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Week Ending: December 19, 2009
Alan Franciscus
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December 13, 2009
Disabled Vets Sue over Firing by General Dynamics
http://seattletimes.nwsource.com
By Gene Johnson
Associated Press Writer
Seattle —
As a disabled veteran, Phil Sprinkle couldn't directly serve in the wars in Iraq or Afghanistan. Instead, he put his skills as an Army-trained mechanic to use as a contractor, spending three deployments in Iraq repairing Stryker combat vehicles.
But when Sprinkle prepared to leave for a fourth tour overseas - this time in Afghanistan - he was fired for failing a physical.
So were dozens of other workers at General Dynamics Land Systems in Auburn, near Fort Lewis. Some of them, like Sprinkle, were disabled veterans, and a handful are now suing the General Dynamics Corp. subsidiary under the Americans with Disability Act and state antidiscrimination law, saying the company at least should have assigned them to noncombat-zone work.
"I never required any accommodations because of my disability," he said. "I'm not out in a foxhole with the guys. I'm in an enclosed, solid defense area. I was there 42 months without any issues."
Peter Keating, a spokesman for General Dynamics Land Systems, which is based in Sterling Heights, Mich., declined to discuss the specifics of the case. But generally, he said, workers sign employment contracts stating that they are healthy enough to deploy worldwide with the U.S. military - and if a worker can't meet that standard, the company must give the job to someone who can.
The company has recently started enforcing the provision more strictly, he said. While some of the company's war zone assignments are in well-guarded military bases, workers sometimes must travel with troops to remote posts.
"If you have diabetes, there's not a heck of a lot of refrigeration up in these remote areas in Iraq or Afghanistan," Keating said. "If I can't get them insulin, it would be inappropriate for me to put them in that position."
The company employs more than 500 people around Fort Lewis, an Army base south of Seattle. Its warehouse in Auburn is a parts-and-supply distribution center for 2,000 Stryker vehicles around the world.
While the workers do sign contracts acknowledging that they must pass physicals, those contracts don't supersede the ADA, which requires that companies make reasonable accommodations for disabled employees, said Darryl Parker, the Seattle attorney who brought the case.
Sprinkle, 51, says he contracted hepatitis-C during his eight years in the Army, perhaps when he was treated for severe burns sustained when a vehicle he was riding in exploded in Germany in 1979. His condition hasn't changed since he was hired at General Dynamics Land Systems in 2004, he said.
The other plaintiffs are Nicomedes Soliza, described in the lawsuit as a diabetic who began working at General Dynamics Land Systems as a mechanic in 2005; Rodney Holland, described as a veteran disabled from exposure to Agent Orange, who was hired in 2004; Josef Goetz, a disabled veteran with hypertension, who was hired as a supply representative in 2007; and Dickie Hall, described as a 30 percent disabled veteran who had lung cancer surgery last year. Hall was hired as a depressor mechanic in 2006.
Soliza and Holland had previously deployed to Iraq, while the lawsuit claims that Goetz and Hall were told when they were hired that they would not have to deploy. All were fired last July after failing physical examinations.
Sprinkle said the company's rules for who is fit to be deployed are tied to those of the Army, and General Dynamics Land Systems could have sought waivers that would have allowed the men to continue to work in combat zones. Keating said he could not confirm that.
Paul Steven Miller, a law professor who heads the University of Washington's disability studies program, said that General Dynamics likely had a responsibility to make accommodations for the workers - especially if they had previously shown they could do the work.
Such accommodations could include assigning them to similar jobs in the U.S. or at one of the company's noncombat-zone facilities around the world. However, if making those accommodations would unduly burden the company - if it would be too expensive, or if other jobs did not exist - the company could be excused from that responsibility, he said.
The lawsuit, filed in U.S. District Court in Seattle last month, also claims age discrimination because all of the plaintiffs are over 40. It seeks back pay and benefits as well as damages.
Sprinkle said two of his six daughters still live at home, and the loss of his six-figure income from working 12 hours a day, seven days a week in a combat zone has been difficult.
"There's financial gain, but it's more than that," he said. "It's pride of ownership and knowing I'm taking part in this war on terrorism as much as I can. My aches and pains were nothing compared to what some of these soldiers were doing."
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Let's Help Patients in Pain
http://www.jsonline.com
Mark Pocan
It's time for Wisconsin to join the growing number of states that give their ill and ailing citizens a wider array of health care options.
The Jacki Rickert Medical Marijuana Act would allow patients and their doctors access to a medicine that has fewer side effects than many addictive, legally prescribed pharmaceuticals on the market that are taken by millions of Americans every day.
It is time we help people like Teresa Shepherd.
Teresa is a 34-year-old mother from West Bend, who looks every bit the fit gymnast who loves biking and martial arts - things she did before she was hit by fibromyalgia, affecting her muscles and causing chronic pain.
Before Teresa was diagnosed seven years ago, she hated to even take aspirin. She now has been prescribed as many as 12 medications at once, which made her feel worse.
"I was dizzy, throwing up, I had no appetite at all and could not eat because of the pain," she said privately after sitting in the audience of a press conference where Sen. Jon Erpenbach and I introduced this bill. "The flare-ups made me feel like I was on fire. I was at the end of my rope."
When a friend suggested marijuana, she was shocked. Desperate, she tried it. It warmed and relaxed her muscles and allowed her to sleep and eat. She is now able to take her dog on a walk to the park with her two boys. The woman who had been prescribed a wheelchair even got back on her sports bike.
"But I'm real nervous," she adds. "I've got kids. If I get caught, I can go to jail. But this allows me to be a wife and a mother in my home."
The Jacki Rickert Medical Marijuana Act is about patients. It is about medical options. It is about compassion.
The public is ahead of the policy-makers on this issue. Statewide polling has shown a 75.7% approval of medical marijuana. People who have watched loved ones in pain and dying do not view this as a partisan issue.
In November, the historically cautious and conservative American Medical Association shifted its policy in favor of studying marijuana's medicinal uses. President Barack Obama announced a federal hands-off policy toward state laws on medical marijuana. And Gov. Jim Doyle has said he would sign a medical marijuana bill, as long as a doctor's written consent is required.
I'm in California right now, and while I'm here, I will visit a compassion center dispensary and ask questions about what has worked and what can be improved. California was the first state to pass such a law back in 1996 so it has been working through problems. It is important to note that our legislation is markedly different.
We are advocating strong restrictions so it does not offer recreational access to marijuana.
Our bill provides a medical necessity defense to avoid prosecution for someone obtaining or growing a small, regulated amount of marijuana with a doctor's written permission.
Patients must obtain the doctor's recommendation, a license and pay a fee of $250. A compassionate center must pay an annual fee of $5,000 and meet other regulations. Both will be regulated by the state Department of Health Services
This bill has been rewritten, evolved and improved over time as 13 other states now permit access to medical marijuana and another 17 are actively debating it.
Much of our language replicates Michigan's law, which passed with 63% of the vote on a ballot last November. We also took language from Rhode Island that has become the nationwide standard when it comes to nonprofit distribution organizations.
Medical conditions that qualify a patient include cancer, glaucoma, AIDS/HIV, Crohn's disease, a Hepatitis C, Alzheimer's disease, post-traumatic stress disorder and several other chronic or debilitating diseases that cause wasting away, severe pain or nausea, seizures or severe muscle spasms.
The Jacki Rickert Medical Marijuana Act is named after a woman suffering from Ehlers-Danlos Syndrome (a disorder that attacks joints and tissue), who led patients on a 210-mile trek from Mondovi to Madison in her wheelchair.
