Monday, February 14, 2011

In The News; New hepatitis C drug

Happy Valentines Day
The Medicine of the Heart by ~MorganaFiolett

Wishing you all a heartfelt Valentines Day. If you need a bit of inspiration today take a few minutes and visit the Fight Like A Girl Club.
The site has this lovely program....
Our “Recycled” Club Members Photo Gallery spotlights amazing Fight Like A Girl Club members who have undergone organ transplants as well as some of the beautiful people who have donated organs. If you are an organ donor recipient, we would love to add your photo to this Gallery. We do require that you be a member in order to appear in our photo albums, however, if you are not a member yet, it is super easy and FREE. CLICK HERE to take the Power Pledge and join the Fight Like A Girl Club. If you are already a member and would like to have your photo added, CLICK HERE to upload.

New hepatitis C drug
14 February 2011
Scientists in the UK have developed a compound to combat the hepatitis C virus that could be taken as a pill.

David Pryde and his team from Pfizer Global Research and Development, Sandwich, have made new compounds to activate a protein in the immune system called TLR7 - toll-like receptor 7 - which fights the infection. Toll-like receptors identify foreign DNA, such as a virus, and produce proteins that inhibit the virus' replication.

300 million people suffer from hepatitis C worldwide. The virus that causes the disease resides in the liver and can lead to cirrhosis, with some sufferers requiring liver transplants. Current treatments only cure half of patients and are administered intravenously. Recent research has focused on increasing the effectiveness of the drugs and on developing oral treatments.
Pryde's team made heterocyclic analogues based on the structure of purines, known activators of TLR7 and the basis of current oral drugs. 'The most potent TLR7 agonists are purine-based,' explains Pryde. 'But we wanted to design potent non-purine based agonists to maximise the chances of avoiding any unwanted off-target pharmacology.'

When they tested the compounds against a hepatitis C cell line, the team found that one of the compounds, a trifluoromethyl derivative, was highly selective for TLR7. The agonist also had comparable performance to injected alternatives at doses below 50mg.
'Medicinal chemistry is often castigated for surrendering synthetic elegance in order to gain compound access. Pryde elegantly repudiates this, accomplishing both elegance and access,' says Adam McCluskey, an expert in drug design and discovery from the University of Newcastle, Australia.

Pryde and his team hope to make the agonist more soluble and to increase its potency further before moving on to human trials.
Catherine Bacon

FDA’s lack of oversight of foreign pharma manufacturing
February 14, 2011
The US Food and Drug Administration is planning to outsource more of its international factory inspections to third-party auditors, Bloomberg Businessweek reports.The announcement comes in the wake of a September 2010 report from the Government Accountability Office criticizing the FDA’s lack of oversight of foreign pharma manufacturing plants, many of which have never been inspected. According to the report, the agency inspects drug facilities abroad once every nine years on average, compared with once every two to three years for plants on local soil.“We recognize that third-party inspection programs need to be a bigger part of the discussion because we can’t do all the work ourselves,” John Taylor, FDA acting principal deputy commissioner, said at a conference in Washington, DC last week. “We’re looking at anything, anything and everything that will allow us to leverage our resources better.”For more on the FDA’s ‘Beyond Our Borders’ initiative, check out our news story from last year.
From Natap

Sustained High Levels of HCV-infection Among IDUs in USA - Prevention of Hepatitis C Virus in Injecting Drug Users: A Narrow Window of Opportunity -editorial
Liver Cancer Triples, NO HCV Testing Funds: Aging with HCV
Phase 3 ILLUMINATE Study Supports 24-Week Telaprevir-Based Therapy Within a Response-Guided Regimen for People with Hepatitis C Who Had Not Received Prior Treatment - press release from Vertex

The role of triple therapy with protease inhibitors in hepatitis C virus genotype 1 naïve patients - pdf attached

