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Week Ending: December 12, 2009
Alan Franciscus
Editor-in-Chief
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This Issue:
December 5, 2009
Mother of 3 Needs Liver Transplant
http://www2.wrbl.com
By Alison Flowers | Digital Journalist
As the healthcare debate rages on in the U.S. Senate, one woman tries to hang on and wait for a life-saving transplant.
Yvonne Fodor-Russ is a mother of three school-age boys. Just over a decade ago, she learned she had contracted Hepatitis C, possibly while working in the healthcare industry, a system upon which she now depends every second.
Russ has end-stage liver disease. A few weeks ago, her “MELD” score, the scale to determine the gravity of the disease, put her on the donor list for a transplant. The wait period is about a year.
“Treatment is no longer an option because these medications are very powerful,“ said Dr. Shankar Thiruppathi, Russ’ GI physician. “They can actually make her liver fail. At this point, given the stage of her liver disease, right now liver transplant is pretty much her only option.“
But even though Russ has partial Medicaid and Medicare coverage, Social Security and Disability, the extraneous costs of getting a transplant, especially post-operative care can be a life-long, financial drain. In some cases, the post-op medication can run $20,000.
That’s why Russ registered with the Georgia Transplant Foundation’s fundraising program. The organization will match up to $10,000 (one-time only) of whatever she is able to raise.
“I just wish she’d have the self-confidence and the ability to do what she used to be able to do,“ Russ’ 15-year-old son, Jeremiah, said. “I really, at least, want her to see me grow up and graduate.“
It’s been an emotional battle for Russ. Between sobs, she managed to say, “I just worry about my children. What’s going to happen to them if something happens to me?“
News 3 is on your side with how you can help Yvonne Fodor-Russ and her family.
Donations may be mailed to the following address (please indicate ‘Yvonne Fodor-Russ Fund’ in the check’s memo line):
ATTN: TFP
Georgia Transplant Foundation
6600 Peachtree Dunwoody Rd.
600 Embassy Row, Suite 250
Atlanta, GA 30328
You may also call 770-457-3796 to find out more about donating or visit http://www.gatransplant.org.
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December 6, 2009
Another Patient Files Lawsuit Claiming Hepatitis B Infection from Doctor's Office
http://www.app.com
By Chelsea Michels • Toms River
TOMS RIVER — About a month after oncologist Dr. Parvez Dara filed a lawsuit against his former business associates and an employee to clear his name, another lawsuit has been filed against him by a former patient who has been diagnosed with hepatitis B.
Candace Salgado Plaza, a former patient of Dara's who sought treatment in 2008 for breast cancer and lymphoma, and her husband Rafael, are suing Dara after Candace was tested and diagnosed with hepatitis B on Jan. 7.
The amount of damages is not specified, but the suit asks for punitive damages, interest, costs of the lawsuit and attorney fees.
"It's a shame Dr. Dara valued profits over patient care and safety," said Lakehurst-based Kenneth T. Palmer, an attorney with the law office representing the Salgado Plazas. "Now, in addition to cancer, Mrs. Salgado Plaza and the multiple other infected patients have to deal with hepatitis B for the rest of their lives. Had Dr. Dara implemented and adhered to even the most basic safeguards for handling blood work, this tragic situation would have been avoided."
Candace Salgado Plaza, of Lakehurst, received treatment at Dara's Toms River office beginning in June 2008, according to the suit. She received port flushes, blood work, chemotherapy and transfusions that involved blood, syringes and catheters.
"We are aware of the recent lawsuit that has been brought against Dr. Parvez Dara by one of his former patients," said Tim White, a spokesman for Dara. "While it is our policy not to comment specifically on ongoing litigation, we are preparing to aggressively defend Dr. Dara against this lawsuit. Dr. Dara has a number of strong defenses including the fact that there are a number of possible medical reasons that explain why hepatitis B may have developed among patients — particularly those being treated for cancer with chemotherapy."
In April, the state Board of Medical Examiners temporarily suspended Dara's medical license as he was being investigated by health officials after five of his patients were infected with hepatitis B.
Dara, who practices in Toms River and the Whiting section of Manchester, came under fire after investigators said they found unsafe practices in his offices including open medication vials, syringes taken out of their sterile wrapping, the reuse of single-dose medication vials, blood spilled in multiple areas of the chemotherapy room and other problems.
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Hepatitis C Can Take Toll on Sufferers
http://www.pennlive.com
By Body and Mind staff
It’s been called the silent epidemic.
Hepatitis C is the most common chronic blood-borne viral infection in the United States with 4 million Americans infected. Because it can linger for decades with no symptoms, many don’t know they have it until they’ve already suffered significant liver damage.
Hepatitis C is contracted by contact with infected blood. In America, it’s mostly caused by sharing needles used to inject illegal drugs, but it can be contracted in other ways, said Tina Navitsky, certified registered nurse practitioner who manages all hepatitis C patients for Jackson Siegelbaum Gastroenterology.
“People say, ‘How’d I get this?’ And I ask them in their entire life did they ever use IV drugs, even once,” Navitsky said of her new patients, who are often shocked at their diagnosis. “They come from all walks of life, from people with no jobs to executives.”
She encourages treatment because an active virus can lead to cirrhosis, or scarring, of the liver and liver cancer. Only two treatments exist; a new one is on the horizon in 2011, Navitsky said. Sometimes the medication works; sometimes it doesn’t. But either outcome can exact a heavy toll.
Surviving the side effects
Alan Hook, 58, contracted his virus through a tainted blood transfusion during open heart surgery in 1970.
“It just laid dormant in me,” Hook said. “So, I thought, I’ll leave it alone.”
But in 2005, routine testing showed danger. On a 0-to-4 scale, with 0 being a healthy liver and 4 being “you sitting on a bed waiting on a transplant,” Hook was at No. 2.
“I never had any outward [signs]. You couldn’t tell. I had no idea,” Hook said. “I wasn’t losing weight. I wasn’t turning yellow. I didn’t know.”
His choices: a radically changed lifestyle with no guarantee that liver damage would abate or extended drug treatment with possible side effects.
“If you have hepatitis C, you can’t touch alcohol,” he added. “I thought, this is not good. Twenty years of Penn State home games, tailgating, and now you tell me.”
“I thought, man, if I don’t do anything I have to be very careful the rest of my life,” Hook recalled. “With all the cardiac stuff I’ve been through, I thought, I’ll do the treatment. Maybe I’ll get lucky.”
Depending on the genotype of the virus, treatment consists of weekly pegylated interferon injections and ribavirin, a daily oral medication, for 24 or 48 weeks. Patients who don’t respond can try injections of Infergen, a different type of interferon, and ribavirin. The first treatment carries a 60 percent success rate for individuals with genotype 1 and an 85 percent success rate for genotypes 2 or 3; the rate drops to 33 percent for the second option, Navitsky said.
Side effects can include fatigue, skin rashes, depression, loss of appetite and weight, and insomnia.
Initially, Hook was just tired, but a month into treatment, the drugs walloped him while he was Christmas shopping.
“I stood in Penney’s thinking, ‘I don’t know why I’m here. I don’t want to be standing up.’ I didn’t want to be alive,” he recalled. “You just felt like the most severe case of flu a human being can have and still be alive.”
Hives and incessant itching, slight hair loss, lack of appetite and a metallic taste to food and drink accompanied the overwhelming fatigue and depression.
“I had a lack of interest in anything and everything,” he said. “Every three to four days I prayed I would die and wouldn’t have to deal with it any more. I would not wish this on my worst enemy.”
Navitsky, a breast cancer survivor, said the side effects often make people want to quit treatment. While the young and otherwise healthy often tolerate treatments better, maintaining a good diet, positive outlook and normal life will help.
“I went through chemotherapy. I can appreciate the side effects. I lived them,” Navitsky said. “I’m their cheerleader. I keep them going. I’m a big promoter of staying active. You need a positive attitude.”
Hook said he thinks younger patients would “breeze through” the treatment, but older patients with other health problems should “find an attitude and screw it onto your head good. You’re going to need it.”
Hook’s treatment ended six months early on Dec. 20, 2007, when blood tests showed the virus was undetectable. It has remained so. But, Hook said, the disease did claim a victim: his career.
Hook’s employer and co-workers were aware of his illness, and he missed no more than two weeks of work, he said. Despite the acceptance, Hook said a remark he made to a co-worker about side effects, suicide and death was misconstrued, and he was let go after more than 10 years on the job. He’s collecting unemployment and attending school for a new career.
“I should have been on short-term disability; I was that sick. I was that loyal and dedicated and, in the end, look what it got me,” he said. “To say I’m bitter would be a gross understatement.”
Navitsky encourages patients to tell their families about their infection, but it’s up to them what they reveal to others. “You don’t have to report it to [the state]. You don’t need to tell anyone else,” she said. “As long as you are aware you can transmit it through blood, watch the blood, and don’t expose others.”
