Pergolide Cleared for Equine Veterinary Use by FDA

This announcement just in from the FDA:

May 11, 2007

CVM Working to Address Concerns about Supplies of Pergolide for Horses

The Center for Veterinary Medicine (CVM) is aware that veterinarians and horse owners are concerned about the issuance of an FDA Public Health Advisory (PHA), www.fda.gov/cder/drug/advisory/pergolide.htm, detailing the removal of pergolide products from the market. Pergolide, a drug used to manage the signs and symptoms of Parkinson’s disease in humans, is being removed from the market due to concerns about cardiac side effects.

CVM recognizes that veterinarians are prescribing pergolide for the treatment of Cushing’s Syndrome in horses. Veterinarians have been prescribing the drug under the provisions of the Animal Medicinal Drug Use Clarification Act which allows veterinary practitioners to prescribe approved human drugs for “extralabel” use in animals.

FDA is working with the sponsors of the approved products and all other interested parties to ensure that pergolide remains available to treat Cushing’s Syndrome in horses until a new animal drug application is approved for that use. This includes trying to make the approved product available through veterinary distribution channels and exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide. Bulk substance used for pharmacy compounding should be labeled for “animal use only.” All pharmacy compounding must be done under a valid veterinary prescription to treat an affected horse.

Although the sponsor has stopped marketing pergolide for human use, CVM will also work with sponsors who are interested in seeking approval of a new animal drug application for the use of pergolide to treat Cushing’s Syndrome in horses.

For more information, contact Christopher Melluso, DVM, at Christopher.Melluso@fda.hhs.gov or (240) 276-9065.

New Lameness Treatments: IRAP™ Therapy

One of several new high-tech treatments for equine lameness is the creation of an enriched serum injection for horses with potential joint damage. "IRAP" is not a new hip-hop group; it's a therapy that has quickly made its own place at the table of equine therapy, especially for sport horses and racehorses whose owners expect a return to the previous level of soundness and performance...in the shortest possible length of time.

Interleukin-1 Receptor Antagonist Protein (IRAP™) therapy works like this: the veterinarian, often a surgeon or lameness specialist, injects a horse’s affected joint with serum that contains anti-inflammatory proteins that block the harmful effects of Interleukin-1 (IL-1), an inflammatory cytokine that has been shown to accelerate destruction of cartilage during osteoarthritis. (A cytokine is a chemical secreted by the immune system to attack infections and damaged or dying cells.)

What makes the process a little complicated is that Interleukin-1 (IL-1) is a quite normal part of the horse's inflammatory response but it can sometimes be detrimental to a horse's joints and accelerate damage to cartilage there. IRAP™ creates a barrier that prevents IL-1 from having its damaging effect.

Since the serum sample is derived from the horse’s own blood, there is minimal risk of an adverse reaction. The incubated serum also does not contain any drugs.

The treatment process consists of drawing a blood sample using a special syringe containing glass beads. The blood is incubated for 24 hours and a centrifuge separates the serum from the red blood cells. The serum, now enriched with Interleukin-1 receptor antagonist protein, is divided into three or four doses. The horse receives one dose injected into the affected joint once weekly for three to five weeks.

A quick check around the web found that quite a few vet clinics are promoting IRAP therapy. Here are some comments from veterinarians:

Dr. Laura Werner of The Equine Center in San Luis Obispo, California: "The reason IRAP is so exciting is its potential for a long-term effect on battling osteoarthritis. Whereas some of the therapies might only have short-term effect, IRAP has the potential to stop the cartilage matrix from being degraded and increase healing. IRAP has the ability to stop the inflammation cycle and bring comfort to your horse. The research on IRAP is ongoing but the results have been very encouraging."

Dr. Laurie Tyrrell of Virginia Equine Imaging: "IRAP can also be used as maintenance therapy throughout a competition season to reduce the amount of steroid use. IRAP therapy is not for every horse. There are some factors that make a horse a less successful candidate; however the therapy shows great promise for horses that have become refractory to traditional management of osteoarthritis, as well as offering an alternative therapy for those worried about excessive use of corticosteroids."

According to the web site of Steinbeck Country Equine Clinic in Salinas, California: "Coffin joints and stifles that don’t respond well to steroid injections seem to be the most popular condition to treat (with IRAP therapy). Reactions are uncommon largely due to the fact that it is the patient’s own serum."

IRAP is one of the many therapies and treatments that will be on the program of the 4th International Equine Conference on Laminitis and Diseases of the Foot to be held in West Palm Beach, Florida, from November 2-4.

Pergolide Update: Resource Blog Launched for Horse Owners Concerned about Drug Ban

Above: a horse shows common signs of Cushings disease, including the telltale long coat that does not shed. Horse owners report a rapid improvement of the appearance of horses when they receive pergolide as a medication for Cushings disease. Photo courtesy of our friend, Dr. Christian Bingold.

