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HCV ADVOCATE WEEKLY NEWS REVIEW:
A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: June 11th, 2005

Alan Franciscus
Editor-in-Chief

To download pdf version click here


This Issue:

• Psychiatric Comorbidity among Hepatitis C - Positive Patients

• Inmates Get Hepatitis Vaccine

• Clinton's Human-Rights Crime

• Gov't Lacks Fund to Address Hepa B Cases

• Can Salons Spread Infection?

• City, Police Chief Agree to Crack-Pipe Compromise

• Day of Music to Bring Awareness of Disease

• Court: Patients May Not Use Pot Legally

• Hepatitis B Virus Infection in Dialysis Patients

• Reuse of Supplies to Blame for Hepatitis Outbreak

• Vertex's Hepatitis C Pill Could Be a Blockbuster

• Hepatitis Vaccine Proves a Bitter Business

• Freeland Man with Hepatitis C Sentenced for Spitting in Cop's Face

• Johns Hopkins Team Finds 'Ancestral' Hepatitis-C Virus at the Root of Evolution in Infections

• Researchers Create Infectious Hepatitis C Virus in a Test Tube

June 5 th, 2005

Psychiatric Comorbidity among Hepatitis C - Positive Patients
SourceURL:http://focus.psychiatryonline.org
Focus 3:261-265 (2005)

Sonia P. Yovtcheva, M.D., M.Sc., Muhamad Aly Rifai, M.D., James K. Moles, M.D., and Brian J. Van Der Linden, M.D., M.P.H.

This study assessed the prevalence of psychiatric disorders among hepatitis C patients at a Veterans Affairs Medical Center. Medical records of 306 randomly selected hepatitis C-positive patients were reviewed for past and present DSM-IV-based psychiatric disorders. Each psychiatric diagnosis was independently confirmed with DSM-IV criteria using symptoms recorded in the chart. Only independently confirmed diagnoses were included for analysis. Mood disorders were present in 38% of patients; personality disorders in 30%; PTSD in 19%; other anxiety disorders in 9%; and psychotic disorders in 17%. Although alcohol use disorders were found in 86% of this patient population, intravenous drug use disorders were present in only 28%. Our data indicate that prevalence rates of a variety of psychiatric disorders are higher in veterans with hepatitis C than in the general population. Mood, anxiety, personality, and psychotic disorders were all relatively common in these patients. Psychiatric disorders may influence the course and treatment of hepatitis C infection, and psychiatrists as well as internists should be aware of the substantial psychiatric comorbidity in patients with this infection.

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Inmates Get Hepatitis Vaccine
SourceURL:http://www.wcax.com/

RUTLAND, Vt. More than half the inmates at the Marble Valley Correctional Facility in Rutland are now protected against two types of hepatitis.

The inmates volunteered to receive the vaccinations against hepatitis A and B.

Nurse Manager Richard Frank says the rise of hepatitis has been exponential. He says it's the largest category of chronic illness in the facility.

Drug manufacturer GlaxoSmithKline donated about 250 hepatitis vaccines to the state's prisons. A hepatitis vaccine shot costs at least 70 dollars.

Frank says the clinic at the Rutland jail was the first in the state. Other facilities will hold similar clinics in coming weeks.

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Clinton's Human-Rights Crime
SourceURL:http://worldnetdaily.com
By Joseph Farah

This week the Canadian Red Cross issued a weak apology for killing more than 3,000 people with tainted blood.

The organization was fined $4,000 for distributing the plasma tainted with the AIDS virus and hepatitis C.

That an organization as prominent as the Red Cross could get away with mass murder is bad enough, but the international press never bothered to scratch beneath the surface of the story. No one bothered to ask the simple question: From where did this tainted blood originate?

There's a reason for that.

Even a cursory probe would lead directly to a former president of the United States - Bill Clinton.

As only WorldNetDaily reported, Bill Clinton was at the center of a scandal in Arkansas in the 1980s involving the sale of contaminated blood to Canada - blood that would be distributed by the Red Cross.

As governor of Arkansas, Clinton awarded a contract to Health Management Associates to provide care to the state's prisoners. The president of the company was a long-time friend and political ally of Clinton and was later appointed by him to the Arkansas Industrial Development Commission. Later, he was among the senior members of Clinton's 1990 gubernatorial re-election team.

Health Management Associates struck a deal with the state, signed by Clinton, to collect and sell blood from Arkansas prisoners. Because of the exploding AIDS crisis, U.S. regulations did not permit the prisoner blood to be sold legally within the United States. But HMA found a willing buyer in Canada -Connaught, a Toronto blood fractionator, which didn't know the source of the supplies. The blood was also sold to other countries.

Sales continued until 1983, when HMA revealed that some of the blood might be contaminated with AIDS and hepatitis.

Whistleblower Michael Galster, who conducted orthopedic clinics in the Arkansas prison system during the period blood was collected, charged HMA officials knew the blood was tainted as they sold it to Canada and a half-dozen other countries.

His thanks was an arson attack on his clinic.

Here is perhaps the least well-known Clinton scandal.

As governor of Arkansas, Bill Clinton knowingly oversaw the illicit sale of state prison blood to hemophiliacs and others - spreading AIDS and other deadly diseases to thousands in the 1980s.

Galster says Clinton organized a payoff plan to various officials, including a judge, to make sure the blood sales continued. He claims millions were made from the conspiracy because between 5,000 and 8,000 units of blood were shipped every week from one prison alone. He even witnessed inmates drawing blood from each other with dirty needles.

While the Canadian Red Cross apologized for the death of 3,000 from the distribution this bad blood, no one really knows how many have died. They stopped counting Canadian deaths in the blood scandal in 1997. And, of course, no one - not the United Nations, nor the United States - has bothered to chronicle the death toll in the other countries that received the tainted blood from Bill Clinton's death factories in Arkansas.

I don't know about you, but I think there should be indictments over this crime. If ever there was a reason for an international human-rights tribunal to be invoked for trial and punishment of those responsible for a massive human-rights violation, this would seem to be the appropriate case.

Think about it - public officials making deals with private companies to permit them to collect tainted blood and sell it overseas. This was about trading the lives of unknown foreigners for profit and political expediency. Simple as that.

