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Week Ending: May 10 , 2008
Alan Franciscus
Editor-in-Chief
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This Issue:
May 3rd, 2008
Health Dept. urges testing, vaccinations for hepatitis a, b, c
http://www.burlingtonfreepress.com
BURLINGTON – The Vermont Department of Health is encouraging anyone at risk for infection from three viruses that harm the liver - hepatitis A, B and C - to be aware of these diseases, to get tested, and to get vaccinated. May is Viral Hepatitis Awareness Month.
When someone has hepatitis A, the virus is present in the stool (fecal matter). The virus can be spread from person to person by putting something in the mouth that is contaminated with infected stool. For this reason, the virus is more easily spread under poor sanitary conditions, and when good handwashing is not observed.
People can also get hepatitis A by consuming contaminated water or ice, raw shellfish harvested from water contaminated by sewage, and uncooked fruits, vegetables or other foods contaminated during handling.
Hepatitis B is spread through blood-to-blood contact and through sexual contact. Both hepatitis A and B can be prevented by a vaccine available at health care provider offices statewide, or at one of the 12 Health Department district offices. The Health Department is offering the vaccine free of charge, after scheduling an appointment, at district offices in Bennington, Brattleboro, Springfield, Newport and St. Johnsbury during May. Vermonters at risk for infection with hepatitis A or B are encouraged to get vaccinated.
People who use street drugs, have multiple sexual partners, men who have sex with men, anyone who has sex for money, people with liver disease, or anyone who has sex with a person-at-risk are eligible for free vaccinations.
Hepatitis C, the second most commonly reported communicable disease in Vermont, is preventable by avoiding contact with infected blood, but there is no vaccine for the virus. Vermonters at risk for hepatitis C often do not know they are infected, since they commonly do not develop symptoms and can remain unaware for years.
Based on national statistics, as many as 12,000 Vermonters could be infected with hepatitis C. Most are not likely aware they are infected.
Unlike hepatitis A and B, there is no vaccine for hepatitis C. The only way to prevent hepatitis C is to prevent exposure.
Free and anonymous hepatitis C testing is available at three syringe-exchange programs in Burlington, St. Johnsbury and White River Junction. Because injection drug users are at highest risk for exposure, low-cost sterile syringes are are also available without a prescription at some pharmacies in Vermont.
Possession of needles and syringes as part of a needle exchange program is not in violation of Vermont’s paraphernalia law.
For more information about hepatitis and for information on how to schedule a vaccination, see the schedule below, or visit the Health Department website at:
http://healthvermont.gov/local/vaccine-clinics.aspx.
Bennington:
-- Department of Health, Bennington District Office, call Christine Bongartz for more information or to set up an appointment, (802) 447-6400.
Brattleboro:
-- Department of Health, Brattleboro District Office, by appointment, (802) 257-2880, Monday-Friday, 8 a.m. to 4:30 p.m.
Springfield:
-- Department of Health, Springfield District Office, by appointment, (802) 885-8933, Monday-Friday 8 a.m. to 4:30 p.m.
Newport:
-- Department of Health, Newport District Office, on May 12th from 3 p.m. to 6 p.m., no appointment necessary. Call Linda Oliver or Barbara Thompson at (802) 334-6707 for more information.
St. Johnsbury:
-- Department of Health, St. Johnsbury District Office, on Friday May, 16, 2008 from 8:30 a.m. - 12 p.m., by appointment. Call Ed Demott at (802) 748-5151 for more information.
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May 4th, 2008
Young man's death gives new life, new bonds
http://www.azcentral.com
The ArizonaRepublic
Josh was 19. Jeff was 56.
One had the charm of youth. The other was dying from hepatitis C, which had destroyed his liver.
One year ago, their worlds collided.
A car accident minutes from his Glendale home ended Josh Florence's life.
From that violence, Mesa resident Jeff Register would get a second chance, receiving the young man's liver and a kidney.
In a spirit of giving born during deepest pain, the two families have united. They talk, they hug and on Saturday they celebrated the slight-built kid whose life was cut short.
Jeff, who is recovering well, said both families are healing through their bond.
"It is about the most unusual relationship human beings in this world could have," he said.
And he embraces it.
"They saved a stranger's life. In the most horrible situation, they reached out."
Although such interaction between donor and recipient families is not common, organ donation has moved from a being tightly sealed procedure to one that is more open when both parties agree.
Josh left the house about 10 a.m. on a Wednesday.
He was just going to run to the store to get a phone charger.
He told his mom, Sandy, "I love you," and the door shut. The endearment was typical. Josh's family is close-knit and he was the only boy, the middle child.
Both sets of grandparents were close. Josh was a charmer. A "politician" is what grandpa called him.
He worked at a landscaping nursery.
Minutes after leaving the house, Josh had driven to the intersection of 43rd Avenue and Thunderbird Road and was waiting to turn. Another driver, who would be charged with manslaughter, slammed into Josh's vehicle.
Sandy got the call. She and family raced to John C. Lincoln Hospital, where they learned Josh had suffered a brain stem injury.
The family was faced with the question of whether to donate his organs. He had not signed up for the donor registry, so the choice was theirs. Fortunately, Sandy and Josh recently discussed the issue. She knew what he would want. The family chose to give what they call "the gift."
Josh died at 9:15 a.m. May 3, 2007.
That day, on the other side of the Valley, Jeff Register, his wife Kathy and his old dog headed to Yuma on a job call.
He was a small business owner who had found his niche repairing hospital equipment, mainly surgical tables. Hospitals far and wide called for his services.
He was diagnosed with Hepatitis C almost two years earlier. He had some theories on how he got it, but nothing conclusive.
What he did know was that he was dying. "I was 93 percent dead and running on 7 percent of my liver," Jeff said.
The Arizona man had been in three comas and had a matter of months to live without a transplant.
His skin was yellow. The medicine he swallowed each morning kept him in the bathroom for hours until he could manage to leave the house around noon.
He said he had grown numb, but worked when he could so that he wouldn't leave his wife of nearly 30 years with nothing.
In a Yuma motel, Kathy picked up the ringing cell phone at 2:30 a.m. on May 4. "We have a match for Jeff," the donor hospital informed.
