Gilenya approved. Now what?

So the FDA has approved a pill for MS, Gilenya (nee fingolimod). Now all we need is some data that tells us which of the available disease-modifying drugs might work better. Until somebody starts to generate comparative data, choosing a DMD for MS will be like choosing which brand of cigarettes to smoke: "Yeah, I like that Avonex is cheaper, but it's really a woman's brand. Rebif seems to work OK, but only black people shoot Rebif. Me, I'm more of a rugged, outdoorsey Copaxone guy."

If you want to reduce the cost of providing care for chronic conditions like MS, you should probably start by figuring out whether some drugs work better than others. If it turns out that some work better than others, create an incentive for using the drugs that work best. If they're all equally effective, create an incentive for using the drugs that are cheaper.

First research testing CCSVI theory

Yesterday, my feed from PubMed turned up what seem to be the first couple articles testing Zamboni's CCSVI hypothesis, from the Annals of Neurology:

Sundstrom, et al.:

To test this hypothesis, we studied 21 relapsing-remitting multiple sclerosis cases and 20 healthy controls with phase-contrast magnetic resonance imaging. In addition, in multiple sclerosis cases we performed contrast-enhanced magnetic resonance angiography. We found no differences regarding internal jugular venous outflow, aqueductal cerebrospinal fluid flow, or the presence of internal jugular blood reflux. Three of 21 cases had internal jugular vein stenoses.

Doepp, et al.:

Fifty-six MS patients and 20 controls were studied. [...] Except for 1 patient, blood flow direction in the IJVs and VVs was normal in all subjects. In none of the subjects was IJV stenosis detected. IJV and VV BVF in both groups was equal in the supine body position. The decrease of total jugular BVF on turning into the upright position was less pronounced in patients (173 +/- 235 vs 362 +/- 150ml/min, p < 0.001), leading to higher BVF in the latter position (318ml/min +/- 242 vs 123 +/- 109ml/min; p < 0.001). No differences between groups were seen in intracranial veins and during VM. None of the subjects investigated in this study fulfilled >1 criterion for CCSVI.

So it seems unlikely that MS is caused by CCVSI. Could it nevertheless be true that the "liberation" procedure cures, or at least alleviates, MS? Will anyone bother to find out?

UPDATE: Here's a link to a short Wall Street Journal piece about the impact of this research.

NYT on Zamboni "liberation"

Today's NYT presents a piece about the Zamboni "liberation" procedure as a case study in patient use of the internet:

The controversy has exposed the deep frustration of many people with this incurable, disabling disease, who feel that research has let them down. It is a case study in the power of the Internet to inform and unite angry patients—which may be a double-edged sword. Pressure from activists helped persuade the Multiple Sclerosis Society to pay for studies of Dr. Zamboni’s theory, but the Internet buzz has also created an avid market for a therapy that is still unproved.

“It’s eye-opening the way this group of patients has grabbed hold of the social-networking technology,” said Dr. Simon, an interventional radiologist at JFK Medical Center in Edison, N.J. “They’ve taken this to a level I’ve not seen in other patients. Patients used to read an article or two. Now, they’re actually seeing procedures on YouTube. Is this the future of medicine?”

If there was a cure for MS, I'd be in a hurry, too. But the only way to know if this CCSVI is for real is to wait for the scientists.

Try Googling 'CCSVI' and you'll find plenty of people who already want to sell you the miracle cure: No waiting! Top docs in India! A woman described in the NYT managed to pursuade an interventional radiologist in the US to perform the procedure, for about $10,000:

Although it was, technically, an experimental procedure, Dr. Simon said he did not have to ask his hospital for permission to perform it. The details were similar to other procedures that interventional radiologists do every day. It is not uncommon for them to take a device approved for one purpose and use it for another, like putting a bile-duct stent into a blood vessel — a practice called “off-label” use, which the Food and Drug Administration allows. Interventional radiology, Dr. Simon said, is an “off-label specialty” that depends on innovation and adaptability.

Eh, not quite

Let's sum up: the condom catheter, or "Texas catheter" (I wonder why that is) is a pain in the ass to get set up, might lead to a bladder infection, and could be a serious hit to your self-esteem. For me, it isn't right for daily use, but I think there might be occasions for which it would be a big help. Maybe for travel or events where one might not be able to get to the bathroom for long while.

I guess if there were any magic-bullet interventions out there, they probably would have been fired by now.

A few hitches

1. I am blessed with a dually-dysfunctional bladder: it wants to let stuff out when I want to hold it in, but it won't empty completely when I ask it to. I can usually persuade it to empty most of the way by gently pressing on and massaging it with my hand. That's fine when I'm standing at a urinal, but when I'm at my desk it might look a little weird. The upshot is that the bag will be happy to catch whatever my bladder decides to let out, but in order to truly empty I'll still need to adjourn to the men's room. If I don't, I run the risk of developing a bladder infection--something I haven't had a problem with yet.

