Thursday, April 30, 2009
I got called twice and seated for neither jury.
The first case involved a young woman accused of shop lifting from Wal-mart and trespassing after warning. Although I agreed that I could be open minded and fair about the case, I pretty much could see the word "GUILTY" written across her forehead. She had all kinds of *attitude* when presenting herself to the jury and did a lot of eye-rolling and arm crossing which just gave off a "whatevah" kind of vibe.
When the lawyer for the defense stood to perform the voir dire, he asked us as a group if anyone owns a business. I told him I used to. He asked what kind. I said "a print shop here in town".
He said "would being a business owner make you more prejudicial in deciding a case where a business had been the victim?"
I said "No. I am equally against someone stealing from my workplace OR my home."
I saw his pen fly out and flick off a check mark... apparently next to my name.
That was the very first case. We waited around all day, reading books, talking, napping, etc. while other names were called and people came and went on their way to other courtrooms to be picked or rejected.
Wednesday, April 29, 2009
Basel, April 29, 2009 - New Phase III results presented at the American Academy of Neurology (AAN) congress show that 80-83% of patients taking FTY720 (fingolimod)*, an investigational oral compound for relapsing-remitting multiple sclerosis, remained free of relapses during the one-year study compared to 69% of those on interferon beta-1a, an established standard of care (p<0.001).
These data reinforce previous results from the TRANSFORMS study announced in December 2008 showing that the relapse rate at one year was 52% lower in patients taking FTY720 0.5 mg than with interferon beta-1a, or Avonex®** (0.16 vs. 0.33 respectively). The relapse rate with FTY720 1.25 mg was 38% lower than with interferon beta-1a (0.20 vs. 0.33, both p<0.001).>
"TRANSFORMS is the first Phase III clinical trial to show that oral fingolimod may provide patients with an alternative choice to currently available medications for treating relapsing-remitting multiple sclerosis," said Jeffrey Cohen, MD, lead investigator of the TRANSFORMS study and staff physician at the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment and Research in Cleveland, Ohio, USA.
Also presented at AAN were longer-term results from an ongoing open-label Phase II extension study (n=155). This showed continued low relapse rates after four years of treatment with FTY720, with no significant change in the safety profile from three to four years.
In TRANSFORMS, FTY720 was generally well-tolerated with 87% of FTY720 patients completing the study on treatment. The most commonly reported adverse events, seen in more than 10% of patients in all three study arms, were headache, nasopharyngitis and fatigue. Adverse events seen in FTY720-treated patients in TRANSFORMS included transient reductions in heart rate at the start of treatment, small increases in blood pressure on average, elevations in liver enzymes (also seen with interferon beta-1a), and a small number of cases of macular edema. In terms of serious adverse events, infections, bradycardia and atrioventricular block, malignancies and dyspnea were reported in less than 2% of FTY720-treated patients. Following the preliminary release of data in December 2008, a patient who had discontinued FTY720 treatment in August 2008 died from aspiration pneumonia related to a progressive neurological condition in February 2009. The exact nature of the underlying diagnosis is unclear, but viral testing has proved negative, including testing for progressive multifocal leukoencephalopathy (PML). A role for FTY720 could neither be confirmed nor excluded. In general, the safety profile of the FTY720 0.5 mg dose appeared to be better than that of the 1.25 mg dose.
Read the rest, including disclaimers, etc. [click here].
Tuesday, April 28, 2009
Ted, our *mutual friend* had been murdered.
We had wondered why he hadn't been around in the past 6 months, but Ted's like that. He's an aging hippy that always has something going on, some new scheme to try and make money without actually working. Mostly it was selling collectible car parts on ebay and buying/selling property. He seemed to do well at both and spent his time however he saw fit.
To think he has been murdered and I'll never see his bearded grin show up at my sliding glass door again (which he knew ticked me off as I prefer to have visitors come to the front door and not scare the crap out of me), well it just leaves me really sad.
And thinking about how nothing we can do will stop the inevitible from becoming the Present. At some point, and the day will come, we will each face our mortality.
I can picture Ted standing here having this very conversation with me and giving me his philosophy on what comes after... I just can't believe he is gone.
Like dandelion seeds scattered by the wind, he is no more. And while we weren't the best of friends (and I often found myself ticked off at him for pushing my buttons which greatly amused him), I do miss him and now feel so vulnerable to the fragility of life itself.
And it was so pointless and preventable that it pisses me off that it happened at all.
He went to argue with someone he's had a long-standing feud with. I vaguely remember him recounting tales of why the two families (much like the famed Hatfields and McCoys) didn't get along.
