Victory at Codex Over Dangerous Vet Drug! – Part 2

This continues coverage of the Codex Committee of Residues of Veterinary Drugs in Food (CCRVDF) meeting held in Chicago, IL, from April 23-27, 2018.

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Editor’s Note: This article is intended for information purposes only. Because state and municipal laws vary greatly, as do the circumstances of individual cases, readers are advised to contact an attorney for specific legal advice. © Scott C. Tips 2018

The New Religion
The worship of God has been largely replaced by the worship of Science. At Codex meeting after Codex meeting, I have personally witnessed the majority of vocal Codex delegates being painfully obsequious to the merest pronouncement on a scientific matter by JECFA. (JECFA is the acronym for the Joint FAO/WHO Expert Committee on Food Additives and is the Codex-spawned expert group upon which Codex committees rely for expert scientific opinions in forming Codex standards.) Unfortunately for all of us, their collective genuflection at the altar of “Science” is very badly misplaced since JECFA relies in large measure upon published scientific studies and suspect sponsor-provided (read, Merck) industry research to reach its conclusions with a lack of transparency due to trade-secrecy claims on the part of the industry sponsor.

When a 2009 study revealed that “up to 72%” of scientists admitted their colleagues were engaged in “questionable research practices,” and that some 14% were engaged in outright “falsification,” we can safely assume that there is a problem with published science.

And when, in 2011, another team at Bayer HealthCare in Germany reported that only about 25% of published preclinical studies could be validated enough to justify projects continuing, we can take even more heed of this problem.

In fact, the problem was further highlighted by a group of scientists at a California biotech firm who took the trouble to double-check the results of 53 published landmark studies in cancer research and blood biology. Only 6 of the 53 studies could be proven valid. So, while almost 90% of the landmark studies were flawed, they had all been passed off to the public as fact.

Others, such as respected medical editor Dr. Marcia Angell, are just as insistent: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

And Dr. Richard Horton, the Editor-in-Chief of The Lancet, seconded Dr. Angell’s conclusions when he said that “[t]he case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness….”

With so much “junk” science being passed off as “real” science, and with so many professionals and academics meekly accepting counterfeit science, current science is more in the nature of a religion than a method of critical thinking about the World and trying to discover the truth about how it really operates.

Undue Influence at Codex
JECFA is highly regarded by most of the Codex delegates, so much so that they think that whatever JECFA says, the Codex committees should accept, without question. Almost alone, the NHF has challenged and questioned JECFA for decades. It has also at times supported JECFA. It was only because Drugs for Animals – bitterly angry at its sudden and unexpected loss on the zilpaterol issue – made it an issue with the FAO and WHO representatives that it even flared up at the CCRVDF meeting after all these years.
Ironically, the fact that Drugs for Animals could even make it an issue reveals the extent to which the drug industry controls or influences the risk assessors (such as JECFA), the risk managers (such as Codex), and the regulators.

Confirming this undue influence, another Drugs for Animals representative boldly told the CCRVDF delegates there in Chicago, “In my 18 years of attending Codex here, this is the first time that a sponsor is not happy with a change.” Really? In 18 years, the change that the CCRVDF committee made to the Flumethrin risk assessment was the very first and only time that an industry sponsor was not happy? It takes incredible arrogance to say something like that. Clearly, the vet drug industry thinks it owns this Codex Committee and along with it, evidently JECFA as well.

JECFA Science Too Often Fails Us
Since JECFA has publicly anointed itself as the bastion of “real” science, it might be worth remembering that JECFA science has failed us on more than one occasion. JECFA has wrongly declared all of the following health hazards safe: (1) rBGH or rBST (recombinant bovine growth hormone or recombinant bovine somatotropin); (2) Aspartame; (3) Glyphosate; (4) Ractopamine (animal growth promoter); and (5) Zilpaterol.

There is not enough space in this article to give the details of each of JECFA’s above-mentioned failures, but a short glimpse at JECFA’s own industry-influenced assessments of the risks of rBGH should be proof enough of the failure of Codex science. Curiously enough, during its own first two reviews, JECFA had specifically excluded any consideration of mastitis issues, conveniently claiming that these safety problems were outside the scope of its review. So, contrary to pro-rBGH claims, there had not really been three JECFA reviews of all the issues.

