#4 Letter from Shepler to CMA of 3/6/03

[Guest guest]

Below is a letter to Hanson, the attorney who is in charge of the

legal office at CMA.

Lynn

------------------------

Subj: CSA recommendation on Lyme disease

Date: 3/6/2003

<A HREF= " mailto:chanson@... " >chanson@...</A>

CC: <A HREF= " mailto:jlewin@... " >jlewin@...</A>, <A

HREF= " mailto:adsiefkin@... " >adsiefkin@...</A>

File: C:\My Documents\LDA ConflictsofInterestinLymeDisease.doc (880128

bytes) DL Time (505581 bps): < 1 minute

Dear Ms. Hanson:

I am writing to call your attention to serious irregularities that occurred

in CSA's formulation of the policy recommendation on Lyme disease. This

involves the failure by multiple parties to disclose their financial

conflicts of interest concerning this disease prior to CSA formulating a

recommendation. This policy on Lyme disease should be invalidated due to CSA

members or their representatives failing to adhere to the organization's

rules on financial disclosure.

As noted in the attached report compiled by the Lyme Disease Association,

there are two models of the disease: the business model of Lyme disease, and

what is the true, unvarnished version of the disease. CMA is being

manipulated into adopting the business model of the disease. Note that CMA

would have no reason to be concerned about such a circumstance because CMA

has not been apprised of these scientists' ties to industry.

In terms of the substantive materials that CSA was provided, CSA was

manipulated in terms of what was disclosed (medical literature was cherry

picked for articles promoting industry's version of the disease) and what was

*not* disclosed.

For example, CSA was not apprised about the manner in which policies such as

this have been used in other states to harass practicing physicians who do

not agree with the industry model. Industry scientists have appeared as

witnesses against practicing physicians in actions before state medical

boards. In formulating a policy, CMA needs to have a clear understanding

about the potential misuses of any recommendations about this disease.

CSA was also not apprised about how these policies are used by industry

scientists to reinforce their business model as the standard of care through

their alliances with insurance companies. Policies such as what CSA is

proposing have been used to cut off patients' access to treatment. The

business model of Lyme disease serves not only pharmaceutical companies

involved in Lyme disease vaccine development, but also insurance companies

that want to find reasons to cut costs. If CMA adopts any recommendation

related to Lyme disease, the organization needs to understand its potential

for misuse by insurance companies.

FAILURE BY CSA MEMBERS AND THEIR REPRESENTATIVES TO DISCLOSE FINANCIAL

CONFLICTS OF INTEREST

The process by which the Lyme disease policy was adopted shows a failure to

disclose financial conflicts of interest at multiple levels: (1) individual

physicians having input into the committee failed to disclose their ties to

industry and/or their status as inventors on Lyme disease patents; (2) UC

faculty failed to disclose the university's financial interest in the disease

as evidenced by the Lyme vaccine patents owned by UC, and advertised as

available for licensing on the UC website; and (3) authors of the

peer-reviewed articles cited by CSA contributors failed to disclose the

authors' conflicts of interests to the respective journals.

Lovett, MD of UCLA responded on behalf of CSA Internal Medicine

Scientific Committee member, Alan Fogelman, MD. Dr. Lovett appears not to

have disclosed that he is a named inventor on three patents for Borrelia

antigens that can be used in Lyme disease vaccines. This total does not

reflect a search of the world patent literature, but simply what can be found

using the search engine on the website for the U.S. Patent and Trademark

office (www.uspto.gov).

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=1 & f=G & l=50 & co1=AND & d=ptxt & s1=Lovett.INZZ. & s2=Borrelia\

& OS=IN/Lovett+AND+Borrelia & RS=IN/Lovett+AND+Borrelia " >6,153,194</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=1 & f=G & l=50 & co1=AND & d=ptxt & s1=Lovett.INZZ. & s2=Borrelia\

& OS=IN/Lovett+AND+Borrelia & RS=IN/Lovett+AND+Borrelia " >Borrelia burgdorferi outer

membrane proteins </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=2 & f=G & l=50 & co1=AND & d=ptxt & s1=Lovett.INZZ. & s2=Borrelia\

& OS=IN/Lovett+AND+Borrelia & RS=IN/Lovett+AND+Borrelia " >5,854,395</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=2 & f=G & l=50 & co1=AND & d=ptxt & s1=Lovett.INZZ. & s2=Borrelia\

& OS=IN/Lovett+AND+Borrelia & RS=IN/Lovett+AND+Borrelia " >Cloned borrelia

burgdorferi virulence protein </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=6 & f=G & l=50 & co1=AND & d=ptxt & s1=Lovett.INZZ. & s2=Borrelia\

& OS=IN/Lovett+AND+Borrelia & RS=IN/Lovett+AND+Borrelia " >5,558,993</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=6 & f=G & l=50 & co1=AND & d=ptxt & s1=Lovett.INZZ. & s2=Borrelia\

& OS=IN/Lovett+AND+Borrelia & RS=IN/Lovett+AND+Borrelia " >Cloned Borrelia

burgdorferi virulence protein </A>   

Licensing agreements vary, but my understanding is that inventors typically

receive 1% of the revenues generated by a product.

