Friday, September 28, 2012

Liver Cells, Insulin-Producing Cells, Thymus Can Be Grown in Lymph Nodes, Team Finds

ScienceDaily (Sep. 27, 2012) — Lymph nodes can provide a suitable home for a variety of cells and tissues from other organs, suggesting that a cell-based alternative to whole organ transplantation might one day be feasible, according to researchers at the University of Pittsburgh School of Medicine and its McGowan Institute for Regenerative Medicine.

In a report recently published online in Nature Biotechnology, the research team showed for the first time that liver cells, thymus tissue and insulin-producing pancreatic islet cells, in an animal model, can thrive in lymph nodes despite being displaced from their natural sites.

Hepatitis virus infection, alcoholic cirrhosis and other diseases can cause so much damage that liver transplantation is the only way to save the patient, noted senior investigator Eric Lagasse, Pharm. D., Ph.D., associate professor, Department of Pathology, Pitt School of Medicine. Children with DiGeorge syndrome lack functional thymus glands to produce essential immune cells, and diabetes can be cured with a pancreas transplant.

"However, the scarcity of donor organs means many people will not survive the wait for transplantation," said Dr. Lagasse, whose lab is at the McGowan Institute. "Cell therapies are being explored, but introducing cells into tissue already ravaged by disease decreases the likelihood of successful engraftment and restoration of function."

In the study, his team tested the possibility of using lymph nodes, which are abundant throughout the body and have a rich blood supply, as a new home for cells from other organs in what is called an "ectopic" transplant.

They injected healthy liver cells from a genetically-identical donor animal into lymph nodes of mice at various locations. The result was an enlarged, liver-like node that functioned akin to the liver; in fact, a single hepatized lymph node rescued mice that were in danger of dying from a lethal metabolic liver disease. Likewise, thymus tissue transplanted into the lymph node of mice that lacked the organ generated functional immune systems, and pancreatic islet cell transplants restored normal blood sugar control in diabetic animals.

"Our goal is not necessarily to replace the entire liver, for example, but to provide sufficient cell mass to stabilize liver function and sustain the patient's life," Dr. Lagasse said. "That could buy time until a donor organ can be transplanted. Perhaps, in some cases, ectopic cell transplantation in the lymph node might allow the diseased organ to recover."

Co-authors of the paper include Junji Komori, M.D., Ph.D., Lindsey Boone, Ph.D., and Aaron DeWard, Ph.D., all of Pitt's Department of Pathology and the McGowan Institute, and Toshitaka Hoppo, M.D., Ph.D., of the McGowan Institute.

The project was funded by National Institutes of Health grants P30CA047904 (through the University of Pittsburgh Cancer Institute) and R01 DK085711.
The above story is reprinted from materials provided by University of Pittsburgh Schools of the Health Sciences.
Junji Komori, Lindsey Boone, Aaron DeWard, Toshitaka Hoppo, Eric Lagasse. The mouse lymph node as an ectopic transplantation site for multiple tissues. Nature Biotechnology, 2012; DOI: 10.1038/nbt.2379

Thursday, September 27, 2012

Officials urge public to receive flu vaccination

Officials urge public to receive flu vaccination

 September 27, 2012

Officials from various medical organizations united today to deliver a single message to the public: Get the influenza vaccine.

“The last several years have demonstrated that influenza is predictably unpredictable,” Howard Koh, MD, assistant secretary for health at the US Department Health and Human Services, said during a press conference. “Although the last flu season was mild, people cannot become complacent. When it comes to flu, you can’t look to the past to predict the future.”

Since the CDC’s universal recommendation took effect in fall 2010, the United States seems to be on track in protecting against influenza, according to William Schaffner, MD, past-president of the National Foundation for Infectious Diseases, professor and chair of preventive medicine at Vanderbilt University and a member of the Infectious Disease News Editorial Board. Research has shown that when people know the vaccine is recommended for them, they are more likely to get the vaccination.

