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...