Wall Street analysts expected the most recent Lyme vaccine (Kline

Beecham's LYMErix) to generate $120 million in revenue the first year it was

on the market. Inventors would thus split $1.2 million -- just for the first

year.

Alan Barbour, MD of UC Irvine was named by members of the CSA as the foremost

expert on Lyme disease, and a possible representative for CMA on the Lyme

Disease Advisory Committee -- an advisory committee of the California

Department of Health Services.

Barbour was one of the named inventors for the ospA antigen used in LYMErix.

He would be among those who split the projected $1.2 million.

Barbour is the named inventor on over 85 patents involving possible Lyme

vaccines. NOWHERE IS IT MENTIONED IN ANY MATERIALS FROM CSA THAT BARBOUR

HOLDS SUBSTANTIAL FINANCIAL INTERESTS IN LYME VACCINE ANTIGENS. Certainly

there were people on CSA who were aware. Was CSA informed?

As of last year, the search engine at Delphion.com (includes U.S. and foreign

patent offices) brought up over 85 patents under Dr. Barbour's name for

Borrelia antigens. Below are the links for twenty-five patents found at the

website for the U.S. Patent and Trademark office (www.uspto.gov). Dr. Barbour

has referred to Borrelia antigens as " a rich vein of gold. "

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=1 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,509,017</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=1 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >66 KDA antigen from

Borrelia </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=2 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,451,769</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=2 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Compositions and

methods for administering Borrelia DNA </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=3 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,437,116</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=3 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >VMP-like sequences of

pathogenic borrelia </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=4 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,300,101</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=4 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Methods and

compositions including a 13kD B. burgdorferi

protein </A><A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=5 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,296,849</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=5 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Methods and

compositions including a 13kDa B.

burgdorferi protein </A>

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=6 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,204,018</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=6 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >66 kDa antigen from

Borrelia </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=7 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,203,798</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=7 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Borrelia antigen

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=8 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,183,986</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=8 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >OspA DNA and lyme

disease vaccine </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=9 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,143,872</A>        <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=9 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borreli\

a & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Borrelia burdorferi Osp

A and B proteins and immunogenic

peptides </A><A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=10 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,090,586</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=10 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >66 kDa antigen from

Borrelia </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=11 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,083,722</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=11 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Borrelia antigen

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=12 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,077,515</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=12 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Flagella-less borrelia

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=13 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,068,842</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=13 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >66 kDa antigen from

Borrelia </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=14 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >6,054,296</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & p=1 & u=/netahtml/searc\

h-bool.html & r=14 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrelia & OS=IN/Barb\

our+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >66 kDa antigen from Borrelia

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=15 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,932,220</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=15 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Diagnostic tests for a

new spirochete, Borrelia lonestari

sp. nov. </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=16 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,850,018</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=16 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Expression control

sequence for general and effective

expression of genes in plants </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=17 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,846,946</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=17 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Compositions and

methods for administering Borrelia DNA </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=18 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,777,095</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=18 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Osp A and B Sequence

of Borrelia burgdonferi strains ACA1

and IP90 </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=19 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,688,512</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=19 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Borrelia antigen

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=20 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,585,102</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=20 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Flagella-less borrelia

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=21 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,582,990</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=21 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >DNA encoding borrelia

burgdorferi OspA and a method for

diagnosing borrelia burgdorferi infection </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=22 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,571,718</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=22 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Cloning and expression

of soluble truncated variants of

Borrelia OspA, OspB and Vmp7 </A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=23 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,523,089</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=23 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Borrelia antigen

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=24 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,436,000</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=24 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Flagella-less borrelia

</A>   

<A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=25 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >5,246,844</A>    

   <A

HREF= " http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2 & Sect2=HITOFF & p=1 & u=/n\

etahtml/search-bool.html & r=25 & f=G & l=50 & co1=AND & d=ptxt & s1=Barbour.INZZ. & s2=Borrel\

ia & OS=IN/Barbour+AND+Borrelia & RS=IN/Barbour+AND+Borrelia " >Virulence associated

proteins in Borrelia burgdorferi (BB) </A>

   

CSA does not appear to have been informed that Terkeltaub, MD is a

member of Kline Beecham's Speaker's Bureau, the company that brought us

LYMErix. Terkeltaub spends an inordinate amount of time in his lecture notes

focused on the Lyme vaccine. This is surprising given that the vaccine was

never recommended for use in California. While the Memo from the Center for

Medical Policy and Economics makes no mention of Dr. Terkeltaub's

relationship to Kline Beecham, acknowledgment of this relationship can

be found on an article he published on Lyme disease in the journal,

" Geriatrics. "

Confirmation that the UC is the owner of several patents for Lyme disease

vaccine antigens can be obtained by contacting the UC Office of Technology

Transfer.

