Positively Aware Online News Brief. Current HIV News and events
POSITIVELY AWARE 5/21/2012
Follow us.FDA Panel Approves Over-The-Counter HIV Test
Is Risk of Sudden Cardiac Death Higher for the HIV-Positive?
Looking for HIV-Positive Organ/Tissue Donors for Research
Justice Department Settles Suits over HIV Discrimination
APLA Condemns ADAP Cost-Sharing Plan
Big Excellent 20th Reunion to Premiere Off-Broadway in June
FDA Panel Approves Over-The-Counter HIV Test
The U.S. Food and Drug Administration (FDA) asked a panel of outside experts if the first over-the-counter home HIV test should be approved. The test would allow people to test themselves for the virus at home, without medical supervision, and get results in a matter of minutes. On May 15, the advisory panel recommended approval. The agency is not required to follow the panel's advice, although it usually does.
In a trial conducted by OraSure Technologies Inc., makers of the test, it correctly detected HIV in those carrying the virus 93% of the time. That rate is below the FDA-recommended 95% threshold for accuracy. The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved for U.S. consumers.
The test was more accurate at correctly clearing patients who do not have HIV. In company studies, OraQuick correctly identified HIV-negative users 99% of the time. When used by professionals, the test is shown to identify both carriers and non-carriers accurately 99% of the time.
In their briefing documents, FDA scientists noted both the benefits and risks of expanding HIV testing with the take-home diagnostic kit.
“There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status,” the reviewers state. “However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected.”
Edward Kuras, Prevention Manager at TPAN in Chicago, where they use the OraQuick test, expressed the same opinion voiced by other AIDS advocates—while he can see the benefits of having a test that people can use in the privacy of their own homes, thus alleviating the fear of stigma at an HIV clinic or testing facility, he is concerned about the lack of pre- and post-test counseling, especially if they test positive.
“My concerns about OTC testing are numerous. I worry about the teenagers who are being bullied and find out they are HIV-positive…all alone. I worry about strict parents forcing their children to take the test. I worry about the domestic violence and suicide attempts that may result from a positive result,” says Kuras. “Many people in the days immediately following a positive result are hopeless and frozen with fear. How will they know where to go for help?”
Gilead plans to have an 800 number for people to call that would provide referrals to local agencies and providers.
The FDA will make its final decision on approval later this year.
Is Risk of Sudden Cardiac Death Higher for the HIV-Positive?
In a comprehensive, retrospective 10-year University of California, San Francisco (UCSF) study, researchers found patients with HIV/AIDS suffered sudden cardiac death at a rate four times higher than the general population.
“As part of my ongoing research in 2010, we were looking at every instance of sudden death in San Francisco,” said first author Zian H. Tseng, MD, an electrophysiologist and an associate professor of medicine in the UCSF Division of Cardiology. “I noticed that many of these cases involved individuals with HIV infection who were dying suddenly. I wondered if there was some sort of connection there.”
He began collaborating with Priscilla Hsue, MD, a UCSF associate professor of medicine and the director of the HIV Cardiology Clinic at San Francisco General Hospital and Trauma Center (SFGH), who is one of a few cardiologists in the country who specializes in HIV. To her knowledge, no one had ever explored the link between HIV and sudden death.
In a paper published May 15 in the Journal of the American College of Cardiology, Tseng, Hsue, and other researchers conducted a retrospective study of 2,860 HIV patients from April 2000 to August 2009 at San Francisco General Hospital’s Ward 86, the first HIV/AIDS-specialized clinic, to comprehensively characterize all deaths. They studied medical records, death certificates, paramedic reports, and interviews with family members, doctors, and other clinicians.
During that period, cardiac-related deaths accounted for 15% of overall mortality. Of that group, 86% died of sudden cardiac death.
“To put that in context, we’re able to compare the rate of sudden death in this population with the overall San Francisco population,” Tseng said. “So adjusted for age, race, demographics, and other variables, the rate of sudden death in the HIV population is more than four times higher than the general population.”
“The fact that the vast majority of cardiac deaths were sudden is surprising and implies that we, as clinicians, need to be aware of this potential health issue among patients with HIV,” Hsue added. “Our findings also highlight many things that we still don’t know about HIV and sudden death. Did these individuals die of unrecognized coronary artery disease? What can we be doing as clinicians to identify patients at risk and to intervene beforehand?”
Researchers believe HIV changes the electrophysiology of the heart in a way so pronounced that it causes conduction abnormalities. And some HIV medications can throw off the heart’s electrical cycle, which increases the risk of sudden death. These and other variables could be contributing factors.
“Acknowledging the limitations of a retrospective analysis, what’s interesting about this study is that it opens up many related questions we can ask in future studies, such as which high-risk patients might benefit from defibrillator implantation.” Tseng said.
Looking for HIV-Positive Organ/Tissue Donors for Research
Requirements for research are different than requirements for transplant, and it is important to understand that anyone at any age may be a research donor candidate. A history of disease does not preclude donation for medical research. Scientists frequently need affected tissue in order to investigate treatments.
