FDA Request That H&P Recall Povidone Iodine Prep Solutions W-other Multiple brands affected

Earlier this year the HCV community remembers all too well the recall for prep pads manufactured by Triads parent company H&P. The prep pads were packaged with pegasys in the U.S . and Pegintron outside the U.S. It was reported that the pads from H&P were potentially contaminated with a rare bacteria, Bacillus cereus.

Click Here To Review All Previous Updates

Released Aug 27 2011
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H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing

Multiple brands affected - listed below

[Posted 08/27/2011]

AUDIENCE: Pharmacy, Consumer, Risk Manager

ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions. This recall has been initiated at the request of FDA.

BACKGROUND: Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.

RECOMMENDATION: Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
Download form 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Swabsticks
Amerinet
Cardinal Health
Nova Plus
PSS Select - Select Medical Products
Triad
Triad Plus

Prep Solutions
American Fare - Smart Sense, Kmart
Amerinet
Equaline, Albertson's
Fred's
Good Neighbor - Good Neighbor Pharmacy, Amerisource Bergen
Good Sense - Geiss, Destin & Dunn, Inc.
Leader - Cardinal Health
Major
Meijer
Nova Plus
Premiere Value - Chain Drug Consortium
PSS Select - Select Medical Products. PSS World Medical
Triad - Triadine
Triad Plus
Walgreens
Winn Dixie - Medic

Gel
Triad Plus

Scrub
Amerinet
Nova Plus
Triad
Triad Plus

08/24/2011 - Press Release 3 - H&P Industries, Inc

H&P Industries, Inc. Issues a Voluntary Recall of All Lots of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel

Contact:Consumer:262-538-2907
Returns:mailto:recall.coordinator@handpindustries.com%20?subject=

FOR IMMEDIATE RELEASE -
August 24, 2011 -

H&P industries, Inc., a manufacturer of over-the-counter drug products has initiated a voluntary recall of ALL LOTS (Lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C)of Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel manufactured by H&P Industries, Inc.

This recall has been initiated at the request of the FDA. H & P Industries, Inc. manufactured these Povidone Iodine products without having in place a system for microbial testing at the time of release, without having a system for testing of incoming components, and without having procedures designed and established to prevent objectionable microorganisms in these drug products. Although H&P Industries, Inc.’s investigation and extensive testing did not find contamination, and the products met H&P Industries, Inc., finished goods specifications, H&P Industries, Inc. is voluntarily recalling all Povidone Iodine Products due to and in accordance with the Consent Decree of Condemnation, Forfeiture, and Permanent Injunction entered in the Eastern District of Wisconsin (Civil No. 2:11-cv-00319-AEG) on June 13, 2011. Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals.

Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions whereby they may have been rendered injurious to health. H&P Industries, Inc. has not ever received reports of adverse events or contamination attributed to these Povidone Iodine products. The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles. These products were distributed in the United States. Specific customers distributing the product and selling it at the wholesale and hospital level are being notified by e-mail with instructions on how to return the product. Consumers that have any of these types of products in their possession should not use the product and should return it to the place it was purchased.

Consumers with questions can call H&P Industries, Inc. at 262-538-2907 Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time.

CUSTOMERS WHO DIRECTLY PURCHASED PRODUCT FROM H&P SHOULD NOT RETURN THE PRODUCT ON YOUR OWN.

Email H&P Industries, Inc. at mailto:recall.coordinator@handpindustries.com?subject= to make all return arrangements. Returns will be processed once recall acknowledgements and/or a notice of destruction have been received. Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online:www.fda.gov/medwatch/report.htm1 Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2.
Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

Mythbusters: Learn the Truth about Food Safety in Your Home

Mythbusters: Learn the Truth about Food Safety in Your Home
By Howard Seltzer, National Education Advisor, Center for Food Safety and Applied Nutrition, FDA

It’s September, so it’s time for us to bust some myths.
Beginning in the mid-90’s, National Food Safety Education Month has focused public attention on safe food handling and preparation. Since 2009, the U.S. Department of Agriculture, the Food and Drug Administration, and the Centers for Disease Control and Prevention, in cooperation with the non-profit Partnership for Food Safety Education, have marked the occasion by exposing myths about food safety that somehow keep cropping up.

Food safety myths may not sound very serious. But they may cause food handling mistakes that can lead to food poisoning, severe illness, and even death. So it’s important to get the facts straight.

Here are the myths — and the facts — for 2011:
Myth: I eat a vegetarian diet, so I don't have to worry about food poisoning.
Fact: Fruits and vegetables are an important part of a healthy diet. But justlike other foods they carry a risk of foodborne illness. Always rinse produce under running tap water, including fruits and vegetables with skins and rinds that are not eaten. Never use detergent or bleach to wash fresh fruits or vegetables as these products are not intended for consumption. Packaged fruits and vegetables labeled “ready-to-eat” or “washed” don’t need to be re-washed. Learn more tips at: http://www.foodsafety.gov/keep/types/fruits/index.html.

