Yet another study casts doubts, this time, on ‘landmark’ cancer drug clinical trials

The recent study from researchers C. Glenn Begley and Lee Ellis is the third study in as many years to question the validity of some drug clinical trials. These researchers found that a mere 11 percent of 53 papers on cancer published in reputable, peer-reviewed journals was solid, while the other 89 percent could not be reproduced, implying that it may be false or at the very least misleading.

“The scientific community assumes that the claims in a preclinical study can be taken at face value – that although there might be some errors in detail, the main message of the paper can be relied on and the data will, for the most part, stand the test of time,” wrote the authors about their findings. “Unfortunately, this is not always the case.”

Worse, the 53 published papers on cancer were all considered to be ‘Landmark’ studies yet Begley and Ellis discovered that only six of them could be reproduced and confirmed in a clinical setting.

“[I]t looks like the scientific literature is contaminated with a growing number of tainted studies, which may reach 89 percent, the results of which are not reproducible by any means,” writes Eleni Roumeliotou for about the shocking findings. “This means that to an extent, we have based our healthcare and clinical guidelines on fake studies that reported untruthful results in order to accommodate the interests of industrial corporations.”

In a second study, this time by University of Michigan Dr. Reshma Jagsi, M.D,at least 17 per cent of research studies had serious conflicts of interest – they were not independent but following Pharmaceutical Company funding, research results were influenced in a pre-determined direction.

“Given the frequency we observed for conflicts of interest and the fact that conflicts were associated with study outcomes, I would suggest that merely disclosing conflicts is probably not enough,” said Dr Jagsi. “It’s becoming increasingly clear that we need to look more at how we can disentangle cancer research from industry ties.”

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Beating cancer with chemotherapy and better drugs

The mythology of cancer sees many claims. One of which is that we are beating cancer due to earlier diagnosis and better drugs. Let us consider the available research on chemotherapy – for almost every cancer patient treated with drugs is still, inevitably, given at least one round of good old chemotherapy.

Available research evidence does indeed point to chemotherapy having a positive effect for some cancer patients.

Let’s start here:

(1) The Department of Oncology at North Sydney Cancer Centre in 2004 published a report evaluating chemotherapy over the years and concluded that ‘it only made a minor contribution to survival’. The figures they came up with were 2.3% in Australia and 2.1% in America. In Britain there are 320,000 people diagnosed with cancer a year. About 60 per cent have chemo (although some of these people do not actually have cancer and were misdiagnosed by mammograms etc). Being generous and assuming no misdiagnoses, that would mean that chemotherapy had an effect on about 3,600 people. I cannot tell you from the research whether ‘effect’ means they were cured or whether they reached 5-year survival, or what. Sorry, I didn’t find the research very clear on that point.

(2) Somewhat alarmingly, last year we had the report from the Fred Hutchinson Cancer Center in Seattle that concluded ‘Chemotherapy can cause cancer to return’. Note that they did not say, ‘we know cancer can return after chemo’, which is how Cancer Research responded to this study. They said CAUSE – apparently chemotherapy can cause healthy cells to produce a protein WNT16B and this is taken up by cancer cells – it helps them re-grow and even protects them from the next round of chemotherapy.

You may feel that all this misses an important point and that drugs have moved on – chemo is past it; old hat: Drugs like Tamoxifen, Aromatase Inhibitors and Herceptin are not really chemotherapy agents, and you’d be right. In 2012 a couple of reports shed some light on the current state of play.

(3) Firstly, one study (lead by Professor Carlos Caldas – reported in Nature) had Cancer Research all excited. A ‘landmark study’ from their Cambridge Institute showed there were 10 different ‘clusters’ of breast cancer types. ‘No longer does one size fit all’ they cried at CRUK. (It would be churlish of me to mention that CANCERactive have been saying that for ten years, but what the heck). In the future CRUK are suggesting they can more accurately develop treatments for each cluster. The problem at the moment is that there are only treatments for two of the clusters, the Tamoxifen/AIs one and the ‘HER-2 targeted therapy using Herceptin’ cluster. So here’s a real improvement: 2 out of 10 is better that 2.3 per cent.

(4) Unfortunately, the excitement was crushed somewhat when three research studies reported on the existence of Cancer Stem Cells at the heart of tumours. A couple of UK cancer centres (Bart’s Hospital and the Blizzard Institute, London) have even isolated these nasty little cells. Apparently, if you don’t kill them off, they can re-grow.

In one of the three studies (from the University of Texas South Western Medical Centre), there were statements such as ‘Cancer Stem cells are in charge of tumours’, and the lead researcher, Dr Louis Parada and the other researchers added, ‘In the past we have tried to get rid of the entire stew of cancer cells. But shrinking a tumour by 50% is irrelevant. No current drugs tackle cancer stem cells – but at least we now know what to go after’.

(5) We are by no means ‘against chemotherapy’ at Junk Science UK, we just think the mythology and the hype needs to be calmed down. Perhaps the final words should therefore go to Duke’s University Medical Centre in Carolina who in their 2012 report concluded that ‘Patients with cancer are largely being mislead into believing that the drug they are being offered is somehow going to cure them’.

Oh dear.

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