My dog, Phoebe, is going to turn 10 years old next month. It has not always been a certain thing that she would. When I adopted her at only 10 months of age from a kill-shelter here in New York City, Phoebe was badly abused and left for dead. After months and months of living in a loving home and supportive environment, she became less combatitive and aggressive, and her true, warm and loving nature came out.
Suddenly, with no warning signs, Phoebe’s life was in danger. At only a few months past her 3rd birthday, Phoebe came down with an acute “attack” of Immune-Mediated Hemolytic Anemia (IMHA). After three weeks in the hospital, she was out of imminent danger. Phoebe stayed on oral chemotherapy and steroids for over a year. Even so, the prognosis for her age and breed was only 85% mortality within 4 years.
It is now 7 years later. This past February, when going in for pre-dental blood work (for anesthesia clearance) we noticed her liver enzymes were way off. We’ve always known that one of the longer-term side effects of prolonged steroid use could be developing of Diabetes or Cushing’s disease. After further testing, it was confirmed for us on February 17th of this year, that Phoebe had full-blown Cushing’s Disease.
Historically Mitotane has been the treatment of choice for PDH. Mitotane causes selective necrosis of the zona fasiculata and the zona reticularis of the adrenal cortex. An induction period and a maintenance protocol are required with the use of mitotane and there is a relatively high incidence of side effects. This is not a good option for a dog like Phoebe with a history of IMHA. Mitotane could very easily over-treat her and throw her into Addison’s Disease or worse- a relapse of IMHA which, with her (now) Cushing’s Disease, would almost certainly be fatal.
Trilostane is a new drug to the US market. It works in a completely different way. It is a competitive inhibitor of the enzyme 3-beta hydroxysteroid dehydrogenase. It works at the level of the adrenal gland to block the normal steroidogenisis pathway of pregnenolone to progesterone to cortisol, aldosterone, and androstenedione.
The use of Trilostane for the treatment of PDH has been studied and reported on in the last five years. The results of these studies have been uniformly very positive. Clinical results include a reduction in clinical signs such as polydypsia, polyuria, polyphagia, panting, increased activity level, improved coat quality and skin condition. Treatment with Trilostane results in reduction of both cortisol and aldosterone; although the reduction in cortisol was more marked than the reduction in aldosterone.
Phoebe is alive today because of Trilostane. While available by prescription for many years in the U.K. under the brand name "Vetoryl", Trilostane is not available in the U.S. (pending FDA approval).
We buy Phoebe her Trilostane from a compounding pharmacy. They are responsible, efficient, and they are one of the only such institutions that will provide Phoebe with this life-saving and life-sustaining medication. Without it, her liver would shut down, and she would die (either from the progression of Cushing’s Disease or, more likely, from a relapse of IMHA).
I bring a unique perspective to this issue, as I am not just the pet-owner of a dog whose life depends on compounded medication. I am also a board qualified surgeon who takes care of hundreds of human patients each year. I rely on the FDA to regulate the pharmaceuticals industry to make sure that when I prescribe my human patients a medication, I can rest assured that they are getting exactly what I prescribe.
In my opinion, The FDA is right to investigate and regulate compounding pharmacies to make sure that medications are not being bought and sold without a doctor’s prescription (like some of the internet “pharmacies”.) However, to deny Phoebe and the countless other human and animal patients access to life-saving medications simply because they are manufactured in compounding pharmacies is simply immoral. Sadly, it seems that the FDA’s motivation is not that they’re acting in the interests of the general public’s safety. Rather, it seems this recent push to ban compounding pharmacies is primarily driven by the greedy motivations of the private pharmaceutical companies, like Wyeth. It is in their financial best-interests to restrict access to medications from compounding pharmacies. It is also clear that it is in the best interests of patients (human and animal) like Phoebe who depend on these life-saving and life-sustaining medications to keep compounding pharmacies operational and accessible.
There is a saying that you cannot solve complex problems with simple solutions. You can’t end world hunger by feeding a homeless, hungry person. Similarly, if you try to address the issue of disreputable, irresponsible, internet-based compounding pharmacies that sell dangerous and controlled substances to strangers over the internet by categorically banning the entire industry, you run the risk of throwing the proverbial baby out with the bathwater. Patients like Phoebe will pay the price. This is a complex situation that requires a more involved solution. It requires regulation, investigation and approval of credible compounding pharmacies that give life-sustaining medications otherwise unavailable while shutting down the disreputable ones that prey on the public.