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

Imagine a drug for animals that has no purpose other than to bulk up that animal with muscle so that when it is slaughtered, the rancher (or more likely the ranch industry) can make a few extra dollars off each animal. The drug has no health benefits, but instead has health detriments, not only for the poor animals but for the poor humans who then unknowingly consume its residue-tainted meat. Add one more toxic residue to the synthetic stew that comprises the typical human diet.

Meet ZilpaterolLike its evil twin ractopamine, zilpaterol hydrochloride (tradename Zilmax®) is a beta-adrenergic agonist (bAA) drug given to cattle and other food animals to take nutrients away from fat production and push them instead into muscle, creating a leaner and ostensibly more valuable animal. Zilmax is about 125 times more potent than ractopamine.[i]  Although not a steroid, the drug does have steroid-like effects on animals and humans. These effects can be devastating.

The drug company Merck, which holds U.S. Patent No. 8,580,772 for Zilmax, had widely marketed and sold the drug for years, after its approval by the U.S. Food and Drug Administration. In fact, its annual sales in North America were $159 million in 2012,[ii] before Merck responsibly suspended sales of Zilmax in 2013 due to health concerns about cattle hooves falling off and even worse.

The “even worse” part of zilpaterol’s “adverse unintended consequences” is that “the cumulative risk and incidence rate of death was 75 to 90% greater in animals administered the bAA compared to contemporaneous controls.”[iii] In humans, elevated heart rates, arrhythmias, myocardial infarctions, and deaths have resulted from bAA drugs.[iv] Another study, published in 2018, confirmed that zilpaterol hydrochloride administration to cattle predisposes them to cardiac disease.[v] Despite attestations to the contrary, then, zilpaterol given to cattle can be harmful both to the animals and to humans consuming their meat.

So, why, then, does Merck irresponsibly and dishonestly pursue establishing a Codex Alimentarius standard for residues in meat?  The simple answer: An approved Codex standard would be Merck’s golden ticket to worldwide sales. And the cash machine could recommence chi-chinging.

Merck’s Minions, “Drugs for Animals”Think of the Orcs in the film Lord of The Rings, dress them up in suits and ties and sometimes skirts, and you might get a good feel for the dark servants of Merck. As part of its master plan, Merck long ago spawned an industry front group euphemistically called “Health for Animals.” For a good laugh, just imagine if J.R.R. Tolkien had named his hideous creatures the “Brothers of Peace” instead of Orcs. It would be that silly.

This front group has strongly lobbied for regulatory approval of these and other dangerous animal drugs.[vi]  To be sure, Health for Animals, to my knowledge, has never met a vet drug it didn’t like and shuns natural alternatives to drugs, which is why — if honest labels were required of Codex INGOs — the front group’s real name should be “Drugs for Animals.”

Front groups with impressive names are created by drug companies to endorse drug solutions to health problems that will coincidentally also benefit those companies’ bottom lines. I myself see the same type of front groups aplenty populating Codex Alimentarius meetings around the World. Their names — such as Health for Animals for Merck and Crop Life for Monsanto — provide just enough veneer to disguise to the non-discerning viewers their true purpose.

At the last meeting of the Codex Committee of Residues of Veterinary Drugs in Food (CCRVDF), held in Chicago, IL from April 23-27, 2018, at least 14 Merck and other industry representatives were there operating under the umbrella of Drugs for Animals or as members of country delegations. It would not be a stretch or hyperbole to describe industry front groups such as this one as the dark subconscious of Codex.

Codex BattlegroundOne of the major and most hotly contested issues addressed by the CCRVDF at its April Chicago meeting was zilpaterol, which had begun wending its way up the 8-step approval process to final adoption by the Codex Alimentarius Commission. At this meeting it was at Step 4 and it was widely expected by its sponsors to be advanced by the Committee to Step 5 or even Step 5/8, the latter of which would mean almost certain quick adoption by the Commission at its next meeting in Rome this past July.

