Thursday, December 30, 2010

Hepatitis News:Liver Disease A Few Safety Concerns

Liver Health

Contamination Prompts Recall of Liver Protectant

By John Gever, Senior Editor, MedPage TodayPublished: December 30, 2010
Six lots of injectable acetylcysteine (Acetadote) manufactured by Cumberland Pharmaceuticals have been recalled because of particulate matter found in some vials, the company said.The drug is used to prevent acute liver injury in patients taking potentially toxic amounts of acetaminophen.Cumberland said it was not aware of any adverse events but was recalling the products as "a precautionary measure."The company believes the particles originated in the product's glass containers, which were produced by a former supplier. Cumberland said it switched to a different source of vials in August 2009.

The exact product being recalled is Acetadote (acetylcysteine) Injection, 20% solution (200mg/mL) in 30 mL single dose glass vials, NDC 66220-107-30.

Affected lot numbers, with expiration dates, include 090304 and 090331 (February 2011), 090401 (March 2011), 090511 (April 2011), and 090602 and 090616 (May 2011).

The product was distributed to U.S. wholesalers and distributors nationwide.Cumberland's announcement did not include specific instructions to hospitals or other providers who may have the product in stock. The company, based in Nashville, can be contacted at (877) 484-2700.

Avelox Could Harm Liver, Health Canada Warns
Ottawa, Ontario: It was quietly floated back in March. However, the Canadian health authority earlier this year warned of a potential adverse reaction stemming from Avelox that could pose a threat to an individual's liver.
Avelox antibiotic, or moxifloxacin, is commonly used to treat a broad spectrum of bacterial infections."Health Canada has conducted a safety review and concluded that Avelox may be associated with the rare but potentially life-threatening risk of liver injury, including liver failure," the Canadian health authority—the equivalent to the US Food and Drug Administration—said in a statement released March 22.An earlier safety review by the European Medicines Agency prompted Health Canada to conduct its own safety review of moxifloxacin, which is an antibiotic within the quinolone family.

The review also found that while the potential for liver-related side effects was well documented on the Canadian product label, Health Canada determined that there needed to be a better job done with regard to communicating that information to patients in a real and effective way.Avelox, like many antibiotics in the quinolone family, can cause Avelox tendon rupture and other adverse reactions related to the tendon—including Avelox tendonitis. With other antibiotic products in the quinolone class getting a fair bit of ink in the media over tendon problems, more people are at least becoming aware of the potential for serious side effects involving tendons.

However, the potentially rare risk to proper liver function is not well known. It is also a sad truth that most patients do not read product labels or medication guides, leaving it to their doctor to sort all that out on the patient's behalf.Some doctors do not adequately inform their patients as to the possibility or potential severity of Avelox adverse reactions.Health Canada advised patients experiencing symptoms ranging from loss of appetite and abdominal pain, to dark urine and yellowing of the skin or eyes, "to stop taking Avelox and contact a health-care professional immediately."

Seafood safety concerns for those with liver disease

Created: 12/29/2010 05:22:28 PM PST

Today, if you walk into a seafood restaurant or store and do NOT see a sign that opens by stating, in English and Spanish: "Eating raw oysters may cause severe illness and even death in persons who have liver disease (for example, alcoholic cirrhosis), cancer or other chronic illnesses that weaken the immune system. ... " you should not hesitate to mention the lapse to a manager.

Of course, another hazard of shellfish and mollusks (in other words, oysters, clams and mussels) is hepatitis A, the most serious viral infection associated with seafood consumption. Contamination is most likely when human sewage pollutes an aquaculture site. The largest outbreak to date (affecting almost 300,000 people) occurred in China in 1988. The victims all ate clams from a sewage-sullied growing area.
Since hepatitis A virus targets the liver, it is a special threat to people with pre-existing liver disease. Fortunately, they can be well-protected by a safe and effective vaccine.
Dr. Claire Panosian Dunavan is an infectious disease specialist and a professor of medicine at the David Geffen School of Medicine at UCLA and a resident of Pasadena..
Continue reading......

Dec. 29, 2010
“Outbreak” of Hepatitis A Confirmed
by Cabell
Huntington Health Department
Release Huntington, WV (HNN) - Eleven cases of Hepatitis A have been confirmed in Cabell County, according to a Cabell-Huntington Health Department news release. Hepatitis A is a liver disease caused by a virus which found in the stool of an infected person. The disease is spread from person to person by hands that have not been washed after going to the bathroom or touching items such as diapers or linens soiled by a bowel movement.

It can also be spread by water or ice and by eating uncooked foods that may have become contaminated during handling. Hepatitis A can also be spread through common household items such as unclean eating utensils.
Symptoms include:
* tiredness* stomach pain* fever* dark urine* loss of appetite* yellowing of the skin and eyeballs* nausea
If you think you have any of the above symptoms, please contact your doctor. Hepatitis A is vaccine preventable disease. The hepatitis A vaccine is a two-dose shot and is available at the Health Department.

FDA News and Announcements
12/27/2010 FDA: Don’t Eat Tiny Greens Brand Alfalfa Sprouts or Spicy Sprouts
12/24/2010 FDA: Rolf’s Patisserie recalling all desserts made after November 1

Treatment of HCV Infection in 2011

A prediction Made In February Of 2010
By Mitchell L. Shiffman

Based on current data and ongoing clinical trials using DAA, I have attempted to speculate about the treatment of chronic HCV infection in 2011. The year 2011 will open with our current standard of care: peginterferon and ribavirin. Between now and 2011, a declining number of patients will likely be treated with peginterferon and ribavirin because of the desire to delay treatment until a DAA is available.

