September 3, 2010

H.I.V. Prevention Gel Hits Snag: Money

Joao Silva for The New York Times
Volunteers who took part in a trial of a microbicide listened to results in Vulindlela, Kwazulu-Natal Province, South Africa.

Published: September 3, 2010
JOHANNESBURG — When scientists celebrated the announcement in July that a vaginal microbicide had finally been found that significantly reduced H.I.V. infections in women, there was still a prosaic — though essential — piece of the puzzle missing: money.
Donors have not committed enough money for even one of the two studies needed to confirm a promising South African trial of the microbicide and get it into women’s hands. Only about $58 million of the $100 million needed for follow-up research has been pledged, according to Unaids, the United Nations AIDS agency. Experts say shifting global health priorities and tight finances in the West are making it hard to raise the rest.

Advocates say any delay could be deadly. Most of the 22 million people infected with H.I.V. in sub-Saharan Africa are women, and about a million women on the continent are infected each year. If subsequent studies find the gel effective, women could use it to protect themselves even when men refuse to use condoms.

“We have to keep our eye on the prize,” said Dr. Catherine Hankins, chief scientific adviser to Unaids. “It’s in reach. We have to close the funding gap and get the gel to women.”

Dozens of scientists and public health experts at a conference here last week agreed on the research needed to speed the microbicide to widespread use. They called for two more trials in southern Africa and steps to promote and distribute the vaginal gel, infused with the antiviral drug tenofovir, through family planning programs.

The original study of the gel found that women who used it before and after sex were 39 percent less likely over all to contract H.I.V. than those who used a placebo. Those who used the gel most regularly cut their odds of infection by 54 percent.

Researchers have tried for two decades to find a microbicide to fight H.I.V. transmission. So far, the American and South African governments have come up with a vast majority of the additional research money, while Britain’s Department for International Development, a major supporter of microbicide research, has committed nothing.

Participants in the conference said an agency official said the British government’s priorities were shifting away from AIDS and toward maternal and child health, malaria and tuberculosis.

“H.I.V./AIDS is perceived to be very expensive research, and there’s a sentiment in the U.K. that it’s time to shift priorities,” said Tim Farley, a World Health Organization scientist who attended the conference.

The British agency was noncommittal in a statement, saying that future spending “will be made based on impact on poverty eradication on the ground.”

Researchers also worry that the Bill and Melinda Gates Foundation, the most important philanthropic supporter, has not committed major financing for the additional studies on the gel. Dr. Stefano Bertozzi, who heads the foundation’s AIDS programs, said the gel — with a solid study showing its effectiveness — was just the kind of project that rich countries could justify to taxpayers. “It should be an easy case for South Africa, ourselves and others to make,” Dr. Bertozzi said.

He said the foundation was excited about the results, but tried to focus on riskier, longer-term research. The foundation has committed more than $250 million to microbicide research.

The hope is that two additional studies would provide the evidence to adopt the gel on a large scale. Three rigorous studies have established that male circumcision reduces a man’s risk of H.I.V. infection by at least half, and governments across Africa are beginning to offer it.

For the microbicide, researchers plan to lead one of the confirmatory studies in South Africa, where an estimated 5.7 million people are infected, more than in any other nation. Scientists would conduct the second study in five southern African nations.

Experts say investing in AIDS prevention is fiscally far preferable to the costs for lifelong treatment. Mead Over, a health economist at the Center for Global Development, says that providing antiretroviral therapy to the five million people with AIDS in Africa already receiving it will cost $72 billion over the next four decades. That amount rises to $225 billion if the number of people on treatment continues to grow.

“Donors should not be nickel and diming this research because by spending only $100 million they have a prospect of saving billions of dollars in treatment costs,” Mr. Over said.

Advocates make the case on humanitarian grounds.

“We see every day women getting infected by H.I.V.,” said Nomfundo Eland of the Treatment Action Campaign, an advocacy group here. “The sooner we can get a method in the control of women the better.”


Week 4 Rapid Virological Response Predicts Sustained Response to Interferon-based Hepatitis C Treatment

SUMMARY: Rapid virological response (RVR), or undetectable plasma hepatitis C virus (HCV) RNA at 4 weeks after starting treatment with pegylated interferon plus ribavirin, has been confirmed as a good indicator of which patients will go on to achieve sustained virological response (SVR) at 6 months after completion of therapy, according to a review article published in the June 2010 issue of Alimentary Pharmacology and Therapeutics.

