The ethical debate

The ethical debate

Pirated drugs are becoming more commonplace in veterinary medicine. Although this is especially true in equine medicine, it has permeated all aspects of clinical medicine. Veterinarians are substituting drugs approved by the U.S. Food and Drug Administration (FDA) with inferior products that make claims that they are generic equivalents to brand name drugs. These claims are untrue and misleading to owners and trainers. This issue also presents new challenges for the equine practitioner in discussing the issue with his or her clients. How do you effectively discuss the subject without causing a potential rift with clients?

This article examines this ethical dilemma, and it answers how to effectively communicate with clients about the impact of pirated drugs on their horses.

Ethical debate During the past 13 years as an ethicist, I (Rollin) have examined more than 150 ethical issues that have arisen in veterinary medicine, either directly or in the columns I write. While some of these issues represent true dilemmas, with strong arguments that can be marshaled on each side of a given issue, many others are quite straightforward and their ethical resolution is unambiguous.

I cannot think of a better example of an issue with clear ethical resolution than the one facing us in this discussion-the use of pirated drugs -where veterinarians dispense copies of established veterinary drugs. The basic reason that this is a problem is that these drugs compounded from bulk ingredients-unlike the branded (FDA-approved) products or approved U.S. generic equivalents and registered products-do not undergo FDA-approved testing for safety, efficacy and are not produced under conditions that conform to FDA's Good Manufacturing Practices, which include standards for quality, purity, stability, strengths and consistency. In my view, dispensing such drugs, as done by many veterinarians to increase profit well above what they can make with approved drugs, violates every sort of moral obligation inherent in veterinary medical ethics.

Set in law The Federal Food, Drug and Cosmetic Act (FDCA) stipulates that if a drug is not produced under "good manufacturing" procedures, an assurance of quality, strength, potency, consistency and stability, then the drug is misbranded, adulterated and mislabeled.

FDCA (Sec.501.[351]) states that a drug or device shall be deemed to be adulterated: "if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing or holding do no conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess."

Ethical obligation: Using untested non-quality controlled drugs violates a veterinarian's obligation to the animal, experts say. Counsel your clients by talking to them candidly about these important issues.
This is not just law, but clinically and pharmacologically essential. Unless Good Manufacturing Practices are followed, it is nearly impossible to assure that what a label says is in the formulation is actually in the formulation and will be there for a reasonable period of time (i.e. shelf-life). When one substitutes an approved drug, to be administered by a given route, with a pirated (i.e. counterfeit with the intention of using the substandard product to replace the approved product), then one by definition is applying substandard care.

Crossing that gray line Veterinarians, by virtue of their profession, have moral obligations to clients, animals, peers and the profession, themselves and society in general. A brief examination of each of these categories will manifest that the use of pirated drugs is paradigmatically violative of all aspects of veterinary ethics.

Using untested, non-quality-controlled drugs violates a veterinarian's obligation to the animal patient, because these drugs may be ineffective or even dangerous. For example, CBS reported that in 1995 counterfeit cough medicine was associated with the death of 89 people in Haiti, and counterfeit gentamicin caused 66 deaths and numerous cases of irreversible severe reactions. Since owner and animal interest coincide in treating disease, using counterfeit drugs that may be ineffective or harmful also harms the client, whose interest is in treating a sick animal.

In the same vein, dispensing such medication violates veterinarians' obligations to society under whose aegis veterinarians are chartered as professionals. The Veterinarian's Oath tells us that veterinarians are charged with using their scientific and science-based knowledge to the benefit of society. Insofar as science has shown the inefficacy and dangers of counterfeit drugs, dispensing them violates society's trust in veterinarians, who, in using such drugs, place self-interest over obligation. For precisely the same reason, counterfeit drug use violates a practitioner's obligation to peers and the profession, by eroding public trust in veterinary medicine.