Matt's Blog

Some Transplant Patients may Not Need Anti Rejection Drugs
Scientist have given hope to some organ transplant patient by suggesting that
they may not need the anti rejection drugs to which they are otherwise resigned
to for a life time.
Researchers at Lucile Packard Children's Hospital and the Stanford University
School of Medicine used simple blood sample to identify a pattern of gene
expression shared by a small group of patients who remained healthy without
medication. This group who beat the odd have given many a hope of respite from
the anti rejection drugs.
The findings suggest that transplant recipients who share the same pattern of
genes but are still on conventional medication may be able to reduce or
eliminate their lifelong dependence on immunosuppressive drugs. The study may
also help physicians determine how best to induce acceptance, or tolerance, of
donor organs in all transplant patients, regardless of their gene expression
profiles.
"We're very excited by the findings," said Minnie Sarwal, MD, PhD, a pediatric
nephrologist at Packard Children's. "Most transplant patients who stop taking
their medications will reject their organ. But now we have the chance of telling
someone committed to a lifetime of drugs that it may be possible to minimize
their exposure to the drugs."
Although the anti-rejection medications, known as immunosuppressants, tamp down
the immune system enough to permit lifesaving organ transplants, their benefits
come at a price. They also quash the body's natural response to dangerous
invaders, such as bacteria and viruses, and to rogue cancer cells.
Transplant physicians prescribing immunosuppressants to their patients walk a
fine line between avoiding organ rejection and increasing the risk of infection
and cancer.
Sarwal, associate professor of pediatrics at the medical school, is the senior
author of the research, which will be published Aug. 20 in the advance online
edition of the Proceedings of the National Academy of Sciences. She collaborated
with physicians at Stanford and Packard Children's, as well as with colleagues
from the Veterans Affairs Palo Alto Health Care System and several institutions
in France, China and the Netherlands.
The researchers used microarray, or gene chip, technology to compare gene
expression patterns in blood samples from 16 healthy volunteers with those from
three groups of adult kidney transplant recipients from the United States,
Canada and France: 22 people on anti-rejection medications who had healthy donor
kidneys, 36 people who were taking their medications but who were still
rejecting their organs and 17 "tolerant" people who had successfully stopped
taking their medications without rejecting their donated kidneys.
Sarwal and her collaborators found that the expression pattern of just 33 genes
in a random sampling of peripheral blood could be used to accurately pick out
more than 90 percent of the tolerant patients. What's more, one out of 12
stable, fully medicated patients and five out of 10 patients on a modified,
low-dose immunosuppressant regimen shared very similar expression patterns.
The findings imply that patients regularly taking immunosuppressants who have a
strong matching pattern for the tolerance genes may be able to safely reduce or
even eliminate their dependence on the medication. Equally important, it
suggests that patients who don't share the gene pattern, even if on very
low-dose medication, should be particularly vigilant about continuing to take
their immunosuppressants.
"For the first time, we now have evidence that will help us say to the five out
of 10 patients without this expression pattern, 'Please, please don't think
about changing your medications'," said Sarwal. "At the same time, we may be
able to say a different patient, 'We'd like to try to cut back your drugs.'"
Although it's not known exactly how the 33 genes identified by the researchers
affect the development of tolerance, the expression and function of nearly
one-third are controlled by a regulatory molecule called TGFbeta. Sarwal and her
colleague speculate that the genes somehow affect the development of immune
cells responsible for distinguishing self from non-self.
But they caution that even long-term tolerance may not last forever; immune
challenges such as severe infection can sometimes cause rejection of a donated
organ years after anti-rejection medication was successfully stopped.
"The real value of this technology is the ability to easily and repeatedly
monitor patients over long periods of time," said Sarwal. "We can keep an eye on
this genetic signature and watch for changes that might indicate the beginning
of rejection before any clinical signs are apparent. This could be a very
exciting advance for both patients and physicians as it can lead to the ability
to, for the first time, safely customize immunosuppression for an individual
patient."
http://www.medindia.net/news/Some-Transplant-Patients-may-Not-Need-Anti-Rejectio\
n-Drugs-25280-1.htm

Not Paying for Medical Errors
Medicare, the government insurance program for older Americans, has announced
that it will soon stop paying hospitals for the extra costs of treating certain
patients whose illnesses are compounded by preventable errors. The effort won't
save much money at first, and it will impose additional testing and
documentation burdens on many hospitals, but it should promote better care. If
the initial steps are expanded, it could yield greater savings as well.
Under current payment rules, Medicare typically pays hospitals more for treating
a surgical patient whose illness is complicated by an infection than it would if
there were no infection present. That is true even if the infection is caused by
sloppy sanitary practices in the hospital itself. The perversity of a payment
system that actually rewards incompetence rather than penalizing it seems
self-evident. So Medicare is clearly wise to start changing the incentives.
Starting on Oct. 1, 2008, Medicare will no longer pay extra for eight specific
conditions that could generally be avoided if the hospital followed proven
preventive procedures or common-sense precautions. Medicare will no longer pay
hospitals to retrieve surgical tools or sponges left in a patient after the
initial operation. Nor will it reimburse for extra care given patients harmed by
incompatible blood or air embolisms, for treating bedsores developed in the
hospital, injuries caused by falls in the hospital, infections caused by
prolonged use of catheters in the bladder or blood vessels, or a surgical site
infection after coronary artery bypass surgery.
One element missing from the initial steps is any penalty for the doctors who
commit some of the errors. The hospital loses any extra payment for a second
operation to retrieve an object left behind the first time, which seems
appropriate given that nurses are supposed to keep track of all instruments and
sponges. But an errant doctor, who may also be culpable, can get paid for
operating again. In future years, Medicare needs to consider reforms in
physician payments as well.
Hospital spokesmen are worried that some of the conditions are not entirely
preventable and that some patients, for example, are prone to bedsores no matter
how good their care. They also worry that they will have to absorb the costs of
additional tests when a patient arrives to establish whether an infection is
already present before a catheter is inserted. But these initial conditions were
chosen with the help of experts in the belief that they could reasonably be
prevented by following evidence-based guidelines. And the extra tests and
documentation should help improve patient care.
Meanwhile, patient advocates seem pleased with the new rules now that steps have
been taken to prevent hospitals from shifting the costs of preventable errors to
patients or their insurers. Medicare officials will need to monitor the
situation closely and be prepared to make adjustments if hospitals are unduly
burdened. But they are clearly on the right track in seeking to prevent errors
that harm patients and drive up the cost of health care.
http://www.nytimes.com/2007/08/21/opinion/21tue1.html?_r=1&th&emc=th&oref=slogin

FACTS TO PONDER :
A) The number of physicians in the U.S. is
700,000.
B) Accidental deaths caused by Physicians per year are
120,000.
Calculation) Accidental deaths per physician is
0.171
Statistics courtesy of U.S. Dept of Health Human Services.
Now think about this:
Guns:
A) The number of gun owners in the U.S. is
80,000,000.
(Yes, that's 80 million..)
(B) The number of accidental gun deaths per year, all age groups, is
1,500.
(Calculation) The number of accidental deaths per gun owner is
.000188
Statistics courtesy of FBI
So, statistically, doctors are approximately 9,000 times more dangerous than gun
owners.
Please alert your friends to this alarming threat.
We must ban doctors before this gets completely out of hand!!!!!

This Might Get You to Quit Smoking
It's hard to believe that anyone would start smoking in 2007. It's
understandable that folks with a 40-year smoking history have trouble giving up
the habit, that is, treating their nicotine addiction. When asked, the majority
of smokers wish they could quit.
Smokers keep smoking.
The big health scares, of course, are respiratory diseases like emphysema and
lung cancer. Both diagnoses are slowly-executed death sentences. The smoker's
final years are spent short of breath with progressive loss of mobility.
Smokers keep smoking.
Cigarettes also play a big role in atherosclerosis and high blood pressure. That
greatly increases the risk of stroke and heart attack - more miserable ways to
spend your retirement (and your children's inheritance!)
Yep, smokers keep smoking.
Smoking cessation programs work so long as the smoker is motivated to quit for
good, yet fatal tobacco-induced diseases appear to be an insufficient deterrent.
Many smokers are in denial and believe "someone else" will have the bad luck.
Okay. So if a slow, inexorable decline in health leading to premature death
won't stop a person from smoking, will anything else? How about blindness? How
about spending your retirement unable to drive a car or read a book?
Age-related Macular Degeneration (AMD) is the leading cause of acquired
blindness in adults over 50. As the American population continues to mature the
number of seniors going blind from AMD is expected to climb steadily. We've
posted lots of blogs about AMD but this may be the most worthwhile.
Although the causes of AMD are felt to be multifactorial (heredity, environment,
genetics, inflammation, nutrition, etc.), the only known AMD risk factor that
can be controlled is smoking. Severe, irreversible vision loss from AMD is 4
times more likely to occur in smokers. Conversely, smokers who quit for 20 years
reduce the risk similar to those who have never smoked. Smoking cessation will,
on average, extend a person's life by 6-8 years. But here's the important part
about that newfound longevity: statistically, those bonus years will more likely
be spent without visual disability or shortness of breath.
Most health plans cover smoking cessation because it is cheaper for insurance
companies to help you stop than to treat your subsequent smoke-related health
problems. Even if you do not have insurance coverage, the daily $4 per pack cost
of cigarettes could easily cover your smoking cessation treatment.
Will this information be enough to help you quit smoking once and for all?
Related Topics:
a.. 10 Overlooked Reasons to Quit Smoking
b.. Quitting Tobacco
Technorati Tags: smoking, AMD, macular degeneration, blindness, vision, eye
health
Posted by: Dr. Lloyd at 9:30 AM
http://blogs.webmd.com/eye-on-vision/2007/07/this-might-get-you-to-quit-smoking.\
html?ecd=wnl_smk_082007

