From; NATAP
Estimated Enrollment: 210
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
This study is not yet open for participant recruitment.
Verified on October 2011 by Novartis
Purpose
This study will assess the safety and efficacy of alisporivir plus pegylated interferon alfa2a and Ribavirin as well as boceprevir plus pegylated interferon alfa2a and Ribavirin in African American chronic hepatitis C genotype 1 patients that have never received treatment for their hepatitis C.
Clinic infection doctor suing Ottawa Hospital
CBC News Posted: Oct 19, 2011 11:38 AM ET
An Ottawa doctor whose lax infection prevention practices may have led to a hepatitis and HIV scare is in the midst of a lawsuit against the Ottawa Hospital.
Court documents show Dr. Christiane Farazli and her husband filed a lawsuit in 2009 suing the Ottawa Hospital for more than $3 million for negligence relating to the care of the doctor's back injury.
Farazli is accusing the hospital of not diagnosing her back injury properly after visits to the Ottawa Hospital's Civic campus.
Ottawa Public Health (OPH) revealed Monday Farazli, a gastroenterologist who ran a private clinic located at 1081 Carling Ave., Suite 606, had "not always followed" cleaning protocols surrounding endoscopies, a procedure in which a medical instrument is used to examine the interior of a hollow organ or cavity of the body.
This arose after following an inspection by The College of Physicians and Surgeons and a local investigation by OPH starting in June.
Also on Monday, registered letters were sent to about 6,800 patients who underwent the procedure at the clinic between April 2002 and June 2011. In the letter, they are told to get checked for hepatitis B, hepatitis C and HIV.
Stephanie Fortunato, one of Farazli's patients, told CBC News Tuesday Farazli had mobility issues and had to perform endoscopies while sitting down.
Documents also show Farazli has launched at least two previous lawsuits against the Ottawa Hospital.
Natalie Cole Remarks on Hepatitis C Awareness
C-SPAN Oct 19, 2011
A warning has been issued over illegal ‘tattoo parties’ after a nine-year-old child received a permanent tattoo.
In another incident in the Falkirk area an adult gave tattoos to adults under the age of 18 at a party involving alcohol and drugs.
Central Scotland Police has issued a warning over the practice of tattooing children after they had received reports of both recent incidents..continue reading..
Side effects include fatigue and flu-like symptoms. The other medications can cause irritability, mood swings and depression. Ten to 15 percent of patients have dropped out because of difficulties.
“Most people have been waiting for this long enough that they really want to get it out of their system,” Iyer said...continue reading..
Differences In Two Key Metabolic Enzymes - Why Some People Are More Susceptible To Liver Damage?
Differences in the levels of two key metabolic enzymes may explain why some people are more susceptible to liver damage, according to a study in the October 17 issue of the Journal of Cell Biology...continue reading...
From Medscape
Efficacy of Anti-viral Therapy in Hemodialysed HCV Patients
Alimentary Pharmacology & Therapeutics, October 2011
When a less-than optimal donor liver is all that's available, the rewards may outweigh the risks.
Journal of Medical Case Reports, October 2011
Hepatitis C Virus Core Protein Induces Fibrogenic Actions
Chronic HCV infection is a major cause of liver fibrosis, yet little is known about HCV-specific steps in its pathogenesis. What is the role of HCV in establishing a profibrogenic state?
Abbott To Split: Two Pharmas Are Better Than One?
Abbott is creating what it calls a research-based pharma that will feature a portfolio of existing meds, such as Humira and Synthroid, along with a pipeline of some 20 compounds in Phase II or Phase III development to treat immunology, chronic kidney disease, Hepatitis C, oncology and neuroscience. Based on 2011 estimates, the operation would have nearly $18 billion in sales.
continue reading..
FDA
FDA: U.S. Marshals seize food products at Illinois warehouse
These conditions included live rodent and birds, rodent carcasses, gnawed product packaging, significant amounts of rodent fecal matter, rodent urine stains, and rodent nesting material. The seized goods, which had been under an Illinois Department of... Full Article at U.S. Food and Drug Administration
WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said GlaxoSmithKline PLC (GSK.LN, GSK) violated the agency's good-manufacturing practice rules at a U.K. plant.
