Fernando BoteroThe American Association for the Study of Liver Diseases November 2011 Annual Meeting Updates
From NATAP
AASLD: Cost-effectiveness analysis of a multidisciplinary support program in hepatitis C treatment - (11/22/11)
AASLD: Treatment Week 12/24 Stopping Rules for Boceprevir (BOC) Combination Therapy with Peginterferon+Ribavirin (PR): Exploratory Analyses of SPRINT-2 and RESPOND-2 - (11/22/11)
AASLD: In Vitro Assessment of Potential Drug-Drug Interactions Between Telaprevir and Cyclophilin Inhibitors in the Treatment of Chronic Hepatitis C - (11/22/11)
AASLD: An Evaluation of Neutropenia in the Pivotal Studies of Boceprevir Plus Peginterferon alfa-2b/Ribavirin - (11/22/11)
Acetaminophen: Repeated Use of Slightly Too Much Can Be Fatal
Laurie Barclay, MD
November 22, 2011 —
Repeated doses of slightly too much acetaminophen (known as paracetamol in the United Kingdom and elsewhere in Europe) can be fatal, according to the results of a large, single-center cohort study published online November 22 in the British Journal of Clinical Pharmacology."On admission, these staggered overdose patients were more likely to have liver and brain problems, require kidney dialysis or help with breathing and were at a greater risk of dying than people who had taken single overdoses," senior author Kenneth J. Simpson, MBChB (Hons), MD, FRCP (Edin), from the University of Edinburgh and Scottish Liver Transplant Unit in the United Kingdom, said in a news release."They haven't taken the sort of single-moment, one-off massive overdoses taken by people who try to commit suicide, but over time the damage builds up, and the effect can be fatal," he adds.
In the United Kingdom, acetaminophen hepatotoxicity is the leading cause of acute liver failure (ALF).
However, the effect of a staggered overdose pattern or delayed hospital presentation on mortality or need for emergency liver transplantation was previously unknown.
Of 663 patients admitted with acetaminophen-induced severe liver injury between 1992 and 2008, 161 (24.3%) had taken a staggered overdose. Compared with patients who took an overdose at a single time, patients with staggered overdose were significantly older and more likely to abuse alcohol.When asked why they repeatedly ingested more than the recommended dose of acetaminophen, patients with staggered overdose most often cited pain relief as their rationale (58.2%).
Compared with patients who took an overdose at a single time, those who took staggered overdoses had lower total ingested doses and lower serum alanine aminotransferase (ALT) levels on admission. Nonetheless, they were more likely to be encephalopathic and to require renal replacement therapy or mechanical ventilation.
Although mortality was higher in staggered overdoses than in single-time overdoses (37.3% vs 27.8%; P = .025), the staggered overdose pattern was not an independent predictor of mortality.
For staggered overdoses, sensitivity of the King's College poor prognostic criteria was reduced (77.6%; 95% confidence interval [CI], 70.8% - 81.5%).
Delayed presentation to medical services more than 24 hours after single-time overdose occurred in 44.9% of those in whom accurate timings could be determined, and was independently associated with death or liver transplantation (odds ratio [OR], 2.25; 95% CI, 1.23 - 4.12; P = .009).
In their logistic regression analysis, the investigators controlled for signs and symptoms, such as hepatic encephalopathy and prothrombin time, as well as various demographic factors."Staggered overdoses or patients presenting late after an overdose need to be closely monitored and considered for the paracetamol antidote, N-acetylcysteine [NAC], irrespective of the concentration of paracetamol in their blood," Dr. Simpson said.Because both these groups are at increased risk of developing multiorgan failure, they should be considered for early transfer to specialist liver centers.
Limitations of this study include reliance on patient recall regarding the time of last ingestion, total paracetamol dose, and suicidal intent; limited data regarding the use of concomitant P450 enzyme inducers or recent fasting; and selection bias for the more severe cases of acetaminophen toxicity in Scotland."[T]his large cohort study demonstrates the deleterious effects of delayed presentation and staggered overdose pattern upon outcome following paracetamol-induced acute liver injury," the study authors conclude. "Both delayed presentation more then 24 hours and staggered overdoses are strongly associated with multiorgan injury and the need for [liver transplantation].
