Weekend Reading- Hep C Top Social Networks and Blogs

Hello Folks,

Most weekends this blog offers up a few substantial links to relevant HCV information, click here for previous "Weekend Reading" articles.

This weekend readers will be provided with links to hepatitis C support and information found on two popular social networks; Facebook and Twitter. 

These social sites offer current updates, and personal experiences along with support from people who understand the anxiety, fear and medical obstacles experienced after being diagnosed with this chronic and sometimes serious disease.

Despite all of these benefits, social networking has a potential risk if you're not careful.

 Facebook is not meant to replace your professional care, members offer support not medical advice.

Remember information you receive about HCV treatment, liver health or medications doesn't come from medical professionals. If you join a group that does have a healthcare professional, they do not know your particular medical background. The information may not be accurate, always consult with your physician before making any changes, or before taking any "natural" product such as herbs or
supplements.

The Disease

Liver disease in people with hepatitis C affects everyone differently, while it may progress slowly in most people, it can also progress quickly in others. A few host factors including duration of infection, co-infection with HBV or HIV, age, race, gender, genotype, alcohol use, smoking, other underlying disease (diabetes), all have an impact on liver disease progression.

Connecting With Other People Who Have HCV

 Facebook is one way to connect with other people coping with HCV. You may run into a member which shares close to the same medical scenario as your own, rather they are healthy and living with hepatitis C, waiting to undergo therapy, or living with serious health conditions related to the virus.

HCV Treatment and Facebook

If you're considering HCV therapy, surrounding yourself with support will get you through those many ups and downs.  Sometimes just sharing information about HCV or treatment can go a long way.

Treatment is not for everyone, only you and your physician know if treatment is right for you. For people that do begin therapy, the side effects are not easy, but most people find out that it's something they can handle. The bottom line is that each person is different.

Hang On Its Gonna Be A Bumpy Ride

When it comes to therapy, general discussions about those lovely side effects are best left up to the people who hated them. Forming these close bonds online certainly provide what our families or physicians can not.

Why?

Its simple, they haven't ridden "Mr. Toad's Wild Ride." 

They have no idea what it feels like to feed a rash and starve a brain.

Whats The Price Of Admission ?

We have two price points, both are non-refundable.

1-Expensive

Months on interferon and ribavirin.

2- More Expensive

Adding; either incivek or victrelis.  

  

I'm just kidding folks, but one thing I can attest to is the power of humor. For me treatment was a whole lot easier to get through when the people around me had a great sense of humor.  I found those people online, we laughed our way through therapy and lived to tell about it.  Laugh, its good for the soul

Before you check out these Facebook pages take a look see at; The Hepatitis Comics: Levity for the Liver

We begin with Facebook and HCV therapy

The World of Hepatitis C Support

This Facebook page is one of my favorites, with 123 members waiting to answer your questions. The devoted woman (find out her name after you join Facebook) diligently watches over her wall, adding news and HCV research while in the throes of HCV treatment. Click here to join in on the support.

Trish Cannizzo Calcote (Trish da Dish)

If you're fighting your way through treatment, Trish understands the challenge. She is eight weeks into 48 weeks of triple therapy. Please join her Facebook page by clicking here, or join Trish at one of  best and most established HCV support forums online.

Oh My Aches and Pains!
This talented author has an incredible blog you won't want to miss. Connect with Selena on Facebook, and Twitter.

Recently she updated her blog with this article;15 Ways Hepatitis C Treatment is Kicking My Butt. Read more about Selena here @ Oh My Aches and Pains.


Support For People After HCV Treatment

Jared Bryan Smith

 After landing on this Facebook page you'll have the opportunity to connect with Jared Bryan Smith the author of Hippopotamus Sea. His book on sobriety, battle against hepatitis C, and subsequent spiritual awakening is written first hand for anyone to read, for free if need be, on Books4free.com, or download it on Smashwords for less then a dollar.

In April on the authors blog he writes about his post-treatment experience with brain fog, headaches, and the reason he made a conscious choice to use Celexa over opiates, you can read the entry here.

Dragon Slayers - Post Treatment - cleared or not - all are welcome here

The Facebook support group was set up by a gentlemen after he completed HCV therapy. For many people who complete treatment side effects may linger, this is a great place to connect with people who understand that these post side-effects "Aren't All In Your Head." Click here to join the support group.

HCV Vets On Facebook

HCVets.com Educational Website & Support Forums

This group is provided by past and presents members of the United States Military with Hepatitis C (HCV) to assist fellow Retirees / Veterans / Active Military and Dependents with awareness to the Hep C virus exposure methods during military service. This informative Facebook page also offers information on the VA healthcare system and important political issues for veterans who are living with HCV. An additional great resource for information is the related HCV Vets.com website. As a side note the individuals behind this Facebook page are experienced advocates who have devoted years to helping veterans with hepatitis C. Click here to join the group and begin making a connection with other veterans.

Support and HCV Awareness

Daryl Luster

Daryl Luster is responsible for the "Hepatitis C Kills"awareness poster which he has prepared for World Hepatitis Day. To learn more about HCV and view additional posters visit his incredible website.

I visit Daryl's Facebook page on a daily basis, (he has no idea I stalk him). One day I found this point on quote Daryl made casually in a reply to another Facebook member.

"Knowledge and understanding gives empowerment, and that is so very important for walking the path of HCV."

On Facebook Daryl truly connects with people who are dealing with Hep C. The good news is that Daryl is virus free, still he continues to offer support and awareness.

Click here to visit his Facebook page and join this compassionate, kind, HCV advocate.

 Peter Rabbits

For all those people living in the UK, this Facebook page is currently active laying the groundwork for a HCV awareness campaign unlike any other; Mr. Peter will be spreading HCV awareness from atop three peaks spread across the British Isles.

Read about Peters hepatitis C awareness campaign through the Hepatitis C Trust Website.

Learn more at his Facebook page or contact Peter on Twitter. Peter is awesome, and delightful to chat with, post on his wall!

Autoimmune Hepatitis And Hepatitis C Support

The Hepatic Muslim

This Facebook page was created by a lovely lady who suffers with both hepatitis C and autoimmune hepatitis. The group offers support to all, although it was set up to support the Muslim community battling HCV. If you live in Pakistan, this Facebook page is a great starting point for support. Click here to join the group, and please visit the accompanying website; The Hepatic Muslim.  

A message from the web mistress;

"My Dear Sisters and Brothers, The Purpose of my starting this site, InshaALLAH is to raise awareness and educate others about Hepatitis, and to offer a means of emotional support for other Muslims who have this disease."

 Twitter

For me, Twitter is a beneficial tool for keeping up with HCV and liver disease news. I check updates a few times a day, and follow links to abstracts, full text data, clinical trials, and articles on the new drugs in development.

News and Journals HCV

Gastro & Endo News‏@gastroendonews

No. 1–rated independent monthly newspaper providing news and information for 17,000+ gastroenterologists, colorectal surgeons, hepatologists, PAs and NPs.

AASLD‏@AASLDNews

AASLD is the leading organization of scientists and healthcare professionals committed to preventing and curing liver disease.

