Kenny 1 Mark Kenny Dr.

Jarman COMM 535 30 June 2010

Effectiveness Evaluation of HFAs Letter to Senator Carl Levin Since 1983 the Food and Drug Administration (FDA) has instituted a policy banning men who have had sex with other men (MSM) at any time since 1977 from donating blood. As of today, this is a permanent deferral, a slightly-less antagonistic term for ban, meaning that MSM can never donate blood. This policy is based on scientific evidence which shows a great disparity between the rate of blood-borne pathogens, such as HIV and Hepatitis, that occur among MSM and the rate of occurrence within other high-risk categories. Gay Mens Health Crisis has lobbied for policy changes claiming that the current ban discriminates against the gay community. On March 4, 2010, Senator John Kerry sent a letter signed by seventeen other senators to Margaret Hamburg, Commissioner of the U.S. Food and Drug Administration, requesting a review of the current FDA policy and requesting that it be modified from a permanent deferral to a one-year deferral for MSM (Carter). On March 25, 2010, the Hemophilia Federation of America (HFA) sent a letter to Senator Carl Levin, one of those who signed Senator Kerrys letter to Ms. Hamburg. This letter expresses HFAs concern for blood safety, as an organization representing thousands of Americans who receive blood-products on a regular basis and this letter will be the focus of my effectiveness evaluation. As a father of four children with hemophilia A, including two boys with severe hemophilia A that receive infusions at least every other day, blood safety is an issue which I am

Kenny 2 passionate about. I believe that the rhetoric presented by HFA could have been more effective if it had focused on overcoming barriers that existed within the intended audience. The main theme of HFAs letter is that a comprehensive blood safety policy based on the precautionary principle is necessary to protect... recipients of blood and plasma components (Stevens). In their Statement on Blood Donor Deferrals, the World Federation of Hemophilia (WFH) states that the precautionary principle implies that, in the absence of a scientific consensus that harm would not ensue, decisions must err on the side of caution (WFH Blood Product Safety, Supply and Availability Committee). The purpose of the letter is to present HFAs policy and their support of a review, but also to inform the senator(s) that in the absence of scientific consensus that the action or change in policy is not harmful, the burden to prove an action or change in policy is not harmful is the responsibility of those who advocate taking the action or making the change (Stevens). In other words, HFA will support a change in policy when those seeking the change can scientifically prove that the change would not result in further risk. The actual audience is known, as the letter is addressed to Senator Carl Levin, but I believe the implied audience includes all of the senators that signed the letter to the FDA. The rhetorical barriers that I believe exist with the implied audience include pre-existing attitudes about the subject, misperception, complexity of the issue and the cost (the time and effort required to open the websites and read the Supporting Examples and References attached to the HFA letter). The HFA letter, including attachments, attempts to overcome these barriers using credibility, appeal to the value of health and safety, example and statistics. They use their status

Kenny 3 as a non-profit organization representing many people (and many votes) to add credibility. They appeal to the value of health and safety throughout the letter: As the end users of blood and plasma products, this issue is one of safety, science and the need to adhere to the precautionary principle (Stevens). They do it again while providing an example of risk: An infected unit could be released during a window period or due to a quarantine release error (Stevens). They include statistics from the CDC in the attachments: the rate of new HIV diagnoses among men who have sex with men (MSM) is more than 44 times that of other men and more than 40 times that of women (Centers for Disease Control and Prevention). Although I identify strategies that HFA uses, I do not believe they did so effectively, nor do I believe they overcame the rhetorical barriers I have identified. I believe that these senators have a pre-existing attitude about the subject, and perhaps that attitude is based on misperception. I think these barriers work together to create one difficult barrier to overcome: complexity of the issue. Senator Carl Levin is one of twelve hard-core liberals to sign the letter. Three more are still obvious leftists and only two can be classified as moderates. Not a single Republican signed the letter. These politicians represent the very constituents that are lobbying for a modified blood donor policy and have only been presented a well-crafted artifact from the Gay Mens Health Crisis that highlights the discriminatory nature of the current policy. The policy is discriminatory, but not without reason. Blood donor deferral policies are discriminatory based on scientific evidence for the purpose of providing safe products to those who need them. HFA is addressing a liberal audience which has traditionally supported the gay communitys lobbying efforts. In order for these politicians to satisfy their constituents, HFA will need to provide them with a reasonable argument for not supporting a

