DID SA, UK SCIENTISTS COMMIT FRAUD TO SILENCE NOAKES?

By Marika Sboros

Did South African scientists really commit scientific fraud to silence Prof Tim Noakes? The case against them is building.

The US peer-reviewed journal PLoS ONE is now investigating the Naudé Review, which it published in July 2014. The Health Professions Council of SA used it as key evidence to charge Noakes with unprofessional conduct.

The HPCSA found Noakes not guilty on all points of the charge on April 21, 2017. Thereafter, Noakes’s instructing attorney, Adam Pike, of Pike Law, wrote to PLoS ONE. Senior editor Dr Renee Hoch replied to say that the journal is “conducting a full reassessment” of the review.

All the universities involved have refused to investigate or “reassess” their academics’ role in it. UCT Faculty of Health Sciences deputy dean of research Prof Karen Sliwa said that only one out of the six researchers is from UCT. Four are from Stellenbosch University, one from the Liverpool School of Tropical Medicine. Thus, it would “seem preferable” for Noakes to complain to Stellenbosch.

Noakes says that’s like the Anglican Church saying it won’t investigate paedophilia claims against its priests because the Catholic Church has more claims against its priests.

Dr Celeste Naudé

The Naudé Review is a meta-analysis that named after lead author and Stellenbosch nutrition academic Dr Celeste Naudé. The authors concluded that low-carb diets are “no more effective for producing weight loss than are high-carbohydrate, or so-called isoenergetic, ‘balanced’ diets”.

They also concluded that there is “probably little or no difference in weight loss and changes in cardiovascular risk factors up to two years of follow-up”.

Naudé’s co-authors included Prof Jimmy Volmink, Stellenbosch Dean of Faculty of Health Sciences and UCT nutrition associate professor Marjanne Senekal. The sole UK researcher is Liverpool School of Tropical Medicine professor Paul Garner.

Senekal is a co-author of the “UCT academics letter“, which a Cape Town newspaper published in August 2014. Co-authors include Prof Wim de Villiers, now Stellenbosch vice chancellor and UCT’s current Medical School dean, Prof Bongani Mayosi. They use accuse Noakes of being a bad scientist and a danger to public health.

Senekal was also a consultant to the HPCSA against Noakes. All the Naudé reviewers have received funding from food and/or soft-drink industries for their research. US investigative journalist Russ Greene also showed links between Senekal and others opposed to Noakes with the Coca-Cola front, International Life Sciences Institute.

Click here to read: Noakes vs ILSI ‘queenpins’ trying to nail him

 

Yet in their declaration of competing interests, the Naudé researchers paint a very different COI portrait.They say: “No authors currently receive or have received funds from commercial organisations that could directly or indirectly benefit from the question addressed by this research or its findings”.

Dr ‎Zoë Harcombe and advocate Ravin ‘Rocky’ Ramdass

That’s debatable – at best.

Noakes is a UCT emeritus professor. He realised the pivotal role of the Naudé Review in the case against him during the November 2015 hearing session. He, therefore, asked British obesity and public health researcher Dr Zoë Harcombe to investigate.

Harcombe found it riddled with errors, 14 of them major, enough to make the review fatally flawed. She subsequently became an expert witness for Noakes at the October 2016 hearing session.

She and Noakes published their findings in the SAMJ in December 2016. They asked whether UCT and Stellenbosch scientists had made mistake or mischief?

The authors’ first response was a media statement. They claimed that evidence at the October 2016 hearing session had addressed all the errors. They also claimed that Harcombe had “conceded more than seven times” that the errors were not material to their findings.

Both statements are false, as hearing transcripts show. Senekal was present throughout the hearing. She would – or should – have conveyed that to her co-authors.

Dr Marjanne Senekal, Dr Ali Dhansay at HPCSA trial

They then responded in a letter to the SAMJ in December 2016. Again, they claimed to have addressed all errors but did not do so. Instead, and remarkably, they pointed Noakes and Harcombe to new errors.

They also claimed that Noakes and Harcombe lacked “understanding of current methods in evidence synthesis”.

In a terse rebuttal letter to the SAMJ in April 2017, Noakes and Harcombe described that as “cheap”.

“We understand the Naudé et al protocol only too well,” they said. “Indeed, we appear to understand it rather better than do its authors.”

Instead of addressing the numerous errors in detail, point by point, the Naudé Review authors admitted to only one error. That was the inclusion of a duplicate study. That alone is grounds for retraction of the article, Noakes and Harcombe said.

The researchers also appeared to confess to using data from ITT ( intention-to-treat) analyses instead of completers for some studies. They also only reported analysing the data that way once Noakes and Harcombe forced them to respond to the errors.

As Noakes explained it to me: When researchers set up a trial, they may follow the subjects during the trial and then report what they find. For example, they may start with 100 patients, of which 80 comply with the trial and do everything they’re expected to do. Thereafter, the researchers report the data for those 80. Or, if they do an ITT, they don’t bother to check if everyone complied. They just report the outcomes.

Click here to read: ADSA desperately seeking to nail Noakes? 

