FDA and OTC Tests

I attended a part of an FDA Blood Control conference yesterday, and was one of 7 people to have 3 minutes to present my opinions on whether FDA should approve over-the-counter (otc) rapid, self-administered HIV tests. In partnership with RJ Hadley in Chicago and Christine Harris in Austin, TX, we had submitted a written statement the week before.

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.

Faith and Hospitality

I have now been here at the William Penn House for two years. First as an intern and for six months as the “hospitality coordinator.” My job description contains what you would expect- check guests in and out, do laundry, make the House a welcoming place. Hospitality is an integral part of what we do here at the William Penn House and has been the main focus of our mission since the Corys opened their home to young peace protesters in 1968. But as I approach my two year anniversary with the House, I find myself wondering what exactly hospitality is and why it matters.

If hospitality is just giving people a bed and a meal, then it is easy and requires little of me or the rest of the staff besides showing up on time in the morning with a service-industry-required smile. And many hotels and hostels work on that level. But the William Penn House is a special place. Here we try to answer the question of what does God require of us in response to the stranger, the other, the traveler. At first the answer seems clear and easy. Jesus told a parable in which the faithful are commended by the King because “I was a stranger and you invited me in.” When we welcome others, we welcome God.

But the truth is it is hard to welcome the stranger who is demanding and angry, the guest who is needy and always seems to want more, and the guy who creeps you out just a little. It is hard to see that of God in those who are not grateful or treat me poorly. Also, in the day to day running of a hostel I tend to get caught up in the details and tasks. I can easily lose sight of the moment and brush the guest aside so that I can get my “work” done. But in fact, my work is in welcoming that stranger in, not in giving them a bed and breakfast, but by engaging with them, listening to their story and not just going through the motions of reception.

Every day here I am challenged to take what I believe to be true, that God calls us to reach out to the other, and practice it in my interactions with guests. I need to slow down and be willing to hear from a lonely traveler about where he’s been. I need to be patient in explaining six times where the bathroom is to the guest who doesn’t speak English well. And I need to be willing to give grace to the grouchy and rude guest who doesn’t seem to appreciate that I am bending over backwards to help her. In this, I hopefully grow closer to the individual that God calls me to be and our guests receive a tangible example of God’s love in their lives. This is hospitality.

Faith Kelley, Hospitality Coordinator

Uganda and anti-homosexuality laws

Dave Zarembka is a member of the Bethesda Friends Monthly Meeting, and is the head of the Africa Great Lakes Initiative. Like me, he has been pretty passionate that we maintain open relations with Friends United Meeting despite its hiring policy that does not allow for the hiring of anyone in a relationship that is not recognized by law (meaning any gay couple, or a hetero couple not legally married). It is with this in mind that I think serious consideration needs to be given to this letter sent out by Dave:

Dear Friends,

The Uganda legislature is considering one of the most repressive laws
that I have ever heard of. This law is geared against homosexuals, their
parents, teachers, counselors, landlord/lady, medical practioners, etc.
Punishment for homosexuality includes life imprisonment or the death
penalty. In addition everyone in the society will be an informant. Here
are some of the provisions:

- any parent who does not denounce their lesbian daughter or gay son to
the authorities will be fined Ush 5,000,000/= (about $250 in a country
where many live on $1 per day) or put away for three years.
- any teacher who does not report a lesbian or gay pupil to the
authorities within 24 hours will be fined Ush 5,000,000/= ($250) or put
away for three years in prison.
- any landlord or landlady who happens to give housing to a suspected
homosexual risks seven years of imprisonment.
The Ugandan Civil Society Coalition on Human Rights and Constitutional
Law concludes, "In short, this bill targets everybody, and involves
everybody: it cannot be implemented without making every citizen spy on
his or her neighbours."
It is time for folks to organize like the anti-aparteid movement in South
Africa. Boycott visitng Uganda, no investment, withdraw current
investment, ban on visas for politicans and atheletes, etc. Pressure the
US Government to confront President Museveni of Uganda who is reported to
be supporting the bill. Uganda is one of the US's stongest allies in
Africa so the US Government can put a lot of good pressure on Uganda.
(Uganda supports the US against those "bad guys" in Sudan, has AU troops
in Somalia). There is lots of potential for action and should include
both North America and Europe. Campaign to get them kicked out of the
Commonwealth.

