Friday, June 29, 2012

Hepatitis Weekly Rewind:Are Practitioners Using Novel HCV Agents?


Friday is here with the fourth of July soon to follow, have a safe and fun filled holiday folks.

The family is heading to the lake for the fourth this weekend, but apparently I won't be sharing a room with my four year old grandson.

I thought we had a thing going, roommates for life, until he ratted me out to his mom. He told my daughter that grandmum makes scary sounds at nite nite time. After explaining to my fair haired grandson that I don't mean to make scary sounds, I just sing in my sleep. He replied with; "Grandmum you don't sing! You make long scary monster sounds. You scared me inside my stomach."

Oh my, I  suppose I did.

The bottom line? I'll be sharing a room with his seven month old brother. Not for life, just until he can talk. I so understand.

As this week ends we take a look back at the most relevant HCV headlines, including today's news with updates as the day progresses. Click here to view previous "HCV Weekly Rewind" articles.

Chronic hepatitis C: Treat or wait?

If you are considering hepatitis C treatment three articles on the website are worth a look see. The first article is from the June-July issue of AGA Perspectives, in the paper physicians Donald Jensen, MD, Archita P. Desai, MD, and Gregory T. Everson, MD, debate the risks and benefits of initiating therapy now versus waiting for future treatments. Another article published yesterday at and written by staff writer Don Sapatkin offers information for the baby boomer. The delicate balancing act of when to treat HCV is discussed along with a look at some HCV drugs in development. In the third article Alyson N. Fox, MD and the renowned Ira M. Jacobson, MD discuss interferon free HCV therapies. Click here to view the articles and links.

In the short video below Dr. Marion Peters mentions-in light of the new interferon free therapies on the horizon- not pushing genotype 1 patients into treating with telaprevir or boceprevir, unless liver damage is considerable.

Are Practitioners Using Novel Agents?

Dr. Marion Peters answers the question of whether practitioners are using novel therapies in a clinical setting as much as they should.

Click To Play

View additional videos @ Impact Infectious Disease

Updates On Incivek - Telaprevir and Victrelis - Boceprevir

FDA Hepatitis Update - Incivek (telaprevir) product labeling

Drug Interactions - Telaprevir and buprenorphine.
Effect of telaprevir on the pharmacokinetics of buprenorphine in volunteers on stable buprenorphine/naloxone maintenance therapy.Luo X, Trevejo J, van Heeswijk RP, Smith F, Garg V.
Antimicrob Agents Chemother, 2012, 56(7): 3641-7.

Telaprevir, an orally administered inhibitor of HCV NS3/4A protease, is both a substrate and inhibitor of CYP3A which suggests that coadministration of telaprevir may increase systemic exposure to buprenorphine. This study was designed to investigate the effect of telaprevir on the steady-state pharmacokinetics of buprenorphine and norbuprenorphine, to measure opiate withdrawal symptoms, and to determine whether dose adjustment is needed for patients who are concomitantly treated with telaprevir.

Telaprevir (750 mg every 8 h) was coadministered with buprenorphine/naloxone (4:1 ratio as sublingual tablets) for 7 days with food to HCV-negative volunteers on stable, individualized, buprenorphine maintenance therapy. Pharmacokinetic profiles of buprenorphine, norbuprenorphine, and naloxone were measured over the 24-hour dosing interval on day -1 (buprenorphine/naloxone alone) and day 7 of telaprevir coadministration. Opioid withdrawal symptoms were evaluated throughout the study (via questionnaires and pupillometry).

Buprenorphine AUC was essentially unchanged; Cmax for buprenorphine along with Cmax and AUC for norbuprenorphine, and Cmax for naloxone were modestly decreased during coadministration with telaprevir. Buprenorphine AUC and Cmax decreased by 4% and 20%, norbuprenorphine AUC and Cmax decreased by 9% and 15%, naloxone Cmax decreased by 16%. Coadministration of telaprevir did not increase withdrawal symptom frequency, and there were no serious adverse events reported during or after completion of telaprevir coadministration.

These results suggest dose adjustment may not be necessary when telaprevir and buprenorphine/naloxone are coadministered.
Click here for the abstract from PubMed.

