HCV Weekly Rewind Of Hepatitis C News and Research

Greetings,

This weeks review of HCV headlines and latest research for the week of May 14, including updates as the day progresses. Click here to view previous or future"HCV Weekly Rewind" articles.


In The News-Hepatitis Awareness

U.S. health officials want all baby boomers to get tested for hepatitis C.
The Centers for Disease Control and Prevention on Friday released draft recommendations calling for all baby boomers to get a one-time blood test for the liver disease. That's everyone born from 1945 to 1965.
Click here for the CDC press release....

All baby boomers should get hepatitis C test -CDC
Fri May 18, 2012 1:14pm EDT
(Reuters) - All baby boomers should be tested at least once for the liver-destroying hepatitis C virus, according to proposed guidelines from U.S. health officials released on Friday.The often-undiagnosed virus is transmitted through contaminated blood. While infection rates have dropped dramatically since the early 1990s - due in part to the introduction of blood and organ screening - many older adults are still at risk, according to the U.S. Centers for Disease Control and Prevention, which released the draft guidelines.

According to the CDC, one in 30 baby boomers - the generation born from 1945 through 1965 - has been infected with hepatitis C, and most do not know it.

A one-time, cost-effective blood test would "identify hundreds of thousands of hidden infections," said Dr John Ward, director of CDC's division of viral hepatitis.

He likened the proposal to existing age-related guidelines on screening for diseases including breast cancer, cervical cancer and high cholesterol.

Hepatitis C causes serious liver diseases, including liver cancer - the fastest-rising cause of cancer-related deaths - and is the leading cause of liver transplants in the United States.

The CDC said it believes routine blood tests will address the largely preventable consequences of the disease, especially in light of newly available therapies that can cure around 75 percent of infections.
The field has attracted broad interest with two new hepatitis C drugs - Incivek from Vertex Pharmaceuticals Inc and Merck & Co's Victrelis - reaching the U.S. market in the past year.

Companies including Gilead Sciences Inc and Bristol-Myers Squibb Co aim to improve on those medicines with pills that do not need to be combined with injections of immune system boosters, which have side effects that can deter patients.

More than 15,000 Americans, most of them baby boomers, die each year from hepatitis C-related illness, such as cirrhosis and liver cancer.

Current U.S. guidelines call for testing only individuals with certain known risk factors for hepatitis C infection.

The CDC said it will accept public comment on the draft recommendations from May 22 to June 8.
Final recommendations will be issued later this year.
(Reporting By Deena Beasley in Los Angeles; editing by John Wallace and Matthew Lewis)
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How much do you know about hepatitis C?
By Jennifer Huget
Hepatitis C is one of those infections I hear about but never really pay much attention to; naively or not, it never has struck me as something I need to worry about, at least on a personal level.

Apparently I am not alone. A survey conducted by the American Gastroenterological Association (AGA) released this week shows that 74 percent of people born between 1945 and 1965 either have not been tested or don’t remember whether they’ve been tested for hepatitis C, which is spread via contact with infected blood.

But the CDC counts about 3.2 million people in the U.S. as having hepatitis C, which can linger without causing noticeable symptoms for years but can cause serious liver damage, failure, or cancer. In fact, according to that agency, it’s the leading cause of those conditions — and the need for liver transplant — in the United States.

People who have ever used intravenous drugs, had blood transfusions or organ transplants before 1992 (when stricter screening practices took hold), had tattoos or body piercings, work in health-care settings or have HIV are at increased risk of having hepatitis C. Baby boomers — “the majority of whom were likely infected during the 1970s and 1980s when rates were highest,” according to the CDC, are considered at increased risk.

According to the CDC, more than 15,000 deaths each year in the United States are attributable to hepatitis C.

While there’s not yet a vaccine to prevent hepatitis C, it can be detected through a simple blood test and, in many cases, it can be cured. With that in mind, the AGA encourages people to get themselves tested and offers hepatitis C information through a campaign called I.D. Hep C.