Canadians should not accept a simple apology from the Canadian Red Cross. They should demand real justice be extracted from those responsible for this crime in the United States - beginning with Bill Clinton.

Related stories:

Canada's Red Cross guilty in HIV scandal
'Blood Trail' author's clinic burns

Related columns:

The pricetag for Blood-gate
Blood trail grows cold
Blood scandal and Clinton's plumbers
We always get our man
Clinton's Arkansas blood scandal

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Gov't Lacks Fund to Address Hepa B Cases
SourceURL:http://www.sunstar.com
By Marie S. Neri

THE lack of funds hampers the Department of Health (DOH) from helping stop the spread of Hepatitis B in the country.

Health Secretary Francisco Duque III said they could only allot 40 percent of their budget since the cost of the vaccines is too high.

He said DOH records on Hepatitis B cases in 2004 showed that 10 to 12 percent of Filipinos are "silent carriers" of the virus and 10 percent of the cases developed to liver cirrhosis then cancer in the long run.

Duque said they are coordinating with local government units (LGUs) to help them secure funds for the purchase of Hepatitis B vaccines to immunize newborn babies and prevent them from getting the virus.

He said the DOH is in the process of finalizing their new campaign on immunizing the newborn babies against Hepatitis B.

New-born babies should be immunized three times, the first dose should be given within 48 hours after delivery, the second dose will be when they reach six weeks and the third shot would be given when the child reaches 10 weeks.

Duque said Hepatitis B vaccines are given to health workers assigned to high-risk areas and selected health centers in the country.

Dr. Mario Villaverde, DOH health and policy officer, said most of the liver cancer cases in the Philippines have been traced to the presence of Hepatitis B virus in their blood.

He also said even if the person is already a Hepatitis B virus carrier, it would take 25 to 30 years for the ailment to develop into liver cancer.

Duque said the mortality rate of liver cancer in the country is very low but it is the third leading cause of deaths among Filipinos aged 50 and above.

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Can Salons Spread Infection?
SourceURL:http://www.thirdage.com
by Charles Downey

When you sit down to have your fingernails manicured, you're probably more worried about which shade of polish to choose than catching a potentially deadly disease.

Back in 1965, a medical researcher managed to trace several hepatitis B patients back to a barber who unintentionally transmitted the disease by shaving all the patients with the same razor. The barber had used a disinfectant, but it wasn't strong enough to kill all the germs.

In those days, many of the serious blood-borne diseases that plague us today – such as HIV/AIDS, hepatitis B and C – were less prevalent. Medical researchers say as many as four million Americans now have hepatitis B. But 10% of those cases have no known cause. Researchers investigating hepatitis C cases say 30% of patients have not shared needles with another illicit drug user’ the chief means of transmission.

Medical researchers are now asking: could poorly trained cosmetologists and barbers using dirty instruments be unwittingly spreading diseases?

A Closer Look at Salons

Texas dermatologist Shelly A. Sekula, M.D., has looked closely at the sanitary practices of the cosmetology and barber industry and found conditions sadly lacking.

"Nail and hair salons may be a source of blood-borne as well as other infectious diseases," says Dr. Sekula who practices in Houston, Texas, and chairs the Legislation Committee for the Texas Dermatological Society. "There is good evidence that razors, nail files, barber's scissors, tattoo needles, and body piercing instruments are risk factors for transmitting hepatitis B and C."

Dr. Sekula's interest in this area began when she saw one patient with a contagious fungal infection on her toes and feet. When questioned, the patient remarked that she had noticed just "one little cut" after the pedicure. "And the red warning flags went up," Dr. Sekula says.

"If I was going into a nail salon, I would look for a photo license of the operator. I would also ask about sterilization procedures and would not permit an electric drill to be used on my nails. Nail drills whir so fast, they can easily penetrate the nail and cut you." And they may have cut the person before you, too. So if you do wear acrylic nails and opt for the nail drill, you can buy and bring your own drill bits, designed solely to reduce the risk of nail infections from using community, multiple-use instruments.

Adds Phoebe Rich, M.D., president of the Council for Nail Disorders in Schaumburg, Illinois: "There is a potential for the spread of infection if the salon instruments are not properly cared for."

Proper Precautions

• Sterilization
• The best sterilization methods are steam, ethylene oxide gas, dry heat and chemical germicides. Anything that can draw blood – nail clippers, cuticle scissors, callus paring blades, reusable and straight razors – should be soaked in a chemical germicide.
• "However, most states only require cosmetologists and barbers to use a low-level hospital grade disinfectant’ which may or may not kill all the microorganisms," Dr. Sekula says. "To really be safe, I suggest bringing your own instruments." And don't be fooled by operators who wear face masks. They're not protecting you – they're protecting themselves from breathing in fumes and nail dust.
• Gloves
• Though cosmetologists rarely wear them, latex gloves are another important safety precaution. Why don't they wear them? Perception. If you sat down in a salon for a manicure or a pedicure, and the technician put on a pair of rubber gloves, you might think she had some contagious condition.
• Actually, she would be protecting you from any ailments suffered by the previous client. Many professionals – health and dental workers, emergency teams, firefighters, police and correctional officers – wear latex gloves because they are using a technique known as "universal precautions." That means limiting the spread of blood diseases by assuming that everybody's blood, bodily fluids, and tissues are infectious.
• "The federal Occupational Safety and Health Administration (OSHA) requires any worker at risk of contracting an infection to wear gloves," Dr. Sekula says. "But, curiously, OSHA regulations leave it to employers and the various states to decide if workers in the cosmetology and barber industries should wear gloves."