When treatment doesn’t work
Rick, a retired electrician in central Pennsylvania, doesn’t know how he contracted hepatitis C.
Thirty years ago, preparing for a regular blood donation, a test showed Rick’s liver enzymes were high. Subsequent tests showed what was then called non-A, non-B hepatitis; he was told it might never cause problems. Ten years later, improved medical knowledge classified it hepatitis C, and he was told that it could be 20 years before he experienced problems.
In almost exactly 20 years, tests revealed high liver enzymes, and a biopsy showed the beginning of cirrhosis. Rick had initial success with the same drug regimen Hook used, but his viral load began to climb. He was unresponsive to the second treatment option. Five years ago, he hit stage 4 cirrhosis.
“That’s it. There’s no stage 5,” said Rick, 56. “My condition is getting to the point where I have to think down the road now to a possible transplant.”
Aside from fatigue, Rick’s worst symptom is itching. “This makes you itch to death. It’s unbelievable,” he said.
He also gets intermittent stabbing pains where his liver is located. “I knew something was going on when that started happening,” he said. “I’ve had itching for two years and pain for one. That’s how I knew everything was going south.”
Lifestyle changes came swiftly after the cirrhosis.
“I love beer. I’ve always had a beer or two with dinner. I’m not the type to drink 25 beers. But people like me enjoy the taste,” he added. Drinking — even a non-alcoholic beer — is off limits.
“This country is so set in alcohol. It’s a part of our culture. It may be easy for you to say don’t have a drink, but go to a Christmas party and for everybody that’s the big thing.”
Rick retired in April. He’s enjoying family time and motorcycle rides with his dog, but he doesn’t ride with his buddies as much to the VFW and won’t date.
“With all of this going on now, I wanted to be out while I had time to enjoy myself,” said the divorced father of two young adult sons. “I’m not as social as I used to be. I don’t date. I don’t want to bring anybody into what I’m looking at right now.”
Although his motto has been to “roll with whatever life gives you,” testing for a possible transplant has surprised him.
“If you get a transplant, your whole life changes. I didn’t realize it,” he said. “If you asked me 15 years ago, I would have told you, ‘No way. I’d die before I do that.’ The reality is I don’t have a choice.”
The price is staggering — nearly $500,000 for the transplant and $2,500 monthly lifetime drug bills — and he lamented other post-transplant changes such as being required to wear long sleeves and gloves in the sun.
“Can’t go out in the summer. That’s the last thing I have going for me,” he said. “People don’t understand.”
Rick’s former workplace was extremely supportive, giving him ample time off when necessary and treating him no differently.
“I told people I worked with, and they’re just not the type to worry,” he said. He noted, however, that most people don’t know anything about the virus, and that’s what usually causes problems for those infected.
“It only takes one nitwit to ruin everything,” he said.
The ABCs of hepatitis
Hepatitis means inflammation of the liver. Toxins, certain drugs, some diseases, heavy alcohol use, and bacterial and viral infections can all cause hepatitis. Hepatitis is also the name of a family of viral infections that affect the liver; the most common in the U.S. are hepatitis A, B and C.
All three viruses can be detected by a blood test. Vaccinations are available for hepatitis A and B but not C.
Hepatitis A — Spread through fecal-oral contamination. This can happen if you don’t wash your hands well after using the bathroom or changing a diaper or if you eat uncooked food prepared by an infected person. Symptoms can last less than two months to six months.
Hepatitis B — Spread through blood and other body fluids. Having unprotected sex with an infected person, using illegal injection drugs, or using the razor or toothbrush of an infected person can put you at risk. Infected mothers can pass it to their babies at birth. Acute cases can become chronic.
Hepatitis C — Spread primarily through direct contact with infected blood. It can be transmitted through contaminated needles with IV drug use as well as tattooing or body piercing with contaminated needles or ink. The first stage of the disease is called acute hepatitis C. Some people fight off the virus, but most cases evolve into chronic hepatitis C.
Source: Centers for Disease Control, American Liver Foundation.
Hepatitis C risk factors
- IV drug users who share needles
- High-risk sexual behavior
- Infants born to infected mothers
- Recipients of blood and/or organ transplants before 1992
- Hemodialysis patients
- Getting a body piercing or tattoo with contaminated needles or ink
- Health care or public safety workers
- Unsafe therapeutic injections
Hepatitis C support group
- WHEN: The second Tuesday of every other month. The next meeting is from 6-7:30 p.m. Jan. 12.
- WHERE: In the waiting room of Jackson Siegelbaum Gastroenterology, 423 N. 21st St., Camp Hill, Suite 100.
- WHO: Anyone with hepatitis C. Attendees do not have to be patients of the practice to participate.
- INFORMATION: Call 525-6445 for more information.
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Police Accused Of Spying on Addicts at Needle Centre
http://www.pressandjournal.co.uk
By Iain Ramage
Health workers fear service being shunned in case of surveillance
Police have been accused of spying on drug addicts when they try to use a needle exchange centre set up to stop the spread of hepatitis C and HIV.
Health workers fear people are shunning the centre in Inverness because they are worried about officers keeping them under surveillance.
And there are concerns that addicts will simply drop dirty needles in public places – rather then have them disposed of safely.
According to a city councillor and former police officer, some drug injectors are staying away from the Waterloo Place centre because of the police presence.
Northern Constabulary has dismissed the claim, but NHS Highland said yesterday the issue was of regular concern.
SNP councillor John Finnie praised the efforts of the police and health agencies to tackle intravenous drug use, but urged officers not to deter addicts from seeking help at the needle exchange service.
He said: “While no one is suggesting ‘no go' areas for the police, it is vitally important the police do nothing which might restrict access to this vital service.
“Clear guidelines exist regarding surveillance operations and they include the need to consider wider community risks.”
NHS Highland substance misuse co-ordinator Dougie Montgomery said there had been “regular concerns regarding the police presence in Waterloo Place” and that the matter was “being discussed with senior officers”.
Northern Constabulary’s Inverness area commander Chief Inspector Andrew MacLean denied that there had ever been surveillance of the premises.
He said: “We monitor the stop and search of individuals suspected to be in possession of illegal drugs and there is no evidence to suggest these searches have been carried out on people going to and from the exchange programme.
“If an officer has reason to suspect any individual is in possession of illegal drugs, he or she is fully entitled to search them under the terms of the Misuse of Drugs Act.”
Inverness Crime Prevention Panel chairman Jim Ferguson said police had a duty to operate “in every area that they see fit when it comes to dealing with criminal activity”.
Suzy Calder, chief officer of the Highland Alcohol and Drug Partnership said: “If these issues were raised then this is certainly something that would be discussed by the partnership.
“We have to appreciate the police’s position in terms of other ongoing enforcement activity that may be going on that happens to coincide around that area but the partnership wouldn’t shy away from having that discussion to establish the facts.”
The Waterloo Place centre offers a new-for-old syringe exchange, testing and immunisation for hepatitis and other blood-borne viruses, treatment of injection-induced wounds and safety advice.
There are similar facilities in Nairn and Ross-shire and pharmacies provide needle exchanges in Inverness, Nairn, Fort William, Tain, Alness, Wick, Kyle and Portree.
Read more: http://www.pressandjournal.co.uk/Article.aspx
/1510331?UserKey=#ixzz0Z2HK1oS8
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Medical Conditions Covered by Wisconsin's Proposed Jacki Rickert Medical Marijuana Act
http://www.examiner.com
Madison NORML Examiner
Gary Storck
MADISON: AB554/SB368, The Jacki Rickert Medical Marijuana Act (JRMMA), sponsored by Rep. Mark Pocan (D-Madison) and Sen. Jon Erpenbach (D-Waunakee), would allow patients undergoing a "debilitating medical condition or treatment" to possess and use a small amount of medical cannabis.
As the JRMMA is based on the law Michigan voters passed in Nov. 2008, with a majority in every county, it lists debilitating conditions included in Michigan's law.
However, the JRMMA also contains two qualifying conditions not included in Michigan law. The first is post traumatic stress disorder (PTSD), which is included in California's law by virtue of the clause: "or any other illness for which marijuana provides relief". PTSD was also added to New Mexico's list of qualifying conditions after patients petitioned the state medical cannabis program and they concurred.
The other condition is Ehlers-Damlos Syndrome (EDS), and it has never before been specifically included in any state medical cannabis bill language. EDS is a group of inherited disorders marked by extremely loose joints, hyperelastic skin that bruises easily, and easily damaged blood vessels. EDS is included as it is also one of the medical conditions that the bill's namesake, Jacki Rickert is afflicted with, and she was approved for, but never supplied with, federal medical marijuana supplies to treat it.
