How to Help, Step 1: Contact the FDA

In my latest exchange with Dr. ANS he made it clear that the best thing we can all do at this time regarding the withdrawal of midodrine is to make our voices heard, by contacting both the FDA and our representatives. The decision was about politics, not patients.


I contacted the FDA on Wednesday. Many of you have asked about writing letters and where to send them.


The form is simple. It requires your name, email address, and desired text.  


If you are interested in helping to speak up about midodrine and the devastating effects losing it is going to have on my life and that of others, I have included two versions of a letter below, so that you may choose to cut and paste the text of the one with which you are most comfortable. I simply made a few edits to the letter I emailed.  There is no paragraphing because that is the way the letter gets sent via email.

Letter 1: Includes a 'personal story' about me. You need to substitute in your relationship to me. I have marked this section in bold. Otherwise you only need to cut and paste.


Letter 2: Does not include the 'personal story' and is just the facts.


I am not putting pressure on any of you to do this. I am simply making the process as easy as possible for those who are interested in helping.


The link to contact the FDA is:


http://www.fda.gov/AboutFDA/CentersOffices...DER/default.htm 


At the top of the page, you will see the headline: CDER Contact Information. Click on the first hot link you see, the "Contact CDER Form".

It will take you less than two minutes, I promise!

Over the next week, I hope to finish the letters to our representatives and post those if you are also interested in helping with that task. 

Thank you in advance for helping. I express my gratitude on behalf of myself, the doctors who prescribe this medication, and the other patients who take this medication (some of whom are my dear friends).

Blessings,

Emily

Letter 1:

I strongly urge you to reconsider your withdrawal of ProAmatine (midodrine hydrochloride) from the market. While I understand that the FDA has an obligation to enforce its rules and regulations, the decision to withdrawal ProAmatine from the market completely fails to take into account the hundreds of thousands of people who will be left suffering with debilitating symptoms of Orthostatic Intolerance. My [friend, daughter, niece, etc.] is one of those people. Midodrine has significantly improved her quality of life. Over the past 12 years, she has tried over 70 medications to treat her various health conditions which include Postural Orthostatic Tachycardia Syndrome (POTS) and Neurally Mediated Hypotension (NMH). None have been as effective OR free of side-effects as midodrine. While you are recommending that patients talk to their health-care providers regarding alternative treatments, you are keenly aware that ProAmatine is the ONLY FDA approved drug to treat Orthostatic Intolerance and there are NO reasonable substitutes for it. In addition, you have chosen to withdraw a medication that has NEVER been called out for any safety issues since it was first approved in 1996. You have made it completely cost-prohibitive for any of the manufacturers of midodrine to benefit from doing the follow-up studies you are requiring, and hence keeping the medication on the market. If the FDA is truly doing what is right for those who take the medications you approve and monitor, you will take into consideration the fact that lives like hers will be completely devastated by the withdrawal of ProAmatine. You will find a solution that allows ALL involved to benefit--the FDA, the manufacturers, and the patients who count on ProAmatine to help them work, care for children, and engage in normal activities of daily living.

                  -----------------------------------------------------------

Letter 2:

I strongly urge you to reconsider your withdrawal of ProAmatine (midodrine hydrochloride) from the market. While I understand that the FDA has an obligation to enforce its rules and regulations, the decision to withdrawal ProAmatine from the market completely fails to take into account the hundreds of thousands of people who will be left suffering with debilitating symptoms of Orthostatic Intolerance. While you are recommending that patients talk to their health-care providers regarding alternative treatments, you are keenly aware that ProAmatine is the ONLY FDA approved drug to treat Orthostatic Intolerance and there are NO reasonable substitutes for it. In addition, you have chosen to withdraw a medication that has NEVER been called out for any safety issues since it was first approved in 1996. You have made it completely cost-prohibitive for any of the manufacturers of midodrine to benefit from doing the follow-up studies you are requiring, and hence keeping the medication on the market. If the FDA is truly doing what is right for those who take the medications you approve and monitor, you will take into consideration the fact that lives will be completely devastated by the withdrawal of ProAmatine. You will find a solution that allows ALL involved to benefit--the FDA, the manufacturers, and the patients who count on ProAmatine to help them work, care for children, and engage in normal activities of daily living. 