Futhermore, patients will likely be tested for the IL-28B haplotype; only those with the CC allele, and a high chance to achieve SVR, are likely to be treated with peginterferon and ribavirin. Patients with mild fibrosis may also opt to defer therapy because they have a low likelihood of developing significant fibrosis over the next several years.

Hey, I have a question about this IL28B gene and hepatitis c treatment.....

During this time, I anticipate more uniform application of the concepts of response-guided therapy. Patients who achieve RVR will be treated for 24 weeks, patients with cEVR will be treated for 48 weeks, and STR patients will be treated for 72 weeks. We will be more prepared to modify the doses of peginterferon and ribavirin to limit adverse events in patients who have already become HCV RNA undetectable. The use of epoetin-α will be limited to only those patients who become anemic very rapidly (within the first 1 to 2 months of treatment). This limitation will be especially true if IL-28B testing determines that the patient has a high chance for SVR.

It is anticipated that the first DAA will be approved by the US Food and Drug Administration by mid-late 2011. At that time, patients will be treated with triple therapy: peginterferon, ribavirin, and a DAA. About 80% of patients will achieve RVR and SVR of 70% is anticipated. The treatment duration will be reduced for all patients with RVR to 24 to 28 weeks, depending on whether a “lead-in” strategy using peginterferon and ribavirin is adopted. Relapse will be less than 5%; the remaining 10% of patients will simply be unable to tolerate the side effects of one or more of these three medications and will prematurely discontinue treatment. Patients who become HCV RNA undetectable after week 4 will be treated for 48 weeks. Patients who do not become HCV RNA undetectable by treatment week 8 to 12 will likely stop treatment. It remains to be determined if patients who do not achieve SVR with triple therapy could be more effectively treated after 2011 with a combination of DAAs.

See Full Text Here..........................


January 2011 HCV Advocate Newsletter
Download printable version
In This Issue:
Top 10 News of 2010 Alan Franciscus, Editor-in-Chief
HealthWise: Vitamin D and the Liver Lucinda K. Porter, RN
HCV Snapshots Lucinda K. Porter, RN
AASLD 2010: Part 2 Alan Franciscus, Editor-in-Chief

December 2010 HCV Advocate Newsletter
Download printable version
In This Issue:
AASLD 2010 Conference – Part 1 Alan Franciscus, Editor-in-Chief
IL28B Gene Highlighted at AASLD Liz Highleyman
HealthWise: 2010 Liver Meeting Update Lucinda Porter, RN
HCV Snapshots Lucinda Porter, RNHCV Advocate Eblast
Stay informed on the latest news here to register for email alerts

HBV Journal Review
HBV Journal ReviewJanuary 1, 2011,
Vol 8, no 1by Christine M. Kukka


EU -- Guidelines for Testing HIV, Viral Hepatitis and other Infections in Injecting Drug Users

December 30, 2010 20:23

Guidelines for Testing HIV, Viral Hepatitis and other Infections in Injecting Drug Users

Source: European Monitoring Centre for Drugs and Drug Addiction

Infectious diseases are among the most serious health consequences of injecting drug use and can lead to significant healthcare costs. Injecting drug users are vulnerable to a range of infectious and communicable diseases through a variety of risk behaviours, and because of underlying conditions such as poor hygiene, homelessness and poverty. This leads to higher morbidity and mortality in this group as compared with the same age groups in the general population. In addition, IDUs can act as a core group carrying infections that may pose a risk to the general population.Although HIV and hepatitis C infections remain the most important public health problem among IDUs, this document recognises that other blood-borne viral infections and various bacterial infections also play an important role in the health and well-being of IDUs. As the coverage of effective antiretroviral treatment and treatment for other infections in IDUs is being scaled up, access to and uptake of testing for HIV and other infectious diseases in IDUs also needs to be increased.Evidence-based interventions such as opioid substitution treatment, needle exchange programmes and other elements of the ‘comprehensive package’ for IDUs are important measures to prevent HIV infection, hepatitis and other infections in this group (WHO, UNODC and UNAIDS 2009), given that prevention of injecting drug use itself still proves to be very difficult.The recommendations in this document are primarily targeted at high-income countries with lowlevel or concentrated HIV epidemics where recorded infections are largely confined to individuals with risk behaviour, such as IDUs. This includes most European countries.

Monitoring by Nurses Aids Chronic Illness Care
Patients with chronic illnesses and coexisting depression had significantly better control of both conditions when medically supervised nurses provided guideline-based care, data from a randomized trial showed.
Continue reading............

Calif. liver recipient, 13, on mission of thanks
Published December 30, 2010

PASADENA, Calif. – Eleven-year-old Mikey Carraway's liver had failed — doctors had two weeks at most to find an organ donor to save his life. Two days later, they had one — 18-year-old Johnny Hernandez, who suffered a fatal brain injury in a motorcycle crash.
Mikey, now 13, and his mom Shaheda Wright thanked the Hernandez family in person Wednesday in a rare meeting between a donor family and an organ recipient.
"We just want to say to you that if it wasn't for your decision at tough time in your life, my son wouldn't be here today," Wright said.

"You don't have to thank me," said Johnny' s mother, Christine Hernandez, tears spilling down her cheeks. "It was a gift from God."