Drug Interactions - Boceprevir and ciclosporin or tacrolimus.
Pharmacokinetic interaction between the HCV protease inhibitor boceprevir and cyclosporine and tacrolimus in healthy volunteers.Hulskotte E, Gupta S, Xuan F, et al.
2012, Epub ahead of print.
This open-label, fixed-sequence, pharmacokinetic interaction study evaluated boceprevir (an strong inhibitor of CYP3A4/5) with ciclosporin and tacrolimus, both of which are substrates of CYP3A4. HCV-negative subjects received single doses of ciclosporin (100 mg) alone and in combination with boceprevir (800 mg three times daily). For the tacrolimus study, HCV-negative subjects received single doss of tacrolimus (0.5 mg) alone and in combination with boceprevir (800 mg three times daily).
Boceprevir increased ciclosporin AUC and Cmax by 2.7-fold and 2.0-fold. Tacrolimus AUC and Cmax increased by 17-fold and 9.9-fold in the presence of boceprevir. Neither ciclosporin nor tacrolimus coadministration had a meaningful effect on boceprevir pharmacokinetics.
Dose adjustments of ciclosporin should be anticipated when administered with boceprevir and should be guided by close monitoring of ciclosporin blood concentrations and frequent assessments of renal function and cyclosporine-related side effects. Coadministration of boceprevir with tacrolimus requires significant dose reduction and prolongation of the tacrolimus dosing interval, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Advances in molecular biology have allowed investigators to begin to understand the mechanisms of HCV infection and replication. Advances in understanding of viral kinetics have provided tools to identify patients who are most likely to attain SVR. With the advances in the science of HCV infection, the first part of the 21st century has seen the development and early introduction of a number of direct-acting antiviral (DAA) drugs. These novel medications interfere with critical steps in HCV replication and have the potential to significantly increase SVR rates. This article will review the key elements of HCV replication and evaluate the various classes of new and investigational DAA that have the potential to create a revolution in the management of patients with chronic hepatitis C.

Affordable Care Act -  Insurers can no longer reject adults with hepatitis C.

Thursday the Supreme Court declared in a 5-4  vote to uphold the Affordable Care Act, declaring it constitutional. The outcome as it relates to people with HCV is that starting in 2012 insurers can no longer reject adults with hepatitis C, and other pre-existing conditions.  Read more about the historic vote here, and just what this means to you here.

Here are some highlights:
The uninsured 
The decision leaves in place the so-called individual mandate -- the requirement on Americans to have or buy health insurance beginning in 2014 or face a penalty -- although many are exempt from that provision. 
In 2014, the penalty will be $285 per family or 1% of income, whichever is greater. By 2016, it goes up to $2,085 per family or 2.5% of income.Health care exchanges, which are designed to offer cheaper health care plans, remain in place as well.
The insured 
Because the requirement remains for people to have or buy insurance, the revenue stream designed to help pay for the law remains in place. So insured Americans may be avoiding a spike in premiums that could have resulted if the high court had tossed out the individual mandate but left other requirements on insurers in place.
Young adults 
Millions of young adults up to age 26 who have gained health insurance due to the law will be able to keep it. The law requires insurers to cover the children of those they insure up to age 26. About 2.5 million young adults from age 19 to 25 obtained health coverage as a result of the Affordable Care Act, according to the U.S. Department of Health and Human Services. 
Two of the nation's largest insurers, United Healthcare and Humana, recently announced they would voluntarily maintain some aspects of health care reform, including coverage of adult dependents up to age 26, even if the law was scrapped.
People with pre-existing conditions
Since the law remains in place, the requirement that insurers cover people with pre-existing medical conditions remains active. 
The law also established that children under the age of 19 could no longer have limited benefits or be denied benefits because they had a pre-existing condition. Starting in 2014, the law makes it illegal for any health insurance plan to use pre-existing conditions to exclude, limit or set unrealistic rates on coverage. 
It also established national high-risk pools that people with such conditions could join sooner to get health insurance. As of April, a total of only about 67,000 people were enrolled in federally-funded pools established by the health care law, according to the National Conference of State Legislatures. 
More than 13 million American non-elderly adults have been denied insurance specifically because of their medical conditions, according to the Commonwealth Fund. The Kaiser Family Foundation says 21% of people who apply for health insurance on their own get turned down, are charged a higher price, or offered a plan that excludes coverage for their pre-existing condition.
Continue Reading @ CNN

Related articles
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Read more here:
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Supreme Court’s decision means more physicians are needed

Biosimilar standard interferon

An interesting abstract compared "biosimilar standard interferon" with pegylated interferon in HCV genotypes 2 or 3. You can view the abstract here, the results showed that a higher SVR was seen in patients receiving Peg-IFN plus RBV versus the biosimilar.

