Snapshots in Chronic Pain

It’s been two hours. I hurt from sitting up straight without anything supporting my back. My face feels tired from smiling and forced cheer. The paper of the exam table feels like sandpaper against the back of my knees, and I lost feeling in my hands after they asked me to squeeze and press and push and squeeze again, for some indeterminate test of muscle strength, when the problem is my nerves.

My medication history is nil at the moment; it’s been years since I’ve had anything prescribed to control the pain, and they know this. They’ve explained that they also cannot and will not ever prescribe pain medication for me–I’ll have to find a willing primary care physician. That’s deflating; why am I here?

They hand me a cup to piss in on my way out the door. No pain medication, hours of going over my history, and I still have to prove that I’m not on any drugs, just for the pleasure of their company.

The bill, before insurance, is nearly $1000 for the piss test. I’ll have to pay nearly $100 out of pocket.

swirl

The physical therapist wants to see me three times a week. My co-pay is $40 a visit. She talks of curing me in the next few months. I can’t decide what’s funnier: that I can afford $480 a month for physical therapy, that I can leave work early three times a week, or that I can be cured.

She cringes and recoils when she learns where my husband works. If he’s not with me, my physical therapy appointments only last 40 minutes. If he’s there, they always last over an hour.

swirl

I am soaked in a downpour earlier this week, fast-moving thunderstorms that overtake me on the way home. I lose track of the number of times I change temperature environment, going in and out of air conditioned buses and building, first dry and then dripping wet. My skin is now on fire, like I’ve been severely sunburned. But there’s no proof, there’s just the flinching if I am touched, the desperate attempts to find the softest clothes to wear, the effort at hiding my body from any direct air.

It is the middle of summer, but I’m bundled for late fall, arms covered and gloves on. My T3 is so ineffective as to be laughable, and it’s my own fault; opting–no, arguing–for the weakest opioid possible after my experience with the pain management doctors. To reiterate that I’m not drug-seeking, I’m not a junkie, I should not be judged or stigmatized, I am strong and only want the minimal medication possible to stop the pain.

I only want the minimal medication possible to stop the pain.

The pain has not stopped.

Teens Think Up Ethically Questionable STI Detection Method

Because there’s nothing the media likes more than a good look at all these teeny genius stories (except maybe catching a politician with their pants down, figuratively or literally), the primary non-Supreme-Court-ruling-on-Obamacare story making the rounds right now is the S.T.EYE condom, developed by three teenage boys from the Isaac Newton Academy in London. The S.T.EYE changes colour* when it comes in contact with a sexually transmitted infection (hence the name), which is being heralded as ground-breaking, revolutionary, disruptive technology–of course, since this was a TeenTech entry and winner. One of the young inventors, Daanyaal Ali, 14, says that they created the S.T.EYE because they wanted “to make something that made detecting harmful STIs safer than ever before, so that people can take immediate action in the privacy of their own homes without the often-scary procedures at the doctors.” (And as an aside, I find it fascinating that the teenagers want to reduce the embarrassment of going to clinics and emphasize “the privacy of your own home” line so frequently used by DTC advocates without stopping to consider the major hurdle of: duckie-pretty-pink--large-msg-131051452728if you’re putting the condom on to have sex with someone(s) else, then you’re not alone and we’re right back to the embarrassment-only this time it’s in the privacy of your own home while you’re naked in front of someone you want to have sex with. Which kind of sounds like it should be the beginning of an 80s movie starring Jon Cryer.)

This is an ambitious goal, and it’s laudable that teenagers are behind the idea; a validated, direct-to-consumer, at-home STI test that is inexpensive and accurate would be a great addition to public health. I’m not sure anyone can disagrees with that. The problem here is in implementation: the teens envision their test being wrapped up in a condom, which means that at least one person’s STI test will be revealed after-the-act, rather than before. While you may think “great, post-exposure notice,” it’s not that simple. What happens, for example, to informed consent? You’re talking about revealing whether or not someone has an STI to not just themselves but their partner(s)-at-the-moment; is there something that clearly identifies these as S.T.EYE condoms? Will it be impossible to miss that this condom your partner is providing (or that you provide a partner) will glow in the presence of an STI, regardless of who is infected? Will all parties need to sign a contract honoring the privacy of all participants before opening the condom? Will it come with a EULA-disguised-as-informed-consent? Remember, informed consent can’t be coercive-is right before having sex the bestest time in the world to assure non-coerced consent?

