Critical Information about FDA Approval of Benlysta for Lupus

I am just adding this information about the FDA and the pending approval of a one of its kind, very first Lupus Medication Benlysta. I have been following the clinical trials and all of the information about it now for at least 3 years, awaiting the day it is formally approved and I can have my first infusion hopefully. If any of you are Lupus victims, know someone with Lupus, or just are an advocate voice, here is a portion of the newsletter I get from Lupus.org. It contains an email address where you can email your thoughts, comments and encouragement to one of the FDA members that will have some weight about getting the medication approved. Thanks so much for all of your incredible support for myself and so many others...

Here is the article:

Here is a portion of the newsletter I get from Lupus.org. It has the email address of one of the women at the FDA who will have something to do
with Benlysta, the brand new Lupus medication, first ever of its kind,
FDA approved by Dec 9th 2010!! Please send her a brief email of your
hopes and feelings about getting this approved. :)

Food and Drug Administration to Hold Hearing on BENLYSTA®

On November 16, 2010, the Food and Drug Administration (FDA) will hold a hearing to discuss the application to approve BENLYSTA® (belimumab) as a
treatment to reduce disease activity ...in adults with active, autoantibody-positive lupus.

If approved, BENLYSTA® will be the first drug to be specifically developed
for lupus and the first new treatment for lupus in more than 50 years.

While BENLYSTA® may not be appropriate for all people with lupus, having a
new approved treatment for lupus would be a significant step forward and
would provide a pathway for future approval of the arsenal of therapies
required to manage a disease as diverse and complex as lupus.

Make your voice heard! It is important for the FDA Committee to have a clear
understanding of the diversity of the disease and how it impacts people
with lupus and their families. You can help by sharing your story about
why new treatments are needed and the hope for new treatments in the
future.

Email your short statement to Yvette Waples at the FDA, Yvette.waples@fda.hhs.gov by November 1, 2010.

