Red is in the Rainbow: A Closer Look at Blood Donation Discrimination

via HuffPost Gay Voices, by Emily Horowitz

We met this past August: six of 42 American University freshmen selected to participate in the School of Public Affairs' Leadership Program.

We were tasked with identifying a social issue connected to gender and sexuality and working to change it. After two months of intense, sass-filled discussions, we zeroed in on an issue that we all felt needed to be changed: the Food and Drug Administration's policy that bans men who have had sex with men (MSM) even once since 1977 from ever donating blood.

Enacted in 1985 at the height of the AIDS scare, this measure was deemed necessary by confused scientists and puzzled politicians.

Today, however, it is outdated and unreasonable. It is difficult to resist concluding that the continuation of this policy is the result of homophobic stereotypes.

In order to fully understand the ban and the issues stemming from it, we first assembled a policy memorandum that examined all sides of the policy.

We learned how blood is tested for HIV and that with current technologies, there is a 1 in 1.5 million chance of infected blood passing through the screening processes.

We also learned that the United States is in the midst of a critical blood shortage, which America's Blood Centers states would end if we increased the annual blood supply by just 1 percent.

In 2010 the Williams Institute at the University of California's Los Angeles School of Law estimated that if the MSM blood ban were lifted, there would be approximately 219,000 additional pints annually, an increase of 1.4 percent.

This means we could increase the lives saved by blood donations each year by up to 657,000 (given that one pint donated can save as many as three lives) and eliminate blood shortages for the foreseeable future.

Also in 2010 a group of 18 United States Senators, including John Kerry (D-Mass.) and Kristen Gillibrand (D-N.Y.), advocated that the FDA change its policy, to no avail.

Keeping this knowledge in mind throughout the fall semester, we became further impassioned by the need for reform. We forged relations with nearby organizations such as the D.C. Center for the LGBT Community, and with nearby college campuses. Finally, spring semester arrived, and the hands-on action commenced: it was time to start our project.

Our three-point plan is comprised of education, awareness, and political action. We established ourselves as Red Is in the Rainbow.

Through social media websites such as Facebook and Twitter, we are spreading the word about the blood ban and facts pertaining to it.

To make a personal impact, we will be hosting blood drives across Washington, D.C. this April. To bring awareness to how many people are prevented from donating blood, we will be distributing stickers stating, "I have a friend who can't donate blood.

Ask me why," and "I can't donate blood. Ask me why." We hope that these will encourage discussion of the discriminatory policy and further spread the word. Finally, we aspire to put political pressure on the FDA to change its policy.

By coordinating a letter campaign, we seek to communicate to policy makers just how much harm this ban inflicts and put forward an alternative we believe more appropriate: a one-year waiting period between male-to-male sexual contact and blood donation, the same waiting period that a person who has sex with a prostitute or a person infected with HIV/AIDS must undergo.

A one-year deferral period has become the choice of most other industrialized nations who have amended their policies, the most recent of which was the United Kingdom.


Read the rest

Don't Delay HIV Prevention for Gay and Bi Men

by David Ernesto Munar, via HuffPo

Lives will be saved when the Food and Drug Administration puts its stamp of approval on a groundbreaking preventative approach called pre-exposure prophylaxis, or PrEP, recently found to reduce HIV infections.

With PrEP, people who are not infected with HIV take a daily pill, usually used to treat the disease, to help prevent infection -- as part of a broad HIV
prevention approach that includes condoms and safer-sex counseling.

But the longer the FDA waits before beginning its review of the HIV medication Truvada for prevention, the more lives will be unnecessarily lost. This is particularly true for those at greatest risk: gay and bisexual men.

We urge the FDA to immediately begin its review for approval of Truvada for PrEP for gay and bisexual men.

Read the rest.

