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The secret life of data

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In 2013, Dr. Maryanne Demasi was investigating the clinical trial data on statins when she learned the raw data had been kept secret, held by a group of researchers called the Cholesterol Treatment Trialists (CTT) out of Oxford University. Here, Demasi explains why such secrecy undermines what she terms "the bedrock of science: contestability and replicability." She also notes the ways the landscape has changed since 2013, opening the door for independent review of the data on statins and other drugs.

Read MoreThe secret life of data

Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

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On June 29, 2019, The New York Times published a report entitled “FDA Names 16 Brands of Dog Food That May Be Linked to Canine Heart Disease.” The story was an update to previous coverage of an FDA investigation into the nutritional causes of a rare canine heart disease called dilated cardiomyopathy (DCM). The investigation, ongoing since July of last year, is a unique example of a veterinary nutrition story managing to transcend the veterinary community and grab the attention of the pet-owning public. Unfortunately, the majority of the reports on this story ignore the financial conflicts of interest possessed by the veterinarians at the heart of the FDA’s investigation, and all mischaracterize the actual state of the scientific record concerning canine DCM.

Read MoreBad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

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Tom Mullen
November 28th, 2019 at 3:59 am
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

I'm with Tanya on this, Schulof article is full of erroneous conclusions and unfair characterizations - accusing those Vets in the FDA study of having no objectivity. UC Davis and Tufts clinical work-up on this issue IS peer-reviewed and these are amongst the very best vet scientists and medical professionals. Thank you, but I trust their analysis over Mr. Schulof's mindless dismissive of careful studies on this subject, and his comment that none of his customers came down with heart disease - really? I've never heard of your food so please stop comparing your mom and pop brand probably made in your kitchen to nationally implicated brands and companies that have a history of being dishonest i.e. weren't Champiomn and Diamond sued on other issues? My Rottweiler was diagnosed with DCM after 9 exact years of rarely anything but Taste of the Wild a food brand implicated. As my rott coming from impeccable breeding I can go back 5 generations and NOT ONe instance of DCM. WHAT ELSE could have caused this? The fact that some of these foods or ingredients are prepared in China doesn't help their position too. So, my cardiologist the day I found out we switched her food immediately and she is on pemobendin. Second Echo is coming next week and hopefully if I see ANY improvement from her first Echo, youre damn right her mild case of DCM was caused by Taste of the Wild. Fucking common sense.

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Erin Wysmuller
August 25th, 2019 at 3:47 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

What I took from looking into this was that "grain free" dog food was replacing calories normally from grain with calories from vegetable proteins (like pea and soy protein) rather than increasing meat. So I started looking into making my own dog food. At least I know what I am putting in it and don't have to figure out who to trust in these huge companies/industries.

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Coleman Shum
August 19th, 2019 at 6:42 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

This is AWESOME! My girlfriend is a Vet Tech and the doctors she works with have been trying to help prevent people from switching up their dogs diets to grain free because of all the heart issues they've been seeing in studies! Just because you're grain free doesn't mean your dog should be :)

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Tanya Civco
August 12th, 2019 at 8:12 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

To be clear, taurine supplementation alone has not corrected this issue in the cases of this version of heart failure. Taurine deficiency is a well-known reason for dilated cardiomyopathy, but that is part of what is interesting (from a scientific perspective) and frustrating (from a clinical perspective) is that whatever is going on in these diets is as of yet unexplained and the "simple" solution of taurine deficiency is not solely to blame.

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Tanya Civco
August 12th, 2019 at 7:56 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

To be clear, I am not even saying that there may not be some benefit to a legume or potato-based diet over a corn-based diet. What I am saying is that anyone that makes a pet food needs to be sure that they formulate their diets so they at least start at safe for the animal. After that, make any claims you want about why your diet is superior to someone else's. But first you have to get to safe.

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Tanya Civco
August 12th, 2019 at 7:54 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

The crux of the issue with these grain-free diets is that they were formulated and sold without them actually being fed first to dogs and cats at the pet food companies. Some subtle essential but as yet unidentified nutrient has been absent long enough and these animals are now showing up with heart disease. It took as long as it did to figure out just this part because enough cases needed to show up to enough veterinarians nationwide to the pattern to become evident.

