January 11, 2013

Published in Journal Watch Gastroenterology January 11, 2013

Further justification for use of HCV therapies to achieve sustained virologic response

Previous studies suggest that achieving sustained virologic response (SVR) with interferon-based therapy reduces rates of liver failure and liver-related deaths in patients infected with hepatitis C virus (HCV) (JW Gastroenterol Jun 1 2007). To explore whether SVR might also lead to reduction in all-cause mortality — considered the most definitive clinical endpoint — investigators conducted a multinational, long-term cohort study involving 546 consecutive patients who were treated with an interferon-based regimen for advanced fibrosis or cirrhosis. Secondary outcomes were liver failure, liver-related mortality, liver cancer, and transplant. The median follow-up duration was 8.4 years.

Of 530 participants included in analyses (median age, 48; 70% men), 54% had cirrhosis. Thirty-six percent of patients achieved SVR. In comparison with patients who did not achieve SVR, these patients had significantly lower 10-year cumulative rates of all-cause mortality (8.9% vs. 26%) as well as liver-related mortality or transplantation (1.9% vs. 27.4%), liver failure (2.1% vs. 29.9%), and liver cancer incidence (5.1% vs. 21.8%). In multivariate analysis, SVR was independently associated with reduced risk for all-cause mortality (hazard ratio, 0.26; 95% confidence interval, 0.14–0.49) and reduced risk for liver-related mortality or transplantation (HR, 0.06; 95% CI, 0.02–0.19).

Comment: This study provides compelling evidence that successfully clearing HCV is associated with not only improved liver outcomes, but also lower all-cause mortality. Similar findings have been shown in patients coinfected with HIV and HCV (JAMA 2012; 308:370). Although the study population was limited to patients with advanced fibrosis or cirrhosis, this subset of patients with HCV infection is also the most difficult to treat. These findings demonstrate direct clinical benefits of HCV therapy and justify its use to achieve SVR. Moreover, these benefits were achieved with a low number needed to treat of only seven. With the development of more effective, safer regimens, the clinical benefits of SVR should only be greater in the near future.

Atif Zaman, MD, MPH

Citation(s):

van der Meer AJ et al. Association between sustained virological response and all-cause mortality among patients with chronic hepatitis C and advanced hepatic fibrosis. JAMA 2012 Dec 26; 308:2584. (http://jama.jamanetwork.com/article.aspx?articleid=1487498)

Medline abstract (Free)

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47184_GOVXLOGO

January 10, 2013 09:00 ET

Initial Data Expected in Late 2013

ATLANTA, GA--(Marketwire - Jan 10, 2013) - GeoVax Labs, Inc. (OTCQB: GOVX), an Atlanta-based biopharmaceutical firm developing vaccines to prevent and treat HIV/AIDS, announced it has completed enrollment in a nine-patient Phase 1/2 clinical trial testing the safety, immunogenicity and ability of its DNA/MVA vaccine to elicit protective immune responses in HIV-infected individuals.

The primary goal of this study is to document the safety and immunogenicity of GeoVax's vaccine in HIV-positive patients with well-controlled infections using oral HIV drug medication. Following vaccination, the trial includes a short period of drug-interruption to evaluate the ability of the vaccine to control the infection in the absence of continuing drug therapy. The Phase 1/2 trial (designated GV-TH-01) consists of priming with a recombinant DNA vaccine followed by boosting with a recombinant modified vaccinia Ankara (MVA) vaccine. The vaccine regimen elicits both antiviral antibody that can block infection and antiviral T cells that can recognize and kill infected cells. The trial is being conducted at the AIDS Research Consortium of Atlanta, the Alabama Vaccine Research Center at the University of Alabama, Birmingham and the AIDS Research Alliance of Los Angeles.

Robert McNally, Ph.D., President and CEO of GeoVax, stated, "This pilot study is our first trial investigating use of a therapeutic vaccine to address the need for a treatment that is better tolerated and less costly than the HIV oral medications currently available. We anticipate having meaningful data from the program later this year."

Harriet Robinson, GeoVax's Chief Scientific Officer, commented, "Our next step planned for our therapeutic vaccine development program is a Phase 1 clinical trial to investigate the use of our vaccine in combination with standard-of-care drug therapy in young adults. This trial will likely be conducted by the International Maternal Pediatric Adolescent AIDS Clinical Trial Group (IMPAACT). One of the hopes for therapeutic vaccination is that combining a vaccine with drugs will allow the eradication of virus from an infected individual. Drugs primarily prevent infection whereas a vaccine can both block infection and kill infected cells."

About GeoVax

GeoVax is a biotechnology company developing human vaccines for diseases caused by HIV. GeoVax's vaccines are unique in expressing virus like particles that display the trimeric membrane bound form of the HIV-1 envelope glycoprotein. All preventative Phase 1 human clinical trials conducted to date tested various combinations and doses of our DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic T cell) immune responses, as well as, the vaccines' safety. Successful results from a Phase 1 study supported a Phase 2a trial that was completed in the 3rd quarter of 2012.

