PF Families at FDA Hearing

PULMONARY FIBROSIS PATIENT ORGANIZATIONS APPLAUD EFFORTS OF PATIENTS, FAMILIES AT FDA HEARING
PF Patients Plead with FDA Advisory Panel to Hear Their Voices, Understand Their Plight

Silver Spring, Maryland - March 10, 2010- The Coalition for Pulmonary Fibrosis (CPF) and the Pulmonary Fibrosis Foundation (PFF) are applauding the efforts of Pulmonary Fibrosis (PF) patients and family members for their work to convey to the FDA and an FDA Advisory Committee the sense of urgency and desperation regarding the disease and the lack of treatment options. Their words were heard yesterday by the 11 member Advisory Committee and representatives of the FDA during a public hearing portion of the FDA Pulmonary-Allergy Drugs Advisory Committee discussion of a potential new therapy in the fight against PF. The committee voted 9 to 3 to recommend approval for the drug by the FDA.

If approved, the therapy, Pirfenidone, would be the first FDA approved drug for PF. PF is a progressive, relentless and irreversible scarring of the lungs which renders patients unable to breathe and is almost invariably fatal within two to five years. "There's no question that the patient perspective was heard by the FDA and the panel," said Mishka Michon, Chief Executive Officer of the Coalition for Pulmonary Fibrosis. "Family members and patients spoke from their hearts and conveyed the sense of urgency they feel in desperately waiting for a treatment for this horrific disease."

"We are humbled by the courage and determination of our patients," said Daniel Rose, M.D., President of the Pulmonary Fibrosis Foundation. "The voice of the patient community is a critical component in finding solutions to PF."

The panel listened to testimony of 15 PF patients and family members for an hour. It also received a stack of letters from patients and families across the country who could not attend the meeting in person.

Advocate Joy McBride opened the public hearing portion of the meeting by sharing with the panel the loss of her father and uncle to PF. "The hardest part was hearing from the doctors 'there is nothing I can do for you'" she said. "Today, there is still no known cause, no cure, and no hope."

Patient Tommy Spivey traveled with his wife from Wilmington, North Carolina to speak to the panel. "I have one grandchild and one on the way and I would like to live long enough to get to know them," he said. Spivey, who says his disease is currently not progressing, traveled to Japan in 2009 to gain access to Pirfenidone and is currently taking the drug.

Kaitlyn Bergen shared with the panel details of her father's illness and subsequent death to PF in 2006. "Pulmonary Fibrosis will continue stealing valuable and meaningful years from families," she said.

Though Timothy Cooney's father is one of a small number ofsurvivors of the disease as a result of a successful lung transplant more than a year ago, he delivered his message to the panel on behalf of his family and in memory of his grandmother who was claimed byPF . "On a sinking ship, if the life raft has a few holes in it, people will still take that raft," he said.

At the end of the day-long meeting, one panelist, Rodney Mullins, consumer representative for the committee, echoed Cooney's comments in his final remarks. "We don't know how leaky the lifeboat is, but it's a lifeboat."

The Advisory Committee's recommendations are not binding but will be considered as the FDA completes its review of the New Drug Application (NDA) for the drug. Pirfenidone received Orphan Drug, Fast Track and Priority Review designations by the FDA. A target date of May 4, 2010 for FDA action has been set.

For more information please visit
www.pulmonaryfibrosis.org or call 312-587-9272.

Help

Most people who are diagnosed with pulmonary fibrosis live less than five years beyond the diagnosis. There is no FDA approved cure. There is no FDA approved treatment. The current experimental treatments are for slowing progression or easing symptoms-- none are for a cure.

Please help by clicking this simple link and voting for CHASE to donate to our cause. It costs nothing.

Thanks.

IVIG (without riboflavin)

So today I did my first treatment of IVIG therapy. IVIG, or Intravenous Immunoglobulin, is a nightmare. Ok, it only mostly sucks a lot, but it's not technically so much a nightmare as a major PITA. They take plasma from 1 to 10 thousand people to make one unit of IVIG, which is fortified with gamma globulin, but has not so much as a milligram of riboflavin. Or crunchy honey coating, either. No hearts, moons, stars, or clovers last time I checked into it. But it does contain five types of antibodies known to fight infection in the body, so don't get all snooty, k? What kind of antibodies do you sport, there, smart-arse?

Point is, my body stopped fighting infections due to the absolute crap I have put it through trying not to die from pulmonary fibrosis. Plus I'm now chronically anemic and the transfusions of USDA prime Ahmed blood don't seem to do the job any longer.

So for five days, and once a month thereafter, I will be getting an IV of IG and some crackers. It takes several hours for this stuff to trickle into me, so I'm on the George Bush Senior plan at the infusion lab. (Get it? Trickle down. haha!)

