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January 09, 2011 09:34 PM Eastern TimeOn November 22, 2010, Vertex completed the submission of its New Drug Application (NDA) for telaprevir to the United States Food and Drug Administration (FDA). A response from the FDA regarding the company’s request for Priority Review of the telaprevir NDA is expected this month. The FDA’s goal for completion of its review for NDA submissions granted Priority Review status is six months from the NDA submission date.
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Liver Disease a Possible Predictor of Stroke
ScienceDaily (Jan. 7, 2011) — People suffering from fatty liver disease may be three times more likely to suffer a stroke than individuals without fatty liver, according to a study by researchers at St. Michael's Hospital and the London Health Sciences Centre. The study is the first to find a link between nonalcoholic fatty liver disease -- a disease characterized by the accumulation of fat in the liver in non drinkers -- and stroke.
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By Josh Kegley at 10:56pm on Jan 8, 2011 — jkegley@herald-leader.com Modified at 10:56pm on Jan 8, 2011

The Lexington VA Medical Center issued a statement Saturday apologizing after six patients underwent cataract surgery with a surgical tool that was not properly sterilized.
Jo Ann Baldwin, 58, of Richmond, said hospital officials told her the tool might have been contaminated with HIV, hepatitis B or hepatitis C. Baldwin's husband, Vietnam War veteran Daryl Baldwin, 58, underwent surgery for cataracts in March and was one of the patients potentially affected.
Daryl Baldwin has tested negative for the diseases, she said, but the couple said they were concerned that hospital officials waited nine months to warn them about the potential contamination.



This post is to aid an anonymous commenter, below, and to recap and update post my November 23, 2010 piece on it. What's known: Vertex filed with the FDA on November 23, 2010. What's also known: Vertex will update on FDA status by the end of January 2011.


Merck Leg Up on Vertex in Race to Hepatitis C Drug?
Fierce Biotech reported yesterday that Merck announced that both the FDA and EMA have accepted its application for boceprevir for expedited review. Meanwhile, Vertex is still waiting on confirmatin from the FDA on its application for telaprevir. Both drugs are for the treatment of hepatitis C infections.
Regulatory watchers expect both drugs to be approved sometime during 2011 and then the real race will be on for sales in the hepaitis C treatment market. Both drugs are expected to have a big impact on the status of current therapies for the teatment of chronic hepatitis C infections.

AHMEDABAD: During the routine check-up, if you get diagnosed with a fatty liver, sit up and take notice. Fat deposits in liver are an invitation to diabetes, according to leading endocrinologist Dr Anoop Mishra. The doctor has even identified two genes which are responsible for the faulty liver metabolism.
Dr Mishra, who is chairman of the Fortis-CDOC Centre for Excellence for Diabetes, New Delhi, was in Ahmedabad to participate in the conference of Association of Physicians of India (APICON). He said that there was 50 per cent hike in the number of cases where fat deposits on the liver compromised the metabolism.


Medical News Today
EDDA Technology Successfully Installs IQQA®-Liver At Mayo Clinic In Arizona
08 January 2011EDDA Technology, a leading provider of advanced computer assisted radiology and surgery solutions, announces the successful commercial installation of its IQQA®-Liver Enterprise product at Mayo Clinic, Scottsdale, AZ...


David Tuller(The New York Times, January 3, 2011)

"Chronic fatigue syndrome causes a host of debilitating symptoms…But what causes the syndrome itself?

Since the first cases in the United States were identified in the 1980s, scientists have been divided over that question. Some have suspected that one or more viral infections are likely to play a central role. But many other researchers…have dismissed it as stress-related, psychosomatic or simply imaginary. Now recent back-to-back announcements have highlighted both the volatility of the issue and the ambiguity of the science, and have alternately heartened and dismayed patients."



Lab Results 101: Liver Function Tests
Yesterday, January 08, 2011, 12:22:47 AM
Doctors generally look first at the level of the liver enzyme GGT. Generally speaking in “normal liver function tests” the level of GGT is not greater than 45. If your GGT is greater than 100, the doctor will look at the levels of the other liver enzymes to try and work out possible causes of liver damage.


Bone Loss In Liver Disease
Friday, January 07, 2011, 11:11:00 PM
Gastroenterology Volume 140, Issue 1 , Pages 22-25, January 2011

The Impact of Gastrointestinal and Liver Diseases on Bone: It Ain't Like Menopause! Bone remodeling can also be affected by systemic disease. Chronic gastrointestinal diseases such as inflammatory bowel disease (IBD), celiac disease, and liver diseases including primary biliary cirrhosis, and primary sclerosing cholangitis


Fatty Liver: Utilizing Ultrasound and Liver Biopsy
Friday, January 07, 2011, 10:22:43 PM
Podcast: Gastroenterology Podcast January 2011:

Prevalence of NAFLD and NASH Utilizing Ultrasound and Liver Biopsy

An important prospective study in the January Gastroenterology sought to define define the prevalence of both nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) among a largely middle-aged group of outpatients.



