August 25, 2010

Aug 25, 2010 By Leslie Canham, CDA, RDA

Two recent events brought national attention to infection control in dentistry. The first case was in West Virginia during a two-day “Mission of Mercy” dental clinic held at a high school in June of 2009. Three patients and two clinic volunteers were identified as having acute hepatitis B infection. County, state, and federal agencies have been working to determine how they contracted the disease.

There is laboratory evidence that weaknesses in infection control have been identified. The clinic was held in a temporary dental setting, and investigation suggested that some of the equipment was not cleaned properly or was not functioning correctly. In addition, there was no infection preventionist involved in the clinic setting and operations. An infection preventionist is an expert who specializes in preventing infection in health-care settings.

As a result of the hepatitis B infections, notification letters were mailed to 1,137 patients and 826 volunteers. The letters recommended testing for hepatitis B, hepatitis C, and human immunodeficiency virus (HIV).

The second event was the dental clinic at John Cochran Veterans Administration Medical Center (VAMC) in St. Louis. Dr. Gina Michael, a spokesperson for VAMC, said that the dental instruments were sterilized but the proper sequence of instrument processing was not followed. It was determined during an audit that the breach in protocol for instrument processing took place from February 2009 to March 2010. Because the VAMC could not determine that the risk to patients was zero, 1,800 patients were notified that they could have been exposed to hepatitis B, hepatitis C, or HIV. Patients were also offered testing, evaluation, and counseling.

What happened? The dental instruments at the VAMC dental clinic were supposed to go directly from the dental clinic to a central sterilization room. In the central sterilization room, the instruments were to be placed in an instrument washer, placed in sterilization wrap, then placed in the sterilizer. Instead, the instruments were hand scrubbed by the dental assistants in a sink in the dental clinic, dried, wrapped, and then sterilized.

Dental instruments can be cleaned by hand scrubbing or by automated processes. However, the VAMC audit revealed that its policy of placing instruments in an instrument washer was not followed. As a result of the breach in their protocol, VAMC could not be 100% sure that every instrument used in each patient’s mouth was perfectly clean.

Cleaning instruments is the most important step in instrument processing

Cleaning should precede all disinfection and sterilization processes. It should involve removal of debris as well as organic and inorganic contamination. Removal of debris and contamination is achieved either by scrubbing with a surfactant, detergent, and water, or by an automated process (e.g., ultrasonic cleaner or washer-disinfector) using chemical agents. If visible debris, whether inorganic or organic, is not removed, it will interfere with microbial inactivation and compromise the disinfection or sterilization process.

Considerations in selecting cleaning methods and equipment include:

1.Efficacy of the method, process, and equipment

2.Compatibility with items to be cleaned

3.Occupational health and exposure risks

Use of automated cleaning equipment (e.g., ultrasonic cleaner or washer-disinfector) does not require presoaking or scrubbing of instruments and can increase productivity, improve cleaning effectiveness, and decrease worker exposure to blood and bodily fluids. Thus, using automated equipment can be safer and more efficient than manually cleaning contaminated instruments.1

These breaches in infection control remind us that we must have protocols for instrument processing and be sure that everyone is following the same routine. Even well-intentioned dental workers can make grave errors or omissions in infection control that can cause an infection-control disaster. You can reduce the risk of infection transmission by receiving ongoing training in infection control, conducting periodic audits of your dental office’s procedures for instrument processing, and having your infection-control protocols in writing. When it comes to patient safety, infection control is in your hands.

To receive a complimentary copy of an Instrument Processing Protocol checklist, send an e-mail to Leslie@LeslieCanham.com.

Author bio
Leslie Canham is a dental speaker and consultant specializing in infection control and OSHA compliance. She has more than 36 years of experience in dentistry. Canham is the founder of Leslie Canham Seminars, providing in-office training, mock inspections, consulting, and online seminars and webinars to help the dental team navigate state and federal regulations. Reach Canham at (888) 853-7543 or Leslie Canham.

Reference
1 Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings 2003. MMWR 2003; 52(RR-17):21.