The AGA’s campaign is funded by a pharmaceutical company called Vertex, whose new hepatitis C drug, Incivek, was approved by the FDA last May.

The CDC devotes a substantial chunk of its Morbidity and Mortality Weekly Report (MMWR) to hepatitis, with papers about tracking infection among patients exposed to hepatitis B or hepatitis C virus in health-care settings, outbreaks of hepatitis B among residents of assisted living facilities in Virginia that are linked to their assisted blood glucose monitoring, and hepatitis C infection that’s associated with drug use among adolescents and young adults. “The findings in all three reports underscore the importance of viral hepatitis surveillance in detecting outbreaks and changes in transmission patterns,” the MMWR report notes.

Why all this hepatitis news?
This month marks the 17th federally designated (by the U.S. Department of Health and Human Services) Hepatitis Awareness Month, and this Saturday, the 19th, is the first-ever National Hepatitis Testing Day, also set by that agency.

So, will you get yourself tested?
By Jennifer Huget | 07:00 AM ET, 05/18/2012
Source

Tracking down hepatitis C virus spread
May 18, 2012 at 1:11 AM           
ATLANTA, May 18 (UPI) -- The number of hepatitis C virus cases in people age 30 and younger in six rural Wisconsin counties went from eight in 2009 to 24 in 2010, officials said.
A report published in the Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report said among the 25 patients investigated medical records of 21 were reviewed, 17 patients were interviewed and 16 provided blood samples for quasispecies analysis to assess relatedness of their hepatitis C virus.

"Of the 25 patients, 28 percent had symptoms of jaundice, consistent with acute hepatitis C virus infection. All 25 patients had antibodies to hepatitis C virus by enzyme immunoassay," the report said. "Ninety-four percent of 17 interviewed patients admitted to sharing hypodermic needles, drug preparation equipment, or drug snorting equipment. Ninety-four percent of 17 interviewed patients admitted to either injecting drugs [12 patients], snorting illicit drugs [16 patients], or both [12 patients]."

Three of eight patients who reported injecting opioid pain relievers started injecting prescription opioids and switched to injecting heroin or methamphetamine after a median of three years, the report said.

"Six specimens could be analyzed at the CDC for variations and four of them were genetically similar in that region," the report said. "These underwent quasispecies analysis but were unrelated, suggesting that patients were infected through unrelated networks of hepatitis C virus transmission and that many other undetected cases might also exist."
Source

EDT OraSure Technologies Announces Rapid HCV Testing Initiatives for First National Hepatitis Testing Day

BETHLEHEM, Pa., May 18, 2012 (GlobeNewswire via COMTEX) -- OraSure Technologies, Inc. today announced its support of numerous rapid hepatitis C (HCV) testing initiatives for the first National Hepatitis Testing Day, taking place on May 19, 2012. These testing initiatives, happening in more than 20 cities across the country, will help encourage thousands of people across the U.S. to get tested for hepatitis C with the OraQuick(R) Rapid HCV test.

Among these programs is the Check Hep C NYC program, being launched today by The Fund for Public Health in New York, in partnership with the New York City Department of Health & Mental Hygiene Office. This city-wide initiative will provide hepatitis C community-based services, including rapid hepatitis C testing for New Yorkers at risk for hepatitis C. The program will aim to test at least 5,000 persons for hepatitis C using the OraQuick(R) HCV rapid test.

"With the release of a new HCV rapid test, more individuals will become aware of their HCV status and will need HCV-related services," said New York City Deputy Health Commissioner Dr. Jay Varma. "It is imperative that New Yorkers with hepatitis C be linked with health care and human services providers in their communities, and Check Hep C is designed to get this done as effectively as possible."

OraSure is also working with Walgreens and local community-based organizations to provide free screenings for hepatitis C at six Walgreens retail pharmacies in Chicago, Houston, St. Louis and Washington D.C. on Saturday, May 19. Testing will be conducted by the local community-based organizations.

Additional OraQuick(R) HCV testing initiatives are taking place this week in Chicago, Columbus, Honolulu, Houston, Los Angeles, New York City, Washington, D.C. and various other cities.