But that was back in western NY state and altho he makes frequent trips between FL and NY to get car parts to sell on ebay, I thought the feud was all in the past.
Apparently it wasn't.
Ted went to the guy's house and fought with him in the driveway. When the guy ran into his house, Ted followed full of rage. The man ran to his bedroom and locked the door behind him. Ted, unarmed but angry, stood outside the door yelling at him to come out and banging on the door.
The man in the bedroom had a shotgun.
One blast through the door and Ted, who only had words as a weapon, lay dying on the floor.
The man who shot him calmly called 911 after bystanders to the incident tried unsuccessfully to administer CPR, and reported that he needed the cops to come because he had just killed a man.
And with that, Ted's laughter, wise-ass comments, eagerness to lend you a hand, and gentle friendship was extinguished forever.
I just can't picture him as the "aggressor" in a confrontational situation, but everyone has lost their temper before. Now I wish I had paid more attention to the stories of why they had a beef to settle. Then maybe I could see why Ted had become so angry and chased the guy right into his home.
In NY state, you can shoot to kill if you are in fear for your life. The grand jury decided that is just what this guy did and that he had every right to. Never mind the long standing feud, or the fact that Ted was unarmed. He made a poor judgment call to visit this guy... and paid for it with his life. My guess is that no matter what the problem was, Ted wouldn't have thought it worth losing his life over. Nor taking one.
Can you picture a hippy all laid back and grinning with his long hair, beard, faded, ripped t-shirt, holey jeans and tennis shoes held together by duct tape doing such a thing? I can't.
Death is a slap in the face. Death is ugly. Death is unfair. And death keeps stealing my friends.
I feel like it's circling me.
The worst part about all of this??
The indignity that I can't find a single obituary or eulogy to Ted. The newspaper story just has him as the victim of an incident. It didn't even humanize him. It was all about the other guy.
Now that I've read that and seen the outcome of a story about a person I knew pretty well, it makes me wonder about our whole justice system. True, I wasn't there and Ted could have been menacing and maybe scared the other person bad enough to use deadly force...
Or maybe the guy set him up, running right to his gun and figuring he'd end it once and for all. A trap that he knew he'd get out of by playing the self defense card. Finally winning the feud once and for all.
But the fact that he's gone and life goes on and it seems just like he never existed... that creeps me out and pisses me off. Something ought to have changed because of his having been here, and there should be some kind of hole -- other than the one in my psyche -- that is left by his absence.
Not one line in the local paper.
Just a For Sale sign in front of his house.
So, that's why I'm writing this. Something needs to be out there somewhere to say goodbye to Ted.
We loved you (sorta, ya big lug) and will miss you.
We'll miss you showing up in God knows what kind of new clunker you got for a song so you can rev it up in the driveway and ask the old man what he thinks that noise might be.
I'll miss looking casually over to the back door and jumping out of my skin because you freaked me out by standing unannounced on my back patio.
I'll miss the way you kept trying to talk me into helping you with your real estate ventures, and trying to get me to make that website for your car parts.
I'll miss how you knew it all, or thought you did.
I'll miss how you told such wacked out stories that we never believed you once you had some Jack Daniels in you.
Guess maybe we should have paid more attention.
I'll remember your wave as you left on your trip to NY. "See ya!" you yelled.
In heaven, Ted.
Monday, April 20, 2009
Today I have to report to the courthouse at 9 am, paper in hand. First off, I can't believe they would send me a piece of paper a month in advance and tell me that I had to bring it to court. If I so much as open the electric bill and set it down I can't find it 10 minutes later. I have spent a solid month stressing over making sure I'm constantly aware of where that paper from court is at all times.
I pinned it to my cork board, but I so rarely do something like that that I worried I wouldn't think to look there. Then I put it on top of the stack of stuff in front of my computer but fretted that it would be buried in the chronological order of stuff that piles up there. Then I folded it up and stuck it in my purse.
I rarely, if ever, carry a purse. I'm a license in my back pocket, money in the front kinda gal. I don't carry around makeup because I don't wear it, and all that other junk that women tend to haul around just seems better left at home to me.
But I figured if I put it in my purse, and then trained myself to use the purse that by the time I went to court I would have the whole dilemma solved. So I've been carrying around this little canvas satchel for a month now. Well, not always carrying it around because there have been 3 times I had to return home for it because all my money now resides there and the grocery store no longer takes wampum. Besides, I wasn't totally sure what "wampum" was and didn't want to seem ignorant at the checkout when trying to pay with parking lot scrapings.
