Christie Keith writes a disturbing story on PetConnection.com about the slowdissemination of information about common drugs used by veterinarians duringsurgeries. If you're a pet owner, you'll want to ask your vet if he usesthese drugs. Keith compares this debacle to the 2007 recall of pet food. Keith writes that the Federal Drug Administration does not have theauthority to do a mandatory recall on drugs and the distributors of thedrugs were under no obligation to contact veterinarians. More pets died as aresult. The two drugs are Butorphanol and Ketamine, often used as part ofthe anesthia during dental cleaning. Readers: Spread the word. Someone needs to do that job! Do you ever questionwhat drugs your veterinarian is using? She writes: This complaint probably sounds familiar to anyone who remembers the 2007 petfood recall, when questions about who made your pet's food, and whether anyof its ingredients came from China, were impossible to determine fromreading the label. The 2007 pet food recall was also marked by enormous problems in obtaininginformation from the FDA. Many journalists and bloggers, including me,regularly reported recalls that the FDA did not announce until days or evenweeks later -- a scenario that's playing out all over again today. Entire story:
http://www.sfgate.com/cgi-bin/article.cgi?f=/g/a/2010/01/13/petscol011310.DTLYour Whole Pet - Christie Keith Major veterinary drug recall gets bigger Animal anesthetic drug pulled off market, but questions remain By Christie Keith, Special to SF GateWednesday, January 13, 2010 What if your veterinarian was using a recalled drug -- and didn't know it? That's not a hypothetical question. On Sept. 4, at least two veterinarydrugs made by Teva Animal Health, Inc., a division of Israeli-based TevaPharmaceutical Industries, were recalled by the FDA, which shut the companydown in July. But few veterinarians or pet owners were aware of the recalluntil the end of December. Although the reported deaths of five cats led the FDA to issue public recallnotices on Dec. 22 and Dec. 29, just what products are involved, and overwhat time period they were manufactured and sold, remains unclear. The recalls involve two commonly used injectable veterinary drugs:butorphanol, a fast-acting opioid used to control pain from surgicalprocedures in dogs and cats, and the anesthetic agent ketamine. Ketamine is part of a "cocktail" of drugs that induces anesthesia inanimals, including dogs and cats. It can be used, usually with valium, priorto surgery, a dental cleaning and sometimes as a form of restraint forprocedures such as an imaging scan. It's not the only drug that can be usedin this way, but it's one of the most common. The only explanation so far given as to just what's wrong with the recalledketamine came in a press release issued by the FDA on Dec. 22, which said,"This recall is being conducted as a result of an increased trend in seriousadverse events associated with this product, including lack of effect,prolonged effect, and death." Timeline of a recall Because pets are anesthetized more often than humans -- for example, nearlyall dogs and cats are spayed and neutered at a young age -- the potentialnumber of affected animals is huge. You'd expect, then, that veterinarians,the people who are buying and administering these drugs, would have been thefirst to learn that they were being recalled. You'd be wrong. Although it was the nation's largest manufacturer of generic animal drugs,almost no one in the veterinarian community had heard of Teva Animal Healthuntil the FDA shut it down on July 31, citing adulterated drugs and multipleviolations of good manufacturing practices at its St. Joseph, Mo., facility. If you were a veterinarian or a member of the public, there was no furthernews about Teva until Dec. 22, when the FDA announced the company wasrecalling its injectable ketamine hydrochloride following the questionabledeaths of five cats undergoing anesthesia with the drug. It was obvious something else had occurred between the summer shutdown andTeva's announcement, however, because the FDA's recall notice referenced anearlier "distributor-level recall." But there was no copy of that recallnotice on the FDA website, it didn't appear to have been published anywhere,nor could I locate a single veterinarian who had seen a copy. If they had seen it, what happened a week later would have come as less of asurprise. On Dec. 29, Teva announced that the recall was extending toketamine manufactured by Teva but sold under the brand names of some of thebiggest players in the veterinary -- and human -- pharmaceutical world:Ketaset (Fort Dodge/Pfizer), KetaVed (VEDCO), KetaThesia (Butler), VetaKet(LLOYD Laboratories), Ketaject (Phoenix), Keta-Sthetic (RVX),and AmTechGroup, Inc. The information flow stops here Veterinarians, along with their patients' owners, suddenly realized theywere the last link in a mostly-broken chain of information emerging -- or,more correctly, trickling out -- from Teva, the companies for which it wasmanufacturing drugs, their distributors and the FDA. There are many unanswered questions. For example, how far back in time didthe recall extend? Dates listed on the site of the American VeterinaryMedical Association suggest that the recalled ketamine has been distributedto veterinarians as early as 2006, a timeline confirmed by Denise Bradley,senior director of corporate communications for Teva. Furthermore, why did it take so long to notify veterinarians about theketamine recall, and why have they still not been notified about thebutorphanol recall, which includes the brands EQUANOL (VEDCO), ButorJect(Phoenix) and TorphaJect (Butler)? I contacted the FDA's Center for Veterinary Medicine about the earlier"distributor-level recall," and Laura Alvey, the agency's communicationsstaff deputy director, e-mailed me a copy of the notice sent by Teva to itsdistributors. That letter, signed by Joseph DelGobbo of Teva's quality control departmentand dated Sept. 4, stated that the distributors were under no obligation tonotify their customers -- veterinarians -- about the recall. "If you want torequest return of product from your customers," it read, "that is acceptablealthough not required." The letter also included this statement: "This recall is being conductedvoluntarily and with the knowledge of the Food and Drug Administration."