Hepatitis C Weekend News;Risk from reused single-used syringes
EDMONTON —More than 170 patients from the Hinton area are being contacted and tested for HIV and hepatitis after a health-care worker reused syringes that may have contaminated medication
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It's the same story repeated from 2008, when 2,700 dental and endoscopy patients from High Prairie had to be tested for blood-borne pathogens because of syringe reuse. Alberta had clear standards against the practice even before the Health Quality Council of Alberta launched an investigation and recommended many changes in hospital culture and staff training.
"They assured us they were going to fix this problem," NDP Leader Brian Mason said. "I don't believe we can trust this Progressive Conservative government with our health-care system
Hinton patients tested for blood infection
Risk from reused single-used syringes
Addison Whitney Develops Name for Newly Approved Hepatitis C Treatment
Addison Global branding firm names newly approved INCIVEK.Whitney is pleased to announce the FDA approval of INCIVEK™ (telaprevir) from Vertex Pharmaceuticals Incorporated. INCIVEK is a prescription medication used with peginterferon alfa and ribavirin. The new drug will treat chronic hepatitis C genotype 1 infection in adults with stable liver problems who have not been treated before or who have failed previous treatment.
After developing the name INCIVEK, Addison Whitney streamlined the approval process by conducting safety validation research and providing Vertex with supporting documentation for the FDA review. “This was a true collaboration with our clients at Vertex that required a time sensitive approach to all aspects of the naming process,” said Daniel Plaisance, Vice President.
INCIVEK is expected to become a leading treatment for hepatitis C. FDA panelists said it appeared to raise the cure rate for hepatitis C to about 80 percent, compared with 40 percent with current therapies. The FDA has approved INCIVEK tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver).
“This is a very exciting time for Addison Whitney Health,” said Senior Vice President Vince Budd. “Not only is it great to see another one of our brands approved for a potential blockbuster product, but it showcases our high success rate of getting names approved by the global health authorities. Our clients have already received a number of approvals for names our company created, screened, tested and supported this year; and I look forward to seeing many more over the coming months.”
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About Addison Whitney:
Addison Whitney is a global, full-service brand consulting firm. Founded in 1991, the firm offers branding expertise in the areas of verbal branding, visual branding, brand strategy, and research and analysis. Clients come to Addison Whitney from industries including: consumer, technology, business to business, financial, hospitality and other market segments. Addison Whitney health, a specialized healthcare division of Addison Whitney, serves the branding needs of pharmaceutical, biotechnology, life science, and medical specialties. For more information, visit http://www.addisonwhitney.com/.
PSI-7977 + BMS-790052 Trial for Hepatitis C
Pharmasset announced the start of a Phase 2a study of an all-oral antiviral regimen of HCV polymerase inhibitor PSI-7977 plus NS5A replication complex inhibitor BMS-790052
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.Related; Hepatitis C Investigational Drugs; Interferon-free combinations
Prolonged Entecavir for Slow Responders Treatment-naive hepatitis B patients who stay on entecavir (Baraclude) monotherapy despite suboptimal response at 48 weeks are likely to go on to achieve undetectable viral load.
HIV/AIDS Pandemic Hits 30-Year Mark With Hope
It has been 30 years since the first description of what would come to be known as AIDS -- three decades of sometimes stumbling progress toward halting a deadly pandemic.
Healthy You
Be on Alert for 'Super Toxic' Bug in Travelers, CDC Says
6/3/2011 Medscape Gastroenterology Headlines
The CDC is warning clinicians to be on the lookout for a rare strain of E coli in travelers. Tomatoes, cucumbers, and lettuce remain prime suspects as a source of the potentially deadly infection.
Medscape Medical News
NEW YORK (AP)
-- On the path from farm-to-fork, there are many ways that foods can pick up nasty germs like the E. coli bug sickening more than 1,600 people across Europe. But there are steps consumers can take to avoid getting infected.
Health officials haven't pinpointed the source of the food poisoning outbreak that has hit Germany the hardest, but they're focusing on lettuce, tomatoes and cucumbers.
E. coli lives in the guts of people and animals and ends up in fecal matter. Those germs can end up in the water that irrigates fields or is used to wash just-picked crops. Or it winds up on the equipment used to harvest and pack up produce, said Jeffrey T. LeJeune of Ohio State University's Ohio Agricultural Research and Development Center in Wooster.
