Clinical Research: Who Can You Trust?

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In an ideal world, clinical research would be objective, independent and reliable. It used to be but, sadly, these days it isn’t always like that.

Fame and fortune can await researchers who report breakthroughs or shed light on hotly-debated subjects. Some can succumb to temptation. I cite a few examples.

By the way, I’m definitely not saying you can’t trust any clinical research; far from it. At Muscles & Marbles, we depend entirely upon clinical (and health) research that we can trust. The examples I cite below are extreme; they’re to show the worst side of medical manipulation or fraud. There is a very good side too.

COVID-19 and Hydroxychloroquine

In May 2020, the New England Journal of Medicine and The Lancet published two papers whose authors claimed that the malaria drug hydroxychloroquine wasn’t just ineffective against COVID-19, it was deadly.

The papers were based on research from a little-known US company called Surgisphere, which said it had collected data from hundreds of hospitals around the world. The papers also claimed that the anti-parasitic drug Ivermectin reduced the death toll among COVID-19 patients.

clinical-research-trust-trump
Great fan of hydroxychloroquine for COVID

Within days, large randomized trials of hydroxychloroquine were stopped. ‘Solidarity’, the World Health Organisation’s trial of potential COVID-19 treatments, paused recruitment into its hydroxychloroquine arm.

These moves were doubtless influenced by the words of then-US-president, Donald Trump, who was spruiking the virtues of the drug (along with bleach) to eradicate the virus. Using an old-school malaria drug like hydroxychloroquine for a new-age virus was controversial – even demented some may say – at the time, so it’s hardly surprising that so many studies ground to a halt.

Yet, other researchers wrote to the same journals, with a different argument; they said the data on which the papers were based were not credible. They were right: when the journals investigated, they found that much of the original data had been fabricated. ‘How could these fraudulent studies have passed the peer-review process of two of the most influential and prestigious medical research journals?’ asked The Scientist.

How could these fraudulent studies have passed the peer-review process of two of the most influential and prestigious medical research journals?

The Scientist

Good question. Surgisphere had no track record in this field, and even a cursory scan would have revealed that its CEO Sapan Desai had a checkered career in medicine and faced several lawsuits for malpractice.

By the way, I’m not saying that hydroxychloroquine was the magic bullet for COVID; its efficacy is still being hotly debated, these days. My point is about veracity of sources and lack of scrutiny by peer reviewers and journal editors. As you’ll see in our free eBook, The Secrets Behind 9 Medical Myths, peer review is no longer about meticulous, methodical scrutiny.

Another example of research that was peer-reviewed yet fraudulent, follows. This one had far more widespread consequences.

‘Medicine or Mass Murder’?

In an earlier example, back in 2009, the European Society of Cardiology (ESC) introduced a best-practice guideline, which was based on research by Don Poldermans from the respected Erasmus Medical Centre in Rotterdam. The guideline, which affected heart disease patients all over Europe, stated that Beta-blockers should be given to patients to protect their hearts during high-risk surgery.

clinical-research-trust-ersasmus
Erasmus Medical Centre, Rotterdam

Two year later, British cardiologists Graham Cole and Darrel Francis were unable to reproduce Poldermans’ results and started digging around. They found that Poldermans’ research had been entirely fabricated; instead of saving lives during high risk surgery, the perio-operative use of beta-blockers increased the risk of death by 27%.

Cole and Francis estimated that this practice cost some 800,000 lives across Europe over a period of 5 years. The tragedy here is that more than half of those deaths occurred after Cole and Francis first advised the ESC of their finding. The ESC best practice guideline wasn’t changed until 2014, three years after their advice and five years after the practice began.

This finding is so large that the only context in the last 50 years comes from the largest scale professional failures in the political sphere.’

Drs Graham Cole and Darrel Francis

‘Medicine or Mass Murder’ was the title of the article on the Poldermans scandal by by Larry Huston from Cardiobrief.

Be Gentle with this Heart of Mine

Moving to stem cell research, Piero Anversa was a giant in the field, working with his team in a lab at the Harvard-affiliated Brigham Hospital in Boston. Anversa had discovered cells in the heart (c-kit stem cells) that suggested the organ had the ability to regenerate, and published over 30 papers with his findings.

Other stem cell researchers were unable to replicate Anversa’s experiments, and Harvard launched an investigation in 2015. It found that Anversa had falsified and/or fabricated data in virtually all his research papers.

Such an earthquake has rarely, if ever, shattered a research field. There was a lot of hope, and to see all this was really terrible… I think it’s very important to restart the field because it has such a bad reputation.’

Thomas Lüscher, Editor-in-Chief, European Heart Journal.

Broken Bones

On the subject of bones, Yoshihiro Sato’s fraud was one of the biggest in scientific history.  He was a bone researcher at an obscure hospital in southern Japan and claimed his methods could reduce hip fractures in older patients by 70 – 80%. This was without precedent.

It turns out that he had fabricated data for dozens of clinical trials that were published in international journals. Yet, for years, no one questioned his research; in fact, its significance was amplified: meta-analyses (analyses of many trials) that included his trials reached the wrong conclusions, other researchers carried out trials based on the truth of Sato’s research and professional societies based medical guidelines on it.

It took nutrition researcher Allison Avenell and colleagues from the University of Auckland over a decade to expose Sato’s lies. One tragedy was that Sato took his life in 2016 after his fraud was exposed; the other was that medical journals refused to publish the whistleblowers’ findings or withdraw Sato’s papers, which continued to inspire unsuspecting practitioners all through this period.

JAMA and JAMA Internal Medicine would not publish the whistleblowers’ paper, even though both had published Sato’s fraudulent studies. The Journal of Bone and Mineral Research promised to investigate Sato’s papers, but also refused to publish the whistleblowers’ paper. The editors of Trials said they didn’t want to get involved.

Journals don’t really like going back to investigate when things go wrong. They complain that it’s time-consuming and laborious and difficult.’

Andrew Grey, University of Auckland

Sadly, these examples show a theme that can recur: clinical trial results can be published in respected journals without being checked. It’s only if adverse effects are seen in non-clinical trial populations that any red flags might be raised. Even then, other researchers have to scour the original data looking for anomalies or errors, or attempt to reproduce the original results. It’s only if they do all this and then fail to reach the same conclusions as the author, that red flags arise.

In both cases, these actions take precious time, during which the original research recommendations are still in print and being followed. A s a result, real people can be being exposed to harm, sometimes death.

While, 350 years ago when it began, peer review did check research data for accuracy before publication, that is no longer the case.

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References

Drug Trials Hide Conflicts for Doctors – New York Times
Medicine or Mass Murder? Larry Huston, Cardiobrief
Stem Cell Research Shattered after Fabrication Scandal, Cardiovascular Research Foundation
Tide of Lies, Science
List of scientific misconduct incidents, Wikipedia

Kim Brebach

Kim Brebach

Hi, I’m Kim Brebach, boomer, information researcher, technical writer and Joiner of Dots at M&M. In my spare time, I review wines and love to cook.

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