Unifying Against the Organ Ban
ANALYSIS / Sex workers, prisoners & drug users also affected

March 25, 2008

Gay men aren't the only people officially discouraged from donating organs since Health Canada quietly enacted its controversial policy last December. Sex workers, prisoners and IV drug users are also subject to the ban.

But you'd never know about these prohibited groups from the flood of mainstream-media headlines. "Sexually active gay men no longer allowed to donate organs," said CBC.ca when the story broke on Jan 7 and most queer press coverage has barely mentioned other affected communities.

Conversations among gay men have been characterized by anger and a sense of righteous indignation over a policy most consider problematic. But sometimes the discussions have a subtle subtext: "Just because I'm gay doesn't mean I automatically have AIDS. I'm not like the irresponsible gay men who get HIV. And why am I being lumped in with whores, druggies and junkies?"

University of Toronto student Lawrence Lucas started an online petition supporting the right of sexually active gay men to donate organs. Endorsed by Egale Canada and promoted via social networking site Facebook, the petition has garnered more than 3,000 signatures. Many signatories decry any association between gay men and others targeted by the policy.

"Just because I'm a sexually active gay male does not mean that I have HIV or live a high-risk lifestyle. Ninety percent of us are educated and normal," commented Clayton from Edmonton. "I don't understand how they can put IV drug users in the same sentence with gay men. This is offensive," wrote Nicholas from Anjou.

What does it mean when gay men distance ourselves from drug users or sex professionals? How does the response reflect the changing social status of gay men or attitudes toward people with HIV? And why is no one asking what the other affected groups have to say about the ban?

Twenty-five years ago gay men were just as stigmatized as other groups the media and medical establishments deemed high risk. In the post-Will and Grace era gay men have successfully fought for greater social acceptance, while others still lag behind.

Amy Lebovitch, a sex worker and member of Sex Professionals of Canada, is not surprised the media have focused exclusively on gay men. "They've made greater progress on human rights," she says. "Sex workers have a long way to go in terms of getting basic respect from everyone else."

Lebovitch says it's ironic sex workers are targeted by the ban. "Because of the nature of our work we're more conscious than most people about sexual safety and health. We get tested and provide education to our clients."

She thinks the policy will increase sex-work stigma. "If sex workers can't donate organs, this reinforces the misguided idea there's something wrong with us."

Connor McCollum of the Prisoners' HIV/AIDS Support/Action Network says prisoners are in fact at greater risk of contracting HIV because of the unsafe conditions in which they're forced to live.

"Correctional services deny people access to harm-reduction materials — needle exchange, safer-tattooing equipment. Even the things they're supposed to supply — condoms, lube, dental dams, bleach — they don't."

But that doesn't justify the outright ban, he says. Prisoners are aware of the new restrictions and upset about them, says McCollum. "People in prison with Hepatitis C need liver transplants — but other prisoners are forbidden to share a portion of their liver with a friend in need because of the Health Canada policy."

Few queer advocates have spoken out about prison issues in the context of fighting the ban, though. "The gay mainstream is more acceptable to the status quo" than more-stigmatized groups, says McCollum. "Some queers see elements of our own community as unsavory.

"It's a panic response — not wanting to be lumped in with sex workers or prisoners, even though many of them are queer," he says. "The irony is that gay men are fighting against the stereotype that HIV is only a gay disease, but want to separate themselves from people in their own community who are seen as diseased."

The urge some queer men feel to disassociate themselves from men with HIV might lead to greater stigma in the wake of the organ ban. "Some negative gay men believe those who have HIV deserve it," says Murray Jose, executive director of the Toronto People with AIDS Foundation. "Internalized homophobia, other discrimination in the gay community, such as racism — all those things impact our tendencies to judge others.

"For example their own feelings of discomfort around being able to enjoy sex freely may lead some to perceive that people with HIV have more sex than they do, imagining the amount of sex led to their infection."

People with HIV/AIDS have their own organ transplant issues, Jose says. "Many people who've been on meds for a long time, their organs start to shut down.

"Long-term survivors experience kidney failure, cardiac arrest, heart disease, liver disorders — and face barriers left, right and centre from the healthcare establishment. Oftentimes they are denied transplants, told, 'It's not worth it, you're going to die anyway.'"

It's common for surgeons to refuse to give transplants to people with HIV, he says.

"There's no clear policy on where we fit into priorities for organ transplants and by eliminating gay men and other communities when there's already an organ shortage it's even more unlikely people with HIV who need organs will get them. It's a vicious circle."

Jose calls for a unified approach involving all affected communities. "Let's look at this issue holistically," he says.


Viruses, Ethics & Organs: A Timeline

August 1986
Two US men acquire HIV after receiving organs from an auto-crash victim. The donor had tested antibody-negative.

June 1995
Baseball legend Mickey Mantle stirs ethical controversy when he receives a liver transplant after cirrhosis brought on by alcoholism, as well as Hepatitis C infection.

December 1995
AIDS treatment activist Jeff Getty receives a successful baboon bone marrow transplant. He dies 11 years later of heart failure at age 49.

December 1998
Alan Hext becomes the first person with HIV to receive a liver transplant, followed several years later by outspoken AIDS activist Larry Kramer.

September 2005
California enacts a law to prevent insurance companies from denying funding to people with HIV seeking transplants.

February 2007
Italian doctors transplant kidneys and a liver from a woman who later turned out to be HIV-positive after her medical records were marked incorrectly.

November 2007
Media reports that four patients in Chicago acquired HIV and Hepatitis C from organs harvested from a gay man. One says she wasn't made aware of the risk, sues the hospital.

January 2008
Health Canada admits to a policy implemented the month before that "excludes from consideration" the organs of men who've had sex with men in the past five years, current inmates or anyone who spent more the three days of the past year incarcerated, anyone who has done sex work in the past five years, and all nonmedical IV drug users.

Sources:
CBC, CNN, Morbidity and Mortality Weekly Report, Reuters, Poz Magazine

By Shawn Syms, http://www.xtra.ca

MRSA

1. Drug-resistant Staph killed 2,300 Canadians in 2006

March 27 2008

An estimated 2,300 Canadians died in 2006 after contracting antibiotic resistant Staph bacteria, costing the national heath-care system between $200 million and $250 million that year, new figures suggest.

The figures, based on data gathered from a national surveillance program undertaken in 48 Canadian hospitals, indicate doctors saw 29,000 new patients carrying methicillin-resistant Staphylococcus aureus (MRSA) bacteria on their skin or nostrils in 2006.

Of those, 11,700 contracted new MRSA infections.

MRSA, one of the strongest drug-resistant bacteria currently known, can live on human skin without causing infection. However, if it gains entry to the body through a cut or wound, it can cause serious illness and death, according to the Mayo Clinic's website.

MRSA infections are often contracted by patients who are already in the hospitals.

Researchers believe the data, calculated by infectious diseases expert Dr. Andrew Simor and presented in a report by the Public Health Agency of Canada, contains a cross section of institutions that is wide enough to be representative of Canadian hospitals as a whole.

Simor, the chief of microbiology and infectious diseases at Toronto's Sunnybrook Health Sciences Centre, co-chairs the surveillance program. He said the 2006 figures show a slow but steady increase over previous years.

"The good news is our rates remain substantially less than what is seen in the United States and many other parts of the world," Simor told The Canadian Press.

According to the report, 62 per cent of the new MRSA cases reported in 2006 were acquired in hospitals.

Dr. Michael Gardam, the director of the University Health Network's Infection Prevention and Control Unit in Toronto, says he's glad to see this dangerous infection finally getting some attention.

"MRSA has been around for 40-50 years," he told CTV's Canada AM on Thursday. "This isn't new. It's amazing that only in the last few years is the public starting to hear about this.

"This is the untold secret of hospitals. People can come in for some reason and then end up dying from something they caught in the hospital."

He said that thanks to the SARS epidemic of 2003, hospitals are slowly but surely improving their techniques for preventing such infectious diseases.

"These things are often transmitted in similar ways," he said. "If we can fix the fundamental problem of us not wearing the right equipment and not washing our hands, these things will get better."

MRSA Reaching Beyond Hospitals

Community-acquired MRSA accounted for 15 per cent of the cases reported in the study. The rest were acquired in long-term care facilities, hospitals outside the monitored network or were of unknown origin.

The rate of MRSA cases acquired outside hospitals has nearly doubled over the past five years, according to Simor.

The strain of bacteria more common in community settings usually causes persistent skin infections, but can also trigger severe pneumonia and bloodstream infections.