Selecting a Safe Nail Salon

To help you decide if a salon provides sanitary nail services, the United States Food and Drug Administration (FDA) experts suggest you consider the following:

• Is the salon licensed?
• Licenses should be prominently posted, both for the salon and the operators. If you don't see them, ask.
• How are nail implements sanitized?
• Autoclaving (heat sterilization) is best, says Ralph Daniel, M.D., a dermatologist in Jackson, Mississippi. But most states allow chemical sterilizing as long as the implements are immersed in the solution for at least 10 minutes between customers.
• Ask the technician what the salon's practices are.
• If they're using a chemical solution, check the product's label for words like "germicidal" to indicate that it is strong enough to kill bacteria. If in doubt, bring your own implements, Daniel suggests.
• Is there a pre-service scrub?
• Both the nail technician and the client should wash their hands with an antimicrobial soap before nail work begins.
• Is each customer given a fresh bowl of soapy water to soak their nails in and is a new nail file used for each customer?
• Both practices should be followed.
• Is the facility neat and clean?
• Paul Kechijian, M.D., a clinical associate professor of dermatology and chief of the nail section at New York University, compares selecting a salon to selecting a restaurant. "Ask yourself when you walk in: would you want to eat there?" he says.
• Is there a strong smell of fumes in the salon?
• If there is, it's a sign that the facility is poorly ventilated, says John Bailey, Ph.D., acting director of FDA's Office of Cosmetics and Colors. Inhaling the fumes from nail products can make you sick.

The Spread of Disease

A client in a salon may have an injury to the cuticles, a cut in the nail folds, or could have bled when calluses were removed too deeply. A hair cutter could have accidentally nicked his client. Customers might have open areas or cracks in their scalps. Crusts, scales and lice can attach to combs and brushes and easily transmit infection or infestation to the next unwitting patron.

In 1989, a warning was sounded that barber scissors and razors contaminated with blood can pass along the human immunodeficiency virus (HIV). A medical researcher found that hepatitis C could be transmitted via the straight razors commonly used in barber shops to trim sideburns and necks. The researcher dunked razors from five different barber shops into five commonly-used sterilizing solutions. Results? None of the five solutions destroyed hepatitis C, even though some were soaked for six hours, 24 hours, and seven days.

"Other research shows that hepatitis B can survive outside the body for seven days or more on chairs, headrests, workbenches, instruments and tools," Dr. Sekula says. "Hepatitis B is one hundred times more contagious than the HIV virus."

According to the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia, hepatitis B is now the leading cause of liver transplantation and the second leading cause of cirrhosis (after alcohol) in the United States. About 10,000 Americans will contract hepatitis B this year with that number expected to triple over the next two decades. Currently, the CDC says hepatitis B costs the US $700 million yearly in lost work and health care costs.

Cuts, nicks and scrapes at the beauty salon or barber shop can also lead to other, less deadly, conditions for both clients and shop operators, including warts, bacterial and fungus infections, and reactions to various products and fumes.

Reducing the Risk

"The risks would be virtually eliminated if operators used disposable instruments, wore rubber gloves, employed proper hand washing and used appropriate sterilization techniques," says Dr. Sekula. She would also like to see physicians appointed to the governing boards in every state so the beauty industry can have the latest health information.

Resources:

1. Finger nails: looking good while playing it safe. US Food and Drug Administration. Available at: http://www.fda.gov/fdac/features
   /095_nail.html
2. Gitlin, N, Nohe, FS, and Weiss, M. Hepatitis C: Risk of a haircut. Annals of Internal Medicine. 1997;126(5).
3. Hair and nail salons linked to infectious diseases. American Academy of Dermatology. Available at:
   http://www.aad.org/PressReleases
   /salons.html
4. Wagner, R.F. Risks of infection to dermatologists, cosmetic workers, and the public. International Journal of Dermatology. 1990;29:253-257.

Elizabeth Smoots, MD
November 2003

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June 6th, 2005

City, Police Chief Agree to Crack-Pipe Compromise
SourceURL:http://ottawa.cbc.ca
CBC News

OTTAWA -- Ottawa's medical officer of health has agreed to not distribute crack kits to anyone under the age of 18, after pressure from police Chief Vince Bevan.

Paraphernalia and literature included in the kits handed out by the city's public health workers.

The city started distributing the free kits at the beginning of April. They contain everything needed to smoke a rock of crack, including lip balm for chapped or burned lips and mints to create saliva.

The program is an extension of the harm reduction program that includes a needle exchange. It's meant to reduce the spread of HIV and hepatitis C among the city's inveterate drug users.

Bevan protested the city program loudly, saying it sends the wrong message to youth. He also sought a legal opinion about whether those handing out the kits are breaking the law. But Bevan agreed stand down, as long as the kits were only available to adults.

FROM APRIL 22, 2005: Crack-pipe program survives review

Starting Wednesday, no one under the age of 18 will have access to the city's free crack pipes.

While not ideal, Dr. Robert Cushman says the compromise is worth it.

"For someone who's addicted to crack at the age of 17, who's HIV and hepatitis C-free, it's scary," said Cushman. "But again, as I said earlier, this opportunity, this compromise, and with the support of the politicians, we'll be able to maintain more than 99 per cent of this program, and then we can move on to look at greater drug issues that are confronting us in our community."

Cushman agreed to the compromise because he was afraid the entire program would be lost if some restrictions weren't put in place.

Cushman, Mayor Bob Chiarelli , and Chief Bevan met Monday with a group of community and health leaders to talk about an integrated drug strategy for the city to combat drug addiction. Then on Tuesday, the mayor formally announced the formation of a working group on the issue.

The mayor said the group's work is more necessary than ever because there is a "tsunami" of drugs heading towards the city, referring to crystal meth, the newest drug to hit Ottawa's streets.

"The debate over crack pipes was controversial but necessary for our community," Chiarelli said Tuesday in a release announcing the group's formation. "It has provided our city with a wake-up call on the lack of resources and treatment options that are available to drug users."

Still, city Coun. Shawn Little didn't want to give up his fight to dismantle the crack-pipe program. He presented a motion to that effect at council Wednesday.

Little even questions the needle exchange program, which has been around for years. "I'd like to do a deeper analysis and see whether or not we should be reconsidering that program as well," said Little.

City council sidestepped the issue, voting to forward the issue to the newly formed working group on drugs.

Aside from Bevan and Cushman, other members of the working group include: Dr. Jack Kitts, the Ottawa Hospital; Dr. Simon Davidson, CHEO; Robert Laviolette, Maison Fraternité; Bruce Marshall, University of Ottawa Health Services; Barb MacKinnon, CAS; and Marguerite Keeley, Centre Town Community Health Centre.

