Monday, March 28, 2011

Hepatitis C News and Updates; Recall citalopram (Celexa)

A lovely Monday here in Michigan today folks, another day for "sifting through all the 'dreck' that's out there in an effort to find things that are both encouraging and helpful to our (way too) fast-growing community."

The latter was a quote from an intelligent woman who monitors/hosts a great HCV forum online. Her dedication spans over 10 years, on the forum she has calmed the fear of thousands newly diagnosed and living with hepatitis C. The hostess goes by Joy, which I find so appropriate. Thank you Joy for continuing to reach out to the HCV community, thousands upon thousands of people have found you to be an inspiration. Another shout out to a very bright and interesting member aka Henry, looking forward to reading more from you in the future. The message board continues to be a great place for information and a must visit for anyone looking for HCV support.

Girl versus virus: The 4 things I learned about journalism when I became the story

by Meg Heckman

Updated Mar. 17, 2011 12:20 pm

Nearly two years ago, my boss suggested that I turn myself into a story.I was halfway through a grueling round of experimental treatment for hepatitis C, a potentially-fatal liver disease I contracted as an infant. My experience had all the trappings of compelling journalism. There was a simple central tension — girl versus virus — and a simple, central question: Will she be cured? Plus, HCV is a sweeping, under-reported epidemic with the potential to cost billions of dollars and millions of lives....Continue Reading...

Just in case you missed it.......

From December 2010

To Prevent the Donation of Infected Organs, Attention Turns to More Rapid Testing

Released: 3/28/2011 7:00 AM EDT

Source: Chembio Diagnostic Systems, Inc.

Newswise — A kidney recipient in a New York City hospital recently contracted HIV from the transplanted organ, which came from a living donor, according to the New York State Department of Health. Although an initial screening had been performed on the donor, he or she apparently had unsafe sex after the test but before donating the kidney. The Department of Health is now recommending that hospitals test donors for HIV, as well as the hepatitis C and B viruses, within 14 days of donating an organ. “This unfortunate event, while quite rare, raises critical questions about the safety risks involved in organ transplantation, and specifically how and when donors are screened,” says Lawrence Siebert, CEO of Chembio Diagnostics, a New York-based developer and manufacturer of rapid diagnostic tests for the growing point-of-care testing market. “The 14-day period recommended by New York State may not be good enough. We have a test that could screen for HIV and HEP on the very day an organ is donated.”

Chembio has developed a patented, next-generation testing approach known as Dual Path Platform (DPP®) technology. The original focus for DPP® is rapid HIV testing, although it can be adapted to test for numerous infectious diseases, including influenza A/B and bird flu, as well as HEP B/C. These point-of-care assays are intended to significantly shorten the time to diagnosis and to lessen the costs of testing. They incorporate a range of features, including a good control of challenging sample types such as oral fluid, as well as an excellent capability for multiplexing—the ability to test for multiple diseases simultaneously. The Centers for Disease Control and Prevention chose to implement a rapid influenza test created by Chembio because of its ability to test all at once for multiple strains. “Our DPP® assays can incorporate a cassette with up to five test lines on it, each of which is capable of confirming the presence of a specific condition at the same time,” Mr. Siebert says. “In a mere 15 minutes, with just one blood sample or oral fluid sample, we can determine to a very high degree of accuracy whether an organ donor is HIV-positive and whether he or she has HEP B/C. If performed immediately before an organ donation, this test would considerably lessen the chances of an infected organ being transplanted into a patient, and could deliver a result within minutes.” A new generation of rapid point-of-care tests for HIV and HEP B/C—such as those being developed by Chembio—could help ensure that donated organs are healthy, and that unfortunate incidents like the one reported in New York City do not reoccur. For more information, log on to

Are the Epstein-Barr and Hepatitis C Viruses Linked?

March 28, 2011

What do the Epstein-Barr virus and Hepatitis C virus have in common? Not very much that will impact anyone with either condition; however, their connection could guide future research to eventually find a Hepatitis C cure.

Helping with a hepatitis epidemic

BETSEY BRUNER Sun Staff Reporter

When Meredith Potts, director of Flagstaff International Relief Effort (FIRE), returned to the U.S. from a recent humanitarian visit to Mongolia, she received wonderful news: Her organization had received a grant for $21,000 to help prevent the spread of hepatitis in Mongolia.

