Monday, August 17, 2009
In June, we ventured into a new area with regards to promoting HIV-testing and “KNOW YOUR STATUS”. We joined with people from Washington DC and DuPage County, IL to coordinate and support HIV-testing events, while also handing out materials about testing options (including home-based/portable HIV testing that is available on-line and not FDA-approved). Awareness that we had these tests led to, at first, admonition from the FDA to “cease and desist” with having these test. After receiving a call from FDA and talking further about our desire not to break laws but to give people testing options, while also being clear that the current system is laden with limitations, bureaucracy and wasteful spending, we found some doors opening to promote our ideas and energy flowing in the right direction. Subsequent conversations with FDA and CDC also led to a meeting at the White House Policy Office that took place on Thursday, August 13. Joining this meeting were Byron Sandford, Ex.Dir. of William Penn House, Lois Johnson, a Wheaton resident who lost her son to AIDS in 1995 and has been very passionate about stopping the spread of HIV, and Hannah Kelley, an intern at Penn House. The meeting was very exciting for us, as a grassroots group, to be at this level of conversation. The person we met with, Greg Millett, is an epidemiologist who is new to his White House position (having moved over from the CDC), and is one of only two people in the White House AIDS office (Jeffrey Crowley being the other). They are awaiting clearance of more people to work with them.
Rather than focus on just the White House meeting, I am going to summarize here all that we have learned about HIV-testing, the HIV/AIDS system of testing and treatment, and where we might go from here. Included is some information that was given “off-the-record” which to me means that, as a grassroots person, I can be affirmed in what we have suspected, and we need to exert pressure to bring about change so that fear of knowledge is no longer a deterrent to doing what we need to do.
• There is a lot of agreement from people in all these governmental offices that there is waste, there is frustration, and no one really knows how to implement the best plans. For example, the CDC has been encouraging all people to get tested for HIV, but at the state level, HIV-programs continue to ask discerning and intimidating questions that date back to the time when the only people being tested were people who had discerned a certain level of risk. Routinely, we asked “how do we eliminate these questions from the testing process?” and no one really had a good answer.
• The current HIV-tests in this country are considered a level 3 community risk, meaning a rigorous approval process by the FDA. The current issues have little to do with efficacy or toxicity of tests, but are more a question of whether our society is ready for portable/home-testing. There are also arguments that accurate data cannot be collected, but we already have that problem.
• The current, approved HIV-tests in the US may be inferior to tests that are used overseas.
• It seems like “AIDS, Inc.”’s solution is simply more money for to pay for tests and testers. This is a costly and risky proposition, especially if the current testing protocols remain.
• “HIV-testing is free and easy”, according to one activist. Testing, in fact, is not easy everywhere, nor is it always free. Consider my experience at a testing clinic in Washington: a 4-page intrusive questionnaire, and sitting in a waiting room where any semblance of anonymity is lost. In addition, pragmatically, this clinic is not a place that all people would find comfortable. Going to the MD for testing is an option, but not all MD’s are up-to-date on HIV-testing issues, and there is a cost here. Other anecdotes: in Salt Lake City, clinic hours are from noon to 4, weekdays, and cost $25 (for a $10 test), and in Elgin, IL, because of funding, one clinic is discouraging people from coming to them for testing if they are not in a high-risk group.
• Perhaps one of the biggest problems we face is this: the Obama Administration is committed to following hard facts and stats, not morality, as the guiding principle. This is great, but presents its own challenge: how do we get stats about the community ability to self-administer HIV-testing unless we roll-out self-administered HIV-testing? This seems to be the big catch-22, and perhaps one reason we need an anthropologist, sociologist and psychologist as well as epidemiologists calling the shots.
Ultimately, what I think we take away from this is that within the various departments, all people mean well, are intelligent, passionate and committed, but our biggest challenge is that we need to shift the paradigm in our society of responsibility for prevention and testing from “them” to “us”. It seems like the only way to do this is to just do it. Lengthy multi-year studies will move policies forward, but won’t shift the paradigm of responsibility; meanwhile, HIV will continue to spread.
Here are some specific next steps for us:
• Continuing to work with Bernie Branson (at CDC) on having input on an NIH-led trial to promote and increase testing among gay men.
• Apply for CLIA waivers to be approved as a testing organization (perhaps 2 – one for WPH, one for Mosaic).
