pet connection

Today’s the day that Sally and Stephen Miller, owners of ChemNutra, Inc., the company that imported the melamine-laden protein powder that led to the 2007 pet food recall, and the illness and death of tens of thousands of dogs and cats, will be sentenced.

But if you were hoping for justice or even just tough love, you’re probably going to be disappointed. Via reader Sandi Shaw, from the government’s sentencing memorandum (PDF):

Sentencing is scheduled for Friday, February 5, 2010, at 10:00 a.m. before United States Magistrate Judge John T. Maughmer. As more fully explained below, the Government recommends that the Court adopt the agreement of the parties and impose a sentence of three years probation on each defendant, to include certain conditions of probation for each defendant, all as set forth and agreed to by the parties in the plea agreement.

The government concludes the Millers were at fault, and what they did caused great harm:

Because of the neglect of these defendants, because they failed to exercise foresightand vigilance, the public suffered greatly. Thousands of innocent pets became seriously ill and many suffered death. It is impossible to talk about this case without realizing that the defendant’s criminal conduct posed and caused substantial physical injuries, death, and psychological injuries.

Seems the Millers are still balking at the charges, even though they’ve pled guilty to them — and the government’s not very happy about that:

The defendants pled guilty to misdemeanor violations of the Food, Drug, and Cosmetic Act (FDCA). Particularly in this case, the nature, circumstances, and seriousness of misbranding and adulteration crimes go far beyond the misdemeanor label that is attached to them.

And this:

Every factual objection [they are making] can be traced to one or more allegations in the indictment which the defendants either admitted was true or agreed could be used to determine their sentence.By raising these objections, the defendants could be viewed as being in breach of the terms of the plea agreement. In case of breach, the Government is released from its obligations under the agreement, the defendants remain bound by their guilty pleas, and the defendants are sentenced without the benefit of the promises made by the Government.

[....]

(T)he defendants have never admitted that they knowingly imported wheat gluten that was misbranded and adulterated with melamine.

In fact, the Government does not contend and does not ask the Court to conclude that the defendants had actual knowledge that the imported wheat gluten was adulterated with melamine.

But the fact that the defendants did not actually know that the imported wheat gluten was adulterated with melamine does not prevent the Court, or anyone else for that matter, from concluding that the defendants acted recklessly or with more than mere negligence.

There’s a lot more, including an overview of just how and why the Millers should have been able to detect and prevent this tragedy. It makes for some rough reading.

I don’t know what the actual sentence will be, but I’m pretty sure it will be along the lines laid out in the memorandum: Probation, and a small fine. That’s it.

And the Millers still have their friends, too. Plenty of them sent letters (here and here) to the court  testifying to what good, righteous, honest, religious, upstanding citizens the Millers are. Not a word about what happened to the people and pets affected by the adulteration of the alleged wheat gluten with melamine — but lots of sad stories about how hard this has been on the Millers.

Who are, I’m sure you’ll be glad to know, back in the food ingredient importing business already.

What if they recalled your pets’ drugs, and no one told your veterinarian?

That’s what’s happening right now, in a series of veterinary drug recalls that have been going on quietly, without public notice or so much as a letter to America’s veterinarians, since Sept. 4.

Although there have been reports of a Dec. 22 recall and Dec. 29 expanded recall of one drug, ketamine, both here and by the Veterinary Information Network’s News Service, an FDA document released yesterday revealed a number of details that had not previously been reported.

Two drugs, not one, were involved, and the recall itself began quietly more than 3 and a half months before a public recall notice was issued. Not even veterinarians were informed.

From my column this morning for SFGate.com:

Because pets are anesthetized more often than humans — for example, nearly all dogs and cats are spayed and neutered at a young age — the potential number of affected animals is huge. You’d expect, then, that veterinarians, the people who are buying and administering these drugs, would have been the first to learn that they were being recalled.

You’d be wrong.

[....]

Veterinarians, along with their patients’ owners, suddenly realized they were the last link in a mostly-broken chain of information emerging — or, more correctly, trickling out — from Teva, the companies for which it was manufacturing drugs, their distributors and the FDA.

There are many unanswered questions. For example, how far back in time did the recall extend? Dates listed on the site of the American Veterinary Medical Association suggest that the recalled ketamine has been distributed to 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 the ketamine recall, and why have they still not been notified about the butorphanol recall, which includes the brands EQUANOL (VEDCO), ButorJect (Phoenix) and TorphaJect (Butler)?

[A letter], signed by Joseph DelGobbo of Teva’s quality control department and dated Sept. 4, stated that the distributors were under no obligation to notify their customers — veterinarians — about the recall. “If you want to request return of product from your customers,” it read, “that is acceptable although not required.”

There’s more… a lot more. Including this from Dr. Paul Pion, co-founder and president of VIN, who does all of us who have worked with him over the years proud with this statement:

“Once it becomes clear there is a problem, all concern should turn to getting the information to veterinarians so they can do the right thing for their patients,” Pion said. “Everyone who has the information, whether they believe it’s their job or not, should share it.

