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Week Ending: November 28, 2009
Alan Franciscus
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November 21, 2009
Backed by House, 6 patients sue Pawlenty, state officials
http://www.startribune.com
By Baird Helgeson, Star Tribune
In July, a doctor cataloged 16 maladies that have left Frederick Becton living on government assistance.
At 65, Becton endures constant pain from a bad shoulder. Hepatitis C leaves him exhausted, and late-stage kidney disease tethers him to a dialysis machine three days a week.
For five years, Becton's doctor has considered his medical problems so severe that she prescribed a special diet, heavy on lean meats, vegetables and grains. To help with the costs, Becton has gotten $250 from a little-known state program geared to such patients.
Last month, Becton got a letter: No more grocery money from the state. Instead, the state has suggested he and the other 5,071 Minnesotans on the program scour local food shelves, apply for food stamps, or, for those with feeding tubes, Medical Assistance.
Gov. Tim Pawlenty sliced the program's $5.3 million appropriation as part of a $2.7 billion emergency budget reduction in June. The nutrition cuts prompted a lawsuit that offers a glimpse into a program that serves some of the state's poorest residents.
"It's going to be pretty tough," said Becton, who lives in public housing in downtown Minneapolis. "I went through a lot of humiliation to get it, and now it's gone."
The program covers only 11 special dietary conditions, including those with special protein requirements, lactose intolerance, dangerously high cholesterol, liver disease or women or are pregnant or nursing.
Dollars for diets
Each diet has a dollar value. Hypoglycemics got $30, while those with a menu of qualifying ailments received several hundred dollars per month. Statewide, the average monthly payout was $77.
Typically, recipients were elderly, blind or disabled and living on federal and state assistance. To tap extra food money, they needed to show a letter from a doctor saying the diet was necessary.
Filed earlier this month, the lawsuit paints a grim picture of those served by the program, which started in 1974 as part of a massive federal overhaul of the welfare program.
Forough Mahabady had kidney cancer, two hip replacements and has severe digestive problems.
Unable to work, the Hennepin County woman lives on $955 a month in federal aid plus $200 a month from the program to pay for her prescribed, high-protein diet.
Darlene Bullock, of Aitken County, is diabetic, had a stroke in 1993, heart bypass surgery in 2005 and a stent placed in her heart this year.
She receives food stamps and got $119 a month from the state to pay for her doctor-ordered dietary needs.
Injunction sought
"It's the bottom of the income spectrum," said Tom Pingatore, human services program manager for Hennepin County, which had about 1,775 people getting dietary aid. "They are a vulnerable group."
The cuts might have gone unnoticed if Mahabady, Bullock and four others hadn't filed suit against Pawlenty and other state officials to block the cuts. The DFL-led House is taking the rare move of writing a brief in support of the lawsuit, which claims Pawlenty broke the law and violated the state constitution with his cuts.
The lawsuit seeks a temporary injunction that would reinstate the benefits until the case is resolved.
Health and human services officials say they can't recall the dietary program ever being the subject of political ire or controversy.
The program was among 27 health and human services programs targeted by the cuts, known as unallotments.
"These were difficult decisions, but were necessary in order to balance the state budget during a time of unprecedented economic challenges," said Brian McClung, Pawlenty's deputy chief of staff. One factor, he said, was "what types of other resources might be available to the persons affected by unallotments."
Get food needs met elsewhere
In a Sept. 11 letter to human services workers, Charles Johnson, assistant commissioner for the state's Children and Family Services Administration, said there might be other places for those on the program to get their food needs met.
For instance, Medical Assistance might pay for supplements ingested with a feeding tube, taken for metabolic problems, dairy allergies and other conditions that interfere with a body's ability to absorb nutrition. People who get their food money cut might qualify for additional food stamps.
The program's clients are being directed to various low-income assistance programs, and social workers are steering them to 211 crisis hot line and area food shelves, Pingatore said.
But food shelves don't reliably stock the foods needed by those on special diets.
"We are left scratching our heads sometimes, trying to find people help," Pingatore said.
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November 23, 2009
Increasing Long-Term Survival in Patients with Severe Liver Cancer
www.medicalnewstoday.com
In patients with unresectable (unable to be removed by surgery) liver cancer, an interventional radiology procedure called triple-drug transcatheter arterial chemoemobolization (TACE) followed by a liver transplant may significantly increase a patient's chance of long-term survival, according to a study published in the December issue of the American Journal of Roentgenology.
Liver cancer is the fourth most common cancer in the world and is responsible for more than 500,000 deaths worldwide annually. During triple-drug TACE, anti-cancer drugs are injected directly into the blood vessel feeding a cancerous tumor. An embolic agent is placed inside the blood vessels that supply blood to the tumor, in effect trapping the chemotherapy in the tumor.
The study, performed at the David Geffen UCLA School of Medicine in Los Angeles, included 124 patients with unresectable liver cancer. Twenty-eight patients underwent triple-drug TACE followed by a liver transplantation; 96 patients underwent triple-drug TACE only. "In our study, patients who underwent triple-drug TACE followed by liver transplantation showed the longest survival," said Antoinette S. Gomes, M.D., lead author of the study. The median survival in the transplant recipient group was 112.80 months. In the no-transplant group, the median survival was 15.75 months.
"Until recently, there has been considerable controversy regarding the benefits of emobolization therapy in patients with unresectable liver cancer," said Gomes.
"In our series, survival after TACE was best in patients who ultimately underwent liver transplantation. However triple-drug TACE alone still improved survival in patients who did not undergo a liver transplantation," she said.
Source: Heather Curry, American College of Radiology / American Roentgen Ray Society
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Diet Rich in Processed Food Linked to Increased Risk for Depression
www.medscape.com
News Author: Pauline Anderson
November 10, 2009 — Patients who consume a diet rich in high-fat dairy products and fried, refined, and sugary foods are at increased risk of developing depression, whereas those whose diet is rich in fish, fruit, and vegetables are at lower risk of developing depression, a new study shows.
Although other research has looked at the relationship between single nutrients and depression, this is the first study to investigate the effect of dietary patterns on depression.
The results suggest that diet should be considered a potential target for the prevention of depressive disorders, said the study's lead author, Tasnime N. Akbaraly, PhD, who completed the study while at the Department of Epidemiology and Public Health, University College, London, United Kingdom.
"The study can be an argument to help convince patients who have unhealthy eating behaviors that consuming a healthy diet not only controls excess weight but also may lower the risk of depression," Dr. Akbaraly added.
The study was published in the November issue of the British Journal of Psychiatry.
2 Dietary Patterns
Part of the Whitehall II, a population-based study of London-based civil servants aged 35 to 55 years, the analysis included 3486 patients who completed the Food Frequency Questionnaire.
Participants were asked how often, on a 9-point scale ranging from never to 6 or more times per day, they consumed a list of 127 foods in the previous year. The food list was "anglicized" and included foods common to the United Kingdom — fish and chips, for example, said Dr. Akbaraly.
Along with her colleagues, Dr. Akbaraly grouped the foods into 37 predefined food groups and eventually created 2 dietary patterns — a "whole" food pattern that included a high intake of vegetables, fruits, and fish, and a "processed" food pattern that included a high consumption of desserts, fried foods, processed meat, refined grains, and high-fat dairy products.
The latter diet is similar to the "Western" diet, said Dr. Akbaraly who is now at the Institut National de la Sante et de la Recherche Medicale, in Montpellier, France.
Novel Finding
Five years later, the participants completed the Center for Epidemiologic Studies–Depression, a 20-item self-report of depressive symptoms. Using a 4-point scale, participants were asked to score the frequency of their depressive symptoms during the previous week.
The study found that participants with a high intake of processed foods had higher odds of depression compared with those with the lowest intake (odds ratio, 1.58; 95% confidence interval, 1.11 – 2.23).