Saturday's Winding Thoughts

This past week was more than hectic. Between the two of us, we had 3 visits to do tests and doctors visits in Dallas, and then a new doctor for Jim here in Ennis. In the middle of all of those, we had news that I am losing my insurance at the end of the year, our car acted up, I spent hours on the phone getting the insurance company, the doctor’s offices, and our pharmacy to do their jobs. We actually got our rugs cleaned yesterday, even while dealing with both of us in pain, and being worn out from the previous 4 days of being so busy. I was thrilled to see Saturday morning roll around for a change.
If I told the entire story of how many phone calls I made this week to the insurance company, to doctors offices, and the pharmacy, you would probably not believe me.
I think the one thing I got out of all of it, is that I spent MY TIME doing THEIR JOBS! That is what I just don’t get. All of us spend our hard earned money to pay for services, yet why is it we have to stay on top of people to make sure things get done correctly. If I had caused some of the issues I had this week when I was working, I would have lost my job for sure. I was flat LIED TO by one doctors office in Dallas. They claimed to have spoken to my insurance company, and that my insurance told them they would NOT pay for a very expensive evaluation that the INSURANCE COMPANY requires before I can have the pain pump surgery. I guess they thought they would collect almost 300.00 from ME, and I would not check up on them. I made a call that afternoon to my insurance company who first of all said they NEVER TALKED to anyone from that doctors office, and secondly, that visit WAS COVERED! Sure enough (as they HOLD MY FUNDS UNTIL INSURANCE PAYS), that visit will be paid for by the ins. company, all but my small co-pay! I have to wonder if they do that knowing the insurance does not pay all that well, so they tell certain patients that collecting cash from the patients knowing they must have that test first, before the can proceed.
That was just one instance, not including the other several things like another doctors office not faxing what the insurance needed about a new medication that I needed approval on... that the pharmacy first messed up by not sending the form to the doctor. Then the doctors office in spite of several phone calls from myself and my insurance did not fax over what the insurance company needed in order to approve the medication. And I have been waiting now for almost 4 weeks and it still is NOT approved.
Then another physician has a new nurse, that has been at the office long enough to know 3 of my medications come from a specialist pharmacy in Dallas. The doctor has to approve the medications, the pharmacy has to pick those up, then process them, and then MAIL them to me here in Ennis. Yet, the past two months I have had to make 2 follow up calls to remind the nurse that I am in Ennis, and she needs to do her part a couple of days earlier than some, because of them having to mail them. She messed up last month and we had to make a rush trip to North Dallas to pick my medications up because I would be out before they could get them to me. I have been seeing this doctor now for 4 years, and I have been getting my medications the same way all that time. Yet, I still have to make follow up calls in order to get my meds on time.
Then Thursday we both had visits in Dallas. Jim’s was first and we were told it might take over an hour to do all of the paperwork. So, we scheduled my MRI/arthrogram, which was in East Dallas, and his appointment was in West Dallas, several hours later, so we would not conflict with mine. Well, his paperwork only took about 30 minutes, and we had 3 hours or more to spend, waiting on mine. Well, we went ahead thinking maybe they might get me in early, and they could on the arthrogram, but not the MRI, which had to be done within about 30 minutes or so from the contrast being put in my shoulder. Thus luckily it was a beautiful day, so we spent a couple of hours just sitting in the sun, reading and resting in the parking lot of the hospital. The MRI actually ran late due to the patient in front of me, so it was at least 2:30 before they got me in (I had been told it would be at 1:30)... but we managed to get out of Dallas just before rush hour got really bad. We were totally exhausted by that time, but got home safe. Our car overheated on Jim Wednesday afternoon. We thought it was a broken radiator hose or the thermostat stuck wide open. But, hopefully it was just because of it being such a small radiator, it was a little bit low of water and antifreeze, so it just needed more of those. So far around town it did not overheat on us, but would did not want to chance it in traffic in Dallas, so we took my Mom’s car instead. Jim’s not sure about his new doctor. I went with him and can relate. The doctor changed his medication, to something Jim had never had, but did NOT explain anything to him, like it would take 3 to 5 days before it built up enough to work. He also did not tell him some of the bad and adverse side effects. Things that any physician, especially a new one, giving out a new medication that has some potentially adverse side effects, should tell every patient. So, as far as a doctor, he seems to be good, but he has no communication skills with patients.
The good thing is that I am a step closer to finding out whether I do have another tear or more tears in the rotator cuff in my shoulder, plus arthritis bad enough that I need a shoulder replacement (I know that does not sound good really, but I want to know for sure what the problem is), plus I am now going to be where I can have the “trial” for the pain pump. Once I have that trial time, and it works, then I can have the surgery, which from everything I have heard from all of my physicians, along with all I have heard from patients, and online, I will be much more less in pain, with much less medication with the pain pump. So, even though it entails a major surgery, the end result is a very positive thing for me. The issue for me is that my chronic pain is from Lupus, degenerative joint disease, degenerative disc disease, & other issues, such as probably Rheumatoid Arthritis. Thus, even replacing the shoulder, and all of the surgeries I have already had does not stop the pain. There is nothing they can actually “fix” that can stop all of it. They can stop the shoulder pain by a replacement, but my body will still hurt, first due to the Lupus. My other joints like toes, feet, ankles, wrists, fingers, hands, etc. still will give me fits. So will my neck, etc.... thus a pain pump for me is the answer. Hard to accept for sure, but I totally understand why.

In between all of the above, I also spent several hours online researching a new health insurance policy to begin on January 1. The issue with that is I have to try and make sure all of my doctors take it, and all of my medications are covered. Not an easy task, but it seems I may have found one. I need to verify for sure my doctors are going to take it, along with also making sure they are going to cover my medications, but the indication online initially makes me think this one make work out. ☺ A very good thing, since I have several specialists, and quite a few medications.

I could moan, groan and fuss. Believe me I was not a very happy camper at times due to those that are supposed to do their jobs, seemingly not doing them. Yet, it seems that I am definitely not the only one. There are many, many people out there going through the very same as myself, and some much worse.

Yes, the pain is bad. Yes, fighting with insurance, pharmacies and doctors offices is frustrating. Yes, having to go to Dallas more than once a week here lately is an exhausting situation.

But, I have to accept that is a part of my life. Even though I don’t know why I am dealing with the physical realms of these chronic illnesses... only to think it opens doors for me to tell others my story. It opens doors to new places and people online. So, there is a reason for it all.

