News (Updated May 15, 2011)

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Experts debate destroying last smallpox viruses

(AP) – 14 May, 2011

LONDON (AP) — Smallpox, one of the world's deadliest diseases, eradicated three decades ago, is kept alive under tight security today in just two places — the United States and Russia.

Many other countries say the world would be safer if those stockpiles of the virus were destroyed.

Now for the fifth time, at a World Health Organization meeting next week, they will push again for the virus' destruction. And again it seems likely their efforts will be futile.

U.S. and Russian government officials say it is essential they keep some smallpox alive in case a future biological threat demands more tests with the virus. They also say the virus samples are still needed to develop experimental vaccines and drugs.

It was in 1996 that WHO's member countries first agreed smallpox should be destroyed. But they have repeatedly delayed a demand for destruction so that scientists could develop safer smallpox vaccines and drugs. That's now largely been done: There are two vaccines, a third in the works, and there are experimental drugs being developed for treating it, but not curing it.

Yet even if most of WHO's member countries vote to set a new date for destruction, the agency doesn't have the power to enforce the decision.

The scientific community remains divided over whether the smallpox samples should be destroyed. The respected journal Nature editorialized against it earlier this year, arguing that scientists need the ability to do further research, and perhaps develop new vaccines and treatments in an era of possible biological attack. However, one of the most prominent figures in wiping out the deadly, disfiguring disease is in favor of destroying all remnants of it.

"It would be an excellent idea to destroy the smallpox viruses," said Dr. Donald A. Henderson, who led WHO's eradication effort in the 1970s. "This is an organism to be greatly feared."

He says possession of smallpox by those not authorized to have it should be made a crime against humanity and that international authorities should prosecute any country found with it.

A report by independent researchers commissioned by WHO last year concluded there was no compelling scientific reason to hang onto the viruses and that the stockpiles were mainly needed to continue advanced development of the drug treatment and satisfy regulatory requirements. Yet other scientists contend the stockpiles could still provide valuable information in the future.

Smallpox is one of the most lethal diseases in history. For centuries, it killed about one-third of the people it infected, including Queen Mary II of England , and left most survivors with deep scars on their faces from the hideous pus-filled lesions. The last known case was in Britain in 1978 when a university photographer who worked above a lab handling smallpox died after being accidentally exposed to it from the building's air duct system.

Smallpox vaccines are made from vaccinia, a milder related virus. "We have many ways of looking at smallpox, including gene mapping, that means we don't need the actual (smallpox) virus," said Henderson, who is now with the Center for Biosecurity at the University of Pittsburgh Medical Center.

American and Russian officials disagree.

Dr. Nils Daulaire, director of the U.S. Department of Health and Human Services' Office of Global Affairs, said the U.S. will again ask WHO to postpone a decision calling for the stockpile's destruction. He said U.S. scientists need more time to finish research into how well new vaccines and drugs work against the virus. But he acknowledged U.S. officials also want their own supply in case terrorists unleash smallpox as a biological weapon and additional study is needed.

A scientist at the Russian laboratory where smallpox is kept, who spoke anonymously because he was not authorized to speak to the press, said the virus should be kept in case similar ones pop up in the future and more studies are needed.

Meanwhile, officials from developing countries are anxious to close the last chapter on the disease.

"There is a consensus to destroy the viruses, so how come we're in this situation where we're pandering to the U.S. and Russia ?" asked Lim Li Ching, a biosafety expert at Third World Network, a group that lobbies on behalf of developing countries.

Oyewale Tomori, a virology professor at Redeemer's University in Nigeria , said most African countries want smallpox destroyed. Tomori also sits on a WHO Advisory Committee on smallpox. " Africa is one part of the world where a biological attack with smallpox is likely to have a more devastating effect," he said.

Keiji Fukuda, WHO's assistant director-general for health security and the environment, said the agency remains concerned about the possibility of smallpox's return. "The chance of an outbreak is reasonably low, but not zero," he said. With the new vaccines and drugs, Fukuda was optimistic any smallpox outbreak would be stamped out relatively quickly though acknowledged any new cases might spark global alarm.