"This finding was observed after taking into account the potential confounding factors such as age, socioeconomic status, education, marital status, total energy intake, other health behaviors, and other health status, making the associations very robust," said Dr Akbaraly.
She added that this is a novel finding. "There are no studies showing the deleterious effect of food pattern on depressive symptoms."
As for participants who fell into the whole food dietary pattern, the study found they were less likely to report depression (odds ratio, 0.64; 95% confidence interval, 0.49 – 0.93) after adjusting for potential confounders.
Potential Mechanisms
There are several possible mechanisms that might explain the association between a processed food diet and depression, said Dr. Akbaraly. There is some evidence of a correlation between sugar consumption and the rate of depression.
In addition, the Western diet has been associated with higher risk of coronary heart disease and inflammation, both of which have been reported to be involved in the pathogenesis of depression.
"Many processes such as oxidative stress processes, or insulin resistance processes, could be involved," said Dr. Akbaraly, adding that further research is needed to determine exactly how refined foods might affect risk for depression.
As for how a "whole" food diet might protect against depression, such a diet includes fruits and vegetables that are rich in antioxidants — nutrients that have been shown to reduce risk for depression.
In addition, the diet includes many foods including cruciferous vegetables, leafy vegetables, and other vegetables and dried legumes that are a rich source of folate. Previous research has shown that low levels of folate may affect levels of neurotransmitters that may be involved in depression. This diet also includes lots of fish, a source of polyunsaturated fatty acids that might also reduce the incidence of depression.
Target for Depression Prevention?
However, according to Dr. Akbaraly, the benefits of the whole food diet do not lie in individual nutrients. "In my opinion, the protective effect of diet on depression comes from a cumulative and synergistic effect of different nutrients from different sources of foods, rather than the effect of one isolated nutrient. If that's the case, it's important to assess the impact of the overall diet on health outcome, as people don't eat isolated nutrients."
The study results could result in diet becoming a potential public health target for depression prevention, said Dr. Akbaraly.
To verify that dietary patterns affected depression, rather than the other way around, the authors undertook a series of sensitivity analyses. They found no significant association between previous reports of depression and dietary patterns assessed 6 years later, suggesting that depression did not predict dietary behavior.
In addition, the association between dietary patterns and depressive symptoms remained significant after excluding participants with prior depression.
Although a healthy diet may be only 1 component of a healthy lifestyle, the results of the study did not change significantly after adjusting for lifestyle factors such as physical activity, smoking, total energy intake, and body mass index.
Are Results Generalizable?
Asked by Medscape Psychiatry to comment on the study, Michelle B Riba, MD, a past president of the American Psychiatric Association and associate chair and professor of psychiatry, University of Michigan, Ann Arbor, said the study adds important information to the depression literature.
"This is a good step, and the authors should be commended," she said, adding that a lot of patients want to learn what lifestyle habits might help prevent depression.
However, she added, it is a single study and it has limitations. The study sample — middle-aged, white office workers who self-reported their dietary intake — is somewhat "skewed," she said.
"The investigators did have blacks and Asians in the survey group but took them out due to differences in eating patterns," said Dr. Riba. "They were studied but not included in the results, which is a limitation to the usefulness of the study to other groups of people."
The authors have disclosed no relevant financial relationships.
Br J Psychiatry. 2009;195:408–413.
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My View: Ignoring Prisoners' Health Imperils Community
http://www.miamiherald.com
By John P. May
Special to The Miami Herald
Meeting the health needs of some of the sickest and most complex patients in our community is theresponsibility and privilege of those who deliver healthcare in jails and prisons. Like those in uniform who also protect and serve, these healthcare providers must maintain professionalism, integrity, competency and ethics in challenging environments that are often ill-designed for healing and far from therapeutic. These healthcare providers advocate for and deliver services in the best interests of their inmate patients. The community ought to appreciate and support these efforts, even if only because the community's own health and safety ultimately benefit when proper care is given to inmates.
The impact of incarceration on public health is significant. Incarcerated populations are known to have high rates of transmissible diseases because of preexisting problems including poor access to healthcare, high risk lifestyles and living in close quarters. Frequently landing in jail or prison marks the first time these individuals have had access to medical services, mental health treatment and dental care. Often substance addiction complicates disease processes and treatments.
Each year in the United States more than 12 million people are released from jails and prisons. A slightly larger number enter each year, owing to a steady increase in our jail and prison populations. This is an important intervention point for screening, treating and preventing disease. A report to the U.S. Congress by the National Commission on Correctional Healthcare shows an estimated 98,500 to 145,500 inmates released from U.S. prisons and jails in 1996 were HIV carriers. Another 38,500 had AIDS, and an additional 155,000 were infected with hepatitis B while another 1.3 million to 1.4 million were infected with hepatitis C. In Florida, an HIV test is mandatory prior to leaving the state's prison system and is typically available to jail and prison inmates upon request, along with other preventive health information. Women are screened for cervical and breast cancer, while men are tested for prostate cancer. Vaccinations are administered, along with other preventive healthcare.
Failure to identify and treat disease among prisoners and failure to provide a continuum of health and social services to those transitioning from jail or prison perpetuates disease and disenfranchisement, resulting in higher healthcare costs for everyone. Through an adequate jail or prison-based health program of disease screening, treatment and discharge planning, the negative impact of health conditions that affect the public can be minimized.
Nonetheless, healthcare for inmates is often rejected by both the public and public officials. Had it not been for a Supreme Court judgment ruling that prisoners have a right to adequate healthcare, few would receive it at all. And this despite the fact that the purpose of jails and prisons is public safety, and part of public safety is protecting the public's health.
The physician's creed -- in Latin primum non nocere or ``first, do no harm'' -- guides those of us providing healthcare to incarcerated persons to build care systems that meet our patients' needs and insure that during their incarceration they are not vulnerable to health deterioration. The task is not easy, and it's made more difficult by those who do not value our mission. If only for reasons of self-interest, prison healthcare deserves public support. Assigning disparate values to the lives of prisoners in comparison with those of the general public puts the community in peril. Infectious diseases do not respect the boundaries of prison walls, nor can we forget that the prisoner will once again walk among us.
Dr. John P. May is chief medical officer at Armor Correctional Health Services, a minority-owned enterprise incorporated in the state of Florida that provides comprehensive medical, dental and mental health services exclusively for inmates in jails and prisons.
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November 24, 2009
Pharmasset Announces the Continued Enrollment of the Phase 2b Clinical Trial of RG7128 for the Treatment of Hepatitis C
www.medicalnewstoday.com
Pharmasset, Inc. (Nasdaq: VRUS) announced that the enrollment of Cohort 2, led by its partner Roche (SWX: ROG.VX; RO.S, OTCQX: RHHBY), will continue for the remaining 300 genotype 1 and 4 patients in the ongoing phase 2b trial of RG7128, a first-in-class nucleoside analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. The decision was reached after a scheduled review by an independent Data Monitoring Committee (DMC) of all available safety data from the first cohort of approximately 100 patients completing 8 or 12 weeks of RG7128 or matching placebo in combination with pegylated interferon and ribavirin.
The DMC reviewed any potential drug discontinuations, incidence and details of adverse events, and selected laboratory assessments. No safety events in the DMC review were considered significantly different from those expected from HCV patients taking pegylated interferon and ribavirin treatment. The committee expressed no safety concerns that would preclude enrollment of the remaining 300 patients in the ongoing phase 2b study in the HCV positive genotype 1 and 4 population, and have not recommended modification of dose or duration of any RG7128 dosing regimens. Enrollment of these patients pre-screened for this Cohort in the fourth quarter 2009 has begun and is expected to be complete by the end of the first quarter of 2010.