I suggest that these actions begin immediately before the bill is enacted
into law.

Peace,
David Zarembka
Lumakanda, Kenya

I will get in touch with some folks about what actions we might be able to put
together on this.  I am pretty sure that Bishop Akinola's Anglican church, which
has strong moral and financial support here in the US, is a part of this, so action
may not only be about Uganda, but some of the congregations here that have
left the Episcopal church to join Akinola's church.

Beware the Common Enemy

What do Stalin, Saddam Hossein, and the Taliban all have in common? Each one, at one point in our history, was an ally of the US. It was not that these people were at one time fundamentally different in character than what we now know them to be, but it was that we shared a common enemy; with Stalin, it was Hitler; with Hossein it was Iran, and with the Taliban in Afghanistan, it was Russia. In the latter two cases, there was much more to it than just the common enemy. There were also issues of corporate greed, and the desire to control oil that was the underpinnings of the US economy that was dependent on the auto and housing industry. As Franklin Roosevelt said about a mid-20th century Nicaraguan ruthless dictator, "Somoza may be a son-of-a-bitch, but he's our son-of-a-bitch". (Note: there is some question about whether Roosevelt said this, but there is no doubt that he was a strong supporter of this corrupt, greed-driven dictator because he was against communism)

What does all this have to do with current events? Beyond international policy practices that still continue, this phenomenon of "my enemy's enemy is my friend" has reared its head in the healthcare debate as well. The "enemy", in this case, is Obama. For some, it is his policies, including a proposal for a single-payer option in healthcare. There is certainly room for debate here, as there are legitimate concerns about funding a program like this. (I personally have two concerns about the healthcare issue: the first is that we expect too much from healthcare, and the second is that government is an institution that is way too slow and bureaucratic to really get anything done, but I welcome the discussion).

For the fiscal conservatives who have legitimate concerns about either the financing of a program or merely have concerns about the role that government might play in healthcare (keeping in mind that Medicare, Medicaid, and the VA are already in place), having your issues heard is currently being drowned out by other "anti-Obama" allies who have more insidious motivations. Among the allies include a colllusion of: corporate greed folks, the Republican leadership that is looking for any opening to regain some power, a right-leaning media looking for viewership, and blatant racists who simply cannot believe that a black man is President. Here's how, to me, it seems to be playing out: The more corporate folks (Dick Armey, healthcare corporations, Fox News) whip people into an emotional frenzy that then comes out in the form of fear of communism, fascism, government killing old people, loss of gun rights. The racism gets thinly veiled by comments about the country being taken over by Muslims. The success of this movement is dependent on keeping people's fears heightened, and calling these fear "patriotism".

For the benefit of all of us, it would be great if we could all take a deep breath, relax, listen, and re-engage the frontal lobes. If we could open up dialog with real exploratory questions, and seek common solutions, we would all benefit. But for those who really have concerns about any government expansion in the role of healthcare, it is important to pull apart from those who are dependent on polarizing effect of "my enemy's enemy is my friend" approach. The blatant racists, partisans looking merely for power, and corporate greed folks are exploiting you for their personal agenda and care little for your real concerns. In fact, they don't want you to think. They just want you to be angry.

Pigs at the Trough

I just got back from a presentation at the DC Department of Health's AIDS Administration. Let me start by saying that all the people in the room were caring people who have their hearts in the right place, so this is not about them as individuals. This is, however, an absolute slamming of "AIDS, Inc." - an institution that has completely taken over and has no intention of going away.

Here's why: The presenters gave a lot of data about the sexual behavior of "msm" (men who have sex with men). What the data showed is that msm still make up the highest number of people contracting HIV and that sex and drugs impact behavior. There were lots of slides with numbers, statistics and terms - including one item that showed that 64% of respondents knew the HIV-status of their last sexual partner. The problem with this last issue - which I raised - was whether this information was reliable. The presenters said that it was a good thing that these people think it is, but I would actually say that it may not be good - it could be reinforcing the false sense of security that you could just tell if someone has HIV based on their word and how they look.

