Dr Philip Baker and the Lymerix misadventure

Medical topics with questions, information and discussion related to Lyme disease and other tick-borne diseases.
RitaA
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Re: Dr Philip Baker and the Lymerix misadventure

Post by RitaA » Wed 4 Jul 2012 19:30

Henry wrote:RitaA: The FDA published two reports based on an analysis of ALL of the reported adverse events with respect to the LYMErx vaccine. There was no evidence to indicate that any were vaccine related. Furthermore, an extensive HLA analysis was done for those who reported arthritic episodes after vaccination. There was no correlation between arthritic episodes and the epitopes reported to be related to an autoimmune reaction to a subregion of the OspA molecule. So, there was no foundation for that possibility either. In fact, the incidence of adverse events reported for LYMErx were less than those generally reported for the annual flu vaccine.

In all of the criticism raised about LYMErx, it is apparent that many don't understand the rationale as to how the vaccine was designed to work. LYMErx does NOT provide protective immunity as is the case for most commonly administered vaccines (e.g., the flu shot). What the vaccine does is generate the production of antibodies against OspA. Since Borrelia are localized in the midgut of infected ticks where they make a lot of OspA on their surface, the antibody vs OspA in the blood of vaccinated people is able to kill/neutralize Borrelia in the midgut, thereby prevent them from migrating to the salivary glands where they can transmit infection. So, LYMErx -- by design-- was a transmission blocking vaccine.
Henry:

I only recently learned how LYMErix worked, so it's probably not common knowledge among most of today's Lyme disease patients.

As you have alluded to, there are possible adverse effects associated with any type of vaccination. The same applies to almost any type of medical intervention (come to think of it), and that's why it's so important for doctors and patients to carefully weigh the risks versus the benefits for any treatment -- regardless of the illness/disease. There's no doubt that North Americans have become a pill-popping society compared to the rest of the world. We also have higher rates for certain types of elective surgeries.
Henry wrote:Rita: I wonder if the two doctors were LLMDs.
Although Dr. Bakken didn't name the two doctors in yesterday's radio interview, I must admit I wondered about this myself when he mentioned possible "reporting bias" (or something to that effect). Some people obviously know who the two doctors are/were, but I suspect there are confidentiality rules surrounding adverse effects reports. If that's the case, the general public may never know.

Edited:

1) to change "adverse reactions" to "adverse effects"

2) to include a link to VAERS - Vaccination Adverse Effects Reporting System:

http://vaers.hhs.gov/index

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inmacdonald
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Re: Dr Philip Baker and the Lymerix misadventure

Post by inmacdonald » Sun 8 Jul 2012 20:51

Editorial
Lyme disease vaccines deserve a second look

July 08, 2012

A decade after a vaccine for Lyme disease was pulled from the market amid poor sales and public controversy, New Englanders need to ask: How long should we allow a largely preventable disease to continue unabated? In most years, according to the federal Centers for Disease Control and Prevention, more than 20,000 cases of the tick-borne bacterial infection are diagnosed in the United States. A vaccine would be especially useful in New England, the mid-Atlantic states, Minnesota, and Wisconsin — which account for more than 94 percent of all Lyme disease cases. Yet as WBUR reported in a recent series on Lyme disease, dogs can be vaccinated against Lyme disease, but people cannot.

The drug firm then known as SmithKline Beecham got FDA approval in 1998 for a human vaccine called Lymerix, but experts offered inconsistent advice about who should get the vaccine. Never-proven claims that the Lyme vaccine caused arthritis and other symptoms scared off some patients and raised the possibility of big legal judgments. For the manufacturer, the limited sales didn't justify the risks.

But with a decade of hindsight, people in the areas most affected by Lyme disease deserve a second look. Not everyone will be accepting; opposition to the measles, mumps, and rubella vaccine has become entrenched among some parents, even as the research that initially fueled it has been discredited. Yet it's precisely because of that controversy that medical authorities, the media, and the general public may weigh claims by vaccine critics more carefully.

As Lyme disease cases continue to emerge, public health authorities in New England need to lead the drive to bring existing vaccines back — or promote research on new and better ones.
--------------------------------EDITORIAL - BOSTON GLOBE - AUTHOR NOT OTHERWISE SPECIFIED--------------

CORRECTION TO ORIGINAL POST:
Sheila M. Statlender, Ph.D.
Clinical Psychologist, DID NOT AUTHOR THE ABOVE.
HER REMARKS ABOUT LYME VACCCINATION MAY BE FREELY VIEWED
ON THE WBUR WEBSITE - PANEL DISCUSSION WITH DR THOMAS MATHER - APPROX 60 MINUTES LONG
Last edited by inmacdonald on Thu 12 Jul 2012 5:49, edited 1 time in total.

