Matt's Blog

Girl hurts finger in needle box
A child has been injured after putting her hand in a box of used syringes
at a hospital in Leicester.
Shannon Taylor, aged three, was found with her hand in the needle bin by
her mother when they were visiting a friend at the Royal Infirmary.
A nurse took her to casualty for an emergency hepatitis C jab but the
family will have to wait a year to see if she has contracted HIV.
Leicester Royal Infirmary said they were investigating the incident.
Injury risk
The toddler's mother, Lisa Tubby, said: "She was kneeling down with her
hand right in the box.
"I pulled her hand out of the box, and in pulling her hand out I've
actually seen the used needles. I knew they were used because there was blood
all on them and everything.
"And it wasn't until I'd pulled her hand all the way out I realised she'd
got a little gash between her little finger and the one next to it."
In a statement, a hospital spokesperson said: "Hospitals are dangerous
places and it is vital that parents with young children closely supervise them
at all times.
"Needle disposal bins are kept close to patients to allow immediate
disposal and lower the risk of injury.
"Staff were not in the room during the incident, but once informed they
acted appropriately. The incident is being investigated."
http://news.bbc.co.uk/1/hi/england/leicestershire/6720229.stm

Event aims to educate medical workers on hepatitis C
By Andrew Dunn : The Herald-Sun
news@...
Jun 4, 2007 : 10:15 pm ET
DURHAM -- Hepatitis C is usually a silent assailant. About 80 percent of its
victims display no symptoms.
But a Durham conference today seeks to inform health care workers about this
largely unknown disease, which results in permanent liver damage.
The hepatitis C virus (HCV) is the most common chronic bloodborne viral
infection in the country, according to the Centers for Disease Control and
Prevention. About 1.8 percent of Americans have been infected.
About 150,000 North Carolinians suffer from the disease, numbers calculated from
population estimates. Though the state requires reports from cases of more than
60 other diseases, none are required for hepatitis C.
Vaccines exist for Hepatitis A and B, but not C.
Today's conference, sponsored by the Piedmont HIV Integrated Community Access
System, is part of a larger effort by PHICAS to raise awareness of this disease,
and is targeting nurses, health educators and members of community-based
organizations and faith communities.
"Here, in the Durham area, we are involved in initiatives to integrate care for
persons infected with HCV, promote education and awareness within the health
care-provider and public communities, and promote testing for HCV," Marc Kolman,
the group's director, said in an e-mail.
State Epidemiologist Jeffrey Engel will open the conference with a briefing on
infection statistics, requirements for reporting cases and ways to prevent
infections.
Kelly Zirbes, executive director of advocacy group Hepatitis C Aware, will speak
about battling the stigma the disease still carries, before several sessions
will be held by doctors on prevention and treatment.
Hepatitis C is spread by contact with the blood of an infected person.
Sharing needles is a common means of infection, though medical workers are also
at risk.
The conference, at the Hilton Durham hotel, is co-sponsored by N.C. Public
Health and the Wake Area Health Education Center.
http://www.heraldsun.com/durham/4-853591.cfm?

Nexavar Receives Fast Track Designation From The FDA For Metastatic Liver Cancer
Bayer Pharmaceuticals Corporation (NYSE: BAY) and Onyx Pharmaceuticals, Inc.
(Nasdaq: ONXX) announced today that Nexavar(R) (sorafenib) tablets has been
granted Fast Track designation by the U.S. Food and Drug Administration (FDA)
for the treatment of metastatic hepatocellular carcinoma (HCC), or liver cancer.
Nexavar was approved by the FDA in December 2005 for the treatment of patients
with advanced renal cell carcinoma (RCC).
The Fast Track program is designed to expedite the review of drug compounds for
the treatment of patients with serious or life-threatening diseases where there
is an unmet medical need for new therapeutic approaches and where the product
has the potential to demonstrate an effect on a serious or life-threatening
aspect of the condition. Fast Track designation allows a company to file a New
Drug Application (NDA) on a rolling basis as data become available. This permits
the FDA to review the filing as it is received, rather than waiting for the
entire document prior to commencing the review process. With Fast Track
designation, there may be more frequent interactions with the FDA and there may
be the possibility of a priority review, which could decrease the typical review
period.
"We are pleased that Nexavar has received Fast Track designation by the FDA for
this difficult-to-treat patient population, and we look forward to submitting
our Phase III data when the analyses are complete," said Susan Kelley, M.D.,
vice president, Oncology, Bayer Pharmaceuticals Corporation.
A Phase III trial of Nexavar administered as a single agent to patients with
advanced liver cancer is currently underway. Recently, this trial completed
patient enrollment. The study is designed to measure differences in overall
survival, time-to-symptom progression and time-to-tumor progression (TTP) of
Nexavar versus placebo. A randomized Phase II trial for liver cancer patients to
evaluate the efficacy of Nexavar in combination with the chemotherapeutic agent
doxorubicin is currently open and recruiting patients.
About Hepatocellular Carcinoma
Hepatocellular carcinoma, also known as primary liver cancer, is the most common
form of liver cancer and is responsible for 80 percent of the primary malignant
liver tumors in adults. It is the fifth most common cancer in the world. In
2002, approximately 626,000 HCC cases were reported worldwide, with 15,000 cases
in the United States and 53,600 in Europe. HCC is most prevalent in developing
countries, particularly in East and South-east Asia, the Pacific Basin, and
sub-Saharan Africa. Of the 626,000 cases worldwide, approximately 410,000 were
reported in Eastern Asia (with 346,000 in China and 40,000 in Japan alone). HCC
causes more than 600,000 deaths annually worldwide. The five-year relative
survival rate is about seven percent.
About Nexavar
Nexavar is an oral multi-kinase inhibitor that targets both the tumor cell and
tumor vasculature. In preclinical models, Nexavar targeted members of two
classes of kinases known to be involved in both cell proliferation (growth) and
angiogenesis (blood supply) -- two important processes that enable cancer
growth. These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and
FLT-3.
Nexavar has been studied in more than 20 tumor types and in more than 8,000
clinical trial patients. It has demonstrated combinability with multiple
anticancer agents. Nexavar is also being evaluated in Phase III clinical trials
for the treatment of metastatic melanoma, or skin cancer, and non-small cell
lung cancer (NSCLC). In addition to company-sponsored trials, there are a
variety of Nexavar studies being sponsored by government agencies, cooperative
groups and individual investigators.
Important Safety Considerations for U.S. Patients Taking Nexavar Based on the
currently approved package insert for the treatment of patients with advanced
kidney cancer, hypertension may occur early in the course of therapy and blood
pressure should be monitored weekly during the first six weeks of therapy and
treated as needed. Incidence of bleeding regardless of causality was 15% for
Nexavar vs. 8% for placebo and the incidence of treatment-emergent cardiac
ischemia/infarction was 2.9% for Nexavar vs. 0.4% for placebo. Most common
treatment-emergent adverse events with Nexavar were diarrhea, rash/desquamation,
fatigue, hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events
were 38% for Nexavar vs. 28% for placebo. Women of child-bearing potential
should be advised to avoid becoming pregnant and advised against breast-feeding.
In cases of any severe or persistent side effects, temporary treatment
interruption, dose modification or permanent discontinuation should be
considered.
For U.S. Nexavar prescribing information, visit http://www.nexavar.com
About Onyx Pharmaceuticals, Inc.
Onyx Pharmaceuticals, Inc. is engaged in the development of novel cancer
therapies that target the molecular basis of cancer. With its collaborators, the
company is developing small molecule drugs, including Nexavar with Bayer
Pharmaceuticals Corporation. For more information about Onyx's pipeline and
activities, visit the company's web site at: http://www.onyx-pharm.com.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (http://www.bayerpharma.com) is part of the
worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.
Bayer HealthCare AG, with sales of approximately 9.4 billion Euros in 2005, is
one of the world's leading, innovative companies in the healthcare and medical
products industry. The company combines the global activities of the Animal
Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals divisions.
Bayer Pharmaceuticals Corporation is part of the new Global Pharmaceutical
Division, established January 1, 2006, which consists of the former Biological
Products and Pharmaceutical Division and now comprises three business units:
Hematology/Cardiology; Oncology and Primary Care. Bayer HealthCare AG employed
33,800 people worldwide in 2005.
Bayer HealthCare AG's aim is to discover and manufacture innovative products
that will improve human and animal health worldwide. The products enhance
well-being and quality of life by diagnosing, preventing and treating disease.
Forward Looking Statements
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation, development
or performance of the company and the estimates given here. These factors
include those discussed in Bayer's public reports filed with the Frankfurt Stock
Exchange and with the U.S. Securities and Exchange Commission (including its
Form 20-F). Bayer assumes no liability whatsoever to update these
forward-looking statements or to conform them to future events or developments.
This news release also contains "forward-looking statements" of Onyx within the
meaning of the federal securities laws. These forward-looking statements include
without limitation, statements regarding the timing, progress and results of the
clinical development, regulatory processes, and commercialization efforts of
Nexavar. These statements are subject to risks and uncertainties that could
cause actual results and events to differ materially from those anticipated.
Reference should be made to Onyx's Annual Report on Form 10-K for the year ended
December 31, 2005, filed with the Securities and Exchange Commission under the
heading " Risk Factors" and Onyx's Quarterly Reports on Form 10-Q for a more
detailed description of such factors. Readers are cautioned not to place undue
reliance on these forward- looking statements that speak only as of the date of
this release. Onyx undertakes no obligation to update publicly any
forward-looking statements to reflect new information, events, or circumstances
after the date of this release except as required by law.
Nexavar(R) (sorafenib) tablets is a registered trademark of Bayer
Pharmaceuticals Corporation.
Bayer Pharmaceuticals Corporation; Onyx Pharmaceuticals, Inc.
http://www.bayerpharma.com
http://www.medicalnewstoday.com/medicalnews.php?newsid=45119

Modafinil's use in combating interferon-induced fatigue.
Martin KA, Krahn LE, Balan V, Rosati MJ.
Department of Psychiatry and Psychology, Mayo Clinic Arizona, 13400 East Shea
Boulevard, Scottsdale, AZ 85259, USA. martin.kariann@...
Interferon (IFN) is an effective agent in the treatment of chronic viral
hepatitis C. A variety of adverse neuropsychiatric effects including anxiety,
depression, delirium, psychoses, and mania complicates its usage.
IFN-alpha-induced depression is presumed to be composed of two overlapping
syndromes: a depression-specific syndrome characterized by depressed mood,
anxiety, and cognitive complaints, and a neurovegetative syndrome consisting of
fatigue, anorexia, somatic pain complaints, and psychomotor retardation [1]. Our
results show that depression-specific symptoms peak at 12 weeks of IFN therapy
and respond well to serotoninergic antidepressants [2]. We conclude that
neurovegetative symptoms are relatively treatment refractory to antidepressants,
occur early in the course of treatment, and tend to persist for the duration of
therapy [1].
PMID: 17318387 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=173183\
87&dopt=Abstract