GeoVax's 2nd generation preventive vaccine is currently in phase 1 testing and is planned to progress to phase 2 efficacy testing, given safety and immunogenicity are as expected. Overall, the GeoVax vaccine, in various doses and combinations, has been tested in close to 500 humans. GeoVax is also enrolling patients in a Phase 1 therapeutic trial for individuals already infected with HIV. For more information, please visit www.geovax.com.

About HIV/AIDS

HIV infection, which can lead to AIDS, is a pandemic that can affect anyone, regardless of race, gender, age, or sexual orientation. 33 million people are currently infected globally; it is estimated that there will be 2.5 million new infections this year. Since the beginning of the epidemic, more than a million people in the U.S. have contracted the virus. Every 9 1/2 minutes, someone in the U.S. is infected with HIV. Globally, HIV is the top killer among women of reproductive age. HIV is a worldwide disease with different subtypes (or clades) of the virus predominating in different regions of the world. Clade B is the predominant subtype in North America. Globally, most infections involve subtypes AG, B and C. GeoVax vaccines are currently designed to function against clade B.

For more Information, please visit www.geovax.com.

Forward-Looking Statements

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent AIDS in humans, vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

Contact Information

CONTACT
Dian Greisel, Inc.
Dillon Heins
Investor Relations
Susan Forman or Laura Radocaj
Public Relations
212-825-3210

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Neuropathy and HIV: A Progress Report

Friday, 09 November 2012

Author // Dave R

Categories // Health, Treatment, Living with HIV, Dave R

Dave R writes...Neuropathy affects up to 40% of all people with HIV, yet the treatment has remained more or less the same for decades. Prescribing drugs meant for other diseases, has led to haphazard results; time for a change - but is it happening?

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Couple the conditions neuropathy and HIV-infection together and in 2012, you have more people than ever who understand what you’re talking about. Growing older and surviving with HIV seems to mean the increase of long-term, age or HIV-related, side-effect conditions like neuropathy. To save time in relation to this article; much more information about the disease and its links to HIV can be found in other articles here, here and here.

It’s an infuriating and frustrating problem for both patients and doctors. Neuropathy is one of those diseases where the mainline, standard treatments seem to have remained static for the last thirty years or more. Occasionally, a different anticonvulsant is tried out, or a combination of antidepressant and anticonvulsant, analgesic, or opiate but this comes more from a feeling of hopefulness than conviction and good science on the part of doctors. In general, people who unfortunately end up with neuropathy from whatever cause (and there are over a hundred!) follow the same medication routes that have been used since the 60’s, until hopefully something works. It really is a sticking a wet finger in the wind sort of medical approach. The downside is that many people are never prescribed anything that really works for them and the symptoms can gradually worsen. In the end, the only pain-killing options are opioids, with all their attendant side effects and addiction potential. Little wonder that all involved tear their hair out with frustration. Medicine isn’t meant to be this way in the 21th Century; even HIV sees progression with its medications!

That’s probably why so many people turn to alternative therapies and supplements to try anything that might relieve the problems. In that sense, different supplements and therapies spring up every year like mushrooms in a field. Some end up being tested and approved and genuinely help people but many are pretty much worthless and a waste of money. That’s the biggest problem with neuropathy; it creates desperation and the need to clutch at straws. Yet the problem is largely unrecognised by the population at large, despite there being 20 million Americans alone who suffer from various forms of nerve damage. To be clear, only certain types of neuropathy can be reversed and even then, only when they are discovered very early in the disease – generally it’s something with you for the long haul.

Over the last decades, it has been a doom and gloom scenario for many people, as they work their way through drugs meant for other diseases in the hope that they will eventually get some relief from their neuropathic symptoms.

However, that very increase in numbers of people suffering serious nerve damage has sparked a wave of studies in the research world and glimmers of hope for sufferers. Unfortunately people living with HIV can’t take any of the credit; if it were just our little demographic, a cynic might suggest that new research wouldn’t be so forthcoming. Luckily for us (but not if you also have diabetes), it is the explosion in diabetes cases that is driving the need for effective treatments for neuropathy. The burgeoning disease of diabetes is the single largest cause of nerve damage, especially in the burger and sugar-guzzling West. That becomes a drain on health budgets and services; ergo a new enthusiasm in the research labs.

The outlook for neuropathy patients may not be quite as gloomy as it once was then and this article will bring you up to date with some of the more recent developments within the scientific and medical world. Be warned though, these will probably not result in ‘cures’ or even off-the-shelf medications in the very near future but do show that the pharmaceutical industry seems to be finally waking up to the fact that this is a huge problem across the entire spectrum of society. Significant progress seems to have been made even during the last year. As you know, drug companies are not known for their philanthropic motives but there’s a vast amount of money to be made as soon as effective treatments can be developed and that, plus pressure from health regulators to deal with diabetes, will unfortunately, probably be the driving force behind finding new treatments. That said; do we care how they get there? Not if we have neuropathy we don’t! Whatever the motives, we’re going to love the pharmaceutical company that brings us genuine relief from nerve damage.

