las

Welcome all seeking refuge from low carb dogma!

“To kill an error is as good a service as, and sometimes even better than, the establishing of a new truth or fact”
~ Charles Darwin (it's evolutionary baybeee!)

Tuesday, January 21, 2020

What's the Problem with Nutrition Research? Is it True Health Iniative or NutriRECS?


Hello World .. and anyone still reading this blog!!

Yes, it's been forever.  I've been generally pretty well.  Knocking about on social media (Facebook and some Twitter) ... occasionally getting the urge to blog, write something, get to 80% then lose the mojo.   What has turned into a long hiatus wasn't planned, but it happened due to running out of steam and still seeing the same old, same old.  I may or may not discuss more at some point, but if I don't just jump back in and blog, I probably never will again!

And so, with that said ...

𐩘𐩘𐩘𐩘𐩘𐩘𐩘𐩘𐩘𐩘𐩘


The following editorial in JAMA has been making the rounds on my Facebook feed, and I have a bit of a different take and reaction to it ... one that comes from roughly a decade now of delving into dietary recommendations wars from where I "stand".



I would encourage everyone to read this before this blog post.  It's interesting to me how differently people react and would love if you join in comments.


Before I begin here, this post will not be discussing red meat studies and the healthfulness per se.    I also want to make it clear that this is not an endorsement of Dr. David Katz or his True Health Initiative.   But it is also crystal clear where Katz and the THI's biases lie ... the message is not hidden on their website:  True Health Initiative.


This is the current Top Story on the site.




A little TL,DR summary:

  • An ostensibly independent group, NutriRECS, cofounded by Dr. Bradley Johnston, Dr. Pablo Alonso-Coella and Dr. Malgorzata (Gosia) Bala, had a number of studies published in Annals of Internal Medicine last fall.    Groups such as this are seemingly the next tack in the Guidelines wars ... an end-run around the government's Dietary Guidelines Advisory Committee recommendations.  
  • Their main conclusion was that there is no evidence suggesting that Americans should eat less red meat or even the less of the processed red meat subgroup often singled out.
  • Katz and THI, contacted Annals in an effort to get the articles/studies pre-emptively retracted pending further evaluation.  
  • Conflicts of interest regarding industry funding and members of NutriRECS emerged.
  • The JAMA article counters by downplaying NutriRECS' conflicts and the journal's role in somewhat ignoring them and shifting the focus on Katz/THI's behavior and conflicts.

I am all for organizations like NutriRECS ... the more information and analysis of the evidence that can be done, the better.  The problem arises with the use of the term *independent*, implying no influence by governments or industries.  So it IS serious when a co-founder and the lead researcher on the red meat study, Dr. Bradley Johnston, failed to disclose his ties to the beef industry.  


A New York Times Article



Tara Parker Pope and Anahad O'Connor shed light on Johnston's failures to disclose in the New York Times:  Scientist Who Discredited Meat Guidelines Didn’t Report Past Food Industry Ties
"... as recently as December 2016 he was the senior author on a similar study that tried to discredit international health guidelines advising people to eat less sugar. That study, which also appeared in the Annals of Internal Medicine, was paid for by the International Life Sciences Institute, or ILSI, an industry trade group largely supported by agribusiness, food and pharmaceutical companies and whose members have included McDonald’s, Coca-Cola, PepsiCo and Cargill, one of the largest beef processors in North America."   {the NYT links were left intact}
Asked about this conflict,  Johnston defended himself as such:
"He said he did not report his past relationship with ILSI because the disclosure form asked only about potential conflicts within the past three years. Although the ILSI-funded study publication falls within the three-year window, he said the money from ILSI arrived in 2015, and he was not required to report it for the meat study disclosure."
This is, frankly, ridiculous, and is still in violation of the standard COI.   You can download the form, the pertinent section:
Place a check in the appropriate boxes in the table to indicate whether you have financial relationships (regardless of amount of compensation) with entities as described in the instructions. [...]  You should report relationships that were present during the 36 months prior to publication.   {emphasis on form}
The  DOIs for Clinical Guidelines, are a bit more specific to include both financial and intellectual interests.  In any case, for an organization that holds itself out as independent, to omit this information for the lead author on a technicality is highly suspicious.   Exploiting loop holes to conceal conflicts from journal readers is hardly a mark of integrity. 