CCO Hepatitis‏@CCO_Hepatitis
Clinical Care Options creates innovative, interactive Hepatitis CME programs. Follow us to be the first to know when content is published.

Reuters Health‏@Reuters_Health

HCV Information

GastroHepTV 

A peer reviewed, independent on-line audio/video/blog channel broadcasting to the global gastroenterology & hepatology community

Alan Franciscus‏@HCVAdvocate

Info about hepatitis C including news, updates to HCV Advocate Web site, HCV trainings, conferences and traveling around the country and speaking about HCV.

Lucinda K. Porter RN‏@LucindaPorterRN
Author of Free from Hepatitis C.Working to make the world healthier & free of hepatitis C, while offering occasional levity for the liver

CAP‏@CAP_CHOICES
The Caring Ambassadors Program mission is to help improve the lives of those affected by long-term diseases through advocacy, information, and support.

Hep Magazine‏@hepatitismag
Hep is the go-to online source for educational and social support for people living with hepatitis C (HCV), hepatitis B (HBV) and hepatitis A (HAV).

Hepatitis Foundation‏@The_Liver_Lady
The Hepatitis Foundation International is dedicated to promoting liver wellness and preventing disease

Transplant HCV

Ian Quill‏@ianquill
Ian Quill : My World - I blog for me and people like me, beating HepC

Ricki Albertoni‏@rickisjourney

Clinical Trials

Clinical Trials

Offering clinical trials news alerts on thousands of medical / heath conditions.

CAM For HCV

Healthy Hepper‏@healthyhepper

This website specializes in Complementary and Alternative Medicine CAM for the Hepatitis C Virus HCV.

Misha Cohen‏@DocMisha

Doctor of Chinese Medicine - Hepatitis B, Hepatitis C, Cancer Support, Metabolic Syndrome X, Chinese Herbs, Acupuncturist, Integrative Medicine

HCV Support

HCV Support‏@HCVSupport

Dedicated to Providing Knowledge, Support and Encouragement to those affected by Hepatitis C.

Awareness

Hep Edu Project

The Hepatitis Education Project aims to support people living with viral hepatitis and increase awareness about the disease through education and advocacy.

Inspirational

Fight Like A Girl C‏@FightLikeAGirlC

Join the Fight Like A Girl Club, tell your story, give and receive support, share hope, and claim your Power!

Pharmaceutical

pharmalot‏
The latest news and views about the pharmaceutical industry, with Ed Silverman of Pharmalot.com.

Pharma News
Tweeting pharma industry latest news and trends from various pharma platforms accross the Web

Adam Feuerstein The Street

Sr. Columnist at TheStreet

Blogs

The Hepatitis C Mentor & Support Group, Inc.
The Hepatitis C Mentor and Support Group (HCMSG) was founded by two Hepatitis C patients. The founders joined forces in 2010 to ensure that Hepatitis C patients in New York State have access to information and support services that will help them manage and overcome Hepatitis C with strength, dignity and fellowship.

Defeating Hep C 

A MINORITY voice in the battle of Hepatitis C - "the silent liver killer"

NEWS FLASH: I'm an "UNDIE!!!!!"

Hepatitis Reserach Fund

News and research

Blog @ GastroHeptv.com

Written by Dr Paul Targett-Adams

After completing his PhD on the molecular biology of herpes simplex type 1 DNA packaging at the MRC Virology Unit at Glasgow in 2001, he embarked upon his post-doctoral research career focusing upon the intricate molecular details of hepatitis C virus (HCV) RNA replication. Later, in 2008, he joined the Antivirals Research Unit at Pfizer UK to continue his work on HCV with the added bonus of directly translating his research knowledge to investigating HCV mechanisms amenable to drug discovery programs. It was at Pfizer that his interest in HCV NS5A inhibitors, an exciting and intriguing new class of anti-HCV molecules was first piqued. In 2012 he joined Medivir AB in Stockholm as a Principal Scientist committed to discovering and developing novel antiviral medicines to combat a range of virus infections of global medical significance; including, of course, HCV

Other HCV Websites

This page of links will take you to the premier Hepatitis C sites and keep you informed with breaking news, clinical studies, new drugs, podcasts, newsletters, support, personal experiences, chat rooms, forums and more.

If you know of a great Facebook page or Twitter account you would like to add email me or reply to this message.

Have fun, laugh, learn, and share.

Tina :)

DDW-Liver Disease: Good News and Bad News

From Medscape Gastroenterology

Liver Disease: Good News and Bad NewsDigestive Disease Week 2012

William F. Balistreri, MD

Click here to view the new Medscape video with Dr. Bill Balistreri discussing data from last months DDW; including treatment for HCV, and fatty liver disease.

Emerging Data in Liver Disease
Hello, I am Dr. Bill Balistreri, Professor of Pediatrics and Medicine at the University of Cincinnati College of Medicine and Cincinnati Children's Hospital. I am here at Digestive Disease Week (DDW) in San Diego to discuss emerging data on liver disease for Medscape.

Studies presented at DDW 2012 have highlighted 2 major issues that have received attention over the past year. The first issue is new strategies for the treatment of hepatitis C virus (HCV) infection, including the possibility of an interferon-free regimen. The second issue is concern about the rising incidence and impact of obesity-related liver diseases: nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH)

The Good News: Treatment for HCV Infection
First, the good news: Combination therapy with pegylated interferon and ribavirin has long stood as the standard of care for patients with chronic HCV infection. Although effective in achieving high response rates, this regimen is associated with troublesome side effects. Thus, the development and approval of 2 effective protease inhibitors, telaprevir and boceprevir, was hailed as a new era of therapy for patients with hepatitis C genotype 1 infection.

Several studies were presented to document that these direct-acting antiviral agents allow more effective and shorter durations of treatment. For example, in patients infected with HCV genotype 1, for whom previous standard therapy failed to eliminate the virus, treatment with either of these protease inhibitors was shown to be significantly more effective, with sustained viral response rates 2- to 3-fold higher compared with traditional therapy.

An American Association for the Study of Liver Diseases (AASLD) plenary session presentation^[1] reported that when telaprevir was used in combination with peginterferon and ribavirin, the dose of ribavirin was able to be substantially reduced. Ribavirin dose reduction to less than 600 mg/day had no substantial effect on sustained viral response (SVR) rates in patients given telaprevir combination treatment. In another study,^[2] when boceprevir was used in combination with peginterferon and ribavirin, SVR was achieved in patients who had been nonresponsive to previous therapy.

Despite the optimism about the prospects for this treatment of HCV, a remaining concern is the fact that telaprevir and boceprevir must be used in combination with peginterferon and ribavirin. This is far from the ideal regimen. In fact, because of poor tolerability, many treatment candidates will decide not to pursue treatment or to defer treatment until a simpler regimen is available.

However, other studies suggest that an interferon-free regimen (and perhaps even a ribavirin-free regimen) is no longer a dream. A number of compounds encompassing several distinct drug classes are currently under development. These drugs bring us one step closer to the long sought-after ideal: the ability to delete interferon injections from treatment strategies.

