dyer@spdcc.UUCP (Steve Dyer) (10/17/86)
>In several interviews with officials of the F.D.A., there was a clear >indication that if aspirin had to be cleared today, that the F.D.A. >would make aspirin a controlled substance. Strictly speaking, which is what we like to do in sci.med, a "controlled substance" is a drug listed on one of the five Drug Enforcement Administration schedules which are numbered from I to V, roughly in order of decreasing abuse potential (at least as viewed by the medico-political bureaucracy.) The assignment of a drug to one of these schedules imposes strict controls on its manufacture, distribution and dispensing, and limits the number of refills allowed on its prescriptions. Now, the FDA can allow a drug to be sold over the counter or be restricted to use on prescription. A prescription-only drug, while certainly "controlled" is not necessarily a "controlled substance", and its status as prescription-only says nothing about its abuse liability. I have a tube of antibiotic eye ointment in my medicine cabinet which can be sold only on prescription, but it is not going to fetch much on the street. In the case of aspirin, were it introduced and approved today, it almost certainly would be limited to sale on a prescription. This is just standard practice for any new drug. If long-term experience demonstrates a drug's safety and efficacy in conditions for which self-medication is thought safe, then the drug may be allowed to be sold over the counter. Recently, drugs such as ibuprofen (analgesic), miconazole (anti-fungal), diphenhydramine (antihistamine) and others have been moved to OTC status. Aspirin is a powerful drug with effects on many different biochemical pathways, and it's worth keeping that in mind, if only for the added placebo effect, when you take it in the future. But, its abuse potential is just about NIL. There's no way it could ever be a controlled substance in the way that phrase is used. There is plenty of precedent for making an old drug a (more) controlled substance, however. In the early 70's, paregoric, a tincture of opium used for decades for treating diarrhea and easing teething pain, was moved from Schedule V to Schedule III, a move which automatically restricted it to be sold only on prescription. >There is a more "effective" form of the active ingredient in aspirin >which is made from boiling birch or aspen bark. Before "modern >medicine", this "tea" was often given to patients for fever and >pain. The instability and impurities however made the practice >very dangerous. It was not uncommon to get the equivelant of >2000 mg. (4 extra strength tablets) in a single cup. Two or three >cups of this "tea" could be quite interesting. Yeah, if salicylate intoxication is considered interesting. Maybe to a med student or intern; NOT to the victim! -- Steve Dyer dyer@harvard.HARVARD.EDU {linus,wanginst,bbnccv,harvard,ima,ihnp4}!spdcc!dyer
rb@cci632.UUCP (Rex Ballard) (10/22/86)
In article <433@spdcc.UUCP> dyer@spdcc.UUCP (Steve Dyer) writes: [excellent article on FDA schedules, restrictions...]. >But, its [aspirin] abuse potential >is just about NIL. Not quite, aspirin *abuse* has been shown to be a major factor in ulcers. In spite of warnings to the contrary, many people do take aspirin for extended periods of time, and more that the amount reccomended for a 24 hour period. [me] >>There is a more "effective" form of the active ingredient in aspirin >>which is made from boiling birch or aspen bark. Before "modern >>medicine", this "tea" was often given to patients for fever and >>pain. The instability and impurities however made the practice >>very dangerous. It was not uncommon to get the equivelant of >>2000 mg. (4 extra strength tablets) in a single cup. Two or three >>cups of this "tea" could be quite interesting. [steve] >Yeah, if salicylate intoxication is considered interesting. Maybe to >a med student or intern; NOT to the victim! Just in case anyone is confused here, "birch bark tea" can be very dangerous. I was not trying to reccomend it. >Steve Dyer Rex B.
dyer@spdcc.UUCP (Steve Dyer) (10/24/86)
>In article <433@spdcc.UUCP> dyer@spdcc.UUCP (Steve Dyer) writes: >[excellent article on FDA schedules, restrictions...]. >>But, its [aspirin] abuse potential >>is just about NIL. >Not quite, aspirin *abuse* has been shown to be a major factor in ulcers. >In spite of warnings to the contrary, many people do take aspirin for >extended periods of time, and more that the amount reccomended for a >24 hour period. Geez. Just as "controlled substance" means something quite specific, so does the phrase "abuse potential". There may be a group of people who habitually does themselves with aspirin for real or imagined ills, but the "abuse" is not related to the pharmacological actions of aspirin. In the same vein, it is not "aspirin abuse" that can cause a propensity to developing ulcers. It may be necessary to prescribe long-term high doses of aspirin or other anti- inflammatory drugs even though they can produce outright stomach ulcers or simply gastric bleeding. In selected cases, the therapeutic benefits outweigh the chances of GI problems and other side-effects. Aspirin is not thought to have any psychotropic effects which would otherwise cause it to be chosen as a drug of abuse. -- Steve Dyer dyer@harvard.HARVARD.EDU {linus,wanginst,bbnccv,harvard,ima,ihnp4}!spdcc!dyer