Friday, February 25, 2011

Hepatitis C News; Antiviral Therapy for HCV "Attitudes Regarding Future Use" Also "BMS-790052, BMS-650032"

Coverage From NATAP
Reported by Jules Levin
The 21st Conference of the Asian Pacific Association for the Study of the LiverAPASL
Feb 17-20, 2011
Bangkok, Thailand

"In summary, the responses to this Internet-based survey of more than 1,000 current HCV treaters indicated that although the majority of respondents appear ready to utilize DAA agents in the future, referrals to "hepatitis C experts" will increase when these agents become available. In addition, future referrals to ID specialists appear to be limited. Finally, as more than half of respondents to the survey with "minimal knowledge" of DAA therapies also appear to be willing to utilize these compounds in the future, significant provider education will be required to minimize inappropriate use of these agents."

Just In;

Scripps Pioneers Individualized Medicine by Offering Genetic Testing to Hepatitis C Patients
Individualized Therapies Now Available for Drug Treatment of Hepatitis C
SAN DIEGO, Feb. 25, 2011 (GLOBE NEWSWIRE) -- Scripps Health is one of the first health systems in the United States to offer genetic testing as part of its care for hepatitis C patients planning to undergo drug treatment.
The tests offer hope to the more than 4 million patients diagnosed annually in the U.S. with hepatitis C and could spare them from taking interferon, which is commonly prescribed. Interferon causes flu-like symptoms as a side effect and costs more than $50,000 annually. Instead, the genetic test determines whether patients have a common gene variant that predicts a favorable cure rate if they are treated with the drug combination therapy of pegylated interferon and ribavirin.
A manuscript describing this approach to treatment, authored by Paul J. Pockros, MD, clinical director of research at the Scripps Translational Science Institute, head of the Division of Gastroenterology and Hepatology and director of the Liver Disease Center at Scripps Clinic, will be published in the journal Drugs in March.
"This is a huge step forward in the movement toward individualized medicine," said Dr. Pockros, "As a physician, knowing what drug therapies will have benefit and which ones won't based on a patient's IL28B genotype is significant because we are able to be more targeted in our approach to treatment."
This is the first of numerous genetic tests that will accurately give doctors vastly improved data, leading to better prescription of drug treatments. Later this year, a second test will be available that will accurately predict anemia in hepatitis C patients taking the pegylated interferon and ribavirin drug combination. Anemia is one of the most common side effects of the regimen. This will allow doctors to modify the therapy before starting the regimen to prevent patients from developing this problematic side effect.
Genetic testing for hepatitis C patients carries significant implications for patient care, as there are more than 4 million infected people in the United States, most of them undiagnosed and untreated.
Scripps Clinic now routinely orders IL28B genotyping on all patients with Hepatitis C who are potential candidates for anti-viral therapy. If the patients have a favorable IL28B genotype and advanced fibrosis on liver biopsy, doctors can initiate therapy with the current standard of care. If patients have a less favorable genotype or they have mild fibrosis, doctors can recommend waiting for FDA approval of direct acting antiviral drugs to improve their chances of response.
Currently, LabCorps Diagnostics is performing the IL28B testing for Scripps patients, a procedure covered by most insurance plans. The results are transmitted to the treating physician in about one week and the treatment choice is tailored based on the patient's likelihood to have a favorable response.
The hepatitis C genetic testing is the latest example of Scripps' leadership in individualized medicine. Scripps doctors were the first to use genetic testing for cardiovascular patients planning to undergo elective stent procedures to determine if they have one or more of the common gene variants linked to an inability to metabolize the anti-clotting drug Plavix (clopidrogel). Plavix is the second-most commonly prescribed drug in the United States and is given to most patients after they receive coronary stents.
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 22 outpatient centers and clinics. Scripps has been recognized by Thomson Reuters as one of the Top 10 health systems in the nation for quality care. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at
This information was brought to you by Cision
Prediction of response to Hep C therapy using genetic polymorphisms
The decision model was generated by data mining analysis.
The model predicted sustained virological response with 78% specificity Journal of Hepatology

March's issue of the Journal of Hepatology investigates the pre-treatment prediction of response to pegylated-interferon plus ribavirin for chronic hepatitis C using genetic polymorphism in IL28B and viral factors.

Pegylated interferon and ribavirin therapy for chronic hepatitis C virus genotype 1 infection is effective in 50% of patients.

Recent studies revealed an association between the IL28B genotype and treatment response.
Dr Masayuki Kurosaki and colleagues from Japan developed a model for the pre-treatment prediction of response using host and viral factors.

Data were collected from 496 patients with hepatitis C genotype 1 treated with Pegylated interferon/ribavirin at 5 hospitals and universities in Japan.

IL28B genotype and mutations in the core and intereron sensitivity determining region (ISDR) of hepatitis C were analyzed to predict response to therapy.

The IL28B polymorphism correlated with early virological response and predicted null virological response and sustained virological response independent of other covariates.
The research team found that mutations in the ISDR predicted relapse and sustained virological response independent of IL28B.

