Democratic Rep. Jared Polis is calling for a relaxation of FDA restrictions on blood donations from gay and bisexual men in the aftermath of Sunday's shootings at a nightclub in Orlando.
“My blood is as good as yours (O+ in my case),” Polis tweeted Sunday in the hours after the shooting, which left 50 dead and dozens wounded. “Friends and spouses being turned away from donating blood to help their loved ones.”
“Blood donors needed to help victims of #Orlando mass shooting, but friends and spouses of those in need not allowed to give,” Polis wrote.
In December 2015, the FDA announced it was replacing a lifetime prohibition on donations from gay and bisexual men with a new policy that allows them to donate blood -- but only if they have not had sexual contact with another man for at least one year.
In 1983, the FDA banned gay and bisexual men from ever being eligible to donate blood to protect people receiving blood transfusions from the possibility of getting infected with the human immunodeficiency virus, which causes aids.
But gay-rights advocates and many medical groups have been urging the FDA to lift the ban for years. They argue the policy is discriminatory because it singles out gay and bisexual men and that it is unnecessary because blood donors can be screened for HIV.
Some, however, have urged the FDA to keep the ban, saying that infected people can slip through the screening process. Blood tests remain negative for about nine days after a person has been infected with HIV.
On Sunday, Polis called the restrictions "morally bankrupt" and "dangerous." But Dr. Lewis Katz, an infectious disease specialist and the Chief Medical Officer for America's Blood Centers, said the restrictions are appropriate, given the data at hand.
"The FDA moved in the direction they moved based on data generated in the US," Katz said. "Data generated in other developed countries blood systems, most particularly Australia and others, that demonstrated that moving from permanent to one year, was not associated with an increased risk by the metrics that we used."
Read a full transcript:
Warner: So Congressman Jared Polis of Colorado has called for a relaxation of FDA rules on gay men donating blood. After the Orlando shooting, the Boulder democrat called the restrictions 'morally bankrupt'. Men cannot donate if they've had sexual contact with another man in the past year. That is actually an easing of an earlier lifetime ban. Polis is with us by phone and for added perspective, we're also joined by Dr. Louis Katz. He's an Infectious Disease Specialist and Chief Medical Officer for America's Blood Centers. Gentlemen, thanks for being with us. Representative Polis, why do you call this 'morally bankrupt'? These restrictions. Polis: Well it really plays off stigmas dating from the 1980s. A couple points that are relevant here, obviously my blood as a gay person is the same as a straight person's blood. What puts somebody at risk for an STD and of course our blood supply is screened but we still want to screen out people that are high risk is behavior, not sexual orientation. So you know it's certainly fair to ask if somebody's used IV drugs or if they've engaged in unprotected sex but whether that is, whether they're gay or straight is entirely irrelevant to whether they've led a high risk lifestyle or whether they're in a monogamous, married relationship and have a very low degree of risk. And so many gay people because of the nature of this terrorist act were obviously moved to help and wanted to help and are unable to give blood, in some cases even to help their own spouse or friend who might have been a victim of this horrible act in Orlando. Warner: So what you're saying is that you would like the determination not to be made on orientation but on behavior? Polis: Well absolutely. That's what puts somebody at risk is if they're an IV drug user or if they've engaged in unprotected sex. Obviously if you're, whether you're gay or straight, if you're in a monogamous and married relationship, you're certainly not in any higher risk category, whether you're gay or straight. In fact the FDAs own study found that the prevalence of HIV in male blood donors was actually lower in gay men, .25 percent than it was in the overall population of .38 percent. And again it's perfectly fair to apply standards for behavior as questions, and those need to be applied to both gay people and straight people the same way. Because whether you're gay or straight, you can be either safe or engage in risky activity and that's the kind of screening that we should have for donors, rather than just as a blanket ruling say just because of who you happen to love, you're not able to help those in need. Warner: Let me put to you a statistic from the Centers for Disease Control and Prevention that men who have sex with men, and let's say that's a broader category, in other words, those may be people who don't identify as gay, so men who have sex with men account for 78 percent of new HIV infections among males, sixty-three percent of all new HIV infections. From a public health standpoint, why not place limits on that demographic, given those statistics. Polis: Well it's not the demographic of being gay that's a risk factor, it's having unprotected sex so asking a question is perfectly fair, have you, if somebody has had unprotected sex, if they used IV drugs, there's other risk categories that can appropriately be screened for but they're the same