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Tanya Civco
August 12th, 2019 at 7:49 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

The basis by which I am making my statement is that I am a practicing veterinarian who is seeing this disease in my and my colleague's patients. There is a new form of heart disease showing up in mostly dogs but a few cats fed mainly grain-free diets. What is different with this disease is that if caught early enough it can often be reversed just by changing the diet. This is the reality, pure and simple. The veterinarian's that are trying to get the message out to the general public are not tied to anything other than we want our patients to stop getting sick and dying. The message you are sending is harmful to animals.

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Alan Marsh
February 29th, 2020 at 3:58 pm

You make some valid points. It is your mandate to care for pet's health. But there's a serious issue with what veterinarians are telling their clients with regard to the inconclusive data being consistently put in the news by Freeman and others. Just to be on the level; I too am in the pet business and have a financial stake in this situation. The primary issue I have is that the conclusion of the explanation offered to pet owners with regard to the DCM issue is consistently; "You can only feed Purina, Hill's and Royal Canin." Why? "Because those companies are the only ones who have board certified vets and do the proper testing." The problem with that? 2015, Purina, propylene glycol and Beneful sickened and killed how many thousands of dogs? 2019 and Hill's vitamin D. Millions of pounds of Hill's products recalled... Let me repeat that; millions of pounds of products. And again, hundreds if not thousands of dogs sickened and killed. What does this say about mega-company oversight? Nonexistent? Only when pet's start getting sick and dying? From what I see, smaller brands cannot approach quality control with this level of inattentiveness because they can't afford a multi-million dollar judgment against them and stay in business.


The majority of pet owners are suspicious when they take their pet to the vet and are told to avoid "boutique" stores and to only shop at the grocery stores and big-box retailers. More often than not this impugns the veterinarian in the eyes of pet owners. To follow that with a recommendation to feed Purina? Most pet owners aren't buying it. In fact, it confuses them. More often than not we hear a baffled statement like; "Ahhh, my vet told me something about getting off of grain free foods and to buy Purina." Often their association with Purina is that it's a not quality brand that informed pet owners feed their pets.


If the advice being given was based on ingredients, I would not be sharing my thoughts here. The FDA's premature focus on correlative and not conclusive brands and their role in diet related DCM is at this point, specious at best. In addition, the veterinarians who are now applying the word "boutique" to independent pet retailers followed by a warning to not shop at; "those kinds of stores" are offering a baseless assertion not backed by science. I would go so far as to question the business practices and ethics of these assertions. Even the cat litter and collars we sell are now dangerous? This all rings of some ulterior motive that might have some basis in pet health but is being delivered with vigor for some other reason(s). And again, this comes down to the ingredients used in kibble because virtually every product is made using the same equipment, manufacturing process and is packaged in virtually identical packaging.


If veterinarians want to properly address this issue, they need to focus on ingredients, not brands and what type of retailer might be available for pet owners to purchase their pet's food and other products. To clarify the dubious nature of this slander, it's not every veterinarian who is on this bandwagon of bashing smaller brands and the stores who sell them. Many times I've asked a customer that has been shopping with me for years; "Did your vet warn you about DCM, boutique foods and independent pet supply stores?" and they respond; "No. she/he didn't say anything about any of that." So apparently this is not something that is being mandated from on high but an assumed liability issue being taken on by individuals. I've even heard of instances where articles and vets told pet owners that they don't need to bother reading ingredient panels on pet food. To push this sort of thing to the limit; I have a local vet near me who feeds raw to her own pets but admonishes any pet owner who divulges that they would dare to feed raw, followed by that "Purina recommendation." How about the millions of diabetic and overweight dogs? Where's the FDA report on that? Where's the furor over feeding chicken flavored corn to dogs? Hardly. All of this is over less than .001% of the dogs in the United States and still, has NO conclusive data behind it.