Goodbye Magic Midodrine?

In February of 2009, I wrote a blog post about a medication I started taking to increase my blood pressure when standing and sitting. I titled the post Magic Midodrine because the medication has been so life-changing for me. Every 3 1/2 hours the little alarm on my phone buzzes to let me know it's time to take another dose of my magic midodrine.


Last week news broke that the FDA has decided to pull midodrine off the market, leaving doctors and patients blind-sided.  I've been feeling very sad and devastated by this news. 


This news came on the tails of an increase in my Rocephin dose by my PCP (without consulting me first), that has left me even more crashed out. I've been able to get the dose lowered again, but not before the higher dose pushed me past my 'tolerable' limit. I was still herxing enough from the increase in mid-July! I'm also in the midst, as I mentioned in my previous blog post, of trying to find a new Lyme doctor and pursuing other options for treatment.  I'll try to write separate blogs when I am able, but it's been hard to keep up with any sort of communication these days.


Back to the midodrine: Here is what we know so far, what it means for patients like me, and what can be done to try to help. People have been asking me a lot of questions in response to this news, and I have tried to answer them as well as possible. 


The 'technical' stuff is first, and the 'emotional' and 'personal' stuff is last...so you can choose what you want to read! 

Why is the FDA pulling midodrine off of the market?


ProAmatine (the name brand of midodrine) was approved in 1996 via the FDA's accelerated approval process. The FDA requires companies who receive this type of approval to conduct follow-up studies indicating the drug's efficacy. 


However, the FDA has NEVER actually enforced this rule. Until last week, that is, when they decided to withdraw ProAmatine (and subsequently its generics) from the market for failure to provide adequate follow-up studies. 


Shire, the drug company who manufactures ProAmatine, argues that they did conduct follow-up studies but the FDA found them to be inconclusive.


Apparently, the Government Accountability Office called out the FDA on its failure to enforce the rules regarding follow-up studies for drugs approved on the fast-track program. It specifically cited ProAmatine as an example.


It is incredibly important to note that midodrine has NEVER been called out for safety issues. In fact, it is incredibly well-tolerated and safe. This is part of what makes this action by the FDA so frustrating for those of us who rely on this medication.

Why won't Shire or those who manufacture the generics (five companies) do more follow-up studies instead of pulling the drug off of the market?


The short answer is money. Low blood pressure isn't a big money maker.


Even before the FDA announced its withdrawal of ProAmatine from the market, Shire had apparently notified them in November of 2009 that they would stop manufacturing ProAmatine effective September 30, 2010.


The FDA made its official announcement regarding the withdrawal of ProAmatine from the market for failing to conduct follow-up studies on August 17th. The generic companies have 30 days to respond to the FDA's actions but I don't think any of us expect those manufacturers to decide to take on the follow-up studies either.


It would cost Shire $25 million dollars to conduct the studies the FDA requires. Shire makes $500,000 a year off of ProAmatine. This is 0.1% of their profits. 


About 100,000 people rely on midodrine to control symptoms of low blood pressure upon standing. 


So, why in the world would they spend the money to do the studies for such a small group of patients? They wouldn't, and I completely understand that.

Will midodrine be available from other countries?


Nothing is known at this point. The drug is available and manufactured in Canada and Europe. At issue is whether any of the manufacturers of the generic would want to continue manufacturing the drug in those countries, when it can't be available in the U.S. It is hard to imagine there being enough demand for the drug if it isn't FDA approved in the U.S.


Even if the drug is available, it is extremely expensive. For me, a month's supply would cost about $800. Obviously, this is not sustainable over the long-term.

Will the drug still be available at all?


The FDA does have an expanded-access program, which can allow patients to receive a medication on a case-by-case basis. The patient must have a serious or life-threatening illness that cannot be treated with an alternative medication.


This would make things pretty complicated, and insurance often doesn't cover a drug that would now be considered more 'experimental' than proven. Plus, one of the manufacturers has to feel that it is worth their time and money to both create an extended access program and continue to manufacture midodrine.

What can be done?