"We welcome Roche's decision to open enrollment of Cohort 2 for the remaining 300 patients in the phase 2b trial," stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We are encouraged by the safety profile of RG7128 to date, which, when coupled with the higher barrier to resistance offered by nucleoside and nucleotide analog inhibitors has the potential to improve SVR rates over the current standard of care."
Additional RG7128 Studies
Pharmasset's development partner, Roche, plans to initiate a number of additional, longer duration phase 2b trials with RG7128 in the first half of 2010. An additional study in patients infected with HCV genotypes 2 and 3 is being planned to initiate later in 2010.
About the RG7128 Phase 2b Trial
The Phase 2b trial is anticipated to enroll a total of about 400 HCV-infected patients with genotypes 1 or 4 who have never received HCV treatment. The trial is evaluating the dose and duration of treatment with RG7128 in combination with Pegasys® plus Copegus®(ribavirin)The primary efficacy endpoint of the trial is the proportion of patients achieving an SVR, defined as serum HCV RNA below the limit of detection as measured by the Roche TaqMan assay 24 weeks after completion of treatment. Patients are equally randomized into one of 5 arms:
- 24 weeks of total treatment, with RG7128 500mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by 12 weeks of Pegasys and ribavirin ("12+12")
- 24 weeks of total treatment, with RG7128 1000mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by 12 weeks of Pegasys and ribavirin ("12+12")
- 24 weeks of total treatment, with RG7128 1000mg BID in combination with Pegasys and ribavirin for 8 weeks, followed by a further 16 weeks of Pegasys and ribavirin ("8+16")
- 48 weeks of total treatment, with RG7128 1000mg BID in combination with Pegasys and ribavirin for 12 weeks, followed by a further 36 weeks of Pegasys and ribavirin ("12+36")
- A control arm with Pegasys and ribavirin for 48 weeks.
Patients randomized to the 24-week regimen will discontinue all treatment at week 24 if they have achieved a rapid virological response, defined as serum HCV RNA below the limit of detection at week 4, a strategy known as "RVR-guided" treatment. Patients who do not achieve an RVR will continue on the standard of care therapy (Pegasys and ribavirin) until week 48.
Source: Pharmasset, Inc
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Antiviral Therapy for Hepatitis C Appears To Be Declining in the U.S.; Lack of Diagnosis Is Primary Barrier to Treatment
http://www.news-medical.net
Researchers from the University of Michigan determined that only 663,000 of the approximately 3.9 million Americans with hepatitis C virus (HCV) infection received antiviral therapy between 2002 and 2007. Treatment rates appear to be declining, in part because only half of the patients know they are infected. If this disturbing trend continues, by 2030 less than 15% of liver-related deaths from HCV will be prevented by antiviral therapy. This study, the first to analyze nationwide practice patterns for HCV treatment, is published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.
HCV is a common blood-borne infection that slowly damages the liver by causing inflammation of liver tissue, which can lead to cirrhosis, chronic liver disease, and liver cancer. In the U.S., HCV is a major public health burden and the leading cause of liver transplantation. According to the Centers for Disease Control and Prevention (CDC) 8,000-12,000 deaths occur each year due to HCV. While the incidence of new infections has declined, past studies point to a twofold to fourfold increase in death over the next 20 years due to widespread cases with longstanding infection.
Michael Volk, M.D., M.Sc., and colleagues obtained data of new patient prescriptions for pegylated interferon alpha-2a and -2b, sold under the brand names Pegasys and Peg Intron, respectively, and filled between 2002- 2007. Results of the prescription audit showed there were 126,000 new prescriptions for pegylated interferon products in 2002 and by 2007 that figured declined to 83,000 prescriptions. Researchers project fewer than 1.4 million patients would be treated cumulatively with antiviral medication by 2030 if the downward trend continued.
To further understand the decrease in antiviral therapy, researchers investigated treatment decisions using data from the National Health and Nutrition Evaluation Survey (NHANES) Hepatitis C Follow-Up Questionnaire. They discovered that 49% of respondents were previously unaware of their diagnosis and 24% of patients with HCV were not recommended for treatment by their physician. Approximately 9% of those surveyed did not follow up with their doctors regarding their HCV, 8% refused treatment, and only 12% received treatment. "It is concerning that half of all people with hepatitis C in the U.S. are unaware of their diagnosis," said Dr. Volk. "Even with the development of new and better medications on the horizon, such medications will have less than optimal impact unless more patients are diagnosed and referred for treatment."
The study further suggested that barriers to HCV screening may be attributed to lack of health insurance, limited access to standard medical care, and lower priority for testing by primary care doctors. "This is unfortunate," added Dr. Volk, "since young patients who don't go to the doctor often may be the best candidates for antiviral therapy." The authors conclude that increased public health efforts are needed to improve access to antiviral therapy, and recommend further research of health services delivery and quality of care for HCV patients.
http://www3.interscience.wiley.com
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Advanced Hepatitis Drug Nears FDA Approval
http://www.sdbj.com
By Heather Chambers
San Diego Business Journal Staff
BIOTECH: Telaprevir for Patients Who Have Failed Standard Treatments
Vertex Pharmaceuticals Inc., maker of the HIV treatment Lexiva, has made a business of tackling some of the world’s most difficult-to-treat diseases.
Next year, the company plans to submit a first-of-its-kind drug candidate to the FDA for treating chronic hepatitis C virus infections in people who have failed standard treatments.
Analysts see the drug, called telaprevir, as a potential blockbuster because roughly 650,000 of the 3.2 million Americans living with HCV infections have failed standard therapies.
Four times more prevalent than HIV in the United States, the deadly liver disease also represents a major concern among aging baby boomers, who represent more than half of the patients in the U.S.
A report commissioned by Vertex this year demonstrates how medical costs for HCV patients could rise from $30 million today to $85 billion in the next 20 years. Government payers like Medicare will increasingly be footing the bill on treatment costs, according to Vertex CEO Matthew Emmens.
“That is a tsunami that is making its way toward the health care industry,” Emmens said during a recent stopover visit to the company’s San Diego research laboratories.
Emmens took over as chairman and CEO in May following a career with Britain’s Shire Pharmaceuticals Group plc, maker of Adderall, where he succeeded Vertex founder Joshua Boger as CEO. The two have known each other for years, dating back to their early days at Merck & Co. Inc. in the 1980s.
Roughly 175 researchers work at the La Jolla facility, formerly home to Aurora Pharmaceuticals before Vertex acquired the company for $600 million in stock in 2001. Most of its scientists are focused on an experimental cystic fibrosis drug candidate, known as VX-770, which could reach the FDA following telaprevir.
Before it does, Vertex could see its first commercial revenue stream if telaprevir passes regulatory muster. For the three months ended Sept. 30, Vertex reported a net loss of $149.6 million on revenues of $25 million.
Promising Data Released
Vertex wowed investors earlier this month when the company released some preliminary data on the drug at a Boston conference of the American Association for the Study of Liver Diseases.
In 161 patients treated for the first time, the drug produced a clinical cure, defined as a sustained virological response, in 80 percent of those taking the drug. It had the same effect when given twice a day or three times a day.
Earlier results involving a small number of patients who had failed to respond to standard treatments or relapsed after taking the standard drugs, achieved 57 percent and 90 percent clinical cure rates, respectively, when the drug was added to their regimen.
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NVHR: New Data Finding Fewer than 1 in 5 Hepatitis C Patients Receiving Antiviral Therapy is ‘Wake-Up Call’ for Washington to Act
http://www.hcvadvocate.org/news/Wakeup.html
- University of Michigan Researchers Call for ‘Increased Public Health Efforts’
- Sandt: Current Hepatitis C Virus Detection & Surveillance Efforts ‘Wholly Inadequate,’
- Challenges Congress to Act on Honda-Dent Legislation to Support State-based Programs
Washington, DC—New peer-reviewed data finding that fewer than one-fifth of the nearly 4 million Americans infected with chronic hepatitis C virus have received anti-viral therapy in recent years should be a wake-up call that Congress needs to move urgently on bipartisan legislation to support new state-based detection, research, and surveillance efforts, the National Viral Hepatitis Roundtable (NVHR) said today.