I've had tens of thousands of pet owners purchase products from my store. I have yet to have one customer assert that me or my staff were negligent in the food recommendations we have made. We talk about ingredients. We educate, not alienate. If a company has proven themselves to have a track record of consistent quality control and a focus on quality ingredients, we recommend them. Recently a customer brought in a bag of Royal Canin. After several minutes of close examination, it was still unclear what the source of animal protein was in the product. Or how about a product formulated to deal with diarrhea with corn starch as its first ingredient? Seriously? Corn starch as the first ingredient? I would gather that this would pretty quickly solidify the stool but what about the roller-coaster effects on blood glucose levels? If a brand shows a fealty to profit over pet health, you won't find their products on our shelves. If the final part of the DCM conversation was to recommend a brand with a proven track record of putting pet health over profit, stores like mine would be well stocked with those vet recommended products. The truth is that I hear scant attention being paid to a company's actual track record and the ingredients they choose to put into their products. Trust me; my customers have every opportunity to learn the difference between meat-meal and sustainably sourced, grass-fed angus beef.


Let the studies show conclusive evidence. Let the industry as a whole respond to the ingredient issues. STOP following the FDA's lead and confusing your clients with chicken-little tactics about "brands you can't trust." Or don't and stores like mine will just keep recommending the veterinarians in our area who never use the word "boutique" to describe our businesses and who are infinitely more concerned with ingredients and their conclusive effects on pet health than the logo on the bag or the research grant that helped fund their education.

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Tanya Civco
August 5th, 2019 at 7:16 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

So we are to believe you, with no research authority and a clear financial tie to a pet food industry over the veterinary cardiologists who have no ties or financial gain at all and are just trying to stop animals from dying? The truth (if anyone cares) is that right no ones what is the issue, but there are dogs that are showing up with a type of heart failure that should not get this disease due to genetics alone. In some lucky cases, switching the diet reverses the disease. That means there is a clear, irrefutable causality behind these diets and heart failure. Other dogs have not been so lucky and have died of their diet-induced disease since their symptoms were not recognized in time. The veterinary community does not yet fully know what the issue is with these diets, they just know there is a clear, undeniable connection between certain diets and heart disease in dogs. To be safe, no one should feed these foods until they can be proven safe

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Timothy Johnson
August 6th, 2019 at 5:15 pm

The vet cardiologists what work for Tufts and UC Davis have absolutely no ties to the pet food industry? Seriously, are you dense? Their buildings and much of their research is funded by Purina. So sure, they are completely objective. Secondly, the FDA has already proved their hypothesis WRONG. Boutique - because some of the foods on the list are from larger companies, eg. Fromm (I don't consider them Boutique), Nutro (Mars), Merrick (Purina), Taste of the Wild, Nature's Domain, and 4Health (Diamond), Blue Buffalo (General Mills), Natural Balance (JM Smuckers - who also owns Rachael Ray, Gravy Train, 9 Lives). In fact over half of the 10/16 listed are owned by large manufacturing companies). Exotic - hmmm. Also false. Grain-free? 10% were grain inclusive, but again, people haven't been calling on vets to report all those cases of DCM on grained foods. Vets where I live aren't reporting any suspected cases, why, because most of the people can't afford the diagnostic testing to prove it it's DCM. If they are feeding cheapo food, and can't hardly take them yearly for vaccines and other basic care, what makes you think every single dog owner whose dog has a heart condition is reporting it, or even getting care for it. The people that were feeding these types of food ARE the people most likely to take their dogs to the vets when something is wrong, the ones who will pay for their animals to be treated, and saved at any cost.

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Daniel Schulof
August 6th, 2019 at 8:20 pm

Tanya --


As I wrote above, your statements about financial conflicts of interest are incorrect. I've spelled them all out. Just repeating this over and over again does not make it so.


There is not a single case in the scientific literature of a dog with DCM being switched from a grain-free diet to a grain-containing one and conditions improving, UNLESS TAURINE SUPPLEMENTATION IS PAIRED WITH THE DIET SWITCH. And, because taurine supplementation alone has been often shown to improve DCM outcomes, it makes all the sense in the world to assume that its the taurine (not the diet switch) that yielded the improved outcome. If you think that statement is wrong, please tell me where I missed something and I'll correct it. But I didn't see a single case in the DCM studies that have been published in the past year (or before) in which diet change alone precipitated clinical improvement.