The best action we can all take right now is to contact both the FDA and our representatives. I will follow up this blog post with contact information as well as sample letters (that is my next project!).  Even Dr. ANS emphasized this as the best thing we can do right now. Remember to remind the FDA and your representatives that this decision was a political one, and not about patients.

How much longer will I be able to get midodrine?


Shire will stop manufacturing ProAmatine on September 30th. I have a wonderful pharmacist who is willing to stockpile as much midodrine as she can for me, as long as it continues to be available through her supplier. I am the only patient at my pharmacy who uses this medication (surprise, surprise!). The supply likely won't run out immediately, but we have no idea now long it will be available.


The other problem is that, even if she can stockpile six months or so of midodrine, my insurance my stop paying for it once they figure out that the FDA has pulled ProAmatine off of the market.


So, things are very up in the air.


Right now, I'm continuing to take midodrine as I do every day. Every 3 1/2 hours, four times a day. I'm trying to take it one day at a time, knowing that the only thing I can do is enjoy it while I have it.

Why is the withdrawal of midodrine so devastating?


Midodrine is literally the only drug ever approved to treat Orthostatic Intolerance (low blood pressure upon standing, which is a huge part of my ANS issues). 


No substitutes exist.


At this point all of the other drugs used to treat those of us with ANS dysfunction are used off-label (SSRIs, beta-blockers, etc.), but none have the very special mechanism that midodrine does. 


Over the years, I have tried almost 70 medications to treat my various conditions or the symptoms of them. When I started midodrine at the beginning of last year, I felt that I had finally found the closest thing to a magic pill I have ever found. 


When I was not on treatment for Lyme last summer, we were able to go on outings and I could sit up for longer periods of time. I had a major change in all of my symptoms (which I wrote about extensively in that first post, so I won't repeat it here). 


For those of us who take this medication, we are looking at a huge change in the quality of life that midodrine gives us. For some members of the forum I am on, midodrine has given them the ability to lead an almost 'normal' life--they work, raise a family, participate in hobbies. Without midodrine they cannot function.


Even though I'm not going on outings now, midodrine has been one of the major tools we have used to help me tolerate the Lyme treatment. The more intense the antibiotic therapy the more problems I have with blood pressure. 


One of the biggest and scariest questions is whether or not I will be able to tolerate the treatment for Lyme if I do not have midodrine.


Midodrine has helped me to get through both an endoscopy and my surgery to insert my port without my blood pressure crashing out. 


If I really think about what will happen when midodrine is no longer available, I feel sad, devastated, angry and terrified. I really can't even imagine life without this medication. And I'm so very sad along with my other friends who rely on this medication too. I really don't know what I will do without this medication.


I feel like each time we think we'll get a little breather from the constant medical battles (for home care, for lexapro, etc.) something else comes up. The last thing I feel like I have energy for right now is writing more letters and using more energy to fight, fight, fight for this medication. But it is what has to be done. And I will do it.


When will we find a way to make healthcare about the patient and not about politics and money? Why pick on a medication that has not viable alternatives for those it helps? Why make it so impossible for Shire or the other manufacturers to do follow-up studies? 




Blessings,

Emily

Photos:  We've been trying to get out for short StRolls as often as possible in the evenings. I'm usually feeling quite ill, but we make the effort even if it is just to the corner and back! On Sunday evening, the rain streamed down through the sunlight. I knew this meant it was 'rainbow weather'. And sure enough, when we went out for our StRoll there was a GORGEOUS rainbow. I also snapped a photo of the evening sky on our way back home. And a photo of Asher, all ready to go for our StRoll. I haven't been able to take many photos lately, so I had to use a lot of similar ones in this post! :P


When we go out for our StRolls I definitely think about how the combination of midodrine and having The Rolls has made outings of any sort possible.

An 'Un-Sugar-Coated' Update

Last night I was able to spend some time with Mom sitting on the patio, processing the many emotions I'm feeling as we approach one year of treatment on the Rocephin.  I am filled with so many unanswered questions and facing difficult decisions about my medical care and my treatment.  

Physically, I've been struggling immensely since increasing the Rocephin after Carrie, Sam and David left. It makes me weak and tired. It aggravates my ANS so that standing and sitting become even more difficult. It makes me feel out of it. Sometimes I have trouble finding the words I need.  It increases my neck pain. I can't even remember the last time I left the house, other than for a short StRoll in The Rolls.