Patients presenting with these overdose patterns should be treated as high risk for progression to ALF, and should receive NAC in their presenting hospital whilst awaiting serial ALT and PT levels."This study received no external funding. The authors have disclosed no relevant financial relationships. Br J Clin Pharmacol. Published online November 22, 2011.
University launches iphone app for hepatitis treatment
The University of Liverpool has launched an iphone app, HEP i-chart, that provides Hepatitis C (HCV) patients with quick and easy access to the latest information about drug interactions.
Hepatitis C was first discovered in the 1980s when it became apparent that there was a new virus (not the already known hepatitis A or B) causing liver damage. Hepatitis C causes inflammation and swelling of the liver. It is estimated that over 170million individuals – representing 3% of the world's population – are chronically infected with the Hepatitis C virus (HCV). Statistically, as many people are infected with HCV as are with HIV.
Since its identification, drug treatment to eradicate the virus has advanced greatly, especially in the last few years. Two new drugs have recently been licensed for treatment of HCV, and there are more drugs in development.
HEP i-chart is based on the website (http://www.hep-druginteractions.org/) developed at the University by Professor David Back and Professor Saye Khoo which provides a comprehensive online guide to the interactions between anti-hepatitis drugs and other drugs. It is a tool that provides Hepatitis C patients and healthcare professionals with immediate access to up-to-date information on potential drug interactions between HCV drugs, and other drugs that the patient may be prescribed as well as over-the-counter, recreational or herbal medications.
Existing HCV drugs, newly licensed drugs and drugs in development can have interactions with each other and with other drugs which can impact on their effectiveness – sometimes with serious consequences. For this reason, some drug combinations must not be used, whilst others must be given with caution, possibly requiring adjustment or monitoring.
Professor of Pharmacology, David Back, said: "We are delighted to launch with our partners – KnowledgePoint360, MSD and Janssen- this new i-phone application that provides Hepatitis C patients and healthcare professionals with instant and easy access to information about HCV drug interactions which is relevant and reliable and up-to-date. This resource is especially important as new HCV drug treatments are approved and come into use."
Professor Graham Foster, President of the British Association for the Study of the Liver (BASL) said: "This new app, HEP i-chart, is a timely and much-needed resource for HCV patients as the number of new drugs which are available to treat Hepatitis C increases."
Hepatitis Screening Offered With Routine Colonoscopy Accepted by 75%
ATIONAL HARBOR, MD. – A screening colonoscopy can provide a convenient opportunity to simultaneously test older adults for hepatitis, based on a study of 500 patients, 75% of whom agreed to blood tests for hepatitis A, B, and C.
Adults aged 50-65 years (the "baby boomers") represent a high-risk population for hepatitis, and hepatitis C in particular, because of possible exposure to high-risk activities in their teens and twenties, said Dr. Dawn Sears of Scott & White Hospital in Temple, Tex. The findings were presented at the annual meeting of the American College of Gastroenterology.
Men make up 70% of chronic hepatitis cases, and they are less likely to see a doctor regularly than women, she noted. "Colorectal cancer screenings are often the only physician encounter for men aged 50 to 60 years," she said.
To increase hepatitis screening in older adults, Dr. Sears and her colleagues tested whether combining hepatitis testing with routine colonoscopy appointments would be effective.
Patients were mailed information about hepatitis along with their instructions for colonoscopy preparation. On the day of their colonoscopies, patients met with a research nurse, signed a consent form, and completed a patient risk form. Blood was drawn for hepatitis screening when the IV was placed prior to the colonoscopy.
A total of 376 of 500 patients (75%) undergoing colonoscopies agreed to hepatitis testing. The study population was 42% male and 58% female. Risk factors in the patients’ histories included high-risk sexual activity, getting a tattoo prior to the year 2000, injecting or snorting drugs, having a blood transfusion before 1992, having a sexual partner with known hepatitis, being a health care worker who had been stuck with a needle, and spending at least 2 days in jail.