What Are Biosimilars?
Biosimilars are copycat versions of expensive biotechnology drugs. Although technically these "biosimilars" are not called generic.

The above abstract included patients from Brazil where "Biosimilar standard IFN" is currently available. Biosimilar are also available in Europe, Canada and Japan but however not in the U.S.

The FDA states ; Unlike most prescription drugs made through chemical processes, biological products generally are made from human and/or animal materials.

An example is Amgen's white blood cell-booster Neupogen, a biosimilar which is on the market in Europe.

In February of this year the FDA issued three biosimilar draft guidelines to assist the industry in developing biosimilar versions of currently approved biological products in the United States. After the guidelines were issued the FDA welcomed open comments on the draft for 60 days, you can view those comments here, and a summary can be viewed here.

Some experts have concerns for the well-being of patients prescribed these products. This week the Huffinton Post  published an article written by ,  highlighting the FDA's role in ensuring safe and effective biosimilars.

Approved Pathway for Biosimilars Must Be Patient-Focused
Unlike chemically-produced pharmaceuticals, biologics are extremely complex. Biologics are manufactured using recombinant DNA and have molecular sizes that are several hundred times larger than chemical drugs like Tylenol. For this reason, biologics cannot be exactly replicated; instead, only similar copies or "biosimilars" can be created. Small differences in the structure of the innovator drug and the attempted copy could affect the efficacy, safety and tolerance of the drug for the patients.  
The FDA must ensure that a vigilant traceability system is in place to allow for better identification of products and ultimately protect patients. And by providing a unique and distinctive naming and labeling system, the FDA will be able to document cases of adverse effects and will be better able to act quickly before they can harm patients.

For HCV geeks, this month published in the World Journal of Gastroenterology is an updated report on diagnosis, epidemiology and clinical implications of occult hepatitis C virus infection. Occult HCV, occult defined as hidden, can be found in patients without detectable HCV antibodies. HCV advocate explains this mystery in their 2004 newsletter. Click here for the newsletter and here for updated report.

Genotype 4 hepatitis C, insulin resistance and fatty liver: Bad things come in threes

In an editorial published in the June issue of The Canadian Journal Of Gastroenterology researchers looked at hepatitis C, insulin resistance and fatty liver.  In the paper authors concluded that insulin resistance and fatty liver seen in HCV was not genotype dependent, with negative outcomes seen across all genotypes, including genotype 4.
Read the editorial here...

Impact of ribavirin - retreatment of HCV

Impact of ribavirin dose on retreatment of chronic hepatitis C patients
Retreatment of CHC patients who have failed prior antiviral therapy is an important clinical issue. Our study evaluated the efficacy of retreatment of CHC patients who relapsed after combination therapy with PEG-IFN plus RBV. The overall SVR rate achieved was 42%. An important point of our study is the inclusion of a homogeneous population of prior relapsers to the PEGIFN-α plus RBV combination therapy. Most previous studies analyzed the efficacy of retreatment with PEG IFN plus RBV based on groups composed mainly of patients who failed conventional IFN-based therapy without distinguishing between non-responders and relapsers,or between monotherapy and combination therapy.

Hepatitis in the Elderly

Viral Hepatitis in the Elderly
As life expectancy continues to rise, elderly adults represent a rapidly growing proportion of the population. The likelihood of complications of acute and chronic liver disease and overall mortality are higher in elderly populations. Several physiological changes associated with aging, greater prevalence of co-morbid conditions, and cumulative exposure to hepatotropic viruses and environmental hepatotoxins may contribute to worse outcomes of viral hepatitis in the elderly. Although pharmacotherapy for hepatitis B and C continues to evolve, the efficacy, tolerability, and side effects of these agents have not been studied extensively in elderly adults. Immunization against hepatitis A and B in naïve elderly adults is an important public health intervention that needs to be revised and broadened.