2. I need to figure out how to keep the bag up by my knee instead of down by my ankle. As the bag fills, of course, it gets heavier and starts creeping down and pulls at the "condom."

3. Walking with a fullish bag, especially one that's slid down a bit, causes an audible gurgling/sloshing sound.

OK, that was weird

I suppose after a while, I will learn not to panic at the sensation of something warm running down my leg. It's going to take some time, though.

It felt a little odd to lock myself into a stall in the bathroom, prop my foot on the toilet, pull the cuff of my pants up, and release the valve on the bottom of the bag. But maybe not quite as odd as locking myself into a stall to change my own diaper 3 times during a work day.

It feels, and looks, sorta precarious, just sorta taped on there, connected to some tubing that leads to a bag on my shin.

I'm really, really self-conscious today

A casual Friday in summer seems like a good day for one's first try with an external catheter, or what the packing calls an "incontinence management device" (IMD). Today, I'm experimenting with a device called the GeeWhiz, an award-winning variation on the condom catheter. In a nutshell, it differs from the usual setup in that the "condom" is held in place not just by taping around the outside but also by a piece of double-sided sticky silicone on the inside as well. (You can see a creepy diagram here) We'll see if this clever design is worth the added expense--a 10-pack of daily use kits plus a leg bag and bed bag costs $59.95 + $10 shipping.

Putting the thing on wasn't too bad, but if I'm going to use this thing on a regular basis, I'm definitely going to need to give myself a trim in that region. And the tube that extends to the leg bag is definitely visible through my khakis.

Summer

Summer ain't what it used to be. I've still got the fishing boat, mainly because it was easier to ignore it than to sell it, but I haven't been back out since May. My hope is that I'll be able to persuade my wife to join me for a few lazy afternoons when it's not too hot. And I'm resigned to putting a little more money into it to fix a few small annoyances.

I'm also resigned to making some adjustments in my own life. I caved in and ordered a condom catheter set-up, having reached the point where I'm having to change pads 3 or more times a day. I'm hoping it will save me a few trips to the bathroom during the work day. I'm also hoping I can figure out how to keep my gut working properly--I'm going to see a new GI doc next month. If I can get my plumbing issues under control, I think I stand a much better chance of staying in the work force. If not, I could end up trying to get disability benefits based not on crushing fatigue, cognitive decline, or neuropathic pain, but on the basis of a hyperactive bladder and a lazy colon. I can't think of a more annoying end to my career.

Recalibrating

Fishing season opened last weekend, so Sunday I sallied forth. I lugged the batteries out to the boat, put a beer and some bait in a cooler, collected rods, tackle box, and PFD, and hitched the trailer to the truck. By the time I got to the landing I was exhausted, but I managed to get the boat in the water and the motor started. A few hours later, it was pretty clear to me that I should definitely quit fishing solo and probably sell my leaky, abused boat.

I just don't have the energy, and it's not fun anymore. I need to readjust my life and do less. I want to quit some stuff and have more juice available to do what's left. I want to leave fewer things half-finished, half-assed. While I was out not enjoying fishing, my tomato, onion, and pepper seedlings for the garden were wilting in the sun. My new guitar's gathering dust. I've never even taken the nifty condenser mic I bought a couple years ago out of the box. There's a used Soloflex machine in pieces in the basement. There are a dozen bags of compost and peat in the garage waiting to be mixed into the garden. I've still got skiing equipment in the house somewhere--I haven't used that for at least 6 years. The printmaking inks and art supplies in the basement, the unopened yoga book, notions about road trips and vacations abroad, get rid of it all--it's unbearable to think about.

Let's have a big garage sale, liquidate everything, and start over.

Beginnings, middles, and ends

It's spring, and change is in the air.

At work, colleagues are announcing departures and retirement. There will be cakes and the obligatory speechlets and talk about hiring replacements or not and people moving to new offices and jockeying to score coveted office furniture and to ditch disfavored assignments. And in the fall, we'll regroup and cowboy up for another go-round. In the fall, I'll give some thought to whether I'm prepared for another go-round, and while I'm still thinking about it I'll notice that I've started going around again. That's the way it works, because when I leave this job, it will almost certainly not be because I'm retiring or moving to another job.

Carmen's graduating from nursing school in a few weeks. She's done really well, and I'm so proud of her. The job market's not great right now, but I'm guessing she'll find work right away--it just might not be exactly what she wants to do, or where she wants to do it. In any event, it might at last be fiscally possible for me to reduce my work hours.

