Challenging the FDA

I'm a little late in posting this, as I've been sick the past two days. That's the downside of living alone, if I don't do it, it doesn't get done. Which is also why the cats are out of food (cooking for them is great, but I really need to build up the freezer stash!) , the dishes haven't been done, and if I hadn't dragged myself out last night none of us would be eating today either. (Also known as the 'lose-weight-because-you-have-no-food-in-the-house-diet').

Alright, on with the information. I'm stalling a bit, because I have mixed feelings about some of what I'm going to post here. There is so much information, so I'm going to give you a bunch of links - I really hope you'll go read full posts.

Because not only is the FDA denying FACTS, we've got reports (via an exceptional survey and the comments on the melamine risk assessment) from FDA scientists that confirm that there are serious problems within that organization. And they confirm that what we are told is not necessarily the truth. (I'm being generous with that last statement.)

And yeah, I'm being a bit more chatty today. I just can't keep doing this unless I get more personal in these posts. It's been mostly 'business' until now (here anyway) - but you know what? I'm NOT a reporter. I'm NOT a journalist. I'm a blogger. And until this food recall started I'd only been blogging for a month, so I'm barely that. What I am is one pissed off pet guardian/owner/parent, just like you. And I need to 'chat' more, or I'm going to lose my mind. We're at the 3 month mark tomorrow, with no end in site.

Anyway, on to the 'news'. The FDA says acetaminophen wasn't found in pet food. Um, okay. Sure. Whatever you say. See the post at petconnection and the comments. http://www.petconnection.com/blog/2007/06/13/fda-rules-out-acetaminaphen-findings/

In response to that ridiculous statement by the FDA, see Don Earl's update - and his Challenge to the FDA. I join him in that challenge. Go read the rest of his page, at this link:
http://www.petfoodrecallfacts.com/lab.html

...
June 13, 2007: In the news today, with hundreds of pet owners across the country reporting acetaminophen poisoning like symptoms in their dead or dying pets, the FDA announces their official position is to stand down. Who didn't know that? Perhaps it would be best to disband the FDA. It would save tax payers several billion dollars a year. The savings to corporate America on lobbyists and the usuals could be passed on to consumers. And, the lack of oversight would be the same as it is now, with private citizens bearing the burden of testing the safety of products at their own expense as you see here.
...
FDA ACETAMINOPHEN CHALLENGE
As amazing as it may seem, after the announced FDA stand down on testing for acetaminophen, the FDA then snuck over to ExperTox to try to glom onto samples. I and at least 4 others I am aware of were contacted for permission to release samples to the FDA.

The one thing we know for sure at this point is the 5 samples the FDA earlier claimed to have tested for acetaminophen, were NOT those tested by ExperTox.

Several others, along with myself, refused permission for the FDA to take the samples off ExperTox premises. We did however agree to allow the FDA to test the samples under the supervision of ExperTox at the ExperTox lab.

So, here’s the challenge:

* Let the FDA rent the ExperTox facilities for one day to duplicate the ExperTox results on those samples which tested negative for melamine, but positive for cyanuric acid and/or acetaminophen.

* Let the FDA bring in the experts of its choice to participate in the tests.

* Let ExperTox personnel act in a supervisory and oversight capacity to make sure everything is done according to Hoyle.

* Let the media bring in as many camera crews as it is possible to squeeze into the room without interfering with the work.

* Let the games begin.

Added 11:45am: ConsumerAffairs.com on the subject…

http://www.consumeraffairs.com/news04/2007/06/pet_food_recall57.html

…
ConsumerAffairs.com contacted the manufacturer of the confirmed pet food that tested positive for acetaminophen -- Menu Foods of Canada. That company makes Pet Pride food.

A spokeswoman for Menu Food said the company had no comment on ExperTox’s findings. But spokeswoman Sarah Tuite told us: “The Pet Food Institute (PFI) has provided comment.”

That organization represents the makers of 98 percent of all dog and cat food produced in the United States, and calls itself “the voice of U.S. pet food manufacturers.”