Mikey and his mom, who live in Oakland, arrived in Pasadena for Saturday's Rose Parade, in which Mikey will represent the California Transplant Donor Network on the "Donate Life" float. The float, titled "Seize the Day," will feature 30 organ recipients and the portraits of 60 donors made out of flowers

The Hernandez relatives, who live around inland Southern California, came to Mikey's hotel to meet him with photos of Johnny and a DVD of his funeral service. There were tears aplenty, but also some laughs.
"Do you feel Mexican at all now?" Denise Leyva, Johnny's aunt, asked Mikey. "Are you getting sudden cravings for tacos?"
J.R. Aranda, one of Johnny's close friends, related that Johnny was such a fan of the Oakland Raiders, he had the team's insignia tattooed on his upper arm — unbeknownst to his mother.
Mikey, also a diehard Raiders follower, said he wants to get one in the same place. "Kid, wait a minute," his mother cautioned. Instead, Aranda presented Mikey a blanket with the team symbol on it.
Donors and recipients don't often want contact, said Cathy Olmo, community development manager of the Oakland-based California Transplant Donor Network. Most donor families want to move on with their lives and prefer not knowing details. The network encourages recipients to write a letter to their donors, and for most on both sides, that suffices, she noted.
Mikey and his mom, though, are exceptional cases.

They are "paying forward" Mikey's gift of life by feeding the homeless once a month in a park in West Oakland in a venture called Mikey's Meals. Over the past two years, they estimate they've served 3,500 people. The events also serve to raise awareness about organ donation.
It was Mikey's idea, said Wright, 36. When she asked Mikey how he wanted to repay the generosity of his liver donor, well before they had contact with the Hernandezes, he said "feed the homeless."
"It was the first thing that popped into my head," he said. Now it's become his favorite thing to do.
At first Wright was paying for the food out of her own pocket, but recently various sponsors have stepped up, including the Oakland Fire Department and a local high school, and the event has expanded to include giveaways of school supplies and holiday toys.
"Mikey is an extraordinary young man," Olmo said. "He's really taking this cause to heart. It's a powerful message from him."

Judging by sheer odds, Mikey was lucky. More than 107,000 people across the nation are waiting for organs — 16,000 of them need livers, which tend to collapse fast so the window of time to find a donor is slim.

Mikey's liver failure came on suddenly — doctors believe from a virus. "He had been perfectly healthy," Wright said. "This was definitely a shock."

As Wright waited anxiously, the Hernandez family was facing death in another hospital. Johnny, who was an avid weightlifter and studied the Bible, had gone to night school on his motorcycle and collided with a truck on a freeway onramp. He was on life support.

Christine Hernandez said she had never thought about organ donation, but it turned out Johnny had. He was one of only 26 percent of Californians whose driver's license carries the pink dot denoting an organ donor — he had signed up after seeing the pink dot on Aranda's license.
"He thought that was pretty cool," Aranda said.

It was an agonizing decision, but the family decided to honor Johnny's wishes although his dad, Bob Hernandez, had a hard time when doctors came in with a list of organs and tissues for possible harvesting.

"He said 'you're tearing up my son' and had to leave," said Christine Hernandez, who has a tattoo with her son's name and dates of birth and death on her inner wrist.
Six months later, the family received word that Johnny's heart, lungs, kidneys, and liver saved five lives, including three children, and his corneas restored sight to others. The other recipients have not contacted the Hernandezes, but two months ago they heard from Wright and the families started connecting.

"I feel they're like extended family," Wright said.
For Christine Hernandez, the new relationship has helped her find solace and give meaning to the senseless end of a young man's life. "I don't know if closure will ever be complete," she said. "But it's a way of moving forward."

2011: ACH-1625 Shown to significantly reduce viral load

What's Next for Achillion Pharma?

Achillion stock (ACHN) has been flat all year, underperforming the biotech indices as well as its peers in the Hepatitis C drug development community. The stock began to leap a couple days after the company announced that data from ongoing clinical studies of ACH-1625 has been accepted for presentation at the 21st Annual Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) to be held February 17-21, 2011. It has since climbed from $2.73 to close at $4.00 Wednesday, a 47% increase since the December 6th announcement.
So why all the excitement? Achillion had been making headlines all year; it promoted two new drugs into the clinic, began Phase II trials for lead candidate ACH-1625, presented at multiple industry conferences, and raised a total of $71.4 million in stock offerings.

The reason, I believe, is a key phrasing in the press release, “data from ongoing clinical studies of ACH-1625” was to be presented at the conference. There is only one ongoing study: A 144 patient Phase IIa randomized, double blinded trial of ACH-1625 in combination with ribavirin and peg-interferon alpha. The trial begins with a dose-ranging 28 day phase that will be evaluated to determine the optimal dose for the final 12 week treatment phase.

The company had initially targeted March 2011 for release of the first set of results. Having the ability to move the release date up to February speaks well for trial enrollment. This data will provide the first look at how Achillion’s lead candidate performs in a larger setting and importantly, in combination with current standard of care. ACH-1625 has already been shown to significantly reduce viral loads in patients by 3 to 4.25 log10 and maintain a sustained viral response even after therapy has stopped. It has also been shown to be safe up to 2000mg/day, a level far above the highest dose tested in this Phase IIa.

Pre-clinical studies show ACH-1625 to be additive-synergistic to ribavirin and peg-interferon alpha; this study will be a first look at how well those studies translate in the clinic. Although 28 days is still short, the multiple active drug doses as well as a placebo control will allow investigators to gauge in detail the effectiveness of ACH-1625 in this combination. In any case, a full profile of the compound and its potential as part of this three-drug regimen will be in known by the end of 2011. There’s a lot riding on this study.

Aside from its lead compound, Achillion also has a lineup of several other HCV antivirals in development. The once promising ACH-1095, an inhibitor of the NS4A protease is in Phase I. It was originally developed in collaboration with Gilead (GILD), but its rights have since been handed back to the company- though Gilead still retains the ability to opt in at a later stage in the compound’s development.