Myth: Freezing foods kills harmful bacteria that can cause food poisoning (also called foodborne illness).
Fact: Bacteria can survive freezing temperatures. Freezing food is not a method for making foods safe to eat. When food is thawed, bacteria can still be present and may begin to multiply. Cooking food to the proper internal temperature is the only way to kill harmful bacteria. Use a thermometer to measure the internal temperature of cooked foods. See the chart at: http://www.foodsafety.gov/keep/charts/mintemp.html.

Myth: Locally grown, organic foods will never give me food poisoning.
Fact: Any food from any source can become unsafe if it is not handled and stored properly. Consumers in their homes can take action to keep themselves and their families safe. That is why it is important to reduce your risk of food poisoning by practicing the four steps to food safety: Clean, Separate, Cook, and Chill. Learn more about these steps at: http://www.foodsafety.gov/keep/basics/index.html.

Myth: Plastic or glass cutting boards don't hold harmful bacteria on their surfaces like wooden cutting boards do.
Fact: Regardless of the type of cutting board you use, it should be washed and sanitized after each use. Solid plastic, tempered glass, sealed granite, and hardwood cutting boards are dishwasher safe. However, wood laminates don’t hold up well in the dishwasher. Once cutting boards of any type become excessively worn or develop hard-to-clean grooves, they should be discarded.

Mythbusters of past years can be found at
http://www.foodsafety.gov/keep/basics/myths/.

Facebook App; Watching Viruses "Friend" a Network

Watching Viruses "Friend" a Network
Tuesday, August 30, 2011

TAU develops a Facebook application to track the path of infection
From SARS to swine flu, virus outbreaks can be unpredictable — and devastating. But now a new application through the ubiquitous social networking site Facebook, developed in a Tel Aviv University lab, is poised to serve as a better indicator of how infections spread among populations.

Dr. Gal Almogy and Prof. Nir Ben-Tal of the Department of Biochemistry and Molecular Biology at TAU's George S. Wise Faculty of Life Sciences have developed a Facebook application called PiggyDemic, which allows users to "infect" their friends with a simulated virus or become infected themselves. The resulting patterns will allow researchers to gather information on how a virus mutates, spreads through human interaction, and the number of people it infects. Their research was recently presented at the annual retreat of the Safra Bioinformatics Program.

Programming a social disease
Dr. Gal Almogy
Currently, scientists use mathematical algorithms to determine which virus will spread and how, but this method has some flaws. It assumes that a virus has equal distribution across populations, but that is simply not the case, the researchers say. Patterns of social interaction must also be taken into account. "HIV is concentrated in Africa; certain types of flu are widespread in North America and Asia," explains Dr. Almogy. "Adding the element of human interaction, and looking at the social networks we belong to, is critical for investigating viral interaction."

Facebook, notes Dr. Almogy, is an ideal tool for such an undertaking. The social networking site's digital interactions simulate in-person interactions. Viral infections like the flu are a social phenomena, he explains.

Once added to a user's Facebook account, PiggyDemic follows the user's newsfeed to determine the people they interact with. Users are deemed "susceptible," "immune" or "infected" with various simulated viruses, and can pass them on to their online contacts. Researchers then follow these interactions using network visualization software, and watch the links between users as the "viruses" are passed on.
According to Dr. Almogy, accurate modeling of viral dynamics is critical for developing public health policy. Issues such as the use of vaccinations, medications, quarantine and anti-viral procedures will be better informed if we are able to predict more accurately the course of infection.

Taking your vitamin C
Prof. Nir Ben-Tal
More than a research tool, PiggyDemic is also a game (users try to infect as many of their friends as possible), a teaching tool (users make choices that help them live a healthy life), and potentially a method for high-resolution, real-time tracking of virus outbreaks.
"People who have this software can report if they are actually ill," says Dr. Almogy. "If we know who their friends are and the sequence of the infecting virus, we can figure out which virus they have and how it passes from one person to another." If the network is large enough, he explains, they might be able to post warnings of possible outbreaks to Facebook networks, letting people know when it's time for a hefty dose of vitamin C.
The application has already provided a signficant finding, the researchers report. Flu's peak period, winter, is usually attributed to environmental conditions. But the researchers' findings suggest there are other forces at work.