“I can assure you that this industry takes the issue of the safety of pet food products with the utmost seriousness,” PFI’s spokesman Kurt Gallagher said Tuesday.

Gallagher said his industry and the FDA are investigating ExperTox’s findings. But he cast doubts about the laboratory — and its test results.

“Through our contacts in Texas, which is where the lab is located that conducted the analysis, we have learned there is genuine concern among key toxicological and analytical experts about the lab and the actual test results,” Gallagher said.

The Lab Manager for ExperTox told us today that her company stands by its finding.

What Experts?

Expertox’s Donna Coneley also said she doesn’t have any idea what Texas experts Gallagher and PFI are talking about.

“They never name the experts they’re working with,” Coneley said. “When someone says ‘people I know say this,’ it sounds to me like they’re trying to say there are experts who have looked into this and don’t agree with the findings. But I don’t believe there are.

“To me, it sounds like they’re talking about imaginary experts,” Coneley said.

Coneley said the only experts her lab has worked with about the findings are those with the FDA. In fact, she told us she had the FDA on another line during our interview today.

“The pet food manufacturing companies have had ten-minute discussions with us about how we did our tests,” she said. “But they’re not experts.

“The (scientists at the) FDA are the only people we’ve been talking to about our findings.”

Coneley said her lab tested about 100 to 150 samples of food.

When asked if she was surprised the lab didn’t detect melamine in the samples of Pet Pride it tested, she said: “We did find that (chemical) in other samples. I don’t have my paperwork in front of me to tell you how many samples, but I can tell you we did find melamine in some. We also found melamine and cyanuric acid in some samples.”

But ExperTox did not find the rat poison and cancer drug, Aminopterin, in any of the pet food it tested, Coneley said.

Note: A poster at petconnection provided an update

Scientists at the New York State Department of Agriculture discovered that toxin in some samples of pet food it tested shortly after Menu Foods announced its recall in March.

Don't Look, Don't Find

In the meantime, pet owner Earl wonders why the country’s leading laboratories aren’t imitating ExperTox’s tests.

“They're using a protocol to quickly scan for thousands of substances. Once having identified a substance using that method, they are then able to run more specific tests to confirm the results.

“The question that comes to my mind is with so many people affected, and so many people needing hard answers to how this happened, why the nation’s top labs are limiting their tests to what they read in the morning's paper? You won't find what you don't look for.”

And from Christie over on PetConnection.com - an exceptional post that you must read, showing exactly how FDA documents can mislead:
Scientists review FDA conclusions on melamine, other contaminants in human food

On May 24, the FDA asked six scientists to review the process the agency used to conclude that melamine and related compounds posed no health risk to people eating the meat of animals given contaminated feed. The document submitted for review was the Interim Melamine and Analogues Safety/Risk Assessment, in which the concept of the “dilution effect” was laid out.
...

In a study released on June 7, the FDA concluded:

Overall, there was consensus from the peer reviewers that the conclusions of the S/RA were appropriate. In addition, recognizing the time-sensitive context in which the S/RA was developed and the time-sensitive need for the S/RA results, the peer reviewers concurred that the methodology, data, assumptions, and exposure scenarios used were appropriate.

Translation:

The FDA was working with limitations of what they knew and the timeframe in which they had to make an evaluation, and within those limitations, their conclusions, choices, and assumptions were appropriate. They are not saying they were correct, however.

After the jump, I’ll include some of the actual comments made by the scientists. If you want to review the document itself, it’s here.

Christie then continues to tear the above conclusion to shreds, by taking the reviewer comments and translating them to the truth. Please read the full post, it really is exceptional work.

Added 11:45am: And now for results of a survey - done of FDA scientists.
http://www.ucsusa.org/scientific_integrity/interference/fda-scientists-survey-summary.html

In 2006, the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER) distributed a 38-question survey to 5,918 FDA scientists to examine the state of science at the FDA. The results paint a picture of a troubled agency: hundreds of scientists reported significant interference with the FDA's scientific work, compromising the agency's ability to fulfill its mission of protecting public health and safety.

