Tuesday, November 22, 2011

HCV News Ticker-How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow

New On The Web Site

Ontario first province to reimburse new chronic hepatitis C treatment VICTRELIS™ Now Available for Eligible Patients in Ontario
The Canadian Liver Foundation is pleased that Ontario’s public drug program has agreed to reimburse boceprevir for the treatment of chronic hepatitis C,” says Dr. Morris Sherman, Chairman of the Canadian Liver Foundation. “Boceprevir represents a major advance in our ability to cure this disease, and as a result, fewer patients will have to struggle with the consequences of end-stage liver disease, liver transplants and liver cancer. We applaud the research efforts that led to this breakthrough and hope other provinces will follow Ontario’s lead and rapidly reimburse this important treatment.”


Treatment Update


Source- CCO

The Beckoning Future: How Hepatitis C Drugs in Development May Affect Practice Today and Tomorrow

Review the current benefits and limitations with protease inhibitor-based HCV therapies, and the emerging data on potential future regimens and the advances they represent.


The New Elements of HCV Care: Practical Skills to Optimize Protease Inhibitor–Based Therapy

Review the approved indications and proper management of HCV-infected patients with the newly approved protease inhibitors.

* Free Registration Required


The American Association for the Study of Liver Diseases November 2011 Annual Meeting

Updates From NATAP

  • AASLD: Impact of Anemia and Ribavirin Dose Reduction on SVR to a Telaprevir-based Regimen in Patients with HCV Genotype 1 and Prior Peginterferon/Ribavirin Treatment Failure in the Phase III REALIZE Study - (11/21/11)

  • AASLD: Boceprevir/Merck HCV Presentations - AASLD, IDSA - (11/21/11)

  • AASLD: New HCV Drugs at AASLD - (11/21/11)

  • AASLD: MicroRNA Drug Safe in Ongoing HCV Study - (11/21/11)

  • AASLD: GSK's eltrombopag Platelet Booster Aids HCV Therapy - (11/21/11)

  • AASLD: Liver Cancer Therapy Positive in Early Trials - (11/21/11)

  • AASLD: Fatty Liver May Benefit from Mediterranean Diet - (11/21/11)


  • Fatty Liver Disease

    Researchers Surprised To Find Fatty Liver Disease Poses No Excess Risk For Death

    Non-alcoholic fatty liver disease (NAFLD) is a common condition associated with obesity and heart disease long thought to undermine health and longevity. But a new study by Johns Hopkins researchers suggests the condition does not affect survival.

    A report on the study was published online last week in BMJ, the British medical journal.

    "Physicians have considered fatty liver disease a really worrisome risk factor for cardiovascular disease," says study leader Mariana Lazo, M.D., Ph.D., a postdoctoral fellow at the Johns Hopkins University School of Medicine's Welch Center for Prevention, Epidemiology, and Clinical Research. "Our data analysis shows this doesn't appear to be the case. We were surprised to say the least because we expected to learn by how much non-alcoholic fatty liver disease increased the risk of death and instead found the answer was not at all."

    Using health information collected from 11,371 Americans between 1994 and 1998 and followed for up to 18 years as part of the Third National Health and Nutrition Examination Survey (NHANES III), the researchers checked liver enzyme levels and ultrasound tests for evidence of NAFLD, and ultimately looked at death rates associated with NAFLD. The participants ranged in age from 20 to 74 during the data collection years. Because the ultrasounds were originally taken to assess gallbladder health, Lazo and colleagues from Johns Hopkins looked at each recording to determine the presence of fat in each person's liver. People whose livers are 5 percent fat or more are considered to have NAFLD.

    The Johns Hopkins team found no increase in mortality among those with NAFLD, which was identified in approximately 20 percent of the NHANES participants. At the end of the follow-up period, mortality from all causes was 22 percent, or 1,836 individuals. Cardiovascular disease was the cause of death for 716 participants, cancer for 480 and liver disease for 44.

    Although the researchers found no increase in deaths, Lazo says further study is needed to determine whether more advanced NAFLD has serious long-term consequences for the liver, a vital organ that turns what we eat and drink into nutrients and filters harmful substances from the blood.

    NAFLD, which some researchers have called the nation's next epidemic, is characterized by the liver's inability to break down fats and fatty build up in the organ. Found in roughly one in three Americans, it is most prevalent in those who are obese, and those with diabetes and cardiovascular disease. The spectrum of disease ranges from simple fat build-up to inflammation to the scarring and poor liver function that characterize cirrhosis. Chronic liver disease has long been associated with long-term alcohol consumption, but as the name suggests, NAFLD is found in those who are not heavy drinkers.

    "We don't yet know why mortality is not affected or whether there might be some actual protective effect of non-alcoholic fatty liver disease," she says, "but it looks like the liver's ability to accumulate fat may somehow shield the body from the detrimental effects of other health problems such as obesity and diabetes," she says.