Recent Developments in Research

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The following are some of the many recent developments in understanding of how, what and why nerves are damaged and what can be done to alleviate the results.

First, a step backwards but an important one for many people currently being prescribed the anticonvulsant Lyrica (pregabalin) for neuropathy. For those who haven’t already heard, in May 2012 Lyrica (Pregabalin) was dropped as a treatment for diabetic and HIV-related neuropathy by none other than its makers, Pfizer. It proved to be ineffectual in treating neuropathy from those causes. Despite this, doctors all over the world are still prescribing it because they either haven’t heard, or because it’s on the standard list, or they have always prescribed it and have a number of patients for whom it seems to have worked. The fact is that the majority of people have found no improvement from taking Lyrica (pregabalin) and what’s more have suffered more from the side effects than from the neuropathy itself. It may be worth discussing this with your specialist if that’s the case for you. For Pfizer to withdraw support for their own drug is hugely significant – no drug company cuts the throat of its own cash cow for no reason!

By far the largest area of research is at molecular and cellular level which may leave most people scratching their heads and reluctant to read on. However, scientists in both universities and the pharmaceutical company research departments seem to have recently invested a great deal more time in looking at nerve cells, why they are damaged and what processes both chemical and physical cause so much pain and discomfort for neuropathy patients. Of course, this sort of research has undoubtedly been going on for years but with discouraging results, (otherwise new treatments would have been available long before now). The technology must also have improved to the point where more detailed and specific research is now possible. Published scientific findings also stimulate both new research and competition, so exciting results in one university or research lab tend to encourage others to top them with results of their own. More money for research may also be available, as political decisions outside the pharmaceutical industry influence progress. Administrations everywhere are realising the huge costs associated with ‘life-style’ illnesses like, diabetes, cancer, HIV and others. They also realise that continuing to pour money into paying for ineffective treatments with side effects just prolongs the process and increases costs exponentially. The pharmaceutical companies may finally be facing pressure from politicians but they are also beginning to realise the vast profits to be made from finding the ‘mother lode’ of nerve damage treatments. They can no longer really justify making profits from and using up reserves of drugs used for other medical conditions, when they have such a hit and miss effect on neuropathy patients. Sheer numbers and potential profits, then, are driving the search for new drug treatments.

So is it possible to describe some of the developments in molecular and cellular research for nerve damage? I’ll give it a go and have to confess my own understanding is about as shallow as most people’s but we need to have an idea of what sort of treatments are going to affect our futures with this disease. If nothing else, it helps us to understand exactly how complex the whole problem is.

The first is new research that has identified precisely which cells and which sub-sets of cells, are responsible for long-term nerve pain. See an explanation here.

Then studies have identified the cells (Schwann cells) which protect the myelin sheath which is the insulation layer around nerves (to give you an idea, a myelin sheath is like the plastic around electricity wires – you get a short circuit if that is damaged too). More information about this research can be found here.

Further research has identified the importance of something called metabolomics. This looks at why nerve pain persists for so long and why many medications have no effect. The clue lies in a by product of cellular membranes called DMS which seems to be present in large amounts in the spinal cords of lab rats and mice with neuropathy. They are working on finding ways of inhibiting this DMS and thus relieving long-term pain. More information here.

Similarly, American researchers have discovered a group of drug molecules which are found naturally in the body and stabilise other molecules, in order to block neuropathic pain. The idea is that these selective molecules inhibit a key enzyme called soluble epoxide hydrolase. Blocking this enzyme successfully blocks pain sensations. This then has implications for developing new drug treatments which will work much better on neuropathic symptoms. The problem is that the research is still in a very early stage. Read more here.

Another research study aims to block nerve pain signals by using glycene. Glycene is an amino acid which is known as an inhibitory neurotransmitter. It works at the junction between two nerves, known as the synapse and halts the transmission of pain signals along those nerves to the brain. However, glycene quickly dissipates in these places and some have recommended taking supplements to encourage the body to create more naturally. This study questions the efficiency of that but points out that glycene is one of the very promising natural products of the body which needs and is getting much more research. More information here.

Yet another research study has discovered that a certain protein (LRP4) has to be present on the surface of both muscles and in the brain in order to regulate muscle function. If this isn’t the case, several conditions including neuropathy can occur. Many neuropathy patients discover that their muscles stop working efficiently and lose strength after time – the lack of this protein LRP4 in both muscle cells and neurons leads to communication breakdown, which as we all know leads to the numbness, tingling and pain which often appear with nerve damage. Finding a way to either maintain protein levels or introducing it externally may well help reduce the problem. More information here.