“There are many factors that make it easier than ever for everyone to receive influenza vaccine,” Schaffner said. “Influenza vaccination is more accessible than ever. We have multiple types of influenza vaccine to meet the needs of anyone who wishes to get vaccinated.”

There also is plenty of vaccine to go around. More than 85 million doses of influenza vaccine have been distributed as of Sept. 14, and manufacturers project that approximately 135 million doses of the vaccine will be available this year in doctors’ offices, public health clinics, pharmacies, retail stores and other venues.

Coverage rates
According to CDC data published today in Morbidity and Mortality Weekly Report, overall rates of influenza vaccination have remained steady during the past two seasons.
Approximately 42% of the US population received the influenza vaccine during the 2011-2012 season vs. 43% in the 2010-2011 season.

Approximately 52% of children received the influenza vaccination in the 2011-2012 season vs. 53% during 2010-2011. Broken down by age, the influenza vaccination rate goes down. Whereas 75% of children aged 6 to 23 months received the vaccine last season, only 34% of adolescents received the vaccination.

“Flu vaccination is especially important for young children who are at risk for complications,” Koh said. “The good thing about the past flu season, there were no racial or ethnic disparities in flu vaccination coverage for children.”

Conversely, influenza vaccination rates for adults leave much room for improvement. Approximately 39% of adults aged at least 18 years received the influenza vaccination last season vs. 41% in the 2010-2011 season. Among adults at high risk, the coverage rate was 45% last season vs. 47% in the 2010-2011 season.

Although adults aged at least 65 years had the highest coverage rates among adults, at 65%, this rate is actually a decline from the 74% rate seen in the 2008-2009 season.

Vaccination among pregnant women was approximately 47%, which is significantly higher than the 30% seen in the 2008-2009 season. According to Laura Riley, MD, director of obstetrics and gynecology infectious disease at Massachusetts General Hospital, the American College of Obstetricians and Gynecologists recommends the influenza vaccine for pregnant women.

“Influenza is five times more likely to cause severe illness in pregnant women than women who are not pregnant,” Riley said. “The flu vaccine is safe and offers protection for the mother. Research shows that it can also decrease the baby’s risk of getting flu for up to 6 months after birth.

Health care workers also have seen slightly increased rates of influenza vaccination. Last season, the rate of vaccination was 67% vs. 64% in the 2010-2011 season. The highest rate was among physicians. Hospitals had the highest rates of vaccination coverage and the lowest rates were seen among health care professionals — other than physicians and nurses — working in long-term care facilities.

2012-2013 season
This year’s influenza vaccination includes three strains. One, A/California/7/2009 (H1N1)-like virus, was in last year’s formulation. The two new strains included in this year’s formulation are A/Victoria/361/2011 (H3N2)-like virus and B/Wisconsin/1/2010-like virus.

Schaffner also said there are four different options for receiving the vaccine for various populations: nasal spray; the traditional intramuscular injected vaccine; a high-dose injection for adults aged at least 65 years; and an intradermal vaccine with a smaller needle.

In addition, although vaccination is the first and most important step, other preventive actions such as good hand hygiene and cough hygiene are important. In the event of infection with influenza, antiviral drugs, such as oseltamivir (Tamiflu, Genentech) and zanamivir (Relenza, GlaxoSmithKline), are recommended by the CDC to reduce the risk for serious complications.

Of course, prevention is key, which is why vaccination is so important.

“We all know that the national election is going on and in the spirit of the upcoming election, this is one national fight that is easy to agree on,” Schaffner said. “Everyone should vote yes for vaccination.”

For more information:
CDC. MMWR. 2012;61:753-757.
CDC. MMWR. 2012;61:758-763.

Disclosure: Koh, Riley and Schaffner report no relevant financial disclosures.