Treatment also makes me very emotional. I don't know if I become emotional simply because I feel crappy, or because the Rocephin is targeting the Central Nervous System and as the Lyme dies off, I'm more likely to experience cognitive problems, depression, anxiety, and ANS agitation. 

One day, I tried to write an email to several family members. When I re-read it later, I almost cried. I felt embarrassed that the email was so inarticulate and repetitive. This is one of the major reasons I haven't been able to blog lately. 

Along with the effects of the treatment itself I'm dealing with a lot of medical issues. 

Some of the issues are the constant battles for medications I need ("Formulary" has to be one of my least favorite words!), keeping up with day to day things such as the infusions, medication refills, home care, coordinating care between doctors, etc. What seems like it should be a simple phone consult or prescription refill can often turn into a time-consuming and stressful 'project'. 

I don't know how a person has time to 'rest and heal' when they are fighting so many other battles. It is incredibly frustrating!

On a larger scale though, I'm feeling very up in the air about my medical team and how we move forward in treatment as we approach one year of IV antibiotics. The major reason I never blogged about our trip to NJ and NY is because it left me feeling that I needed to make some major changes in my medical care, and I've spent much of the summer navigating that. Thankfully, through a time that feels very chaotic, Dr. ANS has remained my steadfast 'point guard.' 

I know that the chaos and transition will lead me to where I need to be. At first our trip to NJ and NY felt like a huge disappointment and waste of time, energy and money. Later, as I processed the trip, I realized that it served as confirmation that I needed to 'shake things up', that I needed new eyes and minds on my team. I'm confident that this transition will lead me to where I need to be in terms of better treatment and care, but being in the midst of the chaos has been incredibly difficult. 

So, between the physical challenges of the treatment itself, the daily demands of managing my care, the questions about how best to proceed with and find a new team, and wondering where I 'should' be this far into treatment, I've been feeling overwhelmed and exhausted.  That is the honest, and 'un-sugar-coated' scoop. 

I am grateful today for the energy to blog, and I pray that I will be able to resume this one thing that I treasure so very much.  Thank you for continuing to bless me in so many ways.

Blessings,

Emily

Photos:  Zinnia's that Abbie brought from her yard. Aren't they gorgeous?

Ambien CR and Lexapro APPROVED!

Just a little post with some good news on the medical front.


I got a phone call this week that my psychiatrist (locally) was able to get both my Ambien CR and my Lexapro approved!


Many of you who have read my blog since the beginning remember how hard I tried to get that little blue pill, the Ambien CR, approved.  It was a stressful and frustrating process, to put it mildly. I guess I finally jumped through enough hoops--sleep study, great letters from the sleep doctor, help from a psychiatrist--to get it approved.  This is a HUGE out of pocket expense relieved.


When I went to see Dr. Neuropsych Lyme, he switched me from Celexa to Lexapro, on which I am doing much, much better. Of course, with my insurance, I must 'try and fail' at a list of medications in the formulary before I can receive the medication I need. In the past I have tried all of those medications. Somehow my local psychiatrist was able to get the approval through, after the neuropsych doctor left me in a total bind (no samples left, no willingness to follow-up with MA, and we ended up paying out of pocket).  


Over the past twelve years I have tried 23 (count 'em) other psych meds (SSRIs, SNRIs, tricyclics, benzodiazapines, and everything in between) before finding those that would help with sleep, anxiety, depression, and some of the ANS over-stimulation (SSRI's are a first line treatment for POTS). So, we are definitely celebrating finally having the ones that work covered!


We're still dealing with other insurance battles, but when I got the phone call about these meds I was definitely rejoicing!




Blessings,


Emily


Photo:  Little blue pill

Happy 9th Birthday to Mr. Fuzz!

I can't believe Asher is NINE!

We finally had a bit of respite from the oppressive summer heat we've been having, so I was able to take Asher outside to open his present. He enjoyed it immensely (as he always does!). He LOVES to open presents.

A box for me? 

What's in here??

Oooh, look at all of these treats!

