Transcript Document

2007 RRP Focus Session
International RRP ISA Center
Presented by
Michael D. Green, MSW, LICSW (2001-7)
September 15, 2007
Washington D.C.
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Who We Are
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RRP ISA’s mission is to better the lives of RRP
patients and families by providing Information,
Support and Advocacy (ISA) to the RRP
community, physicians and researchers.

We are a non-profit 501(c)(3) organization. We are
considered a charitable foundation by the IRS.
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Information, Support and Advocacy (ISA):
What We Do
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Maintain a very active website and message board;
issues with website to be fixed shortly.
Provide patient counseling and case-management;
Organize RRP-related conferences, Funding
research into the causes and treatment of RRP.
Maintain large online survey/database (135
questions, hundreds of respondents).
See brochure for more.
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Policy Board
Up to 9 individuals
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Scientific Advisory Panel
Bettie Steinberg, PhD
Tom Broker, PhD
Keerti Shah, PhD
Richard Schlegel, MD, PhD
Robert Horlick, PhD
Farrel Buchinsky, MD
Robert Bastian, MD
Ben Heath, PhD
Vincent Bonagura, MD
Lisa Orloff, MD
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A Few of Our Research Efforts
Thwart
HAMLET
Erbitux & p53 Drugs
Cidofovir Pro-drugs (HDP)
AAV2
Maura Gillison-Hopkins
Aerosol and Ventricle Issues*
Amolimigene
TA-CIN TA-HPV (Xenova) Alum
Outpatient Laser Surgery (5 options)
Merck/ACIP Gardasil*
Artemisinin*
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More on Gardasil
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VLP-based vaccine (used viral coat proteins
only)
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Confers near-total immunity against HPV 6, 11,
16 & 18 (Koutsky et al., [list publication, or
“verbal communication”]
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Merck used reproductive tract data as main data
source to generalize regarding therapeutic
efficacy elsewhere in the body.
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Merck’s Research Conclusions
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Since Gardasil had no treatment effect in the
reproductive tract, it was inferred that it couldn’t
be effectively used in treatment anywhere.
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Since Gardasil was a VLP, it was unlikely to be
useful in treatment (reasoning based on
assumption that VLPs aren’t useful
therapeutically).
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Dr. Ian Frazer, et al
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Dr. Ian Frazer, the immunologist widely credited with
inventing Gardasil, has said that VLPs can be used
therapeutically.
Dr. Frazer is currently using a VLP treatment RRP
vaccine in Brisbane and China.
Similar to Gardasil but without the alum adjuvant.
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More on VLPs today from Richard Schlegel, MD, PhD.
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What Does the AIDS Data Tell Us?
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AIDS patients get all kinds of opportunistic
HPV-infections except HPV of the respiratory tract
(RRP).
Most AIDS treatment centers have never even
heard of RRP.
For AIDS patients, the incidence of RRP is the
same as in normal patients.
Something seems to allow AIDS patients to
clear HPV in the respiratory system but not
elsewhere in the body.
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Logical Conclusions
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The respiratory system functions differently
from the reproductive system, at least in AIDS
patients. Local immunity seems to be enough for
AIDS patients to clear HPV in the respiratory
system.
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The assumption that reproductive data maps to
the respiratory system is highly questionable,
given the AIDS data.
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Another Look at Gardasil
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Perhaps low cytotoxic potential (alum issue) but
we can’t say it has none.
We really don’t know. High level staff at Merck
have in fact already conceded this point.
At the levels to which Gardasil boosts
immunity—hundreds of times over baseline—it
may have an unknown effect on the local
immune system in ways we don’t yet understand.
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Can Gardasil help RRP patients??
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Interesting Case Study of ONE
Has used cidofovir, MMR, Accutane (isotretinoin),
PDT, interferon, Acyclovir, I3C, DIM and many
different alternative approaches. Never had a 3-4 month
period time without some re-growth.
Since February 2006, voice has been strong except for
the residual effect of ~60 surgeries. Since early 2006,
there has been no regrowth.
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What was done differently? Artemisinin
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Abundant literature showing that artemisinin
can act as a potent cytotoxic agent against HPVinfected cells.
Dr. Schlegel’s Georgetown research with dogs.
Began using artemisinin myself in February
2006.
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Results of Using Artemisinin
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No symptoms (no hoarseness) indicative of
generalized necrosis. Likely it didn’t cause kill all
the HPV-infected cells.
Minimal side-effects.
Repeated use of artemisinin every 4-6 weeks.
Voice sounds fine, NO regrowth.