Transplant doc turns right hand into left
By: thinkSPAIN
A man who lost his left hand in an accident forty years ago has had his
right hand amputated, converted into a left hand by removing the thumb and
re-attaching it next to the little finger, and grafted onto the stump of his
left arm.
The pioneering surgery was performed by Dr Pedro Cavadas at the Virgen del
Consuelo Hospital in Valencia on the 29th April.
The operation was performed after the patient, who is set to be discharged
from hospital in the next day or so, lost control of his right hand after a
stroke three years ago.
Dr Cavadas explained yesterday that the patient, who can already move his
fingers but has no sense of touch, should be able to use the hand "reasonably
well" in a couple of months' time after an intensive course of physiotherapy.
The surgeon went on to say that that it is unlikely that the man will ever
be able to use the hand "completely normally" given that forty years have gone
by since his left hand was amputated.
http://www.thinkspain.com/news-spain/13179

Liver biopsy in cirrhotic patients.
Sherman KE, Goodman ZD, Sullivan ST, Faris-Young S; GILF Study Group.
University of Cincinnati College of Medicine, Division of Digestive Diseases,
Cincinnati, Ohio 45267-0595, USA.
Liver biopsy remains an important tool for the evaluation of patients with
hepatic disease. However, clinicians utilize a variety of biopsy techniques
including automated cutting needle devices, manual cutting needles, and
aspiration needles. Using a large study cohort of patients with advanced
fibrosis/cirrhosis we sought to evaluate practices and outcomes of the biopsy
technique used by study investigators across the United States. All biopsy
samples were from patients with suspected advanced fibrosis or cirrhosis because
of hepatitis C virus (HCV) infection. Individual study investigators were
permitted to use any biopsy technique. Biopsy specimens were centrally evaluated
for tissue adequacy and fragmentation, and were histologically scored using
accepted criteria. We evaluated a total of 923 liver biopsy specimens from 502
patients performed at 62 clinical sites. The average duration of HCV infection
was 27.9 +/- 0.46 yr. Automated cutting needles were significantly more likely
to provide adequate specimens for evaluation than aspiration needles (P <
0.005). Automated cutting needles produced significantly longer biopsies than
other techniques (P < 0.05), except for a limited number of cases in which a
surgical wedge biopsy was obtained. Tissue fragmentation was observed in 39.2%
of liver biopsies obtained using an aspiration technique, but in only 4.7% of
samples collected using an automated cutting needle (P < 0.001). We conclude
that automated cutting needles provide superior liver biopsy specimens compared
with aspiration techniques in subjects with advanced fibrosis/cirrhosis. No
specific safety issues attributable to a particular biopsy method were
identified.
Publication Types:
a.. Clinical Trial, Phase II
b.. Multicenter Study
c.. Randomized Controlled Trial
d.. Research Support, N.I.H., Extramural
PMID: 17324127 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=173241\
27&dopt=Abstract

SAVE THE DATE!
The Sheraton Safari - Orlando
June 28 and 29, 2007
Hepatitis A and B are both vaccine preventable, yet there continue to be new
infections of both reported in Florida. The number of hepatitis C cases in the
United States and Florida continues to grow. Over 300,000 Floridians are
infected with hepatitis C, many of whom do not know it because they have not yet
experienced outward symptoms.
This conference agenda will address viral hepatitis issues related to
prevention, treatment, best practices in outreach and advocacy, laboratory,
cultural sensitivity and competency and epidemiology. Presentations will
include basic, intermediate and advanced information on hepatitis by renowned
national and Florida experts in the field.
Continuing education credit will be available for nurses and doctors.
Purpose of the Conference:
The conference will provide the opportunity for Floridians with an interest in
hepatitis and those who work with Floridians at risk of disease the opportunity
to learn more about the disease, what's new in treatment, services available to
those who think they are infected, updates on hepatitis A, B and C, how to
provide support and care for a friend or family member that is infected and
other issues regarding the liver
The agenda will feature experts and leaders from around Florida and from the
Centers for Disease Control and Prevention, the National Alliance of State and
Territorial AIDS Directors, the American Liver Foundation and other
organizations that provide services for individuals at risk of viral hepatitis.
Conference is sponsored by the Florida Department of Health, the Gulf Coast
Chapter of the American Liver Foundation and the Florida Hospital
Intended Audience:
Doctors, nurses, public health professionals who work in STD, HIV, hepatitis,
epidemiology, immunization and other programs, advocates, consumers infected
with hepatitis and others affected by the hepatitis epidemic.
Goals of the Conference:
1) Increase participant awareness, knowledge and skills regarding hepatitis
diagnosis, prevention, advocacy and treatment
2) Provide a collaborative forum for the sharing of ideas and best practices
about a disease that is fifty to one hundred times as infectious as HIV
Objectives of the Conference:
By the end of the conference, participants should be able to:
1) Identify ways that hepatitis A, B and C are transmitted
2) State several ways to prevent hepatitis transmission
3) Identify " best-practices " for the medical management of hepatitis C
4) Identify the components of an effective hepatitis support group
5) Recognize the range of laboratory interpretations regarding hepatitis
tests and what they mean.
6) Identify several benefits of integrating hepatitis prevention services
into other related public health programs
7) Describe the national and state perspectives on the epidemic.
Plenary Speakers:
Christopher Kennedy Lawford, renowned hepatitis prevention advocate, actor and
author
Steven Wiersma, M.D., M.P.H., Associate Director of Science and Global
Activities, Division of Viral Hepatitis, Centers for Disease Control and
Prevention in Atlanta, and former State Epidemiologist for the Florida
Department of Health
Thelma King Thiel, Chairman and Chief Executive Officer of Hepatitis Foundation
International in Silver Spring, Maryland
Registration and hotel information:
Registration forms and agenda information are located at
http://doh.state.fl.us/disease_ctrl/aids/hep/hepatitisconf2007.html
The conference hotel is the Sheraton Safari Hotel and Suites Lake Buena Vista
12205 South Apopka-Vineland Road
Orlando, FL 32836
Reservations: (407) 239-0444 or (800) 423-3297
If you have any questions, please contact Nosipho Beaufort at (850) 245-4444
x2430 or by email at Nosipho_Beaufort@... .

AIDS and Behavior, July 2007, Vol.11, 4, p. 603-10.
The Impact of Chronic Hepatitis C on Health-Related Quality of Life in Homeless
and Marginally Housed Individuals with HIV.
Tsui JI, Bangsberg DR, Ragland K, Hall CS, Riley ED.
San Francisco Veterans Administration Medical Center, University of California
San Francisco, judith.tsui@... .
Although infection with Hepatitis C Virus (HCV) and Human Immunodeficiency Virus
(HIV) frequently co-exist, there has been little research to determine the
effects of HIV/HCV co-infection on health-related quality of life (HRQOL). We
performed a cross-sectional analysis of baseline data from 216 participants
enrolled in a community based study of HIV-infected homeless and marginally
housed individuals, using multivariable linear regression analysis to determine
if co-infection with HCV was independently associated with lower short-form 36
(SF-36) questionnaire scores. We found that individuals with HCV had
significantly lower mean SF-36 scores in the domains of physical functioning,
bodily pain, social functioning and role limitation due to emotional health, and
that HIV/HCV co-infection was independently associated with a lower physical
component score but not a lower mental component score after controlling for
numerous covariates. These results suggest that co-infection with HCV may have
an adverse effect on HRQOL among homeless and marginally housed individuals with
HIV.

Teen drugged with hepatitis C syringe, violated, court told
By KATHY WEBB - The Dominion Post | Wednesday, 6 June 2007
A 14-year-old girl was drugged, sexually violated and given hepatitis C by a
builder working at her home, the High Court at Napier was told yesterday.
Sean Lesley Riley, 28, who had hepatitis C when he is alleged to have injected
the girl five times in her hand, is on trial on three counts of sexual violation
by unlawful connection, injuring the girl by infecting her with a disease with
reckless disregard for her safety, and threatening to kill her and her family if
she told anyone.
Crown prosecutor Clayton Walker told the court that the girl was home alone
during school holidays in December, 2005, while her mother was at work and her
young sister was being looked after elsewhere.
Riley was renovating a porch at the home.
In court yesterday, Riley sat in the dock behind a screen as the girl wept
during her description of an afternoon in which she was allegedly stupefied,
repeatedly injected and subjected to a sexual ordeal.
She told the court that Riley had offered her a drink of water while she was
sitting in the lounge.
She accepted and drank about half of it before starting to feel dizzy and not
being able to hear properly.
The girl said she saw Riley go out to his truck and put a cigarette lighter
beneath a spoon, then put its contents into a syringe he had taken from the
glovebox.
He got his 15-year-old nephew to hold the girl's wrist tightly while he put the
syringe into the top of her hand.
The girl said she tried to resist but felt too weak.
Riley told her he was giving her Ritalin, which would make her "do things", she
said.
She was then taken out to Riley's truck and driven, first to Riley's wife's
home, then to a shed at the back of an unknown property.
There, he again heated up something in a spoon and injected it into her hand
before forcing her to give him oral sex.
Riley allegedly gave her three more injections, and violated her twice more
before she blacked out.
At one stage she woke and found him violating her.
Eventually, Riley asked the girl what time her mother finished work.
He put her back into the truck and told her not to say a word to anyone about
what had happened "or me and my family would be dead".
Riley told the girl's mother that the three of them had been out getting quotes
for building work.
The girl, still feeling ill, told her mother she did not want dinner.
She went straight to her bedroom and tried to sleep, but stayed awake all night.
The next day, terrified of being alone at the house with Riley again, she sent a
text message to a friend, asking her to visit.
She told the friend what had happened, but swore her to secrecy.
It was not till six months later, unable to keep it to herself any longer, that
she told her mother, who called police.
Blood tests revealed she had hepatitis C.
Mr Walker told the court that Riley had been diagnosed with hepatitis C about
six months before the alleged attack on the girl.
At the time, he was on a methadone programme.
He said Riley denied everything the girl alleged.
The trial is before Justice Denis Clifford and a jury of six men and six women.
Riley's lawyer is to cross-examine the girl today.
http://www.stuff.co.nz/stuff/4084768a12855.html

Liver cancer, hepatitis B, poorer outcomes
HONG KONG, June 5 (UPI) -- Liver cancer patients with high serum levels of
hepatitis B virus face poorer outcomes and are more likely to develop severe
hepatitis, says a Chinese study.
The study, published in Hepatology, found that patients with high
pre-chemotherapy levels of hepatitis B DNA had a significantly increased
incidence of severe hepatitis, which was associated with the worst survival.
Hepatitis B is associated with a more than 200-fold increase in risk of liver
cancer.
Winnie Yeo, of the Chinese University of Hong Kong, examined the significance of
pre-chemotherapy hepatitis B DNA levels in the blood on the survival of
hepatocellular carcinoma -- liver cancer -- patients. The researchers studied
188 patients participating in a phase III randomized controlled trial comparing
two different chemotherapy regimens.
Ninety-two percent had evidence of hepatitis B infection, according to the
study.
http://www.upi.com/Consumer_Health_Daily/Briefing/2007/06/05/liver_cancer_hepati\
tis_b_poorer_outcomes/8944/