The NVHR warns that without congressional action, millions of Americans infected with chronic hepatitis C virus – particularly African Americans – are at serious risk of developing cirrhosis, liver cancer, and liver failure and will add billions of dollars in unnecessary costs to our health care system every year.
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 United States through strategic planning, leadership, coordination, advocacy, and research. www.nvhr.org
“These shocking data should serve as a wake-up call that current public-health detection, treatment, and surveillance efforts for chronic hepatitis C viral infection are wholly inadequate,” said NVHR Chair Lorren Sandt. “In terms of detection and treatment, the proverbial low-hanging fruit has been picked. In order to help our system reach under-served populations, Congress needs to act now on the bipartisan Honda-Dent legislation. Without action from Washington to support state-based efforts, millions of Americans will suffer from severe hepatitis-related complications and cost our health system tens of billions of dollars annually in avoidable medical costs.”
The alarming research trends identified in the new study were conducted by researchers at the University of Michigan and published in the December issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD). Among the key findings:
November 24, 2009
• Only about 663,000 of the estimated 3.9 million Americans infected with chronic hepatitis C virus received antiviral therapy between 2002 and 2007;
• Treatment rates appear to be declining in part because only one-half of all HCV patients know they are infected;
• Barriers to HCV screening including the absence of health insurance coverage, limited access to standard medical care, and lower priority of HCV testing by primary care physicians; and
• Increased public health efforts are needed to improve access to antiviral therapy and the researchers recommend further research of health services delivery and quality of care for HCV patients.
Last month, bipartisan legislation, “the Viral Hepatitis and Liver Cancer Control Act,” was introduced in the US House of Representatives by Congressmen Mike Honda (D-Calif.) and Charles Dent (R-Penn.) and co-sponsored by 10 House Members. HR 3974 would support a comprehensive prevention, research, and medical management referral program for chronic hepatitis B and chronic hepatitis C virus infection. The bill would provide a relatively modest $90 million in funding in 2011 – with additional funding thereafter – that will increase the ability of the Centers for Disease Control and Prevention (CDC) to support state health departments in their prevention, immunization and surveillance efforts.
An estimated 5.4 million Americans are infected with either chronic hepatitis B or chronic hepatitis C infection. Most individuals are not aware they are infected and unable to take advantage of promising treatments. According to the respected research firm Milliman, the cost of chronic hepatitis C virus infection alone could reach $85 billion annually by 2024. Medicare and Medicaid are projected to absorb a disproportionate share of those costs.
In 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 to mitigate complications in those individuals with chronic infections.
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Women's Health: Combating a Common Virus
http://www.northwestgeorgia.com/
By Dr. Gerald F. Joseph Jr.,
American College of Obstetricians and Gynecologists president
Hepatitis B (HBV) is a viral infection that attacks the liver, the organ that filters and cleans the blood and helps with digestion. Over time, HBV can destroy the cells of the liver and cause the organ to swell and eventually stop working. Hepatitis B is a common infection in the US—more than 46,000 new infections were reported in 2006.
Some people with a hepatitis infection will not have any symptoms, while others may experience muscle aches, fatigue, loss of appetite, nausea, dark-colored urine and light-colored stool, and yellowing of the skin and whites of the eyes (jaundice). See your doctor immediately if you have any of these symptoms.
Anyone can get HBV. It is spread by direct contact with bodily fluids—such as blood, semen, or vaginal fluids—of an infected person. Up to 60 percent of HBV infections are spread through contact with an infected sexual partner. Infants of mothers with HBV can be infected before or during delivery. Contaminated needles used for tattooing or IV drug use can spread HBV. You are also at an increased risk of contracting the disease if you live with an infected person, have sex with more than one partner, work in a job that involves contact with human blood, or receive blood transfusions or blood products. Individuals with these risk factors should talk to their doctor about getting screened for HBV.
If you test positive, do not donate blood or plasma or arrange to be an organ donor, do not share toothbrushes or razors or other objects that could be in touch with blood, and tell past and present sex partners and the people you live with of your condition.
In most adults, the infection will clear up on its own within a few weeks. Once the infection has cleared, the majority of sufferers will have immunity against getting it again in the future. However, an estimated 800,000 to 1.4 million Americans never fully get rid of it, putting them at risk for scarring (cirrhosis) of the liver, liver failure, or liver cancer.
There is no cure for HBV, but vaccination is available. Pregnant women who have risk factors and who have tested negative for HBV, infants and teens who haven’t been previously vaccinated, and high-risk adults should be vaccinated against HBV.
Chronic HBV infection can be treated with medication. If you have HBV or if your partner is infected, you should use condoms every time you have sex and avoid oral-anal contact.
For more information, the ACOG Patient Education Pamphlet “Protecting Yourself Against Hepatitis B” is available in English and Spanish at www.acog.org/publications/
patient_education.
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November 25, 2009
Vitamin D Boosts Treatment of Chronic Hepatitis C
http://www.empowher.com
Maryann Gromisch
Hepatitis C is an inflammation of the liver caused by the spherical, enveloped single-strand RNA virus. The World Health Organization estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). In the U.S., HCV accounts for 20% of all cases of acute (severe and of short duration) hepatitis, an estimated 30,000 new acute infections, and 8000 to 10,000 deaths annually. Chronic (long term) hepatitis C is predominately transmitted by percutaneous (through the skin) exposure to infected blood.
The treatment with most promising results is a combination of pegylated interferon alfa (Pegasys, PEG-Intron) and the antiviral drug, ribavirin (Vitrazole). Interferon alfa is a protein which the human body produces naturally as a defense response to viral infections. Pegylation describes a chemical process that makes the interferon last longer in the body. Interferon increases the potency of ribavirin in the treatment of HCV.
Adding a daily dose of Vitamin D to the regimen of pegylated interferon-alfa 2 and ribavirin might increase the response rates, according to an abstract which was presented at the Liver Meeting 2009, the 60th Annual Meeting of the American Association of the Study of Liver Disease.
"This preliminary study confirms the benefit of adding Vitamin D to conventional antiviral therapy in patients with chronic hepatitis C". states lead investigator, Saif M. Abu-Mouch, MD, from the Department of Hepatology, Hillel Yaffe Medical Center in Hadera, Israel.
In the study, 58 patients, the control group, who were diagnosed with HCV, were randomly assigned to the protocol of peginterferon-alfa 2b 1.5 ug/kg once per week and ribavirin 1000 to 2000 mg daily. Thirty-one patients received the same treatment plus Vitamin D 1000 to 4000 IU daily. By the fourth week of treatment, a rapid virological (pertaining to viruses) response was seen in 44% of the patients who received Vitamin D and in 18% of the control group. At the twelfth week of treatment, 96% of the group who received the addition of Vitamin D and 48% of the control group were HCV RNA negative.
"The study is surprising and promising because Vitamin D is something very easy to use and there is no toxicity. It's also interesting that the group treated with Vitamin D had more severe disease than the control group. I think this can be considered a strong result from a small study", commented Laurent Tsakins, MD. who was an attendee of the meeting.
Maryann Gromisch is a registered nurse, who has working on the medical, surgical, and critical care units of a hospital, and with a gastroenterologist in a private practice setting.
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Human Genome Sciences Submits BLA to FDA for ZALBIN for Chronic Hepatitis C
http://www.rttnews.com
(RTTNews) - Human Genome Sciences Inc. (HGSI: News ) announced the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration or FDA for ZALBIN for the treatment of chronic hepatitis C.
