lane said her symptoms were more than a simple

reaction to a vaccine, like a sore arm or a slight flu. She claims the

vaccine, which was given in three doses and a one-year booster, triggered a

pre-existing case of Lyme disease, which had never been diagnosed. She

participated in the trial, along with her husband, after being concerned for

many years about Lyme disease, since the family lives in a wooded area and

has many animals. Lane said her symptoms appeared soon after receiving the

third shot. " Within two days I became very ill, " she said. At first she

thought it could be premenstrual syndrome, but as the symptoms worsened, " I

knew something was terribly wrong with me. " Rashes, anxiety, severe pain,

numbness, sensitivity to light and memory loss were some of the problems Lane

said she has experienced since that time. During one episode, her liver

showed signs of deterioration and she endured a persistent 103-degree fever.

She awoke one night in 1997 shaking so uncontrollably, her husband rushed her

to the hospital.At her bedside that night was her friend, Sullivan of

Hyannis, who later committed suicide because, her friends say, she could no

longer endure the physical and neurological problems she suffered from Lyme

disease.Lane went to Tratt, who told her symptoms were coincidental and urged

her to stay in the study. She obtained her own Lyme disease blood test,

called the Western blot test, which looks for antibodies the patient's own

body has produced to fight the Lyme disease infection. It came back positive

for Lyme disease. Her health has improved, but Lane is still on antibiotics

for the disease and she says she has not been able to work since 1997.She

said she knew the vaccine was losing advocates when she testified before the

FDA advisory committee last year. She said when one member of the group asked

the 25 doctors on the panel who would give the vaccine to their wife or

children, not one raised their hand.

'It's tough to know the benefit'

Dr. Sam Donta, an infectious disease specialist at Boston Medical Center, who

has an office in Falmouth, has been treating Lane since her diagnosis. He

said he became interested in studying Lyme disease when he lived and worked

in Connecticut in the 1980s, around the time the disease was first identified

in the town of Lyme. He said the Lyme disease research budget at the federal

government's National Institutes of Health is " pitiful. " In order to stem the

Lyme disease epidemic, he said, there must be adequate research into how the

Lyme disease bacteria causes the long-term problems, and how to treat it. " The

disease just isn't being taken seriously, " he said. " If you polled most of

the doctors on the Cape, they would belittle it. " Dr. , a family

practice physician in Mashpee, said he had concerns about the vaccine and

never recommended it to his patients. He said there was never any proof it

was effective. " It's tough to know the benefit because the people who took it

and were protected will never know, " he said.Dr. Donta doubts sluggish sales

were the primary reason for GlaxoKline's decision to pull the vaccine.

He and Coughlin speculate that the lawsuits, and FDA concerns, also played a

part. But spokeswomen from both the FDA and GlaxoKline denied that

claim. "This was not as a result of any pressure from FDA, " said an agency

spokeswoman. " It's very hard to link to any of the (reported ill effects) to

the vaccine. " Glaxo spokeswoman Ramona DuBose said hundreds of thousands of

people were vaccinated in 1998, the first year it was on the market. The

projections for this year had decreased to 10,000. " That's not enough to

sustain the product, " she said. Base costs are included for all drugs, which

make it necessary to sell a certain amount to keep the product viable, she

said.DuBose said the company does not know why the vaccine did not succeed.

Part of it, she surmised, was the difficulty asking an otherwise healthy

adult to get a series of shots against a potential disease. She said Glaxo

will continue to defend the safety of LYMErix against the lawsuits.The

company is not pursuing any other vaccine at this time, she said.Coughlin

said he hopes the future of Lyme disease research will include another safer

vaccine, as well as better diagnosis and treatment. Targeting deer, which are

a critical link in the Lyme disease bacterium's life cycle, has also begun.

Researchers are currently testing a deer feeding station where an insecticide

is triggered as they feed, dousing their heads and killing any ticks they are

carrying. Studies in Texas showed a 95 percent reduction in the number of

ticks in the research area. The device is now being tried in the Northeast.

Cape Cod Times

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