Early this year in January, a second NS3 protease inhibitor, ACH-2684, was nominated to enter clinical development. It's interesting that Achillion is developing additional NS3 inhibitors considering there are so many out there. This one is being positioned as more potent and effective against commonly seen viral mutants. It will enter Phase I trials in 2011.
The NS5A inhibitor, ACH-2928, was nominated in mid-year. It is also set to initiate Phase I testing in 2011. ACH-2928 is one of the few NS5A inhibitors currently in development. The most prominent competitor compound is BMS-790052 from Bristol Myers Squibb (BMY), currently in Phase II and looking pretty good. Both of these compounds have similarly high potencies in vitro.

Achillion also has some work in antibiotics and HBV, but they are not a major focus. The goal now is to push forward with its HCV pipeline. 2011 will be pivotal for the company as data comes in from its lead project. Funds raised during the year will allow it to complete both portions of the Phase II trial and at the same time initiate two separate Phase I studies. It will be interesting to see how the company chooses to proceed from there.

7 Major Advances Predicted for Health & Medicine in 2011

Also See : Getting Ready For 2011 @ Hepatitis C New Drugs

7 Major Advances Predicted for Health & Medicine in 2011

Dec 29, 2010

By Lauren Cox

MyHealthNewsDaily Contributor

In terms of advancement in the fields of science and medicine, 2010 was a stellar year. German doctors appeared to have cured a man of HIV. Doctors watched a drug called PLX4032 melt away the tumors of melanoma patients who otherwise were out of treatment options. And scientists created the first "synthetic life."

What significant advances can we expect in 2011?

Here are seven predictions, provided by experts in these fields who gave MyHealthNewsDaily the lowdown on what might promote our health next year.

Prediction 1: Results of a promising HIV vaccine will be announced.

An American man made international headlines this month when German doctors announced he had been cured of the virus that causes AIDS. The HIV-positive man had suffered from acute myeloid leukemia — a deadly blood cancer — so in 2007 the doctors performed a bone marrow transplant to treat the leukemia. They were lucky enough to find a bone marrow donor with a rare mutation, called Delta 32, that provides natural resistance to the human immunodeficiency virus.

Three years after the transplant, the man continued to show no signs of HIV.

But for all the media attention to this case, another scientific advance is likely to help more people battle HIV and AIDS in 2011.

In 2009, studies in Thailand showed a vaccine could reduce the risk of contracting HIV by about 30 percent. Dr. Susan Zolla-Pazner, an HIV researcher at the New York University Langone Medical Center in New York City, said it was the first sign of real success for an HIV vaccine, and a guide to future research.

"It was the first and only light in a very dark tunnel that suggested that we were beginning to get off of home plate in terms of making any progress," Zolla-Pazner said.

Reflecting on the case of the German achievement, Zolla-Pazner pointed out that only a tiny fraction of HIV patients would be able to find matching bone marrow from a naturally resistant donor, and even then, those patients would risk dying from the bone marrow transplant procedure.

"It shows that, in theory, with bone marrow transplants, you can cure [HIV], which is interesting. But certainly it is not anything that could be applied even on a small scale, let alone on a vast scale with millions of people," Zolla-Pazner said.

So instead of bone marrow transplants, Zolla-Pazner is setting her hopes on HIV vaccine advancements.

"If there's a clear answer about what that vaccine did to provide protection, it provides a foundation to build another vaccine," she said.

Zolla-Pazner said more results based on the experimental vaccine are expected to be announced in mid-2011.

Prediction 2: Many broken hearts will be fixed by freezing them.

The 2.2 million people in the United States afflicted with atrial fibrillation will see another tool in the fight against their condition in 2011: a device that freezes heart tissue.

A healthy heart contracts under a timed pattern of electrical signals, but people with atrial fibrillation have irregular electrical signals, causing the upper chambers of their heart to quiver instead of beat, according to the American Heart Association. Atrial fibrillation can lead to fatigue, shortness of breath, and even stroke.

This month the Food and Drug Administration approved the Arctic Front cardiac cryoablation catheter system device, which freezes sections of heart tissue instead of burning them with radio-frequency energy. Doctors can use the device to purposefully scar certain sections of the heart, blocking the irregular signals that create atrial fibrillation.

"This treatment model has shown to cure this disease in 70 percent of patients," said Dr. Moussa Mansour, who used the device in clinical trials at Massachusetts General Hospital in Boston.

"The old way [radio-frequency ablation] had a similar range of success, but we believe it is easier to do it in the new way," Mansour said. Now that the cryoablation technique has been approved, he added, more people will receive therapy.

Prediction 3: The lowered bar for lap-band surgery will have an impact on the decisions made by millions of obese Americans.

Surgery is one of the more controversial solutions to the nation's obesity problem, even though research shows stomach surgery for weight loss is sometimes the most effective treatment.

This coming year will open up the option of bariatric weight-loss surgery to millions more Americans. Until recently, only people with a body mass index (BMI) of at least 40, or those with BMIs of 35 and higher with another serious health problem related to their obesity, were candidates for lap-band surgery from Allergan, according to the FDA. In the lap-band procedure, a doctor places an inflatable silicon ring around the upper portion of the stomach and constricts it.

In late 2010, the FDA voted to change the eligibility criteria for the Allergan procedure. Now, most people with a BMI of 35 or higher, and patients with a BMI of 30 or higher who also have another serious medical condition, can undergo the operation.

"Only one in 50 people will keep 50 pounds off for one year using diet and exercise. It's just a profound waste of time for people who are obese," said Dr. George Fielding, an advocate of the surgery who works in the Division of Bariatric Surgery at NYU Langone Medical Center.

