Tuesday, November 16, 2010

FDA recommends new Lupus drug for approval!

[from WSJ:]

A Food and Drug Administration panel of outside experts recommended Tuesday that the agency approve lupus drug Benlysta, developed by Human Genome Sciences Inc. and GlaxoSmithKline PLC.
The 13-to-2 vote increases the likelihood of the drug getting to patients with the autoimmune disease, making it the first new treatment in more than 50 years. The panel also voted that the data surrounding the drug demonstrated its effectiveness and its safety.

Lupus has historically been a difficult development area for drug makers, partly because of the varied nature of its symptoms make it hard to prove a treatment is effective in a large-scale clinical trial. Attempts to develop new treatments for the condition have created a long list of failures.
Benlysta is important for both companies as it one of the most important new drugs in Glaxo's pipeline and Human Genome Sciences has no products on the market.
Leerink Swann & Co. analysts project that global sales of Benlysta could exceed $5 billion in 2020. The drug's success in two large studies, called Bliss, has produced consistent speculation that Glaxo, or another large drug maker, would acquire Human Genome.

Lupus occurs when the body attacks itself, causing inflammation and tissue damage virtually anywhere in the body, making it both difficult to diagnose and treat. It affects about 1.5 million people nationally, according to the Lupus Foundation of America.

Benlysta is designed to help relieve lupus symptoms that can include joint pain and swelling resembling severe arthritis as well as rashes and inflammation of the kidneys. It blocks a protein required for the development of certain immune system cells thought to play a key role in lupus.

If Benlysta is approved, its label will likely include strong warnings, as many drugs for rheumatoid arthritis already do. After voting on the approval, many panel members urged that the label of the drug should note that the drug hasn't been tested in certain populations, including those with severe kidney disease.

On Tuesday, researchers who worked with the companies presented data from large clinical trials that they said showed the drug was effective.

After failing earlier testing, the companies worked with the FDA to design the trials with a never-used combination of several disease-activity measures, including the drug's effect on recurring flare-ups and on symptom severity.

At the meeting, numerous lupus patients testified about their experiences with the disease including constant fatigue, crippling pain and respiratory problems that required lengthy, repeated hospitalization. They expressed frustration with the lack of effective therapies and urged the FDA to approve Benlysta.

Some patients--many of whose travel expenses were reimbursed by the companies--talked about their positive experiences with the drug in clinical trials. Most of the patients who testified were women or teenage girls; lupus largely targets females of child-bearing age.

Because the disease can cause various symptoms, physicians traditionally use different treatments, including anti-inflammatory drugs, steroids, antimalarials and immunosuppressants, all of which have their own potential side effects.

FDA staff scientists also testified and reiterated concerns expressed in an analysis released Friday that associated the drug with an increase in death, and serious side effects including infections and adverse psychiatric events.

Panel member David Blumenthal, assistant professor of medicine at Case Western Reserve University, strongly questioned the presentation of clinical data for Benlysta. The first study, called Bliss-52, only included patients in Asia, Latin America and Eastern Europe, and therefore wasn't representative of lupus patients in the U.S., he said.

The second study, Bliss-76, used patients from the U.S. and Western Europe and showed less effectiveness results than the previous trial after a year. A six-month follow-up showed that some benefits of the drug declined.

Several panel members reiterated Dr. Blumenthal's doubts about the strength of that data. Panel members and the FDA representative expressed concerns that the drug appeared less effective or perhaps even harmful in certain subgroups including African-Americans. Agency scientists also noted that African-American patients' symptoms seemed to worsen on Benlysta. That is particularly troublesome because African-Americans generally have a more aggressive form of lupus, the FDA memo said.

A company-affiliated researcher said at Tuesday's meeting that the results in African-Americans were disappointing and needed to be addressed in future research.

Rheumatologist Murray Urowitz of the University of Toronto told the panel that several factors, including lupus patients' continued use of the steroid prednisone during Bliss tests, make doing any clinical trials on lupus "daunting."