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Day of Music to Bring Awareness of Disease
SourceURL:http://www.nevadaappeal.com
by Judy Lynn, Special to The Appeal

Hepatitis C awareness drives concert at the Pony Express Pavilion

Hepatitis C Awareness, a nonprofit organization, has announced its first "Hep C Aware - Carson City" concert to be from noon-9 p.m. June 18 at the Pony Express Pavilion in Carson City.

After losing a close friend to hepatitis C in 2001, Kelly Zirbes and her band, Kelly's Lot, began a four-year campaign offering hepatitis C information at their shows. With the desire to reach a mass level of awareness of this disease, Kelly put out a few calls to fellow musicians across the country to help raise the awareness of hepatitis C on a national level by distributing information at various local music gigs around the nation's venues. The response was astounding and led to the founding of HepCAware.org. A postcard was designed for the campaign, and a grass-roots movement began.

Vicki Dalton from Carson City heard about the postcards and contacted Kelly about helping distribute them in Carson City. Inspired by Vicki, the "Hep C Aware Street Team" was formed, which has now grown into a national coalition of street teams working together with the musicians to raise awareness of this deadly disease that affects over 4 million Americans every year.

Dalton, who lives with hepatitis C, called upon her employer, Carson-Tahoe Hospital, to sponsor the event and booked the Pony Express Pavilion.

Hepatitis C is a disease of the liver caused by the hepatitis C virus (HCV).

The virus is present in the blood and is spread when infected blood from one person enters the body of another.

It causes the liver to form tiny scars, which, over time, join together and begin to prevent blood from flowing freely through the liver.

Chronic hepatitis C infection is the most common indication for liver transplantation in the United States.

It affects more than 4 million people in the United States, and an estimated 8,000-10,000 Americans die annually of complications related to HCV.

Hepatitis C infection is a major public health problem throughout the world, yet it is largely preventable. Prevention can happen through education programs, rigorous efforts to protect blood supplies and major intervention programs for such at-risk populations as recreational intravenous drug users. There is no vaccine for hepatitis C.

Risk factors include receipt of blood, blood products or an organ transplant prior to 1992, sharing of drug paraphernalia (injecting or snorting), being stuck by a used blood needle, received kidney dialysis, getting tattoos or body piercings, having had sexual activity that involves contact with blood, incarceration, sharing personal-care items such as toothbrushes or razors with an infected person, fighting in a war (especially Vietnam). If you are in any of these categories, you may have been exposed to hepatitis C. Get tested.

The concert will feature performances by Rick Monroe, Che Zuro, Kung Fu Sophie, Slim Chance, Gene Butler, 7th Fall and Kelly's Lot. There will be dancing by The Desert Goddesses and special guest speakers.

The Pony Express Pavilion is at Mills Park. The concert will end at 9 p.m. and is free to the public. The proceeds from the raffles, food sales and all donations will go to Hepatitis C Awareness, Inc. to help start a task force in Carson City.

For more information on this event, call Judy Lynn at (818)-769-2701. For more information, visit www.hepcaware.org.

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Court: Patients May Not Use Pot Legally
SourceURL:http://news.yahoo.com
By GINA HOLLAND, Associated Press Writer

People who smoke marijuana because their doctors recommend it to ease pain can be prosecuted for violating federal drug laws, the Supreme Court ruled Monday, overriding medical marijuana statutes in 10 states.

The court's 6-3 decision was filled with sympathy for two seriously ill California women who brought the case, but the majority agreed that federal agents may arrest even sick people who use the drug as well as the people who grow pot for them.

Justice John Paul Stevens, an 85-year-old cancer survivor, said the court was not passing judgment on the potential medical benefits of marijuana, and he noted "the troubling facts" in the case. However, he said the Constitution allows federal regulation of homegrown marijuana as interstate commerce.

The Bush administration has taken a hard stand against state medical marijuana laws, but it was unclear how it would respond to the new prosecutorial power. Justice Department spokesman John Nowacki would not say whether prosecutors would pursue cases against individual users.

In a dissent, Justice Sandra Day O'Connor said the court's "overreaching stifles an express choice by some states, concerned for the lives and liberties of their people, to regulate medical marijuana differently."

The women who brought the case expressed defiance.

"I'm just going to keep doing what I'm doing. I don't really have a choice but to, because if I stop using cannabis, I would die," said Angel Raich of Oakland, Calif., who suffers from ailments including scoliosis, a brain tumor, chronic nausea, fatigue and pain. She says she smokes marijuana every few hours.

Diane Monson, an accountant who lives near Oroville, Calif., has degenerative spine disease and grows her own marijuana plants. "I'm going to have to be prepared to be arrested," she said.

The ruling does not strike down California's law, or similar ones in Alaska, Colorado, Hawaii, Maine, Montana, Nevada, Oregon, Vermont and Washington state. However, it may hurt efforts to pass laws in other states because the federal government's prosecution authority trumps states' wishes.

John Walters, director of national drug control policy, defended the government's ban. "Science and research have not determined that smoking marijuana is safe or effective," he said.

California's law, passed by voters in 1996, allows people to grow, smoke or obtain marijuana for medical needs with a doctor's recommendation. Monson and Raich contend that traditional medicines do not provide the relief that marijuana does.

California has been the battleground state for medical marijuana. In 2001, the Supreme Court ruled in a California case that the federal government could prosecute distributors despite their claim that the activity was protected by medical necessity.

Two years later the justices rejected a Bush administration appeal that sought power to punish doctors for recommending the drug to sick patients. That case, too, was from California.

California Attorney General Bill Lockyer said Monday that "people shouldn't panic ... there aren't going to be many changes."

Local and state officers handle nearly all marijuana prosecutions and must still follow any state laws that protect patients.

"I think it would look bad if the federal government focused its prosecution authority on a sick person," said Daniel Abrahamson, with the Drug Policy Alliance. "Individual patients growing for their own purposes have not been the targets of the federal authorities. We hope that it stays that way."

The government has arrested more than 60 people in medical marijuana raids since September 2001, according to the National Organization for the Reform of Marijuana Laws.

Congress could be the next stop for the debate.