ACH-3102-Achillion Announces Positive Proof-of-Concept Data

Achillion Sees Positive Results in Hepatitis C Study
By Ben Fox Rubin
Achillion is among a handful of companies racing to bring an all-oral regimen for hepatitis C to the market. The new drugs being developed would eliminate an injectable drug used in the current standard treatment, interferon, which can be difficult for patients to tolerate. Major players working on new hepatitis C drugs include Gilead Sciences Inc. (GILD) and Bristol-Myers Squibb Co. (BMY).
Following positive results from a Phase 1a trial for its ACH-3102 drug, Achillion has initiated a pilot Phase 2 trial evaluating the drug. The company said the drug showed "robust antiviral activity" in its trial.
 *ACH-3102 received fast-track designation from the U.S. Food and Drug Administration in May.
Continue Reading....

Achillion Announces Positive Proof-of-Concept Data With ACH-3102

-Second-Generation Pan-Genotypic NS5A Inhibitor Achieves Potent Antiviral Activity of Mean Maximum 3.74 Log10 Reduction Following a Single Dose -

- Initiated Enrollment in a Phase 2 Clinical Trial Evaluating ACH-3102 Plus Ribavirin for the Treatment of HCV Genotype 1b-
*ACH-3102: All-oral, interferon-free pilot Phase 2 12-week trial of ACH-3102 and ribavirin for the treatment of HCV GT 1b

- Hosting Analyst Day Today With Live Webcast Beginning at 1:00 p.m. ET -

NEW HAVEN, Conn., Sept. 27, 2012 (GLOBE NEWSWIRE) --

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced positive proof-of-concept results with ACH-3102, a second-generation pan-genotypic NS5A inhibitor being developed for the treatment of chronic hepatitis C viral infections (HCV). Administration of a single-dose of ACH-3102 to genotype (GT) 1a HCV-infected subjects resulted in a mean maximum 3.74 log10 reduction in HCV RNA (range 2.9 — 4.6 log10). Significant reductions in HCV RNA were achieved in subjects with resistant variants at baseline, including L31M and Y93C variants.

Based on these data, combined with safety and tolerability results from the Phase 1a trial in healthy subjects evaluating up to 14 days of ACH-3102, Achillion has initiated a pilot Phase 2 clinical trial evaluating ACH-3102 in combination with ribavirin for the treatment of patients with chronic GT 1b HCV.

"We believe these proof-of-concept results demonstrate the differentiation of ACH-3102 from first-generation NS5A inhibitors. The potency of ACH-3102 was successfully shown against genotype 1a, historically the hardest to treat HCV subtype," commented Michael Kishbauch, President and Chief Executive Officer of Achillion. "Furthermore, we believe the enhanced resistance profile of ACH-3102 observed in vitro has been validated in the clinic with robust antiviral activity against baseline mutations such as L31M. These results support our belief that this second-generation pan-genotypic NS5A inhibitor has the potential to become a cornerstone compound."

ACH-3102: Phase 1 Program
In May 2012, Achillion initiated a Phase 1a clinical trial evaluating the safety and tolerability of single and multiple ascending doses of ACH-3102 in healthy volunteers. To date, 42 healthy volunteers have received a single dose of ACH-3102, ranging from 25 mg to 1,000 mg. An additional 32 healthy volunteers have received 14 days of ACH-3102 once-daily evaluating various dosing regimens. Preliminary data from the single and multiple ascending dose groups demonstrated that ACH-3102 was well tolerated at all doses evaluated. There were no serious adverse events and no clinically significant changes in vital signs, electrocardiograms (ECGs), or laboratory evaluations. All reported adverse events were classified as mild or moderate and were transient in nature.
In August 2012, Achillion initiated a Phase 1b clinical trial enrolling a total of 14 patients infected with GT 1a chronic HCV, of which 2 received placebo and 12 received a single dose of 50 mg, 150 mg or 300 mg ACH-3102. No serious adverse events were reported and there were no patient discontinuations.