They tossed their belongings in the car as they raced back to the Valley to Good Samaritan hospital. Jeff was in surgery by noon, receiving a liver and kidney transplant that would take seven hours.
Coming out of the fog of near death, with the return of reason, he said he immediately considered that he was alive because someone had died. A week later, Jeff left the hospital. One month later, he got a letter from the Florence family.
Communication between donor families and recipients, although still not common practice, has been increasing. In the past 10 years, the Donor Network of Arizona has recognized that some donor families and recipients want to know one another.
In the early years of organ transplants, such procedures were more like old-style child adoptions, tightly sealed. They were handled that way out of a sense of protection for donors and recipients, said Marcel Pincince, manager for donor family and advocate services with the Donor Network of Arizona.
The fear was in the "what ifs."
But Pincince said that if families "at their worst moments can make the decision to give life, they can certainly make the decision if they want to communicate."
Today, the network makes sure both parties consent before revealing identifying information. Donor organizations throughout the United States have developed similar protocols, but do not statistically track the meetings, said Paul Schwab, executive director, of the Association of Organ Procurement Organizations in Virginia.
Some find the communication to be healing. In other cases, donor families find it too painful or some recipients feel at a loss for words and even guilt, Pincince said.
Jeff said that rather than guilt, he felt deep compassion for this unknown family that reached out in the midst of tragedy. "I can't say enough," he said.
When the family's letter arrived, Jeff responded.
After five months and much correspondence later, a far healthier Jeff and his wife called to say they were moments away from the Florence' Glendale home.
The family, still grieving, stared as he and Kathy walked in.
Then the questions came from both sides, details of one another's ordeals.
"I morally owed it to them. It's that plain and simple," Jeff said. "They were there for me when they didn't even know my name."
The two families have met several times since then. Josh's father Steve talks with Jeff by phone with some regularity. Sandy hangs up with a motherly "take care of the liver" or a reminder to get a good night's rest.
The Florence family has also reached out to, but not yet heard from, two other recipients who received Josh's heart and his pancreas and other kidney. They hope some day those connections might be made, so they might share the larger story of their son and know that the recipients lives have been made fuller.
Do the donations ease the hurt of so suddenly losing a child?
Never.
Josh's bedroom is a memorial to each treasured memory. His landscaping apron hangs on a peg along with his soccer jerseys. The trophies he'd earned and photos are displayed.
Family and friendsgathered this weekend to remember Josh on the anniversary of his death. Jeff and his wife joined them.
Through donating his organs, Josh's family has memorialized his giving nature.
"I know my son would be very proud of his family," Sandy said.
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May 5th, 2008
Hepatitis C a 'giant' that sleeps no longer
http://www.nationalpost.com
Tom Blackwell, National Post
Study finds incidence of illness soaring
The "sleeping giant" of hepatitis C in Canada has clearly awoken, concludes a new Alberta study that found the incidence of severe illness triggered by the liver virus -- and the resulting burden on the health care system -- has grown explosively.
The number of hospitalizations for serious complications of the virus, the number of deaths while in hospital and the lengths of hospital stays jumped 400% between 1994 and 2004, the Calgary-area research found.
The results outstripped earlier projections that foresaw caseloads doubling over a similar time span.
One expert says the dramatic findings should be a wake-up call for governments that spent more than $2-billion compensating the small percentage of patients who got hep C from tainted blood but have largely neglected actual medical treatment.
"Shortly following its discovery, hepatitis C was described as a sleeping giant," says the paper, just published in the Canadian Journal of Gastroenterology by Dr. Robert Myers, a Calgary liver specialist. "Our data support previous findings that the giant has indeed awoken."
The study was accompanied by an editorial, headlined "The juggernaut rolls on unchecked," that recommends at least another $40-million be devoted to fighting the virus.
Specialists say the health care system must do a much better job of caring for hepatitis C patients if it is to slow the onslaught of serious liver-damage cases. While an estimated 250,000 Canadians --close to 1% of the population -- are infected with the virus, only about 20,000 have been treated with drugs that can cure many of them. About one-third are infected and do not even know it, experts say.
"A quarter-million people have hepatitis C, and we don't have a game plan," said Dr. Kevork Peltekian, chairman of the Canadian Liver Foundation.
One of the chief problems is a shortage of hepatologists, the liver-disease specialists. In Calgary, patients must wait nine to 12 months just for a consultation with one, Dr. Myers said.
Not much can be done about that in the near future. But better educating the public and family physicians, funding nurses who can extend the reach of the specialists and increasing efforts to track down overlooked patients would help treat more people, doctors say.
Those hepatitis nurses do exist now, but often are funded by drug companies, potentially skewing treatment toward the medication made by those firms.
First identified in 1989, hepatitis C causes inflammation that can lead to cirrhosis of the liver -- dangerous scarring of the organ -- or liver cancer, though patients often go symptomless for 20 years or more.
Canadian patients include intravenous-drug users, tainted-blood victims and immigrants who in many cases contracted the virus from unsanitary medical instruments.
The new study analysed hospital records from the Calgary Health Region from 1994 to 2004, identifying more than 4,000 hep-C-related hospital admissions.
Hospitalizations and deaths quadrupled over the decade, while hospital costs leapt 40% in each of the final three years.
Health care is currently dealing mostly with people who were infected in the 1960s and 1970s and are now suffering serious complications, Dr. Myers said.
The rate of new infections is not slowing down, however, promising a constant supply of serious complications in future.
Dr. Morris Sherman, a Toronto hepatologist who wrote the "juggernaut" editorial, noted that compensation to tainted-blood victims came as a result of a "patient-and media-driven furor," although there was less evidence of official negligence than with HIV-tainted blood products.
The result is that "$2-billion has been spent on 15% of the patients with hepatitis C, and very little of it was spent on medical services," Dr. Sherman said.
Drugs that became available about six years ago can cure half of those who take them, though many patients are ineligible because of other conditions or drugs that mix badly with the medications.
Still, specialists agree that a lot more patients could be treated.
Part of the problem is that family doctors are using outdated tests that often fail to detect liver disease in hepatitis C patients, Dr. Sherman said.
