NY Times article on disease and disease risk testing
Kathleen
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Subject: NY Times article on disease and disease risk testing
Date: Thursday, April 13, 2006 02:43:26 [View Source]
Dear New York Times,
Regarding your article on medical diagnostics (below):
There's an entire world out there of disease testing
which has been twisted, spun, abused, by certain
individuals associated with Yale University, namely,
the members of the "American" Lyme Disease Foundation
(www.aldf.com), Tufts, New York Medical College, and
Harvard.
Specifically, the diagnosis of "Lyme disease" was spun
by Allen Steere to falsely qualify Yale's LYMErix
vaccine and to assure that almost all NIH and CDC
grant money is given only to persons who agree that
"Lyme disease" is an inflammatory arthritis in a knee
rather than a borreliosis (permanent nerve and brain
infection). You can see what was done with the
testing for Lyme disease here:
http://www.fda.gov/ohrms/dockets/ac/01/slides/3680s2_11.pdf
I recommend getting the full text journal article
published by Allen Steere and Frank Dressler that is
contained in the CDC's Dearborn conference booklet,
which is this one:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=8380611&query_hl=3&itool=pubmed_docsum
because that Steere article is not at all like
Steere's first assessment of what the blood testing of
Lyme looks like:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=3531237&query_hl=5&itool=pubmed_docsum
And CDC agreed in 1990 with that:
http://actionlyme.org/CDC_DOCUMENTS_1990.htm
And you can see, Mark Klempner, formerly of Tufts,
found that there is a genetic susceptibility to the
Multiple Sclerosis version of Lyme disease, but that
finding was never reported to the press or anyone
other than the not-too-bright attendees of a medical
conference in Rhode Island in 2001:
http://actionlyme.org/Klempner_DQB1_0602.html
Klempner found a significant portion of persons who
have chronic "seronegative" Lyme have the Multiple
Sclerosis, Lupus, and narcolepsy haplotype
HLA-DQB1*0602- which is associated also with immune
incompetence, and is also associated with more severe
forms of tuberculosis. Tuberculosis is caused by the
fungus, Mycobacterium tuberculosis. LYMErix, or OspA,
is a fungal type triacyl lipopeptide with a Pam3Cys
union between the lipid and the protein portion, and
as you can see from my website, the homepage, chronic
exposure to these kinds of fungal lipopeptides is
associated with immune suppression.
A copy of that audiotaped Klempner conference is in
the office of the DCF-Rowlandgate US Attorney Kevin
O'Connor, in New Haven, CT. In other words, my claims
are verifiable. Mark Klempner made those statements.
Mark Klempner also found that the new Steere version
of a positive blood test for Lyme was only 4%
accurate, while Steere himself found his own blood
testing standard to be only 72% accurate for people
with full blown Lyme arthritis (and his genetic
haplotype). Steere never assessed his own test for
the neuroborreliosis version of Lyme.
New York Medical College's Gary Wormser found the
Steere method to be only at best 25% accurate. You
can find these links to the scientific journal
articles which support my claims linked from my
website.
http://actionlyme.org (see the navigation bars)
All of that means Chronic Lyme is associated with
Chronic Lyme, or, that because Lyme is a relapsing
fever borreliosis, Lyme becomes "seronegative." These
borreliae shed lipoproteins; people with chronic Lyme
no longer make antibodies to Lyme after a while.
(Google "bacterial star wars")
Therefore, there is an entire bogus testing industry
out there, including the placement of Mark Klempner
and Alan Barbour - two major participants of this Lyme
disease testing FRAUD - as the heads of CDC Level 4
bioweapons labs, who know Chronic Lyme is Chronic
seronegative Lyme, but who have consistently lied to
the press and in the scientific journals in more
recent history, and have even gone so far in this
cover up, as to falsely pretend these poor thing FRAUD
"scientists," especially Allen Steere, are the
"victims."
I mean in particular to point out your NYTimes
magazine article by David Grann,
http://www.vaccinationnews.com/DailyNews/June2001/StalkDocSteereReLymeDis.htm
because I myself talked to David Grann in Albany, when
we were lobbying for Medical Board reform and the end
to the persecution of MDs who treat Lyme as if it is a
relapsing fever borreliosis. Which it is.
What I told Grann was basically what I told the FDA 4
months earlier (Jan 2001), yet Grann never mentioned
we were hardly "stalking Allen Steere," if we were
lobbying in Albany, giving testimony to the FDA,
exposing this fraud to the right people, and attending
Lyme disease public hearings in Hartford, in
Washington, in front of Congress, and the like.
Therefore, we Lyme victims would appreciate it if the
NY Times would expand your "medical diagnostics as a
new industry" inquiry to do a better explainer on what
is a VALID METHOD, according to FDA rules, because as
you can see, the 1991 Yale method to diagnose Lyme
meets those METHOD VALIDITY requirements:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=1894359&query_hl=6&itool=pubmed_docsum
It's patented in the US under Patent No. 5,618,533.
What the Method Validity rules are, are easy to look
up, or you can have one of your writers simply call
the FDA and have someone there explain it to you.