JECFA also missed important data that rBGH-injected cows lost an average of 100 pounds after six months, and that their hearts and spleens and other stressed organs had grown abnormally large. Also overlooked by JECFA are studies and, in some cases, the industries’ own data showing that: (1) rBGH use significantly increases mastitis rates; and (2) the average length of treatment for a case of mastitis is almost six times longer in the rBGH-treated cows compared to untreated cows.

Yet, despite this and an enormous amount of other, unbiased evidence out there, JECFA and its worshippers at Codex continue to insist that rBGH is safe. With antimicrobial resistance (AMR), JECFA had even twisted the lack of data on AMR into a conclusion that AMR is not an issue with rBGH use! As every true scientist knows, an absence of data means scientists wait to draw conclusions until they have the data.

Too, we suspect that JECFA’s expert body on AMR may not be as disinterested as they should be in making their risk assessments of rBGH. An NHF investigator found that one of the Codex Antimicrobial experts, Y. Tamara, was working for Mead Johnson’s GMO division in 2004 where he obtained a U.S. patent for a GMO grain.

All in all, the JECFA review of the safety data on rBGH was incomplete, amateurish, and ignorant of health issues such as mastitis, excess pus, and overuse of antibiotics to try to correct the pus in milk. If JECFA were truly doing its job, then it would be ruthless about tracking down each and every hint of evidence that rBGH poses a human and animal health problem. At present, this dangerous drug rBGH hovers at Step 8 final adoption by Codex all because of JECFA’s failed assessments.

A Victory Nevertheless
Still, zilpaterol was stopped – at least for now. CCRVDF, the committee responsible for considering zilpaterol, will not meet again for two years. But at the Codex Commission meeting held in Rome, Italy, July 2-6, 2018, the pro-zilpaterol forces had clearly been at work to push their money-making, non-health agenda. The new directive from the top was that “science” must be respected and non-scientific reasons could not be used to hold a standard back.

NHF and others objected to that directive, with NHF stating that it had given ample scientific reasons why the zilpaterol standard should not be adopted. NHF even challenged the claim that the drug-happy zilpaterol crowd had any science backing their position.
Codex is a promising institution that has the potential to be even better. But Codex will never be better as long as industry thinks it “owns” Codex and JECFA. JECFA should have enough dignity and self-respect to stop itself from being led around by the nose by industry. The motto of Codex after all is “Safe, Good Food for Everyone” and not “More Sales for Industry.”

Everyone at Codex has an absolute duty to work to ensure safe and good food for the World’s people. And that duty is shirked by anyone who meekly accepts without challenge whatever swill is being passed off as “science.” WF

scott tips

A graduate of the University of California at Berkeley Law School, Scott C. Tips currently practices internationally, emphasizing Food-and-Drug law, business law and business litigation, trade practice, and international corporate formation and management. He has been involved in the nutrition field for more than three decades and may be reached at (415) 244-1813 or by e-mail at scott@rivieramail.com.

Endnotes:
1. Daniele Fanelli, “How Many Scientists Fabricate and Falsify Research? A Systematic Review and Meta-Analysis of Survey Data,” PLOS One, May 29, 2009, at http://journals.plos.org/
plosone/article?id=10.1371-journal.pone.0005738.
2. Prinz, F, Schlange, T & Asadullah, K, “Believe it or not: how much can we rely on published data on potential drug targets?” Nature Rev. Drug Discov. 10, 712 (2011), at https://hopecenter.
wustl.edu/wp-content/uploads/2012/01/Nat-Rev-Drug-Disc-reproducibility-article.pdf.
3. Begley CG & Ellis LM, “Drug development: Raise standards for preclinical research,” Nature, 483, 531-533 (29 March 2012); doi:10.1038/483531a, at https://www.nature.com/articles/483531a.
4. Dr. Marcia Angell, “Drug Companies & Doctors: A Story of Corruption,” NY Review of Books, January 15, 2009, at http://www.nybooks.com/articles/2009/01/15/drug-companies-doctorsa-story-of-corruption/.
5. Dr. Richard Horton (editor-in-chief of The Lancet), “Offline: What is medicine’s 5 sigma?” The Lancet, 11 April 2015, Vol 385, No. 9976, p. 1380, at https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)60696-1/fulltext. A special thanks to Jon Rappoport at https://jonrappoport.wordpress.com/2018/03/08/shocking-victory-for-proponents-of-alternative-medicine/.

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