But Dr. Urowitz, who participated in the companies' Benlysta research, added that results from clinical trials indicate good efficacy compared to placebos in relieving some symptoms.

The president of the Lupus Foundation of America, Sandra Raymond, told the advisory committee that patients need new drugs that will improve their quality of life, and recommended Benysta's approval. The foundation, like several lupus groups that urged FDA approval, receives donations from the drug industry.

Thursday, November 11, 2010

Stats

Finish time: 5:28:15

We raised: $3,000

Money raised by Team Life Without Lupus: over $130,000!

Thanks all :)

Tuesday, November 9, 2010

J's pictures


First Avenue



Reunited with my ski jacket and my boy.

And my girls.


My awesome gloves purchased at the expo.


Celebratory cake!

Monday, November 8, 2010

Marathon part 5: Manhattan, again

I missed the Harlem choir I'd heard about. Perhaps I was out of it? Or maybe they got tired before I got there. In any case, there was a lot of music and a flock of very enthusiastic kids handing out random food. I felt bad turning it all down, but was feeling some nausea from the exertion, three Nutrigrains ingested to get me that far and a half cup of Gatorade every mile.

I was very glad to have been warned that the first sight of trees is a park, but not the park. It's Marcus Garvey, and we ran around it to continue along Fifth Avenue. We headed down Fifth Avenue, but it was all up hill. Looooooong uphill. I knew it was long; I knew I'd be tired. I knew from Saturday exactly where than 24 mile mark was and I told myself to look ten feet in front of me and not to the top of the hill. Let the hill come to me, I love you hill, come to me hill. The crowds grew again. I listened to both the roar and a blasting ipod for power. I thought, this is as tough as it gets and I'm doing it. I was fine, and the truth is that I never doubted my ability to finish (saving severe migraine, ferry breakdown or other catastrophe). Am I "digging deep" now? Even at mile 23.8 after almost two miles of hill, I wasn't and I knew I wasn't. My feet hurt and it was not that easy to keep my legs going, but there was no wall, there were no cramps, and I've done harder.

I hit 90th Street, went into the park, hit the 24 mile mark, passed the Met at the top of a hill. I realized I was making it; it was basically the end. I suddenly remembered why I was running and thought about why I didn't feel like I was "digging deep". I had dug deep just to keep myself moving when I was stuck in a never ending and undiagnosed lupus flare, when I didn't have a lot of hope that that I'd be able to physically function like a "normal" person and have the energy to have "normal" person experiences without constant pain and be happy. This just wasn't as hard; I was in control.

On the way down the hill, I passed my parents, best friends and my person. I held it together, smiled and kept it light, but burst out crying thirty seconds later. Had I not been diagnosed and lucky enough to respond well to my life-quality-saving medication, I could've missed my out-of-this world college experience and these people that will always be my second family; and a third family from law school that I thought I'd been too lucky already to find and keep (even if by gchat). I could've missed the energy  to jump into a train-distance relationship, move to Manhattan, make decisions fueled by ambition. I certainly would have missed the opportunity to see my people looking at me like they had no doubt I could run that far and my dad look at me at mile 24.5 without concern.

I pulled it together up the last hill to Central Park South. A spectator just to my left yelled "you can do it, Kate, you've got it, looking strong!" I rounded the corner and gradually picked up the pace along Central Park South. I smelled horse poop and wondered whether it really would have been that hard to clean the street for forty thousand people on their last legs. I hit Columbus circle, saw the glowing orange sun beginning to set between two buildings, and turned back into the park between a stage and some kind of metal structure with lighting equipment. I could see the mile 26 sign. I picked up the pace and people cheered louder, which I knew they would. I hit mile 26 and ran faster. They cheered louder and yelled things about a strong finish. The signs read "300 yards," "200 yards," and then I saw the finish line and the cameras. I smiled, pumped my arms harder, and sped across the line.