Other sources are animal waste used as fertilizer or from wildlife in the fields. And people are also a major source of contamination, said LeJeune, a veterinarian who has studied E. coli.
"And not just the chef at the greasy spoon who doesn't wash his hands," said LeJeune. "It can happen anywhere along the chain."
Many large farms avoid using manure because of the risk, he said. Manure is typically treated and dried before it is applied to a field, but "there's nobody standing over a farmer's shoulder all the time."
Organic farmers tend to use more manure and natural fertilizers than non-organic producers. Hilde Kruse, a food safety expert at the World Health Organization, said organic food producers were under the same obligations as any other farmers to ensure their practices meet proper hygiene standards.
"It's very difficult to guarantee that compost is sterile and if you can't do that, you are essentially spreading contaminated feces on food intended for human consumption" said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
The European outbreak, which involves a super-toxic E. coli bug, was initially linked to organic cucumbers from Spain, but tests didn't back that up. Based on what patients said they ate before getting sick, health investigators are still focused on cucumbers, tomatoes and lettuce. Greens like lettuce and spinach make it easy for bacteria to hide within leafy folds.
LeJeune says washing fruits and vegetables helps remove E. coli but "you're not going to get rid of it all." He suggests removing "hot spots" - damaged or dead parts like the brown edges on lettuce.
Other advice: Wash your hands before preparing or eating food - especially after using the bathroom or changing a diaper; keep raw meat separate from other foods; and thoroughly cook food.
He also recommends just making better food choices - skipping things like an undercooked hamburger or unpasteurized apple juice to avoid getting sick.
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AP Medical Writer Maria Cheng in London contributed to this report.
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Online:
http://www.foodsafety.gov/ Side Effects? These Drugs Have a Few
By GINA KOLATA
Published: June 4, 2011
Dr. Jon Duke of Indiana University was trying to figure out why his patient’s blood platelets were abnormal. Could it be a side effect of one of the dozen drugs the man was taking, a number that is not uncommon among elderly people?He began reading the label of each and every drug. “I was just overwhelmed,” Dr. Duke said. The lists of possible adverse reactions went on and on.
Now he knows why. In a new paper in the Archives of Internal Medicine, Dr. Duke and two colleagues report that the average drug label lists 70 possible side effects and some drugs list more than 500. “This was beyond even what I’d expected,” he said.
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Drug Product Recall Due to Possible Penicillin Contamination
6/3/2011 Medscape Gastroenterology Headlines
Concerns over potential cross-contamination of nonpenicillin drug products with penicillin have resulted in a nationwide recall of multiple repackaged products.
Medscape Medical News
Throat Cancer Linked to Virus
Laura Landro
(The Wall Street Journal, New York, May 31, 2011)
"A sharp rise in a type of throat cancer among men is increasingly being linked to HPV, the sexually transmitted human papillomavirus...A new study from the National Cancer Institute warns that if recent trends continue, the number of HPV-positive oral cancers among men...could surpass that of cervical cancers among women…Recent studies show about 25% of mouth and 35% of throat cancers are caused by HPV, according to the Centers for Disease Control and Prevention. Men account for the majority of cases…Studies have shown that the cancer can show up 10 years after exposure to HPV, which has become the most common sexually transmitted virus in the U.S."
Report Deals Blow to Fatigue Sufferers
Deborah Kotz
(The Boston Globe, June 1, 2011)
"Two years ago, patients with chronic fatigue syndrome felt vindicated by a study in a leading scientific journal that linked their ailment to a virus…evidence their symptoms were not imagined. But yesterday, the same journal published findings that cast serious doubt on those conclusions…The 2009 study in the journal Science…was shot down yesterday by Bruce Alberts, editor in chief of the journal…In addition, new research…found no evidence of the retrovirus in chronic fatigue patients who were previously identified as being infected…The number of chronic fatigue patients is not known, but some medical groups estimate there are about half a million in the United States."
FDA seizes elderberry juice concentrate at Kansas company
Wyldewood Cellars was continuing to make unproven claims to treat diseases
At the request of the U.S. Food and Drug Administration, U.S Marshals seized elderberry juice products that have been distributed by Wyldewood Cellars Inc., based in Peck, Kan., because the products are unapproved and misbranded drugs.