Risks of Resistance and the New Anti-Viral Agents for HCV
Dr. Stuart Ray discusses the biggest risks faced with resistance to the new direct acting antiviral agents for hepatitis C infection.

Click To Play
View additional videos @ Impact Infectious Disease

HCV Drugs In Development

Just In

TMC435 and daclatasvir interferon free Phase II trial to Commence Shortly
 STOCKHOLM, Sweden, Jun 29, 2012 (PR Newswire Europe via COMTEX) -- STOCKHOLM, Sweden, June 29, 2012 /PRNewswire/ -- - The phase II interferon-free combination study with TMC435 and daclatasvir will evaluate treatment-naive or previous null responder patients with HCV genotype 1a and 1b - The study will include approx. 180 patients and will evaluate a combination of TMC435 and daclatasvir, with or without Ribavirin, in four different cohorts for 12 or 24 weeks of treatment Medivir AB (OMX:MVIR), the research-based pharmaceutical company focused on the development of high-value treatments for infectious diseases, announces that a phase II combination study with the investigational compound TMC435 and Bristol-Myers Squibb's investigational compound daclatasvir will start in July. This study is part of the clinical collaboration agreement between Janssen R&D Ireland and Bristol-Myers Squibb Company announced on 2 December 2011 and on 18 April 2012.

TMC435 and daclatasvir (BMS-790052) TMC435, a once daily potent NS3/4A protease inhibitor (PI) in phase III clinical development for the treatment of chronic genotype-1 hepatitis C virus (HCV) infection, will be investigated in an interferon free phase II trial in combination with Bristol-Myers Squibb's investigational NS5A replication complex inhibitor, daclatasvir (BMS-790052), also in phase III development.

The purpose of this study is to assess the efficacy and safety of TMC435 and daclatasvir in combination with or without Ribavirin in chronic genotype-1 hepatitis C infected patients who are treatment-naive or null responders to previous Peginterferon alfa/Ribavirin therapy.

Study design In this open label phase II study the potential to achieve sustained viral response (SVR), 12 (SVR12) and 24 (SVR24) weeks post treatment in treatment-naive and null responder patients infected with HCV genotype 1a and 1b will be evaluated. Patients with advanced liver disease (F3/F4) will be allowed up to approx. 35% of the total treated population.

Cohort one and two will include patients with genotype 1b where TMC435 and daclatasvir will be dosed with or without Ribavirin for 12 weeks with a 36 weeks follow-up or for 24 weeks with a 24 weeks follow-up.

Cohort three and four will include patients with genotype 1a where TMC435, daclatasvir and Ribavirin will be dosed for 12 or 24 weeks with a 24 weeks post treatment follow-up.

For additional information from these recently updated studies, please see Study of Daclatasvir and TMC435 for Subjects With Genotype 1 Chronic Hepatitis C @
click here to continue reading..

On Tuesday Presidio announced 3-day monotherapy data for HCV NS5A inhibitor PPI-668.
In the Phase 1b trial HCV naïve genotype-1 patients were dosed at either 40, 80, 160 or 240 mg, once daily for three consecutive days.
The Phase 1b efficacy observations indicated consistently rapid, marked reductions in patients’ serum viral load (HCV RNA levels), that were dose-related. Patients’ HCV RNA reductions typically exceeded 3 log10 IU/ml (99.9%) by Day 2. During the 3-day treatment period, mean maximal HCV RNA reductions for the 4 dosing groups were:
  • 3.2 log10 IU/mL in the 40 mg dose group
  • 3.5 log10 IU/mL in the 80 mg dose group
  • 3.5 log10 IU/mL in the 160 mg dose group
  • 3.7 log10 IU/mL in the 240 mg dose group
There was only one minimal-responder in the trial. A patient in the 240 mg dose group was found to be fully resistant at baseline with 100% of this patient’s pre-treatment HCV RNA containing 3 genetically linked NS5A resistance mutations. This patient was excluded from the efficacy analysis of the 240 mg cohort, since he was pre-resistant and could not contribute to dose-response inferences. 
Five other patients with detectable resistance mutations at baseline, including those harboring the relatively common L31M variant, responded well to PPI-668 treatment, with multi-log HCV RNA reductions.
According to the press release the drug showed positive efficacy and safety supporting advancement of PPI-668 to Phase 2 combination studies. Presidio completed a protocol amendment and will explore the pan-genotypic clinical efficacy of PPI-668 in HCV genotype-2a/3a patients with recruitment underway. The companies pipeline also includes PPI-383, a non-nucleoside polymerase inhibitor to treat HCV.
Click here to read the press release...........