A proactive horse owner in Pennsylvania has pleaded her case for U.S. Food and Drug Administration (FDA) release of the Parkinson's disease drug "pergolide" for equine veterinary use by enlisting the power of the broadcast media. Horseowner Judy Amick and her veterinarian were interviewed for a story that ran on the 5:00 news yesterday on WJAC-TV6, the NBC affiliate in Johnstown, Pennsylvania.

Pergolide is widely used to medicate horses suffering with Cushings disease. Many people credit oral pergolide medication with controlling their horses' Cushings symptoms, especially the periodic low-grade laminitis that is a common side effect of the disease.

Recently, pergolide was removed from the US drug market by the FDA because of side effects experienced by human users.

Horse owners say that their horses have no side effects, and that the drug is actually keeping horses alive that would have to be euthanized without the drug.

Click on this link to watch a clip from the segment: http://www.wjactv.com/news/13288711/detail.html?rss=john&psp=news

The withdrawal of pergolide has been a call to arms for Pennsylvania veterinary expert and author Eleanor Kellon VMD. She is the resident medication expert on the 5000-member "Cushings list" discussion group on Yahoo.com. The discussion group helps support owners of horses with Cushings or insulin resistance problems.

To mobilize of horse owners to take action in the pergolide situation, Kellon has launched a blog designed to give details on the drug's political battles, and to give owners resources for letterwriting and petitions.

Click on this link to go to the new blog: http://pergolideaction.blogspot.com/

"This site has been started to keep (people) current on the latest information in the fight to keep pergolide available for our horses," Kellon writes of the new blog. "There is at present no viable alternative to pergolide to control Cushing's Disease (PPID) or to stave off the debilitating, often painful and life-threatening side effects of this disease."

Kellon encourages horse owners to sign the "Save Pergolide" petition, and use the site's links to write to federal and state officials, elected representatives, equine veterinarian associations, state horse councils and groups.

Martin Deacon Wins 2007 Farriers Prize at Badminton Horse Trials

At the prestigious (and grueling) Badminton Horse Trials in the Cotswold district of England this weekend, one of the world's best farrier competitions was held, and there were no anvils or forges in sight.

Each year, Badminton presents The Farriers Prize, which is a "Plaque to Owner and Farrier of the Best Shod Horse." As I recall, the horses put forward for the prize are inspected and evaluated by a representative of the Worshipful Company of Farriers.

In the past two years, the winners were Welsh farrier teammates and world champion competitive farriers, James Blurton and Billy Crothers. Another year, I remember the prize going to Sam Head, son of Mac Head FWCF, for his shoeing job on one of William Fox-Pitt's horses.

This year's winner was Top 12 finisher Sarah Cohen's Hide and Seek II, and the winning farrier was Martin Deacon FWCF of Leicestershire, England. Sarah was also the highest-placed British rider this year.

Martin is a very well-known farrier in Britain, and a stalwart of the Worshipful Company of Farriers. He is also the author of one of the most popular books sold in the Hoofcare and Lameness library; No Foot No Horse (Foot Balance: The Key to Soundness and Performance) is Martin's treatise on using conventional balance paradigms to shoe both correct and crooked-legged horses. Portions of the book have been reprinted as articles in Hoofcare and Lameness over the years.

Photo of Clayton Fredericks presenting W P in Limbo at the initial vet inspection in front of Badminton House in Gloucestershire, England courtesy of Kit Houghton and Mitsubishi Motors. Yes, the game of badminton takes its name from this estate, although the game was brought back to England by British officers who had been stationed in India. When it was played at an 1873 party on the lawn on Badminton House, the home of the Duke of Beaufort, the nameless game became ever linked to the foxhunting estate.

Accelerometry for Track-to-Hoof Evaluation Funded in Canada

"Comparing track surfaces using accelerometry and strain measurements on the hoof as biomechanical indicators of the hoof track interaction" is the title of a study that has received second-year funding at the university of Guelph in Ontario, Canada. Principle researchers are Drs. J. Thomason and A. Cruz.

The Quarter Racing Owners of Ontario recently joined both the Ontario Thoroughbred and Standardbred Racing Industry and private donors to fund Equine Guelph’s Research Program athe University of Guelph. This generous support has enabled the program to celebrate an important milestone with funds surpassing $500,000 for 2007-2008 for equine research.

Stem Cell Therapy for Suspensory Injury Shown on Vet Hospital Video

Here's a link to a video of a surgical procedure at the New England Equine Practice in Patterson, New York. This is one type of procedure for stem cell therapy. The surgeon extracts bone marrow from the horse's sternum to harvest stem cells, which are then injected into the tendon or ligament that is damaged.

The video is posted at this link:
http://www.lohud.com/apps/pbcs.dll/article?AID=/20070505/VIDEO/305050015&SearchID=73280174051805

More information on this type of therapy, which was developed by surgeon Roger Smith at the Royal Veterinary College in England, is at the web site of the Vetcell company, marketers of the procedure.

You can also read an article about New England Equine Practice's new surgical facilities and hospital.