The National Disease Research Interchange (NDRI) is a non-profit organization in the U.S. that provides approved biomedical researchers with access to human tissue. NDRI was founded as the National Diabetes Research Interchange by Lee Ducat, the mother of a diabetic child and a founder of the Juvenile Diabetes Foundation, who was frustrated by the lack of information and had hope for a cure for her son’s condition. Today NDRI, with funding from the National Institutes of Health, provides all types of normal and diseased tissues to researchers studying a wide range of common and rare diseases and disorders, including HIV/AIDS
To find out more about donating tissue and organs, click here.
The National Minority AIDS Council (NMAC), Harvard University’s Center for AIDS Research (CFAR), and the National Black Gay Men’s Advocacy Coalition (NBGMAC) are sponsoring a webinar on Tuesday, May 29 from 3:00 – 5:00 pm EST.
An update on the current state of biomedical HIV prevention research and a discussion of the implications of these new strategies for black gay and bisexual men will be provided by moderator Gary Daffin of NBGMAC/NMAC Be The Generation Bridge Initiative and speakers Rev. Keron Sadler, the NAACP’s Manager of Health Programs; NMAC’s Moises Agosto; Dr. Kenneth Mayer, CFAR and Co-Director/Medical Research Director, The Fenway Institute; Keith Green, AIDS Foundation of Chicago and Co-Chair, Chicago Black Gay Men's Caucus; Christopher Chauncey Watson, George Washington University School of Public Health and Health Services and Co-Chair, Young Black Gay Men's Leadership Initiative; and Ernest Hopkins of the San Francisco AIDS Foundation and Chair, NBGMAC.
Visit this site to register and view speaker details.
Justice Department Settles Suits over HIV Discrimination
The Justice Department announced on May 11 that it has reached two settlements resolving claims that health care providers refused to serve people with HIV in violation of the Americans with Disabilities Act (ADA).
The first complaint was filed by a man with HIV who went to the Mercy Medical Group Midtown Clinic in Sacramento, California. After meeting with the patient and examining him, a podiatrist at the clinic informed the patient of his treatment options. Although surgery was one of the treatment options, the podiatrist incorrectly told the patient that he could not perform the surgery because of a risk that he would contract HIV from the patient during surgery. The podiatrist’s actions were determined to have violated the ADA by denying the patient the full and equal enjoyment of the services offered at the clinic on the basis of his disability.
The second complaint was filed by a man with HIV who went to the Knoxville Chiropractic Clinic North in Knoxville, Tennessee for chiropractic treatment following an automobile accident. After examining him, the doctor determined that the patient required 24 subsequent appointments to treat his injuries. On his third visit to the clinic, however, the receptionist informed him that the doctor would not see him because they could not treat people “like him.” The Justice Department determined that the Knoxville Chiropractic Centers had a blanket policy of refusing treatment to people with HIV in violation of the ADA.
“It is critical that people with disabilities, including HIV, not be denied equal access to goods and services, especially to health care services. The Civil Rights Division takes discrimination based on unfounded fears and stereotypes about HIV very seriously,” said Thomas E. Perez, Assistant Attorney General for the Civil Rights Division. “We applaud Mercy Medical Group and CHW Medical Foundation, as well as Knoxville Chiropractic Centers, for working cooperatively with the Justice Department to resolve these matters quickly and fairly.”
The settlement agreements require the entities to develop and implement a non-discrimination policy and to train staff on the requirements of the ADA. In addition, Mercy Medical Group and CHW Medical Foundation are required to pay $60,000 to the complainant and $25,000 as a civil penalty, and Knoxville Chiropractic Centers is required to pay $10,000 as a civil penalty.
The Department of Justice provides a webpage specifically dedicated to information about the ADA and HIV. Those interested in finding out more about these settlements or the obligations of public accommodations under the ADA may call the Justice Department’s toll-free ADA information line at 800-514-0301 or 800-514-0383 (TDD) or visit the ADA’s website. ADA complaints may be filed by sending an email to ada.complaint@usdoj.gov.
The 2012 International AIDS Conference, scheduled for July 22-27, will be held in Washington, D.C. As a result of President Obama ending the travel ban against HIV-positive people from outside the country, this will be the first time since 1990 that the conference will be hosted by the United States.
More than 20,000 people from over 200 countries who are HIV/AIDS advocates, policy makers, and people living with HIV, along with 2,000 journalists, are expected to attend the conference. In addition to discussing lessons learned over the many years of fighting the disease, many participants are coming on a mission to move the world closer to a cure for AIDS. They also will be looking for this country's leaders to reaffirm to the world a willingness and determination to fund HIV/AIDS medical research, testing programs, treatment, prevention, and education around the globe at a time when domestic HIV/AIDS funding is shrinking.
Washington, D.C. is an appropriate location for the biennial conference because of the major impact HIV is having on local residents. D.C. Mayor Vincent Gray believes the conference could not have come at a better time and the event will allow world HIV advocates a critical view of the local resources available to address the crisis in the District.
Positively Aware will be reporting live from the conference via Facebook and Twitter and covering it in the September/October issue.