Arrayed against a zilpaterol standard were the European Union (EU), Norway, Switzerland, Russia, Bosnia, Mozambique, Indonesia, Egypt, Kazakhstan, and the National Health Federation (NHF), the only consumer organization in attendance at this meeting.  China would have added its voice to oppose zilpaterol but the United States government — which strongly supports a zilpaterol standard — for some reason refused to grant the Chinese delegates visas to attend the meeting.[vii]

Chairing the meeting was Dr. Kevin Greenlees, senior advisor for science and science policy, and employed by the Center for Veterinary Medicine of the U.S. Food and Drug Administration, which was particularly fortunate because Dr. Greenlees followed in the gracious tradition of the previous CCRVDF Chairman Dr. Steven Vaughn and was equally fair-minded and impartial in running this meeting. From beginning to end, and even in the face of taxing and tedious disputes among the Codex delegates, Dr. Greenlees never once lost his professionalism nor treated anyone, including NHF, unfairly.

Wanting to advance the zilpaterol standard were the usual suspects: the United States, Mexico, and the rest of the entire Western Hemisphere plus those countries who had possibly been cajoled into joining forces with the U.S., such as Ghana, Nigeria, Kenya, South Africa, Japan, Zimbabwe, and Togo.[viii] All of them stated that they were relying upon the “science” provided by JECFA on zilpaterol (clearly without doing their own due diligence).[ix] The ostensible leaders of the push for zilpaterol were, of course, those two countries who have never met an unhealthy Codex standard they did not love: Australia and New Zealand, also known as the regional branch offices for Monsanto and Merck.

At the start of the morning of the second day of the Codex meeting, the Chairman opened the discussion on zilpaterol with the JECFA secretariat reaffirming that the proposed MRLs for zilpaterol were safe and the zilpaterol standard could move forward. The European Union (EU) delegate, Risto Holma, acquiesced on the safety issue but strongly and articulately opposed having the MRL advance for EU policy reasons. Bosnia, Switzerland, and Russia quickly supported the EU, while New Zealand argued that the EU’s concerns were outside the parameters of Codex. Evidently, New Zealand supports torturing animals for minor profit while poisoning its own people with toxic drug residues to add to the long laundry list of other toxins and contaminants we are all exposed to on a daily basis. Many delegations spoke out both for and against zilpaterol.  The Italian delegate was especially vocal and animated against zilpaterol. Finally, after all of the country delegates had their chance to speak, the Chairman called upon NHF to speak.

The NHF in the Chicago Codex meetingI told the Committee that growth promoters do not belong in animal husbandry and that zilpaterol’s endocrine-disruptive effect on the reproductive capabilities of animals must be considered here; that zilpaterol’s use in horses was already banned, so why are we trying to use it in cattle?; that no risk assessment of this compound had been done in connection with other vet drugs given to food animals so there is no information on the cumulative and synergistic effects on humans or animals from the drug residues of zilpaterol and other drugs acting together; that contrary to others, NHF does believe that animal health is pertinent to consideration at Codex because of its direct and indirect effects upon humans not even to mention our duty to be humane to animals; that consumers must be made aware of what they are consuming and virtually none have any idea that when they are eating meat, they are eating vet-drug residues such as zilpaterol, along with hefty doses of antibiotics, thereby denying consumers the right to know and choose; and that zilpaterol is really no different than ractopamine, which as everyone at Codex must remember, engendered a tremendous and bitter fight for years in this Committee and then again at the Commission level, and that this issue could do the same.

Drugs for Animals spoke next with a prepared speech that argued zilpaterol had no impact on animal welfare, that it was the most studied vet drug before the Committee, and that 65 studies have concluded zilpaterol is safe and effective. Of course, from studies mentioned in this article, we already know that zilpaterol does indeed have a negative impact on animal welfare and the so-called 65 (industry?) studies proving zilpaterol safe are instead suspect.

The Chairman was in a tough position, with the room almost evenly divided. Sensing the obvious — that there was no consensus — the Chairman quite reasonably stated that all work on zilpaterol be stopped. That set off an angry explosion amidst the pro-zilpaterol crowd, which began pushing the idea that there was a “consensus on the science” and therefore zilpaterol could move forward.