Medscape


A Medscape reader asks about the management of an older woman with HCV cirrhosis and exacerbation of Crohn's disease.
Medscape Gastroenterology, December 2010


2011 HCV Newsletters

CAP-Hepatitis C NewsLetters
Read about the latest hepatitis C newsfrom the mainstream media and the medical community.
Newsletter(HTML)
January


NYC Viral Hepatitis Newsletter
NYC Department of Health & Mental Hygiene
Office of Viral Hepatitis Coordination


HIV

Kenya: The Silent Killer That Continues to Claim Children's Lives
Miriam Gathigah (Inter Press Service, January 4, 2011)
"Medical experts have warned that malaria and HIV have monopolised interventions geared towards curbing child mortality in Kenya, thus ignoring the equally deadly killer, diarrhoea…Recent statistics show that although child mortality has decreased from 120 per thousand deaths to an all-time low of 74 per thousand deaths over the last five years; there are no clear strategies to the killer disease. Many children…succumb…even as the country strives to realize the Millennium Development Goal 4 of reducing child mortality."


Anemona Hartocollis (The New York Times, January 2, 2011)"The New York City Health and Mental Hygiene Department released the advertisement on YouTube and television in early December, intending to show that even though an H.I.V. diagnosis is no longer a death sentence, neither do H.I.V. drugs guarantee good health…For New York, the H.I.V. advertisement is just the latest in a series of graphic YouTube public service ads tackling health issues…created to reach young people through a medium they understand. The H.I.V. public service ad falls into a tradition of attention-grabbing messages."Free registration required.


Off The Cuff

BEIJING: Just thinking about hanging on a 400m-long zip line, swaying 50m above the roaring Nujiang River is scary, admits Li Jiasheng. But the 33-year-old rural doctor in Fugong county of Nujiang Lisu autonomous prefecture, Yunnan province, knows the zip line is the fastest way to reach Watuwa village, on the other bank of the Nujiang Great Canyons, for his house call.


In this week’s Patient Money column, Walecia Konrad asks Dr. Jeffrey Kullgren, an internist at the University of Pennsylvania who researches consumer-driven health care, for advice on how to negotiate with a doctor or other medical provider. “Your physician may be just as uncomfortable with these conversations as you are,” he said. “That’s because — and I can tell you firsthand — doctors are simply not trained for this. I was trained to give the very best care for my patients, regardless of cost.”


Associated Press Featured Article
January 08, 2011
Scientist haunted by misuse of drugs he invented
By Associated Press ,

WASHINGTON (AP) — David Nichols studies the way psychedelic drugs act in the brains of rats. But he's haunted by how humans hijack his work to make street drugs, sometimes causing overdose deaths.
Nichols makes chemicals roughly similar to ecstasy and LSD that are supposed to help explain how parts of the brain function. Then he publishes the results for other scientists, hoping his work one day leads to treatments for depression or Parkinson's disease.


Ethics

By: David Matas
David Kilgour and I have concluded, first in a report released in July 2006 and updated in January 2007, and then in a book titled Bloody Harvest released in November 2009, that Falun Gong practitioners have been killed in China in the tens of thousands so that their organs could be sold to transplant patients. Falun Gong is a modernized blending of the Chinese exercise, Buddhist and Taoist traditions............

Also See: Organ Harvesting In China


Lewis Smith(The Independent, London, January 5, 2011)"Leading surgeons are calling for the Government to consider the merits of a legalised market in organs for transplant. A public discussion on allowing people to sell their organs would, the doctors say, allow a better-informed decision on a matter of such moral and medical significance. At stake are the lives of thousands of people who may die before a suitable donor can be found...But there are serious concerns that introducing payments for people who donate their organs would result in poor and vulnerable people coming under severe pressure to alleviate their financial problems by selling a part of their body."


Flu

AndrĂ© Picard(The Globe and Mail, Toronto, January 2, 2011)"It’s flu season in the Northern Hemisphere and, unlike last year, there is not the drama of H1N1, nor the unprecedented attention influenza was afforded by media and public health officials as a result. Instead of one global pandemic, there are a series of outbreaks of different types of influenza in various parts of the world and they garner only local press coverage…Paradoxically, this 'normal' flu season will likely prove far more deadly than the pandemic."Free registration required.

Emily Dugan, Nina Lakhani and Brian Brady(The Independent, London, January 2, 2011)"Health experts are warning of a 'surge' in flu cases this week as schools reopen and the UK returns to work…As deaths and hospitalisations from the disease continue to soar, the increase is expected to push the crisis towards an epidemic…The Government is accused of making 'serious misjudgements' and not doing enough to prevent the spread of the disease, following budget cuts to educational health advertising…Clinicians are also warning that since the vaccine takes up to 10 days to provide immunity it may now be too late for many, as the disease is expected to peak within the next fortnight."

Jeremy Laurance (The Independent, London, January 7, 2011)


From Nature:

Fraud investigation rocks Danish university
Neuroscientist quits after accusations of academic misconduct.

Legal highs: the dark side of medicinal chemistry
Synthetic chemist David Nichols describes how his research on psychedelic compounds has been abused — with fatal consequences.


In Praise of Nurses
By DANA JENNINGS
Dana Jennings
I love and admire nurses.
Oncology nurses and ostomy nurses. Radiation nurses and post-op nurses. And those essential, always-there-when-you-need-them, round-the-clock nurses. (And though most of my experience is with female nurses, I admire male nurses, too.)
Now this isn’t some abstract infatuation, based on seeing “South Pacific” one too many times. I’ve been hospitalized six times in my life, and the medical personnel I came to know best — and like best — were the nurses.
To generalize: Nurses are warm, whereas doctors are cool. Nurses act like real people; doctors often act like aristocrats. Nurses look you in the eye; doctors stare slightly above and to the right of your shoulder. (Maybe they’re taught to do that in medical school?)


FDA

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