The role of triple therapy in HCV genotype 1-experienced patients pdf attached

Medivir begins phase Ia trial of hepatitis C polymerase inhibitor TMC649128
Huddinge, Sweden
Monday, February 14, 2011, 15:00 Hrs [IST]
Medivir AB the emerging research-based specialty pharmaceutical company focused on infectious diseases, announced the start of a phase I a clinical trial with TMC649128 intended for the treatment of chronic Hepatitis C Virus infection.TMC649128 is a nucleoside NS5B polymerase inhibitor that has already demonstrated an attractive pre-clinical profile. It is anticipated that this profile would see TMC649128 be used in combination with HCV directly acting antiviral agents, given their high genetic barrier to resistance and antiviral activity across multiple HCV genotypes.

In pre-clinical studies, TMC649128 displayed in vitro activity across multiple HCV genotypes and a high genetic barrier to resistance.The phase I a trial is a double-blind, randomized, placebo-controlled single-ascending dose trial to assess the safety, tolerability and pharmacokinetics in healthy volunteers and will be conducted in Belgium. TMC649128 is being developed in collaboration with Tibotec Pharmaceuticals.Medivir entered a Research and Development agreement in the field of Hepatitis C Virus polymerase with Ortho Biotech Products LP, an affiliate of Tibotec in May 2008. The development of TMC649128 falls under this agreement and by entering clinical development, a milestone payment of Euro 7 million has been triggered for payment to Medivir.“We are extremely excited to see TMC649128, our first HCV nucleoside inhibitor, move into clinical development”, stated Bertil Samuelsson, CSO of Medivir. “The start of this phase I a trial underlines Medivir’s commitment to the development of novel and innovative Hepatitis C treatments. We view nucleoside inhibitors as cornerstone components of future HCV treatment paradigms in combination with directly acting antiviral agents and a TMC649128 component could set them apart from other HCV drug classes.” Medivir and Tibotec are also jointly developing the once daily protease inhibitor TMC435 for treatment of Hepatitis C Virus infections (HCV).Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Company has a strong R&D portfolio and has recently launched its first product Xerese/Xerclear.

“Hot Topics Roundtable Conference”
This week in New York on Wednesday and Thursday the “Hot Topics Roundtable Conference” will be taking place.
With the following panel in place to discuss hepatitis C ;
Hepatitis C Company Representatives:
Milind Deshpande, Executive Vice President and Chief Scientific Officer, Achillion Pharmaceuticals, Inc.
To be announced, Biolex, Inc.
Douglas L. Mayers, M.D., Executive Vice President and Chief Medical Officer, Idenix Pharmaceuticals Inc.
Joseph Patti, Chief Scientific Officer and Senior Vice President, R&D, Inhibitex, Inc.
M. Michelle Berrey, M.D., M.P.H., Pharmasset, Inc.
Ian F. Smith, Executive Vice President and Chief Financial Officer, Vertex Pharmaceuticals Incorporated
MEDACorp Opinion Leaders:
Jules L. Dienstag, MD, Harvard Medical School
Christoph Sarrazin, MD, J.W. Goethe-University Hospital
Howard Liang, Ph.D., Analyst, Biotechnology, Leerink Swann
Seamus Fernandez, Analyst, Major Pharmaceuticals, Leerink Swann
Josh Schimmer, M.D., Analyst, Biotechnology, Leerink Swann
Jonathan Eckard, Analyst, Biotechnology, Leerink Swann

Feb 14, 2011 11:31 ET
Caring Ambassadors Program Launches Unique New DVD Series "Hepatitis C: Choices in Care"
OREGON CITY, OR--(Marketwire - February 14, 2011) -

The Caring Ambassadors Program (CAP) proudly announces the release of the new DVD series "Hepatitis C: Choices in Care -- Distinctive Viewpoints on Choices for Your Hepatitis C Journey." The 2-disc set offers over nine hours of leading expert physician interviews, patient consultations, panel discussions, Power Point presentations and 30 minutes of Qi Gong exercises specifically geared towards people living with hepatitis C.