The community-acquired cases addressed in the report are not representative of the actual number of infections, as they only include the cases that were bad enough to prompt the infected to seek hospital care -- not those treated by a family doctor or in a clinic.

The increase in such cases is viewed by disease control experts as an alarming trend, particularly as they more often involve people who don't fit the profile for MRSA infection.

This movement is something that concerns Dr. John Conly. Head of the department of medicine at University of Calgary, he has been following community acquired MRSA in the city and says what used to be common only in marginalized groups is spreading to the general population.

"We're seeing now probably 20 per cent to 30 per cent (of infection cases) where we have no logical explanation," he said, noting community acquired cases are actually outpacing those stemming from hospitals in a few areas.

According to the director general of the Public Health Agency's centre for communicable diseases and infection control, more needs to be done to fight MRSA in hospitals and in the community.

Dr. Howard Njoo said containing the resilient bacteria is one of the most important battles to win from the perspectives of both disease prevention and cost effectiveness.

The Canadian Press, http://www.ctv.ca


2. The Power of the Superbug Discovered

March 25, 2008

Seattle - The power of the superbug -- Staph aureus -- to overcome human defenses has been uncovered by U.S. researchers.

Scientists at the University of Washington in Seattle discovered that these bacterium, including the notorious methicillin-resistant Staph aureus, or MRSA, produce lactic acid that counteracts the environment the body produces to prevent most bacteria from growing.

The study, published in Science, focused on nitric oxide -- a chemical the body produces to create an environment noxious to most bacteria. The nitric oxide acts as a natural antibiotic and is excreted by human cells, especially in the nose, that usually keeps microbes from undergoing respiration or fermentation. However, the ability of Staph aureus to produce lactic acid in the presence of nitric oxide keeps the Staph growing.

When Staph aureus was modified and lost its ability to make lactic acid, it could no longer tolerate nitric oxide. The modified bacteria also lost their ability to survive in host immune cells and no longer caused lethal disease in mice.

"MRSA has become an enormous public health problem," study lead author Dr. Ferric Fang said in a statement. "Staph aureus has already colonized about one-third of the world's population, so traditional antibiotics will probably not be the complete answer to the MRSA problem."

United Press International

Canadian Medical Association Under Fire

March 27, 2008

Toronto - Canadian politicians are questioning why the Canadian Medical Association is running an Internet ad for doctors for Australia despite a domestic shortage.

The ad is on the association's medical journal site and encourages Canadian doctors to relocate to Queensland, Australia, CTV News reported.

However, the CMA launched its own campaign Jan. 15 to lobby federal and provincial governments to recruit and retain more doctors in Canada, where it says 26,000 more doctors are needed to match international standards for doctors per capita, the report said.

Ontario Health Minister George Smitherman told CTV News he found the association's acceptance of the ad confusing.

"It's not a tactic that seems to make sense," Smitherman said. "To be aiding and abetting the international effort to lure our doctors does seem somewhat inconsistent."

An unidentified spokesperson for the association told CTV recruiting runs all over the world and the Australia ad is no different than a classified ad, and will remain on the site.

United Press International

Banned at the Border

1. Rally held to protest US HIV ban
HIV/AIDS / Bill to end the ban hailed as 'major step' forward

March 26, 2008

Banned At The Border. There's no place for public policy 'based on stigma and wrong information and prejudice and fear,' says NDP MP Bill Siksay (pictured left) (Nathaniel Christopher photo)

About two dozen people gathered at the Vancouver Art Gallery Mar 16 to protest the US ban on HIV-positive travellers, and to support a bill now making its way through the US Senate to repeal the ban.

Martin Rooney organized the protest after he was fingerprinted, interrogated and eventually turned back at the border last November.

"We were hauled into immigration," he told protesters. "I was fingerprinted, photographed, run through the FBI Most Wanted List and, two and half hours later, sent home. I have never felt more violated in my life."

The US has barred HIV-positive travellers and potential immigrants from entering the country since 1987, when the ban was first proposed by Senator Jesse Helms. A new policy introduced by President George Bush in 2006 led to a proposed waiver which would allow some HIV-positive people to visit the US temporarily — provided they bring all the HIV meds they'll need for their stay, prove they have medical insurance accepted in the US, and promise not to engage in behaviour that could put the American public at risk.

Not good enough, says California Democrat Barbara Lee, who introduced the HIV Non-Discrimination in Travel and Immigration Act in the US House of Representatives last August. The bill was later introduced in the US Senate by Democrat John Kerry and Republican George Smith. A Senate committee approved the bill Mar 10; it now goes before the full Senate.

"The attempts to fix this law through a complex waiver system, while admirable, still don't do anything to rectify the discriminatory underlying problem," Kerry explained last December when he co-introduced the Senate bill.

Gay activists in the US hailed the bill's advance through the Senate.

"We appreciate the support by the Senate Committee on Foreign Relations and now urge the full Senate to repeal this unjust and sweeping policy that deems HIV-positive individuals inadmissible to the United States," says Human Rights Campaign president Joe Solmonese. "There remains no public health rationale for treating HIV more harshly than other communicable diseases."

"On this topic there's no place in public policy for policy that's based on stigma and wrong information and prejudice and fear," agrees NDP MP Bill Siksay. "And that's what we have with this travel ban for folks here who are living with HIV and AIDS.

"The United States has some questionable allies when it comes to promulgating this kind of policy," the Burnaby-Douglas MP told the protest. "The countries that maintain this policy are not the leaders in progressive and appropriate policies around the world."

The US is one of only 13 countries around the world with an HIV ban. The others are: Armenia, Brunei, China, Iraq, Qatar, South Korea, Libya, Moldova, Oman, Russia, Saudi Arabia, and Sudan.

Vancouver Centre MP Hedy Fry also denounced the ban, saying it defies any logic and reason.

"AIDS is not a communicable disease based on walking down the streets, like TB is for instance. You cannot sneeze and get it. You cannot touch someone and give it to them. If you spit on the street nothing happens. It's very interesting if you looked at this from a purely medical perspective," she told the protest. "It just doesn't make sense, it's discriminatory."

A similar ban would never be accepted in Canada, she said. "That kind of thing would have a Charter challenge right away because in our Charter you're not allowed to discriminate against anyone based on sexual orientation."

Helen Kennedy has less faith in the Charter under the current Conservative government. "Now more than ever we have to be vigilant in fighting for our rights and maintaining those rights that we have fought so hard to get over centuries and decades," the executive director of Egale warned the protest.

NDP MP Penny Priddy, who represents Rooney's home riding of Surrey North, was also on hand to support the bill to repeal the ban, but points out the battle is far from over.

"There's a piece of legislation in front of the United States Congress; it is the first step and not the last. Because I have no doubt that it could go through every single step and if it ends up on President Bush's desk it'll be vetoed with a presidential veto."

Nicole Murray-Ramirez, a city commissioner for San Diego and Queen Mother of the Americas for the Imperial Court System, apologised for the US government.

"As an American and a Christian I wish to sincerely apologise to my Christian brother Martin Rooney for being denied entry to my country. I wish to apologise as an American citizen to all Canadians who have been denied entry to my country."

Murray-Ramirez reminded the crowd that despite the US government's stance, many people within the US oppose the ban.

The US-based organization Immigration Equality hailed the Kerry-Smith bill as the "first major step in 15 years" to repeal the ban on HIV-positive travellers.

"We are confident that this vote by the full Senate will be successful and will move the United States one step closer to lifting the HIV immigration ban," says Immigration Equality's legal director, Victoria Neilson.

By Nathaniel Christopher, http://www.xtra.ca


2. HIV-Positive Canadian Takes On U.S. Travel Ban
Two-decade-old law that allows U.S. to refuse entry to those who carry the virus that causes AIDS may be overturned

March 29, 2008

Vancouver - A harrowing encounter between an HIV-positive Canadian travelling to the United States and a U.S. border guard has helped thrust a long-standing but little-known law back into the political ring.

The U.S. Senate is expected to vote next month on a bill proposed by Massachusetts Senator John Kerry that would lift what he calls a Draconian travel ban that has caused thousands of Canadians and other foreigners to be refused entry to the United States because they have the virus that causes AIDS.

Martin Rooney is among them.

The Surrey, B.C., man was on his way to Bellingham, Wash., for the Remembrance Day long weekend last November to shop, with the Canadian dollar trading at about $1.07 against the greenback. After lining up for four hours to reach the U.S. customs booth, he was asked where he worked.

"I said I was on disability. He said what's my disability. I said I have HIV," said the 47-year-old, who was diagnosed in 1989.

The customs officer told him he needed a special visa waiver to enter the country, even though Canadians do not require a visa to travel to the United States.

