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Tuesday, May 1, 2018

Men who have sex with men blood donor controversy in the United ...
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The men who have sex with men blood donor controversy is the dispute over prohibitions on donations of blood or tissue for organ transplants from men who have sex with men (MSM), a classification of men who engage (or have engaged in the past) in sex with other men, regardless of whether they identify themselves as bisexual, gay, or otherwise. Advocates for change to the prohibition is frequently addressed in terms of bisexual and gay men. Restrictions on donors are sometimes called "deferrals", since blood donors who are found ineligible may be found eligible at a later date. However, many deferrals are indefinite, meaning that these donations may not be accepted at any point in the future, thus constituting a de facto ban. The restrictions vary from country to country, and in many cases, men are deferred even though they always have protected sex or have not had sex with men for many years. The restrictions affect these men and, in some cases, any female sex partners. They do not otherwise affect other women, including women who have sex with women. The United States Food & Drug Administration (FDA) asserts that the one year deferral window is "supported by the best available scientific evidence".

Many LGBT organizations view the restrictions on donation as based on homophobia and not based on valid medical concern since donations are rigorously tested to rule out donors that are infected with known viruses such as HIV, Hepatitis B, and Hepatitis C. They state the deferrals are based on stereotypes. Proponents of the lifetime restriction defend it because of the asserted risk of false negative test results and because the MSM population in developed countries tends to have a higher prevalence of HIV/AIDS infection. The UK government advisory committee, SABTO, stated in 2013 that "the risk of transfusion of HIV infected blood would increase if MSM were allowed to donate blood". In July 2017 however, the UK government reduced the one year deferral window to three months, to take effect in the following months, resulting from SABTO's updated conclusions that "new testing systems were accurate and donors were good at complying with the rules". Furthermore, NHS Blood and Transplant are now investigating how possible it is for MSM, depending on degree of risk, to donate without even the three month deferral.

Advocates for change to MSM prohibitions point out that screening of donors should focus on sexual behavior as well as safe sex practices since many MSM may always have protected sex, be monogamous, or be in other low risk categories. Some groups in favor of lifting the restrictions support a waiting period after the blood is donated when the donor is considered to have had behavior considered higher risk, and before it is used, to match the blood bank's window of testing methods. While HIV is reliably detected in 10 to 14 days with RNA testing, older testing methods provide accuracy for only up to 98% of positive cases after three months.

There are massive amounts of residual fear about blood product contamination stemming from the contaminated blood scandals, which causes thousands of deaths due to HIV and Hepatitis C in patients requiring a blood transfusion. Contaminated blood put haemophiliacs at massive risk and severe mortality, increasing the risk of common surgical procedures. People who contracted HIV from a contaminated blood transfusion include Isaac Asimov, who received a blood transfusion following a cardiac surgery.


Video Men who have sex with men blood donor controversy



HIV/AIDS

In many developed countries HIV is more prevalent among men who have sex with men (MSM) than among the general population.

In the United States in 2005, MSM, African Americans, and persons engaging in high-risk heterosexual behavior accounted for respectively 49%, 49%, and 32% of new HIV diagnoses. In 2009 in the United States, African Americans accounted for 47.9% of new HIV diagnoses reported that year, but represented approximately only 12% of the population.


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Current situation

List of countries with their stand on MSM blood donors

This list shows countries that had restrictions on blood donors. Most national standards require direct questioning regarding a man's sexual history, but the length of deferral varies.

A comparison of confirmed HIV positive blood donations before and after the change did not see a statistically significant difference.

The Australian Red Cross Blood Service pushed to have the deferral period lowered from twelve to six months however it was rejected by the Therapeutic Goods Administration (TGA). The Red Cross will re-submit their application to reduce the deferral period to six months in 2018.

European Union

Italy, Latvia, Poland, Russia and Spain are the only European countries that don't discriminate when it comes to blood donation. The donation is allowed if the donor hasn't had a risky sexual encounter, but not depending on the sexual orientation of the donor. The UK since November 2017 has implemented a 3 month deferral policy on all gay/bi men who want to donate their blood, the lowest in the western world. However this does not apply to Northern Ireland, which still has a 12 month deferral period in place. The Advisory Committee on the Safety of Blood, Tissues and Organs recommended the policy change after a study concluded that a total ban may breach equality legislation and that the risk of HIV reaching the blood supply would only increase by approximately 2%.