According to the CDC, hepatitis C is the most common chronic blood-borne infection in the U.S., and a leading cause of chronic liver disease, cirrhosis and liver cancer. More than four million people are estimated to have hepatitis C in the U.S. -- including 1 in 33 baby boomers (those born between 1945 and 1965). It is estimated that up to 75 percent of those individuals infected with HCV are unaware of their status.

"We are proud to be among the many organizations taking action today against hepatitis C by promoting greater awareness, education and testing for those at risk for the disease," said Douglas A. Michels, President and CEO of OraSure Technologies. "Of the more than four million Americans estimated to be infected with HCV today, most are unaware. Our new rapid OraQuick(R) HCV test makes testing easier and more accessible."

OraQuick(R) HCV is the only FDA-approved rapid, point-of-care test for the detection of antibodies to the hepatitis C virus. The test, which utilizes the OraQuick(R) technology platform, provides results in 20 minutes.

About OraSure Technologies

OraSure Technologies is a leader in the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its innovative products include rapid tests for the detection of antibodies to HIV and HCV at the point of care and testing solutions for detecting various drugs of abuse. In addition, the Company is a leading provider of oral fluid sample collection, stabilization and preparation products for molecular diagnostic applications. OraSure's portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health.

For more information on OraSure Technologies, please visit www.orasure.com .

This news release was distributed by GlobeNewswire, www.globenewswire.com  

SOURCE: OraSure Technologies, Inc.

Hepatitis C testing rate low and knowledge of the infection poor in the US 'baby boomer' generation
Michael Carter

Published: 18 May 2012

Only a quarter of US individuals in the generation most likely to have hepatitis C have ever been tested for the infection, results of a survey conducted by the American Gastroenterological Association (AGA) show.

Moreover, 80% of patients in the “baby boomer”generation (born between 1945 and 1965) did not consider themselves as having any risk of the infection. This is despite the findings of a recent US mortality survey showed that hepatitis C deaths were concentrated in the 45 to 64 age group.
An estimated 5 million individuals in the US are infected with hepatitis C and up to 50% of these infections are diagnosed.

Surveillance data suggests that 82% of infections are concentrated in the baby boomer generation. Three-quarters of hepatitis C-related deaths also occur in this age group.
Hepatitis C screening strategies are risk based, focusing on individuals with a history of injecting drug use. The authors of one recent study commented that this approach had been “notably unsuccessful, as few have been screened for risk and are still only tested when they have symptoms…few physicians ask about the major risk factor for HCV, injecting drug use, and few interviewees wish to admit this behavior.”

Some doctors are therefore advocating an “age-based” approach to testing, with efforts focusing on patients aged 45 to 64, the generation with the highest prevalence of the infection.
The results of the latest survey suggest that there is very low awareness of hepatitis C in this baby boom generation.

“Alarmingly…results revealed that while baby boomers are most at risk of having hepatitis C, the majority are unaware of their risk and have never been or are unsure if they have been tested,” states a factsheet accompanying the results of the study.“This lack of knowledge has significant implications because, of the nearly 5 million Americans infected with hepatitis C, 82% are baby boomers.”
The online survey was conducted by the market research company Harris Interactive on behalf of the AGA. A total of 1006 individuals born between 1945 and 1965 completed a questionnaire enquiring about their knowledge of hepatitis C, testing history and discussions about the infection with health-care providers.

“The survey was developed to determine how knowledgeable baby boomers across the US are about hepatitis C, to reveal where the lack of understanding for hepatitis C lies among this at risk population and identify where more education and action are needed,” says the factsheet.
Even though over eight in ten hepatitis C infections are in patients aged 47 to 67, the majority (80%) of study participants did not consider themselves as being at risk of the risk. Only 17% were aware that their generation had the highest prevalence of the infection.

The participants were also largely unaware about many important facts about hepatitis C.
Crucially, only 18% were aware that the infection could be cured. Half believed that prevalence of the infection was similar across age groups, with 25% stating that the risk was greatest for those in their 30s and early 40s.