What Jacki pushed for - then and now - is health care reform. It's a humane approach to helping the sick, and it's time we show compassion and permit this medical option to help people like Jacki and Teresa.
The Senate and Assembly health committees will hold a public hearing on the Jacki Rickert Medical Marijuana Act at 10 a.m. Tuesday in the Capitol, Room 412 E. We expect to hear from many people whose quality of life could be made better by passage of this bill, and I invite you to join us.
Rep. Mark Pocan is a Democrat from Madison.
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Statin and Diabetes Drug Show Activity against Hepatitis B Virus in Laboratory Studies
http://www.hivandhepatitis.com
By Liz Highleyman
Typically, drugs studied for hepatitis B treatment were designed or selected for their antiviral activity, but researchers sometimes also test other types of commonly used agents.
Simvastatin
In the first study, investigators from the University of Oklahoma and Georgetown University Medical Center looked at interactions between simvastatin -- which is widely used to manage elevated cholesterol -- and the nucleoside/nucleotide anti-HBV drugs lamivudine (Epivir-HBV), adefovir (Hepsera), entecavir (Baraclude), and tenofovir (Viread).
Combinations of these agents were tested in a laboratory study using cultures of 2.2.15 cells. The combinations were designed to deliver equipotent (equal potency), though not equimolar, concentrations of each agent, based on the EC90 (90% effective concentration) of the drugs when used as monotherapy.
The researchers found that simvastatin interacted favorably overall with all 4 anti-HBV drugs, especially at dose ratios that resemble combinations likely to be used clinically. As the relative concentration of simvastatin increased to an excessive level, however, the favorability of the interactions progressively decreased.
Simvastatin demonstrated approximately equal degrees of synergy with tenofovir (3:1) and adefovir (10:1), and the highest degree with the 300:1 combination of simvastatin plus entecavir; interactions with lamivudine (100:1) were the least favorable. In all combinations, the addition of the nucleoside/nucleotide agents did not increase the cytotoxicity (propensity to damage cells) of simvastatin.
Rosiglitazone
In the second study, researchers from Tohoku University School of Medicine in Sendai, Japan, evaluated the suppressive effect on HBV replication of bezafibrate, used to treat elevated blood lipids, and rosiglitazone (Avandia), used to manage diabetes.
Prior research has indicated that peroxisome proliferator activated receptors (PPARs) -- which play a role in glucose and lipid metabolism -- may also influence immune response against viruses; therefore, agents that activate PPARs may stimulate this response.
In this laboratory study, the investigators assessed the effects and toxicity of bezafibrate (a PPAR-alpha agonist) and rosiglitazone (a PPAR-gamma agonist) added (24 hours later) to cultures of HepG2 cells infected with a genotype HBV genome with no mutations in the core promotor or precore regions.
The 50% cytotoxicity concentration of rosiglitazone was almost 150 mcM and that of bezafibrate was almost 250 mcM; lamivudine demonstrated no cytotoxicity at concentrations less than 1 mcM.
HBV DNA levels decreased when the bezafibrate concentration was greater than 200 mcM, but at this level it had considerable cytotoxicity. In contrast, rosiglitazone decreased HBV DNA at 5 mcM with no cytotoxicity. On this basis, the EC50 (50% effective concentration) of rosiglitazone was calculated as 9.8 mcM. Rosiglitazone also suppressed replication of HBV strains with core promoter and/or precore mutations in addition to the wild type strain.
"In this study, it was suggested that the replication of HBV was inhibited by rosiglitazone," the researchers concluded. "The mechanism is uncertain and is being investigated now."
12/4/09
References
T Bader, B Korba, and M Bronze. Simvastatin has significant antiviral synergism in vitro with anti-HBV drugs. 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009). Boston. October 30-November 1, 2009. Abstract 408.
Y Wakui, J Inoue, Y Ueno, and others. Rosiglitazone suppresses the replication of hepatitis B virus in HepG2 cells. 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2009). Boston. October 30-November 1, 2009. Abstract 444.
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December 14, 2009
Milk Thistle Treats Chemotherapy-Induced Hepatoxicity
www.medscape.com
Nancy Fowler Larson
December 14, 2009 — Hepatoxicity caused by chemotherapy can be successfully treated with milk thistle (MT), according to a study of children with acute lymphoblastic leukemia (ALL) published online December 14 in Cancer.
"Currently, there are no substitute chemotherapy agents that provide the same effectiveness against ALL yet preserve liver function. There are also no hepatoprotective medications that allow chemotherapy to continue to be administered while preserving liver function," write Kara M. Kelly, MD, from the pediatric oncology department at Columbia University Medical Center, New York City, and colleagues. "Thus, adjunctive agents that may enable optimal doses of chemotherapy to be administered without necessitating a decrease in the recommended doses of chemotherapy are of clinical significance and may further improve survival in children with ALL."
Earlier studies have shown that MT reduces liver damage caused by cirrhosis or ingested toxins. The goal of this MT evaluation was to determine whether the herb can safely and effectively remedy chemotherapy-induced liver inflammation — a common adverse effect that can necessitate reduction or suspension of the cancer treatment.
The randomized controlled, double-blind study consisted of 50 children with ALL who were in the maintenance phase of therapy and had a hepatic toxicity of grade 2 or greater on amino alanine transferase (ALT), aspartate amino transferase (AST), or total bilirubin (TB) levels.
For a period of 28 days, patients received either MT (5.1 mg/kg/day) or a placebo. Patient visits and reports and chart reviews were used to monitor the safety of MT. Liver inflammation was determined by blood level increases of AST and ALT.
On day 28, there were no noteworthy alterations in mean ALT, AST, or TB levels. However, the authors write, "at day 56, the MT group had a significantly lower AST (P = .05) and a trend toward a significantly lower ALT (P = .07)." Ingesting MT seemed to produce no negative effects, and the herb did not reduce the effectiveness of chemotherapy. Furthermore, patients taking MT were more likely to maintain their prescribed chemotherapy dosages.
"Although not significantly different, chemotherapy doses were reduced in 61% of the MT group compared with 72% of the placebo group. In vitro experiments revealed no antagonistic interactions between MT and vincristine or L-asparaginase in CCRF-CEM cells," the authors write.
The study authors noted that their research was made stronger by product quality analysis, stability testing, and a goal of quantifying plasma levels of silibinin. They also reported several limitations. These included the study's small sample size and an MT dose that may have been smaller than necessary. They also acknowledged that those taking MT had a rate of compliance that was appreciably lower than that of the placebo group. Overall, however, they hailed their findings as an important step toward using MT to treat hepatotoxicity in cancer patients.
"Despite our study's limitations, it provides preliminary evidence that MT may be a safe, effective, supportive-care agent," the authors write. "Future investigations are needed to determine the appropriate dose and duration and to identify populations that may gain the largest clinical benefit."
The American Institute for Cancer Research, the Tamarind Foundation, and the National Cancer Institute supported this study. The study authors have disclosed no relevant financial relationships.
Cancer: Published online December 14, 2009.
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Cannabis Won't Treat Hepatitis C
http://www.dailylobo.com
By Hunter Riley | Daily Lobo
On Friday, panelists from the Department of Health’s Medical Cannabis Advisory Committee approved four new conditions for DOH Secretary Alfredo Vigil to consider adding to the program.
Jose Pacheco, a medical cannabis card holder, attended the meeting to petition for cluster-type headaches and migraines to be eligible for treatment with medical cannabis.