Another project has looked into how the brain stores memories of pain and why for instance, phantom limb pain occurs (when a limb is lost, people still feel the pain as if it’s still there). Again, it concerns a type of protein (PKMzeta) which builds and maintains memory by strengthening the connections between neurons. Scientists think that if they can block the activity of PKMzeta, they can reduce the hypersensitivity that causes nerve pain and they’re well on their way to finding something that will do just that. Again, a work in progress we have to say but the future looks a little more hopeful. Read more here.

Finally in this group of studies, the possibilities of nerve transplantation are being explored, in cases where nerves are damaged. This means basically transplanting immature neurons in the hope that they will grow into full nerve cells. During the studies small fractions of the transplanted cells survived and matured into functioning neurons. The cells then integrated into the nerve circuitry of the spinal cord, forming synapses and signalling pathways with neighbouring neurons. Most importantly, as a result, pain hypersensitivity associated with nerve injury was almost completely eliminated. Whether health authorities will be able to cope with the expense of this sort of transplant treatment is the question but there’s little doubt, it sounds promising! More information here.

You can see from these few examples that many people and research labs are busy working at the most basic level of nerve behaviour to find where, why and how, molecular and cellular activity cause such unpleasant neuropathic symptoms. Genetic research is another fast-growing sector, largely due to the huge advancements in techniques in that area and eventually, altered or modified DNA may provide permanent answers. It is slow work though and we have to hope that sooner rather than later a significant breakthrough will be made. Hoping that just one of the studies above may lead to real treatment progress, gives room for optimism.

Researching Nature

Research is not only being done at microscopic levels within the body but studies are also being done in nature to see if there is anything in the animal and plant kingdoms which may help. This has produced some strange studies and conclusions.

  • A certain sea-snail saliva for instance could be a replacement for morphine in the future. Read more here.
  • Taiwanese scientists have discovered a compound derived from certain corals called Capnellene. This may also work on certain cells (microglia) and significantly reduce neuropathic pain. More information here.
  • Scorpion, spider and snake venoms may also provide answers to controlling nerve pain. These venoms work on the sodium channels in the nervous systems of mammals, so it seems logical that controlled doses may help with neuropathic symptoms. Read more here.
  • Turmeric (also known as Curcumin, Curcuma) which is used widely in cooking, is one of the new buzz words for helping with all sorts of problems including neuropathic pain. Every now and then, a natural remedy emerges that catches on in the market; sometimes with merit and sometimes not. However, one of the most promising is Turmeric or Curcumin, a root used widely in Asian cuisine, generally in powder form. It’s cheap and maybe worth a try – some people swear by it but do your own research. More information here.

Of course the best known natural remedy used to help with neuropathic problems is cannabis. The hysterical reactions to cannabis for medical purposes are much more to do with politics and ‘the war on drugs’ than the medical benefits it can undoubtedly bring for many people. It’s one of the very few recognised effective remedies for neuropathic pain but a) you have to be aware of the laws in your area, b) you have to be able to smoke it (with all its associated lung dangers) and c) you have to be able to cope with getting high (mildly or otherwise). For those reasons many people can’t take advantage of cannabinoids. However, there has been a new synthetic version of THC (the principle working element of cannabis) created by the University of Calgary and this could prove to be a godsend for many neuropathy sufferers because smoking will be removed from the equation. It is far more likely to be accepted by law agencies because it can then be issued on prescription. However, like most developments, we’re not there yet. (Read more here.

Other approaches

There are many more studies and investigations of potential natural remedies, from many different natural sources taking place. If only a handful end up being successful and effective and available to our doctors, or on the shelves of our health food shops, it could relieve suffering for millions.

It seems that no stone is being left unturned in the search for answers and that includes looking at other cultures and other medical practices. Acupuncture and acupressure have been tried by many neuropathy patients over the years, with varying levels of success. Like everything else at the moment, it works for some but not for others. However, new research has discovered that much longer-lasting effects can be achieved by so-called PAP injections (prostatic acid phosphatase) using the same pressure points used for centuries in acupuncture. This so-called PAPupuncture therapy has been proved (in the lab) to extend pain relief much further than with normal acupuncture methods and may well be a useful therapy in the future, for those who don’t wish to increase their drug consumption. Read more here.

Finally in this section, it may seem that the world is turned on its head but a modified version of the herpes virus is thought to theoretically work on peripheral nerves, so that pain can be directly reduced in those areas. A scary thought perhaps, if you’re to be injected with herpes but perhaps logical if you think that Shingles is also a form of neuropathy and is caused by a herpes virus. Anyone suffering from Shingles, knows what nerve pain can do! More information here.

Lastly, apart from the searches for new medications and treatments, which are very difficult for the layman to understand, scientists are also trying to develop better versions of current drug treatments. We know about the random success/failure rate of antidepressants and anticonvulsants and it is likely that there isn’t much progress to be made in those drug areas. We also know about the last resorts in the opioid family. Effective pain killers but often strongly addictive and loaded with side effects, they are unfortunately a question of necessity for many neuropathy patients.

