The Gathering Storm: The Fda Meets
With lawsuits pending and questions from the public and the media, and facing an increasingly complex and explosive situation, the FDA reconvened its advisory panel on 31 January 2001 to discuss the future of the Lyme vaccine. The participants included the FDA scientific advisors, the LYMErix manufacturer, independent experts, practising physicians, the vaccine victims and their lawyers.
This panel, described by one participant as raucous and riotous , provided a forum for all of the stakeholders . In support of the vaccine, the FDA summarized the VAERS data and concluded that the evidence did not support a causative association. The vaccine manufacturer, now GlaxoSmithKline following a corporate merger, assured the assembled parties that the LYMErix vaccine did not cause harm to its recipients. They reviewed the status of their phase IV post-marketing surveillance. Practising physicians spoke of vaccine efficacy by describing the dramatic reduction in Lyme disease cases in their own practices.
Others raised concerns about the vaccine’s safety. Scientists argued a potential role for genetic susceptibility and OspA-related autoimmunity in vaccine complications. Poignant presentations by several vaccine victims described in detail their suffering. The prosecuting lawyers for the largest class action suit claimed that manufacturers suppressed reports of adverse events from the licensing trial and provided inadequate warnings to genetically susceptible individuals.
Suits Say Lyme Vaccine Caused Severe Arthritis
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Three patients sued the maker of the new Lyme disease vaccine yesterday, contending that it had given them a severe form of arthritis.
The lawsuits are the first to be filed individually by members of a group that brought a class-action suit last winter against the manufacturer, SmithKline Beecham, asking that it expand its vaccine labeling. The class-action suit seeks to have the labels include the concerns of some scientists that a new form of so-called autoimmune arthritis — in which the body’s immune system begins to attack its own tissue — could be triggered by the vaccine, which has been on the market since December 1998.
Stephen A. Sheller, of Sheller, Ludwig & Badey of Philadelphia, the firm that filed both the suits by individuals who seek personal damages and the class-action suit, said a fourth patient has also filed a suit in the Philadelphia Court of Common Pleas, charging that the vaccine caused a resurgence of his apparently dormant Lyme disease. Mr. Sheller said the firm was also reviewing the complaints of more than 100 other patients.
SmithKline Beechham said it had not seen the suits and could not comment but defended the safety of the vaccine. And Food and Drug Administration officials stood by their decision to approve the vaccine.
A Yale spokesman, Thomas P. Conroy, said the university had not seen the complaint, and that it was not aware of any conflicts of interest in its research on the vaccine.
Risk Communication And Policy Implications
Risk communication represents the process of informing individual and collective decision-making by describing benefits as well as risks. As illustrated by the case of Lyme vaccine, the issues involved often become very complex and require an in-depth understanding to accurately access risk. However, the public attention span is typically short. The media often serve as the only channel through which the general public obtains its health information.
In the aftermath of the LYMErix market withdrawal, we must look for lessons learned. The vaccine developers believed they developed a safe and effective vaccine to prevent the most common tick-borne infection in the United States. Even available post-market surveillance failed to demonstrate convincing harm from the LYMErix vaccine. After review of available data, the FDA found insufficient evidence to support a causal relationship between the reported adverse effects and the vaccine and continued to permit use of the vaccine. However, the public’s perception of potential risks, heavily influenced by the negative press coverage and limited awareness of the benefits of the vaccine, decreased consumer demand for the vaccine.
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The Lyme Vaccine That Wasnt
Its a kind of horrifying story, actually, says The New Yorkers Sue Halpern.
It turns out that we cant talk about a future vaccine for Lyme until we talk about one that used to be available.
There was a Lyme disease vaccine about 20 years ago, Sue says, made by a company called SmithKline Beecham.
It was called LYMErix. Youd get a series of three shots over the course of a year, and eventually your body would be able to make antibodies that would kill Borrelia burgdorferi. Not when it was inside your body, but before the tick even transferred it to you.