The mean maximum HCV RNA decline for each dose group is provided below:
Mean maximal Range decline
Dose decline HCV RVAHCV RNA
5043.783.35 — 4.16
1a 15043.522.91 — 3.98
30043.933.40 — 4.60

An assessment of clinical virology was conducted on baseline samples from all 12 patients receiving a single-dose of ACH-3102. Sequencing revealed one patient had a baseline L31M mutation (300 mg dose group, maximum HCV RNA decline of 3.4 log10) and another patient had a baseline Y93C mutation (300 dose group, maximum HCV RNA decline of 4.6 log10). These mutations have been previously reported to convey a high level of resistance to first-generation NS5A inhibitors which was not observed following exposure to ACH-3102.

ACH-3102: All-oral, interferon-free pilot Phase 2 12-week trial of ACH-3102 and ribavirin for the treatment of HCV GT 1b
Achillion has initiated patient enrollment in an open-label Phase 2 pilot trial evaluating 12-weeks of once-daily ACH-3102 in combination with ribavirin for the treatment of HCV GT 1b. This study will initially enroll up to 16 treatment-naïve patients with GT 1b IL28B CC HCV. Patients will receive 225 mg of ACH-3102 on day 1 followed by 75 mg of ACH-3102 once daily on subsequent days in combination with twice daily ribavirin. The primary objective of the trial is to determine the safety and sustained virologic response 12 weeks after the completion of treatment (SVR12) with secondary endpoints assessing safety, pharmacokinetics, pharmacodynamics, and virologic endpoints including rapid virologic response (RVR) and extended RVR (eRVR). Achillion expects to report initial RVR results from this study during the fourth quarter of 2012.

Mr. Kishbauch further commented, "With the initiation of this all-oral 12-week study evaluating ACH-3102 and ribavirin for the treatment of HCV genotype 1b, we have rapidly advanced our portfolio and believe the attributes of ACH-3102, as well as sovaprevir, our Phase 2 protease inhibitor, have the potential to provide optimized compounds for the broad treatment of HCV."

Analyst Day Webcast
Achillion is hosting its inaugural Analyst Day and simultaneous webcast on Thursday, September 27, 2012 at 1:00 p.m. Eastern Time. To access a copy of the presentation and the live audio webcast of the event, please visit Please connect to Achillion's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. A replay of the webcast will be available on beginning approximately 2 hours after the conclusion of the event.

About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide including more than 5 million people in the United States, more than twice as widespread as HIV. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.

About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit or call 1-203-624-7000.

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to the favorable activity and potential benefits of ACH-3102 and sovaprevir, and expectations about milestone achievement including the potential to report RVR results during the fourth quarter of 2012. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things, Achillion's ability to: replicate in later clinical trials the positive results found in nonclinical studies and earlier stage clinical studies of sovaprevir, ACH-2684, and ACH-3102; advance the development of its drug candidates under the timelines it anticipates in current and future clinical trials; obtain necessary regulatory approvals; obtain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Wednesday, September 26, 2012

On 'Sound Medicine': Hepatitis C and baby boomers, tropical disease, and the modern-day plague

On 'Sound Medicine': Hepatitis C and baby boomers, tropical disease, and the modern-day plague

September 26, 2012
INDIANAPOLIS -- This week, award-winning “Sound Medicine” welcomes Anne Ryder as its host, starting with the Sept. 30 program. Please check your local NPR stations’ listings for broadcast dates and times.

Sound Medicine” covers controversial ethics topics, breakthrough research studies and the day-to-day application of recent advancements in medicine. It’s also available via podcast and Stitcher Radio for mobile phones and iPads and posts updates on Facebook and Twitter.

While founding host Barbara Lewis takes a leave of absence, “Sound Medicine” welcomes Anne Ryder as its interim host.
Ryder is a freelance television journalist, writer and member of the Indiana Broadcast Hall of Fame. She spent 20 years as an anchor and reporter at WTHR, the NBC affiliate in Indianapolis, where she covered stories of resilience in the face of trial and difficulty. Her reporting has taken her from Bosnia and the Kosovar refugee camps of Albania to Calcutta, where she was granted a rare interview with Mother Teresa. Ryder has earned 16 regional Emmy Awards, five national honors and the Doris H. Merritt Award from the Indiana University School of Nursing for her support of the nursing profession. Ryder graduated from the journalism school at the University of Missouri-Columbia and holds honorary doctorates from three other universities.

