Bowing to legal pressure from the supplement maker Herbalife, Elsevier earlier this year retracted — and then removed — a paper which claimed that a young woman in India died of liver failure after using the company’s products. The move has led to more legal threats.
In August 2018, a group of researchers in India published a report in the Journal of Clinical and Experimental Hepatology about the death, involving a 24-year-old woman who had taken a variety of supplements produced by Herbalife, a massive, and massively controversial, maker of nonprescription diet aids.
The group, led by Cyriac Abby Philips, of Cochin Gastroenterology, in Kerala, India, asserted that tests of Herbalife products similar to those the woman had been taking revealed the presence of heavy metals, bacteria and, in most samples, “undisclosed toxic compounds including traces of psychotropic recreational agent.”
The case report — titled “Slimming to the death: Herbalife®-associated fatal acute liver failure-heavy metals, toxic compounds, bacterial contaminants and psychotropic agents in products sold in India” — is far from the first time scientists have linked Herbalife products to liver damage. They’ve done so here, here and here, to cite just a few instances.
Philips tweeted about the story yesterday, and those tweets formed the basis of a post by Elisabeth Bik. In response to a request yesterday from Retraction Watch, Philips sent us correspondence — which we have made available in the various links in this post — backing his claims that Herbalife launched a crusade against the paper to have it removed.
First, he alleges that after the article appeared, employees at Herbalife contacted him demanding he provide them evidence for the assertions in the paper:
I replied saying that all proof was present in the peer reviewed published study. Thereafter, Elsevier forwarded me an email from Prof Steven Newmaster of University of Guelph (who is funded by Herbalife), who wrote a long list of issues with respect to the article and asking Elsevier to retract the paper. Elsevier advised me to reply to the letter in a point by point manner.
Philips complied.
Elsevier then received a second letter from a group linked to Planitox, a Brazilian consulting firm with ties to Herbalife, critical of the case report.
The editor in chief suggested that I write a point by point rebuttal. I did that and both the letter and the reply were published by the Journal.
The authors of the Planitox letter have since withdrawn their submission.
Philips said he then received a letter from a local law firm, again demanding that his group turn over evidence to support their paper, a demand they repeated a month later. A law firm Philips had hired responded, but:
little did I know that [Herbalife’s representatives] were sending multiple legal letters to the Journal editor in chief, editorial assistants, the society and its president etc.. behind our backs. … The editor in chief called me and said they are going to re-review the paper as per COPE guidelines to look for scientific integrity. I agreed. He asked me to furnish original patient data including the liver biopsy report with unmasking of patient detail. I did that too and the re review started and I was not notified of any integrity issues, no fraudulent data, no plagiarism, nothing. It was clean paper. If it was not, I would have been notified.
Notification of a sort did follow. Philips says he received an email from Sameer Gupta, an Elsevier official in charge of the region, stating that the journal would be retracting the paper for “legal reasons.” That’s what a retraction notice said in January.
That’s not what the notice now says, however. Instead, it reads:
This article, which was published in the March-April 2019 issue of the Journal of Clinical and Experimental Hepatology (“JCEH”), has been removed at the request of the JCEH’s Editor-in-Chief and the Indian National Association for the Study of the Liver (INASL).
INASL and JCEH no longer support the content of and conclusions drawn in the article because the scientific methodology, analysis and interpretation of data underlying the article were insufficient for the conclusions drawn, and, with its removal, the article can no longer be relied upon.
In a statement to Retraction Watch, Herbalife said:
The claims made in Dr. Philips’ et al original article were false and unsubstantiated. According to Elsevier’s Policy on Article Withdrawal, ‘in an extremely limited number of cases, … an article [may be removed] from the online database where the article is clearly defamatory, or infringes others’ legal rights, or where the article is, or we have good reason to expect it will be, the subject of a court order, or where the article, if acted upon, might pose a serious health risk.’ The original article contained numerous deficiencies, inappropriate analytical methodologies and incomplete investigative protocols. We presented to the publisher a comprehensive analysis of product testing by three independent international laboratories that undermined the findings of the article. Based on those deficiencies the publisher, Elsevier, took the extraordinary step of removing the article at the request of the Journal of Clinical and Experimental Hepatology (“JCEH”) and the Indian National Association for the Study of the Liver (INASL), stating they “no longer support the content of and conclusions drawn in the article because the scientific methodology, analysis and interpretation of data underlying the article were insufficient for the conclusions drawn.”