“Damn the lawyers, corporate protocol, quarterly sales goals or fear of being blamed. Because the truth will ultimately be known, and any attempt to delay or sugarcoat the information serves only to dissipate confidence in the entire system. And any individual or company who has reliable information and doesn’t share it should be held personally and corporately responsible for any adverse reactions that occur after that.”

Amen, Paul.

Read the complete article here — and please, because this presents such a danger to so many pets whose veterinarians may still be unaware of the scope, both known and unknown, of this recall — tell your friends, and discuss it with your pets’ veterinarians.

Brava Betsy Saul! I always love it when worthy people are not only recognized for their great work, but get wealthy in the process.   Woman’s Day magazine released their list of 50 Women who are changing the world.  The names include Oprah, Angelina Jolie and Billie Jean King.  Best of all, Betsy Saul!  Betsy’s the founder of petfinder.com, and of course, their work has been an unparalleled success over the years.   The wealthy part?  When Petfinder was bought by Animal Planet three years ago for $35 million.   Further proof that you can do well by doing good! (thanks to Gina for the heads up on this)

Pets helping people: the genetics edition. The Boston Globe tipped me off to work underway to use the genomes of dogs to find cures for human conditions such as obsessive compulsive disorder.  The groundbreaking study, which is a partnership between the Broad Institute, the Cummings Veterinary School at Tufts University, and UMass Medical School, is analyzing dobermans with OCD issues, then looking for analogous “hotspots” in human and canine genetic maps.

“This is exactly where we were hoping to get to,’’ said Elinor Karlsson, a postdoctoral fellow at the Broad Institute, a genetics research center in Cambridge, and coauthor of a paper on the subject. “This is taking a disease that people have had a lot of trouble working with in humans, that seems to be a multigenic and complex psychiatric disease, and using a dog breed to look at something completely new about that disease – something we wouldn’t be able to find in any other species.’’

This is a powerhouse alliance.  When and if results are announced, I’ll report them here.

Fee waivers boost cat adoptions: Makes sense, right?  If you make it more economically attractive to adopt a pet, more pets should get adopted.  Guess what?  It works.   USA Today spotlights the trend, with examples from Maine to Walnut Creek, and Charleston to Salt Lake.  Always reassuring to see common sense approaches triumphant.

Melamine in Chinese milk – again! I know, right?  Just when you thought you’d read the last of melamine showing up in a food-related story out of China, Christie tipped me to a post from Dr. Marion Nestle, which includes a link to the New York Times story.  Melamine was found in pet food out of China in 2007, artificially boosting protein levels.   The next year, it showed up in infant formula in China. Now, a Chinese dairy which was previously implicated in 2008 has been shut down because of contaminated milk powder, found to have high traces of — yes, melamine.   Optimism for long-term improvement may not be warranted yet, as Dr. Nestle points out.

Why?  Maybe Chinese adulterators are getting a double message.  Here are a couple of items I picked up off Chinese news sources on the Internet (Google the names to find the sites):

• Li Changjiang, the director of the inspection agency that failed to deal with the melamine problem, was forced to resign from the agency. He has overcome his disgrace, more or less.  He was just appointed deputy head of a major anti-pornography group.

• Zhao Lianhai organized the parents of victims of the infant formula adulteration to try to get compensation.  He was put under house arrest in November and formally arrested in December.

Sorry, but I’m afraid this problem isn’t going away quickly, and neither are controversies over a lack of government control related to it.   Expect this to reappear in the future, somewhere.

A boy’s best friend, especially against cougars: In British Columbia, a cougar (the big cat, not um, you know) attacked an 11 year old boy.   The family’s golden retriever Angel stepped in, distracted the cougar, and in fact took the brunt of the assault.  And lived!  Loyal reader (and my lead volunteer researcher) Snoopy’s Friend sent me a great link to a heart rending, but ultimately positive story.

The officer fired two rounds into the cougar’s rear end, but the cougar continued its attack.

The officer closed in to within five feet and shot the cougar again, killing it.

Even after it was killed, the cougar’s jaws were clenched on Angel’s face, Forman said.

Angel was silent for a few moments but then took in a big gasp of air and got up.

Best Friends weighs in on TNR for homeless cats:   TNR (trap/neuter/release) might be one of the two or three most contentious pet-related public policy issues  today.    On the heels of a Los Angeles County Superior Court judge’s ruling that bars the city from nominally supporting a TNR policy (and therefore encourages more cats to be killed), Best Friends Animal Society weighed in with a press release, saying TNR helps bird as well as cat populations.  Interim CEO Mike Castle slammed the judge’s decision, saying

“Best Friends believes that the needs of free-roaming community cats and the requirement that municipalities help care for them are best encapsulated in the term ‘community cats,’” asserts Castle.

“The effort to eradicate homeless cats is not only an inhumane, costly approach, it also is futile,” Castle continues. “If killing community cats were the solution, free-roaming cats would be eliminated by now. In fact, catching and killing one group of community cats simply opens that niche for another group of cats.”

Personally, I’m all in favor of an adult discussion on the issue. That’s not to say I’m optimistic it will happen, but it would be nice to give it a shot, right?

