Canadians Lend Their Support

Bridie before being started on Pergolide showing many of the "typical" signs of Cushing's disease






After a year on Pergolide, you can see how much healthier and perkier Bridie appears.





Excerpts from Angela's letter to Canadian publicatons -

I am writing this letter to inform you of the plight of many thousands of Cushing's Equines in the USA - and quite possibly in Canada in the near future - if the issue with Pergolide withdrawal by the FDA (due to side effects in humans but never documented in equines) is not resolved quickly. The drug Pergolide is the treatment of choice for Equine Cushing's or PPID. My Shetland pony of 20 years is on Pergolide for Cushing's and she is healthy and happy. Not so prior to the diagnosis and drug intervention. Bridie had laminitis and founder with rotation in all four hooves and was in considerable pain. With “DDT”- diagnosis, diet and trim with keen hoof management, it took 12 months of rehabilitation to return to health and she is NOW pain free. Without the medication Pergolide to control her symptoms I would have no choice but to have her humanely put to sleep. This is the dilemma.

The U.S. FDA, which on March 29 2007 withdrew the drug Pergolide, still has not brought forth any resolution to the predicament they put us in. As a consequence of this, thousands of horses are at risk to be euthanized due to uncontrolled symptoms of Cushing's - the most common and severe symptoms being crippling laminitis and founder. The reserve drug supplies are almost gone and production has been halted. We have asked the FDA to amend this desperate situation with an EXEMPTION FOR COMPOUNDING PERGOLIDE for special veterinary use.

At present news stations and horse publications are now addressing this issue with editorials and news spots highlighting this horrendous situation. Yet, many vets and caregivers are still not current on the situation. Without Pergolide to control the symptoms they can progress to laminitis and founder within two to three weeks. Time is running out for these equines as Pergolide production has been halted in the U.S.A. An online petition has over 4,500 signatures to date and this number grows every day. We are requesting all venues to provide public information on the desperate plight of these equines and beseech the FDA to address this issue IMMEDIATELY!

Horse Owner's Response to Generic FDA Reply

I am glad to hear that the FDA is apparently working on a solution to the
pergolide crisis.

However, if you will forgive me, I am having a hard time believing that your
agency really understands the urgency of the pergolide situation. Because, in my opinion, if you really got it, the FDA would have solved the problem by now.

Please understand that every day the FDA drags its feet and does not resolve
this crisis is a precious day that is wasted, where our horses are closer to not having the life saving drug that they need. Horses that die due to a pergolide shortage will have died needless and premature deaths. We should not have to lose a single horse before the FDA acts.

There are no more pergolide pills available in the pharmacies, the only "legal"
source of the drug, according to your agency. Supplies of the bulk drug for compounding are quickly dwindling. We do not have the luxury of time waiting for the FDA to get around to a solution. PLEASE RESOLVE THIS NOW.

"The lives of our horses are in your hands and, if you were in our place, you
would realize that waiting is not an option.

Sincerely,

[Horse Owner and Horse]

Generic CVM Response to Letters

This is representative of the fairly generic responses to their letters being received by horse owners from CVM Ombudsman Marcia Larkins, V.M.D.
"Review and consideration" can take a long time.

"Your email messages to Dr. Sundlof and to the CDER Ombudsman were forwarded to me. Thank you for sharing your story about your horse. The Center for Veterinary Medicine (CVM) is sensitive to your concerns about [horse's name] health and well being. As stated in my previous response to you CVM is very aware of the impact of the withdrawal of the human pergolide product. The future availability of the product to veterinarians for use in the treatment of Equine Cushing's Disease is currently under review and consideration by CVM. The Center understands the importance and sense of urgency among horse owners about this product and is actively working on finding a resolution as soon as possible."

Sherri's Letter (with pictures of Aletheia)

Dear Governor Bredesen,

While I realize my concern may not be top of your list of priorities, IT IS THE TOP OF MY LIST and tens of thousands of other horse owners. I am including a few photos of my mare to try to put this all in perspective for you.


This is my mare and her last foal..... before Cushings and the resultant Founder.

I am writing you about the recent recall of the drug Pergolide from the market. This move by the FDA has created an urgent and disastrous situation for not only my horse but thousands of horses with Equine Cushing's disease (PPID).