In Ireland, Men who have sex with men (MSM) may donate blood if they have not engaged in oral or anal sex with another man at least 12 months prior to a donation. This policy came into effect from 16 January 2017. On 27 July 2015, Tomás Heneghan, a 23-year-old University of Limerick student and journalist from Galway began a legal challenge in the High Court against the permanent deferral imposed on MSM donors. He argued that the questionnaire and interview process used by the IBTS does not adequately assess the risk of disease transmission posed by his donation. He claims this is in breach of EU law. He said that both failed to consider the length of time between a donor's last sexual experience and the end of a "window period" in which infections are sometimes not detected. Heneghan's previous sexual activity posed no risk of infection, according to HSE-approved advice and he said the service had no evidence upon which it could legitimately impose a life-long ban on him donating blood. Following several adjournments of the case to allow the blood service and Department of Health to examine and develop the donation policies, in late June 2016 the Irish Blood Transfusion Service recommended that the lifetime ban on MSM be reduced to a 12 month ban. Later that week the Minister for Health Simon Harris agreed to the recommendations and announced the reduction would take place. However no timeline was reported for the implementation of the new policies.

On 26 July 2016, Tomás Heneghan dropped his High Court challenge against the service as an end to the lifetime deferral on MSM blood donors had been announced in the interim. Heneghan then wrote about his experiences of challenging the ban in a number of national media outlets. On 2 October 2016, it was reported that Minister Harris would implement the new policy from 16 January 2017, almost seven months after he announced the policy change. On 16 January 2017, Heneghan (now 25) attended a blood donation clinic in D'Olier Street, Dublin and became the first man who has had sex with another man to donate blood openly in the Republic of Ireland since the lifetime deferral policy was first introduced in the 1980s. However he also criticised the new 12 month deferral policy on MSM and called on Ireland's Health Minister to initiate a review of the IBTS and replace the 12 month deferral period for MSM with no deferral or a 3 month deferral on all donors following sexual intercourse.

A similar policy exists in the rest of the European Union and is the prevailing interpretation of the European Union Directive 2004/33/EC article 2.1 on donor deferrals. The policy, however, is not very specific and refers to "high risk sexual contact." The UK interprets the directive to include all forms of homosexual sex as falling within 2.2.2 of Annex III to the directive "Persons whose behaviour or activity places them at risk of acquiring infectious diseases that may be transmitted by blood", requiring a deferral based on the window period for the diseases involved, and sets this at 12 months, despite the Annex suggesting 6 months for risk of exposure to Hepatitis B. Hélder Trindade, President of the Portuguese Institute of Blood and Transplantation (IPST), stated in 2015 that sexually abstinent homosexuals may give blood, but that MSM is definitely seen as a risk factor.

In Finland, the parliamentary ombudsman launched an investigation on the possible unconstitutionality of the lifetime ban in January 2006. In June 2008, it was concluded that the ban was not unlawful in Finland as it is based on "appropriately reasoned epidemiological information" and because it is related to sexual behaviour rather than sexual orientation. The ombudsman added that people over the age of 65 and people who lived in Britain during the bovine spongiform encephalopathy (mad cow disease) outbreak are also screened out during blood donor interviews. In December 2013, the Finnish Red Cross blood service announced it was lifting the ban and introducing a one-year deferral instead.

Since 10 July 2016, France implemented a 1-year deferral period policy on all gay and bisexual men donating blood.

New Zealand

Since 2009, the New Zealand Blood Service (NZBS) had deferred males who have had oral or anal intercourse, with or without protection, with another male for five years. From the formation of the NZBS in 1998 to 2009, the deferral period had been ten years, but reduced to five years following an independent review of blood donation criteria in 2007-8 which found no significant difference in risk to the blood supply for deferral periods of five years compared to ten years.

In 2014, the NZBS dropped the ban period from 5 years to one year following the recommendation of Medsafe. Their decision was mainly caused by recently gained facts about HIV transmission in Australia which already had a one-year deferral. The new 1 year deferral has been in effect since 15 December 2014.