Henry
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Re: Dr Philip Baker and the Lymerix misadventure

Post by Henry » Wed 11 Jul 2012 16:25

Specific information on ALL reported adverse events for LYMErx may be found by doing a search on this site:

http://wonder.cdc.gov/vaers.html.

I tried to find out who reported each adverse event posted, but was not able to do that. I don't think the search enables one to get that information. Since arthritis was the major adverse effect reported, I used that term in my search.

Lorima
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Re: Dr Philip Baker and the Lymerix misadventure

Post by Lorima » Thu 12 Jul 2012 3:09

Dr. MacDonald,

Do you mean to indicate that Sheila Statlender wrote this editorial? I found the text in Boston.com as a Globe editorial, but there's no author given. I wouldn't think she would be inclined to trust Lymerix, as she and her three children were all taken in, with serious consequences, by the two-tier test from the same, um, promoter. If I'm not mistaken, she critiques Lymerix in the panel discussion hosted by WBUR. These may be the relevant papers:

Is it thee or me?--autoimmunity in Lyme disease.
Klempner MS, Huber BT.
Nat Med. 1999 Dec;5(12):1346-7. No abstract available.
PMID: 10581067 [PubMed - indexed for MEDLINE]
Related citations

Association of antibiotic treatment-resistant Lyme arthritis with T cell responses to dominant epitopes of outer surface protein A of Borrelia burgdorferi.
Chen J, Field JA, Glickstein L, Molloy PJ, Huber BT, Steere AC.
Arthritis Rheum. 1999 Sep;42(9):1813-22.
PMID: 10513794 [PubMed - indexed for MEDLINE] Free Article
Related citations

25.
Identification of LFA-1 as a candidate autoantigen in treatment-resistant Lyme arthritis.
Gross DM, Forsthuber T, Tary-Lehmann M, Etling C, Ito K, Nagy ZA, Field JA, Steere AC, Huber BT.
Science. 1998 Jul 31;281(5377):703-6.
PMID: 9685265 [PubMed - indexed for MEDLINE] Free Article
Related citations

26.
The mimic of molecular mimicry uncovered.
Gross DM, Huber BT.
Trends Microbiol. 1998 Jun;6(6):211-2. No abstract available.
PMID: 9675794 [PubMed - indexed for MEDLINE]
Related citations

As "hv808ct" said, these papers and the theory they advance didn't hold up (though they weren't retracted), but the fact that they were published at the same time as Lymerix was being sold to the public seems to be ample cause for mistrust of the vaccine's creators and promoters.

A patent was filed on this vaccine candidate, in anticipation of Lymerix causing autoimmune damage:
An effective second-generation outer surface protein A-derived Lyme vaccine that eliminates a potentially autoreactive T cell epitope.
Willett TA, Meyer AL, Brown EL, Huber BT.
Proc Natl Acad Sci U S A. 2004 Feb 3;101(5):1303-8. Epub 2004 Jan 23.
PMID: 14742868 [PubMed - indexed for MEDLINE] Free PMC Article

It seems kind of silly to suggest that any of these researchers, and/or those who have failed to correct or curb them, be given yet another chance to experiment on the public. I'm not saying they're intentionally putting people at risk of being crippled, just that they seem to be insufficiently competent in scientific thinking and practice to be trusted with something so complex.

Thanks, Henry, for the VAERS link. It says there were 2274 events reported, in all.
"I have to understand the world, you see."
Richard Feynman

RitaA
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Re: Dr Philip Baker and the Lymerix misadventure

Post by RitaA » Thu 12 Jul 2012 4:08

Lorima,

Thanks for posting the number of adverse events. I tried using the query function earlier today but forgot to include the VAERS ID field, and therefore didn't get any results on my first attempt. You just inspired me to try again, and there are indeed 2274 events reported -- a far cry from the 120 that Dr. Bakken mentioned in the recent WBUR radio segment of "Living with Lyme disease". Perhaps Dr. Bakken was referring only to physician-reported events that were deemed "serious" or some other criteria, but he certainly didn't make that clear.

Here's what Dr. Michael Tosi, a pediatric Infectious Diseases specialist, had to say about LYMErix in today's New York Daily News:

http://www.nydailynews.com/life-style/h ... bled=false
Health

The Daily Checkup: The threat of Lyme disease returns as temperatures climb in summer

Protect against bites from deer ticks by wearing adequate clothing and checking your skin after being outdoors

By Katie Charles / NEW YORK DAILY NEWS
Wednesday, July 11, 2012, 6:00 AM

The specialist:

A professor of pediatrics at Mount Sinai Hospital, Dr. Michael Tosi specializes in treating children with all kinds of infectious diseases.