Launch of Several Novel Therapies Will Drive Dramatic Near-Term Growth in
the Hepatitis C Virus Drug Market
However, Market Will Contract After 2011, According to a New Report from
Decision Resources
WALTHAM, Mass., June 5 /PRNewswire/ -- Decision Resources, one of the
world's leading research and advisory firms for pharmaceutical and
healthcare issues, finds that the drug market to treat the hepatitis C
virus will experience dramatic growth through 2011 as the launch of several
novel therapies, beginning in 2009, significantly alters the standard of
care. However, the market will contract after 2011 as the
treatment-eligible pool of hepatitis C virus-infected patients declines in
the United States, France, Germany, Italy, Spain, the United Kingdom, and
Japan.
The new Pharmacor report Emerging Hepatitis C Virus Therapies finds
that the most highly anticipated drugs in development are the hepatitis C
virus- specific protease and polymerase inhibitors. The uptake of protease
inhibitors, such as Vertex/Johnson & Johnson/Mitsubishi's Telaprevir,
Schering-Plough's Boceprevir, and InterMune/Roche's ITMN-191, will be
driven by their impressive efficacy rates, safety, and oral formulation.
Furthermore, leading gastroenterologists and hepatologists believe that
polymerase inhibitors such as Idenix/Novartis's valopicitabine,
Wyeth/ViroPharma's HCV 796, Roche's R1626, Abbott's A-837093, and Merck's
MK 0608 will also drive significant growth in the market to treat the
hepatitis C virus.
"Physicians and thought leaders expect that the novel protease and
polymerase inhibitors will be used in combination with long-acting
interferon- alpha such as Roche's Pegasys, Schering-Plough's Peg-Intron,
and Novartis/Human Genome Sciences' Albuferon-alpha," said Aaron Woolsey,
Ph.D., analyst at Decision Resources, Inc. "As a result, the introduction
of novel second- and third-line therapies will invigorate sales of
long-acting interferon-alpha agents and contribute to overall market
growth. Paradoxically, because we project that hepatitis C virus incidence
will not keep pace with mortality and treatment-cure rates after 2016, the
improved efficacy of novel therapies will improve cure rates, resulting in
a decline in the number of treatment-eligible patients."
About Pharmacor from Decision Resources
Pharmacor is a unique family of studies that assesses a host of market-
impacting factors and analyzes the commercial outlook for drugs in research
and development.
About Decision Resources
Decision Resources (http://www.decisionresources.com) is a world leader in
market research publications, advisory services, and consulting designed to
help clients shape strategy, allocate resources, and master their chosen
markets.
All company, brand, or product names contained in this document may be
trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@...
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/06-05-200\
7/0004601865&EDATE=

The Coastal Post - June 1999
Did Transplanted Chimpanzee Testicles Start AIDS Epidemic in 1920s?
By Jim Scanlon
With the recently published research in "Nature: The International Weekly
Journal of Science", that chimpanzees from Central Africa are the origin of HIV,
the Human Immunodeficiency Virus that causes AIDS, speculation has once again
arisen as to how this virus got into human bodies.
Ever since the epidemic began in the U.S. early 1980s mostly among gay white
males and inner city black and brown intravenous drug users there has been
speculation, some of it wild, as to how the virus got into humans.
There were theories that strange, bizarre African fertility ceremonies involving
males being stimulated by the blood of the African Green Monkey were
responsible. Sex with animals was also alluded to. Since this same monkey's
kidneys were used in the production of vaccines, there was speculation that this
was the start and the vaccination programs in Africa helped spread it widely.
One famous author even pinpointed the person responsible for the spread of AIDS
in the United States to a French Canadian Flight Attendant. While others
implicated sinister agents of US Biological Warfare Center in Fort Dietrict,
Maryland who deliberate introduction a modified virus into the gay population.
Black Muslim leaders favored a similar version deliberately introduced into the
Black Community.
What was generally overlooked, or at least not emphasized unduly, was the role
of transplanted tissue from one human being to another. Blood transfusions were
certainly held responsible for thousands of cases of AIDS, hundreds of thousands
of cases of hepatitis B and millions of cases of the now recognized Hepatitis C,
which was then called Non-A, Non-B. Hemophiliacs as a group were devastated by
contaminated clotting factors.
Thousands of children were infected with a fatal brain disease,
Creutzfeldt-Jacob Disease from human growth hormone made from the pituitary
glands of courses, British cattle were infected by Mad Cow Disease from enriched
feed supplements made from dead rendered cows.
Blood and its refined constituents were and continue to be highly valuable
commodity in a billion dollar health care industry with collection basically
unsupervised and spread out over the world. Collections were made from the down
and out, prisoners, alcoholics and drug addicts for small sums of money.
Transfusion of blood and the administration of drugs by injection, while quite
safe in the US was not so safe in Third World countries.
Many scientists and others are now warning that the transplantation of animal
parts (xenotransplants) into sick human beings to save their lives caries the
potential for transferring virus from the cells of these animals into humans
with unknown consequences. Just the other day permission was granted to use a
part of a pig to replace a failed valve in a terminally ill boy. Cattle parts
are similarly used.
On a molecular level, resistance is growing against using insecticide bacterial
genes in plants to produce insect resistant crops. That is, the pesticide is
built in. It is presumed that the consumer will not be hurt like the hapless
worm eating the plant and that the Frankenstein Pollen will not "jump" into
other crops or weeds.
To its credit the medical industry has now tightened controls and infections are
very low, but what is not recognized is the extent that epidemics can be and are
doctor, or hospital caused illness. That is to say industrial concerns, driven
by the potential for enormous profits will open a "Pandora's Box" of horrors
totally beyond our power to control" The drug company and the producer get the
benefit, everyone else gets the problem
In Nature, Vol. 398, page 657, 22 April, 1999 appears a letter, "Did Parisians
catch HIV from monkey glands?" referring to the famous research done by
professor Serge Voronoff, professor of experimental surgery in Paris in the
1920s in which he used the testicles of executed criminals to restore virility
in aging men.
As demand overtook the limited supply, Voronoff turned to using testicles from
Chimpanzees which, due to their highly sexual way of life, are extremely large
for their body size. These procedures were called "monkey gland" operations in
the tabloid press.
Since France controlled an enormous part of Central Africa before World War II,
it is entirely likely that HIV-1 was present in the transplanted tissue, and in
this way, the virus entered Homo Sapiens, with consequences we face today.
This "theory" is definitely not new, and would have to explain how the virus
"bounced" back to Africa and infected untold million of people in the last
seventy years, so this theory doesn't make much sense except in a mythical
sense.
What is does illustrate, is the extreme danger of mixing tissue from one species
to another, of mixing genes from bacteria to food crops. We have enough trouble
mixing tissue, such as blood, within our own species without using tissue from
domestic animals.
The ancient Romans said, "Life Imitates Art". Thinking back at the Grade-B
Science Fiction movies that I saw in which someone always seems to say to the
mad scientist, "There are some things man should not meddle in," it seems that
"Life imitates Grade-B movie Art."
http://www.coastalpost.com/99/6/9.htm

Science Vault: Monkey to Human Testicle Transplant
Category: Science Vault
Posted on: June 5, 2007 12:30 PM, by Shelley Batts
[This is part of a series I'm doing here on Retrospectacle called 'Science
Vault.' Pretty much I'm just going to dig back into the forgotten and moldering
annuls of scientific publications to find weird and interesting studies that
very likely would never be published or done today (and perhaps never should
have.) I'll probably try to do it once a week (and if you have suggestions,
please do email me with them.)]
The development of surgical organ transplantation in humans will always be
considered a landmark in medical science, and the scientists that pioneered the
risky operations both brilliant and innovative. Well, most of those scientists
anyway. One in particular, a surgeon by the name of Serge Voronoff, will live on
in medical infamy for performing transplants which, while at the time (late
1800s) were lauded as genius, would eventually disgrace him. Adding to the
intrigue is the fact that this surgeon was the student of Nobel Prize winner
Alexis Carrel, from whom he had learned the technique of transplantation. The
surgery's aim was "rejuvenation" (anti-aging) and all began when Dr. Voronoff
became interested in eunuchs and castration.
Voronoff's hypothesis was this: hormones, like testosterone produced by the
testes, would reverse aging by a process he called "rejuvenation." One of his
first experiments used himself as a test subject. He injected ground up dog and
guinea pig testicles under his own skin, but was disappointed when this did not
result in any verifiable effect. He reasoned that living grafts of testicular
tissue, rather than injections, would have a more dramatic and lasting
rejuvenation effect.
This lead to cross-species glandular transplantation surgeries. His early
experiments involved transplanting thyroid tissue into humans with a thyroid
deficiency. He also began transplanting the testicles of executed criminals into
rich old guys (as a treatment for senility and schizophrenia), but had to stop
when the demand for the procedure far exceeding the supply of criminal
testicles. At this point, Voronoff began using monkey testicles instead, and his
first "monkey gland" to human transplant took place in June of 1920.
"I dare assert," he wrote, "that the monkey is superior to man by the sturdiness
of its body, the quality of its organs, and the absence of those defects,
hereditary and acquired, with which the main part of mankind is afflicted."
A thin slice of testicle would be inserted into the recipient's scrotum, with
the hope that it would fuse with the endogenous tissue. This...er...innovative
approach was applauded by hundreds of the worlds leading surgeons at the
International Congress of Surgeons in London in 1923. His work also delved into
the transplantation of monkey ovaries into human women. He even went a bit
further and transplanted a human ovary into a monkey, and then attempted to
inseminate the monkey with human sperm. (It didn't work.) Voronoff conducted
extensive transplantation experiments within species as well: over 500
transplantations on sheep, goats, and a bull. These involved grafting testicular
tissue from younger animals onto older animals, to measure whether they received
"rejuvenation" and renewed vigor. His results showed a dramatic invigoration in
before/after type pictures, published in respected journals from the Lancet to
Scientific American.
The proposed effects of his human "monkey gland" surgery were far reaching, from
improved sex drive to a cure for a myriad of mental disorders. By the Great
Depression over 500 men had received Voronoff's therapy, the demand becoming so
high that he had to set up his own monkey farm to keep up. However after decades
of promises, and hundreds of patients, it eventually became clear that the
treatments resulted in none of the positive effects that Voronoff lauded. In
fact, quite a few patients had major complications, infections, suffered shock,
etc.
In addition, testosterone was finally isolated as the hormone secreted by the
testes, and therefore the target chemical of the transplantation surgeries (ie,
to get it to produce more) had been found. But when testosterone was injected
into animals, while Voronoff thought they would become strong and virile, that
just didn't happen, and it also did not slow aging or prolong life. A
particularly loud skeptic, British surgeon Dr. Kenneth Walker, termed Voronoff's
treatment as "no better than the methods of witches and magicians."
This was devastating to Voronoff's reputation and career. His clinic languished
and disappeared, as did all respect for his methods. He died in relative
obscurity, although recently the negative perception of his work has relaxed
somewhat. But there is a rather disturbing hypothesis out there that posits that
the AIDS virus entered the human population through Voronoff's transplantation
work.
Decades later, a David Hamilton published a book "The Monkey Gland Affair" which
in essence debunked the transplantations by explaining that tissue from another
species would be rejected, not absorbed, and would at best result in scar
tissue. Any (rare) slight improvements seen in transplant recipients were likely
placebo effect.
Sources and more info:
Sharon Romm. 1983. Rejuvenation Revisited. Aesthetic Plastic Surgery. doi
10.1007/BF01570668
http://www.gvsu.edu/english/cummings/issue9/Gillybo9.htm
http://en.wikipedia.org/wiki/Serge_Voronoff
1923 Time Article on Voronoff
http://scienceblogs.com/retrospectacle/2007/06/science_vault_monkey_to_human.php

