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Is AVMA recall update missing the point?
By Christie Keith
January 14, 2010
So, is the AVMA’s take on the ketamine recall new information, a clarification, or spin?
A few minutes ago, I followed a tweet by @AVMAvets that read:
Butorphanol NOT affected by ketamine recall
The included link took me to an update on the AVMA website, which said:
Butorphanol is not affected by the expanded ketamine recall. Several butorphanol products manufactured by Teva Animal Health, Inc. were recalled as a precautionary measure at the distributor level in September 2009. Neither Teva Animal Health, Inc. nor the FDA Center for Veterinary Medicine has observed an increasing trend of adverse event reports associated with the use of these butorphanol products that would justify further action beyond the initial precautionary recall in September.
It is true that butorphanol has not been recalled beyond the distributor level, as ketamine has been. And it’s true, or at least, true as far as we know, that there have been no reports of adverse events associated with the recalled butorphanol.
Indeed, even the five cats whose deaths triggered the Dec. 22 ketamine recall and Dec. 29 expansion of that recall may not have died due to ketamine. We don’t know.
What we do know is this: Teva Animal Health, Inc. was shut down by the FDA on July 31 for a long list of problems (PDF) with their drugs, including “foreign material floating in” another injectable medication, non-sterile water used to formulate drugs, improperly formulated gentamicin sulfate (an antibiotic) and numerous other failures to properly manufacture drugs, including levothyroxine sodium, a thyroid supplement.
From that moment on, the FDA ordered them not to sell or distribute their drugs any more, to anyone.
On Sept. 4, Teva sent a letter to its distributors and recalled butorphanol and ketamine that they had in stock. This letter, entitled “Urgent Drug Recall,” instructed them to “cease distribution” of these drugs and stated that the FDA was aware of the recall.
Teva also told its distributors that they could recall product from the customers to whom they’d sold it — veterinarians — but it wasn’t required that they do so.
And they didn’t.
So I have a question for the AVMA: Don’t you think your member veterinarians should have been given this information about this “urgent drug recall” back in September, when the distributors were, and allowed to decide for themselves?
Why do the distributors get the “precautionary measure” of a recall, but not the veterinarians who are the ones giving these drugs to their patients?
Not to mention that I believe I have a right to know if my veterinarian is giving my pet recalled drugs from a company shut down by the FDA for adulterated drugs and bad manufacturing practices. I have a sneaking suspicion my veterinarian feels the same way.
Don’t you?
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Gee, according to the Health Blog of the Wallstreet Journal, Teva’s revenue is about 50 billion dollars because they make a lot of human generic drugs.
If this company does the same with human drugs as it does with animals drugs—not purefying materials before we get them—we all might be in trouble.
It could be there is more carelessness in animal drug divisions, I dunno.
Sad, sad, situation when the animals get substandard drugs!
Comment by Evelyn — January 14, 2010 @ 8:24 pm
The information we posted on our site yesterday was accurate. Despite your allegation, the AVMA has no reason to “spin” the facts because our primary goal is to make sure veterinarians have ACCURATE information. Conspiracy theories aside, the fact is that the distributor level recall was made in accordance with FDA guidelines for that class of recall and in compliance with the consent decree between Teva and FDA. If either of them had received adverse event reports that would trigger a Class I recall, wider distribution of the recall notice (and at higher urgency) would have been made. For further clarification of the guidelines for recalls or of the consent decree, contact the FDA.
Comment by Dr. Kimberly May — January 15, 2010 @ 6:48 am
There’s no “conspiracy theory” here. Just the facts, and the factual context.
We want our veterinarians to have those facts, not reassurances. After all, it’s their hearts, reputations and businesses on the line — and our pets’ lives. There’s no doubt that what was done and how it was handled was legal. But legal is not always right.
You may not think companies and their distributors have an ethical responsibility beyond their legal mandates to alert health-care professionals about product that might be on the shelves of veterinary hospitals. I disagree.
Dr. Paul Pion, head of the Veterinary Information Network, is a brave a man as has ever lived, and his heart is always where it should be (and as a cardiologist, he knows where it should be). What he told Christie rings true, and I repeat it here:
I trust our veterinarians to make their own decisions about what to do with that information. But give them the information they need to make those decisions.