In the interim, how can we tailor therapy and predict response rates? Investigators noted that patients infected with hepatitis C genotypes 2 and 3 achieve SVR rates between 70% and 80% in clinical trials. However, in real-life settings, lower SVR rates in the range of 55%-65% are reported. In work presented here,^[3] predictive factors for nonresponsive patients with genotypes 2 and 3 included daily alcohol intake greater than 40 g, HIV co-infection, low thyroid-stimulating hormone (TSH) levels, the presence of cirrhosis, and the duration of infection. These risk factors should be assessed and may suggest the need for an intensified treatment course.

Further data^[4] were presented on a major genetic predictive factor: a single nucleotide polymorphism in the upstream region of the interleukin-28B gene. Genotype CC is the strongest factor predictive of SVR in patients with HCV genotype 1 treated with peginterferon and ribavirin. This CC genotype was also shown to be associated with a significantly higher rate of spontaneous clearance in both white and African American patients with exposure to HCV. This information will be of value when counseling patients.

The Bad News: Fatty Liver Disease on the Rise
Now the bad news: NAFLD has become the leading cause of liver disease in North America, as a result of the rapidly increasing prevalence of obesity. However, accurate population-based data on the incidence of NASH are sparse, in part because the diagnosis requires histopathologic documentation.
In a study presented here,^[5] the temporal trend in the prevalence of NASH in one US county over the past 30 years was reported. In this Mayo Clinic review of 555 autopsy records, there was a significant increase between 1981 and 2010 in mean body mass index, as well as in the prevalence of obesity, in this county. There was also a striking increase in the prevalence of steatosis and NASH. Among persons who were obese, the prevalence of steatosis increased from 23% in the 1980s to 49% in the 1990s, and to 60% in the most recent era. Even in nonobese patients, the prevalence of steatosis increased from 12% (1980s) to 27% (1990s) to 36% (today).

In a related study,^[6] investigators examined trends in the prevalence of NAFLD in children over the past 2 decades. They used nationally representative data from the National Health and Nutrition Examination Survey (NHANES) data sets, spanning 1988-2008. More than 10,000 adolescents were included in this analysis. The percentage of adolescents who were obese increased from 11% to 21% over this 30-year period. Suspected NAFLD increased from 4% to 10%. Among obese adolescents, the prevalence of elevated aminotransferase levels increased 120%, from 17% to 37%.

The bottom line is that suspected NAFLD in children is increasing in prevalence and affects about 10% of all adolescents. Of note, the increase in NAFLD was not solely defined by the number of overweight children. The increased prevalence of NAFLD was much greater than the increase in the prevalence of obesity. These data strongly support recommendations to screen for NAFLD in obese adolescents. This raises the question as to the best screening and confirmation methods. Specifically, is there a noninvasive way to diagnose NASH?

Several studies^[7,8] presented here indicate that this is possible, to a degree, using serum biomarkers of hepatocyte apoptosis and oxidative stress. Circulating markers of hepatic cell death -- cytokeratin 18 fragments and soluble Fas (Fas ligand) -- were shown to be useful for the diagnosis of NAFLD and NASH. A prediction model was also developed.

A combination of these markers had superior diagnostic performance for detecting NASH compared with measurement of the individual markers.

In addition, newer magnetic resonance techniques, such as measurement of the proton-density fat fraction, correlate with histology-determined steatosis grade in adults with NAFLD. However, a study^[9] reported here documented that the amount of hepatic steatosis on imaging does not necessarily correlate with the severity of liver disease, and steatosis is not linearly related to disease progression. Future studies will need to explore the natural history of NAFLD, the interplay between hepatic steatosis and fibrosis, and whether novel imaging or MRI techniques can be used as a noninvasive means to study disease progression by fat mapping and changes in fat distribution over time.

Why are we concerned? Obese patients with fatty liver are at increased risk for early morbidity and mortality.

This begins during adolescence. A study presented at DDW 2012^[10] evaluated the association among obesity, fatty liver, and cardiovascular risk in pediatric patients. They documented that obesity may in fact confer a cardiovascular disease risk burden that is comparable to that of patients with familial dyslipidemias. Thus, earlier recognition and medical intervention is warranted.

Another study^[11] reported that moderately severe obstructive sleep apnea and hypoxia are common in obese patients with biopsy-proven NAFLD. Obstructive sleep apnea and hypoxia were also associated with more advanced fibrosis in pediatric patients. A large multicenter cohort further documented that NAFLD is a predisposing condition for hepatocellular carcinoma. Of concern, NAFLD-associated hepatocellular carcinoma often occurs in the absence of cirrhosis. This may suggest the need to revise current guidelines, which suggest surveillance programs for cancer in patients with cirrhosis.

Finally, one study^[12] reported the long-term follow-up of a liver-related death rate in patients with nonalcoholic fatty liver disease and alcoholic-related fatty liver disease. A similar proportion of patients with NAFLD and with alcoholic fatty liver disease developed cirrhosis. However, patients with NAFLD had a worse overall survival than patients with alcoholic-related fatty liver disease. These sobering studies underscore the urgent need to enhance our efforts to reduce the trend in obesity rates and the prevalence of fatty liver disease.

Thank you for listening. This is Bill Balistreri, for Medscape.

References

http://www.medscape.com/viewarticle/764670?src=rss

Hepatitis B-Court ruled against Tennessee veteran who claims he contracted HBV at Murfreesboro VA hospital

Court rules against Tenn. vet in colonoscopy case

Posted at: 06/01/2012 6:05 PM
By KRISTIN M. HALL

(AP) NASHVILLE, Tenn. - Years after thousands of veterans learned they may have been exposed to infections at government-run hospitals, many are still mired in legal battles seeking compensation from the Department of Veterans Affairs.

In the latest legal setback, a federal appeals court has ruled against a Tennessee veteran who claims he contracted hepatitis B after employees at the Murfreesboro VA hospital negligently failed to properly clean colonoscopy equipment. The ruling could have an impact on similar lawsuits against the VA. 

The court found that Carl Huddleston’s claim, filed more than three years after the procedure, came too late, even though he acted within months after he learned his health could have been endangered. The three-judge panel of the 6th Circuit Court of Appeals ruled last week. 

Huddleston was one of more than 10,000 veterans notified in 2009 that they needed to be tested for hepatitis B and C and HIV infection because of endoscopic cleaning mistakes at VA facilities in Murfreesboro, Tenn., Augusta, Ga. and Miami. The VA said Friday that 90 patients were found to be positive with one or more of the three viruses.....

Continue Reading.........

U.S. Prepares Groundwork for Biosimilar Approval

U.S. Prepares Groundwork for Biosimilar Approval

With the recent release of FDA draft guidelines, launch of the first oncology biosimilars is looming

by Rosemary Frei, MSc

 

As biosimilar drugs make their way to American soil, clinicians, regulators, pharmaceutical executives and patients alike are asking: How long will it take for the first biosimilars to reach the U.S. market? How much lower will their prices be than the original molecules they mimic? How quickly will they be accepted by clinicians and patients?

Biosimilar medications—also known as follow-on biologics—are virtually identical or highly similar versions of large and intricate biologic molecules like monoclonal antibodies. Brand-name biologics are already essential for the treatment of breast, colorectal, esophageal, gastric, head and neck, kidney and non-small cell lung cancers; and Hodgkin’s and non-Hodgkin’s lymphoma. They also are vital in the treatment of cancer- and chemotherapy-induced anemia and neutropenia. The hope is that biosimilars will significantly improve the affordability of, and access to, cancer medications.