And other difficulties: how do you know who “triggered” the glow? Presumably it glows the same “uh-oh” colour regardless of which side of the condom the exposure occurred on. What if there are multiple partners? Are they considering impregnating dental dams with the same technology to include lesbians, or is this only for penis-based sex? Will the antibodies in the condom react to antigens in saliva? Can you still use lube? But, with exception of exactly who this condom is being created for, those issues are largely technical issues, and they’ve been well-deconstructed elsewhere.

Autonomy to make decisions, ability to consent after given full information, privacy of medical information; these are all pretty basic medical ethics 101 concepts, and they’ve been ignored here. I certainly don’t fault a trio of teenagers for that-but I can and do fault the teachers who encouraged them to pursue this line of thought, as well as the people who awarded it as innovative (not to mention the non-critical journalists breathlessly reporting it).

Innovation is the lifeblood of the technology industry; I understand that. My father had his own technology business when I was a kid. I was part of the technology innovation industry for a decade, and played a role in disruptive medical technologies.1 I was raised in Silicon Valley before it was Silicon Valley; I do understand, and I have no real interest or desire to stifle creativity, innovation, or even disruption. The problem is that in the pursuit of “can” at all costs, “should” is being left in the dust. Should we develop condoms that glow on exposure to STIs? Maybe not. Why? Well, how about the scenario where someone is killed for exposing someone to an STI? How about the person who is too embarrassed or ashamed to get help and kills themselves? What about the person who is shamed across their community, online, for having an STI, with a glowing condom as “proof”? And why do I even have to reach for such dramatic examples of “maybe we shouldn’t do this,” when “how do you manage consent” is such a present and problematic issue?

Of course, this isn’t just about innovation-it’s also about disruption. And the disruption here isn’t the idea of color-changing-upon-STI-detection condoms, but who is having the idea: teenagers. These teens are envisioning medical devices that are conveying diagnostic information, and they’re doing so outside of the normal channel that we expect medical devices to be developed in. That means the typical standards that are in place for medical device development (specificity, standards, quality control, labeling requirements, documented risks, etc) haven’t been addressed (or likely even thought about). To quote Nick, “In the world of distributed technology, these things are increasingly up to the individual, and we need to start adopting an “ethics of design” into our disruptive tech scene.” In other words, this project shouldn’t have made it to a technology competition without serious consideration given to plausibly, specificity, testing standards, and the other things that, presumably, the condom manufacturing company that has partnered with these teen boys will now take on.

It’s fantastic that there are challenges like TeenTech to encourage teenagers to pursue STEM-related careers. However, we need to make sure that we are setting the foundations to good research by teaching all aspects of research and development, including ethics, and make sure that our enthusiasm for encouragement doesn’t overshadow the necessity of ethical oversight.


*26 June 2015: Just a quick clarification, based in Maggie’s nice comment below: I want to stress that the idea the teens presented at TeenTech are conceptual ideas, not actual prototypes or working models. I do think that this stage is definitely where the “ethics of design” needs to be built in, but presumably–hopefully–that dialog will continue happening as the teenagers partner with a company to see what happens in science after you have that initial “oh hey” idea.

June: National Ship Live Anthrax Month!

ff_anthrax_fbi4_fOkay, I know we’re a bit ahead of June, but we’re within shipping for June, right? And at this point, a rather concerning pattern of “shipping live anthrax” is developing.

Yep! It’s that time again! Er, yet another mishap involving a lab sending a viable select agent to someone who shouldn’t have it. Er, someones. In this case, an unknown number of private commercial labs in nine states. NINE! And that would be alarming in and of itself, without that whole one year ago gift that keeps on giving. Or the previous Oakland Children’s Hospital incident in 2004.