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Health Department Encourages Public To Learn Risk Factors For Viral Hepatitis
http://www.medicalnewstoday.com
The Alabama Department of Public Health and the Centers for Disease Control and Prevention urge the public to learn the risk factors of viral hepatitis during May, Hepatitis Awareness Month.
Viral hepatitis is caused by several different viruses, and it can be a serious liver disease. Dr. Donald Williamson, state health officer, said, "More than three million Americans have been infected with hepatitis C, a blood-borne virus which often does not cause symptoms."
People at risk for hepatitis B and C include:
- injection drug users
- people who received a blood transfusion or organ transplant prior to 1992
- people who have unprotected sex with multiple partners
- people who get a tattoo or body piercing in unsanitary conditions
One in every 10 Americans is affected by some form of liver disease. The liver, the largest organ in the body after the skin, is essential for survival. If the liver is not working properly, a person can become very sick and can even die.
Ask your physician about your risk of acquiring hepatitis and your possible need for vaccine.
Hepatitis A is usually transmitted by eating food or drinking water that has been contaminated through fecal matter containing the virus.
Hepatitis B and C are transmitted through blood or body fluids. They are commonly passed on through sexual contact, intravenous drug use, and use of contaminated blood products. Hepatitis B virus can also be passed from mother to infant during birth.
Hepatitis A and hepatitis B vaccines are routinely recommended for those aged 18 years and younger and for certain high risk adults. Currently, there is not an available hepatitis C vaccine.
For more information, log on to http://www.CDC.gov/hepatitis.
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May 6th, 2008
Can-Fite Successfully Completed Phase I Clinical Trial with its 2nd Drug CF102
http://www.therapeuticsdaily.com
PETACH TIKVA, Israel--(BUSINESS WIRE)--May 5, 2008 - Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, announced today the successful completion of a phase I clinical trial with its second pipeline drug, CF102. Can-Fite is developing CF102 for the treatment of liver disease including hepatocellular carcinoma (HCC) and hepatitis C (HCV). The trial was a first exposure in humans and was conducted in the US under an IND in 25 healthy volunteers who were given the drug at 1 of 5 escalating doses.
The trial successfully met its objectives of evaluating the safety profile and pharmacokinetic (PK) of CF102 single doses, and of determining a dose range for future clinical studies.
CF102 was very well-tolerated, with no severe adverse events (SAEs) seen and no dose-limiting toxicity observed. No effects on vital signs, clinical laboratory tests, or electrocardiograms were recorded. The half-life time of CF102 supports once- or twice-daily dosing and exposure levels are above those expected to have pharmacologic activity in HCV and HCC.
Based on the results obtained, the trial was considered a complete success.
These results will allow Can-Fite to continue developing CF102 for various liver diseases.
Prof. Pnina Fisman, CEO of Can-Fite, said today that: "the successful completion of this phase I trial with CF102 promote Can-Fite to a status of a biotechnology company with 2 pipeline drugs in clinical trials, an evidence to the Company's clinical development capabilities and nature of the drugs under development."
Can-Fite currently intends to develop CF102 for the treatment of liver diseases including HCC and HCV. CF102, which was developed based on Can-Fite's technology platform is a targeted drug with high affinity and selectivity to the A3 adenosine receptor.
This receptor is highly expressed on the surface of cancerous and inflammatory cells and not on normal body cells. CF102 binds to its target receptor on the surface of affected cells and promotes programmed cell death (apoptosis). In preclinical trials, CF102 was shown to be effective against liver cancer. Trials conducted in collaboration with two of the leading hepatitis laboratories in the world have also shown that CF102 inhibits reproduction of hepatitis C virus (HCV).
CAN-FITE BIOPHARMA LTD CAN-FITE BIOPHARMA LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by Prof. Pnina Fishman, an investigator from Rabin Medical Center, and patent attorney Dr. Ilan Cohn, a senior associate at Reinhold Cohn Patent Attorneys. Prof. Pnina Fishman serves as the CEO of Can-Fite. The Company was founded on the basis of scientific findings made by Prof. Pnina Fishman and focuses on the development of molecule-based drugs that bind to receptors of cancerous or inflammatory cells and inhibit their development.
Can-Fite's development pipeline currently has two drugs: CF101 and CF102. The company is simultaneously conducting several preclinical and clinical trials with the two drugs for various indications. CF101 is being studied for the treatment of rheumatoid arthritis (Phase IIb), dry eye syndrome (Phase II) and psoriasis (Phase II). Can-Fite develops CF102 for the treatment of liver conditions, including liver cancer, hepatitis infections and liver tissue regeneration.
Contact
Can-Fite BioPharma
Pnina Fishman, Ph.D., Chief Executive Officer
Tel: +972-3-9241114
Fax: +972-3-9249378
pnina@canfite.co.il
http://www.canfite.com/
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Grapefruit Compound Inhibits Hepatitis C Virus
http://www.washingtonpost.com
TUESDAY, May 6 (HealthDay News) -- The grapefruit flavonoid naringenin inhibits the secretion of Hepatitis C virus (HCV) in infected cells and could offer a new approach for treating the disease, according to a Harvard Medical School study.
About 3 percent of the global population is infected with HCV, which can lead to cirrhosis and liver cancer. The current standard therapy of interferon and ribavirin is only effective in about 50 percent of cases and can cause major side effects, according to background information in the study.
Recent research suggests that HVC may be "hitching a ride" along the lipoprotein life cycle, and that compounds and dietary supplements that influence lipoprotein metabolism may also affect HCV.
In this new study, researchers demonstrated that HCV is actively secreted by infected cells while bound to a very low-density lipoprotein.
"Silencing apolipoprotein B (Apo-B) mRNA in infected cells causes a 70 percent reduction in the secretion of both ApoB-100 and HCV. This ApoB-dependent HCV secretion pathway suggests a novel therapeutic approach for the treatment of HCV infection," the researchers wrote.
They then tested the grapefruit flavonoid naringenin and found it reduced HCV secretion in infected cells by 80 percent.
"The concept of supplementing HCV patients' diets with naringenin is appealing," the researchers wrote. But they noted the intestinal wall doesn't absorb naringenin well, which means therapeutic doses of the flavonoid would have to be given by injection or combined with other compounds to boost its absorption by the intestines.