“Seven moths ago I underwent brain surgery,” Pacheco said at the meeting. “I couldn’t walk. I couldn’t talk, and I had migraines every day. I spent the latter part of one year in the hospital. Getting back on your feet is hard to do, especially when you’re taking 50 or 60 pills to stay alive. That’s what I would be doing if I wasn’t in the program and if I wasn’t getting supplies.”
Pacheco said after he got his card he dropped down to taking about 14 pills per day.
“Medication for me runs anywhere from $4,000 to $5,000 a month,” he said. “I’m on Medicare and Medicaid, and they still don’t pay for some of my meds. And they still don’t pay for medical marijuana. Even though we have our licenses out here, we still can’t get it when you need it. You have to place an order; you have to wait. Many times your order won’t even be filled.”
The committee heard petitions for five conditions including cluster-type migraine headaches, Blepharospasm (eyelid twitch), Bipolar II Disorder, Hepatitis C and Ankylosing Spondylitis (an inflammatory disease of the spine and neck).
Hepatitis C was not accepted for consideration by the Department of Health secretary.
Petitioners did face some opposition from the panel and a doctor in the audience about how strict the diagnosing should be for Hepatitis C.
Steve Jenison, medical director for the Bureau of Infectious Diseases, is a member of the committee and said that Hepatitis C is already approved under the program, but only if the patient has undergone treatment with Alpha Interferon and Ribavirin. Alpha Interferon and Ribavirin is a treatment used in Hepatitis C patients to sustain the immune system.
“This (petition) is for the inclusion of any individual with Hepatitis C infection with a qualifying condition, whether that person is currently on treatment with Alpha Interferon and Ribavirin or not,” Jenison said.
Lawrence Leyba is a semi-retired anesthesiologist and family practice doctor who has worked with about 10,000 Hepatitis C patients. Leyba said medical cannabis should not be a treatment for the majority of cases.
“The idea that cannabis helps is a novel presentation here because I feel that, frankly, cannabis should be legalized for anyone to use at any time if he so wishes because it is a primarily recreational drug,” Leyba said in the meeting. “That being said, I see that there is a committee of professionals that are trying to do a good job as per the New Mexico citizens.”
Leyba said most Hepatitis C patients don’t exhibit symptoms, and few patients are incapacitated by the disease.
“I just feel that to approve cannabis use for Hepatitis C is so incredibly generic and without a solid foundation for the well-being of patients who are asymptomatic with hepatitis C,” he said.
Patrick Sullivan, the petitioner for Hepatitis C, said medical cannabis would help to alleviate a large variety of his symptoms, including nausea, vomiting, depression, fatigue and weight loss.
“If I do Ribavirin I have approximately a 35 percent chance of remission,” he said. “I don’t think that I should be required to take this treatment and compromise my immune system, especially when there are other anti-viral treatments available.”
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NVHR Applauds Congressional Action to End Federal Ban on Funding Syringe Exchange
www.prenewswire.com
Legislation Critical to Stemming Tide of Tens of Thousands of New Chronic Hepatitis Infections Annually
WASHINGTON, Dec. 14 /PRNewswire-USNewswire/ -- Legislation approved by Congress providing for federal funding of syringe exchange will be crucial in helping to reduce tens of thousands of new viral hepatitis infections occurring each year in the United States, the National Viral Hepatitis Roundtable (NVHR) said today. The provision was included in the FY 2010 Consolidated Appropriations bill approved by the House and Senate this weekend. President Obama is expected to sign the measure shortly.
The NVHR is a coalition of more than 150 public, private, and voluntary organizations dedicated to reducing the incidence of infection, morbidity, and mortality from viral hepatitis in the US through strategic planning, leadership, coordination, advocacy, and research. www.nvhr.org
"NVHR is pleased that Congress has acted on this sensible legislation that will reduce new viral hepatitis infections and ultimately save lives," said NVHR Chair Lorren Sandt. "Syringe exchange is a crucial tool in a comprehensive arsenal of counseling and medical referral programs designed to reduce drug use and infection. NVHR wishes to thank Representative Jose Serrano, Chairman David Obey, and thousands of activists for their tireless efforts in helping to address this critical public health issue."
An estimated 5.4 million Americans are infected with chronic viral hepatitis B and C and the majority are unaware they are infected. Injection drug use with shared syringes or equipment is the leading cause of hepatitis C, and 70 percent of people who inject drugs are infected. If left untreated, hepatitis B and C can cause serious liver disease, including cirrhosis, liver cancer, and liver failure. Needle exchange programs are an essential strategy to prevent the spread of hepatitis B and C infection, and provide vital counseling, testing, education, hepatitis A and B vaccine, and referral to medical care. According to the respected research firm Milliman, the cost of chronic hepatitis C virus infection alone could reach $85 billion annually by 2024, with Medicare and Medicaid absorbing a disproportionate share of those costs.
In early January 2010, the Institute of Medicine (IoM) is expected to release a report on viral hepatitis in the United States that outlines strategies for reducing the incidence of viral hepatitis infection and addressing medical complications in those individuals with chronic infections.
SOURCE National Viral Hepatitis Roundtable
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December 15, 2009
New Suppressor of Common Liver Cancer
www.medicalnewstoday.com
Tumor suppressor genes make proteins that help control cell growth. Mutations in these genes that generate nonfunctional proteins can contribute to tumor development and progression. One of the most well-known tumor suppressor genes is BRACA1, mutations in which are linked to breast cancer. Ze-Guang Han and colleagues, at the Chinese National Human Genome Center at Shanghai, People's Republic of China, have now identified SCARA5 as a candidate tumor suppressor gene in human hepatocellular carcinoma (HCC), a form of liver cancer that is the fifth most common cancer worldwide.
While it has been known for a long time that genetic inactivation of tumor suppressor genes can contribute to tumor development and progression, only more recently has it been determined that inactivating tumor suppressor genes by a mechanism known as epigenetic silencing has the same effect. In the study, analysis of HCC tissue samples indicted that SCARA5 was frequently subjected to genetic loss and epigenetic silencing and that SCARA5 protein downregulation was most marked in HCC tissue samples characterized by tumor invasion into the blood vessels (a sign of aggressive disease). Further analysis in HCC cells lines in vitro and after xenotransplantation into mice were consistent with SCARA5 being a tumor suppressor gene. The authors therefore suggest that SCARA5 protein downregulation as a result of SCARA5 genetic loss and epigenetic silencing can contribute to HCC tumor development and progression.
Title: Genetic and epigenetic silencing of SCARA5 may contribute to human hepatocellular carcinoma by activating FAK signaling
Author: Ze-Guang Han, Chinese National Human Genome Center at Shanghai, Shanghai, People's Republic of China.
View this article at: http://www.jci.org/articles/view
/38012?key=WYUeOaDgqG3U70r15PKV
Source: Karen Honey: Journal of Clinical Investigation.
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OraSure Technologies Receives CE Mark for OraQuick(R) Rapid HCV Antibody Test
http://money.cnn.com
Globe Newswire
First and Only Oral Fluid Rapid HCV Test Bearing a CE Mark
BETHLEHEM, Pa., Dec. 15, 2009 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (Nasdaq:OSUR) announced today that it has received approval to affix the CE mark to its OraQuick(R) Rapid HCV Antibody Test. A CE mark is required to sell this test in the 27 countries that currently make up the European Union. The OraQuick(R) Rapid HCV Antibody Test is the first and only rapid Hepatitis C test bearing a CE mark that can be used with oral fluid.
