March 2001 Archives

I could always taste a difference in her pink parts as the month unfolded. Just after her period it would smell a little bit like spring rain. Toward the middle of her cycle it would take on a slightly sweet taste. A day or two before the red river would flow it would turn dark, musty and pleasantly earthy.

Avanti is the first male polyurethane condom available in Canada. Made from a specially developed polyurethane material, Avanti is the perfect condom for those who are latex sensitive. Moreover, this condom is odour-free and because it is made with a polyurethane material, it is thinner than regular latex condoms and provides increased sensitivity and heat transfer.

Meanwhile, US researchers are developing a pill which will mean women have just four periods a year and take the pill for 84 days, rather than weekly cycles at present.

CHINESE RESEARCHERS have found a gene in rats that produces a compound that defends against sexually transmitted diseases. It has the potential for powerful effects against various microbes, including the AIDS virus and those causing other sexually transmitted diseases, the researchers report in this week's issue of Science.

State Attorney General Charlie Condon said a proposed bill that seeks to prevent state health officials from handing out condoms to teen-agers younger than 16 is legal.

Yet perhaps her most memorable observation was when a fellow inmate was so fed up with being forced to perform oral sex for a prison guard, she had an accomplice smuggle out the semen she had spat into a perfume bottle. DNA tests conducted on the sperm sample incriminated her abuser.

A member of the Lubbock Health Department noted that sexually transmitted diseases, such as chlamydia and gonorrhea, were 65 percent and 72 percent above the state rates, respectively, in 1998. A more comprehensive sex education program aside from abstinence was advocated.

The national census of the United Kingdom will record same-sex partnerships for the first time this year, but some are concerned that the results will be used to inaccurately portray the size of the GLBT community in the country. --------

The Vatican yesterday acknowledged a damning report that some Roman Catholic priests and missionaries force nuns to have sex with them, and in some cases commit rape and coerce the victims to have abortions.

"Two years ago, looking at shows with sexual intercourse, 1 in 10 had safer-sex messages in them. Now it's 1 in 4," said Victoria Rideout, a vice president of the Henry J. Kaiser Family Foundation of Menlo Park, Calif.

09/29/98 - Subcommittee on Health & Environment

H.R. 4431 - HIV Partner Protection Act

Statement of Dr. Helene Gayle

Doctor

CDC

1600 Clifton Rd

Atlanta, Georgia 30333

I am Dr. Helene Gayle, Director of the National Center for HIV, STD, and TB Prevention at the Centers for Disease Control and Prevention. Thank you for the opportunity to testify today about issues related to HIV prevention partner counseling and referral services in the context of H.R. 4431, the HIV Partner Protection Act. I'm especially happy to be here because it's an opportunity for me to share with you CDC's updated guidance on HIV partner counseling and referral services -- which has just been released for public comment.

However, before we focus on partner counseling and referral services, let me briefly describe the major goal of HIV prevention in this country and the sound public health approaches that we think are needed to achieve this goal. Our goal is to prevent HIV infection by reducing behaviors likely to transmit the virus and assisting individuals at risk or already infected in gaining access to prevention services, medical care, and other needed services. This ambitious goal can be achieved only by using a comprehensive strategy. Elements of this strategy must include monitoring the epidemic; informing the public regarding risk and modes of transmission; conducting health education and risk-reduction activities, including school-based education efforts for youth; promoting and implementing HIV prevention counseling and testing; providing referrals for medical treatment as well as prevention and social services; and promoting and implementing STD screening and treatment. An essential component of HIV counseling and testing is reaching out to and counseling sex and needle-sharing partners of persons identified as HIV positive. These partners are often unaware that they have been exposed to HIV and some may already be infected. All must have access to counseling, testing, and other prevention or treatment services. Each of these elements contributes to preventing the spread of HIV. Together, they become a powerful prevention strategy. No single activity, by itself, will achieve the overall goal of preventing new HIV infections.

I will briefly describe CDC's current recommendations for partner counseling and referral services, or PCRS, and our current requirements for programs providing these services. The goals of PCRS are, first, to provide services to sex and needle-sharing partners of HIV-infected individuals so they can avoid infection or, if already infected, can prevent transmission of HIV to others; second, to help HIV-infected partners gain earlier access to counseling, medical evaluation, and other prevention, treatment, and support services. CDC has required States to establish standards and implement procedures for PCRS since 1988, when it was referred to as "partner notification."