questions that should be asked of people who are gay or straight. Obviously you look at whether it's HIV or any other virus, it could be communicated through sexual relations, straight or gay, that doesn't discriminate and obviously one of the fastest increasing groups are in fact straight people with regard to HIV infections. So in addition to making sure our blood is screened, which we do, we should have a behavioral based screening for donors rather than simply sexual orientation or race or any other characteristic that in and of itself is not a risk factor. It may correlate with a risk factor but we have the ability to actually find out the risk factor itself. And many gay Americans are of course are married and in committed and monogamous relationships and they're not in any higher risk category than a similarly situated straight person who's married and monogamous. Warner: All right. Let's bring in Dr. Louis Katz, again Infectious Disease Specialist and Chief Medical Officer for America's Blood Centers. And Dr. Katz, from your perspective, what do you make of the idea of behavioral assessments as opposed to a sort of blanket assessment of a demographic. Katz: Well I, it's really the next logical consideration in what for me has been a process that started in 1982 or 1983. That is the assurance of the safest possible blood supply, not just HIV but Hepatitis B, C, other organisms. I think at this point the policy promulgated by FDA most recently a one year deferral that is being implemented around the country as we speak, is in part based on the historical success of the MSM, men who have sex with men, approach to deferral. But also on the lack of data regarding the kind of behavior based deferrals that the congressman refers to and that we're all, I think, very interested in exploring. Warner: So that's unchartered territory to some extent you are saying but that. Katz: Yeah, it really is. In the United States, absolutely. The rest of the world, there are countries where this is being done. Italy, Spain, I believe Argentina, don't quote me on that, several, four or five. But the screening environments where this is being undertaken are completely different. The shape of the epidemics are different, the kind of personnel used to screen blood donors are different and I can tell you from long experience with the Food and Drug Administration that historic change will not come without data that suggests strongly that we have no decrement in safety. And I will point out that the data that moved us from a permanent deferral to a one year deferral was in large part gathered by the blood community, to my organization, America's Blood Centers, the American Red Cross and AABB, have advocated since I think 2002 for a re-look at our approach to deferral of men who have sex with men. So I'd like to, it's a little self-serving, I'll point out we're out in front of this. Warner: I want to ask you about the more recent change. So there was the lifetime ban on men who have sex with men giving blood and then the rule changed to, late last year, to say ok, if you're a man who has sex with a man, you can give blood only if you haven't had sex with a man for a year. Katz: A little hollow isn't it. Warner: Well practically speaking, it may strike some as identical to an outright ban. What do you make of it? Katz: Right. I think I've made that point repeatedly in a number of forums, including speaking to my friends and colleagues at the FDA. To ask somebody to abstain from sex for a year is not that far from a permanent deferral so we understand that. The FDA moved in the direction they moved based on data generated in the US, data generated in other developed countries blood systems, most particularly Australia and others, that demonstrated that moving from permanent to one year was not associated with an increased risk by the metrics that we used. So as many people have said, use the metaphor, it's a first step and it is absolutely. The infrastructure that was used to generate the data, some of the data, a big piece of the data, that was used to move from permanent to a year, has now been funded I believe through about five years, it's called the Transfusion Transmitted Infections Monitoring System and data collected from that system and others will be used to inform current policy and changes in policy going forward. Warner: Got it. So it will be monitored and then more steps may be taken. And so Congressman Polis. Polis: If I can get in here, I think what's so frustrating with so many of us is clearly common sense, science, it's conduct, not orientation that is a risk factor. There is nothing innate to one's sexual orientation that places one at higher risk. It is behavior, it is conduct. And it's conduct and behavior regardless of whether you're straight or gay or bisexual. If somebody is having unprotected sex with multiple partners, they are at risk. They're at risk if they're straight, they're at risk if they're gay. Warner: So Representative, do you think that in this regard things are moving too slowly? Because what we're hearing from Dr. Louis Katz is that these decisions are made very gradually over time with lots of data and that in his mind it needs to unfold thoughtfully. Do you think it's moving too slowly? Polis: Well I, the initial decision, I'm sorry this change from a year ago as you indicated is really not much of a change. I mean gay people are still not allowed to donate blood. I mean who would have