So the tick attaches to you and starts feeding off of you, says René Najera, from the History of Vaccines Project. And the antibodies attack the bacteria in the tick’s gut and begin destroying it there before it even gets into you.
LYMErix was almost 80 percent effective at preventing Lyme disease. It first became available in 1998. When we announced Roberts question, some of you pointed this out that weve had a Lyme vaccine before. But I had literally never heard of LYMErix. Maybe because I was in elementary school in the 90s, and it wasnt available for kids to take. But about 1.5 million doses were sold for adults.
Jack McCullough, of Montpelier, got two doses of LYMErix. He and his family used to vacation on Marthas Vineyard, which was, and still is, a Lyme hot spot.
Top Veterinarians Say A Blizzard Of Lawsuits May Be The Way To Protect Dogs From Over
You may be a party to a potential class action lawsuit arising from the misrepresentation of the need for these pet vaccinations. If, within the last four years, you have paid for any of the following pet vaccinations without receiving adequate disclosure, you may have a claim for damages. The vaccines include the following:
1) Annual vaccination for canine distemper, parvovirus, and feline distemper, rhinotracheitis, calcivirus
2) Corona virus vaccination.
3) Leptospirosis or Lyme disease vaccination
4) Feline Aids vaccine, Feline Infectious Peritonitis vaccine, or Giardia vaccine
If you have paid for any of the above vaccinations in the last four years and would like information concerning your rights, please send an email to:
Se Habla Espanol
Critter Fixer Pet Hospital, Bob Rogers DVM, 5703 Louetta Spring, TX 77379
Every year over 30 thousand dogs and cats in the U.S. die from adverse reactions from unnecessary vaccines. It has been ten years since the article first appeared in the Journal of the American Veterinary Medical Association entitled Are We Vaccinating Too Much? in which and Dr Ron Schultz stated, Clients are paying for something with no effect except the risk of an adverse reaction.
We need your help. I feel that a class action lawsuit is the only way pet owners can get fair and ethical treatment for our loved ones.
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What Is Lyme Disease
Lyme disease is the most common vector-borne disease. It is caused by Borrelia burgdorferi, a spirochete carried by backlogged and deer ticks. When an infected tick bites a human, the bacteria will travel into the bloodstream if untreated. Ticks are born without the bacteria, but frequently pick it up from the host they attach themselves to after birth.
Glaxosmithkline Developed A Safe Effective Lyme Vaccine Decades Ago
The three-dose vaccine worked by stimulating disease-fighting antibodies in human blood. If a black-legged tick bit a vaccinated person, the antibodies attacked the Borrelia burgdorferi bacteria in the tick’s gut, preventing it from being transmitted to the human host.
The vaccine was about 75% effective at preventing Lyme disease after three doses in clinical trials.
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Judge Rules Lawsuit Against Idsa Baseless
In legal rulings issued on Sept. 1 and Sept. 20, a federal judge in Texas dismissed all claims a group of Lyme disease patients had brought against the Infectious Diseases Society of America.
In November 2017, a group of Lyme disease patients sued IDSA, individual doctors who wrote IDSAs clinical guidelines on Lyme disease, and major national and regional health plans, alleging a conspiracy between IDSA and the health plans regarding the methodology and contents of IDSAs Lyme disease guidelines. On Sept. 1, the judge found plaintiffs had produced no evidence to support their conspiracy claims.
In January 2021, plaintiffs had added new fraud claims against IDSA, alleging that IDSAs Lyme disease guidelines contain false representations regarding Lyme disease testing and treatment. On Sept. 20, the judge dismissed plaintiffs fraud claims, holding that IDSAs guidelines set forth explanations of medical research knowledge based on citations to other published studies and clinical trials not naked assertions of fact and make clear that adherence to the guidelines is voluntary, with the ultimate determination regarding their application to be made by the physician in light of each patients individual circumstances.
Seek Out Experts Across Disciplines
Multidimensional problems like Lyme disease and school reopening during COVID-19 require multidisciplinary solutions. As a tick-borne disease that affects many parts of the human body, Lyme disease requires expertise from a range of medical specialties such as infectious disease, cardiology and neurology in addition to expertise from entomologists and ecologists.