Students on hepatitis C alert


29 Mar, 2011 01:00 AM

SUNBURY Downs College students are helping raise awareness about hepatitis C among young people. Representatives from Hepatitis C Victoria visited the school last week to educate year 11 students on the infectious disease. Organising teacher Michelle Nugent said it wasn't about scaring students, but ensuring they knew about prevention and treatments. "There are 10,000 new cases each year, and with things like piercings and tattoos they need to be aware. They learnt about how it's contracted, where to go for help and the importance of annual health checks. A lot of people trace their family tree but not their medical history." Students are taking part in a competition run by Hepatitis C Victoria called Street Shot. Street Shot is a health promotion initiative using photography as a medium to educate young people about hepatitis C-related issues. As part if the initiative, students will be required to take photos to reflect the issues related to hepatitis C and submit a short essay explaining their entry. Individuals and teams from across Victoria can enter and the competition winner could receive up to $1000. "It's not meant to be scare tactics but awareness, even if you have it it's not a death sentence. It's about finding out about your health," Ms Nugent said. Last year, Sunbury Downs College was the only public school in Victoria to take part in the competition. It received second and third prizes. On average, about 25 per cent of people who contract hepatitis C will clear the virus naturally within the first 12 months. For the remaining 75 per cent of people, the virus is not eliminated and likely remain in their body for the rest of their lives. It's estimated about 74,200 Victorians have been infected with the hepatitis C virus.

Competition winners will be announced on June 17.


AAPM: Capsaicin Patch Eases HIV Neuropathy Pain


WASHINGTON -- Difficult-to-treat HIV-associated neuropathic pain appears to be eased for at least three months with a one-time, 30-minute application of an 8% capsaicin patch (NGX-4010, Qutenza), researchers said here.

March 28, 2011, 12:37 pm —

Interesting ?

Hep C Drug Stocks in the Spotlight

The following is a company-by-company sketch of the hepatitis C drug research to be presented at EASL 2011 that is of most interest to the Street.... Check It Out

From Chasing the Alpha on Biotechs

Some dates to note on biotech calendar

There are 2 upcoming medical conferences that any investor in biotechnology companies should be well aware of. Next week is the beginning of the International Liver Congress™ 2011 by the European Association for the Study of the Liver (EASL, link). This conference runs from March 30 thru April 3rd. After seeing what an abstract can do for Pharmasset Inc.(NASDAQ: VRUS), other players in this space like Achillion(NASDAQ: ACHN) and Inhibitex(NASDAQ: INHX) should start to make some moves. In particular, Achillion has some highly anticipated 28-day data from a Phase 2 study of ACH-1625. Management has made it clear that they wish to partner out ACH-1625, so this upcoming data should be an important value driver down the road. Complete data on the Phase 2 trial is not expected until later in the year. Achillion also has several other next-generation HCV antivirals in development, including ACH-2928 and ACH-1095. It's important to note that most value in the HCV space is created in Phase 1 and 2, not necessarily from Phase 3 studies. See more on ACHN here and Jason Napodano's story on INHX here.... continue reading..

Small Snippet...

This Week’s Health Industry News


Wednesday marks the start of the annual meeting of the European Association for the Study of the Liver, in Berlin. The investment house Leerink Swann said in a note to investors on Monday that important results are expected for Bristol-Myers Squibb’s interferon-free and ribavirin-free direct antiviral agent, which “could greatly expand the market for agents for hepatitis C.


From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts

Some Bottles of Citalopram Recalled Due to Mislabeling

Deborah Brauser Authors and Disclosures Posted: 03/28/2011

March 28, 2011 — Certain bottles labeled as containing the antidepressant citalopram (Celexa) are being recalled by Greenstone LLC because they may instead contain the hyperplasia-treating drug finasteride, reports a MedWatch safety alert issued today by the US Food and Drug Administration (FDA).

This could be a particularly serious mistake for women who are pregnant or are considering becoming pregnant because taking or even handling finasteride is associated with a possible increased risk for abnormalities to a developing male fetus. In addition, patients with depression who inadvertently discontinue taking prescribed citalopram as a result of the mislabeling snafu may experience increased symptoms or worsening of their disorder. "Citalopram is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs) or pimozide; it is also contraindicated in patients with a hypersensitivity to citalopram or any of the inactive ingredients in the tablet," the FDA warns. All 100-count bottles of citalopram 10-mg tablets and 90-count bottles of finasteride 5-mg tablets with the lot number FI0510058-A on the labels are included in the recall and should be returned to the pharmacist where purchased. "The recall is due to the possibility that incorrect labels have been placed on the bottles by a third-party manufacturer," writes Greenstone in a release.

