First of all let me say that we, as a manufacturer of pharmaceutical products and vaccines, take any report of an adverse event on any of our products, seriously.
Lyme disease is caused by the bacterium Borrelia burgdorferi and is transmitted to humans by the bite of infected blacklegged ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Lyme disease is diagnosed based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks; laboratory testing is helpful in the later stages of disease. Most cases of Lyme disease can be treated successfully with a few weeks of antibiotics.
LYMErix was a vaccine introduced into the marketplace and intended intended for the prevention of Lyme's disease.
GSK's "Do More, Feel Better, Live Longer" video
(Windows Media Player or RealOne Player required to view)
A 1992 CDC activity report obtained by United Press International (UPI) says the agency had an agreement "with SmithKline Beecham that currently funds three positions at (the CDC) for the purpose of providing information of use in developing advanced test methods and vaccine candidates."
May 26th, 1998
Food and Drug Adminstration Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee Meeting
For transcript click here. (RTF document)
Dr. Pietrusko: "Good morning. On behalf of SmithKline Beecham Pharmaceuticals, I would like to thank the FDA and the Advisory Committee for allowing us the opportunity to review data on LYMErix, our new vaccine for the prevention of Lyme disease that is currently under review by CBER at this time. The efforts of many researchers, investigators, and colleagues are appreciated as well as the family support in bringing this product forward at this time. SmithKline Beecham now also would like to publicly recognize the fine efforts of the CBER review team under the leadership of Dr. Karen Elkins. Oftentimes, the truly remarkable efforts of the Agency go unrecognized. This team worked diligently and provided valuable scientific input as well as prompt feedback during the review process."
December 21st, 1998
The FDA sends an approval letter authorizing SmithKline Beecham (GSK) to manufacture and prepare Lyme Disease Vaccine (Recombinant OspA) for import into the United States, for sale, barter, or exchange.
January 22nd, 1999
The CDC issues a Notice to Readers: Availability of Lyme Disease Vaccine through its publication Morbidity and Mortality Weekly Report.
February 18th, 1999
The CDC endorses Lyme disease vaccine for people age 15-70 who work or recreate in possible tick-infested areas. According to CDC meeting transcripts where the advisory committee weighed its recommendation, five of 10 committee members disclosed their financial conflicts of interest with vaccine manufacturers. Three of the five had conflicts of interest with SmithKline Beecham.
By now more than 1.4 million people had received the vaccine, according to the CDC. However, the vaccine has prompted hundreds of adverse-event reports. The government database used to track these events (VAERS) listed over 600 emergency room visits, several dozen life-threatening reactions, dozens more hospitalizations, almost 200 disabilities, and a handful of deaths.
GlaxoSmithKline faces hundreds of lawsuits by people who said they suffered side effects.
"It should have never been approved in the first place," said Karen Forschner of the Lyme Disease Foundation, a nonprofit that obtained clinical-trial data that she said raised questions about the extent to which side effects were recorded properly.
January 31st, 2001
The FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee held a meeting for the purpose of reviewing the safety of the LYMErix vaccine. At a critical point during this meeting a tall, well-dressed man swept up to the podium from somewhere in the back and motioned the presenting scientists away.
It was time for damage control, and David Wheadon, Vice President Regulatory Affairs and Product Professional Services, GlaxoSmithKline, took charge, saying:
First of all let me say that we, as a manufacturer of pharmaceutical products and vaccines, take any report of an adverse event on any of our products, seriously. And certainly the things that we heard today we take seriously.
That is notwithstanding we have to also understand that the way the post-marketing reports surveillance system works in this country, not just for LYMErix, but for all vaccines, for all drugs, you do not in how these things are collected capture the emotion that we heard here today.
I'm not saying that that is belittling, or minimizing what we heard. But the way the system is you take the sort of emotion and the gestalt, and the stories that we heard, and you have to then transfer that into event terms like arthritis, like arthrosis, like congenital deformities in the case of whatever.
It all goes into a database where you do your analysis as objective, and as scientific, and in or not there is, indeed, a signal.
(Database ... scientific ... signal ... objective. Sure, Dr. Wheadon. "Scientific and objective" as in: GlaxoSmithKline's fraudulent miscoding of suicide attempts recorded during Paxil's clinical phase III trials as "emotional lability"?)
LYMErix Powerpoint slide show January 21st, 2001 presentations:
made during the January 31st, 2001 FDA Center for Biologics Evaluation and Research Vaccines and Related Biological Products Advisory Committee LYMErix safety review:
Clare Kahn, Ph.D., Vice President N.A. Regulatory Affairs, Vaccines, GlaxoSmithKline
LYMErix Safety Data Reported to the Vaccine Adverse Event Reporting System (VAERS)
Additional January 21st, 2001 meeting materials
LYMErix: FDA Review of Pre-licensure Safety Data and Update (PDF)
LYMErix review briefing document (PDF) for the Vaccines and Related Biological Products Advisory Committee
Sheller, Ludwig and Badey submission for review
The General Accounting Office delivered a report to Senator Chris Dodd, D-Conn., on this issue. It says that CDC employees "are listed on two Lyme-disease related patents" including "a 1993 joint patent between CDC and SmithKline Beecham Corporation." The report also said that six of 12 consultants working for the CDC on Lyme vaccines "reported at least one interest related to a vaccine firm."
November 28th, 2001
Open Session of the FDA Vaccine and Related Biological Products Advisory Committee (Use word search to locate first mention of LYMErix testimony.)
Extended remarks given by Karen Vanderhoof-Forschner, BS, MBA, CPCU, CLU to the Food and Drug Administration's Vaccine Advisory Committee Meeting. (This is an absolute "must read" manifesto. As you'll see, it was just "business as usual" for GSK (SKB).
Her synopsis:"The Lyme vaccine trial and approval process have been seriously flawed, vital information has been withheld from the Vaccine Advisory Committee and the FDA, and experts who could have helped provide critical analysis were never invited to participate ... enough to compromise all trial data and cast doubts on the integrity of all involved.
For an abbreviated version of her comments click here.
February 25th, 2002
SmithKline Beecham (GSK) pulls the vaccine off the market claiming "sales of LYMERIX are insufficient to justify the continued investment." GSK also withdraws an FDA application to market a pediatric version of the vaccine.
Barbara Fisher, who sat on the FDA advisory panel that heard testimony from people claiming injury from LYMErix, agreed that Glaxo's decision to discontinue the vaccine was overdue.
"The evidence has been compelling for some time," said Fisher, who also heads the nonprofit National Vaccine Information Center. "The science says that certain people are vulnerable to this product."
Karen Forschner of the Lyme Disease Foundation said "It [the LYMErix vaccine] was based on bad science. It's a crummy vaccine that's probably caused significant injury to people, but information wasn't shared with the FDA or the public," she said. "This decision will probably save thousands of people from having similar problems."
May 21, 2002
Meeting of the FDA Vaccine and Related Biological Products Advisory Committee (Use "word search" function to jump to LYMErix-related testimony.) Some great testimony from LYMErix victims and consumer advocates.
Chronological search FDA for LYMErix related documents
LYMErix Victim Letters to the FDA (PDF)
"I Dare You to Take the First Dose of the Lyme Vaccine"
Neurological Impairment Seen in Patients Given LYMErix
Tick Puts Drugs Maker in the Rough