Six Diseases of the Liver, Six Different Viruses, One Name: Hepatitis
Millions of people get hepatitis. Some become very sick. Others never even
know they are infected. Transcript of radio broadcast:
20 August 2007
MP3 - Download Audio
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VOICE ONE:
This is SCIENCE IN THE NEWS in VOA Special English. I'm Barbara Klein.
VOICE TWO:
And I'm Steve Ember. This week, we will tell about six diseases of the liver.
The six diseases come from six different viruses. Doctors have one name for all
of them: hepatitis.
(MUSIC)
VOICE ONE:
The liver is in the upper right part of the stomach area. This dark red organ
is big -- it weighs more than one kilogram. And it has a big job. The liver
helps clean the blood and fight infection. It also helps break down food and
store energy until the body needs it.
Hepatitis destroys liver cells. Some kinds of hepatitis are much more serious
than others. Scientists have identified the six kinds of hepatitis with the
letters A, B, C, D, E and G. Which kind a person has can only be known from
tests for antibodies in the blood.
Antibodies are special proteins that the body's natural defense system produces
in answer to a threat. Identify the antibody and you identify the threat.
VOICE TWO:
Hepatitis A is usually spread through human waste in water or food. It is in
the same group of viruses as those that cause the disease polio.
The hepatitis A virus causes high body temperature, weakness and pain. It
causes problems with the stomach and intestines, making it difficult to eat or
break down food. Also, the skin of a person with hepatitis may become yellow.
This is a sign that the liver is not operating normally.
To help prevent the spread of hepatitis A, people should wash their hands after
they use the restroom or change a baby's diaper. People should also wash their
hands before they eat or prepare food.
VOICE ONE:
Hepatitis A can spread quickly to hundreds or thousands of people. But the
virus is deadly in less than one percent of cases. Many people infected with
the virus never even get sick. But those who do generally recover within two
months.
The World Health Organization says hepatitis A is often found in Africa, Asia
and Central and South America. People who have had hepatitis A cannot get it
again. There is a vaccine to prevent hepatitis A. America's Centers for
Disease Control says the vaccine is the best way to protect against the disease.
(MUSIC)
VOICE TWO:
The World Health Organization says hepatitis B is one of the major diseases of
mankind. W.H.O. officials say two billion people are infected with the
hepatitis B virus. More than three hundred fifty million of those infected have
lifelong infections. The highest rates are in developing countries.
This virus is in the same group as the herpes and smallpox viruses. Hepatitis B
vaccines have been given since the early nineteen eighties. The W-H-O says the
vaccine is ninety five percent effective in preventing the development of
infection in both children and adults.
VOICE ONE:
Hepatitis B spreads when blood from an infected person enters the body of
another person. An infected mother can infect her baby. The virus can also
spread through sex, and if people share injection devices.
Blood products from an infected person can spread hepatitis B. People also can
get infected if they share personal-care products that might have blood on them.
Examples include toothbrushes and hair-cutting equipment like razors.
VOICE TWO:
Worldwide, most hepatitis B infections are found in children. Young children
are the ones most likely to develop a lifelong, or chronic, infection. The risk
of such an infection is small for children older than four years.
About ninety percent of babies infected with hepatitis B during the first year
develop chronic infections. Such persons are at high risk of death from liver
disease or liver cancer. The hepatitis B vaccine is considered to be the first
medicine that can protect people against liver cancer.
(MUSIC)
VOICE ONE:
Hepatitis C is even more dangerous. Like hepatitis B, it spreads when blood
from an infected person enters someone who is not infected. The hepatitis C
virus belongs to the same group of viruses as yellow fever and West Nile virus.
Most people infected with hepatitis C develop chronic infections, often without
any signs. They are at high risk for liver disease and liver cancer.
The World Health Organization says about one hundred eighty million people are
infected with hepatitis C. The W.H.O. reports that as many as four million more
become infected each year. And it says that one hundred thirty million of those
with the disease may develop diseases of the liver, including liver cancer. The
W.H.O. says the highest rates of infection are in Africa, Latin America and
Asia.
VOICE TWO:
Scientists have been working to develop a vaccine against hepatitis C. The
virus was first observed in nineteen seventy-four. But it was not officially
recognized as a new kind of hepatitis until nineteen eighty-nine.
The Centers for Disease Control says about four million Americans have been
infected with hepatitis C. It says that those especially at risk include
persons who inject themselves with drugs and those who received blood or blood
products before nineteen ninety.
(MUSIC)
VOICE ONE:
Hepatitis D is also spread through blood, but only infects people who already
have hepatitis B. The virus greatly increases the chance of severe liver
damage. Experts say hepatitis D infects about fifteen million people around the
world.
Doctors say the best way to prevent hepatitis D is to get vaccine that protects
against Hepatitis B. Doctors can treat some cases of hepatitis B, C and D. The
drugs used are very costly, however. But they are less costly than another
treatment possibility: getting a new liver.
VOICE TWO:
The fifth virus is hepatitis E. Experts say it spreads the same way as
hepatitis A -- through infectious waste. Cases often result from polluted
supplies of drinking water. Medical science recognized hepatitis E as a
separate disease in nineteen eighty.
Hepatitis E is also found in animal waste. Studies have shown that the virus
can infect many kinds of animals, including cows, monkeys and pigs.
VOICE ONE:
The W.H.O. says many hepatitis E cases have been reported in Central and
Southeast Asia, North and West Africa and Mexico.
No vaccines or medicines are effective against hepatitis E. Most people
recover, usually in several weeks or months. But the disease can cause liver
damage. And, in some cases, hepatitis E can be deadly.
The virus is especially dangerous to pregnant women. Twenty percent of women
with hepatitis E die in the last three months of pregnancy.
VOICE TWO:
Scientists discovered yet another kind of hepatitis in the nineteen nineties.
It has been named hepatitis G. The hepatitis G virus is totally different from
any of the other hepatitis viruses.
Donald Poretz is an infectious disease specialist and professor at the
Georgetown University School of Medicine in Washington, D.C. He says the
hepatitis G virus is spread through blood and blood products. But he says the
virus has not yet been found to cause any real disease.
VOICE ONE:
There are no cures for any kind of hepatitis. The only way to protect against
infection is to receive vaccines against hepatitis A and B, and avoid contact
with the other viruses. And that may be very difficult.
Remember that some kinds of hepatitis spread through sex or sharing needles.
Blood products should be carefully tested for hepatitis. People in high-risk
groups and those who have had hepatitis should not give blood. They also should
not agree to provide their organs to others after they die. Donated organs can
also spread hepatitis.
VOICE TWO:
Health experts say people can take other steps people to protect themselves.
These include always washing your hands with soap and water after using the
restroom. Also, wash your hands after changing a baby's diaper and before
preparing or eating food.
Experts also say travelers should not drink water of unknown quality when
visiting foreign or unknown areas. Visitors to such areas also should avoid
eating uncooked fruits and vegetables. And, again, do not forget to wash your
hands!
(MUSIC)
VOICE ONE:
This SCIENCE IN THE NEWS was written by Nancy Steinbach. Our producer was
Brianna Blake. I'm Barbara Klein.
VOICE TWO:
And I'm Steve Ember. You can download transcripts and audio of our programs, at
www.voaspecialenglish.com. Listen again next week for more news about science
in Special English on the Voice of America.
http://www.voanews.com/specialenglish/2007-08-20-voa3.cfm

Doctors Urged To Admit Fault in Medical Errors, Apologize
Hospitals increasingly are creating policies that encourage doctors who
make medical mistakes to apologize to patients, the Chicago Tribune reports. In
the past, physicians have been "too proud, too afraid of malpractice lawsuits
and too worried about losing face" to make apologies, according to the Tribune.
The movement is supported by industry groups such as the Joint Commission,
formerly known as the Joint Commission on Accreditation of Healthcare
Organizations, and the National Quality Forum.
"One of the biggest obstacles to disclosure is the fear of lawsuits," the
Tribune reports. Although some contend that admission of errors will make it
easier for patients to file suit, others say that an apology and compensation
for injuries will reduce that likelihood.
More than 30 states have passed "apology laws" that prevent apologies for
medical errors from being used in court. Democratic presidential candidates
Sens. Barack Obama (Ill.) and Hillary Rodham Clinton (N.Y.) have proposed
legislation that would promote disclosure to reduce malpractice lawsuits. The
Department of Veterans Affairs and facilities affiliated with Harvard Medical
School have policies in place that encourage staff to disclose errors to
patients, apologize and explain how they will prevent such errors in the future.
Steven Kraman, who helped develop the disclosure program at the Lexington VA
Medical Center in Kentucky, said that admitting errors is a way for hospitals to
learn from mistakes and develop ways to ensure they do not happen again,
outweighing the potential costs of apologies.
During the first year of its disclosure policy, the University of Illinois at
Chicago Medical Center had one malpractice claim filed among 40 acknowledged
errors, according to the Tribune. UIC CEO John DeNardo said, "The best way to
approach this is to own up to the fact that an incident happened and ask what
can we do to fix it and make the situation better" (Graham, Chicago Tribune,
8/19).
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47008

USA Today Op-Eds Assess Recent Court Decision on Experimental Medications for
Terminally Ill Patients
USA Today on Tuesday published an editorial and an opinion piece addressing
a decision last week by the U.S. Court of Appeals for the District of Columbia
Circuit that terminally ill patients do not have the right to obtain access to
unapproved experimental drugs that potentially are lifesaving. Summaries appear
below.
a.. USA Today: Supporters of increased access offer an argument that is "as
powerful as it is simple: Why not let a patient and his or her doctor, rather
than bureaucrats, make the final, desperate, informed decision?" a USA Today
editorial states. "FDA asserts that it is responsive to such patients, that many
have benefited from access to unapproved drugs" and that the agency "does not
want to stand in the way of such patients," the editorial notes. However,
"thousands of patients and their doctors still face daunting obstacles,"
according to the editorial. FDA's position is "understandable," but "why not
create an 'Abigail test' that would make it easier for terminal patients who
have exhausted other options to try promising drugs that are nearing final FDA
approval?" the editorial asks (USA Today, 8/21).
b.. Andrew von Eschenbach, USA Today: "Over the years, thousands of patients
with life-threatening diseases have been treated with drugs before FDA granted
final approval," FDA Commissioner von Eschenbach writes in a USA Today opinion
piece. He continues, "For example, from 1996 to 2004, while clinical trials were
ongoing for eight different cancer drugs, 33,000 additional patients were
permitted by FDA to be enrolled in expanded access programs." He adds, "There
is, and always must be, a pathway for such options." However, von Eschenbach
concludes, "allowing mass marketing and promotion of unproven therapies would
have serious consequences: false hope and lack of real medical progress that
could ultimately lead to control and cure of devastating illnesses" (von
Eschenbach, USA Today, 8/21).
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47019

Dentists Can Be First To Detect Some Medical Conditions
Some dentists are giving patients blood tests before and after treatment of
gum disease to help screen for more than 20 medical conditions, including
diabetes, heart disease, colon cancer, Hodgkin's lymphoma and chronic heartburn,
the Chicago Sun-Times reports. Bacteria that cause gum disease release toxic
byproducts into the bloodstream, which can increase levels of blood sugar,
cholesterol and C-reactive protein, or CRP, which is a measure of systemic
inflammation. Studies have shown that gum diseases might increase the risk of a
number of health problems, including heart disease and premature births.
If treatment of gum disease does not lower levels of blood sugar, cholesterol
and CRP, it could indicate that a patient has some underlying disease. Testing
before and after gum disease treatment costs about $150 and typically is not
covered by insurance, according to Ronald Schefdore, a dentist who gives routine
blood tests. In addition to blood tests, some dentists are giving patients oral
cancer tests; correcting patients' bites to treat headaches, neck and shoulder
pain, and ringing in the ears; and fitting patients with oral devices to stop
snoring.
"We're discovering that the mouth has implications for the whole body," dentist
Ivan Valcarenghi said. Schefdore said, "If every dentist practiced this way, we
could improve the health of the world overnight" (Ritter, Chicago Sun-Times,
8/19).
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47009