The researchers also noted that naringenin and several other compounds in grapefruit have significant drug-drug interactions.
"Future studies would focus on long-term ability of naringenin and perhaps other citrus flavonoids to reduce viral load in animal models and long-term cultures of primary human hepatocytes," the researchers concluded.
The study was published in the May issue of Hepatology.
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Global groups slam hep C ban
http://www.arabianbusiness.com/
by Joanne Bladd
The Ministry of Health hopes to force countries to screen migrant workers before they depart for the UAE.
The United Arab Emirates (UAE) has been singled out for condemnation by global health organisations following the news that the hepatitis c virus (HCV) has been added to the country's list of deportable diseases.
A Ministry of Health circular, which was leaked to the press last month, said that visa applications and renewals would now include a screen for HCV. Existing residents will face deportation if they test positively for the virus.
The news comes three weeks before the inaugural World Hepatitis Day.
Charles Gore, president of the World Hepatitis Alliance, called the decision "incredibly disappointing.
He said: "I find it particularly surprising weeks before the first World Hepatitis Day, which focuses on how global a problem this is. The notion of exporting the disease does not quite fit in.
The Australian Hepatitis Association told Medical Times it was "disappointed" at the UAE government's decision.
Dr Zainab Khazaal, director of preventive medicine for the Health Authority Abu Dhabi (HA-AD) defended the government's resolution, declaring the matter a "question of health economics." She said: "The UAE and other GCC countries take these measures to protect their population.
The move is intended to force countries to screen migrant workers for HCV before they arrive in the UAE, Khazaal said.
"If we can make them enforce this, as a preliminary recruitment process...then that should reduce the rate.
Asia's high prevalence of HCV means the decision is likely to affect a high number of UAE residents. But Gore suggested the "unethical" move is equally likely to hamper the UAE's attempts at establishing a globally competitive health service.
"A world-class health system is not just a delivery of services and the latest equipment. It's also about ethics," he said, adding that, with travel, diseases can no longer be viewed in terms of single country health.
"I think other countries will feel far less inclined to cooperate with the UAE if they are going to have this mentality regarding diseases. No single country is an island any more and it is a very unfortunate way to deal with a health problem.
"You can't just wish the problem away, except for in the very short-term.
HCV is a major cause of acute hepatitis and chronic liver disease, including cirrhosis and liver cancer. According to the World Health Organisation, an estimated 170 million persons are chronically infected with HCV worldwide, and 3 to 4 million persons are newly infected each year.
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‘It’s important to come forward and get tested’
http://trurodaily.com
JASON MALLOY
The Truro Daily News
Former drug user hopes to inspire others to go for HIV, hepatitis C testing
TRURO — Sticking a needle full of drugs in her arm used to scare Sandra. But it never stopped her from shooting up.
Not too long ago, the 25-year-old, Truro-area woman craved the drug and needles so bad she used “dirty” needles to ease her pain.
“It’s common to share needles. If you’re hard up enough you will do it, unfortunately,” she said. “It has a hold over you so bad.”
Sandra’s addiction, like many, started innocently. She was taking medication prescribed by her doctor to deal with pain associated with a kidney disorder.
About two years ago a friend suggested trying something else. Before long, Sandra was hooked to the rush of the needle.
“I looked like a pin cushion,” she said describing her damaged arm from shooting upwards of 25 times a day at the peak of her use.
But the drugs were taking their toll on the young woman, who was also afraid she may have contracted hepatitis C through sharing needles. Last year, Sandra was in rough shape when she decided to get tested.
“(The nurse) said she didn’t think I was going to make it back to get the results (in about two weeks time),” Sandra recalled.
HIV and hepatitis C can be spread by unprotected sex and using contaminated needles and other drug equipment. While she feared knowing the results, Sandra knew it had to be done.
“You don’t really want to know,” she admitted.
“I was so scared. I was sure I was going to come up positive” for hepatitis C.
But she considers herself one of the lucky ones. She was negative for the both hepatitis C and HIV and has cleaned her life up for both herself and her family.
She discusses her situation openly, hoping others take precautions themselves. Sandra is also encouraging others to take advantage of a new anonymous and free testing service offered monthly in Truro through a partnership with the Northern AIDS Connection Society (NACS) and the Halifax Sexual Health Centre.
“It’s important to come forward and get tested,” she said.
“You could be passing it to just about anybody.”
The clinic also includes a pre and post-counselling session. To book an appointment or for more information call the NACS office at 895-0931.
jmalloy@trurodaily.com
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Health warning issued about Niagara Falls tattoo artist
http://www.wcax.com
BUFFALO, N.Y. (AP) - Health officials are urging clients of a Niagara Falls tattoo artist to be tested for HIV and hepatitis.
Authorities say an investigation found that eight people developed skin infections after receiving tattoos from John Portik.
While no one is known to have contracted HIV or hepatitis from the tattooing, Niagara and Erie County health officials say clients should be tested for the diseases because they don't know whether Portik took proper infection control precautions.
A telephone listing for Portik was not in service Tuesday afternoon.
Portik has been ordered to stop tattooing and has surrendered his tattooing equipment.
Anyone who has gotten a tattoo from him since 2001 is being encouraged to get tested.
Anyone who needs to be tested should contact their health care provider, the Niagara County Health Department (716-439-7470), or the Erie County Health Department (716-858-2929). Additional questions and concerns could also be directed to a New York State Health Department Call Center (800-808-1987).
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Assets Frozen for 2 Doctors Involved in Hepatitis Crisis
http://www.lasvegasnow.com
A hearing held about assets of Drs. Dipak Desai and Eladio Carrers concluded late Tuesday. Attorneys were trying to get Desai's assets frozen, saying he may be trying to protect his money illegally. The judge granted a preliminary injunction.
The injunction was granted against Dr. Desai, his wife and Dr. Eladio Carrera and any entities they own. They must get court approval to move money and assets over $50,000.
An injunction was not granted against Dr. Vishvinder Sharma and Dr. Clifford Carrol. The judge says he only imposed this against the doctors who had their licenses suspended by the state medical board.
The ruling is a victory for the attorneys representing thousands of patients of the business. They wanted the injunction so the doctors could not hide assets.