The one year deferral period for MSM is on par with the one year deferral period for persons engaging in prostitution outside of New Zealand and people who have resided in a country which has a high (1% or more) HIV prevalence. Females who engage in sexual intercourse with a male who has had sex with another male are also deferred for twelve months.

United States

In the US, the current guidance from the U.S. Food and Drug Administration (FDA) is to defer any male donor who has had sex with another man (MSM) in the past year. This has been so since December 2015.

Female sexual partners of MSM are deferred for one year since the last exposure. This is the same policy used for any sexual partner of someone in a high risk group. The argument used to follow these policies is that blood should be collected from a population that is at low risk for disease, since the tests are not perfect and human error may lead to infected units not being properly discarded, and these population groups would be considered a high risk. The policy was first put in place in 1983 by the FDA, which regulates blood donations to profit and non-profit organizations.

Donors of what the FDA calls "HCT/P's", a category that includes transplants (other than organs) and some reproductive tissue, notably anonymous semen donations, are ineligible for five years after the most recent contact. UNOS policies for Organ donation require the hospital receiving the organ to be notified if the donor was an MSM within the past 5 years. The organs are generally used unless there is a clear positive test for a disease. The one year deferral was approved by the FDA on 21 December 2015, replacing a lifetime ban on donations from MSM.

History of calls to change the policy

  • In 2006, the AABB, American Red Cross, and America's Blood Centers all supported a change from the current US policy of a lifetime deferral of MSM to one year since most recent contact. One model suggested that this change would result in one additional case of HIV transmitted by transfusion every 32.8 years. The AABB has suggested making this change since 1997. The FDA did not accept the proposal and had concerns about the data used to produce the model, citing that additional risk to recipients was not justified.
  • On 19 August 2009, the Assembly Judiciary Committee in California passed AJR13, the U.S. Blood Donor Nondiscrimination Resolution, calling upon the FDA to end the MSM blood ban.
  • In April 2010, the New York City Council passed a resolution calling on the U.S. Food and Drug Administration (FDA) to eliminate the ban stating "This ban was based on prejudice, a knee-jerk reaction, and misunderstandings about the HIV/AIDS disease. Given the constant need for blood, it does not make common sense to prohibit donations from an entire population."
  • On 1 June 2010, the Council of the District of Columbia passed a resolution calling on the FDA to "reverse the lifetime deferment of blood donations by men who have had sex with men since 1977 in favor of a policy that protects the safety and integrity of the blood supply that is based on an up-to-date scientific criteria."
  • In June 2013, the American Medical Association issued a statement calling on the FDA to change the policy, stating that "The lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science."
  • In July 2013, the American Osteopathic Association approved a policy calling on the FDA to "end the indefinite deferment period for Men who have sex with Men (MSM)", and to "modify the exclusion criteria for MSM to be consistent with deferrals for those judged to be at an increased risk of infection."
  • On 14 December 2015, Jordan Moll-Vigrass, Congressmen Brian Higgins and the Pride Center of Western New York held a community rally in Buffalo, New York to rally against the Food and Drug Administration policy that bans blood donations by gay and bisexual men. Moll-Vigrass, who is openly gay and had been in a committed relationship for four years, was refused as a blood donor after disclosing his sexual orientation during the questionnaire screening process. Outraged by the federal policy and disappointed by being refused as a blood donor, Moll-Vigrass started to advocate for change. "The government's unfounded policy is hurtful to the people being turned away solely based on sexual orientation and the millions of others who will be in need of a lifesaving blood donation," said Higgins. "Eligibility should be based on risk-based science rather than outdated, fear-based speculation."
  • On 21 December 2015, the U.S. Food and Drug Administration changed the policy by replacing the indefinite deferral with a 1-year deferral. The change was proposed the previous July.
  • On 27 May 2016, the U.S. Food and Drug Administration approved of a new blood donor history questionnaire for general use by blood establishments, which is compatible with the deferral for 12 months. Before this update, the approved questionnaires were compatible only with an indefinite deferral of blood donations from MSM.
  • As of December 2016, the American Red Cross reports that MSM may be eligible to donate blood if they did not have sex with another man in more than 12 months. The American Red Cross reports that, in January 2017, the organization began donor reinstatement of MSM who were previously deferred from donating, and who later became qualified to donate blood in accordance with the new donation deferral period of 12 months. The American Red Cross website specifies that this 12-month deferral does also apply to transgender men who have sex with men, but does not apply to transgender women who have sex with men.