Why are baby boomers being urged to be tested for hepatitis C?
The Centers for Disease Control and Prevention has released new recommendations that every member of the baby boomer generation (born from 1945 through 1965) receive a one-time blood test to screen for hepatitis C. More than 2 million baby boomers are known to be infected, accounting for 75 percent of all Americans living with the virus, which may be present for many decades before symptoms appear. Theresa Rohr-Kirchgraber, M.D., who regularly sees patients at Wishard Hospital and serves as director of the IU National Center of Excellence in Women’s Health, discusses the recommendations, what tests are used to determine its presence and what steps carriers can take to avoid fatal liver damage.

Why is the incidence of Chagas disease growing in the U.S?
At least 300,000 people in the U.S. have Chagas disease, an ailment historically found in Latin America. Chagas is caused by a parasite that circulates in the blood and attacks the heart, colon and esophagus. It is the leading cause of heart failure in Latin America and is known to remain undetected for decades with a lack of noticeable symptoms. Peter Hotez, M.D., Ph.D., founding dean of the National School of Tropical Medicine at Baylor University, discusses the growing prevalence of Chagas disease in the U.S. and how his group in Texas is working to figure out its transmission, prevalence and better treatments.

How is the Middle Ages plague treated today?
Though rare, the Bubonic plague/Black Death, commonly associated with millions of deaths during the Middle Ages, still exists in modern-day America, with about 11 cases reported each year since 1976. These cases are mostly concentrated in the Southwest where the habitat best supports it. Anna Schotthoefer, Ph.D., a researcher at the Marshfield Clinic Research Foundation in Wisconsin, shares how we treat plague today and why it needs to be treated quickly.

How can setting goals aid terminally ill patients?
In another installment of the “Patient Listening” series, Kevin Rand, professor of psychology at IUPUI, discusses his research involving interviews with patients who are nearing the ends of their lives and for whom treatment is no longer possible. Rand addresses what these patients are most looking forward to as they near the end of their life’s journey and the importance of goal-setting, and he shares some of the stories of those he has been interviewing.

“Sound Medicine,” co-produced by the IU School of Medicine and WFYI Public Radio (90.1 FM) and underwritten in part by Indiana University-Purdue University Indianapolis, is aired on the following Indiana public radio stations: WBSB (Anderson, 89.5 FM), WFIU (Bloomington, 103.7 FM; Columbus, 100.7 FM; Kokomo, 106.1 FM; Terre Haute, 95.1 FM), WNDY (Crawfordsville, 91.3 FM), WVPE (Elkhart/South Bend, 88.1 FM), WNIN (Evansville, 88.3 FM), WBOI (Fort Wayne, 89.1 FM), WFCI (Franklin, 89.5 FM), WBSH (Hagerstown/New Castle, 91.1 FM), WFYI (Indianapolis), WBSW (Marion, 90.9 FM), WBST (Muncie, 92.1 FM), WBSJ (Portland, 91.7 FM), WLPR (Lake County, 89.1 FM) and WBAA (West Lafayette, 101.3 FM).
“Sound Medicine” is also broadcast on these public radio stations across the country: WLRH (Huntsville, Ala.), KSKA (Anchorage, Alaska), KTNA (Talkeetna, Alaska), KUHB (Pribilof Islands, Alaska), KUAF (Fayetteville and Fort Smith, Ark.), KIDE (Hoopa Valley, Calif.), KRCC (Colorado Springs, Colo.), KEDM (Monroe, La.), WCMU (Mount Pleasant, Mich.), WCNY and WRVO-1 (Syracuse, N.Y.), KMHA (Four Bears, N.D.), WYSU (Youngstown, Ohio), KPOV (Bend, Ore.) and KEOS (College Station, Texas).