As far as I'm concerned, there ought to be a universal, publicly available disclosure of funding and other COI going back 10 years at least.  As it stands, these D/COIs change through the years and even between journals, and one has to track back history through various journals to connect the dots.   Just about every scientist has some conflict of interest that may influence their work and create bias (conscious or otherwise) in their work.  They don't work for free, nobody expects them to.  So the next best thing is for true transparency in these statements and real consequences for errors.  As it stands, there is not much more than public rebuke in most cases, and a correction noted in the publication.  Indeed even in an egregious caseThe British Journal of Sports Medicine temporarily retracted an article by Malhotra, Noakes and Phinney for failure to disclose conflicts.  It was ultimately republished (yet Phinney still failed to disclose Virta in the works).  There should at least be dollar ranges specified for speaking fees, book sales, etc. 

Even if Johnston skirts current C/DOI requirements, as noted in the  NYT piece, he has run afoul of such statements regarding this very funding in the study in question published in the very same journal!
"When Dr. Johnston and his colleagues first published the sugar study, they said that ILSI had no direct role in conducting the research other than providing funding, but later amended their disclosure statement in the Annals after The Associated Press obtained emails showing that ILSI had “reviewed” and “approved” the study’s protocol."
And yet, despite this black mark on his record, Annals editor-in-chief Dr. Christine Laine appears to support Johnston, and by extension her journal. 
“We are really leaving it to the authors to disclose,” said Dr. Laine. “We advise authors if they wonder ‘Should I disclose this or not,’ they should err on the side of disclosure.”
And then, she sowed the seeds of deflection ...
Dr. Laine noted that people on both sides of the meat issue have conflicts of interest. “Many of the people who are criticizing these articles have lots of conflicts of interest they aren’t talking about,” she said. “They do workshops on plant-based diets, do retreats on wellness and write books on plant-based diets. There are conflicts on both sides.”
Dr. Laine said if Dr. Johnston had chosen to disclose a financial relationship with the food industry group, it would not have changed the journal’s decision to publish the research.
I don't have any problem with Annals publishing the study with that disclosure, but surely peer review and the ultimate acceptance process would at some point have reminded the journal of Johnston's past transgressions, and that they WERE aware of his relationship with ISLI.  This simply makes the journal look bad, and they are definitely not alone as "prestigious" medical journals failing to rigorously enforce commonsense disclosures.


The JAMA Article:  The Sorry State of Nutrition Research?



When this article,  Backlash Over Meat Dietary Recommendations Raises Questions About Corporate Ties to Nutrition Scientists , first flickered through my Facebook feed, I thought it was about the authors of those recent studies.  Instead, it was about Katz, his THI, and then branched out to cover other like minded organizations and affiliated doctors and scientists. 


On first read, I readily admit my own biases were triggered by Dr. David Ludwig (still my pick for Worst in Nutrition Science) being quoted re: quality of research, followed by "all science is wrong" Ionnidis, who has somewhat of a hero status among the low carbers.    And so I tracked down more info via the NYT article and re-read JAMA.    On second read, the intent of the article as an instrument of deflection and possible slander emerges.   

Let's be clear here.  This article is about supposed conflicts of interest of those pointing out the serious conflict of interest of the lead author and co-founder of NutriRECS and perhaps the negligence of editors at Annals for allowing this to happen.    


Still, NONE of the various doctors, scientists and organizations implicated were being called out for D/COI issues on research they sought to publish!