None of the patients had hepatitis B surface antigens, and 77% did not have antibodies against hepatitis A and B. Four patients had results suggesting previously undiagnosed hepatitis C, and all four complied with the recommended follow-up polymerase chain reaction (PCR) testing. One patient had a positive PCR follow-up, and that patient is beginning triple therapy, Dr. Sears said. All patients who were found to have hepatitis C antibodies had risk factors for hepatitis C infection, she noted.
"We should ask about risk factors and consider screening for hepatitis B and C," Dr. Sears said. "Gastroenterologists see most baby boomers at least once. We understand the [test] results, and this provides the highest quality, most efficient health care for our patients."
Dr. Sears said she had no financial conflicts to disclose.
Liver Transplant
Cost of a quality-adjusted life year in liver transplantation
The latest issue of Liver Transplantation investigates cost of a quality-adjusted life year in liver transplantation.
Cost issues in liver transplantation have received increasing attention, but the cost-utility is rarely calculated.
Dr Fredrik Åberg and colleagues from Finland compared costs per quality-adjusted life year from the time of placement on the liver transplant waiting list to 1 year after transplantation for 252 liver transplant patients, and to 5 years after transplantation for 81 patients.
The researchers performed separate calculations for chronic liver disease, acute liver failure, and different Model for End-Stage Liver Disease (MELD) scores.
For the estimation of quality-adjusted life years, the health-related quality of life was measured with the 15D instrument.
The team found that the median costs, and quality-adjusted life years after liver transplantation were €141,768 and 0.9 for 1 year, and €177,618 and 4 for 5 years, respectively.
MELD scores more than 25 demonstrated higher 5-year costs
Liver Transplantation
The research team noted that costs of the first year were 80% of the 5-year costs.
The researchers observed that main cost during years 2 to 5 was immunosuppression drugs.
The cost/quality-adjusted life year ratio improved from €158,400/quality-adjusted life year at 1 year to €44,854/quality-adjusted life year at 5 years, and the ratio was more beneficial for chronic liver disease patients versus acute liver failure patients, and for patients with low MELD scores versus patients with high MELD scores.
Although patients with chronic liver disease and MELD scores more than 25 demonstrated markedly higher 5-year costs than patients with MELD scores less than 15, the cost/quality-adjusted life year difference was less pronounced.
Dr Åberg's team concluded, "Cost/quality-adjusted life year ratio for liver transplantation appears favorable, but it is dependent on the assessed time period and the severity of the liver disease."
Liver Transplant 2011: 17(11): 1333–1343
23 November 2011
This editorial "Thanksgiving Gift " comes to you from the wonderful and inspirational blog;
Donate Life - Organ Donation Blog
Liver Cancer
Is Radiofrequency Ablation as Good as Surgery for HCC up to 4cm?
By Rob Goodier
NEW YORK (Reuters Health) Nov 18
Hepatocellular carcinoma patients who underwent radio frequency ablation (RFA) had a similar survival rate to those who had a surgical resection in a new study from China.
There was no difference in survival even for tumors up to 4cm in diameter, researchers reported November 7th at the annual meeting of the American Association for the Study of Liver Diseases in San Francisco.
The abstract was one of 10 that Dr. Jake Liang, president of the AASLD, singled out to present to the media from among 2300 abstracts at the conference. But at least one expert said the study can't definitively answer the question of whether ablation is as good as surgery for this kind of cancer.
The trial was headed by Dr. Ma Kuansheng at Southwest Hospital in Chongqing. The researchers randomly assigned 168 patients with early-stage hepatoma to either surgery or RFA. Each patient had no more than two tumors less than 4cm in diameter.
Survival rates were similar: 96% in the surgery group and 93.1% in the RFA group at one year, 87.6% with surgery and 83.2% with RFA at two years, and 74.8% and 67.6%, respectively, at three years.
Predictors of survival after ablation included multiple tumors (relative risk 3.85, p = 0.018) and preoperative indocyanine green clearance (RR 3.544, p = 0.002).