Dominique Pollara, Desai's attorney said, "The plaintiffs have no right to the property. They have no interest in the property."
"Without the injunction here, judge, this court and all of these attorneys, thousands of victims may very well waste two years of their lives," said John Muije, plaintiffs' attorney.
Desai is the doctor at the center of the hepatitis scare which exposed patients to hepatitis. He's the owner of the Southern Nevada Endoscopy Center, which is in the middle of the investigation.
Attorneys for some of those patients say they want to make sure Desai doesn't move his assets to protect them.
"There has been some talk and some hanky panky that Dr. Desai transferring assets of automobiles, cash, some bank accounts and if that's true, there are some terribly injured people who are suffering as a result of Dr. Desai's actions," said Ed Bernstein.
Also, the Las Vegas City Council will try to decide Wednesday what to do with the $500,000 fine levied against the Endoscopy Center of Southern Nevada.
The health department and Metro have asked for some of the some of the money to offset costs of the investigation.
The DA's office is also asking for a part of it to help in any possible prosecution.
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May 7th, 2008
Astellas: FDA Delays Transplant Drug Approval
Reuters Health -
By Edwina Gibbs
TOKYO (Reuters) - Japan's Astellas Pharma said on Wednesday it would suffer further delays in approval for a new version of its key transplant drug after U.S. authorities said they were not ready to approve it for liver transplants.
Astellas is keen to gain approval for Advagraf, a modified release version of transplant drug Prograf, which brings in some $2 billion in annual sales but lost U.S. patent protection last month.
Advagraf, which is taken once a day, has already been approved in Europe. Prograf is taken twice a day.
Astellas spokesman Takeshi Suda said the U.S. Food and Drug Administration has made a point about the drug's efficacy and safety in its latest action letter but he declined to elaborate.
Receiving an action letter usually means that a drug faces a delay of at least six months before receiving approval.
The FDA declined in January 2007 to approve Advagraf for heart transplants and requested data on kidney and liver transplants.
In March this year it requested further information on Advagraf for kidney transplants.
"I don't think this will come as much of a surprise to the market. If they weren't going to approve it for kidney transplants then they probably weren't going to approve it for liver transplants in the space of a month," said Mizuho Securities analyst Hiroshi Tanaka.
While other drugs can easily lose up to half their sales after a patent ends, doctors and patients dealing with the chances of organ rejection are expected to be reluctant to switch to a generic transplant drug.
Basing their assumptions on slow generic inroads into Novartis's immunosuppressant cyclosporine when it went off patent, most analysts are forecasting annual sales declines of only around 10-15 percent for Prograf.
In a market dominated by Prograf and Novartis's cyclosporine, Prograf commands about 60 percent of the immunosuppressant market for a class of drugs known as calcineurin inhibitors.
In new transplants, its holds market share of around 84 percent for kidney transplants, 90 percent for liver transplants and 63 percent for heart transplants.
Astellas also announced it had received European approval to market Mycamine, a drug to prevent Candida infections in blood stem cell transplants, which include bone marrow transplants and to treat Candida fungal infections of the oesophagus.
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Charity CD launched in fight against hepatitis
http://www.birminghammail.net
by Maria Norris
I WILL be launching a charity CD in aid of the Hepatitis C Trust to coincide with World Hepatitis Day (WHD) 8 on May 19.
This CD is my brainchild. I am currently undergoing treatment for hepatitis C (HCV).
With the help of fellow HCV patients and other friends, I have co-ordinated the compilation of this CD and the cover graphics.
The CD consists of 14 original tracks, donated by local artists, three of which I sing myself.
In order to gear the CD specifically towards raising awareness of HCV, I have included a song about living with the virus, written and performed by a fellow patient.
I also recite a poem which I wrote about being diagnosed with HCV entitled 'Not Me!' which is the title given to the CD. The cover includes some basic facts on HCV, the words to my poem and a personal message from me.
The Hepatitis C Trust has supported this project by funding the production of the CD and I am happy to donate all proceeds from sales to The Trust's Awareness Campaign.
You can listen to a track from the CD, entitled 'Someday', which I sing, by clicking on www.hotshare.net/audio/46633-3661997981.html
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Infection fears raised for substance abusers
http://www.onmedica.com
OnMedica staff
Drug users are still too vulnerable to dangerous infections despite well performing drug treatment services, says a national report.
A report showing results from the second of three annual reviews to assess the performance of substance misuse treatment services in England found inconsistent practice across the country for testing for and treatment of hepatitis B and C.
The report, produced by the Healthcare Commission and the National Treatment Agency (NTA) for substance misuse, reviewed 149 “local drug partnerships” in England – which include representatives from PCTs, local authorities, the police and the probation service.
The two bodies found that the number of people receiving specialist drug treatment had more than doubled from 85,000 in 1998-99 to 195,400 in treatment during 2006-07, while estimates for 2007-8 show 210,800 people will receive treatment.
Overall, the review showed there had been considerable improvement in the commissioning and performance management of drug treatment services, resulting in more service users receiving better treatment.
However, there were significant deficits, particularly in the provision of vaccination for hepatitis B and testing and treatment for hepatitis C.
This is a particular concern, they say, because 90% of all hepatitis C diagnoses are associated with injecting drug use.
Local drug partnerships were asked 45 questions across 10 criteria, resulting in 34% of them gaining an overall score of “excellent”, 45% “good” and 21% “fair”.
Anna Walker, chief executive of the Healthcare Commission, said: “As the UK has one of the highest recorded drug-related death rates in Europe, it is a clear national priority to minimise the impact of substance misuse.
“It's very encouraging that thousands more people are now getting the treatment they need, and this review shows there is much to celebrate about the progress made.
“However, it is worrying that the majority of hepatitis C cases are associated with injecting drugs, yet we know access to testing and treatment for the disease is patchy across the country.
“Similarly, access to clean needles provided by out of hours exchanges varies considerably. These are the areas that need to improve if the health of those who inject drugs is to be tackled effectively, and drug-related deaths reduced.”
Paul Hayes, the chief executive of the NTA for substance misuse, said: “The review highlights inconsistent practice across the country in key areas of delivery such as testing for and treatment of hepatitis B and C.