Here is the JRMMA text listing debilitating conditions and treatments:
- 961.01 (5m) "Debilitating medical condition or treatment" means any of the following: (a) Cancer, glaucoma, acquired immunodeficiency syndrome, a positive test for the presence of HIV, antigen or nonantigenic products of HIV, or an antibody to HIV, Crohn's disease, a Hepatitis C virus infection, Alzheimer's disease, Amytrophic Lateral Sclerosis, nail patella syndrome, Ehlers-Danlos Syndrome, post-traumatic stress disorder, or the treatment of these conditions. (b) A chronic or debilitating disease or medical condition or the treatment of such a disease or condition that causes cachexia, severe pain, severe nausea, seizures, including those characteristic of epilepsy, or severe and persistent muscle spasms, including those characteristic of multiple sclerosis. (c) Any other medical condition or any other treatment for a medical condition designated as a debilitating medical condition or treatment in rules promulgated by the department of health services under s. 961.436 (5). -- Text of JRMMA.
PTSD is not just something many Iraqi and Afghani war vets are returning home with, but also something all too common in the general public in those who have endured traumatic situations. Cannabis is uniquely able to help those with PTSD put bad memories behind them.
Dr. Tod Mikuriya wrote about PTSD including how returning Vietnam vets utilized cannabis.
- approximately eight percent of the >9,000 Californians whose cannabis use I have monitored presented with PTSD (309.81) as a primary diagnosis. Many of them are Vietnam veterans whose chronic depression, insomnia, and accompanying irritability cannot be relieved by conventional psychotherapeutics and is worsened by alcohol. For many of these veterans, chronic pain from old physical injury compounds problems with narcotic dependence and side effects of opioids.
- Survivors of childhood abuse and other traumatic experiences form a second group manifesting the same symptoms —loss of control and recurrent episodes of anxiety, depression, panic attacks and mood swings, chronic sleep deficit and nightmares.
Today's vets are finding it a potent remedy too.
While Wisconsin's JRMMA is on the cutting edge of state medical cannabis bills, additional medical uses are being explored in states like California, where the wide focus of their law has allowed its use by children with autism, as well as patients suffering from social anxiety and attention deficit disorder. Substituting medical cannabis for toxic, often addictive and/or organ-damaging heavy pharmaceuticals has shown great promise. Medical cannabis patients can titrate doses to suit their needs, rather than being chained to a daily prescription they must take the rest of their life, side effects and all.
On Tuesday, Dec. 15, 2009 at 10am in Room 412 East of the State Capitol, two Wisconsin State Legislature Health committees are scheduled to hold a combined hearing on the JRMMA, Those attending can expect to hear from a diverse array of patients reporting how cannabis treats a wide range of medical conditions, both those included in the JRMMA and some that are not, but perhaps should be.
For more information on the Jacki Rickert Medical Marijuana Act, the Dec. 15 combined Health committee hearing and how to submit testimony, bill text and status, all the latest news and how you can help, visit JRMMA.org, IMMLY.org or MadisonNORML.org. Visit my Madison NORML Examiner articles archive.
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December 7, 2009
Lentivirus-Based RNAi Can Be Used to Suppress HBV Replication
www.newsrx.com
Researchers from Nanjing Medical University provide details of new studies and findings in the area of hepatitis B virus
"Chronic hepatitis B virus (HBV) infection is an important cause of cirrhosis and hepatocellular carcinoma. The major challenges for current therapies are the low efficacy of current drugs and the occurrence of drug resistant HBV mutations," researchers in Nanjing, People's Republic of China report.
"RNA interference (RNAi) of virus-specific genes offers the possibility of developing a new anti-HBV therapy. Recent reports have shown that lentiviral vectors based on HIV-1 are promising gene delivery vehicles due to their ability to integrate transgenes into non-dividing cells. Herein, a lentivirus-based RNAi system was developed to drive expression and delivery of HBV-specific short hairpin RNA (shRNA) in a mouse model for HBV replication. Hepatitis B surface antigen ( HBsAg) and hepatitis B e antigen ( HBeAg) in the sera of the mice were analyzed by quantitative sandwich enzyme linked immunosorbent assay ( ELISA) technique, hepatitis B core antigen ( HBcAg) and HBsAg in the livers of the mice were detected by immunohistochemical assay, HBV DNA and HBV mRNA were measured by fluorogenic quantitative polymerase chain reaction (FQ-PCR) and quantitative real-time PCR respectively. Co-injection of HBV plasmids together with the lentivirus targeting HBV shRNA induced an RNAi response. Secreted HBsAg was reduced by 89% in mouse serum, and HBeAg was also significantly inhibited, immunohistochemical detection of HBcAg or HBsAg in the liver tissues also revealed substantial reduction. Lentiviral mediated shRNA caused a significant suppression in the levels of viral mRNA and DNA synthesis compared to the control group," wrote L. Deng and colleagues, Nanjing Medical University.
The researchers concluded: "Lentivirus-based RNAi can be used to suppress HBV replication in vivo, it might become a potential therapeutic strategy for treating HBV and other viral infections."
Deng and colleagues published their study in BMC Gastroenterology (Hepatitis B virus inhibition in mice by lentiviral vector mediated short hairpin RNA. BMC Gastroenterology, 2009;9():73).
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Rep. Johnson Reveals He Has Hepatitis C
http://www.foxnews.com
AP
Rep. Hank Johnson, D-Ga., has revealed that he has hepatitis C, a serious liver disease that can lead to fatal complications such as cancer or liver failure.
WASHINGTON -- Rep. Hank Johnson, D-Ga., has revealed that he has hepatitis C, a serious liver disease that can lead to fatal complications such as cancer or liver failure.
In recent months, the 55-year-old Johnson has appeared thin and frail. The two-term Atlanta-area congressman said in a statement that he has been undergoing rigorous treatment to eradicate the disease, which was first diagnosed in 1998. He said the treatment is going well and that he has been free of the hepatitis C virus for almost a year.
Johnson said he doesn't know how he contracted the virus, which is spread through contact with infected blood. He said he plans to use his public profile to raise awareness of the disease, which infects some 4 million Americans.
Rep. Johnson’s statement on hepatitis C
LITHONIA, GA – “Over the past year, I have been on a robust course of treatment for hepatitis C (HCV), a virus that affects more than four million Americans. I am pleased to announce that my therapy is progressing well. My physician is encouraged by my response to treatment and expects complete success eradicating the virus.
I hope that my disclosure will provide others suffering from HCV with confidence to speak out and educate the community about this illness. Through clinical trials and medical research, we must always seek new, more effective treatments.
I plan to use my position as a public figure to raise awareness of the consequences of this infection and let others fighting hepatitis know that it is possible to succeed and excel while battling this disease.
The causes of this disease are many, but in the end it does not matter how someone contracted the virus. Like so many millions of others, I was infected many years without ever knowing how I contracted it.
In fact, more than half the people who have hepatitis C don’t know how or when they contracted it. And many are fearful of the treatment regimen that impacts your life in unusual ways. Having come through a long course of treatment, I want to send a strong message that a cure is possible but you must be tested and treated.
I will be working with the National Viral Hepatitis Roundtable (NVHR) to help educate my colleagues and the public to learn more about this largely misunderstood disease. It is treatable, but we must devote the will and resources it deserves in light of the urgent need.
Though this infection has caused me some discomfort and frustration, it has in no way affected my ability to legislate and serve my constituents. My record of attendance at votes and in committee meetings is outstanding. I have passed three major bills in this year alone. As Chairman of the Judiciary Subcommittee on Courts and Competition Policy, I have led an active and effective committee. And as Southeast Regional Whip in the House leadership I played a significant role in rallying my colleagues’ support for historic health reform.
Today, I also announce that I will co-sponsor legislation offered by several of my colleagues in October, 2009 – H.R. 3974 – which would establish, promote, and support a comprehensive prevention, education, research and medical referral program for viral hepatitis infection.
It is a testament to the 111th Congress that we have men and women willing to stand up for average Americans and their families who have been impacted by hepatitis C and related illnesses. It is also gratifying that this is a bi-partisan bill because disease respects no socio-economic status, party or political philosophy.”
Rep. Johnson’s physician, Dr. Maria Sjogren of Walter Reed Army Medical Center:
“Congressman Johnson can be an inspiration to thousands of people who suffer from this illness. He has been a model patient, sticking with his course of treatment even when it was most difficult. His determination shows that people suffering from hepatitis can live normal lives and continue to be productive citizens.”
Martha Saly, Director of the National Viral Hepatitis Roundtable (NVHR):
“On behalf of the entire chronic viral hepatitis community, we offer Congressman Johnson our support, prayers, and encouragement,” said Saly, who was treated for hepatitis C in 1999 and cleared the virus. “Congressman Johnson’s announcement shines a much-needed spotlight on a public-health issue that has historically resided in the shadows. We are hopeful that Congressman Johnson’s announcement will help spur greater awareness about the need for increased prevention, detection, and treatment of chronic viral hepatitis B and C.”
