Why Can't Veterinarians Get The Medicine They Need To Treat Your Dog For Heartworms ?

What You Can Do ?

This is an archived article. It Is no longer relevant

This article is out of date. In October of 2013, Merial announced that it was increasing its European production of Immiticide® to meet US demand. But despite their assurances to the contrary, Immiticide® availability remained spotty.

In February, 2017 Merial's competitor, Zoetis announced that they were introducing an identical product, DIROBAN™, and promised more reliable availability.

Ron Hines DVM PhD ....September 12, 2011

Lots of my articles are plagiarized and altered on the web to market products and services. There are never ads running or anything for sale with my real articles. Try to stay with the ones that begin with http://www.2ndchance.info/ in the URL box or find all my articles at ACC.htm.

In August, 2011 Merial, the makers of Immiticide, a critical product in the treatment of dog's with heartworms, abruptly sent a letter to all veterinarians telling them that the product would not be available until further notice. No date or explanation was given.

Much has changed in the culture of the pharmaceutical industry since George Merck guided his Company to glory in the 1920s - Dr. Merck is one of my greatest heroes.

Their current CEO, Chris Viehbacher, through a spokesperson, cryptically announced that:

"new manufacturing challenges" not related to previous interruptions in immiticide supply, were the current problem. The announcement continued to say that the current unavailability is "related to technical issues providing the finished product". In other statements, they vaguely talked about the difficulties of finding suitable sources of the active ingredient, melarsomine.

 

The spectacular element in the current problem is how little information Merial's management is willing to provide to their own field representatives and practicing veterinarians alike. Merial staff know what might happen to them personally when they do not follow the rules.

 

 

At veterinary gatherings , rumors abound. Some mention increasing demands from the regulators of OSHA, The EPA and The FDA. But Merial representatives have been extremely quite about informing us veterinarians what is going on.

I was not able to get any of the Staff of the FDA"s animal drug regulatory arm, the CVM, to give me additional information as to when my clients will get this medication. Neither the CVM Director, Dr. Dunham, or Dr. Flynn responded to my emails and my phone calls were never returned. The flashy CVM-FDA website does not even acknowledge a shortage or unavailability of Immiticide ("Hello? Anyone home?").

I do not have the resources to pursue the matter with them. Perhaps one of you, reading this article, has the time and temperament to do so. If so, God Bless you; I will help you in any way I can and I will revise this article according to the information you send me. You can view some of the players phone numbers below.

I spend some time attempting to understand the current situation and this is what I found :

At one time, there was a US supplier of the raw ingredient in Immiticide, melarsomine. There no longer is. Immiticide's active ingredient is arsenic. Arsenic's use in America is highly regulated by multiple agencies. Current EPA , OSHA and NIOSH arsenic regulations are vague and overlap and will make it quite difficult for a new one to come online any time soon without a very forceful advocacy. (pharmaceutical-grade melarsomine might still be manufactured 128470-15-5). 

Merial states that their current "mystery supplier" is overseas. The only listed overseas supplier of melarsomine displayed in FDA records is LOBA Feinchemie GmbHm , a reagent and fine-chemical supplier with multiple locations, but based in Austria.

Merial states that the supply problem is occurring at their packaging subcontractor in the US.  The label of the Immiticide sold in both Canada and the Philippines states that it is packaged for Merial by Bedford Laboratories, a division of Ben Venue Laboratories Inc. of Bedford Ohio.

There is an interesting fact that may have something or nothing to do with our current predicament. It concerns the fact that in 1997, Bedford Laboratories was purchased by another giant drug company, Boehringer Ingelheim GmbH , based in Germany. Boehringer is a direct competitor of Merial (now part of a French company, Sanofi )

There is little love lost between these two Pharma Giants. They have sued each other frequently - at least once in 2009 and are currently in court again in Atlanta.

So Immiticide might be a toxic brew in many respects. For now, this is what the Heartworm Society recommends your vet do.

Please share any information you may have with me; I will post it here.

I've made my evening rounds, checked the water bowls, locked everything up. Its late and I should have headed home long ago. I give my Lab, a pat on the head and ask him "What's up Max ? Are we caught in the crossfire between two Pharma Giants? Have unreasonable regulatory roadblocks and bureaucratic incompetence taken this important drug off the market? Or, is this a slick ploy by a clever CPA in creating shareholder value , ie soften up veterinarians and the public to accept a huge price increase when Immiticide does come back on the market ? "Max, too bad George Merck isn't around any more." RSH

So What Can You Do ?
 

1. Today, September 12th, there are 50 billion web pages like this one indexed by Google. .. Merial and the FDA are counting that this page will not be opened very often. You can change that by mailing the URL, of this page to as many dog lovers as you know. URL = http://www.2ndchance.info/heartwormImmiticideshortage.htm (Just cut and paste the URL into an email to friends who love their pets.)

2. Contact Chris Viehbacher in Raleigh and explain, politely, in your email that your future purchase of Merial/Sanofi brand products are linked to the way he handles this veterinary emergency.

3. Contact Bernadette Dunham , in charge at the FDA, whose Mission is supposed to be to assure that each and every pet has access to the medications it needs, when it needs them. Ask if she might move faster to get this problem solved and explain to her that your personal pet's health , not the sensibilities of Merial , should be foremost in her mind.

Click Here to get their complete staff contact information

Back to article on heartworms