"He hauled me into a backroom. ... He put on a set of rubber gloves to hold each of my fingers. Nobody else wore rubber gloves. Then he fingerprinted me, photographed me, ran me through the FBI's most-wanted list and told me to go back to Canada and not return until I came back with a waiver," Mr. Rooney said. "I felt like I was being treated like a terrorist."

He went public with his story soon after, winning the support of several B.C. members of Parliament, including Hedy Fry, Penny Priddy and Bill Siksay.

The United States is one of 13 nations, including China, Iraq, Saudi Arabia and Sudan, that still ban HIV-positive visitors and immigrants.

Under the Immigration and Nationality Act, in place since 1987, the U.S. secretary of Health and Human Services has the authority to determine what constitutes "communicable diseases of public health significance" that would prevent non-U.S. citizens from entering the country. HIV is the only medical condition singled out as a basis for inadmissibility under the law.

"This law was written when little was known about the disease and destructive stigmas often won the day," Mr. Kerry, a Democrat, wrote in an e-mailed statement to The Globe and Mail. "With new knowledge about the disease, we must make it clear that this discriminatory, Draconian law will no longer be tolerated."

His bill, inserted as an amendment to President George W. Bush's $50-billion global AIDS relief package, was approved this month by the Senate foreign relations committee.

It is now up for a full vote on the Senate floor before it can move to the House of Representatives, where California Democratic congresswoman Barbara Lee has championed it.

"People shouldn't have to worry, [they] shouldn't have to live in the shadows of any disease," she said in an interview yesterday, praising Mr. Rooney for making his story public. "It's very courageous of him to do what he did and I just hope that we can get rid of this ban so that people don't have to worry about it."

The U.S. consul-general in Ottawa, Keith Powell, confirmed that while Canadians do not require a visa to travel to the United States, the law requires those with HIV to apply for a visa waiver of ineligibility.

But critics say the process is expensive, time-consuming and bogged down in red tape. Mr. Powell conceded it can take two weeks or longer, because documentation from a doctor stating the traveller's medical condition must be forwarded to an adjudication committee.

Although the U.S. Department of State said statistics are not available on how many Canadians have been turned away at the border for being HIV-positive, the number is likely in the thousands because the ban has been in place for more than two decades, said Helen Kennedy, executive director of gay-rights organization Égale Canada.

She is co-ordinating a campaign to encourage Canadian politicians to press their U.S. counterparts to ensure Mr. Bush signs Mr. Kerry's bill.

But Foreign Affairs Minister Maxime Bernier has not got involved. On Jan. 18, he wrote that while he regretted Mr. Rooney's "unpleasant" border experience, "as a sovereign state, the United States retains the prerogative to determine the screening procedures for the entry of foreign nationals into the country."

Meanwhile, public-health officials and human-rights activists on both sides of the border have long been calling on the U.S. government to lift the ban.

"As a person that treats people with HIV, this legislation has no scientific validity or foundation," said Julio Montaner, director of the B.C. Centre for Excellence in HIV/AIDS and president-elect of the International AIDS Society.

By Unnati Gandhi, The Globe and Mail

Medical Marijuana

1. Medical Marijuana Patient & HIV/AIDS Sufferer Paul Doyle Makes Time For The Media

Bloomington, Illinois - As the General Assembly breaks for the spring holiday season, a local medical marijuana patient is one of many around Illinois urging lawmakers to pass a bill to protect seriously ill people like him from arrest for using doctor-recommended medical marijuana.

Paul Doyle, a Hillside resident who has battled AIDS since 2002, is available to television, print and radio outlets to tell his personal story and how legal medical marijuana protection would improve his life.

For the first time ever, both chambers of the General Assembly are considering medical marijuana bills. According to a recent poll conducted by Mason-Dixon Polling and Research, Illinois residents favor allowing seriously and terminally ill patients to use marijuana for medical purposes by a 68-27 percent margin.

Most medical professionals also agree on the need for legal protection for medical marijuana patients and their doctors. Last month, the American College of Physicians – the second largest U.S. medical association representing 124,000 physicians – issued a policy paper calling for legal protection for medical marijuana patients and for the federal government to respect the will of voters in states with medical marijuana laws.

Illinois could become the 13th state to protect its sick and dying from arrest for using medical marijuana with a doctor's recommendation – and the first in the Midwest. Similar legislation is currently under consideration in Minnesota and New York, and voters in Michigan will likely see a medical marijuana initiative on their November ballot.

http://pr.cannazine.co.uk


2. Former Surgeon General: Mainstream Medicine Has Endorsed Medical Marijuana

March 26, 2008

One of America's largest and most important groups of physicians has moved to cut through the clutter of political controversies over medical use of marijuana. Lawmakers and the public alike would do well to pay attention.

The American College of Physicians is the largest medical specialty organization and the second largest physician group in the United States. Its 124,000 members are doctors specializing in internal medicine and related subspecialties, including cardiology, neurology, pulmonary disease, oncology and infectious diseases. The College publishes Annals of Internal Medicine, the most widely cited medical specialty journal in the world.

In a landmark position paper released in February, these distinguished physicians are saying what many of us have been arguing for years: Most of our laws have gotten it wrong when it comes to medical marijuana, and it's time for public policy to get in step with science.

Right now, the laws of 38 states and the federal government bar use of marijuana as a medicine. Federal law classifies marijuana as a Schedule I drug, defined as having no accepted medical use and being unsafe for use even under medical supervision.

ACP's position paper urges "reclassification into a more appropriate schedule, given the scientific evidence regarding marijuana's safety and efficacy in some clinical conditions." The document goes on to call for protection of physicians' right to "prescribe or dispense medical marijuana in accordance with state law" and "strongly urges protection from civil or criminal penalties for patients who use medical marijuana as permitted under state laws."

ACP supports its position with 10 pages of scientific documentation and references. They cite data showing relief of the nausea, vomiting and wasting that can worsen the misery of cancer, AIDS and other diseases; of the pain and tremors associated with multiple sclerosis; and for relief of pain caused by a variety of other conditions. They note that marijuana in combination with some pharmaceuticals may produce more benefit than either drug alone.

ACP calls for more research, but then adds a critical point: In some areas, the efficacy of medical marijuana has already been established, and it's time for studies designed to determine the best dose and route of delivery.

The ACP position paper demolishes several myths, starting with the notion still proclaimed by some politicians that marijuana is unsafe for medical use. The College notes that the most serious objection to medical marijuana -- potential harm to the lungs from smoking -- has largely been solved by a technology called vaporization, already proven in scientific studies.

The ACP position paper also explains that there is no reason to believe that protecting medical marijuana patients leads to increased drug abuse. "Marijuana has not been proven to be the cause or even the most significant predictor of serious drug abuse," the doctors write. "Opiates are highly addictive, yet medically effective ... There is no evidence to suggest that medical use of opiates has increased perception that their illicit use is safe or acceptable."

This is an historic document. Large medical associations are by their nature slow, cautious creatures that move only when the evidence is overwhelming. The evidence is indeed overwhelming that, as ACP put it, there is "a clear discord" between what research tells us and what our laws say about medical marijuana.

It appears that voters and lawmakers in a number of states will consider medical marijuana proposals this year, and Congress will again be asked to stop federal attempts to interfere with the 12 state medical marijuana laws already in place. It's time to end that "clear discord" and put science ahead of politics.

Dr. Joycelyn Elders served as U.S. Surgeon General from 1993 to 1994, and is currently distinguished professor of pediatrics and public health at the University of Arkansas School of Medicine in Little Rock.

By Dr. Joycelyn Elders, http://www.alternet.org


3. Texas Patient Wins Landmark Acquittal in Medical Marijuana Case
Rare Victory for "Necessity Defense" Seen as Potentially Trend-Setting.

March 27, 2008

Amarillo, Texas - A Texas patient who uses medical marijuana to treat the symptoms of HIV won acquittal on marijuana possession charges March 25 based on a "necessity defense."

Though such a defense - which requires the defendant to establish that an otherwise illegal act was necessary to avoid imminent harm more serious than the harm prevented by the law he or she broke - has rarely been successful in Texas, the jury took just 11 minutes to acquit 53-year old Tim Stevens. The trial was hotly contested.

Stevens had never been in trouble until Amarillo police arrested him for possessing less than 4 grams of marijuana. As a result of his HIV infection, Stevens suffers from nausea and cyclical vomiting syndrome, a condition so severe that he has required hospitalization and blood transfusions in the past.

