As Massachusetts scientists get ready to test a new anti-Lyme disease shot, they are nervously hoping to avoid the kind of public relations disaster that doomed a Lyme disease vaccine developed from Yale University research in the 1990s.
The approach being tried at the University of Massachusetts Medical School would involve a single injection that could “prevent you from acquiring Lyme disease before you are even exposed,” said Dr. Mark S. Klempner, head of the MassBiologics team working on the project.
Klempner said this new concept resulted from the same Yale studies that enabled development of a Lyme disease vaccine, a drug that was withdrawn from the market in 2002 after lawsuits, allegations of serious side effects and reams of negative media reports.
“We’ve tried to address some of those concerns,” Klempner said of the problems encountered by the Lymerix vaccine, which the Centers for Disease Control and Prevention estimated to be 80 percent effective against Lyme disease. “We think our stuff is better,” Klempner said.
An effective anti-Lyme Disease medicine could be a major benefit for people in Connecticut, where the illness was first named, and across the nation. Lyme disease is considered the most widespread disease transmitted by insects in the U.S., and 2017 has been a boom year for the tick populations that spread Lyme disease.
The CDC estimates that about 300,000 new cases of tick-borne disease are reported annually in the country. In Connecticut, more than 1,750 confirmed or probable cases of Lyme disease were reported to state health officials last year.
The medicine that MassBiologics doctors are getting ready for initial human testing would use a specific human antibody that could “prevent the transmission of [Lyme disease bacteria] from the tick to humans,” Klempner said. A single shot could cost up to $200 and would protect an individual for up to six months, according to Klempner.
Using a single human antibody in a pre-exposure injection is different from a vaccine, which can produce multiple types of reactions in some people. The antibody approach would have virtually no side effects, Klempner said: “The complications are virtually zero.”
The CDC has made available a video from a conference titled, “Vaccines for Lyme Disease: Past, Present and Future.” The scientists involved noted that this case was the first time that a vaccine licensed by the Food and Drug Administration had been “withdrawn because of low public demand and class-action lawsuits.”
CDC researchers concluded the vaccine was 80 percent effective, and the agency’s video labeled the Lyme disease drug “a scientific success but a public relations fiasco.”
Another study published in 2006 in the scientific journal “Epidemiology and Infection” concluded the withdrawal of the vaccine was “a loss of a powerful tool for Lyme disease prevention.”
The introduction of Lymerix by its maker, SmithKline Beecham Pharmaceuticals of Philadelphia (now GlaxoSmithKline), was followed by complaints from a relatively small number of patients that they experienced symptoms of chronic arthritis after taking the vaccine.
Although reviews by the CDC and the FDA determined the drug met all federal safety standards, a $1.4 billion class-action suit was filed against the pharmaceutical company and there were widespread media stories about the controversy. The lawsuit was finally settled with the withdrawal of the vaccine and a payment of $1 million paid to the plaintiffs, although the plaintiffs in the case got none of the money.
Company officials insisted that the controversies surrounding the medicine were not the trigger for the decision to withdraw it from the marketplace. Instead, the company blamed low demand for the drug, which saw its use plunge from hundreds of thousands of vaccinations during the first year of its use to a projected 10,000 in 2002.
“It was all bogus,” Durland Fish, professor emeritus at the Yale School of Public Health specializing in vector-borne pathogens like Lyme disease, said of the furor surrounding Lymerix. He said pharmaceutical companies “are still afraid – nobody will touch it, and nobody else will develop a Lyme disease vaccine.
“The opposition to the Lyme disease vaccine was totally irrational.”
Fish said the antibody approach “is another way around the vaccine issue.”
Klempner is familiar with the problems encountered by the Lymerix vaccine. He said those difficulties extended beyond “bad press” and claims about adverse side effects that were proven false.
According to Klempner, the CDC gave the vaccine a “very lukewarm recommendation,” and was subsequently “highly criticized for that decision” by many in the medical community. The drug company’s campaign to educate doctors about the new vaccine was “by many accounts not very strong,” Klempner said.
The advantages of the single human antibody approach is that only one annual shot would be required, as compared to the three shots-per-year for the Lymerix vaccine, Klempner said. The single antibody would make the patient immediately immune even if bitten by an infected tick by blocking the bacteria from ever leaving the tick’s body, he said.
Klempner said his unit is now looking for about $3.2 million in new funding to pay for the first round of human tests, which he said could begin as early as next spring. Additional testing and federal reviews would be necessary, Klempner said, and that his own very optimistic estimate for making the drug available to the public would be sometime in 2020, assuming the testing and approvals to well.
“This is really a new approach to preventing Lyme disease,” said Fish.
“It looks pretty good,” Fish said, adding he is worried that the MassBiologics medicine could run into the same sort of problems that plagued Lymerix. Fish said he was not involved in the original research at Yale that led to development of the vaccine.
“It’s tragic,” Fish said of the combination of issues that eventually doomed Lymerix. “It should never have happened, but it did.”
Lymerix has become a byword in medical research circles for how not to market a vaccine, and the topic of multiple studies about what went wrong.
“We’re trying to make it no more costly than the vaccine was,” Klempner said, which was about $200 for the course of the vaccinations. He said MassBiologics is a “nonprofit organization … dedicated to affordable public health medicines.
“We are committed to keeping it at an affordable price point.”
Dr. Virginia Bieluch, chief of infectious diseases at the Hospital of Central Connecticut in New Britain, also called the Massachusetts research “an interesting approach.”
But she said that she “can see cost as being a potential issue,” since the shot would only last for a single tick season.
Bieluch also cautioned that the single human antibody approach wouldn’t provide protection against any of the other emerging tick-borne diseases. Connecticut public health officials reported that in 2015 – the latest annual results available – there were 286 cases of babesiosis and 120 cases of granulocytic anaplasmosis in this state.
Both diseases can cause major health problems. Bieluch said babesiosis is “potentially fatal” for vulnerable populations such as the elderly.
“I think babesiosis will someday eclipse Lyme disease as the most significant tick-borne disease,” Fish said.
But until that happens, most people will likely be looking for more effective protection against Lyme disease.
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