A panel of HIV specialists is recommending that U.S. regulators approve the first over-the-counter HIV test designed to quickly return a result in the privacy of a person's own home, a new option which could expand testing for the virus that causes AIDS.
The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of OraQuick HIV test outweigh its potential risks for consumers. The test kit uses a mouth swab sample to detect the presence of HIV within 20 minutes.
The manufacturer OraSure already sells a version of the test to doctors and other health professionals. Studies showed the test was less accurate when used by consumers, but panelists said that the benefits of expanding HIV testing outweigh a small decrease in test accuracy.
NAT wish to shift the emphasis, saying there should be an assumption that a sexually active gay man should have a regular HIV test rather than seeking it out from a STD clinic.
The number of people living with HIV in the UK will this year reach 100,000 and 25% will be unaware of their infection. Latest statistics show half of adults living with HIV are diagnosed late.
Chief executive of NAT Deborah Jack has said it is important the NHS recognizes that HIV testing is cost effective and realise it saves money in the long run.
She said: ‘At present it is a scandal that most people with HIV are living for at least five years undiagnosed and that many repeatedly attend healthcare without any recommendation of an HIV test, and with testing guidelines ignored by many healthcare professionals.’
Stonewall’s research say a quarter of the men they surveyed had never been tested for a sexually transmitted infection and 30% had never had an HIV test.
The most common reason for not testing is an assumption they are not at risk. But a third say they have not tested for HIV because they have not had any symptoms – even though early testing, diagnosis and treatment before symptoms occur is clearly linked to better long-term outcomes.
Others say they haven’t been offered tests, they don’t know where to go, the clinics are intimidating or the testing process is off-putting.
NAT policy officer Steve Akehurst told Gay Star News: ‘The biggest thing is we shouldn’t be afraid of HIV, what we should be afraid of is undiagnosed HIV.
‘The worst thing is not to know that you have HIV.’
Gilead Sciences Inc's Truvada tablets appear safe and effective for reducing the risk of HIV infection, U.S. regulators said on Tuesday. But they recommended a cautious approach for using the drug in efforts to prevent the virus that causes AIDS.
Food and Drug Administration staff said Truvada, which is already being used by patients with the human immunodeficiency virus, is well tolerated overall by uninfected people and may prevent infection in high-risk individuals when used in combination with other strategies.
FDA staff also acknowledged a strong correlation between the drug's efficacy at reducing HIV infection and the willingness of those taking it to adhere to the treatment.
Their 47-page review document said preventive use of the drug -- a combination of Gilead's HIV drugs Emtriva, also known as emtricitabine, and Viread, or tenofovir -- should be weighed carefully against an individual's risk for infection, readiness to adhere to the treatment and potential for kidney problems.
"The individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment," the report said.
Truvada represents a potential milestone in the evolution of the worldwide AIDS epidemic by offering a tablet capable of preventing infection. An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention.
An outside panel of experts is scheduled to examine the FDA review documents on Thursday and make recommendations that U.S. health regulators will consider in deciding whether the drug should be used as a preventive treatment.
Some experts warn that the drug is only partly effective against HIV and that using it to prevent infection could cause protection from the virus to falter if patients fail to adhere to treatment.
Shares in Gilead Sciences were off 1.5 percent at $49.17 after the FDA released the review document.
CONCERNS OVER DRUG RESISTANCE
UBS analyst Matthew Rodin told investors that the review should have only limited impact on the company because Truvada, which has FDA approval to treat people infected with HIV, is already being used off-label as a prophylactic.
He said a Friday advisory committee meeting on Gilead Sciences' Quad HIV pill for controlling the HIV virus could have bigger implications for the company. Quad is seen as key to Gilead's continued dominance of the market for HIV drugs.
Meanwhile, FDA staff acknowledged that resistance is likely to occur among people who become infected while taking the drug. "The frequency of resistance might be minimized by limiting the duration of drug exposure after infection occurs," the review document said.
The Boston-based Fenway Health Institute, which advocates for the lesbian, gay, bisexual and transgender communities, issued a statement calling on the FDA to approve the drug as a means of reducing the risk of HIV infection.
"If the FDA approves the additional indication of the use of tenofovir-emtricitabine ... health programs and individuals will have improved choices," the group said.