Change gets a lot of attention. Beginnings and ends register in a way that middles can't; that's just how we're wired, at least initially. But I'm trying really hard to cultivate my awareness of, and appreciation for, the middles. Meditation is a great tool for that. So is a canoe.

In the spring, I try to make it out to a certain creek when the water is high to float downstream through the damp woods. The first time I paddled it, I was maybe 11 or 12, and my dad and I fished for trout with the grasshoppers we collected from a field by our house. These days I need to be accompanied by others strong enough to get the boat to and from the water, but it's still a magical ride.

Right up until the point where we tip over the canoe.

Today's lesson in perspective: open defecation

NYT has a little piece today about a Unesco and WHO report concluding that 1.1 billion-with-a-b people "practice" open defecation. That means about 17% of all humans poop on the ground, though NYT helpfully adds that "[c]overed pits and outhouses are not considered 'open defecation,' while buckets and long drops over running water are." Way back in 1990, the figure was 25%. So compare any hits to your standard of living to the millions of people who no longer have to poop on the ground.

Research confirms: men are jerks

According to this study, men are 6 times more likely to leave a seriously-ill spouse than women. Not really surprising, but this plays right into my primary making-sense-of-having-MS story, which is, more or less, that among those with the crappy luck to develop MS, I am a very lucky guy.

Conquering Everest, or maybe the lawn

Lori Schneider, a 52-year-old retired teacher with MS, reached the summit of Mt. Everest on Thursday, May 21. "She said, 'I'm here Dad, I'm on the summit, I made it,' " Neal Schneider recounted. "She was very, very happy, as you can imagine."

Congratulations, Lori.

That same evening, Doug Lee-Knowles, a 38-year-old lawyer with MS, mowed the back yard. "He said, 'The Office was a re-run,' Doug's wife recounted. "He looked like he was gonna pass out, as you can imagine."

Congratulations, Doug.

As I've said before, I don't get much out of the adventures of super-crips like Lori. But I bet Lori gets plenty out of her climbs. I get a similar, if smaller, charge out of doing ordinary stuff that has gotten increasingly difficult for me over the last half-dozen years: mowing the grass, washing the dog, and, a while back, replacing a dodgy distributor rotor.

I suppose I've given up on doing the kind of stuff that other people would care to read about in the newspaper. But I'm still fighting hard to hang on to the trappings of ordinary life. Nobody wants to read about a guy with MS making dinner or continuing to drive a manual transmission, but stuff like that sure makes me feel good.

Honda develops robotic mobility aids

Kewl! Today, gearhead blog Jalopnik reports on a pair of gizmos from Honda that could be really useful to people with MS. Does the 7-lb. Honda Stride Management Assist (in the Jalopnik photo at left) sound like something you could use? Snip:

It's designed for people with weakened muscles that can still walk on their own, but could use some help getting back in shape after an injury or tackling difficult tasks like walking up steps. Basically, a motor sits on each hip and helps lift the leg using and arm and strap connected down by your knee. Its your own movement that activates and controls the length and degree of assistance, so you won't find the device trying to force you into movements you didn't already want to make.

The other gizmo is called the Honda Bodyweight Support Assist. It helps support the wearer's body weight in a variety of positions; Jalopnik says "It's like your very own seat that walks around with you wherever you go." It's wonkier-looking (kinda like a robotic dancing coach?) and weighs 14 lbs. Both devices are powered by batteries good for 2 hours of use.

The last time I got excited about a mobility aid was when the Segway came out. These seem to have a lot more potential for use in the real world (I think the lightest Segway, the p Series, weighs 70 lbs.). If American automakers were coming up with stuff like this, I'd have an easier time seeing the importance of maintaining a domestic auto industry.

Putting on your game hair

Interesting piece in NYT by Dana Jennings reflecting on the "buzz cut" hairdo he got shortly before undergoing surgery for prostate cancer. Jennings says he needed the "primal ferocity" that a buzz cut conveys. More generally, Jennings says that style or fashion or appearance is an important way for sick people to communicate with themselves and the world around them:

It was only after the fact that I learned that my hair-shearing reaction to having cancer wasn’t so unusual. I understood that the buzz cut spoke of a new me. It still reminds me that I’ve been tempered in the crucible of cancer, that I have changed. But it’s also part of a muted tradition that’s consistent with the transformation, transition and trauma that I’ve gone through.

I can dig that. I've been sporting my own buzz cut for the last couple years. Every two weeks, I sit down with the clippers and a #2 guard and trim off the half-inch or so that's accumulated. (For the record, Jennings goes with a much closer 1/0 cut every 3 weeks--dude, that's badass.)