PiggyDemic's viruses are not explicitly programmed to have a seasonal pattern, and yet like the real-life flu, they also display recurrent peaks of infection. Though researchers are not yet certain what drives these periodic peaks in the PiggyDemic eco-system, they indicate that a simple viral strategy superimposed on the basic structure of human society has a strong tendency to display periodic bursts of viral activity regardless of environmental conditions. "The flu doesn't maintain itself at a steady rate of infection," explains Dr. Almogy. "Yearly peaks of infection may serve instead as 'seeding periods,' similar to the 'blooming' process we see in flowering plants."

To download the application to a Facebook account, go to http://apps.facebook.com/piggydemic/.

Hepatitis C; Response To Treatment Geno 3-fibrosis but not race encourages relapse

European Journal of Gastroenterology & Hepatology:
September 2011 - Volume 23 - Issue 9 - p 747–753
doi: 10.1097/MEG.0b013e3283488aba

Original Articles: Hepatitis

Response to antiviral therapy in patients with genotype 3 chronic hepatitis C: fibrosis but not race encourages relapse

Shoeb, Daniaa; Rowe, Ian A.b; Freshwater, Dennisb; Mutimer, Davidb; Brown, Ashleyc; Moreea, Sullemand; Sood, Ruchitd; Marley, Richarda; Sabin, Caroline A.e; Foster, Graham R.a

Abstract
Background and aims:
We completed a retrospective analysis of patients with genotype 3 hepatitis C virus (HCV) undergoing therapy in four UK centres with large populations of patients from the Indian subcontinent.

Materials and methods:
Notes on all patients treated with pegylated interferon and ribavirin were reviewed and factors that influenced the response were examined.

Results:
Six hundred and four patients with genotype 3 HCV were studied, of whom 299 were Asians. Median age was 43 years, 65% were men and 24% had cirrhosis. Overall, 457 (76%) patients achieved sustained virological response (SVR). By multivariable analysis it was found that ethnicity was not associated with an impaired response but age, cirrhosis and diabetes were significantly associated with a reduced SVR, the likelihood of a response was reduced by 25% per 10-year increment in age, by 59% among individuals with cirrhosis and by 62% among individuals with diabetes mellitus. Most patients who did not achieve an SVR relapsed (15%) rather than failing to achieve an end of treatment response.

Conclusion:
The response to antiviral therapy in genotype 3 HCV is not affected by South Asian (vs. Caucasian) ethnicity, but age, cirrhosis and diabetes reduce the response. Treatment failure most often is due to relapse.

Source

Hepatitis; FDA Draft Guidance Document May Limit Patient Access to Tests

FDA Draft Guidance Document May Limit Patient Access to Tests
Released: 8/30/2011 1:30 PM EDT
Source: Association for Molecular Pathology

“Some products used for laboratory tests are available only as research or investigational use only products,” explained AMP Professional Relations Chair Dr. Elaine Lyon. “If this guidance were to be finalized, we’re concerned that patients won’t be able to access tests such as those for Hepatitis C genotyping, newborn screening and HLA testing,” added Dr. Lyon.

Newswise — WASHINGTON, DC, August 30, 2011—
The Association for Molecular Pathology (AMP) submitted comments to the US Food and Drug Administration on the draft guidance document titled, “Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions.” AMP is very concerned that this guidance could compromise the quality of patient care by severely reducing the availability of certain reagents and laboratory developed testing services that have become the standard of care for many diseases or conditions. Specifically, if enforced in its broadest sense without sufficient accommodations for low test volume or sufficient time for manufacturers to achieve submission compliance, the draft guidance document could result in reduced availability of testing services would limit a healthcare provider’s ability to manage patient care, and ultimately limit patient access to new or improved molecular tests.

“Some products used for laboratory tests are available only as research or investigational use only products,” explained AMP Professional Relations Chair Dr. Elaine Lyon. “If this guidance were to be finalized, we’re concerned that patients won’t be able to access tests such as those for Hepatitis C genotyping, newborn screening and HLA testing,” added Dr. Lyon.

AMP supports FDA clearance and approval of research use only (RUO) and investigational use only (IUO) products, especially test kits and test systems. However, to prevent disruption of patient care, accommodations should be made to ensure continued patient access to critical tests as manufacturers come into compliance and/or instances where low test volume would deter a manufacturer from submitting an application to the FDA for that product.

“While AMP appreciates the FDA concern over the use of RUO and IUO products in laboratory developed tests, the Association questions the underlying assumption that the guidance will encourage most manufacturers to seek clearance and approval for their RUO and IUO products,” said Dr. Lyon. AMP members fear that instead of seeking FDA review, some manufacturers will choose to withdraw RUOs from the clinical market. This has already occurred for many analytes, from blood-borne pathogens to sexually transmitted diseases. This would then create a shortage of supplies to develop laboratory tests, resulting in a scarcity of tests, and ultimately, barriers for patients’ access to medically necessary tests.
Dr. Lyon added, “Today we are asking the FDA to consider the downstream implications of the guidance on the supplies and materials for laboratory testing, and allow for circumstances where clinical laboratories can develop tests using RUO and IUO products when no other products are available.”