By Liz Highleyman

Standard treatment for chronic hepatitis C using pegylated interferon (Pegasys or PegIntron) plus ribavirin produces sustained response -- considered to be a cure -- about half the time, with HCV genotypes 2 and 3 (treated for 24 week) showing better response rates than hard-to-treat genotypes 1 or 4 (treated for 48 weeks).

Treatment is expensive and can cause difficult side effects, however, so it is useful to have an early indicator to enable patients to stop treatment that likely will not turn out to be successful.

F. Fred Poordad from Cedars-Sinai Medical Center in Los Angeles and colleagues collected data from previous published clinical trial reports in order to evaluate the predictive value of RVR as an indicator of SVR and viral relapse.

  • Data supported a 24-week regimen for HCV genotype 1 patients who achieved RVR.
  • The positive predictive value -- or how often RVR accurately predicted SVR -- was 77.8% for patients treated for 24 weeks versus 85.7% for those treated for 48 weeks, not a significant difference.
  • However, lack of RVR among genotype 1 patients "should not be viewed as a criterion for extending treatment duration beyond 48 weeks."
  • Negative predictive values -- or how often lack of RVR predicted failure to achieve SVR -- were 60.9% for genotype 1 patients treated for 48 weeks and 52.7% for those treated for 72 weeks, not a significant improvement with longer therapy.
  • Among people with HCV genotypes 2 or 3, RVR also had a high positive predictive value.
  • Negative predictive value, however, varied according to treatment duration, indicating that a 24-week regimen is warranted for genotype 2 or 3 patients who did not achieve RVR. 
Based on these findings, the study authors concluded, "The present analysis confirms RVR as a strong predictor of SVR that can be used to tailor treatment duration, but which also should be appreciated in the context of treatment duration and regimen."

Investigator affiliation: Hepatology and Liver Transplantation, Cedars-Sinai Medical Center, Los Angeles, CA.


FF Poordad. Review article: the role of rapid virological response in determining treatment duration for chronic hepatitis C. Alimentary Pharmacology and Therapeutics 31(12): 1251-1267 (Abstract). June 2010.


First Medical Marijuana Ad on TV (Video)

Friday, September 3rd, 2010 at 6:20 am

In Sacramento, California, the first medical marijuana ad was aired on television. The local Fox affiliate, KTXL, FOX40, aired the 30 second ad on Monday for CannaCare. The commercial (see video below) features testimonials for patients as the text ‘crawl’ describes how cannabis can relieve symptoms of illnesses such as hypertension, diabetes, HIV, hepatitis C and others. The commercial is believed to be the first in the United States for medical marijuana. CannaCare is not a medical marijuana dispensary, which are the places patients go to purchase cannabis.

The acting general manager of KTXL, Mike Armstrong, defends the station’s decision to run the ad during it’s 10pm local news broadcast. “It is a matter of record within the medical community that medical marijuana can have positive results in helping relieve nausea and vomiting among cancer patients receiving chemotherapy and increasing appetites among AIDS patients.”

CannaCare is a medical marijuana advocacy group. They do NOT sell marijuana! They primarily offer patients and the general public information on the medical use of marijuana as well as the legal details regard state and community laws. CannaCare does provide information on growing and cultivating marijuana, plus a list of suppliers of growing equipment.

Based in Seattle, CannaCare has branches in several states that have adopted medical marijuana laws. The TV ad does not use the term ‘marijuana’ at all during it, instead calling the product cannabis. Medical Marijuana relieves diseases such as AIDS/HIV, MS, diabetes, as well as chronic pain from arthritis. It’s benefits to assisting cancer patients ravaged by the side effects of chemotherapy are well documented.

KTXL, the Fox affiliate in Sacramento, has broken ground airing the first medical marijuana ad in the nation. There is no word yet if CannaCare intends to expand the ad campaign to include other states that allow the use of cannabis. Watch the commercial yourself (below) and decide for yourself if it will destroy Western Civilization.