Lifesaving organ transplant mission ends with 6 dead
(Ann Arbor, Michigan-AP, June 5, 2007) - The patient lay on the operating table,
prepped for transplant surgery. In the air over Lake Michigan, a twin-engine
plane sped his way, carrying a team of surgeons and technicians, along with a
donor organ on ice. The plane never made it, crashing into the lake's choppy
waters and killing all six people aboard Monday.
Now the critically ill patient could become the accident's seventh fatality.
"It was a very sad moment in the operating room" when word was received that the
plane had gone down on its way from Milwaukee, said Dr. Jeffrey Punch, chief of
transplant surgery at the University of Michigan Health System hospital in Ann
Arbor.
Hospital officials and organ-donation authorities would not identify the
transplant patient - other than to say he was a man - and would not say what
type of organ he was awaiting, citing medical privacy rules. But one of the
doctors killed was a cardiac surgeon, suggesting the patient was about to get a
new heart or lungs.
He was put back on the waiting list for another organ and was reported to be
"very critically ill." Authorities would not comment on his chances of finding
another organ in time.
The Cessna Citation crashed about 5 p.m., shortly after takeoff on a flight to
Ann Arbor that should have taken 42 minutes. One of the pilots reported severe
difficulty steering the plane because of trouble with its trim system, which
controls bank and pitch, said National Transportation Safety Board investigator
John Brannen.
Brannen said the pilot had signaled an emergency and was making a left turn and
heading back to the Milwaukee airport when the plane went down.
The cause of the crash was under investigation. Brannen said the plane's safety
and maintenance records were not immediately available.
Killed were both pilots, two University of Michigan surgeons, and two
technicians whose job was to prepare the organ for transplant.
"We now know our team is lost," said Dr. Robert Kelch, chief executive of the
University of Michigan Health System. "This is a tremendous blow to the
institution, one from which we won't quickly or easily recover." He added: "They
died while trying to do what it is they do every day - helping someone else find
hope."
As of Tuesday afternoon, the donor organ, which was packed in ice in a cooler,
had not been found. Hearts can last outside the body for only four to six hours
and lungs eight hours, said Dr. Tony D'Alessandro, executive director of
University of Wisconsin Hospital and Clinic Organ Procurement organization.
On the morning of the crash, the Ann Arbor hospital's Survival Flight Team had
received word that an organ was available at an unidentified hospital in the
Milwaukee area, and immediately assembled to bring it back to Ann Arbor,
officials said.
The team included two veterans, cardiac surgeon Dr. Martinus "Martin" Spoor and
transplant donation specialist Richard Chenault II, who had flown dozens of such
missions. Also on the team was Dr. David Ashburn, a 35-year-old
physician-in-training in pediatric cardiothoracic surgery, and another
transplant donation specialist, Richard LaPensee.
The team flew to Milwaukee, and the two surgeons removed the donor's organ,
which was then packaged for transport. The team contacted the Ann Arbor hospital
and gave the go-ahead for the surgery to begin on the transplant patient at 2:45
p.m., Punch said.
Authorities would not give any details on the donor, but major organs are
typically taken from people who die suddenly in accidents or other calamities
that leave some of their organs undamaged. The plane took off as light rain fell
with winds at 12 mph, gusting to 22 mph. At the controls were Dennis Hoyes and
Bill Serra, two pilots who worked for Marlin Air Inc., the university's
jet-service contractor. The company had no comment.
The plane hit the water at about 190 mph, authorities said. By midday Tuesday,
only small parts of the aircraft - including pilot seats and small pieces of the
cockpit - had been found, the Coast Guard said. The operating room at Ann Arbor
was immediately notified that the plane had gone down, and the surgeons stopped
the operation more than two hours after it had started, hospital officials said.
Hospital officials would not disclose how far along the surgery was, but said
that typically they do not remove the transplant recipient's old organ until
they have a replacement in hand. A recent NTSB study found that accidents
involving emergency medical services flights - those carrying patients or organs
for transplant - have been increasing. Between January 2002 and January 2005
there were 55 such accidents and 54 deaths. The study found several safety
problems.
According to NTSB reports on its Web site, the agency has investigated 36
accidents or minor incidents involving Cessna Citations since 1983. Five of the
accidents involved fatalities, killing 22 pilots and passengers. Dick Knapinski,
a spokesman for the Experimental Aircraft Association in Oshkosh, described the
Cessna Citation as an "extraordinarily safe aircraft."
"The Citation airplanes are equipped with some of the best instrumentation. Much
of what they have are on par with commercial airlines," Knapinski said. Spoor,
37, made about 10 air transplant flights per year, the university said.
Chenault, 44, spent 18 years coaching girls at Father Gabriel Richard High
School near Ann Arbor, a coed Catholic school with 500 students in grades nine
through 12. He was going to get coach-of-the-year honors in both girl's track
and girl's cross country at a sports banquet Monday night, but never made it.
LaPensee, 48, enjoyed flying radio-controlled model planes. And when a spot
opened for a University of Michigan life flight medical technician three years
ago, he jumped at it.
Ashburn, 35, came to the university in 2005 for a cardiac surgery residency and
would have begun his pediatric cardiac surgery fellowship in July, said
Mary-Lynn Hodges, a family friend. "Every day, the doctors, nurses and flight
personnel of Survival Flight do heroic work in saving the lives of others, and
that is how we will remember those who perished in Monday's tragedy - as
selfless heroes," University of Michigan President Mary Sue Coleman said.
Each year, the Survival Flight Team flies about 150 organ donations and 1,200
patients by helicopter and jet. Dr. Sue V. McDiarmid, the president of the
United Network for Organ Sharing, which coordinates organ transplants, said a
recipient who does not get an organ retains his or her spot on the list. The
patient's eligibility for an organ is calculated according to a formula that is
based, in part, on how sick the person is.
http://abclocal.go.com/wtvd/story?section=nation_world&id=5366306

Hi everybody. This survey won't be going on much longer. Long on NOW and
see if you qualify! Easy way to get $50! :-) and YES you WILL get the
$50 if you qualify.

Does HCV Ever Really Go Away?
Highly sensitive assays indicated that patients with clinical resolution of HCV
continued to harbor the virus and exhibit persistent active viral replication.
Long-term follow-up of patients who have cleared hepatitis C virus (HCV), either
spontaneously or after successful therapy with interferon and ribavirin,
suggests that the likelihood of recurrence is low. This conclusion is based on
analysis of HCV RNA assays. However, HCV RNA assays have a variable range of
detection, especially at low viral levels, and no assay results can completely
eliminate the possibility of the virus's presence. Some evidence suggests that
HCV is not only present in blood and liver, but also may be present in cells of
the lymphatic and central nervous systems. If these locations harbor virus that
is undetectable by standard assays, that could have important implications for
disease recurrence. HCV antibodies can persist up to 20 years after resolution
of clinical infection, suggesting that the virus and its antigens may persist,
but at extremely low levels.
In this elegant study, researchers isolated specimens of serum peripheral blood
mononuclear cells (PBMCs) and dendritic cells from 5 patients who had
spontaneously cleared HCV infection and from 11 patients who had responded to
antiviral treatment. Patients had been infected for 9 to 41 years, and treated
patients had been followed for 12 to 60 months after completion of therapy.
Using an extremely sensitive technique (involving reverse transcription and
nested PCRs, followed by southern hybridization of the amplified products to
virus-specific probes), the authors achieved a sensitivity limit 10 viral
genomic equivalents/mL: They identified positive-strand viral RNA in 4 of 5
patients with spontaneous clearance of the virus and in all 11 patients with
therapeutic responses (in 15 of 17 serum samples, 88% positive overall).
Examination of PBMCs cultured in the presence of a mitogen stimulator yielded
similar results; 81% of specimens harbored detectable levels of positive viral
RNA strands. Dendritic cells isolated from 7 patients indicated that 86% had
positive HCV RNA strands. As evidence of active replication, the researchers
also performed assays for negative RNA strands on PBMCs; 9 of 12 specimens (75%)
had detectable levels of negative RNA, suggesting viral activity. Overall, all
patients were found to be have detectable viral RNA either in serum, PBMCs, or
both up to 60 months after completion of therapy.
Comment: All patients in this study had clinical resolution of HCV and met
accepted criteria for sustained response: normalization of liver enzymes,
undetectable viral RNA levels by standard assays, and improvement in histology.
However, highly sensitive assays indicated that all patients continued to harbor
the virus and that active viral replication persisted in about 75%. Whether such
low viral levels can subsequently result in relapse of disease is unknown.
Theoretically, the virus could be transmissible and could re-emerge in
immunocompromised patients (e.g., post-transplant patients). Relapse rates in
longitudinal studies have been as high as 8%, but whether this represents true
relapse or "fresh superinfection" is uncertain. In a review of the current
study, the authors mention similar findings that were recently reported by
another group in which only 2 of 17 specimens were HCV RNA negative 40 to 109
months after successful interferon therapy (Hepatology 2005; 41:106).
- Kenneth D. Flora, MD
Published in Journal Watch Gastroenterology February 16, 2005
http://gastroenterology.jwatch.org/cgi/content/full/2005/216/1

Who's in Your Network?
Good friends can help keep you from losing your mind sometimes. Literally.
Case in point: Some people don't have much memory loss from Alzheimer's disease,
even though their brains show physical signs of it. And the more good friends
and close family they have, the less affected their memory seems to be.
Coincidence?
Mental Immunity
Sometimes, the human brain can function fairly normally even when physical
signs of a disease -- such as the brain "tangles" associated with Alzheimer's --
are present. Check your memory with this quick test.
Researchers call this resilient power of the brain "neural reserve." Think of it
as the brain's capacity to keep working even though it's physically injured. And
it's not clear why, but having lots of close friends and family -- the kind you
can call on for help or confide in about private matters -- appears to help
shore up those neural reserves.
More on Your Mind
Other ways to bolster your neural reserves? Continue your education, play games
(such as sudoku), and exercise regularly.
http://www.realage.com/news_features/tip.aspx?v=1&cid=18006

Ooops, I see you already posted the hoax part, Pam- it was the last
post on the board and I hadn't got to it yet :-)
Pretty good story though!
Dennis near Seattle

In case you didn't know, the television show was a hoax, the woman
donor was only an actress playing that role. The contestants were
real, however, they knew that the contest was a hoax. It was done to
raise awareness. I think that it was the former producer of the
television program who had previously died from kidney failure
(presumably while awaiting a kidney for transplant) which is why they
did the show, a tribute and a statement of the cause.