The company said the BLA submission includes the results of 2 pivotal Phase 3 clinical trials showing that 900-mcg albinterferon alfa-2b dosed every 2 weeks met its primary endpoint of non-inferiority to peginterferon alfa-2a dosed once each week.
The Phase 3 studies, known as ACHIEVE 1 and ACHIEVE 2/3, evaluated albinterferon alfa-2b vs. peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naïve patients with chronic hepatitis C, the company added.
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Scientists See Little Difference in Survival Rates between Non-Alcoholic and Alcoholic Liver Transplants
http://www.allheadlinenews.com
David Goodhue - AHN Reporter
Miami, FL (AHN) - Researchers with the University of Miami School of Medicine said there is little difference in the survival rate of liver transplant patients who are sick because of alcohol use and those who have non-alcohol-related liver disease.
The researchers said in a statement that non-alcoholic steatohepatitis is on the rise in the United States, possibly because more people are becoming obese. It affects up to 5 percent of all Americans and is the major cause of cirrhosis of the liver behind hepatitis C and alcoholic liver disease.
People with the condition typically do not know they have it until the damage to the liver is irreversible, leaving transplant as their only option.
The researchers compared transplant records from 1997 to 2007 and actually saw a trend of lower survival for non-alcoholic liver disease transplant patients than in those whose drinking caused their condition. However, they said in a statement that the trend was statistically insignificant.
The study is published in the December issue of the journal Liver Transplantation.
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Tips for Managing the Flu with Liver Disease
http://www.liversupport.com
by Nicole Cutler, L.Ac.
Even with the vaccinations available for seasonal flu and swine flu, many people are still getting sick. Discover six natural approaches to fight the flu for those who have fallen victim to one of these flu strains – an especially helpful list for those with compromised liver health.
Editor’s Note: The following is for informational purposes only and is not intended to replace or supersede medical advice. If your health is in jeopardy, consult with a physician right away.
Now that we are deeply entrenched in the 2009 flu season, few of us can ignore the fears surrounding this year’s influenza strains. With millions of people falling ill to one or the other, precautions against both seasonal flu and swine flu are dominating the public health arena. For those with liver disease, deciding how to best manage either type of flu can be especially challenging.
Pharmaceutical companies have risen to the demand for protection against both influenza strains and, thus, vaccines for each strain are currently available:
A. Seasonal Flu Vaccine – The flu shot is approved for use in people older than six months, including healthy people and people with chronic medical conditions, such as liver disease. Since they may be more vulnerable to complications, some doctors advise people with liver disease to receive the yearly seasonal flu vaccine.
B. Swine Flu (H1N1) Vaccine – As of September 2009, the U.S. Food and Drug Administration approved four vaccines against H1N1. With the supply limited, current recommendations for who should be vaccinated against H1N1 involve those with health conditions associated with a higher risk of medical complications from influenza. (This includes those with advanced liver disease.)
Beyond Vaccinations
Receiving a flu vaccine is both a personal and medical decision that is influenced by a variety of factors. Despite these vaccinations and efforts by public health officials to reduce the spread of illness, people everywhere are still getting sick.
Unfortunately, those with liver disease may not fare as well taking traditional cold and flu medicines. This is because some over-the-counter cold and flu medicines contain acetaminophen, which can put an additional toxin load on an already compromised liver. In addition, many people prefer to use natural solutions instead of dealing with the side effects inherent to most drugs.
Since having a chronic underlying illness like liver disease increases complications from the swine flu, getting rid of this particular virus safely and swiftly is paramount. Regardless of which strain of flu has found its way past your defenses, there are plenty of things someone with liver disease can do in favor of a quick recovery. Besides staying home to avoid infecting others, these natural approaches can safely help many people manage the flu:
1) Gargle – Based on the chemical principle of osmosis, gargling with salt water is a good way to ease throat pain and inflammation as well as reduce the quantity of viral particles in your throat.
2) Steam – Being careful not to burn yourself, breathing in steam from a bowl of hot water or in a hot shower helps keep mucous membranes moist and break up congestion. Adding one drop of eucalyptus essential oil will add another dimension to clearing the sinuses.
3) Rest – When battling the flu, your body needs plenty of rest. The immune system functions much better with at least eight hours of sleep each night. When sick with the flu, the body’s daily demand for sleep is usually greater than eight hours.
4) Herbal Formulas – Several expertly designed herbal formulas help support the immune system while simultaneously fighting viruses. Jason’s Famous Cold and Flu Formula is one example of a powerful, balanced blend of herbs to reduce the duration of the flu and prevent complications from arising.
5) Zinc – One of the most overlooked home remedies for the flu is zinc. This mineral increases the production of disease-fighting white blood cells and also helps these cells release more antibodies.
6) Flu Buster Tea – This concoction can easily be prepared in your kitchen. Simmer 4 – 6 pieces of fresh ginger and 2 whole garlic cloves in water for about 10 minutes. Then pour the ginger/garlic hot water over a peppermint tea bag. Add honey and lemon to taste. This home brew helps ease fevers, coughs, body aches, congestion and a sore throat.
Seasonal and swine flu vaccinations may help prevent many cases of the flu this year. Even so, an estimated 22 million Americans have been sickened by swine flu alone since April of 2009. Besides their applicability for those whose liver is unable to process some medications, the six suggestions above for managing the flu can also help anyone seeking natural solutions for fighting H1N1 or seasonal flu.
References:
- http://news.yahoo.com/s/ap/
20091113/ap_on_he_
me/us_med
_swine_flu, CDC’s swine flu toll: 4,000 dead, 22 million ill, Lauran Neergaard, Retrieved November 14, 2009, Yahoo, Inc., November 2009.
- http://www.antonnews.com/
massapequanobserver
/opinion/3245
-liver-lines-october-2-2009.html, Liver Lines, David Bernstein, MD, FACP, FACG, Retrieved November 14, 2009, Massapequan Observer, Anton Community Newspapers, October 2009.
- http://www.britishlivertrust.org.uk
/data/5/pages
/2.aspx?pid=226
#swine_am, Flu/Swine Flu & Liver Disease, Retrieved November 14, 2009, British Liver Trust, 2009.
- http://www.fluhelp.org/, Flu Virus Help, Retrieved November 14, 2009, fluhelp.org, 2009.
- http://www.hepatitis-central.com
/mt/archives/2009
/09/should_those
_wi.html, Should Those With Hepatitis C Get a Swine Flu Shot?, Nicole Cutler, L.Ac., Retrieved November 14, 2009, Natural Wellness, 2009.
- http://womanmagz.com/discover
-a-natural-treatmen
t-for-swine-
flu-and-protect-your-family-from-infection/, Discover A Natural Treatment for Swine Flu and Protect Your Family from Infection, Donald Olivia, Retrieved November 14, 2009, WomanMagz, 2009.
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November 26, 2009
Metobolomics Uncovers Key Indicators of Nonalcoholic Fatty Liver Disease
www.medicalnewstoday.com
A recent metobolomics study by researchers from Virginia Commonwealth University Medical Center in Richmond found that impaired peroxisomal oxidation of polyunsaturated fatty acids (PUFA) is associated with the progression of nonalcoholic fatty liver (NAFL) to nonalcoholic steatohepatitis (NASH). The study also found significantly higher plasma monounsaturated fatty acids in the blood of patients with NAFL and NASH. Full findings appear in the December issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.
Nonalcoholic fatty liver disease (NAFLD) affects a third of the U.S. adult population, with many cases found in obese individuals. NAFLD ranges from NAFL, a benign condition where fat accumulates in the liver of people who drink little or no alcohol, to a more serious state known as NASH where inflammation or scarring of the liver occurs and which can progress to liver failure.