Hepatitis C-related discrimination in pharmacy-based opioid replacement therapy programs: does it exist?

Original article by: M Temple-Smith, K Jenkinson, J Wallace
Reference: Australian Pharmacist Jun 2012;31(6):494-497

Source: Australian Pharmacist
Keywords: Aggression; Analgesics-Narcotic; Australia; Dispensing; Drug Abuse; Hepatitis C; Maintenance Therapy; Methadone; Pharmacist-Patient Relationships; Pharmacists-Community; Pharmacy Services-Community;
Date published: 29/06/2012 10:14

by: Pharm-line
The epidemic of hepatitis C is characterised in Australia by its major transmission route of injecting drug use. Many people with hepatitis C have reported discrimination by health care practitioners, including pharmacists, resulting in a reluctance to attend health services or to disclose their status when they do. This study investigated this issue from the pharmacist's perspective, by interviewing 21 pharmacists primarily working in community-based pharmacies in and around Melbourne, Australia, about their experiences, knowledge and attitudes towards people with hepatitis C.
Most participants of the study assumed opioid replacement therapy (ORT) clients could have hepatitis C but felt no reason to ask. Many pharmacists displayed empathy in relation to injecting drug users and others had developed good relationships with clients. However it was also apparent that pharmacists had little opportunity to share experiences with other pharmacists, and professional isolation for pharmacists participating in the ORT programme was common. ORT service guidelines may benefit from revision, particularly in relation to support for dispensers, after wider consultation with pharmacists. (13 refs.)

Fatty Liver

Phase 2b Trial of RP103 for Non-Alcoholic Steatohepatitis ("NASH")
Raptor Pharmaceutical Corp. ("Raptor" or the "Company") today announced that a first patient has been dosed in its Phase 2b clinical trial evaluating the safety and potential efficacy of RP103 as a potential treatment of non-alcoholic steatohepatitis ("NASH"), an advanced form of non-alcoholic fatty liver disease ("NAFLD") in children. The patient was dosed at the Clinical & Translational Research Institute at the University of California, San Diego ("UC San Diego"). RP103 is Raptor's proprietary delayed-release microbead formulation of cysteamine bitartrate.

Support - Awareness - Testing - Newsletters

Hepatitis C patients petition for life-saving drug combination
Read the article here, and sign the petition here.

July 2012 Newsletter @  HCV Advocate

Download printable version
Alan Franciscus, Editor-in-Chief
HCV Snapshots: DDW 2012
Lucinda K. Porter, RN
Disability & Benefits: SSD – Financial Eligibility
Jacques Chambers, CLU

HealthWise: Hepatitis C: One World, Many Faces
Lucinda K. Porter, RN

HCV Advocate Eblast
Stay informed on the latest news here to register for email alerts

CDC Trying Out Free Rapid AIDS Test At Drugstores
The $1.2 million project will offer free rapid HIV tests at pharmacies and in-store clinics in 24 cities and rural communities, the Centers for Disease Control and Prevention announced Tuesday.
Officials are hoping testing for the AIDS virus will become a routine service at drugstores like blood pressure checks and flu shots.

New National Hepatitis C Referral Resource Maps
A new online resource for users all over the country to quickly pinpoint geo-mapped locations that provide the support and services most commonly sought by case managers, counselors, educators, and persons affected by hepatitis C.

Fort Lauderdale, FL, June 26, 2012 --( HealthPro Solutions is pleased to announce the launch of “Interactive Referral Resource Maps,” a novel nation-wide resource helping patients and providers locate important hepatitis C services. Visit


Italy hospital conducts first fully robotic liver procedure
A minimally-invasive fully robotic right liver lobe resection and procurement for adult-to-adult living donor liver transplantation was performed at the Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) in Palermo.