Office of Technology Transfer

University of California

Office of the President

1111 lin Street, 5th Floor

Oakland, California 94607-5200    

Main Office Telephone: (510) 587-6000

General Facsimile: (510) 587-6090

<A HREF= " http://www.ucop.edu/ott/ " >Website: http://www.ucop.edu/ott/dev/</A>    

Sun, MD of the California Department of Health Services (DHS) is also

noted to have contributed an opinion to CSA. CSA members should be informed

that policy at DHS is controlled by Dennis, MD, head of the

Vector-Borne Disease Division at the CDC. Dr. Dennis is known to consult to

Kline Beecham and Connaught, companies involved in developing Lyme

vaccines. CSA should also be informed that the CDC itself owns patents on

Lyme disease vaccines, and is co-owner of a Lyme vaccine in conjunction with

Kline Beecham (now Glaxo).

Many believe that officials at the CDC have been coopted by industry

interests. Although the Kline Beecham vaccine (considered a " first

generation " product) has been removed from the market, there are plans for

3rd and 4th generation vaccines. A vaccine intended for the U.S. market is

presently being tested in Europe.

The articles cited in the Memo from CMA's Center for Medical Policy and

Economics appear to have been cherry-picked from the literature, and have a

clear bias in favor of industry. ALL OF THE ARTICLES REFERENCED BY CSA

CONTRIBUTORS WERE WRITTEN BY INDUSTRY-AFFILIATED SCIENTISTS WHO HAVE A

PARTICULAR AGENDA --- VACCINE COMMERCIALIZATION.

If these articles are examined, it is extremely unlikely that any of these

publications call to the attention of the reader the industry objectives at

play in the published work.

CSA members do not seem to be alert to the fact that industry and its

scientists target the peer-reviewed literature as a way to reach practicing

physicians and influence their decisionmaking.

THE BUSINESS MODEL OF LYME DISEASE IS NECESSARY TO BRING VACCINE PRODUCTS TO

MARKET

The business model of Lyme disease exists for no other purpose than to bring

vaccine products to market. It does not serve the interests of patients who

are ill with the disease, or the interests of practicing physicians. The

business model serves only the interests of industry and its scientists.

The business model of Lyme disease denies the existence of persistent

infection, and other clinical phenomenon that have been earlier acknowledged

by industry scientists. This includes the phenomenon of asymptomatic or

subclinical infection, and seronegativity.

The Lyme disease " controversy " is not a true controversy. In my opinion, it

is a PR campaign to hide the fact that industry scientists have published

studies acknowledging aspects of the disease that currently present obstacles

to vaccine development. Rather than solve the scientific problems, industry

wants to cover up this prior knowledge. They count on practicing physicians

and the public not looking at what industry scientists published ten or

fifteen years ago. Industry scientists now make false and misleading

statements about the disease. Rather than characterize this as " fraud " --- a

more apt description, in my opinion, for what is going on here -- they spin

it as a " controversy. "

Let us recall that this is a similar type of campaign waged by Hill &

Knowlton for its tobacco clients after industry became aware that its product

caused cancer. What was an increasing *certitude* about the links between

smoking and cancer, was spun as a " controversy. "

Three aspects of Lyme disease have been a focus for industry distortion: (1)

persistent infection; (2) asymptomatic or subclinical infection; and (3)

seronegativity. The same group of industry scientists that are now claiming th

ese phenomenon do not exist, have published studies in the past affirming

these findings, and/or have issued opinions that affirm the existence of

these phenomenon as reported in other studies in the peer-reviewed

literature.

It is critical to understand that it would be impossible to conduct vaccine

trials for Lyme disease if these phenomenon are acknowledged to exist. It

would also not be possible to market a vaccine to practicing physicians if

these phenomenon were acknowledged to exist. What physician would administer

a vaccine to a patient if he/she was unsure if the patient was already

infected? What IRB would approve a study that couldn't discern who was

infected with the organism, and who wasn't -- and thus whether you injected

someone with a vaccine who was already infected? The scenario is absurd. No

study that took these problems into account in its design would make it

through an IRB.