"... clear, irrefutable causality." No, that's incorrect for two reasons. One, it hasn't actually been shown (see the last paragraph). Two, that's not what causality is. You can see this for yourself by trying to find an example where the word "causality" is used in either the FDA investigation or any of the scientific work discussed in my piece. You'll find that not only do the authors NOT use the word "causality," they also don't use the word "correlation." Even THAT hasn't been shown here, let alone causality.

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Tom Mullen
November 28th, 2019 at 4:03 am

Thank you Tanya - right on! Read my comment below too

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Pierre-Olivier Camp
July 29th, 2019 at 5:01 pm
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

Correlation dosen't mean causation.


Ice cream sales is correlated with shark attacks.

Magarine sales is correlated with divorce rate in Maine.


The FDA just reported the data collected from various veterinarians; its not a peer reviewed study but more like observational data. The actual studies will begin in fall. If people understood the scientific approach (and vocabulary), there would be less conspiracy theories floating around.


My 2 cents


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Daniel Schulof
July 29th, 2019 at 9:12 pm

Hi Pierre. Of course there is a difference between correlation and causation. But in this case, there actually isn't even any evidence of correlation. In fact, that's my argument why the JAVMA article ought to be retracted. JAVMA should not be publishing articles in which authors claim that there is an "apparent association" between two variables when there isn't any evidence of correlation, particularly when the article isn't peer-reviewed.

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Tanya Civco
August 5th, 2019 at 8:51 pm

Right now, what the veterinarians are trying to do (with actually very little help and much foot-dragging from the FDA) is to get the word out that there is as yet an unexplained, as far as the exact cause of the nutritional defect, but irrefutable connection between certain diets (with a commonality that most, but not all, are grain-free with a high percentage of pea and potato in the ingredients) and heart failure and death in dogs. It is not peer-reviewed because the community is still trying to understand what the underlying issue with these diets is. It's like when AIDS first came out. Scientists knew there was an infectious disease spread through blood and other bodily fluids that was killing people. The first step is to alert the public that this is an issue so they can avoid the behavior linked to the disease. This is where the veterinary community is right now with the diet. They are saying do not feed these diets as they are killing some dogs.

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kirsten zielinski
July 29th, 2019 at 12:55 am
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

i have always said, vet schools teach next to nothing about nutrition and what they do teach is taught by the pet food industry. and they make $ off of the bad science with their fake prescription diets that are basically corn/soy/wheat/crap. easier to feed raw and not have the worries.

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Joanna Kimball
July 29th, 2019 at 4:52 am

It's absolutely not true that vet students don't get nutrition classes. That's a myth that needs to die. But even in a world where general practice vets don't know about nutrition, how about the actual boarded vet nutritionists? The ones who specialize in nutrition and have specialized in it their whole lives? What are they saying? THE SAME THING, JUST LOUDER. The veterinary nutrition community is one of the most vocal about the DCM problem, and they are saying to get OFF "boutique" foods that are designed to appeal to humans and not designed to feed dogs.

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Daniel Schulof
July 29th, 2019 at 9:04 pm

Hi Kirsten. When I was conducting the research associated with my book I reviewed the curriculum at every AVMA-accredited veterinary school in the country. In more than 30% of vet schools, students weren't required to take a single nutrition course in order to graduate. And in all but three schools that did require some nutrition coursework, the only requirement was a single, one- or two-credit course.

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Tanya Civco
August 5th, 2019 at 8:45 pm

While there may not be full courses in nutrition at every veterinary school there is nutrition built into the courses for both large and small animal medicine, so it is actually a firm part of the training of all veterinary students and veterinarians, despite what Mr. Schulof's research showed. Medical schools do not necessarily teach nutrition as a separate part of the curriculum, for better or worse, but I would argue that you would still trust the nutritional advice given to you by your doctor if they made specific recommendations they deemed important to your health.

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Tanya Civco
August 6th, 2019 at 3:08 pm

And, lastly, I did some research to see if Mr. Schulof's claim that only 3 veterinary schools have nutrition as part of the curriculum. The first 6 of 7 schools (just googling "veterinary school curriculum) and going down the list in no particular order) I looked at all had clinical nutrition as part of the core curricula and were separate courses, double already what Mr. Schulof claimed, at which point I stopped searching.