While there are other legal options for patients, Stevens wrote, "perhaps even more important than these legal avenues is the democratic process, in which the voices of voters allied with these (California women) may one day be heard in the halls of Congress."

Still, even supporters say it is unlikely Congress would pass a law allowing physicians to prescribe marijuana.

O'Connor was joined in her dissent by two other states' rights advocates: Chief Justice William H. Rehnquist and Justice Clarence Thomas. While conservatives may not necessarily support medical marijuana, they have pushed to broaden states' rights in recent years.

O'Connor, who like Rehnquist has had cancer, said she would have opposed California's medical marijuana law if she were a voter or a legislator. But she said the court was overreaching to endorse "making it a federal crime to grow small amounts of marijuana in one's own home for one's own medicinal use."

Thomas said the ruling was so broad "the federal government may now regulate quilting bees, clothes drives and potluck suppers throughout the 50 states."

The case was hatched when Monson's backyard crop of six marijuana plants was seized by federal agents in 2002. She and Raich sued then-U.S. Attorney General John Ashcroft, asking for a court order letting them smoke, grow or obtain marijuana without fear of arrest, home raids or other intrusion by federal authorities.

They claimed protection under the Constitution, which says Congress may pass laws regulating a state's economic activity so long as it involves "interstate commerce" that crosses state borders.

The case is Gonzales v. Raich, 03-1454.

On the Net:
The ruling in Gonzales v. Raich is available at:
http://wid.ap.org/documents/scotus
/050606raich.pdf

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Hepatitis B Virus Infection in Dialysis Patients
SourceURL:http://www.gastrohep.com/

The latest Alimentary Pharmacology & Therapeutics reports that anti-Hep B core antibody is related to anti-Hep C antibody supporting shared modes of transmission, and the rate of anti-Hep B virus core antibody is higher in seropositive dialysis patients.

Occult Hepatitis B virus infection occurs in serum Hepatitis B surface antigen-negative patients with detectable Hepatitis B virus viraemia in serum.

The epidemiology and clinical significance of occult Hepatitis B virus infection remains controversial with only limited information about its prevalence in patients on long-term dialysis.

Dr Fabrizi and colleagues addressed the epidemiology of occult Hepatitis B infection in a large cohort of dialysis patients.

Occult Hepatitis B virus was absent in this study group of 213 patients - Alimentary Pharmacology & Therapeutics

The researchers screened a large cohort of 585 Italian chronic dialysis patients.

The research team tested from this population, 213 Hepatitis B virus surface antigen seronegative patients.

The team used Amplicor Hepatitis B virus Monitor Test to detect Hepatitis B virus viraemia, or virus-DNA, in serum.

The researchers found that occult Hepatitis B virus infection was absent in all patients.

Persistent Hepatitis B virus surface antigen carriage was less frequent than anti-Hepatitis B virus core antibody seropositive status in this study group.

The team observed that no dialysis patients seropositive for anti-Hepatitis B core antibody in serum had detectable Hepatitis B virus-DNA by polymerase chain reaction technology.

The researchers noted no significant association between abnormal biochemical liver tests and serum anti-Hepatitis B core antibody.

Nominal logistic regression analysis demonstrated an independent and significant relationship between anti-Hepatitis C antibody and anti-Hepatitis B virus core antibody in serum.

In addition, the research team found that the rate of seropositive patients for anti-Hepatitis B virus core antibody was higher among study patients than controls with normal renal function.

The difference between study patients and controls partially persisted after correction for demographic parameters, and viral markers.

Dr Fabrizi concludes, "Occult hepatitis B virus was absent in our study group."

'Anti-Hepatitis B core antibody was significantly related to presence of anti-Hepatitis C antibody supporting shared modes of transmission."

'Clinical studies based on molecular biology techniques provided with higher sensitivity are planned.'

Aliment Pharmacol Ther 2005: 21(11):1341

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June 7th, 2005

Reuse of Supplies to Blame for Hepatitis Outbreak
SourceURL:http://www.cancerpage.com

NEW YORK JUN 06, 2005 (Reuters Health) - A large outbreak of hepatitis C virus (HCV) that occurred at a cancer clinic a few years ago seems to have resulted from the reuse of contaminated syringes and IV bags, according to a report in the Archives of Internal Medicine.

The outbreak, which was first reported in September 2002, occurred at an outpatient clinic in eastern Nebraska. Dr. Alexandre Macedo de Oliveira, from the Centers for Disease Control and Prevention in Atlanta, and colleagues describe their investigation of the outbreak.

The researchers contacted 613 clinic patients who visited the clinic during the likely exposure period, from March 2000 through December 2001. Of these patients, 494 were tested for HCV infection.

Ninety-nine patients were identified with new HCV infections, all of whom had started treatment at the clinic before July 2001, the investigators note.

Genetic tests confirmed that the HCV strain was the same in all cases. The researchers believe the virus came from a patient with chronic hepatitis C who started treatment at the clinic in March 2000.

Having an intravenous line irrigated or "flushed" with saline raised the risk of HCV infection, the report indicates. "Shared saline bags were probably contaminated when syringes used to draw blood from venous catheters were reused to withdraw saline solution," the authors note. This procedure was corrected in July 2001, they add.

"This report is a reminder that all suspected cases of healthcare-associated bloodborne infections deserve vigorous investigation because they might signal a widespread problem," the researchers emphasize.

SOURCE: Annals of Internal Medicine, June 7, 2005.

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June 8th, 2005

Vertex's Hepatitis C Pill Could Be a Blockbuster
SourceURL:http://www.forbes.com
Matthew Herper

Hepatitis C currently brings some 30,000 deaths a year in the U.S., but that number could reach 90,000 by 2015. The rising tide could boost tiny Vertex Pharmaceuticals (nasdaq: VRTX - news - people ), according to Geoff Porges, the biotech analyst at Sanford C. Bernstein. Bernstein's market forecast indicates that VX-950, an experimental hepatitis C drug, could bring in annual sales of $1.8 billion by 2010. That assumes that Vertex can win a drug development race with Schering-Plough (nyse: SGP - news - people ), which is developing its own similar drug. Bernstein rates Vertex at "outperform" with a target price of $15 and Porges writes that the company's stock could make gains as plans for further trials of the drug, which is in mid-stage trials, are announced. Recently, Novartis (nyse: NVS - news - people ) inked one of the biggest early-stage drug development deals ever with Anadys Pharmaceuticals (nasdaq: ANDS - news - people ), a small biotech.