The clock is already ticking toward the entry of biosimilars into the American market. This is because the 12-year patent-protection period will soon end for some brand-name products (Table 1, page 48). For the epoetin-alfa products Epogen (Amgen) and Procrit (Janssen Products), as well as Aranesp (darbepoetin alfa, Amgen) and Neupogen (filgrastim, Amgen), protection will run out in 2013. Some monoclonal antibody products, such as Rituxan (rituximab, Genentech/Biogen Idec), will likely lose their exclusivity protection as soon as the fourth quarter of 2015 and early 2016.

Continue Reading..............

Liver Cancer Rates Continue to Rise, Vigilance Warranted

By: MITCHEL L. ZOLER, Family Practice News Digital Network
June 1

SAN DIEGO – The U.S. incidence of hepatocellular carcinoma continues to soar, and will likely remain on that trajectory for at least a couple of decades, fed in large part by the obesity and type 2 diabetes epidemics, as well as by infections with hepatitis virus types C and B.

"I think rates will increase for another 10-20 years," predicted Dr. Alita Mishra, one of two researchers who reported results at the meeting from independent studies that documented increased rates of U.S. hepatocellular carcinoma (HCC) cases during the 2000s.

Greater vigilance is therefore needed to spot incident cases early, she said in an interview. While patients infected with hepatitis C virus who develop cirrhosis usually undergo routine, serial ultrasound screening for liver lesions, regular surveillance occurs less often in patients with cirrhosis who are infected with hepatitis B virus, or those with cirrhosis due to non-alcoholic fatty liver disease (NAFLD) secondary to obesity or type two diabetes. "Patients with cirrhosis should undergo regular HCC screening regardless of the underlying cause," Dr. Mishra said at the annual Digestive Disease Week.

One analysis, based on data collected by the Surveillance Epidemiology and End Results (SEER) registry of the National Cancer Institute, showed that U.S. HCC rates rose three-fold from 1975-2007, including a 33% rise during 1998-2007, Jessica A. Davila, Ph.D. reported at the meeting.

The second analysis, using data collected by the Nationwide Inpatient Sample (NIS), showed that the number of patients hospitalized with HCC per 100,000 hospital discharges jumped from 148 in 2005 to 213, said Dr. Mishra, a hospitalist at Inova Farifax (Va.) Hospital.

"HCC is rising because of hepatitis C viral infection, especially in people born during 1945-1965," Dr. Mishra said in an interview. Many of these people don’t know they are infected, and it usually takes decades for them to develop HCC.

The second big factor is the rising prevalence of obesity and type 2 diabetes. "Hepatitis C infections are now falling, so perhaps the rise in new HCC cases will eventually peak, but not if other factors like obesity and type 2 diabetes continue to push it up," she said.

"What is driving a lot of the increase is hepatitis C virus, and the high prevalence of hepatitis B virus in foreign-born Asians," said Dr. Davila, a clinical epidemiologist at the Houston VA Medical Center and Baylor College of Medicine in Houston.

"A lot also has to do with obesity and type 2 diabetes and their association with non-alcoholic fatty liver disease, especially in middle-aged, Hispanic women. I think we’ll see the greatest increase in HCC in women during the next 2 decades," Dr. Davila said. She also predicted increasing numbers of hepatitis C virus-driven HCC cases in the short term "as the [infected] cohort ages, increasing numbers will develop advanced fibrosis and eventually HCC," she said.

Dr. Davila’s study used data from SEER, which the National Cancer Institute began in 1973 to collect data on cancer cases from about 14% of the U.S. population in selected states and metropolitan areas. During 1975-2007, SEER tallied a total of 21,472 HCC cases, about 80% of which occurred in people aged 50-79 years, and about three-quarters of cases in men.

Continue Reading Page Two @ Family Practice News, Page One....

Bristol CEO says Gilead holding out on hep C tie-up

Bristol CEO says Gilead holding out on hep C tie-up

June 1, 2012 | By Ryan McBride

FierceBiotechBristol-Myers Squibb ($BMY) isn't giving up on pushing Gilead Sciences ($GILD) to move ahead with further study of the two companies' oral drugs as a combo treatment for the hepatitis C virus, with Bristol boss Lamberto Andreotti reiterating that joining forces could be best for patients and each of the drugmakers, Reuters reported.

In April a mid-stage study showed that a combo of Gilead's nucleotide inhibitor GS-7977 and Bristol's daclatasvir wiped out signs of hep C in 97% of patients with genotype 1 cases of hep C after 12 weeks of treatment--impressive results that generated enthusiasm among analysts and clinicians. However, Gilead, which acquired 7977 in its $10.8 billion Pharmasset buyout, hasn't budged amid calls from Bristol and clinicians to agree to a Phase III program involving the companies' experimental drugs.

As Reuters reports, Gilead has focused on developing oral drug combos against the liver-damaging disease from its own pipeline. But Bristol, which made a smaller Hep C gamble of its own with the $2.5 billion buyout of Inhibitex in January, is obviously keen on teaming up in the race to develop all-oral treatment for hep C, which is typically treated with injections of interferon, which causes miserable side effects. With the Pharmasset purchase, Gilead put itself at the front of the pack of oral Hep C drug developers that also includes Vertex Pharmaceuticals ($VRTX), Abbott Labs ($ABT) and the small developer Achillion Pharmaceuticals ($ACHN).

"[Bristol and Gilead] have a different point of view about whether to enter Phase III (trials) with that combination," Andreotti said, as quoted by Reuters. "We believe, for both patients and companies, it is better to move forward" with the late-stage studies.

With some 170 million hepatitis C patients around the world, and many patients forgoing treatment with existing drugs, the patient-friendly oral drugs are eventually expected to generate $20 billion in annual revenue. Gilead has clearly bet hugely to grab its share of that market.
- check out Reuters' report

Source

Related Articles:
Analysts pounce on positive Phase II data on hep C combo
Lack of Gilead and BMS teamwork on hep C draws ire
Gilead wows analysts as 7977 combos quell hep C in most patients
Gilead Sciences bags Pharmasset's hep C pipeline in $11B buyout

Read more: Subscribe: http://www.fiercebiotech.com/signup?sourceform=Viral-Tynt-FierceBiotech-FierceBiotech

TGIF-Weekly Rewind - Hepatitis C News and Research

Greetings,
HCV Rewind is a weekly publication with a look back at this weeks headlines, including today's news with updates as the day progresses. Click here to view previous or future"HCV Weekly Rewind" articles.

We begin with Bristol-Myers shout out to Gilead Sciences - hinting once again for a collaboration. The drugs; Gilead's HCV drug  GS-7977 and Bristol's drug daclatasvir. Interim results were at 100% SVR in genotype 1 treatment-naive patients, view the data here .

Reuters  excerpt;

Bristol-Myers Chief Executive Lamberto Andreotti, speaking on Thursday at the Sanford Bernstein Strategic Decisions Conference in New York, said patients and both drugmakers stand to benefit if combined Phase III trials of the two medicines are pursued.