HHS Charges South Florida Company With Medicare Fraud
As part of a joint effort to combat illegal Medicare activity, HHS and the
Department of Justice on Monday announced charges against R&I Billing in South
Florida for fraudulently billing Medicare $170 million for infusions of HIV
drugs, Bloomberg/Washington Post reports.
In an e-mail statement, HHS and DOJ said, "From roughly October 2002 through
April 2006, HIV clinics in South Florida serviced by this biller, Rita Campos
and her company R&I Billing, allegedly provided bills to Medicare that indicated
patients were being injected with excessive amounts of HIV medications." The
statement added, "Based on the claims filed by Campos, Medicare paid more than
$100 million for these fraudulent services" (Larkin/Marcus, Bloomberg/Washington
Post, 8/21).
On Monday, federal authorities instructed Medicare beneficiaries to be on the
lookout for fraudulent companies that might be billing the program for
drug-infusion services that never were administered, the Newark Star-Ledger
reports. The warning was issued as part of the federal crackdown on the $4.5
billion drug-infusion industry, particularly in South Florida (Stewart, Newark
Star-Ledger, 8/21).
Another measure in the crackdown will require all clinics in South Florida that
offer drug infusions to reapply within the next 30 days to qualify for Medicare
participation, the Miami Herald reports (Dorschner, Miami Herald, 8/21).
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47005

The Foundation for Health Coverage Education (FHCE) has developed an interactive
web site
A new tool developed to allow consumers the ability to better determine their
eligibility for public and private health plans was featured in the Washington
Post today ("Ineligible, Don't Be So Sure." Gerber, Washington Post, 8/21, Page
HE01).
The Foundation for Health Coverage Education (FHCE) has developed an interactive
web site that allows consumers from all 50 states and the District of Columbia
to assess options available. "While the information on the site isn't new...its
interactive format lets users shortcut through complexities to personalized
options much more quickly and easily. The foundation, funded largely by the
insurance industry, argues that the oft-cited figure of 43 million uninsured
Americans includes many people who don't know of the choices available to them."
(Gerber, Washington Post, 8/21)
The website is one of four ways the FHCE highlights on their website to help
people find coverage.
1.. Website/Health Coverage Eligibility Tool - Consumers answer 5 questions to
help determine which programs they could qualify for.
2.. Phone/US Uninsured Help Line - A Hotline (800-234-1317) is available 24
hours/7 days a week.
3.. Health Care Options Matrix Grid - Consumers can print or download their
state's free quick reference guide to public and private health care options.
4.. State-by-State Application & Enrollment Database - Consumers can find
resources and applications, by state.
The mission of the FHCE is: "To simplify public and private health insurance
eligibility information in order to help more people access coverage".
To access these tools on the FHCE website, go to:
http://www.coverageforall.org/

The Untouchables
By Michelle Andrews
Posted 8/20/07
Denied! These conditions will typically make you "uninsurable" in the market for
individual coverage:
· amyotrophic lateral sclerosis (ALS; Lou Gehrig's disease)
· anorexia
· arthritis
· brain or spinal cord injury
· cancer (diagnosed or treated within the past five years)
· chemical dependency
· coronary heart disease
· cystic fibrosis
· diabetes
· epilepsy
· hemophilia
· hepatitis C
· HIV/AIDS
· kidney disease
· Lou Gehrig's disease (see above)
· lupus
· multiple sclerosis
· muscular dystrophy
· osteoporosis
· paraplegia or quadriplegia
· Parkinson's disease
· pregnancy
· stroke
· transplanted organ
Source: Georgetown University Health Policy Institute
Expect Hiccups
Think your good health guarantees you coverage? Think again. Even relatively
minor conditions like these can get you turned down for individual insurance:
· acne
· back pain
· high blood pressure
· mild depression
· old sports injuries
· 20 pounds overweight/underweight
Source: Georgetown University Health Policy Institute
http://health.usnews.com/usnews/health/articles/070820/20preconditions.b1.htm

Share of Seniors With Drug Coverage Significantly Increased Under Medicare Part
D, Some Seniors Still Vulnerable to High Costs, Study Finds
The Medicare prescription drug benefit has significantly increased the
share of seniors with drug coverage, but one in five beneficiaries reported
delaying or not filling prescriptions because of cost, according to the results
of a survey published online Tuesday in the journal Health Affairs, the Los
Angeles Times reports. The survey -- conducted in October 2006 by the Kaiser
Family Foundation, the Commonwealth Fund and Tufts-New England Medical Center --
included more than 16,000 seniors (Alonso-Zaldivar, Los Angeles Times, 8/21).
According to the study, the percentage of seniors without prescription drug
coverage dropped from 33% in 2005 before the benefit took effect to 8% in 2006
(Ross, Cox/Longview News-Journal, 8/21). Overall, about half of all seniors were
enrolled in the drug benefit at the time of the survey, 31% received drug
benefits from a former employer and 3% were covered through the Department of
Veterans Affairs. The survey found that about one-quarter of seniors enrolled in
the Medicare drug benefit said they had switched to lower-cost generic drugs,
and more were using mail-ordering programs for 90-day supplies of drugs at a
lower cost.
Twenty percent of Medicare drug plan beneficiaries said they did not fill or
delayed filling a prescription because of cost, compared with 23% of those
without drug coverage, 8% of those with employer-based benefits and 12% of
seniors with coverage through the VA (Los Angeles Times, 8/21). About one in
four Medicare drug plan beneficiaries said they spent more than $100 in
out-of-pocket drug costs per month, and 8% said they spent more than $300 per
month, according to the survey. This compares with 11% of those without drug
coverage and 5% of VA beneficiaries and those enrolled in employer-sponsored
plans who said they spent more than $300 per month, the survey found
(Cox/Longview News-Journal, 8/21).
According to the Times, some of the higher costs for Medicare drug plan
beneficiaries appear to be because of the so-called "doughnut hole" coverage
gap, under which beneficiaries are responsible for 100% of total prescription
drug costs between $2,400 and $5,450 (Los Angeles Times, 8/21). Other studies
estimate that 3.4 million to 4.7 million beneficiaries are eligible for but do
not receive low-income subsidies that would close the coverage gap. The survey
found that about half of low-income seniors not receiving these subsidies were
aware of their availability (Cox/Longview News-Journal, 8/21).
Comments
Lead study author Tricia Neuman, vice president of the Kaiser Family Foundation
and director of the Foundation's Medicare Policy Project, said, "I was somewhat
surprised to see the disparities between [Medicare] plans, and employer and VA
coverage. When you control for health status, income and other differences, the
strong finding that employer plans provide better coverage than Medicare comes
through loud and clear" (Los Angeles Times, 8/21). According to Neuman,
"Low-income subsidies really make a difference for those seniors who receive
them, but there are still millions of low-income seniors who are eligible for
this help but are not getting it. Our study confirms the importance of doing
more to get additional assistance to low-income seniors" (Cox/Longview
News-Journal, 8/21).
Kaiser Family Foundation President and CEO Drew Altman said, "The Medicare drug
law achieved its primary goal of providing drug coverage to most seniors who
previously lacked it," adding, "But the survey found a significant number of
seniors in Part D plans paying sizable amounts out of pocket for their
medications and delaying or not filling their prescriptions for cost reasons."
Commonwealth Fund President Karen Davis said, "In addition to covering more
seniors, it's important that coverage be adequate to ensure financial protection
and access to prescription drugs," said, adding, "We still have a lot of work to
do to make sure that Medicare beneficiaries -- particularly those who are most
vulnerable because of low incomes or chronic illness -- can get the drugs they
need and are not subject to burdensome out-of-pocket costs."
Rep. Pete Stark (D-Calif.) said the drug benefit is "a system basically designed
to create profits for private insurance plans. I don't want to see it repealed,
but I want to see it repaired." CMS officials had no comment on the report (Los
Angeles Times, 8/21).
Free access to the study is available online.
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47004

Mbeki in South Africa liver transplant scandal
By Sebastien Berger in Johannesburg
Last Updated: 3:58am BST 21/08/2007
The South African president, Thabo Mbeki, was yesterday dragged into a scandal
surrounding his health minister, who it is claimed jumped the queue for
transplant organs.
South African newspapers alleged that Manto Tshabalala-Msimang received a liver
despite being a heavy drinker. The Sunday Times of South Africa claimed she had
been seen drinking since she received the organ, from a teenage suicide victim.
It claimed there were "more deserving recipients on the liver transplant waiting
list" and the allocation was "inappropriate" according to medical experts.
The opposition Democratic Alliance will today submit a parliamentary question
asking if Mr Mbeki telephoned the hospital to ask them to prioritise Ms
Tshabalala-Msimang's case.
A spokesman for the party said the question was based on information from "a
very reliable source".
"The life of someone else with a less risky medical prognosis may have been lost
as a result of the President's call," said party leader Helen Zille.
"The minister of health is able to get access to the most sophisticated medical
interventions that money can buy to save her from what appears to be a
self-inflicted problem.
"If this is the kind of justice South Africans must live and die with, there is
something wrong with our democracy."
Mr Mbeki's spokesman, Mukoni Ratshitanga, said the allegation was "complete
fiction". "The president never called any doctor at the hospital and it is the
sort of claim that would be made by somebody who does not know President Mbeki,"
he said. "He would never do such a thing."
Ms Tshabalala-Msimang, 66, was dubbed "Dr Beetroot" for insisting that
vegetables could help Aids sufferers. But she has long-standing ties with Mr
Mbeki dating back to their time in exile during apartheid. "In the ANC your
personal history is very important," said Steven Friedman, of the Institute for
Democracy in South Africa.
"I'm pretty sure she is doing exactly what he wants her to do, so why should he
get rid of such a loyal servant?"
The ANC has a huge parliamentary majority and is virtually guaranteed to win the
next election, so public account-ability in South Africa is really more an
internal party matter.
A spokesman for the minister denied the newspaper's reports as "false,
speculative and bizarre" and in a sign the party is closing ranks behind the
minister, its national working committee last night condemned the messenger,
expressing "deep concern and outrage at the continued violation by the Sunday
Times newspaper of the principle of patient-doctor confidentiality".
http://www.telegraph.co.uk/news/main.jhtml?xml=/news/2007/08/21/wsa121.xml