The debate then become focused on what constituted “consensus” or agreement amongst the delegates.  When I again got the chance to speak for NHF, I strongly argued that “Contrary to what others have said, we do not have consensus. Consensus is defined as the absence of sustained opposition. There is sustained opposition to the standard. And that is what counts here. The Committee does not exist to just rubber-stamp JECFA or any other scientific decisions. Otherwise, why do we exist? We might as well adjourn and have a clerk with a rubberstamp in a back room take care of our business. There is no consensus.”

The Chairman then announced,“There is no consensus even though we have followed the rules. I find it disappointing that we cannot do here what we have done with the gentian-violet standard. We are closing debate on this at this time.”

Then began the objections, a whole litany of them as delegation after delegation cried out in protest. South Africa complained “it was scary to come all this way to hear science being defeated,” while Drugs for Animals spoke about the Committee’s “failure” while leveling a thinly veiled threat against Codex: “This will have a chilling effect on sponsors in future work.” In other words, no more drugs for you drug-happy regulators! We could only wish that it were so.

Before going to lunch, the Greek and a few other delegates had come over to thank NHF for its strong comments about zilpaterol.  While they were doing that, I noticed the Drugs for Animals executive director was up at the head table showing something on his smartphone to the JECFA secretariat. I thought nothing much of it at the time. After all, we had won.

Coming back from lunch, as the meeting started, I stepped out into the hall to make a telephone call. When I came back into the room and took my seat, I saw and heard that the delegates were giving thunderous applause to the JECFA secretariat. It was then that I learned that he had just publicly attacked NHF for having called JECFA science “junk science” on social media.

Later, when I spoke with Tom Heilandt, the Codex Secretariat, he told me the same Drugs for Animals person had just come up to him and shown him a photo on his phone taken of Tom and me somewhere together as if there were presumed collusion or something wrong in having a photo of the Secretariat taken with a Codex INGO delegate. This clear attempt at intimidation of the Codex Secretariat by the Drugs for Animals executive director shows just how angry, vengeful, and desperate these people can be. WF

(Part 2 will appear in the October issue of WholeFoods Magazine.)

Endnotes[i] Dr. Joseph Mercola, “Zilmax: Slaughterhouse Observations Raise New Concerns about This Growth-Promoting Drug,” Mercola.com, Nov 5, 2013, at https://articles.mercola.com/sites/articles/archive/2013/11/05/zilmax-side-effects.aspx. [ii] Merck Press Release, “Merck Animal Health Strengthens Commitment to Five Steps to Responsible Beef, Merck.com, Aug 16, 2013, at http://www.mrknewsroom.com/press-release/animal-health/merck-animal-health-strengthens-commitment-five-steps-responsible-beef. [iii] Loneragan GH, Thomson DU, Scott HM, “Increased Mortality in Groups of Cattle Administered the b-Adrenergic Agonists Ractopamine Hydrochloride and Zilpaterol Hydrochloride,” PLOS One, Vol. 9, Issue 3, March 2014, e91177, at http://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0091177&type=printable. [iv] Ibid. [v] Neary JM, Garry FB, Gould DH, et al., “The beta-adrenergic agonist zilpaterol hydrochloride may predispose feedlot cattle to cardiac remodeling and dysfunction,” F1000Research, March 2018, 7:399 (doi: 10.12688/f1000research.14313.1), at https://f1000research.com/articles/7-399. [vi] Health for Animals website, accessed May 19, 2018, at https://healthforanimals.org/aboutus/about-us.html. [vii] Per NHF private source of information. [viii] Report of the 24th Session of the CCRVDF, Chicago, Illinois, April 2018, Paras. 53-54, at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252FCX-730-24%252FFINAL%252520REPORT%252FREP18_RVDFe.pdf. [ix] 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.https://wholefoodsmagazine.com/wp-content/uploads/2016/02/LegalTips-39.jpg

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.

Published in WholeFoods Magazine August 2018