"Surgery does work, it's just so well established," he said. "All around the world, no matter what method you use, you can see results."

Fielding noted that if a person with diabetes and a BMI of 30 loses 50 pounds and keeps it off, he has an 80 percent chance of coming off their diabetes medications. "There are millions of people, literally, with the BMI of 30 and 35 who have diabetes," he said.

But physicians who specialize in weight loss warn about the dangers of opening a patient’s body when there are other options.

"The issue with surgery, any kind of surgery — banding, bypass, etc. — is they work, by far, better than anything else. The problem is that they are surgery, so they're invasive, " said Dr. Lee Kaplan, director of the Massachusetts General Hospital's Weight Center. "They have risks associated with them. "

Kaplan said only 2 percent of patients who meet the criteria for weight-loss surgery actually undergo the procedure, in part because of the risks. Because of this, he doesn't think dropping the criteria by 5 BMI points will drastically change the odds of an obese person submitting to the procedure.

Kaplan acknowledged that research on people who’ve had weight-loss surgery has contributed to the understanding of exactly how the body can lose weight — or keep it on.

"We're learning an enormous amount from surgery, even though surgery itself is used infrequently," Kaplan said. Doctors used to think weight-loss surgery worked by making the stomach smaller, but they have found evidence that the surgery actually changes physiological mechanisms in the body that eventually determine whether or not a person gains weight, he said.

Prediction 4: School lunches will get a makeover that will lower obesity in the next generation.

More than about any surgery, obesity experts are excited about the Healthy, Hunger-Free Kids Act, which takes effect in 2011.

The new legislation raises the federal reimbursement rate for school lunches by 6 cents per meal, according to the American Academy of Pediatrics. The bill will allot an additional $4.5 billion toward school lunch programs over 10 years, and it has tasked the U.S. Department of Agriculture with creating nutrition standards for food sold through vending machines in schools.

"If you can tell a kid at age 5 or 6, ‘Look, this food is really yummy — it just doesn't come from McDonald's, it's just fresh food,' then you've got a chance," Fielding said. "Once a kid is fat and 10 or 12 years old, it doesn't matter how much you're going to tell them, it's hot air."

"You can make the next generation have a chance by teaching them about healthy food," he said.
Kaplan called the legislation "terrific. "

"When the [school lunch] program was developed 50 years ago, the focus was not on obesity, it was on malnutrition," Kaplan said. "Now … we see obesity is an even bigger problem than malnutrition."

Prediction 5: Restaurant menus that list calories will help us cut our daily total.

This year the nation will follow New York City in requiring restaurant chains to post calorie counts next to standard menu items. The mandate comes as part of the Patient Protection and Affordable Care Act, and requires chains with 20 or more locations to list calories by spring 2011.

Physicians who specialize in weight loss say the move will help some who don't realize their latte has 300 calories, or that their favorite dish might pack more than 1,000 calories. But the doctors aren’t predicting whether it will make a dent in the nation's obesity rate.

"I don't think people care. If they did, they wouldn't be going to these stores, because they all know what they are," Fielding said.

The mandate also requires the listing of calories in vending machines and "similar retail food establishments," according to the FDA.

"I think it might help," Kaplan said. But realistically, the effect "is going to be quite modest."

However, Kaplan added, "I think the risk of doing this is essentially zero, and the benefit is undetermined. But with so little risk, I think we ought to do it."

Prediction 6: Genomics will find medicines that work for you.

Sequencing an entire human genome cost about $3 billion a decade ago. Last year it cost around $10,000, according to Dr. Eric Topol, director of the Scripps Translational Science Institute in La Jolla, Calif.

Topol said he expects to see the price drop again in 2011, to about $4,000. And with lower financial barriers, he said, more medical advances from genomic research will come in the next year.

"This field is exploding," he said.

For example, Topol said, last year pharmacy benefit managers Medco and CVC/Caremark started examining the genes of patients on the widely used heart drug Plavix. The researchers identified two genes — called PON1 and CYP2C19 — that can determine how a person would respond to Plavix.

"These two genes explain why this drug, which is the second biggest drug in the world, is so inconsistent," Topol said. "Two-thirds of patients on Plavix do well, but the others either don't see the drugs’ effects and/or suffer from side effects."

Genotyping has already found mutations that would determine a person's response to malaria drugs, blood thinners, and breast cancer therapy, Topol said.

For the hepatitis C drug interferon, Topol said, researchers have identified genes that could save about half of all hepatitis C patients from side effects.

"Fifty percent of people don't respond [to interferon], and that drug costs $50,000 and it makes you sick," Topol said. "That is a really striking example.”

Genetic analysis “saves lots of money; it saves patients from being sick for years with a drug that doesn't help them."


ALSO SEE: Hey, I have a question about this IL28B gene and hepatitis c treatment.....

Prediction 7: Genomics will help us understand cancer.

Topol predicted the low cost of genome sequencing will also bring good news in cancer research next year, "because the sequencing is becoming so much cheaper and fast, and because bioinformatics is getting more advanced," he said.

With faster technology, Topol said it's become increasingly feasible for cancer researchers to compare a person's genome — the "germ line" genome the patient was born with — with the mutated genome of his or her cancerous tumors, to find the genes that are driving the cancer. In other words, they’ll find the genes that are making cancerous cells act cancerous.

Topol said such research has already benefited melanoma patients taking the powerful drug PLX4032. Genomic research has showed melanoma patients with tumors that have what's known as a BRAF mutation will benefit from the drug, while patients whose tumors don't have that mutation will likely get worse with the drug.

Topol said similar research is "just going to get better" in 2011.