    There is no treatment for NAFLD, other than lifestyle changes, including weight loss, and only a liver biopsy can determine how serious NAFLD is. Lazo says she hopes new methods are developed that more easily identify more advanced stages of NAFLD, which may not be harmless.

    Still, she says, her research suggests that with respect to long-term survival of people with non-alcoholic fatty liver disease, "it may not matter if you have the disease or not."

    The research was supported by grants from the National Institute of Diabetes and Digestive Diseases and the American Diabetes Association.


    HIV


    Massive Scale Up In Access To HIV Treatment
    Written by Catharine Paddock PhD
    "We have seen a massive scale up in access to HIV treatment which has had a dramatic effect on the lives of people everywhere," Michel Sidibé, Executive Director of UNAIDS, told the press as a new report by the Joint..

    Social vulnerability associated with lack of satisfaction with health care; doctors need to provide more support
    Roger Pebody
    Published: 22 November 2011

    Patients who are socially disadvantaged or who lack social support tend to be less satisfied with the health care they receive, French researchers report in AIDS Care. The authors suggest that clinicians need to make extra efforts with such patients in order to achieve good outcomes.

    Several previous studies have shown that people who are satisfied with their health care have better quality of life, are more likely to adhere to their medication and less likely to drop out of contact with the health care system.

    Moreover an American study found that patients with HIV who were comfortable discussing personal issues with their doctor, who perceived their doctor as more empathetic or who perceived their doctor to be knowledgeable about HIV were more satisfied with their care..Continue Reading...


    Healthy You



    Study: Fight afternoon slump with protein, not sugar rush

    To combat mid-afternoon energy crashes, new research suggests reaching for a protein-rich snack instead of sugar-laden treat is the way to go.

    It’s a common habit among workers who hold day jobs: come 3 pm or so, candy bars are unwrapped and sugar-laden beverages pried open. The objective? A sugar rush to fend off mid-day drowsiness.

    But scientists out of the University of Cambridge have found that protein -- not sugar -- is what activates the cells that make people alert and burn calories. The study was published in the November 17 issue of the journal Neuron.

    Orexin cells secrete an important stimulant in the brain called orexin/hypocretin. When the body doesn't have enough, it can lead to narcolepsy and weight gain. After comparing how different nutrients affect these cells, researchers found that amino acids -- which are found in proteins like egg whites -- stimulate the orexin neurons more than others while glucose lowers their activity.

    Moreover, the amino acids also worked by preventing glucose from blocking the activity of orexin cells. In other words, the amino acids worked as a defensive shield against the sugar's offensive assault.

    The new findings may explain why protein-rich meals can make people feel less calm and more alert than carbohydrate-heavy meals, researchers added.

    "Sleep patterns, health, and body weight are intertwined. Shift work, as well as poor diet, can lead to obesity," said lead researcher Denis Burdakov in a release.

    Meanwhile, a study out of the University of Missouri this spring also found that eating a protein-rich breakfast can increase satiety and help stave off hunger pangs throughout the day.

    "To combat obesity and insomnia in today's society, we need more information on how diet affects sleep and appetite cells. For now, research suggests that if you have a choice between jam on toast, or egg whites on toast, go for the latter,” Burdakov said.


    Big Pharma



    Source- Pharmalot

    Former Synthes Execs Jailed For Fatal Clinical Trial
    Three executives from Synthes, a device maker that was recently purchased by Johnson & Johnson, were sentenced yesterday to prison for their roles in an unapproved trial of a bone-cement drug that led to three patient deaths. A fourth exec will be sentenced later. All four pleaded guilty to one misdemeanor count of shipping an adulterated and misbranded product in interstate commerce.

    Gilead Is Paying How Much For Pharmasset?
    Investors, though, are mixed. Here is what some of the wags are saying
    … The Pharmasset “HCV franchise is clearly in the lead with a very attractive clinical profile,” writes Leerink Swann analyst Joshua Schimmer. “…While we understand the strategic rationale, the price tag is lofty for a pre-commercial asset and not aligned with what we would like to see from Gilead, in terms of capital allocation…While over the long-term this deal may prove to be value-creative, we will not have clarity on this front for a number of years.”

    Counterfeit Drugs

    Source- Spoonful Of Medicine

    Harsher penalties proposed to counter counterfeit drug peddlers
    Congress is, yet again, throwing a fit about counterfeits. Now, US lawmakers from both political parties are proposing a new measure to increase the criminal penalties for the manufacture, sale or trafficking of counterfeit medicines.