Controversial NI gay men blood donation ban lifted - ITV News
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Reasoning for the restrictions

Blood services first and foremost must ensure that all blood received for donation is safe for transfusion purposes. This is achieved by screening potential donors for high risk behaviors through questionnaires and interviews before blood is taken, and subsequent laboratory testing on samples of donated blood.

Blood services commonly justify their bans against MSM using the statistically higher prevalence of HIV and hepatitis of MSM in population studies.

In the earliest years of the AIDS epidemic, there were no reliable tests for the virus, which justified blanket bans on blood donations from groups at high risk of acquiring or having HIV, including MSM. These restrictions are similar to present-day restrictions in most countries on people residing in the United Kingdom during the BSE ("mad cow disease") epidemic of the 1980s and early-to-mid 1990s, due to the absence of a test for its human form, variant Creutzfeldt-Jakob disease (vCJD).

In 1985, early tests using the ELISA method looked for antibodies, which are the immune system's response to the virus. However, there is a window period when using this method in which a person who has been infected with HIV is able to spread the disease but may test negative for the virus. This window period can be as long as three to six months, with an average of 22 days. Tests using the ELISA methods are often still used in developed countries because they are highly sensitive. In developing countries, these tests are often the only method used to screen donated blood for HIV. To cover the window period resultant from the use of these tests, donors are also screened for high risk behaviors, one of which is a history of same-sex sexual activity among male potential donors. Other groups with similar restrictions include commercial sex workers, injecting drug users, and people resident in countries with a high HIV prevalence (such as sub-Saharan Africa). Newer tests look for the virus itself, such as the p24 antigen test, which looks for a part on the surface of the virus, and Nucleic acid tests (NAT), which look for the genetic material of the virus. With these tests, the window period is shorter, with an average duration of 12 days. Fourth generation combination HIV tests are conclusive at 3 months, and Hepatitis B tests are conclusive at 6 months.

Risks are also associated with a non-MSM donors testing positive for HIV, which can have major implications as the donor's last donation could have been given within the window period for testing and could have entered the blood supply, potentially infecting blood product recipients. An incident in 2003 in New Zealand saw a non-MSM donor testing positive for HIV and subsequently all blood products made with the donor's last blood donation had to be recalled. This included NZ$4 million worth of Factor VIII, a blood clotting factor used to treat haemophiliacs which is manufactured from large pools of donated plasma, and subsequently led to a nationwide shortage of Factor VIII and the deferral of non-emergency surgery on haemophiliac patients, costing the health sector millions of dollars more. Screening out those at high risk of bloodborne diseases, including MSM, reduces the potential frequency and impact of such incidents.


New blood donation rules to allow gay men and prostitutes to ...
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Criticism of the restrictions

Objections to the restrictions, including those from the American Medical Association and the American Red Cross, are generally based on the idea that improvements in testing and other safeguards have reduced the risk from transfusion transmitted HIV to an acceptable level. Blood shortages are common, and advocates for change to the policies point out that excluding healthy donors only makes the problem worse. "Ideal" inventories are at least a three-day supply, but many blood centers struggle to meet this demand.

Further advocating for change stems from the fact that the ban is a blanket ban encompassing all men who have had sex with another man, even with protection and even if the HIV status of these men's partners is shown beyond doubt to be negative. Advocates for change point out that a promiscuous straight male is a higher-risk donor than a gay or bisexual man in a monogamous relationship, but the former will usually be allowed to donate blood. Furthermore, other high-risk activities such as having sexual contact with anyone who has used needles to take drugs not prescribed by their doctor have a set deferral period before the donor is allowed to donate blood, whereas in some countries MSM donors are deferred indefinitely. Female donors who have sexual contact with MSM are sometimes deferred temporarily.