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December 8, 2009
Initiation of CYT107 Study in HBV Expands Company's Hepatitis Investigations, which Include Three Ongoing Studies in Hepatitis C (HCV)
www.medicalnewstoday.com
Cytheris SA, a clinical stage biopharmaceutical company focused on research and development of new therapies for immune modulation, today announced that it has begun enrolling patients in its Phase I/IIa clinical program evaluating the company's investigative immune-modulator, recombinant human Interleukin-7 (CYT107), in combination with standard antiviral treatment and vaccination in HBeAg-negative chronic hepatitis B-infected (HBV) patients.
"Cytheris is currently conducting three clinical trials of CYT107 in chronic hepatitis C-infected patients in Europe and Asia," said Michel Morre, DVM, President and CEO of Cytheris, "and we are now pleased to initiate CONVERT in chronic hepatitis B infection here in Europe, underscoring our dedication to exploring new treatment options for the millions of patients throughout the world afflicted with these devastating viral infections."
"Though the most effective HBV antiviral drugs have shown a remarkable ability to rapidly drop HBV viral load, even with these powerful drugs the percentage of patients reaching HBsAg seroconversion - the ultimate goal of therapy - remains low," said Christophe Hézode, MD, of the Department of Hepatology-Gastroenterology at Hospital Henri Mondor, Creteil, France, Principal Investigator and International Study Chairman for the trial. "This failure to cure the disease explains why investigators have tried to boost long-term immunological response through patient vaccination or immunomodulation, though these attempts have so far been insufficient to fully control the disease. It is our hope that combining IL-7 with an antiviral and a vaccine will ultimately result in the production of a protective and long lasting immune response against the HBV virus in a significant proportion of treated patients."
About the Study (CLI-107-10)
CONVERT is a randomized open label, controlled multicentre Phase I inter-patient dose escalation study, followed by a Phase IIa extension of 1 or 2 dose levels of CYT107 which have demonstrated safety and sufficient immunological or antiviral activity. The primary objective of the study is to determine the short and long-term safety and biological activity of CYT107 in patients with a HBeAg-negative chronic hepatitis B virus who have, at screening, undetectable HBV DNA and who have been stable for at least 3 months with antiviral treatment.
The trial will initiate at 7 study centers in France and 3 sites in Italy.
At each dose level, two cohorts of 4 patients, 3 treated with CYT107 and 1 control patient, will be run in parallel. The treatment of the two cohorts is characterized by the following:
- Tri-therapy group: patients will receive CYT107 + HBV vaccine (GenHevac B Pasteur(R)) + antiviral treatment [BARACLUDE(R) (entecavir) or VIREAD(R) (tenofovir)] and one control patient will receive only antiviral treatment.
- Bi-therapy group: patients will receive CYT107 + antiviral treatment (entecavir or tenofovir) and one control patient will receive antiviral treatment only.
Patients with chronic HBeAg-negative hepatitis will be assessed for study participation if they have undetectable HBV DNA for at least 3 months when treated with entecavir or tenofovir. For all included patients the antiviral therapy will be continued during the full duration of the study. Patients will be followed up to Week 48, with a mid-term evaluation of the biological activity at Week 16.
According to Thérèse Croughs, MD, Chief Medical Officer of Cytheris, "The combination of three factors is expected to result in producing a protective immune response against the HBV virus in a significant proportion of patients:
- The severe drop in viral load produced by HBV antivirals such as entecavir or tenofovir will decrease the frequency of PD-1 expressing T cells and rescue them from exhaustion, leaving room for protective T cells expressing the IL-7 receptor (CD127+),
- The repeated administration of GenHevac B Pasteur(R) vaccine should support the production of anti-HBV specific T cells, including central memory T cells, and it is these cells that will be further augmented and supported by CYT107 treatment and,
- The cycle of CYT107 treatment will both facilitate the production of naïve CD4 and CD8 T cells available for specific antigen response and support the production of long lived central memory specific T cells."
The restoration of a specific immune response should translate into HBsAg seroconversion together with direct elimination of residual viral DNA. Moreover, the anti-fibrotic effects CYT107 may prevent or slow the evolution to cirrhosis. In this early clinical study, the aim will be to better understand how to optimize this combined therapeutic approach to favor a shortened treatment regimen through induction of a protective and long lasting immune response.
About Hepatitis B
Hepatitis B virus (HBV) is a hepatotropic non-cytopathic DNA virus, which is transmitted percutaneously, sexually and perinatally. Two billion people in the world are estimated to be infected with the hepatitis B virus. Chronic infection with HBV is a major cause of liver disease, ranking as a substantial cause of cirrhosis and hepatocellular carcinoma (HCC). An estimated 350 to 400 million people are living with chronic HBV infection which annually accounts for 1 million deaths from cirrhosis, liver failure, and hepatocellular carcinoma, representing 30 percent of all cirrhosis cases and approximately 50 percent of all HCC cases worldwide.
The incidence of acute HBV infection has decreased dramatically in Western countries since the mid-1980s following the introduction of an effective vaccine: in the U.S., the incidence in the general population decreased by 75 percent between 1990 and 2004, a reduction which can be attributed to the availability of an effective vaccine and widespread immunization of infants and high-risk populations.
The same is true for Europe, where in Germany the incidence of reported acute HBV cases dropped from 7.5 cases/100,000 inhabitants in 1995 to 1.4 in 2005, and in Italy, where a similar trend was observed following introduction of the anti-HBV vaccination for newborns and young children in 1991.
In low endemic countries HBV is usually acquired via injection drug use, sexual contacts, or body piercing activities, while in endemic regions (seroprevalence–8percent), such as Asia, most infections are acquired perinatally.
Currently available options for the treatment of chronic HBV infection include standard and pegylated interferon alpha and five oral antiviral agents (lamivudine, adefovir, entecavir, tenofovir and telbivudine). According to a recent comprehensive literature search, entecavir efficacy is superior to that of lamivudine, which in turn would be superior to that of adefovir in nucleoside-naïve patients with chronic HBV infection. Low doses of tenofovir are also more potent than adefovir in chronic HBeAg negative hepatitis B.
Available antiviral treatments, especially entecavir and tenofovir, have been shown to induce a remarkable and rapid drop of HBV viral load as measured by viral DNA. However, even with these powerful drugs the percentage of patients reaching HBsAg seroconversion remains extremely low and the viral load increases at the end of treatment.
About Interleukin-7 (CYT107)
Recombinant human interleukin-7 (CYT107) is a critical immune-modulator for immune T-cell recovery and enhancement. As a growth factor and cytokine physiologically produced by marrow or thymic stromal cells and other epithelia, IL-7 has a critical and, at some steps, a non-redundant stimulating effect on T lymphocyte development, notably on thymopoiesis and, downstream from the thymus, on homeostatic expansion of peripheral T-cells.
A first-generation form of rhIL-7 was shown in pre-clinical and Phase I studies in oncology and HIV-infected patients to be well tolerated in repeated dose trials, with long-lasting increases in both CD4 and CD8 T cells. CYT107 is a second-generation rhIL-7 product made by Cytheris via a recombinant mammalian cell culture system.
Clinical trials conducted on more than 120 patients in Europe, North America and Taiwan have demonstrated the potential of IL-7 to expand and protect CD4+ and CD8+ T-cells.
Currently, Cytheris is conducting multiple international investigations of IL-7 in HIV, HCV, idiopathic CD4 lymphocytopenia (sponsored by NIAID/NIH) and cancer, the latter including an NCI/NIH-sponsored study of IL-7 in combination with dendritic cell vaccines in a pilot study of tumor vaccination in children and a study designed to restore CD4+ and CD8+ counts following T-cell depletion due to bone marrow or peripheral blood stem cell transplant (being conducted at the Memorial Sloan-Kettering Cancer Center in New York City).
Source: Cytheris
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Life after Transplantation
http://www.thebostonchannel.com
By Rhonda Mann
Beth Israel Deaconess Medical Center Staff
“It's an experience I could have lived without,” jokes Darcy Deer about his liver transplant in 2001. Then, he pauses. “Actually, it's an experience I couldn't have lived without.”
Hepatitis C had destroyed Darcy's liver and with the waiting list for a liver so long, he believes he would have never survived to receive a cadaver organ. His cousin became his rescuer, offering a portion of his own liver. While Darcy was eternally grateful, he had given little thought to what lay ahead.
“There is plenty of information on what to expect beforehand and when you're in this position of needing a transplant, you don't care about what happens afterward,” he recalls. “The transplant was the easiest part. Surviving the post-transplant treatment is the hard part.”