Extensive research has established medical marijuana as an effective treatment for nausea and vomiting associated with HIV/AIDS and cancer chemotherapy, uses recently acknowledged by the prestigious American College of Physicians.

Key in establishing Stevens' medical necessity was the testimony of Dr. Steve Jenison, medical director of the Infectious Diseases Bureau for the state of New Mexico's Department of Health.

"This case proved to be a testing ground for public attitudes toward medical marijuana," said attorney Jeff Blackburn, who represented Stevens. "Even in a very conservative part of a very conservative state, jurors were willing to listen to the facts about medical marijuana and give Tim a break, and I hope this case will help to create a trend in Texas."

"The common sense and decency exhibited by this Amarillo jury is typical of what we see from voters around the country," said Ray Warren, director of state policies for the Marijuana Policy Project in Washington, D.C., and a former North Carolina Superior Court judge.

"The American public doesn't want to see seriously ill patients arrested and jailed for simply trying to stay alive with the help of medical marijuana. It's time for legislators in Texas and around the country to follow the public's lead and take action to protect patients, so that no one battling a life-threatening illness has to live in fear of arrest."

With more than 23,000 members and 180,000 e-mail subscribers nationwide, the Marijuana Policy Project is the largest marijuana policy reform organization in the United States. MPP believes that the best way to minimize the harm associated with marijuana is to regulate marijuana in a manner similar to alcohol.

http://salem-news.com

TB & HIV/AIDS

1. TB Patients Chafe under Lockdown in South Africa

March 25, 2008

Port Elizabeth, South Africa — The Jose Pearson TB Hospital here is like a prison for the sick. It is encircled by three fences topped with coils of razor wire to keep patients infected with lethal strains of tuberculosis from escaping.

Slide show: http://www.nytimes.com/slideshow/2008/03/24/world/20080325SAFRICA_index.html

But at Christmastime and again around Easter, dozens of them cut holes in the fences, slipped through electrified wires or pushed through the gates in a desperate bid to spend the holidays with their families. Patients have been tracked down and forced to return; the hospital has quadrupled the number of guards. Many patients fear they will get out of here only in a coffin.

"We’re being held here like prisoners, but we didn’t commit a crime," Siyasanga Lukas, 20, who has been here since 2006, said before escaping last week. "I’ve seen people die and die and die. The only discharge you get from this place is to the mortuary."

Struggling to contain a dangerous epidemic of extensively drug-resistant tuberculosis, known as XDR-TB, the South African government’s policy is to hospitalize those unlucky enough to have the disease until they are no longer infectious. Hospitals in two of the three provinces with the most cases — here in the Eastern Cape, as well as in the Western Cape — have sought court orders to compel the return of runaways.

The public health threat is grave. The disease spreads through the air when patients cough and sneeze. It is resistant to the most effective drugs. And in South Africa, where these resistant strains of tuberculosis have reached every province and prey on those whose immune systems are weakened by AIDS, it will kill many, if not most, of those who contract it.

As extensively drug-resistant TB rapidly emerges as a global threat to public health — one found in 45 countries — South Africa is grappling with a sticky ethical problem: how to balance the liberty of individual patients against the need to protect society.

It is a quandary that has recurred over the past century, not least in New York City, where uncooperative TB patients were confined to North Brother Island in the East River in the early 1900s and to Rikers Island in the 1950s.

In the early 1990s, when New York faced its own outbreak of drug-resistant TB, the city treated people as outpatients and locked them up in hospitals only as a last resort.

Most other countries are now treating drug-resistant TB on a voluntary basis, public health experts say. But health officials here contend that the best way to protect society is to isolate patients in TB hospitals. Infected people cannot be relied on to avoid public places, they say. And treating people in their homes has serious risks: Patients from rural areas often live in windowless shacks where families sleep jammed in a single room — ideal conditions for spreading the disease.

"XDR is like biological warfare," said Dr. Bongani Lujabe, the chief medical officer at Jose Pearson hospital. "If you let it loose, you decimate a population, especially in poor communities with a high prevalence of HIV/AIDS."

But other public health experts say overcrowded, poorly ventilated hospitals have themselves been a driving force in spreading the disease in South Africa. The public would be safer if patients were treated at home, they say, with regular monitoring by health workers and contagion-control measures for the family. Locking up the sick until death will also discourage those with undiagnosed cases from coming forward, most likely driving the epidemic underground.

"It’s much better to know where the patients are and treat them where they’re happy," said Dr. Tony Moll, chief medical officer at the Church of Scotland Hospital in Tugela Ferry. It is running a pilot project to care for patients at home.

Some 563 people were confirmed with extensively drug-resistant TB last year in South Africa and started on treatment, compared with only 20 cases in the United States from 2000 through 2006. A third of those patients in South Africa died in 2007; more than 300 remained in hospitals.

Further complicating matters, South Africa’s provinces have taken different approaches to deciding how long to hospitalize people with XDR-TB. In KwaZulu-Natal, the other province with the most cases, the main hospital is discharging patients after six months of treatment, even if they remain infectious, to make room for new patients who have a better chance of being cured. The province is rapidly adding beds, part of a national expansion of hospital capacity for XDR-TB.

"We know we’re putting out patients who are a risk to the public, but we don’t have an alternative," said Dr. Iqbal Master, chief medical officer of the King George V Hospital in Durban.

Two days of interviews with patients cloistered here at the Jose Pearson hospital offered a rare glimpse of what all sides agree are the wrenching human costs of the patients’ confinement, as well as their rebellious feelings about being cut off from their loved ones.

Zelda Hansen, 37, the wife of a welder and mother of sons ages 4, 12 and 14, has lived at the hospital for more than a year. She was among the 31 extensively drug-resistant patients who escaped from the 350-bed hospital before Christmas, along with 57 patients with less severe strains of drug resistance. Her eldest son had started to seem like a stranger to her, she said, while her youngest, her "flower pot," was growing up without her guidance.

Once home, she said: "I just sat and watched them. And I was very happy."

Soon the media trumpeted news of the infectious runaways. A provincial health department spokesman vowed they would be "hunted down." On Dec. 23, a Sunday morning, Mrs. Hansen said, police officers wearing infection-control masks came to her door. A crowd of neighbors gathered for the spectacle.

Mrs. Hansen refused to go. She begged for a few more days — just through Christmas.

Her middle son, Trevino, 12, fearing she had done something wrong, offered his barefoot mother his sneakers, called tekkies here.

" ‘Here, Mommy, take my tekkies, go with the police,’ " she said he had pleaded with her. " ‘Please, Mommy, go.’ "

Back at the hospital, on the outskirts of Port Elizabeth, Mrs. Hansen descended into despair. "I felt like going to the trees and just hanging myself, I was so humiliated," she said.

When news of South Africa’s outbreak of extensively drug-resistant TB was announced in Toronto in 2006 at an international AIDS meeting, it sent shudders through the ranks of infectious-disease specialists. These virulent strains had rapidly killed 52 of 53 patients.

Drug resistance emerges in large part because health care systems too often have failed to ensure that patients successfully complete treatments with first- and second-line drugs, according to international health officials.

The medicines for ordinary TB here cost about $36 and take six to eight months to cure the patient. The drugs for XDR-TB cost about $7,000, and treatment lasts two years. At the start, patients endure four to six months of painful daily injections in the buttocks or thigh, a morning ritual at Jose Pearson that leaves faces scrunched up in agony. A 10-year-old boy whose mother recently died here of the disease rubbed cream into his backside to relieve the ache. He now lives on the XDR-TB ward as its solitary child, with no family around.

"I do think about my mother," he said. "But I don’t cry because I’ll never get her back again."

Dr. Lindiwe Mvusi, who manages the government’s tuberculosis program, said the hospitals shouldn’t be seen as prisons, and that requests in special circumstances to go home should be considered individually.

The Jose Pearson hospital had suspended all weekend passes to patients for months, and only recently reinstated them for the handful of XDR-TB patients showing signs of becoming noninfectious.

The provinces began diagnosing and treating XDR-TB on a large scale more than a year ago, but the question of where to care for South Africans who remain infected after two years or more of treatment is unsettled.

"We expect they will die at some stage, but what do we do with them in the meantime?" asked Dr. Mvusi. "Do we send them home or keep them in a sanitarium for life?"

At Jose Pearson, patients who have different degrees of drug resistance — with XDR-TB being more deadly than multidrug-resistant TB — live in different quarters, but they mix on the grounds. Infectious disease experts say that some of the multidrug-resistant patients are likely to catch the more severe XDR strains of tuberculosis directly from their fellow patients.