Scientists are discovering that opioids are a group of drugs with more possibilities and their effectiveness is probably more easily adapted and manipulated. Consequently, new opioids and members of the opioid/morphine family are coming on to the market. Tapentadol,(Nucynta in the USA and Palexia in Europe) for instance, is newly approved in the States and can be equated to Tramadol but works slightly differently, more effectively and with less side effects. It will be a welcome alternative for many people. Read more here.

Researchers are also looking for ways to prolong the pain-killing effects of morphines and opioids, thus reducing the need for higher doses and reducing addiction dangers. They have found that Resveratrol, (naturally found in red wine) can preserve the effects of morphine in rats - most importantly, in rats that have developed morphine tolerance. In humans, morphine tolerance creates a need for higher doses to achieve the same effect so discovering something that delays tolerance, or maintains the pain killing effects, is clearly of great value. See more here.

Conclusion

If you’ve got this far, you’re probably reeling from information-overload but the intention is to reassure you that serious efforts are being made to find solutions for both nerve damage and the uncomfortable results of that for millions of people. Eventually, a few will make it through the rigorous processes and end up as viable options for our doctors to prescribe. Unfortunately, it takes time and that’s difficult to swallow for a patient in extreme pain or discomfort. You’re already on drugs for your neuropathy; they may be working or not, or just partly. All you want is something to take the problem away and preferably a one-drug-cures-all type of treatment. The truth is that that’s not going to happen in the very near future but it will eventually happen. Finally, health authorities and pharmaceutical companies are getting their acts together and working for us instead of palming us off with dangerous drugs meant for other diseases.

Money will play a part in the speed of progress and research finance is often the first to go in times of financial crisis, along with the willingness of health authorities and insurance companies to pay for expensive new drugs but the picture is brighter than ten years ago. All concerned are realising that neuropathic pain is a far greater problem than they ever imagined and the increase of the diseases that cause it (along with people living longer) is only going to make that bigger. Something has to be done to reduce the costs of long term treatment and that means finding things that genuinely work. Lab rats and mice may view this with horror but for many people with neuropathy, it just can’t come soon enough!

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Americans Live Sicker, Die Younger

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By David Pittman, Washington Correspondent, MedPage Today

Published: January 10, 2013

WASHINGTON -- Despite spending more on healthcare, Americans die sooner and experience more illness than people in other high-income countries, a study released Wednesday found.

For example, lung disease was more prevalent and associated with higher mortality in the U.S. compared with other countries, and American children were less likely to live to age 5, according to the report Shorter Lives, Poorer Health, issued by the National Research Council and the Institute of Medicine.

Researchers were surprised by the gravity and pervasiveness of the disparities and couldn't pinpoint a cause to a specific disease, said study chair Steven Woolf, MD, professor of family medicine at the Virginia Commonwealth University in Richmond, Va. Poor health results also can't be blamed on a single racial, ethnic, or socioeconomic group, he added.

The disparity found between the U.S. and 16 comparable countries showed itself in all ages, from birth to 75. And while the U.S.'s mortality rate has been lagging for some time, the report found poor comparable health status cuts across income, education levels, and health insurance status.

"No single factor, but a combination is likely to explain the U.S. health disadvantage," Woolf said in a call with reporters Wednesday.

For the report, the blue-ribbon panel compared health outcomes in the U.S. to 16 comparable high-income or peer countries. It found a consistent pattern of higher mortality and poorer health in the U.S. for every 5-year age group starting from birth.

Specifically, the panel found:

  • Since the 1990s, U.S. adolescents have had the highest rate of pregnancies and have been more likely to acquire sexually transmitted infections
  • The U.S. has the highest prevalence of HIV infection for ages 15-49
  • Americans have lost more years of life to alcohol and other drugs than people in peer countries
  • For decades, the U.S. has had the highest obesity rate among high-income countries
  • From age 20 onward, U.S. adults have among the highest prevalence of diabetes among peer countries
  • Americans reached age 50 with a less favorable cardiovascular risk profile than their peers in Europe

"Americans who do reach age 50 generally arrive at this age in poorer health than their counterparts in other high-income countries, and as older adults they face greater morbidity and mortality from chronic diseases that arise from risk factors that are often established earlier in life," the report stated.

While there are many possible causes, one leading factor is American culture, which tends to cherish personal autonomy and less government intrusion -- attitudes that produce more unsafe and unhealthy behaviors, Woolf said.

Americans also rely on cars for transportation more and eat food generally prepared in a less healthy way. And the U.S. has a smaller number of primary care providers than its peer countries and greater problems coordinating care, the study found.