The European Union requires companies to comply with the Medical Devices Directive ("MDD") and In Vitro Diagnostics Directive ("IVDD") in order to sell medical devices in Europe. The CE mark is evidence that OraSure and its OraQuick(R) Rapid HCV Antibody Test meet the quality and other requirements of these directives. The Company is currently pursuing the required individual country registrations and expects to begin selling the test in Europe during the first quarter of 2010.
"We believe that the OraQuick(R) Rapid HCV Antibody Test, with its ability to test using a simple oral fluid or finger-stick blood sample, will be a valuable tool in identifying more individuals infected with Hepatitis C," said Douglas A. Michels, President and Chief Executive Officer of OraSure Technologies. "CE mark approval of our OraQuick(R) Rapid HCV Antibody Test represents a significant achievement and major milestone for our Company."
On a world-wide basis, there are an estimated 180 million people who are chronically infected with HCV, with an estimated three to four million individuals newly infected each year. According to the World Health Organization, most HCV infection is currently undiagnosed and up to 80 percent who have HCV show no signs or symptoms.
According to a new report issued by the UK Health Protection Agency on December 11, 2009, entitled "Hepatitis C in the UK -- The Health Protection Agency Annual Report 2009," it is currently estimated that approximately 185,000 individuals in the UK are chronically infected with Hepatitis C, including more than 8,000 people who were diagnosed in 2008 in England.
"This new hepatitis C test will help to diagnose people before their livers are damaged beyond repair," said Charles Gore, Chief Executive of The Hepatitis C Trust, the national charity for HCV in the United Kingdom. "Hepatitis C is preventable and treatable so it's a scandal that the death toll continues to rise simply because people haven't yet been diagnosed. The UK desperately needs to diagnose the 100,000 patients who are unaware they are living with the virus and to stop further transmissions. This simple, quick test will allow us to reach more people who would otherwise not have access to testing."
As previously announced, OraSure has entered into agreements with Merck & Co. (through its predecessor Schering Plough Corporation) to collaborate on the development and promotion of the OraQuick(R) HCV test. Under the terms of these agreements, the Company has been and will be reimbursed by Merck for a portion of its costs to develop the test and obtain regulatory approvals. Additionally, Merck will provide promotional support, including detailing the test in the physicians' office market worldwide.
With the CE mark, the OraQuick(R) Rapid HCV Antibody Test is the second rapid test manufactured by OraSure to receive such approval. In June 2007, OraSure received approval to affix the CE mark to its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test which is currently being sold widely in the European Union. OraSure is also actively seeking approval of its OraQuick(R) Rapid HCV Antibody Test by the U.S. Food and Drug Administration (FDA).
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices. These products are sold in the United States as well as internationally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities.
OraSure Technologies is the leading supplier of oral-fluid testing solutions for drugs of abuse and for the detection of antibodies to HIV.
For more information on the Company, please go to www.orasure.com.
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Investors Eagerly Await Anadys’ Clinical Trial Results
http://www.sdbj.com
By Heather Chambers
San Diego Business Journal Staff
BIOTECH: Firm Seeks Piece of $2B Hepatitis C Virus Drug Market
If Anadys Pharmaceuticals Inc. had a tough year convincing analysts of the value of its hepatitis C drug candidate this year, clinical trial results due out at the end of the year could settle a score.
The San Diego-based company, which has seen its stock fall 67 percent since the beginning of the year, will soon have the kind of data in hand that will either boost its stock and partnership prospects or send investors fleeing, according to analysts.
“These results will be closely followed by just about every investor who’s interested in the hep C space, and there’s quite a few,” said Stephen Willey, a biotechnology analyst with Thomas Weisel Partners in New York.
The data concerns Anadys’ lead drug candidate, ANA598, which will be tested in people infected with the hepatitis C virus. The study enrolled 90 patients who are given the drug or a placebo, in combination with the standard treatments — pegylated interferon alpha and ribavirin.
Before the end of the year, Anadys plans to release preliminary results demonstrating the safety and efficacy of its drug at four weeks, giving it a good indication of the drug’s performance. Full results of the trial are expected to be released early next year.
Vital Information
Willey said the upcoming data has the ability to increase investor confidence in the drug, which could compete against major industry players Gilead Sciences Inc. and Pfizer Inc. as best-in-class.
“There’s a lot riding on it for the company,” he said.
Earlier results, which demonstrated that the Anadys drug candidate has the ability to wipe out 99 percent of the virus circulating in the bloodstream in three days, were overshadowed by safety concerns in a 24-patient trial in healthy volunteers. Anadys revealed that three patients taking its drug dropped out of an early stage trial after developing a rash. Investors quickly interpreted the data as cause for concern and began unloading shares in the company. Anadys’ stock, traded under the symbol ANDS, fell 40 percent that day to $3.51, the biggest percentage drop on Nasdaq. Its 52-week range was $1.44 to $8.43 as of Dec. 9.
In June, Anadys cut 40 percent of its staff, leaving 29 workers.
CEO’s Perspective
CEO Steve Worland said the data was wrongly construed as affecting patients with HCV, rather than healthy volunteers who have no incentive to stay on the drug. Additionally, he said speculation surrounding a possible buyout fueled even greater volatility.
“I certainly hope and believe that now we’re a little more data-focused and less speculative about short-term interest in a transaction,” he said.
The market for an HCV drug has gathered steam in recent months, especially since Vertex Pharmaceuticals Inc. agreed to pay more than $375 million to acquire ViroChem Pharma Inc. in March. The acquisition advanced Vertex’s strategy to pursue novel combinations of specifically targeted anti-viral therapies for hepatitis C in the treatment of HCV infection, the company said.
New treatments have the potential to cure patients who have failed previous HCV therapies, a number estimated at 650,000 of the 3.2 million Americans living with HCV infections.
Decision Resources, a research and advisory firm for pharmaceutical and health care issues, predicts that the hepatitis C virus drug market will expand dramatically from $2 billion in 2008 to nearly $7.7 billion in 2013 in the U.S., France, Germany, Italy, Spain, the United Kingdom and Japan.
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Occult HCV Infection: An Unexpected Finding in a Population Unselected for Hepatic Disease
http://www.plosone.org
Occult Hepatitis C virus (HCV) infection is a new pathological entity characterized by presence of liver disease and absence or very low levels of detectable HCV-RNA in serum. Abnormal values of liver enzymes and presence of replicative HCV-RNA in peripheral blood mononuclear cells are also observed. Aim of the study was to evaluate occult HCV occurrence in a population unselected for hepatic disease.
We chose from previous epidemiological studies three series of subjects (n=276, age range 40–65 years) unselected for hepatic disease. These subjects were tested for the presence of HCV antibodies and HCV-RNA in plasma and in the peripheral blood mononuclear cells (PBMCs) by using commercial systems. All subjects tested negative for HCV antibodies and plasma HCV-RNA and showed normal levels of liver enzymes; 9/276 patients (3.3%) were positive for HCV-RNA in PBMCs, identifying a subset of subjects with potential occult HCV infection. We could determine the HCV type for 8 of the 9 patients finding type 1a (3 patients), type 1b (2 patients), and type 2a (3 patients).
The results of this study show evidence that occult HCV infection may occur in a population unselected for hepatic disease. A potential risk of HCV infection spread by subjects harbouring occult HCV infection should be considered. Design of prospective studies focusing on the frequency of infection in the general population and on the clinical evolution of occult HCV infection will be needed to verify this unexpected finding.
Authors: Laura De Marco et al.
