Serene Forest

Thursday, September 17, 2015

"New" Drug For Periodic Paralysis $163.80 For One 50mg Tablet!! (Revision)


"New" Drug For Periodic Paralysis $163.80 For One 50mg Tablet!!
I have written two blog articles in recent weeks about the drug Dichlorphenamide, also known as Keveyis, made by Sun Pharmaceuticals Industries Ltd (Taro Pharmaceutical). The first article was to announce a new drug, which had been approved by the FDA to treat Periodic Paralysis (PP). The second article was written after the facts were discovered about the new drug. Today, I find it necessary to write a third article since the cost for the drug has been announced and the stock market is showing gains for Sun Pharmaceuticals after the announcement.
I want to explain a few things before I continue, however. The Periodic Paralysis Network (PPN) was created to help individuals who have been diagnosed with Periodic Paralysis or those who are not yet diagnosed but have symptoms of Periodic Paralysis. Due to the nature of a mineral metabolic disorder, most drugs are harmful and even deadly for those with the varying forms of PP. The major way that the PPN has chosen to help others is to share natural methods to manage the symptoms and paralytic episodes. We have grown to be an organization to provide support, education, and advocacy to our members and attempt to bring awareness of PP to the world.
We are members of an international medical advocacy association working to provide safe and appropriate medical care, so as an advocacy group, we feel it is our duty to attempt to keep our members as safe as possible and to advocate for their medical rights. At least fifty percent of our members cannot take the  “new” drug due to terrible short term and long term side effects. Due to the reasons above and for liability reasons, we have chosen to refrain from discussing drugs in our support group and opt to discuss the natural and common sense methods.
When the new drug announcement was disclosed, we wanted to be fair and hoped for the possibility of something “new” and different, so we were happy to discuss it. However, we found out it was the same as the other drug already being used, which causes harm to a portion of our members. At that time, we felt in necessary to warn our members of the facts…a mistake with drugs can kill some of us…so it is a serious issue. In both articles, to be fair, we mentioned that some of us do well on it and we are happy for those members, but regardless of that, nearly one half of those individuals who do get some relief from it, continue to develop side effects, both short term and long term.
When the outrageous cost was announced, as well as the benefit this would have for the Pharmaceutical Company involved, and because we are advocates for ALL individuals with Periodic Paralysis and the members of our forum, we felt it necessary to write about this. I, myself, cannot take it, so the cost does not directly affect me, but some individuals with Periodic Paralysis can and do want to take it and some rightfully, want to try it. We support these individuals but warn them to use caution.
Information has come to me today that indicates the pharmaceutical company is now saying that the drug will be available for everyone, even if he or she cannot afford it. I hope that is the case, we will see in the future if that is true or not.
For those who wish to take the drug but cannot afford it; and for those who need to know or would like to know about the individuals for which the drug was created and for the pharmaceutical company that has seen fit to charge $163.80 for one pill that could change the lives of some very ill individuals, if they could afford it; I have written the following:
(I have edited my original article. This following is the edited version…)
This drug has been touted as a new drug and the first drug approved by the US Food and Drug Administration (FDA) to treat a group of metabolic disorders known as the Periodic Paralyses. Until now, off-label drugs (drugs used for other purposes) had been used with some success for some of the individuals with this disabling and serious medical condition.
For the community of people who suffer the horrible effects of this disorder, also known as an ion channelopathy, this was big newsa new drug AND it is approved by the FDA! This brought rejoicing and hope to the more than (under-estimated) 5,000 individuals in the United States with various forms of Periodic Paralysis (PP).

This excitement was short-lived, however, for more than half of the individuals who are incapacitated from this cruel condition.

 It turns out that Keveyis, also known as Dichlorphenamide, is not new at all. It is the same type of drug as the off-label drugs being used by some individuals. Some are having great success, but not without short and long term side effects. Dichlorphenamide is a carbonic anhydrase inhibitors (a diuretic) and it is sulfa-based. Some individuals with other forms of PP cannot use it without serious side effects. Some have nearly died from it and deaths have been reported from its use.

Another issue is, it is not new to Periodic Paralysis and has been used previously by patients with Periodic Paralysis for many years at a cost of about the same amount as a bottle of aspirin, but was pulled from the market while studies were done over several decades. Before that time some people had success with it, but others had terrible side effects from it.