The article begins:

It’s almost unheard of for medical journals to get blowback for studies before the data are published. [...]
Annals Editor-in-Chief Christine Laine, MD, MPH, saw her inbox flooded with roughly 2000 emails—most bore the same message, apparently generated by a bot—in a half hour. Laine’s inbox had to be shut down, she said. Not only was the volume unprecedented in her decade at the helm of the respected journal, the tone of the emails was particularly caustic.
“We’ve published a lot on firearm injury prevention,” Laine said. “The response from the NRA (National Rifle Association) was less vitriolic than the response from the True Health Initiative.”
This is worded in such a way as to implicate THI for the caustic bot emails, but note that Laine does not actually say this.   Further, we are offered no examples of the vitriol.  It's a lengthy article, so it would not appear that word count limitations were an issue.  Before condemning someone's behavior, I like to know what it is they are accused of.  It could very well be that this deluge came in response to a plea by THI and/or Katz specifically, and included an aggressively worded boilerplate.  We are, however, offered no real evidence of such, nor any clue what exactly was so bad.  Pretty irresponsible journalism by the author Rita Rubin and JAMA.    

The article calls out Katz and THI Council members, Harvard researchers Walter Willett and Frank Hu.   The trio contacted Laine in advance of publication, in an attempt at pre-emptive retraction.  Something described as unusual (it is) .  Hu is another name that triggers me, as he was among the 2015 DGAC members attacked by Nina Teicholz in a highly irregular case of a medical journal (BMJ) commissioning a clearly biased journalist to conduct an investigation paid for by the Laura and John Arnold Foundation (same backers as Taubes' NuSI).  To this day, the Nutrition Coalition obscures its agenda, and somehow they have no ties to industry while two heavily invested actors IN the nutrition industry (Volek and Halberg with Virta), but I digress ...  (more here if interested, plenty related re: NuSI here

After that peer journalistic fiasco, I can certainly understand why Hu, specifically, might take unusual action in advance of these latest articles.   Whether or not any THI board members' plant-based biases and advocacy played a role in their actions, they raised a legitimate question regarding the independence and neutrality of NutriRECS.

Laine's ultimate comment is condescending to say the least:
“Some of the researchers have built their careers on nutrition epidemiology,” Laine said. “I can understand it’s upsetting when the limitations of your work are uncovered and discussed in the open.”

Continuing on ...


This is how Rubin first addresses the D/COI issue, linking to the NYT article
Subsequent news coverage criticized the methodology used in the meat papers and raised the specter that some of the authors had financial ties to the beef industry, representing previously undisclosed conflicts of interest.
Then 
The Annals published 5 systematic reviews—4 that included results from randomized clinical trials (RCTs) and observational studies examining the relationship between red meat and health, and a fifth that looked at health-related values and preferences about eating meat. Based on the reviews, the authors produced a guideline that concluded adults needn’t change their meat-eating habits.    {red/highlight emphasis mine}

If I may backtrack for a moment here,  I think the DOIs for Clinical Guidelines (see subsection What Disclosures are Mandated) published in Annals should certainly apply, and Johnston is clearly in blatant violation of this.  Laine bears responsibility as well, as she's been editor-in-chief for a decade, thus presided over Johnston's prior disclosure transgression, and should have taken extra care given the bombshell nature of what was to be published.  

And now, here's how Rubin elaborates on the D/COI issue:


The guideline’s lead author, Bradley Johnston, PhD, is a cofounder and director of NutriRECS, an independent group that says it uses its members’ expertise in clinical issues, nutrition, public health, and evidence-based medicine to produce nutritional guidelines that aren’t hampered by conflicts of interest.
[...]
The New York Times was the first organization to raise the issue of potential conflicts of interest among the meat papers’ authors. An October 4 article noted that Johnston, who reported having no conflicts of interest in the 3 years prior to publication, coauthored a December 2016 Annals study that was funded by the nonprofit International Life Sciences Institute (ILSI), which is primarily supported by the food and agriculture industry.
[...]