    Currently, prison times and fines for dealing in counterfeits are the same as any other illegal trade. But “counterfeit medication poses a grave danger to public health that warrants a harsher punishment,” the legislation’s co-sponsor Senator Patrick Leahy, a Democrat from Vermont, wrote in a statement. The Counterfeit Drug Penalty Enhancement Act, introduced yesterday in both houses of Congress, would increase the maximum penalties for first-time offenders to 20 years in prison with a $4 million fine; repeat offenders could be dinged as much as $8 million.

    But, if precedent on Capitol Hill means anything, this bill is not set to go far. Tim Fagan’s Law, named after a teenager who was injected with counterfeit medicine after a live transplant, was first proposed in 2003 to increase penalties for dealing in counterfeit drugs. However, the legislation has been sitting pretty in committee for six years now, and is reintroduced every year with no advance.

    For more on counterfeits, read our April 2010 news focus on the subject.


    The Fight Against Counterfeit Drugs

    Below is a video from the March 2011 60 minutes story called "The Fight Against Counterfeit Drugs," narrated by America's favorite medi-journalist Dr. Sanjay Gupta.





    Buying Prescription Medicine Online: A Consumer Safety Guide

    Make sure a Web site is a state-licensed pharmacy that is located in the United States. Pharmacies and pharmacists in the United States are licensed by a state's board of pharmacy. Your state board of pharmacy can tell you if a Web site is a state-licensed pharmacy, is in good standing, and is located in the United States. Find a list of state boards of pharmacy on the National Association of Boards of Pharmacy (NABP) Web site at www.nabp.net

    The NABP is a professional association of the state boards of pharmacy. It has a program to help you find some of the pharmacies that are licensed to sell medicine online. Internet Web sites that display the seal of this program have been checked to make sure they meet state and federal rules. For more on this program and a list of pharmacies that display the Verified Internet Pharmacy Practice Sites™ Seal, (VIPPS® Seal), go to www.vipps.info

    Look for Web sites with practices that protect you

    A safe Web site should:

    1. be located in the United States and licensed by the state board of pharmacy where the Web site is operating (check www.nabp.net for a list of state boards of pharmacy)

    2. have a licensed pharmacist to answer your questions

    3. require a prescription from your doctor or other health care professional who is licensed in the United States to write prescriptions for medicine

    4. have a way for you to talk to a person if you have problems

    BE SURE YOUR PRIVACY IS PROTECTED

    Look for privacy and security policies that are easy-to-find and easy-to-understand.

    Don’t give any personal information (such as social security number, credit card, or medical or health history), unless you are sure the Web site will keep your information safe and private.

    Make sure that the site will not sell your information, unless you agree


    Complementary Medicine / Alternative Medicine


    No Double Standards For Natural Health Products
    Natural health products and medicinal foods should be subject to the same regulations as pharmaceutical drugs to ensure safety and efficacy, states an editorial in CMAJ (Canadian Medical Association Journal).

    While pharmaceutical drugs are subject to rigorous evaluation and must provide significant evidence of their therapeutic effects and that the benefits outweigh risks, natural health products in Canada are not. Many contain active pharmacological substances that can have potent effects and interactions which should have warnings.

    "The multibillion-dollar natural health products industry sells the perception that because its products are "natural," they must also be safe, such that comprehensive testing like that required for pharmaceuticals is not required," write guest author Dr. Stuart MacLeod with CMAJ editor Dr. Matthew Stanbrook and colleagues. "However, it is a near-universal truth that any substance that exerts a beneficial effect on a biological system will also have the potential for adverse effects."

    Health Canada created the Natural Health Products Directorate 10 years ago, but the regulatory framework that governs it does not protect the consumer.

    "All health claims for any product should be subject to a common set of regulations, starting with consistent and easily understood standards of evidence proportional to health risks and benefits," conclude the authors.

    "Uniform regulations are the best way to protect consumers while still allowing choice."


    'If only a rub down with rose petals could cure ill health'

    We know that the history of medicine is in part a history of brutalism.

    Surgery was torture without the interrogation. Psychiatry was masochism in a different coat and pharmaceuticals an experiment in chemistry.

    We are at a more fortunate point and benefit from a medical sophistication that borders on miraculous. However, even now some interventions can seem brutal, almost primitive in their ability to make patients feel worse. From a distance, they can seem toxic, even violent; close up, we can see that they can appear harmful, invasive. Medicine sometimes wages a war on illness, and who likes war?

    So we have complementary therapies. Let’s face it, we would like it to be the case that a dab behind the ears with some ylang ylang and a rub down with rose petals would cure all our ails. We would like to find a cure for cancer by humming like a giant bee or by sipping the diluted wee of elves through a straw made of goats’ horn. However, most clinical trials - and I don’t want to give the impression of rushing to judgement here - seem to suggest that not only do these interventions not work but also there are no such things as elves.......Continue Reading...

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