AMP’s recommendations include:1. To avoid the disruption of patient care, carefully consider enforcement discretion or alternative regulatory pathways to address circumstances where no FDA cleared/approved products are available, particularly for those products with limited sales volume.2. Direct enforcement requirements for 510(k) or PMA submissions toward test kits and test systems. 3. Create a consistent and clear pathway to encourage and facilitate ASR, 510(k) or PMA applications for RUO and IUO products, with a reasonable compliance timeline. The pathway must include flexibility to be responsive to rapidly evolving areas. 4. Accommodations should be made to enable certain reagents such as primer or probe mixes to be sold as ASRs. Alternatively, another regulatory pathway could be designed for products that are too complex to qualify as ASRs but are not full test kits or test systems. 5. Clearly state the scope of the guidance. Clarify which products currently labeled as RUOs and IUOs the guidance covers, e.g., test kits, instruments, software, and reagents.

About AMPThe Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit www.amp.org.

Video; Victrelis, and Incivek-2 new drugs to fight Hepatitis C

Ali Gorman, R.N. More: Bio, Facebook, Twitter, News Team
August 30, 2011 (WPVI) -- The Food and Drug Administration recently approved two new drugs that could be revolutionary. They will dramatically raise the cure rate for a disease that ot too long ago didn't have a treatment.

When Kelly Ann Hester learned she had Hepatitis C in 1993, the disease didn't even have a formal name and doctors didn't give the young mother much of a future...Continue reading..

Hepatitis C-Needlestick Injuries – A Nurse's Story-Video

Staff Education Tool: 'Needlestick Injuries – A Nurse's Story' Video




The National Institute for Occupational Safety and Health, a part of the CDC, offers a free, nine-minute video featuring an interview with Diane Mawyer, a nurse whose life was changed by a sharps injury that infected her with hepatitis C.

Hepatitis C Monday News Ticker; Paediatric HCV, Two New Drugs for Chronic Hepatitis C and More

New On The Blog;
Canada-Victrelis;New Hep C drug priced out of reach of most patients
Maternal hepatitis B and hepatitis C carrier status influences perinatal outcomes
Fatigue In HCV Infection: A Review (1989-2011)

In The News

Clinic: Patients Might Have Been Exposed To Hepatitis, HIV
Victims Potentially Exposed Between 2006 To 2011
Updated: 1:50 pm CDT August 29, 2011
MADISON, Wis. -- Dean Clinic officials said on Monday that a former employee might have exposed some patients to blood-borne diseases like hepatitis and HIV during the last five years.
Clinic officials released a news release on Monday saying that they've informed state and local health officials about the results of their internal review. They said that the employee conducted "inappropriate use of insulin demonstration pens and finger stick devices" during patient visits between 2006 and 2011. They're now contacting 2,345 patients to check if they were exposed to hepatitis B, hepatitis C and HIV.

Officials said that they will either call or send letters and have prepared to answer patients' questions. They said that they conduct the necessary testing and coordinate "follow-up care and support patients' needs."

Dean leaders said that they're committed to helping those affected.
"Dean Clinic is committed to supporting our patients. There is nothing more important to us than the health, well-being and safety of the people we serve," said Dr. Craig Samitt, president and CEO of Dean Clinic, in the news release. "Our goal is to ensure that those who may have been affected by the inappropriate use are promptly informed, tested and supported."
As a result of these incidents, officials said that they're "reeducating patient care staff on the proper use of these types of devices, enhancing our auditing and monitoring procedures related to these devices and improving our process for routinely observing the clinical practices of our staff."
Stay tuned to WISC-TV and Channel 3000 for continuing coverage.

HIV Donor's Organs Transplanted Into Patients
UK, Monday August 29, 2011
A hospital in Taiwan has apologised after organs from an HIV positive donor were transplanted into five patients in a case described as "appalling negligence".
The five are now being treated with anti-viral drugs but experts say it is very likely they will contract HIV.

And their treatment will be further complicated due to the fact they must take medication to stop their new organs being rejected.
There are also concerns among the medics who performed the operations that they may have also contracted HIV.

The family of the 37-year-old donor, surnamed Chiu, chose to donate his organs after he fell to his death in northern Hsinchu city last week.
But the relatives said they were not aware that he was an HIV carrier.
Chiu went into a coma on August 24 and his liver, lungs two kidneys and heart were transplanted to five patients on the same day.

Four of the transplants took place at the National Taiwan University Hospital (NTUH) in Taipei, while the heart operation was carried out at another hospital.
Continue reading..