In a 2010 landmark study in the New England Journal of Medicine, researchers found that giving a daily dose of Truvada to men who have sex with men can reduce HIV infection rates 44 percent.
But other research shows that Truvada's high price makes it too costly to provide it to all homosexual and bisexual men, who account for more than half of the estimated 56,000 new infections annually in the United States.
A team of researchers at Stanford University had estimated that giving a daily preventive dose of the drug to all U.S. men who have sex with men would cost $495 billion over 20 years in terms of the cost of drugs and healthcare visits.
The strategy would be far more effective if it targeted men who are at high risk of developing HIV because they have five or more sexual partners a year, they said.
If just 20 percent of these high-risk individuals took the drug, the research team found, it could prevent 41,000 new infections over a period of 20 years at a cost of about $16.6 billion.
A new national multi-media campaign launched today in Sydney by the National Association of People living with HIV/AIDS (NAPWA) urges people living with HIV to get up to date about the latest advances in HIV treatment, with new more effective and better tolerated treatments also capable of significantly reducing the risk of transmission to others.
Launching the campaign at ACON’s headquarters, media personality and long-time HIV health advocate Ita Buttrose also fired a parting shot at the Federal Government, urging Health Minister Tanya Plibersek to help steer the government clear of complacency in regards to Australia’s HIV response.
“I’m talking about such barriers as no access to rapid HIV testing in Australia, our state of restrictions to prescribe the HIV treatments earlier in the course of HIV infection, dispensing arrangements where people can only have their scripts filled at hospital pharmacies in business hours,” Buttrose said.
“I mean can you believe it?”
The campaign aims to encourage people with HIV to talk to their doctor about important new developments in HIV treatment and prevention with advertisements to run across national print media and billboard posters at key sites in Brisbane, Melbourne and Sydney.
It will be the first campaign of its kind to use mainstream media and public advertising sites to promote HIV treatment awareness, with NAPWA president Robert Mitchell suggesting that recent scientific advances show that treatment can also help with the prevention of HIV.
“Unfortunately, many people with HIV are still unaware of recent treatment improvements, new information about living with HIV long term, and the added benefit that being on treatment can have in reducing the risk of HIV transmission”, Mitchell said.
President of the Australasian Society for HIV Medicine, Dr Edwina Wright, commended NAPWA’s campaign as well as its target message.
“There’s growing evidence that starting treatment as soon as someone is positive or certainly very early in their illness when their immune system is good has benefits,” she said at the launch.
“The point here is that we need to be talking to our patients about this evidence and we invite you to come and discuss this evidence. It’s nuanced, it can be tricky.”
New US HIV treatment guidelines released last month, and supported by NAPWA, now recommend treatment for all people with HIV, regardless of whether they are newly infected or have more advanced HIV infection.
Simon O’Connor, the executive officer of Queensland Positive People, told the audience he hoped it would be the current generation which eventually conquered HIV.
“A lot of people are operating under an old view of HIV in its treatment,” he said.
“Today the picture is actually quite different. Many people with HIV need only take one pill a day. Treatments are effective long term and side effects and toxicities are minimal for many people.”
The GMC has reminded doctors of their duty to avoid discrimination, after a survey of gay and bisexual men showed that their health needs are often neglected. Respondents reported higher than average levels of domestic abuse, mental ill health and use of alcohol, tobacco and illegal drugs, but said that services tended to focus purely on sexual health.
Stonewall had responses from 6861 gay and bisexual men from across Britain to its health survey, the largest ever conducted. This showed that a third of gay and bisexual men who have accessed healthcare services in the past year have had a negative experience related to their sexual orientation; and a third of gay and bisexual men are not out to their GP or healthcare professionals – they are more likely to be out to their manager, colleagues, family and friends than their GP.
Unmet health needs are common among gay and bisexual men. In the past year, 3% of gay men and 5% of bisexual men had attempted suicide, compared with 0.4% of men generally. One in six gay and bisexual men aged 16-24 have harmed themselves in the past year.