After all of these years we have finally figured out that Asher must have food allergies. So, he got a box full of his new favorite special treats!

Now what? Aren't there any more presents to open?

Mr. Handsome 

Poor Asher started out having a wonderful birthday, but it didn't end so well. Neighbor Scott stopped over and Asher desperately wanted to play. It is hard to know exactly what is going to set off a pain episode for him, or how much is 'too much', but he ended up in excruciating pain the rest of the day. Panting, pacing, and unable to lie down. I even had to call the emergency vet at 11:30 PM to try to figure out what other pain meds I might be able to give him.  Thankfully, after some rest, pain meds and CST session he is doing much better, but he still needs to remain low-key. 

He's right here next to my recliner keeping me company as I type this blog.

Despite his neck pain (which does inhibit him from engaging in some favorite activities), he is still his same puppy-like self. And my constant companion. 


Doesn't that sweet face make you smile? It always does me!

Blessings and Happy Birthday to Asher!

Emily

Photos:  Me and Asher (taken by Scott); Asher opening his birthday present.

One Cool Visit: Carrie, Sam and Nephew David

I'm still flying high (although exhausted) from seeing Carrie, Sam and Nephew David over the weekend.  They arrived Saturday evening just when the heat wave finally broke. We were so excited to go out after dinner for a StRoll. 

After a long day of traveling and hair full of mustard, it was time for a bath. I can't believe how much bigger David is compared to last time he was here for bath time.

We hung out and watched 'The Show' (The Muppet Show), which I haven't seen since I was a little kid, before David's nap Sunday afternoon. He napped for 2 1/2 hours!

During David's nap time, Sam relaxed with a good book and Carrie and I got in some much-needed girl time. She even painted my fingernails for me while I reclined! I felt so pampered. Every time I look at my pretty painted finger nails I think about our lovely visit.

Nothing is the same as being together in person to have meaningful connection with friends. What a HUGE blessing to have 2 1/2 hours together just to talk about anything and everything, catch up on things we don't have time to over email, or discuss more intimate things that are hard to capture in email.  Having this kind of time with my closest friends is something I miss tremendously.

Time for some goldfish crackers and apple juice with Dad after nap time. Just as David was waking up I was heading to my nap. The biggest thing that made this visit go more smoothly than usual for me was that I actually slept the night before they got here, the night they were here, and napped. Usually, my ANS is so wired I can't sleep and I'm struggling even more to get through a visit.

I tried to savor the time I did have with them, rather than feel sad about the amount of time I needed to spend resting to enjoy the time that I was awake. 

Carrie and Sam are so low-key and easy to have as visitors. Mom cooked up an amazing menu of foods all fresh from the local market, so we ate quite well.  Thank you Mom! And no, I don't have a single photo of her from the weekend! Darnit!  

Carrie has been here so many times over the years and seen me really sick, so I am learning with each visit to let go more and more. To accept what is, and not resent what is not. I know that Carrie will accept me in whatever state I am in when she arrives. And since she has been here so many times, she knows where everything is and the routines of my sleep, naps, eating, etc.  This really helps me to let go of my desire to be a 'hostess' and just let her come visit and spend time with me.  I haven't quite gotten to this place with any other overnight guests yet!

Dave-O loved his new Fozzie bear that he got before the long car ride here. David is such a bright light. He is confident, content, social, smart as a whip, cute as a button, and incredibly happy, joyful and well-loved. It's so much fun to see how his personality has bloomed since his last visit here. 

One of his favorite questions? Ask him if you are "Cool" or "Nerdy". He will giggle and shout "Nerdy!" It seems we're all nerdy, and no one is cool!

He is also a charmer. Still. Just like he was when he was here at seven months of age. 

When you ask him to say "Cheese" and smile for the camera he likes to look at the picture on the camera to see how it came out! 

How can one not feel happy with this little guy around? My heart absolutely melted when he arrived and said "Aunt Emily". I loved hearing "Aunt Emily" all weekend long! Carrie and Sam have made such an effort to make sure that, even though I don't get to see David often, he knows all about his Aunt Emily. This means more to me than I know how to express.

The farm animals and wooden puzzles Mom got from the library were a BIG hit. Here he is posing with the cow. He thought this picture came out quite well.