The FDA issued a warning letter to GlaxoSmithKline on Oct. 7. The letter, which was posted on the agency's website Tuesday, stemmed from a March 2011 inspection of a drug-manufacturing plant in Worthing West Sussex, United Kingdom.
The FDA said the company didn't establish appropriate procedures to prevent microbiological contamination of drug products. A disinfectant used to clean manufacturing areas wasn't able to remove all types of bacteria, FDA said. It wasn't clear if this resulted in any finished drugs becoming contaminated.
In a statement, GlaxoSmithKline said the only product made by the plant that is supplied to the U.S. is Timentin, which an injectible antibiotic. The company said all batches of Timentin have met "all release standards and we are confident that the batches are safe and efficacious." Glaxo has been working with the FDA to resolve issues raised by the warning letter and the firm said it would submit a "comprehensive response" to the letter by the end of this month.
The warning letter also cited the company for failing to follow certain laboratory-control procedures. The FDA said it may withhold approval of new applications for new products or additional approvals of existing products until all the violations outlined in the letter are corrected. The letter doesn't impact products already on the U.S. market.
FDA Warns Jazz Pharmaceuticals For Violating Drug Side-Effect Reporting Rules
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The Food and Drug Administration warned Jazz Pharmaceuticals Inc. (JAZZ) for failure to properly submit reports on serious adverse drug events.
Drug companies are required to report to FDA any reports of side-effects that might be associated with drugs sold by the company. In cases where companies receive reports of adverse events that are considered serious or unexpected, the information must be reported to FDA within 15 calendar days, and companies are required to conduct an investigation into the reports. An adverse-event report itself doesn't mean a drug caused a problem.
In a warning letter dated Oct. 11, the FDA said Jazz failed to submit 74 serious, unexpected adverse drug reports associated with the company's narcolepsy drug Xyrem during a seven-year period. Among the reports, at least 10 of them involved a patient death. Narcolepsy is a sleep disorder.
Jazz Pharmaceuticals share prices were down 7% to $39.97 in recent trading.
The warning letter stemmed from an inspection of the company's Palo Alto, Calif., headquarters that was conducted in April and May of this year.
A Jazz Pharmaceuticals spokesperson wasn't immediately available to comment on the letter. However, the letter stated that a company representative told FDA that the firm hadn't been aware of the serious, adverse event drug reports because they had been made to a specialty pharmacy that distributes Xyrem. The FDA said Jazz received a separate warning letter in 2007 for similar postmarketing adverse-drug event reporting violations.
U.S. FDA chemist pleads guilty of insider trading
18 Oct 2011 20:39
* Chemist resigned position from FDA
* SEC civil charges still pending (Adds resignation)
WASHINGTON, Oct 18 (Reuters) - A U.S. Food and Drug Administration chemist pleaded guilty on Tuesday to charges that he used confidential information about upcoming drug approvals to secretly make millions of dollars.
Cheng Yi Liang, 57, was accused of buying and selling stock in more than 25 companies with confidential FDA information to rack up just over $3.77 million in profits and avoid losses between July 2006 and March 2011.
He pleaded guilty to two counts of securities fraud and making false statements in federal court in Maryland. His son was also initially charged in the case but prosecutors later dismissed those charges.
In the scheme, Liang reviewed documents about the progress of experimental drugs using an FDA database that includes confidential and non-public documents about trials, studies and correspondence, according to court papers filed last month.
Liang made the trades based on the inside information using his home computer or on an Apple iPad, according to a court filing on Tuesday.
"In a shocking abuse of trust, Mr. Liang exploited his position as a chemist in the FDA's Office of New Drug Quality Assessment to cash in, using the accounts of relatives and acquaintances to hide his illegal trading," said Lanny Breuer, head of the Justice Department's criminal division.
Information about prescription drug approvals or denials can prompt big stock swings and has been the subject of insider trading investigations previously; however, it is rare for such a case to involve a government employee.