Dr. Yuman Fong, a hepatobiliary surgeon at Memorial Sloan-Kettering Cancer Center in New York City who was not involved in the research, pointed to a growing body of research suggesting that ablation compares to surgery for small carcinomas. In that context, the finding is not surprising, but welcome, he told Reuters Health.
"This is an important finding because most patients with HCC have cirrhosis and cannot have a liver resection," Dr. Fong said. "Ablation therefore becomes a life saving, safe and effective therapy for these patients."
But Dr. Myron Schwartz, a surgical oncologist at the Mount Sinai Hospital in New York City, warned of flaws in the study's design.
He told Reuters Health that as a reviewer for the AASLD he had read the abstract when it was first submitted. Among the study's problems, he said, is that it appears to contradict a larger body of evidence suggesting that the failure rate for ablation increases with the size of the tumor.
"It is well-documented that local failure of RFA increases rapidly with increasing tumor diameter," he wrote in an email. "Failure at 2cm is around 5%, whereas at 4cm it's as high as 40%."
Also, he suspects that some of the patients randomized to surgery may not have been good candidates for the procedure.
Resection patients should have normal liver function (including normal ICG clearance) and no portal hypertension, he said. "The fact that impaired ICG clearance was an independent risk factor for poor outcome in this study allows one to conclude that patients with impaired ICG clearance were allowed to enter the study."
Furthermore, according to Dr. Schwartz, patients with multiple tumors are not optimal resection candidates "since multiple tumors imply intrahepatic dissemination and a high likelihood of remote recurrence regardless of how the index tumors are treated."
"The bottom line is that this trial adds nothing," Dr. Schwartz said.
"The real question," he added, "which hasn't been answered directly by a randomized trial but on which a consensus seems to be building, is whether ablation is equivalent to resection even for optimal resection candidates when there is a solitary hepatocellular carcinoma of 2cm or less in diameter."
"The answer seems more and more to be, Yes," Dr. Schwartz said. He added that guidelines are starting to reflect that agreement, "and it's what we do these days."
OAKLAND, Calif., November 22, 2011 – HIV-infected patients are at increased risk for cancer as a result of both their impaired immune system and lifestyle factors, such as smoking, according to researchers at Kaiser Permanente.
The study, which appears in the current issue of Cancer Epidemiology, Biomarkers and Prevention, is among the first to directly compare the risk of cancer in HIV-infected patients with a comparison group without HIV infection, while accounting for major cancer risk factors.
Of the 10 cancer types studied, six were more common in HIV patients, compared with patients without HIV infection — including, Kaposi's sarcoma, non-Hodgkin lymphoma, Hodgkin lymphoma, melanoma, anal cancer and liver cancer, while prostate cancer was less common. Lung and oral-cavity cancers also occurred more frequently in HIV patients, although most of the risk appeared to be due to risk factors such as smoking, according to the investigators.
Further analysis suggested that immunodeficiency — as measured by CD4 count (a measure of the strength of the immune system) — was positively associated with the risk of all studied cancer types, except prostate cancer. The amount of HIV virus in the blood, however, was only associated with two cancers, Kaposi sarcoma and non-Hodgkin lymphoma, they said.
Most cancers found to be associated with immunodeficiency had a known infectious cause, suggesting a mechanism in which an impaired immune system cannot adequately suppress certain cancer-causing viral infections such as human papillomavirus or hepatitis, investigators explained . They also acknowledged that for some cancers, such as lung and oral-cavity cancers, the elevated risk was multifactorial and likely resulted from both an impaired immune system and risk factors such as smoking.