Hopefully, you and others are aware or being made aware that Pergolide is the only viable treatment for these horses and that it is a very common and debilitating disease.

A study by Dr. Frank Andrews DVM, MS, ACVIM, at the University of Tennessee, found that 56% of horses 13 years of age and over are affected by this disease. (See The Horse, March 2006.). Needless to say, not all of these horses are being properly diagnosed, but many are.

The Michigan Cushing's Project, a landmark study by Dr. Harold Schott at MSU established Pergolide saves lives of these horses.

My foundation mare, Aletheia – the love of my life, suffers from Equine Cushings disease and foundered severely (20+ degrees of rotation several years ago). I have spent tens of thousands of dollars on Vets and Farriers, Sterile Maggots for her feet, consultations with experts, diet balancing and Pergolide to make my mare stable and reasonably sound with a good quality of life.


This is Aletheia the first month she was on Pergolide, a special diet,
and a special area constructed to allow her to be with the herd, yet safe.

Had I not found a group on the internet four years ago (with upwards of 5,000 members) that understands and is on the cutting edge of this disease, my mare would not be alive today. She is on a special diet – I drive 6.5 hours every 90 days to get her Plain Beet Pulp. I have constructed a special paddock for her to have close contact with her friends (my other horses) while keeping her safe with 24 hour access to her oversized stall and outdoor paddock. In addition to her special diet and living arrangements she is provide 1.5 milligrams of PERGOLIDE (compounded) per day (2 mg during the fall seasonal rise). WITHOUT THE PERGOLIDE SHE WILL DECLINE RAPIDLY FORCING ME TO EUTHANIZE HER DUE TO THE INCREASE IN FOOT PAIN, MUSCLE WASTING, LETHARGY, DEPRESSION, FATIGUE AND IMPAIRED IMMUNITY.


Aletheia after 6 months on Pergolide, diet and yet another special area
constructed for her health, safety and pleasure !

I was first told by my supplier of Pergolide that access to the drug would not be an issue for at least the foreseeable future. I am now being told that there will be none available within the next 30 – 60 days! I would stockpile it if that were possible, however the drug has a shelf-life of somewhere less than 6 months. UNLESS SOMETHING IS DONE QUICKLY……… THOUSANDS OF HORSES – INCLUDING MINE WILL SUFFER OR DIE NEEDLESSLY AND PREMATURELY…..


I urge the FDA to immediately institute the provision for regulatory discretion as detailed in CVM Program Policy and Guidelines Manual, Guide 1240-4170, by publishing an exemption from the prohibition on compounding from bulk drug with specific reference to horses with Cushing's disease, as at least an interim solution. The FDA had been supplied with documentation of the impending shortage, documentation of need, and absence of alternatives for horses. To allow even one horse to suffer needlessly is an outrage.


PLEASE, make this simple solution a priority for the tens of thousands of horses in need a reality before it is too late…….


Sincerely,

Sherri Soper
Moscow, Tennessee

Great Personalized Letter

My letter to Senator McCain


I worked on McCain's first bid for US Senate - though I no longer live in AZ,
thought maybe this might help...

Kirsten
______________________

Dear Senator McCain,

Think way back to 1986 - I was that cute redhead at your headquarters in
Phoenix with whom you would flirt on occasion. (All in good fun, and even with
your wife present.) Anyway, I've been telling people for years that I hoped you
would be elected to the highest office so that I could say the President used to
flirt with me. (And of course that meant something before Clinton.)

At any rate, 20 years later and not nearly as cute (and now married to soon to
be retired Lt. Colonel Karl W******), I am writing to ask a favor...

I know you are very very busy, but...

We horse owners are facing a crisis. Pergolide, the only drug that manages
Equine Cushing's disease, has been pulled from the market. For people, there
are other alternatives, but for the horses there are none. A group of over
3,000 of us have signed a petition and sent it to the FDA without satisfactory
response to date. Thousands of horses' lives depend on this drug.

Below is the letter that has been sent along with the contact information; I
am hoping that you can do something to help usher a life-saving response soon.