Source:DentistryIQ

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Hepatitis C nonprofit faces copyright suit over RJ

Consumer group offers help to defendants over R-J copyright suits

By Steve Green
Published Wed, Aug 25, 2010 (9:26 a.m.)
Updated 1 hour, 41 minutes ago

The Electronic Frontier Foundation, an influential group that works to promote freedom of speech and consumer rights on the Internet nationwide, announced Wednesday it will try to help some of the defendants that have been sued by Righthaven LLC of Las Vegas for posting material online from the Las Vegas Review-Journal.

The EFF, based in San Francisco, since 1990 has intervened in lawsuits and Congress to protect consumer privacy rights and online freedom of speech in the digital age.

For instance, it recently teamed with the ACLU in successfully arguing federal agents don't have unlimited rights to install Global Positioning System location-tracking devices in vehicles without a warrant, and the EFF has assisted individuals targeted in mass lawsuits over the unauthorized downloading of movies and music.

The EFF called a recent series of lawsuits filed by the U.S. Copyright Group over movie downloads, implicating more than 14,000 people, "predatory copyright infringement lawsuits" aimed at shaking out "settlements from ordinary people with few resources to defend themselves."

Wednesday, the EFF said it is seeking to assist defendants in the "Righthaven copyright troll lawsuits."

"Righthaven, founded in March of 2010, files hundreds of copyright infringement lawsuits on behalf of newspaper publishers against bloggers who make use of news content without permission. To that end, Righthaven searches the Internet for stories and parts of stories from the newspapers that they represent. Once they find content that has been re-published, Righthaven purchases the copyright to the article and sues the owner of the blog," the EFF said.

"Just like the U.S. Copyright Group shakedowns, and the RIAA (Recording Industry Association of America) shakedowns of the recent past, Righthaven relies on the threat of enormous statutory damages associated with the Copyright Act to scare defendants, often individual bloggers operating non-commercial websites, into a quick settlement, reportedly ranging from two to five thousand dollars. The Righthaven lawsuits are of particular concern because they sometimes target the operators of political websites who re-publish newspaper stories, chilling political speech. Righthaven has also targeted the newspaper's source for the very articles allegedly infringed," the statement said.

The EFF said it doesn't have the resources to defend everyone who asks for help in dealing with Righthaven.

"However, if we cannot represent you directly, we will make every effort to put you in touch with attorneys who can," the group said in a note posted for Righthaven defendants.

A request for comment on the EFF announcement was placed Wednesday with Righthaven CEO Steven Gibson, an attorney who also heads the Las Vegas office of the Detroit law firm Dickinson Wright PLLC.

Kurt Opsahl, a senior staff attorney at the EFF, said the organization has been monitoring the Righthaven lawsuits for some time.

"For the newspaper industry, this (Righthaven) is a new twist" in copyright enforcement, he said.

The usual procedure in the newspaper industry has been that when copyright infringements are detected online, newspapers contact the offending website and ask that the material be taken down and replaced with a link.

Opsahl said the EFF has been concerned that the Righthaven initiative may be deterring freedom of speech on the Internet because people who have the right to post some material online under the fair use doctrine may not be doing so, for fear of being sued.

Eric Goldman, associate professor at the Santa Clara University School of Law in California and director of the High Tech Law Institute there, suggested EFF will be a formidable opponent for Righthaven.

"I think the EFF's involvement reinforces that Righthaven's lawsuits jeopardize free speech online," Goldman said. "The EFF's involvement also ensures that more Righthaven defendants will be represented by top-notch lawyers. Righthaven's business model partially depends on being able to get defendants to settle quickly. It becomes a lot more expensive to litigate; and even more to litigate against knowledgeable and skilled attorneys.

"The EFF attorneys are among the best in the business -- they are all rock star litigators -- so Righthaven's costs have just gone way up. Plus, the EFF attorneys know how to litigate cases like these, so Righthaven's probability of winning its lawsuits just went down," Goldman said.

The EFF announcement may offer some encouragement to Righthaven defendants who haven't been able to afford to hire an attorney. In many of the cases, attorneys say, Righthaven's settlement offers make the cases cheaper to settle than to fight.

Ryan Gile, an intellectual property attorney with the Las Vegas law firm Weide & Miller LTD, which has been in contact with some of the Righthaven defendants, said the effectiveness of the EFF's involvement may hinge on how many defendants it's able to help and what criteria it uses to decide which cases to become involved in.

