Letter to Congressional Horse Caucus

This letter was sent to the Co-Chairs of the Congressional Horse Caucus on behalf of the over 5000 members of the Equine Cushings list and all owners of horses afflicted with Cushing's disease.


FDA Action Causes Horse Health Crisis

Dear Congressmen Stearns and Chandler,

As co-chairmen of the Congressional Horse Caucus, we are writing to ask for your urgent help in requesting the FDA to act upon the drug crisis now facing approximately 75,000 horses in the United States afflicted with Cushing’s Disease or Pituitary Pars Intermedia Dysfunction (PPID).

As you know, on March 29,2007, the FDA asked for voluntary withdrawal of the drug pergolide used in the treatment of Parkinson’s disease secondary to studies confirming cardiac valvular dysfunction in a small subset of human patients. The FDA was apparently not aware of the impact withdrawal of this drug posed to horses diagnosed with Cushing’s Disease. For the past 10 years, pergolide has been the Gold Standard treatment for this disease. While pergolide does not cure PPID, it allows for equines to maintain an excellent quality of life and function. At present, there are no viable drug therapy substitutes for pergolide.

Our group is led by the nationally known and published equine veterinarian; Eleanor Kellon, VMD.[i] Dr. Kellon is co-owner and veterinary advisor of the Equine Cushing’s List (http://groups.yahoo.com/group/EquineCushings). We are over 5,000 members strong (including international members) and we are fighting to ask the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID.

Dr. Kellon has conservatively estimated that of the 10 million horses in the United States, approximately 75,000 are afflicted with PPID.[ii] As of the week of May 2nd, our group has confirmed from ALL compounding wholesalers that NONE have ordered pergolide and NONE will do so until the FDA gives the green light. Additionally, we now estimate that there is only a six week supply of the drug in the United States as of May 9th.[iii]

Without this drug, these horses face certain euthanasia. The primary cause of death will be laminitis secondary to their uncontrolled disease; the very same laminitis that took the lives of Barbaro and Secretariat.

Congressmen, you are both from states with large equine populations. You understand that the equine industry is a vital part of our economy. Both of you and the members of your caucus have already demonstrated your commitment to the equine population by your exceptional work on the Horse Protection Act.

We have contacted the FDA to no avail. Since the March 29th FDA announcement, Dr. Kellon and many of our members have had direct contact (phone, fax, and e-mail) with the appropriate individuals at the FDA. There is still NO definitive plan in place to resolve this crisis. We strongly feel that it will take the voice of Congress to alert the FDA to the consequences of their inaction. By asking the FDA to issue a specific exception to the prohibition on compounding from bulk drug as it pertains to pergolide in equines with PPID you and the members of the Congressional Horse Caucus will save the lives of thousand of horses.

Thank you for considering these horses as constituents of your respective states. Thank you for helping us save the lives of these horses and for ensuring that their devoted owners will have the medication they need for their equine companions.

Sincerely,


Susanna R. Gordon, MD
List Moderator, Equine Cushing’s Group

Kathleen Gustafson, PhD
List Moderator, Equine Cushing’s Group

________________________________________
[i] For further information, Dr. Kellon may be contacted at:
Eleanor M. Kellon, V.M.D.
Equine Nutritional Solutions
58 Maple Farm Road
Ephrata, PA 17522
drkellon@aol.com

[ii] Canvass of Equine Veterinarian Practices, May 2007
[iii] Communication between Eleanor Kellon, V.M.D. and suppliers, April and May, 2007

For background summary, please see articles at:
http://www.thehorse.com/ViewArticle.aspx?ID=9526&nID=7
http://www.thehorse.com/ViewArticle.aspx?ID=9405&kw=pergolide

Current petition signatures as of 10 May 2007:
http://www.ipetitions.com/petition/savepergolide/signatures.html

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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!

New Jersey Readers Get the Pergolide Message!

Hunterdon County Democrat story features Kellie and her TB eventing horse Kelton.


"Horse owners are hoping they can convince both the FDA and the manufacturers to keep the drug available to veterinarians, too. It was not known how many horses are being treated with pergolide, but it is possible that more horses use it than people."

Read the story and see Kellie and Kelton here:
http://www.print2webcorp.com/news/njcom/hunterdon/horsenews/20070501/p16.asp?st=p16_s1.htm

5 O'Clock News Spot on WJACTV - NBC Affiliate Station

"The drug Pergolide, although unsafe for humans treating Parkinson's, was used to treat horses with Cushing's Syndrome."

"A drug used to treat humans with Parkinson's Disease has been pulled off of the market by the U.S. Food and Drug Administration. Now, horse owners who use the drug Pergolide say that it will leave them unable to treat their horses suffering from Cushing's Syndrome."

See the story and news clip here:
http://www.wjactv.com/news/13288711/detail.html

Canadian Media Contacts

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http://www.cbc.ca/includes/newsworld/contacts/cbcmorning_story_idea.html
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http://www.cbc.ca/national/yourturn/index.html

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