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Obama Wants Senate to Pass Health Reform before Christmas
www.medscape.com
Mark Crane
December 15, 2009 — It's now or perhaps never for healthcare reform, President Barack Obama told 60 members of the Senate Democratic caucus at an unprecedented White House meeting Tuesday as they race to pass legislation before the Christmas recess.
"This bill is the most significant reform of healthcare since the creation of Medicare," Obama said after the meeting. The bill will "save money for families, for businesses and government. And it will save lives."
Obama conceded the bill "won't include everything that everybody wants," in an apparent reference to Congress' inability to pass a government-run health insurance plan or expand Medicare to those aged 55 to 64 years. "No bill can do that. We can't allow differences over individual elements of the bill" prevent us from achieving reform, he said.
The Senate bill "bends the cost curve, is deficit neutral, extends coverage, and makes important insurance reforms," Obama said. "There are still some disagreements that need to be ironed out. I'm cautiously optimistic that we can get this done."
A Herculean Task
Earlier in the day, White House Communications Director Dan Pfeiffer told The Politico, "If President Obama doesn't pass health reform, it's hard to imagine another president ever taking on this Herculean task. For those whose life's work is reforming health care, this may be the last train leaving the station."
Vice President Joe Biden reiterated the "now or never" message Obama delivered to spur legislators to adopt his key domestic policy. "If healthcare does not pass in this Congress...it's going to be kicked back for a generation," he said on MSNBC's Morning Joe show.
The White House meeting came as it appeared that neither a government-run "public option" or an expansion of Medicare to citizens aged 55 to 64 years would appear in the Senate bill. The measures ran into strong opposition from some senators and most healthcare provider groups.
After a Democratic caucus meeting Monday night, several senators said the Medicare expansion would be dropped from the bill because it was not likely to receive the 60 votes needed to stop a Republican filibuster. Senate Majority Leader Harry Reid, D-Nevada, had proposed expanding Medicare as a compromise to win over senators opposed to a "public option" health plan.
Sen. Joseph Lieberman of Connecticut announced he would filibuster against expanding Medicare, and several other senators, including Sen. Ben Nelson, D-Nebraska, expressed reservations as well. After the meeting, Lieberman said, "I'm ready to vote for healthcare reform. Put me down tonight as encouraged about the direction these talks are going."
Compromised Needed
"The general consensus was, we shouldn't make the perfect the enemy of the good," Sen. Evan Bayh, D-Indiana, told reporters after leaving the caucus meeting. "And if in order to get all the insurance reforms accomplished, a number of the other good things in the bill, dropping the Medicare expansion is necessary, then that's what should be done."
Sen. Tom Harkin, D-Iowa, also said it appeared Democrats were moving toward a bill without the Medicare option. Sen. Russ Feingold, D-Wisconsin, who supports the public option and the Medicare idea, said, "Things are not moving in the right direction."
Reid told reporters that there was strong support for most of the provisions in the Senate bill. "Democrats are not going to let the American people down," he said. "I am confident that by next week, we will be on our way to final passage."
Several liberal senators who strongly favored a public option said they are willing to compromise to pass healthcare reform. "There's good stuff in the bill. It's a giant step forward," said Harkin. Sen. John D. Rockefeller IV, D-West Virginia, said, "We're not going to get all that we want. But we're going to get so much more than we have."
The 2074-page legislation would make the largest change to the American healthcare system since the creation of Medicare in 1965. It would provide coverage to 30 million uninsured Americans and ban health insurance policies such as refusing coverage to people with preexisting medical conditions. It would also impose mandates on most employers to provide health insurance and on individuals to purchase it. The bill also requires about $500 billion in cuts to Medicare over 10 years.
The House of Representatives passed its version of healthcare reform last month. Its measure, which includes a public option, will have to be reconciled with the Senate bill before Obama can sign it into law.
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December 16, 2009
Achillion Announces Positive Preliminary Phase 1b Proof of Concept Data with ACH-1625 to Treat Hepatitis C
http://finance.yahoo.com
Achieves 3.94 log10 Reduction in HCV RNA with Continued Safety and Tolerability
NEW HAVEN, Conn., Dec. 15, 2009 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN - News) today reported proof of concept data from the preliminary results of its phase 1b clinical trial of ACH-1625, demonstrating that treatment with ACH-1625 achieved a mean 3.94 log10 reduction in HCV RNA after five-day monotherapy, with continued good safety and tolerability in patients with hepatitis C (HCV). ACH-1625 is an inhibitor of HCV NS3 protease that was discovered and is being developed by Achillion.
The Phase 1 Program
In June 2009, Achillion initiated dosing in a randomized, double-blind, placebo-controlled phase 1a/1b clinical trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-1625 after single and multiple ascending oral doses in healthy volunteers and oral repeat doses for 5 days in subjects with hepatitis C infection. The trial is taking place in Europe and will enroll at least 54 subjects, including both healthy volunteers and HCV-infected patients.
In September 2009, Achillion announced positive results from the phase 1a segment of the study. Subjects in the phase 1a single ascending dose (SAD) segment of the study received single doses of ACH-1625 ranging from 50 mg to 2000 mg. Subjects in the phase 1a multiple ascending dose (MAD) segment of the study received 5 days of ACH-1625 up to a maximal dose of 2000 mg per day.
Preliminary data from the SAD and MAD trial segments demonstrated ACH-1625 was well tolerated at all doses and there were no serious adverse events, no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.
Proof-of-Concept Results
Today, Achillion announced proof of concept data from the preliminary results of the phase 1b segment of the study. Subjects in this first dosing cohort of HCV-infected patients received doses of 600 mg BID (n=9, randomized to 6 active drug, 3 placebo). Preliminary results showed that a mean reduction in viral load of 3.94 log10 was achieved in the treatment group, as compared to a mean reduction of 0.22 log10 in the placebo group. All subjects in the treatment group had viral load decline between 3.0 and 4.5 log10, and two subjects reached undetectable levels of HCV RNA. Safety results from this dosing group were similar to those observed in the phase 1a segment of the trial. There were no serious adverse events, no clinically significant changes in vital signs, ECGs, or laboratory evaluations. All reported adverse events were classified as mild or moderate, were transient and showed no apparent dose relationship.
Furthermore, all patients had viral loads that remained suppressed for at least 7 days after dosing was completed, maintaining a mean reduction of more than 2.0 log10 from baseline through day 12, the last day of viral load measurement in the study.
Preliminary analysis of viral dynamics of ACH-1625 demonstrates a very rapid reduction in HCV RNA levels after the first dose. ACH-1625 displays high efficiency for inhibition of viral production, with mean efficiency of 0.9994 out of maximal efficiency of 1.0000.
"In addition to the dramatic reduction in viral load after 5 days of monotherapy, ACH-1625 demonstrates slow viral rebound, which is an important differentiating characteristic, as this continued suppression of viral load after discontinuation of the drug may translate into a more durable antiviral response," noted Dr. Elizabeth Olek, Chief Medical Officer at Achillion. "These positive proof-of-concept results corroborate our findings from pre-clinical studies with ACH-1625, which demonstrated high potency, unique pharmacokinetic properties, and an excellent safety profile."
Michael Kishbauch, President and Chief Executive Officer of Achillion, commented on the positive results, "These compelling interim results are very encouraging as we continue to advance the clinical development of this compound for the treatment of HCV. Not only are the results especially robust, but they give us proof-of-concept ahead of schedule. This is a credit to our top-notch research and development team, which deserves recognition for its scientific excellence and tireless efforts."