"Taken together, we believe our results support cancer prevention strategies that combine routine prevention activities, such as smoking cessation, with earlier HIV treatment to help maintain a patient's immune system," said study lead author Dr. Michael Silverberg, PhD, MPH, a research scientist with the Kaiser Permanente Division of Research in Oakland, Calif. The main goal of the study, he added, was to determine how much of the increased cancer risk in HIV patients resulted from their disease, and how much was due to risk factors. To accomplish this goal, they performed a cohort study from 1996-2008 of adult HIV-infected and demographically similar HIV-uninfected individuals from Kaiser Permanente Northern and Southern California. The risk for 10 cancer types were compared between groups, while adjusting for cancer risk factors including smoking, alcohol/drug abuse, and overweight/obesity. They also evaluated the effect of CD4 and HIV virus levels, both of which are markers for HIV disease severity.
"After adjusting for risk factors, the incidence rates of six of 10 cancers were markedly elevated in HIV patients. When we looked more closely we discovered that for most cancers studied — eight of 10 — HIV patients with the lowest CD4 had higher rates compared with those without HIV," said Dr. Silverberg. "These findings need confirmation in other settings, particularly colorectal cancer, which has not been previously linked to immunodeficiency."
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Additional researchers on the study include: Chun Chao, PhD and Lanfang Xu, MS, with Kaiser Permanente Department of Research & Evaluation in Pasadena, Calif.; Wendy A. Leyden, MPH, Charles Quesenberry, Jr., PhD, and Romain S. Neugebauer, PhD, with Kaiser Permanente Northern California Division of Research; Michael Horberg, MD, with the Mid-Atlantic Permanente Research Institute; William J. Towner, MD, with Kaiser Permanente Los Angeles Medical Center; Daniel Klein, MD, with Kaiser Permanente Hayward Medical Center; Robert Dubrow, MD, PhD, with the Yale School of Public Health; and Donald I. Abrams, MD, with the University of California at San Francisco.
Funding was provided by grants from the National Institutes of Health, the Garfield Memorial Research Fund and Pfizer Pharmaceuticals.
About the Kaiser Permanente Division of Research (http://www.dor.kaiser.org/)
The Kaiser Permanente Division of Research conducts, publishes and disseminates epidemiologic and health services research to improve the health and medical care of Kaiser Permanente members and the society at large. It seeks to understand the determinants of illness and well-being and to improve the quality and cost-effectiveness of health care. Currently, DOR's 400-plus staff is working on more than 250 epidemiological and health services research projects.
About the Kaiser Permanente Department of Research & Evaluation (http://www.kp-scalresearch.org)
The mission of the Department of Research & Evaluation is to initiate and conduct high-quality, public-sector health services, epidemiologic, behavioral and clinical research that has a demonstrable positive impact on the health and well-being of Kaiser Permanente Southern California members and the general population.
About Kaiser Permanente
Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America's leading health care providers and not-for-profit health plans. Founded in 1945, our mission is to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We serve approximately 8.9 million members in nine states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: www.kp.org/newscenter.
Contact:
Danielle Cass
danielle.x.cass@kp.org
510-267-5354
Kaiser Permanente
Over two-thirds of HIV-positive military veterans in the US have a mental health disorder, according to research published in the online edition of AIDS. The presence of certain mental health problems was associated with an increased risk of death and HIV disease progression.
“Our results reflect ‘the real world’ of clinical practice, where challenging patients with complex comorbidities are much more common than in the clinical trial setting,” comment the investigators.
Improvements in treatment and care mean that many HIV-positive patients have a near-normal prognosis. However, the impact of mental health disorders on the outcomes of patients taking antiretroviral therapy is poorly understood.
Earlier research has shown that HIV-positive military veterans in the US have high rates of substance abuse and mental health problems. Therefore investigators from the Department of Veterans Affairs conducted a retrospective study to see if a number of psychiatric disorders hastened HIV disease progression and time to death.......Continue Reading..
Nurutdinova D et al. Mental health disorders and the risk of AIDS-defining illness and death in HIV-infected veterans. AIDS 25, online edition, doi: 10.1097/QAD.0b013e32834e1404, 2011 (click here for the free abstract).
15 to 20 percent of all human cancers are caused by viruses
New evidence links virus to brain cancer
(Medical Xpress) -- Tilting the scales in an ongoing debate, University of Wisconsin-Madison researchers have found new evidence that human cytomegalovirus (HCMV) is associated with glioblastoma multiforme (GBM), the brain cancer that killed Sen. Edward Kennedy.