So, now I am trained, partly, to carry a purse. The letter is neatly folded in the purse. My bifocals and car keys and license and money are also in the purse so as to remind me that I need to strap on the canvas satchel before leaving the house. Thus I will "remember" the letter because I can't possibly leave without it.
I tried all this with the corkboard first, but that was awkward to carry around.
Anyhow, all joking aside, while I am more than ready to do my civic duty and serve my community by screaming out "hang the bastard!", I am more terrified of this than I am about having an MRI.
Maybe because I have had that "conditioning" treatment when you are faced with your fear repeatedly in order to overcome it. (Not out of choice, but I've had a few more than normal due to this clinical trial).
The thought of standing before a room full of people and having to recount any mundane details of my life has me locked in fear. I once tried to get a permit for a conditional use for my home so that I could operate my print shop out of the garage. I had to speak before the city board and the general public gathered there. When I spoke it sounded more like a croaking frog chomping down on a squealing mouse. My words came in grunts and squeaks.
It was then I realized I'm no public speaker.
So today, if my attempt to play the MS card and get out of all this stress inducing circus fails me, I will at least have an opportunity to face my fear of public speaking and hopefully overcome in with a minimal amount of embarrassment and a semi-human speaking voice.
If I can just get past the "it's all about me" part, then jurors get to sit back and shut up. The worst part will be over. And I have learned to sleep sitting up, so I'm good to go. :-) (you know I'm kidding, don't ya?)
If I get picked for some juicy trial I'll blog about it after it's all over. I've been looking for something to talk about anyhow.
wish me luck (croak).
Thursday, April 16, 2009
I don't so much care for this news that broke yesterday on Reuter's:
Patient on Novartis’ MS Drug FTY720 Gets Hemorrhaging Focal Encephalitis
April 14, 2009
Novartis (NVS) is reporting that one of its shining star drugs in development may be in trouble. Doctors in the trial for FTY720, also known as Fingolimod, have reported a case of hemorrhaging focal encephalitis in one patient. The company said the patient concerned was recruited into the study seven months before hospital admission for the reported event, before which no new disease activity had occurred.
Eric Althoff from Novartis commented on the scenario:
“As per normal procedures, this particular case was communicated in a timely fashion to health authorities and study investigators. It is difficult to interpret an isolated case report without the benefit of the full Phase III data set. At this stage, a relationship with FTY720 can neither be excluded nor confirmed.”
FTY720 works as an immunosuppressant, causing lymphopenia by preventing lymphocytes from leaving lymph nodes. The drug has already demonstrated superiority over Biogen’s Avonex and is currently in an ex-US Phase 3 study called FREEDOMS I. The trial is comparing two doses of the drug vs placebo in 1,272 MS patients.
The drug is a potential star because it is given orally (all MS drugs on the market are injection) and has already demonstrated superior efficacy over Avonex. The main concern is safety, safety and safety. Up until now, the known safety issues had been transient heart rate reductions, elevated liver enzymes, skin cancer, infections (there have already been two fatal viral infections) and minor increases in blood pressure. This is the first serious brain inflammation case in the trial which would put concerns about the drug’s safety right up there with Tysabri.
The safety issue might be a positive for Merck’s cladribine which is in a race with NVS to become the first oral MS therapy. Cladribine also had some issues earlier this year when the company reported four patients had died of cancer.*********************************
It's weird. Even though I'm a full-fledged, professional, card-carrying Hypochodriac, the news of the bleeding brain infection (as far as I can figure, that's what Hemmorhaging Focal Encephalitis means) does not stun me into a frozen state of panic whereby I am unable to ingest my daily pill.
On the contrary, I get up and yawn and stretch with eyes still half closed (regardless that it's the crack of 9a.m.) and slug my little capsule down with a swig of decaf. Oblivious to any idea that should be swelling up in my subconscious that my brain may get infected and bleed.
I just can't seem to muster the fear. I guess it's because I tell myself that when complications like this arise, I don't know the full back story and the poor person that had these complications obviously was not well by definition since we all (in these clinical trials) have a MS diagnosis. I feel like since I quit smoking, started eating better and got on this trial, my MS has been whipped into submission and I'm actually quite healthy.
That reminds me of the one time I saw an eye doctor in the study. I forget how it came up, but I replied to whatever the question was with : "other than having MS I'm healthy as a horse."
He just stared at me before bursting out laughing. I, at first, couldn't see the humor, but I guess to someone who doesn't HAVE MS, the diagnosis must seem like the ultimate branding of Incurable Illness. I tend to see it as an annoyance and a Life Obstacle. We all have them. Mine just happens to be MS. That doesn't mean I can't be *otherwise healthy*.