"We look forward to sharing additional data from the next cohort of the phase 1b study in early January 2010, when we plan to host an investor conference call to review both segments of the phase 1 trial, in addition to updates on other Achillion progress. In addition, we expect to present the full data set from the phase 1a and phase 1b study at the upcoming EASL (European Association for the Study of Liver Disease) meeting in April 2010 in Vienna," concluded Mr. Kishbauch.
About ACH-1625
ACH-1625 is an HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-1625 is an open chain, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-1625 demonstrated high potency, unique pharmacokinetic properties and an excellent safety profile at high drug exposures. With its rapid and extensive partitioning to the liver, as well as high liver/plasma ratios demonstrated in preclinical studies, Achillion believes that ACH-1625 has the potential for once daily dosing. ACH-1625 has shown low single-digit nanomolar potency that is specific to HCV. It is equipotent against HCV genotypes 1a and 1b at IC50 ~1nM.
About Achillion
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease -- hepatitis C, resistant bacterial infections and HIV. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
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December 17, 2009
DHD2 Recommends Body Art Shop Owners Contact State about Licensing Requirements
http://www.ogemawherald.com
By Jeff Patrus
Staff Writer
OGEMAW COUNTY — District Health Department No. 2 Health Officer Lynnette Benjamin, in a Dec. 4 letter to body art owners in Ogemaw County, said those owners should contact the Michigan Department of Community Health regarding licensing requirements.
On Nov. 23, the Board of Health for District Health Department No. 2, which includes Ogemaw County, passed a motion determining that DHD No. 2 would not be involved in the state’s Body Art Program. The motion also called for DHD No. 2 to notify the Michigan Department of Community Health of that decision.
“The body art regulation is state legislation as a public health policy to protect citizens,” Benjamin said. “The decision the board made is based on their concern that locally we do not have the fiscal infrastructure nor the staffing capacity to fulfill program requirements. We have notified the state as to this decision and are awaiting how the state will provide the support for our local businesses.”
She said there are currently eight body art facilities within the DHD No. 2 coverage area, including two in West Branch: North Star Tattooz, and Eye of the Lotus. In addition, another such facility, Ink Blots, is located in Rose City.
Michigan’s Public Act 149 of 2007 states that “individuals shall not tattoo, brand, or perform body piercing on another individual unless that tattooing, branding, or body piercing occurs at a body art facility licensed by the Michigan Department of Community Health.” In addition, the act states that it is “aimed at decreasing the risk of transmission of bloodborne diseases such as hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency virus (HIV).”
James McCurtis, a spokesman with the Michigan Department of Community Health, said that legislation was passed in December 2007, and was implemented on Sept. 1 of this year.
He said that county health departments are in charge of inspecting each local body art facility to make sure it is in compliance with PA 149 as well as any other local regulations. However, he said the state has no legal recourse to make sure counties abide by that rule.
“There is no way we can make them do it,” McCurtis said. “We don’t have any authority to compel local health departments to do this. We’re exploring ways to make the appropriate changes with the state legislature.”
He said that the department has received approximately 60 applications for body art facility licenses, and has issued approximately 20 of those licenses. McCurtis also said there are about 400 total body art facilities in the state of Michigan that need to be licensed.
“A lot of facilities wanted this legislation to weed out the underground places,” he said. “They wanted to have their businesses be legitimate.”
McCurtis said the cost for body art facilities to obtain a license is $500 for three years, with the cost of a renewal at $300 for three years.
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December 18, 2009
Flamel Technologies Announces the Initiation of a Phase 2a Clinical Trial of Flamel’s IFN-Alpha-2b XL in Patients with Chronic Hepatitis C Virus Infection
http://www.earthtimes.org
LYON, France - (Business Wire) Flamel Technologies (NASDAQ:FLML) today announced the initiation of a Phase 2a clinical trial of Flamel’s Interferon alpha-2b XL (IFN-alpha-2b XL), which is based on Flamel’s Medusa® platform for controlled release of biologics. IFN-alpha-2b XL is being developed as a controlled release of unmodified interferon alpha-2b for the treatment of chronic hepatitis C virus (HCV). This Phase 2a randomized study, known as ANRS HC 23 COAT-IFN (COnfirmation of Anti-viral activity and Tolerance of Interferon alpha-2b XL), is sponsored by the Agence Nationale de Recherche sur le SIDA et les Hépatites Virales (ANRS). The Phase 2a study is designed to evaluate IFN-alpha-2b XL in combination with ribavirin in genotype-1 chronic hepatitis C patients who are either naïve to treatment or previous non-responders to standard interferon therapy (PEGylated interferon plus ribavirin).
The study will evaluate two doses of Interferon-alpha-2b XL (27 and 36 MIU) administered once a week for 12 weeks in combination with weight-based ribavirin in treatment-naïve and non-responder hepatitis C patients with genotype-1 HCV. The comparator arm of patients also comprises sub-groups of either treatment naïve or non-responder genotype-1 patients, each of which will be administered with PegIntron® (1.5µg/kg) once a week for 12 weeks in combination with weight-based ribavirin. A total of 84 patients (28 patients by arm which will be equally split into naïve and non-responder patients) is expected to be enrolled in the trial. The study will assess viral response: the primary endpoint will be viral load reduction at week 4 and week 12. Investigators will also be looking at the percentage of patients achieving Rapid Virological Response, or RVR, defined as an undetectable viral load at week 4, and Early Virological Response, or EVR, defined as a viral load reduction greater than 2 log at week 12. Another endpoint that investigators will be assessing closely is the safety and tolerability data for both doses of Interferon-alpha-2b XL versus PegIntron. Results from the study will be used to select the doses of Interferon–alpha 2b XL for the pivotal confirmatory clinical trial.
Roger Kravtzoff, Flamel’s Director of Preclinical and Clinical Development commented: “We are very pleased to pursue the clinical development of this very promising product. Better safety and efficacy will be important outcomes for the next generation of interferon products, which we believe will continue to be part of the standard of care for HCV treatment, even with the advent of new small molecule drugs currently in clinical development. The potential benefits of IFN-alpha-2b XL have been highlighted by the results of the Phase 1b trial which indicated:
- Better tolerance, characterized by a marked reduction in side effects for patients given IFN-alpha-2b XL compared to those who received PegIntron; and
- Better antiviral activity, characterized by:
- A statistically significant reduction in viral load for genotype-1 patients compared to similar patients who received PegIntron.
- A marked reduction in viral load for “non-responder” patients compared to similar patients who received PegIntron.
If these results are confirmed in the COAT-IFN study using longer treatment, we believe that IFN-alpha-2b XL provides a better therapeutic option to treat patients.”
The principal investigator of the study, Professor Christian Trepo (Hôtel Dieu Hospital - Lyon), remarked: “The results of the prior phase 1b study were encouraging in that the most difficult to treat patients, namely genotype-1 non-responders, experienced a greater reduction in viral load when given 27 MIU of IFN-alpha-2b XL than patients administered the standard dose of PegIntron. Moreover, the trend we observed in the study suggests that the advantages of Interferon-alpha-2b XL with respect to viral load reduction are cumulative and may become more pronounced during the longer treatment regimens used in the COAT-IFN study.”