Lyme and tick borne diseases were seen as a "gold
mine," in vaccines and test kits by the participants
of this ALDF cabal. I explained it all to George
Pataki in the summer of 1999. I explained it to NY AG
Eliot Spitzer's staff at the same time. Spitzer's
office alluded to my suggesting this problem to the US
Attorney's office, because, as they told me, Spitzer
would have to protect the illegal and incompetent
behavior of the New York OPMC (Medical Board).
Eventually I did just that:
http://actionlyme.org/USDOJ_COMPLAINT_RICO.htm
even though it should have been CT AG Blumenthal's or
Spitzer's job to do and not mine.
Here is more data on who is a venture cap investor in
this fraud:
http://actionlyme.org/ALDF_BOARD.htm
I'd love to know what Mort Zuckerman was told. Can
you have David Grann stalk Ol' Morty for us, and find
out?
Thanks,
Kathleen M. Dickson
23 Garden Street
Pawcatuck, CT 06379
860-599-5451
==========================================
The New York Times
April 13, 2006
A Crystal Ball Submerged in a Test Tube
By ANDREW POLLACK
When her hairdresser asked her last fall whether she
would continue wearing her hair long, Elizabeth Sloan
broke down crying. Unbeknown to the hairstylist, Ms.
Sloan had recently had a breast tumor removed and was
expecting to begin chemotherapy, which would probably
mean losing her hair.
But later that day, Ms. Sloan received the results of
a new $3,500 genetic test, which indicated that her
cancer probably would not come back even if she
skipped chemotherapy.
"It was a huge relief," said Ms. Sloan, 40, a mother
of two young boys who lives in Manhattan. "I did not
want to napalm-bomb my body with chemicals."
The test taken by Ms. Sloan, known as Oncotype DX and
offered by a company called Genomic Health, is part of
a new wave of sophisticated genetic or protein tests
that are starting to remake the diagnostics business,
both for the technology they use and the way they are
developed and sold.
Traditionally regarded as a low-profit, poor cousin of
prescription drugs, diagnostic tests are emerging as
high-profit products in their own right. Test
developers are "trying to do what pharmaceutical
companies have done with their drugs," said Jondavid
Klipp, managing editor of Laboratory Industry Report,
a newsletter.
Unlike the conventional $10 cholesterol or blood sugar
test, the new tests are expensive, often
patent-protected and are marketed directly to doctors
or in some cases patients instead of to medical
laboratories. The effectiveness of some tests is being
assessed using clinical trials, as Genomic Health has
done with its Oncotype DX.
The company's test could receive new attention as a
result of a major medical journal study, published
yesterday, which found that women with a certain kind
of breast tumor might not benefit from chemotherapy.
Genomic Health's test could potentially be used for
further screening by such women and their doctors.
But the trend toward such high-priced tests, many of
them not yet covered by insurance, is raising concerns
in some quarters that diagnostics could become a new
contributor to rising health care costs - while
increasing the gap between people who can afford good
health care and those who cannot.
In any case, the new generation of tests represents
some of the first fruit of the long-anticipated genome
revolution and could help pave the way to personalized
medicine, in which treatments would be tailored for
each therapy, potentially making them more effective
and less costly. Such tests are either now available
or being developed for purposes like detecting cancer
early, monitoring heart transplants and choosing which
drugs might work best to treat cancer, AIDS or heart
disease.
Within its industry of genetic testing - a business
now estimated at $5 billion and growing by 25 percent
annually - Genomic Health is being seen as a model.
"They are raising the tide for everyone else," Jorge
Leon, the president of Leomics Associates, a
diagnostics consulting firm, and the acting chief
science officer at Orion Genomics, which is developing
tests to detect cancer. He said Genomic Health had
done a "fantastic" job of validating its test using
clinical trials and then of "packaging it in a
Starbucks package at a high price."
Kleiner Perkins Caufield & Byers, the prominent
Silicon Valley venture capital firm that provided
early financing for Genomic Health before it went
public last year, is now backing four other companies
with the same business model, said Brook Byers, a
partner. But some experts are concerned that Genomic
Health and companies with similar business models
perform all the testing in their own laboratories,
rather than selling or licensing the tests to a
variety of hospital and commercial labs. That makes it
difficult to measure a laboratory's reliability by
comparing it with others, and it lowers the pressure
to improve the test.
"I don't think having a sole provider of a medical
service, a test, is in the best interest of public
health," said Dr. Debra Leonard, a professor of
pathology and laboratory medicine at Weill Medical
College of Cornell University. "It can't be validated
by other people. And there's no making the test
better. And there's no competition on pricing."
The Food and Drug Administration has also become
concerned that such tests are not properly regulated.
Tests done by a single laboratory are currently
classified as laboratory services and do not usually
need F.D.A. approval, unlike test kits that are sold
to hospitals and doctors. But the F.D.A. has sent
letters to some providers of these tests saying that
tests used to diagnose disease may legally be
considered medical devices and require agency
approval.
One such test, to detect ovarian cancer, is still not
on the market two years after its developer,
Correlogic Systems, received such a letter from the
F.D.A. Genomic Health got a letter in January, raising
at least the prospect that its test may have to come
off the market while it undergoes F.D.A. review.