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Hepatitis Vaccine Proves a Bitter Business
SourceURL: http://www.rediff.com
C H Unnikrishnan in Mumbai

The Hepatitis-B vaccine market, which is shared by more than 13 players, has not grown beyond Rs 120 crore (Rs 1.2 billion) against the projected Rs 600 crore (Rs 6 billion) by 2004-05.

Retail prices, which were in the range of Rs 250 to 300 per dose two years ago, have now come down to less than Rs 100. Serum Institute of India slashed the prices of its Hep B Vaccine brand by 50 per cent a couple of months back.

"Prices are expected to come down further by 20 to 25 per cent," said Vijay Anand, director, Sathguru Management Consultants, a Hyderabad-based leading management consultancy company. Cheaper imports from Korea and China have also made matters worse for the industry.

While Pfizer and Cadila Healthcare have already withdrawn from the market, the Hyderabad-based Bharat Biotech and Shanta Biotechnics, pioneers in the segment, are shifting their focus to newer vaccines. The Delhi-based Panacea Biotec is introducing new variants -- a combination vaccine in the same segment.

Pankaj Patel, chairman & managing director, Cadila Healthcare (Zydus), said the segment is overcrowded with brands and value growth is declining.

"It did not make any economic sense for us to continue in the market," he said. Cadila recently snapped its joint venture with Korean Green Cross to market the HB VAC.

A Pfizer official said the company discontinued its brand -- Hepashield -- as it was not relevant in the Indian market.

"The market has been spoilt by certain players who could sell the product at less than the cost price," said Krishna Ella, chairman and managing director, Bharat Biotech.

The current players in the market include GSK (Engerix B), Bharat Serum (Hepacine B), Serum Institute (Genvac -B), Panacea Biotec (Enivac HB), Unichem (Unihep- B), Intas Pharma and Indian Immonulogicals.

Rajesh Jain, joint managing director of Panacea Biotech, said only those companies with an edge in technology and quality could sustain in the market as growth, in value terms, was disappointing.

Khaleel Ahmed, executive director, Shanta Biotechnics, said since the local market was shrinking in terms of value and margin, the company was focusing on exports by supplying to the Unicef, World Health Organisation and other international health agencies.

The other big reason for the market stagnation was the government's refusal to include the product in its national immunization programme.

"Shanvac B was launched by Hyderabad-based Shanta Biotechnics in 1998 outside the NIP at a time when indigenous vaccine makers were aiming only at the government-run programme. This was on account of high development costs, less R&D capability and IP related issues," said a pharmaceutical sector analyst.

The next three years saw another 12 Hep B vaccines hit the market. "However, none of them has been able to hit the target. The volume of business might have grown but revenue generation is stagnant on account of continuous price cuts," added the analyst.

Some manufacturers, which set up plants with high expectations, are now trying to forge alliances with companies with a strong marketing force.

"Existing players can absorb another 20 per cent cut in the prices. Beyond that level, many players will be forced to make an exit," said Anand of Sathguru Management.

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Freeland Man with Hepatitis C Sentenced for Spitting in Cop's Face
SourceURL:http://www.msnbc.msn.com
By PAUL KRUPSKI, The Standard-Speaker

Joseph Jacobs, 33, of Schwabe Street, pleaded guilty to aggravated assault by prisoner for spitting in a police officer's face while knowing he has hepatitis.

USA - WILKES-BARRE - Freeland resident Joseph Jacobs was sentenced Tuesday to spend one to two years in a state prison by a Luzerne County judge who said exposing police officers to a communicable disease was serious criminal misconduct.Jacobs, 33, of Schwabe Street, pleaded guilty on April 5 to aggravated assault by a prisoner for spitting in Freeland Police Officer Joseph Stec's face while knowing he is infected with hepatitis C.

The incident occurred Sept. 25 after Jacobs was arraigned for assaulting his girlfriend and while he was being held at the police station for transport to the county prison.

Stec said the spit landed on the left side of his face and ear and that Jacobs later admitted to having hepatitis C while his blood was being drawn for testing.

Jacobs said the incident evolved from an argument with his girlfriend, who complained to police that he had thrown an ashtray and bruised her face.

Police said Jacobs used obscene language and threatened to use a 9mm pistol as he was being removed from the home.

Stec said the obscenity and weapon threat continued in the patrol car and at the police station and that Jacobs made sexual remarks to Officer Jason Brobst.

Jacobs told Judge Thomas Burke, "I'm really sorry for what I've done. Drugs and alcohol really messed up my life."

Assistant District Attorney Nancy Violi asked for a period of incarceration and noted, "This is not his first encounter with the law."

Burke said Jacobs' prior record score was 5 and included violations dating back to his first DUI in 1989. The judge said Jacobs had some harassment matters in 1996, although he was found not guilty, and similar conduct in 2000 involving terroristic threats.

Jacobs attributed the criminal behavior to the fact that "alcohol played a big role in my life."

Burke said threatening a police officer "is very serious business" and that he is fortunate, because of the lapse of time, that his fiancé "is not seeking jail time as a victim."

"Law enforcement is out there to keep the general public safe and for them to have to face serious threats is intolerable," the judge said.

Burke imposed a one-year probation for simple assault, consecutive to the prison term and six months of concurrent probation for a count of disorderly conduct.

Jacobs was ordered to provide a DNA sample and to pay the $250 cost. He received credit for 12 days served and was told to report at 8 a.m. on Monday to the county prison to have arrangements made for his transfer to the state system.

Jacobs is receiving medical treatment. The judge said he would receive an evaluation, counseling and treatment in state prison.

The judge gave him the remainder of the week to put his medical affairs in order and continued bail pending his reporting to jail.

Additionally, the judge permitted Jacobs to have contact with his fiancé but not hit or threaten her.