During those years, many people with PP were involved in studies using the drug. Many of those individuals did well, but when the study was completed, the drug was no longer given to the patients. They had to go without any treatment or take the off-label drug that was not as effective.

 So we have a new drug that is not new at all, which was taken away from individuals who really needed it and were doing well with it. Then we had twenty-three years of studies being done at which time people with PP were using it and feeling some relief from their horrible symptoms and episodes of paralysis and gradual permanent muscle weakness. After that, the drug was taken away and the patients were left to fend for themselves, with the promise that sometime in the future, the drug would be available for everyone!

The drug is touted as being a treatment for
periodic paralysis”…to mean all formsthis is misleading. There are many forms of Periodic Paralysis. This drug can only be used for a few forms, or genetic mutations of this condition. To the remainder of those with the wrong mutations and who cannot take it, there are serious side effects and possible death.

There are several forms of Periodic Paralysis and many genetic mutations for each form. The different types cause the paralytic episodes, muscle weakness and other symptoms in varying ways. Potassium shifts in the body abnormally either in low, high or within normal ranges caused by many triggers. This happens as follows depending on the various forms.
  • Paralysis results from potassium moving from the blood into muscle cells in an abnormal way,
  • Paralysis results from problems with the way the body controls sodium and potassium levels in cells.
  • Paralysis results when the channel does not open properly and potassium cannot leave the cell.
  • Paralysis results when potassium shifts within normal ranges.
  • The sodium channels close much too slowly and the sodium, potassium, chloride and water continue to flow into the muscles.
  • Or the normal pores in the muscle cell walls just do not work correctly.
Knowing this information, my question is as follows, How can one drug possibly treat and correct all of these possible malfunctions?

These realizations were very disappointing to many of us. We were hoping for more research and for possibly some new forms of treatment…not drugs, because most of us cannot take any form of drugs.

Then came the day with the announcement...The “new” drug is now available for use in the United States of America. The cost?????? $163.80 for one 50mg tablet!!! Most individuals need more than that a day, so for two tablets a day it is estimated that the cost will be $120,000.00 per year, for each person!!! Imagine a family with several people with the same condition? After all, it is an inherited disorder. Most insurance companies will not pay for this drug.

Most people who suffer from Periodic Paralysis are disabled and live on Social Security. This drug will never be available for them to use.

Many of those who wanted to try it were going to take a risk just to see if it might help, knowing the probable side effects. But now, this opportunity has been taken from her.

In the past year, I was contacted by three pharmaceutical representatives seeking information about and from individuals with Periodic Paralysis. I was told there was a “new” drug for Periodic Paralysis that was about to be released. They wanted the names of the members of our PPN Support Group so they could be interviewed about this 'up and coming' “new” drug.

I told each one that I could not give out the names of my members and that I wanted to know more about the drug before revealing such information. I did not want to give false hope to our members. I know that most drugs are harmful to us. I did an interview myself with the first team. I personally explained the facts to them about the issues with the use of drugs with a mineral metabolic disorder. I explained that most of us needed other things to help manage our symptoms.

We need potassium readers that cost $350.00 a piece and are not paid for by insurance. We need other medical devices to monitor our vital signs when in paralysis because during episodes of muscle weakness or paralysis, which may last many hours, there may be serious heart arrhythmia, fluctuating heart rate and blood pressure, choking, breathing issues and low oxygen levels. A patient may stop breathing or go into coronary or respiratory arrest or both and therefore, the patient must never be left alone during an episode and all vitals must be constantly monitored. I described the diet we must follow and how we need to avoid triggers, which can trigger the paralytic episodes. These include but are not limited to: most drugs including antibiotics, food fillers and dyes, pesticides, sugar, salt, gluten, stress, anesthesia, IV’s, stress (good and bad), exercise, exertion, carbohydrates and much more. I explained that, for those reasons, we need a special, natural and organic diet, which is very expensive.

I continued to explain that we have to pay for these things out of our own pockets because insurance does not cover them. I explained that if they really wanted to help us they could research ways to help us to get what we need and for insurance to pay for them. I discussed how most doctors, even the “specialists” know little about the condition. We need a way for all medical professionals to be trained properly about Periodic Paralysis for better recognition, diagnosis and treatment in a timely manner (my own diagnosis took over fifty years!) If they want to really help us, these are the things we need…not another drug we cannot take.

