Pharmaceuticals


The FDA’s Center for Veterinary Medicine has posted updated Cumulative Adverse Drug Experiences (ADE) Summaries Reports, containing data from 1987 through 11 April 2007.

More information about the ADE reports can be found here and here (the latter page describes limitations in the ADE reports). An FAQ on the ADE reports is here. The form for submitting an ADE is here.

Reports are arranged by active ingredient (generic drug names are used), species, and route of administration. Some drugs have hundreds or thousands of reports; others have only a handful. Each report includes a list of reported reactions. Unfortunately, reaction types don’t seem to be fully standardized, so one can find the same type of reaction listed several different ways. For example, the report on carprofen administered orally to cats lists eight reports of “K HI, BLD” and one report of “K HI, BLOOD.” Similarly, what is the difference between “HYPOTHERMIA” and “HYPOTHERMIA, BODY,” both of which are reported six times. Some of the reported reactions are puzzling: one cryptic reaction reported for carprofen is “BLD.”

Still, the ADE reports are a wonderful resource for veterinarians who might be wondering if the odd reaction they’re seeing to a drug has been reported by anyone else.

The latest American Journal of Veterinary Research arrived at catmanager’s office the other day. The issue (Vol. 63, No. 3) is available online here. Of note in the new issue:

  • A study (246–250; abstract here) of buprenorphine’s effects on horses finds (as with other opioids) a significant excitatory response to doses at 5 μg/kg and 10 μg/kg but an analgesic effect at only the higher dose.
  • A study (258–264; abstract here) of the long-term (90 days) oral use in dogs of five NSAIDs finds only minor changes “in hemostatic and serum biochemical variables” for each studied drug. The study did find variability in the frequency of adverse gastrointestinal effects, with carprofen causing the fewest, followed by meloxicam. The authors recommend periodic monitoring of dogs on long-term NSAID administration with CBC, serum chemistry, and endoscopy.
  • A controlled study (290–296; abstract here) finds autologous conditioned serum (ACS) beneficial in the treatment of horses with osteoarthritis. The authors caution that further studies, including clinical trials, are necessary to confirm the finding and determine ACS’s mechanisms of action.
  • A study (313–322; abstract here) finds that bethanechol might benefit cows with motitility disorders.

The first hour of today’s Diane Rehm Show featured a discussion of the U.S. Food and Drug Administration with Dr. Janet Woodcock, deputy commissioner and chief medical officer of the FDA; David Kessler, former FDA commissioner; and Gardiner Harris, a reporter with the New York Times. Audio of the segment, which included discussion of antibiotic use in food animals and the recent news stories about the agency’s decision to fast-track cefquinome, can be found here (mp3), here (RealAudio), or here (Windows Media).

The April issues of the Journal of Animal Physiology and Animal Nutrition (Vol. 91, Issue 3–4) and the Animal Science Journal (Vol. 78, Issue 2) are now available.

An AP story published in the New York Times and Washington Post, explores a concern increasingly shared by pet owners: the safety of drugs we are giving their pets. “Since the year 2000, reports of side effects in animal drugs have gone up about 90 percent, to 34,603 last year, FDA records show.” The story notes that veterinarians say this figure is largely meaningless because most drug reactions aren’t reported. Catmanager suspects, however, that figures like this (and the media attention around them) are bound to raise concerns in pet owners, regardless of the underlying reality of drug safety. Perception is everything, and most of the public is not in a position to adequately evaluate statistical claims. The answer to that equation isn’t hard to figure out.

Another widely run AP story (including in the New York Times and Washington Post) discusses the increasing role pharmaceuticals are playing in the lives of pets. According to the article, spending on drugs for pets has finally overtaken drug spending for farm animals. Catmanager feels the article tries to cover too much ground, jumping from the ethics of spending money for pet medicines to the rise of Internet pharmacies to regulation and the FDA to the impact of veterinary insurance. The differences in how this story is being titled are interesting. The Washington Post originally used the title “Americans Stuffing Their Pets with Drugs.” USA Today changed “Stuffing” to “Tenderly Stuff.” The Atlanta Journal Consitution goes with “Americans Increasingly Medicating Pets.”

The New York Times profiles 90-year-old retired veterinarian Dr. Ben Sann, who still works out five or six times each week, is passionate about Shakespeare (naturally, he loves King Lear the best), and is still trying to adjust to life without his wife of fifty-seven years (she died a few years ago). “‘“You have to understand,’ he says, ‘I was never important to anyone but my wife.’” A lovely, bittersweet article.

Dr. Peter Glassman (the founder of the company behind Pet Portals) blogs today about what we charge clients for their pets’ drugs. He suggests that as veterinary clinics face increasing competition from nontraditional sources for the same drugs (think PetMeds, WalMart, and so on), we need to rethink how we price drugs and whether, as an industry, we can continue to rely on product sales as a main source of profit:

The revenue model wherein the number one practice profit center is dispensed products and not healthcare services worked well in the eighties. It doesn’t work so well now and it probably won’t work so well in the future. Practices, in my opinion, need to rely less upon product sales and more upon providing healthcare services.

Dr. Glassman’s post is thought-provoking and asks some important questions. Even those practitioners and practice managers (like catmanager) who haven’t yet felt the sorts of pressures to which Dr. Glassman’s hospital has already responded would do well to start thinking about the issue.

A front-page story in yesterday’s Washington Post (free registration required), “FDA Rules Override Warnings about Drug,” reports that the FDA is on track to approve cefquinome for use in cattle, a move the FDA’s advisory board recommended against last fall.

The blog Allergy and Immunology reports on research published in the April 2005 issue of Nature Medicine involving a novel molecule designed to block cat allergies (abstract here). The molecule, which “loosely tethers a feline and a human protein together,” prevented allergic reactions in rats and in human cells in a test tube. Catmanager can’t tell why Allergy and Immunology chose to report on this now, but the research is interesting.

Some (most?) head south for winter vacations. Maryland veterinarian Carl Rogge heads to Alaska to volunteer his services to the dogs and mushers in the Iditarod sled dog race. The Baltimore Sun has a nice article about Dr. Rogge and his annual northern “vacation.”

The U.K.’s Observer Sport Monthly has a fascinating story on Eclipse, the eighteenth-century progenitor of the vast majority of today’s thoroughbreds, including the “past six Derby winners.” The story involves royalty, rogues, prisons, and horse portraiture, as well as some interesting tidbits of veterinary history. (Thanks to Jenny Davidson at the Light Reading blog, which is where catmanager first came across the story.)