About five million Americans are infected with HCV, making hepatitis C the most common chronic blood-borne viral illness in the U.S. HCV is the leading cause of chronic liver disease and liver cancer in the U.S. and the most common indication for liver transplantation. In January 2010, the Institute of Medicine (IOM) released its report, "Hepatitis and Liver Cancer, A National Strategy for the Prevention and Control of Viral Hepatitis." The committee found that many health care providers lack an adequate knowledge of HCV and that chronic hepatitis C patients are often confused about their treatment and disease management options.
The DVD series addresses these knowledge gaps by providing a shorter version of the book, Hepatitis C Choices, 4th Edition. The book presents evidence-based conventional and alternative treatment options and is the collective effort of leading medical experts and hepatitis C patient advocates. It is still the only book, and now DVD, of its kind.

"I was scared and did not know which way to turn when I was diagnosed with hepatitis C. I had a lot of unanswered questions," said Randy Dietrich, Board Chair of the Caring Ambassadors Program. "This information combined with the book was what I wanted to make an informed decision about my care."

The Caring Ambassadors Program produced "Hepatitis C: Choices in Care" to educate the public and health care community about hepatitis C. CAP believes it is vitally important that everyone with hepatitis C virus (HCV) know their disease status and have accurate and ample information to make the best health care decisions. Education is essential for making informed choices and taking charge of one's health.

"Hepatitis C: Choices in Care" is available for free viewing at the Caring Ambassadors Program Hepatitis C website at The entire DVD series "Hepatitis C: Choices in Care" can also be purchased for $10.00 plus shipping and handling.

Boston Medical Center's CARE Unit receives additional NIH funding
The Clinical Addiction Research and Education (CARE) Unit in the Section of General Internal Medicine at BMC was recently awarded a $1,886,087 renewal grant from the National Institutes of Health to expand its education of physicians-in-training to become sophisticated implementers of substance use screening, assessment and treatment research.

This is the second renewal from the national institute on Drug Abuse to fund this R25 education grant for years 11-15. In addition, the CARE Unit conducts research, provides health care and informs clinical and public health practice and policy to improve the lives of people with unhealthy alcohol and other drug use.

According to the Principal Investigator of the grant Jeffrey Samet, MD, MA, MPH, the treatment of patients with drug abuse is limited by a shortage of physicians qualified to conduct clinical addiction research and trained to translate research advances into practice. "Expertise in addiction medicine is a notable deficiency among two groups of physicians who could provide great benefit with such skills: physicians who provide primary medical care to people with addictions and physicians who provide care for patients with HIV and Hepatitis C virus (HCV) infection. Although effective approaches to screen, assess and treat addiction are being developed, the supply of physicians to implement these advances lags behind," he added.
Healthy You
Non-alcoholic cirrhosis and the risk of stroke
The latest Liver International investigated non-alcoholic cirrhosis and the risk of stroke.
As habitual heavy alcohol consumption is one of the major causes of cirrhosis in the western world, the majority of studies on the relationship between cirrhosis and stroke have focused on patients with alcohol-related liver diseases.

Dr Herng-Ching Lin and colleagues from Taiwan used a nationwide population-based dataset to examine the risk of stroke among non-alcoholic cirrhosis patients over a 5-year period following their diagnosis with non-alcoholic cirrhosis, as compared with the general population during the same period.

The research team used the ‘Longitudinal Health Insurance Database’, derived from the Taiwan National Health Insurance program.
9% experienced stroke during the 5-year follow-up period
Liver International
The study cohort comprised 2336 patients with cirrhosis and the comparison cohort consisted of 11,680 randomly selected subjects.
Stratified Cox's proportional hazard regressions were performed to compare the 5-year stroke survival rate for the 2 cohorts.