Related Articles:

Fox Affiliate Airs Nation’s ‘First’ TV ad For Medical Marijuana

Medical Marijuana Hits the Small Screen

CannaCare Home Page


Why DNA Vaccines May Be Commercially Viable

By: Jim Nelson Friday, September 03, 2010 11:13 AM
In the early 1990s, DNA vaccines for the treatment and prevention of diseases first emerged. Excitement about this technology was matched only by unrealistic expectations regarding the timeline to market. Interest was driven, however, by the real potential of the technology. For the first time, unvaccinatable targets like HIV and hepatitis C were in the bull's-eye. Traditional vaccine technology, using live or inactivated viruses, simply did not provide a viable way to provoke a protective immune response against these diseases.
Moreover, DNA vaccines could be used against diseases other than their historical target, viruses. Early on, it dawned on researchers that this new generation of vaccines could be used to train the immune system to attack cancers and a wide range of other malignancies that act like foreign invaders inside the body.

Conventional vaccines work by having the body's immune system recognize unique antigenic proteins that are part of the virus, triggering an immune response against the invader. The elegance of DNA vaccines is that, rather than introducing into the body an actual virus, only the antigen that would be recognized as foreign is introduced. Scientists realized that they could turn cells in the body into protein-manufacturing plants. By isolating the DNA responsible for producing ONLY the foreign antigenic protein associated with a specific virus, they could get around various issues associated with live or weakened viruses.

Big Pharma companies like Merck, Wyeth and GlaxoSmithKline as well as national labs and academic research facilities poured billions into a "first wave" attempt at producing commercially viable DNA vaccines. Problems delivering the DNA vaccines in a way that provoked a sufficient immune response soon dampened their enthusiasm.

Two basic problems prevented the development of truly effective DNA vaccines. The first was an immature understanding of genetics. In those days, researchers were only beginning to learn how to optimize the DNA sequences to produce antigens with maximum impact. Additionally, there was the familiar "delivery" problem. Cells didn't absorb enough of the DNA plasmids to become effective antigen factories. Since the amount of antigens produced by the body was therefore low, the immune response was insufficient to form the basis of viable drugs.

As a result, early DNA vaccine trials in humans were disappointing. The flow of research dollars slowed. Behind the scenes, however, determined scientists in dedicated startups never lost confidence in the core science. As importantly, alliances were formed and diverse discoveries merged. In recent years, their work has finally begun to bear fruit. I have been aware of this fact for some time. Until now, however, I hadn't identified a company that fits in the Breakthrough Technology Alert portfolio.

But thanks to a series of mergers, a single company holds all the talent and IP needed to deliver on the breakthrough potential of DNA vaccine technology. In fact, they appear to have solved the problems faced by early DNA vaccine researchers.


Cardiff trial for new hepatitis C drug 'successful'

2 September 2010 Last updated at 10:52 ET

Scientists say the first human clinical trials on a new drug to treat infections caused by the Hepatitis C virus have been successfully completed.

The oral medication INX-189, prepared at Cardiff University's Welsh School of Pharmacy in 2008, could now become an approved medicine, the school said.

Around 170m people worldwide have the condition which can cause liver cancer, cirrhosis and death.

Prof Chris McGuigan said the Cardiff trial showed "the drug is safe".

Hepatitis C is the leading cause of liver transplantation in western countries, explained Prof McGuigan, the academic lead on the trials.

The current treatment involves two drugs - ribavirin and interferon, which has to be given as an injection.

Side effects are often severe and lead to patients failing to complete the treatment.

But Prof McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.

"Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg," he said.

He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.

Second trial

In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.

The licence to INX-189 is owned by US pharmaceutical company Inhibitex, which has been working with the Cardiff team.

The company has announced it is looking forward to a second trial to evaluate the compound's effectiveness in Hepatitis C patients.

Cardiff University and Inhibitex filed a patent on INX-189 earlier this year.

It has been cleared for human clinical trials by the Food and Drug Administration in the US.


New Partnership forms to Address the Hepatitis B and C Epidemic in Europe

LUXEMBOURG, September 2, 2010 /PRNewswire/ -- At least 23 million European Union (EU) citizens are currently living with hepatitis B or hepatitis C[i]. In a direct response to the health burden this presents and the recent recognition by the WHO of the seriousness of hepatitis as a global health issue, a unique Partnership comprising key international public and private stakeholders has formed to drive the first EU-wide initiative on hepatitis B and C.

The new Partnership will work to achieve the formation of a European-wide strategy on the communication, prevention and management of viral hepatitis as a healthcare priority. As a first step towards this, the Partnership will host the Hepatitis B and C Summit Conference on 14-15th October 2010, where the latest research and advances will be presented and used to inform and drive future EU strategies and action plans in this neglected disease area. New studies will assess the impact of mobility of populations and patient self-help programmes in relation to the hepatitis epidemic.