Well. I guess in defense of the CDC, who owns the previous mishaps, this was a Department of Defense lab “mishap.”

Skeptical Scully

Very seriously, it appears there’s an issue here beyond “oh oops, culture of carelessness” – we have three clear and separate incidents of live anthrax being shipped out to people who should not have live anthrax:

    2004 – Oakland Children’s Hospital (should have received inactivated anthrax from the CDC; never did figure out what they were doing with anthrax)
    2014 – Three in-house CDC labs (should have received inactivated anthrax)
    2015 – Unknown number of private, commercial labs (should have received inactivated anthrax for “field-based testing to identify biological threats in the environment”)

Can we perhaps maybe finally agree that we have a massive problem with research laboratories, select agents, and oh, I dunno, what’s the word I want? Culture? Accountability?

Oh right!

Safety.


Last night, after I was entirely too tired to edit this post, it came out that not only were multiple labs in nine U.S. states–California, Delaware, Maryland, New Jersey, New York, Tennessee, Texas, Virginia and Wisconsin–and South Korea. Osan Air Base, which is an American military base, but still. A statement from the base says up to 22 people in a training laboratory were exposed: Five active duty Air Force members, 10 active duty Army members, three civilian officials and four contractors, all of whom are now receiving prophylactic treatment. -KH, 28 May 2015

Apple Updates HealthKit’s Ethics Requirements–But Don’t Celebrate Just Yet

In the on-going drama of Apple’s ResearchKit and its lack of conforming to modern expectations regarding human subjects research, Apple has updated the guidelines for apps “using the HealthKit framework or conducting human subject research for health purposes, such as through the use of ResearchKit,”1 requiring “approval from an independent ethics review board.” At first blush, this seems great–one of the bigger problems raised when Apple debuted Health/ResearchKit in March was that there didn’t appear to be any nod to or concession towards the necessity of ethical oversight of human subjects research, a conversation that’s been growing louder over the years, especially as Silicon Valley has become more interested in the potential “killer app” money behind health care products.

Unfortunately, a closer read of the actual guidelines shows that there’s still a lot to be desired, and Apple really needs to actually bring in someone familiar with medical ethics and health policy to help them not only with the language of their guidelines for apps, but also to review any app that wants to utilize the HealthKit framework or use ResearchKit for health-related research.

ResearchKit-HSR-April302015The revised guidelines can be read here; a snapshot of section 27, HealthKit and Human Subject Research, taken on April 30, 2015, can be seen to the right (click to embiggen). The particular language regarding ethics review boards is at the very end:

27.10 Apps conducting health-related human subject research must secure approval from an independent ethics review board. Proof of such approval must be provided upon request.

Obviously, the first and largest problem here is that proof of ethics board approval isn’t required, it merely needs to be available upon request, but a tumble of questions spill forth from that:

  • Who will have the capability to request to see this paperwork?
  • Can end users say “I want to see the ethics board approval?”
  • What is going to trigger Apple wanting to see this paperwork?
  • Who’s going to make sure that there was actually approval, rather than just submission? It’s not like it’s unusual for companies to try to fly under regulatory radar and sell products or services that haven’t been approved for their specific use (see: 23andMe, LuSys Labs).
  • Who at Apple is qualified to know that the ethics approval was granted by a legitimate, registered institutional review board (IRB)? (Does Apple even know how to check this information?)
  • Is Apple’s use of “independent ethics review board” an acknowledgement of outside-the-US names (where “Research Ethics Committee” or “Independent Ethics Committee” are more frequently used), or is this a way to dodge the requirement of use of an IRB, which does have specific and legal meaning within the USA?
  • What level of paperwork is Apple expecting app submitters to have for IRB approval? (Will they need to show the full paperwork filed? Will Apple be policing that paperwork to make sure it was what was necessary for the app’s purpose? Will they require meeting minutes? A one-page sign-off from an IRB?)
  • Precisely what qualifies an ethics review board as “indepdenent”?
  • Uh, what is “health-related” research, anyhow?
  • If the ethics review board says “this isn’t something that needs our approval, so here’s a waiver,” will Apple accept that as “approval”? (Because technically, that’s not approval.)