France:Flu cases widen 3-viral strains to blame including H1N1

Two dead as flu cases widen in France

December 29, 2010

French health watchdogs said on Wednesday the country was officially in the grip of a flu epidemic after 176,000 people had fallen sick, two of whom have died.

To be classified as an epidemic, new cases of influenza recorded by doctors have to number more than 174 per 100,000 people per week.

This threshold was breached last week, when there were 280 cases per 100,000 people.

Three viral strains are to blame, including A(H1N1) 2009, which emerged last year as the novel "swine" flu, according to the epidemiological networks Regional Flu Observation Groups (GROG) and Sentinelles, which is operated by the National Institute of Health and Medical Research (Inserm).

On December 23, Britain's health authorities said 27 people had died of flu, 24 of them from swine flu.

Agencies in both countries have urged people in at-risk groups -- particularly the elderly and those with respiratory problems -- to get vaccinated.

So-called "seasonal" flu epidemics are annual health problems in temperate countries with the onset of winter.

According to the World Health Organisation (WHO), flu epidemics result globally in about three to five million cases of severe illness per year and 250,000-500,000 deaths.

(c) 2010 AFP

Wednesday, December 29, 2010

Fat ? Blame It On Your Genome

Feast, famine, and the genetics of obesity: you can't have it both ways

LA JOLLA, CA—In addition to fast food, desk jobs, and inertia, there is one more thing to blame for unwanted pounds-our genome, which has apparently not caught up with the fact that we no longer live in the Stone Age.

Time: 00:06:13
Video: Courtesy of Salk Institute for Biological Studies
December 15, 2010

That is one conclusion drawn by researchers at the Salk Institute for Biological Studies, who recently showed that mice lacking a gene regulating energy balance are protected from weight gain, even on a high fat diet. These findings have implications for the worldwide obesity epidemic and its consequences, such as type two diabetes.

In the December 16, 2010 issue of Nature, a team led by Marc Montminy, M.D., Ph.D, professor in the Clayton Foundation Laboratories for Peptide Biology, reports that a gene known as CRTC3 decreases energy expenditure by fat cells. "Ideas about obesity are based on concepts of feast or famine," said Montminy. "As humans, we developed ways of coping with famine by expressing genes like CRTC3 to slow the rate of fat burning. Individuals with these active "thrifty genes" had an advantage-they could survive long periods without food."

The idea that mammals harbor genes that slow fat burning was proposed in the 60's, before any genome was sequenced. Some theorized that such thrifty genes provided a survival advantage to our hunter-gatherer ancestors, who often went a long time between meals and needed to hold on to their fat depots. In 2010, however, those genes have become a liability.
To analyze its role in fat metabolism, the researchers engineered mice lacking the CRTC3 gene and put them on diets of varying fat composition. Normal and CRTC3 gene "knockout" mice appeared similar when fed a moderate fat diet. But when fed the mouse version of the Philly cheese steak diet, only the normal mice became obese. "The CRTC3 knockout mice were leaner and protected from obesity," reports Montminy. "They also had about twice as many brown fat cells than did normal mice."

To appreciate this finding, keep in mind that not all fat cells are "bad". When you deplore your waistline, what you are deploring is white fat tissue (also called WAT, for "white adipose tissue"), which serves as a fat storage depot around the midsection and hips. However, a second type of fat-known as brown fat (BAT)-is downright desirable.

"Brown fat is very different from white fat," says Youngsup Song, Ph.D., a postdoctoral fellow in the Montminy lab and the study's first author. "Brown fat tissue burns fat that has accumulated in white fat tissue to generate heat as a way to maintain body temperature."
In fact, some evidence suggests that humans with a genetic propensity to leanness have more brown fat cells than do "ample" individuals. As desirable as that trait may seem in a "super-size me" world, those folks likely had a pretty tough time in the Paleolithic era.
Although the researchers found that CRTC3 loss also perturbs how all fat cells respond to brain signals controlling energy expenditure, they remain particularly intrigued by the brown fat connection. "CRTC3 could be a switch controlling the number of brown fat cells, " says Montminy. "That is key, because if you could make more brown adipocytes, you could potentially control obesity."

To explore how relevant these studies are to humans, Montminy asked clinicians at Cedars-Sinai Medical Center in Los Angeles to search databases of patient genetic information for a particularly interesting human CRTC3 gene mutation, which appeared to represent a more potent form of the normal gene.

Since mice lacking CRTC3 resist obesity, the researchers reasoned that people carrying a revved-up version of the gene might show the opposite tendency. Indeed genetic testing of two groups of Mexican American patients revealed that individuals harboring the active CRTC3 mutation showed increased incidence of obesity.

"This is an example in which findings from rodent research led to a novel discovery in humans," says Mark Goodarzi, M.D., Ph.D., an endocrinologist at Cedars-Sinai and collaborator in the study. "Not all Mexican American individuals with the variant will develop obesity, but those carrying it are at higher risk." Interestingly, non-Hispanic Caucasians carrying the variant do not show increased obesity, a difference likely related to environmental or lifestyle factors.
Overall this study illustrates an important principle: that what is genetically advantageous in one cultural or historic context may not be in another. In fact, Montminy does not view obesity as an aberration or a "disease". "Storing fat in adipose tissue is a normal response. A lot people are obese but do not develop type 2 diabetes," he says, suggesting that genes like CRTC3 could serve as diagnostic tools as well as drug targets. "A goal is to go to your doc and learn whether you have the risk factors to progress to diabetes."