Hepatitis C Drug
Written by Kristi Runyon
Monday, 29 August 2011 10:47
Hepatitis C is a potentially curable form of hepatitis and some recent advances have improved those odds. Learn more about the newest treatment that can rid the body of this chronic infection.

Hepatitis C Hepatitis C (HCV) is an inflammatory disease that affects the liver. It’s caused by infection with the hepatitis C virus. Most people don’t have any symptoms until significant liver damage has occurred. By then, patients may develop jaundice (yellowish coloring of the skin and whites of the eyes), swelling in the stomach or ankles, fatigue, easy bruising, slower blood clotting time, fever, loss of appetite, diarrhea and dark colored urine.

According to the Centers for Disease Control and Prevention, about 17,000 people become infected with HCV each year. Many of those who are newly diagnosed were actually infected 30 to 40 years ago, but didn’t know it because the virus generally doesn’t cause any symptoms for a long time. Some risk factors include: being born to a mother with HCV, having received a blood transfusion or organ transplant before July 1992, having more than one sex partner, using illegal drugs, getting a tattoo with contaminated needles or accidental stick with a needle used on a person with HCV.

HCV is very difficult for the body to clear and about 75 to 85 percent of patients develop a chronic infection. Currently, 3.2 million Americans are believed to have chronic HCV. Up to 20 percent of them will develop liver cirrhosis within 30 years. Nearly 5 percent will die from either liver cirrhosis or liver cancer.

Treating HCV Doctors generally only treat HCV when the disease become chronic. The standard treatment is a combination of pegylated interferon alfa (PEG, or peginterferon) and ribavirin (RBV). PEG is given by weekly injection. RBV is an oral medication taken daily.
Researchers say the two-drug combination successfully cures HCV in only 40 percent of cases. So better treatments are being investigated.

Recently, the FDA approved two new drugs for HCV – boceprevir and telaprevir. Both drugs are in a class of medications, called protease inhibitors, which inhibit replication of the HCV virus. However, when used alone, the virus quickly develops a resistance to the drugs. So doctors are now adding a protease inhibitor to the standard treatment, allowing them to attack the HCV virus with a triple punch. David Bernstein, M.D., Hepatologist with North Shore University Hospital, Manhasset, NY, says the total treatment time is 6 or 12 months, depending upon the patient’s response to the therapy. All three medications are given for the first three months, then the protease inhibitor is discontinued. Patients continue to take the other two medications as directed for the remaining treatment time.

There are six different genotypes of HCV. The protease inhibitors only work against type 1. However, that is the most common type in the U.S. and it is the strain that is most resistant to treatment. Bernstein cautions the protease inhibitors still don’t work for everyone. However, cure rates with the triple therapy are up to 79 percent.
Research compiled and edited by Barbara J. Fister

AUDIENCE INQUIRY
For information about the new drugs: boceprevir - http://victrelis.com/boceprevir/victrelis/consumer/index.jsp?WT.srch=1&WT.mc_id=VI00J&gclid=CPGtwojBwKoCFdZ25Qod4EZ0jg
telaprevir - https://www.incivek.com/?cid=20657&gclid=CMWogN3AwKoCFQbe4AodNGkJDg

For general information on hepatitis C: American Liver Foundation, http://www.liverfoundation.org/ Centers for Disease Control and Prevention, http://www.cdc.gov/hepatitis Hepatitis Foundation International, http://www.hepfi.org/ National Institute of Diabetes and Digestive and Kidney Diseases, http://www.niddk.nih.gov/

Portal vein thrombosis influences outcomes for pediatric liver transplant candidates in the USA
The latest issue of Liver Transplantation evaluates portal vein thrombosis and outcomes for pediatric liver transplant candidates and recipients in the United States.
The effect of occlusive portal vein thrombosis on the mortality of pediatric liver transplant candidates and recipients is poorly defined.

Dr Seth Waits and colleagues from Michigan, USA studied the relationship between portal vein thrombosis and waiting-list and posttransplant survival rates with data from the Scientific Registry of Transplant Recipients.
In all, 5087 liver transplant candidates and 3630 liver transplant recipients were evaluated during the period.

Portal vein thrombosis patients had a lower survival rate in the posttransplant period
Liver Transplantation

The research team found portal vein thrombosis in 1% of the liver transplant candidates, and in 4% of the liver transplant recipients.
Portal vein thrombosis was not associated with increased wait-list mortality.
Conversely, portal vein thrombosis patients had a significantly lower unadjusted survival rate in the posttransplant period.

The team observed that portal vein thrombosis was independently associated with increased posttransplant mortality in multivariate models.