This team never did tell me about the drug or its name, so I did not pass along the information to the members of our Support Group since I had nothing to share.

The second representative never did get back with me after I asked him about the drug. He said he was not allowed to tell me about it, yet he wanted the list of names of all of the members of our support group.

The third representative approached me in a different manner and caught me off guard. She praised my writings on our blog and was terribly “moved” when she read my story. She wanted me to do an interview about the new drug and I told her all of the same information. She was allowed to tell me that at the end of the interview that the “new” drug was actually another carbonic anhydrase inhibitors and knew that it could not help me, or many of the others, from the information I had given to her. She seemed sincere and she assured me that they wanted to gain more information to know of other ways to help those of us who cannot take the “new” drug or any drug. I thought and hoped she was sincere. I now doubt it.

With a heavy heart, I would like to say to her and the pharmaceutical company, which she represents, for those individuals with Periodic Paralysis, who either want to take the drug, or at least try it, and for those of us who cannot take it:

ARE YOU KIDDING!!!!!!!! $163.80 FOR A 50mg TABLET!!!! MOST PEOPLE WILL NEED AT LEAST TWO PILLS PER DAY!!! THAT IS $120,000.00 FOR ONE YEAR FOR ONE PATIENT!!!! NO ONE WHO HAS PERIODIC PARALYSIS CAN AFFORD THAT AND IT IS UNLIKELY THAT INSURANCE WOULD PAY FOR IT!!!!!!!!!!!!!!! THIS IS UNCONSCIONABLE!!! THE PHARMACEUTICAL COMPANIES SHOULD NOT BE ABLE TO DO THIS TO THE SICKEST PEOPLE ON EARTH!!! WE ARE ALREADY DOWN!!!!! JUST KICK US SOME MORE!!!!!!!!

IF YOU REALLY WANT TO HELP US CREATE A DRUG OR A TREATMENT THAT CAN HELP ALL OF US, AND UNTIL THAT TIME BUY EACH FAMILY A POTASSIUM READER AND /OR AND OR AN ISTAT, AS WELL AS, ALL OF THE MEDICAL EQUIPMENT WE NEED FOR MONITORING DURING AN EPISODE, PAY FOR THE SPECIAL DIET WE MUST EAT, PROVIDE US WITH THE ADAPTIVE EQUIPMENT WE NEED, PAY FOR THE OXYGEN WE MUST USE WHEN OUR BREATHING BECOMES TOO SHALLOW DURING PARALYTIC EPISODES, PAY OUR MEDICAL BILLS AND COPAYS, AND MORE…YOU CAN ALSO PAY FOR TRAINING ALL OF THE DOCTORS AND MEDICAL PROFESSIONALS WHO DO NOT KNOW OR UNDERSTAND PERIODIC PARALYSIS. 

ACCORDING TO THE STOCK MARKET REPORTS WE ARE RECEIVING, ABOUT SUN PHARMACEUTICAL INDUSTRIES LTD, THE INTRODUCTION OF THE NEW DRUG KEVEYIS AND THE AMOUNT THAT EACH PILL WILL COST HAS RAISED THE VALUE OF THE STOCK/COMPANY ON THE STOCK MARKET! THE HEADLINE FROM AN ARTICE TODAY SAYS:

“POSITIVE NEWS FLOW PROPELS SUN PHARM’

THAT MEANS THE CEO’S AND STOCK HOLDERS WILL HAVE SOME EXTRA MONEY THAT THEY CAN DONATE TO THE EXTREMELY ILL AND DISABLED INDIVIDUALS WITH PERIODIC PARALYSIS. AFTER ALL, THEY WILL BE MAKING IT OFF OF THEIR BACKS; THE BACKS OF SOME OF THE MOST ILL AND MISTREATED INDIVIDUALS ON THIS PLANET WITH A DRUG THAT MAKES MANY OF THEM WORSE, HAS HORRIBLE SHORT TERM AND LONG TERM SIDE EFFECTS AND CAN EVEN KILL THEM.

I hope it is true that
Sun Pharmaceuticals Industries Ltd. is going to provide this drug to those who cannot afford, anything else is wrong.....