Findings of the study suggested that no more than a quarter of participants had ever been tested for hepatitis C. Moreover, 83% started that they had never even discussed the infection with a health-care provider.

When they did occur, these discussions were clearly beneficial. Individuals who had talked to the doctor about hepatitis C felt more knowledgeable about the infection (76% vs. 30%) and were considerably more likely to have been tested (64% vs. 18%).
The factsheet publicising the findings of the survey can be downloaded here.

Source

Research

Gay Men Have Higher Liver-Related Mortality From HBV Than HCV
By David Douglas
NEW YORK (Reuters Health) May 16 - In a population of men who have sex with men (MSM) -- with a high prevalence of HIV infection -- chronic hepatitis B virus (HBV) led to twice as many liver-related deaths as chronic hepatitis C virus (HCV), researchers report.
"Our findings further highlight the need to expand screening for, and vaccination against, hepatitis B. Individuals found to be infected with hepatitis B need to get evaluated for treatment," lead investigator Dr. Oluwaseun Falade-Nwulia told Reuters Health by email.

In an April 20th online paper in Clinical Infectious Diseases, Dr. Falade-Nwulia of Johns Hopkins University School of Medicine, Baltimore, Maryland and colleagues reported on 680 men with HBV and 343 with HBC taking part in the Multicenter AIDS Cohort Study, including 472 (69.4%) with HIV-1.

Over 6,728 person-years of follow-up, there were 293 deaths from all causes, including 51 from liver disease. The mortality rate per 1,000 person-years was similar between HBV and HBC groups (41.2 vs 46.4) - but liver-related mortality was significantly higher in HBV patients (9.6 vs 5.0).
Forty-six of 51 liver-related deaths were in men with HIV. This gave a corresponding mortality rate per 1,000 person-years of 10.7 in HIV patients and 2.1 in those without HIV.
In HIV-infected men, the liver-related mortality rate has fallen since 2002 in both in those with HBV and those with HCV.

HIV men with CD4 cell counts below 200 cells/mm3 had a 16.2 fold increased risk of liver-related death compared to those with counts beyond 350 cells/mm3.

The authors call for more studies "to determine whether the results are applicable to women, HIV-uninfected individuals or to men who are infected with HBV or HCV through other routes."
Although not directly comparable, a large prospective study in a general Taiwanese population also showed the negative influence of HBV. Participants with inactive HBV were twice as likely to have a liver-related death as controls negative for HBV surface antigen and antibody against HCV. (See Reuters Health report of February 15, 2010.)

The authors of the current study say it "emphasizes the need for a more aggressive approach to the prevention, diagnosis, and treatment of chronic hepatitis B including increasing vaccination rates among all hepatitis B susceptible individuals."

Although fatalities are greater in the immunocompromised, Dr. Falade-Nwulia pointed out that "everyone, regardless of HIV status should be evaluated for treatment of hepatitis B."
Dr. Falade-Nwulia added, "We need to more effectively use the tools we already have against hepatitis B and continue to work towards finding a cure."

Dr. Lionel Piroth of CHU Dijon, France, who did not take part in the study, told Reuters Health by email "I agree with the comments of the authors." He said the new results complement findings he and his colleagues reported several years ago (see Reuters Health report of September 10, 2010), namely, that HIV does not appear to affect the success of HBV treatment.

The US findings, he added, "strengthen the 'old' recommendations to screen and vaccinate (if no HBV serological markers detected) HIV-infected patients against HBV. Furthermore, and even though not statistically significant, the temporal trend observed... highlights the need and the interest of efficient anti-HBV therapy on the clinical evolution of the patients."
SOURCE: http://bit.ly/K83reA
Clin Infect Dis 2012.

Hepatitis C Patients-Milk Thistle Does Not Alter Disease Activity
San Francisco—One of the first rigorous trials to test the popular herbal extract milk thistle (silymarin) has shown that this treatment does not relieve symptoms or slow disease progression in patients with hepatitis C who are nonresponsive to interferon (IFN).