"On the one hand, I think it’s a great development that a well-funded group like EFF is getting involved to help individuals who cannot afford legal representation. On the other hand, barring some kind of legal victory on Righhaven’s legal right to enforce the copyright rights it acquires, the unfortunate fact is that most of these defendants probably did commit copyright infringement under copyright law -- however unintentional and innocent such infringement may have been. Even unintentional infringement can bring a statutory damage award of $200.

"Hopefully, EFF’s efforts can help bring about quick, expedient settlements on behalf of the parties they choose to represent – a settlement amount that such parties can afford to pay if they don’t have to pay any amount to attorneys in legal fees. And for those parties whose use is indeed protected as fair use or by the Digital Millennium Copyright Act, with the EFF’s involvement they will be able to strongly fight back against Righthaven," Gile said.

Las Vegas attorney Michael McCue of the law firm Lewis and Roca LLP, which is representing several Righthaven defendants in settlement talks and litigation, has said options for defendants who can't afford legal assistance include seeking "pro bono," or free, legal assistance from a law firm or public interest group; or they could represent themselves if they are not a corporation.

Other options are to try to negotiate a settlement with Righthaven on their own or they can do nothing and risk a default judgment.

The default judgment option is "very risky," McCue said.

"The default judgment could include an award of damages and attorneys' fees. Righthaven might then record the judgment where the defendant resides and may seek to enforce the judgment by attaching assets and garnishing wages," he said.

McCue reminded website operators that to reduce the potential liability for copyright infringement, they should avoid posting material written by others unless they have written permission.

"Merely providing attribution to the source is not sufficient," he said, adding website operators can also be liable for third-party postings -- the subject of many of the Righthaven lawsuits.

Online service providers to avoid liability must comply with detailed provisions of the federal Digital Millennium Copyright Act. These provisions include designating an agent to receive notifications of alleged infringements and registering that designation with the U.S. Copyright Office, McCue said.

"The online service provider cannot have knowledge of the infringement and cannot be aware of facts or circumstances from which the infringing activity is apparent. The online service provider cannot receive direct financial benefit from the infringing activity. In addition, when receiving notice of an infringement, the online service provider must act expeditiously to take down or block access to the allegedly infringing work," McCue said.

Separately, a group working to control the spread of infections is being sued for copyright infringement by Righthaven after a Review-Journal story was posted on its website.

Righthaven on Tuesday filed suit in U.S. District Court in Las Vegas against the Hepatitis C Support Project of San Francisco and its founder, Alan Franciscus.

Righthaven detects online infringements of Review-Journal stories, obtains copyrights to those stories from the Review-Journal's owner, Stephens Media LLC, and then files suit over the retroactive infringements.

The Hepatitis C Support Project and Franciscus are accused of posting to the group's website, www.hcvadvocate.org, an April 30 Review-Journal story about a woman who lost her lawsuit claiming she was infected with hepatitis C at a Las Vegas hospital.

The suit says the website also allegedly displayed without authorization a June 4 Review-Journal story about the hepatitis outbreak linked to the clinics of Dr. Dipak Desai, though Righthaven isn't seeking damages for that alleged infringement.

Franciscus couldn't immediately be reached for comment on the allegation.

The Hepatitis C Support Project says it was founded by Franciscus in 1997 to address the lack of education, support and services available at that time for people affected by hepatitis c.

"The Hepatitis C Support Project's mission is to provide unbiased information, support and advocacy to all communities affected by HCV (hepatitis c) and HIV/HCV coinfection, including medical providers," the website says.

This is at least the second Righthaven lawsuit over the Review-Journal story about the woman's unsuccessful lawsuit against the Las Vegas hospital.

On June 30, Righthaven sued Fremont, Neb., non-profit Honor Inc., which is associated with the website www.oneandonlycampaign.org. That site educates medical professionals about the One & Only Campaign, promoting "One Syringe Only One Time" to prevent the spread of diseases among patients.

The One & Only Campaign is an initiative led by the Centers for Disease Control and Prevention and the Safe Injection Practices Coalition.

The suit against Honor was settled under undisclosed terms, Righthaven said in court papers Aug. 3.

In both lawsuits, Righthaven demanded $75,000 in damages and forfeiture of the defendants' domain names. Publicly-disclosed settlements in other cases, though, show two defendants paid $2,185 and $5,000, respectively, and were able to keep their website names.

