It seems that every few months we read about another breakthrough cancer cure. We see a picture of a group of solemn people in lab coats and statements about how their new medicine has delivered astonishing results "in a laboratory setting" that will take a year or so to become available to human cancer patients. So why are there so few of these miracle drugs actually in use? To everyone's surprise, it seems that much of the research can't be reproduced. How does this happen?
Cancer continues to be a deadly scourge. Many millions of dollars are invested every year, researching new ways to battle this deadly disease. Hundreds of research results are published each year, reporting on laboratory results using mice, rats or monkeys, that could be extended into human research trials. But when these results (called "pre-clinical research") are used as the basis for human research, the outcomes are rarely encouraging.
Developing a cancer treatment is expensive, both in terms of time and money. As a result, the drug companies depend on these lab results to select the most promising innovations for costly clinical trials. When the drug companies looked at why their success rates were so low, they took a fresh look at the pre-clinical research that was used as the basis for their drug development.
In a commentary published in the March 2012 edition of the magazine Nature, Glenn Begley and Lee Ellis report that when Amgen selected 53 "landmark" pre-clinical studies, they were only able to reproduce the results of 6. That meant that 89% of these ground-breaking research projects did not deliver the promised results when the research was performed a second time. Bayer HealthCare conducted a similar double-check and found that only 25% of the research they checked could be reproduced.
There is no allegation of improper conduct. No one is accused of lying or falsifying their results. However, this inability to reproduce the foundational research certainly explains why triumphant announcements from the lab rat researchers rarely translate into drugs administered in the cancer wards. Equally troubling is the certainty that cancer patients across the country are participating in clinical trials based on research that does not stand up to re-examination. They cannot expect to be cured.
So what can be done? Clearly, the bar is set too low for pre-clinical research results. The rush to publication must be tempered by not only peer review but independent validation of results. Anything less is a terrible waste of millions of dollars and false hope for thousands of desperate cancer patients participating in clinical trials.