HBVandHCV-Direct Comparison of Diagnostic Performance of Transient Elastography
This study was specifically designed to evaluate and compare the diagnostic performance of transient elastography (TE) for the assessment of liver fibrosis in HBV and HCV subjects and was carried out in a single centre and included a large cohort of consecutive subjects who underwent a liver biopsy (n = 565). Its results confirm that TE measurement is an accurate tool for the non-invasive diagnosis of liver fibrosis in patients with chronic viral hepatitis, either related to HBV or HCV.

Neuropsychological dysfunction in cirrhosis and chronic hepatitis C
More recently, it has become apparent that patients with chronic hepatitis C virus (HCV) infection complain of a variety of neuropsychiatric sequela including confusion ('brain fog'), anxiety and depression, in the absence of significant liver disease. Most studies on these issues have been performed by hepatologists who have acted as amateur psychologists. In this review, we discuss some of the pitfalls of neuropsychological assessment and put the published studies on HE and non-cirrhotic chronic HCV infection into context.

Recalled

Johnson & Johnson's Imodium
Johnson & Johnson's McNeil Consumer Healthcare unit is recalling 53,892 packages, or one lot, of the diarrhea treatment Imodium from distributors after discovering some of the packages could have a slight tear or hole.

The packs of 18 Imodium Multi-Symptom Relief caplets don't pose any safety threat, and consumers haven't reported any side effects, the company says. Yet exposure to air, through a pinhole or tear in the packaging, could blunt the pills' effectiveness, the company says.
Because the defect doesn't pose any health risks, J&J says it is only recalling lot number CMF023 from wholesalers, and asking any consumers who might have received a defective package to not use it. Consumers can call 1-888-222-6036 with any questions or concerns.
Source

Pharmaceuticals

Hepatitis C-ACH-3102 Receives Fast Track Designation From the FDA
NEW HAVEN, Conn., May 15, 2012 (GlobeNewswire via COMTEX) -- Achillion Pharmaceuticals, Inc.announced today the receipt of a Fast Track designation from the U.S. Food and Drug Administration (FDA) for ACH-3102 as part of an interferon-free regimen for the treatment of chronic hepatitis C (HCV). ACH-3102 is a pan-genotypic second-generation NS5A inhibitor against HCV that was discovered by Achillion and is currently being evaluated in a Phase 1 clinical trial.

Researchers call for revision of statin guidelines after analysis reveals benefits outweigh risks
Last Updated:May 17, 2012 18:48
Findings from a meta-analysis published in The Lancet suggest that statins reduce the risk of serious vascular events in adults by about 20 percent, regardless of their heart disease status. Moreover, the analysis revealed that this benefit greatly exceeds any known hazards of statin therapy, prompting the study's authors to recommend for a review of UK and international guidelines on these drugs.

Researchers reviewed data from 22 statin-versus-control trials and five trials of more-versus-less statin, involving approximately 175,000 people in total. The analysis found that statins reduced the risk of serious vascular events by 21 percent for each 1 mmol/L reduction in LDL cholesterol in each of the five risk groups the researchers identified, including those at lowest risk for vascular disease. This lowest risk group includes those with a five-year risk of a major vascular event lower than 10 percent, meaning "people who would typically not be judged suitable for statin treatment." Since most statins can reduce LDL by much more than 1 mmol/L, there could be even larger absolute reductions in serious vascular events if statins were used more widely, the researchers noted.

Co-author Colin Baigent calculated that lowering the threshold for prescribing statins to a 10-percent risk of cardiovascular disease within a decade would lead to five million more people taking the drugs. In turn, he noted that this would save 2,000 lives and prevent 10,000 heart attacks or strokes every year. "Half of [these] deaths come out of the blue in people who were previously healthy...If we are going to prevent that half of cardiac or stroke deaths, then we've got to consider treating healthy people," he said.