In both of the lawsuits over the hepatitis lawsuit story, court records indicate the entire story was re-posted on the defendants' websites with the Review-Journal credited for the information and a link provided to the Review-Journal website.

Also sued by Righthaven on Tuesday were HerbalScience Ltd., the Himalaya Drug Co. and an official Righthaven says is associated with HerbalScience and Himalaya, Nabeel Manal.

They are accused of posting on a blogsite, http://www.fighthangover.blogspot.com/, a June 5 Review-Journal story about Walgreens deciding to sell alcohol at its Las Vegas stores.

Himalaya says on its website it owns Himalaya Herbal Healthcare, with global headquarters in Bangalore, India, and a U.S. office in Houston.

A message for comment was left with Manal.

These bring to at least 102 the number of lawsuits Righthaven has filed since March.

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Hepatitis Z does not exist (correction)

Relaxnews Wednesday, 25 August 2010

Ludwig Lettau, MD, MPH, the author of the article "Alphabet Now Complete: NIH Discovers Hepatitis Z Virus," explained to Relaxnews on August 25 that everything he wrote about Hepatitis Z (HZV) was all "a joke" and originally "published over 15 years ago."

Therefore Hepatitis Z does not exist, and on July 30, there were not any cases of such a virus discovered in California amongst cult members preferring to eat raw liver (per the journal Annals of Internal Medicine), as reported in the August 25 Relaxnews story "Health in the future: Hepatitis E to Z."

The World Health Organization (WHO) defines hepatitis as "an inflammation of the liver most commonly caused by a viral infection," with symptoms that include "jaundice (yellowing of the skin and eyes), dark urine, extreme fatigue, nausea, vomiting and abdominal pain." The WHO notes that there are five main types of hepatitis: A, B, C, D and E.

However Hepatitis E (HEV) is no joke and the HEV vaccine (HEV 239) is well underway with promising results showing it is 100 percent effective.

On August 23, Professor Ningshao Xia, MD, the director of the National Institute of Diagnosis and Vaccine Development in infectious diseases at ?Xiamen University in China told Relaxnews, the "license application of this vaccine is now being evaluated by Chinese SFDA [State Food and Drug Administration].

"How long the evaluation will take is uncertain, maybe several months or more than one year. After that the vaccine can be available for use by travelers and in outbreak areas in China," continued Xia.

"The phase 3 clinical trial of the vaccine was funded by scientific grants from Chinese central and local government, and the development of the vaccine was funded by a vaccine company, Xiamen Innovax Biotech," explained Xia.

To ward off HEV before HEV 239 is available it is best to stay clear of contaminated food and water especially in areas where HEV outbreaks are prevalent including Central and South-East Asia, North and West Africa, and in Mexico according to the WHO.

For more information on "Hepatitis A through E and Beyond", go to: http://digestive.niddk.nih.gov/ddiseases/pubs/viralhepatitis/

Full study, "Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial": http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61030-6/abstract

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Also See: Health in the future: Hepatitis E to Z

Applying stem cell technology to liver diseases

Public release date: 25-Aug-2010

Contact: Karen Honey
press_releases@the-jci.org
734-546-5242
Journal of Clinical Investigation

Great excitement greeted the discovery a few years ago that certain cells from mice and humans could be reprogrammed to become inducible pluripotent stem cells (iPS cells), as they hold promise for cell replacement therapy and modeling human disease. Two independent research groups — one led by Ludovic Vallier, at the University of Cambridge, United Kingdom, and the other led by Holger Willenbring, at the University of California San Francisco — have now shown that both possibilities are true for iPS cell–derived liver cells known as hepatocytes.

In the first study, Vallier and colleagues generated iPS cells from patients with various inherited diseases of the liver. These cells were then cultured in a defined way to generate hepatocytes, which were found to recapitulate key features of the diseases affecting the patients from which they were derived. While this study indicates that iPS cells can be used to model diseases of the liver, Willenbring and colleagues showed that iPS cell–derived hepatocytes have both the functional and proliferative capabilities needed for liver regeneration in mice. In an accompanying commentary, Linda Greenbaum, at Thomas Jefferson University School of Medicine, Philadelphia, describes how these studies have extended our understanding of the potential for iPS cells to be used for cell replacement therapy and modeling human disease.