PCRS is a process that begins when people receive HIV prevention counseling and testing. If a person tests positive, the PCRS provider and client together formulate a plan for reaching any sex or needle-sharing partners. The plan should be one that will result in each partner's being informed of possible exposure to HIV and provided with accurate information and counseling about HIV transmission and prevention. Next, the HIV-infected client voluntarily discloses identifying information about partners, and the client and/or the provider informs each partner of possible exposure to HIV. The next step is really the core of PCRS practice: assisting the partner in accessing additional counseling, testing, and other support services. Throughout this process, the confidentiality of the infected person's identity and that of their partners must be preserved.

Let me elaborate on a critical point here that has always been a cornerstone of partner services for HIV and all other STDs. The PCRS process, by its nature, is a voluntary one on the part of the client. A client who tests positive for HIV or any other STDs cannot be mandated to reveal names of partners. In the wake of receiving an HIV-positive test result, clients may fear discrimination, abuse, or domestic violence; they may fear the loss of a job and health insurance or the loss of important personal relationships. The success of the PCRS process absolutely hinges on the trust and cooperation of the person living with HIV, their partners, and their communities. We know that people will cooperate if they believe that their confidentiality will be protected; otherwise they may avoid the system altogether. The way to maximize the public health benefit is to have a valuable service -- one with skilled counselors fully supported by adequate resources -- that people perceive as beneficial and easy-to-use.

Partner counseling and referral services related to HIV infection have evolved from similar services, known as "contact tracing," that were begun in this country in the 1930s as a method of preventing the spread of syphilis. This prevention effort was called contact tracing because public health workers would, and still do, conduct analyses to determine which sex partners were most likely to be infected and then make confidential efforts to locate them and provide treatment. Contact tracing services later expanded to include partners of persons infected with gonorrhea and other sexually transmitted diseases, including HIV, and came to be known as "partner notification" in the 1980s. Today, the term "HIV partner counseling and referral services" more accurately reflects the range of services available to HIV-infected persons, their partners, and affected communities through this essential public health activity.

But of necessity, PCRS for HIV differs from partner services for other STDs. The primary difference is that, despite recent advances in treatment, we do not yet have a cure for AIDS, so HIV, unlike syphilis and gonorrhea, remains a life-long issue for those affected. For HIV-infected persons, PCRS needs to be continuously available. The process begins as soon as an HIV-infected person learns their serostatus, and it continues throughout that person's counseling and treatment. Also, because society frequently stigmatizes and sometimes discriminates against HIV-infected persons and their families and friends, counseling and support must be provided for clients who choose to notify their own partners. For exposed partners who test positive for HIV, PCRS provides assistance in reducing risks posed to others and accessing medical evaluation, treatment, and other prevention and support services to prolong life. As new prevention tools emerge, such as vaccines, better behavioral interventions, and even more effective antiretroviral therapies, PCRS will almost certainly become an even more important prevention tool.

States, territories, and local areas contribute to a national data system maintained by CDC that includes information on more than two million HIV tests reported annually from nearly 10,000 publicly funded counseling and testing sites. While this system does not differentiate spouses from others who are sex or needle-sharing partners, it does record the reasons for seeking HIV counseling and testing services, including referrals by partners and health departments. In 1996, 81,999 tests were conducted for people who were referred for PCRS; of these, 35,260 (43 percent) were referred by their partners, and 46,739 (57 percent) were referred by the health department. More than half of all the people referred were female. Many of these persons did not realize they might have been exposed to HIV and thus did not consider themselves at risk for infection until they received the referral. Nationally in 1996, 4 percent of these referred partners tested HIV seropositive, and in some areas up to 15 to 20 percent were HIV positive. This represents a much higher rate than the national average of 1.5 percent who tested HIV positive at publicly funded test sites that year. These data underscore the importance of the PCRS process in reaching high-risk populations and providing individuals with the critical linkage to appropriate prevention and treatment services. The data also illustrate the degree of success PCRS has already demonstrated.