[snip]

Although treatment is very effective, doctors have yet to develop a transformative breakthrough for preventing Lyme disease. “In the late ’90s, researchers developed a vaccine, but it turned out not to be a very effective or long-lasting vaccine, and it was withdrawn from the market,” says Tosi. “Right now, one active area of research is aimed at developing blood tests that would be simpler than the current format and equally reliable, so that may be the most promising new development.”

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inmacdonald
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Re: Dr Philip Baker and the Lymerix misadventure

Post by inmacdonald » Thu 12 Jul 2012 4:13

Dear Lorima,
I have viewed a recent video fro WBUR which featured Dr Stadlender, Dr Thomas Mather and
a legislative elected representative. Her remarks in the video seemed to indicate that she
was affirmative in Re-introducing some sort of Lyme Vaccine to the public.

I have no personal objections to affording the public an option to try a vaccine, even with
potential adverse effects plainly disclosed to potential recipients in advance of receiving
the vaccine.
I think that the potential recipients should sign an irrevocable waiver
which prevents individual future lawsuits from arising from the effects of the vaccine,without limitation.

The re-introduction, with the ironclad Waiver signed by the potential recipients,
would go a long way toward clearing the pathway for making a vaccine ( Flawed or perfect)
available to the public.

I recall that when the initial vaccine for Hepatitis B became available, many potential recipients
declined to take it because it was derived in part from the serum of patients who had HIV infection
or were ar high risk for HIV infection. As a patient, I elected to receive the first batch of the Hepatitis C vaccine ...( HIV considerations notwithstanding).

The original Vaccine program which was the idea of Dr Jenner, did not have informed consent ot the patient
( a minor child- and not his parents who may have been educationally disadvantaged) --or potential future legal actions on the horizon.

Vaccination may induce Guillan Barre syndrome. Vaccination in patients who do not realize that they
are immunosuppressed, may have very serious additional consequences.

There is no ZERO RISK AVOIDANCE in the area of Vaccination practice.
An adverse effect of Vaccination is an intrinsic part of the fabric of Vaccination.

I have stated before that I oppose the interposition of the federal gorvernment in
decisions which are rendered between individual patients, and their physicians.

When I wrote in a much earlier post about "thinking about the Tusksgee experiment"
I was alluding not to issues of racism ( which are ideed the medical curriculum teachings
about the Tuskegee experiment) , but I was instead alluding to the issue of the Federal government
interposing itself between individualized Physician/Patient decisions.

The Physicians have an obligation to explain the upside and the downside of any medical intervention to the patient in words that the patient can understand. It is the patient/physician consensus judgment which guides therapy after such a frank and open question and answer session has been accomplished.

Let the educated patients chose what therapy they will receive, or decline to receive.

Best to all,
a

Lorima
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Re: Dr Philip Baker and the Lymerix misadventure

Post by Lorima » Thu 12 Jul 2012 14:30

(Note to bystanders: it's important that we know whether Sheila Statlender is involved with this editorial, because she is one of the patient advocates prominently featured in journalist/patient Pamela Weintraub's book "Cure Unknown", a thoroughly referenced history of the Lyme epidemic published in 2008. In the book, Dr. Statlender explains how in 2002 she and her husband, an MD, collected the research articles that describe the formulation of the two-tier test, read them, and realized they'd "been had". As have many others, I had come to a similar realization, by a similar route of collecting and reading the foundational literature, in 2007, a year before the book was published. So I got a kick out of seeing the process of research, insight, and consequent sense of betrayal described so well in the book. You can find it in the short chapter 23, "A Devastating Realization", in Cure Unknown.)

Dear Dr. MacDonald,

Thanks so much for your activity in this forum. It's good to rehash the history of the disease - in the absense of detailed knowledge of the history, it's impossible to explain to reflexive supporters of medical orthodoxy why their faith may not, in this case, be justified.

Of course I'm interested to hear your views on vaccines and medical/government patient interactions in general. If I had to say what my views are, I guess I would have to say that it all depends on the details of the specific case. There are so many ways that medical science and industry can succeed on the one hand, or mislead on the other. Without looking in detail at the history of a particular case, I don't think there's much one can say about the relative merit or faults of any proposed intervention. And even a detailed look only covers what has been published or said in a reliably documented public forum, while much of the discussion that leads to policy decisions happens informally, behind closed doors. I'm not suggesting this is automatically sinister; it's just impractical to expect everything anybody says or does during a complex project to be publicly documented. All those phone calls, all those casual conversations...