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June 9th, 2005

Johns Hopkins Team Finds 'Ancestral' Hepatitis-C Virus at the Root of Evolution in Infections
SourceURL:http://www.eurekalert.org

Scientists discover how virus evades immune system in acute and chronic infections; new vaccines may result

Researchers at Johns Hopkins have uncovered how a majority of the genetic changes in the hepatic-C virus, the most common cause of liver disease, allow it to evade the body's immune system during infection. Hepatitis C infection can lead to cirrhosis, cancer and even death. In a series of experiments that describe the virus' transition from an acute to chronic infection, the Hopkins team found that one-half of the virus' changes in its genome are in sites under attack by the body's immune system. As the virus evolves and these changes weaken the body's immune response, a second set of changes at other sites in the genome are reverting back to an "ancestral" set of amino acids.

"We think this piecemeal exchange is helping the virus evade the body's immune system," says study investigator and infectious disease specialist Stuart Ray, M.D., an associate professor at The Johns Hopkins University School of Medicine. "In a newly infected person, the virus may need to adopt new mutations to escape recognition by the immune system's T cells, which fight infection, but it may need to lose the mutations that had protected it in someone else. Despite pressure to change, the virus is always is restoring its shape."

The Hopkins findings, published in a pair of studies in the Journal of Experimental Medicine this week, are believed to be the first description of the precise genetic changes taking place in the virus during the acute phase of infection, when hepatitis C initially escapes the body's defenses and establishes itself in the body. As the infection moves into the chronic stage, the immune response becomes weak and less effective, but until now, no one could explain exactly why.

A second, related experiment produced similar findings when the Hopkins team partnered with researchers in Ireland to perform what is believed to be the first comparison of genetic changes across multiple genes in strains from chronically infected people to the original strain that infected them.

Ray, who served as senior investigator on the first study and led the second, believes the newly identified ancestral component of the viral genome, called a consensus sequence, could serve as the basis for development of a vaccine that is effective against both acute and chronic infections, thereby stemming the epidemic that currently afflicts more than 170 million people worldwide, including 3 million Americans.

"Hepatitis C is extremely difficult to treat if it becomes chronic," says infectious disease specialist Andrea Cox, M.D., Ph.D., an assistant professor at Hopkins who was lead author of the first study. "While approximately 30 percent of patients have a strong enough immune response to rid themselves of the virus during the acute phase, and current treatments are 90 percent effective at treating any remaining acute infections, these treatments are only 50 percent effective against chronic infections, which otherwise persist for life and can cause death."

According to Cox, the hepatitis C virus naturally mutates, or alters its genome, very rapidly. Its strains have two to three times more genetic variability, for example, than HIV, the virus that causes AIDS, and hepatitis C reproduces more than 100 billion times per day, 100 times faster than HIV. Compounding the problem, the infection is asymptomatic in the acute stage, making it less likely that diagnosis will be made early, when it is easiest to treat.

Conventional wisdom, the researchers say, was that the large numbers of mutations were simply random in the virus' ever-changing genome, but the new study suggests that Darwinian genetic selection is at play. That is, the virus' genome changes in ways that make it more reproductively "fit" in the face of each immune system it encounters, changing what is must to evade the immune system in one host, then restoring itself when the pressure is off.

What Ray's team found when the immune response weakens was that the virus naturally mutates toward a set of 3,000 common amino acids, what the researchers considered the virus' most preferred state. During the acute phase, Ray says, the virus is under severe pressure from the immune response and forced to drift away from the consensus sequence, using mutations to evade the immune response. However, the drift was reversible and, once the virus successfully evaded a particular immune cell, its amino acids reverted back to the consensus set.

To assess the genetic changes in the early stages of infection, the researchers decoded, or sequenced, the virus' genome, made up of RNA, which is very similar to the more widely known DNA that makes up the genome of most organisms. The RNA was gathered from eight newly infected patients in Baltimore, Md., all of whom were offered treatment and were participants in a larger study of infectious diseases in intravenous drug users. The sample group was unusual, allowing analyses before and during the early stages of infection. One patient self-recovered, while the rest proceeded to chronic infection.

Using advanced blood-sorting techniques, the Hopkins team extracted millions of immune system cells, including the systems' principal fighters, called T cells, from blood samples taken between 30 days and six months after infection, when the body's initial immune response kicks in and subsequently peaks.

Immune responses were mapped using a series of more than 500 overlapping synthetic peptides, or strings of amino acids whose code was already known. This allowed the researchers to compare changes observed in the RNA sequence to corresponding shifts in the body's immune response to the infection.

When specifically recognized by T cells, the peptides trigger production of interferon gamma, a protein that acts as a signal to many other immune cells to respond to a new infection. Reductions in the production of interferon gamma would indicate, the scientists say, that the immune system was weakening in its response to the virus' mutations.

After analyzing the genetic changes in the sites, called epitopes, where the T cells specifically bind to the virus, the researchers found no changes had occurred during the one year of follow-up in the one patient who self-recovered. However, in the remaining seven patients, there were changes in 69 percent of T-cell epitopes, showing that the virus had mutated at key locations necessary for chronic infection to proceed.

Additional analysis showed that changes in T-cell epitopes were 13 times more frequent than changes in the remaining genome of the virus. The researchers examined the binding ability of T cells obtained early in infection to recognize 10 viral peptides known to have changed during the first six months of infection. Eight showed severely reduced capacity to stimulate production of interferon gamma, offering confirmation that the virus was mutating to evade the immune system.

Analysis of the viral RNA in the blood of seven patients with chronic infections revealed that eight of 16 changes in genome matched to the consensus sequence, confirming the presence of selective evolutionary pressure toward restoration of an ancestral form of the virus.

In the second study, using blood samples collected in Cork, Ireland, the researchers compared the genetic makeup of the virus in 22 chronically infected women to the original strain that had infected them more than 20 years before. The women were among hundreds accidentally infected in 1977 by a blood product tainted with hepatitis C, providing the researchers with unique access to the source of the infection, which came from a single donor unaware of having the illness.

Using computer analysis techniques developed at Hopkins, the scientists mapped these changes against the genetic makeup of the women's immune response. The researchers found that when viral mutations were clustered in epitopes specific to each woman's immune system, the changes were directed away from the consensus sequence, suggesting immune escape. However, when mutations were clustered in epitopes that were not specific, the mutations were reversions back to the consensus sequence.