Dr Waits' team concludes, "The presence of portal vein thrombosis in pediatric liver candidates was not associated with increased wait-list mortality but was clearly associated with posttransplant mortality, especially in the immediate postoperative period."
Liver Transplant 2011: 17(9): 1066–1072
29 August 2011

Woman hospitalised by abortion
Lateline - 26/08/2011 A woman is in a critical condition in a Melbourne hospital after a late-term abortion at a clinic previously implicated in a hepatitis C scandal.

From;
AJN, American Journal of Nursing:
September 2011 - Volume 111 - Issue 9 - p 22
doi: 10.1097/01.NAJ.0000405053.00454.26

Drug WatchTwo New Drugs for Chronic Hepatitis C
More From Drug Watch @ AJN
New Drug to Treat HIV Infection
New Drug for Type 2 Diabetes

From Journal of Viral Hepatitis
The Impact of Mode of Acquisition on Biological Markers of Paediatric Hepatitis C Virus Infection
K. England; C. Thorne; H. Harris; M. Ramsay; M.-L. Newell
Authors and Disclosures
Posted: 08/29/2011; J Viral Hepat. 2011;18(8):533-541.
© 2011 Blackwell Publishing

Discussion Only;
The impact of mode of acquisition on biological markers of HCV infection in the largest comparison of vertically and parenterally infected children to date was investigated. A significantly higher mean ALT z-score in vertically vs parenterally infected and a significantly higher mean ALT z-score in children infected before 12 months of age, regardless of mode of acquisition, was found. This latter association did not remain when only parenterally infected children were investigated which may be because of small numbers but may also indicate that the differences between groups are not completely explained by age at infection but may be related more directly to the mode of acquisition of infection itself.

Comparing biological markers of HCV infection in vertically and parenterally infected children is problematic in the light of the often substantial differences in populations in terms of age at infection, age at study entry, treatment profile, likelihood of clearance of viraemia or genotype. In the children from the cohorts studied here, four times as many parenterally than vertically infected children received HCV treatment; this may be because of more severe disease in parenterally infected children because of their age or mode of acquisition, as suggested by the finding here of a higher proportion with two or more markers of disease progression. Alternatively, their older age at diagnosis may make them more eligible for the treatment while vertically infected children, who were followed from birth, will have started on a regime of clinical monitoring without treatment. Although HCV therapy is well adhered to in the paediatric population, the unpleasant side effects and the potential impact on growth make the decision to treat a complex one.[18] There could also be bias in terms of the individual clinic or national treatment policies, especially given the continually evolving nature of information on paediatric HCV treatment and the ongoing debate about when to initiate treatment.[19]

This debate on when to initiate treatment is partly fuelled by knowledge that some children spontaneously clear viraemia without treatment. In this study, there was no effect of mode of acquisition on clearance of viraemia in contrast to some previous studies.[20] However, parenterally infected children in the UK National HCV Register were not followed up from the time of infection and possibly a large number of those who cleared viraemia did so before diagnosis or study entry. Therefore, any estimate of clearance here and elsewhere, likely underestimates the true proportion clearing viraemia in parenterally infected groups. Of note, however, the high clearance rates in parenterally infected groups are reported in this and other studies[9,21,22] which would presumably be even higher if those who cleared viraemia prior to diagnosis could be included. It may therefore be the case that parenterally infected children are more likely to clear the virus than vertically infected children but it is unlikely that this can be substantiated as follow-up from infection in parenterally infected children is rare.

No differences were found in the HCV genotype profiles of vertically and parenterally infected children in contrast to Jara et al. who found genotype 1b more frequently in children with transfusion-acquired HCV and genotype 3 more frequently in vertically infected children from seven European countries.[23] It is possible that this is because of differences in the years at which infection occurred and may reflect changes in the genotype profile of the HCV epidemic in Europe as suggested recently.[24] A higher proportion of children with genotypes other than type 1 achieved a SVR to therapy, as has been reported by other paediatric studies.[24]

Additionally, in univariable logistic regression, children with genotype 1 were more likely to have consistently elevated ALT levels and consistently positive HCV RNA PCR results, although the associations did not reach statistical significance likely because of small numbers. This finding does however support those of Harris et al. who suggested that type 1 infections may be more aggressive than types 2 or 3[25] and those of a previous EPHN study which found that intrauterine vertical transmission was more likely to occur from mothers with genotype 1.[26]

As no differences in the genotype profile of vertically and parenterally infected children were found here, it is unlikely that any differences in biological or clinical markers of HCV infection between groups can be attributed to the possible differences in HCV progression by genotype.
In multivariable logistic regression, no association between consistently raised ALT z-scores and mode of acquisition was found, possibly because of a lack of power, although the odds ratio remained below one, indicating higher ALT z-scores in vertically infected children. ALT levels have been shown to peak in the first 2 years of life in vertically infected children[27–29] and to adjust for this peak and any other differences resulting from age at measurement, ALT z-scores were used. The finding of increased ALT z-scores in vertically infected children adjusted for age is similar to an Australian study in which significantly higher geometric mean ALT levels in 16 vertically vs 15 parenterally infected children in the first 5 years of life were found, again after accounting for the early peak in ALT levels.[20]