Simply Age Not Linked To Risk Of Death From Liver Transplant
The age alone of a liver transplant recipient seems not to be linked to the risk
of death following liver transplant, says a report in Archives of Surgery
(JAMA/Archives), August issue.
The authors of the article explain that the over 70s are becoming a larger and
larger proportion of the general population each year. A healthy
seventy-year-old who lives in a developed country, receives high-quality medical
care and follows a healthy diet will live till he/she is 80 or 90.
"As longevity has increased, the burden of liver disease in patients of
advancing age has also increased and is associated with a higher mortality than
in younger adults. In the 1980s, the death rate from chronic liver disease was
highest in patients 65 to 74 years of age. This has led to more older patients
undergoing liver transplantation," the authors wrote.
Gerald S. Lipshutz, M.D., M.S., David Geffen School of Medicine at UCLA, and
team examined the records of patients who had received their first liver
transplant between the years 1988-2005. 62 patients over 70 were compared to 864
aged 50-59. Survival time was measured until death, the last known follow-up or
retransplantation.
During the study period, exactly half (31) of the 62 patients over 70 died,
compared to 345 of the 864 patients aged 50-59. A year later 73.3% of the older
patients and 79.4% of the younger ones survived. Ten years later 39.7% of the
over 70s and 45.2% of the younger ones were still living.
"We found no statistically significant difference in survival in the first 10
years after transplantation for a group of 62 patients 70 years or older when
compared with a younger cohort of 864 recipients aged 50 to 59 years with
similar characteristics. The longest-surviving patient was 88 years old at 15
years after transplantation. One-year unadjusted survival of septuagenarians in
the most recent surgical period, 2001 to 2005, was 94.4 percent," the
researchers said.
26 variables, related to the recipients, donors and transplant operations were
analyzed. The aim was to see which variable(s) predicted patient deaths.
Four variables were linked to death rates:
-- Preoperative hospitalization
-- The liver being kept in cold storage for a long time between its removal and
transplantation
-- Cirrhosis caused by hepatitis C and alcohol
-- An increasing model for end-stage liver disease (MELD) score
Being 70 years old or older did not predict death in transplant patients on its
own.
The researchers conclude "In conclusion, biological and physiological variables
may play a more important role than advanced age in predicting poor survival
after liver transplantation. Measures of physiological age and risk of
complications should be used in the evaluation process of elderly transplant
candidates. Age by itself should not be used to limit liver transplantation."
Archives of Surgery (JAMA/Archives)
Written by: Christian Nordqvist
http://www.medicalnewstoday.com/articles/80060.php

Risk Factors for Mother-to-child Transmission of Hepatitis C Virus
By Liz Highleyman
Hepatitis C virus (HCV) infection in children is mainly acquired via
mother-to-child (perinatal) transmission. In a study published in the August
20,2007 issue of AIDS, French researchers sought to identify risk factors for
mother-to-child HCV transmission, in particular those associated with maternal
virological characteristics or mode of delivery.
The investigators included 214 HCV positive women and their newborn infants seen
at 6 hospitals in southern France between October 1998 and September 2002. About
one-quarter (55%) of the women were HIV-HCV coinfected. The authors collected
data on maternal characteristics, circumstances of delivery, and laboratory data
for the mothers and children. All babies were followed for 1 year, and those
with detectable plasma HCV RNA for 2 years.
Results
. In total, 12 infants had detectable HCV RNA at 1 year of age, yielding an
overall mother-to-child transmission rate of 5.6%.
. 3 of these children became HCV RNA negative between 12 and 18 months of age
and achieved normal alanine aminotransferase (ALT) levels.
. 137 women (69%) had detectable plasma HCV RNA, including all those whose
children were infected.
. 6 children were born to HIV-HCV coinfected women with detectable HCV RNA,
for a transmission rate of 13.6%.
. 6 were born to HCV monoinfected women with detectable HCV RNA, for a
transmission rate of 6.5%.
. The risk of mother-to-child HCV transmission was 3 times higher for HCV-HIV
coinfected women compared to those with HCV alone (P = 0.05).
. When maternal HCV RNA levels were below 6 log IU/ml, the rate of
transmission was significantly higher in HIV-HCV coinfected women (odds ratio
8.3; P = 0.01.
. This association with HIV status did not exist, however, for women with
detectable HCV RNA levels of 6 log IU/ml or higher.
. The rate of HCV transmission did not differ significantly between children
born by vaginal delivery or Caesarean section after membrane rupture and those
born by elective Caesarean section, independent of HIV status.
Conclusion
These findings confirm results of past studies showing that HIV-HCV coinfected
women are more likely to transmit HCV to their babies than those with HCV alone.
The study also confirmed that HCV viral load plays an important role in
mother-to-child transmission/
Department of Public Health, France; CHU Nice, France; CHU Toulouse, France; CHU
Montpellier, France; CHG Antibes, France; Virology Laboratory, France; INSERM
U379, France.
08/21/07
Reference
E Marine-Barjoan, A Berrebi, V Giordanengo, and others (for the ALHICE study
group). HCV/HIV co-infection, HCV viral load and mode of delivery: risk factors
for mother-to-child transmission of hepatitis C virus? AIDS 21(13): 1811-1815.
August 20, 2007.
http://www.hivandhepatitis.com/hep_c/news/2007/082107_a.html

MEDICAID
7. South Carolina To Shift Medicaid Beneficiaries to Managed Care Plans
South Carolina will move more than 550,000 Medicaid beneficiaries to
managed care plans starting Nov. 1, the Columbia State reports. State officials
say the shift will improve preventive care and provide beneficiaries with a
primary care physician, which will reduce costs associated with care received in
hospital emergency departments. Beneficiaries who do not choose a managed care
plan will be assigned one. The enrollment processes is expected to be finished
by the end of 2008. Insurers who offer the plans will receive a payment for each
Medicaid beneficiary they enroll. BlueChoice HealthPlan, a subsidiary of
BlueCross and BlueShield of South Carolina, will be the first insurer to enter
the Medicaid market and is expected to start enrolling beneficiaries this fall
(Werner, Columbia State, 8/15).
Back to Top
STATE WATCH
8. Arkansas Gov. Beebe To Convene Health Care Roundtable
Arkansas Gov. Mike Beebe (D) said he is creating a health care roundtable
to develop ways to improve health care access in the state, the Arkansas
Democrat-Gazette reports. Beebe spoke during a health care conference on
Wednesday sponsored by the Community Health Centers of Arkansas.
The roundtable, which will be organized by state Surgeon General Joe Thompson,
will comprise health care consumers, employers and insurers and will determine
specific goals and proposals to examine. Thompson said that there is increasing
national interest in state initiatives to fund and expand health coverage, such
as the Massachusetts health insurance law.
Beebe said the state might not be able to adopt policies that would create a
universal coverage system in the state, adding, "We've certainly got fiscal
constraints on the ability to do some things." However, he said, "While we wait
on the federal government to see what they're going to do, we have an obligation
as a state to continue to dialogue and see what we can do ourselves to spread
affordability and accessibility." Also at the conference, Beebe asked the
state's congressional delegation to support SCHIP expansion (Smith, Arkansas
Democrat-Gazette, 8/16).

Sunday, August 19, 2007
Surviving Hepatitis C
By Carol Bogart
Five years ago, a woman named Sally in Seattle called me in Ohio to talk about
her Hepatitis C. She was, as I recall, nearing 70 and a retired teacher. Her
niece, an adult lawyer, had taken me to lunch to talk to me about her. She said
Sally was the dearest sweetest woman; one whose husband was gone, had not had
children, and was now alone.
I was a columnist for the local newspaper and had been writing about my own
Hepatitis C. For a year, I endured a clinical trial that was very much like
chemotherapy. The niece told me Sally was afraid to have a liver biopsy, and
wondered if I'd mind if her aunt called me.
As a result of my weekly column, many people you would never suspect to have
this "dirty" disease often linked with injecting illegal drugs had come forward
to either get tested and start treatment, or to simply thank me for giving voice
to a condition about which so many are ashamed.
Like me, Sally had no idea how she'd gotten Hepatitis C. A diabetic, she
wondered whether she'd been infected during a blood draw to check her sugar. I
wondered whether it was a single acupuncture session for my herniated disk. I
don't remember, either, how Sally found out she had it. That I did was a lucky
twist of fate.
I was symptom-free in 1995 (the liver is an "uncomplaining" organ) and covering
a terrible story for a Cleveland television station. It was about a paramedic
who, coming home from work, had flipped the light switch, not knowing that in
the basement, the leaking furnace had filled the house with gas. A small spark
from the switch triggered an explosion that blew him out the door into his
backyard, burned over 75 percent of his body.
As the videographer and I swung into the parking lot at Metro Health Center,
paramedics, firefighters and cops filled the waiting room and halls. Throughout
the night, it was touch and go as their friend and co-worker needed so many
transfusions that the hospital was starting to run out of platelets.
Two days later, the firefighters staged an emergency blood drive. I urged the TV
station's assignment editor to let me cover what was to me a poignant human
interest story: the coming together as one of those whose occupations so often
put them in harm's way.
The first person I interviewed was the paramedic's dad, a retired firefighter
and, usually, self-contained stoic man. Now, with his son hovering at death's
door, he could barely hold back his tears. I talked, too, to the paramedic's
partner on the ambulance, a man so broken up he could barely speak.
When I learned that the paramedic's blood type was O-negative, the same as mine,
I set my reporter's notebook aside - signing up on the spot to donate blood,
despite my lifelong fear of needles.
God moves in mysterious ways.
Two weeks later, a letter from the Red Cross arrived. It said in bold capital
letters across the top: "THIS IS NOT A LETTER ABOUT AIDS BUT . ." I was informed
that my blood had tested positive for Hepatitis C and had been discarded. I was
never again to give blood, the letter said, nor was I to be an organ donor. I
thought about the organ donor sticker that had been on my driver's license for
many years.
A visit to my internist confirmed the diagnosis.
The paramedic made a slow recovery. I might have died but for that decision to
give blood. That's not to say I instantly started treatment. I didn't. In 1995,
despite country singer Naomi Judd's success with Interferon for her Hepatitis C,
for many, it meant terrible side effects, but no eradication of the virus. I had
a young boy at home. I decided to wait until medicine could offer something
better.
By 2001, though, I was feeling very fatigued. Regular monitoring of my liver
enzymes - a barometer of how much damage the Hep C is doing in your liver -
found that they were getting worse. My son was now 16. It was time.
Like Sally, the idea of a liver biopsy terrified me. It was, however, required
of those who wanted to take part in a clinical trial being offered by the
Cleveland Clinic. For the first time, those with Hepatitis C had a shot at a new
"combination" therapy - a three-drug treatment it was hoped might up their odds
of surviving what some call a silent epidemic.
The day of my biopsy, I was grateful to my doctor, head of the clinic's
gastroenterology department, for coming in early to hold my hand as the
"routine" procedure was performed. I would later assure Sally it really wasn't
all that bad. When asked afterward if I needed pain relief, I truthfully
answered, "No."
The result, though, was pretty scary. Stage 3 liver fibrosis (scarring):
bridging and portal. One stage away from full blown cirrhosis. I'd be starting
the trial just in time.
For a year, I injected Pegylated Interferon into fatty tissue in my tummy once a
week and took Ribavarin and Amantadine capsules every day. I lost 60 pounds and
handfuls of hair and, by the 10th month, once failed to recognize a friend I saw
at Kroger's. At the same time the drugs were attacking the virus, healthy stuff
was dying, too.
At night, I ached so much I couldn't sleep. In the last month, the side effects
were so bad that, with the approval of my research nurse, I started cutting back
the dose of both the Interferon and the pills. It was either that, or just stop
taking everything altogether.
I'd been getting the meds and supplies for free thanks to the clinical trial - a
good thing because, otherwise, I couldn't have afforded to get treated.
Pegylated Interferon alone costs a fortune.
Once a month I'd drive the two hours to Cleveland to have eight vials of blood
drawn to monitor my liver enzymes. I wasn't allowed to take Advil during those
12 months (an anti-inflammatory, it could have skewed the results) - but that
meant no relief for my osteoarthritis.
As I was going through my clinical trial, two very close friends were enduring
what would prove to be their final unsuccessful round of chemotherapy - one for
breast cancer, one for leukemia. We told each other that which we didn't tell
those we loved: We were in so much misery, we really didn't care if we died, but
we worried what would happen to those we left behind; in my case, my 16 year old
son. My friends, farm wives, had both been married for more than 40 years.
Dolores and Shirley finally decided: No more chemo. One after the other, they
passed away. At the end of my treatment, my blood work came back "clean." No
trace at all of the Hepatitis C. My enzymes were back to normal.
Every six months, I get the liver panel done. To date - and it's been four years
- I remain Hepatitis free. I'm a Type 2. Ninety percent of the Type 2s in the
clinical trial had the same result. For Type 1's, who are more resistant to
treatment, the success rate was 60 percent. In the '90s, when I was first
diagnosed, Interferon, the sole drug available at the time, cleared the virus in
only 10-15 percent of those treated for Hep C. I felt like a living miracle.
Sally, after we talked at length several times, did have her biopsy and started
treatment. She'd waited too long. She died.
Dr. William Carey, my gastroenterologist, warned me often that the longer I
waited, the more opportunity the virus had to "replicate" and become stronger.
Hep C is a quiet killer. Health officials estimate 4.1 million Americans are
infected. Many are unaware. If you think there's any chance you might have it,
get tested. It could save your life.
For information on testing for Hepatitis C, contact your state or local health
department.
Carol Bogart is a freelance writer/editor. Read her articles at
www.hubpages.com. Contact her at 3bogart@...
http://carolbogart.blogspot.com/2007/08/surviving-hepatitis-c.html