Kidney transplant TV show is a hoax
By TOBY STERLING, Associated Press Writer Fri Jun 1, 7:44 PM ET
AMSTERDAM, Netherlands - A television show in which a woman would donate a
kidney to a contestants was revealed as a hoax Friday, with presenters saying
they were trying to pressure the government into reforming organ donation laws.
Shortly before the controversial program was to air, Patrick Lodiers of the "Big
Donor Show" said the woman was not actually dying of a brain tumor and the
entire exercise was intended to put pressure on the government and raise
awareness of the need for organs.
The three prospective recipients were real patients in need of transplants and
had been in on the hoax, the show said.
The program concept had received widespread criticism for being tasteless and
unethical.
But Lodiers said that it was "reality that was shocking" because around 200
people die annually in the Netherlands while waiting for a kidney, and the
average waiting time is more than four years. Under Dutch rules, donors must be
friends, or preferably, family of the recipient. Meeting on a TV show wouldn't
qualify.
"I thought it was brilliant, really," said Caroline Klingers, a kidney patient
who was watching the show at a kidney treatment center in Bussum, Netherlands.
"I know these transplant doctors, and I thought they'll never go and actually do
it. But it's good for the publicity and there are no losers."
During the show, 25 kidney patients were vetted by "Lisa," and most were quickly
dismissed for being too old, too young, smokers, ex-smokers or unemployed.
Contestants gave moving pleas for why they should receive the organ.
"It really hurt watching that," said Tim Duyst, whose wife is awaiting a
transplant and cannot work. "You're dismissed in a wave of the hand."
Viewers were called on to express an opinion or vote for their favorite
candidate by SMS text message for 47 cents.
The show was produced by Endemol, which created "Big Brother" in 1999.
The Royal Netherlands Medical Association, known by its Dutch acronym KNM, had
urged its members not to participate and questioned whether the program might
just be a publicity stunt.
"Given the large medical, psychological, and legal uncertainties around this
case, the KNMG considers the chance extremely small that it will ever come to an
organ transplant," it said.
All seven of the country's transplant centers had said they not cooperating with
the program, KNMG spokeswoman Saskia van der Ree.
Earlier in the week, the Cabinet declined suggestions from lawmakers to ban the
program, saying that would amount to censorship.

Hepatitis C Can Be Treated, But Many Don't Know They Have It
Created: 5/31/2007 3:41:14 PM
Last updated: 5/31/2007 3:46:26 PM
Hepatitis C is a preventable and treatable virus, but the number of cases is on
the rise.
And it's the leading cause for liver transplantation in the United States.
When left untreated, it can lead to cirrhosis, liver cancer, and even death.
George Santana was one of the 80% of people with no signs or symptoms. The
diagnosis came as a shock last year.
George Santana says, "I had a little fungus in my toe. My doctor had to do some
blood work. He wanted to give me this medication. And that's when I found out
that I had antibodies for Hepatitis C."
It's a viral infection, transmitted through bodily fluids, that causes
inflammation and damage to the liver.
Santana is not alone. He's one of more than 4 million Americans infected.
Dr. Henry Bodenheimer, a Gastroenterologist, says the symptoms include "a
feeling of tiredness, a lack of energy is common. As Hepatitis C progresses
there can be other symptoms: joint aches. Late in the disease, your eyes may
turn yellow or your skin may turn yellow as a sign of jaundice."
Santana doesn't know when and where he was infected.
There were many opportunities, including snorting cocaine, getting a blood
transfusion before blood was routinely screened for the virus, and getting a
tattoo in prison.
George Santana says, "I've lived a very rough lifestyle. I was a former homeless
person. I lived on the street, I've been in gangs. I've used drugs. I've lived
very risky behavior."
An estimated 2/3 of those infected don't know it, so they aren't getting
treatment and they could be putting others at risk.
Which could be why the number of cases is rising.
Dr. Henry Bodenheimer says, "What we are seeing now is people that have been
infected before that are just becoming aware that they have Hepatitis C. The
majority of the cases that we are discovering are not new cases infected this
month, but cases that were infected 20 or 30 or 40 years ago."
And while there's no vaccine, there is a treatment.
Dr. Henry Bodenheimer says, "About half the time we can eliminate Hepatitis C
infection, so it's important for people who have been exposed to know if they
have hepatitis."
Santana gave himself weekly injections of interferon and took ribavirin pills
daily for 8 months. Now he says he's doing great.
http://www.ksdk.com/news/news_article.aspx?storyid=120816

NATAP: HCV Grant Opportunities in Ryan White Care Act
NATAP http://natap.org/

Cure for Your Disease or Empty Promise?
Sugar Pills Have Some People Turning Down Doctor's Advice, But Critics Say
They're Bogus
A Texas-based company, Mannatech, has made hundreds of millions of dollars by
selling sugar pills, and some people are turning down their doctor's advice to
treat serious health issues in favor of the pills. Some people claim Mannatech's
associates promise miracle cures with these pills, while critics say the pills
are a rip off. (ABCNEWS.com)
By JIM AVILA, GEOFF MARTZ, and ANDREW PAPARELLA
June 1, 2007
How much would you pay for a pill made of sugar?
Try $415 million. That's how much Mannatech, a Texas-based company, made in the
last 12 months selling sugar pills and powders made from larch bark and aloe,
known as glyconutrients.
Mannatech says its product, Ambrotose, is a simple nutritional supplement that
helps the cells in one's body communicate with one another. Ambrotose is sold
exclusively by multilevel marketing sales associates who, functioning as
independent contractors, try to sign up customers to buy the product and become
sales associates themselves.
The product is shipped directly from the company to customers, with sales
associates getting a cut of the profits.
But critics say the company's bottom line is has been boosted by unverifiable
health claims made by some of it's multilevel marketing sales force.
A three-month "20/20" hidden camera investigation found outlandish claims being
made by some Mannatech sales associates around the country, extolling what they
say are the extraordinary powers of Mannatech's patented product, called
Ambrotose. Ambrotose costs at least $200 a month -- more than some prescription
drugs.
For example, one Mannatech sales associate in Austin, Texas, said: "People with
cancer call us every single day: 'The tumor is gone!'"
Another in New York said: "She comes in five months after we've worked together,
and she's breast cancer free!"
A Cure for Cancer?
Is this truly a grass-roots, word-of-mouth miracle? Can a nutritional supplement
actually cure cancer?
Angie Rhoads is betting her life that it can.
Most people would say that Rhoads has had the most horrible luck in the world.
The 22-year old lost her mother to a hemorrhage and her father to a fast-growing
brain tumor. Then last year, as she was about to graduate from a college in the
Midwest, doctors discovered that she too had a brain tumor. Rhoads' classmates
rallied around her and raised the money for an operation.
"You know how everyone says, 'Well, it's not brain surgery?' I'm like, well,
yeah it is," said Rhoads.
Surgeons got almost all of the tumor, but were forced to leave two areas behind
to avoid paralyzing her. Rhoads' oncologist told her she stood a good chance if
she underwent an immediate course of radiation and chemotherapy.
But Rhoads had a different idea. She had heard from a friend and from
testimonials that Mannatech's Ambrotose would make her cancer go away, without
the terrible side effects of drugs and radiation. She turned down the doctor's
recommendation in favor of a sugar pill.
She said her doctors were not pleased with her decision. "They pretty much said,
'If you were my daughter you would be doing chemo and radiation,'" said Rhoads.
Rhoads explained that she and one of her doctors agreed that she can always
start chemo and radiation later if her cancer starts to grow, but for now she is
sticking with Ambrotose.
Although she would never counsel others to forgo medical treatment, Rhoads
believes so much in Ambrotose that she even began going on cancer survivor Web
sites to recommend it to other cancer patients. .
What Exactly Is Ambrotose
Mannatech says Ambrotose draws on a new cutting-edge field called glycobiology.
Glycobiology is a legitimate science that looks into how complex carbohydrates
promote cellular communication.
But two of its leading scientists, Dr. Hudson Freeze from the Burnham Institute
for Medical Research in La Jolla, Calif., and Dr. Ronald Schnarr from the Johns
Hopkins School of Medicine, say there is a huge disconnect between this new
science and what Mannatech sells.
"There are authentic, scientific studies that have looked at people drinking
these kinds of materials," said Freeze, referring to glyconutrients. "And it
doesn't really do anything except increase flatulence."
According to Mannatech, many people's bodies don't produce enough of the simple
sugars needed for cells to communicate properly. By ingesting Ambrotose,
Mannatech claims, people get the sugars they need.
But Schnarr says that except for a mere handful of people with a congenital
deficit, virtually every person on earth produces enough of these sugars on
his/her own. "All of the sugar building blocks that we need in our body are made
from the most common foods we eat," he says.
He also says that there is little or no proof that these sugars, if swallowed,
can be absorbed and broken down by the human body.
Mannatech strongly contests these conclusions, citing a large number of studies
and research papers that can be found on the Web at www.glycoscience.org. But
articles, published in the Fort Worth Star Telegram, have linked some of those
studies to a research institute that Mannatech funds.
Mannatech's Response
Our "20/20" investigation found that some of Mannatech's sales force was touting
Ambrotose as a miracle cure that could fix a broad range of diseases from cancer
to multiple sclerosis and AIDS.
Sales meetings and testimonial DVDs recommended by sales associates at meetings
that "2020" attended always began with disclaimers, stating that Mannatech's
products are not meant to "cure or mitigate" any disease. But then began the
testimonials that seem to imply that glyconutrients do just that. For example,
one DVD testimonial stated: "Two months ago, I got a CT scan and my cancer is
gone."
And another said: "I was going into a wheelchair and give up my life.
Glyconutrients have changed my life. They work."
Testimonials like these helped to convince Rhoads, she said, to forgo medical
treatment.
They have also helped to trigger an investigation of Mannatech by the Texas
attorney general into possible "unproven health claims." The attorney general
has yet to file any charges.
There is also a class-action filed by shareholders who allege the company
encouraged its sales associates to say Ambrotose cures a wide range of diseases
to boost sales. Mannatech has denied the allegations and filed a motion to
dismiss the lawsuit.
Mannatech CEO Sam Caster has previously been investigated by the Texas attorney
general and been accused of making misleading claims about a rodent repelling
device that didn't work, and a home insulation product that was reportedly not
as effective as claimed.
Caster told "20/20" that Mannatech makes no specific health claims about its
products. "I don't think dietary supplements treat, cure, mitigate anything. It
is not meant to substitute a doctor's oversight, but it plays an important role
in the whole health equation."
He also said that Mannatech actively polices its sales force to prevent
associates from crossing the legal line in their sales pitches.
Walking the Fine Line
But "20/20's" hidden camera investigation found some Mannatech sales associates
teaching potential recruits how to work around legal restrictions.
"You can't tell people that it's going to cure anything, but you can say, 'I
think I have something that will help you with your cancer,'" a sales associate
told a "20/20" producer who attended one meeting.
And even at Mannatech's corporate-sponsored annual convention held in 2006, a
video obtained by "20/20" shows a high-level sales associate counseling
front-line salespeople in the fine art of walking the fine line.
"How many of you can think of a target or a market to target?" As the audience
calls out, he repeats their suggestions. "Autism? Cancer? Diabetes? There's
millions, right? Now, if they are health specific, can you mention Mannatech?
No, absolutely not. But can you build a list of people who want to know about
that particular situation? Yes."
Rhoads recently went for an MRI. She said that although the results show she is
not cancer-free, she believes Mannatech's products are benefiting her, and she
will continue to ignore her doctor's recommendation for chemotherapy and
radiation.
http://abcnews.go.com/2020/story?id=3228488&page=1&CMP=OTC-RSSFeeds0312