And burst out crying again. An old woman in a visor put the medal around my neck.

My feet hurt a lot at the end and I fell asleep at 8pm last night. Training was harder, and taking the leap to sign up was harder than that. Just going for it without knowing first that my body would cooperate was scary and not what cautious me was used to. This cause is obviously important to me, but it also ended up being an important lesson in how I should be thinking about pushing myself now, going for it without knowing it's a foregone conclusion.

So, a last thank you for contributing to the cause and encouraging me on this journey that has ended up meaning quite a lot to me.

[I'll post some pictures here as they become available so that you all can see my I'm-trying-to-look-cute/hot/tough/happy/relaxed awkward, sweaty smiles.]

Marathon part 4: Manhattan

Everyone knows that the marathon goes up First Avenue, and I knew that. Except that whenever I pictured arriving in Manhattan, in my head, we ran up Second. So, while I was excited to see the crowd I was hearing, exiting the bridge and making a left down to First Avenue just felt really wrong.

But the crowds, as promised, were terrific. They were loud and rowdy (helped, I'm sure, by the bars), reading and screaming my name like they knew me. I counted down block by block until 74th, a rising feeling of nervousness and excitment until I hit the people that actually knew me. Hugs, kisses and refusals of additional supplies. I was happy that I looked good enough that they wouldn't worry before they saw me again.

Up, up, up First Avenue to like 1,950th St.

Then another hill on a stupid little bridge, and back to people with signs!

"Welcome to the Bronx"
"Nice Legs!"
"Go Hotstuff!"
"Beer ===>"
"Your Feet Hurt Cause You're Kicking Ass"
"Who needs toenails? You have glory!"

Steel drumb band, booming something hard rock-y, and then a children's Asian drumming group in full uniform. We couldn't have been in the Bronx for more than twenty minutes to a half hour; in, a semi-circle, and back out. Then, a big hill of a bridge (I will forever notice that all bridges are hills) back to Manhattan.

Leaving the Bronx, there was more than one sign that read: "Run like you stole something."

Marathon part 3: Queens

"Brooklyn Believes in YOU!" turned to "Queens Welcomes You!"

The Pulaski Bridge sucks. It's steep and the surroundings are 'eh'. We ran in a semi circle, I think, through some boring buildings in Queens, which felt annoyingly indirect and, compared to much of the course, unremarkable. But then I saw a beautiful sight, Scandals, my favorite strip club. Why? Location, location, location. I knew it meant I was approaching the onramp to the Queensboro Bridge. Everyone complains about it and a great many people walk up it (because it's a hill, but mostly, I think, because nobody is there to see), but I have never thought the Queensboro was that bad. Running to Manhattan and my waiting people made it mentally easier to stay running, and I took out the ipod for the first time. The song, "Wanna Be," was perfect for meeting my lover with my spice girl friends.

Approaching the end of the bridge, we could hear a loud roar.

[Next up: Manhattan]

Marathon part 2: Brooklyn

Saw the first friendly friend face shortly after mile ten after scanning the crowd wildly along the right side for some seriously blonde hair. Big hugs and company for a minute's walk, and I was back on my way, feeling less alone among strangers. And then far less alone a couple blocks later as I found what I was looking for, a college friend in one of the bands along the route. I realized it after I passed, so I turned around, ran back to him and screamed his name while jumping up and down and waving my arms until his bandmate pointed at me to get his attention. He raised his eyebrows and smiled, I smiled and continued along quite pleased with my scouting.

And then I only got cooler and more suave when I hit the most dead boring part of Brooklyn, Hasidic Williamsburg. There are blocks of no cheering at all. Minimal eye contact. It was as though nobody on the sidewalks and stoops noticed that forty-something-thousand strangers were rushing past the house. And then, thinking that one guy out of a bunch taking pictures was my cousin, I screamed his name to get his attention, poking my head in front of his so that he'd see my face, it would all register and we'd have a nice moment-- a repeat of greeting the band. Only, this was not actually anyone I knew. I suddenly became very grateful that what I was supposed to do in that moment was turn back and run away-- quickly.