HIV/AIDS Organizations Tell FDA and Gilead Sciences: Don’t Delay HIV Prevention for Gay and Bisexual Men and Transgender Women

[Press Release - October 18, 2011]

Thirteen prominent U.S. HIV/AIDS organizations have issued an open letter to the U.S. Food and Drug Administration and Gilead Sciences calling for prompt regulatory review of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women (men who have sex with men, or MSM). The letter urges FDA and Gilead to start the review process that could allow safe and appropriate approved PrEP use as a public health intervention, and not to delay review because of distinct questions about the safety and efficacy of PrEP in heterosexual populations.

[The letter is available online here. LifeLube's mother - AIDS Foundation of Chicago - is a signatory.]

Pre-exposure prophylaxis, or PrEP, is a new HIV prevention method in which an uninfected person takes a daily HIV medication to reduce HIV infection risk. Data from an international study released in November, 2010 called iPrEx found that men and transgender women who have sex with men who received a daily single-tablet dose of the HIV drugs tenofovir and emtricitabine along with condoms and safe sex counseling had an average of 42% fewer HIV infections than those who received condoms and counseling alone.

Advocates assert that the need for new HIV prevention strategies for MSM is urgent. The U.S. Centers for Disease Control (CDC) estimates that MSM account for more than half of all new HIV infections in the United States. CDC logged an estimated 34% increase in HIV infections in young gay men between 2006 and 2009, and a 48% HIV increase among young black/African American gay men over the same period.

“We desperately need new strategies and tools to reduce the rapidly increasing rates of HIV infection in black gay and bisexual men,” said Phill Wilson, executive director of the Black AIDS Institute. “We’ve had evidence of PrEP’s effectiveness in MSM for almost a year now. It’s time to use every tool at our disposal to reduce the 50,000 new HIV infections that occur each year in this country. Prompt FDA review will help ensure that appropriate guidelines for PrEP use are established that can reduce HIV infections and safeguard public health.”

Data on PrEP in heterosexuals raise important but unique questions that may require further study. Two major trials in Africa found that PrEP reduces HIV infection risk in heterosexual men and women substantially. But two other studies present conflicting information about how PrEP works in heterosexuals. Critical and necessary efforts to understand how PrEP interacts with hormonal contraception, or how PrEP may impact pregnancy, however, should not delay access to a potentially lifesaving form of HIV prevention for MSM.

Before the results of the heterosexual PrEP studies were announced, the FDA and Gilead Sciences, the maker of the drugs, were reported to be ready to move quickly to consider approval of PrEP for those MSM who could benefit from the approach. Recent signs indicate, however, that FDA review of PrEP for this population may not start until the agency acquires more data on PrEP among heterosexuals—despite the urgent need for new HIV prevention strategies for MSM, and the fact that PrEP data in MSM were announced nearly one year ago.

“The FDA and Gilead Sciences should move quickly to ensure a thorough review of PrEP for MSM now, while they both work simultaneously and swiftly to thoroughly address questions and concerns about PrEP among heterosexual populations,” said Mitchell Warren, executive director of AVAC “Prompt FDA review of PrEP in MSM is the right thing to do for public health. In the midst of a growing HIV epidemic, HIV prevention delayed is HIV prevention denied.”

Sign on Petition:FDA: Stop preventing gay men from donating blood

via Change.org, By Eric Couto

The Department of Health and Human Services last year upheld their discriminatory policy on banning gay men from donating blood. According to a yahoo news article, "a recent study found that the gay ban costs hospitals 219,000 pints of blood each year".

Coming from a gay man, someone who works in the health field, and someone who has donated for the past 4 years, I find this derogative practice counterproductive and seems to set an image that HIV could possibly only be associated with gay men. About every two months when it is time to donate, I receive a daily phone call asking for a donation until I can actually make it in because of my blood type being O negative.

The CDC reported that in 2008, out of the roughly 41,269 people to have been diagnosed with HIV that year, 13,180 were infected by heterosexual contact. That means 32% of newly diagnosed cases were from heterosexuals. According to the World Health Organization HIV Data and Statistics, women made up more than half the population living with HIV in 2009.