This does suggest that the ideal of a thoroughly informed patient or physician is only attemptable, not reachable. It's unfortunate, but there it is.

With regard to Lyme disease science and industry, the history of the two-tier test going from vaccine-trial tool, to CDC surveillance definition, to diagnostic requirement, for example, does not lead me to be optimistic with regard to the ability of the FDA and CDC to ensure adequate protection for the public. Some other disease fields probably have been treated with much greater rigor, and may merit the trust of the public - it all depends on the details. I'm finding it quite challenging enough to master the history, politics, and science of this one disease. And I have a PhD in molecular and cellular biology, experience researching molecules involved in the human immune/inflammatory response, and a successful drug development experience under my belt. Imagine how much more challenging this is for the average physician or patient.

With regard to Dr. Statlender and the panel:

http://www.wbur.org/2012/06/28/lyme-disease-panel

I just re-viewed the section about the vaccine issue. The discussion was kicked off by a rather patient-hostile leading question from an anonymous audience member which was read from the podium. (I transcribed the question, and I'll treat it in a separate thread.)

Tom Mather, the entomologist, is enthusiastic about the idea of a vaccine, but when asked about Lymerix, he said at about 27:17, "That particular vaccine, I'm not so sure about...it was not that effective in non-human primates...great for dogs...doesn't work the same in every host."
Statlender said she thinks the criticism of Lymerix was "not knee-jerk anti-vaccine" (beginning at 28:26). Then she mentions the potential HLA DR4 problem in 1/3 of the population, the extra bands seen on the Western blot after vaccination, and the seeming re-activation of Lyme disease symptoms in some patients who were vaccinated. She concludes that we need better basic research and diagnostic tests so we can really know who has current Lyme disease and past Lyme disease, and therefore distinguish whether a vacccine works, or not. Otherwise, she says, we're "putting the cart before the horse".

I don't see anything that suggests that she would be in favor of "re-introducing" Lymerix. or any other OspA vaccine.

Dr. MacDonald, can you give me a reference for what you think her connection is, to the Boston Globe editorial? It would be peculiar for something labeled as an "Editorial", without attribution, to come from a patient advocate. Aren't such items usually written by the staff editor(s) of the newspaper in question? (I'm not very conversant with newspaper journalism practices, so if I'm off base on this, please let me know.) If she sent the editorial to you just to call your attention to it, that might account for the discrepancy. Your seeming attribution of its authorship, to her, has already been repeated on another forum, with you cited as the trusted source, so it's important that we clear this up as quickly as possible, before it turns into a sticky rumor.

Best regards,
Lorima
"I have to understand the world, you see."
Richard Feynman

Henry
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Re: Dr Philip Baker and the Lymerix misadventure

Post by Henry » Thu 12 Jul 2012 15:46

A more rigorous and instructive explanation of two-tiered testing and the diagnosis of Lyme disease may be found in the chapter by Dr. Barbara Johnson entitled, "Laboratory Diagnostic Testing for Borrelia burgdorferi infection" in "Lyme Disease: An Evidence-Based Approach" , edited by J.J. Halperin, CABI, 2011, pp 73-89. Copy write law prohibits me from reproducing it here. But, it makes much more sense than the subjective account provided by Weintraub.

RitaA
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Re: Dr Philip Baker and the Lymerix misadventure

Post by RitaA » Thu 12 Jul 2012 18:27

Lorima wrote:(Note to bystanders: it's important that we know whether Sheila Statlender is involved with this editorial, because she is one of the patient advocates prominently featured in journalist/patient Pamela Weintraub's book "Cure Unknown", a thoroughly referenced history of the Lyme epidemic published in 2008. In the book, Dr. Statlender explains how in 2002 she and her husband, an MD, collected the research articles that describe the formulation of the two-tier test, read them, and realized they'd "been had". As have many others, I had come to a similar realization, by a similar route of collecting and reading the foundational literature, in 2007, a year before the book was published. So I got a kick out of seeing the process of research, insight, and consequent sense of betrayal described so well in the book. You can find it in the short chapter 23, "A Devastating Realization", in Cure Unknown.)

[snip]

Dr. MacDonald, can you give me a reference for what you think her connection is, to the Boston Globe editorial? It would be peculiar for something labeled as an "Editorial", without attribution, to come from a patient advocate. Aren't such items usually written by the staff editor(s) of the newspaper in question? (I'm not very conversant with newspaper journalism practices, so if I'm off base on this, please let me know.) If she sent the editorial to you just to call your attention to it, that might account for the discrepancy. Your seeming attribution of its authorship, to her, has already been repeated on another forum, with you cited as the trusted source, so it's important that we clear this up as quickly as possible, before it turns into a sticky rumor.