Peter Jantjes, the chief professional nurse in Jose Pearson’s XDR-TB unit, said that multidrug-resistant patients were turning into XDR-TB patients at an "intense rate."

Vuyokazi Gqawe, 30, a saloonkeeper, was admitted to the hospital more than two years ago with the lesser form of drug-resistant TB, then was found to have the far more dangerous kind in June. "They don’t have the answers," she said.

Mrs. Gqawe was pregnant when she was admitted and gave birth here, but she sent her newborn to live with family. She has since seen her daughter, now 2, only in photographs, except when she once waved to her through the hospital gate. "She didn’t even know who I was," Ms. Gqawe said.

The hospital itself is a caldron of discontent. The staff members and the patients share a pervasive sense of dread.

"It’s going to burst," warned Louise Bruiners, the sole social worker for the more than 300 patients. "Something really bad is going to happen."

Angry patients bully and threaten the staff and have even brandished knives at security guards to get out of the hospital, hospital managers said. Crowds of patients have blockaded the entry gate, demanding weekend passes to go home.

On a recent Saturday, as workmen tried to erect a second buffer gate at the entrance, patients pulled it down, jumped up and down on it and repeatedly heaved a chunk of concrete on it.

The hospital’s management has been trying to make Jose Pearson more tolerable. It has brought in a pool table, flat-panel televisions, soccer balls and sewing machines. Hospital managers hope to bring patients’ families for more regular visits.

"It’s good, the things they’re doing, and we thank them for it," said Mrs. Hansen, the patient who briefly escaped, "but nothing can replace your freedom."

By Celia W. Dugger, The New York Times


2. U.N. To Hold Meeting in June To Examine HIV/TB Coinfection Worldwide

March 27, 2008

A United Nations meeting scheduled for June 9 will examine the relationship between HIV and tuberculosis worldwide with the goal of creating a strategy for the millions of people living with both diseases, Jorge Sampaio, the U.N. special envoy for TB, said in New York on Tuesday, Reuters reports.

"What we need from that meeting is to come out of it with a common strategy to scale up efforts to systematically address HIV/TB coinfection," Sampaio said, adding, "Scientific knowledge leads us this way. On-the-ground experiences lead us this way." According to Sampaio, between 12 million and 15 million people, or about one-third of HIV-positive people worldwide, are living with HIV/TB coinfection. According to the World Health Organization's 2008 global TB report, 700,000 of the 9.2 million new TB cases reported in 2006 occurred among HIV-positive people.

Sampaio said that HIV is a "massive challenge" for global TB control, especially because of the emergence of drug-resistant TB (Reuters, 3/25). He said that multi-drug resistant TB is reaching record high levels and that the disease is distressing health care systems worldwide. Only 10% of all MDR-TB cases likely will be treated this year due to shortages of drugs and laboratory facilities, Sampaio said. He called on international leaders to increase their efforts to fight TB and to ensure that there is a coordinated approach to address HIV/AIDS and TB (U.N. News Service, 3/25).

http://www.kaisernetwork.org


3. New Strategy Backs Combined Efforts at Fighting TB and HIV

March 26, 2008

A new United Nations World Health Organization (WHO) publication issued shortly before the March 24 observance of World Tuberculosis Day, underscores the devastating impact that the spread of HIV (human immunodeficiency virus) has had on TB death rates in developing countries.  It outlines the amplified risks of dying from TB for AIDS patients and for TB carriers who are also infected with HIV.  UN Special Envoy to Stop TB, former Portuguese President Jorge Sampaio, addressed TB concerns in New York on Tuesday.  He noted that of the estimated one-point-five million TB patients dying annually, 200-thousand also have HIV.  Dr. Phillip Nieburg is a non-resident expert on infectious diseases at Washington’s Center for Strategic and International Studies (CSIS).  He describes the relationship between the two ailments and explains how the spread of HIV complicates TB rates of survival.

"The connection works in several ways.   For TB, HIV weakens the immune system, so people who have TB infections are more likely to have severe disease.  That is, people infected with TB, most of whom would never gotten sick during their lifetime (the infection would healed itself), for those people who have HIV, they have a much more likely chance of having active disease. And if they develop active disease, there’s a much greater chance of having a severe outcome," he said.

Although HIV weakens the immune system, Dr. Nieburg says the process can also work the opposite way:  TB can disturb the immune system so that weakened individuals may be unlikely to fight off contracting HIV/AIDS.

"Things that stimulate the immune system actually cause HIV replication or multiplication to occur faster, so there’s a positive feedback system.  People who are infected with tuberculosis have a faster progression of their HIV disease to AIDS and a faster progression of AIDS to a more serious version of it," Nieburg explained.

As a result of the multiple ways co-infection can strike, Nieburg points out that tracking the progression of the ailments can be a tricky challenge for medical authorities in developing countries.

"Things are changing.  A huge proportion of people in Africa have what’s called latent tuberculosis.  That is, they’ve been infected some time early in their life, but they don’t have active disease.  It’s quiescent, and for that group of people, when they get HIV, they have a large chance of having their HIV become activated.  At this point, there are more TB-infected people than HIV-infected people.  It’s just that the two populations are beginning to overlap more and more as HIV continues to spread.  And then on a population level, as HIV spreads and more of those HIV-infected people develop TB, then more new people, who are not infected with either one, will be exposed to tuberculosis," he says.

Nieburg, who is also an adjunct professor at the University of Virginia’s Center for Biomedical Ethics, points out that developing an integrated strategy for treating this lethal combined form of the infection is key to keeping the pandemic in check, particularly in Africa, where it is resurging.

"In general, over the last 30 years, TB rates have been falling all over the world.  The global TB control program has been doing a great job.  And before HIV came along, there was hope actually of eliminating active tuberculosis within our lifetime.  The countries that are heavily impacted by HIV have now seen a reverse because so many TB patients are now developing active disease.  So the more HIV-infected people there are in a country, the more chance there is that the TB rates will also be rising," he noted

By Howard Lesser, http://www.voanews.com

Report Shows 48% Hike in US HIV Cases

March 28, 2008

Washington - Reported new HIV infections in the United States increased by 48 percent in 2006 according to new data from the Centers for Disease Control and Prevention.

The stunning figures, in the CDC Surveillance Report, comes in advance of a long anticipated in depth review of HIV infections that was to have been released early this year but is believed to be months away.

The CDC said last December at the HIV Prevention Conference that it was working on new estimation methods but the federal agency has delayed release of the document.

In its Surveillance Report the CDC this week said there were 52,878 new HIV infections in 45 states and the District of Columbia for 2006.  In 2005, CDC reported only 35,537 new infections in 38 states and the District of Columbia.

HIV/AIDS groups say that the increase is alarming, despite an increase in the number of states reporting.

The seven new states for which CDC is reporting HIV data for the first time in 2006 are:  California, Delaware, Illinois, Maine, Oregon, Rhode Island, and Washington.

"New CDC data showing a 48% higher incidence of new HIV/AIDS diagnoses in 2006 compared with 2005 are just the latest piece of bad news about the sexual health of the American people," said Marjorie J. Hill, PhD, Chief Executive Officer of Gay Men’s Health Crisis (GMHC).

"While there are seven additional states reporting in 2006, this does not account for the 48% jump in new diagnoses.  These devastating numbers reinforce what we have known for quite some time:  that HIV prevention is under-funded and hamstrung by ideological restrictions that force us to fight this epidemic with one hand tied behind our back."

In recent months, government data have shown increases in HIV infections among young men who have sex with men and young women in New York City, especially young people of color. 

Nationally, HIV is up for MSM and dramatically up among Black MSM.  Teen pregnancy rates have also increased for the first time since the early 1990s. Earlier this month, the CDC reported that one quarter of teenage females have a sexually transmitted infection, with nearly half of Black teenage females in the study infected.

Michael Weinstein, President of AIDS Healthcare Foundation, called the new statistics a "catastrophe".

"There is no other word to describe these CDC numbers which underscore the wholesale failure of US HIV prevention efforts." Weinstein said.

"We now face $36 billion in costs associated with lifetime care and treatment of all these infected individuals," said Whitney Engeran, III, Director, Public Health Division, and AIDS Healthcare Foundation.

HIV/AIDS groups have fought for increased prevention funding at CDC. 