This is a common scenario, according to Dr. Michael Curry, Director of Liver Transplantation at Beth Israel Deaconess Medical Center.
“Liver transplantation is one of the biggest surgeries a patient can face and the transplant itself is only a small part of the process,” Dr. Curry says. “Some feel they will be back to perfectly normal living afterwards and they don't realize there is a need for follow-up medical care.”
Dr. Curry says it's critical for patients to have a strong support network of family and/or friends in place so after the transplant, they are cared for and have access to their health providers as needed.
“When you call a patient and tell them their blood test has come back abnormal and they must come back to the hospital, the last thing you want to hear is, ‘sorry, I can't get a ride,’”explains Dr. Curry.
“You don't just go to the hospital for 3 weeks and go home,” explains Darcy. “I was admitted a dozen times between my transplant in June and the end of the year. You need to be ready for that.”
Transplanted patients also must take medications to prevent the organ from being rejected. Because these drugs weaken the immune system, they can also open the door to infection. Patients should wear sunscreen at all times, as the drugs may heighten the risk of skin cancer. Some of these medications also increase blood sugars which can lead to diabetes, or blood vessel changes that can cause high blood pressure and high cholesterol which could lead to more medical visits. One of the greatest challenges, though, is simply getting patients to understand the importance of taking the medication properly.
“There is a heavy patient responsibility,” says Dr. Martha Pavlakis, Director of Kidney and Pancreas Transplantation at Beth Israel Deaconess. “If a patient skips their immunosuppression medications, even just every week or so, the kidney will last only two years instead of a possible 15 years.”
There can also be emotional issues post-transplant. Patients and their families can feel nervous, stressed or depressed with a long recovery process. It may take longer to get back to driving, working – even sexual relations than expected. There may also be financial stress.
Dr. Jim Rodrigue, Transplant Psychologist at BIDMC, says just like running a marathon, patients need to train for both the physical and mental aspects of the race. Even more important, patients should not view the transplant itself as the finish line.
“We often see an increase in depression during the first three to six months post-transplant,” explains Rodrigue. “Just like a long marathon, you need to have people who support you, cheer you on during the difficult times, and you need to find a good pace to heal and to live.” v
Darcy says, the recovery was longer and slower than he expected.
"You can't focus on tomorrow. Think about what you're going to be doing in a year. The long-term goals are what makes it work," he advises.
For Darcy, that long-term goal was sharing basic day-to-day life with his three children--soccer games and school plays he thought he wouldn't be around to see.
"Today I sat on the dock and watched them do water sports," he said. "They're having a ball…and so am I."
To contact the Transplant Center at Beth Israel Deaconess Medical Center, call 617-632-9700 or visit www.bidmc.org/transplant.
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Walgreens to Help Promote Hep B Awareness Citywide
http://www.asianweek.com
Angela Pang
SAN FRANCISCO, CA - San Francisco Hep B Free is partnering with Walgreens to encourage all clinicians citywide to routinely screen their patients for hepatitis B. Beginning Dec. 7, Walgreens will distribute 100,000 informational hepatitis B fliers at more than 60 pharmacy locations throughout the city.
When patients pick up their orders, pharmacists will include the two-sided flyer with their prescription. One side of the flyer contains facts about the disease, while the other side lists several public testing sites and Walgreens locations that provide vaccinations. Those Walgreens locations include 745 Clement St., 1580 Valencia St., Suite 101, 2690 Mission St., and 5260 Diamond Heights.
“As we enter the next phase of the San Francisco Hep B Free Campaign - to influence clinician behavior to screen and test all Asian and Pacific Islanders for hepatitis B - we want to encourage the public to be involved by asking their clinicians about this disease. Having informational flyers about Hep B in Walgreens pharmacy bags will help do so,” said Mitch Katz, MD, Director of the SF Department of Public Health. “We applaud Walgreens for their support of the campaign and hope that we can one day eradicate this disease.”
“Hepatitis is a very serious disease that many people aren’t even aware of,” said Jeff Wong, Walgreens Pharmacy Manager. “In a city where more than one third of its residents are Asian, Walgreens is proud to be supporting a campaign that aims to raise awareness about this vaccine preventable disease.”
Hepatitis B causes up to 80 percent of all liver cancers and disproportionately affects 1 in 10 Asian and Pacific Islanders. A safe and effective vaccine prevents infection and liver cancer caused by hepatitis B.
“With the cold and flu season underway, more patients will head to the pharmacy and will receive the hepatitis B flyers in their bags,” said Dr. Lisa Tang of Kaiser Permanente who chairs the SF Hep B Free Clinicians Outreach Committee. “Our hope is that people will read the flyer - ‘Be a hero. See a doctor who tests for hepatitis B’ and ask their clinician for more information. As more and more patients discuss this with their clinicians, they will hopefully be motivated to learn more about the disease.”
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Lilburn Man Battles Hepatitis C
http://www.myfoxatlanta.com
Reported By: Beth Galvin | Edited By: Leigha Baugham
LILBURN, Ga. (MyFOX ATLANTA) - It's been 35 years since Lu and David Rosenthal said their wedding vows. For more than half their marriage David Rosenthal, a Lilburn mass transit engineer has lived with hepatitis C, a virus that is slowly destroying his liver. Rosenthal contracted the disease from a blood transfusion in 1989.
This week Georgia Congressman Hank Johnson went public with his own battle with hepatitis C. Johnson said he didn't know how he contracted the virus and is undergoing experimental treatment.
Dr. Mark Johnson, a surgeon and director of transplant services for Piedmont Hospital, said the virus is the most common cause of liver transplants in the United States.
"It's so low-grade and smoldering that it can go on for years, decades with no clinical or blood testing evidence that it's attacking and killing liver cells," said Dr. Johnson.
David Rosenthal, who is the father of FOX 5 photojournalist Chris Rosenthal, said he tried standard therapy twice but it didn't work.
In February, David Rosenthal ended up in the emergency room with swelling in his legs. Doctors said the only option for Rosenthal was a liver transplant.
Dr. Johnson took out Rosenthal's liver and replaced it with a healthy donor liver.
"[A] very common complaint from liver patients is they feel cold all the time and within a couple of days of a liver transplant, they feel warm all over again. It's like this whole new life flowing through them," said Dr. Johnson.
Rosenthal still has the hepatitis C virus in his blood, but he says he feels 10, even 20 years younger.
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Jury Selection Underway for Morris Officer Claiming He Was Forced to Quit
http://www.dailyrecord.com
By Peggy Wright • Staff Writer
Jury selection got under way in Newton today for a civil trial on claims by a former Morris County Sheriff's officer that he was forced to quit his job because of taunting and nasty treatment he received from fellow officers who knew he was diagnosed with Hepatitis C.
John Cicchetti's lawsuit against Morris County was transferred for trial in Sussex County, and Superior Court Judge David Rand started jury selection Tuesday.
Cicchetti contends that office superiors failed to stop fellow officers -- two in particular -- from calling him names such as ''hepatitis boy,'' making exaggerated motions of cleaning up around him, wearing latex gloves and refusing to sit near him.
Hepatitis C is a liver disease that can be contracted through a blood transfusion, organ transplant, injection of illegal drugs or intimate contact with a person who has the disease.
Cicchetti has said in his lawsuit that after a bad day of being shunned at work on Nov. 14, 2000, he signed out early and never returned to work. He submitted a formal resignation letter on Feb. 25, 2002, and sued a few months later.
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December 9, 2009
Lentigen Awarded Phase I SBIR Grant for Hepatitis C Vaccine
http://www.prnewswire.com
GAITHERSBURG, Md,, Dec. 9 /PRNewswire/ -- Lentigen Corporation, a biotechnology company specializing in the development and manufacture of lentiviral gene delivery technologies, announced today that it has received a National Institutes of Health (NIH) small business innovation research (SBIR) grant for a program on "A Novel Method of Generating Hepatitis C Virus-Like Particles using Lentivirus". In this program, Lentigen will collaborate with Epixis SA (Paris, France).
The Hepatitis C virus is the most common blood-borne virus and HCV infection represents a major public health concern; approximately 3% of the world's population (200 million people) is chronically infected. Causing fibrosis and cirrhosis of the liver and eventually hepatocellular carcinoma, it is the leading cause of liver transplantation in the U.S. No vaccine is currently available.
Epixis SA has previously designed rVLPs pseudotyped with one or both of the HCV envelope proteins E1 and E2. Mice primed with a recombinant viral vector expressing E1 and E2 can mount unprecedented neutralizing humoral immune responses upon boosting with such pseudotyped rVLPs. Before reaching the clinic, their large scale production calls for a new efficient and safe system.
Therefore, the aim of this grant is the construction of a lentiviral vector expressing HCV rVLPs, and validation of its use for high titer production of HCV-rVLPs from human cells. This uses a similar approach to that being used in the development of a pandemic influenza VLP vaccine at Lentigen, supported by PATH.