There were many other issues I had with the presentation (including the usual - what does any of this tell us that changes what we know? how does this help get people to get tested? How does this change the stigma? etc.). The fact is that this study only reinforces the stigma of HIV as a gay man's disease. But the real kicker is this: these presenters referred to this study as their "baby", that it's only three years old, and that they will be replicating it to two other high risk groups over the next 6 years (3 years each group), and then repeat as they fine-tune their data collection. Meanwhile, there were giggles and chuckles as they talked about the limitations of their work, how they defined msm, and how good they all feel about the data.

ARE YOU KIDDING ME?! We are talking about lives here. Where is the talk about stopping the spread of HIV NOW! Where is the concern that this is not a gay disease, a black disease, a women's disease, but a public health issue?

I did raise the question, with passion. It was heard, and I think registered. I also wonder, however, where is the community outrage?! These people are talking about multi-year studies that tell us what we already know (really, it seemed like what they were studying was a new methodology of epidemiological data collection rather than collection of useful data).

There was some talk about the high levels of support from among people ages 18-34 to make HIV-testing routine in doctor's offices. Two things about this (I mentioned both of these): this is the age group least likely to have a routine around medical care so it's less of a reality, and this is a group that is most amenable to testing, so let's get the tests to them. I made this impassioned plea: the community is ready to take action, to self-administer and make HIV-testing more portable. We either need people like these epidemiologists to help us make the case statistically, or to get out of the way so we can do it.

What is clear, based on all the meetings and conversations now at the highest levels of HIV-administration at both municipal/state (here in DC, sort of the same thing) and federal levels, is this: all people mean well and want well, but the bureaucrats are limited in their power, and the epidemiologists are calling the shots. Unfortunately the shots they are calling are for more studies. We know enough. We need the psychologists, social scientists, sociologists, theologians and artists to now step up and create more options. And, most importantly, the community voice and passion must be raised. This is the only way that change will really happen in any timely matter.

What we did on our summer journey into HIV-testing

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.

Healthcare, living well and letting go

Last week I was going through the mail during my few days at home and, among the many pieces were a few bills for a medical appointment I had in the spring. The total out-of-pocket expenses for this one appointment: nearly $1000. Granted, this includes the $750 deductible, but given the salary I make, it's still alot (considering that on top of this there is an additional $60/month for the co-pays of medication). As I perused the bills, I looked through the labwork that was done and it was filled with things I have no clue about.

At the same time, I was listening to the radio and the on-going debate about healthcare. No doubt we have a broken healthcare system and we need to do more to see that people have access to healthcare, especially preventive medicine. But looking through my own bills, and reflecting on my own recent interactions with my doctor (whose biggest concern seemed to be that I was rejecting the idea of pursuing elective cosmetic surgery to fill out my cheeks that have thinned out as a result of the HIV-progression or treatment).

What I am noticing that seems to be completely absent from the debate about healthcare is that not only should all people have access to healthcare, but perhaps we should also be having a national dialog about what we expect from healthcare and why. I suspect, based on my own bills, that my MD is milking me for billable services. I know that he needs to be monitoring certain things because of new medications, but I also know that in some cases, if something were off, the prescribed course of action is more medication. Do I really need to know that certain levels of something are off, if I am going to refuse the treatment?

That very week, the woman (Hilda) whose house I am living in died. She was in a nursing home for the past 2 years and had not been out of bed for that time, but on Sunday night she got out of bed and fell, breaking her leg and hitting her head. My friend Marilyn (the woman's guardian) got a call at 6:30 in the morning asking whether she wanted to have brain surgery performed on Hilda. She was told she needed to make the decision immediately, not for the patient's sake, but because this was when the operating room was available. Marilyn was told that the surgery was to remove a clot (for a woman who had been basically comatose for a few months). Marilyn was not told about the broken leg. It all smacked of a healthcare decision trying to milk this woman's estate before she died.

Basically, I think we need to open up the national dialog to include a frank discussion that, yes, we are all on the same train progressing to one common end result. We want to use healthcare to help us get there as safely, happily, healthily and productively as possible. But we perhaps should depend less on healthcare for the quality of life things, and focus on some of the basics, while we also commit to healthier living. I don't know that statistics, but have heard about the high proportion of healthcare dollars spent on the last month of life. A part of this makes sense - trying to extend lives is costly. But we should know that all we are doing is extending life, not saving it.