Lyme Disease vaccine? Amid all the debate about 4-posters and culling the deer herd to try bring the incidence of tick-borne diseases under control, did anyone ever entertain the idea of addressing the burgeoning problem from a different perspective?
Turns out, the answer is yes.
It was in 1998 that SmithKline Beecham, now Glaxo SmithKline, brought LYMErix, a Lyme Disease vaccine, to the market.
But within four years, it was pulled from shelves. Because the decision to discontinue its production was based on a business, not a medical decision, Shelter Island Town Engineer John Cronin thinks it’s time for the government to revisit the possibility of bringing LYMErix back on the market.
Mr. Cronin developed Lyme disease long before it was prevalent. He had once worked at pharmaceutical company Merck and had some knowledge of how decisions are made to market or pull various drugs.
It’s why he has shared his information with Supervisor Jim Dougherty and Town Attorney Laury Dowd in the hope they can carry the message to others — particularly U.S. Senators Charles Schumer and Kirsten Gillibrand — with an eye to their introducing legislation that could enable the government to take on the cost of any litigation that might result from use of the vaccine.
It was discovered in post-licensing testing years ago that in very rare cases, people who were pre-disposed to what was called Lyme arthritis could develop it, according to a report compiled by the College of Physicians at Philadelphia.
Another threat was that the vaccine, in rare cases, could cause intussusception, a serious disorder in which part of the intestine slides into an adjacent part of the intestine, with the possibility of blocking food or fluid from passing through, according to the Mayo Clinic.
Intussusception also cuts off the blood supply to the part of the intestine affected and could lead to a tear in the bowel, infection and death of bowel tissue. While it’s more common in cases of intestinal obstruction in children younger than three, it can on rare occasions develop in adults, But in most adult cases, it results from an underlying medical condition, such as a tumor. In contrast, the cause of most cases of intussusception in children is unknown, according to the same report.
Medicinenet.com advises that side effects could include muscle or joint pain, redness at the injection site, flu-like symptoms, fever, rash, severe headache, tingling of muscles in the hands, feet and face, itching, swelling, dizziness and difficulty breathing. It warned of interactions with blood thinning medications, other vaccines and immune suppressants.
When it was prescribed in the United States, it was recommended that the first two injections be given a month apart and then a third injection 12 months later and that it be administered before exposure to areas where Lyme might be contracted
At a 2002 meeting among Lyme Disease Association members and the United States Food and Drug Administration, there were warnings that many doctors administering the vaccine were not recognizing side effects and misdiagnosing some of those symptoms related to the vaccine as other medical problems.
Several reports to the Vaccine Adverse Events Reporting System and threats from various groups fighting to ban the vaccine, the company opted to cease production rather than fight court battles.
Mr. Cronin believes the decision was based on having too few patients back then living in tick-infested areas where Lyme Disease was prevalent, so there was not enough upside to sell the vaccine and too much downside to take on the risk of being sued.
Today, when so many communities parallel the tick-infestation numbers seen on Shelter Island and so many more people are suffering from Lyme Disease, he thinks a different marketing decision might prevail.
“I recognize that it’s not going to protect against every tick-borne disease,” he said.
But with Lyme as the most prevalent of the diseases, Mr. Cronin thinks it’s time to investigate the efficacy of either getting LIMErix back on the market or releasing its ingredients to other manufacturers to test similar products.