New interpretation of Controlled Substances Act oversteps the letter of the law

I wish to complement Greg Cima for his excellent JAVMA News article¹ on possible upcoming changes to the federal Controlled Substances Act. These changes are necessary because of a new interpretation of the act by officials with the Drug Enforcement Agency that would prevent veterinarians in mobile veterinary practices from carrying controlled substances in their vehicles.²

Recently, DEA officials notified some veterinarians that they needed to obtain a separate registration for each location where they store, distribute, or dispense controlled substances. I contend that such an interpretation is an overreach, in that the DEA regulations indicate, “An office… where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular part of the professional practice of the practitioner at such office, and where no supplies of controlled substances are maintained” should not be considered a place where controlled substances are manufactured, distributed, or dispensed.³

As for those registered veterinarians who, when away from their clinic, administer or dispense controlled substances at a particular client's farm or home on a non-regular basis (eg, for euthanasia or nonregular farm visits), registration of that particular client's place should also not be required because the farm or home is not the veterinarian's office. In addition, in United States [DEA] v. Clinical Leasing Service Inc,⁴ the federal Fifth Circuit Court of Appeals declared that a separate registration is required “[i]f a physician intends to dispense controlled substances from a particular location several times a week or month.”

Any veterinarian who administers or dispenses controlled substances in more than one state must have a DEA facility registration for each such state. Also, if a veterinarian stores controlled substances at a client's farm or home, she or he would be subject to the DEA registration requirements for that location. But for the DEA to contend that veterinarians must first register each location where they administer or dispense a controlled substance before they can administer or dispense at that location would seem to go well beyond the spirit of the law.

Gregory M. Dennis

Veterinary Law Center, Leongatha Law LLC, Independence, Mo.

Complementary and alternative medicine merits further exploration

I disagree with the statement by Drs. Simon and Gordon Baker in their recent letter¹ that “[t]he single most important outcome of the billions of dollars of research funded by the National Institutes of Health National Center for Complementary and Alternative Medicine (NCCAM) is the revelation that almost nothing that has been studied had any reproducible effects on patients.”

Consider, for instance, the glucosamine-chondroitin arthritis intervention trial, which was funded by the NCCAM in conjunction with the National Institute of Arthritis and Musculoskeletal and Skin Diseases.² This was a randomized controlled clinical trial designed to test the short-term effectiveness of glucosamine and chondroitin sulfate in human patients with knee osteoarthritis. Researchers found that participants who took celecoxib, the positive control, had significantly better pain relief, compared with those who took a placebo. Overall, participants who took glucosamine–chondroitin sulfate did not have significantly better results than did those who took the placebo. However, in subgroup analyses, glucosamine–chondroitin sulfate was found to provide significantly better pain relief, compared with placebo, for participants with moderate to severe pain.

Although the authors cautioned that their findings for participants with moderate to severe pain were preliminary and needed to be confirmed in further studies, these results, I believe, suggest that there are options for treatment of moderate to severe arthritis other than NSAIDs. To summarize these findings as not showing any reproducible effects on patients is an inadequate analysis of the data. Importantly, this study cost $12.5 million, showing how difficult and costly it can be to obtain a definitive answer on the effectiveness of certain treatments.

I spent a day earlier this year in Los Angeles meeting with academic researchers working with NCCAM to develop research projects. One of the difficult challenges facing researchers working in the field of complementary and alternative medicine is handling the complex approaches required with this type of research because treatments are typically modified for individual patients. Much more effort is needed to work through these challenges, but I believe that future studies will definitely show an impact.

The integrative movement is not about bringing all complementary and alternative medicine modalities into the fold of conventional medicine. There must be at least some scientific evidence for its use before any particular modality is considered for inclusion in a clinician's tool box. Developing evidence is a process, and no single positive or negative finding is sufficient to do that reliably.

I wanted to respond to the letter¹ by Drs. Simon and Gordon Baker regarding pragmatic versus philosophical evaluations of complementary and alternative medicine. As a practitioner who has integrated homeopathy into her practice for more than 16 years, I naturally have a deep interest in objective, fact-based discussions on the topic.

Complementary and alternative medicine is a general term that encompasses a multitude of disparate modalities. These often differ from one another as much as internal medicine differs from surgery. Therefore, I disagree with the attempt by Drs. Baker and Baker to lump them all together when they declare that “such therapies do not work.” Likewise, I take exception to the statement that “[t]he single most important outcome of the billions of dollars of research funded by the National Institutes of Health National Center for Complementary and Alternative Medicine is the revelation that almost nothing that has been studied had any reproducible effects on patients.”

Scientific discovery is a process. When we talk about merging two totally different approaches to medicine, one that is largely mechanistic and one that is largely vitalistic, our discussion of evidence is biased toward proof that can be understood from the mechanistic approach. This by necessity entails years of research to develop the methodology to convert outcomes that may differ from those that are typically expected with, for example, clinical trials on drugs, to data that can be measured according to current mechanistic standards. This boils down to two choices. We can allow ourselves to say that this sounds too expensive and should not be pursued, or we can acknowledge that, given historical records and preliminary findings of studies funded by the National Center for Complementary and Alternative Medicine, complementary and alternative medicine approaches merit further exploration.

I agree with the letter writers that all good medicine should, at least in theory, be considered holistic medicine. However, in their description of the 2006 undercover investigation during which an individual posing as a student about to travel to West Africa contacted 10 homeopaths in and around London to ask about homeopathic alternatives to conventional antimalarial tablets, they neglect to mention that this was not an objective study, but rather an investigation performed by two outspoken skeptics of homeopathy, and was reported not in a peer-reviewed journal but in a blog.

Dismissing complementary and alternative medicine approaches out of hand diminishes the potential for an important exchange of information that holds the potential for life-saving developments. Consider the evolution of nitroglycerin from a homeopathic remedy for headaches to a useful drug for the treatment of angina.² Nitroglycerin was first tested as a homeopathic remedy in the mid 1800s by Constantine Hering, who reported on its dramatic effects in people. According to Fye,² these observations were the first critical step that eventually led to the adoption of nitroglycerin as a treatment for angina. Similarly, my second published report³ on clinical resolution of nasal aspergillosis in a dog following treatment with a homeopathic remedy represented collaboration between a veterinary teaching hospital and a homeopath. As a result, I have been contacted by veterinarians across the United States and from abroad to collaborate on other cases of nasal aspergillosis that have not responded to conventional treatment.