When we are in a rough patch, it seems it is never ending. Yet, the good times in life always prevail. Once the rough patch is over, what comes next is life at its finest. ☺

Again, I will make two trips to Dallas next week. I soon face that trial couple of days for the pain pump. Then I will spend time again in surgery and recovering, but in the hopes that the results will be very good.

I take one step at a time, one or two feet up that mountain, never looking down, always looking up at where the peak it, and the light shines above....

Extremely Important to take Action - Pain Medications & FDA Meeting on October 8th

http://www.painfoundation.org/take-action/natl-efforts/rems/

 This is EXTREMELY IMPORTANT! The meeting about Pain Medication and A Chronic Pain Patient Bill of Rights will be put through the FDA on October 8th! All of our letters need to go into them before this important meeting. The URL will take you to the American Pain Foundation page that tells you exactly what steps to take. All of us patients, family, spouses, caretakers, doctors, and all please take time to you your letters in. :)

Can't use a proper medical term, VAGINA, on a video online or on TV?? CBS is nuts!

Talk about double standards! A dear friend of mine online, who is a OB/GYN and has written a book for women, has just began her new book tour. Lissa Rankin is a well known, intelligent, and just amazing woman, that has a website called "Owning Pink". Her website is just incredible, and women of all ages would greatly benefit from her information there, as well as all of the awesome women who have joined forces there with her.

On her book tour, she was asked by a head person at CBS to do a video spot about her book and the tour. There had already been another video done by a guy and the title of the video is "15 Crazy Things About Sperm" Here is the URL: http://www.cbsnews.com/2300-204_162-10004933.html.

It seems it is perfectly okay to use the term "sperm", or other related words, such as "Penis", "erectile dysfunction" which we see and hear all the time on commercials, but the word "Vagina" was said by another CBS person to be too "racy" for them to put up Lissa's video on their website which is: "15 Curious Things You May Not Know About the Vagina". Now tell me, why is it perfectly fine to use the term sperm, and not Vagina, when it is not slang, it is a medical term, and she in fact is an OB/GYN??!! It is pure sexist as far as I am concerned and women should be outraged everywhere. In fact men should be outraged. It is purely stupid. They can show bloody, horrible violence all over the internet and on TV. It is fine to show half naked women in movies for TV, and advertise medications for Erectile Dyfunction, even as far as saying "Be ready at any time", plus Jimmy Johnson advertising pills and there is even a RACE CAR for "Extendize", but the word Vagina is taboo? This is NOT the stone ages. This is NOT some slang term, and besides it is a video on CBS news on line not in some prime time slot on TV, which should not make a difference at all. Here is a post from Lissa Rankin, where you can read the entire story, and decide for yourself. But this is plain sexist, and I hope all of you stand up and be counted for. After all, all women have them, and there is NO good reason not to use this term.


http://www.owningpink.com/blogs/owning-pink/sperm-trumps-vagina-wtf#comment-8092

Lissa Rankin "New Book Tour" "What's Up Down There?"

There is an incredible woman who is now an OB/GYN that is just a blessing to all who get to know her. She has just began her book tour, for her new book "What's Up Down There?" Lissa is a down to Earth, intelligent lady, that gives us, as women, hope, encouragement, answers, and praise, when we need it the most. Her site and blog, "Owning Pink" is also incredible. There are so many wonderful ladies who are members, that care about one another, and encourage one another to do more, to be more, to live your dreams out, no matter what those dreams might be. After getting to know Lissa, and several more of the women there, I have just totally been inspired to write more on my book. :) When things seem the bleakest in our lives, whether it stems from stress, family, children, spouses, jobs, home, school, illness, or the other 1 million and one things women do to make everyone elses' life better, we often forget that we truly need to be taking care of "us" first. Women as a whole tend to put their own needs on the back burner, so that our children, our parents, our spouses, our friends, jobs, and much more are enlightened and happy.
Then we come to a place that we start to feel "burned out", "spent" and used up. At that time is when we grow into a place of darkness, and we begin to try and find out why we feel so completely useless, when it seems all we do, is be "useful" for all that are around us.