In the analysis, there was no evidence that reduction of LDL cholesterol with a statin increased cancer incidence, cancer mortality or other non-vascular mortality. The FDA recently required label changes to statins, to warn of certain problems associated with the therapies, including diabetes risk and memory problems. "Statins may produce small increased risks of haemorrhagic strokes and in diagnoses of diabetes, but the definite benefits of statins greatly outweigh these potential hazards," the authors concluded.

Current US and European guidelines restrict statin use to people with at least a 20 percent risk of having a major vascular event within 10 years. However, the researchers noted that the data suggest that treating patients with a risk as low as 1 percent was likely to prove cost-effective. The National Institute for Health and Clinical Excellence has indicated that it will update its guidelines, noting that "new evidence on statin treatment thresholds that has become available since publication of the original NICE guideline, including the study reported in The Lancet, will be considered as part of our review." The agency's conclusions will be published towards the end of 2013.

In an accompanying commentary, Shah Ebrahim noted that "this research provides further evidence that statins are an effective and safe way of reducing the risk of heart attacks and strokes even among people at quite low risk of these conditions." He added that "the benefits of giving statins to everyone over the age of 50 would probably save the NHS money in the long run, owing to the savings in health care costs from the heart attacks and strokes prevented."
Source

Counterfeit Drugs

Stopping Fake Drugs From Pakistan Is Too Late for Victims
By Farhan Sharif and Khurrum Anis - May 17, 2012 3:02 PM PT

Excerpt;
read full article here...

In Pakistan’s biggest market for wholesale medicines, it pays to be observant. 

More than 2,500 stalls wedged along dirt lanes in Karachi’s busiest trading district offer everything from Pfizer Inc. (PFE)’s cholesterol pill Lipitor to GlaxoSmithKline Plc (GSK)’s painkiller Panadol. Closer study of the remedies lining rickety shelves reveals the source of an unfolding medical crisis: Lipitor sold in obsolete packaging, Panadol packets missing tell-tale ribbing, and allergy medicine Zyrtec mislabeled as Zytrec.  

Now, the free flow of fake medications channeled through the market for decades may soon be slowed. Lawmakers are poised to pass legislation in June creating an agency to quash the trade after 107 heart patients were killed this year by pills tainted with lethal amounts of an anti-malarial agent. That may help break the ring of counterfeiters in Pakistan, part of a wider network supplying what the World Health Organization estimates is a $431 billion global market for spurious drugs.  

“The issue is serious, demanding serious steps,” said Salman Burney, chief executive of GlaxoSmithKline Pakistan Ltd. (GLAXO)in Karachi. “Better regulation will generate more investment in the pharmaceutical industry, which will mean better quality medicines.”  

The problem spans national borders. Pakistan was one of the10 largest sources of counterfeit goods seized in the U.S. last year, U.S. Customs and Border Protection said in January. Medicines accounted for 85 percent of the value of the Pakistani items obtained.  

At least 30 percent of medicines bought in the country are either counterfeits or substandard, said Kulsoom Parveen, a lawmaker who chairs a Senate health committee. Pharmacies nationwide sell drugs without a doctor’s prescription, enabling the treatments to be taken without medical supervision. 

Chronic Diseases  

The need for effective drug treatments is increasing in Pakistan, where about half of adults older than 50 years sufferhigh blood pressure, according to the WHO. The country had 6.3 million adults with Type-2 diabetes last year, the International Diabetes Federation estimated. By 2030, the tally will be 11.4 million, the 10th-highest tally worldwide, the Brussels-based group predicts.  

Counterfeit medicines don’t just risk lacking their purported active ingredients. Some are potentially deadly --laced with substances that include rat poison, brick dust and paint, said Scott Davis, a former U.S. customs official who heads security in Asia-Pacific for Pfizer in Singapore.  

Less than 1 percent of medicines in developed markets and as much as 30 percent or more in developing countries are fake, the Geneva-based WHO estimates. China and India are probably the biggest suppliers of the counterfeits, which cause 700,000deaths a year among malaria and tuberculosis sufferers alone, according to the Washington-based International Policy Network.