And you HAVE to read the Survey Summary brochure. It's a pdf file at the top of the page under “related links”. A few excerpts...

Almost one in five (18 percent) responded, “I have been
asked, for non-scientific reasons, to inappropriately
exclude or alter technical information or my conclusions
in an FDA scientific document.”

More than three in five (61 percent) knew of cases in
which “Department of Health and Human Services or
FDA political appointees have inappropriately injected
themselves into FDA determinations or actions.”

Three in five (60 percent) also knew of cases “where commercial
interests have inappropriately induced or
attempted to induce the reversal, withdrawal or modification
of FDA determinations or actions.” Fifty percent also
felt that non-governmental interests (such as advocacy
groups) had induced or attempted to induce such changes.

And that’s just the beginning. Not a surprise given what we know now, but, still, stunning.

Then make sure to read 'Selected essay responses”

http://www.ucsusa.org/assets/documents/scientific_integrity/Final-Essay-Summary.pdf

Just a few comments from 21 pages of comments from FDA Scientists:

“We use or are mandated to use ancient scientific methods and it’s almost impossible to update.”

“It is obvious that looking at 1-4% of imported products regulated by FDA is dangerously low and there are not enough field personnel to consistently be thorough in examinations due to the high volume individuals are required to complete daily.”

“Consumers no longer trust FDA decisions or personnel as they know we no longer
enforce the regulations but rather protect regulated industry/big business to the detriment of the consumers.”

“We are so short staffed there is no way FDA can protect the public. It’s just a disaster waiting to happen.”

“I believe it takes serious illness of the public and/or deaths in order to get FDA to do anything (Vioxx as an example). The attorneys for FDA seem to find reasons to turn down cases. It seems as if they are protecting industry not the consumer.”

“The problem at FDA is not the structure of the organization, but the quality and
character of persons in managerial positions. Persons who are ‘yes-men’, who suppress information, minimize risks to patients and place industry’s priorities above those of patients and the public are routinely promoted to positions of authority. There needs to be a better system of a) allowing reviewers the ability to discuss issues IN PUBLIC e.g. in publications without suppression or ‘clearance’ from upper management b) accountability of upper management to their superiors as well as the public c) a change in culture within the Agency to promote scientific discussion, academic achievement, and internal research results…”

“Allowing staff to publish scientific information without censorship by management.”

“Too often, political pressure restricts FDA from providing information to the public.”

“Sunshine! We have many restrictions on what we can say and publish that are
politically, not legally, based. In the past several years final approval to publish or speak is moving to higher and higher levels; lower management is more and more afraid to make decisions…We have trouble getting permission to say that medical products have safety problems. Staff outrage is pervasive.”

“Bullying-I was pressured to recommend to approve a device I thought unsafe.”

And there's more at the links above...

Itchmo has learned Lab finds Cyanuric Acid in Unopened Unrecalled Canned Dog Food

Itchmo.com breaks another one! Thanks to an itchmo.com reader for this one

http://www.itchmo.com/read/lab-find-toxin-in-unopened-unrecalled-pet-food_20070612

The same Texas lab that has reported acetaminophen in pet food, has reported finding cyanuric acid after receiving an unopened container of Hills Science Diet Light Adult canned dog formula. ...

Science Diet Light Adult formula has not been recalled by the manufacturer.

See this previous post for reports by people that believe other non-recalled Hills Science Diet products (mostly dry foods) harmed their pets.

The lab report from Expertox obtained by Itchmo states that the tested product had a best before date of 01 2009 and had the lot number T0520917 7048. Cyanuric acid was reportedly found in concentrations of more than 400 ug/g — that’s micrograms/gram.

Hill’s representatives declined to be interviewed over the phone and emailed questions were not returned in time for this deadline.

An Itchmo reader tested the food based on veterinary tests on a dog. The reader’s email is after the jump. It has been edited to remove personal information.