Study participants included 50 in a lean normal control, 25 subjects with NAFL and 50 patients with NASH. Researchers classified the NAFL group by a diagnosis of fatty liver with the presence of accumulated liver fat of at least grade 1 severity according to the NASH Clinical Research Network criteria. The NASH group included those with at least a grade 1 severity in accumulated liver fat, inflammation and cytologic ballooning of at least grade 1 severity in each. The nonalcoholic nature of the disease was established by clinical assessment that the alcohol consumption was less than 20 gm/day for women and 30 gm/day for men. Lean normal controls were identified by a body mass index between 18-25 kg/m2, absence of symptoms or signs of disease, normal liver enzymes and hepatic sonogram.
The research team, headed by Arun Sanyal, M.B.B.S., M.D., used mass spectrometry (a technique that determines the basic composition of a sample) to analyze blood lipids and metabolites of the NAFL and NASH subjects comparing them with the control group. Data revealed that the development of NAFL is accompanied by increased lipogenesis, ∆ 9 desaturase and LOX activity. "Our study provides the most comprehensive picture of lipid metabolism in NAFLD to date," said Dr. Sanyal.
Results indicate that when the condition of the liver progresses to NASH the lipogenic activity levels off or declines modestly while the LOX activity increases. Simultaneously, there is impaired peroxisomal PUFA metabolism and increase in levels of products of non-enzymatic oxidation of arachidonic acid. "Further study of the role specific metabolic pathways play in the establishment and progression of NASH are needed," concluded Dr. Sanyal. "Our findings serve as a basis for future research of NAFLD."
Article:
"The Plasma Lipidomic Signature of Nonalcoholic Steatohepatitis," Puneet Puri1, Michelle M. Wiest, Onpan Cheung, Faridoddin Mirshahi, Carol Sargeant, Hae-Ki Min, Melissa J. Contos, Richard K.Sterling, Michael Fuchs, Huiping Zhou, Steven M. Watkins, and Arun J. Sanyal. Hepatology; Published Online: November 24, 2009 (DOI: 10.1002/hep.23229); Print Issue Date: Dec 2009. http://www3.interscience.wiley.com/
journal/122542493/abstract
Source: Dawn Peters, Wiley-Blackwell
New Data Emerges on Liver Transplant Survival Rates
www.medicalnewstoday.com
Researchers at the University of Miami School of Medicine compared the outcomes of cirrhotic patients who underwent liver transplants for nonalcoholic steatohepatitis (NASH) versus alcoholic liver disease (ETOH) and found no statistically significant differences in post-transplant survival rates between the NASH and ETOH groups. Study findings are presented in the December issue of Liver Transplantation, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases.
According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, NASH affects 2%-5% of Americans and ranks as one of the major causes of cirrhosis in the U.S. behind hepatitis C and alcoholic liver disease. Incidences of both NASH and nonalcoholic fatty liver disease (NAFLD) are increasing, possibly because of the greater number of Americans with obesity. Obesity also contributes to diabetes and high blood cholesterol, which can further complicate the health of someone with NASH. Because it is often a "silent" liver disease, NASH can lead to cirrhosis and permanent damage. Once serious scarring or cirrhosis is present, few treatments can halt the progression. Liver transplantation remains the only treatment for advanced cirrhosis with liver failure and is increasingly performed in people with NASH.
Vishal Bhagat, M.D, and colleagues demonstrated that liver transplant is an appropriate treatment for NASH patients, with survival rates comparable to those for ETOH patients. The team performed a retrospective chart review on all patients who underwent liver transplant for cryptogenic cirrhosis with NASH phenotype and alcoholic cirrhosis at the University of Miami from January 1997 through January 2007.
Cryptogenic cirrhosis was defined by absence of significant alcohol use (>20 gm/day), negative tests for viral hepatitis, negative autoimmune markers such as anti-nuclear antibody and anti-mitochondrial antibody, and negative markers for hemochromatosis, Wilson disease and alpha-1 antitrypsin deficiency.
The alcoholic cirrhosis (ETOH) group included patients who had history of significant alcohol, had no biochemical, serological and histological evidence of other known causes of cirrhosis, and underwent liver transplant from January 1997 through January 2007. Patients with hepatocellular carcinoma (HCC) and alcoholic cirrhosis with NASH phenotype were excluded from the ETOH group.
Baseline data on alcohol use, BMI, blood pressure and fasting serum levels of glucose, total cholesterol and triglycerides was recorded for both groups prior to liver transplant and after 6 months post-liver transplant. Demographic information was also collected including: recipient age, recipient sex, recipient ethnicity, donor age, cold ischemia time, biopsy proven acute and/or chronic rejection, biopsy proven recurrence of moderate to severe steatohepatitis in the transplanted liver, causes of retransplantation, graft survival, causes of death and patient survival.
"Our study presents the largest patient population with the longest follow-up published so far on the survival of patients with NASH cirrhosis," said Dr. Bhagat. "We found that although there was a trend towards lower patient survival in the NASH group compared with the ETOH group, the difference was not statistically significant."
In both the NASH and ETOH groups, sepsis (with or without multisystem organ failure) was the most common cause of death post-liver transplant, which is consistent with previously published data, followed by cardiovascular causes in the NASH group and malignancies in the ETOH group. Although higher number of patients died from cardiovascular causes in the NASH group (26%) compared with the ETOH group (7%), the difference did not reach statistical significance. "Cardiovascular mortality among NASH patients was much higher than published autopsy results in liver transplant patients and stresses the importance of control of the metabolic syndrome post-transplant in NASH patients," added Dr. Bhagat.
In a related study also published in Liver Transplantation, researchers at the Cleveland Clinic lead by Arthur McCullough, M.D., found that the development of metabolic syndrome following liver transplantation is on the rise and is a significant contributor to cardiovascular complications and morbidity and mortality. "Cardiovascular mortality and higher infection rates among patients with post-transplant metabolic syndrome remains a concern," said Dr. McCullough. "There is clearly a need for prospective studies to help identify and validate risk factors for post-transplant metabolic syndrome and thereby develop interventional strategies."
This study is published in Liver Transplantation.
Article:
"Outcomes of Liver Transplantation in Patients with Cirrhosis Due to Nonalcoholic Steatohepatitis Compared to Alcoholic Liver Disease."Vishal Bhagat, Ayse L. Mindikoglu, Carmine G. Nudo, Eugene R. Schiff, Andreas Tzakis, Arie Regev. Liver Transplantation; Published Online: November 25, 2009 (DOI:10.1002/lt.21927); Print Issue Date: December 2009.
Article:
"Post-Transplant Metabolic Syndrome: An Epidemic Waiting to Happen." Arthur J. McCullough, M Pagadala, S Dasarathy, B Eghtesad. Liver Transplantation; Published Online: November 25, 2009 (DOI:10.1002/lt.21952); Print Issue Date: December 2009.
Source: Dawn Peters, Wiley-Blackwell
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Needle Sticks Can Be a Job Hazard for Medical Students
http://latimesblogs.latimes.com
Almost every job has its hazards, but some have more than others. Case in point: medical students and needle-stick injuries.
Kspcyknc A new study finds that medical students often come in too-close contact with needles, possibly putting them at risk for contracting HIV or hepatitis C. But not all report their injuries. Researchers from Johns Hopkins University School of Medicine and George Washington University School of Medicine & Health Sciences surveyed 699 surgeons-in-training at 17 general surgery residency programs around the U.S.
Almost 60% said they sustained a needle-stick injury as a medical student, with many suffering two injuries. Of the 89 study participants who had their most recent needle-stick in medical school, a little less than half didn’t report the injury to an employee health service. The most common reason? Filling out a report was too time-consuming.