According to the FDA’s complaint, Wyldewood Cellars makes claims in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) that its elderberry juice concentrate cures, treats, or prevents various disease conditions, including AIDS, diabetes and flu. The complaint was filed on May 27, 2011, in the U.S. District Court of Kansas.
“Products with unapproved disease claims are dangerous because they may cause consumers to delay or avoid legitimate treatments,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA is committed to protecting consumers from unapproved products on the market. We will continue to take actions against companies that do not meet federal standards for safety, effectiveness and quality.”
The FDA previously issued a warning letter to Wyldewood Cellars for violating the FFDCA by promoting and distributing its products as drugs. The company responded to the warning letter promising to remove all such claims from its websites. The FDA discovered during subsequent inspections that the company continues to make such claims.
The FFDCA governs the safety and accurate labeling of a trillion dollars worth of products annually, including prescription and over-the-counter drugs, cosmetics, medical devices, blood and tissue products, and the nation's entire food supply except for meat and poultry.
For more information:
Pharmaceuticals
The Hidden Price of Drugs
By ANDREW POLLACK
Pharmaceutical companies are happy to tout the benefits of their newest drugs. But sometimes they seem far less willing to let the public know the price of the product.
The latest example occurred on Tuesday morning when Optimer Pharmaceuticals announced that its new drug to treat diarrhea caused by the bacterium Clostridium difficile would cost $2,800, about twice as much as the existing approved drug.
On Friday, Optimer announced in a press release that the Food and Drug Administration had approved its drug, called Dificid. But the company kept the price out of the press release, saying it would not reveal it until its conference call with securities analysts Tuesday morning.
Whatever the reason for the tactic, it had the result of keeping discussions about what many would consider eye-popping prices out of initial articles about the drug’s approval.
Vertex Pharmaceuticals did this as well after the recent approval of its hepatitis C drug, Incivek. The press release contained a lot of information about how generous the company was going to be in helping customers with their insurance co-payments. But it did not include how much the drug would actually cost — $49,000.
In that case, however, the call with analysts in which the price was unveiled came only about two hours after the approval was announced.
It could be pointed out that analyst calls are also a more supportive environment for a company. Analysts often applaud “premium’’ pricing because it means higher sales for a drug, whereas patients and insurers would have the opposite view.
Merck did put the $1,100-a-week price of its new hepatitis C drug, Victrelis, in its press release. But the price was mentioned in a single short sentence at the very bottom of a press release that was more than 250 lines long.
Dr. Jeffrey H. Albrecht, a gastroenterologist at Hennepin County Medical Center and a professor of medicine at the University of Minnesota, said he was frustrated trying to find documented information, outside of news reports, on the price of the new hepatitis C drugs.
“When you take a step back,’’ he said in an e-mail, “it is really remarkable that patients and physicians often don’t know how much treatments or tests cost.’’
Actually, Merck, Vertex and Optimer did more to make their prices public than some companies, which never reveal their prices. And some companies say they do not want to reveal the price until they actually begin marketing the drug, which in some cases can be weeks or even months after the regulatory approval.
A spokeswoman for Vertex said that price was complicated since patients did not usually pay the listed wholesale price. An analyst call, therefore, was a better way to reveal the information.
“We wanted to get the information out quickly but also avoid confusion about an important and complicated topic,’’ she said.
A spokesman for Optimer said it was not customary to put prices in press releases, and that telling the price to analysts allowed the company put the information in context.
On the call Tuesday morning, Optimer’s chief executive, Pedro Lichtinger argued that the $2,800 price for a 10-day course of treatment with Dificid was in line with prices for some other new antibiotics.
He said Dificid would be cost-effective because it might cut down on hospital stays and other costs associated with treating C. difficile. In clinical trials, Dificid was superior to the only other approved drug, Vancocin, in providing a “sustained clinical response,’’ he said.
Vancocin, an oral form of the antibiotic vancomycin sold by ViroPharma, costs $1,000 to $1,500 for a 10- to 14-day course of treatment at the lowest dose, Mr. Lichtinger said. But some patients get higher doses or longer treatments, multiplying the cost.
ViroPharma has been steadily raising the price of Vancocin and has taken legal action to try to delay approval of generic versions of the drug. Still, many hospitals get around the price of Vancocin by using the intravenous form of vancomycin, which is generic, in a manner that lets patients take it orally.
News Round Up For The First Week In June
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