The procedure was performed using the da Vinci® robotic surgical system, the only one of its kind currently available on the market.

This is the first case in the world performed entirely and exclusively with the robotic technique. In the past, some living donor liver transplants had been performed in the U.S. using the robot, but aided by the surgeon who inserted his hand through an abdominal incision to perform the surgery with the robot. The case carried out at ISMETT was exceptional because it was entirely performed with the robotic minimally-invasive technique; only the robot’s arms operated inside the donor’s abdomen.
Continue reading...

Surgeons Seek Repeal of Transplant Ban Between HIV-Positive People
WEDNESDAY, June 27 (HealthDay News) -- Transplant surgeons plan to meet with U.S. Congressional staff members Wednesday to push for the repeal of a law that forbids HIV-positive patients from getting organ transplants from other HIV-positive people.

If the law is changed, patients infected with the AIDS-causing virus will have more organs available to them for transplantation, advocates say.

Liver Cancer

New biomarker for liver cancer diagnosis

A newly tested serum protein marker for hepatocellular carcinoma (HCC) could improve early diagnosis and better distinguish HCC from non-malignant chronic liver diseases, say Chinese researchers.

 Dickkopf-1 (DKK1) – a secretory antagonist of the WNT pathway – was more diagnostically accurate across a range of scenarios than the most widely tested biomarker for HCC, alpha-Fetoprotein (AFP), a retrospective study involving nearly 1,300 participants found.

 DKK1 maintained diagnostic accuracy for patients with early-stage HCC as well as for AFP-negative disease, which was important since 30-40% of all HCC patients were AFP-negative, the investigators said.

Reporting in The Lancet Oncology, the authors wrote that raised concentrations of DKK1 in serum could differentiate HCC from both chronic hepatitis B virus (HBV) infection and liver cirrhosis

Stem Cells

FDA Reports On Houston Stem-Cell Lab Where Rick Perry Received Experimental Procedure
In July of last year at a Texas stem cell clinic Governor Rick Perry received experimental stem cell surgery to alleviate a back problem. In the procedure isolated stem cells from fat were removed, cultured in a lab and re-injected back into Perry. Such stem cell treatments have not been approved by the FDA. In April Celltex Therapeutics Corp., the Texas stem cell lab where the cells were stored and grown was inspected by the FDA, this week those documents were obtained by the Houston Chronicle and portions of the report was published online, along with a must read article .

Related- Surprising FDA audit report of Celltex a blow to for-profit adult stem cell industry

Update - Celltex Responds to Media Reporting on FDA Visit
"Some media reports and social media chatter suggest that Celltex is somehow acting illegally or providing unapproved treatments. These statements are inaccurate. Celltex is registered with the FDA as a facility that multiplies human cells and cellular products, in particular, adult mesenchymal stem cells. The FDA does not require a company to obtain FDA approval prior to distribution of its HCT/Ps. In addition, the FDA does not issue "licenses," so any reference that Celltex provides "unlicensed" procedures is inaccurate. Celltex's process for reproducing adult mesenchymal stem cells is legal, and there is no requirement that the cells be approved or licensed.....

Healthy You

Having Your Coffee and Enjoying It Too
Even though coffee can cause a temporary rise in blood pressure, the new study, like those before it, found the risk of heart disease to be lower among otherwise healthy coffee drinkers. Other benefits suggested by recent studies include a reduced risk of Type 2 diabetes, "Link takes you to this blog- article link not valid- liver disease" and Parkinson’s disease. Some research has found a reduced risk of depression, dementia and Alzheimer’s disease among coffee drinkers.......................  
Keep in mind, too, that caffeine is a drug. Some medications, including Tagamet, Diflucan, Luvox, Mexitil, estrogens and antibiotics like Cipro and Levaquin, interfere with the metabolism of caffeine and can increase its effects..........
Continue Reading...........

Coffee May Reduce the Risk of Heart Failure
The scientists analyzed five prospective studies, which included more than 140,000 men and women, that related to coffee consumption and heart risk. Four of the studies were based in Sweden, and one was conducted in Finland. They found that those who drank a moderate amount of coffee daily, defined as the equivalent of two 8-ounce American cups per day, may experience protective benefits against heart failure by as much as 11 percent...