Also contributing to the study were Judith Altarejos, Ph.D., Hiroshi Inoue, MD, Ph.D., Rebecca Berdeaux, Ph.D., Jeong-Ho Kim, Ph.D., Jason Goode, Motoyuki Igata, MD., Jose Paz, Ph.D., Meghan Hogan, Pankaj Singh, Ph.D., Naomi Goebel, Lili Vera, and Nina Miller-all of the Salk Institute-and Xiuqing Guo, Michelle Jones, Yii-Der Chen, Kent Taylor, and Jerome Rotter, MD, of Cedars-Sinai Medical Center in Los Angeles, and Willa Hsueh, MD, of Methodist Hospital
Research Institute in Houston.

The research was funded by grants from the National Institutes of Health, the Kieckhefer Foundation, the Clayton Foundation for Medical Research, the Helmsley Foundation, the Cedars-Sinai Winnick Clinical Scholars Award, and the Cedars-Sinai Board of Governors Chair in Medical Genetics.
-Elise Lamar
About the Salk Institute for Biological Studies:The Salk Institute for Biological Studies is one of the world's preeminent basic research institutions, where internationally renowned faculty probe fundamental life science questions in a unique, collaborative, and creative environment. Focused both on discovery and on mentoring future generations of researchers, Salk scientists make groundbreaking contributions to our understanding of cancer, aging, Alzheimer's, diabetes and infectious diseases by studying neuroscience, genetics, cell and plant biology, and related disciplines.

Faculty achievements have been recognized with numerous honors, including Nobel Prizes and memberships in the National Academy of Sciences. Founded in 1960 by polio vaccine pioneer Jonas Salk, M.D., the Institute is an independent nonprofit organization and architectural landmark.

The Salk Institute proudly celebrates five decades of scientific excellence in basic research.

Researchers urge doctors to disclose sleep fatigue before surgery

WEDNESDAY, Dec. 29 (HealthDay News) --

A new commentary calls on doctors to disclose when they're deprived of sleep and not perform surgery unless a patient gives written consent after being informed of their surgeon's status.

There currently aren't any rules about the number of hours that fully trained physicians may work. The proposed new rules would change how doctors handle their own fatigue, the authors of the editorial pointed out.

"This approach would represent a fundamental shift in the responsibility patients are asked to assume in making decisions about their own care and might prove burdensome to patients and physicians, and damaging to the patient-physician relationship," the authors wrote in the Dec. 30 issue of the New England Journal of Medicine, adding that "this shift may be necessary until institutions take the responsibility for ensuring that patients rarely face such dilemmas."

Research suggests that sleep deprivation impairs a person's psychomotor skills -- those that require coordination and precision -- as much as alcohol consumption and increases the risk of complications in patients whose surgeons failed to get much shuteye.

"Sleep deprivation affects clinical performance. It increases the risks of complications. And it is clear from survey data that patients would want to be informed if their physician was sleep-deprived and that most patients would request a different provider," editorial first author Dr. Michael Nurok, an anesthesiologist and intensive care physician at the Hospital for Special Surgery in New York City, said in a news release from the hospital.

"We think that institutions have a responsibility to minimize the chances that patients are going to be cared for by sleep-deprived clinicians," Nurok added.

Some hospitals try to reduce the likelihood that physicians will lose sleep due to their work schedules. However, "a lot of institutions are not going to be able to take that leap immediately, so as an interim step, we believe that patients need to be informed," Nurok said. "This is going to be a policy issue that develops. Elective surgery is the low hanging fruit because there is no urgency to doing it and it can be rescheduled -- ideally as a priority with institutional support. It's a nice place to start to think about policy approaches."

SOURCE: Hospital for Special Surgery, news release, Dec. 29, 2010

Mindfulness therapy no help in fibromyalgia trial

NEW YORK (Reuters Health) - A program aimed at easing stress with meditation and yoga may not be much help for people with the chronic-pain condition fibromyalgia, a recent study suggests.

The study, published in the journal Pain, looked at the effects of so-called mindfulness-based stress reduction -- a technique developed by researchers at the University of Massachusetts in 1979 that combines mindfulness meditation and gentle yoga postures.

The technique is now available throughout the world -- in the form of an eight-week program of classes -- to help people manage general stress or health problems, including chronic pain.

For the new study, researchers led by Dr. Stefan Schmidt, of the University Medical Center in Freiburg, Germany, tested the program's effects among 177 women with fibromyalgia.

They found that women assigned to the mindfulness program showed no greater gains in health-related quality of life than those assigned to a waiting list for treatment.

That meant no significant improvements in either physical symptoms or emotional well-being.

"I'm surprised it didn't work better than it did," Dr. Alex Zautra, a professor in psychology at Arizona State University in Tempe, told Reuters Health. Zautra, who was not involved in the study, said he would have expected better results since people with fibromyalgia would seem to be good candidates for the mind-body therapy.

Fibromyalgia is a syndrome marked by widespread pain -- including discomfort at specific "tender points" in the body -- along with symptoms like fatigue, irritable bowel and sleep problems. It is estimated to affect up to 5 million U.S. adults, most commonly middle-aged women.

The precise cause of fibromyalgia is unknown. There are no physical markers, like inflammation or tissue damage in the painful areas -- but some researchers believe the disorder involves problems in how the brain processes pain signals.

Standard treatments include painkillers, antidepressants, cognitive-behavioral therapy and exercise therapy. However, many people with fibromyalgia find that their symptoms persist despite treatment.

One reason, some researchers suspect, may be because standard treatments do not specifically address the role psychological stress and emotions can play in triggering pain.

Studies have found that people with fibromyalgia have higher-than-average rates of stressful life events, like childhood abuse and marital problems. There's also evidence suggesting they are less aware of their own emotions and have more difficulty holding on to positive feelings compared to people without fibromyalgia.