An FDA spokeswoman said that Liang resigned his position and that the agency has begun taking steps to prevent such activity in the future.
"Mr. Liang's conduct represents both a serious breach of the public trust and an inexcusable departure from the high ethical standards that thousands of dedicated FDA employees maintain," said the spokeswoman Erica Jefferson.
Sentencing for Liang is set for Jan. 9, 2012. He faces up to 20 years in prison for the securities fraud count and up to five years for the false statements count.
Liang also agreed to forfeit the $3.77 million he made, including a home and condominium in Maryland as well as funds in 10 bank and investment accounts, the Justice Department said.
Securities and Exchange Commission civil charges are still pending against him.
The case is: USA v Cheng Yi Liang, No. 11-cr-530, in U.S. District Court for the District of Maryland. (Reporting by Jeremy Pelofsky in Washington; editing by Gerald E. McCormick, Bernard Orr)
Dirty equipment blamed for deadly outbreak in cantaloupe
By JoNel Aleccia
Potentially contaminated processing equipment and problems with packing and storage of whole cantaloupes at a Colorado farm likely led to the deadliest listeria outbreak in the United States in 25 years, which has so far claimed 25 lives in a dozen states, federal health regulators said Wednesday.
Pools of water on the floor of the Jensen Farms packing facility in Granada, Colo., equipment that was not easily cleaned and sanitized and failure to cool newly harvested cantaloupes before sending them to cold storage all contributed to the outbreak, the first-ever listeria contamination blamed on whole melons, federal Food and Drug Administration officials said Wednesday.
"We are quite confident and certain," that those factors led to the outbreak blamed so far for 123 illnesses in 26 states, said Sherri McGarry, senior advisor to the FDA's CORE Network in the Office of Foods, who spoke at a Wednesday press conference.
The news that the problem may have been prevented through basic sanitation practices stunned Jeni Exley, whose 84-year-old father, Herb Stevens of Littleton, Colo., has been hospitalized for nearly two months after a listeria infection caused by contaminated Jensen Farms cantaloupe. He might be able to return home finally this week, said Exley, 55, whose family is suing the farm with the help of Seattle food safety lawyer Bill Marler.
"Shame on them," said Exley. "What kind of statement can I give you without being too angry? It shouldn't have happened. They had control over it."
Investigators tested fruit samples and equipment from Jensen Farms and confirmed the presence of four outbreak strains of the listeria monocytogenes bacteria confirmed in the illnesses and deaths.
The FDA said Jensen Farms, which is based in Holly, Colo., had recently bought used equipment that was corroded and hard to clean.
For example, the equipment used to wash and dry cantaloupe showed signs of dirt and product build-up, even after it had been disassembled, cleaned and sanitzed, the FDA's report said. The equipment had been previously used to process raw potatoes, officials said, which could have left listeria bacteria behind.
In addition, a truck used to haul culled cantaloupe to a cattle operation was parked near the facility and could have introduced contamination to the facility, investigators said. Low levels of listeria in the field also could have introduced the bacteria into the packing facility. And the design of the plant allowed stagnant water to pool on the floor. The FDA had not inspected the farm before the Sept. 10 session that first detected listeria problems.
The FDA issued the company a warning letter detailing violations, but the investigation is still open.
Jensen Farms voluntarily has agreed to correct all problems found in the inspection, FDA Commissioner Dr. Margaret Hamburg told reporters. In addition, the firm has agreed not to process, pack or distribute produce until the agency approves.
The tragic deaths and illnesses have underscored the need for prevention at all levels of the food supply system, Hamburg said.
“If we’re to have a food safety system that truly prevents foodborne illness, we must all practice prevention,” she said.
The conditions at Jensen Farms were not indicative of the produce industry in general, FDA officials noted.
The outbreak has claimed lives in a dozen states, the Centers for Disease Control and Prevention said. They include six in Colorado, five in New Mexico, two each in Kansas, Louisiana, New York and Texas and one each in Indiana, Maryland, Missouri, Nebraska, Oklahoma and Wyoming. People who've died have ranged in age from 48 to 96 years, with a media age of 87.