Professor Angelos Hatzakis of Athens University Medical School and one of the co-chairs of the Partnership Steering Group said: "The burden and challenges associated with viral hepatitis across Europe require the active and concerted involvement of a broad range of stakeholders. Patients, specialists, primary health care providers, epidemiologists, policy makers, those responsible for health budgets, the general public, advocates, donors and the pharmaceutical sector should all work together to deliver the results so needed for these urgent diseases."

The new Partnership involves the European Association for the Study of Liver Disease (EASL) and the European Liver Patient Association (ELPA). Other contributors include the Viral Hepatitis Prevention Board (VHPB), the World Hepatitis Alliance (WHA) and the European Centre for Disease Prevention and Control (ECDC). The conference is supported by the European Commission's Directorate-General for Health and Consumer Protection (DG SANCO) and is being held under the auspices of the current EU Belgian presidency.

Nadine Piorkowsky, President of the European Liver Patients Association (ELPA) and co-chair of the Partnership Steering Group stated: "The development and implementation of specific policies to prevent, diagnose and control hepatitis B and C are long overdue as the burden of these diseases has significantly increased for the last ten years. This conference constitutes an important step forward as we will bring all the latest research to the table with a view to collectively evaluating the findings. The aim of this conference will be to present EU Member States with concrete policy recommendations on hepatitis B and C that can be implemented in their future health programmes."

[i] WHO Europe Region. Hepatitis Fact and Figures.

Accessed 20.08.10

(Due to the length of this URL, it may be necessary to copy and paste this hyperlink into your Internet browser's URL address field. Remove the space if one exists.)

Notes to editors

Contact details

For more information on attending the event and to arrange interviews, journalists should contact our press office:

Isabelle Scali

For more details on the conference and the full list of members of the Steering Group visit:

Distributed by PR Newswire on behalf of Hepatitis B and C Summit Conference


Prevalence and risk factors of hepatitis B and C viruses among haemodialysis patients in Gaza strip, Palestine

The prevalence of hepatitis B virus (HBV) and hepatitis C virus (HCV) and its associated risk factors among haemodialysis (HD) patients in Gaza strip was investigated using serological and molecular techniques.

Results: The overall prevalence of HBV among the four HD centers was 8.1%. The main risk factors were HD center (p=0.05), history of blood transfusion (p<0.01), and treatment abroad (p=0.01).

The overall prevalence of HCV among the four HD centers was 22%. The main risk factors were HD center (p<0.01), time duration on HD (p<0.01), history of blood transfusion (p<0.01), treatment abroad (p<0.01), and history of blood transfusion abroad (p<0.01).

Serum aminotransferases levels decreased in HD patients compared with normal population but still there was a direct association between the activity of liver enzymes and both HBV (p<0.01) and HCV (p<0.01) infection.

Conclusion: The much higher prevalence of Hepatitis viruses among HD patients compared to the normal population of Gaza strip indicates a causative relation between HD and hepatitis viruses transmission. Therefore extremely careful observation of preventive infection control measures is essential to limit Hepatitis viruses'transmission in HD centers.

Author: Abed El-kader El-OttolAbdelraouf ElmanamaBasim Ayesh

Credits/Source: Virology Journal 2010, 7:210

Published on: 2010-09-01

Will Aging Chimps Get to Retire, or Face Medical Research?

Sinbad, thought to be at least 35, is now at a sanctuary in Florida.

Published: September 1, 2010

ALAMOGORDO, N.M. — Flo the chimpanzee bounds about her enclosure, hurls a rubber ball then stares quizzically at the New Mexico green chili pepper that will be her morning snack.

It has been a long time since Flo was on exhibit at the Memphis Zoo, even longer since she learned to smoke cigarettes during a stint with the circus. Most recently, she was a research chimpanzee here in New Mexico, part of an expansive biomedical testing program for hepatitis C and H.I.V.

At the moment, though, she is out of a job — but perhaps not for long.

Flo and the 185 other chimpanzees who live at the Alamogordo Primate Facility at Holloman Air Force Base have not been research subjects for nearly a decade — part of an agreement between the National Institutes of Health and the military, which prohibits using the animals for biomedical tests on the base.

But recently, the health institute decided it wanted to use the chimp colony for medical research again, primarily to help develop the elusive hepatitis C vaccine. This past June, the institute began shipping some of the animals by special trucks to the Southwest National Primate Research Center in San Antonio and plans on moving the remaining chimpanzees by the end of 2011.