The survey also showed that:
Only one in ten gay and bisexual men have ever discussed prostate or bowel cancer with a healthcare professional and only 3% have ever discussed lung cancer
Only one in ten have ever discussed heart disease with a healthcare professional, and only one in five have ever discussed high blood pressure or high cholesterol
Two-thirds of gay and bisexual men have smoked at some time in their life compared with half of men in general
42% of gay and bisexual men drink alcohol on three or more days a week compared with 35% of men in general
Half of gay and bisexual men have taken drugs in the past year, compared with one in eight men in general
One in four gay and bisexual men have never been tested for any sexually transmitted infection, and three in ten have never had an HIV test
Only a quarter said that healthcare workers had given them information relevant to their sexual orientation
Half of the men surveyed had experienced domestic abuse from a family member or partner, compared with 17% of men in general.
Stonewall’s chief executive Ben Summerskill said: “Britain’s 1.8 million gay and bisexual men are being let down by health services which often see homosexuality and bisexuality purely as sexual health issues. As a result hundreds of thousands of gay and bisexual men are in dire need of better support from health professionals.”
The GMC’s chief executive Niall Dickson (pictured) said: “This survey highlights examples of poor treatment and care experienced by gay and bisexual men from doctors and other health professionals. Instances such as these are completely unacceptable.
Our core guidance, Good Medical Practice makes it absolutely clear that doctors must never discriminate unfairly against patients.”
The GMC has produced with Stonewall an information leaflet that explains to lesbian, gay and bisexual patients what they should expect from their doctor.
For many HIV-positive Americans, and those who advocate on their behalf, these are days of anxious waiting as the Supreme Court ponders President Barack Obama's health care overhaul.
This loose-knit community — made up of activists, health professionals and an estimated 1.2 million people living with HIV — has invested high hopes in the Affordable Care Act, anticipating that it could dramatically improve access to lifesaving care and treatment. The act is now in limbo as the high court deliberates on its constitutionality, notably its requirement that most Americans obtain health insurance. A ruling could come in June.
"The HIV treatment community sees the act as a critical step in our fight against the AIDS epidemic," said Scott Schoettes of Lambda Legal, a national gay-rights advocacy group. "People have been counting on it, making plans based on its implementation, so for it to be pulled out from under their feet at this point would be a tremendous loss."
Among its many provisions, the health care law has two major benefits for HIV-positive people: It expands Medicaid so that those with low incomes can get earlier access to treatment, and it eliminates limits on pre-existing conditions that have prevented many people with HIV from obtaining private insurance.
Under current policies, low-income HIV-positive people often do not qualify for Medicaid if they are not yet sick enough to be classified as disabled.
In the view of advocacy groups, this creates a cruel Catch 22 — at a stage when they are still active and productive, these people can't afford the antiretroviral treatments that could help them stay that way. Only when their condition worsens are they able to qualify for Medicaid and get treatment that might have prevented the deterioration.
The health care act would remove the disability requirement and makes Medicaid available to a broader range of low-income adults.
"It will prolong life potentially by decades for literally hundreds of thousands of persons," said the National Minority AIDS Council in its Supreme Court brief. "Individuals can continue to work and go about their daily lives as productive members of society."
According to the Department of Health and Human Services, only about 13 percent of people with HIV have private health insurance and about 24 percent have no coverage at all. As a group, HHS says, these people "have been particularly vulnerable to insurance industry abuses" and face barriers to obtaining care from qualified providers.
Under the new law, insurers cannot rescind existing coverage to adults unless there's evidence of fraud. As if 2014, when the law is scheduled for full implementation, insurers will not be allowed to deny coverage to anyone with HIV/AIDS or impose annual limits on coverage.
Schoettes, who is Lambda Legal's HIV Project director and is HIV-positive himself, says this part of the law would curtail harmful insurance practices.
"Most private insurers have refused to provide affordable coverage to those with HIV," he and other Lambda Legal lawyers wrote in a brief submitted to the Supreme Court in March.
"This market failure has caused serious consequences both for individuals with HIV — who suffer unnecessary illness and premature death — and for society generally in higher overall health care costs and lost productivity," the lawyers wrote. "Virtually all this suffering is avoidable: medical care is available that can turn HIV into a chronic, manageable condition."
America's Health Insurance Plans, which represents major private health insurers, opposed Obama's health care law. The trade group says it supports expanding coverage to most Americans but believes key provisions in the law are poorly designed and will raise costs and cause disruptions.
