Monday, April 19, 2010

When Pharmacists Kill Horses, DoJ Gets Interested

Last April I wrote a post entitled Weights and Measure at the Polo Grounds in which I speculated that the sudden death of 21 polo ponies in Florida would end up being due to

"... an accidental supplements toxin due to mislabeling by someone who does not speak English too well."

I further speculated that the problem was likely Selenium poisoning.

The problem in Florida was that there were too many cooks in the kitchen, and with each turn of the spoon the chance for the supplements recipe to get screwed up rose exponentially.

Time will tell, but I will bet that the final story is that the Spanish-speaking veterinarian gave a formula to the U.S. vet, who then gave it to the compounding pharmacist. Somewhere along the way -- perhaps due to translation problems -- I suspect a microgram measurement for Selenium was translated as a milligram measurement for Selenium. The result was that 21 horses got 1,000 times more Selenium injected into them than they should have.

Death followed pretty quickly.

An equine veterinarian came in on the comments section of this post (see link, above) and defended compounding pharmacies.

With very little research I deduced this vet was affiliated with a compounding pharmacy that promised obliging vets that they would create a dependency model that would indenture their equine clients to the vet. Is that a scam? It sure isn't entirely kosher, is it?

I then went on to note that the business model of non-mail order compounding pharmacies was very shaky and generally subsidized by Medicare and Medicaid fraud in the form of off-label marketing abetted by kickbacks paid to doctors (and sometimes to vets). I also noted that in most cases the drugs being compounded are not FDA-approved.

Guess what? I was right. This morning the U.S. Department of Justice issued a press release:

The United States has filed a civil suit on behalf of the Food and Drug Administration (FDA) in U.S. District Court in the Middle District of Florida, against Franck’s Compounding Lab Inc., dba Franck’s Lab, a compounding pharmacy located in Ocala, Fla. The government alleges that Franck’s has been introducing adulterated, misbranded and unsafe drugs into interstate commerce as part of the company’s veterinary pharmaceutical compounding business, and has asked the court for a permanent injunction that would prohibit Franck’s and its CEO, Paul Franck, from using bulk pharmaceutical ingredients in its compounds. According to the government’s complaint, Franck’s compounded a drug mixture last year that killed 21 polo horses belonging to a Venezuelan team that was in Florida to compete for the United States Polo Championships.

Franck’s is in the business of drug compounding, which is the mixing, combining or altering of drugs to accommodate the particular needs of specific patients. Compounding is common in both human and veterinary medical industries, and the FDA and Department of Justice have long recognized that it is a necessary and valuable service. However, the agencies become concerned when pharmacies use compounding as a way to circumvent the regulatory requirements of the drug approval process and potentially put consumers and animals at risk.

Franck’s compounds drugs for human and veterinary use, but the suit for a permanent injunction only pertains to the company’s veterinary practices. In the past year, inspections at Franck’s have revealed that the company compounds most of its veterinary drugs from active pharmaceutical ingredients called "bulk" ingredients. This practice is prohibited by the statutes and regulations that govern veterinary compounding. Animal drugs created from bulk ingredients do not undergo FDA approval, and no clinical testing or other controls are in place to ensure their safety. The government alleges that Franck’s use of a bad mixture of bulk drugs a year ago led to the deaths of the 21 horses.

In addition to using bulk drugs for compounding, Franck’s also eludes the regulatory scheme by creating drugs that are compounded copies or near-copies of approved drugs that are already on the market. Franck’s distributes its drugs throughout the country. The company has refused to stop these practices in spite of several warnings from FDA that its activities were illegal.

"We allege that the practices at issue in this case contributed to deadly results," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "The Justice Department and our federal partners will work together to pursue pharmacies that put the health and safety of animals at risk."

"Misbranding" for those who wonder, is the same as off-label marketing.

As for Franck's Lab, it is now being sued for $4 million by the horse's owners. And yes the horses did die of Selenium poisoning as I speculated.

1 comment:

Seahorse said...

But for trying to cheat, those horses would be alive. Where's the basis for suit?