Wednesday, November 18, 2009
Here’s how things went yesterday: I arrived at 11:30 with Amanda Haase, a William Penn House intern. We went to the lunch that was hosted by OraSure. At the table, we had some great conversations about how entrenched “AIDS, Inc.” is, and how it is only money that is asked for. We shared the same passions that bureaucracy and institutionalization of services is as much if not more of a problem than the lack of funding. Amen to all that. It’s always nice and affirming to connect with someone that shares sentiments, especially someone in her position. We will certainly continue this dialog.
Then it was on to the committee hearing about the approval of otc tests. The first part of the afternoon was 20-30 minute presentations on the science/technology of rapid tests, and the hoops that have been jumped through so far. While all of these people are clearly smart and dedicated people, what I noticed was how, as is so often the case, they seem to have developed a myopic approach to stopping the spread of HIV that is reliant on the status quo, institutionally. It was the same song and dance about high-risk groups (labels, labels, labels), and a limited appreciation of how otc tests could fundamentally change the landscape. One guy even presented detailed stats and graphs of a model – not even real numbers. I think we would all get more for our money if he were paid to study something that is happening, rather than what could happen.
They were looking at the challenge of marketing and packaging otc tests so that people the highest risk individuals could buy them and use them properly, but never mentioned the power of facebook and youtube to play a role in this, let alone that there are many of us out here who in no way will mark the shift in the landscape of HIV-testing by just letting them sit on the shelves. One epidemiologist, in particular, who kept insisting that “hard science” is needed to prove that these tests can be used effectively before approval can be given, but seemed to be relying on physical science, not social science which is needed here. He even made an analogy between these rapid tests and the development of a vaccine as holding out false hopes, even though these are two very clearly different beasts. Again, the myopia of one’s profession interfering with the big picture.
One option they are considering is buying these tests with a pharmaceutical consultation. It’s a step in the right direction, but I don’t think it will make much of a difference. There was also a healthy discussion of concerns over false-negatives and false-positives. Clearly the latter is more anxiety-producing. Their concern was that false negatives were terrible because of the erroneous security. One panelist, however, felt that in the entirety of all people getting tested, false positives among a few are better than not getting tested at all. I agree with this, especially if there is solid education about all of this that includes that false positives are a distinct possibility, so the person taking the test is more educated regardless of the results.
During the open comment time, every single speaker read statements supporting otc approval. They cited that rapid tests have helped dramatically improve test access, and otc could improve that. Some talked anecdotally; some talked with numbers. One presenter, a rep from a test manufacturer, showed stats from Europe that clearly indicate this can be done well.
As I got ready to speak, I decided to trash what I had prepared, as it was all being said by others, and went from the heart. I talked about how these tests in and of themselves won’t make a difference – that there are entire armies of us that will be the vehicles of change. I mentioned that I have sat around similar tables as they are, and seen great energy and intelligence wasted while ultimately maintaining the status quo. I observed that we are all pieces of a puzzle, and that community efforts are a piece of this puzzle (including the social networking) that they are missing but I know stands ready. I said that it has been over a decade since there has been any big shift in the HIV/AIDS landscape, and that approval of otc tests could be just the ticket. I also held up a sample of the tests we have bought, and said that I already know that these are being used by people who don’t feel comfortable or need the present testing system, and it makes a difference. I challenged the committee to see for themselves what the present HIV-testing experience is like. Go to an MD in Kansas; go to a clinic in Elgin, IL, Salt Lake City, or Washington DC, and do it without fanfare. Experience first-hand the questions, the time limitations, and the costs, and then come back and consider the issue of this option.
We’ll see how far they go with this and how quickly, but without a doubt, the public support and willingness is there. Interestingly, that afternoon, I received an e-mail of a study out of Johns Hopkins that self-administered testing is safe, effective and desired, so now the stats are coming out to.
I think it is really going to take a rise-up in activism akin to what ACT-UP did in the 80’s and 90’s to get medications and research going. There were some on the committee who did react to and seemed to be moved by the passion of the public comments. We need to increase the volume of this ten-fold, a hundred-fold, a thousand-fold. It will make a difference.
On a related note, I also saw that POZ magazine has an article about how youth are not talking enough about HIV. As I observed from this FDA meeting, I don’t think it’s that they are not talking enough; it’s that we have not adapted our communications and our relationships enough to keep the issue present. Heck, we are barely doing it among our peers. As always, it is easier to blame the youth rather than ask what we can do about it. I much prefer to be open to what I can do.
Tuesday, November 10, 2009
We, the undersigned, are submitting these comments to the FDA supporting the approval of over-the-counter rapid HIV-tests. We are people living with HIV/AIDS. We have been active and vocal about HIV/AIDS issues as a whole and have observed the unfolding of the community conversations about the prospect of over-the-counter HIV-testing. What we have noticed is that the driving question has been “Is this a good or a bad thing?” when the question really should be “In what ways can the availability of over-the-counter HIV-tests help us in our collective desire to stop the spread of HIV?” This opens doors to look at the possibilities – many of which are actionable. Here are some thoughts we have:
· The current HIV-testing system is very cost-ineffective (with administrative over-head among other costs). We can also attest to the limitations of the current system – it is often intimidating, humiliating and embarrassing, not always compassionate, and not always free. This includes HIV-testing clinics, health departments and medical providers.