The findings confirm what only a handful of scientists have found, but in a manner that University of Wisconsin School of Medicine and Public Health researchers believe enhances the scientific rigor of earlier studies. The study, published in the advanced online edition (Nov. 16, 2011) of the Journal of Virology, hints for the first time that HCMV may work differently than other cancer-related viruses - possibly by affecting only tumor stem cells, self-renewing cells that keep the tumor growing.
The new research may place HCMV in an expanding group of viruses associated with cancer.
"As many as 15 to 20 percent of all human cancers are caused by viruses, and the number is growing," says HCMV expert Dr. Robert Kalejta, associate professor of oncology at the UW School of Medicine and Public Health (SMPH). "The viruses may not cause cancer on their own, but they play a critical role in the process." Among others, human papilloma virus (HPV) causes cervical cancer, Epstein-Barr virus (EBV) causes lymphoma and hepatitis C virus (HCV) causes liver cancer.
HCMV's role in GBM has been debated, with many scientists and clinicians remaining skeptical. Oncologist Dr. Charles Cobbs of California Pacific Medical Center has been the main proponent of the theory that HCMV contributes to GBM. Dr. John Kuo, assistant professor of neurological surgery and human oncology and a cancer stem cell scientist at the School of Medicine and Public Health, was one of the skeptical ones, but he says he's now convinced that HCMV is associated with human GBM specimens. Still, the association does not prove a causal relationship between HCMV and the development of GBM, he says.
"This study may open up a new unexplored area of research for this incurable disease," says Kuo, who is director of the Comprehensive Brain Tumor Program at UW Hospital and Clinics. He also coordinates clinical trials as chair of the brain tumor group at the Carbone Cancer Center. Kuo and colleagues on the UW brain tumor team currently treat GBM patients with the standard regimen of surgery, followed by radiation and chemotherapy. More research is needed before anti-viral drugs against HCMV could be considered for clinical trials, says Kuo, whose group contributed to the Journal of Virology paper.
Two years ago, Kalejta's team added support to Cobb's position when it showed that two HCMV proteins shut down a key protein that restricts tumor growth in general.
"HCMV can also do every one of the things that are generally considered the 10 hallmarks of cancer," says Kalejta, a member of the McArdle Laboratory for Cancer Research, Carbone Cancer Center, Stem Cell and Regenerative Medicine Center and Institute for Molecular Virology at UW-Madison.
The problem with studying HCMV is that the virus is present in a harmless way in almost everyone, so scientists can't ask if HCMV-positive people are more likely to get cancer than people without HCMV. Kalejta's postdoctoral fellow Dr. Padhma Ranganatan used a standard laboratory test, rather than the ultra-sensitive test Cobb has used, to see if HCMV was present in 75 GBM samples. The UW-Madison researchers also looked to see if the entire virus genome - all of its DNA - rather than just a portion of it was present in the tissues. Finally, they wanted to learn if all cells within the tumor or just some of them were infected.
Kalejta hopes to begin looking for the new mechanism soon. If there is such a mechanism, it could open a new door in cancer biology. It would also convert many more people to the idea that HCMV plays a key role in GBM. "But I think the tide is now turning on the debate," Kalejta says.
Provided by University of Wisconsin-Madison (news : web)
Hall Of Shame
Province pressured to pay up for dirty doctor
By JON WILLING, QMI AGENCY
Posted -22 second ago
OTTAWA -- It's time to put the heat on the province to pay for Ottawa's $750,000 response to the dirty lab investigation, the city health board says.
Ottawa public health is on the hook for the money to pay for its prevention program, which is contacting nearly 7,000 former patients of Dr. Christiane Farazli, suggesting they get tested for infectious diseases.
The College of Physicians and Surgeons of Ontario discovered Farazli's clinic wasn't always cleaning endoscopy equipment properly between procedures.
The fai led inspect ion prompted an investigation by the college and a campaign by public health to warn patients there is a very low risk they were exposed to Hepatitis B, C or HIV.