Kenny 4 modification to the FDAs current policy. Additionally, the issue is complex and lends itself to many misperceptions. Senators simply do not have time to research all of the facts and to come to a reasonable conclusion. They depend on the information and reports that each side presents them. I believe the argument for the FDAs current policy is stronger than the argument for modification and that HFA could have done a better job presenting this to the senators. Gay Mens Health Crisis (GMHC) circulated a report that likely aided in the misperception among the senators. HFA did not address the specific arguments presented in this report, so I do not believe they overcome this barrier. In the Executive Summary of A Drive for Change: Reforming U.S. Blood Donation Policies, GMHC states that the current policy of permanent deferral for MSM is discriminatory, because others at elevated risk of HIV or other transmissible disease are subject to significantly less restrictive deferralsor to no deferral at all (Gay Mens Health Crisis). Although it is unfortunately true that others at risk of HIV have less-restrictive deferrals, the rates of risk are not comparable as this report implies they are. According to a March 2010 CDC report, the rate of new HIV diagnoses among men who have sex with men (MSM) is more than 44 times that of other men and more than 40 times that of women (Centers for Disease Control and Prevention). Furthermore, MSM is the only risk group in the U.S. in which new HIV infections are increasing... steadily... since the early 1990s while new infections have declined among both heterosexuals and injection drug users (National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention). A Drive for Change: Reforming U.S. Blood Donation Policies, also claims that the unnecessary exclusion of large numbers of donors may harm patients in need of blood

Kenny 5 transfusions, and that significant advancements in HIV testing no longer require lengthy deferral periods. All blood is rigorously tested after donation for HIV and other infections and current testing technology can detect HIV in donated blood within days or weeks of infection (Gay Mens Health Crisis). While technology has improved the accuracy and timeliness of tests, HIV is still missed. Including MSM with a disproportionately higher rate of HIV significantly increases risk for blood product recipients. According to the HIV InSite Gateway to HIV and AIDS Knowledge website, [t]he most common test used for HIV screening is the ELISA test, which has a sensitivity of anywhere from 99.5% to 99.9%... This means that, in a sample of 1,000 specimens with HIV, HIV will be missed in 5 cases (99.5% sensitivity) or 1 case (99.9% sensitivity) (Vogel). The U.S. Census Bureaus estimates the U.S. population in 2007 to be just over 301 million. According to Americas Blood Centers, 38 percent of the U.S. population is eligible to donate blood, but less than 10 percent do annually (Americas Blood Centers). Additionally, if just one more percent of all Americans would give blood, blood shortages would disappear for the foreseeable future (Americas Blood Centers). This means that approximately 115 million people are eligible to donate blood, but only about 30 million do. If only 3 million more people would donate blood, there would be no more shortages. According to the Centers for Disease Control, [t]he range was 522-989 cases of new HIV diagnoses per 100,000 MSM vs. 12 per 100,000 other men and 13 per 100,000 women (Centers for Disease Control). Multiplying the sample size of 100,000 by 30 to equal the estimated number of donors needed to end blood supply shortages, this means a range of 15,660-29,670 new HIV cases among MSM compared to 360-390 among other men and women.

Kenny 6 Add to this the fact Vogels statistics show that between 1 and 5 cases of HIV will be missed in 1,000 tests, this means between 15 and 30 missed cases each year among MSM compared to 0.36 and 0.39 missed cases among other men and women, including those in other high risk categories. In three years this is the difference between one life and somewhere between 45 and 90 lives. Furthermore, in 2006, researchers in Sweden discovered a strain of chlamydia undetectable by screening tests and when the researchers figured it out and started using new tests in late 2006, the new strain was responsible for up to 40 percent of Swedish chlamydia infections (Madrigal). A similar misfortune led to a crisis in the hemophilia community in the late 1970s and early 1980s; as a result [m]ore than half of the 17,000 people with hemophilia and 80% of those with severe hemophilia were infected with HIV, a large percentage of whom subsequently died (National Hemophilia Foundation). The U.S. government recognized the tragedy by passing the Ricky Ray Hemophilia Relief Fund Act, which provided monetary compensation to hemophiliacs who contracted HIV from contaminated products (National Hemophilia Foundation). GMHCs argument that because the blood is subject to testing, it is safe, is simply inaccurate. It is what we dont know that has caused the most problems and if MSM have a higher rate of HIV, it is likely that they would have a correspondingly higher chance of developing an undetectable strain of HIV. I believe HFA could have better overcome the misperception/pre-existing attitude and complexity of the issue barriers by presenting all of this information. Instead of communicating information in the letter that highlights the inaccuracies and fallacies of the rhetoric that GMHC has presented to the senators, and providing them with the scientific facts and historical evidence