• Promoting community participation in White House Office on AIDS town-hall meetings around the country in developing a national strategy to end AIDS.
• Continue to work with developers of HIV-tests to get the FDA to open the doors for “over-the-counter/portable/home HIV tests”. This will also take input from community voices.
• I will also continue to promote that people who do not necessarily want to go to through the current testing process look into buying tests on-line ($10).
After all of this, it seems increasingly clear that we really do have all that we need to stop the spread of HIV – tests, willingness to get tested, desire within the “powers that be” to change the system, etc. What we seem to be missing is that “leap of faith” moment to make it happen, or perhaps more accurately, the paralysis of bureaucracy and comfort within the status quo. In my work at William Penn House and through Mosaic Initiative, as I am able to, I will continue to promote the community change. Outside of these organizations, I will also continue to offer demonstrations and sample of the portable tests. I truly believe that all people can find out their status, and we don’t need to sit around waiting for others. We can make it such that no people ever get turned away or are discouraged from testing. I also believe that you empower by giving options, not limiting them. I’ve learned over the last few months that there are kindred spirits working in this vein in the system, but the real change may need to take place outside the system.
Rather than focus on just the White House meeting, I am going to summarize here all that we have learned about HIV-testing, the HIV/AIDS system of testing and treatment, and where we might go from here. Included is some information that was given “off-the-record” which to me means that, as a grassroots person, I can be affirmed in what we have suspected, and we need to exert pressure to bring about change so that fear of knowledge is no longer a deterrent to doing what we need to do.
• There is a lot of agreement from people in all these governmental offices that there is waste, there is frustration, and no one really knows how to implement the best plans. For example, the CDC has been encouraging all people to get tested for HIV, but at the state level, HIV-programs continue to ask discerning and intimidating questions that date back to the time when the only people being tested were people who had discerned a certain level of risk. Routinely, we asked “how do we eliminate these questions from the testing process?” and no one really had a good answer.
• The current HIV-tests in this country are considered a level 3 community risk, meaning a rigorous approval process by the FDA. The current issues have little to do with efficacy or toxicity of tests, but are more a question of whether our society is ready for portable/home-testing. There are also arguments that accurate data cannot be collected, but we already have that problem.
• The current, approved HIV-tests in the US may be inferior to tests that are used overseas.
• It seems like “AIDS, Inc.”’s solution is simply more money for to pay for tests and testers. This is a costly and risky proposition, especially if the current testing protocols remain.
• “HIV-testing is free and easy”, according to one activist. Testing, in fact, is not easy everywhere, nor is it always free. Consider my experience at a testing clinic in Washington: a 4-page intrusive questionnaire, and sitting in a waiting room where any semblance of anonymity is lost. In addition, pragmatically, this clinic is not a place that all people would find comfortable. Going to the MD for testing is an option, but not all MD’s are up-to-date on HIV-testing issues, and there is a cost here. Other anecdotes: in Salt Lake City, clinic hours are from noon to 4, weekdays, and cost $25 (for a $10 test), and in Elgin, IL, because of funding, one clinic is discouraging people from coming to them for testing if they are not in a high-risk group.
• Perhaps one of the biggest problems we face is this: the Obama Administration is committed to following hard facts and stats, not morality, as the guiding principle. This is great, but presents its own challenge: how do we get stats about the community ability to self-administer HIV-testing unless we roll-out self-administered HIV-testing? This seems to be the big catch-22, and perhaps one reason we need an anthropologist, sociologist and psychologist as well as epidemiologists calling the shots.
Ultimately, what I think we take away from this is that within the various departments, all people mean well, are intelligent, passionate and committed, but our biggest challenge is that we need to shift the paradigm in our society of responsibility for prevention and testing from “them” to “us”. It seems like the only way to do this is to just do it. Lengthy multi-year studies will move policies forward, but won’t shift the paradigm of responsibility; meanwhile, HIV will continue to spread.
Here are some specific next steps for us:
• Continuing to work with Bernie Branson (at CDC) on having input on an NIH-led trial to promote and increase testing among gay men.
• Apply for CLIA waivers to be approved as a testing organization (perhaps 2 – one for WPH, one for Mosaic).
• Promoting community participation in White House Office on AIDS town-hall meetings around the country in developing a national strategy to end AIDS.