###

TITLE: Induced pluripotent stem cell–derived hepatocytes have the functional and proliferative capabilities needed for liver regeneration in mice

AUTHOR CONTACT:
Holger Willenbring
University of California San Francisco, San Francisco, California, USA.
Phone: 415.476.2417; Fax: 415.514.2346; E-mail: willenbringh@stemcell.ucsf.edu.

View this article at: http://www.jci.org/articles/view/43267?key=3a682a87848af072f6bc

ACCOMPANYING ARTICLE

TITLE: Modeling inherited metabolic disorders of the liver using human induced pluripotent stem cells

AUTHOR CONTACT:
Ludovic Vallier
University of Cambridge, Cambridge, United Kingdom.
Phone: 44.1223.747489; Fax: 44.1223.763350; E-mail: lv225@cam.ac.uk.

S. Tamir Rashid
University of Cambridge, Cambridge, United Kingdom.
Phone: 44.1223.747489; Fax: 44.1223.763350; E-mail: str29@cam.ac.uk.

View this article at: http://www.jci.org/articles/view/43122?key=834cc7f6d8b865c5ba88

ACCOMPANYING COMMENTARY

TITLE: From skin cells to hepatocytes: advances in application of iPS cell technology

AUTHOR CONTACT:
Linda E. Greenbaum
Thomas Jefferson University School of Medicine, Philadelphia, Pennsylvania, USA.
Phone: 215.503.6345; Fax: 215.503.6282; E-mail: Linda.greenbaum@jefferson.edu.

View this article at: http://www.jci.org/articles/view/44422?key=514b3b37b543850064a2

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Scientists create liver cells from patients' skin

By Kate Kelland

LONDON
Wed Aug 25, 2010 2:05pm EDT

LONDON (Reuters) - British scientists have created liver cells in a lab for the first time by reprogramming stem cells taken from human skin, paving the way for potential new treatments for liver diseases that kill thousands each year.

Cambridge University scientists who reported their results in the Journal of Clinical Investigation Wednesday, said they also found a way of avoiding the kind of intense political and ethical rows over embryonic stem cells which are currently hampering work in the United States.

"This technology bypasses the need for using human embryos," said Tamir Rashid of Cambridge's laboratory for regenerative medicine, who led the study. "The cells we created were just as good as if we had used embryonic stem cells."

Embryonic stem cells are seen as the most powerful and malleable type of cells but are controversial because they are harvested from human embryos when they are just a few days old.

Liver disease is the fifth largest cause of death in developed nations after cardiovascular, cancer, stroke, and respiratory diseases. In the United States, it accounts for around 25,000 deaths a year, and experts say that in Britain liver disease death rates among young and middle-aged people are increasing at a rate of 8 to 10 percent a year.

Rashid said that despite 40 years of trying, scientists have so far never been able to grow liver cells in a lab, making research into liver disorders extremely difficult.

Given a shortage of donor liver organs, alternatives are urgently needed, he added. This study increases the likelihood that alternatives can be found, either by developing new drugs or by using cell-based therapy -- when cells from patients with genetic diseases are "cured" and transplanted back.

Liver diseases can be either inherited, or caused by alcohol abuse or infections such as hepatitis.

STEM CELLS

For their study, Rashid's team took skin samples from seven patients who were suffering from a variety of inherited liver diseases, and three from healthy people to act as comparisons.

They then reprogrammed cells from the skin samples back into a kind of stem cell called induced pluripotent stem (IPS) cells, and then reprogrammed them to generate liver cells which mimicked the broad range of liver diseases in the patients they had come from. They used the same technique to create "healthy" liver cells from the comparison group.

Stem cells are the body's master cells and scientists are trying to find ways to use them to grow new organs, repair damaged hearts or severed spinal cords, or replace brain cells destroyed by strokes, Alzheimer's or Parkinson's disease.

"Previously we have never been able to grow liver cells in the laboratory, so this should open up a whole new sphere of research," Rashid said.

Commenting on the study, Mark Thursz, a specialist in liver disease at Imperial College in London, said it was a major step which may in future be a potential source of new liver cells for patients with liver failure.

