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vespa



Joined: 18 Oct 2010
Posts: 1

Post Posted: Wed Dec 01, 2010 4:38 pm Reply with quote    Back to top    

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm

Print this out, take to your doctor and have her/him submit a request for Pirfenidone to the FDA. It should work.
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jbobbora



Joined: 26 Nov 2010
Posts: 15

Post Posted: Thu Dec 02, 2010 9:25 am Reply with quote    Back to top    

vespa wrote:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm

Print this out, take to your doctor and have her/him submit a request for Pirfenidone to the FDA. It should work.


I recently contacted Intermune at ir@intermune.com

I was told there is no way to currently access Pirfenidone in the US. Its pretty upsetting to me that there is no way to do this.
I specifically asked if there was a compassionate use program and was told no. I think it would be helpful if more people would email Intermune and try to find out what we can do to get something going. The FDA for whatever reason really devastated Intermune when they denied it last march. I'd like to think they had good reason but with so much politics involved I can't help but think we sould be allowed to try it. After all there is nothing else out there specifically for us.. www.intermune.com the person who responded to me was Celeste Marx

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Giving HOPE! My 70 yo dad was told he had IPF by 3 hospitals -went 2 National Jewish-found he had not only autoimmune disease but cancer as well. His lungs were full of fiber & he could not breathe w/o oxygen. case was complicated but he is now great!
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strayze
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Joined: 22 Dec 2002
Posts: 6466
Location: Maryland

Post Posted: Thu Dec 02, 2010 10:32 am Reply with quote    Back to top    

Google uo "fda pirfenidone" The lead article explains The status pirfenidine is within the FDA evaluation process. The external committee assigned to pirfenidone met last Spting. The committee makes recommendations to the Drug Director of FDA.

There are no politics in the drug evaluation process. I know, for I worked there. Any politics would involve issues I was unaware of, if any even existed. People worked hard at FDA to make sure that any drug sold as a prescription drg is safe, and that appropriate cautions are placed on the label.

Indeed, there was a time when some FDA employees went to jail and served hard time for accepting gifts from industry. Even minor gifts like a five dollar lunch counted.

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strayze
IPF-UIP by VATS at Hopkins, 8/00
NSIP by VATS review+ new tets, Nat. Jewish 3/04
Severe symptoms 12/99
Dyspnea since '73
ILD by CXRs since '85
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strayze
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Joined: 22 Dec 2002
Posts: 6466
Location: Maryland

Post Posted: Thu Dec 02, 2010 10:33 am Reply with quote    Back to top    

Vespa, thanks for your post.

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strayze
IPF-UIP by VATS at Hopkins, 8/00
NSIP by VATS review+ new tets, Nat. Jewish 3/04
Severe symptoms 12/99
Dyspnea since '73
ILD by CXRs since '85
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jbobbora



Joined: 26 Nov 2010
Posts: 15

Post Posted: Thu Dec 02, 2010 11:34 am Reply with quote    Back to top    

I have read about 50 articles on Pirfenidone and summized that there was "shock" that it was not approved. I am extremely familiar with getting drugs on a compassionate basis as I survived a rare disease 7 years ago Inflammatory Breast Cancer and then founded a foundation to help others. Some drugs make it through quite easily and others have a hard time. This often depends on politics and who you know as does most things in the world. When there is NO other drug approved for this HORRIBLE deadly disease it seems more than strange that the FDA would not have approved this drug in some capacity. For example, for those considered terminal otherwise.

I made the statement based on reading artlicles like this one.

http://seekingalpha.com/article/203187-intermune-left-gasping-by-fda-rejection-of-pirfenidone

not to critisize the FDA. I am still desprate for any advice anyone has for the newly dx 69 year old. I wrote to Intermune to hear from the horses mouth what was going on. Anyone who would like a copy of their reponse to me is wecome to email me directly.
I am ONLY trying to offer infomation to help. I searched for days about pirfenidone and thought I would hlep prevent someone else from twasting their time.

_________________
Giving HOPE! My 70 yo dad was told he had IPF by 3 hospitals -went 2 National Jewish-found he had not only autoimmune disease but cancer as well. His lungs were full of fiber & he could not breathe w/o oxygen. case was complicated but he is now great!
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Halim



Joined: 05 Nov 2009
Posts: 49
Location: Yorkshire, England

Post Posted: Thu Dec 02, 2010 12:03 pm Reply with quote    Back to top    

The position in the UK is that Pirfenidone is still awaiting approval from the European Medicines Agency, just don't know what in God's name they are still waiting for! Its been available for some time in Japan and has now become available in India; when I raised the possibility of obtaining it from India my consultant said that he would refuse to treat me should I obtain it at my cost from India, I got the notion that these people in the West have got some sort of a superiority complex that they know what is best for us and somehow other countries are not quite good enough! They say my illness is terminal and yet they refuse me treatment with a drug that I will pay for so how is that fair in any way??????
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Jeff Siens



Joined: 04 May 2010
Posts: 129
Location: Poulsbo, WA

Post Posted: Thu Dec 02, 2010 1:06 pm Reply with quote    Back to top    

I use to be very interested in this great new miracle drug that was suppose to cure us of this awful disease, until I spoke with my doctor, which just happened to be one of the doctors responsible for its' existence. He informed me that the drugs side effect on over 66% of the patiences was so bad that the QOL was horrible. He told me to imagine being so nuaseated all day you curl up in the fetal position and live your life that way. Strayze was right when she said the FDA isn't going to let the drug into our country just because we write letters or try to twist their arms because of the compassionate act. We need to keep praying that they find a drug that remove this fibrosis without making us feel worst then we already do. Our day will come now that we our being noticed for a bigger problem then they first suspected. A pill would be a lot cheaper for our government then a lung transplant. Most of us will be on SSI/Medicare/Medicaid when we come up to bat for our tx. I'm sure the 750K spent on research would be much more advantasious then one person lungs. I'm sorry to have to point this out, but we need to keep pushing ourselves until that day comes. I pray that each of you that reads this find strenght in God, and if anybody can help design a charity that can bring in more then 18K a year, we should get on it. We all know how money talks.



vespa wrote:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/AccesstoInvestigationalDrugs/ucm176098.htm

Print this out, take to your doctor and have her/him submit a request for Pirfenidone to the FDA. It should work.
Idea
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Mary J.