"If smallpox were to reappear, we would be in a much better situation than in the past, considering the vaccine supplies and strategies that have been demonstrated to work," he said. He guessed that stamping out a smallpox outbreak would be faster than the four months it took to mostly end the 2003 global outbreak of SARS, where doctors could only isolate patients and trace suspect cases. With smallpox, Fukuda said countries could quickly vaccinate people in surrounding areas and that drugs could be sent to treat patients.

Fukuda said many rich countries like the U.S. have their own smallpox vaccine stockpiles. WHO also has at least 30 million doses for poor countries in case the virus re-emerges, but that supply uses older vaccines that can trigger AIDS in people who have HIV.

David Evans, a smallpox expert at the University of Alberta , who was part of the WHO team that inspected the U.S. and Russian labs holding smallpox several years ago, says he doubts the virus could escape from either facility. The viruses are kept at the U.S. Centers for Disease Control and Prevention in Atlanta and the State Research Center of Virology and Biotechnology in Novosibirsk , Siberia .

Laboratories where smallpox is kept have the highest possible containment measures. Scientists who work with the virus use fingerprint or retinal scans to get inside, wear a full-body suit including gloves and goggles, and shower with strong disinfectant before leaving the lab and taking off the suit. The U.S. smallpox viruses, which include samples from Britain , Japan and the Netherlands , are stored in liquid nitrogen.

Rumors about stockpiles in countries like Iraq and North Korea have never been proven, and Evans said it would be too difficult to experiment with smallpox and keep it a secret. "The nations I would worry about, weird places run by odd dictators, they're just not capable of doing this stuff," he said.

Evans thinks it's unlikely terrorists would resort to smallpox in a biological attack. "If you want to disrupt countries, there are lots of easier ways to do it than to experiment with something so dangerous," he said.

AP Medical Writer Mike Stobbe in Atlanta and Associated Press Writer Mansur Mirovalev in Moscow contributed to this report.

Copyright © 2011 The Associated Press. All rights reserved.

 

FDA clears first new hepatitis C drug in 20 years

(AP) – 14 May, 2011

WASHINGTON (AP) — The Food and Drug Administration on Friday approved a highly anticipated hepatitis C drug from Merck that is the first new treatment for the virus in 20 years.

The first-of-its-kind pill, Victrelis, has been shown to cure more patients in less time than the older drugs now used.

About 3.2 million people in the U.S. have Hepatitis C, a blood-borne disease linked to 12,000 deaths a year. The current two-drug treatment for the virus cures only about 40 percent of people and causes side effects like nausea, fatigue and vomiting.

The FDA said it approved the new drug based on two trials in which more than 65 percent of patients were cured when combining Victrelis with the two older drugs. Like HIV drugs, Victrelis will be prescribed as part of a drug cocktail to fight the virus.

Some patients were also able to eliminate the virus in seven months on the drug, nearly half the time needed with the current treatments alone.

Boceprevir works by blocking the enzyme protease that helps hepatitis reproduce. It differs from the older medications that boost the immune system.

"This new medication provides an effective treatment for a serious disease, and offers a greater chance of cure for some patients' hepatitis C infection compared to currently available therapy," said Dr. Edward Cox, director of the FDA's office of antimicrobial products.

The drug, known generically as boceprevir, is designed to be taken three times a day with meals. Side effects include fatigue, nausea, headache and low blood cell count.

Analysts expect boceprevir to reach annual sales between $800 million and $1 billion. The drug is one of two new hepatitis treatments expected to gain approval this month. Vertex Pharmaceuticals is scheduled to receive a decision on its drug, telaprevir, by May 23. That drug is could garner even higher sales of up to $3 billion due to higher efficacy data, according to analyst estimates.

Hepatitis C is the primary cause of liver transplants in the U.S. and is expected to become a much larger public health problem as aging baby boomers succumb to the disease.

People can get the disease by sharing needles or having sex with an infected person. The disease could also be picked up from blood transfusions before 1992, when testing of the blood supply for the virus began.