To contact the reporters on this story: Farhan Sharif in Karachi, Pakistan at Fsharif2@bloomberg.net; Khurrum Anis in Karachi, Pakistan at Kkhan14@bloomberg.net.
To contact the editor responsible for this story: Jason Gale at j.gale@bloomberg.net.
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Healthy You

Study shows creatine helps negate liver damage from high-diet fats
A collaborative effort between researchers at the University of Alberta, Memorial University and the University of Sao Paulo has shown that creatine, a naturally occurring amino acid in the human body, may contain properties that help fight the onset of non-alcoholic fatty liver disease (NAFLD) due to a high fat diet.

Experts call for clinical trials to test non-skeletal benefits of vitamin D
Observational studies show vitamin D may benefit cardiovascular, skin and metabolic disorders
Chevy Chase, MD—The Endocrine Society's new scientific statement published online today represents the first comprehensive evaluation of both the basic and clinical evidence related to the non-skeletal effects of vitamin D. The statement addresses current research regarding the associations of vitamin D with immune function, hypertension, stroke, skin conditions and maternal/fetal health.
Vitamin D is a steroid hormone that regulates calcium and phosphate levels in the bloodstream and promotes healthy bone growth. Vitamin D deficiency is common throughout the world and results in abnormalities of calcium, phosphorus and bone metabolism which can lead to muscle weakness, osteomalacia, osteopenia and osteoporosis. While some observational studies have shown that benefits of vitamin D may extend beyond bone health, research findings remain inconsistent.

"The role of vitamin D supplementation in the prevention and treatment of chronic non-skeletal diseases remains to be determined," says Clifford Rosen, MD, of Tufts University School of Medicine and chair of the task force that authored the statement. "We need large randomized controlled trials and dose-response data to test the effects of vitamin D on chronic disease outcomes including autoimmunity, obesity, diabetes, hypertension and heart disease."

The scientific statement outlines the evidence that defines the effects of vitamin D on epidermal, neuromuscular, maternal/fetal and neoplastic (abnormal growth) tissues. The authors critically evaluated the literature for each organ system utilizing available evidence from observational studies and randomized trials to determine the strength of associations between vitamin D and tissue-specific outcomes.

Conclusions from the statement include:

• Topical and oral vitamin D may be useful in treating skin disorders such as psoriasis, though large-scale randomized placebo-controlled clinical trials are needed to demonstrate the efficacy of treatment with vitamin D on skin disorders or the prevention of skin cancer.
• The ever-expanding obesity epidemic has been associated with a rising prevalence of vitamin D deficiency, but a cause-and-effect relationship has not been established. Strong evidence does not exist to support the tenet that vitamin D supplementation reduces the risk of type 2 diabetes or the metabolic syndrome.
• Vitamin D supplementation is likely to reduce the risk of falls, particularly in individuals who have low baseline levels (<20 ng/ml) and are supplemented with calcium as well.
• Recent systematic reviews have found that evidence that vitamin D reduces cancer incidence are inconclusive as to causality. Observational evidence is strongest for colorectal cancer but is weak or inconsistent for breast, prostate and total cancer.
• There is a possibility that vitamin D supplementation may lower cardiovascular disease risk, but there are limitations in applying observational data to clinical practice. An insufficiency of evidence from clinical trials does not support recommending vitamin D supplementation for lowering cardiovascular disease risk at this time.
• Clinical trials are needed to test whether vitamin D supplementation during pregnancy will prevent type 1 diabetes in offspring.

The article, "The Nonskeletal Effects of Vitamin D: An Endocrine Society Scientific Statement," appears in the June 2012 issue of The Endocrine Society's Endocrine Reviews.