Clinical Care Options for Hepatitis
CME-Certified Conference Report
New Data on Viral Hepatitis and Related Complications
http://lists.clinicaloptions.com/t/5604/54129/1717/0/
CCO Independent Conference Coverage of the 2007 Digestive Disease Week*
May 19-24, 2007 | Washington, DC
Kris V. Kowdley, MD, FACP, and Mark S. Sulkowski, MD, review the most
important and clinically relevant new data on the treatment and
complications of hepatitis B and C presented at the meeting in Washington,
DC.
Topics include:
- R1626 and HCV-796 Monotherapies in Treatment-Naive Hepatitis C Virus
Genotype 1 Patients
- Pancaspase Inhibitor PF-03491390, Predosing of Taribavirin, and
Rosuvastatin HCV Therapy Strategies
- Outcomes and Retreatment Options for Patients Who Do Not Achieve SVR
With Peginterferon and Ribavirin Therapy
- HCV-Positive and -Negative Hepatic Transplantations Into HCV-Positive
Patients
- Darbepoetin Alfa and Filgrastim Treatments for Cytopenias
- Natural History of Hepatitis B and Its Treatment
*CCO is an independent medical education company that provides
state-of-the-art medical information to healthcare professionals through
conference coverage and other educational programs.
This Conference Report is available online at:
http://lists.clinicaloptions.com/t/5604/54129/1718/0/

NCMHD ANNOUNCES NEW DIRECTOR FOR EXTRAMURAL ACTIVITIES AND SCIENTIFIC PROGRAMS
U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH
NIH News
National Center on Minority Health and Health Disparities (NCMHD)
<http://www.ncmhd.nih.gov/
For Immediate Release: Friday, August 17, 2007
CONTACT: Sibyl Bowie Page, 301-402-1366, <e-mail: bowies@...
NCMHD ANNOUNCES NEW DIRECTOR FOR EXTRAMURAL ACTIVITIES AND SCIENTIFIC PROGRAMS
Award-winning epidemiologist and academician Francisco Sy, M.D., Dr.P.H., has
been appointed as the new director of Extramural Activities and Scientific
Programs at the National Center on Minority Health and Health Disparities
(NCMHD), National Institutes of Health (NIH), U.S. Department of Health and
Human Services (HHS).
"Dr. Sy is a unique public servant. He combines the rigor of a bench scientist
with the fervor of a public health advocate. The NCMHD is proud to have him lead
our scientific programs," said NCHMD Director John Ruffin, Ph.D.
"Establishing equity within the healthcare system has long been a passion of
mine. I am humbled and thrilled at being given this opportunity to have a
leadership role in shaping the NIH's research agenda on this issue," said Dr.
Sy.
Prior to being promoted to his new position, Sy oversaw several programs at the
NCMHD: the Community-Based Participatory Research Initiative, Loan Repayment
Programs and Research Endowment Program. In addition, he has represented the
NCMHD and the NIH on a number of trans-NIH and HHS workgroups and committees.
Before coming to the NIH, Sy served as a senior health scientist at the Centers
for Disease Control and Prevention (CDC), Atlanta, GA, where he was the team
leader in the Program Evaluation Research Branch in the Division of HIV/AIDS
Prevention. In 2003, as a member of the CDC's Severe Acute Respiratory Syndrome
(SARS) outbreak investigation team, Sy led community outreach efforts in
Asian-American communities. In 2004, Sy organized the Asian and Pacific Islander
employees at the CDC and became the first president of the Association of
Asian/Pacific Islander Employees of the CDC and Agency for Toxic Substances and
Disease Registry.
Sy was a tenured professor at the University of South Carolina (USC) School of
Public Health where he taught infectious disease epidemiology for 15 years and
served as director of the Master of Public Health program.
Sy is a prolific scientific writer and editor. In 1996, he wrote and published
the book "AIDS Prevention in Multicultural Societies", and he is the founder and
editor of the peer-reviewed journal "AIDS Education and Prevention -- An
Interdisciplinary Journal".
Sy earned his Doctor of Public Health (Dr.P.H.) degree in Immunology and
Infectious Diseases from Johns Hopkins University; Master of Science in Tropical
Public Health from Harvard University; and Doctor of Medicine degree from the
University of the Philippines.
His achievements have earned him high honors in public health. Sy is a Fellow of
the American College of Preventive Medicine; Scientific Fellow of the American
College of Allergy, Asthma and Immunology; and, a Fellow of the Royal Society of
Tropical Medicine and Hygiene. He has received several accolades in his career
including the following selected awards: Department of Health and Human Services
Secretary's Award for Distinguished Service for outstanding community outreach
work during the SARS outbreak (2004); CDC/National Center for Infectious
Diseases Honor Award for outstanding service in the SARS outbreak investigation
(2004); Excellence in Teaching Award from the University of South Carolina
Arnold School of Public Health (1991); and Outstanding Alumnus Award from the
Johns Hopkins University School of Public Health (1990).
The NCMHD <http://www.ncmhd.nih.gov
promotes minority health and leads, coordinates, supports and assesses the NIH
effort to eliminate health disparities. The NCMHD programs focus on expanding
the nation's ability to conduct research and to build a diverse,
culturally-competent research workforce to eliminate health disparities.
The National Institutes of Health (NIH) -- The Nation's Medical Research Agency
-- includes 27 Institutes and Centers and is a component of the U. S. Department
of Health and Human Services. It is the primary federal agency for conducting
and supporting basic, clinical, and translational medical research, and it
investigates the causes, treatments, and cures for both common and rare
diseases. For more information about NIH and its programs, visit
<http://www.nih.gov
###
This NIH News Release is available online at:
<http://www.nih.gov/news/pr/aug2007/ncmhd-17.htm

Trials and error
Gus Cairns
www.guscairns.com
11 May, 2007
A unique joint declaration by AIDS activists, drug companies and academics
has been issued demanding the urgent development of better treatment options for
people co-infected with the HIV and hepatitis C (HCV) viruses.
The statement came out of a conference on co-infection that took place in
Sitges last month, organised by the European AIDS Treatment Group (EATG).
It demands that coinfected people are always included in trials when any
new HCV drug is being developed. It calls on government and drug regulatory
agencies urgently to develop a set of standards that would expedite drug trials
in coinfected people, develop the best tools for monitoring liver disease, and
provide liver transplants for those for whom treatment comes too late.
The statement says: "The patient perspective must be considered part of
the HCV drug development process.
"Studies should include people with the most urgent need for new HCV
therapies."
Liver disease due to hepatitis C, especially amongst people with HIV, is a
huge and growing problem in Europe. The proportion of people with HIV who also
have hepatitis C ranges from 9% in the UK to 20% in France, nearly 50% in Spain
and Italy, and 75% in Russia.
Although most of this is so far associated with injecting drug use, the
BHIVA conference last month heard of accelerating rates of HIV/HCV coinfection
in gay men too.
People with HIV and HCV develop liver damage 3-4 times faster than people
with HCV alone, and are likely to develop liver failure within 10-20 years.
Given that Europe is the world's epicentre for an epidemic of fairly
recently-acquired HIV/HCV coinfection, liver-related mortality can only go up in
future years unless effective and convenient treatments are found fast.
Last year the World Health Organisation said: "In Europe, the prevalence
of hepatitis C virus (HCV) infection in HIV-infected patients is particularly
high - and still rising, in contrast to the rest of the world. Yet only a
minority of HCV/HIV-coinfected patients are treated for their hepatitis. The
compounding effect of coinfection makes the care for these patients a major
challenge."
And yet the largest trial so far conducted of the standard treatment for
HCV in coinfected people, pegylated interferon and ribavirin, found that it
cured only 40% of people with coinfection, and only 30% of people with genotype
1, the most common and virulent strain of HCV.
EATG's Wim Vandevelde told Gay.com: "The whole point is that HCV drugs get
trialled on monoinfected people first and the HIV/HCV coinfected get neglected."
He added: "This is a first. There's never been a similar statement signed
not only by activists and researchers but by nearly all the drug companies."
EATG's Joan Tallada was the conference organiser. He said: "HCV-related
liver disease is now by some way the leading cause of death in people with HIV
here in Spain, and will become so in eastern Europe too.
"We've not such a collaboration of different stakeholders before in
issuing a consensus statement like this. The bottom-line message is that no HCV
treatment must get approved before trials have taken place in co-infected as
well as singly-infected people too.
Safety and toxicity issues are so different in people with HIV, and
interactions with HIV drugs, that we can't tolerate HCV drugs going on the
market which are going to be ineffective or even harmful for people also taking
HIV treatment."
http://uk.gay.com/article/hiv/treatment/5544