When the individual genome changes in each woman were mapped on a grid, each woman formed a unique cluster indicating individual, evolutionary selection. However, some of the changes were shared, suggesting convergence, which would not have occurred had the virus simply mutated at random.

"Our results raise the possibility that a hepatitis-C consensus sequence could be the best practical option for a vaccine," says infectious disease specialist David Thomas, M.D., a professor of medicine at Hopkins who served as senior author of the study of Irish women. "If we can focus vaccine development on the common genetic element in chronically infected patients, then we may be able to make a more effective vaccine."

Funding for these studies, which took place from January 2002 to January 2005, was provided by the National Institutes of Health, including the National Institute for Allergy and Infectious Disease, and the National Institute on Drug Abuse.

Other Hopkins investigators in this research were Timothy Mosbruger; Qing Mao, M.D., Ph.D.; Zhi Liu, M.D.; Xiao-Hong Wang, M.D.; Hung-Chih Yang; Xiao-Hang Wang, Ph.D., Dale Netski, Ph.D.; and Drew Pardoll, M.D. Co-investigators in the first study also included John Sidney, Ph.D., and Alessandro Sette, Ph.D., from the La Jolla Institute for Allergy and Immunology, in San Diego, Calif. Collaborators in the second study, conducted at Hopkins and at Cork University Hospital in Ireland, were Liam Fanning, Ph.D., and Kelizaeth Kenny-Walsh, M.D.

Hepatitis C is the leading cause of liver disease in the United States, causing an estimated 10,000 to 12,000 deaths each year. Hepatitis C is transmitted when blood and possibly other body fluids of an infected person enter another person, primarily through injection drug use, exposures in health care settings, from an infected mother to her baby during birth, and occasionally through sexual exposure. Symptoms of hepatitis C may not appear for years after infection, and diagnosis must be confirmed by blood tests. However, in addition to liver inflammation and tumors, earlier signs of infection are persistent flulike symptoms, including any combination of body aches, headaches, night sweats, loss of appetite, diarrhea, fatigue, rash, nausea and mild abdominal pain. Current treatments for hepatitis C involve weekly injections of pegylated interferon for one year, plus twice daily doses of oral ribavirin. While some patients recover on their own, with their immune system attacking the virus and clearing it from the body, most do not. Scientists have not yet determined why this happens in some patients and not in others.

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Researchers Create Infectious Hepatitis C Virus in a Test Tube
http://www.medicalnewstoday.com

A team of researchers led by scientists at The Rockefeller University has produced for the first time an infectious form of the hepatitis C virus (HCV) in laboratory cultures of human cells. The finding, reported in the June 9 issue of Science Express, will allow scientists to study every stage of the HCV life cycle and develop drugs to treat this life-threatening disease that affects more than 170 million people around the world.

"The inability to reproduce aspects of the hepatitis C virus life cycle in cell culture has slowed research progress on this important human pathogen," says senior author Charles M. Rice, Ph.D., Maurice R. and Corinne P. Greenberg Professor and head of the Laboratory of Virology and Infectious Disease at Rockefeller.

"This system lays the foundation for future test tube studies of the virus life cycle and may help in the development of new drugs for combating HCV," adds Rice, who is the scientific director of the Center for the Study of Hepatitis C, a collaborative research and clinical effort of Rockefeller, Weill Medical College of Cornell University, and New York- Presbyterian Hospital

Like all viruses, HCV cannot replicate by itself; instead it takes over the machinery of a host cell to make copies of itself. Much about the life cycle of HCV remains poorly understood because scientists have been unable to reproduce an infectious form of HCV that they can observe in cell cultures. The method developed by Rice and his colleagues, including scientists at the Massachusetts Institute of Technology and the Scripps Research Institute, changes that.

"The hallmark of viruses is their ability to exist in a form outside the host cell capable of infecting new cells," says first author Brett Lindenbach, Ph.D., a postdoctoral fellow in Rice's lab. "Our method replicates and produces virus particles that can infect new cells, initiating replication in them and leading to the production of more virus particles."

Although little is know about the HCV life cycle, researchers think that in humans the virus enters a liver cell and delivers its RNA and proteins into the cell cytoplasm. HCV carries its genetic information in its RNA, which is separated from the protein, copied, and then joined with new protein components before being released from the liver cell to infect other cells.

Lindenbach, Rice and their colleagues named their infectious cell culture virus HCVcc. Already HCVcc is yielding new knowledge about HCV. In a separate set of experiments, the researchers used HCVcc to confirm that a molecule called CD81, which sits on the surface of the human cell membrane, plays a crucial role in the entry of HCV.

Scientists have known that a protein produced by HCV, called E2, binds to CD81, and they believed that this interaction is necessary for the virus to bind to target cells.

The Rockefeller researchers showed that CD81 molecules that are not attached to the surface of host cells compete with membrane-bound CD81 and inhibit entry of HCV into the cell. They also showed that HepG2 cells, which do not express CD81 but can support HCV RNA replication, could not be infected by HCVcc unless they express CD81.

Liver failure due to hepatitis C is the leading cause of liver transplants in the United States, and about 25 percent of liver cancer cases in the country are associated with HCV. Although about 85 percent of those who are infected develop chronic infection, the virus usually remains undetected for years, or even decades, until it causes advanced liver disease.

Lindenbach's and Rice's co-authors are Matthew J. Evans, Andrew J. Syder, Benno Wölk, Timothy L. Tellinghuisen and Jane A. McKeating at Rockefeller; Christopher C. Liu and Richard O. Hynes at the Howard Hughes Medical Institute, Center for Cancer Research, MIT; and Toshiaki Maruyama and Dennis R. Burton at The Scripps Research Institute.

This research was supported by the National Cancer Institute and the National Institute of Allergy and Infectious Diseases, both part of the federal government's National Institutes of Health. Additonal support was provided by the Charles H. Revson Foundation (to Evans) and the German Science Foundation (to Wölk). Lindenbach is a recipient of the Howard Temin Award of the National Cancer Institute.

Rockefeller University

http://www.rockefeller.edu

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