As women, sometimes we just do not "see" our own needs. We tend to think that the more we do for others, the better we will feel about ourselves. Yet, without tending to our own bodies, minds, souls, and spirits, we are spiraling downward, using up all of our energy on others, and giving to ourselves nothing. Sooner or later we often find ourselves fighting illnesses, depression, & anxiety.
We must learn to follow our own dreams, give ourselves a break, let ourselves off the hook, and allow our own lives to blossom. When we feel whole as a person and woman, then we can do more for others. But, if we allow ourselves to put our needs at the very bottom of that long list, we often are resentful of the very people we love most. Love yourself enough to take care of you, then you will have enough time and love for those around you.

We also have a tough time saying "No!" No matter how full and busy our lives are, many times women just continue to say "Yes, I can" to all requests put on us by jobs, family, spouses, children, and the world. Why shouldn't we be able to do it all??? We are "wonder women" aren't we? Yes, many of us are truly "Wonder Women"! We say yes to everything. Then we wonder why we are exhausted, sick, or in pain. We try and figure out why we are angry or upset, and just can't fathom why, when everyone around us is have their needs met, we are not happy.

Take a very good look in your mirror. Ask yourself when the last time was that you said "no", I can't go to the soccer game tonight, I need to stay at home because I have lots to do, or I am just too tired this one time. Or I need to take a rain check on the Tupper Ware party, or let's postpone the yard sale for two weeks, or let's go out tonight and eat, I don't feel up to cooking. When was the last time you did something totally "selfish" just for you? Had a manicure, had your hair cut, permed or colored (not by yourself, but at the beauty salon), bought yourself a new dress or shoes, took lunch hour for LUNCH, NOT errands, asked the kids to put away their own clothes, asked your spouse for a dinner date, sat down all alone and read a book, or watched your favorite show, did your nails in a new color, or any number of things we should do just for us???

"Owning Pink" and the ladies there, is and are about taking care of you and your needs. Everyone there has been through tough times and wonderful times. The women there understand one another, they listen to one another, and they even meet physically in some places, like for instance, there is a "group" right here in my own county and home town that have meetings on occasion.

I will end for now with a couple of links to go to. Lissa has a FaceBook page, plus she has her "Owning Pink" website, and her new book just went on sale, and is at Amazon also.

Please take a moment to think of something nice that you can do just for you today... even if it is just a 5 minute breather, totally without any noise or interruption to tell yourself, you are truly "worth it". 

http://owningpink.ning.com/

http://www.owningpink.com/

http://www.facebook.com/?ref=home#!/lissarankin?ref=ts


http://www.owningpink.com/node/1241

Clinical Trials on Tenazumab for Osteoarthritis pain halted by FDA because of working "too well".

http://www.msnbc.msn.com/id/34276015/vp/39428302#39428302

How stupid is this??? They find a medication that can take the pain of osteoarthritis away so well, people get their lives back, but the FDA feels it is working "too well", thus they have halted the clinical trials until they can deliberate over it. Why not put a strong warning on the medication, that if you have advanced degenerative joint disease, where the joints are almost worn out enough to require replacements, that you need to not go back to joint intensive type activities, such as jogging, running stairs, running, playing tennis, or any kind of physical activity that puts lots of added stress onto the joints??? Sure we are going to do more once we are out of chronic pain somewhat, but to take it completely out of clinical trials because it works so well seems absolutely stupid to me. One story about it is above... and here is another link...
http://www.eurekalert.org/pub_releases/2010-09/uoc--pis092810.php

Series of Videos From the American Pain Foundation - These are very beneficial

http://www.letstalkpain.com/painmedsafety/

Once again the American Pain Foundation has come through with great information for all of us suffering from chronic pain. This series of videos goes through how medications effect our lives, the positive aspects of controlling pain, from medications to the use of implantable pain devices, all of these are full of informative and good information for pain patients, spouses, caretakers, family and friends. I urge you to take a look and listen to a few of them. I have already listened to numbers 5 and 6, about the implantable devices, since I am facing having a pain pump put in very soon.