Genetic Test Spots Patients at Risk From Viral Infections
A genetic method of identifying patients most likely to develop life-threatening
complications from SARS, bird flu and other dangerous viral infections has been
discovered by Canadian researchers.
They analyzed blood samples from 40 people infected with SARS (severe acute
respiratory syndrome) during the 2003 outbreak in Toronto. They found that
patients with one kind of interferon gene-expression pattern recovered quickly,
while those with another pattern became seriously ill or died, the Toronto Star
reported.
Interferons -- proteins produced by white blood cells -- are the body's
first-line defense against viruses. SARS patients with abnormal interferon
patterns didn't produce enough antibodies to fight the virus, the study found.
It was published Thursday in the Journal of Virology.
The findings provide new insight into how the immune system responds to SARS and
could help doctors identify which patients with severe viral infections require
specialized treatments, the Star reported.
http://www.ajc.com/health/content/shared-auto/healthnews/prss/607444.html

New clinical trials have been posted on the CenterWatch web site,
www.centerwatch.com
CenterWatch also provides educational materials on clinical trials for
patients, care-givers and health consumers. To view descriptions of these
resources, please visit
www.centerwatch.com/bookstore/pubs_cons_patientresources.html.
1) People with Hepatitis C are being asked to participate in a research
study that is being conducted by North Shore University Hospital.. This study is
being conducted in:
- Manhasset, NY
http://www.centerwatch.com/patient/studies/stu117207.html
Additional educational resource that may be of interest to you:
Volunteering for a Clinical Trial, a brief educational pamphlet. If you
would like to order this pamphlet click here:
http://www.centerwatch.com/bookstore/pubs_cons_brochureform.html
Thank you,
CenterWatch

Proposed Revision to Medicare Coverage Related to Underrepresented
Comments due August 18, 2007
CMS (the Center for Medicare and Medicaid Services) has posted their revisions
to the current Medicare Clinical Trials Coverage Policy on their website for
public comment through August 18. This is an opportunity to look at a proposed
change which can make a difference in the inclusion of minorities and other
groups that are under represented in clinical research and share your views.
https://www.cms.hhs.gov/mcd/public_comment.asp?nca_id=210&basketitem=
The Eliminating Disparities in Clinical Trials (EDICT) initiative is calling
attention to this proposed rule change for Medicare clinical trials coverage
regarding the inclusion of underrepresented populations. The EDICT project is a
joint effort of the Baylor College of Medicine and the Intercultural Cancer
Council.
This revision (in quotes below), is part of the recommended Medicare "standards
of a clinical research study" (Section IV, C of the Proposed Memo for Clinical
Trials Policy https://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=210).
Studies must meet this standard to qualify for Medicare reimbursement.
"The research study protocol must explicitly discuss subpopulations affected
by the treatment under investigation, particularly traditionally
underrepresented groups in clinical studies, how the inclusion and exclusion
criteria affect enrollment of these populations, and a plan for the retention
and reporting of said populations on the trial. If the inclusion and exclusion
criteria are expected to have a negative effect on the recruitment or retention
of underrepresented populations, the protocol must discuss why these criteria
are necessary."
Importance of this Policy
a.. The elderly as well as low income, racial/ethnic minorities, and those who
live in rural areas have the smallest percentage of clinical trials
participation. Unfortunately, these same populations also bear a
disproportionate burden of disease morbidity and mortality.
b.. Without adequate representation of these populations in clinical trials,
researchers cannot learn about differences in safety and efficacy between groups
and cannot ensure the generalization of scientific results. This also
contributes to health disparities by keeping the newest techniques and drugs out
of the reach of disadvantaged groups.
c.. This proposed revision addresses common barriers to clinical trial
enrollment by underrepresented populations by addressing standards of good study
design.
d.. The policy includes both the accrual and retention of underrepresented
groups -- this is an important issue that has not been addressed in most
studies.
Submit Your Comments Regarding this Proposed Policy Revision on the Medicare
Website by August 18th.
www.researchadvocacy.org

Inovio Biomedical partner Tripep receives approval to initiate Phase I/II
study of novel vaccine for hepatitis C virus
16 Aug 2007
Inovio Biomedical Corporation announced today that its partner, Tripep AB
of Sweden, received approvals from the Swedish Medical Products Agency and local
ethics committees to initiate a Phase I/II clinical trial of a novel DNA vaccine
designed to treat chronically infected hepatitis C virus (HCV) patients
SAN DIEGO, CA, USA |August 16, 2007 | Inovio Biomedical Corporation
(AMEX:INO), a leader in enabling the development of DNA vaccines using
electroporation-based DNA delivery, announced today that its partner, Tripep AB
of Sweden, received approvals from the Swedish Medical Products Agency and local
ethics committees to initiate a Phase I/II clinical trial of a novel DNA vaccine
designed to treat chronically infected hepatitis C virus (HCV) patients. The
trial will test Tripep's proprietary DNA vaccine, ChronVac-C(R), administered
using Inovio's MedPulser(R) DNA Delivery System, in 12 subjects already infected
with HCV. The trial will be conducted in Sweden at two Karolinska University
Hospitals, the Center for Gastroenterology in Solana and the Infections Clinic
in Huddinge, beginning in October 2007.
"This is the first human study in the world in which a DNA vaccine against
an infectious disease is being administered by in vivo electroporation. This
technology has worked out very well in all animal models that have been
evaluated and we are happy that after only 18 months of collaboration with
Inovio we are able to start clinical studies in humans," said Tripep's CEO, Jan
Nilsson.
"Initiation of Tripep's hepatitis C DNA vaccine trial will mark our fifth
partnered clinical trial using Inovio's proprietary non-viral DNA delivery
technology," stated Dr. Avtar Dhillon, Inovio's president and CEO. "We are
pleased to be working with investigators at the world-renowned Karolinska
Institute to test this novel approach to treat hepatitis C infections, which are
responsible for a large number of liver cancers each year."
About Inovio's Immunotherapy Products
DNA-based immunotherapies including DNA vaccines have the potential to
by-pass inherent scientific obstacles of conventional vaccines that prevent
their development for cancer and chronic infectious diseases such as HIV and
hepatitis C. Pre-clinical data has indicated the ability of Inovio's
technologies to effectively deliver and significantly enhance the potency of
such immunotherapies without the potential safety concerns of viral systems.
Inovio's DNA-based immunotherapy products consist of DNA plasmids and the
Elgen and MedPulser DNA delivery systems. DNA plasmids are designed to express
antigens that can induce an immune response specific to a cancer or infectious
disease-causing organism. These plasmids are created synthetically and readily
manufactured using well-established bacterial fermentation and purification
technology. After a plasmid is delivered into muscle or tumor cells, production
of the desired antigens may induce a preventive or therapeutic immune response
against the intended disease. Inovio's advanced electroporation devices
facilitate delivery and expression of these plasmid DNA-based immunotherapeutics
and have in primate studies and/or interim Phase I data significantly enhanced
antibody and T-cell immune responses relative to plasmid DNA delivered by other
methods, suggesting the potential to provide better protective or therapeutic
effects against complex infectious diseases and cancers.
Inovio is poised to deliver advanced DNA-based immunotherapies, devices
and know-how in this rapidly advancing field. The company is actively licensing
its technology to pharmaceutical and biotechnology companies and supporting
early stage clinical studies arising from its own research efforts or through
academic collaborations.
About Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver.
Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread
primarily by direct contact with human blood, the major causes worldwide being
the use of unscreened blood transfusions and re-use of inadequately sterilized
needles and syringes. As many as 70% - 90% of newly infected patients may
progress to develop chronic infection (WHO: 2002). Of those with chronic liver
disease, 5% - 20% may develop cirrhosis. About 5% of infected persons may die
from the consequences of long term infection (due to liver cancer or cirrhosis).
Globally, an estimated 170 million people are chronically infected with HCV,
which represents a reservoir sufficiently large for HCV to persist, and 3 to 4
million persons are newly infected each year. In the US, while new incidences of
HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have
been infected with HCV, of whom 3.2 million are chronically infected (Centers
for Disease Control and Prevention: 2006).
HCV infections in the liver do not trigger an immune response very
effectively. Certain antiviral therapies, while expensive, are somewhat
effective in treating hepatitis C, but there is no vaccine currently available
to prevent hepatitis C. ChronVac-C(R) is designed to be a therapeutic DNA
vaccine that can stimulate the body's immune system. Animal experiments have
demonstrated that ChronVac-C vaccination activated B-cells and T-cells (the
latter being regarded as the most significant to clearing the chronic infection
relating to hepatitis C) that killed cells producing HCV protein. In humans, the
ChronVac-C DNA plasmid will be injected into muscle tissue, where vaccinations
are usually given, and taken up by muscle cells with the assistance of Inovio's
electroporation-based DNA delivery system. These muscle cells would be expected
to then produce predetermined proteins that may activate the body's immune
system to attack all cells producing HCV proteins.
About Tripep AB
Tripep AB is a Swedish biotechnology research company that develops and
commercializes candidate drugs based on patented and proprietary technologies.
Its main focuses are research and clinical development of ChronVac-C(R), a
therapeutic vaccine against hepatitis C; preclinical research focusing on the
development of therapeutic and prophylactic vaccines against influenza A and
HIV; and the RAS(R) technology platform. More information is available at
www.tripep.se. Contact Jan Nilsson, CEO, at +46 8 449 8480 or
jan.nilsson@....
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX: INO) is focused on developing multiple DNA-based
immunotherapies and commercializing its Selective Electrochemical Tumor Ablation
(SECTA) therapy. Inovio is a leader in developing human applications of
electroporation, using brief, controlled electrical pulses to increase cellular
uptake of a useful biopharmaceutical. Interim human data has shown that Inovio's
DNA delivery technology can significantly increase gene expression and immune
responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical,
University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer
Institute, and International Aids Vaccine Initiative. The SECTA therapy for
locally treating solid tumors is designed to selectively kill cancerous cells
and minimize cosmetic or functional detriments often caused by surgical removal
of predominantly healthy tissue typically treated around a tumor. Inovio's
technology is protected by an extensive patent portfolio covering in vivo
electroporation. More information is available at www.inovio.com .
SOURCE: INOVIO MEDICAL CORPORATION
http://www.pipelinereview.com/joomla/content/view/13868/104/