Links about the drug Keveyis and the pharmaceutical company:


Here is some more information about dichlorphenamide:

http://www.drugs.com/drug-class/carbonic-anhydrase-inhibitors.html



www.businesswire.com/news/home/20150810005655/en/FDA-Approves-Taro
s-Keveyis-dichlorphenamide-50-mg#.VdZBTvRS6ih


Articles and information about issues related to acetazolamide and diamox. 
Contraindications for oral diamox

More information about diamox:

Side effects for children:

I understand that in some cases it may be the best of two evils...a very tough decision...but you must be aware of the possibilities...

https://www.riverpharmacy.ca/faq/are-there-any-side-effects-to-acetazolamide-diamox-avva


PPN Blog Articles written about the effects of drugs/medications/pharmaceuticals/anesthesia in Periodic Paralysis

http://livingwithperiodicparalysis.blogspot.com/2014/06/beware-of-off-label-drugs.html

6 comments:

  1. Hi,

    I know this is an old article. But i had a question regarding the mediaction for ats. I was hoping you could tell me which medicines you use for i use a lot and it seems that they simply loose their use after a while. At the moment thuis is the list of medication i use:

    Flecainide
    Slow-k
    Acetozalemide
    Spironolacton
    Temazepam
    Modafinil


    I used to have birth control for reducing the pain i have. But all of them stopper working after 3 months.

    For extra information
    I was diagnoses with ats at 16 and got the flecainide for i was close to a coma and this was their last solution.

    When i was 19 they started Slow-k acetozolamide and spironolacton for i had to stop with university because my health took a decline and my periodic paralysis got worse. And my kidneys got worse to so(spironolacton is for those)

    When is was 20 they diagnozed me with insomnia due to medication and gave me temazepam for twice a week.

    I am now 22 and startes using the modafinil in februari for extra energy regarding the sleeploss due to my insomnia.

    I am from Holland and my family ia the only one who have this disease in our country
    2 of my younger brothers (i have 3) have ats as does my mom and grandfather.

    They do not use the same amount as medication as i so for the doctors mostly just test them on me and if it works they give them to my family members.

    The oldest uses non for he denies what he has (he is 19 and is handicaped due to a problem my mom had while pregnant)
    The other uses flecainide en acetozolamide which seems to be working fine (he is 17)

    My mom has a pacemaker and uses flecainide.

    My grandfather uses no medicine for ats. He does for his other problems.

    Well it is a long story. And i apoligize for grammar and language mistakes. I hope you could give me some information regarding the medication you use and for which problems you use them. And i was also wondering if you might have problems with weight loss?

    ReplyDelete
    Replies
    1. Hello Marijke,

      I am sorry for the delay in responding, I have been away from my computer.

      Most people who have Periodic Paralysis(PP)/Andersen-Tawil Syndrome(ATS) should never take any drugs. They cause us many symptoms, paralysis and especially heart issues (long QT heart beats. Those of us with PP need to use natural ways to treat our symptoms...changing our diet, avoiding our triggers, getting enough rest, avoiding exercise/exertion, low salt, low sugar, eat only natural foods and much more.

      I take no drugs. I have ATS.Any of those drugs you are taking would kill me. I have been seriously harmed by drugs.

      I know of others in Netherlands with Periodic Paralysis.

      I invite you to join our Periodic Paralysis Network Support Group where you can learn more about it.

      https://www.facebook.com/groups/periodicparalysisnetworksupportgroup/



      Delete
    2. Hai,

      Could you tell me what changes you made for your diet etc.?

      I am very suprised that you can handle it without medication. For i need all my drugs to function normal. For example without the flecainide my heart would have so many ritme mishaps that i would get in a coma. For have been very close to that already. This is because i have a strong long qt (7) and my blood pressure is way too low. So when my body needs to pump more blood when it is cold it shuts itself down. I do not faint but pass out. I have learned there is a difference haha.

      I am very curious how you solve all the problems coming with ats without drugs. And i would like to get more information to it. So i send an invite to the facebook group.

      And what the doctors told US we are the only family with ats in the netherlands. But there are people with other periodic paralysis i think that is what you mean?

      Wel thanks for all your help and info and the link to the facebook group

      Marijke

      Delete
    3. I have sent you a friend request and a message...we can discuss this further, privately.

      Delete
  2. Hi

    Problem is not losing kilo's it's gaining kilo's at the moment i am 45,2 kg and i am 1,61 m long.

    Suppose to weight at leaat 53kg

    But thanks for the tip.

    Marijke

    ReplyDelete
  3. I did not post that article about weight loss...I am sorry that you received it....it did not belong here.....

    ReplyDelete