Most people with hepatitis C don't even know they have the virus until after liver damage has occurred, which can cause abdominal pain, fatigue, itching and dark urine.

Current treatment for hepatitis C runs about $30,000. A spokeswoman for the Whitehouse Station, N.J.-based Merck could not immediately discuss the drug's price. The company will begin shipping the drug immediately.

"We look forward to building on our legacy in the fight against infectious diseases, and to being a part of this exciting new era in the treatment of hepatitis C," said Merck CEO Kenneth Frazier, in a statement.

Merck & Co. Inc. was the first company to market a drug for hepatitis C in 1991 when it launched interferon-alpha.

Copyright © 2011 The Associated Press.

 

Are gay men more at risk for cancer?

By Genevra Pittman

NEW YORK | Mon May 9, 2011

wpeB.jpg (18397 bytes)(Reuters Health) - More gay men reported being cancer survivors than straight men in a new study from California .

That suggests they may need targeted interventions to prevent cancer, the researchers said, but more studies are needed to answer lingering questions. For example, are gay men more likely to be diagnosed with cancer than straight men? Or, are they just more likely to survive if they do get cancer?

"A lack of hard data" on how sexual orientation affects the risk of cancer is "one of the biggest problems we have," said Liz Margolies, executive director of The National LGBT Cancer Network. Margolies, who was not involved in the research, told Reuters Health, "It's critical that we know that for funding and for program planning."

As a step toward addressing the lack of data, researchers looked at three years of responses to the California Health Interview survey, which included more than 120,000 adults living in the state.

Among other health-related questions, participants were asked if they had ever been diagnosed with cancer and whether they identified as gay, lesbian, bisexual, or straight.

The findings are published in the journal Cancer.

Out of 51,000 men, about 3,700 said they had been diagnosed with cancer as an adult. While just over 8 percent of gay men reported a history of cancer, that figure was only 5 percent in straight men. The disparity could not be attributed to differences in race, age, or income between gay and straight men.

About 7,300 out of 71,000 women in the study had been diagnosed with cancer, but overall cancer rates did not differ among lesbian, bisexual, and straight women.

However, among women who were cancer survivors, lesbian and bisexual women were more likely to report fair or poor health than straight women.

Ulrike Boehmer, the study's lead author from the Boston University School of Public Health, said higher rates of human immunodeficiency virus (HIV) may be related to the increased risk of cancer in gay men, but the study couldn't address that question specifically.

Margolies thinks there is more going on. "Gay men as a group have a bunch of risk factors for cancer," she said.

For instance, gay men and lesbian women are more likely to smoke and abuse alcohol than straight men and women. They're also more likely to avoid going to see their doctor for routine physicals or cancer screening, Margolies added - since healthcare providers may not all be tolerant and accepting of their identity.

"I don't think that we're going to get people to have early screening or see doctors except in emergencies ... until they can be guaranteed a safe and welcoming experience" at the doctor's office, she said.

Margolies said that while the new findings are "very important," she cautions about generalizing them too far beyond this individual study. Partially that's because she suspects lesbian women may also have an increased risk of cancer compared to straight women, because they have some of the same risk factors as gay men.

But Margolies and Boehmer agree that there is still an important message to take away from the findings: gay, lesbian and bisexual people need more attention from the healthcare community, specifically when it comes to their cancer risks.

"Because more gay men report as cancer survivors, we need foremost programs for gay men that focus on primary cancer prevention and early cancer detection," Boehmer told Reuters Health in an email.

And, "Because more lesbian and bisexual women than heterosexual women with cancer report that they are in poor health, we need foremost programs and services that improve the well-being of lesbian and bisexual cancer survivors," she added.

"Health care facilities and social service agencies -- any organization that addresses the needs of cancer survivors -- must understand the extra challenges that lesbian and bisexual cancer survivors and gay men have," Margolies concluded.

SOURCE: bit.ly/gzHzeL Cancer, online May 9, 2011.