He said he received the ILSI funding in 2015, which was before the 3-year period for which he was required to report competing interests for the meat articles. However, according to a December 31 correction in the Annals, Johnston didn’t include on his personal disclosure form a grant from Texas A&M AgriLife Research that he received within the 36-month reporting period. The grant funded investigator-driven research about saturated and polyunsatured fats, according to the correction.

This is all addressed in a rather nonchalant manner, but when one considers Johnston's past transgressions and now TWO here one expects there to be some commentary on the true independence of NutriRECS.   In the next paragraph, Rubin aims at THI by pointing out that John Sievenpiper  is a THI member who also has ties to ILSI.  

True Health Initiative member Sievenpiper served as a scientific advisor for ILSI’s Carbohydrates Committee and as vice chair of the ILSI North America Scientific Session 2018. And in late 2015, Canada’s National Post newspaper reported that the Corn Refiners Association retained Sievenpiper as an expert witness to support its case that high-fructose corn syrup is no less healthy than sugar.
So let me get this straight.  I would agree that Sievenpiper's ties to ILSI and other industry groups absolutely DO factor into the independence of NutriRECS.  Why?  Well because Sievenpiper's membership in THI is less relevant than the fact that HE WAS A CO-AUTHOR ON SOME OF THE ANNALS PAPERS. One could legitimately argue that his involvement with THI presents a conflict of interest, but that doesn't play into the narrative that the real bad actors in nutrition science here are Katz and THI, not NutriRECS.  There's more on him in the article, you may wish to read this as well regarding Sievenpiper's position:  The Actual Reason Meat Is Not Healthy

In any case, this is a transition to laying blame on THI.  Talk about burying the lead that not one, but TWO NutriRECS researchers had ties to a powerful industry group while the organization claims independence.  

But wait, there's more!  And even here, THI (Lutz) is mentioned for bringing up the topic that yet another NutriRECS author, Stover, had an ...
undisclosed conflict of interest because his school receives funding from the beef industry. Stover is vice chancellor and dean for the Texas A&M College of Agriculture and Life Sciences, which is part of Texas A&M AgriLife. Lutz’s article noted that 44 Farms, the largest Texas producer of Black Angus cattle, has established an endowment at Stover’s school to support the International Beef Cattle Academy.
Rubin goes on to attempt to explain this away as insignificant.  So here we have THREE NutriRECS authors of a *guideline* with significant, undisclosed D/COIs, one of which Rubin seeks to discredit with his relationship to the "real bad guy",  THI.  


Meanwhile THI is the REAL Conflicted Party?


Meanwhile, industry ties and other potential conflicts of interest seem to be common among THI council members and the organization itself.

While this may be 100% true, it is also 100% irrelevant.* Neither Katz, THI, nor any of its members** was publishing research and guidelines in Annals and failing to adequately disclose the industry ties as part of an organization claiming complete independence.     
* except for the case of Sievenpiper's role in the "independent" NutriRECS 
**  again w/the Sievenpiper exception
In the case of Sievenpiper, this undercuts his credibility and that of his role as a NutriRECS researcher and author.  Not THI. 


Meanwhile ... Everybody Loves a Conspiracy



{I say this in my best Vinnie Antonelli/Steve Martin voice from the movie My Blue Heaven.  If you've never seen it, it's hilarious.  See it!}


This entire Katz/THI hit piece narrative is interwoven with whodunnit innuendo over embargoes, press releases and early access.  What this should do is shine a bright light on the conflicted interests and marketing tactics of the BIG BUSINESS journals themselves.  Instead we get a lot of innuendo, though little proof, that Katz somehow violated the embargo system to any sort of negative outcome or legally meaningful consequence.

To be clear, any time someone signs an agreement, they should honor the letter and spirit of that agreement, however unfair or inconsequential it may seem.  The whole journal embargo thing is a marketing scheme to maximize the impact of publishing research and has spawned some of the worst sensationalist nutrition reporting out there.  Impact factor impacts the journal's bottom line.  Controversy sells, boring nitty gritty of science, etc. does not.