Research work using human embryonic stem cells was put on hold Monday after a district court issued a preliminary injunction halting federal funding for it.

(Editing by Nina Chestney)
 
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12 myths about HIV/AIDS and people who use drugs

July 20, 2010

In a Comment which forms part of the Series in Lancet, 12 myths about HIV/AIDS are debunked.

The Comment is by Dr Steffanie Strathdee, University of California San Diego, CA, USA, and Professor Chris Beyrer, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA (both paper authors in the Series) and colleagues.
  1. Drug users are non-compliant
  2. Drug users do not respond as well to antiretrovirals as do non-drug-using patients
  3. Drug users are difficult to study and have poor retention rates in cohorts, making prospective research studies with drug users difficult or impossible
  4. Drug users are more concerned about getting high than using injecting equipment safely
  5. Drug users don't have much sex; their HIV risks are largely or entirely from needle sharing
  6. If drug users keep using, it is almost inevitable that they will acquire HIV infection
  7. Unlike gay men or sex workers, drug users don't have strong communities, so community interventions are unlikely to work
  8. Rates of drug use are higher among minorities in the USA and other industrialised countries
  9. Needle exchanges encourage drug use
  10. Methadone (or buprenorphine) treatment just exchanges one drug for another
  11. People who use stimulants are all heavy, out-of-control users who won't change their risky behaviours
  12. Fear is an effective deterrent for drug use 
Each of these myths is rebutted in the Comment. For example, there are studies showing that all-cause mortality in HIV patients who had started antiretroviral drugs six years or more ago was similar in both injecting drug users and non-drug users (myth 2). There is also no evidence to show needle exchanges encourage drug use (myth 9), with an Alaskan study showing no difference in drug use between people using a needle exchange and those buying needles from pharmacies. Stimulant users are not all out of control users incapable of reducing risky behaviours (myth 11), with Muasback and colleagues showing risk reduction is possible in HIV-negative heterosexuals and HIV-positive men who have sex with men, despite both groups using crystal meth.

The authors conclude: "The myths about HIV acquisition and people who use drugs are straightforwardly countered by scientific evidence, but like so many forms of prejudice, they persist despite the evidence. It is past time for these prejudices to change. Providers, decision makers, and all engaged in the global fight against HIV infection have an obligation to examine biases against people who use drugs, learn the facts beyond the myths, and let evidence drive responses."

Provided by Lancet

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8 hours ago

Standard precautions are recommended to help decrease the number of sharps-related injuries but some researchers say the effectiveness of gloves in preventing such injuries has not been established. Kinlin, et al. (2010) sought to evaluate factors associated with gloving practices and identified associations between gloving practices and sharps ‐ injury risk.

In a study conducted in 13 medical centers in the United States and Canada, the researchers examined the circumstances involved in healthcare workers who presented to employee health clinics after sustaining a sharps-related injury. The researchers administered structured telephone questionnaires to assess usual behaviors and circumstances at the time of injury.

The researchers report that of 636 injured healthcare workers, 195 were scrubbed in an operating room or procedure suite when injured, and 441 were injured elsewhere. Non-scrubbed individuals were more commonly gloved when treating patients who were perceived to have a high risk of human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection than when treating other patients.

Nurses and other employees were less commonly gloved at injury than were physicians and physician trainees. The researchers report that gloves reduced injury risk in case‐crossover analyses. In scrubbed individuals, involvement in an orthopedic procedure was associated with double-gloving at injury; this gloving practice was associated with decreased injury risk.

Kinlin, et al. (2010) conclude that although the use of gloves reduces the risk of sharps injuries, use among healthcare workers is inconsistent and may be influenced by risk perception and organizational culture. They say that glove use should be emphasized as a key element of multimodal sharps ‐ injury reduction programs.

Reference: Kinlin LM, Mittleman MA, Harris AD, Rubin MA and Fisman DN. Use of Gloves and Reduction of Risk of Injury Caused by Needles or Sharp Medical Devices in Healthcare Workers: Results from a Case ‐ Crossover Study. Infect Control Hosp Epidemiol. 2010;31:908-917.