Mixing herbal and 
prescription meds
Clinical Feature

At a glance
  • Herbal preparations and dietary supplements can have a significant impact on health and wellness.
  • All that is natural is not necessarily safe, especially when combined with other pharmaceutical-grade medications or nonprescription dietary supplements.
  • In order to avoid overdosing on any one component, consumers should be taking only one multivitamin or multimineral supplement at a time and should be aware of the ingredients if they intend to supplement with any other vitamin or mineral product.
  • Manufacturers do not need to register with the FDA or obtain FDA approval prior to marketing a product, and there is no requirement for reporting of adverse events
Herbal preparations have been used by mankind for medicinal purposes for more than 60,000 years. Moreover, field biologists have observed that sick animals change their diet, ingesting small amounts of bitter herbs and plants that they would otherwise avoid, to help facilitate healing.1 There is little question that herbal preparations and dietary supplements can have a significant impact on health and wellness. Beware, however.....
Continue reading........

Itching in Liver Disease

Itching secondary to liver diseases, including primary biliary cirrhosis, primary sclerosing cholangitis, and hepatitis C, is a very difficult symptom for patients to endure and for physicians to manage. The reason why patients with liver disease itch is not known. It has been thought that some substances accumulate in the blood as a result of liver disease, causing itch.Although the nature of the substance(s) that cause itch in liver disease is not known, evidence has been accumulating over the past several years to suggest that some substances that are found normally in plasma known as endogenous opioids (e.g. enkephalins), contribute, at least in part to the itch secondary to liver disease.

It has been proposed that these neurotransmitters cause itch by acting on special areas of the brain. Other substances that also accumulate in the blood in liver disease, including bile acids, may also play a role in this type of itch. There is no strong evidence, however, to support that bile acids cause this type of itch.

Traditionally, the way itch has been studied has been by measuring the concentration of substances known to accumulate in the blood of patients with liver disease who itch. This method, however, has not advanced the understanding of what causes this type of itch.

In order to conduct scientific investigation, investigators have to apply reliable methods that allow for the collection of information that can be analyzed and interpreted in an objective way. The need for the availability of good methods has been recognized for many years by investigators in the field of itch. In this spirit, an instrument was designed over ten years ago that allows for the measurement of the human behavior that results from feeling the sensation of itch: scratching. Several clinical trials that use this method to record scratching have been conducted. These studies have provided some insight into itching and scratching, including the demonstration that some patients scratch with a 24-hour rhythm, known as circadian rhythm. This finding has suggested further that the itch secondary to liver disease is mediated in the brain.

At present there are several medications that are used for the treatment of itch in liver disease. These
medications include cholestyramine, the antibiotic rifampicin, the opiate antagonists naloxone and naltrexone, and the serotonin type-3 receptor antagonist. These medications appear to decrease itching in many patients, but there is no medication that works well for all the patients. This reality underscores the need to continue to look for other medications that may relief the itch secondary to liver disease.

Sleep Loss

Sleep deprivation effect on the immune system mirrors physical stress
June 30 2012
Study looks at white blood cell counts following 29 hours of continual wakefulness

DARIEN, IL – Severe sleep loss jolts the immune system into action, reflecting the same type of immediate response shown during exposure to stress, a new study reports.

Researchers in the Netherlands and United Kingdom compared the white blood cell counts of 15 healthy young men under normal and severely sleep-deprived conditions. The greatest changes were seen in the white blood cells known as granulocytes, which showed a loss of day-night rhythmicity, along with increased numbers, particularly at night.

"Future research will reveal the molecular mechanisms behind this immediate stress response and elucidate its role in the development of diseases associated with chronic sleep loss," said Katrin Ackermann, PhD, the study's lead author. "If confirmed with more data, this will have implications for clinical practice and for professions associated with long-term sleep loss, such as rotating shift work."
Previous studies have associated sleep restriction and sleep deprivation with the development of diseases like obesity, diabetes and hypertension. Others have shown that sleep helps sustain the functioning of the immune system, and that chronic sleep loss is a risk factor for immune system impairment.

For this study, white blood cells were categorized and measured from 15 young men following a strict schedule of eight hours of sleep every day for a week. The participants were exposed to at least 15 minutes of outdoor light within the first 90 minutes of waking and prohibited from using caffeine, alcohol or medication during the final three days. All of this was designed to stabilize their circadian clocks and minimize sleep deprivation before the intensive laboratory study.