Before looking at the innuendo piled on Katz, here is the Embargo Policy at Annals


Under the subheading "Words get around", Rubin implies, but doesn't come out and officially accuse Katz of violating this policy:
Demands to retract the Annals papers before they were published suggest that the journal’s embargo policy had been violated. (Embargoes prohibit reporters and press officers at the authors’ institutions from circulating articles before they’re published. Breaking an embargo is a serious breach.)
An article on the THI website states that the organization had obtained the meat articles 5 days before they were scheduled to be published online.
I went to the article -- True Health Initiative Rapid Media Response -- and it does not say that.  It says that "True Health Initiative received the press release and related reports for red meat reports published in The Annals of Internal Medicine, the Wednesday before their Monday publication."  This is in agreement with the next statement in JAMA:
Laine said Katz was on the Annals’ press release list because he writes a weekly column for the New Haven Register, a Connecticut newspaper.
Katz said he circulated only the press release—“that’s in the public domain”—but not the embargoed articles, among THI colleagues, telling them that the guideline “looks like it’s going to be a serious problem for us.”
Oddly, after all the discussion of Sievenpiper, there's no speculation over the role he may have had in discussions.  In any case,
Actually, embargoes apply to press releases as well as the articles themselves, said Angela Collom, the Annals media relations manager. The Annals and many other journals post releases to a website run by the American Association for the Advancement of Science that restricts access to members of the media who agree to embargo policies.

I don't know if the AAAS website has specific policies about sharing of press releases, etc., but there is NOTHING in the Annals embargo policy that seems to prohibit sharing of press releases -- only publishing anything before the short lead time between 5pm on Monday when the embargo is lifted and Tuesday publication.  To repeat the yellow highlighted passage:
Annals sends advance copies of the journal to members of the news media the week before publication. Reporters may not publish stories based on this information until 5:00 p.m. (U.S. Eastern time) the day before the date of publication of an issue.

The Annals guidelines paper was originally published on October 1, 2019 (PDF) and was corrected and republished on Nov 19th.   THI's is dated October 15 and all it does is state that they had obtained copies of press releases.  Absent evidence to the contrary, we have, a *possible* breach of protocol for which Annals has retaliated by striking Katz from the media list.


Your mileage may vary, but to my reading, nobody violated the embargo by publishing anything in advance and circulating information to THI members does not violate the prohibition against doing so to "media, manufacturers or government agencies".   At worst we're probably in a gray area, but it is clear that Laine did not appreciate the pre-emptive efforts spearheaded by THI.  

The New York Times piece highlights issues with NutriRECS and Annals who published not just the systematic reviews, but guidelines.   It is this behavior, and the fact that -- accompanied by some level of vitriol or not -- Laine was made aware of some of these issues prior to publication, yet proceeded anyway.  Laine seems unaffected by the serious issues of conflicts of interest on the part of  NutriRECS, and seems rather more interested in brushing off any criticism and concerns as some sort of partisan sour grapes. 

Rubin rather enthusiastically shifts blame on Katz and THI rather than holding a competitor journal and NutriRECS responsible for their violations of the public trust.


Letters Were Written


For all of the innuendo about vitriol and subterfuge, Rubin only mentions, but does not quote from, a letter sent to Laine by Katz, THI and others.

“It’s really frightening that this group, which includes people like Walter Willett and Frank Hu at the Harvard School of Public Health, which happens to be my alma mater, were aware of this and assisting it,” Laine said.
Really?   Frightening???  That prominent researchers expressed grave concerns, most specifically that the conclusions of the most pertinent systematic review do not support the guideline?  That perhaps such bombshell articles might warrant further review before publication??

Many sharing this Rubin-JAMA article are doing so on the basis of the "chilling" tactics of Katz and THI -- some sort of attempt to stifle scientific discourse.  It's not surprising given how craftily the real "bad actors" here have managed to shift blame to the messenger.