Concerning the effectiveness of PCRS, we know that, in general, HIV-infected persons and their partners readily accept PCRS and, with appropriate counseling, will not only provide confidential and very sensitive information, but will actively assist in finding and encouraging partners and spouses to receive counseling and testing. Also, when located, sex partners are generally receptive to confidential notification by the client or the health department and will usually seek HIV testing. Another indication of the efficacy of PCRS is the fact that many people at high risk for infection are linked by this process to prevention services that have been proven to be effective.

Notwithstanding these benefits to public health, it is also important to note the practical limitations of PCRS. Frequently it is difficult or impossible to determine exactly when a person became infected with HIV and when specific sex or needle-sharing partners were exposed to the virus. During the potentially long period during which the virus could have been transmitted, the HIV-infected person may have had many partners. In addition, the HIV-infected person may not be able to identify all partners or know how to reach others who are known. Because of the long time periods involved, often it is difficult for the client or health department to locate all the partners, especially those exposed years earlier. Also, while many HIV-infected persons willingly participate in PCRS, fear or misunderstanding of health department policies and practices may keep some HIV-infected persons from coming forward or revealing information needed to reach partners and spouses. Another limitation is the lack of human and financial resources in the public health arena necessary to carry out this important prevention activity.

Let me now describe some of the numerous ways that CDC has been working to further strengthen and enhance PCRS activities. As a result of the reauthorization of the Ryan White legislation, each State is required to certify to CDC in writing the State's intent to comply with the spousal notification requirements contained in the legislation. Programmatic and legal staff of CDC and the Health Resources Services Administration have developed procedures and criteria for certifying each State's compliance with Ryan White CARE Act requirements that mandate that States make a good faith effort to notify spouses of known HIV-infected individuals. All States certified compliance by February 1997 and have taken action to implement spousal notification. No state opposed the requirements.

In addition to the specific activities related to spousal notification, CDC also provides technical assistance and guidance to help States achieve optimal performance in their PCRS programs. Spousal notification requirements have been reviewed and emphasized by CDC at numerous meetings, conferences, and workshops involving State and local HIV prevention programs and national organizations. CDC has published scientific articles on HIV prevention partner notification in peer-reviewed journals, emphasizing its importance, especially as it relates to primary prevention and linkage of HIV-infected persons to treatment. CDC has delivered training on PCRS through a satellite video conference and at national conferences, and training is currently being conducted at State and local health departments for staff who implement PCRS programs.

As I mentioned at the beginning, CDC, with input from a wide range of partners, also has developed comprehensive guidelines for HIV PCRS and recently mailed the draft to all health departments for comment. The HIV Partner Protection Act of 1998 and this new PCRS Guidance share important goals of notifying partners, including spouses, who may have been exposed to HIV and linking them to appropriate prevention and medical services. CDC believes that the new PCRS Guidance elevates partner counseling and referral services to a higher standard of public health practice and a greater degree of potential effectiveness. We will receive comments on the Guidance and will then finalize and implement it. If fully funded with adequate resources, we believe that PCRS would be very effective in achieving the goal of the HIV prevention while enactment of legislation such as the Partner Protection Act of 1998 would not add further public health benefit.

Let me now briefly address some other issues related to the HIV Partner Protection Act. The Act departs from the CDC Guidelines and science-based public health practice by mandating reporting of all HIV-positive tests, by client name, without any provision to support the continuation of anonymous testing. The resulting effect will be to discourage and drastically reduce anonymous testing opportunities. Anonymous testing has been strongly encouraged by CDC Guidelines and is integral to public health practice because it has been proven to bring people for testing earlier in the course of infection and also bring in people who might never access such services or who might access them only when symptoms of disease develop. CDC currently recommends that people who test positive in anonymous settings be linked with medical care so they can receive life-prolonging clinical services. In States that require name reporting, the names of clients who tested positive anonymously are reported to State health departments at the point of interacting with medical care providers.

In addition, we are concerned that directive legislation may inadvertently constrain the application of sound public health activities that require greater flexibility. For example, studies have shown that clients might fear having their partners notified because they have reason to anticipate a violent reaction from the partner. Providers must be sensitive to the threat of violence and other issues of concern to the client. PCRS providers should have the flexibility to make an assessment prior to notifying the partner and seek expert consultation before proceeding with notification. Legislative mandates could decrease the flexibility that public health staff require to apply sound judgment in complicated situations, as are frequently encountered when providing PCRS, especially those situations involving the potential for interpersonal violence. Passage of this or other legislation that might reduce this flexibility could prevent clients who fear such violence from seeking counseling and testing for HIV.