White blood cell counts in a normal sleep/wake cycle were compared to the numbers produced during the second part of the experiment, in which blood samples were collected during 29 hours of continual wakefulness.

"The granulocytes reacted immediately to the physical stress of sleep loss and directly mirrored the body's stress response," said Ackermann, a postdoctoral researcher at the Eramus MC University Medical Center Rotterdam in the Netherlands.

The study, "Diurnal Rhythms in Blood Cell Populations and the Effect of Acute Sleep Deprivation in Healthy Young Men," was a collaborative effort between the Department of Forensic Molecular Biology at Erasmus MC University Medical Center Rotterdam and Chronobiology, Faculty of Health and Medical Sciences at the University of Surrey, United Kingdom. The laboratory study was conducted at the University of Surrey Clinical Research Centre.

For a copy of the study or to arrange an interview with an AASM spokesperson, please contact PR Coordinator Doug Dusik at 630-737-9700, ext. 9364, or

The monthly, peer-reviewed, scientific journal SLEEP is published online by the Associated Professional Sleep Societies LLC, a joint venture of the American Academy of Sleep Medicine and the Sleep Research Society. The AASM is a professional membership society that is the leader in setting standards and promoting excellence in sleep medicine health care, education and research (

Read more about sleep disorders from the American Academy of Sleep Medicine on the Your Sleep website, Help for people who have a sleep problem is available at more than 2,400 AASM-accredited sleep disorders centers around the United States.


Stanford health psychologist Kelly McGonigal discusses how stress shapes us

Stanford Med, Behavioral Science, Mental Health, Stanford News
Stress is an inevitable part of daily life and sometimes it can feel as though you might crack under the pressure. While you may never be able to eliminate stress completely, you can learn to identify its source and manage it better. This month, Stanford health psychologist Kelly McGonigal, PhD, explores the evolutionary roots of stress and how our stress instincts interact with modern challenges in her Stanford Continuing Studies course.

In the following Q&A, McGonigal discusses the science of stress and how it affects the mind-body relationship, and she offers tips on managing the body’s flight or fight response.

How does stress affect the human body?
The physical stress response is more complex than most people realize. Sure, we recognize this when we’re under pressure. The heart speeds up, our blood pressure spikes and maybe we feel our stomachs churn and our jaws clench. But these stress symptoms are just a small part of a complicated cascade of changes in your brain and body.
It begins when the brain detects – or even just imagines – any kind of threat. It could be to your survival, like realizing a car is about to crash into you. Or it could be a threat to your ego, like getting criticized by your boss. The brain then unleashes a stream of chemicals that shifts the mind and body into emergency mode.
The brain shuts down regions important for long-term planning and juices up regions that help you react quickly and without much thinking. The body sends its resources to the systems that will help you flee from danger or fight to defend yourself (that’s why the heart is pounding!). It takes those resources away from things like digestion, reproduction and healing. That’s a big part of why chronic stress is so harmful for health and can increase risk of heart disease, infections and digestive or metabolic disorders.
At the same time all this is happening, stress hormones released throughout the body are shaping our behavior. The hormone oxytocin is a key part of the stress response for women. It creates the desire to be close to others, to seek social support and hugs and protection. Among men, there may be an increase in vasopressin and testosterone. These two hormones increase the competitive drive and desire to defend yourself and those you care about. And among just about everyone, the stress hormone cortisol makes us crave whatever we are addicted to, from cigarettes to cookies to checking our phones or email.

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Off Topic

MRI Birth: The Full Movie
by Wouter Stomp on Jun 27, 2012

We have already teased you twice with some still images in earlier posts about the first birth that happened inside an MRI machine under real-time imaging, but only now has the actual movie been released. Accompanying a paper, which reveals a few additional details on the clinical rather than the technical side of things, the movie shows the accelerated real-time cinematic MRI series in the mid sagittal plane during the whole birth process. It starts when the mother starts performing expulsive efforts with the amniotic membranes still intact and it ends just before the fetus pops his head out in order to avoid exposure to MRI noise. Enjoy the movie!

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