(Note: All recalls are voluntary, as the FDA does not have mandatory recallauthority.) That Sept. 4 distributor-only recall included all the brand name ketamineproducts not referenced until the second, "expanded" recall on Dec. 29, aswell as the butorphanol recall that has still not been publicly announced. "It's been extremely frustrating to veterinarians," said Jennifer Fiala, whohas been investigating the recall for the Veterinary Information Network, orVIN, an online community and information database for veterinarians andveterinary students. "They're worried that the drug on their shelves isgoing to create an adverse event in the animals they treat." That frustration is compounded by the fact that veterinarians have no way ofknowing whether or not the drugs in their clinics were manufactured by Teva. Alvey provided me with the federal government's labeling regulations fordrugs. They're difficult to decipher, but buried in the text is the factthat drugs made by Company A and sold under the label of Company B canlegally bear the label "Manufactured for Company B." The drug label does nothave to include where, or by what company, a drug was actually produced. Fiala finds that appalling. "Wouldn't it have been nice for a vet to be ableto look at the label on a vial of Ketaset and see it was manufactured byTeva?" she said. "I can look at the label on my shirt and it will tell me itwas made in China, but it can't say 'made in St. Joseph, Mo.' on a drugyou're supposed to ingest or administer?" 2007 pet food recall redux? This complaint probably sounds familiar to anyone who remembers the 2007 petfood recall, when questions about who made your pet's food, and whether anyof its ingredients came from China, were impossible to determine fromreading the label. The 2007 pet food recall was also marked by enormous problems in obtaininginformation from the FDA. Many journalists and bloggers, including me,regularly reported recalls that the FDA did not announce until days or evenweeks later -- a scenario that's playing out all over again today. As of this writing, the ketamine recall information on the FDA's veterinaryrecall information page is limited to a link to the Dec. 21 notice. The ketamine recall has not been mentioned on the FDA's much-hyped pethealth alert widget, which has so far mostly been used to issue mundane petholiday safety warnings. There is also no sign of the Dec. 29 notice expanding the recall, althoughit was reported by Jennifer Fiala on VIN as well as on Pet Connection. Nor did the FDA update its site with a list of recalled brands and their lotnumbers, which can be found instead on VIN and on the site of the AmericanVeterinary Medical Association. Broken faith Dr. Paul Pion, a veterinary cardiologist in Davis, and co-founder andpresident of VIN, deplores the faltering, sometimes dammed-up, flow ofinformation from both the drug companies and the FDA. "Once it becomes clear there is a problem, all concern should turn togetting the information to veterinarians so they can do the right thing fortheir patients," Pion said. "Everyone who has the information, whether theybelieve it's their job or not, should share it. "Damn the lawyers, corporate protocol, quarterly sales goals or fear ofbeing blamed. Because the truth will ultimately be known, and any attempt todelay or sugarcoat the information serves only to dissipate confidence inthe entire system. And any individual or company who has reliableinformation and doesn't share it should be held personally and corporatelyresponsible for any adverse reactions that occur after that." That's a battle cry pet owners can rally behind, including the owner of adog named Rogue, who lives in Washington state and asked that her name bewithheld so as not to cause problems with her veterinarian, who is stillcaring for her dog. "Rogue broke his tooth, and it became infected," she said. "In mid-December,I took him to the best veterinarian in our area, a specialist, and shescheduled him for surgery to remove the tooth." Neither Rogue's owner nor the veterinarian cut any corners. At 10 years old,Rogue, a chow-chow, is considered a canine senior citizen, so he had what'sknown as a "geriatric panel," blood tests that screen for common old-ageproblems that might make anesthesia more risky for him than a younger dog. "The vet listened to his heart with a stethoscope when she examined himbefore the surgery," his owner said. "He was fine. Everything came backnormal." But shortly after the veterinarian injected Rogue with a combination ofketamine and valium, his heartbeat became abnormal. She had to immediatelyabort the procedure and wake him up to protect his life. Rogue was referred to a heart specialist, who diagnosed him with a seriouscondition known as a second-degree heart block. There's no way to know ifthe anesthesia caused the heart condition, or if it was the result of somepreviously undiagnosed problem. But when his owner heard about the ketaminerecall on Dec. 22, she checked with her vet right away. The veterinarian assured her that she hadn't used Teva's ketamine on Rogue,but Fort Dodge's Ketaset instead. Unfortunately, a few days later, Rogue'sowner learned that brand, too, was being recalled. She followed up with afax to her veterinarian asking about the expanded recall and what risk itmight pose to her dog, but so far has had no response. This void of information, from the highest corporate levels of Big Pharma,to the halls of government, right down to the plight of a sick dog and hisworried owner, does as much damage to public health as tainted food anddrugs. It does it by destroying trust. People lose faith in their doctors, petowners lose faith in their veterinarians, and veterinarians and doctors aswell as average citizens lose faith in agencies like the FDA, ostensiblytasked with protecting both human and animal health. "The domino effect applies," observed Fiala. "Everybody falls." © 2010 Hearst Communications Inc. To report corrections and clarifications, contact Reader Editor Brent Jones.For publication consideration in the newspaper, send comments to
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