Joined: 12 Jan 2010
Posts: 1428
Location: Michigan

Post Posted: Thu Dec 02, 2010 6:18 pm Reply with quote    Back to top    

jbobbora, I am terminal but I am NOT willing to take or do anything just to extend my LIFE! It is about QUALITY OF LIFE for me. There is NO cure for this disease and the same drugs have been around for yrs. and I seen first hand what the side effects do and still have 14 members of my family dead from Fibrosis. This drug was NOT accepted for good reason. I hope that if you do get this drug (Pirfenidone ) for your Dad that you tell him about the side effects and let him decide if he wants to take it. I'm sorry about your Dad having this devastating disease, I know about watching someone you love die from it but just having it is enough to deal with, without dealing with side effects from the drugs the DRS. want us to take. This is just my own personal opinion and I believe everyone has the right to make their own decisions about life and death issues. I will pray for you and your Dad!

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Mary JLM-UIP/IPF-Jan.2008 / Fibromyalgia / Osteoporosis / IBS / Gerd /--- 1 Cor 14:13--Three things will last forever; Faith-Hope-Love and the greatest of these is LOVE!!!
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jbobbora



Joined: 26 Nov 2010
Posts: 15

Post Posted: Thu Dec 02, 2010 8:15 pm Reply with quote    Back to top    

I am so saddened that you would feel the need to address me personally in all caps about the fact you are not willing to take or do anything just to extend your life. I thought this was a support site. Where on earth did I suggest you should do anything you do not want to do. I simply was letting the list know that I contacted Intermune and found out its not available right now. I gave my opionion as hundreds of others have done that I think it should be approved if it was shown to work at all because the other result is often death. Of course everyone has the right to make there own life and death decisions! My dad was just DX and as I said we are devastated and scrambling for answers. I went directly to the drug company to find out some info and thought it might help others. I thought this was a support site not a site where every last word would be picked apart. The pulmonologist we see here has 2 patients who did so well on Pirfenidone that they are now on no drugs and doing quite well. It worked for some and not others so I believe that not all drugs work for all people but if you want to try it and there are not other options then a person should have the freedom to try the drug. Never did I suggest that everyone would feel the same way.

_________________
Giving HOPE! My 70 yo dad was told he had IPF by 3 hospitals -went 2 National Jewish-found he had not only autoimmune disease but cancer as well. His lungs were full of fiber & he could not breathe w/o oxygen. case was complicated but he is now great!
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Mary J.



Joined: 12 Jan 2010
Posts: 1428
Location: Michigan

Post Posted: Thu Dec 02, 2010 9:13 pm Reply with quote    Back to top    

jbobbora, I wasn't trying to come down on you or just single you out, all I was doing was expressing my opinion and I apologize if that is the way it came across and I ask for your forgiveness? This is a support site but we are dealing with life and death issues. I'm sorry you felt I was trying to pick apart what you said. I just feel it is important to know all info that is available and out there too. I really am not trying to add to your devastation and pain. I just wanted you to be cautious. I don't know what more I can say.

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Mary JLM-UIP/IPF-Jan.2008 / Fibromyalgia / Osteoporosis / IBS / Gerd /--- 1 Cor 14:13--Three things will last forever; Faith-Hope-Love and the greatest of these is LOVE!!!
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Mrs. W
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Joined: 30 Jun 2005
Posts: 2503
Location: Wisconsin

Post Posted: Thu Dec 02, 2010 10:05 pm Reply with quote    Back to top    

Mary J. I know you have recently been dealt another blow, with the death of your cousin, another member in your family to die from lung disease.
We are all trying to deal with the issues that go hand in hand with the disease. These are all tough issues, and can hit raw nerves. Not having any medications really to help, besides NAC, is also hard. So, we do get excited to read new things.
We are all here to help each other and come alongside as friends. Sometimes it's hard, because we can't see each others faces' or see the tears...we are just reading the type face on the computer screen and can't hear the voice behind it, it's easy to misunderstand one another.
jbobborra, I'm so very sorry about your dad's recent dx, I remember trying to find what I could for John. It was very kind for you to share what you learned on the drug website with the rest of us. I'm hoping the best for your dad, and you as his caregiver.
Pam

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Mrs. W Former Firefighters(Pam) and (John)
Sarcoid/PF. UW Madison rl tx 11-8-05. ChronicRejection 1/10 My Caregiver verse:"..Be strong and courageous. Do not tremble or be afraid, for the Lord your God is with you wherever you go." Joshua 1:9
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Mary J.



Joined: 12 Jan 2010
Posts: 1428
Location: Michigan

Post Posted: Thu Dec 02, 2010 10:40 pm Reply with quote    Back to top    

Pam, thank-you for commenting on my response to jbobbora. I felt really bad that there was a miss communication. I agree with you that not being able to see each other or how we react to things said is so much harder, than if we we're in person. Maybe I need to be alittle more sensitive and I will work on that.

_________________
Mary JLM-UIP/IPF-Jan.2008 / Fibromyalgia / Osteoporosis / IBS / Gerd /--- 1 Cor 14:13--Three things will last forever; Faith-Hope-Love and the greatest of these is LOVE!!!
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