Thank you,
And best of everything to you.
Kirsten (B***) W********

Contact at FDA:
David J. Horowitz
Deputy for Compliance Policy
Phone: 301-827-4225
Fax: 301-443-6591
david.horowitz@fda.hhs.gov

"Time is running out for these horses. We urge the FDA to immediately
institute the provision for regulatory discretion as detailed in CVM
Program Policy and Guidelines Manual, Guide 1240.4170 by publishing
an exception from the prohibition on compounding from bulk drug with
specific reference to horses with Cushing's Disease as at least an
interim solution. We have fulfilled the requirements for
documentation of impending shortage, documentation of need and
absence of alternatives for horses. To allow even one horse to suffer
needlessly is an outrage. Human pharmacies with generic pills - those
that even have any - are price gouging. An owner informed me
yesterday her cost went up over 100%. These horses desperately need
an affordable solution."

Patti's Letter to Sen McCain

I sent the following to Senator John McCain using the government contacts link .

(Please feel free to cut/paste this if you'd like to use it as a guideline for your own letter to your elected representatives.)

To Senator John McCain 4/25/2007

Re: FDA Pergolide Withdrawal

If the continued availability of pergolide is not ensured, many horses with Cushing's disease (Pituitary Pars Intermedia Dysfunction or PPID) will be at risk to suffer the debilitating side effects of this disease. Cushing's is a "senior" disease - many with younger fit horses might not consider this important right now but any seasoned campaigner can be affected. Pergolide (obtained by veterinary prescription through compounding pharmacies or branded Permax which is no longer manufactured) is currently the only viable (effective and economical) treatment for this condition in horses. There currently are no alternatives.

For background:

Link to FDA notice
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html

Link to article which summarizes the situation
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide

Link to petition
http://www.ipetitions.com/petition/savepergolide?e

This petition currently has over 3400 signatures, including many veterinarians. Eleanor Kellon, VMD, has spearheaded and is devoting countless hours to this effort in behalf of many thousands of Cushing's horses and their owners - contacting federal [FDA and CVM] and state officials, veterinary schools and organizations, writing articles, and working with pharmacists and research veterinarians in the U.S. and abroad.

This is a complex issue mired down in FDA rules and regulations beyond the scope of the average citizen or veterinarian.

Your attention and intervention into this current situation would be greatly appreciated by thousands of horse owners.

Respectfully,

Patti Kuvik
Vail AZ

Claire's Letter to the FDA

Posted to EC Photos, reprinted with permission of author.

Dear Fellow Listers,

At Robin & Dr. Kellon's request I am posting a link to the letter I sent yesterday to Dr. Marcia Larkins and Dr. Stephen Sundlof at the FDA:
marcia.larkins@fda.hhs.gov
stephen.sundlof@fda.hhs.gov

The reason I'm linking to it, rather than pasting it directly into this email is because it contains photos that I think are a very important and integral part of the message. And as you know we can't post photos directly into this list's messsages.
Read Claire's letter to the FDA.

Please understand that this letter is merely a SAMPLE of a personalized FDA plea. Please DO NOT copy my wording as it would really lessen the impact on those at FDA if they get letters that are very similarly worded -- BUT you can certainly use it as a starting point and modify it to fit your personal situation. The more letters they receive from horseowners talking about their specific horses, the more likely they are to view this as a very REAL threat to very REAL horses. Dr. Kellon has hit them with facts and numbers and hopefully educated them as to the value & importance of pergolide for treatment of these horses. You and I can make it real & personal. These are not just numbers, these horses are very real and part of our families.

Please write !! tell them your story...and specifically ask them to make a <<<"specific exemption from compounding from bulk drug for pergolide to be used to treat equine PPID">>>

If we lose just one horse due to the unavailability of pergolide ...it's one too many !!!!! Jump on the band wagon and write to everyone who might have an impact.I have sent everyone in my address book the petition to sign and will continue to write letters until this issue is resolved.

At their request, I even wrote a story for a local AZ publication the "Bridle & Bit"...hope they can get in their next issue.We need to speak out ...loud & clear!!!!For my beloved Tamera and every horse out there that needs pergolide!!!!

Claire from AZ

[Claire's article in Bridle & Bit]