The American Red Cross recently announced that donations were at their lowest in May and June, and that O negative was in need since anyone needing a transfusion can receive O negative. Every single donation of blood or plasma is screened for HIV, Hepatitis, and other infectious diseases. So why discriminate against homosexual men if all is tested?

Read more and sign the petition.

HHS Moves to Review Outdated Lifetime Gay Blood Donor Deferral

[Sources: Senators John Kerry (D-Mass) & Representative Mike Quigley (IL-05) , GMHC]

LifeLube today applauded the U.S. Department of Health and Human Services (HHS) for outlining concrete steps toward ending the outdated, discriminatory lifetime ban on gay men from donating blood.

In a question-and-answer document, HHS described four areas of necessary study to allow a further review of the existing policy, and implementation of the June 2010 recommendations from the Advisory Committee on Blood Safety and Availability (ACBSA).

These areas include:

•    How the risk of blood transmissible diseases in the current donor population relate to the risk factors in donors;

•    The root cause of quarantine release errors (QRE), the accidental release of blood not cleared for use that potentially put the blood supply at risk;

•    If potential donors correctly understand the current questionnaire and if men who have sex with men (MSM) would comply with modified deferral criteria; and

•    If alternative screening strategy (e.g. pre- and/or post-qualifying donation infectious disease testing) for MSM (and potentially other high-risk donors) would assure blood safety while enabling data collection that could demonstrate safe blood collection from a subset of MSM or other currently deferred donors.


Highlighting what some of our state officials and partners have done for this effort thus far, we want to continue to fight to end discriminatory ban.

In February 2010, GMHC released a comprehensive report titled "A Drive For Change: Reforming U.S. Blood Donation Policies," which details the FDA's current blood donation guidelines and provides recommendations for alternative guidelines that emphasize behavior-based deferrals. In June 2010, GMHC provided testimony at the ACBSA meeting held to review the MSM policy. GMHC has long advocated for consistently applied standards of rigorous, scientifically-based blood safety, contributing to an increased pool of blood donors

In June 2010, Mark Skinner spoke on behalf of the American Plasma Users Coalition (A-PLUS) at the ACBSA meeting held to review the MSM policy.  A-PLUS is a coalition of national patient organizations created to address the unique needs of over 125,000 patients with rare diseases that use life-saving plasma protein therapies and are dependent on blood plasma therapies to lead healthy.  A-PLUS has acknowledged that the scientific basis for the permanent deferral requires review, and previously indicated that there are a number of factors which should be fully evaluated before making a revision to the policy. Such evaluation and research could lead to a policy revision that maintains or enhances the safety of blood and blood products.

Senator John Kerry has been a longtime advocate for updating this discriminatory policy.  Last year, he wrote two separate letters to the FDA urging them to abolish the policy along with an op-ed on the ban in Bay Windows, New England’s largest LGBT newspaper.

Congressman Mike Quigley spear-headed an op-ed co-authored by seven House Democrats urging HHS to revise its blood donation policy.  Quigley and Kerry also wrote also a bi-cameral letter to HHS calling for an end to the ban and submitted testimony to HHS for a two-day hearing reviewing the policy.

Chicago: Tunney Leads Efforts to End Gay Blood Ban

via EDGE Chicago, by Joseph Erbentraut

With their passage of a resolution calling for the reversal of the federal ban of gay and bisexual male blood donors, the Chicago City Council’s Health Committee last week joined a growing number of influential entities that have spoken out against the policy.

The policy, which has been on the books since 1985, bars any man who admits to having engaged in sexual activity with another man at any point since 1977 from donating blood for life. Gay Chicago alderman Tom Tunney and other pro-repeal advocates claim the ban perpetuates negative stereotypes of gay men as "public health threats" and could even threaten the nation’s blood supply in the not-so-distant future. Already this year, city councils in New York and Washington, D.C., have also called for an end to the ban, as did the California Assembly’s Judiciary Committee in 2009.

Read the rest.

FOXY - Gay Blood Ban Controversy: AIDS Activist (and LifeLuber) Weighs In

[The U.S. Department of Health and Human Services has decided to continue the controversial policy of banning gay men from donating blood. We talked live with Jim Pickett of the AIDS Foundation of Chicago.]