Following a mass shooting targeting a gay nightclub in June 2016, there were reported expressions of frustration and disapproval by a number of gay and bisexual men who were forbidden to donate blood to victims, with LGBT activists across the country and a group of Democratic lawmakers urging the ban to be lifted. The FDA later said it had no plans of changing the regulation and will reevaluate its policies "as new scientific information becomes available".


Controversial NI gay men blood donation ban lifted - ITV News
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Activism in favor of reform of MSM donor policies

Student and faculty activism on campuses

In Canada

  • The students association at Carleton University in Ottawa, Ontario voted in 2012 to maintain a ban on blood clinics on campus.

In the United States

  • In 2005, a student activist at the University of Vermont (UVM) filed a complaint with the university's Office of Affirmative Action, contending that American Red Cross blood drives on campus violated UVM's non-discrimination policy. The office recommended that the university no longer allow the Red Cross to conduct blood drives on campus, but the UVM administration rejected the recommendation, stating that it would not be in the interests of public health. Student and LGBT activism on the issue continued at UVM. In 2007, the UVM Student Government Associated voted down, by a 16-15 vote, a nonbinding resolution calling on the university to ban blood drives over the policy.
  • In 2007, a group of Greek organizations at Iowa State University pulled their support for a blood drive, causing controversy.
  • In 2008, San Jose State University President Don Kassing suspended all blood drives on campus on the ground that the MSM policy for blood donors violated the university's non-discrimination policy.
  • In 2008, a faculty member at Sonoma State University proposed a resolution in the faculty senate to ban blood drives on campus, The faculty senate passed the resolution by a 21-13 vote, clashing with the student senate, which passed a resolution earlier the same month noting the discrimination, but expressing support for the monthly blood drives because of their importance.
  • In 2010, an GLBT student group at Keene State College protested blood drives on their campus.
  • In 2011, the academic senate of Queens College, City University of New York recommended that all blood drives on campus should cease.
  • In 2013, a group of University of Michigan students favoring a loosening of the MSM blood-donation policy started a ""Bleeding for Equality" initiative in which individuals ineligible to donate because of the policy would bring eligible individuals to donate on their behalf, so as to both promote blood donation and also demonstrate that the amount of additional blood that could potentially be collected if the policy changed. The Michigan Daily, the student newspaper of the University of Michigan, editorialized in favor of a loosening of the MSM blood donation policy.
  • On 27 July 2016, in the wake of the tragedy in Orlando on 12 June 2016, Blood is Blood hosted a blood drive on 27 July from 12 p.m. to 6 p.m. at the American Red Cross WNY Chapter Headquarters in Buffalo, NY. Jordan Moll-Vigrass, Founder of Blood is Blood & Matthew Crehan Higgins, Executive Director of the Pride Center of WNY spoke at the event to raise awareness of existing archaic policies preventing many gay men from donating blood.

In the United Kingdom

  • The National Union of Students LGBT Campaign runs a "Donation Not Discrimination" campaign to have the blood ban changed, while also advocating continued donation by those who are not banned from donating.

Elsewhere

In 2015, Welsh writer and poet, RJ Arkhipov, exhibited a poetry series written with his own blood as ink in protest of the MSM blood donor restrictions. His poem Inkwell discusses the shame and stigma surrounding "gay blood". An abecedarian poem, each line of Inkwell's five quatrains begins with letters from each of the blood groups, alternating between A, B, AB and O.


The science behind the FDA's new blood donation policy
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See also

  • Gay sexual practices
  • Terminology of homosexuality

Orlando needs blood donations, but the FDA still bans many gay, bi ...
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References


FDA to re-evaluate blood donation ban for gay men - CNN
src: cdn.cnn.com


External links

  • FDA:Blood Products Advisory Committee, 09Mar2006 transcript See page 53 (page 59 of the pdf) for the discussion of test error rates. Warning: this is a 133 MB scanned transcript.
  • CDC: HIV/AIDS among Men Who Have Sex with Men
  • British Medical Journal Debate: Should men who have ever had sex with men be allowed to give blood? No
  • British Medical Journal Debate: Should men who have ever had sex with men be allowed to give blood? Yes

Source of the article : Wikipedia

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