As a doctor, Dr. May, you should know: Sunshine is the best disinfectant.
Comment by Gina Spadafori — January 15, 2010 @ 8:17 am
“On Sept. 4, Teva sent a letter to its distributors and recalled butorphanol and ketamine that they had in stock. This letter, entitled “Urgent Drug Recall,” instructed them to “cease distribution” of these drugs and stated that the FDA was aware of the recall.
Teva also told its distributors that they could recall product from the customers to whom they’d sold it — veterinarians — but it wasn’t required that they do so.
And they didn’t.
So I have a question for the AVMA: Don’t you think your member veterinarians should have been given this information about this “urgent drug recall” back in September, when the distributors were, and allowed to decide for themselves?”
I am waiting for Dr May to address this without the blah-blah of what the FDA guidelines are..I know the “voluntary” recall as a “precaution” means nothing to me…what I want is when an “urgent drug recall” happens that my vet knows about it before I do from a blog on the internet…I have little faith in hearing that the FDA is running the show as I knew more about the melamine crisis than they did back in March 2007 and sadly still probably know more…My vet that was trying to save two dying cats from melamine depended on me searching the net bringing him the latest as he had no faith in the FDA contacting his office..in fact they never did..I think many petowners are skeptics now because of the poorly handling of poison in the food supply.
Comment by Carol V — January 15, 2010 @ 8:22 am
Tylenol is expanding their recall to include among other things, Benadryl tablets and St. Joseph’s aspirin. Occasionally, I’ve been told by vets to use these products. Apparently it has to do with a chemical sprayed on wooden pallets causing gastro-intestinal issues.
The only link I have is this one: http://www.comcast.net/article.....inancehero
Weird that it’s appearing first under “Finance.”
Comment by Pam — January 15, 2010 @ 8:27 am
The first article I saw on the pet-food recall was about six paragraphs focused on Menu Foods and buried in the Wall Street Journal.
Like to think things change, but …
Comment by Gina Spadafori — January 15, 2010 @ 8:30 am
I wonder if this St Josephs problem is behind Troopers recent tummy issues ? The codes aren’t the same,but the bottle I was using is finished & the new ones weren’t purchased at the same time. Unlike Dr May I proceed with caution about these things. This baby aspirin is getting returned ! As Carol said,the past 3 years have taught me to expect additions to every recall list & not trust the companies or the FDA to notify anyone. I do my own searching about it. Thank goodness for all the sites [like this 1] with great researchers.
Comment by Leslie K — January 15, 2010 @ 8:48 am
Everything reeks of Menu Foods. Six different brand names of OTC’s made by one manufacturer.
http://www.mcneilproductrecall.com/
Comment by Pam — January 15, 2010 @ 8:57 am
With my tiny voice, I say let us change the law, Mr. President and Congress, so that recalls can be made by the FDA mandate and not let the manufacturer decide—because they usually do what is best for themselves and to heck with the “public good”.
Comment by Evelyn — January 15, 2010 @ 9:46 am
Dr. May, first of all, thank you very much for taking the time and coming here to address this.
I agree that this recall was conducted within the scope of existing law and regulation, or, as you said, “the distributor level recall was made in accordance with FDA guidelines for that class of recall and in compliance with the consent decree between Teva and FDA.”
What it boils down to, Dr. May, is that I believe those laws and regulations are wrong. Not only do I believe that, but so do all the legislators who have already introduced laws to change some of them, and to require greater transparency and a shift in focus to protecting the individual citizen and not industry.
Even at FDA, including the CVM, there are staff members advocating for and beginning to implement those changes, and some who feel hampered in the agency’s mission by existing regulations.
So on this I will have to respectfully disagree with you.
Last, the official word from CVM on the Teva recall, when I asked them to confirm that this entire matter was conducted in accordance with the law, was this:
“I want to emphasize that the recall is ongoing. FDA will monitor it to completion including assessing recall effectiveness and performing audit checks.”
Just as during the pet food recall, it’s not acceptable to me and to millions of pet owners to be told to wait until that process is complete to know that our pets may have been at risk. We need and deserve to know now.
And our pets’ veterniarians need and deserve to know, as well, so they can use their judgment and professional expertise to guide us through the decision-making process.