The organization's spokesman, Robert Zirkelbach, acknowledged that under the current system, individuals with HIV or AIDS do find it hard to obtain private coverage if they already had the disease. "If people wait until after they're sick, they're often not able to get it," he said.
However, he said health plans were active in trying to improve treatment and care for HIV-positive Americans, both their own clients and others. He said insurers did sometimes rescind coverage on grounds that a patient had not fully disclosed required information, but that such instances were rare.
Among HIV-positive people without private insurance, many rely on public programs such as Medicaid and Medicare, but others are not eligible. As a last resort, if they meet the low-income criteria, they can seek financial assistance through the federal Ryan White Care Act.
However, advocates say the result is often patchwork health care — or no care at all. Many uninsured people don't get tested, don't know their HIV status and unwittingly transmit the infection to others.
Antiretroviral treatment is expensive — often more than $18,000 per year. But advocacy groups say treatment is cost-effective, enabling more people to be self-sufficient and reducing later spending on acute care and stays at hospices.
Advocacy groups also contend that the positive effects of the federal health care act can be foretold by the experience of Massachusetts, which adopted similar legislation in 2006. According to a study last year by Harvard Law School's Center for Health Law and Policy Innovation, new HIV infections dropped by 37 percent in Massachusetts from 2005 to 2008, while rising by 8 percent in the rest of U.S.
By federal estimate, about 50,000 new cases of HIV infection occur annually in the United States. The Centers for Disease Control's latest figures show that gay and bisexual men account for about 60 percent of the new infections; blacks also are affected disproportionately, accounting for about 13 percent of the population and about 44 percent of new HIV infections.
The CDC also says the HIV infection rate in poor urban areas is far higher than for the rest of the U.S. — and is on par with the rate in such AIDS-devastated countries as Haiti and Angola.
"HIV is a disease of poverty," said Dr. Michael Saag, an HIV physician and researcher at the University of Alabama at Birmingham. "That's why the health care law is critically important."
In Alabama, he said, funding to provide HIV treatment for low-income people has not risen to meet growing demand, and clinics lack adequate staff and resources.
"Once on treatment, transmission of HIV is cut to almost zero — but where do these people get treatment?" Saag asked. "The question to people who are against the Affordable Care Act is, 'What are we going to do instead?'"
Saag is a past chairman of the HIV Medicine Association, representing more than 4,800 health care professionals and researchers. The current chair, Dr. Judith Aberg of the New York University School of Medicine, recently pleaded for the health care law to be upheld.
"For the first time in 30 years, thanks to advances in HIV prevention and treatment research, we can realistically envision the end of the greatest pandemic of our time," she said. "To reach this goal, we cannot afford to take any steps backward."
In Illinois, state Rep. Greg Harris, who is HIV-positive, has joined with colleagues in fighting to minimize funding cuts for the AIDS Drug Assistance Program, a joint state-federal initiative providing HIV medications to low-income people.
Harris believes the Affordable Care Act can be a huge help in providing more HIV-positive people with health insurance. Were it to be rejected by the Supreme Court, he said, "It would take away a lot of hope for a lot of people."
in a letter to Dr. Ken Zucker obtained exclusively by Truth Wins Out, Dr. Robert Spitzer made an unprecedented apology to the gay community — and victims of reparative therapy in particular — for hisinfamous, now-repudiated 2001 study that claimed some “highly motivated” homosexuals could go from gay to straight:
Several months ago I told you that because of my revised view of my 2001 study of reparative therapy changing sexual orientation, I was considering writing something that would acknowledge that I now judged the major critiques of the study as largely correct. After discussing my revised view of the study with Gabriel Arana, a reporter for American Prospect, and with Malcolm Ritter, an Associated Press science writer, I decided that I had to make public my current thinking about the study. Here it is.
Basic Research Question. From the beginning it was: “can some version of reparative therapy enable individuals to change their sexual orientation from homosexual to heterosexual?” Realizing that the study design made it impossible to answer this question, I suggested that the study could be viewed as answering the question, “how do individuals undergoing reparative therapy describe changes in sexual orientation?” – a not very interesting question.