• Continue to work with developers of HIV-tests to get the FDA to open the doors for “over-the-counter/portable/home HIV tests”. This will also take input from community voices.
• I will also continue to promote that people who do not necessarily want to go to through the current testing process look into buying tests on-line ($10).
After all of this, it seems increasingly clear that we really do have all that we need to stop the spread of HIV – tests, willingness to get tested, desire within the “powers that be” to change the system, etc. What we seem to be missing is that “leap of faith” moment to make it happen, or perhaps more accurately, the paralysis of bureaucracy and comfort within the status quo. In my work at William Penn House and through Mosaic Initiative, as I am able to, I will continue to promote the community change. Outside of these organizations, I will also continue to offer demonstrations and sample of the portable tests. I truly believe that all people can find out their status, and we don’t need to sit around waiting for others. We can make it such that no people ever get turned away or are discouraged from testing. I also believe that you empower by giving options, not limiting them. I’ve learned over the last few months that there are kindred spirits working in this vein in the system, but the real change may need to take place outside the system.
Labels: bureaucracy, hiv-testing, HIV/AIDS, home-based testing, home-testing, politics
Friday, June 19, 2009
Self-administered HIV-testing and the AIDS Inc. Racket
There was a time when people with HIV and those around them were actively banging on and banging down doors of legislators, public health officials, and pharmaceutical companies. If there was even a whiff of a possible treatment there were calls, letters, and protests to get these treatments out to people with HIV even if the treatments had not completed their rigorous trial phases. At the same time, countless alternative and experimental treatments were being done. Some of these at worst were benign (such as massage, acupuncture, meditations, etc.), and for many of us, were instrumental to our need to stay actively engaged in our treatment. There were other types of remedies that were being promoted – such as drinking one’s own urine – that spoke to the desperation of the times. Clearly, the big enemies of the times were the politicians, federal regulators, and the corporate pharmaceutical companies that were slow on investing in the development of products that could help slow the progress of the virus.
At the same time, there emerged a similar fight around means to stop the spread of HIV Condom distribution and needle-exchange programs continue to be political and cultural hot-potatoes, as the liberal left tend to be for full-dissemination of these programs, whereas the conservative right tend to resist such programs, regardless of statistics. The two sides have become so polarized that they often don’t see the emerging new threats out there such as the energized gay porn industry that is increasingly marketing unprotected sex, and the rise in unprotected sex in bath houses, events like the International Male Leather convention in Chicago every Memorial Day, and in solicitations on-line. This, for much of the gay HIV-industry, is like the crazy aunt. We know she’s there and a member of the family, but we don’t dare speak too loudly about it lest our enemies catch wind of what’s going on. Some of this has to do with an AIDS bureaucracy that, to this day, still has not adopted its message about HIV/AIDS to meet the new realities – that HIV is not the deadly disease it was, but is very much something we don’t want to see spreading. This is really a topic for another time.
Despite all of this, however, there is one interesting observation that I have seen over the past few month, that I find both interesting and troubling: home-based testing. For clarity’s sake, home-based testing is simply a test that one can self-administer and get the results within 20 minutes. The technology for doing this has existed for twenty years – it’s a simple assay test that screens for HIV anti-bodies It’s the same test that one gets in a clinic. For many who are afraid to go to clinics to get tested because of the lack of anonymity (you can’t be anonymous if you have to go to a public place, can you?), or for those who live in areas where medical providers may not be warm to the idea of testing their patients, or for those who do home-pregnancy tests and want to also make sure of their HIV-status, or for those who are in mixed “HIV” relationships and want to simply do what they can to insure that they are being responsible, or for those who are willing to spend $10 for a test at home rather than go through a lengthy process, or for countless other reasons, the option of home-tests may be just the kind of thing that can help people access testing and ultimately slow the spread of HIV.
So, where’s the outrage? Why is the FDA making Orasure, one of the manufacturers of self-administered HIV-tests (the very ones that are used in many HIV-testing clinics) go through a lengthy process to get approval to sell these directly to the general public? Where are all those organizations and activists that are demanding more funds and looser rules regarding needle-exchange programs, condom distribution, and mobile testing units? Why aren’t they lining up demanding that the FDA speed up this process, just as they did with HIV-medications that we now know were sped through an approval process despite minimal positive effect and high toxicity? Because they are lined up against approval of greater distribution of self-administered HIV-tests, and for many of them, testing is a job.