What then are our recommendations? We would like to have the opportunity to implement the new PCRS Guidance and then evaluate its outcomes and impact. CDC will provide technical assistance to State and local programs to build the service delivery capacity of PCRS programs and will continually assess PCRS practice across the country as programs are further developed and strengthened. Knowing the subcommittee's interest and concern, we would be happy to provide a progress report in six months from the date the Guidance is finalized, which we anticipate to be by year's end.

CDC is committed to strengthening HIV prevention efforts in reaching sex and needle-sharing partners, providing them with counseling about prevention, and, if they are infected, linking them to medical care and treatment. For this to be accomplished, CDC could support State and local health departments in expanding counseling and testing services, increasing the number of skilled counselors who establish that all-important trust with clients, providing more access to antiretroviral treatment and other needed services, and establishing new data collection systems. A significant investment of resources is needed to cover the costs of this large but essential piece of a comprehensive HIV prevention strategy.

Thank you for the opportunity to present our views on this important public health topic. I will be glad to respond to any questions you or other members of the subcommittee may have.

The House Committee on Commerce

2125 Rayburn House Office Building

Washington, DC 20515

(202) 225-2927

[email protected]

N-9 can cause HIV infection

For years, men and women have been using sexual lubricants and pre-lubed condoms containing a spermicidal detergent called nonoxynol-9 (N-9) believing that they are protecting themselves from HIV and other sexually transmitted diseases.

Now, it appears that they have been wrong. Dead wrong.

And thus far, no public or private agency in San Francisco has taken steps to warn them about it, though one lube manufacturer has recently taken the substance out of their product.

"N-9 has now been proven ineffective against HIV transmission, [and] the possibility of risk, with no benefit, indicates that N-9 should not be recommended as an effective means of HIV prevention," read a "Dear Colleague" letter dated August 4 from Dr. Helene Gayle, director of the National Center for HIV, STD, and TB Prevention of the Centers for Disease Control and Prevention.

N-9, a spermicide approved by the Food and Drug Administration for use as a contraceptive, is widely added to many sexual lubricants and condoms. Although it was previously believed that the chemical could reduce the risk of HIV infection, the additive could actually be leaving consumers more vulnerable to infection by creating perforations in the vaginal or rectal walls.

"Anyone currently using N-9 as a microbicide to protect themselves from HIV transmission during anal intercourse should be informed of the ineffectiveness of this agent and warned of the potential risk of this practice," said Gayle.

Gayle's letter was prompted by a study of over 1,000 African female sex workers, in which half of the women were given a gel laced with N-9, and the other half were given a placebo gel that appeared to be identical, but contained no N-9. Both groups of women in the study, sponsored by the Joint United Nations Programme on AIDS, were reportedly encouraged to use condoms, though many relied on the gel.

The women using the N-9 gel were about 50 percent more likely to be infected than those using the placebo.

"Further, the more frequently women used only N-9 gel (without a condom) to protect themselves, the higher their risk of becoming infected," Gayle reported. "Simply stated, N-9 did not protect against HIV infection and may have caused more transmission. Women who used N-9 also had more vaginal lesions, which might have facilitated HIV transmission."

Because the FDA never approved use of N-9 as a microbicide to protect against HIV infection, lubricant manufacturers do not claim that it helps prevent infection on their product labels. Also for this reason, FDA is not likely to issue a recall of products containing N-9, and has not issued a warning to anyone using it in anal intercourse.

The CDC plans to review its current prevention guidelines, which recommend use of a condom "with or without a spermicide," over the next few months.

Wet dumps N-9

"We've voluntarily taken it out of our products, based on the letter from the CDC," Michael Trygstad, CEO and founder of Trigg Inc., told the Bay Area Reporter. Trygstad's company manufactures the Wet line of sexual lubricants, with substantial marketing programs targeting the gay community. "I felt the responsibility to take it out."

Very little research has been done looking at the utility of microbicides in anal sex in people, and Gayle's letter did not mention gay men specifically. But because the lining of the vagina is capable of sustaining much more "wear and tear" than the lining of the rectum, in lieu of waiting years for the research to be even funded, the risk of using N-9 extends to anyone who practices anal sex.