The Fatal Flaw in the Study – There was no way to judge the credibility of subject reports of change in sexual orientation. I offered several (unconvincing) reasons why it was reasonable to assume that the subject’s reports of change were credible and not self-deception or outright lying. But the simple fact is that there was no way to determine if the subject’s accounts of change were valid.
I believe I owe the gay community an apology for my study making unproven claims of the efficacy of reparative therapy. I also apologize to any gay person who wasted time and energy undergoing some form of reparative therapy because they believed that I had proven that reparative therapy works with some “highly motivated” individuals.
Robert Spitzer. M.D. Emeritus Professor of Psychiatry, Columbia University
Zucker, to whom Spitzer’s letter is addressed, is the editor of the Archives of Sexual Behavior, the journal in which Spitzer’s study was originally published in 2001. At that time, the study was a surprise that created a media firestorm which captured the nation’s attention. Dr. Spitzer was the last person in America one would have expected to produce a study bolstering the claims of ‘ex-gay’ activists — after all, he had previously led the charge in 1972-73 to remove homosexuality from the list of mental disorders in the Diagnostic and Statistical Manual (DSM) of the American Psychiatric Association. Earlier this month, Dr. Spitzer dealt “ex-gay” programs a fatal blow by officially renouncing his study in the American Prospect article he mentions in his letter above. That renunciation kicked out the final leg from the stool on which the proponents of ‘ex-gay’ therapy based their already shaky claims of success, or as Arana put it, removed from the ex-gay “fringe movement. . . its only shred of scientific support.”
Dr. Spitzer’s apology to the victims of “pray away the gay” therapy and the greater LGBT community marks a watershed moment in the fight against the “ex-gay” myth. We commend him for it, because not only will it solidify his legacy as a respected doctor and significant historical figure, but it will help to greatly hasten the day when the scourge that is reparative therapy is eradicated forever and LGBT people can live openly, honestly, and true to themselves.
British health services are failing gay and bisexual men who are more likely to use drugs, smoke, self-harm and attempt suicide says Stonewall report
Gay and bisexual men are more likely to smoke, drink, take drugs, self-harm, attempt suicide and be depressed – but they’re often overlooked by health services.
That’s the damning verdict of a survey by Stonewall into the health of gay and bisexual men in Britain – the biggest study of it’s kind in the world.
Their report out today (25 April) found that 3% of gay men and 5% of bisexual men have attempted suicide in the last year alone – by comparison to just 0.4% of men in general.
And 6% of gay and bisexual men aged 16 to 24 have tried to kill themselves in the last year. That’s six times more than the average for men in that age range.
The study showed that half of gay and bisexual men have been the victim of domestic abuse by a family member or partner since the age of 16 – around three times more than men in general.
It also indicates gay and bi men drink alcohol more and are more likely to smoke than straights. And half of them have taken illegal drugs in the last year – four times more than the average for men.
Positively, gays and bisexuals are much less likely to be overweight or obese than other British men. But only a quarter take enough exercise and many worry about how they look with a higher proportion struggling with eating disorders.
Despite all this, gay and bisexual men are often overlooked by health services and health information messages, including around cancer, often don’t get through to them.
Worse still, a third of the gay and bisexual men surveyed, who had used healthcare services in the last year had a ‘negative experience related to their sexual orientation’.
And although it can help with diagnosis and treatment, gay men are more likely to be out to their friends, family, work colleagues and manager than to their doctor.
Stonewall chief executive Ben Summerskill said: ‘This deeply troubling report provides hard evidence that Britain’s 1.8 million gay and bisexual men are being let down by health services which often see homosexuality and bisexuality purely as sexual health issues.
‘As a result hundreds of thousands of gay and bisexual men are in dire need of better support from health professionals. This landmark report makes a number of recommendations that could help health services improve before more lives are ruined.’
Britain’s National Health Service (NHS) only has patchy monitoring of LGBT health issues and policy on sexual-orientation discrimination are not universal.
But a Department of Health spokesperson told Gay Star News: ‘All patients, irrespective of their sexual orientation, should expect the best care on the NHS. Anything less is unacceptable.
‘That's why lesbian, gay and bisexual people are prioritized in our Mental Health Strategy as we recognize they are at a higher risk of mental health problems, violence and self-harm.