During a health-board meeting Monday night, Coun. Maria McRae emphatically called for the board to insist the province provide money to the health unit. Otherwise, the whole Farazli response would come out of the pockets of city taxpayers.
It would be "despicable" if the city had to pay because a clinic, regulated by the college, failed an inspection, McRae said.
"I don't like this cat-and-mouse game," she said.
McRae likened it to her time on the police services board when police begged the feds for money to help maintain law and order in the nation's capital.
The board agreed public health should pressure the province for cash.
The city's legal department said it's premature to talk about pursuing the costs through legal channels.
The college said this week its investigation into Farazli is ongoing.
Big Pharma
Vertex Pharmaceuticals Announces Webcast of its Presentation at the 23rd Annual Piper Jaffray Health Care Conference
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its corporate presentation at the 23rd Annual Piper Jaffray Health Care Conference on Tuesday, November 29, 2011 at 11:00 a.m. EST.
The presentation will be webcast live and may be accessed from ‘Events & Presentations' on the home page of Vertex's website at www.vrtx.com. A replay of the webcast will also be available on the Company's website for two weeks following the presentation. To ensure a timely connection, it is recommended that users register at least 15 minutes prior to the scheduled webcast.
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis, epilepsy and other life-threatening diseases.
Vertex's press releases are available at www.vrtx.com.
Vioxx Settlement: The U.S. Justice Department said Merck agreed to pay $950 million and plead guilty to a criminal misdemeanor charge to resolve allegations that the company promoted its now-defunct pain drug Vioxx for rheumatoid arthritis before the FDA approved it for that use, the WSJ reports. Merck had reserved that amount last year to cover the settlement. The settlement includes a payment of about $628 million to settle civil allegations that Merck representatives made inaccurate statements about Vioxx’s cardiovascular safety to boost sales, but Merck denies those allegations and is admitting no wrongdoing or liability, the paper says.
FDA
As the FDA attempts to toughen its oversight of manufacturing facilities in far away lands, plants in Puerto Rico are also undergoing added scrutiny. The latest example is a San Juan plant operated by Mylan Laboratories, the generic drugmaker, which received a warning letter last month for significant violations of good manufacturing practices.
Grand Rounds
Grand Rounds is a weekly summary of the best health blog posts on the Internet. Each week a different blogger takes turns hosting Grand Rounds, and summarizing the best submissions for the week.
Hosted this week by Diabetes Mine
By AmyT on November 22, 2011
Welcome to Grand Rounds, Vol. 8, No. 9, the 2011 Thanksgiving edition of the weekly summary of the best health and medical blog posts on the web. Many thanks to the organizers at Get Better Health for inviting us to host!
In a world where major economies are imploding and a climate catastrophe seems impending, there is still much to be thankful for — especially in the arena of health and medicine, where technology is empowering a revolution of sorts in hospitals, clinics and doctors’ offices, and in patients’ everyday lives.
A few submissions from grand rounds, to read more click here
What We’re Collectively Thankful for, from all around the med-blogosphere:
Last week’s host, Alvaro Fernandez at Sharp Brains, is thankful that everyone contributing to and reading Grand Rounds has a human brain (no bots, we hope!), and thankful that the human brain is not fully pre-wired.
Jenni Prokopy, Editrix at the amazing site Chronic Babe, just published a great patient blog carnival about “Gettin’ Our Gratitude On.” A must-read!
Preparing for surgery, White Turk at SrubsIsReal is thankful for a newfound transparency in medicine: “you have to understand bullshit and be comfortable enough with it to strip a legal document down to what it’s really saying.” Amen!
Elaine Schattner, both a doctor and a patient at Medical Lessons, is hoping physicians will keep things personal, remembering that their patients are fellow human beings, and not just digital images for the files.
Jessie Gruman, president and founder of the Center for Advancing Health and blogger at the Prepared Patient Forum, is hoping for improved survivorship care in the years to come, i.e. Who Will Help Cancer Survivors Stay Healthy When Treatment is Over? A great question.