had the foresight to say we think there's going to be a crisis in Orlando, I'm going to abstain for a year just so I can give blood. I mean it just doesn't make any sense. There's nobody who thought that way. There's basically still a ban. I think society understands, certainly science understands that there are risk factors in one's exposure to STDs. One's orientation and who they're attracted to, is not a risk factor. If someone is in a married relationship, a monogamous relationship, they're at no greater risk if they are gay or straight and likewise if there are straight people who have multiple partners or gay people, it's completely appropriate to screen them out. But there's nothing innate with who one is attracted to that in and of itself is a risk factor. It's entirely based on conduct, IV drug use, unprotected sex and, very appropriately to secure a national blood supply, those should be items that we screen for. Warner: So the FDA did entertain the idea of lifting the restrictions entirely but according to the AP, the agency said doing so could quadruple the number of HIV transmissions through blood transfusions. The current rate is one in two million blood units. So Representative Polis, I know that you keep pointing to behavior as the determinant here, but what do you make of those FDA numbers which is that if the policy changes, there might be a quadrupling of HIV transmissions. Polis: Well again they were obviously cooked up to defend the current policy. If the FDA instituted better screening to help weed out for instance a promiscuous straight person who would have a higher risk than a married gay man, for instance of HIV transmission, the risk would actually go down with HIV transmission. So I don’t think anybody in the LGBT community who wants to help is saying lower the standards and put people at risk of contracting HIV. If anything we're saying increase the standards. Make sure we have a better way of screening gay and straight people as long as it's the same way of screening them both to weed out those who engage in higher risk behavior and simply say that they can't donate. They should absolutely be done in a way which further decreases the risk of HIV transmission in blood by having a more meaningful form of screening rather than an arbitrary one where again somebody who's married and in a same-sex relationship and monogamous for decades, somehow can't donate blood even though they're in the lowest possible risk group allowing them to donate blood, will bring down the overall prevalence of any type of contamination of the blood supply. We want more people from the lowest risk groups and we're excluding those under the current policy. Warner: Dr. Katz, what is the strength of screening for HIV and other STIs in the blood supply? Is it very good? Katz: Well the tests that we use are among the most sensitive laboratory assays ever developed for any indication anywhere in medicine. They are superb. And we've gone from when I started on this journey in the very early 1980s, no test, to 1985 we had a window that is an era before testing could detect an infection of two months. And we're down now to nine/ten days with nucleic acid testing. I think the inescapable logic that the FDA uses in support of their historic and current approach are the numbers that you quoted earlier. That four percent of the population is victim of almost three-quarters of the new infections. So their argument is that the sexual orientation that they require us to elicit is in fact strongly associated with whatever behavior resulted in transmission and that's really the core of their argument. And I think on an intellectual basis, I absolutely agree with the Congressman. If we are able to elicit behaviors effectively from a broad spectrum of donors, we can move in the way that he'd like to move. The problem is demonstrating that that does not produce a decrease in safety and that's what FDA is and will demand. I understand where they're coming from. Absolutely. Warner: So very briefly, we've got to wrap up. I'm so sorry. Representative Polis, can I ask you just before we go, will you move in any concrete way to make this happen? Is that legislation or ? Just very briefly. Polis: Well yes, I mean obviously given this tragedy in Orlando and obviously the outpouring of support and the ridiculous situation of where even the spouses of those that needed blood aren't able to contribute blood along with many of their friends. I think it's really pulled, it's really shown the American people kind of the counter-productivity of this. There's so much goodwill and people want to help. Warner: So will you take a concrete step? Is there a concrete step? Polis: Yeah of course. We're renewing our, we've been working on this for five years and we're renewing our efforts to [unclear] a letter with a number of my colleagues to tell the FDA to address this urgently in the interest of securing our national blood supply, making it safer. Allow those who just happen to be gay and are low risk to be able to help out and contribute blood just as others are. Really the blood of gay people is the same as the blood of straight people as we saw with those whose blood was spilled in Orlando this last weekend. Warner: Representative Jared Polis, a Boulder democrat and Dr. Louis Katz, Infectious Disease Specialist with America's Blood Centers. They joined us by phone and we'll continue after a break. On Colorado Matters from CPR News. |