 

Canadian bedbugs carry superbug bacteria: study

(AFP) – 12 May, 2011

WASHINGTON — Could bloodsucking bedbugs get any creepier? Turns out, the answer is yes.

Bedbugs carrying potent drug-resistant staph bacteria have been found in a poor section of Vancouver , Canada , said a report released by the US Centers for Disease Control and Prevention on Wednesday.

Five bedbugs were plucked off the bodies of three hospitalized patients from a rough section of downtown Vancouver where rates of poverty, HIV and injection drug use are high.

The bugs were tested and found to be infected with methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus faecium (VRE), said the CDC's Emerging Infectious Diseases report.

It was unclear whether the people infected the bugs or the bugs infected the people.

"To our knowledge, no conclusive evidence has demonstrated disease transmission by bedbugs," said the study, which called for further research due to the admittedly small sample of patients.

"Bedbug carriage of MRSA, and the portal of entry provided through feeding, suggests a plausible potential mechanism for passive transmission of bacteria during a blood meal."

In other words, contamination could theoretically happen if a person scratches where a bedbug has attached to the skin, causing an abrasion that allows the bacteria room for entry.

MRSA is a staph infection increasingly seen in hospitals that can turn deadly if it gets into the bloodstream or a surgical wound.

VRE is a type of bacteria that can live on the skin and in the intestines without harming a person, but can cause serious health issues in people who are ill or have weakened immune systems.

Both bacteria have developed resistance to many antibiotics.

As many as 31 percent of people living in that section of Vancouver, known as Downtown Eastside, have reported bedbug infestations, and both VRE and MSRA infections are commonly seen at the nearby Saint Paul's Hospital, the report said.

A boom in bedbug populations has been witnessed across North America and western Europe over the past 10 years. Researchers believe the surge may be fueled by increasing world travel and growing resistance to pesticides.

Copyright © 2011 AFP. All rights reserved.

 

J&J unit finds traces of fungicide in HIV drug

BANGALORE | Wed May 11, 2011 (Reuters) - Johnson & Johnson unit Janssen said it was in discussions with regulatory authorities in five countries to address trace amounts of a fungicide found in certain lots of its HIV drug Prezista.

This comes on the back of a series of J&J recalls related to the presence of the chemical.

The discussions were initiated by Janssen after it received four consumer reports of an uncharacteristic musty, moldy odor.

The widespread recall of J&J's Tylenol pain reliever and other medications also originated with complaints of a musty odor. The company has recalled more than 300 million bottles and packages of adult and children's consumer medicines since early 2010.

Janssen's investigation determined that the odor is likely caused by trace amounts of tribromoanisole (TBA) -- a fungicide used in packaging materials -- found in bottles sourced from a common supplier.

A very small number of patients reported temporary gastrointestinal symptoms after taking the HIV drug, but there were no reported serious adverse events caused by the presence of TBA.

"We do want to make it clear that patients should not stop taking their medication," the company said.

Anyone experiencing an uncharacteristic odor associated with Prezista 400mg or 600mg tablets should return their tablets to their pharmacist for immediate replacement, Janssen added.

The countries affected include Canada , the United Kingdom , Ireland , Germany and Austria . Discussions with regulatory authorities are underway to determine the appropriate course of action in each market, the company said in a statement.

Although no injuries have been linked to the ongoing recalls, they have sullied J&J's reputation, pressured its share price and sparked Congressional investigations.

TBA is a byproduct of a chemical preservative sometimes applied to wood and often used in the construction of pallets on which products are transported and stored.

An internal investigation is underway with suppliers to evaluate all potential sources of TBA, Janssen said.

 

Taking HIV drugs helps protect partner- US study

CHICAGO | Thu May 12, 2011 May 12 (Reuters) - People with HIV who took antiretroviral drugs cut the risk spreading the infection to their uninfected sexual partner, U.S. government researchers said on Thursday.

The findings also suggest that the protection is strongest when patients take the drugs as soon as possible.

The clinical trial, known as HPTN 052, was to end in 2015 but the findings are being released early because the treatment worked so well.

 


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