"This is the only lot number being recalled and no other lots or markets are believed to be impacted." Any patient concerned that the wrong medication may have been taken because of this mislabeling is urged to contact their clinician as soon as possible. Both patients and clinicians should report all adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing an online report at or by calling 1-800-332-1088 to request a preaddressed reporting form for mailing. The forms can also be faxed to 1-800-FDA-0178. Greenstone LLC is a wholly owned subsidiary of Pfizer Inc. Authors and Disclosures Journalist Deborah Brauser is a freelance writer for Medscape.Deborah Brauser has disclosed no relevant financial relationships.

FDA Warns Consumers to Stop Using Soladek Vitamin Solution

Kelly Dunst on 03 28, 2011

The U.S. Food and Drug Administration is warning consumers to stop using Soladek, a vitamin-solution product marketed by Indo Pharma, S.A., of the Dominican Republic, because the product may contain dangerously high levels of vitamins A and D.

Soladek is marketed with claims that the product treats “hypo and avitaminosis, rickets, growth, dentition, lactation, fractures, infection, convalescence, protection and regeneration of certain epithelium (bronchial, glandular, ocular, cutaneous), corticotherapy, aging and pregnancy.” The product is sold in a box labeled in Spanish and containing a vial of the solution. FDA recently received information that tested samples of Soladek contained levels of vitamin A and vitamin D that were many times the recommended daily allowances for these vitamins. Intake of excessively high levels of these vitamins poses a risk to human health...Continue reading...

Metastatic Colon Ca Drug Recalled

APP Pharmaceuticals has recalled five lots of irinotecan hydrochloride, used to treat metastatic colorectal cancer, because fungal contamination was found in one lot.

Healthy You

Predicting serious drug side effects before they occur

All medications have side-effects from common aspirin to herbal remedies and from standard anticancer drugs to experimental immunosuppressants. However, predicting important side effects, serious adverse drug reactions, ADRs, is with current understanding almost impossible. However, a neural network technology trained with past data could give drug companies and healthcare workers a new tool to spot the potential for ADRs with any given medication.

Writing in the International Journal of Medical Engineering and Informatics, at team from the University of Medicine and Dentistry of New Jersey, has developed a new model that tests show is 99.87 percent accurate in predicting adverse drug reactions among 10,000 observations and 100 percent for non-serious ADRs.

Peng-fang Yen and colleagues Dinesh Mital and Shankar Srinivasan explain how obligatory warning labels on medication packaging often serve only to cause concern among patients, while products withdrawn from the market because of repeated ADRs repeatedly undermine the pharmaceutical industry. From the medical industry's point of view and the perspective of patients, this is a growing concern that might be remedied with new technology, saving lives, reputations and healthcare costs.

The Food Drug Administration (FDA) in USA and the World Health Organization (WHO) monitor the safety of medications continuously. However, technology that could identify possible ADRs at the earliest possible stage of drug development, licensing and marketing is urgently needed, especially given the potential risks to patients in emerging areas of healthcare and the potential risks to shareholder confidence.

The team's artificial neural network is a mathematical model of the biologic neural network embedded in computer software. It is trained by feeding in structural and physical data associated with known pharmaceutical products and any ADRs. A feedback loop discards those connections where a wrong prediction of a known outcome is made and as data are added the ANN builds up a network of correct "predictions". After sufficient training, the ANN can then be tested on another set of pharmaceuticals and outcomes checked against known ADRs. If confidence is sufficiently high, the ANN can be used to predict ADRs for new drugs. The team has demonstrated an accuracy of 95 percent in preliminary tests and is now using a much larger data set of 10,000 drug molecules and ADR observations to train the ANN to a much more refined level. ### "Prediction of the serious adverse drug reactions using an artificial neural network model" in Int. J. Med. Eng. Informat., 2011, 3, 53-59

From Harvard ; World Health News

Who Will Care for the Onslaught of Aging Baby Boomers?

Ana Veciana-Suarez (The Miami Herald, March 25, 2011)

"With the U.S. population growing grayer, job prospects for home health aides -- and every worker providing healthcare to seniors, for that matter -- are quite rosy. As the 78 million baby boomers live longer with more chronic illnesses, the country will face a shortage of professionals trained to meet the special needs of the elderly…It’s not just the elderly who will be affected by this shortfall, however. Experts predict that fewer medical practices will accept new patients and people will face longer waits to see physicians -- if they see them at all. Instead, more nurse practitioners and physician assistants will provide front-line care."

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