· The current strategy of targeting “high-risk” groups and bringing them into the current testing system only adds to the stigma that we are striving to overcome. All persons sexually active are at risk.
· The concerns about linkage to care can be addressed when people such as ourselves are able to sit with or speak with co-workers, family, and friends to self-administer tests. We know first-hand the importance of care, as well as the limitations of care and the need to assert ourselves. OTC tests can be a means to help us educate others while promoting testing.
· OTC tests are ideal for repeat testers and for people without HIV who are in relationships with people with HIV. The presence of these tests in places where people are highly sexually active and are ignoring the bowl of condoms in the room. The mere presence of these tests may get people to stop and think.
· Women in either healthy or domestically abusive/violent relationships will be more empowered and able to take control of their own health much safer and quicker with the availability and approval of OTC HIV home tests. Placed next to the “at home pregnancy test”, more women would be alerted to the message anyone can become HIV+.
· For many people, the stigma of getting tested can be very intimidating resulting in not testing at all. Many of these people, if they knew they were positive, they would go for treatment and counseling. We know many people who have stated this including ourselves had the option been available.
· There is a concern that people who self-administer HIV-tests and find out they have HIV will harm them selves. Clinically, there is no data to support this. Besides, the FDA routinely approves medications that have harmful, even deadly side effects, and issues warnings about this. Similar warnings can be added to OTC tests including 24-hour hot lines and live peer support lines.
· In the past 2 years, we have seen first-hand many individuals, members of congregations including entire congregations be turned away from testing because they are not in the “high-risk” groups. Many of these people live in communities where asking for an HIV-test from a medical provider carries social and professional consequences as well and is more costly and time consuming for the consumer. Many of these people would be willing to pay $10-12 for an OTC test.
· The ability to test oneself can be extremely empowering.
· The presence and availability of OTC HIV-tests in stores will help market the message that we all can get tested for HIV.
Approval of OTC HIV-tests will not solve the problems we face, but such approval will provide a new option for people. It will provide a new way for those of us who are passionate and committed to stopping the spread of HIV to reach out. To be sure, vigilance about compassion, linkage to care, and factual education is required. We view these tests as a means to accomplishing all of this.
RJ Hadley, Community Organizer, Activist
Brad Ogilvie, Program Coordinator, HIV-testing advocate
William Penn House,
Monday, November 02, 2009
What happens when you ask a group of people to imagine that they are charged with the task of promoting a community-wide plan to get everyone tested for HIV? This is an experiment that we have been doing over the past few months, and it has been enlightening for me, as well as educational for the participants as questions about open up for conversations about the current system. Inevitably, issues of mandated vs. voluntary testing come up, and it is readily agreed that voluntary testing is the best way to go. But we can effectively promote a culture that makes HIV-testing the norm rather than the exception through marketing, and making access to testing as easy as possible. Issues about reporting and linkage to care also come up, but these are already issues in the current system, and issues that the current system has not been able to overcome.
Given that over-the-counter (OTC) rapid HIV-tests could become a reality in the near future, I have asked groups to consider ideas for promoting "KNOW YOUR STATUS". Here is a list of what two classes at Wilmington (OH) College came up with recently:
- Do HIV-testing in 7th grade
- Institute guidelines that offer HIV-testing upon high school graduation or earning a GED
- Routine testing at medical appointments
- Encourage HIV-testing when getting drivers licenses/state ID's, or registering a motor vehicle
- Include information about HIV-testing on cigarette and alcohol packaging
- Include HIV-testing as part of a marriage license
- For employers, ask/encourage new hires to get tested, but not tying in results of the test to employment. A precedent for this is at a tea company in Kenya that offered testing and counseling, and insured that the employer did not know the employee's status. The result was a decrease in absenteeism.
- Offer a tax-deduction for those who got tested (or purchased a test, at least)
Each one of these, in and of themselves, can raise concerns when they move towards "mandated" vs. voluntary, and it is a healthy discussion. The point is that there are many things we can do.
Compare this with what "experts" tend to come up with: expanding HIV-testing to ER/hospital admissions, and paying people with HIV to get into care. The blind spot here is that they are looking at ways to get people to where they are (looking from the inside out), whereas The Mosaic Initiative and William Penn House, through this work, are encouraging and nurturing an approach that remains outside the system. The hopefully-impending approval of OTC rapid tests can move this effort far further far faster than we could have imagined even 6 months ago.
How do you think you can use OTC rapid tests to complement the current system to move us towards the goal of getting all people to know their status?