FDA Begins Process of Ending Gay Blood Donor Ban

Via POZ - The Food and Drug Administration (FDA) has started the process to review and possibly end the ban on blood donations from gay men, the Washington Blade reports.

The Department of Health and Human Services has scheduled meetings June 10 and 11 with the Advisory Committee on Blood Safety and Availability to consider “the most important factors (e.g. societal, scientific and economic) to consider in making a policy change,” states a notice published by the Federal Register.

Can gay and bisexual men give blood?

via Medill Reports, by Candace Adorka
 
Excerpt:

Gratzer said heterosexual donors who have had sex with another person who is known to be infected with HIV are asked to defer from donating blood for a year. This gives enough time for blood tests to detect HIV in the donor. He said the policy needs to be reformed so it matches the policy applied to heterosexual donors.  

“It does have an impact on the gay and bisexual communities, and the LGBT community more broadly, because it is seen as a further stigmatizing decision: gay and bisexual men yet again are told we are bad people, we can’t contribute to society and we are further stigmatized by our own government for something that scientifically is not a fair policy.

Read the whole thing.

GMHC Report Explores Alternatives to Lifetime MSM Ban

We hope the report will encourage the FDA to revise its guidelines to be more in step with current technology and to avoid reinforcing stigma.

 The Food and Drug Administration (FDA) currently bans any man who had sex with another man (MSM), even once, since 1977 from donating blood.  The policy does not consider the potential donor's HIV status, frequency or risk of sexual activity, or if he is in a monogamous relationship.  Today, Gay Men's Health Crisis (GMHC) released a report, A Drive for Change: Reforming U.S. Blood Donation Policies, detailing the history of the policy, efforts towards revision, and analysis of alternative donation criteria.

Advances in HIV screening of blood supplies since the 1980s make the chance of receiving a unit of HIV infected blood one in 1.5 million.  Guidance, for most donors, takes into account the "window period," the short period after HIV infection whereby a HIV screening would not detect infection.

Current FDA guidance includes a questionnaire of potential blood donors that asks 48 questions about current health status, medical history, blood donation history, sexual practices, drug use, and other behaviors.  But risk factors are not uniformly applied.  A heterosexual donor who has had sex with a knowingly HIV-positive partner 366 days ago would be eligible for donation.  By contrast, a man who has had sex with another man, regardless of the frequency, safe sex practices involved, or duration since the episode, is denied for life.

"Across the country, we experience critical shortfalls of blood supplies on a consistent basis," said Janet Weinberg, Chief Operating Officer at GMHC.  "Yet only five percent (or less) of Americans that are able to donate blood do so.  We call on the FDA to re-examine discriminatory policies that categorically exclude potential blood donors, including gay and bisexual men," added Weinberg.

The report analyzes alternative recommendations for blood donation by gay and bisexual men using a comprehensive framework to assess actual risk of HIV transmission and increased availability of blood supplies. The framework, called "DONATE," provides a way to understand how the use of advanced technology and objective screening standards can decrease the risk faced by recipients of blood products, while at the same time reducing the discriminatory impact on MSM, expanding the pool of blood donors (thereby reducing the potential for blood shortages), and raising awareness of HIV/AIDS risk among donors in general, regardless of sexual orientation or gender.

GMHC thanks Davis Polk & Wardwell LLP (Davis Polk) for their immense contribution in researching and writing this report. "We believe it is important to help GMHC highlight the current challenges with FDA blood donation guidelines," said Joseph Wardenski, a former Davis Polk associate and primary author of the report.  "We hope the report will encourage the FDA to revise its guidelines to be more in step with current technology and to avoid reinforcing stigma," added Wardenski.

Click here for the report.