GMHC said that under the Bush-Cheney administration, funding for prevention at CDC has dropped 19 percent in real dollar terms.

www.365Gay.com

Indian Generic Drug Maker Strides Acrolab Receives Tentative FDA Approval for Combination Antiretroviral

March 26, 2008

FDA on Tuesday announced that it has given tentative approval to Indian generic pharmaceutical company Strides Acrolab for its fixed-dose antiretroviral drug that contains lamivudine, nevirapine and stavudine, Reuters/Yahoo! Malaysia News reports (Reuters/Yahoo! Malaysia News, 3/26). Tentative FDA approval means that although existing patents or other issues prevent marketing of the drug in the U.S., the drug is qualified for consideration in the President's Emergency Plan for AIDS Relief (FDA release, 3/24). The FDA approval is for multiple strengths of the combination therapy, according to Dow Jones (Dow Jones, 3/24). The two versions are 30 milligrams, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively, and 40 mg, 150 mg and 200 mg of stavudine, lamivudine and nevirapine, respectively (FDA release, 3/24).

http://www.kaisernetwork.org

HIV Decimating Education in Mozambique

March 26, 2008

More than one-sixth of Mozambique's 9,000 teachers are dying of HIV/AIDS each year, lowering the quality of education and jeopardizing future development, a government official told Reuters yesterday.

Education and Culture Minister Aires Aly said in an interview that the pandemic had become a national emergency, eroding a critical human resource that is key to the poor southern African nation's economic development.

"We are losing 17 per cent of our 9,000 teachers each year, which means we are talking of 1,360 workers lost to HIV/AIDS, and the disease is spreading very fast at national level," he said.

Health officials say more than 16 per cent of the 20 million Mozambicans between the ages of 14 and 49 - generally the most economically productive - are infected with HIV, and an estimated 500 new infections occur each day.

"This is a crucial issue for us and we are trying to train more teachers for them to be able to deal with it (the pandemic) in the communities. Teachers play a major role in the economic development of this country," he said.

Despite its limited skilled labour force, Mozambique's economy has boomed in recent years, spurred by a rise in foreign investment and development aid, and GDP growth is projected to hit eight per cent this year after reaching 7.5 per cent in 2007.

Aly said the devastating effect of HIV/AIDS on the country's human resources threatened to damage its economic prospects.

Mozambique, still one of the world's poorest nations, is struggling to raise the $150 million a year it needs to rebuild its dilapidated education infrastructure, neglected during the 17-year post-independence civil war that ended in 1992.

Very few of those needing anti-retroviral drugs in the former Portuguese colony have access to the life-saving treatment.

By Charles Mangwiro, Reuters, The Montreal Gazette

Vaccines

1, Merck AIDS Vaccine Failure May Doom Promising Study

March 24, 2008

A once-promising study of an AIDS vaccine developed by the U.S. will be scaled back and may be scrubbed after the failure of a related Merck & Co. effort.

The vaccine, created by the U.S. National Institutes of Health's Vaccine Research Center in Bethesda, Maryland, may be studied in about only 2,000 people in the U.S. and Africa, rather than 8,500 as had been planned. An international AIDS research group that has helped bring six vaccines to human testing will say today that it has pulled out of the trial.

Support has declined for clinical studies of existing experimental AIDS vaccines since September, when Merck announced its shot may have made people more vulnerable to infection. AIDS researchers say concern was further heightened this month after a second test of Merck's product, conducted in South Africa, found more infections among those vaccinated.

``There isn't a clear understanding of why,'' said Wayne Koff, senior vice president for research and development for the International AIDS Vaccine Initiative, based in New York. Koff said in an interview that his group told the NIH last week it wouldn't participate in the vaccine trial, called PAVE-100.

``I think we have a safety unknown here,'' Koff said. His group, which funds and manages AIDS vaccine research, is notifying its affiliated testing sites in Africa that it won't help enroll participants to carry out the U.S. trial.

Opposition to the Trial

More than 33 million people worldwide are infected with HIV, a lethal germ, spread through sex and infected blood, that causes AIDS. While about two dozen AIDS drugs are approved, lifetime treatment costs for each U.S. patient are estimated at almost $619,000, and doctors say a vaccine is essential to preventing new cases. The failure of the Merck shot will set back HIV vaccine research for years, scientists have said.

The AIDS Healthcare Foundation, the Los Angeles-based provider of care and support for about 65,000 patients in 20 countries, called for a moratorium on HIV vaccine research.

``It's unfortunate that it took an AIDS vaccine trial that made more people become infected to make people pay attention and stop this runaway train,'' said Michael Weinstein, the group's president, in a telephone interview today. ``There's no validity in the underlying idea that there will be an AIDS vaccine.''

Before spending more money and time on a human test of the government's vaccine, researchers should go back to trying to understand the AIDS virus, said Ronald Desrosiers, a Harvard University scientist.

``I am against seeing it go forward,'' he said in an e- mail. ``I am willing to listen to arguments to the contrary, but have not heard any yet to make me feel otherwise.''

`A Post-Merck World'

David Baltimore, a Nobel Prize winner and leading expert on the AIDS virus, told the American Association for the Advancement of Science meeting in Boston last month that no progress on a vaccine has been made since the disease was discovered 25 years ago.

While AIDS vaccine trials still have merit, for the immediate future, they should be designed to answer questions about how they work, rather than whether they can prevent transmission of the virus, Mitchell Warren, executive director of the New York-based AIDS Vaccine Advocacy Coalition, said in a telephone interview last week.

``We're living in a post-Merck world and we're going to have to ask questions in a different way and operate in a different reality,'' he said. Merck officials declined to comment on the U.S. study.

Recruitment Challenges

The U.S. vaccine, referred to as the VRC vaccine for the center where it was developed, has at least two features in common with Merck's. Both aim to arouse immune defenders called T-cells against HIV, and both contain a cold virus called adenovirus-5.

In the Merck study, vaccinated men were at increased risk of HIV if they started the study with a high level of immunity to the cold virus, meaning they previously had been exposed to the virus. Researchers saw the same pattern in early results of an African test of the Merck vaccine, which was also halted last year on safety concerns.

No one with high levels of immunity to adenovirus-5 will be enrolled in the government vaccine trial, called PAVE-100, should it proceed, said Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, part of the NIH. That may rule out nine of 10 of potential participants in Africa, where levels of infection with the adenovirus are much higher than in the U.S., Koff said. A requirement that men in the study be circumcised, rare in some African communities, would also complicate recruitment, he said.

``We were convinced that we would have a difficult time enrolling significant numbers of individuals,'' Koff said.

`Something to Learn'

The government vaccine contains additional elements that might make it more effective than Merck's, said Warren of the AIDS Vaccine Advocacy Coalition. It uses DNA that researchers hope will induce human cells to make vaccine-like proteins, which in turn will generate a protective immune response. The cold virus in the vaccine is also hoped to provoke a stronger immune response than Merck's shot did, he said.

``It's a different product,'' he said. ``There's certainly something to learn by advancing PAVE-100.''

Koff's group had planned to assist in studying the government's vaccine in about 1,000 people in Africa. Finding participants who would have to be circumcised and lacking immunity to the infection-linked cold virus may be difficult. Human studies of AIDS vaccines should probably be kept small and aimed at discovering how to design better shots than the current crop, Koff said.

Research Summit

``Most of the information from these studies will feed into discovery, unless we were to be surprised in a positive way,'' he said.

NIAID, the U.S. infectious-disease agency, is holding a meeting tomorrow with AIDS researchers from across the country to review its $497-million AIDS vaccine research program, including the ``balance'' of human trials against laboratory research. An earlier-scheduled meeting to discuss the government's vaccine test was postponed in February until after the vaccine summit.

``In every organization, it's useful to stop and take stock, particularly when you've had an unanticipated result,'' said Bruce Walker, a Harvard Medical School AIDS researcher who's coordinating studies to determine what happened in the Merck shot's trial. ``That's what this is about.''

By John Lauerman, http://www.bloomberg.com


2. NanoViricides to Begin HIV Animal Trials

March 27, 2008

West Haven, Conn. - NanoViricides, Inc. (OTC BB: NNVC.OB), announced today that preliminary animal trials of HivCide-I(TM<>><>><>>), the Company's proposed HIV therapeutic, will begin soon at a BSL-3 facility in Boston, MA. The initial results are expected by the second week of May. These animal studies will be conducted by Dr. Krishna Menon, PhD, VMD, MRCS, a world-renowned authority in preclinical and toxicological studies of novel therapeutics.

"The need for more therapeutic alternatives to combat HIV is greater than ever, especially after the complete failure of two highly-publicized HIV vaccine trials, the first conducted by VaxGen and the second by Merck." said Eugene Seymour, MD, MPH, CEO of NanoViricides.