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Daniel Schulof
August 6th, 2019 at 8:07 pm

This is another reply for Tanya. You're misquoting me -- I didn't say that only three AVMA-accredited vet schools required a nutrition course. I said that of those that do, only three require anything more than a single 1-2 credit course. And I stand by that. Please correct your comment.

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Alice Yau
July 27th, 2019 at 5:59 pm
Commented on: 190727

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Jeremy R
July 27th, 2019 at 11:57 am
Commented on: Bad Science and Financial Conflicts of Interest Plague the FDA’s Investigation Into “Grain-Free” Pet Foods and Dilated Cardiomyopathy

Thank you for this post. Embarrassingly I saw these media articles and immediately started searching for a different product for my dog. I was duped! Industry driven research is often discussed, especially here, but this is an example that resonated with me.

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Tanya Civco
August 5th, 2019 at 8:36 pm

Jeremy, this is *not* industry-driven research. This is a situation where board-certified veterinary cardiologists with absolutely no financial ties to the pet food industry are seeing animals die from nutritionally induced heart disease. They are making these findings known to the public at large while the exact cause of the nutritional issue is further studied because they simply want to stop animals from dying. You can choose to believe experts within the field with years of training and specialization or pseudo-science. Daniel Schulof has a pet food company, so one person in this conversation with an actual financial interest to skew the conversation away from science and fact is him, not the veterinarians trying to save lives.

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Daniel Schulof
August 6th, 2019 at 8:04 pm

Tanya -- I can't respond to your comment directly on this platform, but I hope you can see this response to Jeremy's comment. All of the conflicts of interest possessed by the veterinarians responsible for the work at the heart of the retraction demand are specified in the body of the retraction demand itself (including previously undisclosed ones that only came out as a result of the California Public Records Act investigation I conducted). On what basis are you arguing that those veterinarians don't possess the conflicts I've cataloged? The evidence is there for everyone to see.


By all means doubt my motivations here -- I've made no effort to hide them. In fact, I'm explicitly calling attention to them -- they are a big part of my motivation here. I believe my company is being unfairly scapegoated for something we have nothing to do with. If you think I've said something inaccurate or you think the scientific case I've made is wrong in some way, then tell me which aspect of the retraction demand you're referring to and why: (1) the data scrubbing by Adin et al? (2) the failure to test for cysteine and methionine by Stern et al? (3) the evasion of the peer-review process in the case of the JAVMA evidence review? (4) the various mischaracterizations of the evidentiary record from the JAVMA evidence review? Like what do you think I got wrong?

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Li Juebin
July 27th, 2019 at 3:51 am
Commented on: 190727

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Casey Pierce
July 27th, 2019 at 2:35 am
Commented on: 190727

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Richard Sheehan
July 27th, 2019 at 1:01 am
Commented on: The secret life of data

MaryAnne, we met in Santa Cruz a few weeks back at a Crossfit DDC. I understand the importance of proprietary data and use it regularly. And it generally comes with restrictions on its use and sharing. In finance and economics, there are strong requirements for sharing the data for any study and that requirement runs across virtually all journals. In many cases, the data must be placed in a repository of the journal. The only generally accepted exception to the rule is for proprietary data. So I'm not surprised that they refused to provide the data. However, again in finance and economics, even if you cannot share the data you are expected to share any and all programs and code used to analyze the data. That's a far cry from having the data itself, but having the programs, code and raw results from the data could be nearly as informative as the underlying data. At a minimum, you should be able to determine things like whether the sample sizes were appropriate, whether there were outliers removed or other manipulations made to the data and whether those manipulations may have compromised the results, and whether the results were statistically significant and medically or economically significant. It should be possible to review those documents without compromising the proprietary data. If they cannot make that documentation available, then I would argue that there's likely a problem with the underlying analysis or that they simply don't want to expose their study to a rigorous external review. Either way, it would appear to be a serious breach of scientific protocol. Good luck!

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