“This is especially positive, I believe, as these patients also experienced significantly fewer adverse events than patients in the comparator PEGinterferon group. Side effects associated with interferon treatment are debilitating and treatment limiting. Therapeutic outcomes are often negatively affected by the adverse events experienced by HCV carrier patients to the extent that dose reductions become necessary. Many patients may even choose to discontinue therapy. The previous Phase 1b results suggest that IFN-alpha-2b XL potentially provides at least equivalent and possibly better therapeutic benefits with fewer side effects in comparison to existing interferon-alpha based therapies. Indeed, entering the age of new anti-HCV molecules, what is most urgently wanted is the improvement of tolerance of the still needed interferon-alpha which is the number one hurdle of therapy. The confirmation of improved efficacy in the most hard to treat, genotype-1 non-responder patients will be most useful, especially in the future context of multiple therapies involving protease and polymerase inhibitors.”
About IFN-alpha-2b XL
IFN-alpha-2b XL is a new formulation of recombinant Interferon alpha-2b based on Flamel’s proprietary Medusa nanoparticle delivery system. Medusa is a versatile biologics carrier for the development of a wide range of novel and second-generation long-acting native protein and peptide products. IFN-alpha-2b XL is designed to provide patients with a longer acting and more tolerable approach to interferon therapy compared with approved interferon regimens.
About Flamel
Flamel Technologies, S.A. is a biopharmaceutical company principally engaged in the development of two unique polymer-based delivery technologies for medical applications. Micropump® is a controlled release and taste- masking technology for the oral administration of small molecule drugs. Flamel's Medusa® technology is designed to deliver controlled-release formulations of therapeutic proteins, peptides and other biologics.
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Anadys Hepatitis C Drug Meets Key Study Goals
http://www.businessweek.com
Anadys Pharmaceuticals Inc. said Thursday its experimental hepatitis C drug is meeting key goals in a midstage clinical trial.
The company said 56 percent of patients receiving ANA598 in a combination treatment had undetectable levels of the virus after four weeks, based on the interim data. The patients also received pegylated interferon and Ribavirin, which is considered the standard of care for the virus.
The results compare with 20 percent of patients receiving placebo plus the standard of care achieving undetectable levels of hepatitis C. Patients will receive ANA598 for 12 weeks in the study, followed by standard of care treatment for 12 or 36 additional weeks.
Hepatitis C is a viral infection causing swelling of the liver and can lead to scarring and potential liver failure.
An independent committee recommended escalating the study to a dose of 400 milligrams from 200 milligrams. The company expects to start the additional dose in January.
Earlier this year, a large number of patients dropped out of an early stage study after they developed a rash. In the most recent results, the company said eight patients reported a rash through the interim analysis date, seven mild cases and one moderate case.
The field of developing hepatitis C treatments has grown more competitive, prompting Wall Street to more closely watch side effect results for many drugs in various stages of development. The field includes Vertex Pharmaceuticals Inc., which is nearly done with late-stage development of telaprevir. Other potential future products include Pharmasset Inc. and Roche's RG7128, InterMune Inc. and Roche's ITMN-191, and Achillion Pharmaceuticals Inc.'s ACH-1625.
Shares of Anadys fell 23 cents, or 7.8 percent, to $2.71 in morning trading. Shares have traded between $1.44 and $8.43 over the last 52 weeks.
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Ban Lifted on Federal Funding for Needle Exchange
http://www.npr.org
Susan Sharon
After two decades, Congress has voted to lift a ban on federal funding of needle exchange programs. AIDS activists are cheering the move, saying it legitimizes needle exchange in the nationwide fight against HIV/AIDS.
For years, needle exchange programs in three dozen states have provided clean needles to intravenous drug users as a way to reduce the transmission of HIV/AIDS and Hepatitis C. But the programs have relied solely on state and local funding because of a longtime ban at the federal level. For years, some regarded needle exchange as an incentive for drug addicts to continue to use.
Bill McColl of the Washington, D.C.-based advocacy group AIDS Action says some are afraid federal backing conflicts with the zero-tolerance policy for drug use.
But he says he sees the vote to lift the ban as a vote for science.
"There are eight federal reports that show that syringe exchange will decrease HIV and Hepatitis," McColl says. "It doesn't increase substance abuse. You know, this is a real opportunity to do some serious outreach to a population that is often overlooked."
Around the country, the rate of needle exchange continues to increase. According to the North American Syringe Exchange Network, more than 30 million clean needles were distributed last year. Even in a rural state like Maine, the numbers are up.
Patsy Murphy, director of the Eastern Maine AIDS Network in Bangor, says her organization distributes about 4,000 needles every month.
Murphy says many of her clients were originally prescribed painkillers for an injury or illness, but for whatever reason they started abusing drugs. And when they couldn't get doctors to prescribe them, they started buying drugs on the street.
Jonathan Gagnon says he started shooting up about six months ago.
"I was at my friend's house and they were shooting up Dilaudid, and they said snorting it and popping it would give you nothing like the feeling of shooting it, so I said, 'OK, let's try it,' " Gagnon says. "Once I did it, I fell in love."
Gagnon is HIV positive. He goes to the Eastern Maine AIDS Network for support services and counseling, but he also goes to get clean needles. He says he can't take the chance of contracting hepatitis C.
The Bangor program is one of four needle exchanges in Maine, and one of an estimated 200 nationwide. Now that federal money could be made available to fund needle exchanges, Bill McColl of AIDS Action hopes more cities will launch programs.
"There are a number of states and localities that don't currently have syringe exchanges, such as Las Vegas or Miami, that I think have very serious injection drug use issues that I think could benefit from this change," McColl says.
The end of the federal ban on funding does not guarantee additional money for needle exchange programs, but AIDS activists say it's a symbolic achievement that will, at the very least, reinforce an old message that clean needles save lives.
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Morris Undersheriff: I Tried to Stop Harassment
http://www.dailyrecord.com
NEWTON — A top official in the Morris County Sheriff's Office testified Thursday that he took every measure he believed he legally could to stop the emotional abuse a now-ex-officer says he received from a few co-workers who knew he was diagnosed with hepatitis C.
A civil jury of nine people started hearing testimony Dec. 10 on former Sheriff's Officer John Cicchetti's claims that he was tormented and his life endangered by two or three "grinders" — his word for mean-spirited fellow officers — between November 1998 and November 2000. He took an unpaid, extended medical leave then before formally resigning in February 2002.
Through attorney John Paragano, Cicchetti, now 57, is seeking unspecified damages for emotional distress from the sheriff's office, and blames superior officers for failing to take action to stop the perceived discrimination. The trial was transferred to Sussex County to avoid a conflict with Cicchetti's former place of employment.
Paragano on Thursday called Morris County Bureau of Law Enforcement Undersheriff John "Jack" Dempsey as a witness and repeatedly asked why Dempsey didn't order an internal affairs investigation.
"He only wanted everything stopped," Dempsey said. ''He did not want a formal investigation."
Dempsey said he first learned of Cicchetti's concerns in April 2000 and accepted from him an eight-page memo that outlined what the officer viewed as abusive conduct. Cicchetti's worries centered mainly around now-retired Officer John McWilliams, who, Cicchetti alleged, was sarcastic or ceased conversations with others when he appeared.
McWilliams, according to Cicchetti, soaked inmate handcuffs in alcohol before handing them to him, or wouldn't pass him work items, acting as though he was contaminated.
Cicchetti also has complained that his radio transmissions were "clicked" so communications could not be transmitted to him; that mouth wash and dirty clothes were tossed around his locker; and that someone he couldn't see, driving a Dodge pick-up, revved the vehicle engine at him one evening as though threatening to run him down.
Dempsey said he took Cicchetti's complaints seriously but said there was no way to corroborate many of his claims. But,Dempsey said, he asked the Morris County Prosecutor's Office if he could install a hidden videocamera in the male sheriff's officers' locker room to see who might be trashing Cicchetti's locker, and learned he couldn't.