I have been engaged recently in an effort to advocate for approval and dissemination of self-administered tests. Perhaps naively at first, I was taken aback by the resistance of HIV-testing organizations. Over time, as I have settled into listening to the reasons why there is the resistance, I have come to see that many of the concerns are not permanent barriers. But there is a lack of conversation stifles creativity and possibility. Furthermore, many of the concerns about home-based testing already exist: many people do not follow-up with care, and the current tracking system is not accurate (notice the sharp increase in the estimates of newly-infected last year from 40,000 to 56,000 – still just estimates), nor is it timely as it tends to track where the leading edge of the virus has already been, not where it is going next. Finally, if the current system worked well, there would be no need for this conversation.
Cynically, I have to say that what I have seen is this: the very people who were demanding more action twenty years ago to get government to do something, still will make demands, but have also staked a turf around testing and do not want to see that go away. I don’t think that there is a real consciousness on the parts of the people working in these systems to do this: I really think it is more a matter of a movement becoming an institution (and perhaps becoming a bit of a racket).
One of my favorite expressions: Insanity is doing the same thing over and over and expecting different results. Other than when applied to computers, this generally holds true. I am not saying that home-based, self-administered testing will solve all the problems. But I do think it can bring about a new level of dialog and passion. That’s what we are venturing into (see www.dontguess-test.com). Join us.
There was a time when people with HIV and those around them were actively banging on and banging down doors of legislators, public health officials, and pharmaceutical companies. If there was even a whiff of a possible treatment there were calls, letters, and protests to get these treatments out to people with HIV even if the treatments had not completed their rigorous trial phases. At the same time, countless alternative and experimental treatments were being done. Some of these at worst were benign (such as massage, acupuncture, meditations, etc.), and for many of us, were instrumental to our need to stay actively engaged in our treatment. There were other types of remedies that were being promoted – such as drinking one’s own urine – that spoke to the desperation of the times. Clearly, the big enemies of the times were the politicians, federal regulators, and the corporate pharmaceutical companies that were slow on investing in the development of products that could help slow the progress of the virus.
At the same time, there emerged a similar fight around means to stop the spread of HIV Condom distribution and needle-exchange programs continue to be political and cultural hot-potatoes, as the liberal left tend to be for full-dissemination of these programs, whereas the conservative right tend to resist such programs, regardless of statistics. The two sides have become so polarized that they often don’t see the emerging new threats out there such as the energized gay porn industry that is increasingly marketing unprotected sex, and the rise in unprotected sex in bath houses, events like the International Male Leather convention in Chicago every Memorial Day, and in solicitations on-line. This, for much of the gay HIV-industry, is like the crazy aunt. We know she’s there and a member of the family, but we don’t dare speak too loudly about it lest our enemies catch wind of what’s going on. Some of this has to do with an AIDS bureaucracy that, to this day, still has not adopted its message about HIV/AIDS to meet the new realities – that HIV is not the deadly disease it was, but is very much something we don’t want to see spreading. This is really a topic for another time.
Despite all of this, however, there is one interesting observation that I have seen over the past few month, that I find both interesting and troubling: home-based testing. For clarity’s sake, home-based testing is simply a test that one can self-administer and get the results within 20 minutes. The technology for doing this has existed for twenty years – it’s a simple assay test that screens for HIV anti-bodies It’s the same test that one gets in a clinic. For many who are afraid to go to clinics to get tested because of the lack of anonymity (you can’t be anonymous if you have to go to a public place, can you?), or for those who live in areas where medical providers may not be warm to the idea of testing their patients, or for those who do home-pregnancy tests and want to also make sure of their HIV-status, or for those who are in mixed “HIV” relationships and want to simply do what they can to insure that they are being responsible, or for those who are willing to spend $10 for a test at home rather than go through a lengthy process, or for countless other reasons, the option of home-tests may be just the kind of thing that can help people access testing and ultimately slow the spread of HIV.