“The NTA will be working with all partnerships to spread best practice more consistently and has agreed action plans for improvement with the poorest performing areas.”
Following the results of this review, work has been carried out by the Commission and the NTA with the 25 lowest performing partnerships. Action plans were developed to improve performance and good progress has already been made in implementing this.
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Medical board refuses to release Desai complaints
http://www.lasvegassun.com
By Marshall Allen
Group accused of protecting doctors, not public
Chief Deputy District Attorney Scott Mitchell, one of the prosecutors handling the Desai case, says the medical board has refused to comply with a request from Metro Police detectives for any complaints against Desai that have been filed with the board. The request by police is allowable under Nevada law.
Mitchell said the medical board has lost sight of its primary mission.
“I think they are so far removed from what they’re supposed to be doing that it hasn’t occurred to them that they’re protection for the public, not interference for the doctors,” Mitchell said of the medical board. “They’re running interference for doctors is what they’re doing.”
Desai, the majority owner of the Endoscopy Center of Southern Nevada, has been accused of ordering his nurses to reuse syringes and single-use medicine vials to save money. The dangerous injection practices led to eight people being infected with hepatitis C and about 50,000 being told to get tested for infectious diseases, according to the Southern Nevada Health District. Metro Police are investigating whether the medical neglect of Desai and others caused substantial bodily harm to patients.
A source familiar with the investigation said the decision to refuse Metro’s request was made by Tony Clark, the board’s executive director and acting general counsel, and Lyn Beggs, the deputy general counsel. Clark did not return calls for comment. Beggs said she would not comment on the specific case, but that generally speaking complaints that have not resulted in disciplinary action are confidential under Nevada Revised Statute 630.336, Subsection 4.
“We complied with the subpoena with any public information we had and provided that to them,” Beggs said.
Mitchell noted that Subsection 6 says the board may turn records over for a criminal investigation. It says in part: “This section does not prevent or prohibit the Board from communicating or cooperating with any other licensing board or agency or any agency which is investigating a licensee, including a law enforcement agency.”
Investigators on Thursday sought the advice of Nevada Attorney General Catherine Cortez Masto’s office and learned there was no problem with the board’ releasing the complaints for the sake of a criminal investigation.
But on Friday the medical board again refused to turn over the complaints.
The attorney general’s office did not reply to the Sun’s request for comment.
Sources close to the investigation are now concerned that the longer the wait for the records that have been requested, the greater the chance they will be destroyed or lost.
The board, which has strong connections to Desai, has been widely criticized for the way it has handled the Endoscopy Center investigation. Before Desai was disgraced by the hepatitis C scandal, he was one of Nevada’s most prominent doctors. He is a former member of the medical board, and three current board members have had to recuse themselves from the investigation into his conduct because of their close ties. One founded an insurance company with Desai, another has done consulting work for him and the third is his personal physician.
Clark assured Assemblywoman Sheila Leslie during Tuesday’s meeting of the Legislative Committee on Health Care that the medical board’s primary goal is to protect the public, not cover for doctors. She said she was dismayed to learn from the Sun that the medical board was refusing to comply with Metro’s request for complaints against Desai.
“This situation sounds like more stonewalling to me,” Leslie said. “Given the circumstances of this tragedy in Las Vegas, it’s almost incomprehensible that they would get in the way of law enforcement doing their job. I just find it appalling that they would throw up roadblocks to law enforcement getting what they need.”
Leslie said the Nevada law seems to clearly state that Metro should have access to the records. But it does not mandate that the medical board turn over the records, and Leslie said the law may need to be tightened.
But then she suggested a different approach to reform.
“I’m beginning to wonder if it’s the statute that needs tightening or if it’s the medical board that needs removing,” Leslie said. “Perhaps we need to start over with the medical board. This morning they said they are here to protect the public. But their actions this afternoon contradict their testimony. I would like to know why they’re not going to release that information.”
The nine-member board is appointed by the governor.
Leslie noted that it took nine weeks for the medical board to suspend Desai’s license, an action it could have taken days after the announcement that his clinic had caused the hepatitis C outbreak. The situation required aggressive action, she said, but the board has responded “with a cavalier attitude.”
Dr. Javaid Anwar, president of the medical board, did not return the Sun’s calls for comment.
Leslie also questioned why Clark is serving as both executive director and the acting general counsel.
“I don’t think that’s very healthy,” she said. “I don’t know of another organization that operates like that. How can you advise yourself if your actions are appropriate?”
Leslie said she’s lost faith in the medical board’s ability to protect the public.
On a separate front Tuesday, Clark County District Judge Allan Earl granted a motion by plaintiffs for a preliminary injunction barring the Endoscopy Center of Southern Nevada and Desai and partner Dr. Eladio Carrera from conducting any transaction of $50,000 or more without the court’s permission.
On April 30 the Sun reported that Desai had tried to ship his two Mercedes-Benzes to Dubai, and attorneys for people suing Desai were concerned that he might try to liquidate his assets, which would make it difficult for them to gain access to his money if there’s a judgment against him.
Desai’s lawyer, Dominique Pollara, from Northern California, said Desai is not trying to move any of his assets.
“He’s a U.S. citizen and has no intention going anywhere,” she said.
Sun reporter Jeff German contributed to this story.
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City Decides How Hepatitis Fine Will be Spent
http://www.lasvegasnow.com
Melissa Duran, Reporter
City leaders have decided on what they believe is the best way to spend $500,000 to help in the valley's current health crisis. Attorneys for the Endoscopy Center on Shadow Lane gave city leaders a half a million dollars one month ago as part of a civil fine.
The mayor immediately decided the money would go to help in the current health crisis, but several agencies requested it. Wednesday, we found out exactly who's going to get it.
It's not a lot of money when you consider the magnitude of the valley's current health crisis. Still, Metro, the district attorney's office and Nevada Health Centers all took a stab at getting a piece of $500,000 paid out to the city.
They all got their wish.
The city will give Metro $161,000 to partially pay them back for a company they hired to organize thousands of patient files.
"Metro put forth the money to get this company online because of the fact that we needed to move -- there was too much delay," said Capt. Al Salinas of Metro.