Boro Dropulic, Lentigen's President and Chief Scientific Officer, commented, "The collaboration represents the integration of two important technologies to generate highly immunogenic HepC VLPs. The project is consistent with our strategy of applying Lentigen's technology in diseases of high unmet therapeutic need."
About Lentigen Corporation
Lentigen Corporation is a privately owned biotechnology company focused on the development of lentiviral vector technology for a wide range of therapeutic, vaccine, and bioproduction applications. Lentiviral vectors are the most efficient vehicles for the delivery of genes or gene silencing sequences stably into cells. Lentigen is a highly collaborative company, co-developing Lentiviral vector-based products across a broad spectrum of bench to clinical applications. Collaborations include The National Institutes of Health, PATH, The University of Pennsylvania, The University of Pittsburgh and The U.S. Army. For further information, visit www.lentigen.com.
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Inmate Loses Claim over Allegedly Tainted Razor
http://www.courthousenews.com
By Jeff Gorman
(CN) - An inmate who says he contracted herpes and hepatitis C by a contaminated razor does not have an actionable claim, a Texas appeals court ruled.
Arturo Solis sued the Texas Department of Criminal Justice, claiming that he was forced to shave with a contaminated razor and contracted herpes and hepatitis C.
The trial court dismissed the case because Solis failed to establish a waiver of sovereign immunity.
On appeal, Chief Justice Tom Gray of the Waco-based 10th Texas Court of Appeal noted that this immunity can be waived under the Texas Tort Claims Act, when a governmental unit provides equipment that lacks a safety component.
But "Solis makes no contention in his pleadings that there was an integral safety component missing from the contaminated razor," Gray concluded.
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Patients Contract Hep C in Dialysis at Hospital
http://www.chinadaily.com.cn/
By Wang Zhuoqiong (China Daily)
Fifteen people were infected with the Hepatitis C virus (HCV) during hemodialysis treatments at a hospital in Anhui province since November.
Zhu Yunwu, deputy director of the hospital, said 15 of the 70 people contracted the virus during the treatments. Some 24 of the 70 tested positive for Hepatitis C, but nine of the 70 were not infected during the treatment, and must have contracted it elsewhere, Zhu said.
An uraemia patient Chu Chenqiang discovered that he was infected with Hepatitis C after he had more than 100 hemodialysis treatments in Huoshan County Hospital.
Zhu told the Beijing Times yesterday that the longer the patient was taking hemodialysis treatment, the more the risk of getting the virus. The infection rate is about 30 percent in China.
About 70 percent of the patients with the HVC can effectively rid their body of the virus after medical treatment, Zhu said.
With eight hemodialysis machines, the hospital has treated 201 patients with uraemia. The causes of the infection of HCV are still under investigation.
Wang Fangyun, director of the hospital quality management department, told the Beijing Times that the hemodialysis office has been reconfigured, separating patients with HCV from those without. The new hemodialysis treatment office, with four new machines, is in place to eliminate the infection rate. The incident is not an isolated case in hospitals across the country. In March, 20 patients were infected with Hepatitis C during hemodialysis treatments at two hospitals in Shanxi province.
The infected patients are among 47 people who received hemodialysis at the Taiyuan Public Transportation Company's hospital and the Shanxi Coalmine Central Hospital between December and January. The hospital leaders were sacked after the incident was exposed.
The same month, at least 64 people were infected with HCV after receiving blood transfusions in a county hospital in Guizhou province.
The problem was discovered after an unnamed patient was given a blood transfusion during an operation in the People's Hospital of Pingtang County in March 2001.
Hospital staff traced the blood to donor Li Cailing, 43, a native of Jiangsu province, who had kept donating up to 20,000 ml of blood for money to the hospital from October 1998 to June 2002.
The latest Ministry of Health's circular urged medical institutions and hospitals at all levels to strengthen safety awareness and take effective measures for safety in hemodialysis.
Beijing News contributed to the story
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December 10, 2009
Doxorubicin Transdrug(R): Significant Increased Survival Rate in Patients with Advanced Hepatocellular Carcinoma Treated in a Phase II Clinical Trial
www.medicalnewstoday.com
BioAlliance Pharma SA (Paris:BIO), a company dedicated to the treatment and supportive care of cancer and AIDS patients, announces positive survival data in its phase II clinical trial with doxorubicin Transdrug® in patients with advanced hepatocellular carcinoma (primary liver cancer).
Doxorubicin Transdrug®, a treatment presented in the form of nanoparticles delivered via hepatic intra-arterial route, was granted an orphan drug status in Europe and in the United States. The product is being evaluated in patients with advanced hepatocellular carcinoma, one of the leading causes of mortality in cancer.
BioAlliance Pharma phase II results showed a 88.9% survival rate after 18 months of treatment in patients having received three intra-arterial doxorubicin Transdrug® injections, as per protocol. This increased survival rate is relevant compared to the 54.5% rate observed in patients with the current standard of care (usually transarterial chemoembolisation with a cytotoxic drug).
Based on these data, BioAlliance Pharma will design new approaches using doxorubicin Transdrug® while reducing pulmonary adverse events that led to the suspension of the trial.
"BioAlliance Pharma is capitalizing on its proprietary Transdrug® nanotechnology by developing oral drug formulations", said Dominique Costantini, President and CEO of BioAlliance Pharma. "We are applying this innovative know-how to the treatment of various cancers using oral irinotecan nanoparticles instead of intravenously administration. BioAlliance Pharma aims at improving the irinotecan's risk-benefit ratio and has recently presented positive preclinical data at several international symposia", added Dominique Costantini.
Source: BioAlliance Pharma
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Is It a Disability or Job Unhappiness???
http://nashualaw.blogspot.com
A disabled employee who is doing a poor job should anticipate getting fired if he has not told his employer he needs an accommodation for his disability. Such a firing led to the Massachusetts Federal Court lawsuit of Peter Kinch v. Quest Diagnostics, Inc. Kinch had worked for Quest for approximately 25 years before he was fired on November 2005. At that time, he worked as a Processor in Quest’s Specimen Processing Department. Kinch has had Hepatitis C since the early 1990s.
Quest began experiencing problems with Kinch in 2002 wherein he received several poor annual reviews and written and oral warnings following from 2002 through 2004 criticizing him for, among other things, failing to consistently meet production standards, taking too many breaks, demonstrating little initiative, and failing to adhere to performance standards. The deficiencies continued in 2005. On two occasions in April 2005, Kinch received verbal warnings. When he failed to show improvement, in May 2005 Quest placed him on a personal improvement plan. On June 8, 2005, Kinch received another verbal warning. Over the next several weeks, Kinch satisfied Quest’s production requirement, but, unfortunately, that did not last long and on July 15, 2005, Quest issued Kinch a final written warning due to his poor production. Kinch refused to sign the warning and told his supervisors that the medications he was taking for Hepatitis C were affecting his work. They referred him to Disability Services which granted him a leave of absence effective July 18, 2005. Kinch returned to work on October 6, 2005 and his poor production resumed. On November 9, 2005, when his supervisor spoke to him about his failure to meet production requirements, Kinch explained that he was unhappy with “what he does.” Quest thereafter terminated him and he sued stating that Quest discriminated against him because of his disability and failed to accommodate him.
Prior to Kinch’s termination on or about March 2005, he told his team leader that he was starting treatment with the drug Pegintron for his Hepatitis C and gave his team leader a booklet describing possible side affects of the medication. Kinch also told his co-workers about the treatment and possible side affects. He submitted to the Court that was enough to put Quest on notice that he needed a reasonable accommodation so that he would be able to perform the essential functions of his position. The Court disagreed. Typically, an employee must request an accommodation as an employer is not required to accommodate a need that it does not know exists, unless the need for an accommodation is obvious.
In Kinch’s situation, he only gave his supervisor a booklet describing possible side affects of the medication he planned to take. He provided no evidence to the Court that he brought to Quest’s attention that the medications were actually having a negative impact on his work after he had returned from his leave of absence. In fact, instead of Kinch stating that his medications were negatively affecting his production, he stated he was unhappy with the work he does. Given the evidence submitted to the Court, it found that Kinch did not have a right to go to a jury with his claims against Quest and summary judgment was granted in favor of Quest against Kinch’s claims.
It is possible that Kinch’s medication was causing him to be depressed and distracted from his job or otherwise causing his poor performance, yet, his employer should not have had to guess what the cause was for his poor performance. It is also possible that Kinch just did not like his job and no reasonable accommodation could change that fact.