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Aug. 25, 2010, 6:00 a.m. EDT

SEATTLE, Aug 25, 2010 (BUSINESS WIRE) -- ZymoGenetics, Inc. /quotes/comstock/15*!zgen/quotes/nls/zgen (ZGEN 4.85, -0.01, -0.21%) today announced enrollment has been completed in the Phase 2b clinical trial with PEG-Interferon lambda and ribavirin in chronic hepatitis C virus (HCV) infection. ZymoGenetics is investigating PEG-Interferon lambda in collaboration with Bristol-Myers Squibb Company /quotes/comstock/13*!bmy/quotes/nls/bmy (BMY 25.81, -0.21, -0.81%) for the treatment of HCV infection.

"We're very pleased to have completed the enrollment in the Phase 2b PEG-IFN lambda clinical trial in less than three months," said Eleanor L. Ramos, M.D., Senior Vice President and Chief Medical Officer of ZymoGenetics. "The rapid enrollment to this study speaks to the motivation and enthusiasm of the clinical trial investigators to help address the unmet medical need in hepatitis C and also to the outstanding execution by our clinical team. We should now be able to assess the primary endpoint earlier than originally projected, and we look forward to assessing the data and planning for Phase 3."

The Phase 2 EMERGE study is an international, randomized multi-center clinical trial with PEG-Interferon lambda and ribavirin in treatment-naive patients with HCV. The Phase 2b study enrolled 570 patients with genotypes 1, 2, 3 and 4 chronic HCV infection. The study is assessing the safety and antiviral efficacy of three doses of PEG-Interferon lambda (120 mcg, 180 mcg and 240 mcg) compared to PEGASYS(R). Weekly subcutaneous doses of PEG-Interferon lambda or PEGASYS are being administered for 48 weeks in genotype 1 and 4 patients and for 24 weeks in genotype 2 and 3 patients. All patients also receive daily ribavirin. The primary endpoint of the trial is the proportion of patients who achieve undetectable levels of HCV RNA after 12 weeks of therapy (complete Early Virological Response). Achievement of Early Virologic Response will also be assessed by patient IL-28B genotype, which has been shown to be a robust predictor of treatment success with the combination of interferon-alpha and ribavirin.

PEG-Interferon lambda

PEG-Interferon lambda (IL-29) is a novel interferon in development for hepatitis C. The native human interferon lambda proteins are generated by the immune system in response to viral infection, and signal through a different receptor than type I interferons, such as interferon alpha. Because this receptor is present on fewer cell types within the human body, it is hypothesized that PEG-Interferon lambda may be able to demonstrate an improved safety and tolerability profile compared to alpha interferons.

About ZymoGenetics

ZymoGenetics is a biopharmaceutical company focused on the development and commercialization of therapeutic proteins for the treatment of human diseases. The company has developed and is marketing RECOTHROM(R) Thrombin, topical (Recombinant) in the United States. ZymoGenetics has two product candidates in Phase 2 clinical development: PEG-Interferon lambda, being studied in collaboration with Bristol-Myers Squibb for treatment of hepatitis C virus (HCV) infection, and IL-21, being tested as a potential treatment for metastatic melanoma. In addition, ZymoGenetics has an anti-IL-31 monoclonal antibody in preclinical development, which it expects to test initially as a treatment for atopic dermatitis. Several of the product candidates previously identified through ZymoGenetics' discovery research efforts have been licensed to and are being developed by third parties, including Merck Serono and Novo Nordisk. ZymoGenetics is eligible to receive milestone payments and royalties related to these assets. For further information, visit http://www.zymogenetics.com/.

ZymoGenetics Forward-Looking Statements

This press release contains forward-looking statements, including statements related to conducting and analyzing the results of clinical trials. Words such as "believes," "should" and "could" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ZymoGenetics' current expectations and involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to ZymoGenetics' ability to design and conduct clinical trials, the possibility that clinical trial results may vary between different arms of a clinical trial and the difficulty of using prior clinical trial results to predict future outcomes, as well as those other risks detailed in ZymoGenetics' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2009 and periodic reports on Form 10-Q and current reports on Form 8-K. Do not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and, except where required by law, ZymoGenetics undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

PEGASYS(R) (Peginterferon alfa-2a) is a registered trademark of Hoffman La Roche.

SOURCE: ZymoGenetics, Inc.

ZymoGenetics, Inc
Susan W. Specht 206-442-6592

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