How Influenza Pandemics Occur

The National Institute of Allergy and Infectious Diseases explains the emergence and potential spread of new influenza viruses of new influenza viruses.

Hepatitis C -Analyst expects Gilead momentum

Related:Vertex Reports New Data On ALS-2200 In Hepatitis C Patients - Supporting Advancement into Phase 2 All-Oral Studies in 2012; Ends Development of ALS-2158

Investment Commentary

Ahead of the Bell: Analyst expects Gilead momentum

The Associated Press

Shares of Gilead Sciences Inc. may gain momentum from a Vertex Pharmaceuticals Inc. decision stop development of a potential hepatitis C treatment, according to a Barclays analyst.

Vertex said Tuesday it will end development of a drug labeled ALS-2158 after a study showed there was "insufficient antiviral activity to warrant proceeding with further clinical development." ALS-2158 was in early-stage development.

But the Cambridge, Mass., company also said it expects to start mid-stage studies by the end of the year on another potential treatment labeled ALS-2200. The drug developer will test that molecule in separate studies that combine it with ribavirin and Incivek to treat people with a form of chronic hepatitis C.

Incivek, from Vertex and Johnson & Johnson, was one of two new hepatitis C drugs approved last year, after a two-decade drought for new treatments. The other was Victrelis from Merck & Co.

Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. As many as 5 million people in the United States are infected with chronic hepatitis C, and most are unaware of their infection, according to Vertex.

Analysts say the market for treatments is potentially lucrative for drugmakers. More people are expected to be diagnosed with the tough-to-treat disease as the baby boomer generation ages.

Last month, drugmaker Bristol-Myers Squibb Co. also said it will scrap development of a potential hepatitis C treatment after at least one patient suffered heart failure. Gilead shares climbed after that announcement.

Analyst Ying Huang said in a research note the Vertex announcement will provide "additional positive momentum" for Gilead heading into November's annual meeting of the American Association for the Study of Liver Diseases in Boston. Gilead, based in Foster City, Calif., has a couple potential hepatitis C treatments under development, including one labeled GS-7977 that many analysts see as promising.

The Barclays analyst expects confidence behind Gilead's potential treatments to remain high.

Routinely analyzed parameters may indicate NASH, fibrosis in obese patients

Routinely analyzed parameters may indicate NASH, fibrosis in obese patients

Francque SMA. Clin Gastroenterol Hepatol. 2012;10:1162-1168.
  • September 26, 2012
A scoring system incorporating routine parameters determined the presence and severity of nonalcoholic steatohepatitis and fibrosis in obese patients more accurately than published systems in a recent study.

Researchers performed liver-related tests on 542 overweight or obese patients, including blood analysis, ultrasound, and genetic and aminopyrine breath tests. Liver biopsy was performed on 313 patients within the cohort who showed signs of potential nonalcoholic fatty liver disease (NAFLD). The participants who received biopsies were randomly assigned to design (n=200) and validation cohorts (n=113). Investigators created scoring systems to predict the presence and severity of fibrosis and NAFLD and compared their accuracy to that of various existing systems, including NAFLD liver fat score, FLI, APRI and BARD score.

Nonalcoholic steatohepatitis (NASH) was present in 52.1% of patients, and significant fibrosis was detected in 19.5%. ALT levels greater than 40 U/L, ultrasound steatosis scores and elevated fasting C-peptide levels were associated with NASH. A score designed to diagnose NASH according to these factors was more accurate than all other evaluated systems according to ROC analysis (AUROC=0.854 in the design group and 0.823 in the validation group).

Correlations were observed between NASH severity and these three factors, and researchers also developed a score incorporating them to determine NASH severity, with an R2 of 0.491. Investigators noted correlations between NASH and CK18 and PNPLA3 polymorphism levels, but incorporating these factors did not improve diagnostic accuracy.

Waist circumference and fasting C-peptide and AST levels were predictive of advanced fibrosis in both groups. The scoring system incorporating these factors was found more accurate than other evaluated systems, with an AUROC of 0.811 in the design group and 0.788 in the validation group for the detection of significant fibrosis (R2=0.352 for score).