Rethinking Is Urged on a Vaccine for AIDS, experts said at a scientific meeting on Tuesday, reported the New York Times. The AIDS Health Care Foundation called for the suspension of money for HIV vaccine research and reallocating resources into effective HIV/AIDS prevention, testing and treatment strategies. But Dr. Fauci, the top federal official responsible for AIDS research, strongly rejected the proposal. "Under no circumstances will we stop AIDS vaccine research," Dr. Fauci said at the conclusion of the meeting, the report further said. (http://www.nytimes.com/2008/03/26/health/policy/ 26HIV.html?_r=1&ref=health&oref=slogin.)

"Control of viremia is the most important factor in keeping HIV infection from developing into symptomatic AIDS," said Dr. Howard Fields, VP of Virology at the Company, adding "nanoviricides drugs are designed precisely for controlling viremia by eliminating the circulating virus."

"This is a proof of principle study and will be expanded further with a larger follow-up study to be performed at a major government research institution later in the year," added Dr. Anil R. Diwan, President of the Company.

About NanoViricides:

NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for viral therapy. The Company's novel nanoviricide(TM<>><>><>>) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H5N1 bird flu, seasonal influenza, HIV, hepatitis C, rabies, and dengue fever, among others.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward looking statements are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance, or achievements of the company to be different from those expressed or implied including the success of the Company's research and development efforts, the availability of adequate financing, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process, described in the "Management's Discussion and Analysis" section of the Company's Form 10-KSB and other reports and filings with the Securities and Exchange Commission.

Source: NanoViricides, Inc., http://www.foxbusiness.com

Salmonella & HIV/AIDS

1. How HIV Turns Food-poisoning Into Lethal Infection

March 24, 2008

Nearly half of all HIV-positive African adults who become infected with Salmonella die from what otherwise would be a seven-day bout of diarrhea. Now, UC Davis School of Medicine scientists have discovered how salmonella becomes lethal for AIDS patients. Their findings also implicate a mechanism by which HIV evades the powerful drugs used to treat AIDS.

"We have found the defect in the immune response that allows Salmonella to cross the mucosal barrier of the gut, enter the bloodstream and infect other organs," said Andreas Bäumler, a UC Davis professor of medical microbiology and immunology and co-author of the study.

The results of the study, which will be published online by Nature Medicine March 23, revealed that viral infection of the intestine results in the depletion of a type of white blood cell, called Th-17, in the gut mucosa. This T helper lymphocyte produces IL-17, a cytokine or chemical messenger that plays a crucial role in the inflammatory response, recruiting other immune system cells to the site of infection.

This kind of interruption in the gut's immune response could be allowing HIV to maintain reservoirs that evade drug treatments, said Satya Dandekar, professor and chair of the department of medical microbiology and immunology.

"It's like putting out the fire, but leaving the embers smoldering," Dandekar said.

The rise in patients with acquired immune deficiency syndrome (AIDS) in sub-Saharan Africa has led to a dramatic increase in the frequency of non-typhoidal Salmonella serotypes (NTS), the strains of the bacteria that cause acute food-borne disease world wide. Normally, this infection is limited to the intestine, causing gastroenteritis. In AIDS patients, however, the infection spreads to the bloodstream and causes what is called NTS bacteremia.

While at a conference, Bäumler was surprised to learn from epidemiologist and physician Melita Gordon of the University of Liverpool that Salmonella was quickly becoming one of the leading causes of death in parts of Africa. (Gordon is a co-author on the current paper.) Bäumler returned to Davis and approached Dandekar about collaborating.

Dandekar had been studying the role of gut-associated lymphoid tissue in HIV. In a 2006 study, she found that HIV continued to replicate in the gut mucosa and suppress immune function in patients being treated with antiretroviral therapy -- even when T-cell counts from blood samples from the same individuals indicated antiretroviral treatment was working.

"We think the real battle between an individual's immune system and HIV is happening in the gut mucosa where there is massive destruction of immune cells," Dandekar said. Gut-associated lymphoid tissue, she pointed out, accounts for 70 percent of the body's immune system.

In HIV-infected patients, there is a gradual loss of CD4+ T cells over time. These cells, also called T helper cells, organize the immune system's attack on disease-causing invaders, like Salmonella. Unlike the steady decline of T cells in peripheral blood, there is a very rapid loss of CD4+ T cells in the gut mucosa, Dandekar said.

"We wanted to know whether the loss of the CD4+ T-cells in the gut contributed to the inactivation of the immune system one sees in HIV-infected patients," she said.

Both Bäumler and Dandekar said the timing was perfect for their collaboration. Together, they developed a novel technique that allowed them to study early intestinal responses to Salmonella infection in rhesus macaques infected with simian immunodeficiency virus (SIV), an established model for HIV infection.

"We found that animals that had no SIV infection were able to generate immediate responses to bacterial exposure, producing Th17 cells in large amounts," Dandekar said. The SIV-infected animals, however, had either a significantly lower response or lacked did not produce measurable amounts of the cytokine.

"This muted Th17 response led to dissemination of Salmonella from the gut to the peripheral blood," Dandekar said.

The team of researchers also used mice that lacked the IL-17 receptor, an arm of the mucosal immune response, to confirm that IL-17 deficiency leads to increased systemic dissemination of Salmonella.

"We believe IL-17 deficiency causes defects in the mucosal barrier of the gut," Dandekar said.

Both Bäumler and Dandekar agreed that the results of their collaboration have exciting implications for both HIV and Salmonella research and, more importantly, get scientists closer to finding treatments for HIV and the deadly form of Salmonella.

In terms of HIV, the results suggest that Th17 may make a good biomarker for monitoring HIV infection and testing the efficacy of vaccines and other therapies. They also suggest that efforts to enhance Th17 function may improve existing antiretroviral treatments.

"We are interested in looking at different molecules and compounds to see if we can boost mucosal immune defenses in the gut," she said.

Dandekar is also interested in looking at Th17 function in those who respond well to treatment and in long-term non-progressors, those individuals who carry HIV for years without going onto develop AIDS.

"Now we know these cells are playing a big role, but we need to better understand how they are contributing to immune inactivation and inflammation," Dandekar said.

In terms of Salmonella, Bäumler's next step is to discover the mechanisms by which non-immunocompromised patients are able to rid themselves of the infections.

"We now know which cytokines orchestrate the mucosal barrier function, but we still don't know what kills these bacteria," he said.

The study was funded by the National Institutes of Health.

Adapted from materials provided by University of California - Davis - Health System.

http://www.sciencedaily.com


2. Steer Clear of Salmonella

March 26, 2008

A new study shows that food poisoning can be especially dangerous—even deadly—for HIV-positive people. The best way to beat Salmonella? Avoid it altogether.

A recent study conducted by scientists from the University of California Davis School of Medicine published online by the journal Nature Medicine found that while Salmonella usually just causes seven days of diarrhea in most people, the food-borne bacterium Salmonella can spread to the bloodstream and other major organs in people living with HIV, causing a potentially fatal condition called non-typhoidal Salmonella serotypes (NTS) bacteremia. In response to our coverage of this news and your comments about the dangers of food poisoning for people living with HIV, POZ decided to share some tips on how you can best protect yourself from Salmonella infection.

Salmonellosis, or the disease caused by Salmonella infection, has been shown to affect HIV-positive people up to 100 times more than HIV-negative people. What’s more, its effects can be more serious in HIV-positive people. Salmonella bacteria—one of the most frequently reported causes of food-borne illnesses—can enter the body through contaminated foods or liquids. Symptoms of salmonellosis include severe diarrhea, fever, chills, abdominal pain and vomiting. Call your doctor if you think you have salmonellosis; go to the nearest emergency room if you are experiencing symptoms that are severe, such as extreme dizziness, fainting, sharp cramping pains or difficulty breathing.

Though there are antibiotic treatments to help treat the infection, one of the best ways to protect yourself is to lower your risk of Salmonella infection in the first place. Check out these tips:

• Wash your hands thoroughly with soap and warm water before and after handling foods, and after using the bathroom, changing a baby’s diaper or having contact with animals.
  
• When dining out, be cautious of meats and food that you don’t think are completely cooked.
  
• Buy pasteurized milk, and only buy eggs in cartons that identify the supplier, making sure to check that they are not cracked or soiled. And look for pasteurized eggs (www.safeeggs.com).
  
• Sanitize before, during and after the cooking process. Clean your hands, counter surfaces, cutting boards and utensils that have been in contact with raw meats after each use to avoid spreading bacteria around your kitchen.
  
• Know your foods that contain raw eggs, including homemade eggnog, mayo, Caesar salad dressing, cookie dough and undercooked French toast.
  
• Be especially careful in the summer months at barbeques and outdoor events. Don’t leave food outside for more than an hour if the temperature is above 90 degrees.