"We have a different point of view about whether to enter Phase III (trials) with that combination," Andreotti said. "We believe for both patients and companies, it is better to move forward" in the short term.

But Andreotti said Gilead instead seemed intent on looking "in-house" -- focusing instead on combinations of its own products. Gilead officials could not immediately be reached to comment.

Continue Reading @ Reuters

Incivek- Vertex Receives FDA Warning Letter
Speaking of big Pharma, Vertex was in the hot seat over a warning letter issued on May 25th by the FDA. Vertex published a patient story describing their personal experience treating with  Incivek. The FDA found the patients letter misleading and said it implied most or all cirrhotic prior null responders will successfully achieve SVR on Incivek, here's an excerpt from the warning letter.

Overstatement of Efficacy 
Promotional materials are misleading if they contain representations or suggestions that a drug is better or more effective than has been demonstrated by substantial evidence or substantial clinical experience. The branded story is an account of James’ life and medical history since being diagnosed with hepatitis C. Specifically, the story describes James’ diagnosis of stage 3 cirrhosis and subsequent null response after 6-months of treatment with pegylated-interferon and ribavirin combination therapy. After treatment with Incivek combination therapy, the story claims:

"And six months after treatment ended, I found out I’d cleared the virus. That made me feel so good. I was so happy to know I’d be around a little longer to see my son grow up." [page 5]
". . .I’m cleared, I can take my son to the batting cage. We go sailing on my boat and take nice vacations. I even retired from the railroad and started a successful cab business, which I really enjoy. I’m loving life." [page 5]

 While these claims may be an accurate reflection of James’ own experience with hepatitis C and treatment with Incivek, this branded story misleadingly implies that most or all cirrhotic prior null responders infected with hepatitis C will successfully achieve Sustained Virologic Response (SVR) on Incivek combination therapy. FDA is not aware of substantial evidence or substantial clinical experience to support this implication. One patient’s treatment response does not constitute substantial evidence. According to the Clinical Studies section of the PI, of the prior null responders with cirrhosis tested in clinical trials, 14% who received

Read the FDA warning letter here,and the patients Incivek story here.

New guidelines for Nonalcoholic Fatty Liver Disease (NAFLD)
In other news the AASLD along with the American College of Gastroenterology and American Gastroenterological Association, published new guidelines for Nonalcoholic Fatty Liver Disease (NAFLD).  The recommendations in the guideline include the following topics;
NAFLD in other chronic liver diseases
Natural History
Screening of Family Members
Non-invasive assessment of steatohepatitis and advanced fibrosis in NAFLD
Metformin
Thiazolidinediones
Vitamin E
Ursodeoxycholic acid (UDCA), Omega-3 fatty acids, and Miscellaneous Agents
Alcohol use in patients with NAFLD and NASH
Statin use in patients with NAFLD and NASH
Aspects of NAFLD Specific to Children and Adolescents
Lifestyle modification
Lifestyle intervention
and more...............
Download this timely and free practice guideline.

EASL-Interferon-free drugs in development
On May 28th published over at gastroheptv.com, Dr. Paul Targett-Adams, Principal Scientist at Medivir AB,  offers us coverage from the March EASL conference, highlighting the data on HCV all-oral interferon-free drug regimens. If you stroll over to the site check out this March article; NS5A inhibitors: Picomolar power to combat hepatitis C virus?,  also published by the doctor.

Risk; Over-the-counter (OTC) pain medication containing the active ingredient acetaminophen
A few days ago a study put together by Dr. Michael Wolf, from Northwestern University in Chicago investigated the misuse of over-the-counter (OTC) pain medication containing the active ingredient acetaminophen. In the paper published online in the Journal of General Internal Medicine², the team of researchers asked  participants in the study if taking a second medicine containing acetaminophen would put them at a risk of overdosing, here is what they found.

Excerpt;

To assess 'double-dipping', the patients were told to imagine they were taking a maximum dose of a primary OTC drug and asked whether it would be safe to also take a second medicine with the primary medicine - both of which contained acetaminophen. 

Wolf and team found that nearly a quarter of the participants were at risk of overdosing on pain medication using a single OTC acetaminophen product, by exceeding the dose of four grams in a 24-hour period; 5 percent made serious errors by dosing out more than six grams. In addition, nearly half were at risk of overdosing by 'double-dipping' with two acetaminophen containing products.

Continue reading here

Other headlines for the week of May 28
New Hampshire-Officials confirm hepatitis C outbreak at Exeter Hospital

Preliminary Phase 2 Data of Ocera Therapeutics' OCR-002 for the Treatment of Liver Cirrhosis and Upper GI Bleeding Show Potent Ammonia Reduction

"HCV and the ID physician: A perfect match"

GSK seeks to expand low platelet drug Promacta to hepatitis C patients

Today In The News

All-oral hepatitis C combos threaten interferon

Marc Iskowitz 

June 01, 2012

Scientists are getting closer to finding the killer app in treating hepatitis C, but it may be too soon to pick a winner.

Bristol-Myers Squibb and Gilead say that an all-oral therapy joining daclatasvir from BMS and Gilead's GS-7977 suppressed the virus in more than 95% of patients across a broad spectrum of genotypes.

The two drugs reached a 100% sustained virologic response (SVR), or cure rate, at week four in a common subgroup, genotype 1 patients not previously treated with interferon.

The 100% rate held when ribavirin, another traditional treatment mainstay, was not in the mix, bettering the roughly 90% SVR rate seen in trials for an Abbott triple therapy.

The direct-acting antivirals (DAAs) from BMS, Gilead and Abbott showed the best efficacy and tolerability of those presented at the European Association of the Study of Liver Disease (EASL) in April.

The findings accelerated momentum in a fast-moving category. Not that there haven't been speed bumps. In February, Gilead's ‘7977 came under assault when data showed that six out of six subjects treated with the pipeline drug, all prior “null” responders to an interferon-containing regimen, experienced viral relapse within four weeks of completing an all-oral regimen of ‘7977 and ribavirin. Gilead's stock fell after the news.

Several analysts now believe daclatasvir, an NS5a inhibitor, and ‘7977, a nucleotide analog (or “Nuc”), may form the best treatment “backbone” option across all genotypes.
“The ‘killer app' in HCV is probably an NS5a plus a nuc without ribavirin,” ISI analyst Mark Schoenebaum declared.

The newer protease inhibitors—Vertex's Incivek and Merck's Victrelis—appear vulnerable to the all-oral regimens, but not for a few years.

“These results obviously reinforce the expectation that DAA-only (IFN and RBV-sparing) regimens will likely quickly supplant current HCV treatments when they become available in the 2015/2016 timeframe,” wrote Deutsche Bank's Barbara Ryan in a note.

In a dispatch to investors, Credit Suisse's Catherine Arnold said the data “takes a little shine off” Abbott's HCV program, “but we still view it as a competitive presence.” The triple therapy combines the firm's protease inhibitor ABT-450 + NS5B inhibitor ABT-333 + ribavirin. Another three-drug regimen including NS5B inhibitor ABT-072 also showed a high HCV cure rate.
The Gilead/BMS combo “represents the most compelling all-oral, interferon-free data in the highly visible [HCV] marketplace,” noted Arnold.