Despite America's severe disadvantage in health outcomes, the research found hospital mortality rates are comparable to other countries. "It's when people leave the hospital and go out into the community that quality of life drops off," Woolf said.

Americans need to distinguish between the country's healthcare system -- for which people already spend far more per capita than their peers -- and their personal health. "This study would suggest we need to think about the way we spend our money," Woolf said.

In contrast to all other age groups, Americans age 75 and older fare better than their counterparts in peer countries, the study found.

The U.S. also has better cancer screening and survival rates, better control of blood pressure and cholesterol levels, and lower smoking rates. Its suicide rates don't exceed the international average.

Also, the nation's recent immigrants are generally in better health than native-born Americans, the study found.

Panelists offered a number of policy and research suggestions to move forward.

The country should ramp up efforts to curb disadvantages, they suggested, while philanthropy and advocacy groups organize media and outreach campaigns to inform the general public about its findings to encourage national debate.

New research is needed to uncover the best ways of improving health in the future, the report suggested. The country should work with international partners to harmonize indicators and data collection, and the National Institutes of Health and other research agencies should commit to understanding the factors behind the U.S.'s health disadvantage and lessons learned from other countries.

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J Infect Dis. (2012) doi: 10.1093/infdis/jis677

First published online: November 5, 2012

Juliane Doerrbecker1, Patrick Behrendt1,2, Pedro Mateu-Gelabert4, Sandra Ciesek1,2, Nina Riebesehl1, Corinne Wilhelm1, Joerg Steinmann3, Thomas Pietschmann1 and Eike Steinmann1

+ Author Affiliations

Correspondence: Eike Steinmann, PhD, Division of Experimental Virology, Twincore Center for Experimental and Clinical Infection Research, Feodor-Lynen-Stra├če 7-9, 30625 Hannover, Germany (eike.steinmann@twincore.de).

Abstract

Background. Hepatitis C virus (HCV) transmission among people who inject drugs remains a challenging public health problem. We investigated the risk of HCV transmission by analyzing the direct association of HCV with filters, water to dilute drugs, and water containers.

Methods. Experiments were designed to replicate practices by people who inject drugs and include routinely used injection equipment. HCV stability in water was assessed by inoculation of bottled water with HCV. Viral association with containers was investigated by filling the containers with water, inoculating the water with HCV, emptying the water, and refilling the container with fresh water. Transmission risk associated with drug preparation filters was determined after drawing virus through a filter and incubating the filter to release infectious particles.

Results. HCV can survive for up to 3 weeks in bottled water. Water containers present a risk for HCV transmission, as infectious virions remained associated with water containers after washing. Physical properties of the water containers determined the degree of HCV contamination after containers were refilled with water. HCV was also associated with filter material, in which around 10% of the viral inoculum was detectable.

Conclusions. This study demonstrates the potential risk of HCV transmission among injection drug users who share water, filters, and water containers and will help to define public health interventions to reduce HCV transmission.

Received July 9, 2012. Accepted August 21, 2012.

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Patients rarely told about medication errors

By Andrew M. Seaman

NEW YORK | Fri Jan 11, 2013 4:58pm EST

NEW YORK (Reuters Health) - Patients and their families are rarely told when hospitals make mistakes with their medicines, according to a new study.

Most medication mistakes did not harm patients, the researchers found, but those that did were more likely to happen in intensive care units (ICUs). And ICU patients and families were less likely to be told about errors than patients in other hospital units.

"For the most part, our findings were in keeping with what the existing literature tells us about the where and how of medication errors in a hospital," wrote Dr. Asad Latif, the study's lead author, in an email to Reuters Health.

"The most surprising finding was what we do about them, at least in the immediate time around when they occur," added Latif, from the Johns Hopkins University School of Medicine in Baltimore.

Using a database of about 840,000 voluntarily reported medication errors from 537 U.S. hospitals between 1999 and 2005, the researchers found that ICUs accounted for about 56,000, or 6.6 percent, of the errors. The rest happened in non-ICU units of the hospital.

The vast majority of the mistakes - about 98 percent - didn't lead to a patient being harmed, but those that did were more likely to happen in the ICUs, the researchers reported in Critical Care Medicine.

About four percent of the errors in ICUs ended up harming a patient, compared with about two percent of errors in non-ICU wards. That's not surprising given the fragile condition of ICU patients and the more intensive treatment they receive, the authors note.

Of errors that may have led to patient deaths, 18 occurred in ICUs and 92 in non-ICU areas of the hospital.

In ICUs and non-ICUs, errors of omission - failing to give a patient the medication - were most common. Harmful errors most often involved devices like IV lines and mistakes in calculating medication dosages.

More than half of the time, no actions were taken after an error. In fact, only a third of the hospital staff who made the reported mistakes were immediately told about their errors.

"And the patient and/or their family is immediately informed when an error occurs barely two percent of the time, despite literature supporting full disclosure and their desire to be promptly informed," Latif said.