Significant positive associations were found between consistently high ALT z-scores and both consistent HCV RNA viraemia and ever having evidence of hepatomegaly. There was also a higher odds of having consistently positive HCV RNA PCRs in children ever having evidence of hepatomegaly but not significantly so. The associations between these three markers of HCV-related disease progression support previous studies indicating that they may define a group of children with evidence of chronic progressive HCV or who are at increased risk of rapid or more severe progression.[2] In this analysis, similar proportions of parenterally and vertically infected children had evidence of two or more of these markers of infection. Similarly, no difference was found in the proportion with two or more markers and age at infection, in either all children or just the parenterally infected group. This lack of association with mode of or age at acquisition may have been because of combining the markers of infection into this summary variable and also the small number (15 children) of parenterally and vertically infected children with evidence of two or more markers of infection.

The prevalence of comorbidities in parenterally infected children is high given the nature of their infection during receipt of medical treatment[30] and this may have been influential in terms of the child's ability to mount an initial or continued immune response to HCV infection. In contrast, vertically infected children, although acquiring infection during immune development may benefit from persistence of maternal antibodies.[20,31] These mechanisms require specific investigation and although evidence from this analysis does not support substantial differences between the vertically and the parenterally infected groups, until they can be further defined it is important that the potential differences between them are recognized in a clinical setting. This study also highlights the growing need for epidemiological data on parenterally infected children and the difficulties in analyzing such data. Recent estimates suggest that 40% of HCV infections worldwide are acquired via unsafe medical injections and a great number of these occur in children. It is therefore vital that knowledge of disease progression in parenterally infected children is accurate and that the differences between vertically and parenterally infected groups are clarified to inform more accurate and individualized clinical management.
Read More;
Abstract and Introduction
Materials and Methods
Results
Discussion
References

In Case You Missed It

TAG Offers New Guide to Clinical Trials for People with Hepatitis C
The Treatment Action Group (TAG) has produced a new booklet for people considering...

Remembering Jack Layton: full of energy and compassion
remember the first time I met Jack in Ottawa. Six of us infected before 1986 and after 1990 with hepatitis C because of tainted blood went to Ottawa during the Paul Martin Liberal government.

Outsourcing Pharmaceuticals

More Than Half Of CRO Sales Are Made Outside The US

Cancer drug shortages getting worse, FDA says
Most of these are generic drugs given by injection and used in hospitals to treat serious conditions such as breast and testicular cancer. These shortages are putting patients at risk and compromising their care, experts say.
"FDA has been monitoring shortages for the last six years, and in 2010 we saw a large spike in shortages, which was a large jump from the year before," said Valerie Jensen, associate director of the Drug Shortage Program in FDA's Center for Drug Evaluation and Research. "That's what we are continuing to see in 2011. We are still seeing these large numbers of injectable drug shortages." Continue reading...

MORE: Drug shortages set to reach record levels

Stem Cells

Links; Recommended: Stem Cell Blogs

Five Scientists Receive Stem Cell Research Grants
SAN JOSE, Calif., Aug. 29, 2011 /PRNewswire/ -- BD Biosciences, a segment of BD (Becton, Dickinson and Company), has announced the latest round of winners of the BD Biosciences Research Grant Program.

"BD Biosciences continues to support promising young U.S. and European scientists at critical junctures of their careers," said Robert Balderas, Vice President of Biological Sciences, BD Biosciences. "No biomedical discovery has shown as much promise, so early in its development, as stem cell research. We are pleased, by funding these researchers, to support efforts to treat and cure serious illnesses."

Michael Choi, M.D., Assistant Professor of Medicine at Harvard Medical School, is investigating the conversion of non-liver cells into functional hepatocytes through a combination of transcription factors and microRNAs. Specifically, he will identify transcription factors and microRNAs that help convert or differentiate fibroblasts, embryonic stem cells or endodermal (early liver precursor) cells into hepatic progenitor cells. The long-term goal is a ready source of cells to repair livers damaged from injury or disease.
Continue reading....

Stem cells: distinguishing hype and hope
With the bewildering amount of news about stem cells, how do we tell the difference between hype and hope?