Prior to the time the vaccine trials were on the drawing board, scientists

acknowledged these aspects of the disease. This work was known. Then these

scientists began to work for industry. In reviewing the references, it is

notable that citations to these earlier studies and commentary were not

provided to CSA.

LAWSUITS AGAINST SMITHKLINE BEECHAM AND CONNAUGHT FOR VACCINE INJURIES

ALLEGING REACTIVATION OF LATENT INFECTION

Kline Beecham and Connaught have been sued for the adverse effects

caused by their vaccines. One of the mechanisms of injury alleged in these

lawsuits is that administration of the vaccine caused asymptomatic infection

(obviously, a type of persistent infection) to become reactivated.

Industry wants to define persistent infection out of existence. This is the

genesis of the push to limit patients' access to antibiotics. Antibiotics

would only be necessary if persistent infection was a problem. Industry says

persistent infection is not a problem.

At the time that I lived and worked on Cape Cod, I had a practice that

included many patients suffering from the neuropsychiatric manifestations of

late-stage Lyme disease. With a few exceptions, most of these patients were

followed by an infectious disease specialist in Boston -- Sam Donta, MD. Dr.

Donta is Professor of Medicine at Boston University. Dr. Donta has no

involvement in Lyme vaccine work. I followed approximately 100 patients with

chronic Lyme disease who were patients of Dr. Donta's. 

I have personally never seen a patient who presents with late-stage disease

respond to 30 days of antibiotics. I could not replicate the assertions of

the industry scientists in my clinical observations of these patients. The

claims are utter fiction, in my opinion. No patient responded within 30 days.

However, I observed patients beginning to respond after 90 days, and there

were notable differences for many patients after 6-12 months of oral

antibiotics. In each case where patients elected to discontinue antibiotics

or this was recommended by Dr. Donta, the patient relapsed.

The Klempner study cited in the materials provided to CSA is well known among

those who work with Lyme disease patients as a study " designed to fail. "

Klempner is someone I would characterize as an industry scientist. Klempner

works with Steere, MD who is the best known of all of the industry

scientists.

In making any policy on Lyme disease, it is *critical* that CSA be aware of

the business interests at work behind the scenes. Industry makes every effort

to cover its tracks. Industry needs to manipulate practicing physicians into

adopting the business model as the standard of practice.

If not adopted as the standard of practice, the model of the disease

contained in the design of vaccine clinical trials (i.e., business model)

would otherwise create liability for industry with respect to medical

malpractice, and their failure to adhere to federal regulations governing

human subject research. The trials would not even be possible.

As an additional example of how the trials would not be possible, part of the

business model involves underestimating the risks associated with the disease

--- i.e., the seriousness of the disease, and the probability of acquiring

it. If these risks were known to practicing physicians and the general

public, there might be a different standard related to whether antibiotics

are given prophylactically at the time of a tick bite. But note that

treatment on tick bite would make it impossible to conduct vaccine trials.

If treatment on tick bite was the *standard of care*, it would not be

possible for industry to tell whether a trial participant did not get Lyme

disease because they got the vaccine, or because they got the antibiotics. If

you look at the articles in the peer-reviewed literature by industry

scientists, these articles all come up with the conclusion that treatment on

tick bite is not the appropriate standard of care. Is this any surprise?

Physicians at CMA need to know that they are being targeted for manipulation

by industry on these points. For all I can tell, it seems that CMA is naive

to what is occurring.

In my opinion, for CMA to come up with a policy on Lyme disease, it will take

much more work because these influences of industry need to be defined, the

entire literature on the subject needs to be reviewed (not just what was

cherry-picked for CSA), and then a realistic policy would then have to be

formulated.

This is also a problematic task given that it is rare for any physician

within CMA to have Lyme disease patients in their practice. Lyme disease

patients are known to seek care from only a handful of practitioners in this

State. Physicians involved in formulating a policy have no measure in their

own clinical practices to gauge the veracity of what is being asserted by

industry scientists.       

Likely most of the contributors to the CSA policy on Lyme disease have never,

in fact, diagnosed or treated a case of Lyme disease. Given that these

physicians are recommending only a brief course of antibiotics, it is likely

that these physicians don't even have any empirical experience treating a

patient beyond thirty days. They only know what they have read, and what they

have read has been written by industry scientists.

In my opinion, the CMA should not make any recommendation concerning Lyme

disease at this time. If CMA is intent on doing so, the current

recommendation should be considered void, and a new solicitation should

begin. The current recommendation should be considered void because the

procedure did not adhere to CMA rules on disclosure.

I would be happy to discuss this matter and to answer any questions about

these concerns.

Thank you.

Very truly yours,

Lynn Shepler, MD JD

100 N. Whisman Rd., Apt. 4614

Mountain View, CA  94043

(650) 625-9041

Email: ltshepler@...