The district attorney's office will also get $100,000 to help with prosecution of the case. But if charges aren't filed in this hepatitis case, the DA's office won't get any money.
Christopher Lalli, Assist. District Attorney said, "We don't want this to be perceived as a money grab on behalf of the DA's office. We want the council to have the assurances that we wouldn't use this money unless a prosecution developed."
But the biggest chunk will go to those who need it most -- the patients. The city has dedicated $239,000 to get those infected with hepatitis C from that clinic the help they need. The money will be given out in a grant to Nevada Health Centers.
"Our role is one of bringing the community together to try to assist getting patients care regardless of their ability to pay," said Dr. Carl Heard, Nevada Health Centers, Inc.
Mayor Oscar Goodman is pleased with the city's decision on how to divvy up the money but says other government entities need to start pitching in.
"Step up. This council stepped up, I ask myself sometimes what would happen if this council didn't shut them down, it might still be going on," said Mayor Goodman.
The city manager says they will work with Nevada Health Centers to figure out the best way to spend the money on patient treatment. NHC says that some money will probably be spent on patients who were infected with hepatitis C as a result of this clinic.
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May 8th, 2008
Regional hepatitis-C meeting will be May 19
http://www.visaliatimesdelta.com/
In recognition of May 19 as World Hepatitis Awareness Day, local concerned citizens invite all interested area residents to a town-hall meeting about the disease from 10 a.m. to 2 p.m. on Saturday, May 31, at Hanford Family Connection, 315 W. Lacey Blvd., Hanford.
All aspects of hepatitis-C, a viral infection that attacks primarily the liver, will be covered at the session, said Robert Katz, the local coordinator of monthly group meetings about the disease at Visalia Health Center, 2611 N. Dinuba Blvd., Visalia.
For further information on these activities, call Katz at 562-3139.
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Hep C victims caught in 'waiting game'
http://www.nationalpost.com
Kevin Libin, National Post
Tainted Blood; Many fear they will die before money arrives
CALGARY -After being cut out of federal compensation funds before, and waiting for promised medical help that never showed up, some of Canada's "forgotten" hepatitis C victims are understandably skeptical they'll see a penny from the Conservative government's latest pledge to tainted-blood victims. Unfortunately, they may be right.
"I don't believe I'll get anything in the end," confessed Vikki Boddy of Lethbridge, Alta., who contracted the blood-borne illness through a transfusion in 1984 and has sought federal recompense for over a decade. She says the effects of hep C cost her her job at 35, and medication -- one prescription costs nearly $2,000 a month -- has driven her family to bankruptcy, twice. She predicts she'll die without seeing remuneration.
Almost two years ago, the Conservatives announced a nearly $1-billion settlement for roughly 6,000 "forgotten victims" -- those infected from the blood supply before 1986 and after 1990. They had been shut out of a $1.2-billion deal the former Liberal government offered hep C and HIV patients infected between the two dates. Announcing the new fund in 2006, the Conservatives suggested victims could see money within six months. Nearly two years later, many say they haven't seen dollar one.
"What they do is give you the waiting game. They hope you'll die, frankly," said Jacqui Lemmon, of Oshawa, who has been fighting on behalf of infected family members. Unlike Ontario's class -action settlement for victims of E. coli poisoning in Walkerton, where survivors, once cured, could await a payout, she says, hep C is degenerative and frequently lethal, so "people continue to die waiting for their money."
Jeanie Villeneuve, a hep C victim in Barrie, helps administrate an Internet newsgroup for tainted-blood victims. Of the 50 members, she says, just two say they have been paid.
Crawford Class-Action Services, contracted to dispense the cash, says only that "some" claims from the "pre-86/post-90" fund have been completed. While Crawford publishes statistics of successful claims for the 1986-1990 payout, Josee Lynch, Crawford's senior project manager, says courts overseeing the newer fund have not approved publicizing the data.
Applications could take a while to sort out, Ms. Lynch acknowledges, because many infections took place so long ago and records of transfusions are difficult to locate or no longer exist. Many records required for blood lot "trace-backs" have disappeared. She notes the rigorous conditions that may hamstring victims are part of the courts' arrangement with the government and not Crawford's design.
Victims, most of whom long ago qualified for smaller payouts from provinces and the Red Cross, are frustrated they must prove their cases all over again, this time facing greater scrutiny about where and when they contracted the virus. But hospitals where they were infected may have closed or their physicians may have died. Those applicants must provide an affidavit from someone other than a family member, such as an attending nurse, swearing they witnessed a transfusion that may have been 30 years ago, or a physician willing to surmise that a transfusion was "more likely than not."
It isn't always possible, allows Ken Kolthammer, the Edmonton lawyer who represented Alberta's victims. But while the safeguards may seem demanding, he says, the potential for abuse by people who contracted hepatitis C elsewhere -- say, from intravenous drug use -- exists. "It's unfortunate, but there is no such thing as a perfect class-action," Mr. Kolthammer admits. "In the circumstances, we thought we got a pretty fair deal, but it's not a perfect deal."
For victims, these frustrations are less surprising than fatiguing. "This is a double victimization because not only have you been infected with a virus that may eventually kill you, but now you're being dragged over the coals to get money for it," Ms. Lemmon says.
Thousands have already died waiting for federal money. Transfers to the provinces under the mid-nineties' "care instead of cash" program, supposedly to defray patients' medical costs, never found its way to victims. Predictably, some are now cynical enough to float sinister theories, suggesting the government -- which gets back any unclaimed funds -- is waiting out the victims. More likely, say lawyers close to the case, Crawford may be struggling to keep up with application volumes. They think things are moving at a reasonable pace. But that's going by lawyer time. Tainted-blood victims may not be able to afford to be as patient.
klibin@nationalpost.com
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77 more hepatitis cases may trace to clinic, officials say
http://www.signonsandiego.com
By Ken Ritter
Associated Press
LAS VEGAS – Seventy-seven more people diagnosed with hepatitis C may have been infected during treatment at a Las Vegas outpatient clinic, Southern Nevada Health District administrators said Thursday.
The 77 people are among about 400 former patients of the Endoscopy Center of Southern Nevada who tested positive for the potentially fatal liver virus since an outbreak was made public Feb. 27. After testing, they matched with patient lists and were interviewed, said Brian Labus, senior health district epidemiologist.
