Friday, May 4, 2007

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…….


Sherri Soper
Moscow, Tennessee

New Article on Pergolide Crisis!

Updated information and interview with Eleanor Kellon, VMD
Pergolide Availability: No FDA Announcement, Supplies Running Low
by: Erin Ryder, News Editor
May 04 2007 Article # 9526

"More than a month since pergolide mesylate, a drug commonly used to treat pituitary pars intermedia dysfunction (PPID), also known as equine Cushing's disease, was withdrawn for human use, the FDA has yet to make an announcement on whether it will allow bulk shipments of the drug to be imported for veterinary use."

(read the complete article)

Import Requests - Don't Delay Filing

Posted to EC List May 3, 2007 Msg #91059

I just want to emphasize as strongly as I can how important it is for
each and every owner of a Cushing's horse on pergolide to file one of
these applications to import drug.

**Note that the last line on the instructions says to allow 3 to 4
weeks for processing**

"Processing" isn't the same thing as actually getting permission either.

You have to get this information into the FDA well in advance of your
supply disappearing. Don't count on this getting resolved in time.
Don't rely on what your supplier is telling you. Don't wait because
you're not sure if you can afford imported drug. Definitely don't wait
until you run out. If they come up with a solution before you have to
use this option, great. If they don't, or if there is one in the works
but not up and runnning in time, your horse will be caught high and dry.
Print the file and get it to your vet NOW. Also let your vet know that
they will have to file one for each and every individual horse being
treated with pergolide.

Would also strongly suggest that it be sent with delivery confirmation
or signature required.

This is your safety net. Use it.