Kenny 7 to support the current policy, HFA simply states its policy and reasoning, but buries all the persuasive rhetoric in the attachments. Furthermore, four of the five attachments are presented in the form of a link to a website, requiring the audience to be at a computer and to take the time and effort to open those websites and read the information presented there (and it is A LOT of information). This actually creates the rhetorical barrier of cost (the time and effort required to open the websites and read the Supporting Examples and References attached to the HFA letter). HFAs rhetoric should not present barriers, it should resolve the ones that exist. I do not believe the HFA letter, as it is constructed, employs strategies sufficient for overcoming the rhetorical barriers. In addition, I believe that HFA should have appealed to history (what happened to the hemophilia community in the 1980s), using statistics and testimony from those who suffered the consequences of a contaminated blood supply. The most compelling argument or information should have been presented in the text of the letter, rather than the attachments, and should have at least included the CDCs rate of HIV among MSM statistic. Finally, I believe HFA should have prepared and directed further research to a single document that centralizes the information from the multiple sources and gets to the bottom line: What does it all mean? It means the difference between one life and somewhere between 45 and 90 lives.

Kenny 8 Works Cited America's Blood Centers. "56 Facts About Blood." America's Blood Centers. n.d. Web. 19 June 2010. <http://www.americasblood.org/go.cfm?do=page.view&pid=12>. Carter, Kisa. "Blood Safety Update." Hemophilia Federation of America, 9 Apr. 2010. Web. 29 May 2010. <http://hemophiliafed.org/2010/04/09/blood-safety-update-2/>. Centers for Disease Control and Prevention. CDC Press Release Dated March 10, 2010. Press Release. 9 Mar. 2010. Blood Safety Update. Hemophilia Federation of America, 9 Apr. 2010. Web. 29 May 2010. <http://hemophiliafed.org/2010/04/09/blood-safety-update-2/>. Gay Mens Health Crisis. A Drive for Change: Reforming U.S. Blood Donation Policies. n.d. Blood Safety Update. Hemophilia Federation of America, 9 Apr. 2010. Web. 29 May 2010. <http://hemophiliafed.org/2010/04/09/blood-safety-update-2/>. Madrigal, Alexis. "Researchers Puzzled by Swedish Chlamydia Mystery." Wired News. 2 June 2008. Web. 19 June 2010. <http://www.wired.com/wiredscience/2008/06/researcherspuz/>. National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention. "Fast Facts - HIV and AIDS among Gay and Bisexual Men." Centers for Disease Control and Prevention. 15 June 2010. Web. 17 June 2010. <http:// www.cdc.gov/nchhstp/newsroom/FactSheets.html>. National Hemophilia Foundation. "HIV/AIDS." National Hemophilia Foundation. n.d. Web. 29 May 2010. <http://www.hemophilia.org/NHFWeb/MainPgs/MainNHF.aspx? menuid=43&contentid=39&rptname=bloodsafety>.

Kenny 9 Stevens, Chad, and Kimberly Haugstad. "Hemophilia Federation Letter in Response to March 4, 2010 Letter from US Senators." Letter to Senator Carl Levin. 4 Mar. 2010. Blood Safety Update. Hemophilia Federation of America, 9 Apr. 2010. Web. 29 May 2010. <http:// hemophiliafed.org/2010/04/09/blood-safety-update-2/>. Vogel, Mark. "Can We Really Be Sure of Our HIV Test Results?" HIV InSite Gateway to HIV and AIDS Knowledge. n.d. Web. 19 June 2010. <http://hivinsite.ucsf.edu/insite? page=ask-05-12-12-02>. WFH Blood Product Safety, Supply and Availability Committee. "WFH Statements on Product Safety - 2007." World Federation of Hemophilia. 19 Feb. 2007. Web. 29 May 2010. <http://www.wfh.org/2/9/9_1_statements-2007.htm>.