Doctor's Prosecution Slowed By Medical Problems
LOUISVILLE, Ky. -- A local psychiatrist charged with illegally prescribing drugs
will have surgery before standing trial.
Her attorney said Dr. Wrenda Gallien has serious health problems and needs a
liver transplant, which is why she hasn't been to court.
Gallien is facing multiple felony and misdemeanor charges.
Investigators said a pharmacist tipped them off about Gallien prescribing
Oxycontin, a powerful painkiller they said is routinely abused and sold on the
street.
Judge Susan Gibson set a January trial date on Friday.
http://www.wlky.com/news/13425562/detail.html

Despite Warnings, Kava Still On The Market
Last Edited: Thursday, 31 May 2007, 7:23 PM CDT
Created: Thursday, 31 May 2007, 7:23 PM CDT
Kava is an herbal supplement from a plant found on South Pacific islands.
The FDA put out a warning about Kava five years ago, after a Metro woman
suffered liver failure. Kava remains on the market today, but government
documents show there are still problems linked to Kava.
Kava is supposed to ease anxiety and help you sleep. Six years ago,
Sheryl Granville of Shawnee was in a nightmarish situation after taking the
herbal supplement.
Sheryl: "It's the only body you get and I had to learn the hard way, it
doesn't take much to destroy it," Granville said.
Granville suffered liver failure and had a liver transplant. The FDA had
received 38 reports of medical problems possibly related to Kava. But it was
Granville's case that prompted an advisory five years ago that Kava-containing
dietary supplements may be associated with severe liver injury.
The FDA issued the advisory, but that's it. Kava remains on the market in
the U.S. with some companies voluntarily putting a caution on the label.
Through the Freedom of Information Act, FOX 4 obtained reports received by
the FDA of adverse reactions possibly involving Kava. Cydney McQueen, a pharmacy
doctor at the UMKC Drug Information Center analyzed them. There are nearly 100
reports involving Kava, but McQueen said only 17 provided enough information for
her to judge whether Kava was to blame for the person's health problem.
"Nine of the 17, I can say pretty definitely Kava was at fault for liver
trouble," McQueen said. "Those nine include two deaths. One from liver failure
and the other from complications of a liver transplant."
Nine reports may not seem like much, but McQueen said health problems
linked to herbal supplements are rarely reported.
Roger Farmer still sells Kava at a health food store in Grandview, even
though he said there are alternative supplements to help people sleep.
"We still offer it because some of our customers still use it, and we
believe it is a relatively safe supplement. We always strongly suggest our
customers not use it for more than 30 days continuously," Farmer said.
Manufacturers argue that there's no proof Kava causes liver problems and
that many patients already had liver trouble. But Granville had none. McQueen
said no one understands what it is about Kava that's dangerous for some.
"Until we know what is the real issue, don't take it ever. It's just not
worth it," McQueen said.
McQueen believes the government needs to more strongly regulate Kava or
ban it. Canada and many European countries have.
We asked the FDA to respond to our findings, but we haven't heard back.
Meryl Lin McKean, FOX 4 News
http://www.myfoxkc.com/myfox/pages/News/Detail?contentId=3366805&version=1&local\
e=EN-US&layoutCode=TSTY&pageId=3.5.1

Sentenced to a life on death row
Haydn Lewis
Published 01 June 2007
During the 1970s and 1980s nearly 5,000 people were exposed to Hepatitis C. Of
these more than 1,200 were also infected with HIV. This is just one of the
stories.
On Monday 4 June Haydn Lewis will give evidence to the independent Archer
inquiry into the supply of contaminated blood products to UK haemophilia
patients.
The inquiry is being privately funded - the government says treatment was given
in good faith. More than 1,700 patients have died, many others are terminally
ill.
My name is Haydn Lewis and I have mild haemophilia, a genetic condition which I
was born with in 1956.
Haemophilia is treated by injection of a missing protein and up until 1974 I
only received British blood products donated by volunteers.
However, by 1973 the first commercial blood products were imported into the UK.
These doses were prepared from pooled plasma from thousands of donors. If some
of the donors had a blood borne virus, such as hepatitis C or HIV, then it could
infect the whole batch.
Without consent or being informed of the known risks, I was prescribed
commercial products from high risk paid donors. This meant that there was an
increased risk of hepatitis, HIV, or any other blood borne virus.
In 1985 I was informed I had contracted HIV, even though my medical records
state I tested positive a year earlier.
But let's go back a decade. Two things remind me of 1975. It was the year I got
married to my wife Gaynor and the year when Labour's then Health Minister David
Owen announced he would ensure Britain's blood transfusion services were the
safest in the world by implementing a policy of self sufficiency, only using
British blood donated by volunteers.
He was advised by treating consultants that a target of 30 to 40 million units
would be needed to meet future demand. Owen instructed officials in the
Department of Health that his target should be met by 1977.
By 1978 I was the proud father of two healthy sons - in itself a relief because
haemophilia is carried through the female line.
We subsequently decided that Gaynor should be sterilised to avoid further
pregnancies. It also allowed us to have unprotected sex.
Following my diagnosis in 1985, my wife tested positive for HIV in 1988, this
was also the first year I was tested without consent for Hepatitis C.
But I was only informed I was Hep C (HCV) positive in 1994 and then only when I
asked. My treatment for Aids began in 1995.
In 2001 I was informed that I had received several different batches of blood
products donated by a victim of vCJD.
It's my contention that government did not want patients to know of their HCV
results in 1990 because there were ongoing legal cases relating to the HIV
infection of Haemophiliacs.
At this present time my wife and I are both coping with triple combinations of
drugs for our HIV+ condition. It's only by the grace of god my boys are not HIV
or Hep C+ (HCV).
No two days are the same in the way they affect our ability to deal with and try
to lead a normal family life. Our levels of energy range from being able to walk
around the local park three times a day at best, to only once if we are lucky.
I am writing this as someone who has been prompted by his infection - and that
of his wife - to question the actions and practices of government and the NHS
between the late 1960s and the 1990s.
The Archer inquiry has been set up to look at the use of voluntary donated and
commercially purchased contaminated blood products by the NHS and the impact of
that policy on individuals.
The Inquiry has heard testimony from the infected and the affected.
The witnesses have raised many moral and ethical issues about how patients, were
treated by consultants, the impact of government policy through the 70s and even
up to the present time concerning non-consensual testing of blood for vCJD.
There are many factors to consider, yet there can be none more important than
the political and economic decisions that have affected the care of patients.
Whilst government announces it is releasing yet more documentation, little has
been said which might serve to clear the muddy waters for Lord Archer.
Could it be that the systemic failures of successive governments will be buried
in a pile of paperwork?
When the first commercial blood products were privately imported into the UK in
1973, the practice of consultants encouraging haemophiliac patients out of
hospital beds and on to home treatment was already well under way.
These commercial concentrates were not the safest of products, yet there is
evidence of consultants by-passing the Ethics Committees of the GMC and MRC by
importing these medicines under the pretext of "Life Support Therapy".
But mild haemophiliacs like me were not in this category and consequently were
not deemed to have a life-threatening diagnosis.
Consultants continued with their home treatment crusade for 10 years and by May
1983 - despite the proliferation of warnings from official bodies - they still
had their heads in the sand.
With the UK lagging some 3 years behind the USA, there was plenty of information
out there about the risks to haemophiliacs from blood-borne diseases but
apparently never occurred to those in charge of treating us.
In my view there is only one conclusion the Archer Inquiry can reach - that
ministers failed in their duty of care.
It is not surprising then there are reports that the Department of Health has
given instructions to the medical profession NOT to get involved with the
Inquiry.
Even more damning is the way they have dealt with their policy of damage
limitation.
The haemophilia community, was not informed of the increased risks from
commercial products and couldn't therefore make an informed choice about
treatment.
Having choices in life makes one feel human, having multiple viruses takes those
choices away.
Governments are judged on the way they treat the most vulnerable and they should
be in no doubt about how I feel.
I feel as if I have been sentenced to a life on death row. But it wasn't for a
crime I committed - it was the crime of successive British governments and it's
more than time that they answered for their actions.
You can find out more about this issue by going to Tainted Blood and to the
Haemophilia Society
http://www.newstatesman.com/200706010004