Randy Scott, co-founder and chief executive of Genomic
Health, said the company was in discussions with the
F.D.A., but he would not comment further.
Many testing laboratories say that requiring F.D.A.
approval at the outset would make it uneconomical to
develop many tests, which have smaller sales than
drugs. Genomic Health, for example, performed only
about 7,000 tests in 2005, the second year the test
was offered. And it is still losing money.
"I'm not sure we could exist at all if we were
required up front to have F.D.A. approval," said Mr.
Scott. He said that, industrywide, there were hundreds
of genetic tests, only a handful of them approved by
the F.D.A.
Mr. Scott also said that the price of the Oncotype
test might not be much of a barrier. "We didn't see
much price sensitivity once you get above $1,000," he
said.
He and others in the industry argue that diagnostics
account for only a few percent of overall health care
spending but have a potentially great impact. Mr.
Scott said the Oncotype test could save money over all
by allowing many women to skip chemotherapy, which can
cost $20,000 or more.
In deciding to finance Genomic Health and similar
companies, Mr. Byers, the venture capitalist, said,
"we went and looked at decisions that would lead to
expensive treatments and for which there is little
information."
Another company Mr. Byers is backing, XDx, offers a
$3,000 blood test that analyzes whether a transplanted
heart is being rejected. Such a test may be able to
substitute for the heart biopsies now used to test for
rejection, which themselves cost several thousand
dollars and are invasive.
Genomic Health, which is based in Redwood City,
Calif., is not the first company to offer a
high-priced genetic test as a laboratory service.
Myriad Genetics of Salt Lake City has been offering a
patent-protected test for the risk of developing
breast cancer since the late 1990's. It charges $3,000
for the most thorough version.
At an investor conference in January, Peter Meldrum,
Myriad's chief executive, extolled the
"pharmaceutical-like" profit margins on the breast
test and three other cancer risk tests. Myriad's
testing sales reached $71 million in the fiscal year
ended June, 2005, up 75 percent from the previous
year.
Monogram Biosciences, based in South San Francisco,
Calif., offers tests costing up to $1,460 that help
doctors tell which drugs would be best to use for a
particular patient infected by the AIDS virus. It had
$48 million in revenue last year.
Not all such tests succeed. Exact Sciences has
experienced slow sales of a $500 DNA test, performed
on a stool sample, that screens for colon cancer. Eric
Book, chief medical officer of Blue Shield of
California, said Blue Shield decided not to pay for
the test, in part because it appeared little better
than a $5 test that looks for blood in the stool.
Exact Sciences maintains its test is better, although
it is working to improve it.
Genomic Health, though, expects about 70 percent
growth in sales of its Oncotype DX tests this year, to
12,000. The stock closed yesterday at $9.92, down from
the $12 initial public offering price.
Oncotype DX is only for women whose tumors' growth is
fueled by estrogen and has not spread to lymph nodes.
That accounts for about half of the 230,000 cases of
breast cancer diagnosed in the United States each
year, according to Genomic Health.
Previous clinical trials have shown that after the
tumor is surgically removed, 85 percent of such women,
even without chemotherapy, will not have a recurrence
within 10 years if they take tamoxifen, a hormone
therapy. But because there has been no good way to
determine who among the estrogen-sensitive cancer
patients might benefit from chemotherapy, many women
have taken the treatments anyway, exposing themselves
to needless toxicity. Genomic Health is promoting the
Oncotype DX test as the way for those women to better
gauge their prospects.
In January, the company won approval for reimbursement
for its test for most Medicare patients. But many
insurers still do not reimburse for the test. Last
year, a committee that evaluates technology for Blue
Cross Blue Shield said Genomic Health had not
adequately demonstrated a medical benefit.
Ms. Sloan, of Manhattan, is still working on getting
reimbursement from Oxford Health Plans.
Mary Sullivan, who is 47 and lives in Lido Beach,
N.Y., had the test early in 2005. She said she was
still trying to obtain reimbursement from her insurer,
UnitedHealthcare, which in a letter to her termed the
test "unproven."
Ms. Sullivan said it took more than two months to get
her test results back from Genomic Health, instead of
the two weeks advertised, because additional samples
of her tumor were needed. By then, she said, she and
her doctors had already decided to skip chemotherapy.
The test later classified her as low risk for
recurrence.
Ms. Sullivan said she and her husband had wanted all
the information possible to deal with a life-or-death
situation. "We were going to go through with it
whether the insurance company would pay for it or
not," she said.
Other companies are hoping for similar patient demand.
In February, Aureon Laboratories, a start-up in
Yonkers that has attracted investment from Pfizer as
well as Becton, Dickinson & Company, began offering a
$2,000 test that combines protein analysis, pathology
and other measurements and uses a computer algorithm
in an effort to predict recurrence of prostate cancer.
Asked about the price, Rob Shovlin, Aureon's executive
vice president for sales and marketing, replied, "It's
less than the Genomic Health price of $3,500."
He added, "Patients have given us feedback that they'd
be willing to pay more than that to have this
information."
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