Investigators can't say for sure how the 77 people were infected, Labus said, but they know each was treated between March 2004 and Jan. 11 this year at the clinic.
“They have the obvious risk factor, but we can't say for certain,” Labus said. “This is as far as we can go with these cases. We know they didn't have a positive test before they went to the clinic, and now they're positive.”
Health district investigators found no obvious exposure clusters like those found with seven acute hepatitis C cases linked by DNA testing to several dates last year at the Endoscopy Center of Southern Nevada. An eighth case was traced to a sister clinic, Desert Shadow Endoscopy Center.
The clinics were headed by doctors Dipak Desai and Eladio Carrera, whose Nevada medical licenses have been suspended pending resolution of a state Board of Medical Examiners complaint.
“This is the first of many of these types of reports that will come out when we have data,” Labus said. “There is no way to project how many people will test positive.”
Many people who tested positive for hepatitis C have yet to be interviewed, Labus said. Interviewers ask if each has a history of intravenous drug use, blood transfusions, organ transplants or kidney dialysis, if they received blood clotting agents prior to 1987, or if they have had sexual contact with a person known or suspected to have hepatitis C.
Labus and Jennifer Sizemore, spokeswoman for the Las Vegas-based health district, said local labs have reported receiving about 50,000 hepatitis virus tests since officials issued a call on Feb. 27 asking former patients at the clinic to get tested for hepatitis strains C, B, and HIV, the virus that causes AIDS.
Authorities have said at least that many patients may have been exposed when clinic staff reused syringes and single-use vials of medication during anesthesia.
“Because the patient list we received was not complete, we cannot say for certain if all of the affected patients have been tested,” Dr. Lawrence Sands, chief district health officer, said in a statement released Thursday.
“The health district continues to receive a higher number of positive test results than we did before the notification in February,” he said, “which means people are getting tested and that is a positive outcome.”
Sands said patients who underwent procedures at the clinic in late 2007 or early 2008 will need to be tested in coming months because it can take up to six months for a positive test result to occur.
Labus said no cases of hepatitis strain B or HIV have been linked to the Endoscopy Center outbreak.
Las Vegas police seized medical records from the clinic, and the FBI, the Nevada state attorney general and the Clark County district attorney are all involved in a criminal investigation.
The owners of the clinics have surrendered business licenses and paid a total of $500,000 in fines.
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Nassau medical center issues insulin pen warning
http://www.newsday.com
By Ridgely Ochs
ridgely.ochs@newsday.com
Nassau University Medical Center, concerned about possible reuse of insulin pens in more than one patient, said yesterday it will be sending letters to as many as 185 diabetes patients, urging them to be tested for hepatitis C, hepatitis B and HIV.
The East Meadow hospital said it was still not clear whether a pen, a pre-filled syringe meant to be used in a single patient to dispense insulin, had actually been used in more than one patient. Dr. Steven Walerstein, the hospital's medical director, said there were no reports of any resulting infection.
But Arthur Gianelli, NUMC's chief executive, said nurses had reported hearing of it and the hospital had decided to err on the side of caution. "We don't know if it actually happened, but there was enough hearsay to conclude it might have happened," he said. "We decided we have to do the best we can to protect people's health." The hospital, which said it removed all insulin pens, also notified the state Department of Health, which was on site yesterday investigating.
The pens - generally considered safer than syringes with multidose vials because they are designed to be used by one patient - were introduced at the hospital Nov. 26 after intensive staff education.
The hospital said only those patients known to have ever used the pens - specifically Lantus SoloSTAR and NovoLog FlexPen - from that date to May 5 would be notified to come to the hospital for a free blood test and follow-up. They can call 516-296-4333 for screening and counseling. Diabetic patients who have not used the pens are not considered at risk, the hospital said.
In the meantime, Walerstein said the hospital has reverted to multidose vials for delivering insulin. In November, the state health department announced Dr. Harvey Finkelstein of Dix Hills had infected at least one patient three years earlier through use of multidose vials.
According to Walerstein and other hospital officials, about a month ago a nurse on the medical intensive care unit reported a suspicion that insulin from one patient's insulin pen had been withdrawn into another patient's syringe.
But when interviewed, all the nurses said they knew of no such practice, Walerstein said. The hospital's quality control team then interviewed nurses on other floors. He said some said they had heard of the practice, although none said they had direct knowledge of pens reused in multiple patients. Theoretically, drops of blood containing viruses could be transmitted from one patient to another via the insulin pen's syringe, although Walerstein said there were no reports that had occurred.
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HIV reduces body's ability to control hepatitis C replication
http://www.aidsmap.com
Adam Legge
HIV infection significantly impairs the body’s ability to keep the replication of the hepatitis C virus (HCV) under control when coinfection occurs, says an international group of researchers in an article published in the June 1st edition of the Journal of Infectious Diseases (now online).
HCV infection has emerged as an increasingly serious problem in people with both infections – despite the ability of antiretrovirals to keep HIV under control.
And the way in which HCV acts in a coinfection is significantly different than in people who only have HCV infection.
The authors of this study have compared HCV-specific T-cell responses in two groups of patients: 55 HIV-positive men with acute HCV infection and eight people infected with just HCV. They also looked at HCV persistence: how long the virus stays active in the body.
They found that the majority of coinfected patients (95%) developed persistent HCV infection, a significantly higher proportion than in the HCV infected controls (65%) and more than quoted in previous studies of HCV persistence in monoinfected patients (75%).
They say this strongly suggests that concurrent HIV infection favours HCV persistence.
There was also a significantly higher HCV viral load among coinfected patients than in those with HCV only, implying poorer virological control of HCV in HIV coinfection during the acute phase of infection.
T-cell responses were weaker in coinfection, they add, suggesting HIV affects the cell-mediated responses to HCV during the acute phase, contributing to reduced clearance and control of HCV.
The authors say these results in acute HCV infection add to previous research which suggests that HIV significantly impairs cell-mediated responses to HCV antigens during chronic infection.
Reference
Danta M et al. Impact of HIV on host-virus interactions during early hepatitis C virus infection, Journal of Infectious Diseases 197 (online edition), 2008.
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