The decision model revealed that patients with the minor IL28B allele and low platelet counts had the highest null virological response and lowest sustained virological response.
The researchers found that those with the major IL28B allele and mutations in the ISDR or high platelet counts had the lowest null virological response and highest sustained virologicial response.

The team found that the model had high reproducibility and predicted sustained virological response with 78% specificity and 70% sensitivity.
Dr Kurosaki's team concludes, "The IL28B polymorphism and mutations in the ISDR of hepatitis C were significant pre-treatment predictors of response to pegylated-interferon/ribavirin."
"The decision model, including these host and viral factors may support selection of optimum treatment strategy for individual patients."

In The News

Twelve Pregnant Women Die In Indian Hospital, Contaminated IV Fluids Suspected
Updated: Friday, 25 Feb 2011, 8:29 AM EST Published :

Twelve pregnant women died in 10 days in an Indian government hospital, with contaminated fluids administered during childbirth suspected to be the cause, reports said Friday.
Another five women were in serious condition, according to doctors at Umaid Hospital in the city of Jodhpur, in a case that highlights the often-poor standards of care in state-run health facilities in India.

The first death occurred Feb. 13, and a meeting of leading doctors that was held three days later failed to identify the cause, The Indian Express newspaper reported, citing doctors and officials at the hospital.

"All the women died after severe hemorrhaging, and for now, we believe the cause might be an infection after they were administered tainted IV fluids," Umaid Hospital superintendent N.G. Chaggani told the newspaper.

Police lodged a case against the local company that supplied the fluids and the Indian manufacturer.

"We have begun our investigation and are checking the suspected stock," Jodhpur police commissioner Bhupendra Kumar Dak told the Times of India newspaper.
India has a two-speed medical system in which shabby and often insanitary state facilities coexist with state-of-the-art private hospitals that cater for wealthy overseas medical tourists who visit India for low-cost surgery.
In July, Indian news channel NDTV reported that at least eight children were infected with HIV by blood transfusions given at Umaid Hospital in the previous six months, while 43 contracted Hepatitis C.

In addition to poor standards of care, most Indians are required to pay for their health care out of their own pockets, with the state and insurance companies picking up just a fraction of overall spending.

A major study published in January in British medical journal The Lancet said payments by individuals accounted for 71.1 percent of spending on health, with 39 million Indians pushed back below the poverty line each year because of the cost of care.
Copyright 2011 AFP. All rights reserved.

Monitoring circulating tumor cells using gold nanoparticles
Once these tumor cells are tagged with the gold nanoparticles, laser illumination reveals which cells are tumors in the bloodstream. This technique was tested on 19 patients with head and neck cancer, and showed excellent correlation with previous techniques. If this method can be validated in larger studies, it shows promise as a faster, more economical method to detect circulating tumor cells.
“The key technological advance here is our finding that polymer-coated gold nanoparticles that are conjugated with low molecular weight peptides such as EGF are much less sticky than particles conjugated to whole antibodies,” says Shuming Nie, PhD, a professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University. “This effect has led to a major improvement in discriminating tumor cells from non-tumor cells in the blood.”.. read more...

Hershey, PA Posted on February 24th, 2011

Nanotechnology may open a new door on the treatment of liver cancer, according to a team of Penn State College of Medicine researchers. ...

Researchers evaluated the use of molecular-sized bubbles filled with C6-ceramide, called cerasomes, as an anti-cancer agent. Ceramide is a lipid molecule naturally present in the cell's plasma membrane and controls cell functions, including cell aging, or senescence.Hepatocellular carcinoma is the fifth most common cancer in the world and is highly aggressive. The chance of surviving five years is less than five percent, and treatment is typically chemotherapy and surgical management including transplantation."The beauty of ceramide is that it is non-toxic to normal cells, putting them to sleep, while selectively killing cancer cells," said Mark Kester, Ph.D., G. Thomas Passananti Professor of Pharmacology.Cerasomes, developed at Penn State College of Medicine, can target cancer cells very specifically and accurately, rather than affecting a larger area that includes healthy cells. The problem with ceramide is that as a lipid, it cannot be delivered effectively as a drug. To solve this limitation, the researchers use nanotechnology, creating the tiny cerasome, to turn the insoluble lipid into a soluble treatment.
Healthy You
This year will see an unprecedented surge in the number of Americans becoming eligible for Medicare, as the leading edge of the Baby Boom generation begins to turn 65. This will spark a fundamental shift in the US...

High HDL Levels Tied to Longevity in Men
Friday, February 25, 2011 7:17 AM
Men who reach their 85th birthdays tended to have high levels of good cholesterol while in their 60s, a new study says.

Researchers found that men with the highest good (HDL) cholesterol were 28 percent less likely to die before they reached 85, compared to men in the lowest HDL group.
This paper, published in the American Journal of Cardiology, adds to the evidence that HDL is important for a long life, said Dr. Nir Barzilai, who heads the Institute for Aging Research at Albert Einstein College of Medicine in New York and was not part of the study.
However, "we always have to remember that it's an association," and it does not mean that having high HDL increases life span, he told Reuters Health.