To tackle school reopening, partnered action among epidemiologists, virologists, aerosol engineers, occupational and environmental health specialists, pediatricians, infectious disease physicians, educators and social scientists would build bridges to common ground.
Over the past year and a half, disagreement about school reopening has led to accusations of epistemic trespassing or stepping outside of ones area of expertise and calls to stay in your lane. But widening the lane to include multiple perspectives and building coalitions across lanes could lead to a more complete understanding of school reopening.
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Consumer Class Action Lawsuit Alleges Flea And Tick Collars Cause Harm And Death
Fleas and ticks can carry Lyme disease, making them dangerous, and even potentially fatal, to us all, but especially to dogs who spend a lot of time outside and in whose fur fleas and ticks like to burrow. But when it comes to a certain flea and tick collar, could the protection against fleas and ticks be worse than the dangers posed by the bugs themselves?
Elanco Animal Health is an Indiana-based pharmaceutical company that makes medications and vaccines for animals, including Seresto flea and tick collars. After almost 1,700 incidents of pet deaths and about 900 humans harmed, all of which were reported as having been linked to the Seresto flea and tick collars, Elanco is now facing a class action lawsuit filed by consumers who allege their dogs were either harmed or killed by the collars, as well as a congressional investigation.
According to Karen McCormack, a former employee of the Environmental Protection Agency , the EPA has known about the possible link between the flea and tick collars and the hundreds of deaths associated with the collar but allegedly failed to inform the public of the potential link.
Bayer, the German-based pharmaceutical company, sold its Animal Health division to Elanco for $7.5 billion in 2020. The year before, Bayer reported that the flea and tick collar brought in annual revenues of more than $300 million.
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Lyme Patients File Lawsuit Against Idsa And Insurers Over Treatment Denials
From Courthouse News Service, Nov. 14, 2017:
TEXARKANA, Texas Twenty-eight people claim in a federal antitrust lawsuit that Lyme disease victims are being forced to pay hundreds of thousands of dollars for treatment because health insurers are denying coverage with bogus guidelines established by their paid consultants, who falsely say the disease can always be cured with a month of antibiotics.
Suffering from migraine headaches, an irregular heartbeat, hearing problems and nerve pain, lead plaintiff Lisa Torrey says in the lawsuit filed Friday in Texarkana, Texas federal court that she visited 36 doctors, some of whom misdiagnosed her with multiple sclerosis and fibromyalgia and said her symptoms were all in her head, before she was properly diagnosed with Lyme disease.
People get the disease from the bites of infected ticks and many break out with a large red rash around the bite that looks like a bullseye.
There were more than 28,000 confirmed cases of Lyme disease in the United States in 2015, 95 percent of which came from 14 states in the Northeast and Midwest, according to the Centers for Disease Control and Prevention. The agency estimates that 300,000 people are infected with the disease each year.
Torrey says the insurers began working with Sigal to deny Lyme disease coverage in the 1990s.
Torrey claims doctors who criticized the guidelines as too restrictive put their medical licenses at risk as they were targeted by the insurers.
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But A Cdc Committee Thought The Vaccine Was Unnecessary
Almost as soon as it was approved, though, LYMErix developed a reputation problem.
Lyme disease was initially detected and most prevalent in New England, and cannot be spread from person to person. So those most at risk tended to be people with access to the outdoors along the coast. Some doctors, then, saw LYMErix as a vaccine developed for and benefitting rich, white people. During a 1998 CDC advisory committee meeting, Dr. Chinh Le of Kaiser Permanente Medical Center described the shot as a “yuppie vaccine.”
Le suggested the shot was being marketed to suburbanites who “will pay a lot of money for their Nikes and their Esprit, and shop at L.L. Beans, will have no consideration for cost-effectiveness when they want a vaccine, because they’re going to travel to Cape Cod.”