New Way Of Attacking HIV Looks Promising In Early Trial

March 25, 2008

A new monoclonal antibody treatment that blocks HIV’s ability to infect human cells is safe and effective, according to a preliminary trial in patients the results of which are published in the March 1st edition of the Journal of Infectious Diseases HGS004 is a human monoclonal antibody that binds to and inhibits the activity of the CCR5 receptor on the cell surface. HIV uses both the CCR5 and the CD4 receptors to gain entry to the cell but CCR5 is the primary receptor enabling HIV transmission and replication from the early stages of infection through to progression to AIDS. Small-molecule CCR5 inhibitors like maraviroc and vicriviroc have already been shown to be effective HIV treatments, leading to maraviroc gaining a license last year. But monoclonal antibody drugs have advantages compared to traditional small-molecule drugs. They can be dosed less frequently - biweekly or even monthly- and usually do not interfere with other drugs allowing a greater freedom of combination. They also should theoretically work against resistant strains. However, they have to be injected, rather than taken orally. Preclinical research with HGS004 has shown that it binds tightly to human CCR5, prevents HIV entry and viral transmission. But this new study has looked at its effects in 63 patients infected with CCR5-tropic HIV as a "proof of concept" study - a trial to demonstrate clinical efficacy with a small number of strictly selected patients. All patients were randomised to receive a single intravenous dose of HGS004 at one of five doses – 0.4, 2, 8, 20 or 40 mg per kg body weight- or placebo. After 14 days 54% of patients in the 8, 20 and 40mg/kg group had a greater than log10 drop in HIV RNA levels. In the 40mg/kg cohort four out of 10 patients had a greater than log10 reduction in HIV at day 28. The antibody was well tolerated at all doses, with no increase in toxicities seen at higher doses.

The US authors say this study suggests HGS004 is safe and shows meaningful anti-HIV activity. But they suggest further studies should be carried out with HGS101 – a derivative of HGS004 which is five to ten times more potent but retains other characteristics of the original.

Reference Lalezari J et al. Safety, pharmacokinetics, and antiviral activity of HGS004, a novel fully human IgG4 monoclonal antibody against CCR5, in HIV-1 infected patients. J of Infect Dis 197: 721-727, 2008.

By Adam Legge, www.aidsmap.com

Charting the Future of Protease Monotherapy

March 25, 2008

It has been suggested that using a Norvir (ritonavir)-boosted protease inhibitor (PI) without the use of other antiretrovirals to treat HIV is less effective, and more likely to cause drug resistance, than standard three-drug regimens in clinical trials. However, in an editorial published in the March 30 issue of AIDS, researchers argue that PI monotherapy has the potential to guard against side effects and preserve future treatment options, thereby keeping it in the limelight as a potential treatment option that deserves further research.

The option of using a single protease inhibitor—boosted with a low dose of Norvir—was initially proposed by Joseph Gathe, MD, a clinician and researcher in Houston. In 1993 Gathe first published data showing that Kaletra (lopinavir/ritonavir) used without other ARVs was effective in reducing viral loads to less than 50 copies in people starting HIV treatment for the first time.

More recently, the Abbott-funded Monark study compared Kaletra monotherapy to Kaletra plus Combivir (zidovudine plus lamivudine) in 136 first-time treatment takers. Unfortunately, after 48 weeks of treatment, only 67 percent of people on Kaletra monotherapy had viral loads less than 50 copies compared with 75 percent of people on the three-drug regimen. The difference was statistically significant, meaning that it was too large to have occurred by chance. What’s more, three people who had a virologic failure on the monotherapy arm developed HIV drug resistance, compared with just one person on the triple-drug regimen.

Monark’s questionable results, however, have not quashed the possibility of ARV monotherapy. Andrew Hill, MD, of the University of Liverpool in the United Kingdom, and his colleagues argue in their editorial that, despite the uneven performance of Kaletra monotherapy in Monark and three other studies, the relatively high efficacy seen and the low number of people developing resistance is still remarkable for a single-drug regimen.

They also point out that 90 percent of people on monotherapy whose virus dropped to less than 400 copies by the fourth week of treatment in the Monark study went on to maintain undetectable viral loads for 48 weeks of treatment. Because of this, they reason, it may be possible to attempt a short course of monotherapy in treatment-naive patients, and quickly determine who is likely to respond, thus guarding against the development of drug resistance.

Moreover, Hill and his colleagues highlight a strategy used successfully in the monotherapy trials. In Monark and other trials, if a person on Kaletra monotherapy first achieved an undetectable viral load, but then had a return of detectable virus, they had their treatment "intensified" by adding two nucleoside reverse transcriptase inhibitors, such as Combivir. In such cases, people were almost always able to achieve an undetectable viral load again and thereby prevent the development of drug resistance.

"A strategy of PI monotherapy for most patients, with intensification for the few who need it, may be attractive for many patients and clinicians," writes Hill and his colleagues.

Several new monotherapy trials are moving forward—some using Kaletra, and others using Reyataz (atazanavir) or Prezista (darunavir) boosted by Norvir. In most cases, people are being treated initially with three-drug regimens to reduce their viral loads to undetectable before switching to monotherapy. Hopefully, monotherapy will be associated with better long-term efficacy in these studies than in trials completed thus far.

http://www.aidsmeds.com

Lower-Dose Zerit May Improve Some Side Effects

March 26, 2008

Halving the dose of Zerit (stavudine) may reduce the risk of serious side effects without compromising its efficacy, say researchers of a study published in the April 15 issue of Clinical Infectious Diseases.

Bristol-Myers Squibb’s nucleoside reverse transcriptase inhibitor (NRTI) Zerit has fallen out of favor in many parts of the world because of its side effects, including lipoatrophy, increases in lipid levels, a dangerous buildup in the blood of lactic acid (lactatemia), and an increased diabetes risk. Many of these side effects likely occur because Zerit can damage the mitochondria that help keep cells functioning properly.

In the U.S. and other industrialized nations, NRTI options are plentiful and people can avoid Zerit altogether. But the lower dose may help HIV-positive people who do need it, including those in developing countries where options are fewer and stavudine is affordable.

The study conducted by Grace McComsey, MD, of Case Western Research University in Cleveland, enrolled 24 HIV-positive patients who’d been on full-dose Zerit for at least six months and had signs of mitochondrial toxicity (e.g., lactatemia or lipodystrophy). Approximately half of the trial volunteers reduced their Zerit dose from the standard 40 mg to 20 mg twice daily, or from 30 mg to 15 mg for those weighing 132 pounds or less.

After 48 weeks, six of the 15 participants who’d switched to the reduced-dose Zerit had viral loads that became detectable, compared with only two of the nine participants who remained on the full dose.

In terms of side effects, the average level of fat mtDNA, a marker of mitochondrial health in fat cells, increased by 67 percent in the group who switched to the reduced Zerit doses, but remained the same in the group who stayed on full-dose Zerit. Lactate levels decreased by 0.27 mmol/L in the reduced-dose group, but did not improve in the full-dose group.

Modest improvements in body composition, including pre-study belly accumulation, were reported among those who switched to lower-dose Zerit compared with those who remained on the standard dose of the drug. Similarly, bone mineral density, the loss of which can increase the risk of broken bones, decreased in the group that remained on full-dose Zerit, but remained stable in the reduced-dose group.

McComsey’s team acknowledges that the study is small and that side effect improvements were significantly less than those seen in other studies where participants switched from Zerit to another drug altogether. Given that so many people in the world rely on the availability of stavudine formulations, the authors conclude that the safety and efficacy of reduced dosing is encouraging.

http://www.poz.com

FDA Reviewing Safety of HIV Drugs

March 29, 2008

Rockville, MD (AHN) - HIV drugs manufactured by GlaxoSmithKline and Bristol-Myers Squibb are being reviewed by the U.S. Federal Drug Administration after a study connected the drugs to increased risk of heart attack.

The study of 33,000 HIV patients, which was done to determine the short and long term risk of taking AIDS drugs, revealed that patients taking Ziagen (a GlaxoSmithKline drug) and Videx (a Bristol-Myers Squibb drug) were at increased risk of heart health problems when compared to other types of treatment.

The FDA says that the results that will be obtained from their investigation may lead to labeling changes for both drugs.

FDA said in a notice posted on its website that until their evaluation is complete, health care providers should evaluate the potential risks and benefits of each HIV drugs their patients are taking.

GSK and Bristol said their companies had their own data on the drugs, and both said they found no increased risk of heart attack.

By Cecilia Arceo, http://www.allheadlinenews.com