Take Action: We Need More Safe and Effective Treatments!

[jshearer]

I know that a lot of people who read these boards are constantly looking to take positive action on behalf of themselves and the more than five million other Americans with psoriasis. Here is one opportunity:

On July 12, 2004, two U.S. Food and Drug Administration (FDA) advisory committees met and recommended against approving access to the new psoriasis treatment oral tazarotene. The FDA is not legally required to follow advisory committee recommendations, but it usually does.

The National Psoriasis Foundation disagrees strongly with the committees' recommendation and believes it represents a lack of understanding about psoriasis treatments. The Foundation agrees that patients need to be protected against unnecessary side effects, but believes oral tazarotene offers a much-needed option for patients with moderate to severe psoriasis.

We are asking everyone who can to write the FDA a letter explaining what psoriasis means to you, and why it's important to make more treatments available. We've tried to make it as easy as possible to contact the FDA by creating an e-mail form on our Web site. Just visit the homepage and look for the big exclamation point (!) graphic next to the words "ACTION ALERT".

Or you can link through here: http://www.psoriasis.org/resources/advocacy/oral_tazarotene.php?PHPSESSID=37b82ca8c4e63e39bd88 4f62ae9e546a

If you have any questions, please e-mail advocacy@psoriasis.org.

Thanks,
Joey Shearer
Advocacy Coordinator
National Psoriasis Foundation

[grannyfranny]

I did it. :D

Granny

[jshearer]

After you send your personal comments to the FDA, feel free to post them here for everyone else to see. Maybe you'll even inspire someone else to write.

Thanks,
Joey

[chaimFL]

Here is the letter I wrote:
I am writing in support of FDA approval for the oral version of Tazorotene. As a long time (15 years) sufferer of severe psoriasis (30% or more body coverage) I am fully aware of the physical, social, and emotional damage this disease can do. I'm not sure if you know what it is like to live in Miami and not wear shorts ever. As a matter of fact, because of the way my legs look I have not worn shorts for over 10 years.

It's true that the past couple of decades have yielded new and wonderful treatments that the likes of psoriasis patients have never seen before, but the breakthroughs and new medications must continue to make it to the market. Every new medication brings the possibility of more and more sufferers getting to know what it's like to have clear skin again and not have to worry about the stares, the snickering, the depression, the itchiness, the flakes and I could go on and on with the list of effects this disease has on our lives. One more drug on the market could mean thousands of more patients getting relief.

I have heard that the FDA's Advisory Committees' met and recommended against approving this drug. If I tell you that I was sitting on pins and needles waiting to hear good news that oral Tazorotene was going to be approved so that I could have just one more chance at a normal life it would be an understatement. The wind was literally knocked out of me just for the news that the Advisory Committee gave such a recommendation. The drive and the renewed fight inside me withered and the depression and anxiety resurfaced.

It baffles me that such a recommendation would even become the final word from this Committee because it is not the first drug in it's class. Did the FDA not approve Soriatane, Accutane, and Vesanoid? The study data show Tazorotene to be well in line with previously approved oral retinoids and in some cases even better tolerated by the patients. This is not a new classification of drug, but it could be an improved version and can provide relief to patients, such as myself, who have had zero luck to date with current options.

I can do no more than beseech the FDA to make the right decision with the suffering patient's best interests in mind. We as sufferers want nothing more than more options to experience relief, but we sit at the mercy of the FDA to have the drive and renewed fight resparked in our withered souls.

Best regards!

[kkellogg]

Great letter Hollis - will get mine off this weeked.

Thanks, Joey.

[jshearer]

Chaim: Great, well-informed letter. Thank you for sharing it with everyone.

For Everyone Else: We have a sample letter (with room for a few personal comments) on our Web site if you don't have the time to draft a unique one. The Foundation's web staff has put together a great tool to make it as easy as possible to send your letter to the FDA electronically.

Check out the link: http://www.psoriasis.org/resources/advocacy/oraltaz_online_submission.php

Thanks again everyone. Please write a letter and post your comments on this thread.

Regards,

Joey

[hkowalczyk]

Chaim,

Yes, good letter. Here's what I sent in.

I am writing you today to ask that the FDA approve the new drug oral tazarotene, TAZORAL.

