(Beth Clifton photo)
Regulators act on request from China
(See also Loss of access to ketamine threatens progress in humane euthanasia, by Ruth Steinberger.)
SCHAUMBURG, Illinois––Pending proposals to more strictly regulate veterinary access to ketamine, both in the U.S. and worldwide, have prompted the American Veterinary Medical Association to repeatedly appeal to membership to submit letters of comment to the U.S. Food & Drug Administration supporting AVMA efforts to keep ketamine available.
While the initial comment period closed on October 15, 2015, regulatory proposals receiving a heavy response are often reopened for further comment and reconsideration.
Ketamine
FDA responding to WHO
The Food & Drug Administration on October 5, 2015 “issued a request for comments regarding the abuse potential, actual abuse, medical usefulness, trafficking and impact of scheduling changes on the availability for medical use of 10 drug substances – including ketamine,” the AVMA warned both on October 8 and October 13. “The comments will be considered as FDA prepares a response to the World Health Organization regarding the abuse liability and diversion of these drugs.
“The AVMA is drafting a letter to the FDA that will outline how critical ketamine use is in veterinary medicine and how important it is that it remain available to U.S. veterinarians as we treat our patients,” the AVMA alerts said. “But our voice is made stronger when it is joined by the voices of individual members.”
(Beth Clifton photo)
Ketamine not now controlled internationally
Continued the AVMA, “Ketamine is not controlled internationally under either the Psychotropic Convention or the Single Convention on Narcotic Drugs. The World Health Organization Expert Committee on Drug Dependence,” which has advised the United Nations about relevant aspects of international law since 1971, “reviewed ketamine at its 34th, 35th, and 36th meetings,” but did not take action to restrict it.
“On March 13, 2015,” the AVMA explained, “the United Nations Commission on Narcotic Drugs decided by consensus to postpone the consideration of a revised proposal concerning the recommendation to place ketamine in Schedule IV of the Psychotropic Convention and to request additional information from the World Health Organization.”
A Schedule IV placement would put ketamine in the same category of international regulation as the sedative phenobarbital and the euthanasia drug pentobarbital, among other barbiturates commonly used by veterinarians. This would not significantly affect U.S. veterinary practice or animal shelter procedures.
(Beth Clifton photo)
China wanted stronger regs than proposed
However, the AVMA warned, “The original proposal brought by China to the March 2015 meeting of the United Nations Commission on Narcotic Drugs was to place ketamine in Schedule I, and we have been given different opinions by Food & Drug Administration and Drug Enforcement Agency on whether a more stringent international scheduling of ketamine would impact the U.S. classification. Hence AVMA’s concern and continued engagement and advocacy on this issue.”
Schedule I, by definition, “includes drugs claimed to create a serious risk to public health, whose therapeutic value is not currently acknowledged by the Commission on Narcotic Drugs. It includes synthetic psychedelics such as LSD in addition to natural psychedelics.”
Most Schedule I drugs are already illegal to possess or sell in most of the 183 nations belonging to the United Nations Convention on Psychotropic Substances, which is descended from the 1912 International Opium Convention, reinforced in 1961 by the Single Convention on Narcotic Drugs.
(Beth Clifton photo)
Ketamine banned in Russia
Ketamine possession is already banned or severely restricted by many and perhaps the majority of Convention on Psychotropic Substances member nations. Most influentially, Russia banned ketamine in 1998, after it became notorious through illegal use as a date rape drug, and in connection with human trafficking, especially by the sex trade. Similar legislation and regulations soon followed throughout eastern Europe.
Russian veterinarians were allowed to continue to possess very small amounts of ketamine. The amounts they were allowed were increased in May 2003. In January 2004 the ketamine ban was lifted for licensed veterinary users, but no licensing procedure was established.
Later in 2004 the Russian Drug Enforcement Agency charged 19 veterinarians for alleged illegal use of ketamine.
(Beth Clifton photo)
At least two vets convicted
The Kuzminsky Regional Court of Justice in Moscow, Russia, in May 2004 acquitted veterinarian Konstantin Sadovedov of illegally using ketamine to immobilize a cat during surgery. Two other veterinarians, however, Alexander Duka and Olga Tanayeva, were convicted and given probationary sentences of one and three years, respectively. ANIMALS 24-7 has not learned the outcomes of the other 16 cases.
The Russian Drug Enforcement Agency meanwhile reportedly sued the newspaper Novaya Gazeta and threatened to bring charges against the animal rights organization VITA for publicizing the prosecutions and campaigning to loosen the restrictions on possession of ketamine.
Developed during Vietnam War
First synthesized in 1962, ketamine received U.S. Food & Drug Administration approval as an anesthetic in 1970, and came into widespread use by U.S. military medical units to treat wounded soldiers in the field during the latter part of the Vietnam War.
Misuse of ketamine as a date rape drug was documented in the U.S. disco club scene soon afterward. Concern about the availability of ketamine gradually increased during the next two decades.
(Beth Clifton photo)
U.S. case fueled global concern
In July 2002 former Hornocker Wildlife Institute researcher Patrick Ryan, 51, was convicted on 36 criminal charges including kidnapping, aggravated battery with a deadly weapon, and 20 counts of rape.
Ryan had kept research assistant Jennifer Cashman heavily drugged for seven months in 1996-1997 by slipping ketamine and another animal tranquilizer, telazol, into her food at a bear research station in the Gila Wilderness of New Mexico.
Both Ryan and Cashman were assigned to the station as part of a five-year study of the impact of hunting on bears, commissioned by the New Mexico Dept. of Game and Fish.
After Cashman was hospitalized for two weeks with impaired coordination and blurred vision, having apparently ingested more of the drugs for longer than anyone else on record, friends investigating what they then believed was a severe case of carbon monoxide poisoning found six hours of videotapes showing Ryan sexually assaulting her while she was apparently unconscious.
Her subsequent civil suits against Ryan, Hornocker officials, the New Mexico Department of Game and Fish, and the drug makers were settled out of court. The terms were not disclosed.
While the widely publicized case was pending, the U.S. Food & Drug Administration in August 1999 placed ketamine on Schedule III of the U.S. Controlled Substance Act.
Other internationally influential jurisdictions stringently restricting ketamine possession but allowing limited access by health professionals include Hong Kong, since 2000; Taiwan, since 2003; Canada, since 2005; India, since 2013; and the United Kingdom, since 2014.