‘General Medical Council guidance states that doctors must not discriminate against patients and their personal information must be held in confidence. The latest GP Patient Survey shows that 84% of gay, lesbian and bisexual respondents described their overall experience of their GP surgery as good.’
But despite the official’s reassurance, Stonewall’s report summarizes that there are ‘serious concerns’ about gay and bisexual men’s health and a ‘stark message’ that health bosses need to rethink how they deal with gay patients.
It recommends more training, better policies, tighter monitoring and more work to understand gay and bisexual men’s health needs, tell them what they need to know and help them access health services.
HIV and sexual health charity Terrence Higgins Trust is launching a new programme of free and confidential groups for gay and bisexual men with HIV in the capital, beginning this weekend.
Gay men remain the group most disproportionately affected by HIV in the UK. In 2010, men who have sex with men made up 69% of all HIV infections acquired through sex in the UK that year, despite representing between 3% and 4% of the general population.
Even though medical treatment for HIV has improved significantly, people with HIV can sometimes face a range of issues related to their condition, and these groups provide a safe environment in which such issues can be addressed.
The central London groups over the coming weeks include:
Saturday 21st April (10.00am – 3.00pm): Who to Tell With ongoing high levels of stigma surrounding HIV, it can be difficult for people living with HIV to know how to tell those around them. This one day workshop aims to give gay men the confidence to better take control of who to tell and how to tell them. Those who attend will have the opportunity to share any fears or concerns they may have about telling others their status and discuss any experiences they have faced so far.
Saturday 28th April (6.30pm – 9.30 pm): HIV/HepC Co-infection This three week course offers support for gay men living with both HIV and Hepatitis C. The course will advise these men on how to tell people about their condition, emotional wellbeing, and information and advice on treatment options and how Hepatitis C can be transmitted.
Tuesday 1st May (6.30p.m – 9.00pm): Positively Growing Older With improvements in medication keeping people with HIV alive for longer, the largest group of HIV positive people today are those aged 50 or above. This six week programme welcomes men over the age of 45, or those who have been living with the condition for over ten years. Attendees will have a chance to address any emotional or physical changes they may be going through, and share their general experiences of growing older with HIV.
Monday 14th May (6.30pm – 9.00pm): My HIV: Sex and Relationships This one day workshop gives HIV-positive gay men who have struggled to come to terms with their diagnosis an opportunity to discuss their feelings and receive advice on how to develop meaningful relationships with people in the workplace, friends or sexual partners. Cognitive Behavioural Therapy, motivational interviewing and art therapy are some methods used in the workshop to improve self-confidence and promote positive thinking.
Justin Dickson, Groupwork Project Worker at Terrence Higgins Trust, said: “Not only do these groups offer practical support, but more importantly, they focus on the emotional well-being of the participants. Group members have a great opportunity to talk to others in the same situation, and build friendships and support networks. We encourage anyone who feels they may benefit from attending a group to get in touch.”
Advocates for sex workers in New York have called for legislation that would stop police officers confiscating condoms from prostitutes.
The Sex Workers Project says two surveys suggest that police frequently take away condoms from sex workers as evidence in prostitution cases.
The campaign group says the tactic has led to some prostitutes carrying fewer or no condoms and having unsafe sex.
The Sex Workers Project wants condoms to be inadmissible as evidence.
Under New York City's long-running health programme, an estimated 192m condoms have been handed out since 2007.
HIV infections
The sponsor of the bill, Democratic state senator Velmanette Montgomery, says the measure is not endorsing prostitution.
"It is simply related to the fact that over 100,000 people right now are infected with HIV and Aids in New York City," she said.
But a New York prosecutor told the Associated Press news agency that not allowing supporting evidence such as condoms could allow pimps and traffickers to walk free.
And Alexandra Waldhorn, a spokeswoman for the New York City health department, said that it opposed the bill.
A report from the Sex Workers Project found that carrying condoms was fairly standard among prostitutes, but there were several cases where police had taken condoms without arrest.
The report cited two recent surveys of sex workers, conducted by the city's health department and by an advocate network.
The city health department survey of 63 people, found that 36 said their condoms had been confiscated and 26 told the researchers they had been arrested.