The idea behind mindfulness practices, Zautra said, is that people become more aware of how they are feeling, emotionally and physically, from moment to moment. Then they can start to see how their emotions affect their perceptions of their physical symptoms.

But maybe the problem, Zautra said, is that "awareness by itself is not enough for patients with fibromyalgia."

That is, people with the disorder may need extra help in learning how to manage the emotions that come up when they meditate or practice mindfulness-based yoga.

Another recent study of the "mind-body" approach to fibromyalgia suggested that patients can benefit from addressing their emotions. In that study of 45 women with fibromyalgia, about half of those who underwent a therapy called "affective self-awareness" reported a significant improvement in their pain over six months.

Affective self-awareness -- a newer therapy that is not widely available -- tries to get people to "directly engage" their emotions with the help of various techniques. Mindfulness meditation and "expressive" writing are two of them.

Zautra and his colleagues are in the middle of a clinical trial testing their own mindfulness-based program against standard cognitive-behavioral therapy and general health education for people with fibromyalgia.

So the "jury is still out," Zautra said, as to whether some fibromyalgia patients can benefit from mindfulness practices.

In the meantime, if someone with the disorder wants to try a mindfulness meditation class, "this study doesn't tell them not to," Zautra said.

"But don't expect it to cure your pain," he added. "This study raises questions about when and for whom (mindfulness techniques) may be helpful."

The current findings are based on 177 women with fibromyalgia who were randomly assigned to one of three groups: one that went through the eight-week mindfulness-based stress reduction program; an "active" control group that received relaxation training and learned gentle stretching exercises; and a second control group where patients were put on a waiting list for treatment.

All of the women completed a standard questionnaire to rate their health-related quality of life at the beginning of the study, directly after the therapy program ended, and again two months later.

Overall, Schmidt's team found, the entire study group showed a small improvement in quality of life over time. But there were no significant differences between the three groups.

According to Zautra, one possibility is that only certain subsets of fibromyalgia patients stand to benefit from this or other mindfulness-based therapies.

In one of his own studies, Zautra said, people with rheumatoid arthritis who also had a history of depression benefited more from mindfulness meditation than arthritis patients who had never battled depression.

It's possible -- though not proven -- that the same pattern could hold true for fibromyalgia patients, he noted.

SOURCE: Pain, online December 13, 2010

New chronic hepatitis research from Aichi Gakuin University discussed

December 22, 2010

New chronic hepatitis research from Aichi Gakuin University discussed

According to recent research from Nagoya, Japan, "In chronic hepatitis C, iron might play an important role as a hepatotoxic co-factor. Therefore, venesection, a standard treatment for hemochromatosis, has been proposed as an alternative for patients who respond poorly to anti-viral therapy."

"Hemochromatosis is a disorder that interferes with the body's ability
to break down iron, and results in too much iron being absorbed from
the gastrointestinal tract"

"To improve our understanding of iron-induced hepatotoxicity, we compared the responses to venesection between patients with chronic hepatitis C and those with HFE-hemochromatosis. Fourteen Japanese patients with chronic hepatitis C and eight Italian patients with HFE-hemochromatosis underwent repeated venesection with a serum ferritin endpoint of 20 and 50 ng/mL, respectively. Serum iron indices and liver function tests were measured in pre- and post treatment blood samples from each patient. Body iron stores were calculated using the removed blood volume. In both patients with hepatitis and hemochromatosis, serum ferritin, aminotransferase and hepcidin 25 were reduced after venesection. The serum aminotransferase activity, but not the serum ferritin level, was predictive of effective iron removal treatment. Hepcidin regulation was set at an inappropriately low level in hemochromatosis patients (11.1 +/- 9.2 ng/mL), but not so in hepatitis patients (30.7 +/- 14.5 ng/mL). Inversely, the estimated body iron stores of hemochromatosis patients were 5,960 +/- 2,750 mg, while those of hepatitis patients were 730 +/- 560 mg. Judging from the liver enzyme reduction ratio, patients with hepatitis seemed to be more sensitive to iron hepatotoxicity than hemochromatosis patients," wrote H. Hayashi and colleagues, Aichi Gakuin University (see also Chronic Hepatitis).

The researchers concluded: "Even though the threshold of iron hepatotoxicity and benefit of its removal differ between patients with chronic hepatitis C and those with HFE-hemochromatosis, venesection is a valid choice of treatment to reduce liver disease activity in both diseases."

Hayashi and colleagues published their study in Internal Medicine (Patients with Chronic Hepatitis C May be More Sensitive to Iron Hepatotoxicity than Patients with HFE-Hemochromatosis. Internal Medicine, 2010;49(22):2371-2377).

For additional information, contact H. Hayashi, Aichi Gakuin University, School Pharmacy, Dept. of Medical, 1-100 Kusumoto Cho, Nagoya, Aichi 464, Japan.

Publisher contact information for the journal Internal Medicine is: Japan Society Internal Medicine, 34-3 3-CHOME Hongo Bunkyo-Ku, Tokyo, 113, Japan.

Keywords: City:Nagoya, Country:Japan, Aminotransferase, Blood, Cardiology, Cardiovascular, Chronic Hepatitis, Digestive System Diseases, Enzymes, Ferritins, Gastroenterology, Hemochromatosis, Immunology, Inborn Errors Metal Metabolism, Infectious Disease, Internal Medicine, Iron Metabolism Disorders, Iron Overload, Iron-Binding Proteins, Liver Diseases, Nutritional and Metabolic Diseases, Serum

This article was prepared by Hepatitis Weekly editors from staff and other reports. Copyright 2010, Hepatitis Weekly via

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