Reader’s email:

I received today the test results on the canned food from the case lot my 4-year old Shih Tzu was eating from when her blood work indicated that she was in kidney failure. We did IV for 4 days, antibiotics for one month, and now fluid therapy once a week. She is still alive, eating home cooked food, has a good appetite, but I don’t know where her kidney levels are at present. Her BUN was 160 before the IV therapy. The BUN came down following 4 days on IV, but was still high when I brought her home.

The reader also said that another dog that did not eat the canned food had normal blood tests.

Reports of Illness/Deaths suspected from Non-Recalled Hill's Science Diet foods

I've put the Hill's Prescription and Hill's Science Diet information into this separate post, as we now have THREE different foods from this company that tested postive for toxins in private tests. See items in red below.

Science Diet Light Canned Dog Food - Cyanuric Acid (details here and here)
Science Diet Light Dry Cat Food - Cyanuric Acid and Acetaminophen (details here and here)
Science Diet Sensitive Stomach Dry Cat Food - Acetaminophen (details here and here)

I have seen hundreds of reports of pets who got sick or died - from eating (mostly dry) food that has not been recalled - posted on various sites online. Many of us have been told by FDA officials that they have also received numerous reports of other unrecalled foods causing illness. However, the foods which people keep complaining about have not been recalled. So I'll be doing what I can to 'shine a light' on these reports and complaints, in the fervent hope that as more people become aware of the problem it will be addressed.

These foods need to be thoroughly tested for all possible contaminants (Melamine and the Melamine Compounds including Cyanuric Acid, as well as excess Vitamin D, Aflatoxin, Aminopterin and Acetominophen) - and the results must be made public.

Recently, there was an article about Nutro dry foods (see here), and an entry about Iams (see here). Other brands are here. Reports/comments for those brands are listed in those posts.

This post is for Hill's Prescription and Science Diet foods that people have been reporting. I've been reading these online for many weeks now, and since it seems like many people only look on one or two sites for their information, I'm posting them here to increase awareness, and so that the full scope of the issue is understood better. There are foods out there that still need to be recalled!

These are just a few of the comments that other people have posted online, on other websites, forums and blogs. I am providing links to them so you can check them out for yourself. In most cases I have posted a portion of the comment and you can click the link to read the rest. I've tried to include links from different sites - in most cases there are multiple stories on the same site.

Note that I've left the Quote Marks off to make it easier to read. Everything under a link is from the original poster. Where there is a '...' it means I've edited some of the post. Again, click the links to see the full post.

Disclaimer: These are reports by people like yourself who posted online (or emailed me) that they believe a certain food made their pets sick. This information is simply for you to use as part of making an educated difference about what products you purchase - both for yourself and your pet. None of these foods have been recalled, and the problems reported may have nothing to do with the current round of recalls! If your pet has eaten any of these foods and got sick, please report it to the company and FDA! Some people have been told that the FDA will only test additional foods when they receive enough complaints about it. So if you have a complaint, please contact your local FDA office. http://www.fda.gov/opacom/backgrounders/complain.html

And please, feel free to add your own story in the comment section, or email me with it. (I still have a bunch of emails to work my way through, so it might take me a while to respond but I will get back to you.)

I will post any additional private test results of these foods if/when they become available.


Hill’s Prescription dry c/d Dry Cat Food
http://www.petconnection.com/blog/2007/04/03/pet-food-recall-we-read-the-news-today-oh-boy/#comment-22678Our cat died after eating Hill’s Prescription dry c/d which contains corn gluten

http://www.petconnection.com/blog/2007/04/02/pet-food-recall-cheap-leashes-and-picking-pet-foods/#comment-21462
I also have a cat who went into unexplained acute renal failure in February, on a diet of dry Hill’s C/D (she was healthy and ate the C/D only because it was prescribed for her brother and two vets assured me that it was fine for her also. ...

Hills Prescription s/d Cat Food
http://cats.about.com/b/a/257812.htm#comment-10886
My cat died and I’m sure it was due to Prescription Diet S/D. This product has not be recalled but ... had all the symptoms - jaundiced gums, vomiting, fatigue, frequent urination, extreme thirst. The vet had no idea what was wrong as this all occurred on March 12th, before we really knew about the problems with food. ...