In the total sample of 14,016 patients, the team found that 9% experienced stroke during the 5-year follow-up period.

After adjusting for the patients' geographical location, hypertension, diabetes, coronary heart disease, heart failure, atrial fibrillation and hyperlipidemia, the team found that patients with cirrhosis were less likely to experience stroke compared with those without cirrhosis during the 5-year period.

Dr Lin's team concluded, "We conclude that patients with non-alcoholic cirrhosis were at a reduced risk for stroke compared with the general population."
Liver Int 2011: 31(3): 354–36014 February 2011
Loving your liver: Organ crucial to good health
Published: Friday, February 11, 2011
By Dr. Allen YudovichHenry Ford Health System
Of all the body’s vital organs, the heart is the one that gets the most attention this month. But right underneath it is one of the hardest-working organs we have, our liver. It doesn’t carry the touch of romance the heart does, but it is crucial to our well-being.Our livers change food into nutrients and filter out harmful substances.
The vital functions it performs include:
• converting nutrients into energy, hormones and other essential chemicals;
• cleansing toxic substances (including alcohol) from the blood, then neutralizing or rerouting them for disposal;
• processing drugs;
• storing vitamins, minerals, sugars and iron;
• regulating fat and cholesterol; and• manufacturing bile -- a fluid that helps digest food.
The liver is also generally very good at keeping itself healthy. When it stops functioning well, the term liver disease is often used. But there are actually many forms of liver disease. When symptoms appear, they may include jaundice (a yellowing of the skin or eyes), abdominal pain, lose of appetite and weight loss, dark urine and pale bowel movements. Sometimes the first indication of a problem is found in the results of liver function tests ordered by a physician.
Some forms of liver disease are more common in older adults. Cirrhosis most frequently develops after years of alcohol abuse, although moderate drinkers sometimes develop it as well. Over time, the liver becomes scarred and loses its ability to do what it was designed to.
Other liver diseases, including hepatitis B, C and D, can also lead to cirrhosis.As the disease progresses, symptoms that may develop include nausea, fatigue, itching, vomiting blood and a swollen abdomen.When cirrhosis is caused by excessive drinking, avoiding alcohol and eating a healthy diet may be beneficial because of the liver’s ability to regenerate itself. Medication is used to treat cirrhosis caused by viral hepatitis.Cirrhosis is also one of the risk factors for liver cancer, which most often affects people older than 40. It also affects men more frequently than women.
Other risk factors include smoking, heavy drinking, hepatitis B and C and cancer in another area of the body.Liver cancerLiver cancer can be either primary (meaning it started in the liver) or secondary (beginning elsewhere in the body and spreading to the liver). Secondary liver cancer is far more common than primary, because blood that may carry cancer cells is filtered through the liver.Symptoms include abdominal pain or swelling, jaundice and weight loss, but these rarely appear in the early stages of the disease.
Various tests are used to confirm a cancer diagnosis.
These may include a biopsy, CT scan, an MRI, ultrasound and blood tests.
Treatment options include surgery, chemotherapy and radiation, along with newer treatments such as radiofrequency ablation, which uses heat to destroy tumors, and cryosurgery, which uses cold to do the same thing. A liver transplant could also be necessary.Treatment is most successful when the cancer is diagnosed in an earlier stage and when the patient does not also have cirrhosis.
All forms of hepatitis are inflammations of the liver.
The symptoms are similar to other forms of liver disease, but are often mild. A blood test is needed to confirm a hepatitis diagnosis. Treatment ranges from bed rest and avoiding alcohol to medication, depending on the form of hepatitis someone has.
Primary biliary cirrhosis
This is a chronic inflammation of the liver’s bile ducts that affects women more than men. Those who contract it are usually between 40 and 60 years old. It can lead to cirrhosis and eventually destroy the bile ducts. A healthy diet and medication can alleviate the symptoms, which include itching, fatigue and jaundice.
A liver transplant may eventually be recommended.