RxTrials Institute Drug Pipeline Alert
Romark Begins Trial of Alinia for Chronic Hepatitis C
Romark Laboratories has initiated a Phase II clinical trial of Alinia for
treating chronic hepatitis C in the U.S.
According to Romark, the clinical trial is designed to evaluate the
effectiveness and safety of Alinia (nitazoxanide) tablets administered in
combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in 60
patients with chronic hepatitis C genotype 1 who have failed to respond to
standard therapy (peginterferon and ribavirin).
The trial is part of the company's Studies to Evaluate Alinia for Treatment of
Hepatitis C (STEALTH C) clinical development program, a series of clinical
trials designed to evaluate the safety and efficacy of Alinia tablets in
combination with peginterferon or peginterferon and ribavirin in patients with
chronic hepatitis C.
The trial is designed to evaluate the effectiveness and safety of Alinia
administered 500 mg twice daily for four weeks followed by
Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for
four weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks,
which is the standard of care.
http://www.fdanews.com/newsletter/article?articleId=97359&issueId=10603

Anita Creamer: When will we allow death with dignity?
By Anita Creamer - Bee Columnist
Last Updated 9:50 am PDT Friday, August 17, 2007
Slowly but surely, the political and emotional conversation about the issue of
life has begun to shift from the realm of birth control to death control.
But maybe the fundamental question remains the same: Who's in charge of our
lives, anyway?
It's the baby boomers' fault, of course: That generation, still largely
concerned with aging cute and looking young, is only now beginning to comprehend
what it means to grow old with dignity -- and to die with dignity.
We like to kid ourselves that we'll be able to control what happens.
When you've watched a parent fade away from Alzheimer's-related dementia or
another terminal disease, you know better.
And so you find yourself contemplating quality of life instead of quantity of
years.
Frankly, statistics aren't a source of great comfort here. For example, 5
million Americans have Alzheimer's disease today, according to the Alzheimer's
Association, but without cure or prevention, the disease will affect 14 million
people in this country by 2050.
Maybe we can all manage to dodge those odds, as well as the increased incidence
of Parkinson's disease with age, the half-million annual deaths from cancer and,
for that matter, physical suffering of every possible variety.
Or maybe we'd do well to think about the issues now.
Jay Averill has.
At 74, he's retired and living in Roseville near one of his daughters and her
family. But he saw what his parents went through: Before his mother died several
years ago at age 93, he says, she was physically incapacitated and suffering
from dementia.
"She begged me to kill her," he says. "She said, 'I can't live like this.'
"And what could I do?"
Nothing. Of course not. But it's interesting to consider how long Americans will
be content with that answer.
Since 1979, according to the Field Poll, Californians have consistently
expressed strong support for assisted suicide -- the idea of allowing the
terminally ill to end their own lives through lethal medication.
Early last year, the U.S. Supreme Court upheld Oregon's physician-assisted
suicide law. More than 200 terminally ill patients have made use of the law's
strict provisions to end their lives since Oregon voters ratified it in 1994 and
1997.
But similar, more recent California legislation hasn't been as successful,
despite the fact that the Field Poll says 70 percent of Californians support the
idea of allowing mentally competent, terminally ill adults to decide for
themselves when they're no longer willing to go on living.
Death with dignity, it seems, is easier for most of our politicians to swallow
as a slogan than as a reality.
So where does that leave the rest of us?
We choose up sides when extreme and highly publicized cases come along -- when
Jack Kevorkian, Michigan's controversial death doctor, was on trial for ending
lives in the 1990s, for instance; or even more appallingly, when poor Terri
Schiavo, the Florida woman who languished in a vegetative state for 15 years,
became a political pawn in 2005.
It would be a shame for good people trying to do the best they can for
themselves and their loved ones if the debate over the end of life were to
devolve into the polarized deep freeze that's long characterized the debate over
the beginning of life.
"You don't read about these things," says Averill. "But I feel strongly that
people should be able to choose to end their lives in a dignified manner, and I
wonder how many people who feel that way are out there.
"I imagine the religious people would be up in arms about it. But nonreligious
people still have some say-so in the world, too."
As do those who believe that God granted human beings free will because he
wanted them to use it.
a.. Anita Creamer's column appears Wednesdays, Fridays and Sundays in Scene.
Reach her at (916) 321-1136 or acreamer@.... Back columns at
www.sacbee.com/creamer.
http://www.sacbee.com/107/story/327468.html

Alejandro Escovedo, Detroit Cobras, Boca Do Rio -- ASD Live Music Picks for
Friday, August 17
Fri Aug 17, 2007 at 06:17:58 AM
Alejandro Escovedo, 9 at Great American Music Hall. $20.
"To the relief of fans worldwide, Escovedo's death-defying bout with hepatitis C
is behind him, and his first solo release in four years is at hand. With Velvet
Underground vet John Cale in the producer's chair, "The Boxing Mirror" rivals
anything Escovedo's ever tracked. The album is a taste of Mexico: "The Ladder"
has a dashing bit of romanticism while "Looking for Love" is surprisingly
danceable. The first three tunes, "Arizona," "Dearhead on the Wall" and "Notes
on Air," amount to an emphatic announcement that Escovedo is back in the groove
and evidently none the worse for wear." -- Billboard
http://blogs.sfweekly.com/shookdown/2007/08/alejandro_escovedo_detroit_cob.php

Jail doc's past in question
BY BORYS KRAWCZENIUK
STAFF WRITER
08/18/2007
The Lackawanna County Prison's medical director was fired from a similar post at
a Pittsburgh-based health care services company in 1999 in an apparent dispute
over a new treatment for hepatitis C in state prisons the company served.
Company officials could not be reached to explain his termination, but in a
lawsuit later filed against the company, Dr. Edward J. Zaloga claimed he was
fired because he disagreed with a plan to begin treating the liver disease with
a then-new, unproven drug that ultimately would be a waste of taxpayer money.
The treatment "would waste more than $7 million of the (state) taxpayers' money
on unnecessary and unwarranted medical treatment," he charged in a suit filed
against Wexford Health Sources Inc. in November 1999.
He claimed in his suit that his management practices had created a profit for
the company of $4.1 million, and the company - which at the time was trying to
get the state to pay for the new treatment - feared it might have to pay for
treating inmates if the state found out about its profits. He was fired for
raising the concerns, he alleged.
The suit demanded more than $1 million in unpaid wages, expenses, lawyer's fees
and punitive damages.
The company, in its legal responses, denied earning anywhere near $4 million. It
denied his other claims as well.
County judges rejected Dr. Zaloga's suit in separate rulings in 2002 and 2004
with one judge writing that Dr. Zaloga failed to establish "a report of
wrongdoing ... or waste."
Wexford in its legal filings acknowledged firing Dr. Zaloga but did not say why.
Dr. Zaloga is now co-owner of a company, Correctional Care Inc., of Moosic, that
provides medical services to county prison inmates, and oversees those services.
A former inmate, Shakira Staten, 22, a federal prisoner who gave birth at the
prison July 10 and has since been transferred to Adams County Prison to await
sentencing, has sued him, the company and the prison in federal court.
She claims she was a victim of cruel and unusual punishment because her pleas to
be taken to the hospital when she went into labor were ignored and she had the
baby alone in a cell.
The county Prison Board this week apologized for the way she treated and blamed
a Correctional Care nurse for "serious errors of judgment" that included failing
to properly monitor her labor and unnecessarily delaying taking her to the
hospital. The board barred the nurse from working in the prison.
A secretary in the company's office said Dr. Zaloga was not available for
comment and would only reply to written questions.
A secretary at Wexford Health Sources said no company officials would be
available to comment until next week.
Dr. Zaloga was Wexford's regional medical director for its central Pennsylvania
operations from Feb. 1 to Sept. 29, 1999, the day the company's operations
director dismissed him, according to court records.
County Commissioner A.J. Munchak, the Prison Board chairman, said he was unaware
of the lawsuit or Wexford's dismissal of Dr. Zaloga, who is a longtime friend.
He referred questions to Dr. Zaloga.
"You'll have to ask him," he said.
Asked if anyone conducted a background check when Dr. Zaloga was hired, Mr.
Munchak said, "Background check? On the doctor? Please. Oh, here we go again. No
comment."
The commissioner has touted Dr. Zaloga's credentials in the past, including his
work overseeing the central Pennsylvania prisons. He and other Prison Board
members have consistently praised Correctional Care's work at the county prison,
and view the treatment of Ms. Staten as an exception.
The increase in diagnoses of hepatitis C in the 1990s caused great concerns in
prisons nationwide because it is expensive to treat.
In his suit, Dr. Zaloga said a state task force set up by the Department of
Corrections to develop a treatment protocol was seriously looking at boosting
the use of Rebetron, which had been approved by the Food and Drug Administration
a year earlier, but whose effectiveness had not been established.
The state prison system adoped use of Rebetron in 2001, but reduced its use to
select circumstances two years later, according to information from the
Department of Corrections.
Contact the writer: bkrawczeniuk@...
http://www.thetimes-tribune.com/site/news.cfm?newsid=18723260&BRD=2185&PAG=461&d\
ept_id=415898&rfi=6

Fundraiser will benefit hepatitis clinic
Originally published August 17, 2007
By Jennifer Hill
News-Post Staff
The Frederick County Hepatitis Clinic is hosting a fundraising night this
weekend.
"It's going to be a great evening to come out and enjoy the weather and the food
with some friends to support a good cause," said Victor Buckwold, president of
the clinic's board of directors.
The clinic is opening the event to the public to thank the Frederick community
for its continued support and to raise awareness about hepatitis C.
The fundraiser will feature a bluegrass acoustic band, "The Yardslippers," and a
50/50 raffle.
One hundred tickets at $7 each will be available at the door or in advance at
the clinic or at the restaurant. All proceeds from ticket sales will go to the
clinic. Danielle's restaurant, where the event is being held, will also donate a
portion of the evening's food and bar tab to the clinic.
"Danielle's is just a great place to be in the summertime," said Constance
Callahan, executive director of the clinic.
This is the first time the clinic has hosted a fundraiser with entertainment,
Callahan said. The clinic tries to be creative with its fundraising to draw
large corporations and small businesses alike.
"We want them (business and civic leaders) to know that we're here as a
nonprofit clinic that may be taking care of their employees, friends or family,"
Callahan said. "It takes all of us to take care of each and every one of these
patients."
Hepatitis C is a curable disease that is killing more people in Frederick County
than HIV, said clinic founder Dr. Michael Rudman.
The clinic is in its seventh year of operation.
"When we first started, one out of 16 first-time patients were terminally ill,"
Rudman said. "Now it's one out of seven. At one time, they were treatable. Now,
their conditions are irreversible."
The clinic is almost exclusively volunteer-run. With only three physicians who
donate their time, more volunteer medical staff is always needed.
Frederick County Hepatitis Clinic has 1,450 patient visits per year, and the
cost of each patient's treatment is about $40,000, Rudman said. The clinic is
not affiliated with county or state government, and relies on grants and
donations to provide $1.5 million worth of goods and services.
"We get by the skin of our teeth," he said.
http://www.fredericknewspost.com/sections/news/display.htm?StoryID=63908

Sent: Friday, August 17, 2007 10:25 AM
Subject: NATAP: HCV Testing/Ed in Black Churches by Roche
NATAP http://natap.org/