I'll concede that my 'do had more to do with my thinning hair than it did with MS, but it has changed my own sense of who I am. I think it conveys the sort of no-nonsense practicality that I aspire to. It's low-maintenance, a little severe, and recession-friendly (not that I ever spent more than $20 on a haircut, but still).

Dear blog: I'm just not that into you

It's not you, it's me. I don't know what my problem is, but I'll make it up to you somehow. Really.

Drugs and money: tough choices

Today's NYT has a great article about how Britain decides which drugs it will pay for through its National Health Service. An entity called the National Institute for Health and Clinical Excellence (NICE) has the job of undertaking a cost/benefit analysis for new drugs. It compares a given drug's price with the drug's ability to improve or extend a patient's life. Some drugs make the cut (like Betaseron); others don't (like Avonex).

This makes some people really mad, natch. The value of adding, say, one year to the life of a 75-year-old male smoker is likely to be reckoned much higher if you happen to be the 75-year-old male smoker in question. But if the NHS's budget is finite, what is the alternative?

A cook's manifesto: I'm no chef

Marcella Hazan, who has taught bazillions to make the great eats of Italy in their own kitchen, has an op-ed in the NYT today. She argues that our fascination with food as entertainment and artistry, and with the chefs who create that kind of food, has caused us to devalue the importance of food as family- and community builder, and the people who do the more humble home-cooking. Snip:

I am my family’s cook. It is the food prepared and shared at home that, for more than 50 years, has provided a solid center for our lives. In the context of the values that cement human relations, the clamor of restaurants and the facelessness of takeout are no match for what the well-laid family table has to offer. A restaurant will never strengthen familial bonds.

A while ago, my dad gave me a chef's jacket with my name embroidered on it. I've worn it on occasion while making some fancified food for friends, but after reading Marcella's column, maybe I'll just stick with an old-fashioned apron.

Unexpected cutbacks?

Anybody who's been paying attention has noticed that increases in the prices consumer goods have increasingly taken the form of decreases in the amount of product you get, instead of increases on the price tag. What used to be a half-gallon container of ice cream became 1.75 qts, then (for Breyers, anyway) 1.5 qts. Well, caveat emptor--you gotta keep your eye on the ball and look at the little shelf tags that give per-ounce prices, or do some quick math in your head.

But Kimberly-Clark may be taking this trend to strange new places: my underwear. When I opened my last shipment of Depends Guards for Men, the package announced that I was getting a new, more comfortable fit. I also noticed the package looked a little smaller. After a couple weeks of product testing, I've come to the conclusion that the new, more comfortable fit must have come at the expense of, uh, capacity. So sure, reduced lumpiness in the area in question is bound to increase comfort, just like a 25% smaller cheeseburger makes for a burger with just 75% of the fat in the previous product.

Here's the kicker: if you want the properties of the old product, Kimberly-Clark helpfully offers Depend Boost inserts, which allow you to soup up your existing disposable absorbent garment. In other words, you're welcome to buy the missing 25% of your cheeseburger. Somebody get Ralph Nader on the phone...

Catching up

I've been pleasantly suprised at how many old friends I've bumped into on Facebook--seems like it's achieved the sort of critical mass of users that made eBay the only auction site worth looking at. Anyway, last week I connected with a guy I'd known since I was 6 and went to school with until I went to college.

When you catch up with someone like that, what do you say about MS? Anything? Here's what I said:

Now, the juicy bit: back in 1992, I developed the symptoms of what was diagnosed a couple years later as multiple sclerosis (MS). I’m not sure how much you know about MS, but I’m doing pretty well for someone who’s 15 years into it. I have a lot less stamina than I did 10 or even 5 years ago, which has been frustrating for a guy who’s inclined to be a do-er. I use a cane maybe 50% of the time, mostly for balance, and I’ve had some trouble with chronic pain as a result of nerve damage, but rest of my symptoms are mild-to-moderate indignities. I’m not sure what else to say about it. I think in the last few years, I reached a point where the disease is always with me. At first, it just meant giving myself a shot every couple days and checking in with a neurologist a couple times a year. But now, I’ve got a visibly funny walk and a disabled parking tag, I take a startling assortment of pills, I had a sort of neurological pacemaker implanted in my hip this spring, and I go to bed around 9:00 every night. There aren’t many places I go or things I do without MS coming along with me. It’s almost easier now, not trying to pass for a healthy person.

What else? My mom lives in Madison, but my dad and his second family are in West Salem, so I get back to La Crosse fairly often. Um, turn-ons include comfortable shoes, gin & tonics, and plentiful public restrooms, turn-offs include people who talk too fast, area rugs (tripping hazard), and the McCain health care plan.