To read all submissions click here
FYI
Along with shattering the stigma surrounding the Hepatitis C virus, Dr. Dieterich wants patients to understand that testing positive for the virus is not a death sentence if caught early.
The Mount Sinai Medical Center Launches Initiative to Erase the Stigma of Hepatitis C and Encourage Everyone to Get Tested
NEW YORK, NY--(Marketwire - Nov 16, 2011) - The Mount Sinai Medical Center has embarked on a new mission to educate the public about Hepatitis C and urge more Americans to be tested for this "silent killer." While two million people in the US suffer from Hepatitis C, an additional two million are undiagnosed, putting them at risk for devastating long-term effects. Through an important video program, The Mount Sinai Medical Center's Dr. Douglas Dieterich, Professor of Medicine in the Division of Liver Diseases and former Hepatitis C patient, urges people to take charge of their health by getting tested for the virus, even if no symptoms are present.
Did you know?
- Not all patients are IV drug or intranasal cocaine users. Other ways to contract the virus include: body piercings, tattoos, manicures, pedicures, or even while playing sports such as boxing and rugby
- The virus can creep along very silently, presenting no symptoms or abnormal liver test results for 30-40 years
- Hepatitis C is spread by blood-to-blood contact
- If left undetected, the virus can lead to advanced scarring of the liver, or a condition known as cirrhosis, and eventually cause liver failure or other major complications including liver cancer
- About 4 times as many people will die in 2020 from Hepatitis C then in 2010
"Many people around the world, probably the majority got it, through the fault of the health care system. They got infected needles from vaccines or other medical devices when they were in the medical world," says Dr. Dieterich.
Along with shattering the stigma surrounding the Hepatitis C virus, Dr. Dieterich wants patients to understand that testing positive for the virus is not a death sentence if caught early. Dr. Dieterich himself contracted the virus in 1977 while attending medical school. He accidentally stuck himself with a needle infected with Hepatitis C and suffered from a rare, but acute reaction. Frustrated with his diagnosis and lack of options to treat it, Dr. Dieterich dedicated his career to studying Hepatitis C and finding effective treatment options for those diagnosed. He was cured in 1998 after an 18-month regimen of daily interferon injections and Ribavirin -- an anti-viral drug that was unavailable at the time of his diagnosis. While he was lucky, he knew there was much more work to be done.
Thanks in part to Dr. Dieterich's commitment to better understanding and treating this virus, we have come much closer to a cure for this disease. Today patients have access to new, FDA-approved protease inhibitors that bring the cure rate to 80 percent.
"If we can treat you, we can cure you almost all of the time. So go get tested before it's too late," Dr. Dieterich says.
To learn more and watch patient stories, visit www.leadershiptocure.com.
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The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine is one of the leading medical schools in the United States. The Medical School is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by U.S. News & World Report.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nation's oldest, largest and most-respected voluntary hospitals. In 2011, U.S. News & World Report ranked The Mount Sinai Hospital 16th on its elite Honor Roll of the nation's top hospitals based on reputation, safety, and other patient-care factors. Of the top 20 hospitals in the United States, Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and US News & World Report and whose hospital is on the US News & World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place.
Healthy You
Not So Mmm Mmm Good? Canned Soup and BPA
Patients may ask about a study suggesting that eating canned soup leads to spikes in urinary excretion of bisphenol A (BPA), a chemical found in the linings of many canned goods. The small randomized crossover trial was reported in a research letter in JAMA.
Some 75 adults ate 12 ounces of either fresh or canned soup for 5 days, and then crossed over to the other soup for another 5 days. Urine samples, collected on days 4 and 5 of each phase, were positive for BPA in 77% of participants after eating fresh soup and in 100% after eating canned soup. Average urinary BPA concentration was roughly 23 μg/L higher after consuming canned versus fresh soup.
The authors note that elevated urinary BPA concentrations have previously been linked to cardiovascular disease and diabetes, and conclude that the increase observed here "may be important."
JAMA research letter (Subscription required)
Published in Physician's First Watch November 23, 2011
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