I just want there to be openness and transparency, and for people to understand the process in which you’re expecting us to have faith. And if we find it lacking, I believe we should work to change it.
Comment by Christie Keith — January 15, 2010 @ 10:13 am
Dr. May says that if either FDA or TEVA had received adverse event reports that would trigger a Class I recall, wider distribution of the recall notice (and at higher urgency) would have been made. I have to ask, would anyone have really known at the time if pets were falling ill or dying due to the drug? Many months went by prior to March 16th, 2007 where pets were falling ill and dying due to the tainted pet food but yet somehow that was also missed. I guess Im not as convinced as Dr Mays that two and two would have been put together for anyone to even realize that the drug was the cause.
To me, its really simple and I guess I dont understand the defensiveness that AVMA is displaying. Regarding these drugs or pet food, if its bad enough for the company to recall it or withdraw it, they should be required to put out immediate notice to veterinarians and pet owners who may have that product in their homes or their clinics. I know my vet enough to know if she knew the company pulled the drug, she wouldnt want to take any chances and would choose to not use it. I think most veterinarians would do the same if they are just told of what is happening. Why take an unneccesary risk to keep using it?
And why is it because many of us feel we should be informed when drugs or pet food are recalled or called back or withdrawn, whatever they may call it at the time, we are labeled as conspiracy theorists? I have to say, I expect that kind of labeling from some but not AVMA. Its kind of sad to see.
Perhaps Dr Mays doesnt know that some of the most recent pet food recalls were discovered and brought to light by pet owners. The companies had no intention of putting any notice out until they realized word had gotten out and were forced to. Even then some still refused to put notice out. Many of the complaints I saw were from veterinarians saying they didnt know about the recall.
Comment by Sandi K — January 15, 2010 @ 11:48 am
I know my vet enough to know if she knew the company pulled the drug, she wouldnt want to take any chances and would choose to not use it. I think most veterinarians would do the same if they are just told of what is happening.
I think this is the most important point. Unlike the pet food recall, where some pet owners felt their veterinarians’ objectivity was clouded by the fact that they often sell pet food (I don’t actually hold that view, but many do), NO VETERINARIAN would cling to one brand of ketamine or butorphanol over another. They don’t “retail” these drugs. They have no desire to use a drug that even MIGHT be adulterated or in some way mis-formulated. Why risk it?
I understand that no one wants to see witch hunts based on unsubstantiated rumors, but once FDA has launched an investigation, consumers should be informed and allowed to make our own decisions about whether we want to take a chance it will all work out okay.
The fact that FDA is locked into NOT telling us by current (and, believe me, not liked by many in the agency) regulations that curtail what and when they can inform the public is exactly what erodes consumer trust and weakens our faith, specifically, in the veterinary profession — because we realize not that our vets don’t CARE but that they don’t KNOW any more than we do!
It’s legal, but it’s wrong, and it should be changed. The FDA is supposed to be looking out for the public health, and while it should of course be fair and only report things with a substantive basis, its bias of protection needs to be towards us, not industry.
After all, industry can defend itself with its armies of lawyers and PR professionals. That’s part of the cost of doing business.
Comment by Christie Keith — January 15, 2010 @ 12:01 pm
The legal thing to do vs the moral thing to do…I vote for moral…and I for one do not want or expect my animals or any family members be “test subjects” for a potential illness or worse from a KNOWN potential problem!..that is the key here—-this is a known potential —at least it was when it was “recalled” Not just an internet rumor!
Comment by Carol V — January 15, 2010 @ 12:19 pm
When a company doesnt reveal a known problem with their drugs or pet food, for me, it borders on the edge of animal abuse. From experience, it can be hard enough to get a firm diagnosis with pets let alone throwing in the possiblity its from the food they ate or a drug they received. In my opinion, if the company fails to tell what they know, they are subjecting pets to mis-treatments, tests, procedures, illness or even worse death, that could potentially be avoided if only the vet had known let alone causing unnecessary grief, worry and expense for the owner.
Comment by Sandi K — January 15, 2010 @ 1:05 pm
And now Johnson & Johnson is recalling Benadryl (along with several other OTC drugs) - 20 months after problems first appeared.
Comment by Janeen — January 16, 2010 @ 11:34 pm