Gilead has many HCV compounds to pair its nuc with, including an NS5a like daclatasvir. That makes a Gilead-BMS partnership far from a given.

Ryan also cautioned that other factors—side effects, dosing convenience and cost—“will be important considerations in determining market share.”

Results from a mix of Gilead's ‘7977 and ribavirin hit an SVR rate of 88%—above the 50% the Street had expected, according to Schoenebaum. Abbott's all-oral triple combo may be another good backbone option, while daclatasvir looks like a solid add-on option and BMS is exploring multiple pairing options.

Other nucs in development include Vertex's ALS-2200 and ALS-2158, and biotech firm Idenix's IDX184, which can be combined with its NS5a inhibitor, IDX719.

From the June 2012 Issue of MMM

Quality of Life Undiminished by Telaprevir in Chronic Hepatitis C
By: DIANA MAHONEY, Family Practice News Digital Network
SAN DIEGO – Although the addition of telaprevir to peginterferon/ribavirin therapy for treatment of chronic hepatitis C exacerbates treatment-related side effects, the triple combination does not diminish patient quality of life relative to treatment with the peginterferon/ribavirin regimen alone, a study has shown.

In other words, adding the protease inhibitor "does not further diminish patient quality of life," lead investigator Dr. Zobair Younossi explained at the annual Digestive Disease Week. "The most important contributor to the quality of life measurement in interferon therapy is interferon itself, which is so overwhelming in terms of side effects, especially grade 4 and 5 effects, that it probably overshadows everything else," he said.

Studies have shown that the addition of telaprevir to standard peginterferon alfa-2a/ribavirin (PR) significantly improves treatment efficacy in treatment-naive patients with genotype 1 hepatitis C virus (HCV), but there is a perception that the additional side effect burden from adding telaprevir is prohibitive in some patients, said Dr. Younossi, chairman of the department of medicine at Inova Health System in Falls Church, Va.

Dr. Younossi and colleagues conducted post hoc analyses of data from the ADVANCE trial, in which adding telaprevir to the treatment mix significantly improved patients’ sustained virologic response compared with standard PR therapy

In the ADVANCE study, 1,088 treatment naive HCV genotype 1 patients were assigned to one of three treatment arms: 48 weeks of standard PR therapy; 12 weeks of telaprevir plus 24 weeks PR; or 12 weeks of telaprevir plus 48 weeks of PR. Nearly 80% of patients in both telaprevir groups achieved sustained virologic response, compared with 46% of patients in the standard PR treatment group (N. Engl. J. Med. 2011;364:2405-16).

In terms of side effects, "across all phase III studies, the incidence of rash and anemia (which are the effects we’re talking about with the protease inhibitors) was 56% and 34%, respectively, among telaprevir-treated patients, and 36% and 17% in patients receiving standard treatment," Dr. Younossi said.

To assess whether and to what degree these increases played a role in patient quality of life, Dr. Younossi and colleagues analyzed the results of EQ-5D quality of life questionnaires completed at baseline and at weeks 4, 12, 24, 36, 48, and 72 by 722 patients. They derived a summary index by calculating the percentages of patients reporting problems for each of the five health-related quality of life dimensions measured (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).

After adjustment for age and sex, the baseline mean index values for the EQ-5D were 0.92 for the telaprevir plus 24-week PR group, 0.90 for the telaprevir plus 48-week PR group, and 0.91 for the 48-week PR-only group. The percentages of patients reporting any problems in each of the five qualitative dimensions at baseline were 8.2% for mobility, 2.0% for self-care, 12.9% for usual activities, 25.7% for pain/discomfort, and 25.6% for anxiety/depression, he said.
Continue Reading Next Page ..... Page One....

Hepatitis body warns against hysteria

Updated: 20:53, Friday June 1, 2012
A statewide health organisation says coverage of the sentencing of an officer who assaulted a prisoner, said to be infected with hepatitis C, is fanning community ignorance about the disease.

Hepatitis NSW CEO Stuart Loveday says the facts have been lost in media coverage of the incident.
CCTV footage emerged this year that appeared to show Terry Dolling repeatedly punching prisoner Daniel Vos inside a Newcastle holding cell in October 2011, after Vos spat in Dolling's face.

Mr Loveday says much of the commentary has focused on whether the spitting incident could have exposed Dolling to infection, even though hepatitis C is not spread through saliva.
'The hepatitis C virus is transmitted by blood-to-blood contact,' he said.

If anything, he told AAP, Dolling had increased his chances of catching the disease by punching an apparently infected man.

'It's still quite unlikely, I would suggest, because I did note the prison officer was wearing these thin gloves,' he said.

The community was becoming unnecessarily alarmed, he said.
'Today we had a call from the parent of a child whose teacher said 'Yes, you can catch hepatitis through spitting.''

The state's 3500 prison officers walked off the job for an hour on Friday morning in protest and as a show of support for Dolling, who has been sentenced to seven months with a four-month non-parole period over the assault.
Source
;
Scientists Sequence Genome Of Liver Cancer Caused By Hepatitis B, C.

By Tang Yew Chung | Featured Research
June 1, 2012

Two teams of Asian researchers have independently completed whole-genome sequencing studies of a type of liver cancer commonly caused by hepatitis virus infection.

AsianScientist (Jun. 1, 2012) - Two teams of Asian researchers, one Japanese and the other from China and Singapore, have independently completed large-scale, whole-genome sequencing studies of a type of liver cancer commonly caused by hepatitis B virus (HBV) and hepatitis C virus (HCV) infection.

Both studies were published this week in Nature Genetics, providing important insights into how hepatitis viral infection causes hepatocellular carcinoma (HCC), the most common form of liver cancer worldwide, and may lead to improvements in diagnosis and treatment.

Individuals infected with HBV and HCV are known to have a significantly higher risk of developing HCC. In countries like China and other parts of Asia where hepatitis B is endemic, HBV infection is the predominant cause of HCC.

In Japan, which has the highest HCC rates of any industrialized country in the world, HCV infection is thought to be responsible for the majority of cases.

It is thought that the HBV and HCV genomes are integrated into the genome of the human host in a manner that promotes the accumulation of genetic abnormalities, leading to cancer development.

The China-Singapore team studied tumor samples and adjacent normal tissues from 81 HBV-positive and 7 HBV-negative HCC patients while the Japanese team collected tumor and blood samples from 11 HBV-positive HCCs, 14 HCV-positive HCCs, and 2 HCCs that were not associated with hepatitis infection.

Both teams used whole-genome sequencing technologies to identify novel gene mutations that may be responsible for HCC development and pinpoint locations where the viral genome has been integrated into the host genome.

In particular, the China-Singapore team identified characteristics of HBV integrations that may help the virus to control specific genes in the host tumor, providing new insights into the mechanisms through which HBV integration promotes cancer.

“A deep understanding of the recurring HBV insertions in HCC will help the research community identify novel molecular targets in liver cancer, for which effective treatments are still limited,” said John Luk, a leader of the China-Singapore collaboration.

