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|TOM GRIER'S REBUTTAL STATEMENTS: The Rise and Fall of the Lyme Disease Vaccines:|
|Written by Bettyg|
|27 June 2012|
Dear Doctor Aronowitz,
I have been an advocate of better science in Lyme disease research since 1990 when I was then misdiagnosed by the Lyme experts with Multiple Sclerosis.
Since then I have fought with everything I have for pathology and autopsy data to establish whether Borrelia bacteria can persist within the human brain post antibiotic treatment.
When I first heard in 1995 that the Smith Kline (Glaxo) Lyme vaccine was a subunit vaccine using only Outer Surface Protein -A, I was not just concerned , but like many patients following the literature, I was shocked.
Dr. Alan Steere, MD from Yale had even published in 1989 that the OSP-A protein can accumulate in the joints of infected patients.
He also associated HLA-DR-4 tissue type in Lyme patients with extended arthritis symptoms and associated that with the possible interaction of OSP-A.
Yet the vaccine research not only continued but in my opinion acted belligerently to ignore these facts.
The work done at Valhalla, NY and other medical centers neglected to do proper tissue typing of patients during vaccine trials and patient selection even when people like myself were insisting on tissue typing!
Three years before market, myself and others raised these concerns.
I myself had lunch with Glaxo representatives at conferences and voiced my concerns, and instead of reassurances that tissue typing would be done to isolate HLA-DR4 patients, I got a sales pitch on Lymerix.
They said my concerns were premature and had already been addressed in their preliminary studies.
A year before market, I joined in support with Dr. Thomas Miller (Syphilis researcher California) and his graduate students protesting this vaccine a full year before market citing nearly 100 articles suggesting that OSP-A was a poor choice of antigens.
Some of those articles included work done by Dr. Ronald Schell of Madison, WI, who did work on mice showing the adverse effects on joints of OSP-A vaccines in mice with Lyme disease or from re-exposure to Lyme disease after vaccination.
My point is that Lyme patients were already polarized prior to the vaccine's release.
But not because the vaccine would diminish their ability to get antibiotics.
That is the most absurd and childish thesis and conclusion I can imagine.
They were polarized because of the data we had seen concerning OSP-A as an antigen for the vaccine suggested the potential for crippling arthritis.
In my opinion and the opinion of many of my colleagues who were there in the beginning of Lymerix research:
the public disenchantment with Lymerix occurred when chronically ill, sick Lyme patients who were desperate for any chance to alleviate their symptoms gave Lymerix a chance because they had some unrealistic glimmer of hope that Lymerix would help their symptoms and also protect their families from the ravages of this disease.
They were not properly warned about prior exposure to Lyme disease infection could prime their joints for destruction by OSP-A antibodies.
But instead, many of these hopeful patients ended up worse off, and joined in the CLASS ACTION LAWSUITS because of severe joint and muscle pain.
Many of these patients are people that I know and they are not people who exaggerate or prone to hyperbole.
They are however and continue to be in pain. Severe pain that 12 years later does not respond well to any pain medications short of narcotics!
Your revisionist history is inaccurate and makes no sense.
Yes, most Lyme patients are still anti-Lymerix, but they are not anti Lyme-vaccine.
As support to this position many including myself in the Lyme community have been lobbying and trying for over a decade to get the European Lyme vaccines based on OSP-C protein and Decorin binding protein, and other vaccines that use Borrelia binding proteins.
A vaccine that would stop dissemination of the bacteria throughout the body and trap it in the blood.
Clearly we are not afraid that these vaccines will diminish ours or anyone else's ability to get antibiotics.
The diminished ability to get extended antibiotics for Lyme treatment has already been accomplished by the Infectious Disease Society of America IDSA and their restrictive guidelines; and in my opinion, their refusal to do or support brain autopsy research in human Lyme disease.
The inability to get antibiotics is in no way shaped by Lyme vaccines of past, present or future.
The Lyme community for the most part supports these other vaccines and desires to rekindle vaccine research using better science.
Which means your central thesis is nonsense.
(I have always supported these other vaccines and dismissed OSP-A subunit vaccines based on science and adverse side effects and potential side effects based on science from 1989.)
You say you looked at medical and congressional hearings and comments by the Lyme community.
I read those hearings and what I saw was an awful lot of concerns about vaccine safety and the lack of proper protocols in vaccine testing.