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Gardasil
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Not satisfied with only one moving variable, in July
2006, this subject also began taking Gardasil.
Believed what I was told, i.e., that it had no therapeutic
effect.
After the second injection, voice was even stronger.
People who knew me remarked on it.
Placebo? Who knows? Began questioning Merck’s data.
Could Gardasil have “turned on the lights” at the local
immunologic level? Could artemisinin also be helping
as a cytotoxic agent? Two different variables. Who
knows?
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Pilot Study and Next Steps
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Physician inquiries have been made on this from as far
way as South Korea and Canada. Pulmonary use???
I believe that a pilot study on the Gardasil/artemisinin
combination is urgently needed to find out whether it
works.
Multi-institutional study? Pilot study? Georgetown
University is interested. Others? RFP could be vetted
through Lancet, Laryngoscope and other journals.
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Cautions
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People should NOT experiment with
artemisinin-like drugs, like artemether, on their
own. Neurotoxicities and hearing loss have been
reported in literature with artemether at high
doses.
Artemisinin, however, is one of the most widely
used drugs in the world for malaria; it can be
used quite safely with appropriate medical
supervision.
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More Cautions
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IRB is absolutely required—there have been
problems with some adjunctive treatments that
irresponsibly reassure patients on safety but skirt
need to develop IRB.
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More on website and RRP Support Forum.
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HPV Education Initiative
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RRP ISA has also tried to spread the word for
high profile public education on HPV.
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In our opinion, this isn’t being done very well at
the present.
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No excuse, now that preventative vaccine are
available.
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The Cervical Cancer/Genital Wart
Obsession
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HPV 6, 11 and 16 (the latter only rarely) cause RRP.
One manufacturer, however, dismissed the import of
RRP when it declined to include HPV 6 & 11 in its
prophylactic vaccine, saying they related to genital
warts. Is the name “Cervarix” not gender-biased?
Merck shows only two HPV-caused diseases
(http://www.gardasil.com). It shows cervical cancer &
genital warts. On http://www.hpv.com, also by Merck,
RRP in fact shows, along with cancer of the female
genitalia and cervix, but a whole host of non-gender
based cancers do not appear.
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HPV: Carcinogenesis and epidemiology
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Excluding non-melanoma skin cancers, 6-10% of the estimated
nine million cases of cancer worldwide per year may be
attributable to HPV infection.
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20-24% of all cancers in women from Latin America, Southwest
Asia, and Sub-Saharan Africa are attributable to HPV.
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HPV role demonstrated in cancers of: cervix, anus, rectum,
penis, oropharyngeal tract, larynx and aerodigestive tract, nonmelanoma skin cancers.
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*The current status of development of prophylactic vaccines against human
papillomavirus infections. Technical meeting report, Geneva, 16-18 February,
1999.
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Other Cancers & HPV
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rectal cancer, >50% of all anogenital cancers; 40,000 cases/yr
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penile cancer, 70%; 1,400/yr
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oropharyngeal cancers, 20%
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larynx and aerodigestive tract, 10%
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esophageal cancer 2.5/100k in US, but >200/100k in some
countries
Submitted courtesy of Robert Horlick, PhD (Geneva data/PowerPoint)
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Other HPV/Cancer Data
Johns Hopkins says 25% of head and neck
cancers are caused by HPV.
 Almost all of it in non-smokers/nondrinkers may be.
 Recent data at several institutions
worldwide shows up to 50% of breast
cancers.
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See RRP Support Forum for citations.
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What Can Be Done to Educate
People?
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We have presented on this issue repeatedly in our RRP
Support Forum. We testified at the CDC/ACIP hearing
on Merck’s behalf in Atlanta, and we have talked many
times with high level Merck staff. It isn’t that the FDA
forbids education but it is possible that the big pharma
lawyers think that it does.
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It is clearly not sufficient to rely on the pharmaceuticals.
If they are not interested in mounting a vigorous
educational campaign that includes RRP and other
forms of cancer besides cervical, what can we do?
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Think Outside the Box
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“Outside the Box” was RRP ISA’s subtitle to the last
RRP Focus Session it facilitated in Los Angeles, 2005.
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Starting today, we are inviting cooperation with the
RRPF, the RRP Taskforce, the Papillomavirus Society
and a host of cancer coalitions.
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It is time for a broad-based educational initiative. It is
time to break through the media silence on HPV.
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RRP Support Forum and Website
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More information on HPV, education, RRP
treatment approaches, etc. is on the website
(www.rrpwebsite.org) and our RRP Support
Forum (http://rrpisa.tribe.net/).
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Handouts of forum materials are in back with
brochure.
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