BODY PARTS TO THE HIGHEST BIDDER?
May 30th, 2007 by Father Joe
This is a post with me thinking outloud. I fully accept the Church's teachings
about the dignity of the human body. Donation of an organ is seen as a selfless
and loving act; however, the Church would frown upon any commercialization of
organs for transplant or research. It is, nevertheless, a very complex issue
with many branching questions.
The recent news article that inspired this reflection:
AP NEWS - Dutch reality show that claims to be trying to draw attention to a
shortage of organ donors said Tuesday it would go ahead with a program in which
a terminally ill woman will choose a contestant to receive one of her kidneys.
The program, "Big Donor Show," has been attacked as unethical and tasteless. At
least one member of the Dutch parliament plans to ask the government to block
Friday's broadcast.
"We know that this program is super controversial and some people will think
it's tasteless, but we think the reality is even more shocking and tasteless:
waiting for an organ is just like playing the lottery," Laurens Drillich,
chairman of the BNN network, said in a statement. She said waiting lists in the
Netherlands are more than four years long and 200 patients die annually for lack
of a donor.
This issue of selling, buying, or winning human organs has many moral wrinkles.
Do you recall the Monty Python skit where a person is asked to become an organ
donor? No sooner is the contract signed, that the client is surprised to find
out that the contract means they can extract the organ, now! It was funny back
in the 1960's. Today, it has become the nightmare reality.
Despite our revulsion toward it, take this scenario:
Jill is dying from an incurable illness. Her husband is disabled and she has
five needy children at home. Because of the type of illness, most of her organs
are in good shape and in high demand. She loves her family very much and wants
the best for them. Although she will not be around to see them grow up, she
desperately wants to do something to help keep them together and to provide for
them. She had even dreamed that a few of them might go to college and have
options that she never had. A representative from a wealthy benefactor comes and
offers her hundreds of thousands of dollars for her body parts: heart, lungs,
liver and kidneys. Even the corneas are thrown into the deal. Since she will be
dead anyway, and will no longer need them, should she not be given the
opportunity to sell her organs and provide for her family after she is gone?
What is the alternative? If she signs a regular donor card, she will get no
reimbursement for her organs, although the doctors and hospitals will make a
great deal from their various fees and for professional services. One way or the
other, someone is going to financially benefit from the organs; as their
rightful owner, indeed, as a part of herself, why should she be the only one
excluded?
Should there be a significant distinction between selling the organs of the
living and of the dead?
If organs should go to the highest bidder instead of to those on transplant
waiting lists, would this not force prices up and discriminate against the poor?
Does the buying and selling of body parts reduce the body to a commodity?
Would poor people be unreasonably tempted to sell organs like a kidney or piece
of a liver which they might later need?
Regarding the living, are not such practices too great a health risk?
Does this not open people up to intimidation whereby viable sick people might be
allowed to die in order to get their organs?
Does not the buying and selling of body parts reinforce a "separatist" mentality
toward the human body/soul connection instead of seeing the body as an
expression of the whole human person?
Why is it that I can give away my kidney for free but I cannot sell it for
money? Even if the idea is repugnant to us, what if you needed that kidney or
would die? Or, maybe it would be your mother, or a sibling, or your own child?
What seemed so wrong before, does it still seem wrong? Such an issue should not
be judged solely on feelings, but it is hard not to get emotional about dying
and giving away pieces of yourself.
Did you see the movie called JOHN Q where Denzel Washington played a distraught
father whose son needed a heart transplant? He has no insurance and sees no hope
for saving his child. Entering the hospital he takes hostages and demands that
the doctor save his son. He decides that he will give his son his own heart.
Getting the doctor to agree, he takes his gun and prepares to shoot himself in
the head. It is a powerful film touching upon some of the themes here.
Few of us, except maybe for the Jehovah Witness, would object to the donation of
organs to those who need them. The late Pope John Paul II said back in June of
1991:
Above all, this form of treatment is inseparable from a human act of donation.
In effect, transplantation presupposes a prior, explicit, free and conscious
decision on the part of the donor or of someone who legitimately represents the
donor, generally the closest relatives. It is a decision to offer, without
reward, a part of one's own body for the health and well-being of another
person. In this sense, the medical action of transplantation makes possible the
donor's act of self-giving, that sincere gift of self which expresses our
constitutive calling to love and communion.
Love, communion, solidarity, and absolute respect for the dignity of the human
person constitute the only legitimate context of organ transplantation. It is
essential not to ignore the moral and spiritual values which come into play when
individuals, while observing the ethical norms which guarantee the dignity of
the human person and bring it to perfection, freely and consciously decide to
give a part of themselves, a part of their own body, in order to save the life
of another human being.
Yes, it can be a beautiful self-donation and sign of love.
Is the selling of organs becoming part of that slippery slope from contraception
and abortion? DNA studies and gene manipulation may allow for designer children
while defective models can be terminated. Embryos are harvested and frozen and
discarded. Sometimes they are even fought over in wills or as items in a divorce
settlement. The body is seen as something outside of ourselves that we can
exploit and change. We can eradicate fertility for the pleasure of the body. A
woman can argue, "It is my body," and destroy her child in the womb. The body,
both that of the woman and mother, as well as that of the child, are reduced to
things. The pornography business already counts upon our appreciation of the
body, especially female bodies, as a commodity to buy and sell for purposes of
lust. Our fantasies make bodies interchangeable and heads do not matter, the
person does not matter. We can change our bodies with the help of plastic
surgeons and even go as far as sex-change operations. Michael Jackson used his
face as a plaything, and now he has cartoon eyes, a bozo smile and a plastic
nose. Treating the body as a commodity or thing has consequences. Under
President Clinton, the NIH and other institutions bought and sold body parts,
principally from aborted children, from glossy catalogues that were mailed out
to doctors, hospitals and medical schools. Famous, important and rich people
often bypass transplant donation lists, going immediately to the top and getting
the life-saving surgery and spare-part. No connection is made afterwards with
the new wing to the hospital or the multi-million dollar research project
sponsored by the grateful recipient. Meanwhile a poor African-American janitor
dies because the heart or kidney for which he waited went to someone else.
Does anyone remember a book and movie from many years ago called COMA? Comatose
people were suspended from a roof by cables connected to the large bones of the
body. This prevented bedsores and allowed for the long-term storage of such
patients. Little did anyone know that behind the scenes, unethical doctors were
exploiting these patients for the body parts. The idea was gruesome and
unthinkable, but no more. I see a whole new industry on the horizon. There will
be lawyers who will specialize on contracts to sell, buy and acquire body parts
for their clients. Human organs will be grown in animal hybrids, pushing the
boundary regarding what is human and what is not. Camps will be operated in
Third World Countries where people's organs will be harvested. I recall a case a
few years ago where a man was kidnapped and awoke on the street with one of his
kidneys removed. Such abductions and extractions will become common place as the
price for organs skyrocket in an older population.
Much has been said about the exploitation of the poor and now the sick, but what
about the young and the mentally challenged. There was a case not too long ago
where a couple had a second child in order to have a transplant to save the
older one. One could also feign a botched partial-birth abortion (infanticide)
and deliver a brain-dead child that would live just long enough for organ
harvesting. Retarded people could not give consent to such donations and yet how
much do you want to bet that they will be the first to be sliced and diced.
It is unethical to force people to donate body parts, but we all know that
desperation and unchecked greed can get quickly around that. A dictatorship
might require its citizens to donate organs and body parts, both while living
and when dead.
Women have sold their hair for centuries. There are already people who legally
sell their blood. I read about one guy whose blood is so rare that he is able to
make a living from the few pints he donates each month. Certainly it is an
element of the body that regenerates itself, but still, he is selling something
of himself. I recall reading about obese people who after having gastric bypass
lose hundreds of pounds and need surgery to remove excess skin. This skin is now
proving valuable for research and for use by burn victims. But, should such a
person sell his skin? What about criminals and people on death row? Can they
donate organs and if so does this not create a conflict whereby the state might
be more inclined to execute people when the organs have monetary value or are
intended for some important personage?
My thoughts about all this just ramble on and on. I have nightmares of a Wheel
of Fortune or Price is Right type game show wherein a spin of a wheel will bring
wellbeing to some, a fortune to others, and dissection to losers.
http://fatherjoe.wordpress.com/2007/05/30/body-parts-to-the-highest-bidder/

For those who didn't scroll or don't have HTML turned on......... That was in
1998 and not much has changed :-(
The findings of this report were as follows: The Federal response to the
hepatitis C epidemic has lacked focus and energy. Secondly, the proposed HCV
lookback is too limited. Third, private organizations with some Federal
assistance have taken the lead in HCV public education efforts. I can say that
if you read the report, that was said with a critical edge to it, that private
organizations should not be taking the lead on this. And there are a series of
recommendations, and I'm inside the report on page 2 of it, just to remind you
again.
The Secretary of HHS should take the lead in coordinating the Federal public
health response to the hepatitis C epidemic, including implementation of a
research plan. The Department of Defense should test recruits, active-duty
personnel, and those about to be discharged for hepatitis C infection. The
Department of Veterans Affairs should conduct additional studies of the
prevalence of hepatitis C in veterans' populations. The hepatitis C lookback
plan should be expanded, and the Federal education campaign for HCV infection
should be launched immediately.
What this report wound up concluding, arguing, was that they were not convinced
that the Government was making the public health response to the hepatitis C
epidemic that was required, and so we've been asked to think about, listen to
testimony today on those matters, and then to reaffirm or add or come back and
change what we've been told by that particular subcommittee of the House about
this particular problem.

Kevorkian to be released from prison
By Staff
(AXcess News) New York - Doctor Jack Kevorkian, who has been in prison for over
seven years, is set to be released from his Michigan prison cell Friday.
"Dr Death" as the press called Kevorkian, was jailed for his role in the
assisted suicide of over 100 people.
Kevorkian, who is considered a killer by some and hero by others, is getting a
taste of his own medicine, critics, say, after learning that he is terminally
ill from Hepititis C, a debilating disease of the liver whose only cure is a
transplant. But at Kevorkian's age, doctors say he is too old to go through
such an operation and would have to wait for an available donor even if he was
young enough to survive a liver transplant.
Kevorkian was convicted of second-degree murder in the poisoning of Thomas Youk,
52, in 1998. He had been tried numerous times over the years in assisted-suicide
cases, but the Youk case was his first conviction. He was sentenced in 1998 to
10 to 25 years in a Michigan prison. He served eight and is now being released.
http://www.axcessnews.com/index.php/articles/show/id/11148