Still, Latif said it would be premature for patients and their families to be concerned based just on their findings.

"Studies like this give us the opportunity to find out how we are actually doing, compared to how we think we are doing," he said. "They help us discover associations between the outcomes we are interested in and their potential causes and consequences."

Recent research has found that instituting a blame-free reporting system in hospitals increases the number of reported mistakes (see Reuters Health story of November 21, 2011 here: reut.rs/RKo4oJ).

According to the new paper, one prior study demonstrated that medication errors can add an extra $2.8 million in costs at a single hospital.

Latif added that the healthcare system is always trying to reduce medication mistakes.

"However nothing is fool-proof as we show in our study; there is always the human factor to take into account. The key is what we do if they do happen and to keep striving for perfection," Latif said.

SOURCE: bit.ly/RJWvfa Critical Care Medicine, online December 20, 2012.

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Streaming Well video series aims to promote liver health

11th January 2013

Digital health publisher teams up with the British Liver Trust

London-based healthcare video publisher Streaming Well has launched a series of liver health videos to mark the British Liver Trust’s January Love Your Liver Month.

The videos, which are shared across a network of health channels as well as social media platforms such as YouTube and Facebook, are a series of short educational films that highlight the dangers of liver disease.

Francis Namouk, CEO and co-founder at Streaming Well, explained: “Today we have the ability to reach people with important information that can go viral within minutes.

“The internet is vital in spreading health messages to many people in a highly efficient and accessible manner. These videos are part of a campaign that is vital in limiting the amount of liver-related deaths this country sees every year”.

The films feature consultant hepatologist Dr Mark Wright, who discusses various causes of liver disease, such as alcohol abuse, obesity, high bloody cholesterol and viral infections.

“The problem with the liver is that it suffers in silence,” said Wright.

“You don’t get any symptoms from liver disease until you start presenting complications. At this stage there is less we can do.”

Andrew Langford, chief executive of the British Liver Trust, added: “Year on year we are seeing a significant increase in numbers of people with liver disease and consequent rise in the number of deaths from liver conditions.

“Unfortunately this is alongside a steady decrease in the average age of people dying, with the current average being 58 and it becoming more common to see 20/30 year olds with advanced liver disease on hospital wards,” he finished.

The series marks the first collaboration between British Liver Trust and Streaming Well.

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FDA seeks staff fellow for hepatitis C research

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Published on January 11, 2013 by Bryan Cohen

The U.S. Food and Drug Administration’s Center for Biologics Evaluation & Research recently announced a new position for a staff fellow within its Laboratory of Hepatitis Viruses.

The position, which will fall under the Office of Vaccines Research and Review, will perform novel research using mouse model systems to support hepatitis virus replication. The LHV is currently engaged in research on the molecular biology of the hepatitis virus, particularly studies related to vaccine for the hepatitis C virus.

The fellow will be required to perform regulatory review such as product chemistry, manufacturing and control and validation, and review of clinical protocols, in addition to review of experimental and licensed hepatitis virus vaccines.

According to the Centers for Disease Control and Prevention, hepatitis C is a contagious liver disease caused by infection with the hepatitis C virus. The disease can range in severity from a mild illness that lasts a few weeks to a chronic and more serious illness.

Acute hepatitis C virus infection can lead to chronic infection. When the hepatitis C virus remains in a person’s body, it can cause serious liver problems, scarring of the liver or liver cancer.

The fellow position will first be located on the National Institutes of Health campus in Bethesda, Md., and will be relocated to the FDA’s White Oak campus in Silver Spring, Md. in mid-2014.

This story filed in FDA and tagged Hepatitis.

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New insights into HIV vaccine will improve drug development

Public release date: 10-Jan-2013

Contact: Sarah Avery
sarah.avery@duke.edu
919-660-1306
Duke University Medical Center

DURHAM, N.C. – Four years ago, a potential HIV vaccine showed promise against the virus that causes AIDS, but it fell short of providing the broad protection necessary to stem the spread of disease.

Now researchers -- led by Duke Medicine and including team members from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, the U.S. Military HIV Research Program and the Thailand Ministry of Health -- have gained additional insights into the workings of the vaccine that help explain why it benefited a third of recipients and left others vulnerable. The findings, reported in the Jan. 10, 2013, issue of the journal Immunity, are providing new options for vaccine designers to strengthen the drug.

"This study shows what types of antibodies the vaccine induced and gives us information that can guide the study of future vaccine trials," said senior author Barton Haynes, M.D., director of the Duke Human Vaccine Institute. "Understanding how this vaccine works is important to develop strategies to make it better."

The research team focused on an HIV vaccine candidate tested in the RV144 trail in Thailand. In 2009, AIDS researchers reported that the vaccine protected 31.2 percent of study participants from HIV infection. It was an encouraging protection rate, but short of the minimum 50-percent efficacy required to slow the epidemic, which afflicts an estimated 34 million people worldwide.