The move has spurred outrage among animal rights advocates, primate experts and politicians, who say the chimpanzees — many of them middle-aged and elderly — should get to live out the rest of their lives in peace after years of invasive research. It has also cast a fresh light on the debate over the tipping point between science and ethics, with everyone from the legendary primatologist Dr. Jane Goodall to Gov. Bill Richardson of New Mexico weighing in.

“These chimpanzees have given up their freedom, if not their natural environment, their bodies, their health, their children to research,” said Laura Bonar, program director for Animal Protection of New Mexico, which wants the government to turn the Alamogordo facility into a retirement sanctuary for the chimps. “And at the end of their lives, we can give them something back.”

For the health institute, though, the Alamogordo chimpanzees represent an invaluable resource. As per the agreement with the Air Force, biomedical research cannot be conducted on the animals. That agreement was forged after the institute acquired the chimpanzees from the Coulston Foundation, an infamous New Mexico research laboratory that was found by federal officials to have abused and neglected the animals.

In 2001, the institute gave the private Charles River Laboratories a 10-year contract to provide medical care to the chimps, most of whom have been infected or exposed to hepatitis C and H.I.V. through prior research.

These days, chimps like Flo, who at 53 is the oldest of the Alamogordo colony, spend their days living in small groups in geodesic domes: foraging for food, swinging from structures and whooping greetings at visitors and one another.

Harold Watson, who heads the chimpanzee research program for the National Center for Research Resources, said that with the end of the contract, it only makes sense to use the chimps for their original purpose. The research — which will most likely entail drawing periodic blood samples, liver biopsies and in some cases inoculations of hepatitis C — will be carefully monitored, he said.

“I think people envision pictures of monkeys with electrodes in their heads,” Dr. Watson said. “This is not what we’re talking about.”

The history of primate research, however, has been long and controversial. Because of their genetic closeness to humans, chimpanzees are considered well-suited for studies of how various infectious diseases or psychological environments might affect mankind.

But some have questioned whether that research has yielded any substantive breakthroughs, and the United States is currently the only developed country that continues large-scale confinement of chimps in laboratories, according to the Humane Society of the United States. Supporters of the research say the animals have been critical in the development of hepatitis A and B vaccines.

Pending Congressional legislation known as the Great Ape Protection Act would retire about 500 federally owned chimpanzees currently in laboratories to permanent sanctuary. The Alamogordo colony traces its lineage to the Air Force’s space chimp experiments in the late 1950s. A decade later, the toxicologist Frederick Coulston set out to build the world’s largest captive colony of chimpanzees for research, in New Mexico. His foundation’s tenure was marred by charges of severe mistreatment.

That legacy still haunts the health institute, which got 288 of the chimpanzees around 2001 and has tried to distance itself from the Coulston Foundation.

John Gluck, a professor emeritus of psychology at the University of New Mexico, who has visited the Alamogordo colony at least four times since the 1970s, is worried what a move to Texas would mean for the animals’ physical and mental health, particularly given “the tremendous price” paid by most of the chimpanzees while research subjects of the Coulston Foundation, he said.

“N.I.H., in general, is a place I respect,” Dr. Gluck said. “But it seems to me that they’ve lost both their ethical and scientific compass here.”

Governor Richardson has also urged the institute to reconsider, and Dr. Goodall wrote to the institute that the chimpanzees “will surely suffer considerable physical and emotional distress from this plan.”

Dr. Lon Lammey, the director of the Alamogordo primate facility for Charles River, the private contractor, disputed the notion that the move would be harmful, and said he was “confident the animals would continue to receive optimal medical care.”

Despite the mounting pressure, the institute has shown little sign of changing its plan.

Some 15 miles from the base, a separate group of 82 chimpanzees are also waiting to be moved, but to a lush Florida sanctuary run by Save the Chimps, a rescue group.

The animals were part of a larger group handed over to the rescue organization by the Coulston Foundation after its demise and have gradually been moved to Florida over the past few years. Save the Chimps wants the institute to permanently retire the rest of the Alamogordo chimpanzees to a sanctuary as well.

At the old Coulston facility, which has been transformed into a temporary sanctuary itself, a 13-year-old chimp named JJ clutched a bundle of security blankets while readying for lunch. As a worker placed bushels of fruit in the enclosures, the chimpanzees began to yelp in unison, their cries carrying across the high desert.