Blood Safety: Resolution - November 1998
DEPARTMENT OF HEALTH AND HUMAN SERVICES
OFFICE OF PUBLIC HEALTH AND SCIENCE
ADVISORY COMMITTEE ON BLOOD SAFETY AND AVAILABILITY
SIXTH MEETING
Tuesday, November 24, 1998
8:39 a.m.
Omni Shoreham Hotel
2500 Calvert Street, N.W.
Washington, D.C. 20008
P A R T I C I P A N T S
Members
Arthur Caplan, Ph.D.
Stephen D. Nightingale, M.D., Executive Secretary
Janice K. Albrecht, Ph.D.
Larry Allen
James P. AuBuchon, M.D.
Michael P. Busch, M.D., Ph.D.
Ronald Gilcher, M.D.
Edward D. Gomperts, M.D.
Fernando Guerra, M.D.
Paul F. Haas, Ph.D.
William Hoots, M.D.
Carolyn D. Jones, J.D., M.P.H.
Dana Kuhn, Ph.D.
Tricia O'Connor
John Penner, M.D.
Jane A. Piliavin, Ph.D.
Eugene R. Schiff, M.D.
Marian Gray Secundy, Ph.D.
John Walsh
Consultants
Richard J. Davey, M.D.
Kristine A. Moore, M.D., M.P.H.
Ex Officio Members
Mary E. Chamberland, M.D.
David Feigal, M.D.
Paul R. McCurdy, M.D.
Capt. Bruce Rutherford, MSC, USN
David Snyder, R.Ph., D.D.S.
Also Present:
Jay Epstein, M.D., FDA
Eric Goosby, M.D., DHHS
Lawrence McMurtry, Deputy Executive Secretary
C O N T E N T S
AGENDA ITEM PAGE
Roll Call, Conflict of Interest Announcement 3
Welcome from the Chairman 9
Centers for Disease Control 16
Food and Drug Administration 56
Interorganizational Task Force on HCV Lookback 87
Blood Recipient Organizations 100
American Liver Foundation 115
Lunch 150
Committee Discussion 151
Motions 178
Adjournment 268
P R O C E E D I N G S
DR. NIGHTINGALE: It is one minute after 8:00 in the morning. Good morning. I'm
Dr. Stephen Nightingale, the Executive Secretary of the Advisory Committee on
Blood Safety and Availability and welcome to our Sixth Meeting.
The following announcement is made as part of the public record to preclude even
the appearance of a conflict of interest at this meeting. General applicability
has been approved for all Committee members. This means that unless a particular
matter is brought before this Committee that deals with a specific product or
firm, it has been determined that all interests reported by the Committee
members present no potential conflict of interest when evaluated against the
official agenda.
In particular, as specified in Title XVIII of the US Code at Chapter 208(b)(2),
a Special Government Employee--which all voting Committee members are--may
participate in a matter of general applicability even if they are presently
employed or have the prospect of being employed by an entity that might be
affected by a decision of the Committee, provided that the matter will not have
a special or distinct effect on the employee or the employer, other than as a
part of the class. The example given in 5 CFR 2640.203, which implements Title
XVIII of the US Code, is as follows:
A chemist employed by a major pharmaceutical company has been appointed to serve
on an advisory committee established to develop recommendations for new
standards for AIDS vaccine trials involving human subjects. Even though the
chemist's employer is in the process of developing an experimental AIDS vaccine
and therefore will be affected by the new standards, the chemist may participate
in formulating the advisory committee's recommendations. The chemist's employer
will be affected by the new standards only as part of the class of all
pharmaceutical companies and other research entities that are attempting to
develop an AIDS vaccine.
Committee members have been given a copy of this section of the Code. Additional
copies are available at the desk.
In the event the discussions involve a specific product or a specific firm in
which a member has a financial interest, that member should exclude him- or
herself from the discussion, and that exclusion will be noted for the public
record.
With respect to the other meeting participants, I ask in the interest of
fairness that they disclose any current or previous financial arrangements with
any specific product or specific firm upon which they plan to comment.
Finally, I will make every effort to see that the transcript and the summary of
this meeting and the final draft of any recommendations will be posted on our
Web site by the close of business Monday, November 30th. The Web address is
www.hhs.gov/partner/Blood Safety.
Now, would the Chairman and members please signify their attendance when I call
their names? Dr. Caplan?
CHAIRMAN CAPLAN: Here.
DR. NIGHTINGALE: Dr. Albrecht?
DR. ALBRECHT: Present.
DR. NIGHTINGALE: Mr. Allen?
MR. ALLEN: Present.
DR. NIGHTINGALE: Dr. AuBuchon?
DR. AuBUCHON: Present.
DR. NIGHTINGALE: Dr. Busch? Dr. Busch?
[No response.]
DR. NIGHTINGALE: Dr. Chamberland?
DR. CHAMBERLAND: Present.
DR. NIGHTINGALE: Dr. Davey?
DR. DAVEY: Yes.
DR. NIGHTINGALE: Dr. Feigal?
DR. FEIGAL: Yes.
DR. NIGHTINGALE: Dr. Gilcher?
DR. GILCHER: Yes.
DR. NIGHTINGALE: Dr. Gomperts?
DR. GOMPERTS: Yes.
DR. NIGHTINGALE: Dr. Goosby?
DR. GOOSBY: Yes.
DR. NIGHTINGALE: Dr. Guerra?
DR. GUERRA: Here.
DR. NIGHTINGALE: I know that Dr. Haas is unable to make the meeting. We hope all
goes well with him and his family.
Dr. Hoots?
DR. HOOTS: Here.
DR. NIGHTINGALE: Ms. Jones? Ms. Jones?
[No response.]
DR. NIGHTINGALE: Dr. Kuhn?
DR. KUHN: Present.
DR. NIGHTINGALE: Dr. McCurdy?
DR. McCURDY: Here.
DR. NIGHTINGALE: Dr. Moore?
DR. MOORE: Here.
DR. NIGHTINGALE: Ms. O'Connor?
MS. O'CONNOR: Here.
DR. NIGHTINGALE: Dr. Penner?
DR. PENNER: Here.
DR. NIGHTINGALE: Dr. Piliavin?
DR. PILIAVIN: Piliavin.
DR. NIGHTINGALE: Piliavin. I apologize once again.
Captain Rutherford?
CAPTAIN RUTHERFORD: Here.
DR. NIGHTINGALE: Dr. Schiff?
DR. SCHIFF: Here.
DR. NIGHTINGALE: Dr. Secundy?
DR. SECUNDY: Here.
DR. NIGHTINGALE: Dr. Snyder?
DR. SNYDER: Here.
DR. NIGHTINGALE: Mr. Walsh?
MR. WALSH: Here.
DR. NIGHTINGALE: Thank you. We'd note that Dr. Busch is present at the meeting.
Also present is Dr. Epstein, the Director of the Office of Blood Research and
Review of FDA. Dr. Epstein?
DR. EPSTEIN: Here.
DR. NIGHTINGALE: Thank you. The agenda for today's meeting is the Seventh Report
of the House Committee on Government Reform and Oversight titled "Hepatitis C:
Silent Epidemic, Mute Public Health Response." Dr. Caplan, the Chairman of the
Advisory Committee, will preside.
Dr. Caplan?
CHAIRMAN CAPLAN: Well, we have a busy day this morning. I want to remind the
Committee that we've really been asked by the Surgeon General to take a look at
this Seventh Report of the House Committee on Government Reform and Oversight
from October 15th. We've sent it to the Committee, I think, at least four times,
in my memory of mails that have come. So I hope that the message was clear to
pay attention to this.
I want to just look at three findings and three recommendations in brief. You
know, when we've met in the past, we've had to scramble to the slides and the
overheads, concocting language as we drive toward consensus on certain matters
pertaining to blood safety and availabilty. But in this case, we've got
something to respond to by the end of the day. It doesn't limit us, but there
are some things we're supposed to say something about.
The findings of this report were as follows: The Federal response to the
hepatitis C epidemic has lacked focus and energy. Secondly, the proposed HCV
lookback is too limited. Third, private organizations with some Federal
assistance have taken the lead in HCV public education efforts. I can say that
if you read the report, that was said with a critical edge to it, that private
organizations should not be taking the lead on this. And there are a series of
recommendations, and I'm inside the report on page 2 of it, just to remind you
again.
The Secretary of HHS should take the lead in coordinating the Federal public
health response to the hepatitis C epidemic, including implementation of a
research plan. The Department of Defense should test recruits, active-duty
personnel, and those about to be discharged for hepatitis C infection. The
Department of Veterans Affairs should conduct additional studies of the
prevalence of hepatitis C in veterans' populations. The hepatitis C lookback
plan should be expanded, and the Federal education campaign for HCV infection
should be launched immediately.
What this report wound up concluding, arguing, was that they were not convinced
that the Government was making the public health response to the hepatitis C
epidemic that was required, and so we've been asked to think about, listen to
testimony today on those matters, and then to reaffirm or add or come back and
change what we've been told by that particular subcommittee of the House about
this particular problem.
I want to just note something else that caught my eye. I collected a couple of
things since our last meeting. Some of them, again, Dr. Nightingale, Mac, did a
great job getting materials out to you. Some of you know there were articles in
the New England Journal last week on combination therapy for hepatitis C. While
far from a cure, they were optimistic. I'm not going to go through those
articles or the editorial ran, but things are moving fast in the area of
intervention for hepatitis C. That means, I think personally, that the ante is
raised about the importance of lookback. The ante is raised about the importance
of public education campaigns.
I have a friend who has hepatitis C, and he's been trying very hard to get
access to different forms of therapy, combination therapies. He believes that
the right response for him with his infection is to try and clear the virus from
his body. And I asked him if he felt that this Government and our country was
doing what we should to respond to hepatitis C epidemic, and he said no, because
every day he meets people who didn't realize that they might be infected.
That is not a good situation. So it is, I think, our mandate to the American
people to make sure that if this problem is out there and if there are steps
they can take, either through the cessation of drinking, watching what they do
with ibuprofen, getting themselves vaccinated against other forms of hepatitis,
not sharing razors, or moving towards some of these emerging interventions, we
have to make sure that people are aware of what they need to be aware of, that
medical and health communities are able to answer questions and inform them.
So that's how I see our task, as against that backdrop of saying, well, if there
are steps that can be taken to reduce infection, if there are steps that might
be taken to reduce the burden of the disease, if, as other statistics show,
we've got 4 million people infected and an explosion in the number of people
getting liver transplants due to this particular virus, we have to make sure
we're doing all that we can do in terms of a response, both public and private,
to hepatitis C.
I'd just mention one last comment, and then we'll go to the first witness.
This is a statement from the American Association for the Study of Liver
Diseases. They had a meeting in Chicago and thoughtfully sent me a statement
about one of the things they are bothered about. And they reported at that
meeting about the challenge of hepatitis C, what it was doing in terms of cost
and burden to the American people. But this statement caught my eye.
The main reason for the drastic increase in severe hepatitis C-related liver
disease--that means leading to transplant, leading to death--is that 90 percent
of people with chronic hepatitis C don't know they have it.
Well, that's not an acceptable situation. If that's what the problem is, then
we've got to make sure we are vigilant in pushing to make sure that that number
is much smaller.
So I'll stop there. That's our charge. We want to be mindful of the fact that by
the end of the day we have to say something about this report and what we want
to tell the Surgeon General and, through indirection, the other Federal agencies
here and even Congress. I suspect we might even say if we want them to spend
some more money, we might say they should spend some more money. What the heck?
It's not ours. Well, indirectly. It's so far distant.
So we can move now to the first witness, having reminded you why we're here and
what we're trying to do. I think we're going to hear from CDC first?
DR. NIGHTINGALE: Hear from CDC.
CHAIRMAN CAPLAN: I don't know who we've got from CDC. Oh, Dr. Alter?
DR. ALTER: Thank you. Good morning. I'm Miriam Alter from the Hepatitis Branch
of the Centers for Disease Control and Prevention in Atlanta, and you should all
have a hard copy--most of you should have a hard copy of the presentation. There
may be one or two of you who do not because we may not have brought enough
copies. But if that's the case, I'll be showing the exact same information on
the slides, and we will get you a hard copy if you need it.
As the first presentation today, we would like to review the guiding principles
which underlie the recommendations made by this Committee last year.
Identifying transfusion recipients at potential risk for HCV infection can be
accomplished with two approaches: targeted lookback, which is the direct
notification of prior recipients of donors who later tested positive for HCV,
and how we define positive may, in fact, be the major crux of all the issues
we're dealing with; and general lookback, which includes public notification
through broad education campaigns about the need to be tested, as well as
education of health care professionals to routinely ascertain transfusion
histories of their patients and test those with such a history.
Targeted lookback for transfusion recipients at potential risk for HCV infection
has several advantages. It focuses on a specific group known to be at risk. It
reaches persons unaware they were transfused. And it is perceived as proactive.
This approach also has several disadvantages. Many notifications may be based on
false positive results because supp