###

Founded in 1916, The Endocrine Society is the world's oldest, largest and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 15,000 scientists, physicians, educators, nurses and students in more than 100 countries. Society members represent all basic, applied and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit our site at www.endo-society.org. Follow us on Twitter at https://twitter.com/#!/EndoMedia.
Source

More Evidence Links Early Cannabis Use to Psychosis
"The uniqueness of this study lies in the demonstration of an association between early cannabis use and subsequent schizophrenia-like symptoms that persisted into adulthood and that was not explained by early anxiety or depressive disorders, or exposure to other drug and cigarette use," study author Deidre M. Anglin, PhD, assistant professor of clinical psychology, City College and Graduate Center, City University of New York, told Medscape Medical News.

Off The Cuff

Health Minister approves new Hepatitis C drugs
HEALTH MINISTER JAMES Reilly has confirmed that the most up-to-date and effective treatments for those suffering with hepatitis C will be made available to women infected in Ireland as a result of contaminated blood products.

Speaking in the Dáil this week, Reilly said both boceprevir and telaprevir will be made available – and reimbursed – within the hospital system.

The announcement has been cautiously welcomed by Positive Action, the support group established to represent 732 women who contracted hepatitis C from Anti-D injections between 1970 and 1994.
Spokesperson Detta Warnock told TheJournal.ie that the group has some reservations because it has yet to receive details from the Department of Health or Health Service Executive.
“We’re not quite sure how it’s going to be,” she said. “[The Minister] had agreed to a meeting but none has been held yet. We went throught various TDs to put our questions to him – which happened in the Dáil on Wednesday evening.”

Described as breakthrough drugs by Reilly, boceprevir and telaprevir have proven their efficacy in other jurisdictions and Positive Action has been pushing for them to be included on the HSE’s reimbursement list for months.

The treatments – when given with ribavirin and alpha interferon as a triple therapy – have seen impressive results in the US and elsewhere. Warnock says that when the drug is added to the current dual treatment programme, success rates double from 40 per cent to about 80 per cent.
The Minister acknowledged the results obtained by the drugs when treating adults with hepatitis C.

They are the first to have been shown to clear the body of the virus. This is a welcome development, one that offers real hope of a normal life for persons who have suffered as a consequence of contracting hepatitis C.

Reilly added the HSE is putting protocols in place to allow the treatment to start as soon as possible. Both drugs have passed all the necessary licensing requirements.

“Anyone who meets the criteria under the protocols will have access to these new treatments,” he said.
Warnock has called on the Department of Health to clarify the Minister’s statements about criteria and which drug scheme the treatments will fall under.

The HSE has said that those details will be worked out but the key point is that all barriers to the drugs have now been lifted.

Speaking to TheJournal.ie earlier this year, Warnock said that no woman within her group would take the decision to undergo the treatment lightly.

“It is a bit undertaking,” she said of the months-long, harsh treatment programme.
Currently, there are some women receiving the most up-to-date triple treatment under a named-patient programme at the Mater hospital in Dublin but drug companies are footing the bill to get the product out to market.

Others have already been assessed and are ready to start the 48-week-long process. Reilly said those patients would “progress quickly”.

The Minister also reiterated his commitment to meet with members of Positive Action.

Cost of treatment

It is understood that treatment could cost up to to €50,000 per year per patient.
After an evaluation in January this year, the National Centre for Pharmacoeconomics said it considers telapevir a “highly cost effective therapy” when added to the current dual treatment of interferon and ribavirin of patients infected in the Irish healthcare setting.
About 1,200 women were contaminated with hepatitis C when they received anti-D immunoglobulin manufactured or distributed by the Irish Blood Transfusion Service between 1970 and 1994.
The blood product was administered to new mothers of a certain blood type to prevent haemolytic disease in the foetus of future babies. Warnock said that about 67 of Postive Action’s members have died since it was established in 1994.
Source

China's Plan To Stop Harvesting Prisoner's Organs-Will Be Almost Impossible To Enforce
Zhang, 59, got his liver, but where it came from is something he doesn't want to ask.
"Most of the organs here come from executed prisoners," Gao, 57, says in hushed tones inside a transplant ward at the Tianjin First Center Hospital, the country's largest transplant facility. "I haven't considered whether it's right or wrong. All we want is a good liver."