 

In analysing the data as ITT in some trials only, the Naudé researchers again favoured the low-fat group.

Harcombe told me that ITT might be more ethical and beneficial in drug trials. It captures the important issue of non-compliance in ways that completers don’t, she said.

Noakes has speculated whether the Naudé Review is dodgy enough to constitute scientific fraud. He and Harcombe suggest that were it not for the Naudé Review the HPCSA hearing might not have happened.

In the SAMJ, they referred to the “disproportionate prominence” the HPCSA gave to the review. They quote verbatim from the testimony of HPCSA’s witnesses, starting with dietitian Claire Julsing-Strydom.

Dietitian Claire Strydom

Strydom referred to the importance of a meta-analysis generally and/or the Naudé meta-analysis specifically on 12 separate occasions during her testimony. Also under oath on November 24, 2015, she said of the Naudé Review: “So before any media statements could be made we had to get that information and all these associations were waiting on that…It is not like everybody joined together to now make a statement against Prof  Noakes.

“We were all waiting for the evidence to be published.”

Another prosecution witness, North-West University Prof Hester “Este” Vorster, referred to the review five times and quoted from it verbatim once. A third prosecution witness, MRC staffer, Prof Ali Dhansay, referenced it twice. He also used the term “Cochrane” when referencing. That would have afforded the review “the appropriate esteem”, Noakes and Harcombe said.

Not surprisingly, the review has raised serious questions about motivation. The Heart and Stroke Foundation of SA commissioned the research. Yet there already was a robust Brazilian meta-analysis on the same topic. That review came to the exact opposite conclusion from the Naudé reviewers. 

That raised the question why the HSFSA wanted Naudé to duplicate robust research. And, of course, the HSFSA actively promotes low-fat, high-carb diets and opposes Noakes and LCHF.

The SA Medical Research Council was a funder of the Naudé review. Dhansay is an MRC staffer. In his evidence, he made clear his vehement opposition to Noakes and LCHF. Greene reported that the MRC is investigating Dhansay’s ILSI links.

The responses of UCT and Stellenbosch Universities to concerns over the Naudé review are interesting.

UCT Prof Marc Blockman

Noakes wrote to UCT pharmacology professor Marc Blockman to request an investigation. Blockman is chair of the Faculty of Health Sciences Human Research and Ethics Committee. He said that in the Committee’s opinion, “potential issues” related to the Naudé review were not “issues of non-compliance”.

Investigating complaints of research misconduct also fell “outside the HREC’s mandate”. Blockman, therefore, passed the buck to Sliwa.

However, UCT’s own rules in cases of claims of scientific misconduct require Sliwa to form an interim committee to consider what action the university should take. Thus, in declining to investigate, Sliwa appears to be in conflict with UCT guidelines.

She would also presumably have had to involve Mayosi in the case of such serious allegations against a UCT academic. Sliwa and Mayosi did not reply to questions via email. Nor have UCT’s vice-chancellor Dr Max Price and the university’s management at the highest levels.

Prof Bongani Mayosi

On the UCT Academics’ letter and involvement of UCT’s marketing and communications chief, Linda Rhoda, registrar Royston Pillay remained equivocal. “UCT does not intend responding to all your queries or allegations in your e-mail,” Pillay said. “Failure to do so should not be construed as an admission of the allegations contained therein.”

An appeal to UCT’s head of council Sipho Pityana elicited similar closing of the ranks. He dismissed it all as “robust and rigorous scholarly engagement” that Council “is not equipped to pronounce on”. UCT chancellor Graca Machel also ignored all questions.

Garner and Liverpool School of Tropical Medicine researcher Prof Paul Garner were likewise reticent. Through its media department, the LSTM  said that it fully supports scientific rigour and the peer review process”  in all of its research.

The LSTM also oddly claimed that PLoS ONE was considering “minor corrections” only to the Naudé Review. It refused to clarify why it believed that, despite the PLoS ONE announcement.

In author Daryl Ilbury’s book on Noakes, The Quiet Maverick, Naude claimed “surprise” at the HPCSA’s prominent use of her review. After all, it was on adult, not infant, nutrition, she said.

Noakes, his legal team and all his expert witnesses were just as surprised. After all, the HPCSA insisted throughout that its case was on infant, not adult, nutrition. Yet Strydom and all the HPCSA’s nutrition “experts” gave length testimony on adult nutrition.

The HPCSA’s expensive, external advocate Dr Ajay Bhoopchand tried to exclude Noakes’s evidence in his own defence on the grounds of irrelevance. Bhoopchand even suggested at one stage that Noakes was “burdening” the hearing with evidence on adult, not infant, nutrition.

The chair of the HPCSA’s Professional Conduct Committee, Pretoria advocate Joan Adams, dismissed that objection. She allowed both sides to give or refer to evidence on adult nutrition.

In early May 2017, the HPCSA announced that it will appeal the not guilty verdict for Noakes. Sixty days later it has yet to give its grounds. The Naudé Review may well prove one of its many scientific Achilles heels in its ongoing quest to find Noakes guilty.