J. Daniel Marr is a Director and Shareholder at Hamblett & Kerrigan, P.A. His legal practice includes counseling businesses and individuals on a variety of legal issues and advocating on their behalf. Attorney Marr is licensed and practices in both New Hampshire and Massachusetts. Attorney Marr can be reached at dmarr@nashualaw.com
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A possible Hepatitis C, HIV Threat among East Texas Teens
http://www.kltv.com
By Layron Livingston
SMITH COUNTY, TEXAS (KLTV) - Health officials began their investigation after one young person tested positive for a communicable disease. The exact illness was not made public because of patient confidentiality.
But Dr. Paul McGaha, regional director of state health services said it's possible there could be more young East Texas who have yet to be tested.
McGaha said, fortunately, all 18 tests have come back negative.
"If they don't clean their needles, if they don't use proper infection control, if they don't use proper technique, it is a risk," he said.
McGaha said it's customary to test for HIV and Hepatitis when needles are concerned.
Health officials issued a cease and desist order to Dre Harrison, the man they alleged conducted an illegal tattoo operation from his home at the Liberty Arms Apartment complex.
Liberty Arms management told us they were first notified of the operation by health department staff just days before the Thanksgiving holiday.
Management also said they spoke with Harrison, who is not a resident, earlier this week and he denied the allegations.
"People come in and they ask me, what is this big bump coming up on my skin, and it's hard for me to say, you might want to go get that checked out," said Paul Masson, a tattoo artist. Masson owns Lil Paul's Tattoo Studio and said, unfortunately, those meetings happens frequently.
Glutaraldehyde is a term Masson is all too familiar with. He said any legitimate tattoo artist would be--it's just one of the chemical Masson uses to disinfect his equipment.
Cleanliness is not an option for studios regulated by the state.
Masson said they sterilize their equipment daily, and his entire staff has to be OSHA certified in blood-borne pathogens.
Health officials hope to put a stop to the Harrison operation before more young East Texans are effected.
About 80 percent of people who contract Hepatitis-C show no signs or symptoms of the incurable disease. If infected, the disease could lead to chronic liver disease, which can lead to death.
The Texas State Department of Health Services is offering free screenings to anyone who believes they may have been exposed to the disease.
For information, call 903.533.5330.
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Safety Data from Kid Drug Trials Often Unpublished
http://www.foxnews.com
When drugs approved for adults are studied in youngsters, the research yields important safety data that could guide the use of these medications in children, a report published this week indicates.
But in most cases these studies never appear in peer-reviewed journals, and when they do, half of them don't focus on the important new safety data that's been generated, Dr. Daniel K. Benjamin Jr., from Duke Clinical Research Institute in Durham, North Carolina and colleagues found.
"Specifically, trials that uncover new safety findings are less likely to be published than other types of trials, and trials that uncover results unfavorable to a company (or its product) are less likely to be published than those with favorable results," they report in the Archives of Pediatrics and Adolescent Medicine.
Prescription drugs are often administered "off-label" to children largely because many of them have only been tested in and approved for use in adults. As such, drugs are often given to children without fully knowing if they will be beneficial, harmful, or neither.
To address this problem, the US Congress passed the Food and Drug Administration (FDA) Modernization Act in 1997, which, in part, extends the exclusive marketing rights for a particular drug if the drug maker conducts FDA-requested studies of its effects in children. However, it is unclear how often the results of pediatric drug trials are published in peer-reviewed medical journals and just what information gets published.
In the first 10 years of the so-called "pediatric exclusivity" program, more than 95,000 children were enrolled in 365 pediatric trials for the 153 drugs that were granted pediatric exclusivity extensions. Overall, there were 137 pediatric labeling changes, which means that changes were made to the information the drug company gives to doctors about how the drug should be used.
Benjamin and his team reviewed 129 of the 137 labeling changes. They found that for 96 products (74 percent), no new safety information was added to the product label. For 33 products (26 percent), new pediatric safety information was added to the product label. For 12 of these products, "unexpected and important neuropsychiatric safety findings" emerged in the pediatric drug trials.
For example, in a pediatric trial of ribavirin and interferon alpha for hepatitis C infection, FDA medical reviewers found an increase in suicidal thoughts compared with adults.
Agitation was observed in young children given the stomach acid drug famotidine (marketed as Pepcid or Fluxid). Aggressive and hyperactive behavior was more often seen in children exposed to the bladder-control drug tolterodine (Detrol), and post-marketing data for the migraine drug sumatriptan showed "serious adverse events" in children, which have been only rarely seen in adults, including stroke, vision loss and death.
In addition to the 12 products with neuropsychiatric safety issues, 21 products tested in children had "other important safety findings."
What's concerning, the researchers say, is that less than half of the trials (16 of 33) that generated new safety issues were ever reported in a peer-reviewed medical journal.
What's more, of the 16 trials that were published in reputable journals, 7 articles (44 percent) substantially differed in their presentation and interpretation of the data submitted to the FDA.
In an email to Reuters Health, Benjamin said: "The results investigators and pharmaceutical companies — who have a conflict of interest — emphasize in the peer-review literature are often different than what FDA reviewers report."
"Greater access to data will result in greater dissemination of findings, and thus improve children's health," Benjamin and colleagues conclude in their report.
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Celsion Provides Update on Progress of ThermoDox(R) Phase III Study for Primary Liver Cancer
http://www.celsion.com
Eleven Countries Including China Now Enrolling Patients, Enrollment to Be Complete in Mid 2010
COLUMBIA, Md., Dec 03, 2009 (BUSINESS WIRE) -- Celsion Corporation (NASDAQ:CLSN), a leading oncology drug development company, today provided an update on the progress of its pivotal ThermoDox(R) Phase III "HEAT" trial for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. Following recent regulatory approvals in China, Malaysia, Thailand and the Philippines, the study is now enrolling patients in eleven countries, with the majority of clinical sites located in the Asia Pacific region where HCC is most prevalent.
Enrollment in this 600 patient study continues to accelerate and Celsion expects to meet its objective of completing enrollment by the middle of 2010. A pre-planned, un-blinded interim efficacy analysis will be performed by an independent Data Management Committee when 50% of the endpoint events, tumor recurrence, are realized in the study population. Based on an historical review of RFA cases, Celsion expects the study could be completed by the middle of 2011, and pending positive data, a NDA would be submitted to the FDA before the end of 2011.
Michael H. Tardugno, President and Chief Executive Officer of Celsion stated, "We are pleased with the progress of patient enrollment and expect this trend to continue, based on the rapid start-up of additional clinical sites in China and other Asia Pacific countries. By year end, we expect to have sixty sites enrolling patients, with the majority of patients in countries such as China, Korea, Taiwan and Japan, where HCC is endemic. We have capital sufficient to complete enrollment and should the study show a benefit consistent with its primary endpoint, we would expedite filing for regulatory approvals in the U.S. and other countries where the trial is being conducted."
Celsion's global ThermoDox Phase III study for primary liver cancer is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint is progression free survival with a secondary confirmatory endpoint of overall survival. Additional information on the ThermoDox Phase III clinical study may be found at http://www.clinicaltrials.gov.
About Primary Liver Cancer
Primary liver cancer is a type of cancer that begins in the cells of the liver and is not typically detected early, often resulting in a poor patient prognosis. Mortality amongprimary liver cancer patients is one of the world's highest and ranks as the fifth most common solid tumor cancer. The incidence of primary liver cancer in the USA is approximately 20,000 cases per year and is rapidly growing worldwide. Globally there are approximately 660,000 cases per year, with the major risk factor being Hepatitis B and C in high prevalence in developing countries. There are few non-surgical therapeutic treatment options available as radiation and chemotherapy are largely ineffective in the treatment of primary liver cancer. The standard first line treatment for liver cancer is surgery, either resection or liver transplantation, but 70% to 80% of patients are ineligible for surgery. Radio frequency ablation (RFA), with limitations, has shown to be effective and has increasingly become the standard of care for non-resectable liver disease. Celsion is evaluating its lead drug, ThermoDox, in combination with RFA to improve the range and efficacy of the RFA procedure to treat this difficult disease.
About ThermoDox
ThermoDox in combination with hyperthermia has the potential to provide local tumor control and improve quality of life. ThermoDox is a proprietary, heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers including breast cancer. Localized mild hyperthermia (40-42 degrees Celsius) releases the entrapped doxorubicin from the liposome. This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumor.
ThermoDox has demonstrated evidence of efficacy in a Phase I study for primary liver cancer and the FDA has granted Orphan Drug designation for this indication. For recurrent chest wall breast cancer, ThermoDox is being evaluated in a pivotal Phase I/II open-label, dose-escalating trial that is designed to measure durable local complete response at the tumor site.
ThermoDox(R) is a registered trademark of Celsion Corporation
About Celsion
Celsion is dedicated to the development and commercialization of innovative oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. Celsion has licensed ThermoDox(R) to Yakult-Honsha for the Japanese market and has a partnership agreement with Phillips Medical to jointly develop its heat activated liposomal technology in combination with high intensity focused ultrasound to treat difficult cancers. Celsion has research, license, or commercialization agreements with leading institutions such as the National Institutes of Health, Duke University Medical Center, University of Hong Kong, Cleveland Clinic, and the North Shore Long Island Jewish Health System.