APLA Condemns ADAP Cost-Sharing Plan
AIDS Project Los Angeles (APLA) again called on the California legislature to roll back the governor’s AIDS Drug Assistance Program (ADAP) cost-sharing proposal, which threatens access to life-saving HIV drugs for many of the state’s poorest living with HIV/AIDS.
Governor Brown’s proposal would mean that ADAP clients would, for the first time in the program’s history, be paying more into ADAP than the state would contribute from its own General Fund coffers.
“The governor is asking people with no other means of survival to bear the brunt of California’s fiscal crisis,” says APLA Executive Director Craig E. Thompson. “We know what that means: Cost-sharing co-pays drive low-income people out of care, and tragically, that means higher rates of AIDS-related deaths. And those who are HIV-positive would be forced to make unthinkable choices between life-saving medications or other necessities, like food or rent.”
The governor’s proposal would charge low-income, uninsured Californians who are HIV-positive on average between $813 to over $4,600 annually to continue receiving drug regimens through ADAP. The fees would apply to all Californians who are living with HIV/AIDS but whose earnings exceed the federal poverty level—$10,890 per year for an individual.
“The California State Senate has already rejected the governor’s cost-sharing proposal this year,” Thompson explains, “and now it is up to the State Assembly to do the same. We will continue to work with the legislature and the Brown administration to again defeat this senseless proposal.
“If the state really wants to save money, then we should prioritize and expand HIV prevention programs while guaranteeing access to HIV care and treatment for those who cannot afford it. Any short-term savings generated by this proposal,” Thompson adds, “would be quickly outpaced by a rise in medical costs as more Californians fall ill and rates of new and potentially preventable infections climb.”
For more information, visit apla.org.
Big Excellent 20th Reunion to Premiere Off-Broadway in June
KS Stevens, well known within New York’s queer and Asian communities as a playwright and composer, will debut her original production of Big Excellent 20th Reunion in New York during June, Gay Pride month.
The show includes many compelling characters, including Erica, an adopted HIV-positive 18-year-old, who attends her recently deceased mother’s reunion in order to deliver her last message to her dearest friends from high school, who were all closeted then. Kevin Yih, also HIV-positive and a sober gay therapist, Mitch Johnson, a gay man who was kicked out of the military, bisexual attorney Debra Gonzalez, lesbian cat lover Samantha Blaine, and Danielle Parker, a transsexual former football quarterback, round out Erica’s mother’s high school social circle.
According to Stevens, “There are anthems for everyone and it is a deeply intimate story for those who have ever loved family and friends who are queer, from interracial and/or adopted families, or have been touched by cancer and HIV.”
There will be 19 performances June 6 – 23 at Theatre 80, 80 Saint Mark’s Place, between 1st and 2nd Avenues in Manhattan. Tickets are $55, $30 for seniors over 62 and students and are available online at theatremania.com.
Nickelodeon Seeks Stories of HIV-Positive Youth
Mallory Kydd, from Nick News with Linda Ellerbee, sent out a request for youth ages 11-17 to share their stories of living with HIV for an upcoming documentary to be aired on World AIDS Day.
“We are primarily looking for stories that have a lot of depth. For example, the recent news piece about the 13-year-old boy who had his admission rejected at a private school in Pennsylvania,” said Kydd in an email sent to AIDS service organizations.
Interested parties should contact Kydd at Mallory@LDP.com or by phone at:
Office Phone: 212-463-0029
Cell Phone: 860-287-4768
Regardless of the political consequences of President Obama’s support of gay marriage, his announcement sparked some additional co-sponsors in both chambers for the Respect for Marriage Act which would repeal DOMA. In the Senate, Jack Reed of Rhode Island signed on and in the House, Donna Christenson, delegate from the Virgin Islands, and Norman Dicks from Washington were added. All are Democrats—no surprise there.
With regard to bills that were introduced, Democrat Russ Carnahan of Missouri along with 29 other Democrats introduced H.R. 5711, a bill to amend the Public Health Service Act to provide grants for treatment of heroin, cocaine, methamphetamine, 3, 4-methylenedioxymethamphetamine (Ecstasy), and phencyclidine (PCP) abuse. It has been referred to the Committee on Energy and Commerce, and the Committee on the Budget.
Republicans Trent Franks from Arizona, John Carter from Texas, and Pennsylvania’s Tom Marino joined with 14 Democrats in H. Con. Res 123 recognizing the potential for the virtual elimination of pediatric HIV and AIDS and keeping HIV-positive mothers alive. It was referred to the Committee on Energy and Commerce, and the Committee on Foreign Affairs, which leads me to believe it is not American HIV-positive mothers and their children that they’re worried about. But, hey, it’s bipartisanship!
On May 15, H.R. 3053, the REPEAL (Repeal Existing Policies that Encourage and Allow Legal HIV Discrimination) Act, gained its 30th co-sponsor in Minnesota’s Betty McCullom.
And winning the Most Hypocritical Legislation of the Month would be S. 3083, a bill to amend the Internal Revenue Code of 1986 to require certain nonresident aliens to provide valid immigration documents in order to claim the refundable portion of the child tax credit. It was introduced by Marco Rubio, son of Cuban immigrants. Seriously.