In this group, the vast majority (92%) of injuries that involved high-risk patients were reported, compared with 47% of needle-sticks involving low-risk patients. Also, 72% said the injury was self-inflicted, and more than half believed the injury stemmed from being rushed.
"Medical schools are not doing enough to protect their students and hospitals are not doing enough to make medical school safe," said lead researcher Dr. Martin Makary, in a news release. The associate professor of surgery at the Johns Hopkins University School of Medicine added, "We, as a medical community, are putting our least skilled people on the front lines in the most high-risk situations. Most trainees are still forced to learn to sew and stitch on patients, which puts both providers and patients at risk."
The study appears in the December issue of the journal Academic Medicine. Johns Hopkins has a Summary of Current Practice Guidelines for Occupational Exposures to Bloodborne Pathogens.
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Future of Maine's Needle Exchange Programs in Doubt
http://www.mpbn.net
By: Susan Sharon
AIDS activists around the country think they might have a shot at lifting a two decades-long ban on federal funding for needle exchange programs. Many of the nation's 200 such programs are facing severe budget cutbacks in their states. Several needle exchanges in California have recently been eliminated. In Maine, demand for clean needles has risen dramatically as injection drug use has grown. But none of Maine's four programs will qualify for the federal cash infusion if a particular amendment is approved by Congress.
At the Eastern Maine AIDS Network in Bangor, Executive Director Patsy Murphy and her staff keep track of about 380 clients. About 100 are HIV/AIDS patients who get assistance with medical, legal and mental health needs. The rest are people who regularly use the needle exchange program where they can swap out dirty needles for clean ones as a way to reduce the transmission of HIV/AIDS and Hepatitis C.
"J.J.," who is HIV positive, declined to give his last name. He says he and his friends come here regularly and he says they've learned not to mix up their works. "We keep track of our needles. Like each of us -- like mine has a black mark on it and I keep mine in a certain place and they keep theirs in a certain place."
Clients are regularly tested for HIV. If they're interested in substance abuse treatment or other counseling services, they are referred to outside agencies. Many of them are homeless or couch surfing, so the program also offers personal care products and access to a food pantry. But using drugs on the premises is prohibited.
As an extra precaution, Murphy says exchangers are not even permitted to use the bathroom. "They could use our facilities to shoot drugs. That's not what we're about," she says.
When Murphy first took over three years ago, she says the program was only handing out about 300 clean needles a month. Now she hands out about 4,000. She says the average exchanger is male, between the ages of 25 and 29 and either unemployed or on disability. "Many of the folks were receiving prescription drugs from physicians who prescribed painkillers either through a workers' comp injury or some type of car accident and now they can't get a prescription for it and they purchase drugs on the street."
The needle exchange is one of four similar programs around the state. Andrew Bossie of the Maine AIDS Alliance says all four are facing funding challenges, which is why he and so many other AIDS activists support the lifting of a 20-year-old ban on federal funding. "Some programs are seeing triple or four times the volume of syringes that they're exchanging as they were a year ago. And clearly at this point, with the economic recession, but also the difficulty to fund things, we have not seen our resources keep track with the need has been out there."
Around the country, the general concensus is that needle exchange programs work. Several federal studies have concluded that needle exchange programs reduce transmission of HIV and Hepatitis C without increasing illicit drug use. President Barack Obama campaigned on that theme. And while his first budget did not include funding for needle exchange, some observers say all the signals coming from the White House are good.
"We see needle exchange as a valuable tool as long as it's used within the context of a broader public health strategy," says Dr. Keith Humphreys, a senior policy advisor at the White House Office on National Drug Control Policy, more commonly known as the office of the drug czar. "That includes HIV testing, Hepatitis C testing, medical care, dental care and most of all treatment for addiction."
Humphreys declined to say whether his office would support the lifting of the ban. But he did say there would be a general departure from the previous administration, which he says focused the success of its drug policy strictly on the basis of drug useage. "The Obama administration is going to measure itself and hold itself accountable not just for drug use but also its consequences, and that includes HIV/AIDS," Humphreys says.
Such a position could conceivably pave the way for additional federal money for needle exchange -- with one catch. Bill McColl is the political director at AIDS Action in Washington D.C., who's been following the needle exchange debate in Congress. "They did accept an amendment that would ban the use of federal funding within 1,000 feet of schools, universities, parks, day care centers, video arcades -- I like that one because it's right out of 1980s -- and unfortunately what that means is that, in effect, it would restore the ban," McColl says.
That's because even in states as rural as Maine, all four of the needle exchange programs fall within those limits. Patsy Murphy of the Eastern Maine AIDS Network says her office in a small strip mall adjacent to a park and within walking distance of downtown Bangor has been in its location since 2002 and, for many reasons, she'd prefer not to move. "This is a local issue. We know our community best and we are in the best position to protect our neighborhoods and our children."
For some members of Congress, the idea of providing clean needles to drug users runs counter to the anti-drug message, "Just Say No." Indiana Rep. Mark Souder, for example, supports the ban. He could not be reached for comment for this story, but he told a congressional hearing on drug policy four years ago that, instead of providing addicts with clean needles, "We should break the bonds of their addiction once and for all."
Bill McColl of AIDS Action says that's a misguided position. He points out that the cost of syringe exchange to prevent one HIV infection is about $8,800. The lifetime cost of treating one HIV positive person for life is $730,000. Patsy Murphy says Representatives Chellie Pingree and Mike Michaud have been supportive of her position. But it's unclear where Maine's two senators stand.
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Vibrating Technology Promises to Replace Biopsies in Diagnosing Diseased Tissue
http://www.scientificamerican.com
By Larry Greenemeier
Magnetic resonance elastography (MRE), developed at Minnesota's Mayo Clinic, uses low frequency sound waves to determine whether tissues and organs are too stiff, a sign of trouble
Biopsies, although invasive and unpleasant, are typically the best way to diagnose the health of human tissue, especially the liver. A group of researchers and physicians at the Mayo Clinic in Rochester, Minn., is hoping to change this through a relatively new approach known as magnetic resonance elastography (MRE), which they developed to measure the stiffness or elasticity of tissue and organs without the need for a scalpel.
Through MRE, a device placed on the body near the tissue being tested uses vibration to generate low frequency sound waves that pass through organs that have varying degrees of elasticity. These data are measured and analyzed to determine when tissue is stiffer than it should be, often a sign that it is unhealthy.
In addition to biopsies, doctors often make disease diagnoses by feeling the skin and tissue surrounding an organ with their fingers to determine the level of elasticity (a process called palpation). The goal with MRE is to eliminate the need for painful biopsies and offer a sort of virtual palpation that could even be used to examine organs including the heart and the brain, which doctors cannot reach without major surgery.
Thus far, the most common application of MRE since it was first used at the Mayo Clinic in 2007 has been diagnosing liver disease. The demand for a better way of diagnosing this disease is greater than most people think, says Richard Ehman, a Mayo Graduate School professor of radiology and leader of the Mayo Clinic team that developed MRE. Nearly 170 million people worldwide have hepatitis C infections and one quarter of those cases can lead to liver disease that leaves the organ scarred and otherwise damaged, he says, adding, "The latest estimate is that in the U.S. 5 million people have hepatitis C infections and many people don't even know it."
More than 15 years ago, Ehman began experimenting with mechanically produced seismic waves—called shear waves—that could travel through human tissue. As these waves pass through the body, they displace tissue by a matter of a micron or less. Ehman and his colleagues modified a magnetic resonance imaging (MRI) system to be able to detect these incredibly subtle changes and found that by applying a mathematical algorithm to the data produced by the scan researchers could generate an image that quantified the stiffness or elasticity of an organ. "I was inspired by the power of palpation as a diagnostic tool for physicians," he says. "Simple touch can find things that highly sophisticated equipment can miss."