Boys' Use Of Gardasil Is Approved

[Good news. But.... how VERY annoying that not a word is said in this story about the need of Gardasil for men in terms of gay men's health. The frame here is only around the male role in protecting women from cervical cancer. HELLO! How about protecting gay men from anal cancer???  It's not just a Farrah thing. The lives of gay men, and gay boys, COUNT, dammit.]

via the Wall Street Journal

The vaccine Gardasil won regulators' approval for use in males, setting the stage for a debate over whether boys should routinely receive an inoculation used to prevent cervical cancer in women.

The Food and Drug Administration found Gardasil, which has been approved for use in females since 2006, to be safe and effective in protecting males from genital warts. Now, the Centers for Disease Control and Prevention must decide whether to recommend its routine use in boys, a move that could lead states to mandate inoculation and may prompt health insurers to pay for it. A panel of experts advising the CDC is scheduled to debate the matter next week.

The question isn't straightforward, doctors and infectious-disease experts say, because boys may not directly benefit from being inoculated. Only about 1% of sexually active males in the U.S. develop genital warts, which can be irritating but aren't life-threatening, but males' vaccinations could help women because the sexually transmitted human papillomavirus (HPV) that causes the warts can lead to cervical cancer.


Read the rest.

Related:
Anal cancer prevention: how we are failing men who have sex with men 

The CDC Says, "Swab that Booty!"

The CDC recommends screening of at-risk men who have sex with men (MSM) at least annually for urethral and rectal gonorrhea and chlamydia, and for pharyngeal gonorrhea. Although the standard method for diagnosis is culture, nucleic acid amplification (NAA) testing is generally more sensitive and favored by most experts. NAA tests have not been cleared by the Food and Drug Administration (FDA) for the diagnosis of extragenital chlamydia or gonorrhea and may not be marketed for that purpose. However, under U.S. law, laboratories may offer NAA testing for diagnosis of extragenital chlamydia or gonorrhea after internal validation of the method by a verification study.

To determine sexually transmitted disease (STD) testing practices among community-based organizations serving MSM, CDC and the San Francisco Department of Public Health gathered data on rectal and pharyngeal gonorrhea and chlamydia testing at screening sites managed by six gay-focused community-based organizations in five U.S. cities during 2007. This report summarizes the results of the study, which found that three organizations collected samples for NAA testing and three for culture. In total, approximately 30,000 tests were performed; 5.4% of rectal gonorrhea, 8.9% of rectal chlamydia, 5.3% of pharyngeal gonorrhea, and 1.6% of pharyngeal chlamydia tests were positive.

These results demonstrate that gay-focused community-based organizations can detect large numbers of gonorrhea and chlamydia cases and might reach MSM not being tested elsewhere. Public health officials could consider providing support to certain community-based organizations to facilitate testing and treatment of gonorrhea and chlamydia.

Read the rest at the CDC.

A condom specifically for anal intercourse?

via International Rectal Microbicide Advocates

IRMA chats up Dan Resnic of Strata Various Product Design about the ORIGAMI Condom - a new product in development designed specifically for anal intercourse.


IRMA - Tell us about this ORIGAMI condom you are working on. What is it? How is it different from other condoms?

DAN RESNIC - This is a radical new design concept, made of non-latex material and the first AI (anal intercourse) condom data ever presented to the FDA for review. The data will be used to help establish the first safety standards for a condom used exclusively for AI. ORIGAMI Condoms are designed foremost for the pleasure of both partners and simultaneously to improve safety. Its improved capacity for better sensation during AI is intended to increase consumer acceptability and to promote its consistent use among men and women currently at risk.

The non-latex material we developed is unique. It's been lab tested as a male condom against a leading brand of a male latex condoms. The ORIGAMI material had zero viral permability compared with the latex condom, which had 5% viral permeability. Viral permeability is tested by introducing virus smaller than HIV into sterile water inside the condom, suspended in sterile water for 72 hrs. The water outside the condom is then tested to detect virus that may permeate through the condom. The test is repeated in reverse, starting with virus outside the condom then testing for viral premeability in the opposite direction. The tests are repeated again with pinholes punctured into the condoms. Again, the ORIGAMI tested at zero viral permeability even with puncture holes while the latex condom failed. In addition, the new material will not degrade in sunlight as does a latex condom and, after accelerated aging tests, it is expected to offer an extended shelf life of 10-12 yrs.