Hill's Prescription z/d Cat Food
http://www.petconnection.com/blog/2007/06/01/friday-night-follies-fda-food-safety-and-more/#comment-76743
I had 3 cats die between last year and just before the recall. I think Hills Z/D is what killed them. Some of my cats wouldn’t touch it. some ate it.

Hill's Prescription i/d Cat Food (added 6-9 1pm, brought up from the comments on previous post)
My cat was eating Prescription Diet i/d exclusively and when I opened and started a new bag of it in late March, he became sick. He died on April 02,2007 and I am absolutely positive that the Prescription i/d killed him -- it contains "corn gluten". He was poisioned to death!!!!!


Hills Prescription Diet ID Dry Dog
http://www.itchmo.com/read/several-unconfirmed-reports-of-iams-dry-food-causing-illness_20070323#comment-699
My schnauzer and westie have been sick every time I bring home a bag of dry Science Diet ID from the vet sinece last June. ... It was particularly bad in November thru January requiring a couple of emergency room visits as well as sub-q fluids and and shots for nausea and vomiting. Vet thought my schnauzer had Pancreatitis. She does have a very sensitive stomach and is prone to GI bleed if her diet is not maintained, but the episides almost monthly came after each new bag was opened for her and my westie. .... I have mentioned it to my vet repeatedly. all he says is to phone Hill’s. Did that too. All they did was send me a five dollar coupon toward my next purchase.


Science Diet Indoor Dry Cat Food
http://boards.msn.com/MSNBCboards/thread.aspx?ThreadID=232979>1=9145&BoardsParam=Page%3D17
We lost our sweet 9 year-old cat last week of acute kidney failure. She ate dry food only ( science diet, indoor cat... ... She had never been sick before. Our nightmare included hospitalization, iv antibiotics and a week of home-administered ringer's lactate infusions, before she succumbed. ...

Science Diet Light Dry Cat Food
http://www.gothamist.com/2007/03/17/pet_food_recall.php#comment-1057854
I put ...our twelve-year old black cat to sleep on Monday, March 19, 2007. He and another cat only ate Hills Science Diet light dry food. ... He had kidney failure and was severely dehydrated. ... I emailed Hills about my ...to have it on record. I have not received a returned phone call from the Texas FDA yet. ...

Science Diet Light Dry Cat Food (Added 6-9)
This food tested positive for Cyanuric Acid and Acetaminophen after a sample from an open bag was sent to a private lab. See here for details

Science Diet Hairball Light Formula Dry Cat Food
http://www.gothamist.com/2007/03/17/pet_food_recall.php#comment-1064711
My cat became extremely sick about three weeks ago. He stopped eating, but we thought it was because he was upset with our move...After a week I took him to the vet. He is only 6 and up to this point has always been in perfect health. He was suffering from severe Renal Failure. ... We had been feeding him Hill's Science Diet Hairball Light Formula...

Science Diet Sensitive Stomach Dry Cat Food (Added 6-9)
This food tested positive in private tests for acetaminophen. See here for details.

Science Diet Dry Dog Food
http://www.itchmo.com/read/several-unconfirmed-reports-of-iams-dry-food-causing-illness_20070323#comment-606
I have fed my dog Science Diet Dry Dog Food for 7 years. I bought a new bag at ... and when I opened the bag it had a strange smell and the food looked darker then usual. I gave it to my dog and she ate some and that night she started vomiting. She was sick for two days, and would not eat any more of the food.

http://www.itchmo.com/read/several-unconfirmed-reports-of-iams-dry-food-causing-illness_20070323#comment-656
I stopped feeding Science Diet Dry Food. Since I bought a bag Jan? Feb?my dog hasn’t wanted to eat it ,the few times he did he would lay spread out on his tummy as if he had a tummy ache.

Science Diet Light Canned Dog Food (added 6-12)
This food tested positive for Cyanuric Acid after an unopened can was sent to a private lab. Read more here.