About 12 million men suffered from heart disease and stroke in 2006, but high levels of HDL cholesterol may reduce the risks, according to the American Heart Association.
Low levels of HDL, less than 40 milligrams per deciliter (mg/dL) of blood for men, are known to increase the risk of heart disease, according to the heart association.

The researchers, from the Massachusetts Veterans Epidemiology and Research Information Center in Boston, looked at the medical records of about 650 veterans when they were around 65 years old, then grouped them based on HDL levels.

Starting with low levels of 40 mg/dL, they found that for each 10 mg/dL increase of HDL, the men were 14 percent less likely to have died by 85. Overall, 375 survived to that age.
Also, fewer of the men with higher HDL were overweight, and they tended not to have more than two drinks a day. And fewer of them had heart disease or smoked, compared to the lowest HDL group.

These other factors might have had an effect on survival, Barzilai said. However, the researchers did account for this, and still showed a link between reaching 85 and high HDL levels, he told Reuters Health.

"It's difficult to change HDL levels," Barzilai said. Exercise might raise it a few points, but it isn't a very efficient way to improve, he said. "We need to get a drug eventually."
Merck and Roche are both working on an HDL-raising drug, he told Reuters Health. Pfizer stopped its research into another such drug, torcetrapib, in 2006 because people taking it along with Lipitor in a study had a higher rate of death.

The B-vitamin niacin may raise HDL levels 15 to 35 percent. However, side effects can include liver damage and increased blood sugar, according to the Mayo Clinic.
A three-month supply costs about $9. Niacin is also found in dairy products, lean meats, nuts, eggs, and fish.
However, it's unclear how much raising HDL will prevent heart disease, Barzilai said, so whether drugs might improve people's health remains to be seen.
The study authors could not be reached by deadline.
© 2011 Reuters. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters.

A 48-year-old man was sentenced yesterday to six months' imprisonment suspended for two years and 200 hours of unpaid work for selling and supplying herbal medicines to the public without a marketing authorisation...

Dan Frosch(The New York Times, February 21, 2011)"
Just 15 states and the District of Columbia license naturopaths, according to the American Association of Naturopathic Physicians. That process requires completion of a four-year accredited, specialized school, passing an exam and a certain amount of clinical training. This year, at least 11 states are trying to pass licensing legislation…Naturopaths who favor licensing say they are not interested in becoming medical doctors...Moreover, they contend that it is dangerously easy to get a certificate that shows expertise in naturopathy and people need some way of discerning between a knowledgeable naturopath and a quack."
As thousands of breast cancer survivors battle persistent fatigue, a Michigan State University nursing researcher is studying whether acupressure - a technique where physical pressure is applied to acupuncture points by the...

Off The Cuff
Shan Juan and Cang Wei (China Daily, February 21, 2011)"

About 70 percent of Chinese families improperly use medicine, according to a survey conducted by China Nonprescription Medicines Association. The survey, which polled 10,000 people…concluded that a majority of the populace tends to go to drugstores to buy medications for minor sicknesses instead of seeing a doctor…The reasons for concern are particularly pressing on the mainland, where, because of loose supervision, the public can often buy prescription drugs at drugstores without doctors' prescriptions."

Bruce Japsen(Chicago Tribune, February 19, 2011)
Hospitals across the country are running out of key drugs used in surgeries and to treat some diseases…causing doctors to turn to older treatments...Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies…Drugmakers say they are obliging tougher safety rules put in place by the U.S. Food and Drug Administration, which has intensified scrutiny to avoid allowing unsafe medicines on the market."

Scott Hiaasen and David Ovalle (The Miami Herald, February 23, 2011)
Narcotics agents across South Florida descended on more than a dozen pain the most dramatic effort yet to curb the region’s booming business of illegal prescription narcotics…These clinics have exploded all over South Florida in recent years…making the region the prime supplier of illegal pills in the eastern United States. The clinics attract drug couriers posing as patients who travel from Kentucky, Ohio and West Virginia, where an oxycodone pill can sell for 10 times the price charged by a South Florida doctor.

An undiagnosed genetic disease appears to have been the critical factor in the 2009 death of a University of Chicago researcher from plague, investigators have concluded.
The 60-year-old man, Malcolm Casadaban, PhD, had been working with an attenuated strain of Yersinia pestis, the plague bacterium, as part of his research. The strain was subsequently cultured from his blood after death.

Although a forensic team from state and local health departments and the CDC were unable to determine how exactly Casadaban came into contact with the organism, autopsy results also indicated he had hereditary hemochromatosis, according to a report in the Feb. 25 issue of the CDC's Morbidity and Mortality Weekly Report.

Big Pharma

Drug R&D Costs Are Less Than Estimated -- So Why the High Prices?
André Picard(The Globe and Mail, Toronto, February 23, 2011)
"It costs, on average, $1.3-billion (U.S.) in research and development to bring a new drug to market. That level of investment in R&D by Big Pharma justifies the high cost of prescription drugs. Those statements are repeated so often that they have come to be accepted as fact. But are they fact or fiction? An article in the current edition of the journal BioSocieties...argues that the real cost of R&D is...a fraction of the commonly cited estimate…If R&D costs are only a fraction of what is asserted, then what is the justification for high prescription drug prices?"

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