US health officials worried that the shot’s limited application and marginal health benefits didn’t justify its inconvenient three-dose course, which had to be completed in a year. Officials were also wary that recommending a personalized, discretionary shot would undermine public trust in vaccines in general.
The CDC ultimately gave a lukewarm recommendation about who should get LYMErix. People at high risk of contracting Lyme “should consider” the vaccine, the agency said, and people exposed to tick-infested habitats, but without frequent or prolonged exposure, “may be considered” for LYMErix shots.
Judge Dismisses Lyme Disease Lawsuit Against Idsa Doctors But The Ordeal Has Left Its Scars
Years ago, when rheumatologist Leonard Sigal, MD, was undertaking research on Lyme disease and treating patients with the condition at the Robert Wood Johnson Medical School, in New Brunswick, New Jersey, a regular stream of abuse and threats became the usual background noise of his work. He didn’t get used to it, but it never stopped.
Dr Leonard Sigal
“I was accused of incredibly heinous crimes,” Sigal told Medscape Medical News. “I was accused of lying, cheating, of doing things to make money that were against the public interest and against the interest of patients in general.”
Dr Timothy Flanigan
It’s an experience many doctors who treat Lyme disease have endured, so much so that some infectious disease doctors aren’t comfortable treating patients with Lyme disease, according to Timothy Flanigan, MD, a professor of infectious disease at Brown University, Providence, Rhode Island..
But it wasn’t until Sigal left academia in 2003 that he realized the toll all that background abuse had been taking on him.
“It was a breath of fresh air,” he said. “I didn’t have to go into clinic and argue with people. I didn’t have to read articles in the newspaper that made no sense whatsoever. I didn’t have to hear through second and third parties how such and such was saying horrible things about me. I didn’t have to fight anymore. When I was in industry and working on stuff that had nothing to do with Lyme disease, I realized what a relief it was not to have that burden.”
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Lyme Disease Patients File Federal Antitrust Suit Against Infectious Disease Specialists & Health Insurers
Health, entertainment and LGBT writer
Last Friday, 28 patients filed a federal antitrust lawsuit against the Infectious Diseases Society of America, eight health insurance companies, and seven medical doctors, Courthouse News reported yesterday, because health insurers are denying coverage with bogus guidelines established by their paid consultants, who falsely say the disease can always be cured with a month of antibiotics.
Contrary to the often-reported claim that Lyme disease affects people almost exclusively from Washington, D.C. to New England, and in the Great Lakes region, the lawsuits plaintiffs represent a wide expanse of the United States, hailing from Alabama, Arkansas, Connecticut, Florida, Georgia, Iowa, Ohio, Michigan, Minnesota, Nevada, Pennsylvania, and Texas.*
Among the lawsuits allegations:
In the 1990s, the Insurance Defendants decided that treatment of Lyme disease was too expensive and red-flagged Lyme disease. The health insurance industry made a concerted effort to deny coverage for treatment of Lyme disease. The Insurance Defendants enlisted the help of doctors who were researching, not treating, Lyme disease. The Insurance Defendants paid these IDSA Panelists large fees and together they developed arbitrary guidelines for testing Lyme disease.
The lawsuit names a number of medical doctors, all representatives of the Infectious Diseases Society of America. Among them are:
IDSA Guidelines, Specialists Promoted by Many Medial Organizations
To Answer This Question From Robert Small Of Stannard Brave Little State Takes Stock Of Not One Not Two But Three Pharmaceuticals Currently In Development
In the last 30 years, the incidence of Lyme disease in this country has almost doubled, and because of climate change, ticks are expanding their range. So why isnt it easier to prevent this tick-borne illness?
Thats what Robert Small of Stannard asked Brave Little State. VPRs people-powered journalism project answers questions about Vermont that have been asked and voted on by you, because we want our journalism to be more inclusive, more transparent and more fun.
Robert asked us this: “When will there be a vaccine for Lyme disease?”
Were not just going to answer Roberts question, were also going to explain why he even needs to ask it in the first place.
Note: Our show is produced for the ear. We recommend listening to the audio above if you can! But we also provide a written version of the episode below.
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