Illnesses have occurred in 26 states in people aged younger than 1 to 96, with most cases occurring in people older than 60. Four illnesses were related to pregnancy, including a newborn who fell ill. One miscarriage has been reported.
The peak in illnesses appears to have occurred in mid-August and the number of illnesses reported now appears to be decreasing, said Dr. Barbara Mahon, deputy chief of the Enteric Disease Branch of the Centers for Disease Control and Prevention. But, the long incubation period of listeria means people could become ill up to two months after eating tainted fruit.
“It’s too soon to declare the outbreak over," Mahon said.
FDB cautions public on Adulterated Herbal Medicines on the Market
Ghana News Agency
Accra, Oct.19, GNA - The Food and Drugs Board has cautioned the public to be wary of the herbal medicines they consume because its post market surveillance activities has revealed the influx of herbal medicines, which has been mixed with orthodox medicines.
A statement issued by the board in Accra on Tuesday gave an instance where a herbal medicine supposedly for the treatment of HIV AIDS was found to contain gentamicin, streptomycin, sulfathiazole (all antibiotics) in fruit juice.
It said a herbal product by name Onyame Nti which was also found to contain Dexamethasone (Dexacortin), B Complex and Diazepam (Valium) was being sold for the treatment of Typhoid, Jaundice, Sleepless Nights, Stomach Trouble, Diabetes, hypertension, Menstrual Disorders also indications for children.
A recent seizure of herbal products from Kasoa contained B’ complex, Dexacortin, Valium and Chloramphenicol – for the treatment of typhoid fever, Malaria, Waist Pains and for sleep.
The FDB said these adulterated herbal medicines were being offered to the unsuspecting public, some of whom might be allergic to these ingredients and could also develop new health problems or have their existing conditions worsened.
“Unfortunately these unwholesome herbal medicines are being sold for life-threatening disease conditions like HIV/AIDS, Cancer, Hepatitis, Syphilis, Hypertension, and Diabetes among others.
“It may surprise the public to know that a series of reports made to the FDB indicates that a man developed Liver Cirrhosis and died after taking an herbal medicine supposedly for the treatment of Impotence”.
In as much as the FDB recognizes the medicinal value in plants, it wishes to however advise the general public to always seek proper medical advice before taking any medicine (whether herbal or orthodox) the statement said.
It has therefore requested information from the general public on persons suspected to be in any practice with the potential of endangering public health and safety with respect to FDB’s mandate to call 0244337235, 0244337252, 0208204968 or 0246809509.
Grand Rounds
Hosted This Week By: Sumer's Radiology Site
A few submissions from this weeks grand rounds, to read more click here
Laika's MedLibLog has post about Evidence Based Point of Care Summaries. It goes on like- For many of today’s busy practicing clinicians, keeping up with the enormous and ever growing amount of medical information, poses substantial challenges. Its impractical to do a PubMed search to answer each clinical question and then synthesize and appraise the evidence.
Dr Pullen in his post Keeping Perspective: A Key Role for the Family Physician, believes that one of the most important things he offers to his patients is help in keeping perspective when making medical decisions.
From the Society for Participatory Medicine's blog: there is a post called “When I became a patient, I felt my identity slipping away.”
Relatively new blog about funny things in intern year and residency has an interesting post called statement of will.
To read additional submissions click here
Healthy You
UC Berkeley Wellness Letter
Açaí Juice
In the nutraceutical or nutritional supplements market, there is never any shortage of bandwagons. One of the loudest and largest these days is the açaí bandwagon. Harvested from a Brazilian palm, açaí (ah-SAH-ee) berries are a dietary staple in Brazil and have also been used medicinally by Amazonian tribes. Açaí juice was introduced in the U.S. in 2001, and there are now more than 50 new food and drink products containing açaí. As a juice, pulp, powder, or capsule, it is marketed as a magic path to weight loss, a wrinkle remover, a way to cleanse the body of "toxins," and indeed just a plain old miracle cure. It is often combined with other ingredients, such as glucosamine, so that the claims for benefits multiply exponentially.