I already learned a great deal more, than I already knew from my own research. :) Rhia

Why Always Reporting the Negative side, and never the positive aspects of pain medications?

http://www.nytimes.com/2010/09/24/us/24drugs.html?_r=1&th&emc=th

Yes, another article negatively impacting prescription pain killers from a prominent paper, the New York Times. What I just don't understand is why they are NOT telling the other side of the story, which is how so many people are given their quality of life back, due to these types of medications. Here we are in the middle of National Pain Awareness Month, when positive things should be discussed and told, yet just about every media type, every news station, many newspapers, & other media have chosen to skip over the good news, and put the bad and ugly in words and reports. This is truly infruiating for those like myself, who are true chronic illness and pain patients, we have NO issues with abusing, addiction, stealing, lying, or being one of the "bad" guys, yet this type of representation reeks havoc for our future quality of life. Please join me in making sure we continue to get the GOOD news out about our medications and all the positive ways they affect us.

Thanks so much, Rhia

Chronically Ill Unite September 14 to Blog About Invisible Illness Issues

9/9/09 – SBWIRE – SAN DIEGO — Who would guess that nearly half of the U.S. population lives with a chronic illness? But according to a study by the Robert Wood Johnson Foundation over 133 million people have an illness or condition, most of which are invisible, and many that cause daily pain. Illnesses can range from Reflex Sympathetic Dystrophy to diabetes, multiple sclerosis to fibromyalgia, or painful conditions like back pain and migraines.
With 75 percent of internet users using the internet for health information (Pew Internet Project, 8/08) and many of them seeking support, thousands of bloggers now post daily journals about the emotional challenges they face with daily chronic pain.
National Invisible Chronic Illness Awareness Week, September 14-20, 2009, invites bloggers to have a significant role in their awareness campaign. For example, part of their outreach has been featuring guest bloggers on their own web site invisibleillnessweek.com , as well as inviting bloggers around the globe to commit to blogging about invisible illness issues. To help spread the word they have also create a meme, “30 Things About My Invisible Illness You May Not Know” that people have posted on Facebook, blogs and other social networks.
Lisa Copen, who founded National Invisible Chronic Illness Awareness Week in 2002 says, “Though our illnesses and symptoms may vary, we still have a great deal in common. We can learn from one another about coping and finding the balance of taking care of ourselves yet living life to the fullest.” Copen says patient blogs aren’t depressing like healthy people may assume. “Illness bloggers don’t typically dwell on the logistics of symptoms, lab tests, or hospital stays. Instead, they write on everyday topics and how their illness impacts their families, finances, careers. They may discuss patient advocacy issues, but they also write about vacationing with an illness or dating when you have a chronic illness.”
Invisible Illness Week was recently the host of Grand Rounds, the largest medical blog carnival on the internet.
Over 300 people have officially committed to blogging for Invisible Illness Week so far and many are sharing on their Facebook notes page or other social network. Copen encourages those who do not have a blog to shares something about their illness with Facebook friends, a few Twitter posts, or even in the comments section of the invisibleillnessweek.com web site.
If you would like to join this unique opportunity to blog for awareness about invisible illnesses, see www.invisibleillnessweek.com for details. Invisible
Illness Week’s highlight is a 5-day virtual conference with 20 speakers that can be heard online for free on a topics such as marriage with illness, applying for disability, setting boundaries, and when your child is ill.
Copen is also the founder of Rest Ministries which sponsors the event and IllnessTwitters.ning.com for anyone who “tweets” on health or medical conditions.