Best regards,
Lorima
Hi Lorima, Dr. MacDonald and bystanders,

I have a personal interest in Dr. MacDonald's response since I'm the one who posted the editorial on another forum. I'll make the correction on the other forum regarding the author of the editorial momentarily, but I did want to point this out first in case anyone missed it:
CORRECTION TO ORIGINAL POST:

Sheila M. Statlender, Ph.D.
Clinical Psychologist, DID NOT AUTHOR THE ABOVE.

HER REMARKS ABOUT LYME VACCCINATION MAY BE FREELY VIEWED
ON THE WBUR WEBSITE - PANEL DISCUSSION WITH DR THOMAS MATHER - APPROX 60 MINUTES LONG

Last edited by inmacdonald on Thu 12 Jul 2012 5:49, edited 1 time in total.
My thanks to you for pointing this out, Lorima, and to Dr. MacDonald for setting the record straight. It's important we don't contribute to the misinformation so readily available on the internet.

Cheers,

Rita A

Lorima
Posts: 914
Joined: Mon 29 Oct 2007 20:47

Re: Dr Philip Baker and the Lymerix misadventure

Post by Lorima » Thu 12 Jul 2012 22:20

Thanks, Rita, I did miss Dr. MacDonald's correction up there to his previous post.

Thanks, Dr. MacDonald, for correcting.

Henry...oh dear. I hardly know what to say about Barbara Johnson [the CDC scientist, not the same as Lorraine Johnson, the patient advocate]. Or about your assessment of the rigor of her approach vs Pamela Weintraub's. (By the way, the short chapter in Cure Unknown I referenced regarding Dr. Statlender is not the only thing in the book about the two-tier test. See, for example, Chapter 17, which is thoroughly referenced to the medical literature, and describes in detail the test's questionable genesis, and the nature of its flaws.)

I saw Barbara Johnson's presentation at the IDSA hearings, and I've read several papers on which she's an author. I can't agree that she is more objective than Weintraub. Barbara Johnson's output seems to depend wholly upon faithfully executing the role she's been assigned within the hierarchy of Lyme disease policy-makers and academics. This team is admirably well-organized and efficient. I'm not sure whether their obedience is conscious or unconscious, but it's remarkably tight. Unfortunately they're propagating a vision that is sadly at odds with the physical reality of the disease, which patients can't avoid experiencing, though they'd love to. I live in a highly endemic area, and my observation of the disease and its politics matches that of Weintraub, not Barbara Johnson and her team.

There's nothing objective or scientific about faithfully repeating what you've been told, no matter how august the reputation of the teller.

Beyond the student stage, it's best to give up the idea that one can reliably assess a medical controversy by simply "believing in" whoever has the most power, prestige, influence, etc. Of course, one shouldn't expect everyone to be willing to take on the thankless role of the whistle-blower when that's what is needed. But I think it should be within everyone's capability to stay out of the fight, if they don't have the time or inclination to investigate the situation "on the ground", where the patients live. Maybe you're a member of the Lyme establishment team, though - in that case, I'm sure there's nothing I can say to persuade you to listen to the patients, so my response will have utility only for others.

I could go through the errors in the foundational papers that reveal the flaws in the two-tier test, but I don't think that would help Henry understand, and I think the rest of us know about it already. For me, the most damning paper with regard to the CDC's role in legitimizing the test, is the relatively obscure Craven et al., 1996. I haven't seen anyone else, including Weintraub, discuss it. If anyone is interested in going over it with a fine-toothed comb, let me know and we can start another thread in the Science category.

http://www.ncbi.nlm.nih.gov/pmc/article ... 903216.pdf

Emerg Infect Dis. 1996 Apr-Jun;2(2):136-40.
Improved serodiagnostic testing for Lyme disease: results of a multicenter serologic evaluation.
Craven RB, Quan TJ, Bailey RE, Dattwyler R, Ryan RW, Sigal LH, Steere AC, Sullivan B, Johnson BJ, Dennis DT, Gubler DJ.
Source
Centers for Disease Control and Prevention, Fort Collins, Colorado, USA.
PMID: 8903216 [PubMed - indexed for MEDLINE] PMCID: PMC2639820

Best regards,
Lorima

[Edited to give a better article link, and to distinguish Barbara Johnson from other Johnsons.]
Last edited by Lorima on Fri 13 Jul 2012 0:02, edited 2 times in total.
"I have to understand the world, you see."
Richard Feynman

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