In June, Philips and his colleagues issued their own legal threats against both Elsevier and the journal, claiming that the retraction was “highly defamatory” and “against the principles of professional ethics and natural justice” and demanded either that the paper be restored within a week or that they receive 100 million Rupees ($1.35 million) in compensation.
Elsevier responded with a letter — which Philips calls “half baked” — stating that it was reviewing the claims. Neither the journal nor the INASL replied. However, he said, the PubMed listing for the paper now includes a statement alluding to the legal pressures:
For legal reasons, the publisher has withdrawn this article from public view. For additional information, please contact the publisher.
Philips says he and his colleagues have not pushed a suit, yet:
I have sent a detailed email to COPE for arbitration since COPE guidelines were fully broken in this particular case – since the INASL President, who is not an editorial member steered the EIC [editor in chief] into making a decision without the full approval (no documents or correspondence sent from Editorial board or EIC to us) of the board. If COPE cannot clear the path for restoring our study, then we might take the legal way.
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This cannot and should not stand! Recently, there has been lots of debate about more ambiguous retraction cases than this one, and the ensuing clamor has been substantial. I hope that the outcry about this retraction will be deafening by comparison. This appears to be a clear-cut case of a company suppressing inconvenient evidence by legal threats to a publisher. Dr. Philips has my full sympathy and support.
Hear hear. It’s one thing to pull papers down on Twitter and in open letters where the pressure is social and editors can resist by merely doing nothing. It’s quite another to use legal threats, marshalling the coercive power of the state to suppress academic inquiry and free speech.
I’m no lawyer but I believe in the US there is legislation designed to prevent these things – Strategic Lawsuits Against Public Participation.
The hegemony of Western companies….what can I say…..I wish Ackman would have taken this company down. Instead of releasing their product samples and have them tested by independent labs, the company decides to use legal channels. If the product is safe, release the safety data. The author is a low paid professor/physician in a developing country and the company knows that these kind of threats would make people cave in. Dr. Philips, start a GoFundMe page to fight the hegemony of this company that is too cowardly to release its safety data verified by independent labs.
This is very unfair.
Oh it will stand just fine. Combining a healthy budget for public relations, legal threats, and selective science to manufacture doubt is a time tested product defense strategy. The book ‘Doubt is their Product’ by David Michaels is a good read, author interview at https://www.fastcompany.com/1139299/manufacturing-doubt-product-defense
The same strategies were used by big tobacco, years ago.
The difference is, now we’ll only get to see studies that show that smoking is good for you.
Shame, Elsevier, shame on you for betraying science.
I would have also sued Herbalife as well, for 1.35 BILLIONS as a minimum. That company is a scam, must go bankrupt and cease to exist.
And we all know what kind of company Herbalife is when they threaten a researcher with lawsuits instead of presenting research of their own to show their products are both safe and effective. And it’s not good. But I guess that’s what happens when you’re selling patent snake oil labeled as “supplements”. You don’t have to prove a thing. The money is all that matters. No matter the harm you do.
I do hope the Federal Trade Commission is not deprived of their share of the responsibility. Herbalife is a pyramid scheme. I distinctly recall an investigation by the FTC that clearly showed that it was a pyramid scheme. 93% of their distributors made less than $10 a year from selling to people outside of the company. Instead distributors sold wholesale to distributors they recruited under them, an obvious pyramid scheme.
Also obvious is the scheme of the FTC, who for years took taxpayer’s money to carry out a lengthy (though fruitful) investigation. Only to then use the abundant evidence just to squeeze hundreds of thousands of dollars from Herbaldeath and send them back to prey upon the world.
When the FTC Chairwoman Edith Ramirez was questioned about what the evidence clearly indicated, she curiously stated quote, “they were not determined not to be a pyramid scheme”. Seeming not to realise that that had been the case before they started investigating.
So now here they are, not being determined not to be causing liver failure. The only difference between them and Monsanto is that Monsanto’s poison has a practical use. They should try spraying their product on weeds.
In a further development, the company also leaned on ResearchGate to remove Dr Philip’s personal copy of the paper.
https://twitter.com/drabbyphilips/status/1355107884879630340
Thereafter, Elsevier forwarded me an email from Prof Steven Newmaster of University of Guelph (who is funded by Herbalife), who wrote a long list of issues with respect to the article and asking Elsevier to retract the paper. Elsevier advised me to reply to the letter in a point by point manner.
Knowing what we know now, has Elsevier considered retracting the retraction?
https://www.science.org/content/article/this-scientist-accused-supplement-industry-of-fraud-now-his-own-work-is-under-fire