After failing to challenge the scientific validity of a damning paper on Herbalife’s products, the multi-billion dollar MLM company resorted to legal threats to get it unpublished.

The research paper in question documented the finding of heavy metals in Herbalife products sold in India.

Medical researchers published the study following the death of a patient and Herbalife products consumer, who died of acute liver failure.

Three Professors based out of Brazil contacted Elsevier, the original paper’s publisher, to demand they ‘retract the paper because of a lack of evidence’.

Initially, Elsevier did the right thing and asked the authors of the paper to address Herbalife’s concerns.

They did so and Elsevier published both Herbalife’s concerns and the author’s rebuttal.

As per the letter received by Elsevier, the authors are Flávio A. D. Zambrone, Cristiana L. Corrêa and Lígia M. S. Amaral – all of whom work at Planitox.

As per one of the author’s of the original paper, Planitox is a company funded by Herbalife.

Additionally;

Dr. Zambrone reports grants from Herbalife Nutrition Brazil, outside the submitted work.

The authors work at Planitox that is a Consulting Company in Toxicology and had already provided advisory services in human health area for Herbalife Brazil.

In the Planitox letter, sent on Herbalife’s behalf, the professors claim

the content of the research is shallow, failing to meet minimal scientific quality criteria.

The letter casts doubt on the results found in the original paper, without providing any conclusive errors in either the used methodology or findings.

And indeed this was a point of contention in the original paper’s author’s reply;

We were eager to go through their letter based on the title which stated a ‘necessary critical review’ of our published study, but were despondent to realize the scantiness of constructive criticism and presence of unsubstantiated ‘looming doubts’ from the authors which we will gladly address.

Addressing concerns raised by Zambrone and his colleagues, the author’s wrote;

Zambrone and colleagues stated that our study failed to meet minimal scientific quality criteria, when in fact, the study was designed as per CARE Case Reporting Guidelines which they might be unaware.

In our published study, we have presented complete details of HLN product use, discussed regarding concomitant drug use and very meticulously excluded all other causes for acute liver failure, including a liver biopsy that did not suggest evidence for alcoholic liver disease, contrary to what Zambrone and colleagues have mentioned in their letter.

The authors wrongly state that the patient consumed HLN products as per manufacturer recommendation. Dose and frequency of consumption were followed as per a ‘nutrition club coach’ (who are essentially untrained non-medical associates/sellers of HLN) guidance.

Zambrone et al also wrongly mention the recommended dose of Afresh Energy Drink.

The label recommendation for the drink is ‘1g in 180 ml hot or cold water’ [Supplementary Figure 1A]. It does not mention the frequency or safe limits for consumption as mentioned by Zambrone et al.

The author’s discussion in this regard is purely fictional. Furthermore, different HLN associates/sellers recommend doses that conflict with the manufacturer recommendation, as per their discretion –an important aspect our study report sheds light on – unscientific practices mixed with a commercial interest as a public health concern.

Our analysis of the HLN products was based on high quality, cutting edge and state-of-the-art methodology which we have already discussed in the published report which leaves no room for doubt regarding our conclusions based on the same.

We invite the authors to go through our published report with more attentiveness and be percipient to finer detail since the title of their letter does not justify its content.

The letter by Zambrone et al is far from critical and more of a feeble ‘knee-jerk reaction’ without scientific acumen, to already known, satisfyingly substantiated and reliable reporting on HLN associated liver toxicity.

Ultimately, the true essence of our report was to bring to attention, the unmet need for herbal and dietary supplements to undergo strict testing in clinical trials as for prescription drugs, in the future, in a better world, to improve on public and user health.

This wasn’t the response Herbalife was looking for, and so they hired lawyers in India who threatened the original paper’s authors with legal action.

As retold by one of the original paper’s authors;

I receive(d a) legal notice from (a) lawyers firm based in Delhi advising me to provide proof of evidence regarding my study, or face heavy legal action (and a) defamation suit.

The authors sent a reply to the law firm, advising them they stood by their research and were prepared to defend it in court.

Again not receiving the response they were looking for, Herbalife directed the law firm to go after Elsevier.

They (the law firm Herbalife hired) did not respond back. But then they did something terrible.

They started harassing the journal (and) its editorial board. (They) served multiple legal notices to them behind our back.

This was the last straw. The journal(‘s) editor in chief was threatened and the publisher panicked.

Elsevier conducted a re-review of the original paper “as per COPE guidelines”. The re-review came back “clean (with) no errors”.

In light of the re-review, Elsevier’s review committee ‘advised them to retain the published study’.

Still Herbalife’s hired law firm persisted with legal threats.

So without my consent, without co-author’s consent, the journal and the publisher decided to remove the article from all online sources to “satisfy” the big company and “reduce” legal tension.

Money won and science failed.

Elsevier is a COPE member. COPE is an organization that provides guidance and best practices on publication ethics.

As per COPE guidelines, when a retraction is made “the original paper should (still) remain available”.

In violation of COPE guidelines, Elsevier removed access to the paper.

My take?

If the paper is flawed then by all means challenge it and have it retracted. Resorting to throwing money at lawyers to get genuine research unpublished is appalling conduct from Herbalife.

Herbalife’s products containing harmful amounts of heavy metals is not something that should be swept under the carpet.

I echo Science Integrity Digests’ hope that the authors of the original paper ‘find a publishing house with more courage that will republish their paper.’