And why, you may ask, am I telling anybody? Well I plan to be an absolute bitch for a little while. I hate IV drugs. I hate anything that has to get into my veins directly because my veins are, after what they've been through, rubbish. It takes forever to get a line into me and forever to keep it, and the veins like to be shitty and shut down just for farts and giggles.

So if I love you but snapped at you for no apparent reason it's because my arms hurt and I hate the world. I still love you. I'll do something nice to make up for it soon, I promise.

Do you think the riboflavin might have made this much better? Yeah... I didn't think so either.

Please Vote for Oh Goddess

If you were among the lucky and smart people to pick up Gwen Hayes' Oh Goddess, a really great read contributing to the Coalition for Pulmonary Fibrosis, please consider giving her your vote at Long and Short Reviews:

VOTE HERE

All votes will reward Gwen for her generosity, support her incredible work, and help the Coalition battle this deadly disease.

Plus she deserves it. The book was awesome, as is Gwen!!

CPF News (copy of email)

Below is a copy of a recent email from the CPF.

The Pulmonary Fibrosis Research Enhancement Act (PFREA) has been re-ntroduced in Congress!

This landmark bill,reintroduced on February 13th, would create a national patient registry and increase public awareness of PF! Please note: he bill number has changed from the previous Congress. The NEW bill number is H.R. 1079.

This means that you, a CPF advocate, can now take action to change the future for all PF patients. Last year, over 20 new cosponsors were brought on to the bill because you asked for their support.

To remind you, this is a groundbreaking bill for Pulmonary Fibrosis, the first ever brought forward, and your help is urgently needed!

What the CPF needs for you to do!

* Call or email your member of Congress today to urge them to co-sponsor H.R. 1079 legislation that supports PF research and creates the first National PF Patient Registry. You can simply send an email by using the letter below.

* Email or call all of your family and friends and ask them to please take action. They will first need to register as an advocate."

The efforts of every CPF member are critical to the success of this Bill! Help us make history by continuing to advocate for all PF patients.

Last year, you may have made calls or sent letters or emails to your Members of Congress in support of this bill. Thank you for your efforts. Now, it's a new Congress (as of Jan. 1) and we need to ask you to do it again! Please contact your Members of Congress now and ask them to support this very important legislation.

Capitol in Spring

The PFREA represents the first Congressional legislation to increase federal funding of PF a progressive and ultimately fatal disease affecting more than 128,000 Americans. The PFREA was introduced today by two members of the House of Representatives who know personally the impact of PF. Congressmen Brian Baird (D-WA) and Mike Castle (R-DE), have both lost family members to the disease. Reps. Baird and Castle have been working closely with the CPF since early 2007 on this legislation. They first introduced the PFREA on July, 22, 2008 in the 110th Congress, and by the end of the year had secured 30 members of Congress to serve as co-sponsors - in large part because of your efforts!

What the PFREA will do:

* Fund the creation of a national PF patient registry, and call on the National Institutes of Health (NIH) to expand and intensify PF research efforts.

* Mandate the creation of a National PF Action Plan, in conjunction with the NIH and CDC, which would focus on strategies to improve public awareness of PF, and accelerate patient and medical education strategies. The Action Plan would be provided to the Director of the NIH within one year of the PFREA's passage.

* Call for establishment of a National PF Advisory Board, which would make recommendations to the NIH and CDC concerning thestructure and management of a PF patient registry. The goal of the registry would be to improve understanding of the
cause and progression of PF, improve standards of care, accelerate research and find ways for new therapies to be developed sooner.

* Mandate the establishment of a National Summit on PF, to foster collaboration between Federal Agencies, researchers, patients and advocates to identify new approaches to research and treat PF. The Summit would be held every three years.

If your Member of Congress is listed below, you don't need to ask them to sign onto H.R. 1079 because they already have! Feel free to call or email them to thank them, though!

Rep. Mike Castle (DE), Rep. Norman Dicks (WA), Rep. Jane Harman (CA),
Rep. Mark Kirk (IL), Rep. Zoe Lofgren, (C), Re. John Tierney (MA),
Rep. Nathan Deal (GA), Rep. Jim Gerlach (PA), Rep. Marcy Kaptur (OH),
Rep. Steven LaTourette (OH), Rep. Zachary Space (OH), Rep. Bill Young,(FL).

You are an important Member of the CPF's Advocacy Team! Please reach out to your Members of Congress today and ask them to support this important legislation!


Sincerely,
The Staff of the CPF

Coalition for Pulmonary Fibrosis
Suite F, #227
1659 Branham Lane
San Jose, CA 95118-5226
(888) 222-8541
info@coalitionforpf.org