Offers for açaí have flooded the nation’s email boxes. On the Internet you’ll find a bouquet of endorsements from such celebrities as Oprah, Nicholas Perricone (the TV "skin doctor"), and Rachael Ray (the TV chef), plus statements by these same celebrities denying any such endorsement, or at least any endorsement of a particular brand, except that Dr. Perricone sells a brand of his own. You will also find a war of words among makers of açaí products, each one claiming safety and effectiveness for its particular formulation, and warning of scams by others.
Since açaí came on the market there have been a few studies pointing to potential benefits. Like many other fruits, açaí berries are high in antioxidants (molecules that quell cell-damaging free radicals) and other interesting compounds. But these were lab studies, and the results may not apply to humans. There is no scientific basis for weight-loss claims or any other health claims for açaí. The term "antioxidant" has become a sales tool.
Consumer protection groups such as the Center for Science in the Public Interest (CSPI) and the Better Business Bureau (BBB) have now come out against açaí marketers. "If Bernard Madoff were in the food business," said a CSPI nutritionist, "he’d be offering ‘free’ trials of açaí-based weight-loss products." Online ads regularly promise a free trial, saying that all you have to pay is shipping and handling. The catch is that you must supply your credit card number, and you’ll automatically be signed up for $50 monthly shipments that will prove hard to cancel.
We urge you not to give your credit card number to anybody selling açaí products. Hundreds of complaints have been registered, and you may never get your money back. Beware of web-sites warning you of açaí scams—far from helping you get your money back, most turn out to be just sales pitches for more açaí.
There is no magic berry for weight loss or good health. Açaí berries are no doubt a good food, like other berries, but why pay a fortune for them or supplements containing them?
Ask the Experts
November 2011
Q: My husband loves pumpkin pie. Does it have any nutritional value?
A: Absolutely. It may be the most nutritious pie, if you use the right recipe. Pumpkin is one of the best sources of carotenoids, plant pigments that include beta carotene (an antioxidant that converts to vitamin A in the body) and lutein (important for eye health). It’s rich in fiber and potassium and has some calcium, iron, vitamin C, B vitamins and other nutrients.
Moreover, canned pumpkin, often used in pies, has even more carotenoids and nutrients, ounce for ounce, than fresh because it is more concentrated (cooking eliminates much of the water).
Of course, how healthful pumpkin pie is depends on how much sugar and shortening you use. And some recipes call for cream, cream cheese and whipped cream. Be aware, too, that there’s a big difference between canned pumpkin (80 calories per cup) and canned pumpkin pie mix (280 calories, most from added sugar).
If you make the pie yourself, use plain canned pumpkin (add your own sugar, just enough to satisfy) and nonfat evaporated milk instead of cream—and skip other high-calorie ingredients. You can even bake the filling in a custard dish with no crust. For another nutritious pumpkin dessert, mix canned pumpkin with applesauce or plain low-fat or nonfat yogurt, along with some sugar or honey and spices.
New On The Blog
Arrest All Accessories — Inhibition of Hepatitis C Virus by Compounds that Target Host Factors
Most novel drugs directed against the hepatitis C virus (HCV) including the recently approved NS3/4A protease inhibitors boceprevir and telaprevir are inhibitors of viral enzymes. Since HCV is an RNA virus with a short and highly variable genome, these direct-acting antivirals (DAAs) are prone to rapidly inducing the emergence of resistant HCV variants. This problem could be mitigated by the development of drugs that target host factors that the virus depends on during the various stages of its replication cycle. An increasing understanding of the molecular interactions between the virus and its host cell has allowed the identification of promising host targets for anti-HCV therapy and several host-targeting agents (HTAs) are currently under development.
Chronic Hepatitis C in Children
The natural history of hepatitis C virus (HCV) infection in adults has been established, but less is known about outcome in children. We conducted a retrospective review of patients referred to Birmingham Children's Hospital Liver Unit, from 1991 till 2008, with the diagnosis of HCV was undertaken. Only children with documented positive HCV RNA and a minimum duration of follow-up of 6 months were included.