For more information on Celsion, visit our website: http://www.celsion.com
SOURCE: Celsion Corporation
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December 11, 2009
Hepatitis C Cases Increased by 6% Last Year
http://www.onmedica.com/
OnMedica Staff
There has been a rise in the number of people diagnosed with hepatitis C in England.
Figures from the Health Protection Agency's yearly report on Hepatitis C for 2009 showed that laboratory reporting of newly diagnosed hepatitis C infections in England increased in 2008 by 6% compared to 2007, with 8,196 new cases reported in 2008.
The HPA predicts future burden on the NHS from hepatitis C related liver disease.
It is estimated that currently around 185,000 individuals in the UK are chronically infected with hepatitis C (142,000 in England & Wales, 39,000 in Scotland and 4,000 in Northern Ireland); these individuals are at risk of developing serious liver disease.
Predictions from the HPA indicate that the future burden of this disease on the health service will be substantial if awareness, diagnosis and treatment do not increase. This can already be seen in national mortality figures, hospital admissions and transplant data, which all show that hepatitis C related serious liver disease is continuing to increase year-on-year.
The increase in newly diagnosed cases may be attributable in part to the public information campaigns and the subsequent increase in awareness which has encouraged more people to come forward and get tested, says the HPA.
However, Dr Helen Harris, a hepatitis C expert from the HPA warned that too many people are still undiagnosed.
"It is critical that awareness campaigns are sustained and enhanced if more people at risk of this infection are to be tested and treated," she said.
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NM Considers New Conditions for Medical Marijuana
http://www.newswest9.com
Associated Press
SANTA FE, N.M. (AP) - A medical advisory board will hold a public hearing Friday in Santa Fe to consider petitions for adding new health conditions to the New Mexico Department of Health's medical marijuana program.
The board will review five petitions and make recommendations to the department secretary, who will then make a final decision.
If a condition is approved, anyone with that medical condition can apply to the program.
The conditions under consideration are Hepatitis C undergoing non-antiviral treatment; cluster headaches; bipolar disorder and obsessive compulsive disorder; Ankylosing Spondylitis, a chronic, inflammatory arthritis and auto-immune disease; and Blepharospasm, a neurological movement disorder that causes a twitch of the eyelid.
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Sex with an IDU Doubles HCV Transmission Risk in HIV+ Women
http://www.iasociety.org
Author: Mark Mascolini
Having sex with a male injecting drug user (IDU) doubled the risk of hepatitis C virus (HCV) infection in HIV-infected US women with no history of injecting drugs. The finding adds to evidence that HCV can be sexually transmitted and that this transmission route poses a risk to people with HIV.
HCV is transmitted mainly through exposure to blood products or injecting drug use. But research among men who have sex with men (MSM) indicates that HCV can also be transmitted sexually. To see if women are also at risk of sexual HCV transmission, Women’s Interagency HIV Study (WIHS) researchers studied 3636 women with HIV or at risk of HIV who had HCV results.
Among all women studied, 31.5% were positive for HCV antibody, including 13.5% who reported no history of IDU or blood transfusion. Statistical analysis that factored in blood transfusion, age, HIV infection, unemployment, birth in the United States, history of hepatitis B infection, and current smoking status determined that sex with an IDU almost tripled the risk of HCV infection (odds ratio [OR] 2.8, 95% confidence interval [CI] 2.1 to 3.8, P < 0.0001).
When the researchers divided women into those with HIV and those without HIV, they found that sex with an IDU doubled the risk of HCV infection in women with HIV (OR 1.9, 95% CI 1.3 to 2.7, P = 0.0007). But the same correlation did not hold true in women without HIV (OR 1.1, 95% CI 0.4 to 2.7).
The investigators believe their findings suggest that “sexual transmission may be an important mode of HCV transmission for these high-risk women.”
Source: Toni Frederick, Pamela Burian, Norah Terrault, Mardge Cohen, Michael Augenbraun, Mary Young, Eric Seaberg, Jessica Justman, Alexandra M. Levine, Wendy J. Mack, Andrea Kovacs. Factors associated with prevalent hepatitis C infection among HIV-infected women with no reported history of injection drug use: the Women's Interagency HIV Study (WIHS). AIDS Patient Care and STDs. 2009;23:915-923.
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Righting Wrongs?
http://www.bbc.co.uk
Mark D'Arcy
A stunning debate in the House of Lords on Friday, on what one peer described, with some statistical authority, as Britain's worst-ever medical treatment disaster - the transmission of HIV and hepatitis, as well as other diseases, through contaminated blood products.
The death rate was worse than the Black Death, according to the Labour peer Lord Morris of Manchester, who was moving a private member's bill to compensate the victims and improve the future treatment of the survivors.
The main group of victims were haemophiliacs, people who suffer from a life threatening blood clotting disorder treated with products made from human blood. Thousands died. Lord Morris - the former disability minister Alf Morris - based his bill on the conclusions of an unofficial independent inquiry under the chairmanship of the former Solicitor-General, Lord Archer of Sandwell.
Lord Archer made a series of recommendations on coping with the consequences for the people involved. It calls for the creation of a committee to oversee the future treatment of haemophiliacs, with substantial patient representation. It says patients with haemophilia who have received blood or blood products and their partners, should be tested in case they have been infected with diseases like syphilis, Hepatitis B, HIV, Hepatitis C and HTLV. It also calls for the testing of donated blood.
The report says there should be benefits for those who have been infected, including free prescription drugs, GP visits, counselling, physiotherapy, home nursing and support services. Plus access to an NHS hospital bed and specialist services. And it calls for "direct financial relief" for victims and for carers who have been prevented from working. In the debate, the system by which compensation was paid to some victims or families was denounced as arbitrary.
The Archer report also revealed how the Medicines Inspectorate had visited the Blood Products Laboratory, which then made treatment products for haemophilia - and decided the facilities were so inadequate that they would have closed it down, if they could. It continued operating without interference under the now-abolished doctrine of Crown Immunity, with, Lord Morris said, catastrophic consequences.
There was a lot of comment in the debate on the disappearance of many of the records from that time. As ex-ministers in the department, the former Health Secretary Patrick Jenkin, and the former Health Minister David Owen had both scoured the departmental archives, only to be told the documents they sought had been accidentally destroyed. Lord Jenkin seemed pretty sceptical about that - although there was later some discussion about whether some records had survived, or whether some copies had later emerged from the storeroom of a Scottish solicitor....
The government spokesman on health issues in the Lords, Lady Thornton, (she's a whip, rather than a minister), insisted action was being taken to help the victims, and offered her sympathy. But she thought the bill was unnecessary. By tradition, the Lords never refuse a second reading to a bill - but this one has scant chance of becoming law, as the general election approaches.
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Human Trial for Spoon-Fed Vaccines to Begin
http://vaccinenewsdaily.com
by Ted Purlain
Human trials are soon to begin on an Australian-pioneered technique that could revolutionize the way we vaccinate — by replacing the syringe with the spoon, the Australian Associated Press reported Dec. 8.
Dr Barry Marshall, the Australian scientist who won a Nobel Prize for discovering the bacteria responsible for stomach ulcers, is working on a way to use those same bugs (Helicobacter pylori) to create edible vaccines.
It promises to make having your annual flu shot as painless as downing a spoonful of yogurt.
First, Marshall must solve a problem — the immune system does not normally react to food.
"Previously, people have looked at delivering vaccines on lactobacillus in yogurts, for example, but most of these products just look like food to the immune system and they are ignored," Marshall said.
"The new idea [is to use] the helicobacter, which infects your stomach temporarily.
"In the few days that it is sitting there it could be producing the vaccine, liberating it in the wall of your stomach where it is sensed by the immune system."
The trial, taking in 36 healthy volunteers in Perth, Australia, will begin in January. It will aim to find out which of a range of different strains of the unique bacteria, now known to be widespread and mostly harmless, had the most benign effect on gut.
"Half the people of the world are infected with it and most of them have no symptoms ... so that gives us a bit of confidence about the safety," Marshall said.
"We know exactly what happens when you get helicobacter — mostly nothing and sometimes an ulcer."
The initial trial will take about a year.
The process could also revolutionize the way vaccines are made. It could also hold the key to developing effective vaccines for the world's major diseases that have so far resisted decades of scientific effort.
"Nobody has succeeded with malaria, TB, HIV or hepatitis C at the moment and by having helicobacter delivering [a targeted vaccine] over many months then we may be able to get there," Marshall said.
Marshall was awarded the 2005 Nobel Prize in Physiology or Medicine along with his research partner Dr. Robin Warren.
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