Have something to share? Drop it in the comments, or send me an e-mail.

Photo credits: Betsy Saul – Women’s Day.

We know what the drug companies think, and the health care trade organizations, including the AVMA, think. But what do the majority of Americans think about the FDA’s proposed new early alert reporting system for pet food and veterinary drug recalls?

Impossible to say, as only five of us have commented so far, at least, electronically.

If you’re interested in what Pfizer has to say, you can read it here. Also, the American Society of Health System Pharmacists and the Advanced Medical Technology Association.

Then go add your comments. This is the system we all wanted so badly during the 2007 pet food recall. The rolling ketamine recall that’s going on right now is demonstrating the exact same broken process all over again. We have to do better.

Tell the FDA what you think. Review the document here — give your feedback electronically here.

The snowball keeps rolling downhill in the ongoing recall of ketamine, an anesthetic drug used in veterinary practice.

The story began last summer, when the FDA sued Teva Animal Health, the largest manufacturer of generic animal drugs in the United States, after agency inspections turned up adulterated animal drugs.

On Dec. 7, Teva reported to the FDA that it had begun receiving  reports dating back to November that as many as five cats may have died as a result of the affected ketamine. The FDA says it reviewed those reports on Dec. 11, and issued the following announcement on Dec. 21:

Teva Animal Health, Inc. is expanding a nationwide voluntary recall of Ketamine Hydrochloride Injection, USP CIII 100mg/mL in 10mL vials for all lot numbers within their expiration dates to the Veterinary Level. This product had previously been recalled to the distributor level and is being expanded as a result of an increased trend in serious adverse events associated with this product.

Veterinarians who have this product in their possession are instructed to cease using the product immediately and return it to their distributor.

[....] This recall is being conducted as a result of an increased trend in serious adverse events associated with this product, including lack of effect, prolonged effect, and death and involves all lot numbers within expiration.

Teva Animal Health, Inc is voluntarily recalling the aforementioned product. The FDA has been apprised of this action.

The Veterinary Information Network News Service followed up with an in-depth article on Dec. 29, saying that five cats may have died as a result of the compromised drug, and describing a quagmire of unanswered questions, confusing conversations with a Teva representative who refused to identify herself, and conflicting information about just what drugs were or weren’t involved.

From VIN News Service’s Jennifer Fiala:

The expiration dates of the lots range from September 2009 to February 2012, the FDA says. Additionally, the American Veterinary Medical Association (AVMA) warns practitioners not to rely on the Teva brand name to determine whether their ketamine falls under the recall. Rather, the following signs offer a better indication:

* If the lot number is six numeric digits, the product is not part of the recall.
* If the lot number is seven numeric digits, the product should be returned.
* If the lot number starts with 5401, regardless of the number of digits or the presence of letters in the lot code, the product should be returned.

This recall actually began last summer at the distributor level, following the filing of the FDA lawsuit and a subsequent FDA shutdown of Teva’s manufacturing facility in St. Joseph, Missouri.

Fiala’s report also raised the question as to whether Teva was manufacturing ketamine under other labels — a practice reminiscent of the 2007 pet food recall, when surprised pet owners learned that Menu Foods, a company few had ever even heard of, was manufacturing so many foods bearing other manufacturers’ names.

Today, that question was answered: yes, the Teva recall includes other brands, including Fort Dodge, one of the largest names in veterinary drug manufacturing, and that was acquired by Pfizer this fall. (Note: Pfizer is a sponsor of the Pet Connection newspaper feature’s database.)

The FDA’s Center for Veterinary Medicine today told the VIN News Service that affected labels include:

* AmTech Group Inc. Ketamine Hydrochloride Injection, USP, manufactured by IVX Animal Health Inc., St. Joseph, Mo.
* Butler KetaThesia, distributed exclusively by Butler Animal Health Supply, Dublin, Ohio
* Fort Dodge Ketaset, manufactured for Fort Dodge Animal Health, Fort Dodge, Iowa
* VEDCO KetaVed, distributed by Vedco Inc., St. Joseph, Mo.
* Phoenix Ketaject, manufactured for Phoenix Pharmaceutical Inc., St. Joseph, Mo.
* LLOYD Laboratories VetaKet, manufactured for Lloyd Laboratories in Shenandoah, Iowa
* RXV Keta-Sthetic, manufactured for RXVeterinary Products, Westlake, Texas

It’s crucial to note that veterinarians have had as much trouble getting answers about this recall as pet owners have. The problems with ketamine go back several weeks at least, and there’s no estimate how many animal may have been affected, or might be affected in the future — the inevitable outcome of slow, fragmented recalls with partial and often misleading information being dispensed both by industry and government.

It’s not likely there will be more information over the long holiday weekend, but we’ll keep watching the story as it develops. Gina is speaking with Joshua Sharfstein, the FDA Deputy Commissioner leading the agency’s transparency task force, on Monday — hopefully we’ll have more information for you then.

And kudos to Jennifer Fiala at VIN News Service for moving this story today. You can follow them on Twitter, subscribe to their RSS feed, or just plain old check their website to keep up with their coverage. Great work.