Points raised in the letter:

  • Apparently Laine agreed to revise the press release based on a previous letter, but no revisions were available as of 9/30/19 (the day the embargo is lifted at 5pm)
  • This letter was joined by several more prominent people in the field
  • The "systematic" nature of the review is questioned and omits trials such as PREDIMED that fit criteria stated by NutriRECS. 
  • "We note further that across the expanse of papers there is a consistent pattern in the data of net, statistically significant harm regarding all outcomes- mortality, cardiovascular disease, cancer, and diabetes- with higher intake of meat and processed meat."
  • The guidelines were in contrast to this finding.
  • As your office likely already knows, several highly qualified peer reviewers recommended these papers be rejected based on the above concerns, along with others. We learned this as a byproduct of exchanging our concerns with one another.
The letter ends as follows:

For the sake of public understanding and public health, we the undersigned call upon you to withhold publication of potentially damaging misinformation pending all due and appropriate review of the matter by your office
How frightening indeed?!



He Blogged, How Awful!




Perhaps the most absurd accusation leveled at Katz was that he didn't dutifully write letters to the editor on the Annals site, and rather disseminated his message on his blog.    How ironic, then, that Rubin quotes Ludwig, a party uninvolved in this situation.  Perhaps his JAMA Viewpoint cited wasn't getting much attention?  But Ludwig is a new generation researcher who is active on social media and blogs on Medium to spread the gospel of the Carb-Insulin Hypothesis.   

It's nice to see Ludwig admit that nutrition research is bad ... I assume he includes himself in this assessment (grin).  I may just have a blog post in me on this revelation!!



Some Concluding Thoughts





I think there were some very serious issues raised in the JAMA article, but most of them are glossed over in favor of a hit piece.

Regardless of where one stands on diet in general, plant vs. animal or red meat consumption in particular, the peer review process is broken.  This article illustrates just how much by hijacking one medical journal in defense of another in defense of "independent" NutriRECS, and laying blame at the feet of Katz and his True Health Initiative.    This is irresponsible even if Katz is guilty of all that innuendo implies.


NutriRECS made recommendations published in Annals.   The onus is on them to defend their methodology, conclusions, and indisputable concealment of multiple conflicts of interest.  No amount of THI chicanery can excuse NutriRECS.

Laine tips her hand in the closing salvo of the article:


“The sad thing is that the important messages have been lost,” she said. “Trustworthy guidelines used to depend on who were the organizations or the people they came from.” Today, though, “the public should know we don’t have great information on diet,” Laine said. “We shouldn’t make people scared they’re going to have a heart attack or colon cancer if they eat red meat. 


THIS is more frightening to me, because clearly Laine has taken sides.  She disregards any legitimate concerns that might make her look like she's taken sides undermining her own credibility.   Peer review journals are no longer written FOR peers, and increasingly target the general population for page hits, etc.  I would point out that I have accessed this JAMA article a few times while writing thie (e.g. the page reloaded) and have been served up ads for Duke, Lilly diabetes drugs, and a specific CVD drug ad I can't recall the exact name.   This is a built in COI for the journals themselves who generate ad revenue with controversial hit pieces like this one, shared about the web.    The glass house is made of fragile fine crystal, to say the least.  

I'm not aligned with THI, but their biases are out there front and center in Katz's his organizations websites, etc.  As far as I'm concerned, unless they were behind disrespectful emails and such, there were no "terror tactics" employed here and I'm grateful that there are dissenting voices -- ALL THE WAY AROUND -- to challenge organizations to uphold standards.

To Dr. Laine and the Annals of Internal Medicine I will say this.   Clean up your own acts by taking the D/COI process seriously and imposing meaningful sanctions -- including rejection for publication -- when disclosures for publication in your journal are inaccurate and/or incomplete.  Take ownership of this and stop trying to blame everyone but those responsible!

To Ms. Rita Rubin, I would be far more interested in these conflicts of interest and whether NutriRECS is honest in presenting itself as an (unbiased?) independent source.   I'm also far more interested in who these peer reviewers were that recommended rejecting the articles, and *why*, than I am concerned over a possible violation of an embargo that resulted in raising these issues.  
 


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