The UNAIDS study used about three-and-a-half times the concentration of N-9 as had been used in Wet Original, which contained a 1 percent solution. Robin Ogilvie, CEO of Trimensa, which manufactures Foreplay lubricants, said that he will not be removing N-9 from his products which contain a lesser concentration, about a tenth of 1 percent. Saying that there are "an equal number of positives as negatives about the product," Ogilvie nevertheless acknowledged that his company had reduced the concentration of N-9 in Foreplay from 1 percent to .1 percent about 18 months ago when a study involving cats showed that the higher concentration caused significant irritation to the rectal tissue. The lower concentration was not studied.

Other studies have shown that N-9 can be dangerous to both mice and men, leaving them vulnerable to infection. The B.A.R. reported on March 23 on a study from Dr. David Phillips, a senior scientist with the Population Council, in which mice were easily and quickly killed by a herpes virus when their rectums were previously treated with an N-9 solution. Looking at a biopsy of the rectal tissue under a microscope, Phillips found "places where there was no epithelium at all, just connective tissue. The N-9 had stripped the epithelial cells off of these animals."

Phillips then looked at the chemical's effects on the rectal tissue of four human volunteers, comparing over the counter lubricants containing 1 percent or 2 percent N-9. The results were "striking," Phillips said with "sheets of epithelial cells, hundreds of them, in each one of the samples."

Despite this accumulating evidence, the San Francisco Department of Public Health has no plans to issue an alert about N-9, and while area prevention organizations do not recommend use of N-9 as a means to prevent HIV infection, they also do not recommend that people do not use products that contain the chemical.

Oddly, many prevention organizations and public health workers acknowledge that it has been known for some time that N-9 causes an allergic reaction among some men, and irritation in others. Some organizations give condoms laced with N-9 only on request.

Bryan Burns, the new director of prevention services at the San Francisco AIDS Foundation, said, "We've heard of studies over the years to suggest that N-9 might be an irritant. N-9 does irritate the vaginal lining and we can assume through extension that it will irritate the rectal lining."

Pressed as to whether SFAF will change its policy and discourage use of N-9, he replied, "Perhaps. My perspective is to make sure this information gets into the hands of gay men, and let them make informed decisions about their sexual practices."

"The evidence that we have now is that there's more danger than benefit," commented Martin Delaney, founding director of Project Inform, a national HIV treatment education and advocacy group. While noting that "in fact, it takes a lot of effort to infect people," Delaney said that current research suggests that N-9 can add to the danger of HIV transmission, and called for the FDA "to issue a warning letter on it right now."

The FDA press office did not return a call for comment by press time. "The responsible thing to do is to make sure the consumer is aware as possible," said Jeff Phillips, CEO of SafeSense.com, an online retailer of condoms and lubricants. Although N-9 is by far the most common spermicide added to lubricants carried on his Web site, or on competitor Web sites like Condomania.com, Phillips noted that SafeSense.com also has a new water-based lubricant gel called "DeLube," containing a microbicide called "benzalkonium chloride."

Steven Tierney, director of HIV prevention for DPH, said that his staff will be meeting this Friday, September 8 to discuss the implications of the research that has been done on N-9.

Joseph McNamara, a Hoover Institute fellow, sees the connection as simple common sense. "Many years ago, when I was police chief of San Jose," McNamara remembers, "I cooperated with Planned Parenthood, and I said: 'Your organization prevents more crime than mine does.' Children need love and nurturing. If there's no one there to provide that [because a child is unwanted], many are going to commit crimes and violent behavior. You don't have to be a criminologist to see that the children growing up under these conditions are at high risk. It's an enormous problem for society to have children born that no one wants and no one's able to take care of."

What Schneebaum sought in these remote and hauntingly alien places was not some erotic Eden, like Margaret Mead's Samoa, but merely a positive version of his youthful subway sex. The negative anonymity of the homosexual act, in the midst of a crowd hostile to men fucking men, became, in Peru and Asmat, the welcoming anonymity of fucking men who he would never really know—except in the one way it mattered, the disinterested but connecting closeness of bodies. Or at least that's my theory. Schneebaum himself gently rebuffs all attempts to rationalize his obsession. "There is some element of all that," he said when I offered my interpretation, " but I do not want to understand it. I just want to do it. And now it's getting late in my life and I'll never do anything like it again. It was the best sex I've ever had. What can I say after that?"