The articles can be found at: Fujimoto et al. (2012) Whole-genome Sequencing Of Liver Cancers Identifies Etiological Influences On Mutation Patterns And Recurrent Mutations In Chromatin Regulators and Sung et al. (2012) Genome-wide Survey Of Recurrent HBV Integration In Hepatocellular Carcinoma

———

Copyright: Asian Scientist Magazine. Sources: BGI, Nature Publishing Group.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.
http://www.asianscientist.com/in-the-lab/genome-studies-liver-cancer-hepatitis-b-hbv-hcv-2012/

Hepatitis B

Prevalence of chronic hepatitis B may exceed 2 million, higher in US than previously reported

May 31, 2012

The prevalence of chronic hepatitis B virus (HBV) infection in the U.S. may be as high as 2.2 million cases according to a new study now available in Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases. Findings suggest the higher prevalence of chronic HBV can be attributed to foreign-born persons who were infected in their country of origin prior to arrival in the U.S. Emigrants from Asia and Africa, where infection with hepatitis B is highly endemic, represent close to 70% of the 1.32 million foreign-born persons living with chronic HBV in the U.S. in 2009.

Chronic HBV is a major health burden that experts say affects up to 400 million individuals worldwide, with up to 25% at risk of premature mortality due to primary liver cancer and end-stage liver disease if the infection is left untreated. In the U.S., the Centers for Disease Control and Prevention (CDC) estimate that in 2006 there were 800,000 to 1.4 million persons living with chronic HBV. However, previous reports may underestimate the true burden of chronic hepatitis B as individuals in the U.S. who are institutionalized, homeless, and foreign-born "at risk" populations are underrepresented on national health surveys.

"There is a wide discrepancy in the current estimates of the chronic HBV burden in the U.S.," explains lead author Dr. Kris Kowdley, Director of the Liver Center of Excellence at Virginia Mason Medical Center in Seattle, Washington. "Understanding the ethnic and cultural populations affected by chronic hepatitis B will provide more accurate estimates and help to develop programs for prevention, earlier diagnosis, and access to care for those at greatest risk."

For the present study researchers systematically reviewed the world's medical literature for HBV seroprevalence rates from 1980 to 2010. The team identified 256 disease prevalence surveys for emigrants from 52 countries and 1,797 surveys for the general populations of 98 countries for use in the meta-analysis. Individuals with lower or higher risk of chronic HBV than the general population and groups not likely to emigrate were excluded. These surveys provided data for populations from the 102 countries of origin for migrants to the U.S. as determined in the U.S. Census 2009 American Community Survey.

Analysis determined between 1.04 million and 1.61 million (1.32 million estimate) foreign-born persons were living with chronic hepatitis B in the U.S. in 2009. Chronically infected emigrants were mainly from Asia, Africa, and Central America, accounting for 58%, 11% and 7% of the foreign burden of disease in the U.S., respectively. "Our analysis suggests the total prevalence of chronic HBV is significantly higher, exceeding two million cases or twice the number previously reported," said Dr. Kowdley.

Senior author, Dr. Carol Brosgart, a member of the faculty at the Division of Global Health, UCSF and Senior Advisor on Science and Policy to the Viral Hepatitis Action Coalition at the CDC Foundation added, "This study highlights an important health concern for the U.S. and the need for broader hepatitis B screening of foreign-born individuals. Given our ability to treat chronic HBV and to monitor for emergence of liver cancer when it is treatable, physicians should screen the foreign-born, their children and close contacts. If these individuals do not have chronic infection and are not immune, then they are good candidates for HBV immunization. Hepatitis B is a serious infection with the risk of long-term consequences of cirrhosis, end-stage liver disease, liver cancer and premature death. Today this is a disease that we can prevent and we can treat."

In a related editorial also published in Hepatology, Drs. John Ward, the Director of the Division of Viral Hepatitis (DVH) at the CDC and Kathy Byrd, a medical epidemiologist in the DVH, note, "The study by Kowdley and colleagues provides evidence that numerous and diverse foreign-born populations in the U.S. are at risk for chronic hepatitis B. Nearly 3.5% of all foreign-born persons in the U.S. are living with this disease—a rate more than 10-fold higher than the prevalence of the general U.S. population." The editorial authors further emphasize the need for culturally specific services along with expanded HBV testing and linkage to care and treatment to prevent new infections, liver disease and cancer.

Hepatitis sickens millions around the world and kills one million people each year according to the World Hepatitis Alliance. The World Hepatitis Alliance in collaboration with the World Health Organization (WHO) have designated July 28, 2012 as World Hepatitis Day to raise awareness of viral hepatitis.

More information: "Prevalence of Chronic Hepatitis B among Foreign-Born Persons Living in the United States by Country of Origin." Kris V. Kowdley, Chia C. Wang, Sue Welch, Henry Roberts, and Carol L. Brosgart. Hepatology; Published Online: February 16, 2012 (DOI: 10.1002/hep.24804); Print Issue: July 2012.

Editorial: "Hepatitis B in the United States: A Major Health Disparity for Foreign-Born Minorities." John W. Ward and Kathy K. Byrd. Hepatology; Published Online: April 24, 2012 (DOI: 10.1002/hep.25799); Print Issue: July 2012.

http://onlinelibrary.wiley.com/journal/10.1002/(ISSN)1527-3350

Diabetes

University of Exeter

'Jack Spratt' diabetes gene identified
Research shows that lean people with Type 2 diabetes have greater genetic predisposition to the disease

Type 2 diabetes is popularly associated with obesity and a sedentary lifestyle. However, just as there are obese people without type 2 diabetes, there are lean people with the disease.

It has long been hypothesised that type 2 diabetes in lean people is more 'genetically driven'. A new study from a research team led by the Peninsula College of Medicine and Dentistry (PCMD), University of Exeter, which involved research institutions from around the world, has for the first time proved that lean type 2 diabetes patients have a larger genetic disposition to the disease than their obese counterparts. The study has also identified a new genetic factor associated only with lean diabetes sufferers.

The study is published in PLoS Genetics.

Using genetic data from genome-wide association studies, the research team tested genetic markers across the genome in approximately 5,000 lean patients with type 2 diabetes, 13,000 obese patients with the disease and 75,000 healthy controls.

The team found differences in genetic enrichment between lean and obese cases, which support the hypothesis that lean diabetes sufferers have a greater genetic predisposition to the disease. This is in contrast to obese patients with type 2 diabetes, where factors other than type 2 diabetes genes are more likely to be responsible. In addition, genetic variants near the gene, LAMA1, were linked to type 2 diabetes risk for the first time, with an effect that appeared only in the lean patients.

Dr. John Perry, one of the lead authors of the study, said: "Whenever a new disease gene is found, there is always the potential for it to be used as a drug target for new therapies or as a biomarker, but more work is needed to see whether or not this new gene has that potential."

He added: "This is the first time that a type 2 diabetes gene has been found to act in this way – we do not know why it should be associated in one sub-group of patients and not another. It could point to the fact that type 2 diabetes may not be one disease, but may represent a number of subgroups. Again, more work is required to prove this hypothesis."