New research validates clinical importance of leukemia stem cells
Aug 29
Research published today focuses on patients and shows that acute myeloid leukemia (AML) contains rare cells with stem cell properties, called leukemia stem cells (LSC), that are better at predicting clinical outcome than the majority of AML cells, showing for the first time that LSCs are significant not just in experimental models but also in patients. Stem Cell Network of Canadian National Centres of Excellence, Terry Fox Foundation, Ontario Institute for Cancer Research, Canadian Cancer Society Research Institute

In cell culture, like real estate, the neighborhood matters
Ever since scientists first began growing human cells in lab dishes in 1952, they have focused on improving the chemical soup that feeds the cells and helps regulate their growth. But surfaces also matter, says Laura Kiessling, a professor of chemistry at the University of Wisconsin-Madison.

Healthy You

It's official -- chocolate linked to heart health
High levels of chocolate consumption might be associated with a one third reduction in the risk of developing heart disease, finds a study published on bmj.com today.
The findings confirm results of existing studies that generally agree on a potential beneficial link between chocolate consumption and heart health. However, the authors stress that further studies are needed to test whether chocolate actually causes this reduction or if it can be explained by some other unmeasured (confounding) factor.

The findings will be presented at the European Society of Cardiology Congress in Paris at 10:10 hrs (Paris time) / 09:10 hrs (UK time) on Monday 29 August 2011.
The World Health Organisation predicts that by 2030, nearly 23.6 million people will die from heart disease. However, lifestyle and diet are key factors in preventing heart disease, says the paper.

A number of recent studies have shown that eating chocolate has a positive influence on human health due to its antioxidant and anti-inflammatory properties. This includes reducing blood pressure and improving insulin sensitivity (a stage in the development of diabetes).
However, the evidence about how eating chocolate affects your heart still remains unclear. So, Dr Oscar Franco and colleagues from the University of Cambridge carried out a large scale review of the existing evidence to evaluate the effects of eating chocolate on cardiovascular events like heart attack and stroke.

They analysed the results of seven studies, involving over 100,000 participants with and without existing heart disease. For each study, they compared the group with the highest chocolate consumption against the group with the lowest consumption. Differences in study design and quality were also taken into account to minimise bias.

Five studies reported a beneficial link between higher levels of chocolate consumption and the risk of cardiovascular events. They found that the "highest levels of chocolate consumption were associated with a 37% reduction in cardiovascular disease and a 29% reduction in stroke compared with lowest levels." No significant reduction was found in relation to heart failure.
The studies did not differentiate between dark or milk chocolate and included consumption of chocolate bars, drinks, biscuits and desserts.

The authors say the findings need to be interpreted with caution, in particular because commercially available chocolate is very calorific (around 500 calories for every 100 grams) and eating too much of it could lead to weight gain, risk of diabetes and heart disease.
However, they conclude that given the health benefits of eating chocolate, initiatives to reduce the current fat and sugar content in most chocolate products should be explored.

Off The Cuff

Bird flu fear as strain mutates
Avian flu shows signs of a resurgence, while a mutant strain - able to sidestep vaccines - could be spreading in Asia, the United Nations warns.

Psoriasis 'linked to stroke risk'
People with psoriasis have nearly three times the normal risk of stroke and abnormal heart rhythm, according to scientists in Denmark.
A study of 4.5 million people, published in the European Heart Journal, showed the highest risk was in young patients with severe psoriasis.

Michigan court: Law doesn’t allow pot sales
An appeals court has ruled that Michigan’s medical marijuana law doesn’t permit sales between registered patients.
An appeals court has ruled that Michigan’s medical marijuana law doesn’t permit sales between registered patients.
The ruling, in a case that had been brought against a pot dispensary operated by owners legally allowed to possess and grow the drug, allows local authorities to close similar shops, Reuters reports.

According to the Associated Press:
Compassionate Apothecary, and owners of the mid-Michigan company, claimed they weren’t doing anything illegal because the law allows the “delivery” and “transfer” of marijuana. The business allows its 345 members to sell marijuana to each other, with the owners taking as much as a 20 percent cut. In less than three months, Compassionate Apothecary earned $21,000 before expenses after opening in May 2010.

“The ‘medical use’ of marijuana does not include patient-to-patient ‘sales’ of marijuana. Defendants, therefore, have no authority under the (law) to operate a marijuana dispensary that actively engages in and carries out patient-to-patient sales,” said appeals court judges Joel Hoekstra, Christopher Murray and Cynthia Diane Stephens.

“This ruling is a huge victory for public safety and Michigan communities struggling with an invasion of pot shops near their schools, homes and churches,” State Attorney General Bill Schuette said in a statement. “The court echoed the concerns of law enforcement, clarifying that this law is narrowly focused to help the seriously ill, not the creation of a marijuana free-for-all.”
Michigan is one of 16 states that, along with the District of Columbia, allow marijuana to be used to ease medical conditions. According to the South Bend Tribune, there are an estimated 200 to 300 marijuana dispensaries in Michigan serving the state’s 99,500 residents with medical marijuana cards.