And of course, separate from this is the fact that currently, research (at least within America) only requires IRB oversight if money for that research is coming from the federal government. While yes, it’s true that all legitimate academic journals will require that the research was approved by an IRB and followed the conventions of the Declaration of Helsinki, not everyone is doing research with an eye towards publication within a peer-reviewed journal. This means that anyone doing HealthKit or ResearchKit work who is not embedded within an academic institution that has access to an on-site IRB will have to pay a for-profit IRB to review the app design and research goals – will Apple be looking for proof of payment? (And of course, that assumes that Apple will consider a university IRB “independent.” ResearchKitHealthKitAppleI’m relatively sure Carl Elliott would have some choice words about that particular assumption.)

All in all, this-the entirety of section 27, to be frank-reads as Apple scrambling, post-debut, to mollify the science journalists and media-savvy ethicists who have been honest and critical about Apple’s failures to understand even the most basic aspects of protecting the subject in human subjects research. It doesn’t actually seem to indicate Apple understands what is actually required from those doing human subjects research, only that Apple lawyers seem to be aware that there is a serious potential for a lawsuit here, and thus are trying to figure out how to best cover their corporate asses.


Human Beings are Cruel Things–The Internet Didn’t Create That

There seems to be a new, public wave of hand-wringing over technology changing us, making us mean or cruel. People cry out that the only reason women receive rape and death threats online is because of anonymity; there’s belief that bullied kids would never kill themselves before the internet; there’s a panic over the shaming that many (especially white men) face for revealing their racism, privilege, bigotry. But as Tabatha Southey points out, we–we humans–are cruel. We have always been cruel. We almost certainly always will be cruel.

Lately, humanity has been flattering itself that it was better and kinder before the Internet – as though we never slipped anonymous notes through locker doors in high-school hallways that were echo chambers in themselves, as if we never wrote on actual walls.

I had a growth spurt at 10; by 11 I’d reached menarche and developed breasts–the first out of my school and friend group. By the time I was 12, I was referred to as “Bazoonga Breasts” by everyone in junior high school, because most other girls–and certainly not any other 6th graders–had not developed to the extent I had.

I didn’t hear anyone, except teachers and family, refer to me by my given name for almost two years.

To hear us now, you’d think no one ever ever crank-called late at night, dialled up even before dial-up to offer abuse, stared into other people’s windows through our own twitching curtains.

When I was 13, everyone I ate lunch with, spent time with on the weekends, socialized with, and thought was my friend decided they liked another guy better than they liked me. molg-butterfly-wings-stickerThat guy was mad at me, so convinced everyone to send me letters telling me how worthless I was, how much they hated me, how much everyone wished I would just kill myself.

I took a decent swing at it.

We were never bitches before BBS. We never took our children to public hangings. The way it’s told now, we never publicly shamed anyone, put them in the stocks, or hurled rotten vegetables at them in the street. We never quietly dropped anyone off the guest list at a time when, new social spheres being difficult to access, a true precipice might well lie below.

When I was 20, the people I thought were helping me leave an abusive, violent relationship–the people who had helped me orchestrate fleeing in the middle of the night, getting into a motel room, fending for myself for several days–stood me up. We were supposed to meet at someone’s house and then caravan to another state; they purposefully didn’t show up, leaving me to either return to my abuser or make a 700 mile drive I’d never made before on my own. When I called to ask where everyone was, they told me they’d left hours earlier.

They thought it was funny.

They had, in their words, punked me.

We didn’t start the flame war. Scandalous satirical pamphlets were once cranked out by writers and sold at train stations, like so many primordial blog posts. Political cartoons have a long and vicious history. Incivility is our legacy, not our invention. It is part, but only part, of who we are. And have always been.

No, the internet hasn’t made us cruel. The internet has simply made it impossible to deny the reality of our nature, amplifying what was once small and local into a chorus people can no longer ignore, and are forced to confront with eyes that want excuses for the baseness of our very being.