“We could design and validate scoring systems for NASH and fibrosis on the basis of routine parameters,” the researchers wrote. “Ultrasound significantly adds to the diagnostic accuracy for NASH diagnosis, whereas genetic testing and nonroutine biological tests do not have an added value. Published scores are significantly less accurate. … [However], even our score has a rather unsatisfactory overall accuracy for the diagnosis of fibrosis. … We propose to use the score to exclude the presence of advanced fibrosis. If the score does not exclude advanced fibrosis, a liver biopsy is still necessary to reliably assess liver fibrosis.”

Tuesday, September 25, 2012

What Inspires People to Become Organ Donors?

What Inspires People to Become Organ Donors?

September 24, 2012

Press Highlights Section Editor: Grace L. Su, MD, University of Michigan Medical School

Story By: Kristine Novak, PhD, Science Editor, AGA Journals

Tax breaks don’t seem to encourage people to become organ donors, but Facebook and opt-out strategies do.

According to American Medical News, since 2004, 16 states have enacted legislation giving living organ donors tax breaks. However these have done little to increase numbers of living organ donors, according to a study by Atheendar S. Venkataramani in last month’s American Journal of Transplantation .

States that approved living-donor tax breaks had a rate of 2.64 donors per 100,000 residents—not significantly better than the rate of 2.47 per 100,000 in states without these tax breaks. So why didn’t the state tax breaks help? It could be that the money to be saved through taxes was not enough to get people’s attention. A family of 4 with the median income in Wisconsin that writes off $10,000 in donation-related expenses would see its actual tax burden fall by only $600, the study said.

Facebook has been making its own attempt to inspire people to become organ donors, campaigning last week to boost organ donations in Canada and Mexico—an expansion of a program that began in the US last May, when Facebook began allowing users to post their organ-donation status on their timeline.

They have encouraged users to tell their friends and family that they registered as organ donors and share stories about how and why they decided to become donors; Facebook provides links to official donor registries. Between May 1 and last week, around 275,000 Facebook users posted their donor status on the site, according NPR’sHealth Blog.

According to Donate Life California—the official organ donor registry in the state—on a normal day around 70 people in California register. In the 24 hours following Facebook's announcement on May 1, almost 4000 registered. However, those numbers came back down just as fast as they shot up. By May 6, the number of Californians registering with Donate Life was back to its usual level. NPR reported that, for social media campaigns like Facebook's to work, people need to be continuously prompted.

Gastroenterology Press Highlights Another strategy to increase the supply of organs is presumed consent. Many European countries have implemented this opt-out policy, which has been successful in increasing the organ supply. According to the LA Times Health Blog, Spain, which has an opt-out policy, has a 35% higher cadaveric organ donation rate than the US, where organs can be procured from decedents only if they registered as organ donors or their next of kin approve (an optin strategy).

The opt-out policy appears to change how people think about the morality of organ donation, said a study published in the 18 Sept issue of Proceedings of the NationalAcademy of Sciences of the United States of America.

Shai Davidai et al. analyzed data from 3 studies and found that ‘opt-in’ vs ‘opt-out’ results in large differences in the meaning that people attach to participation.

They surveyed more than 300 people in the US and Europe and found that those who lived in opt-out countries believed that donating organs after death was not a major ethical issue—they ranked it on a heroism scale somewhere between letting other people go ahead in line and volunteering to work with the poor.

Respondents in opt-in countries like the US, however, ranked organ donation after death as being on par with going on a hunger strike for a cause. According to the LA Times Health Blog, the kind of organ donation program causes people to think about the act of donating in different ways.

Davidai et al. concluded that different default policies influence the meaning that people assign to the act of being an organ donor. More than 115,000 people in the US are waiting for an organ, according to the United Networkfor Organ Sharing. About 80% of these patients need kidneys, which living people can donate with little to no long-term medical ill effects.

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