Read more on Hill's here (including correspondence with other pet owners in the response section) Added 6-4 9am
http://catmanager.wordpress.com/2007/03/27/mail-from-hills/

Recalled Food Still on Shelves

More disturbing news, from The Modesto Bee.

Please folks, don't assume that the food on the shelves is safe. Know what foods are on the list. You can print out a 7 page summary at the top of this page, in the "Files to Download" section. The Summary is #1 "The Master List of all Brands Recalled Pet Food Summary". This is something you can take to the store with you.

If you want to check online, the FDA site lets you search by brand name, here: http://www.fda.gov/oc/opacom/hottopics/petfood.html Click on "Search combined list of recalled pet food products"

And if you want to check stores near you, see the "Volunteers help get food off shelves" section at the bottom of this page. (It's at the bottom of every page on this site, so if you click on an individual post, you can always find it by scrolling down.)

Cat survives eating recalled food, so far

Months after a nationwide recall, Andy Tonetti bought tainted cat food from the Save Mart in Angels Camp.

After eating only six pouches of Iams Select Bites, 14-year-old Rasputin was hiding in dark spaces, gagging and losing weight from dehydration.

Six days after Tonetti's purchase on May 29, a veterinarian said the family pet had acute renal failure, the ailment the U.S. Food and Drug Administration warned about at the time of the recall.

"I saw a sale, thought 'Good, we'll get that,'" Tonetti said, noting that his wife had sent him to get Fancy Feast. "Geez, we got the death box."

Ten days later, Save Mart could not explain why a single box of recalled pet food was on the shelf, especially after so much publicity about an industrial chemical that had been added to Chinese wheat gluten used by pet food manufacturers.

...

"We will do whatever we need to do to make it right, or as right as we can make it, given the situation," Alicia Rockwell, Save Mart's communications manager, said Friday afternoon. "We are so sorry."

...

But the only change in the indoor cat's life was his food, so the culprit seemed clear. After a bit of research, the Tonettis learned that the Iams pouches Andy Tonetti bought had been out of circulation for weeks.

Their veterinarian urged them to save the cat, and faxed documentation to the pet food company, which is expected to pay Rasputin's bills.

"Iams told me I'm the first one to call after the recall," said Heidi Tonetti, adding that the company seemed eager to take care of the situation.

Kurt Iverson, a spokesman for Proctor & Gamble Pet Care, which makes Iams pet foods, declined to comment on the Tonettis' claim.

The Tonettis assumed other cats, and perhaps some dogs, might be in danger as well. They said the manager at Save Mart seemed to think they were crazy, but passed their complaint along to corporate headquarters.

...

She said Save Mart took their complaint seriously and performed a computerized check of its sales, determining that one recalled box of Iams Select Bites was sold May 29.

She said all Save Marts, including the store in Angels Camp, pulled pet food off their shelves when recalls of more than 150brands were announced March 15, leaving large gaps in their inventory.

Save Mart will take steps to make sure recalled items don't get past cashiers in the future, perhaps by adjusting computerized scanning systems, Rockwell said.

She could only speculate on how the single box of Iams ended up on the shelf. Perhaps it was misplaced in another part of the store, she said, then was returned to the shelf by a stock clerk.

"The product has been out of the distribution channel for over 10 weeks and there is none left at the warehouse or at the manufacturer," Rockwell said.

Andy Tonetti, a winemaker at Ironstone Vineyards, recalled seeing only one box of Iams on the shelf. He said he chose it because it was marked down. He did not have a receipt, but recalled paying about $4.

...

The black and white cat is purring again, they said, but will need regular checkups and a special diet.

"He's going to be damaged," Heidi Tonetti said.

Added 10:45am: Moved up from the comments

This item saddens me tremendously. The same think happened to a friend of my daughter, except the cat died. The vet said the cat's kidneys were "choked" with crystals. Same product. Iams Select Bites, bought in May in an upscale supermarket. These stores need to be so much more careful.

June 10, 2007 10:40 AM