Since that time, researchers have been studying the vaccine for clues to its successes and failures in the hopes of making improvements. Haynes and colleagues reported last year they had found a correlation between a key antibody response to the drug and a lower risk of infection.

"But that was a correlation of risk, not necessarily a correlation of protection," Haynes said. "We couldn't prove that the antibody was the cause of protection."

In the current study, the researchers have strengthened the association between the vaccine-induced antibodies and found crucial characteristics of the antibodies induced by the vaccine. Analyzing the immune responses produced by three vaccine recipients in the original trial, the researchers isolated four key antibodies that targeted an important site on the HIV virus – a region known as V2.

In spite of variations in the V2 site's structure, the antibodies zeroed in on the virus, specifically binding at a position on the virus' outer coating that was already known for attracting immune warriors called neutralizing antibodies.

But the researchers found that the four vaccine-triggered antibodies worked differently than the neutralizing antibodies. Instead of attacking the virus directly, the vaccine-induced antibodies recognized virus-infected cells and flagged them for an attack by other immune cells.

The findings indicate that these types of V2 antibodies expand the immune system’s arsenal against HIV, potentially enhancing the effects of the vaccine used in the RV144 trial.

"The next step for our research is to explore how to design immunogens to induce antibodies that can have broadly neutralizing activities," said Hua-Xin Liao, M.D., PhD, lead author and research director of Duke Human Vaccine Institute. "Our findings provide new targets for this research."

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In addition to Haynes and Liao, study authors from Duke include Mattia Bonsignori, S. Munir Alam, Georgia D. Tomaras, M. Anthony Moody, Daniel M. Kozink, Kwan-Ki Hwang, Xi Chen, Chun- Yen Tsao, Pinghuang Liu, Xiaozhi Lu, Robert J. Parks, David C. Montefiori, Guido Ferrari, Justin Pollara, Kevin Wiehe and Nathan I. Nicely.

Other authors include Jason S. McLellan, Zhi-Yong Yang, Kaifan Dai, Marie Pancera, Jason Gorman, Peter D. Kwong, John R. Mascola and Gary J. Nabel of the Vaccine Research Center of the NIH; Mangala Rao, Kristina K. Peachman, Jerome H. Kim and Nelson L. Michael of the Walter Reed Army Institute of Research; Sampa Santra and Norman L. Letvin from Harvard Medical School; Nicos Karasavvas and Sorachai Nitayaphan from U.S. Army Medical Component, Bangkok, Thailand; Supachai Rerks-Ngarm from the Ministry of Public Health, Thailand; Jaranit Kaewkungwal and Punnee Pitisuttithum of Mahidol University, Thailand; James Tartaglia of Sanofi Pasteur; Faruk Sinangil of Global Solutions for Infectious Diseases; Thomas B. Kepler of Boston University School of Medicine; Abraham Pinter of New Jersey Medical School; and Susan Zolla-Pazner of VA New York Harbor Healthcare System and New York University School of Medicine.

This study received support from the Bill & Melinda Gates Foundation; the National Institute of Allergy and Infectious Diseases (AI067854, AI100645); the Department of Veterans Affairs; the U.S. Army; the Medical Research and Material Command; the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.; and the U.S. Department of Defense.

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U.S. top court to review free speech of HIV/AIDS groups

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By Jonathan Stempel

Fri Jan 11, 2013 4:26pm EST

(Reuters) - The U.S. Supreme Court agreed to consider whether the government can require groups that receive federal funding for overseas HIV/AIDS programs to have explicit policies that oppose prostitution and sex trafficking.

The requirement that the U.S. Agency for International Development wants enforced was the result of legislation aimed at fighting the spread of HIV/AIDS, but some aid groups argue that it violates their free speech rights.

In a brief order, the Supreme Court on Friday agreed to hear an appeal by the Obama administration and various federal agencies to overturn a lower court decision that had voided the requirement, which is contained in the U.S. Leadership Against HIV/AIDS, Tuberculosis, and Malaria Act of 2003.

Judge Barrington Parker wrote for a 2-1 panel of the 2nd U.S. Circuit Court of Appeals in New York that the challenged provision improperly "compels recipients to espouse the government's viewpoint." He also said advocacy against prostitution is not central to the fight against HIV and AIDS.

The dissenting judge, Chester Straub, countered that the policy requirement was "entirely rational," and neither imposed a coercive penalty on protected rights nor discriminated as a means to suppress ideas.

In its appeal, the government said the 2nd Circuit decision conflicted directly with a 2007 decision by a federal appeals court in Washington.

The funding recipients, including the Alliance for Open Society International Inc, said the 2nd Circuit decision was correct.

A decision is expected by the end of June.

The case is U.S. Agency for International Development et al v. Alliance for Open Society International Inc et al, U.S. Supreme Court, No. 12-10.

(Reporting by Jonathan Stempel; Editing by Eddie Evans)

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