I have had scalp psoriasis for as long as I can remember (I am a 34 year old male) and just recently developed erythrodermic psoriasis. During the last ten months I have felt closer to 90 years than 34 due to this disease. At times the pain has been so intense to the point where I was bedridden. Soriatane, a retinoid, has given me my life back. As you know, oral retinoids show an astounding efficacy rate for this type of psoriasis as well as the pustular form. Aside from their teratogenic effects, retinoids have a good safety profile when compared to any of the alternative drugs available for the treatment of psoriasis.

I have read through the entire transcript of the July 12, 2004 Joint meeting with the Drug Safety and Risk Management Advisory Committee and certainly understand the hesitancy of the panel to give their backing to this drug. However, I believe most doctors are well aware of the teratogenic effects of retinoids and thus would be very careful when prescribing this drug to women of child bearing age. Furthermore, I believe there are cases when even women of this age group are in dire need of this drug and would welcome the fact that it has a shorter half-life than the other retinoids.

I understand that you must weigh all of these risks. However, consider the fact that many of the other drugs currently approved for psoriasis have dire side-effects as well. Indeed, even the latest biologic anti-TNF drugs have been linked to a possible increased risk of lymphoma. Oral tazarotene belongs to the retinod family, a family of drugs with a long history of efficacy and safety.

Something else to consider is the current state of the health industry. Keeping a drug that has shown efficacy and safety off the market will only lead to increased costs for drug companies, and less competition in the marketplace. Companies like Allergan need to be commended for their efforts to improve the lifes of thousands of people. Since Tazoral would only be prescribed for moderate to severe cases of psoriasis, the marketplace is not extremely large, and yet Allergan proceeded with the expense of clinical trials. If this drug is not approved it will likely have a negative effect on the decision of other companies in proceeding in the psoriasis marketplace.

[kkellogg]

I have lived with severe palmar/plantar psoriasis for three years. At the time of diagnosis, I had already watched my mother suffer with the same form of the disease for over a decade. Neither of us has experienced remission. I celebrate my 30th birthday next week.

It is difficult for me to say that I am glad my mother has psoriasis, but I am. She walked the path with bloody feet long before I did. So when I was diagnosed, all I had to do was follow her trail. It began with topical treatments, ratcheted up every follow-up to the next, more potent steroid. When topicals failed, I was allowed to start light therapy (a proven, albeit logistically and financially prohibitive, treatment). After exhausting and abandoning light treatments, I lingered untreated for a long time – patching together a hodge-podge regimen from a drawer full of half-used topicals. Skin thinning. Condition worsening. Hope fading.

In the summer of 2003, I discovered the National Psoriasis Foundation. I joined. I learned. I found a new dermatologist… and another, and another. They prescribed hydroxyurea, antibiotics, oral steroids, methotrexate and cyclosporine, more topicals, and then, the great injectable hope: Enbrel. I was elated. I sobbed tears of relief in the exam room. After twelve injections, an intense allergic reaction forced me to discontinue Enbrel. Reluctantly, I started another round of prednisone to quell the “flare” and waited in horror for yet another rebound (those tapers can be tricky). I was broken emotionally. Currently, I am not taking any medications to treat my psoriasis, save for over counter pain relief, Vaseline, and super-glue to fill the deep cracks in my palms and soles. I am in the process of acquiring a home UVB unit. Right now, my insurance company is reviewing my claim of “medical necessity”.

We need more viable options for moderate to severe psoriasis. I strongly encourage the U.S. Food and Drug Administration to approve the new drug “oral tazarotene”. Oral tazarotene may be a great option for many people. By rejecting this drug, the FDA is rejecting so many patients who, like me, are nearing the end of the treatment path. I feel that the FDA is discriminating against psoriasis patients. I hope you will work to change that. I know I will.

[oakrai42]

My letter is sent. The FDA needs to wake up and smell the roses. There should be an "auto-approve" button on someones desk at the FDA for when anything that contains the word "Psoriasis" comes across it.

-Steve

[jshearer]

Great letters and comments everybody. Keep 'em coming. If you know others on the message boards who haven't written, please encourage them to do so with a PM, IM, e-mail, or call.