Alcoholic liver diseaseAs its name implies, this disease is tied to alcohol abuse, although not all heavy drinkers develop it. Alcoholic liver disease generally develops over a period of years and leads to cirrhosis. Symptoms often don’t appear in the early stages of the disease. When they are present they may include abdominal pain, jaundice, fever, excessive thirst and a loss of appetite. They may also worsen after heavy drinking.All of the above symptoms could also be indicators of a different illness. Anyone who experiences these symptoms should discuss them with their physician.
Allen Yudovich, M.D., is a gastroenterologist at the Henry Ford Medical Center - Fairlane in Dearborn.
For an appointment call (800) HENRYFORD.
Energy drinks put kids, young adults at risk: report
Updated 58 minutes ago
Energy drinks that contain high levels of caffeine and other stimulants may put some children and young adults at risk of serious health problems and should be regulated, US researchers say.
They reviewed scores of scientific studies on the health effects of energy drinks, including brands like Red Bull, Spike Shooter and Redline, and found cases of seizures, delusions, heart problems, and kidney or liver damage.
"Across the world, there are signs that for some people who consume these drinks, there are side effects," Dr Steven Lipshultz of the University of Miami, whose study appears in the journal Paediatrics said.
"The incidence is low, but in certain groups that paediatricians care for there may be higher risks."
Dr Lipshultz's team is especially concerned about the effects on young adults and children, who account for half of the projected $9 billion in US sales of non-alcoholic energy drinks.
The report calls for regulatory action and more research, and comes just months after a US crackdown on alcoholic caffeinated beverages.
Questionable claims
Manufacturers claim their products enhance mental and physical performance.
Red Bull's website, for instance, says the energy drink will increase concentration and reaction speed, and improve vigilance and emotional status.
But according to the Florida researchers, who reviewed the medical literature on the topic, the industry's claims of benefit are questionable.
Because the beverages are classified as nutritional supplements, the US Food and Drug Administration does not require their manufacturers to prove they are safe or effective.
To get a handle on the problem, Dr Lipshultz and colleagues systematically searched studies and manufacturer websites for product information on energy drinks, which they defined as "beverages that contain caffeine, taurine, vitamins, herbal supplements and sugar or sweeteners and are marketed to improve energy, weight loss, stamina, athletic performance and concentration"
They found the drinks have been linked with "serious adverse effects, especially in children, adolescents, and young adults, with seizures, diabetes, cardiac abnormalities, or mood and behavioural disorders or those who take certain medications".
"We couldn't find any evidence at all of any therapeutic effects," Dr Lipshultz said.
Caffeine overdose
Caffeine is a particular worry, according to the team.
Of the more than 5,000 US caffeine overdoses reported in 2007, 46 per cent occurred in youths aged 18 or younger.
According to one study from New Zealand, just one energy drink is enough to make most kids experience some side effect, including mild ones like irritability or upset stomach.
High doses of herbal extract yohimbine have been linked to increased blood pressure and heart rate. And like ginseng, yohimbine may interact with other drugs.
"If it were as simple as energy drinks just containing caffeine, that would be one thing," Dr Lipshultz said.
"The problem is they contain a lot of other substances."
Until the effects of these drinks are clear, Dr Lipshultz says young people with heart disease, seizures, diabetes, high blood pressure, or attention-deficit hyperactivity disorder should avoid the drinks.
Manufacturers downplayed the report.
"This article just draws together material from the internet and largely ignores in its conclusions the genuine, scientifically rigorous examination of energy drinks by reputable national authorities," Red Bull said in a statement.
The American Beverage Association said most mainstream energy drinks contain half the caffeine of a similar-sized cup of coffee.
Coke and Pepsi referred calls for comment to the American Beverage Association, and Hansen declined to comment.
- Reuters
Off The Cuff
Despite having taken an indefinite leave of absence for health reasons, Apple supremo Steve Jobs is still calling all the shots from his Palo Alto home.