I also saw an awful lot of concern
. over product-patents,
. financial conflicts of interest, and
. medical institutions owning patents on Lyme tests
. and working closely with the pharmaceutical industry.
Yes, Lyme patients are concerned that this association clouded good scientific judgement, and continues to motivate papers like this or the paper by Gary Wormser citing that the Embers-Barthhold Monkey Autopsy study was invalid due to lack of blood levels of the antibiotic.
Tell me when has a Yale doctor ever done blood levels on a Lyme patient when treating their late stage symptoms with two weeks of doxycycline 100 mg BID?
If you are going to suggest a treatment protocol, perhaps you should practice what you preach, and do blood and CSF levels on every Lyme patient treated with doxycycline for one day given prophylactically for tick bites.
You also mention the "self-interested actors" within the Lyme patient community.
Would you like to compare the self-interests of those individuals who testified about persistent infection and vaccine side effects compared with the "self-interests" of Yale and Glaxo and other researchers involved with Lymerix, Lyme tests and Lyme disease research???
Is that the can of worms you are willing to open by calling Lyme advocates who are ill "self-interested parties"?
It is hard not to be self-interested when you are sick and disabled.
This revisionist history from YALE is much like the revisionist history from Harvard that was on Wikipedia concerning Dr. Andrew Spielman mentioning that he discovered Lyme bacteria in the Ixodes scapularis ticks with no mention of his invented species Ixodes dammini.
It took many letters from me and others but this was later corrected by Wikipedia.
This is important because the focus on this new local species meant Lyme was only isolated to NE USA.
We now know different. Accurate facts are important in science.
To what purpose did you write your article?
It is certainly a position paper based on opinions and certainly isn't based on facts about the poor vaccine design and poor testing of the ONLY LYME VACCINE to make it to market.
I can see no way that your article helps Lyme patients?
I guess my conclusion and opinion would be that your article is to exonerate YALE and Glaxo, and to place all the problems with the vaccine on the backs of"self-Interested" Lyme patients and revisit the adverse cause and effect of the vaccine on human patients or in animal models.
I am very sorry Dr. Aronowitz if you were convinced to write this paper for reasons other than altruism because in my opinion that would truly make you an accomplice to patient's on going and continued sufferings because of putting profits and the reputation of Yale before safety.
fyi, TOM GRIER DID RECEIVE AN APOLOGY to his above note to the Dr! Tom's rebuttal is in reference to this PUBLISHED article this month!
The Rise and Fall of the Lyme Disease Vaccines:
A Cautionary Tale for Risk Interventions in American Medicine and Public Health
Robert A. Aronowitz
Milbank Quarterly, Volume 90, Issue 2, pages 250-277, June 2012.
Two vaccines to prevent Lyme disease (LD) were developed and tested in the 1990s.
Despite evidence of their safety and efficacy in clinical trials and initial postmarketing surveillance, one vaccine was withdrawn before the regulatory review and the other after only three years on the market.
An investigation of their history can illuminate
(1) the challenges faced by many new risk-reducing products and practices and
(2) the important role played by their social and psychological, as distinct from their biomedical or scientific, efficacy in how they are used, and their ultimate market success or failure.
This article reviewed medical and popular literature on LD vaccines, analyzed the regulatory hearings, and conducted interviews with key participants.
Even if proved safe and effective, LD vaccines faced regulatory and market challenges because the disease was geographically limited, treatable, and preventable by other means.
Pharmaceutical companies nevertheless hoped to appeal to consumers' desire for protection and control and to their widespread fear of the disease.
The LD advocacy community initially supported the vaccines but soon became critical opponents.
The vaccines' success was seen as threatening their central position that LD was chronic, protean, and difficult to treat.
The activists' opposition flipped the vaccines' social and psychological efficacy.
Instead of the vaccines restoring control and reducing fear, demand was undermined by beliefs that the vaccines caused an LD-like syndrome.
The social and psychological efficacy of many risk-reducing practices and products, such as new "personalized vaccines," is to provide insurance and reduce fear.
Yet the actions of self-interested actors can easily undermine this appeal.
In addition to evaluating the scientific efficacy and safety of these practices and products, policymakers and others need to understand, anticipate, and perhaps shape the potential social and psychological work they might do.
Free, full text, pdf file (515K):
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