It took the ensuing decade and a half to develop the technology that could make MRE practical in the human body. GE Healthcare on Monday introduced its MR-Touch device, the first commercial application of MRE technology, which the company has licensed from the Mayo Clinic.
The MRE sequence takes about 15 seconds and can be performed at the end of a standard 45-minute MRI liver exam. If doctors could more easily diagnose liver fibrosis (scarring caused by the hepatitis C virus) or cirrhosis (characterized by the replacement of liver tissue with fibrous scar tissue), they could "treat, halt and in many cases reverse the disease," Ehman says. The technology, he adds, also holds out the possibility of early detection of liver cancer.
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November 27, 2009
Tripep: The ChronVac-C® Study Has Been Successfully Completed with Good Safety and Favorable Clinical Data
www.earthtimes.org
STOCKHOLM, Sweden - (Business Wire) All samples from the 12 patients with chronic Hepatitis C genotype 1 treated with Tripep’s therapeutic vaccine ChronVac-C® have now been collected. The treatment was found to be safe, immunogenic and had transient effects on the serum levels of hepatitis C virus. This provides a proof-of-concept for the therapeutic strategy. In addition, early data from three patients who have initiated standard of care treatment after completing the clinical trial have experienced a rapid loss of the virus, implying a possible role for ChronVac-C® in combination therapies. Tripep will therefore pursue clinical development of ChronVac-C® along two lines, the current ChronVac-C® as an addition to standard of care, and a 2nd generation improved ChronVac-C® as a monotherapy. GMP production and preclinical safety testing of the 2nd generation ChronVac-C® should start in the spring of 2010. Finally, Tripep has filed an application with the Swedish Medical Products Agency to give the last three patients in the finalized study a fifth booster dose 6-12 months after the fourth dose.
All patients have now completed treatment with ChronVac-C®. A first summary of available data (immunological analysis of some samples are still under way) shows that the treatment was found to be safe, immunogenic and had transient effects on the serum levels of hepatitis C virus. In the lowest (167 µg) dose group, no reductions in serum levels of HCV RNA were noted and no immune responses lasting ≥ 1 month were detected. In the 500 µg dose group 2/3 patients showed transient reductions in serum levels of HCV RNA (up to -1,5log10) and in the same two patients T cell responses to the vaccine lasting ≥ 1 month were activated. In the 1500 µg dose group 3/6 patients showed transient reductions in serum levels of HCV RNA (up to -2,4log10) and in two of these three patients T cell responses to the vaccine were obtained that lasted ≥ 1 month. This provides a proof-of-concept for the therapeutic strategy and supports further clinical development. In addition, early data from three patients who now have initiated standard of care treatment after completing the clinical trial have experienced a rapid loss of the virus, possibly suggesting a role for ChronVac-C® in combination therapies. This data will be monitored for as many patients as possible during the coming year to obtain a more solid data base. Tripep will therefore pursue clinical development of ChronVac-C® along two lines, the current ChronVac-C® as in as an addition to standard of care and an improved 2nd generation ChronVac-C® as a monotherapy. Preclinical safety testing of 2nd generation ChronVac-C® should start in the spring of 2010. Finally, Tripep has filed an application with the Swedish Medical Products Agency to give the last three patients a fifth booster dose.
“We are extremely pleased with the outcome of the clinical trial in particular considering that this was the first time ever that a DNA vaccine was delivered using in vivo electroporation against an infectious disease. We now have an excellent basis from which we continue clinical development and are looking forward from the additional exciting clinical data from the patients when they undergo standard of care therapy. We will report these data as they become available to us. Following this success we will now actively expand our therapeutic vaccine program also into chronic hepatitis B were we during 2009 have generated highly promising therapeutic vaccine candidates” says Tripeps CEO Anders Vahlne.
Tripep develops drugs against chronic disease based on proprietary and other parties’ patented and patent pending technologies. Tripep is focusing on the following research projects; wound healing therapy ChronSeal and a therapeutic vaccine against Hepatitis C, named ChronVac-C®, plus the RAS® technology platform. The Tripep share is admitted to trade on First North. Remium AB is Certified Adviser for Tripep AB. For more information, please refer to the company’s Website: www.tripep.se.
In the event of any discrepancy between the Swedish and English versions of this press release, the Swedish version will take precedence.
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November 28, 2009
With Jesper Mattsson
http://www.chinadaily.com.cn
(China Daily)
Having lived with Hepatitis C for nearly 20 years, London-based music producer and songwriter Jesper Mattsson has a personal investment in raising awareness of the chronic viral disease that affects 130 million people worldwide (another 350 million live with Hepatitis B).
As the disease claims 150 million lives every year, the World Health Alliance (WHA) is promoting greater access to vaccines and treatments to halve the annual death toll.
Mattsson, who is Danish, is working with artists from as far afield as Argentina, Norway, Bangladesh and Africa to produce the WHA's first music album aimed at raising the profile of Hepatitis. The album, which will also include a song from Mattsson's own band, will be released on World Hepatitis Day (May 19), a day that came into being last year due to collaborative efforts between North America, Latin America, Europe, North Africa, Australasia and China.
The 44-year-old, whose resume includes stints with legendary producers like Mike Hedges (U2, Dido) and Gordon Raphael (The Strokes), was in Shanghai this week to record one of Shanghai's oldest alternative rock bands, The Honeys (Tianmi de Haizi), the only Chinese contributor on the WHA compilation.
Mattsson took a studio break from recording The Honeys' "Yi Jiang Nan" (Remember Southern China), a song about separated lovers, to chat with Shanghai Star Weekend writer Linda Yu.
Q: Tell us a bit about your band's song for the album.
A: "Juju Man" is about witch doctors in Africa. Our band Crash Atkins is named after a foreign correspondent and Juju Man is sort of like a character - a lot of our songs are his stories as inspired by newspaper articles or stories on the news. Gary Lucas from New York, who Rolling Stone magazine calls perhaps one of the greatest living guitarists today, will play "Juju Man" with us for the WHA project.
Q: Why include China on a project like this?
A: China is a massive country, and you cannot completely ignore China on something like this. Also, the World Hepatitis Alliance is very big here in China and the patient-organization is one of the biggest (about 150 million Chinese live with Hepatitis B and roughly 40 million with Hepatitis C), so it was very important for us from the start to find a Chinese artist.
Q: What made you decide to include a track from The Honeys?
A: I think it's important a serious band gets heard. A lot of people in the United States think that most Chinese artists are pop because a lot of what you hear is stereotypical and is that kind of pop stuff. The Honeys is a band with a long history, they have weight, and have had to endure to keep going here because it's not as easy here to be a rock band compared to the West.
Q: What was it like working with the Shanghai band?
A: Working with them made me feel like they were kind of R.E.M-ish, not like they sound like R.E.M, but for me Michael Stipe has that quality of speaking the truth, there's something that makes you want to listen to him, and lead singer Yu Tian has that quality, too, a real strong kind of presence that is rare.
Q: Do you think Chinese bands like The Honeys, which sing in Chinese, can make it on the world stage?
A: I can't see why not really. There are bands like Sigur Ros, the Icelandic band, singing a language that no one understands and it still sells lots of records. It's not always about people understanding the lyrics; it's about conveying something else. I can't see why a song with Chinese lyrics wouldn't be able to reach an audience outside of China.
Q: What kind of opportunities are there?
A: People are listening to more international music. That's one of the main reasons we didn't want this to be a traditional charity record with a bunch of UK pop stars singing for the WHA. It's much more interesting to go out in the world and say: "Who are they listening to in Bangladesh? Who are they listening to in China? What does Mayan music sound like, and who do the Brazilians like?" I'm sure it will travel beyond language because all the music on this CD is quite heartfelt.
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