Dempsey said he also spoke to McWilliams and warned him to stop if he indeed was harassing Cicchetti. McWilliams denied abusing Cicchetti based on his hepatitis but admitted he disliked Cicchetti for tattling on him about his late return to a post, Dempsy said.
Dempsey said he approved a new job assignment for Cicchetti so he wouldn't have to interact with any of his perceived tormenters, and even sought advice in 2000 from then-county Personnel Director Herman Hoopes to see if he could order a psychological evaluation for one officer who supposedly was hassling Cicchetti. He said he learned he could not.
Cicchetti also griped to Dempsey that fellow officers wouldn't eat lunch with him, Depmsey said.
''I said, 'I can't force people to sit down and have lunch with you,"' Dempsey testified.
He said that, at Cicchetti's request, he didn't undertake a formal investigation but promised if harassment persisted, he would.
Dempsey said the officer did not report any further problems after May 2000 but took an extended leave of absence as of November 2000. The next he heard from Cicchetti was through a resignation letter in February 2002, in which the officer stated he was "subjected to horrible intimidation" and could not return to work, Dempsey said. Cicchetti filed his lawsuit a few weeks later.
A psychiatrist and psychologist have both testified on Cicchetti's behalf that he suffered major depression as a direct result of discrimination on the job.
Dr. Jacob Jacoby, a psychiatrist hired by the county, said Thursday that Cicchetti had to cope with multiple stressful issues in his life before joining the sheriff's office in 1994, and was hospitalized in the 1980s for depression. Jacoby suggested that Cicchetti is paranoid, and perhaps exaggerating conditions on the job to further his lawsuit.
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Protein Examined for Role in Liver Cancer
http://www.medicinenet.com
Robert Preidt
THURSDAY, Dec. 17 (HealthDay News) -- A protein switch called TAK1 helps prevent liver damage, including inflammation, fibrosis and cancer, according to a team of scientists from the United States and Japan.
Learning more about how TAK1 works could improve understanding about the development of liver disease and cancer, and lead to new therapies, the researchers noted in their report, released online the week of Dec. 14 in advance of publication in an upcoming print issue of the Proceedings of the National Academy of Sciences.
"TAK1 appears to be a master regulator of liver function," study co-leader Dr. David A. Brenner, a professor of medicine and dean at the University of California San Diego School of Medicine, said in a university news release.
It was already known that TAK1 activates two proteins that play a role in immunity, inflammation, programmed cell death and cancer. But it wasn't clear whether TAK1 promotes or prevents liver cancer.
To investigate this question, Brenner and colleagues created mice with liver cells that lacked TAK1 and found that the mice had a high rate of liver cell death. To compensate, the rodents' livers produced too many cells, resulting in liver damage that led to liver cancer, the researchers found.
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Spiritual Needs Rank High as Death from Cancer Nears
http://www.medicinenet.com
Serena Gordon
FRIDAY, Dec. 18 (HealthDay News) -- Addressing the spiritual needs of someone with advanced cancer could be just as important as taking care of their medical needs, a new study suggests.
When asked what was important to them at the end of their lives, people dying of cancer ranked two factors highest: pain control and being at peace with God, the study found.
"Medicine tends to focus on the more scientific aspects of the person, and we've made wonderful strides in improving patient care, but there's another important component of patient health: spirituality," explained Dr. Tracy Anne Balboni, a radiation oncologist at the Dana-Farber Cancer Institute in Boston and the study's lead author. "This is clearly an area where some important advancements can be made."
The researchers discovered that people with advanced cancer were far more likely to choose hospice care when their spiritual needs had been addressed. And among those who were very religious, meeting spiritual needs increased the odds that a terminal patient would choose to forgo aggressive, yet often unsuccessful, medical treatments, the study found.
However, at least six of 10 people with advanced cancer reported that their spiritual needs were only minimally or not at all supported.
Results of the study were published online Dec. 14 in the Journal of Clinical Oncology.
Earlier research had found that the most religious patients are much more likely to choose aggressive treatments during their last week of life in an attempt to prolong their life -- even if those treatments don't improve their quality of life. Aggressive treatments include mechanical ventilation and cardiopulmonary resuscitation.
"A religious person might think they need to do aggressive care," said Balboni, adding that they may feel it's wrong to give up. "But, if the medical team engages them more, they can help them understand that it's not necessarily against their religion to forgo futile medical procedures."
The new study involved 670 people with advanced cancer from seven treatment centers in the Northeast and Texas. The final analysis included information from 343 people who later died and whose caregivers completed a post-death interview. The average time between the start of the study and the person's death was 116 days.
For purposes of the study, spiritual care was defined as patient-perceived support of their spiritual needs by their medical team and the receipt of pastoral care services.
Most people (60%) said that their spiritual needs either hadn't been met or were minimally supported at the start of the study, and 54% had not received pastoral care visits. In the final week of life, 73% of the participants received hospice care, and 17% received aggressive care.
Those who had greater spiritual support from their medical team, including doctors, nurses, chaplains and more, reported a higher quality of life as they neared death than did those who felt unsupported spiritually.
People who felt they were getting better spiritual support were 3½ times more likely to receive hospice care. And among highly religious people, those whose spiritual needs were supported were five times more likely to receive hospice care and five times less likely to receive aggressive medical care, the study reported.
"We found that patients whose spiritual needs were well-supported seemed to transition to hospice more frequently and had a marked reduction in the use of aggressive care," Balboni said.
Yet despite the findings, said Dr. Harold G. Koenig, co-director of the Center for Spirituality, Theology and Health at Duke University Medical Center, "few people are getting their spiritual needs met by the medical system."
"Many doctors are uncomfortable discussing spirituality and haven't been trained to do so," he said. "And churches have a role, too. Although it's not a popular topic, churches need to talk about the end of life in the pulpit. People don't know theologically what they're supposed to do."
Religious people, Koenig said, are often left to think they should always have hope and should always "give God a chance to provide a miracle." Hospice care, though, can often provide spiritual guidance and help people prepare for death, he said.
Doctors don't need to actually provide spiritual care, Koenig said, but it's important for physicians to acknowledge their patients' spiritual needs and make sure they're addressed by pastoral care or hospice. "The doctor does have to be the one to orchestrate this," he said.
But if someone's spiritual needs are not being met, Koenig and Balboni agreed that the person -- or a friend or family member -- needs to speak up. And if the patient's doctor doesn't feel qualified to discuss end-of-life spiritual issues, the doctor should be able to refer you to someone who can.
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HMOs Sued over Hepatitis Outbreak
http://www.upi.com
LAS VEGAS, Dec. 18 (UPI) -- Lawsuits against HMOs and insurance companies in Nevada charge they neglected to adequately inspect several Las Vegas clinics suspected in a hepatitis outbreak.
Attorneys for patients who contracted or were exposed to hepatitis C at local endoscopy clinics say HMOs and insurers should be held accountable for telling people what particular health providers they must use, the Las Vegas Sun reported Friday.
If successful, the lawsuits could compel HMOs to thoroughly examine doctors and clinics before sending their insured patients to those providers, the Sun said.
The Southern Nevada Health District said unsafe medical practices at the Endoscopy Center clinics of Dr. Dipak Desai exposed patients to hepatitis through reused syringes and reuse of single-use medication vials for multiple patients.
Nine hepatitis C cases have been connected officially to Desai's facilities by the district, which says more than 100 patients may have been infected, the Sun reported.
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