Dr. Perry concluded: "This study is a truly international one, bringing together research teams from around the world and leading UK institutions such as the University of Oxford, the University of Cambridge, King's College London, the University of Dundee and the University of Edinburgh."

source-EurekAlert

Newsletters

June 2012 HCV Advocate
In This Issue:

HCV Snapshots
Lucinda K. Porter, RN

Disability & Benefits: How Private Are My Medical Records?
Jacques Chambers, CLU

HealthWise: The Power of Support Groups
Lucinda K. Porter, RN

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

Harvard World News

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Germs from India Speed Post-Antibiotic Era
Jason Gale and Adi Narayan
(Bloomberg Markets Magazine, June 2012)

"India’s $12.4 billion pharmaceutical industry manufactures almost a third of the world’s antibiotics, and people use them so liberally that relatively benign and beneficial bacteria are becoming drug immune in a pool of resistance that thwarts even high-powered antibiotics, the so-called remedies of last resort...Antibiotic residues [and resistant germs]...have entered water and sanitation systems...As the superbacteria take up residence in hospitals, they’re compromising patient care and tarnishing India’s image as a medical tourism destination...The germs -- and the gene that confers their heightened powers -- are jumping beyond India. More than 40 countries have discovered the genetically altered superbugs in...patient specimens. Canada, France, Italy, Kosovo and South Africa have found them in people with no travel links, suggesting the bugs have taken hold there. Drug resistance of all sorts is bringing the planet closer to what the World Health Organization [WHO] calls a post-antibiotic era...current varieties of resistant bacteria [already] kill more than 25,000 people in Europe annually...The new superbugs are multiplying so successfully because of a gene dubbed NDM-1 [New Delhi metallo-beta- lactamase-1]...The NDM-1 gene is carried on mobile loops of DNA called plasmids that transfer easily among and across many types of bacteria...[and thus] unlike previous germ-altering genes, NDM-1 can infiltrate dozens of bacterial species...What’s worse, germs empowered by NDM-1 can muster as many as nine other ways to destroy the world’s most potent antibiotics."
Full Text .

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Illegal Kidney Trade Booms as New Organ Is 'Sold Every Hour'

Denis Campbell and Nicola Davison

The Guardian, London - May 27, 2012

"The illegal trade in kidneys has risen to such a level that an estimated 10,000 black market operations involving purchased human organs now take place annually, or more than one an hour, World Health Organisation experts have revealed.

Evidence collected by a worldwide network of doctors shows that traffickers are defying laws intended to curtail their activities and are cashing in on rising international demand for replacement kidneys driven by the increase in diabetes and other diseases.

Patients, many of whom will go to China, India or Pakistan for surgery, can pay up to $200,000...for a kidney to gangs who harvest organs from vulnerable, desperate people, sometimes for as little as $5,000."...Continue reading...

Check out additional articles @ Harvard World News

EMA now publishing side-effects reports online   

World News | June 01, 2012 Lynne Taylor

The European Medicines Agency (EMA) has begun publishing suspected side effects reports for medicines authorised in the European Economic Area (EEA) on a new pubic website: www.adrreports.eu.

The information relates to around 650 medicines and active substances authorised through the European Union (EU) centralised approval procedure. Information on the website is presented in the form of a single report per medicine or active substance. The reports come directly from the EU medicines safety database EudraVigilance, and each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by EU member states and marketing authorisation (MA) holders.

Continue Reading Here...

Is Chagas disease the 'new AIDS'?

A life-threatening parasite transmitted by a biting beetle can cause a person's heart and intestines to swell and burst — but early symptoms are hard to detect

June 1, 2012, at 7:35 AM

A Triatome bug feasts on human blood: This type of beetle is a carrier of Chagas disease, an illness that has infected 8 million people worldwide, and recently has sickened more than 300,000 Americans.
Photo: Dr. James L. Castner/Visuals Unlimited/Corbis

A disease spread by parasitic bugs is being dubbed the "new AIDS of the Americas" by researchers because its initial symptoms are hard to detect. According to a lengthy editorial in the journal PLoS Neglected Tropical Diseases, Chagas disease is slowly — and surreptitiously — spreading to the U.S. from Latin America. Here, a concise guide to the stealthy illness:

What is Chagas?
Chagas disease has infected more than 300,000 people living in the United States and up to 8 million worldwide. It was once largely limited to Latin America, but now the illness is spreading north because of travel and immigration. Chagas is caused by a black wingless beetle called the Triatoma bug, which feeds on human blood and releases a parasite called Trypanosoma cruzi. The tiny 0.78 inch (20 mm) insect typically feeds near the lips of sleepers, earning the nickname "kissing bug." When the beetle is done feeding, it defecates, "pooping out copies of the parasite," says Maryn McKenna at Wired. A sleeping person scratches the itch and unknowingly smears the feces into the wound. "Voila, Chagas infection."

What are the symptoms?
The parasite has a long incubation period similar to HIV/AIDS, causing the disease to come in two phases: acute and severe. During the acute phase, victims can experience fever, general sickness, or swelling in one eye. Afterward the disease goes into remission — sometimes for several years — until victims one day begin experiencing constipation and digestive problems. This is the severe stage, and eventually causes a quarter of the Chagas disease sufferers to develop enlarged hearts or intestines, which can burst and cause sudden death.

Can it spread between humans?
Yes. The disease can spread human-to-human, especially through blood transfusions, if the blood isn't tested for the parasite.

Is Chagas disease curable?
If caught early enough, yes — though a typical treatment takes three months of harsh medication. The main problem, say researchers, is that the long incubation period makes symptoms difficult to detect. There's also a stigma attached that makes sufferers reluctant to seek medical help. It's commonly known in Latin America as "a disease of the poor," says Cassie Murdoch at Jezebel, "so there hasn't been much invested in finding new treatments."

http://theweek.com/article/index/228700/is-chagas-disease-the-new-aids
Sources: Daily Mail, Jezebel, New York Times, Wired
Video- http://www.ksdk.com/news/article/322132/28/The-new-AIDS-of-the-Americas

Off The Cuff

When doctors become addicts
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Kate Hagan

June 2, 2012

It was a ruse that had been used by anaesthetists before him to get their hands on restricted drugs. Nurses at the Croydon abortion clinic at which James Latham Peters allegedly infected 56 women with hepatitis C between 2008 and 2009 suspected he was drawing up saline into syringes. In theatre they saw him shuffling in his pockets and fiddling at a bench. The clinic's director of nursing, Carol Richards, whose job included laying out syringes of drugs needed for the day and carefully accounting for their use in a logbook, remembered Peters dropping more syringes in theatre than other anaesthetists.

Naham (Jack) Warhaft, an anaesthetist with a history of alcohol and drug abuse who now treats other doctors with addictions, said in court last year this was typical behaviour.

''The most common method, and it's relatively easy to accomplish, is for the doctor to request a particular drug for a particular patient but then … use [it] for him or herself. The doctor would achieve it by some subterfuge such as, commonly in an operating theatre situation, doing a syringe swap,'' he told the Melbourne Magistrates Court at a committal hearing that resumed last week for Peters, who is facing 168 charges including conduct endangering life.

Continue Reading @ theage.com

Related Coverage @ theage.com ;
Accused Hep C doctor had history of drug abuse
A doctor accused of infecting 56 women with hepatitis C at a Croydon abortion clinic was among a group of drug-addicted anaesthetists who returned to practice at Box Hill Hospital as part of a rehabilitation program during the 1990s.