Also, we have a new "Action Alert" up on the Web site. Please take the time to send another letter, especially if you're on Medicare (or will be soon). Visit the link: http://www.psoriasis.org/resources/advocacy/medicare.php

Thanks,
Joey

[chaimFL]

Here is a copy of the letter I got in response from the FDA:

Dear Hollis,


Thank you for your letter concerning oral tazarotene. The FDA takes into
consideration all comments it gets both during the Advisory Committee Open
Public Hearing and in letters and e-mails it gets following the Advisory
Committee meetings. I have forwarded your letter to Dr. Wilkin and a copy
has been placed in the meeting official record. I am sure you are aware the
FDA makes decisions based on science and the evidence provided by industry,
but comments like yours allow us to know the views of the patient using the
drug.


The FDA is prohibited from making any comments regarding a drug that is
under review with the exception of those comments made during a public
Advisory Committee meeting. Industry is not restricted in commenting upon
the status of their application therefore they would be a better source of
information regarding the status of oral tazarotene.


Again, thank you for taking the time to express your concerns about oral
tazarotene.


Kimberly


~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Kimberly Littleton Topper
Heath Science Administrator
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Executive Programs
Advisors and Consultants Staff
5600 Fishers Lane (Bldg 5630, Rm. 1091)
Rockville, MD 20857-0001
(301) 827-7001
(F) (301) 827-6801
topperk@cder.fda.gov

[oakrai42]

I received a similar letter back as well. Nothing special though. I was hoping for "Wow! How could we have been so blind! We just approved it!", but wasn't that lucky :)

-Steve

[hkowalczyk]

I was thinking, not only should we send a letter to the FDA, but we need to send a letter to Allergan to show them that their potential customers are interested in their product. Reading the transcript I felt that they dropped the ball on some issues like paying attention a little better to the bone density loss issue and others. Heck I bet if they had thrown a few erythrodermic and pustular patients in there they could have shown astounding results which would have made the efficacy/risk ratio a little better in their favor.

Maybe send the letter we sent to the FDA and add some comments like "I hope this will not discourage your company from pursuing approval for this drug. I believe the FDA panel would be interested in approving this drug if you continued testing to address some of the concerns they brought up during the hearings."


-Henri

[spotweld99]

I have lived with severe palmar/plantar psoriasis for three years. At the time of diagnosis, I had already watched my mother suffer with the same form of the disease for over a decade. Neither of us has experienced remission. I celebrate my 30th birthday next week.

It is difficult for me to say that I am glad my mother has psoriasis, but I am. She walked the path with bloody feet long before I did. So when I was diagnosed, all I had to do was follow her trail. It began with topical treatments, ratcheted up every follow-up to the next, more potent steroid. When topicals failed, I was allowed to start light therapy (a proven, albeit logistically and financially prohibitive, treatment). After exhausting and abandoning light treatments, I lingered untreated for a long time – patching together a hodge-podge regimen from a drawer full of half-used topicals. Skin thinning. Condition worsening. Hope fading.

In the summer of 2003, I discovered the National Psoriasis Foundation. I joined. I learned. I found a new dermatologist… and another, and another. They prescribed hydroxyurea, antibiotics, oral steroids, methotrexate and cyclosporine, more topicals, and then, the great injectable hope: Enbrel. I was elated. I sobbed tears of relief in the exam room. After twelve injections, an intense allergic reaction forced me to discontinue Enbrel. Reluctantly, I started another round of prednisone to quell the “flare” and waited in horror for yet another rebound (those tapers can be tricky). I was broken emotionally. Currently, I am not taking any medications to treat my psoriasis, save for over counter pain relief, Vaseline, and super-glue to fill the deep cracks in my palms and soles. I am in the process of acquiring a home UVB unit. Right now, my insurance company is reviewing my claim of “medical necessity”.

We need more viable options for moderate to severe psoriasis. I strongly encourage the U.S. Food and Drug Administration to approve the new drug “oral tazarotene”. Oral tazarotene may be a great option for many people. By rejecting this drug, the FDA is rejecting so many patients who, like me, are nearing the end of the treatment path. I feel that the FDA is discriminating against psoriasis patients. I hope you will work to change that. I know I will.
Hi, I am currently taking methotrexate but it is not working. I have tried Enbrel and after 26 doses this did not help either. The only treatment that has almost completely cleared my skin is the light treatment UVB. I usually stay clear for 4-6 months . The treatment is inconvienant and I am considering the purchase of a light booth . Could you please email me on the steps you have taken to aquire your unit? rob_sy@yahoo.com :) :)