Given how I have been feeling I could not have asked for a better day with Carrie, Sam and David. I did better physically than I could have ever even imagined I would. My body really rallied. I had had an abdominal migraine a week before they arrived, and had been having a great deal of trouble recovering from it. But I finally did, just in time for their visit. 

I think, given my energy level, I had just the right amount of time with David, but we really didn't overlap much with his awake time and my awake time. I would have really liked to have had some time with him just to play and do puzzles, but I didn't get that.

It is very hard to get David to look at the camera long enough to take a photo! Sam caught this moment with David sitting on my lap in The Rolls. I love it because I think it captures how happy I felt. This year I've struggled just to find some sense of peace and contentment. During this weekend with Carrie, Sam and David, I experience feeling joy and feeling happy. Amen!

Having such a wonderful visit can be bittersweet. I know I won't see Carrie, Sam and David next summer, so it may be two years before they are able to come again. So, unless I can travel there, I will go quite a long time without a cuddle and kiss from David or a hug and face-to-face talk time with Carrie. After they left, I just cried because I miss my closest friends soooo much and I hate being so far away from them. I hate that I have to miss out on so much!  I already knew I missed Carrie, Sam and David but after such a wonderful weekend I think I miss them more now! 

Still, I wouldn't trade those 24 hours with them for the world. What a sustaining way to start heading into my next big Lyme battle with the increased Rocephin.

This might just be my favorite picture from their visit--our Sunday evening StRoll before we put David to bed, and spent our last bit of time together before they headed out Monday morning. I never heard them leave, but at some point I remember waking up to the joyful sound of David's feet pounding the hardwood floors as he ran through the house. 

David loved riding next to me in his stroller. He didn't last too long on my lap in The Rolls though! 

Carrie, Sam and David: Thank you for the blessing of your visit. How can I ever thank you enough for the gift of your time, your friendship, your love, and my nephew? Thank you for the joy and love you bring to my life.

According to David, we may all be nerdy, but that was one cool visit!

Blessings,

Emily

Photos: Lots and lots of photos from the absolute highlight of my year!  Starring Sam, Carrie, and David.

38 Weeks...

Yesterday (Tuesday), I marked 38 weeks of treatment on the IV Rocephin. I had actually lost count of the weeks. 

I also increased the dose for the first time since April, from 1 gram daily to 1.25 grams daily. Once the dose is higher than 1 gram, instead of being able to infuse it with a five-minute push, we have to use a small bag filled with the Rocephin, hang it from a pole and do a 30 minute drip. It's not a big deal, but definitely more time consuming. 

I'm feeling a bit mixed about reaching 38 weeks because the plan was to do one year of IV antibiotics. The ideal dose is 2 grams daily and I'm not in any way close to reaching that dose before we would stop treatment 14 weeks from now. 

Still, at this increased dose I should be able to tell those little spirochetes to look out! As my cousin said: "I hope your body tolerates the change and the spirochetes don't!" Or more strongly put by a friend on Facebook: "Bitch-slap those spirochetes!" (Usually I go more for images of healing light and all that zen stuff, but I kinda like feeling a little martial-artsy about kicking some spirochete butt. :))

I'm already feeling the dose change, on top of recuperating from a visit with Carrie, Sam and my nephew David over the weekend. I LOVE these pictures of David watching "The Show" as he calls it. He is only two, but he is absolutely obsessed with The Muppet Show. He's allowed to watch an episode before his nap and before bed (and I got to cuddle with him while he watched! :)). 

He is so intense and so into "The Show". What do you want to do David? "Show!" 

You can wave your hand in front of his face like a windshield wiper and he doesn't even notice. I think this is about how I was all day yesterday! I watched three episodes of Gilmore Girls in one day. So, I thought these photos were fitting because I think I look a lot like David while I bond with the TV. Just not as cute as him!

In between my bonding with the TV while I get through this dose increase, I hope to still blog a bit, especially about my WONDERFUL visit with Carrie, Sam and David!

Blessings,

Emily

Photos:  David watches "The Show" in my bedroom with me and Sam. Poor Sam and Carrie have seen the episodes soooo many times at this point! And I found a new fun show to watch.