And so I ran and ran and ran and was still in Brooklyn. The hills of Brooklyn. Nobody told me there were hills in Brooklyn! At least the crowds became fun again, the bands came closer together and the signs were funny. That reminds me-- my favorite sign on the back of a Chilean who was tired of being asked: "I am NOT the Chilean Miner!" Second favorite (because it made me laugh when I needed it) was on the back of an eighty something year-old, listing his birth year, age, marathons run, and then saying "What I lack in speed I make up for in endurance. Ask my wife."

A minute of video from the Team Life Without Lupus cheer squad in Brooklyn: http://www.facebook.com/video/video.php?v=458050809175 (you can see me in the still before the video starts in the white visor and then running by soon after it starts)

[Next up: Queens]

Marathon part 1

I felt most like an Olympian in my start village. A large video screen and booming voice gave directions in four or five different languages, which means that most of the time I didn't understand them. I picked up my second bagel of the day, coffee and water, and hung around for a couple hours on curbs, the grass, or up against a tree. Pretty sure everyone but me was shivering; it was a town of goosebumps and arm rubbing. I wore two pairs of pants, long sleeve shirt, singlet, windbreaker, hooded sweatshirt and a ski jacket. I did not look the part of a svelt distance runner, but that ski jacket was my best move of the day.

Our village was right along the start of the bridge, so I got to see the elite men start in the first wave (or at least their upper bodies). They seemed to be gliding and were moving fast enough that it looked as though they were all on motorcycles. There was enough to look at people to talk to that time to my start kind of flew by. Eventually we all crowded into pens at the base of the bridge, the cannon went off and New York, New York began to play. I looked behind me for the one and only time in 26.2 miles. There were very few people; I was starting from the back.

Ascending the bridge, I looked down to Fort Wadsworth. Above the empty villages full of paper cups and discarded sweats were security teams along the perimeter of each roof. I looked back in front of me to the slow moving traffic and continued a very leisurely uphill jog. I took the extra time to thoroughly warm up rather than risk pulling something so early in the day.

Brooklyn was the best and worst of the race. Parts were incredibly lively, fully of bands and cheering residents with funny, colorful signs. I got a marriage proposal from a very enthusiastic stranger and three more asked for my number. So it was in Brooklyn that I decided I must look pretty cute in my orange and bright blue ensemble and started trying to hit the right spots for the event camera men.

I spelled my name out in giant block letters on the front and back of my singlet, but it still took quite a while to get used to strangers cheering me on by name.  I loved the support and the energy, the back and forth with the crowds and high fives, but it certainly confirmed that I would never want to be super famous.


The miles went pretty quickly between the bridge and mile ten, where my first friends were waiting.

[MORE LATER-- would like to get the whole day down, but I've got to start catching up on work too!]

Saturday, November 6, 2010

Last run

Horrible migraines yesterday, but hopefully now that whole head mess is behind me.

Last run this morning, a sloooow jog into the park and back, just long enough to warm my legs and get feel fluid. I had to remind myself to stop grinning so that the tensing of facial muscles wouldn't restart the migraines. I was smiling at anyone in running shoes, some of whom must have shared my excitement, others of whom just saw a smiling idiot this morning.

I hope to feel as happy next time I see this banner.

Thursday, November 4, 2010

What a difference a decade makes

At 16, my biggest question in life was will this ever get better?

Will I ever be able to quickly get out of bed, into the shower, squeeze the shampoo bottle, get my arms through stiff coat sleeves, pry open the fridge door, grab a gallon of milk with one hand and walk down the front steps without feeling overwhelmed by pain, stiffness and exhaustion? Will I know for sure that when I sit down for class, I'll be able to get up with no one the wiser?