Although the Apple saviour hasn't been spotted popping into the office during the three weeks since he cleared his calendar, the Thin White Duke of Cupertino - who is thought to be convalescing properly after returning to work prematurely following a fight with pancreatic cancer and a subsequent liver transplant - is still said to be calling all of the shots.
by Kelsey Matevish Sunday, February 13
While distracted in marketing class last year, College senior Elizabeth Chen dreamed up an idea to help the 2 billion people who have been infected with the Hepatitis B virus. The idea evolved into the Jade Ribbon Charity Fashion Show, which was held at the Inn at Penn on Saturday. The event featured student-group performances, guest speakers, a DJ and a fashion show that featured the work of professional and student designers modeled by Penn students. Penn Team HBV and the Hep B Free Philly campaign also lent their time and effort to the event, which attracted about 200 guests. Inspired by the struggle with breast cancer that several of her family members went through, as well as Valentino’s red fashion show which supported breast cancer, Chen — the vice president of community affairs for Team HBV — decided to create a jade collection to raise awareness for Hepatitis B. “I just found it to be really frustrating that this disease is virtually curable. This is a disease that could be completely eradicated,” said Chen, who wore a jade dress to the event. Off the Beat, Strictly Funk, Penn Dance and the Excelano Project gave performances throughout the event, with members incorporating green into their outfits. School of Medicine professor Kyong-Mi Chang opened the event by explaining Hepatitis B and urging students to get the vaccine. About 340 million people worldwide are chronically infected with the disease, with higher prevalence in Asia and Africa, according to Chang, who is also the director of the GI Hepatitis Clinic. Teresa Lamore, associate program director of the Public Health Management Corporation and guest speaker at the event, encouraged students to donate their time. “I applaud your efforts as college students for bringing awareness to an epidemic,” Lamore said.
“This is affecting everyone. It doesn’t have the face of just one person. I could be infected. You could be infected.” All proceeds from the event were donated to the Asian Liver Center at Stanford University, which researches the high occurrence of Hepatitis B among Asian Americans. Silent auction items and date auctions for models in the show were featured to help reach the goal of raising $3,000, according to Chen. Both participants and guests found the benefit event to be not only educational, but rewarding as well.
College junior and model for the evening Tony Krumbhaar said he enjoyed meeting people through the event, and found modeling to be more challenging than he expected. “It’s reaching outside my comfort zone,” he said. “The biggest thing is being confident; you gotta really have swagger.” “[The student designers] were really good. It was really unique and the models were beautiful, so all in all it was a good show,” Wharton junior Cristina David said.
Withdrawn Painkiller, The FDA And Footdragging
By Ed Silverman // February 14th, 2011 // 10:40 am
In April 2009, Kira Gilbert was prescribed the Darvocet painkiller and died eight days later from pulmonary edema, or a build up of fluid in the lungs. Three months earlier, however, an FDA advisory panel decided the benefits did not outweigh the risks of the drug - which contains propoxyphene, an opiate narcotic. And only a few weeks later, the European Medicine Agency banned the drug..Read more...
February 11, 2011
By T V PadmaOn the face of it, the takeover of six of Indian's key drug firms by major foreign players in the past four years seems to be routine business. But people within the government and industry watchdogs in India have started to worry.
.In 2008, Japan's Daiichi-Sankyo took control of India's largest drugmaker, Ranbaxy Laboratories, located about 20 miles south of New Delhi. Other Indian firms that have met a similar fate include Dabur Pharma, Shantha Biotech, Piramal Healthcare, Matrix Laboratories and Orchid Chemicals and Pharmaceuticals. Local concern grows out of the fact that these companies are major producers of cheap generic versions of essential medicines and vaccines, with wide market access in India and in other developing countries.
(Click here to continue reading.)
Image: Michael Chen, Flickr

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