Romark Initiates Clinical Trial Of Alinia(R) For Chronic Hepatitis C In The
United States
Article Date: 16 Aug 2007 - 0:00 PDT
Romark Laboratories announced that it has initiated a phase II clinical trial of
Alinia(R) (nitazoxanide) for treating chronic hepatitis C in the United States.
The clinical trial is designed to evaluate the effectiveness and safety of
Alinia tablets administered in combination with Pegasys(R) (peginterferon
alfa-2a) and Copegus(R) (ribavirin) in 60 patients with chronic hepatitis C
genotype 1 who have failed to respond to standard therapy (peginterferon and
ribavirin). Pegasys and Copegus are being provided under a collaborative
agreement between Romark and F. Hoffmann-La Roche Ltd.
"We are excited to be participating in this clinical trial," said David Nelson,
M.D., Associate Professor of Medicine, Medical Director of Liver
Transplantation, and Chief of the Hepatobiliary Disease Section at the
University of Florida. "There is a critical need for new therapies for patients
with hepatitis C, particularly those who have already failed existing
therapies."
The company also announced that interim data from an international clinical
trial in patients with chronic hepatitis C will be communicated at the 58th
Annual Meeting of the American Association for the Study of Liver Diseases
(AASLD) in early November 2007.
"Initiation of the US study and communication of our international data
represent important milestones for our development program," said Jean-Francois
Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark who
invented nitazoxanide and is leading its clinical development. "We are
enthusiastic about the results to be presented at the upcoming AASLD meeting and
the opportunity to develop an important new treatment for patients suffering
from chronic hepatitis C."
The company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis
C) development program is being directed in collaboration with the Division of
Gastroenterology and Hepatology at Stanford University School of Medicine by
Emmet B. Keeffe, M.D., Jeffrey S. Glenn, M.D., Ph.D. and Dr. Rossignol who is
also a Stanford affiliate.
Nitazoxanide is the first of a new class of small molecule drugs called the
thiazolides that target cell signaling pathways used in viral replication. Data
related to the in vitro activity of nitazoxanide against virus replication in
hepatitis C virus (HCV) replicons was presented earlier this year at the 20th
International Conference on Antiviral Research.
Stephen A. Harrison, M.D., Chief of Hepatology at Brooke Army Medical Center in
Fort Sam Houston, Texas, said, "The potential for use of nitazoxanide in the
treatment of chronic hepatitis C is exciting. To better optimize treatment
outcomes for patients, we need new antiviral drugs that can be used safely and
effectively in combination with existing drugs or with other new drugs in
development."
STEALTH C Clinical Development Program
The US and international clinical trials described above comprise part of the
company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C)
clinical development program, a series of clinical trials designed to evaluate
the safety and efficacy of Alinia tablets in combination with peginterferon or
peginterferon and ribavirin in patients with chronic hepatitis C.
The STEALTH C-1 trial, conducted in Egypt in interferon-experienced and naive
patients with chronic hepatitis C genotype 4, is a phase II randomized
controlled trial evaluating the effectiveness and safety of three treatment
regimens: (i) Alinia administered 500 mg twice daily for 12 weeks followed by
Alinia-Pegasys combination therapy for 36 weeks, (ii) Alinia 12 weeks followed
by Alinia-Pegasys-Copegus combination therapy for 36 weeks and (iii) Pegasys-
Copegus combination therapy for 48 weeks (standard of care). The study
randomized 120 patients. Patients enrolled in this trial have reached the end of
treatment and are undergoing follow-up for sustained virologic response. Data
from the STEALTH C-1 clinical trial is expected to provide important efficacy
and safety data that will guide the continuing development of nitazoxanide for
treating chronic hepatitis C. Interim data from this trial will be presented at
the 58th Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) in early November 2007.
The STEALTH C-2 trial is a randomized double-blind placebo-controlled trial
conducted in the United States in 60 patients with chronic hepatitis C genotype
1 who have previously failed to respond to peginterferon and ribavirin
combination therapy. This trial is designed to evaluate the effectiveness and
safety of Alinia administered 500 mg twice daily for 4 weeks followed by
Alinia-Pegasys-Copegus combination therapy for 48 weeks compared to placebo for
4 weeks followed by placebo-Pegasys-Copegus combination therapy for 48 weeks
(standard of care).
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV), a virus
spread through direct contact with the blood of infected people. Chronic HCV
infection may cause liver cirrhosis or hepatocellular carcinoma. An estimated
3.2 million people in the U.S. are chronically infected by hepatitis C virus.
Globally, an estimated 170 million people are chronically infected, with three
to four million persons newly infected each year, according to the World Health
Organization.
About Romark Laboratories
Romark Laboratories, L.C. (http://www.romark.com) is a biotechnology company
committed to the discovery and development of innovative new small molecules for
treating infectious diseases, cancers, and autoimmune diseases.
About Alinia
Alinia (nitazoxanide) is indicated in the United States for treatment of
diarrhea caused by Cryptosporidium parvum or Giardia lamblia in patients 1 year
of age and older. Alinia has not been shown to be superior to placebo for the
treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or
immunodeficient patients. The most common adverse events reported by patients
receiving Alinia have been abdominal pain, diarrhea, headache and nausea. In
controlled trials, the frequency of these events has been similar to patients
receiving a placebo.
Romark Laboratories, L.C.
http://www.romark.com
http://www.medicalnewstoday.com/articles/79780.php

Vertex Drug Could Be Huge
By Adam Feuerstein
Senior Writer
8/15/2007 2:54 PM EDT
BOSTON -- The on-and-off love affair between Wall Street and Vertex
Pharmaceuticals (VRTX - Cramer's Take - Stockpickr - Rating) is on again.
Shares of the Cambridge, Mass.-based biopharmaceutical firm have jumped 35%
since the end of June as investors grow more confident that telaprevir, Vertex's
experimental hepatitis C drug, will be a game-changing blockbuster.
On Tuesday, Vertex Chief Medical Officer John Alam and CFO Ian Smith gave me an
update on telaprevir. The body language of both men was very confident. Of
course, Vertex executives have a reputation for being too cocky for their own
good. This is especially true for CEO Joshua Boger -- and it's gotten him in
some trouble with Wall Street in the past.
But in talking with Alam and Smith, the message came through loud and clear that
a rational analysis of the information on telaprevir is convincing enough to
erase any doubts about the drug's efficacy. This is a drug that will
significantly increase the number of patients who can be cured of hepatitis C.
Equally important, telaprevir will help cure these patients in half the time
required today, they believe.
In other words, telaprevir is going to be a big drug. Just how big -- $2 billion
in sales? $3 billion? $4 billion? -- remains to be seen.
An important meeting of liver disease specialists in early November will be the
venue for the release of the latest telaprevir clinical data from ongoing phase
II clinical trials. This is a key meeting for Vertex and one that will be
closely followed by investors.
In recent trading, Vertex shares were up more than 3% to $36.35. With an
enterprise value of $4 billion already, Vertex isn't cheap, given that
telaprevir hasn't yet started phase III studies (they're expected toward the end
of the year) and approval is still two to three years away.
But if telaprevir lives up to its promise and generates sales on the upper side
of the $2 billion-to-$4 billion range, Vertex at $36 and change might look
fairly undervalued.
For more background on Vertex and telaprevir, check out this previous column,
but here's a quick recap:
Telaprevir is a pill designed to attack hepatitis C by inhibiting the protease
enzyme, one of the key enzymes the virus uses to copy itself. This "direct
antiviral" approach differs from current hepatitis C drugs, which boost the
immune system's ability to tamp down and eliminate the virus.
The current standard of care for hepatitis C patients is a weekly injection of
long-acting alpha interferon combined with daily oral doses of a generic drug,
ribavirin. A normal treatment course for Type 1 hepatitis C (the most prevalent
form) takes 48 weeks to complete. But the standard treatment cures only about
40% of patients, and many patients find the side effects, such as flu-like
symptoms, anemia and depression, difficult to tolerate.
Telaprevir is being combined with interferon and ribavirin to create a more
potent and less time-consuming hepatitis C treatment regimen. Three large phase
II studies are under way, investigating various treatment schedules. The most
promising combination right now treats hepatitis C patients for 12 weeks with
the triple combination (telaprevir, interferon and ribavirin) followed by 12
weeks of interferon and ribavirin on their own.
That's 24 weeks of total treatment, or half the current standard of care.
Cutting treatment time is great, but the top priority for telaprevir will be to
improve hepatitis C cure rates beyond the current low-40% range for Type 1
patients.
What will the cure rate (known formally as the sustained virologic response, or
SVR) for telaprevir be after 24 weeks of treatment?
Cowen analyst Rachel McMinn believes telaprevir will boost SVR to the 50%-to-60%
range in the current phase II studies, on the basis of modeling of currently
available clinical data.
And when Vertex runs its pivotal phase III study later this year, telaprevir
cure rates could jump into the 70% range, she says.
"An SVR rate of 60% for telaprevir would represent an approximate 50%
improvement over the cure rate for hepatitis C patients today," says McMinn.
Such an improvement, she adds, would trigger widespread adoption of the drug.
"It would be a huge commercial success."
McMinn is one of the best hepatitis C analysts on Wall Street. She recently
moved from Piper Jaffray to Cowen, where she picked up coverage of Vertex with
an outperform rating. (She also made a great call on ViroPharma (VPHM - Cramer's
Take - Stockpickr - Rating) last week, downgrading the stock the day before the
company's hepatitis C drug HCV-796 blew up over toxicity issues.)
I asked Alam and Smith if they were comfortable with the analyst's prediction
for telaprevir's cure rate, which, by the way, is in line with other Wall Street
analysts. While not wanting to endorse a specific number, both said they felt
that an SVR rate in the 50%-to-60% range was entirely possible from the current
phase II studies -- and that even higher SVR rates were achievable in phase III.
Remember: The SVR data from the ongoing phase II studies will be presented Nov.
2 through Nov. 6 at the annual meeting of the American Association for the Study
of Liver Disease.
Something else helping Vertex these days is that some of the competitors
developing new hepatitis C drugs are stumbling. InterMune (ITMN - Cramer's Take
- Stockpickr - Rating) is developing a drug similar to telaprevir, but its
clinical program has been slow out of the blocks, with delays to the start of
human clinical trials.
ViroPharma's drug looks dead because of problems with liver toxicity, while both
Coley Pharmaceuticals (COLY - Cramer's Take - Stockpickr - Rating) and Anadys
Pharmaceuticals (ANDS - Cramer's Take - Stockpickr - Rating) have been forced to
shelve their respective drugs because of safety issues.
But don't think Vertex won't have competition. In fact, there are other
hepatitis C drugs still moving well through clinical trials, but right now,
telaprevir has a fairly commanding lead. If sustained, that could complicate
efforts by other companies to get their hepatitis C drugs approved.
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