So, where’s the outrage? Why is the FDA making Orasure, one of the manufacturers of self-administered HIV-tests (the very ones that are used in many HIV-testing clinics) go through a lengthy process to get approval to sell these directly to the general public? Where are all those organizations and activists that are demanding more funds and looser rules regarding needle-exchange programs, condom distribution, and mobile testing units? Why aren’t they lining up demanding that the FDA speed up this process, just as they did with HIV-medications that we now know were sped through an approval process despite minimal positive effect and high toxicity? Because they are lined up against approval of greater distribution of self-administered HIV-tests, and for many of them, testing is a job.
I have been engaged recently in an effort to advocate for approval and dissemination of self-administered tests. Perhaps naively at first, I was taken aback by the resistance of HIV-testing organizations. Over time, as I have settled into listening to the reasons why there is the resistance, I have come to see that many of the concerns are not permanent barriers. But there is a lack of conversation stifles creativity and possibility. Furthermore, many of the concerns about home-based testing already exist: many people do not follow-up with care, and the current tracking system is not accurate (notice the sharp increase in the estimates of newly-infected last year from 40,000 to 56,000 – still just estimates), nor is it timely as it tends to track where the leading edge of the virus has already been, not where it is going next. Finally, if the current system worked well, there would be no need for this conversation.
Cynically, I have to say that what I have seen is this: the very people who were demanding more action twenty years ago to get government to do something, still will make demands, but have also staked a turf around testing and do not want to see that go away. I don’t think that there is a real consciousness on the parts of the people working in these systems to do this: I really think it is more a matter of a movement becoming an institution (and perhaps becoming a bit of a racket).
One of my favorite expressions: Insanity is doing the same thing over and over and expecting different results. Other than when applied to computers, this generally holds true. I am not saying that home-based, self-administered testing will solve all the problems. But I do think it can bring about a new level of dialog and passion. That’s what we are venturing into (see www.dontguess-test.com). Join us.
Labels: hiv-testing, HIV/AIDS, home-based testing, home-testing
Friday, May 29, 2009
EMPOWERED
So often in social services and in community work, we hear the word "empower" (as in, "my job is to empower my clients..."). People become empowered when they are given choices, and allowed to make those choices. But when it comes to HIV-testing, this concept is elusive. The technology exists for people to find out in the privacy of their own home their HIV-status (at least through a screening), and in other parts of the world, people are able to acquire these tests easily. But here in the US, the purchase of these tests over the counter is illegal. Lacking FDA approval is the stated reason - which is true - but what are the reasons these tests are not available? Without going into a lengthy diatribe about this, the essential reason seems to be that people are concerned that our society is not ready for people to screen themselves in the privacy of their own home.
I (Brad) recently purchased an HIV-screening kit on-line. With co-workers in Washington, we screened ourselves. For the first time in the 17 years that I have known I have HIV, I visually confirmed for myself that, yest, I do have HIV. It was a subtle shift in my perception. It can also be an empowering experience to further turn around and offer this screening to others.
As we gear up for National HIV-Testing Day, getting government approval to expand the testing/screening options for people is one of our major goals. We cannot effectively stop the spread of HIV until all people know their status. We cannot effectively empower people to do this by limiting their options, but rather by expanding their options.
So often in social services and in community work, we hear the word "empower" (as in, "my job is to empower my clients..."). People become empowered when they are given choices, and allowed to make those choices. But when it comes to HIV-testing, this concept is elusive. The technology exists for people to find out in the privacy of their own home their HIV-status (at least through a screening), and in other parts of the world, people are able to acquire these tests easily. But here in the US, the purchase of these tests over the counter is illegal. Lacking FDA approval is the stated reason - which is true - but what are the reasons these tests are not available? Without going into a lengthy diatribe about this, the essential reason seems to be that people are concerned that our society is not ready for people to screen themselves in the privacy of their own home.
I (Brad) recently purchased an HIV-screening kit on-line. With co-workers in Washington, we screened ourselves. For the first time in the 17 years that I have known I have HIV, I visually confirmed for myself that, yest, I do have HIV. It was a subtle shift in my perception. It can also be an empowering experience to further turn around and offer this screening to others.
As we gear up for National HIV-Testing Day, getting government approval to expand the testing/screening options for people is one of our major goals. We cannot effectively stop the spread of HIV until all people know their status. We cannot effectively empower people to do this by limiting their options, but rather by expanding their options.
Labels: empowered, hiv-testing, home-testing
