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.