Future condom studies currently under funding review include a new, reusable ORIGAMI elastomer material we developed that can be washed and dried in a washer/dryer at high temperatures and can even be sterilized in a microwave or boiling in water and air dried in sunlight without compromising its structural integrity. The latter could be especially significant in regions like Africa and India where cost and distribution can be issues that prevent consistent condom use.

Photos and further details will be made available following FDA pre-market approval.

Read the rest of the interview.

Does this mean the end of the Condom Wars, finally?

FDA: Condoms Work

[Federal Register: November 10, 2008 (Volume 73, Number 218)]
[Rules and Regulations]
[Page 66522-66539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no08-12]

Read the full notice.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2004-N-0511] (formerly Docket No. 2004N-0556)

RIN 0910-AF21
Obstetrical and Gynecological Devices; Designation of Special Controls for Male Condoms Made of Natural Rubber Latex

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the classification regulation for condoms to designate a special control for male condoms made of natural rubber latex (latex). The special control for the device is the guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300.'' The FDA will publish a notice in the Federal Register announcing the availability of the special control guidance document no later than the effective date of this final rule.

DATES: Effective Date: This rule is effective January 9, 2009. Compliance Dates: Premarket notification submissions (510(k)s) for latex condoms filed on or after the effective date of this rule are expected to comply with the requirement of special controls at the time that the 510(k) is submitted. Latex condoms cleared for marketing on or after the effective date of the rule but submitted in 510(k)s filed before the effective date of the rule are expected to comply with the requirement of special controls on or before March 10, 2009. Latex condoms legally marketed before the effective date of this rule are expected to comply with the requirement of special controls December 10, 2009. Specific information on how the rule will be implemented can be found in section II.B of this document.

FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180.

Read the full notice.

Notice Highlight:

FDA concludes that the scientific evidence today continues to fully support the overall effectiveness of latex condoms in reducing the risk of transmission of common STIs. That evidence supports the conclusions that correct and consistent use of latex condoms reduces the risk of transmission of HIV/AIDS and other STIs such as gonorrhea that are sexually transmitted solely by contact with the head of the penis (via genital fluids). Also, the evidence available today provides even more support than was available at the time of publication of the proposed rule for the conclusion that latex condoms are effective in reducing the risk of transmission of other STIs, such as genital herpes and HPV, that can be transmitted not only by contact with the head of the penis, the area covered by a latex condom, but also by contact with infected skin outside the area covered by the latex condom.

FDA Issues Approvable Letter for Pfizer's Antiretroviral Maraviroc

Pfizer in a statement released on Wednesday said it has received an approvable letter from FDA for its antiretroviral drug maraviroc (Celsentri), the Wall Street Journal reports. According to the Journal, an approvable letter means that FDA believes the drug is worth approving but needs additional information before doing so. The company is in discussions with the agency to address outstanding questions and finalize the product labeling as soon as possible, according to the statement (Corbett Dooren/Johnson, Wall Street Journal, 6/21).

An FDA panel of outside experts in April unanimously recommended that the agency approve maraviroc. Pfizer has proposed using the drug to treat people with advanced HIV or AIDS who have not responded to other medications. Maraviroc works by blocking a protein, called CCR5, on human immune system cells that HIV uses as a portal to enter and infect the cell. Pfizer plans to offer the drug with a test developed by Monogram Biosciences that determines if people likely will respond to the treatment.

FDA in April raised concerns that maraviroc could be associated with an increased risk of liver damage, lymphoma and infections. According to FDA, other CCR5 inhibitors under development have been shown to increase safety risk issues. Pfizer said its studies have shown that maraviroc has no significant effect on the heart and did not increase the incidence of liver problems, cancer or infection compared with other HIV/AIDS drugs.

Continue reading from this report via Kaiser's Daily HIV/AIDS Report here.