Hectic Week - Lots going on... Dealing with Lupus Flares, Fatigue and Pain

There is lots out there I am putting on Face Book, along with on some of the sites where I belong and blog. It seems there are so many worthy places to find good information, great advocacy, lots of links where you can read the latest on so many illnesses, and what is being done to fight them, that I try to spend my time between those, and my own blog, my own writing, my book that I so want to desperately complete, and reading. It takes patience, and stamina to just post, especially when you are dealing with even typing making your body hurt. My right shoulder is just giving me fits. So, trying to sit here and type for any length of time is a nightmare. I was so hoping I would see some relief from the cervical injections, but I know those probably will not help my shoulder pain. About the only thing that is going to relief that is replacement surgery, plus now my pain specialist is recommending an implanted pain pump.  Yesterday, I did go through the cervical injections. I am hoping that it might help somewhat, but I have my doubts. The chronic pain has been with me now for so long, and my joints and discs seem to be falling apart more quickly, as the days pass. It truly sucks. It is hard not to want to belong to so many of the pages, groups, blogs and so forth on Face Book, and the other sites I have found. They all have lots of incredible people that are trying their best to do good, to help advocacy, to write, to support others, that it seems impossible not to belong. What I need to do I feel, is begin to take all of my posts, and make sure I keep them. Much of my own writing that could go into my book is right there in my daily posts online.

So, I am making myself a promise starting today. I am going to begin writing everything down in my journal that I post daily. I will try and go back and copy some of the things I have already written, and be sure I put them in the place I am writing for my book. I now realize that taking my posts and doing that would put me in the realms of having my book. I thought about calling it something like - The Dichotomy of Chronic Pain and Illness - Pieces of Me. Which would fit right in, through the daily chronicle of my living and learning about pain and chronic illness. For I am the bits and pieces of my own psyche, my own suffering, my own learning, posting, blogging. It is a daily look at what it is like to go through living with Lupus, RA, degenerative joint disease, the medications, the ups and downs, the flares, and how being online can makes a world of difference, where you can find support through groups, lots of others that become a part of your extended online family, where you find love and caring through others, where you learn more about your diseases, conditions and illnesses, where you find doctors, research, clinical trials, and those passionate about making life better. Without my own line friendships, there are days I would totally give up and give in to be content to sit on my butt, and say to hell with the world of pain. That would be the easiest thing to do. This month is Pain Awareness Month, it is also Invisible Illness Month, that goes right along with many of these illnesses. Those of us that fight these syndromes, illnesses, diseases, and the pain and suffrage that go along with them, can tell you we get to the point daily, we would like to "throw in the towel", but faith, hope, and the love of others keep us coming back to our computers to find people that keep us going, even in the darkest of times. When we can't sleep from pain, when we have endured yet another surgery, or a failed treatment, we come online and there they are, those that want to lift us up, give us hope that we have to smile to ourselves.
It gets me to thinking about all I write daily on these blogs, and groups. I learn so much from so many, I get lifted up when I am at the bottom of the barrel of despair. These people deserve a huge round of applause. They work daily to make life more bearable, even in their own illness and pain, they come to Face Book, to pain blogs, to Lupus blogs, to so many wonderful places online to support those who hurt also. I feel these wondrous people, are just like myself. They are Moms. Dads, patients, caretakers, professionals, novices, writers, poets, every day people, just trying to make a difference. We all want our own pain and suffering to go away. We all want to wake up one morning to read headlines that discoveries have been made for all of these nightmare illnesses and see that the puzzle, the mystery has been finally solved. We want to read some grand medication or therapy will just blow into our lives, and we will be cured for good. We don't want to give up or give into what hurts, but there are days, weeks, months, and even years, that feeling well is just not in our cards. So, we blather on, online about the great days, and the days that suck. We find hope in one post, or online through a news article. We score over the websites that tell us that a cure is near. Just like Benlysta. I have followed that one medication now for a couple of years. It has given me hope, that it will be the miracle of all medications, that it will be my cure all, for the Lupus Flares. Each day I mark off that approval from the FDA is just one more day closer. Yet, will it really be the end all to Lupus flares? The results of clinical trials are saying it is definitely worth trying. But, until it is out on the market, and every day Lupus patients begin to use it, we can only go by what the pharmaceutical companies, and their clinical trials gibberish tell us. Like myself, it is difficult to put your trust in what these companies tell us. After all, they are the ones that prosper if millions take the medication. They are the ones to get rich and benefit the most from us as patients. If the doctors press us, in desperation we are just about willing to try anything if it means we might not have flares, we may see pain relief. We will go to the ends of the galaxy, fly through the black holes of where ever we need to if we remotely feel we might find the final frontier of relief, through the many pills, injections, infusions, patches, and creams. We spend our time awaiting that clinical trial to say, this is the Holy Grail of making us well.