So, while this isn't the greatest news for the clinical trial, I'm not personally freaking out or losing sleep or pausing before tossing back my pill.
Read the packaging insert that comes with your aspirin. Even that stuff can cause death. Everything in life is a gamble. And I'm all in on this hand.
Fingolimod is an oral agent that is now being researched in three Phase III trials. This is the first of a new class of potential MS medications known as "S1P receptor agonists," which work by keeping certain immune cells out of circulation. It does not kill immune cells, but rather "locks" them up in the spleen and lymph nodes, which means that if patients stop the medication, their immune system will be back to normal within a week. The recently reported results of one phase III clinical trial of Fingolimod, TRANSFORMS, has shown that Fingolimod is more effective than interferon beta-1a (Avonex), which is currently a standard of care in the treatment of MS.FYI, I am in the extension phase of the TRANSFORMS trial mentioned above.
The study calculated the annualized relapse rate at one year in patients given one of two varying doses of Fingolimod or an injection of interferon beta-1a. Patients given Fingolimod 0.5 mg exhibited a 52% reduction in relapse compared to those given interferon beta-1a. Those given Fingolimod 1.25 mg also showed a significant reduction in relapses (38%) compared to interferon beta-1a. Both doses met their primary outcome measure – a measurement that is required by the FDA to determine the effectiveness of each study drug – and there was no statistically significant difference seen between the two doses, meaning that the higher dose did not seem to provide greater benefit than the lower dose.
The safety profile of the therapy seen in TRANSFORMS was in line with previous clinical studies. The compound was generally well-tolerated and side-effects included fatigue and headache. However, like with all study drugs there are potential risks. Fingolimod does affect other organs, including the heart, liver and eyes. The therapy suppresses the immune system and there are concerns about the development of potentially serious infections and certain types of cancer, such as skin cancer. There were 7 cases of localized skin cancer lesions seen in the TRANSFORMS study, all of which were successfully removed. The benefit to risk factor of Fingolimod is still being researched and further study on the safety profile needs to be done; more detailed information will likely be released sometime this year.
TRANSFORMS is the first of three clinical trials of Fingolimod. The three different studies collectively will involve more than 3,400 patients from around the world. The two other trials, FREEDOMS and FREEDOMS II, which are both two-year placebo-controlled studies, are underway and results are expected later this year. Novartis, the company that manufactures Fingolimod, expects to send the drug to the FDA for approval at the end of 2009. It is currently unavailable outside of clinical trials.
Sounds like good news, eh?
Tuesday, April 14, 2009
I had spent 10 days non-stop coughing. Day and night. I had almost developed 6-pack abs from all the effort, but that was the only redeeming factor in the plight that had seemed destined to become a way of life.
I'm one of these people who believe that "this too shall pass" and tend to wait out things like head colds hoping to rough it through the tough spots. But after 10 days of no sleep and barely being able to take a breath due to the coughing fit that inevitably resulted, I finally relented, suspecting an infection. Head colds don't last 10 days.
Doc saw me, listened to my chest and back, and told me it was Allergic Rhinitis which had become a sinus infection. Coughing was brought about by post nasal drip. (ewww)
I got a 5 day course of Zithromax and a script for some allergy meds, but I opted to take Benadryl instead since I know how that makes me feel. (I'm skeert to take any new meds that might make me feel dopy[er] so I usually tough it out with nothing).
But I tell you what... no cough drop or cough syrup touched my cough in all that time, yet 15 min after I took a half of my kid's melt in your mouth Benadryl strip (a quarter dose for someone my size/age) I was breathing free and my lungs could relax a little. Now 5 days after beginning the antibiotics I am back to being perfectly normal (as a oddball like me can be).
I guess this means I now have Seasonal Allergies? Nobody mentioned it, but what else could it be?
I can't believe it's been this long since I posted anything (sorry) but honestly, my life has become quite boring and Fingolimod isn't making any news.
Don't get me wrong, I'm not taking the fact that I haven't relapsed yet lightly. I still marvel on a daily basis that my body is acting normally and not shorting out.
OMG I just realized it has been TWO YEARS this month since my last relapse!!! Woohoo!! I mentioned it somewhere the other day that I hadn't relapsed in 20 months but it was definitely April of 07, so that means 24 mos. a.k.a. 2 YEARS! It's the longest I have gone since diagnosis. For real. wow.
No news is good news and you can't get much better than that. :-)