I'm incredibly lucky that I have had excellent medical care and responded dramatically to existing medication. Team Life Without Lupus is fundraising for life-changing medical care for those who cannot afford it, and for research into treatments and cures for the disease, which continues to affect all of us (even those who can keep their legs going for 26.2 miles).

The $2,418.92 we've raised so far, part of the $100,000 raised by Team Life Without Lupus, will fund these medical care and cutting edge research programs of the S.L.E. Lupus Foundation.

One last call- if you were planning to donate but haven't done it yet, now is the time. https://www.firstgiving.com/katemagaram

And for those of you who are planning to come out and see the Marathon (I'd love to see you!), here's a map and information on athlete tracking:

Runner Tracker

Interactive Course Map

Thank you all for your generous support (financial and emotional) and encouragement, and for humoring me through all the marathon talk and lame bedtimes. I'm not sure how to say a big enough thank you to the people who have been supporting me for years, cutting me slack and much needed breaks, and supporting my decisions in taking calculated risks to live life as I want to live it despite lupus. My 16 year old self would not have believed I could be here in a decade.

Wednesday, November 3, 2010

Newark

Booked a hotel in Newark now for Saturday night. The ride should be half an hour shorter than from my apartment, and this way we eliminate a few more unknowns between me and the start (such as a Holland Tunnel problem, of which I have seen many).

For those of you planning to travel anywhere ever, you might want to think twice about booking something at a Crown Plaza hotel if, say, you'd like to show up to an available room. The steam has only stopped shooting from my ears because it's in my best interest to calm down a few dozen notches. Karma, karma, karma...

My calm self has been looking out my office window, thinking how far away the Verrazano Bridge looks to be from here, then reassuring myself that it's really not that far compared to downtown. Then I realized that I'm looking at one of the bridges to Brooklyn and the bridge to Staten Island is waaaay down from there. Yikes. Too far, too far..... I keep thinking that I shouldn't have cheated on my distance runs because now I'm not prepared enough. Of course, I ran until my GPS watch said 20.0 mi, so intellectually I'm pretty sure I followed the program. This is pretty much how all the conversations are going in my head. And in my apartment. Thanks for listening, dude.

Tuesday, November 2, 2010

Hell hath no fury...

... like a woman who, while checking for the third time, just found out her pre-marathon twice-confirmed hotel reservation is suddenly worthless because the hotel is CLOSED.

Pro tip: stay out of my zip code today.

Monday, November 1, 2010

A break from me-related minutiae

Chilean miner running!

Halloween candy is carbs, right?

Right? Right? Simple carbohydrates, sugar, salt... stress relief.

Dedicated enough a marathoner-to-be that I've got a big bowl of goodness on my nightstand to go home to.

Working Girl

To work today, I wore a black dress, herringbone grey blazer, and my New Balance running shoes. Switched to appropriate flats upon arrival, but still felt like as stylish as an 80s Melanie Griffith for twenty blocks.

The name of the game at this point is staying comfortable, avoiding all injuries, and keeping stress below atmospheric levels.

I've had the same type of dreams as before the SAT, LSAT and the Bar. Someone who has to drive me to the start is not listening to me and taking ridiculous detours as time ticks away and I just know I'm going to miss the start. I realize that I'm wearing one correct running shoe and one random old one. I forget my map and get lost on the course. I'm lost on Staten Island and can't find the start-- or I'm late and have to run a long distance to even get to the start. I'm starving and have brought no food. I eat peanut butter and there's nothing to drink at the water stations. My alarm doesn't go off and the hotel wake up call doesn't wake me. Someone takes too long to get dressed and can't drive me to the start. The reserved rental car has been stolen.

I suppose the good news is that there is no standardized test on Sunday. Guess I don't have to worry about last night's dream of forgetting sharpened pencils to fill in the bubbles.